ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Advocate spot-on solution for Small Cats and Ferrets
Advocate spot-on solution for Large Cats
2.
Active substances:
Advocate for cats contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin.
Each unit dose (pipette) delivers:
Unit Dose Imidacloprid Moxidectin
Advocate for Small Cats ( 4 kg) and Ferrets
0.4 ml
40 mg
4 mg
Advocate for Large Cats (> 4–8 kg)
0.8 ml
80 mg
8 mg
Excipients:
Benzyl alcohol
Butylhydroxytoluene 1 mg/ml (E 321; as antioxidant)
.
For a full list of excipients, see section 6.1.
3.
Spot-on solution.
Clear yellow to brownish solution.
4.
Cats, ferrets
For cats
suffering from, or at risk from, mixed parasitic infections:
For the treatment and prevention of flea infestation (
Ctenocephalides felis
), treatment of ear mite
infestation (
Otodectes cynotis
), prevention of heartworm disease (L3 and L4 larvae of
Dirofilaria
immitis
) and treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and
adults of
Toxocara cati
and
Ancylostoma tubaeforme
).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
For ferrets
suffering from, or at risk from, mixed parasitic infections:
For the treatment and prevention of flea infestation (
Ctenocephalides felis
) and the prevention of
heartworm disease (L3 and L4 larvae of
Dirofilaria immitis
).
Do not use in kittens under 9 weeks of age.
Do not use in the case of hypersensitivity to the active substances or to any of the excipients.
2
For ferrets: Do not use Advocate for Large Cats (0.8 ml) or Advocate for Dogs (any size).
For dogs, the corresponding “Advocate for Dog” product, which contains 100 mg/ml imidacloprid and
25 mg/ml moxidectin, must be used.
Please refer to section 4.5.
The product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of
effect might be shorter in these animals.
Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely
to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the
animal in water after treatment may reduce the efficacy of the product.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated
use of an anthelmintic of that class.
The treatment of cats weighing less than 1 kg and ferrets weighing less than 0.8 kg should be based on
a risk-benefit assessment.
There is limited experience on the use of the product in sick and debilitated animals, thus the product
should only be used based on a risk-benefit assessment for these animals.
Care should be taken that the contents of the pipette or the applied dose does not come into contact
with the eyes or mouth of the recipient and/or other animals. Do not allow recently treated animals to
groom each other. Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds
should be prevented.
It is recommended that cats and ferrets living in, or travelling to areas endemic for heartworm are
treated monthly with the product to protect them from heartworm disease.
Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be
made to check the heartworm status of any cat and ferret aged over 6 months, before beginning
prophylactic treatment, as use of the product on cats or ferrets which have adult heartworms may
cause serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection
should be treated in accordance with current scientific knowledge.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Avoid contact with skin, eyes or mouth.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.
After application do not stroke or groom animals until the application site is dry.
In case of accidental spillage onto skin, wash off immediately with soap and water.
People with a known hypersensitivity to either benzyl alcohol, imidacloprid or moxidectin should
administer the product with caution. In very rare cases the product may cause skin sensitisation or
transient skin reactions (for example allergy, irritation or tingling).
If the product accidentally gets into eyes, they should be thoroughly flushed with water.
If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and
show the package insert to the physician.
3
The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and
finished surfaces. Allow the application site to dry before permitting contact with such materials.
Use of the product may result in transient pruritus in cats. On rare occasions greasy fur, erythema and
vomiting can occur. These signs disappear without further treatment. The product may, in rare cases,
cause local hypersensitivity reactions. If the animal licks the application site after treatment, transient
neurological signs may be observed infrequently (see section 4.10).
The product tastes bitter. Salivation may occasionally occur if the animal licks the application site
immediately after treatment. This is not a sign of intoxication and disappears within some minutes
without treatment. Correct application will minimise licking of the application site.
The product may in very rare cases cause at the application site a sensation resulting in transient
behavioural changes such as lethargy, agitation, and inappetence.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any
evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit
assessment by the responsible veterinarian.
During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered.
No interactions between Advocate and routinely used veterinary medicinal products or medical or
surgical procedures have been observed.
Dosage schedule for cats:
The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 1.0 mg/kg bodyweight
moxidectin, equivalent to 0.1 ml/kg bodyweight Advocate for Cats.
The treatment schedule should be based on the local epidemiological situation.
Weight of cat
[kg]
Pipette size to be used Volume
[ml]
Imidacloprid
[mg/kg bw]
Moxidectin
[mg/kg bw]
4 kg
Advocate for Small Cats
0.4
minimum of
10
minimum of
1
> 4–8 kg
Advocate for Large Cats
0.8
10–20
1–2
> 8 kg
the appropriate combination of pipettes
Flea treatment and prevention
One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may
emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions.
Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed
at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the
household flea population. The product should be administered at monthly intervals when used as part
of a treatment strategy for flea allergy dermatitis.
4
Treatment of ear mite infestation (Otodectes cynotis)
A single dose of the product should be administered. A further veterinary examination 30 days after
treatment is recommended as some animals may require a second treatment. Do not apply directly to
the ear canal.
Heartworm prevention
Cats in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected
with adult heartworms. Therefore
prior
to treatment with Advocate, the advice provided in section 4.5
should be considered.
For prevention of heartworm disease, the product must be applied at regular monthly intervals during
the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm
larvae) are present. The product may be administered throughout the year or at least 1 month before
the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until
1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that
the same day or date be used each month. When replacing another heartworm preventative product in
a heartworm prevention programme, the first treatment with Advocate must be given within 1 month
of the last dose of the former medication.
In non-endemic areas there should be no risk of cats having heartworm. Therefore they can be treated
without special precautions.
Roundworm and hookworm treatment
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection
caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the
product can be used as part of a seasonal prevention programme against fleas and gastrointestinal
nematodes.
Dosage schedule for ferrets:
One pipette of Advocate spot-on solution for Small Cats (0.4 ml) should be administered per animal.
Do not exceed the recommended dose.
The treatment schedule should be based on the local epidemiological situation.
Flea treatment and prevention
One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be
necessary to repeat administration after 2 weeks.
Heartworm prevention
Ferrets in areas endemic for heartworm, or those which have travelled to endemic areas, may be
infected with adult heartworms. Therefore
prior
to treatment with Advocate, the advice provided in
section 4.5 should be considered.
For prevention of heartworm disease, the product must be applied at regular monthly intervals during
the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm
larvae) are present. The product may be administered throughout the year or at least 1 month before
the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until
1 month after the last exposure to mosquitoes.
In non-endemic areas there should be no risk of ferrets having heartworm. Therefore they can be
treated without special precautions.
5
Method of administration
For external use only.
Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull
off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown.
Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the
pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the
skin. Application at the base of the skull will minimise the opportunity for the animal to lick the
product. Apply only to undamaged skin.
Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or
undesirable clinical signs.
The product was administered to kittens at up to 5 times the recommended dose, every 2 weeks for 6
treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and
transient rapid respiration were observed.
After accidental oral ingestion, transient neurological signs such as ataxia, generalised tremors, ocular
signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting
may occur infrequently.
6
The product was administered to ferrets at 5 times the recommended dose, every 2 weeks for 4
treatments, and there was no evidence of adverse effects or undesirable clinical signs.
In case of accidental oral uptake, symptomatic treatment should be administered. There is no known
specific antidote. The use of activated charcoal may be beneficial.
Not applicable.
5.
Pharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code: QP54AB52.
5.1 Pharmacodynamic properties
Imidacloprid
, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an
ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more
accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea
stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated
with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the
post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of
cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the
interaction with mammalian nicotinergic receptors and the postulated poor penetration through the
blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has
minimal pharmacological activity in mammals.
Moxidectin
, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the
milbemycin family. It is a parasiticide which is active against many internal and external parasites.
Moxidectin is active against larval stages (L3, L4) of
Dirofilaria immitis.
It is also active against
gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels.
This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions
and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites,
followed by their death and/or expulsion.
5.2 Pharmacokinetic particulars
After topical administration of the product, imidacloprid is rapidly distributed over the animal’s skin
within one day of application. It can be found on the body surface throughout the treatment interval.
Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1
to 2 days after treatment in cats. Following absorption from the skin, moxidectin is distributed
systemically and is slowly eliminated from the plasma as manifested by detectable moxidectin
concentrations in plasma throughout the treatment interval of one month.
Environmental properties
See section 6.6.
6.
6.1 List of excipients
Benzyl alcohol
Butylhydroxytoluene
7
Propylene carbonate
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
6.4 Special precautions for storage
Do not store above 30 C.
6.5 Nature and composition of immediate packaging
Pack sizes
Blister pack containing 1, 2, 3, 4, 6, 9, 12, 21 or 42 unit dose pipettes.
Container material
White polypropylene unit dose pipette with screw cap.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused product or waste materials derived from such veterinary medicinal products should be
disposed of in accordance with local requirements.
Advocate should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
7.
Bayer Animal Health GmbH
D-51368 Leverkusen
Germany
8.
EU/2/03/039/001-004, EU/2/03/039/013-014, EU/2/03/039/019-022, EU/2/03/039/031-038
9.
04/2003
12/11/2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
/.
8
0.4 ml and 0.8 ml per pipette.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
9
1.
Advocate spot-on solution for Small Dogs
Advocate spot-on solution for Medium Dogs
Advocate spot-on solution for Large Dogs
Advocate spot-on solution for Extra-Large Dogs
2.
Active substances:
Advocate for Dogs contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin.
Each unit dose (pipette) delivers:
Unit Dose Imidacloprid Moxidectin
Advocate for Small Dogs ( 4 kg)
0.4 ml
40 mg
10 mg
Advocate for Medium Dogs (> 4–10 kg)
1.0 ml
100 mg
25 mg
Advocate for Large Dogs (> 10–25 kg)
2.5 ml
250 mg
62.5 mg
Advocate for Extra-Large Dogs (> 25–40 kg)
4.0 ml
400 mg
100 mg
Excipients:
Benzyl alcohol
Butylhydroxytoluene 1 mg/ml (E 321; as antioxidant)
For a full list of excipients, see section 6.1.
3.
Spot-on solution.
Clear yellow to brownish solution.
4.
Dogs
For dogs suffering from, or at risk from, mixed parasitic infections:
For the treatment and prevention of flea infestation (
Ctenocephalides felis
), treatment of biting lice
(
Trichodectes canis
), treatment of ear mite infestation (
Otodectes cynotis
), sarcoptic mange (caused by
Sarcoptes scabiei
var.
canis
), demodicosis (caused by
Demodex canis
), prevention of heartworm
disease (L3 and L4 larvae of
Dirofilaria immitis
) and angiostrongylosis (L4 larvae and immature
adults of
Angiostrongylus vasorum
), treatment of
Angiostrongylus vasorum
and
Crenosoma vulpis
and
treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of
Toxocara canis, Ancylostoma caninum
and
Uncinaria stenocephala
, adults of
Toxascaris leonina
and
Trichuris vulpis
).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
10
Do not use in puppies under 7 weeks of age.
Do not use in the case of hypersensitivity to the active substances or to any of the excipients.
For cats, the corresponding “Advocate for Cat” product, which contains 100 mg/ml imidacloprid and
10 mg/ml moxidectin, must be used.
For ferrets: Do not use Advocate for Dogs. Only “Advocate for Small Cats and Ferrets” (0.4 ml) must
be used.
Please refer to section 4.5.
Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely
to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the
animal in water after treatment may reduce the efficacy of the product.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated
use of an anthelmintic of that class.
The treatment of
animals weighing less than 1 kg should be based on a risk-benefit assessment.
There is limited experience on the use of the product in sick and debilitated animals, thus the product
should only be used based on a risk-benefit assessment for these animals.
Care should be taken that the contents of the pipette or the applied dose does not come into contact
with the eyes or mouth of the recipient and/or other animals. Do not allow recently treated animals to
groom each other. When the product is applied in 3 to 4 separate spots (see section 4.9), specific care
should be taken to prevent the animal licking the application sites.
This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with
Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product
as described under section 4.9; in particular, oral uptake by the recipient and/or other animals in close
contact should be prevented.
Advocate should not be allowed to enter surface waters as it has harmful effects on aquatic organisms:
moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters
for 4 days after treatment.
Although the product may be safely administered to dogs infected with adult heartworms, it has no
therapeutic effect against adult
Dirofilaria immitis
. It is therefore recommended that all dogs 6 months
of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm
infection before being treated with the product.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Avoid contact with skin, eyes or mouth.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.
11
After application do not stroke or groom animals until the application site is dry.
In case of accidental spillage onto skin, wash off immediately with soap and water.
People with a known hypersensitivity to either benzyl alcohol, imidacloprid or moxidectin should
administer the product with caution. In very rare cases the product may cause skin sensitisation or
transient skin reactions (for example allergy, irritation or tingling).
If the product accidentally gets into eyes, they should be thoroughly flushed with water.
If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention
and
show the package insert to the physician.
The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and
finished surfaces. Allow the application site to dry before permitting contact with such materials.
Use of the product may result in transient pruritus in dogs. On rare occasions greasy hair, erythema
and vomiting can occur. These signs disappear without further treatment. The product may, in rare
cases, cause local hypersensitivity reactions. If the animal licks the application site after treatment,
transient neurological signs may be observed infrequently (see section 4.10).
The product tastes bitter. Salivation may occasionally occur if the animal licks the application site
immediately after treatment. This is not a sign of intoxication and disappears within some minutes
without treatment. Correct application will minimise licking of the application sites.
The product may in very rare cases cause at the application site a sensation resulting in transient
behavioural changes such as lethargy, agitation, and inappetence.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any
evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit
assessment by the responsible veterinarian.
During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered.
No interactions between Advocate and routinely used veterinary medicinal products or medical or
surgical procedures have been observed.
Dosage schedule:
The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 2.5 mg/kg bodyweight
moxidectin, equivalent to 0.1 ml/kg bodyweight Advocate for Dogs.
The treatment schedule should be based on the local epidemiological situation.
12
Weight of dog
[kg]
Pipette size to be used
Volume
[ml]
Imidacloprid
[mg/kg bw]
Moxidectin
[mg/kg bw]
4 kg
Advocate for Small Dogs
0.4
minimum of
10
minimum of
2.5
> 4–10 kg
Advocate for Medium Dogs
1.0
10–25
2.5–6.25
> 10–25 kg Advocate for Large Dogs
2.5
10–25
2.5–6.25
> 25–40 kg Advocate for Extra-Large Dogs
4.0
10–16
2.5–4
> 40 kg
the appropriate combination of pipettes
Flea treatment and prevention
One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may
emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions.
Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed
at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the
household flea population. The product should be administered at monthly intervals when used as part
of a treatment strategy for flea allergy dermatitis.
Treatment of biting lice (Trichodectes canis)
A single dose should be administered. A further veterinary examination 30 days after treatment is
recommended as some animals may require a second treatment.
Treatment of ear mite infestation (Otodectes cynotis)
A single dose of the product should be administered. Loose debris should be gently removed from the
external ear canal at each treatment. A further veterinary examination 30 days after treatment is
recommended as some animals may require a second treatment. Do not apply directly to the ear canal.
Treatment of sarcoptic mange (caused by Sarcoptes scabiei
var.
canis)
A single dose should be administered twice 4 weeks apart.
Treatment of demodicosis (caused by Demodex canis)
The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against
Demodex
canis
and leads to a marked improvement of clinical signs particularly in mild to moderate cases.
Especially severe cases may require more prolonged and more frequent treatment. To achieve the best
possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied
once a week and for a prolonged time. In all cases it is essential that the treatment should be continued
until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be
stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment.
Alternative treatment should be administered. Seek the advice of your veterinarian.
As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying
disease appropriately.
Heartworm prevention
Dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected
with adult heartworms. Therefore
prior
to treatment with Advocate, the advice provided in section 4.5
should be considered.
13
For prevention of heartworm disease, the product must be applied at regular monthly intervals during
the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm
larvae) are present. The product may be administered throughout the year or at least 1 month before
the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until
1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that
the same day or date be used each month. When replacing another heartworm preventative product in
a heartworm prevention programme, the first treatment with Advocate must be given within 1 month
of the last dose of the former medication.
In non-endemic areas there should be no risk of dogs having heartworm. Therefore they can be treated
without special precautions.
Treatment and prevention of Angiostrongylus vasorum
A single dose should be administered. A further veterinary examination 30 days after treatment is
recommended as some animals may require a second treatment.
In endemic areas regular 4 weekly application will prevent angiostrongylosis and patent infection with
Angiostrongylus vasorum
.
Treatment of Crenosoma vulpis
A single dose should be administered.
Roundworm, hookworm and whipworm treatment
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection
caused by the respective round-, hook- and whipworms. In areas non-endemic for heartworm, the
product can be used as part of a seasonal prevention programme against fleas and gastrointestinal
nematodes.
Studies have shown that monthly treatment of dogs will prevent infections caused by
Uncinaria
stenocephala.
Method of administration
For external use only.
Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull
off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown.
14
For dogs up to 25 kg:
With the dog in a standing position, part the coat between the shoulder blades until the skin is visible.
Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the
pipette firmly several times to empty its contents directly onto the skin.
For dogs of more than 25 kg:
For easy application the dog should be standing. The entire contents of the pipette should be applied
evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At
each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the
tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly
onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some
of the product to run down the animal’s side.
Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects
or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals
for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse
effects or undesirable clinical signs.
The product was administered to puppies at up to 5 times the recommended dose, every 2 weeks for 6
treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and
transient rapid respiration were observed.
After accidental oral ingestion, transient neurological signs such as ataxia, generalised tremors, ocular
signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting
may occur infrequently.
Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly
intervals without any adverse effects, but the safety of application at weekly intervals has not been
investigated in ivermectin-sensitive Collie dogs. When 40 % of the unit dose was given orally, severe
neurological signs were observed. Oral administration of 10 % of the recommended dose produced no
adverse effects.
Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for
3 treatments, without any adverse effects.
In case of accidental oral uptake, symptomatic treatment should be administered. There is no known
specific antidote. The use of activated charcoal may be beneficial.
15
Not applicable.
5.
Pharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code: QP54AB52.
5.1 Pharmacodynamic properties
Imidacloprid
, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an
ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more
accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea
stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated
with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the
post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of
cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the
interaction with mammalian nicotinergic receptors and the postulated poor penetration through the
blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has
minimal pharmacological activity in mammals.
Moxidectin
, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the
milbemycin family. It is a parasiticide which is active against many internal and external parasites.
Moxidectin is active against larval stages (L3, L4) of
Dirofilaria immitis.
It is also active against
gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels.
This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions
and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites,
followed by their death and/or expulsion.
5.2 Pharmacokinetic particulars
After topical administration of the product, imidacloprid is rapidly distributed over the animal’s skin
within one day of application. It can be found on the body surface throughout the treatment interval.
Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 4
to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed
systemically and is slowly eliminated from the plasma as manifested by detectable moxidectin
concentrations in plasma throughout the treatment interval of one month.
Environmental properties
See sections 4.5. and 6.6.
6.
6.1 List of excipients
Benzyl alcohol
Butylhydroxytoluene
Propylene carbonate
6.2 Incompatibilities
None known.
16
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
6.4 Special precautions for storage
Do not store above 30 C.
6.5 Nature and composition of immediate packaging
Pack sizes
Blister pack containing 1, 2, 3, 4, 6, 9, 12, 21 or 42 unit dose pipettes.
Container material
White polypropylene unit dose pipette with screw cap.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused product or waste materials derived from such veterinary medicinal products should be
disposed of in accordance with local requirements.
Advocate should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
7.
Bayer Animal Health GmbH
D-51368 Leverkusen
Germany
8.
EU/2/03/039/005-012, EU/2/03/039/015-018, EU/2/03/039/023-030, EU/2/03/039/039-054
9.
04/2003
12/11/2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
/.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
17
0.4 ml, 1.0 ml, 2.5 ml and 4.0 ml per pipette.
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION REGARDING SUPPLY OR USE
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D.
STATEMENT OF THE MRLs
18
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) responsible for batch release
KVP Pharma + Veterinär Produkte GmbH
Projensdorfer Str. 324,
D-24106 Kiel
Germany
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
Veterinary medicinal product subject to prescription.
The holder of this marketing authorisation must inform the European Commission about the marketing
plans for the medicinal product authorised by this decision.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Not applicable.
19
ANNEX III
LABELLING AND PACKAGE LEAFLET
20
A. LABELLING
21
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Advocate spot-on solution for small cats
Outer carton, pack size of 1, 2, 3, 4, 6, 9, 12, 21 and 42 pipettes.
1.
Advocate spot-on solution for Small Cats and Ferrets
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each 0.4 ml pipette contains:
Active substances: 40 mg imidacloprid, 4 mg moxidectin
Benzyl alcohol
1 mg/ml butylhydroxytoluene (E321: as antioxidant)
3.
Spot-on solution
4.
PACKAGE SIZE
1 pipette
2 pipettes
3 pipettes
4 pipettes
6 pipettes
9 pipettes
12 pipettes
21 pipettes
42 pipettes
5.
For small cats weighing 4 kg or less and ferrets
6.
For cats suffering from, or at risk from, mixed parasitic infections:
For the treatment and prevention of flea infestation (
Ctenocephalides felis
), treatment of ear mite
infestation (
Otodectes cynotis
), prevention of heartworm disease (L3 and L4 larvae of
Dirofilaria
immitis
) and treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and
adults of
Toxocara cati
and
Ancylostoma tubaeforme
).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
For ferrets suffering from, or at risk from, mixed parasitic infections:
For the treatment and prevention of flea infestation (
Ctenocephalides felis
) and prevention of
heartworm disease (L3 and L4 larvae of
Dirofilaria immitis
).
22
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
For external use only.
Read the package leaflet before use.
8.
[Not applicable]
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
Do not use in kittens under 9 weeks of age. Consult your veterinarian before using the product on
pregnant or lactating cats, or on sick or debilitated cats, or on cats under 1 kg and ferrets under 0.8 kg.
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 30 C
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Any unused product or waste materials derived from such veterinary medicinal products should be
disposed of in accordance with local requirements.
Advocate should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Bayer Animal Health GmbH, D-51368 Leverkusen, Germany
23
EU/2/03/039/001
3pipettes
EU/2/03/039/013
4pipettes
EU/2/03/039/019
21pipettes
EU/2/03/039/020
42pipettes
EU/2/03/039/031
1pipette
EU/2/03/039/032
2pipettes
EU/2/03/039/033
9pipettes
EU/2/03/039/034
12pipettes
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
for cats
Flea
Larvae
Hookworm
Roundworm
Heartworm
Otodectes
for ferrets
Flea
Heartworm
24
EU/2/03/039/002
6pipettes
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Advocate spot-on solution for large cats
Outer carton, pack size of 1, 2, 3, 4, 6, 9, 12, 21 and 42 pipettes.
1.
Advocate spot-on solution for Large Cats
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each 0.8 ml pipette contains:
Active substances: 80 mg imidacloprid, 8 mg moxidectin
Benzyl alcohol
1 mg/ml butylhydroxytoluene (E321: as antioxidant)
3.
Spot-on solution
4.
PACKAGE SIZE
1 pipette
2 pipettes
3 pipettes
4 pipettes
6 pipettes
9 pipettes
12 pipettes
21 pipettes
42 pipettes
5.
For large cats weighing between 4 kg and 8 kg.
6.
For cats suffering from, or at risk from, mixed parasitic infections:
For the treatment and prevention of flea infestation (
Ctenocephalides felis
), treatment of ear mite
infestation (
Otodectes cynotis
), prevention of heartworm disease (L3 and L4 larvae of
Dirofilaria
immitis
) and treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and
adults of
Toxocara cati
and
Ancylostoma tubaeforme
).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
25
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
For external use only.
Read the package leaflet before use.
8.
[Not applicable]
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
Do not use in kittens under 9 weeks of age. Consult your veterinarian before using the product on
pregnant or lactating cats, or on sick or debilitated cats, or on cats under 1 kg.
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 30 C.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Any unused product or waste materials derived from such veterinary medicinal products should be
disposed of in accordance with local requirements.
Advocate should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Bayer Animal Health GmbH, D-51368 Leverkusen, Germany
26
EU/2/03/039/003
3pipettes
EU/2/03/039/014
4pipettes
EU/2/03/039/021
21pipettes
EU/2/03/039/022
42pipettes
EU/2/03/039/035
1pipette
EU/2/03/039/036
2pipettes
EU/2/03/039/037
9pipettes
EU/2/03/039/038
12pipettes
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
Flea
Larvae
Hookworm
Roundworm
Heartworm
Otodectes
27
EU/2/03/039/004
6pipettes
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Advocate spot-on solution for small dogs
Outer carton, pack size of 1, 2, 3, 4, 6, 9, 12, 21 and 42 pipettes.
1.
Advocate spot-on solution for Small Dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each 0.4 ml pipette contains:
Active substances: 40 mg imidacloprid, 10 mg moxidectin.
Benzyl alcohol
1 mg/ml butylhydroxytoluene (E321: as antioxidant)
3.
Spot-on solution
4.
PACKAGE SIZE
1 pipette
2 pipettes
3 pipettes
4 pipettes
6 pipettes
9 pipettes
12 pipettes
21 pipettes
42 pipettes
5.
For small dogs weighing 4 kg or less.
6.
For dogs suffering from, or at risk from, mixed parasitic infections:
For the treatment and prevention of flea infestation (
Ctenocephalides felis
), treatment of biting lice
(
Trichodectes canis
), treatment of ear mite infestation (
Otodectes cynotis
), sarcoptic mange (caused by
Sarcoptes scabiei
var.
canis
), demodicosis (caused by
Demodex canis
), prevention of heartworm
disease (L3 and L4 larvae of
Dirofilaria immitis
) and angiostrongylosis (L4 larvae and immature
adults of
Angiostrongylus vasorum
), treatment of
Angiostrongylus vasorum
and
Crenosoma vulpis
and
treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of
Toxocara canis, Ancylostoma caninum
and
Uncinaria stenocephala
, adults of
Toxascaris leonina
and
Trichuris vulpis
).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
28
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
For external use only.
Read the package leaflet before use.
8.
[Not applicable]
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
Do not use in puppies under 7 weeks of age. Consult your veterinarian before using the product on
pregnant or lactating bitches, or on sick or debilitated dogs, or on dogs under 1 kg.
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 30 C.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Any unused product or waste materials derived from such veterinary medicinal products should be
disposed of in accordance with local requirements.
Advocate should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Bayer Animal Health GmbH, D-51368 Leverkusen, Germany
29
EU/2/03/039/005
3pipettes
EU/2/03/039/015
4pipettes
EU/2/03/039/023
21pipettes
EU/2/03/039/024
42pipettes
EU/2/03/039/039
1pipette
EU/2/03/039/040
2pipettes
EU/2/03/039/041
9pipettes
EU/2/03/039/042
12pipettes
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
Flea
Larvae
Whipworm
Hookworm
Roundworm
Angiostrongylus
Crenosoma
Heartworm
Otodectes
Sarcoptes
Demodex
Louse
30
EU/2/03/039/006
6pipettes
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Advocate spot-on solution for medium dogs
Outer carton, pack size of 1, 2, 3, 4, 6, 9, 12, 21 and 42 pipettes.
1.
Advocate spot-on solution for Medium Dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each 1 ml pipette contains:
Active substances: 100 mg imidacloprid, 25 mg moxidectin.
Benzyl alcohol
1 mg/ml butylhydroxytoluene (E321: as antioxidant)
3.
Spot-on solution
4.
PACKAGE SIZE
1 pipette
2 pipettes
3 pipettes
4 pipettes
6 pipettes
9 pipettes
12 pipettes
21 pipettes
42 pipettes
5.
For medium dogs weighing between 4 kg and 10 kg.
6.
For dogs suffering from, or at risk from, mixed parasitic infections:
For the treatment and prevention of flea infestation (
Ctenocephalides felis
), treatment of biting lice
(
Trichodectes canis
), treatment of ear mite infestation (
Otodectes cynotis
), sarcoptic mange (caused by
Sarcoptes scabiei
var.
canis
), demodicosis (caused by
Demodex canis
), prevention of heartworm
disease (L3 and L4 larvae of
Dirofilaria immitis
) and angiostrongylosis (L4 larvae and immature
adults of
Angiostrongylus vasorum
), treatment of
Angiostrongylus vasorum
and
Crenosoma vulpis
and
treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of
Toxocara canis, Ancylostoma caninum
and
Uncinaria stenocephala
, adults of
Toxascaris leonina
and
Trichuris vulpis
).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
31
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
For external use only.
Read the package leaflet before use.
8.
[Not applicable]
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
Do not use in puppies under 7 weeks of age. Consult your veterinarian before using the product on
pregnant or lactating bitches, or on sick or debilitated dogs, or on dogs under 1 kg.
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 30 C.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Any unused product or waste materials derived from such veterinary medicinal products should be
disposed of in accordance with local requirements.
Advocate should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Bayer Animal Health GmbH, D-51368 Leverkusen, Germany
32
EU/2/03/039/007
3pipettes
EU/2/03/039/016
4pipettes
EU/2/03/039/025
21pipettes
EU/2/03/039/026
42pipettes
EU/2/03/039/043
1pipette
EU/2/03/039/044
2pipettes
EU/2/03/039/045
9pipettes
EU/2/03/039/046
12pipettes
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
Flea
Larvae
Whipworm
Hookworm
Roundworm
Angiostrongylus
Crenosoma
Heartworm
Otodectes
Sarcoptes
Demodex
Louse
33
EU/2/03/039/008
6pipettes
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Advocate spot-on solution for large dogs
Outer carton, pack size of 1, 2, 3, 4, 6, 9, 12, 21 and 42 pipettes.
1.
Advocate spot-on solution for Large Dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each 2.5 ml pipette contains:
Active substances: 250 mg imidacloprid, 62.5 mg moxidectin.
Benzyl alcohol
1 mg/ml butylhydroxytoluene (E321: as antioxidant)
3.
Spot-on solution
4.
PACKAGE SIZE
1 pipette
2 pipettes
3 pipettes
4 pipettes
6 pipettes
9 pipettes
12 pipettes
21 pipettes
42 pipettes
5.
For large dogs weighing between 10 kg and 25 kg.
6.
For dogs suffering from, or at risk from, mixed parasitic infections:
For the treatment and prevention of flea infestation (
Ctenocephalides felis
), treatment of biting lice
(
Trichodectes canis
), treatment of ear mite infestation (
Otodectes cynotis
), sarcoptic mange (caused by
Sarcoptes scabiei
var.
canis
), demodicosis (caused by
Demodex canis
), prevention of heartworm
disease (L3 and L4 larvae of
Dirofilaria immitis
) and angiostrongylosis (L4 larvae and immature
adults of
Angiostrongylus vasorum
), treatment of
Angiostrongylus vasorum
and
Crenosoma vulpis
and
treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of
Toxocara canis, Ancylostoma caninum
and
Uncinaria stenocephala
, adults of
Toxascaris leonina
and
Trichuris vulpis
).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
34
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
For external use only.
Read the package leaflet before use.
8.
[Not applicable]
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
Do not use in puppies under 7 weeks of age. Consult your veterinarian before using the product on
pregnant or lactating bitches, or on sick or debilitated dogs, or on dogs under 1 kg.
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 30 C.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Any unused product or waste materials derived from such veterinary medicinal products should be
disposed of in accordance with local requirements.
Advocate should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Bayer Animal Health GmbH, D-51368 Leverkusen, Germany
35
EU/2/03/039/009
3pipettes
EU/2/03/039/017
4pipettes
EU/2/03/039/027
21pipettes
EU/2/03/039/028
42pipettes
EU/2/03/039/047
1pipette
EU/2/03/039/048
2pipettes
EU/2/03/039/049
9pipettes
EU/2/03/039/050
12pipettes
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
Flea
Larvae
Whipworm
Hookworm
Roundworm
Angiostrongylus
Crenosoma
Heartworm
Otodectes
Sarcoptes
Demodex
Louse
36
EU/2/03/039/010
6pipettes
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Advocate spot-on solution for extra-large dogs
Outer carton, pack size of 1, 2, 3, 4, 6, 9, 12, 21 and 42 pipettes.
1.
Advocate spot-on solution for Extra-Large Dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each 4 ml pipette contains:
Active substances: 400 mg imidacloprid, 100 mg moxidectin.
Benzyl alcohol
1 mg/ml butylhydroxytoluene (E321: as antioxidant)
3.
Spot-on solution
4.
PACKAGE SIZE
1 pipette
2 pipettes
3 pipettes
4 pipettes
6 pipettes
9 pipettes
12 pipettes
21 pipettes
42 pipettes
5.
For extra-large dogs weighing between 25 kg and 40 kg.
6.
For dogs suffering from, or at risk from, mixed parasitic infections:
For the treatment and prevention of flea infestation (
Ctenocephalides felis
), treatment of biting lice
(
Trichodectes canis
), treatment of ear mite infestation (
Otodectes cynotis
), sarcoptic mange (caused by
Sarcoptes scabiei
var.
canis
), demodicosis (caused by
Demodex canis
), prevention of heartworm
disease (L3 and L4 larvae of
Dirofilaria immitis
) and angiostrongylosis (L4 larvae and immature
adults of
Angiostrongylus vasorum
), treatment of
Angiostrongylus vasorum
and
Crenosoma vulpis
and
treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of
Toxocara canis, Ancylostoma caninum
and
Uncinaria stenocephala
, adults of
Toxascaris leonina
and
Trichuris vulpis
).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
37
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
For external use only.
Read the package leaflet before use.
8.
[Not applicable]
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
Do not use in puppies under 7 weeks of age. Consult your veterinarian before using the product on
pregnant or lactating bitches, or on sick or debilitated dogs, or on dogs under 1 kg.
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 30 C.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Any unused product or waste materials derived from such veterinary medicinal products should be
disposed of in accordance with local requirements.
Advocate should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Bayer Animal Health GmbH, D-51368 Leverkusen, Germany
38
EU/2/03/039/011
3pipettes
EU/2/03/039/018
4pipettes
EU/2/03/039/029
21pipettes
EU/2/03/039/030
42pipettes
EU/2/03/039/051
1pipette
EU/2/03/039/052
2pipettes
EU/2/03/039/053
9pipettes
EU/2/03/039/054
12pipettes
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
Flea
Larvae
Whipworm
Hookworm
Roundworm
Angiostrongylus
Crenosoma
Heartworm
Otodectes
Sarcoptes
Demodex
Louse
39
EU/2/03/039/012
6pipettes
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Advocate for small cats
Pipette label
1.
Advocate
2.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
0.4 ml
3.
ROUTE(S) OF ADMINISTRATION
4.
BATCH NUMBER
Lot {number}
5.
EXPIRY DATE
EXP {month/year}
40
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Advocate for large cats
Pipette label
1.
Advocate
2.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
0.8 ml
3.
ROUTE(S) OF ADMINISTRATION
4.
BATCH NUMBER
Lot {number}
5.
EXPIRY DATE
EXP {month/year}
41
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Advocate for small dogs
Pipette label
1.
Advocate
2.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
0.4 ml
3.
ROUTE(S) OF ADMINISTRATION
4.
BATCH NUMBER
Lot {number}
5.
EXPIRY DATE
EXP {month/year}
42
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Advocate for medium dogs
Pipette label
1.
Advocate
2.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
1 ml
3.
ROUTE(S) OF ADMINISTRATION
4.
BATCH NUMBER
Lot {number}
5.
EXPIRY DATE
EXP {month/year}
43
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Advocate for large dogs
Pipette label
1.
Advocate
2.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
2.5 ml
3.
ROUTE(S) OF ADMINISTRATION
4.
BATCH NUMBER
Lot {number}
5.
EXPIRY DATE
EXP {month/year}
44
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Advocate for extra-large dogs
Pipette label
1.
Advocate
2.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
4 ml
3.
ROUTE(S) OF ADMINISTRATION
4.
BATCH NUMBER
Lot {number}
5.
EXPIRY DATE
EXP {month/year}
45
MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Advocate spot-on solution for small cats
1.
Advocate for Small Cats and Ferrets
( 4 kg)
2.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
0.4 ml
46
MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Advocate spot-on solution for large cats
1.
Advocate for Large Cats
(> 4–8 kg)
2.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
0.8 ml
47
MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Advocate spot-on solution for small dogs
1.
Advocate for Small Dogs
( 4 kg)
2.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
0.4 ml
48
MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Advocate spot-on solution for medium dogs
1.
Advocate for Medium Dogs
(> 4–10 kg)
2.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
1 ml
49
MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Advocate spot-on solution for large dogs
1.
Advocate for Large Dogs
(> 10–25 kg)
2.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
2.5 ml
50
MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Advocate spot-on solution for extra-large dogs
1.
Advocate for Extra-Large Dogs
(> 25–40 kg)
2.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
4 ml
51
B. PACKAGE LEAFLET
52
PACKAGE LEAFLET
Advocate spot-on solution for Cats and Ferrets
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Bayer Animal Health GmbH
51368 Leverkusen
Germany
Manufacturer for the batch release
:
KVP Pharma + Veterinär Produkte GmbH
Projensdorfer Str. 324, 24106 Kiel
Germany
2.
Advocate spot-on solution for Small Cats and Ferrets
Advocate spot-on solution for Large Cats
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each unit dose pipette delivers:
Unit Dose Imidacloprid Moxidectin
Advocate for Small Cats ( 4 kg) and Ferrets
0.4 ml
40 mg
4 mg
Advocate for Large Cats (> 4–8 kg)
0.8 ml
80 mg
8 mg
Excipients: Benzyl alcohol, 1 mg/ml butylhydroxytoluene (E 321; as antioxidant)
4.
For cats
suffering from, or at risk from, mixed parasitic infections:
For the treatment and prevention of flea infestation (
Ctenocephalides felis
), treatment of ear mite
infestation (
Otodectes cynotis
), prevention of heartworm disease (L3 and L4 larvae of
Dirofilaria
immitis
) and treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and
adults of
Toxocara cati
and
Ancylostoma tubaeforme
).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
For ferrets
suffering from, or at risk from, mixed parasitic infections:
For the treatment and prevention of flea infestation (
Ctenocephalides felis
) and the prevention of
heartworm disease (L3 and L4 larvae of
Dirofilaria immitis
).
5.
Do not use in kittens under 9 weeks of age.
Do not use in the case of hypersensitivity to the active substances or to any of the excipients.
53
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any
evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit
assessment by the responsible veterinarian.
For ferrets: Do not use Advocate for Large Cats (0.8 ml) or Advocate for Dogs (any size).
For dogs, the corresponding “Advocate for Dog” product, which contains 100 mg/ml imidacloprid and
25 mg/ml moxidectin, must be used.
6.
Use of the product may result in transient pruritus in cats. On rare occasions greasy fur, erythema and
vomiting can occur. These signs disappear without further treatment. The product may, in rare cases,
cause local hypersensitivity reactions. If the animal licks the application site after treatment, transient
neurological signs such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary
reflex, nystagmus), abnormal respiration, salivation and vomiting may occur infrequently.
The product tastes bitter. Salivation may occasionally occur if the animal licks the application site
immediately after treatment. This is not a sign of intoxication and disappears within some minutes
without treatment. Correct application will minimise licking of the application site
.
The product may in very rare cases cause at the application site a sensation resulting in transient
behavioural changes such as lethargy, agitation, and inappetence.
In case of accidental oral uptake, symptomatic treatment should be performed by a veterinary surgeon.
There is no known specific antidote. The use of activated charcoal may be beneficial.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Cats, ferrets
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
For external use only.
To prevent licking, apply topically to the skin restricting the area of application to the animal’s neck at
the base of the skull.
Dosage schedule for cats
The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 1.0 mg/kg bodyweight
moxidectin, equivalent to 0.1 ml/kg bodyweight Advocate for Cats.
The treatment schedule should be based on the local epidemiological situation.
54
Weight of cat
[kg]
Pipette size to be used Volume
[ml]
Imidacloprid
[mg/kg bw]
Moxidectin
[mg/kg bw]
4 kg
Advocate for Small Cats
0.4
minimum of 10 minimum of 1
> 4–8 kg
Advocate for Large Cats
0.8
10–20
1–2
> 8 kg
appropriate combination of pipettes
Flea treatment and prevention
One treatment prevents further flea infestation for 4 weeks. Pre-existing pupae in the environment may
continue to emerge for 6 weeks or longer after treatment is initiated depending upon climatic
conditions. Therefore, it may be necessary to combine Advocate treatment with treatments aimed at
breaking the flea life cycle in the surroundings. This can result in more rapid reductions in the
household flea population. The product should be administered at monthly intervals when used as part
of a treatment strategy for flea allergy dermatitis.
Treatment of ear mite infestation (Otodectes cynotis)
A single dose of the product should be administered. A further veterinary examination 30 days after
treatment is recommended as some animals may require a second treatment. Do not apply directly to
the ear canal.
Heartworm prevention
Cats in endemic areas, or those which have travelled to endemic areas, may be infected with adult
heartworms. Therefore
prior
to treatment with Advocate, the advice provided in the section
“SPECIAL WARNING(S)” should be considered.
For prevention of heartworm disease, the product must be applied at regular monthly intervals during
the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm
larvae) are present. The product may be administered throughout the year or at least 1 month before
the first expected exposure to mosquitoes. The treatment should continue at regular monthly intervals
until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is
recommended that the same day or date be used each month. When replacing another heartworm
preventative product in a heartworm prevention programme, the first treatment with Advocate must be
given within 1 month of the last dose of the former medication.
In non-endemic areas there should be no risk of cats having heartworm. Therefore they can be treated
without special considerations.
Roundworm and hookworm treatment
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection
caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the
product can be used as part of a seasonal prevention programme against fleas and gastrointestinal
nematodes.
Dosage schedule for ferrets:
One pipette of Advocate spot-on solution for Small Cats (0.4 ml) should be administered per animal.
Do not exceed the recommended dose.
The treatment schedule should be based on the local epidemiological situation.
Flea treatment and prevention
One treatment prevents future flea infestation for 3 weeks. Under heavy flea pressure it may be
necessary to repeat administration after 2 weeks.
55
Heartworm prevention
Ferrets in areas endemic for heartworm, or those which have travelled to endemic areas, may be
infected with adult heartworms. Therefore
prior
to treatment with Advocate, the advice provided in the
section “SPECIAL WARNING(S)” should be considered.
For prevention of heartworm disease, the product must be applied at regular monthly intervals during
the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm
larvae) are present. The product may be administered throughout the year or at least 1 month before
the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until
1 month after the last exposure to mosquitoes.
In non-endemic areas there should be no risk of ferrets having heartworm. Therefore they can be
treated without special precautions.
9.
ADVICE ON CORRECT ADMINISTRATION
Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull
off cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown.
Part the fur on the animal's neck at the base of the skull until the skin is visible. Place the tip of the
pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the
skin. Application at the base of the skull will minimise the opportunity for the animal to lick the
product. Apply only to undamaged skin.
56
10. WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not store above 30 C.
Do not use after the expiry date stated on the label and carton.
12. SPECIAL WARNING(S)
Care should be taken that the contents of the pipette do not come into contact with the eyes or mouth
of the recipient and/or other animals. Do not allow recently treated animals to groom each other. Oral
uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.
It is recommended that cats and ferrets living in, or travelling to, areas endemic for heartworm are
treated monthly with the product to protect them from heartworm disease.
Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended that attempts be
made to check the heartworm status of any cat and ferret aged over 6 months, prior to beginning of
prophylactic treatment, as use of the product on cats or ferrets which have adult heartworm may cause
serious adverse effects, including death. If adult heartworm infection is diagnosed, the infection should
be treated in accordance with current scientific knowledge.
Treatment of cats weighing less than 1 kg and ferrets weighing less than 0.8 kg should be based on a
risk-benefit assessment.
The product’s efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of
effect might be shorter in these animals.
There is limited experience on the use of the product in sick and debilitated animals, thus the product
should only be used based on a risk-benefit assessment for these animals.
Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely
to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the
animal in water after treatment may reduce the efficacy of the product.
For persons administering Advocate to animals
:
Avoid contact with skin, eyes or mouth.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.
After application do not stroke or groom animals until the application site is dry.
In case of accidental spillage onto skin, wash off immediately with soap and water.
People with a known hypersensitivity to either benzyl alcohol, imidacloprid or moxidectin should
administer the product with caution. In very rare cases the product may cause skin sensitisation or
transient skin reactions (for example allergy, irritation or tingling).
If the product accidentally gets into eyes, they should be thoroughly flushed with water.
If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention
and
show the package insert to the physician.
The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and
finished surfaces. Allow the application site to dry before permitting contact with such materials.
57
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon
how to dispose of medicines no longer required. These measures should help to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
12/11/2010
15. OTHER INFORMATION
Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings
are killed after contact with a pet treated with the product.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated
use of an anthelmintic of that class.
Pack sizes: 0.4 ml and 0.8 ml per pipette; blister packs containing 1, 2, 3, 4, 6, 9, 12, 21 or 42 unit dose
pipettes.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
België/Belgique/Belgien
Bayer SA-NV
J.E. Mommaertslaan 14
B–1831 Diegem (Machelen)
Tel/Tél: +32 2 535 66 54
Luxembourg/Luxemburg
Bayer SA-NV
J.E. Mommaertslaan 14
B–1831 Diegem (Machelen)
Belgique/Belgien
Tél/Tel: +32 2 535 66 54
Република България
Алапис България ЕООД
ул. “Атанас Дуков” № 29
BG София 1407
Телефон: + 359 2 862 46 98
Magyarország
Bayer Hungária Kft.
H-1123 Budapest
Alkotás u. 50
Tel: +36 1 487 4100
Česká republika
BAYER s.r.o.
Siemensova 2717/4
155 00 Praha 5
Tel: +420 2 66 10 14 71
Malta
Bayer Animal Health GmbH
D-51368 Leverkusen
Germany
Tel: +49 2173 38 4012
Danmark
Bayer A/S
Bayer HealthCare
Animal Health Division
Nørgaardsvej 32
DK-2800 Kgs. Lyngby
Tlf: +45 4523 5000
Nederland
Bayer B.V., Animal Health Division
Energieweg 1
NL-3641 RT Mijdrecht
Tel: +31 297 280 467
58
Deutschland
Bayer Vital GmbH
Geschäftsbereich Tiergesundheit
D-51368 Leverkusen
Tel: +49 214 301
Norge
Bayer AS
Bayer HealthCare
Animal Health Division
Drammensveien 147 B
N-0277 Oslo
Tlf: +47 24 11 18 00
Eesti
Magnum Veterinaaria AS
Vae 16
EE-76401 Laagri
Tel: +372 650 1920
Österreich
Bayer Austria GmbH
Geschäftsbereich Tiergesundheit
Herbststraβe 6-10
A-1160 Wien
Tel: +43 1 71146 2850
Ελλάδα
ALAPIS ABEE
GR–19300, Ασπρόπυργος
Αττικής, Τ.Θ. 26
Τηλ: +30 210 5575770
Polska
Bayer Sp. z o.o. Animal Health
Al. Jerozolimskie 158
PL-02-326 Warszawa
Tel: +48 22 572 35 00
España
Química Farmacéutica Bayer, S.L.
División Sanidad Animal
Av. Baix Llobregat, 3-5
E-08970 Sant Joan Despí (Barcelona)
Tel: +34 93 4956500
Portugal
Bayer Portugal S.A.
Divisão de Saúde Animal
Rua da Quinta do Pinheiro, 5
P-2794-003 Carnaxide
Tel: +351 21 4172121
France
Bayer Santé
Division Santé Animale
13, rue Jean Jaurès
F–92807 Puteaux cédex
Tél: +33 1 49 06 58 19
România
S.C. Alapis România S.R.L.
Str. Leordeni 13
Bragadiru, Ilfov 077025 - RO
Tel: +40 21 314 59 31
Ireland
Bayer Limited, Animal Health Division
The Atrium
Blackthorn Road
IRL - Dublin 18
Tel +353 1 2999313
Slovenija
Bayer d.o.o.
Bravničarjeva 13
SI-1000 Ljubljana
Tel: +386 1 5814 451
Ísland
Icepharma hf.
Lynghálsi 13
IS-110 Reykjavík
Sími: +354 540 8000
Slovenská republika
BAYER s.r.o.
Siemensova 2717/4
155 00 Praha 5
Česká republika
Tel: +420 2 66 10 14 71
59
Italia
Bayer S.p.A.
Viale Certosa, 130
I-20156 Milano
Tel: +39 02 3978 1
Suomi/Finland
Orion Oyj
ORION PHARMA ELÄINLÄÄKKEET
Tengströminkatu 8, PL/PB 425
FIN-20101 Turku/Åbo
Puh/Tel: +358 10 4261
Κύπρος
PHARMACARE Ltd.
Τ.Θ. 28351
CY-2093, ΛΕΥΚΩΣΙΑ
Τηλ: +357-22-323060
Sverige
Bayer A/S, Bayer HealthCare
Animal Health Division
Nørgaardsvej 32
DK-2800 Kgs. Lyngby
Danmark
Tel: +46 (0)8-580 223 00
Latvija
Magnum Veterinaaria AS
Vae 16
EE-76401 Laagri
Tel: +372 650 1920
United Kingdom
Bayer plc, Animal Health Division,
Bayer House,
Strawberry Hill,
Newbury,
Berkshire RG14 1JA-UK
Tel: +44 1635 563000
Lietuva
Magnum Veterinaaria AS
Vae 16
EE-76401 Laagri
Tel.: +372 650 1920
60
PACKAGE LEAFLET
Advocate spot-on solution for Dogs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Bayer Animal Health GmbH
51368 Leverkusen
Germany
Manufacturer for the batch release
:
KVP Pharma + Veterinär Produkte GmbH
Projensdorfer Str. 324, 24106 Kiel
Germany
2.
Advocate spot-on solution for Small Dogs
Advocate spot-on solution for Medium Dogs
Advocate spot-on solution for Large Dogs
Advocate spot-on solution for Extra-Large Dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each unit dose pipette delivers:
Unit Dose Imidacloprid Moxidectin
Advocate for Small Dogs ( 4 kg)
0.4 ml
40 mg
10 mg
Advocate for Medium Dogs (> 4–10 kg)
1.0 ml
100 mg
25 mg
Advocate for Large Dogs (> 10–25 kg)
2.5 ml
250 mg
62.5 mg
Advocate for Extra-Large Dogs (> 25–40 kg)
4.0 ml
400 mg
100 mg
Excipients: Benzyl alcohol, 1 mg/ml butylhydroxytoluene (E 321; as antioxidant).
4.
For dogs suffering from, or at risk from, mixed parasitic infections:
For the treatment and prevention of flea infestation (
Ctenocephalides felis
), treatment of biting lice
(
Trichodectes canis
), treatment of ear mite infestation (
Otodectes cynotis
), sarcoptic mange (caused by
Sarcoptes scabiei
var.
canis
), demodicosis (caused by
Demodex canis
), prevention of heartworm
disease (L3 and L4 larvae of
Dirofilaria immitis
) and angiostrongylosis (L4 larvae and immature
adults of
Angiostrongylus vasorum
), treatment of
Angiostrongylus vasorum
and
Crenosoma vulpis
and
treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of
Toxocara canis, Ancylostoma caninum
and
Uncinaria stenocephala
, adults of
Toxascaris leonina
and
Trichuris vulpis
).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
61
5.
Do not use in puppies under 7 weeks of age.
Do not use in the case of hypersensitivity to the active substances or to any of the excipients.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any
evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the risk-benefit
assessment by the responsible veterinarian.
For cats, the corresponding “Advocate for Cat” product, which contains 100 mg/ml imidacloprid and
10 mg/ml moxidectin, must be used.
For ferrets: Do not use Advocate for Dogs. Only “Advocate for Small Cats and Ferrets” (0.4 ml) must
be used.
6.
Use of the product may result in transient pruritus in dogs. On rare occasions greasy hair, erythema
and vomiting can occur. These signs disappear without further treatment. The product may, in rare
cases, cause local hypersensitivity reactions. If the animal licks the application site after treatment,
transient neurological signs, such as ataxia, generalised tremors, ocular signs (dilated pupils, little
pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting, may occur infrequently.
The product tastes bitter. Salivation may occasionally occur if the animal licks the application site
immediately after treatment. This is not a sign of intoxication and disappears within some minutes
without treatment. Correct application will minimise licking of the application sites
.
The product may in very rare cases cause at the application site a sensation resulting in transient
behavioural changes such as lethargy, agitation, and inappetence.
In case of accidental oral uptake, symptomatic treatment should be administered by a veterinary
surgeon. There is no known specific antidote. The use of activated charcoal may be beneficial.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Dogs
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
For external use only.
Apply topically to the skin between the shoulder blades.
Dosage schedule
The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 2.5 mg/kg bodyweight
moxidectin, equivalent to 0.1 ml/kg bodyweight Advocate for Dogs.
62
The treatment schedule should be based on the local epidemiological situation.
Weight of dog
[kg]
Pipette size to be used
Volume
[ml]
Imidacloprid
[mg/kg bw]
Moxidectin
[mg/kg bw]
4 kg
Advocate for Small Dogs
0.4
minimum of 10
minimum of 2.5
> 4–10 kg
Advocate for Medium Dogs
1.0
10–25
2.5–6.25
> 10–25 kg
Advocate for Large Dogs
2.5
10–25
2.5–6.25
> 25–40 kg
Advocate for Extra-Large Dogs
4.0
10–16
2.5–4
> 40 kg
appropriate combination of pipettes
Flea treatment and prevention
One treatment prevents further flea infestation for 4 weeks. Pre-existing pupae in the environment may
continue to emerge for 6 weeks or longer after treatment is initiated depending upon climatic
conditions. Therefore, it may be necessary to combine Advocate treatment with treatments aimed at
breaking the flea life cycle in the surroundings. This can result in more rapid reductions in the
household flea population. The product should be administered at monthly intervals when used as part
of a treatment strategy for flea allergy dermatitis.
Treatment of biting lice (Trichodectes canis)
A single dose should be administered. A further veterinary examination 30 days after treatment is
recommended as some animals may require a second treatment.
Treatment of ear mite infestation (Otodectes cynotis)
A single dose of the product should be administered. Loose debris should be gently removed from the
external ear canal at each treatment. A further veterinary examination 30 days after treatment is
recommended as some animals may require a second treatment. Do not apply directly to the ear canal.
Treatment of sarcoptic mange (caused by Sarcoptes scabiei
var.
canis)
A single dose should be administered twice 4 weeks apart.
Treatment of demodicosis (caused by Demodex canis)
The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against
Demodex
canis
and leads to a marked improvement of clinical signs particularly in mild to moderate cases.
Especially severe cases may require more prolonged and more frequent treatment. To achieve the best
possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied
once a week and for a prolonged time. In all cases it is essential that the treatment should be continued
until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be
stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment.
Alternative treatment should be administered. Seek the advice of your veterinarian.
As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying
disease appropriately.
Heartworm prevention
Dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected
with adult heartworms. Therefore
before
treatment with Advocate, the advice provided in the section
“SPECIAL WARNING(S)” should be considered.
63
For prevention of heartworm disease, the product must be applied at regular monthly intervals during
the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm
larvae) are present. The product may be administered throughout the year or at least 1 month before
the first expected exposure to mosquitoes. The treatment should continue at regular monthly intervals
until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is
recommended that the same day or date be used each month. When replacing another heartworm
preventative product in a heartworm prevention programme, the first treatment with Advocate must be
given within 1 month of the last dose of the former medication.
In non-endemic areas there should be no risk of dogs having heartworm. Therefore they can be treated
without special precautions.
Treatment and prevention of Angiostrongylus vasorum
A single dose should be administered. A further veterinary examination 30 days after treatment is
recommended as some animals may require a second treatment.
In endemic areas regular 4 weekly application will prevent angiostrongylosis and patent infection with
Angiostrongylus vasorum
.
Treatment of Crenosoma vulpis
A single dose should be administered.
Roundworm, hookworm and whipworm treatment
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection
caused by the respective roundworm, hookworms and whipworms. In areas non-endemic for
heartworm, the product can be used as part of a seasonal prevention programme against fleas and
gastrointestinal nematodes.
Studies have shown that monthly treatment of dogs will prevent infections caused by
Uncinaria
stenocephala.
9.
ADVICE ON CORRECT ADMINISTRATION
Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull
off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown.
For dogs up to 25 kg:
With the dog in a standing position, part the coat between the shoulder blades until the skin is visible.
Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the
pipette firmly several times to empty its contents directly onto the skin.
64
For dogs of more than 25 kg:
For easy application the dog should be standing. The entire contents of the pipette should be applied
evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At
each spot part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the
tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly
onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some
of the product to run down the animal's side.
10. WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not store above 30 C.
Do not use after the expiry date stated on the label and carton.
12. SPECIAL WARNING(S)
Care should be taken that the contents of the pipette do not come into contact with the eyes or mouth
of the recipient and/or other animals. Do not allow recently treated animals to groom each other. When
the product is applied in 3 to 4 separate spots, specific care should be taken to prevent the animal
licking the application sites.
This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with
Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product
as described under the section “ADVICE ON CORRECT ADMINISTRATION”; in particular, oral
uptake by the recipient and/or other animals in close contact should be prevented.
65
Although the product may be safely administered to dogs infected with adult heartworms, it has no
therapeutic efficacy against adult
Dirofilaria immitis
. It is therefore recommended that all dogs 6
months of age or more, living in areas endemic for heartworm, should be tested for existing adult
heartworm infection before being treated with the product.
Treatment of animals weighing less than 1 kg should be based on a risk-benefit assessment.
There is limited experience on the use of the product in sick and debilitated animals, thus the product
should only be used based on a risk-benefit assessment for these animals.
Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely
to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the
animal in water after treatment may reduce the efficacy of the product.
Advocate should not be allowed to enter surface waters as it has harmful effects on aquatic organisms:
moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters
for 4 days after treatment.
For persons administering Advocate to animals
:
Avoid contact with skin, eyes or mouth.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.
After application do not stroke or groom animals until the application site is dry.
In case of accidental spillage onto skin, wash off immediately with soap and water.
People with a known hypersensitivity to either benzyl alcohol, imidacloprid or moxidectin should
administer the product with caution. In very rare cases the product may cause skin sensitisation or
transient skin reactions (for example allergy, irritation or tingling).
If the product accidentally gets into eyes, they should be thoroughly flushed with water.
If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention
and
show the package insert to the physician.
The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and
finished surfaces. Allow the application site to dry before permitting contact with such materials.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon
how to dispose of medicines no longer required. These measures should help to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
12/11/2010
15. OTHER INFORMATION
Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings
are killed after contact with a pet treated with the product.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated
use of an anthelmintic of that class.
66
Pack sizes: 0.4 ml, 1.0 ml, 2.5 ml and 4.0 ml per pipette; blister packs containing 1, 2, 3, 4, 6, 9, 12, 21
or 42 unit dose pipettes.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
België/Belgique/Belgien
Bayer SA-NV
J.E. Mommaertslaan 14
B–1831 Diegem (Machelen)
Tel/Tél: +32 2 535 66 54
Luxembourg/Luxemburg
Bayer SA-NV
J.E. Mommaertslaan 14
B–1831 Diegem (Machelen)
Belgique/Belgien
Tél/Tel: +32 2 535 66 54
Република България
Алапис България ЕООД
ул. “Атанас Дуков” № 29
BG София 1407
Телефон: + 359 2 862 46 98
Magyarország
Bayer Hungária Kft.
H-1123 Budapest
Alkotás u. 50
Tel: +36 1 487 4100
Česká republika
BAYER s.r.o.
Siemensova 2717/4
155 00 Praha 5
Tel: +420 2 66 10 14 71
Malta
Bayer Animal Health GmbH
D-51368 Leverkusen
Germany
Tel: +49 2173 38 4012
Danmark
Bayer A/S
Bayer HealthCare
Animal Health Division
Nørgaardsvej 32
DK-2800 Kgs. Lyngby
Tlf: +45 4523 5000
Nederland
Bayer B.V., Animal Health Division
Energieweg 1
NL-3641 RT Mijdrecht
Tel: +31 297 280 467
Deutschland
Bayer Vital GmbH
Geschäftsbereich Tiergesundheit
D-51368 Leverkusen
Tel: +49 214 301
Norge
Bayer AS
Bayer HealthCare
Animal Health Division
Drammensveien 147 B
N-0277 Oslo
Tlf: +47 24 11 18 00
Eesti
Magnum Veterinaaria AS
Vae 16
EE-76401 Laagri
Tel: +372 650 1920
Österreich
Bayer Austria GmbH
Geschäftsbereich Tiergesundheit
Herbststraβe 6-10
A-1160 Wien
Tel: +43 1 71146 2850
Ελλάδα
ALAPIS ABEE
GR–19300, Ασπρόπυργος
Αττικής, Τ.Θ. 26
Τηλ: +30 210 5575770
Polska
Bayer Sp. z o.o. Animal Health
Al. Jerozolimskie 158
PL-02-326 Warszawa
Tel: +48 22 572 35 00
67
España
Química Farmacéutica Bayer, S.L.
División Sanidad Animal
Av. Baix Llobregat, 3-5
E-08970 Sant Joan Despí (Barcelona)
Tel: +34 93 4956500
Portugal
Bayer Portugal S.A.
Divisão de Saúde Animal
Rua da Quinta do Pinheiro, 5
P-2794-003 Carnaxide
Tel: +351 21 4172121
France
Bayer Santé
Division Santé Animale
13, rue Jean Jaurès
F–92807 Puteaux cédex
Tél: +33 1 49 06 58 19
România
S.C. Alapis România S.R.L.
Str. Leordeni 13
Bragadiru, Ilfov 077025 - RO
Tel: +40 21 314 59 31
Ireland
Bayer Limited, Animal Health Division
The Atrium
Blackthorn Road
IRL - Dublin 18
Tel +353 1 2999313
Slovenija
Bayer d.o.o.
Bravničarjeva 13
SI-1000 Ljubljana
Tel: +386 1 5814 451
Ísland
Icepharma hf.
Lynghálsi 13
IS-110 Reykjavík
Sími: +354 540 8000
Slovenská republika
BAYER s.r.o.
Siemensova 2717/4
155 00 Praha 5
Česká republika
Tel: +420 2 66 10 14 71
Italia
Bayer S.p.A.
Viale Certosa, 130
I-20156 Milano
Tel: +39 02 3978 1
Suomi/Finland
Orion Oyj
ORION PHARMA ELÄINLÄÄKKEET
Tengströminkatu 8, PL/PB 425
FIN-20101 Turku/Åbo
Puh/Tel: +358 10 4261
Κύπρος
PHARMACARE Ltd.
Τ.Θ. 28351
CY-2093, ΛΕΥΚΩΣΙΑ
Τηλ: +357-22-323060
Sverige
Bayer A/S, Bayer HealthCare
Animal Health Division
Nørgaardsvej 32
DK-2800 Kgs. Lyngby
Danmark
Tel: +46 (0)8-580 223 00
Latvija
Magnum Veterinaaria AS
Vae 16
EE-76401 Laagri
Tel: +372 650 1920
United Kingdom
Bayer plc, Animal Health Division,
Bayer House,
Strawberry Hill,
Newbury,
Berkshire RG14 1JA-UK
Tel: +44 1635 563000
Lietuva
Magnum Veterinaaria AS
Vae 16
EE-76401 Laagri
Tel.: +372 650 1920
68
Source: European Medicines Agency
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