ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Prac-tic 56.25 mg Spot-on solution for very small dogs
Prac-tic 137.5 mg Spot-on solution for small dogs
Prac-tic 275 mg Spot-on solution for medium dogs
Prac-tic 625 mg Spot-on solution for large dogs
2.
Active substance:
Each ml contains 125 mg pyriprole.
Each pipette of Prac-tic delivers the following:
Unit dose
Pyriprole
Prac-tic for very small dogs
0.45 ml
56.25 mg
Prac-tic for small dogs
1.1 ml
137.5 mg
Prac-tic for medium dogs
2.2 ml
275 mg
Prac-tic for large dogs
5.0 ml
625 mg
Excipients:
0.1% Butylhydroxytoluene (E321)
For a full list of excipients, see section 6.1.
3.
Colourless to yellow, clear spot-on solution
4.
Dogs
4.2 Indications for use
Treatment and prevention of flea infestation (
Ctenocephalides
canis and C. felis
) in dogs. Insecticidal
efficacy duration against new infestations with fleas persists for a minimum of 4 weeks. The
veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy
Dermatitis (FAD).
Treatment and prevention of tick infestation (
Ixodes ricinus, Rhipicephalus sanguineus, Ixodes
scapularis, Dermacentor reticulatus, Dermacentor variabilis, Amblyomma americanum
) in dogs. The
veterinary medicinal product has persistent acaricidal efficacy duration of 4 weeks against ticks.
Do not use in dogs less than 8 weeks of age or with a body weight of less than 2 kg.
Do not use in case of known hypersensitivity to phenylpyrazole class compounds or any of the
excipients.
2
Do not use on sick (e.g. systemic diseases, fever) or convalescent animals.
This product is specifically developed for dogs. Do no use in cats, as this could lead to overdosing.
Do not use on rabbits.
This veterinary medicinal product is for the treatment of ticks and adult fleas. All dogs in a household
should be treated.
In cases of heavy infestation prior to treatment, the dog’s surrounding should be vacuumed and treated
with a suitable insecticide.
Dogs should not be bathed or shampooed from 48 hours before treatment. Immersion of the animal in
water or shampooing within 24 hours after treatment may reduce the efficacy of the veterinary
medicinal product. However, weekly immersion in water did not affect efficacy against fleas and ticks.
This veterinary medicinal product is for spot-on application only. Do not administer orally or via any
other route.
Care should be taken to avoid contact of the veterinary medicinal product with the eyes of the animal.
It is important to apply the dose to an area where the dog cannot lick it off and to make sure that
animals do not lick each other following treatment.
Following treatment, ticks will detach from the host within 24 to 48 hours after infestation; however,
single ticks might remain on the animal. For this reason, a transmission of infectious diseases by ticks
cannot be completely excluded.
ii) Special precautions to be taken by the person administering the medicinal product to
animals
As a precautionary measure, direct contact with the treated animals should be avoided and children
should not be allowed to play with treated animals until the application site is dry. It is therefore
recommended to treat animals in the evening. Recently treated animals should not be allowed to sleep
in the same bed as their owners, especially children.
People with known hypersensitivity to the phenylpyrazole class compounds or any of the excipients
should avoid contact with the veterinary medicinal product.
Avoid skin contact with the pipette content. Wash hands or other exposed body parts after use with
soap and water. If accidental eye exposure occurs, the eyes should be rinsed carefully with water.
Do not smoke, eat or drink during application.
iii) Other precautions
Care should be taken to avoid excessive wetting of the hair with the product since this will cause a
clogged appearance of hair at the treatment spot. However, should this occur, it will disappear within
24 hours post application.
3
The following local reactions may be observed at the application site: fur discoloration, local alopecia
or pruritus. Local cosmetic effects at the application site, such as a greasy appearance or clumpiness of
hair are common. However, those signs disappear within 24 hours of the application.
A brief period of hypersalivation may occur if the animal licks the application site immediately after
treatment. This is not a sign of intoxication and disappears within minutes without treatment. Correct
application will minimise licking of the application site.
4.7 Use during pregnancy and lactation
The safety of the veterinary medicinal product has not been established during pregnancy and
lactation, nor in breeding animals, although in laboratory animal studies no indications of relevant
effects on reproduction or fetal development were observed. Use only accordingly to the benefit/risk
assessment by the responsible veterinarian.
None known.
Spot-on use
Dosage Schedule
The recommended minimum dose is 12.5 mg pyriprole per kg bodyweight, equivalent to 0.1 ml Prac-
tic spot-on solution per kg bodyweight.
Weight of dog
(kg)
Pipette size to be
used
Volume of 12.5 %
(w/v) solution (ml)
Pyriprole
(mg/ kg bw)
2 – 4.5 kg
Very small dog
0.45
12.5 – 28.1
> 4.5 – 11 kg Small dog
1.1
12.5 – 30.6
> 11 – 22 kg
Medium dog
2.2
12.5 – 25.0
>22 – 50 kg
Large dog
5.0
12.5 – 28.4
> 50 kg
Use the appropriate combination of pipettes
Within each weight band the entire contents of the correct size pipette should be used.
Flea treatment and prevention
Pyriprole kills fleas within 24 hours post exposure. One application prevents flea infestation for 4
weeks. The veterinary medicinal product should be administered at monthly intervals when used as
part of a treatment strategy for flea allergy dermatitis.
Tick treatment and prevention
Pyriprole kills ticks within 48 hours post-exposure. One application has acaricidal efficacy duration of
4 weeks.
Method of administration
For external use only.
4
Remove one pipette from the package. Hold it in an upright position. Tap the narrow part of the
pipette to ensure the contents remain within the main body of it. Break the top of the snap-off top
along the scored line.
Part the coat on the back of the animal between the shoulder blades until the skin is visible. Place the
tip of the pipette on the skin and squeeze it gently several times at one or two spots to empty the
contents onto the skin. Apply the 5 ml pipette to 2-3 spots down the backline of large dogs in order to
prevent run-off.
Mild neurological signs such as slight incoordination and unsteadiness were observed in some animals
treated once a month at
three times
the recommended maximum dose for six consecutive months.
Those signs disappeared within 3 hours following administration.
In one out of 8 dogs repeatedly treated with
five times
the recommended dose, the following transient
adverse effects were observed: tremors, ataxia, panting and convulsions. These signs disappeared
within 18 hours following administration.
Following an overdose of
10 times
the maximum dose on a single occasion the following adverse
effects were seen: vomiting, anorexia, reduced body weight, muscle tremors, seizures, unsteadiness,
laboured breathing. All signs resolved within 48 hours, with the exception of the loss of appetite.
An overdose of the veterinary medicinal product will cause a clogged appearance of hair at the
treatment spot for up to 24 hours.
Not applicable.
5.
Pharmacotherapeutic group: Ectoparasiticides for topical use; ATCvet code: QP53AX26
5.1 Pharmacodynamic properties
The veterinary medicinal product is an insecticidal and acaricidal solution for spot-on use, containing
pyriprole as active ingredient.
Pyriprole is an insecticide and acaricide belonging to the phenylpyrazole class. It acts by interacting
with ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-
aminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across
cell membranes. This results in uncontrolled activity of the central nervous system and death of fleas
and ticks. In dogs, adverse reactions are associated with neurological signs caused by metabolites of
the active substance.
Parasites are killed through contact rather than by systemic exposure. Pyriprole kills fleas within 24
hours and ticks (
Ixodes ricinus, Rhipicephalus sanguineus, Dermacentor reticulatus, Ixodes
scapularis, Dermacentor variabilis, Amblyomma americanum
) within 48 hours post-exposure.
Adult fleas are killed before they lay eggs for a minimum of 4 weeks after treatment. Since Prac-tic
completely eliminates egg production, it breaks the flea life cycle.
5.2 Pharmacokinetic properties
In dogs, after topical administration pyriprole is slowly absorbed by skin, leading to a systemic
exposure by its two main metabolites.
5
Following topical administration pyriprole is rapidly distributed in the hair coat of dogs within one day
after application. It can be found in the hair coat throughout the treatment interval.
Environmental properties
Pyriprole may be harmful to aquatic organisms.
6.
6.1 List of excipients
Butylhydroxytoluene (E321)
Diethylene glycol monoethyl ether
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years.
6.4. Specialprecautionsforstorage
Store the pipettes in the original container in order to protect from light.
Do not store above 25°C.
6.5 Nature and contents of container
Immediate packaging:
The spot on pipette is composed of a bright yellow polypropylene shell, with a pale yellow aluminium
foil back coated with a polyethylene terephthalate film. The pipette is contained in a child resistant
soft tempered aluminium foil/PVC blister.
Outer packaging:
Cardboard carton containing 1, 2 or 10 blisters each containing 3 pipettes.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused medicinal product or waste materials, if any
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
The veterinary medicinal product should not be allowed to enter surface water, as it may be harmful for
aquatic organisms.
7.
Novartis Sanidad Animal S.L.
Calle de la Marina, 206
E-08013 Barcelona
Spain
6
8.
EU/2/06/066/001-012
9. DATE OF FIRST AUTHORISATION
18 December 2006
12/03/2010
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/
7
ANNEX II
A. MANUFACTURING AUTHORISATION HOLDER(S) 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
8
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Novartis Santé Animale S.A.S
Usine de Huningue
26 rue de Chapelle
F-68330
France
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
For animal treatment only – to be supplied only on veterinary 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 SAFE AND EFFECTIVE USE
Not applicable
D. STATEMENT OF THE MRLs
Not applicable
9
ANNEX III
LABELLING AND PACKAGE LEAFLET
10
A. LABELLING
11
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
{Cardboard Carton} 56.25 mg
1.
Prac-tic 56.25 mg Spot-on solution for very small dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
125 mg per ml pyriprole.
Each pipette of Prac-tic delivers the following:
Unit dose
Pyriprole
0.45 ml
56.25 mg
Excipients:
0.1 % Butylhydroxytoluene (E321)
3.
Spot-on solution
4.
PACKAGE SIZE
3 pipettes
6 pipettes
30 pipettes
5.
Dogs (2-4.5 kg)
6.
Treatment and prevention of infestations with fleas and ticks.
Kills fleas before they lay eggs.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Spot-on use
1.
Remove one pipette from the package.
2.
Then hold the pipette in an upright position. Tap the narrow part of the pipette to ensure the
contents remain within the main body of the pipette. Break the top of the snap-off top along
the scored line.
12
3.
Part the coat on the back of the animal between the shoulder blades until the skin is visible.
4.
Place the tip of the pipette on the skin and squeeze the pipette gently several times at one or
two spots to empty the contents onto the skin.
8.
Not applicable
9.
SPECIAL WARNING(S)
Read the package leaflet before use.
Avoid contact of the product with skin, eyes or mouth.
Avoid direct contact with the treated animal until the application site is dry.
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not remove the pipette from the packaging until ready to use.
Do not store above 25
°
C
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
The veterinary medicinal product should not be allowed to enter surface water as it may be harmful for
aquatic organisms.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
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.
Marketing authorisation holder
Novartis Sanidad Animal S.L.
Calle de la Marina, 206
E-08013 Barcelona
Spain
13
EU/2/06/066/001 (3 pipettes)
EU/2/06/066/002 (6 pipettes)
EU/2/06/066/003 (30 pipettes)
17. MANUFACTURER’S BATCH NUMBER
<Batch> <Lot> <BN> {number}
14
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Blister (56.25 mg)
1.
Prac-tic Spot-on for dogs
Pyriprole
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
56.25 mg
3.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
0.45 ml
4.
ROUTE(S) OF ADMINISTRATION
Spot-on
5.
BATCH NUMBER
<Batch> <Lot> <BN> {number}
6.
EXPIRY DATE
EXP {month/year}
7.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
15
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Pipette
(56.25 mg)
1.
Prac-tic 56.25 mg
Pyriprole
2.
Novartis Animal Health.
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
LOT {number}
16
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Cardboard Carton (137.5 mg)
1.
Prac-tic 137.5 mg Spot-on solution for small dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
125 mg per ml pyriprole.
Each pipette of Prac-tic delivers the following:
Unit dose
Pyriprole
1.1 ml
137.5 mg
Excipients:
0.1 % Butylhydroxytoluene (E321)
3.
Spot-on solution
4.
PACKAGE SIZE
3 pipettes
6 pipettes
30 pipettes
5.
Dogs (
>
4.5-11 kg)
6.
Treatment and prevention of infestations with fleas and ticks.
Kills fleas before they lay eggs.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Spot-on use
1.
Remove one pipette from the package.
2.
Then hold the pipette in an upright position. Tap the narrow part of the pipette to ensure the
contents remain within the main body of the pipette. Break the top of the snap-off top along
the scored line.
17
3.
Part the coat on the back of the animal between the shoulder blades until the skin is visible .
4.
Place the tip of the pipette on the skin and squeeze the pipette gently several times at one or
two spots to empty the contents onto the skin.
8.
Not applicable
9.
SPECIAL WARNING(S)
Read the package leaflet before use.
Avoid contact of the product with skin, eyes or mouth.
Avoid direct contact with the treated animal until the application site is dry.
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not remove the pipette from the packaging until ready to use.
Do not store above 25
°
C
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
The veterinary medicinal product should not be allowed to enter surface water as it may be harmful for
aquatic organisms.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
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.
Marketing authorisation holder
Novartis Sanidad Animal S.L.
Calle de la Marina, 206
E-08013 Barcelona
Spain
18
EU/2/06/066/004 (3 pipettes)
EU/2/06/066/005 (6 pipettes)
EU/2/06/066/006 (30 pipettes)
17. MANUFACTURER’S BATCH NUMBER
<Batch> <Lot> <BN> {number}
19
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Blister (137.5 mg)
1.
Prac-tic Spot-on for dogs
Pyriprole
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
137.5 mg
3.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
1.10 ml
4.
ROUTE(S) OF ADMINISTRATION
Spot-on
5.
BATCH NUMBER
<Batch> <Lot> <BN> {number}
6.
EXPIRY DATE
EXP {month/year}
7.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
20
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Pipette (137.5 mg)
1.
Prac-tic 137.5 mg
Pyriprole
2.
Novartis Animal Health.
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
LOT {number}
21
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Cardboard Carton (275 mg)
1.
Prac-tic 275 mg Spot-on solution for medium dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
125 mg per ml pyriprole.
Each pipette of Prac-tic delivers the following:
Unit dose
Pyriprole
2.2 ml
275 mg
Excipients:
0.1 % Butylhydroxytoluene (E321)
3.
Spot-on solution
4.
PACKAGE SIZE
3 pipettes
6 pipettes
30 pipettes
5.
Dogs (
>
11-22 kg)
6.
Treatment and prevention of infestations with fleas and ticks.
Kills fleas before they lay eggs.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Spot-on use
1.
Remove one pipette from the package.
2.
Then hold the pipette in an upright position. Tap the narrow part of the pipette to ensure the
contents remain within the main body of the pipette. Break the top of the snap-off top along
the scored line.
3.
Part the coat on the back of the animal between the shoulder blades until the skin is visible .
22
4.
Place the tip of the pipette on the skin and squeeze the pipette gently several times at one or
two spots to empty the contents onto the skin.
8.
Not applicable
9.
SPECIAL WARNING(S)
Read the package leaflet before use.
Avoid contact of the product with skin, eyes or mouth.
Avoid direct contact with the treated animal until the application site is dry.
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not remove the pipette from the packaging until ready to use.
Do not store above 25
°
C
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
The veterinary medicinal product should not be allowed to enter surface water as it may be harmful for
aquatic organisms.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
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.
Marketing authorisation holder
Novartis Sanidad Animal S.L.
Calle de la Marina, 206
E-08013 Barcelona
Spain
23
EU/2/06/066/007 (3 pipettes)
EU/2/06/066/008 (6 pipettes)
EU/2/06/066/009 (30 pipettes)
17. MANUFACTURER’S BATCH NUMBER
<Batch> <Lot> <BN> {number}
24
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Blister (275 mg)
1.
Prac-tic Spot-on for dogs
Pyriprole
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
275 mg
3.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
2.20 ml
4.
ROUTE(S) OF ADMINISTRATION
Spot-on
5.
BATCH NUMBER
<Batch> <Lot> <BN> {number}
6.
EXPIRY DATE
EXP {month/year}
7.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
25
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Pipette (275 mg)
1.
Prac-tic 275 mg
Pyriprole
2.
Novartis Animal Health.
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
LOT {number}
26
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Cardboard Carton (625 mg)
1.
Prac-tic 625 mg Spot-on solution for large dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
125 mg per ml pyriprole.
Each pipette of Prac-tic delivers the following:
Unit dose
Pyriprole
5.0 ml
625 mg
Excipients:
0.1 % Butylhydroxytoluene (E321)
3.
Spot-on solution
4.
PACKAGE SIZE
3 pipettes
6 pipettes
30 pipettes
5.
Dogs (
>
22-50 kg)
6.
Treatment and prevention of infestations with fleas and ticks.
Kills fleas before they lay eggs.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Spot-on use
1. Remove one pipette from the package.
2.
Then hold the pipette in an upright position. Tap the narrow part of the pipette to ensure the
contents remain within the main body of the pipette. Break the top of the snap-off top along
the scored line.
3.
Part the coat on the back of the animal between the shoulder blades until the skin is visible .
27
4.
Place the tip of the pipette on the skin and squeeze the pipette gently several times at 2-3 spots
down the back-line of large dogs to prevent runoff.
8.
Not applicable
9.
SPECIAL WARNING(S)
Read the package leaflet before use.
Avoid contact of the product with skin, eyes or mouth.
Avoid direct contact with the treated animal until the application site is dry.
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not remove the pipette from the packaging until ready to use.
Do not store above 25
°
C
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
The veterinary medicinal product should not be allowed to enter surface water as it may be harmful for
aquatic organisms.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
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.
Marketing authorisation holder
Novartis Sanidad Animal S.L.
Calle de la Marina, 206
E-08013 Barcelona
Spain
28
EU/2/06/066/010 (3 pipettes)
EU/2/06/066/011 (6 pipettes)
EU/2/06/066/012 (30 pipettes)
17. MANUFACTURER’S BATCH NUMBER
<Batch> <Lot> <BN> {number}
29
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Blister (625 mg)
1.
Prac-tic Spot-on for dogs
Pyriprole
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
625 mg
3.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
5.0 ml
4.
ROUTE(S) OF ADMINISTRATION
Spot-on
5.
BATCH NUMBER
<Batch> <Lot> <BN> {number}
6.
EXPIRY DATE
EXP {month/year}
7.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
30
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Pipette (625 mg)
1.
Prac-tic 625 mg
Pyriprole
2.
Novartis Animal Health.
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
LOT {number}
31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET
Prac-tic spot-on solution for dogs
Read this leaflet before use and administer the veterinary medicinal product with caution.
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Marketing authorisation holder:
Novartis Sanidad Animal S.L.
Calle de la Marina, 206
E-08013 Barcelona
Spain
Manufacturer for the batch release
:
Novartis Santé Animale S.A.S
Usine de Huningue
26, rue de la Chapelle
F-68332 Huningue Cedex
France
2.
Prac-tic 56.25 mg Spot-on solution for very small dogs
Prac-tic 137.5 mg Spot-on solution for small dogs
Prac-tic 275 mg Spot-on solution for medium dogs
Prac-tic 625 mg Spot-on solution for large dogs
Pyriprole
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains 125 mg pyriprole as a colourless to yellow, clear solution.
Each pipette of Prac-tic delivers the following:
Prac-tic for very small dogs
Unit dose
Pyriprole
Prac-tic for small dogs
1.1 ml
137.5 mg
Prac-tic for medium dogs
2.2 ml
275 mg
Prac-tic for large dogs
5.0 ml
625 mg
The solution also contains 0.1 % Butylhydroxytoluene (E321)
4.
INDICATIONS
Treatment and prevention of flea infestation (
Ctenocephalides
canis and C. felis
.). Prac-tic is effective
against new infestations with fleas for a minimum duration of 4 weeks. The product can be used as
part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
33
0.45 ml
56.25 mg
Treatment and prevention of tick infestation (
Ixodes ricinus, Ixodes scapularis, Dermacentor
variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus, Amblyomma americanum
). Prac-tic
has a persistent effect for 4 weeks against ticks.
5.
Do not use in dogs less than 8 weeks of age or weighing less than 2 kg.
Do not use in case of known hypersensitivity to phenylpyrazole class compounds or to any of the
excipients.
Do not use in sick or convalescent animals.
This product is specifically developed for dogs. Do no use in cats, as this could lead to overdosing.
Do not use on rabbits.
6. ADVERSE REACTIONS
The following local reactions may be observed at the application site: fur discoloration, local alopecia
or pruritus. Local cosmetic effects at the application site, such as a greasy appearance or clumpiness of
hair are common. However, those signs disappear within 24 hours of the application.
A brief period of hypersalivation may occur if the animal licks the application site immediately after
treatment. This is not a sign of intoxication and disappears within minutes without treatment. Correct
application will minimise licking of the application site.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Dog
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
For spot-on use.
The recommended minimum dose is 12.5 mg/kg bodyweight pyriprole, equivalent to 0.1 ml/kg
bodyweight of the veterinary medicinal product. Within each weight band the entire contents of the
correct size pipette should be used.
Weight of dog
(kg)
Pipette size to be
used
Volume of 12.5%
(w/v) solution (ml)
Pyriprole
(mg / kg bw)
2 – 4.5 kg
Very small dog
0.45
12.5 – 28.1
4.5 – 11 kg Small dog
1.1
12.5 – 30.6
11 – 22 kg
Medium dog
2.2
12.5 – 25.0
22 – 50 kg
Large dog
5.0
12.5 – 28.4
More than
50 kg
The appropriate combination of pipettes
34
Flea treatment and prevention
Pyriprole kills fleas within 24 hours post exposure. One treatment prevents future flea infestation for 4
weeks. The veterinary medicinal product should be administered at monthly intervals when used as
part of a treatment strategy for flea allergy dermatitis.
Tick treatment and prevention
Pyriprole kills ticks within 48 hours post-exposure. One treatment has efficacy duration of 4 weeks.
9.
ADVICE ON CORRECT ADMINISTRATION
For external use only.
Remove one pipette from the package. Then hold it in an upright position. Tap the narrow part of the
pipette to ensure the contents remain within the widest part. Break the top of the snap-off top along the
scored line.
Part the coat on the back of the animal between the shoulder blades until the skin is visible. Place the
tip of the pipette on the skin and squeeze it gently several times at one or two spots to empty the
contents onto the skin. Apply the 5 ml pipette to 2-3 spots down the backline of large dogs so as to
prevent run-off.
When administering the product, try to avoid wetting the fur as this will lead to a clogged appearance.
However, should this happen it will disappear within 24 hours.
In cases of heavy infestation with fleas prior to treatment, the dog’s surrounding should be vacuumed
and treated with a suitable insecticide.
10. WITHDRAWAL PERIOD
Not applicable.
11 SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the pipette after “EXP”.
Do not remove the pipette from the packaging until ready to use.
Do not store above 25
°
C.
12. SPECIAL WARNING(S)
People with known allergies to the phenylpyrazole class of compounds or either of the excipients
should avoid contact with the veterinary medicinal product.
Avoid the contents coming into contact with your fingers. Wash your hands after use and wash off any
product in contact with your skin with soap and water. If the veterinary medicinal product accidentally
gets in your eyes, rinse them carefully with water.
If you or anybody else accidentally swallows this veterinary medicinal product, seek medical advice
immediately and show this leaflet or the label to your doctor.
Do not smoke, eat or drink while handling the veterinary medicinal product.
35
As a precautionary measure, direct contact with the treated animals should be avoided and children
should not be allowed to play with treated animals until the application site is dry. It is therefore
recommended to treat animals in the evening. Recently treated animals should not be allowed to sleep
in the same bed as their owners, especially children.
This veterinary medicinal product is for skin application on dogs only, do not put it in your dog’s
mouth. Take care to avoid the veterinary medicinal product coming into contact with your dog’s eyes.
Apply the dose to an area where the dog cannot lick it off and do not allow your dog or other animals
lick each other following treatment.
Dogs should not be bathed or shampooed from 48 hours before treatment. If you want to wash your
dog, leave at least one day between treatment and shampooing.
If you suspect your dog may be pregnant or if your bitch is nursing puppies or if you want to treat a
breeding dog, contact your veterinarian for advice before use.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with the local requirements.
The veterinary medicinal product should not be allowed to enter surface water, as it may be harmful for
aquatic organisms.
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
12/03/2010
Detailed information on this product is available on the website of the European Medicines Agency
http://www.ema.europa.eu/
15. OTHER INFORMATION
Adult fleas are killed before they lay eggs for a minimum of 4 weeks after treatment. Since Prac-tic
completely eliminates egg production, it breaks the flea life cycle.
Cardboard carton containing 1, 2 or 10 blisters of 3 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.
36
België /Belgique/Belgien:
Novartis Consumer Health B.V.,
Tel /Tél: +32-246 32 390
Magyarország:
Novartis Hungária Kft,
Tel: +36 1 457 6691
Česká republika:
Novartis s.r.o.,
Tel: + 420 2 257 75 331
Malta:
Novartis Animal Health UK Ltd.,
Tel: +44-(0)1763 850 500
Danmark:
Novartis Healthcare A/S,
Tlf: +45-39 16 84 00
Nederland:
Novartis Consumer Health B.V.,
Tel: +31-76 533 00 20
Deutschland:
Novartis Tiergesundheit GmbH,
Tel: +49-(0)89 7877 710
Norge:
Novartis Healthcare A/S,
Tel: +45-39 16 84 00
Eesti:
Novartis Animal Health d.o.o.,
Tel: + 386 1 580 2884
Österreich:
Novartis Animal Health GmbH,
Tel: +43-(0)5338 2000
Ελλάδα:
Premier Shukuroglou Hellas SA,
Tηλ: +30-(210)6538-061/181
Polska:
Novartis Poland Sp. z.o.o.,
Tel: +48 22 550 8 790
España:
Novartis Sanidad Animal, S.L.,
Tel: +34-93 306 4700
Portugal:
Novartis Farma-Produtos Farmacêuticos, S.A.,
Tel: +351-21 000 86 00
France:
Novartis Santé Animale S.A.S.,
Tél: +33-(0)1 55 47 87 47
Slovenija:
Novartis Animal Health d.o.o.,
Tel: + 386 1 580 2884
Ireland:
Novartis Animal Health Ireland Ltd.,
Tel: +353-(0)51 377 201
Slovenská republika:
Novartis Animal Health d.o.o.,
Tel: + 386 1 580 2884
Ísland:
Novartis Healthcare A/S,
Tel: +45-39 16 84 00
Suomi/Finland:
Novartis Healthcare A/S,
Puh: +45-39 16 84 00
Italia:
Novartis Animal Health S.p.A.,
Tel: +39-02 96542205
Sverige:
Novartis Healthcare A/S,
Tel: +45-39 16 84 00
Κύπρος:
Premier Shukuroglou Ltd ,
Tηλ: +357 22 81 53 53
United Kingdom:
Novartis Animal Health UK Ltd.,
Tel: +44-(0)1276 694402
Latvija:
Novartis Animal Health d.o.o.,
Tel: + 386 1 580 2884
România:
Novartis Animal Health d.o.o.,
Tel: + 386 1 580 2884
Lietuva:
Novartis Animal Health d.o.o.,
Tel: + 386 1 580 2884
България:
Novartis Animal Health d.o.o.,
Tel: + 386 1 580 2884
37
Luxembourg/Luxemburg:
Novartis Consumer Health B.V.,
Tel: +31-76 533 00 20
38
Source: European Medicines Agency
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