ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Previcox 57 mg chewable tablets for dogs
Previcox 227 mg chewable tablets for dogs
2.
Each tablet contains:
Active substance:
Firocoxib 57 mg
Firocoxib
227 mg
Excipients:
Iron oxides (E172)
Caramel (E150d)
For a full list of excipients, see section 6.1.
3.
Chewable tablets.
Tan-brown, round, convex, engraved scored tablets.
4.
Dogs
For the relief of pain and inflammation associated with osteoarthritis in dogs.
For the relief of post-operative pain and inflammation associated with soft-tissue and orthopaedic
surgery in dogs.
Do not use in pregnant or lactating bitches.
Do not use in animals less than 10 weeks of age or less than 3 kg body weight.
Do not use in animals suffering from gastrointestinal bleeding, blood dyscrasia or haemorrhagic
disorders.
Do not use concomitantly with corticosteroids or other NSAIDs.
None.
The recommended dose, as indicated in the dosing table, should not be exceeded.
2
Use in very young animals, or animals with suspected or confirmed impairment of renal, cardiac or
hepatic function may involve additional risk. If such use cannot be avoided, those dogs require careful
veterinary monitoring.
Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of
increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be
avoided.
Use this product under strict veterinary monitoring where there is a risk of gastrointestinal bleeding, or
if the animal previously displayed intolerance to NSAIDs. Renal and/or hepatic disorders have been
reported in very rare cases in dogs administered the recommended treatment dose. It is possible that a
proportion of such cases had sub-clinical renal or hepatic disease prior to the commencement of
therapy. Therefore, appropriate laboratory testing to establish baseline renal or hepatic biochemistry
parameters is recommended prior to and periodically during administration.
The treatment should be discontinued if any of these signs are observed: repeated diarrhoea, vomiting,
faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic
biochemistry parameters.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Wash hands after use of the product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
Return halved tablets to the blister and keep out of the reach of children.
Emesis and diarrhoea have occasionally been reported. These reactions are generally of a transitory
nature and are reversible when the treatment is stopped. Renal and/or hepatic disorders have been
reported in very rare cases in dogs administered the recommended treatment dose. Rarely, nervous
system disorders have been reported in treated dogs
If adverse reactions like vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss,
anorexia, lethargy, degradation of renal or hepatic biochemistry parameters occur, use of the product
should be stopped and the advice of a veterinarian should be sought. As with other NSAIDs, serious
adverse effects can occur and, in very rare cases, may be fatal.
*
The frequency of possible adverse effects is defined using the following convention:
Rare (affects 1 to 10 animals in 10,000)
Very rare (affects less than 1 animal in 10,000)
Do not use in pregnant or lactating bitches.
Laboratory studies in rabbits have shown evidence of maternotoxic and foetotoxic effects at dose rates
approximating the recommended treatment dose for the dog.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse
effects and accordingly a treatment-free period with such drugs should be observed for at least 24
hours before the commencement of treatment with Previcox. The treatment-free period, however,
should take into account the pharmacokinetic properties of the products used previously.
3
Previcox must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Gastrointestinal tract ulceration may be exacerbated by corticosteroids in animals given non-steroidal
anti-inflammatory drugs.
Concomitant treatment with molecules displaying action on renal flow, e.g. diuretics or Angiotensin
Converting Enzyme (ACE) inhibitors, should be subject to clinical monitoring. Concurrent
administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk
of renal toxicity. As anaesthetic drugs may affect renal perfusion,
t
he use of parenteral fluid therapy
during surgery should be considered to decrease potential renal complications when using NSAIDs
peri-operatively.
Concurrent use of other active substances that have a high degree of protein binding may compete
with firocoxib for binding and thus lead to toxic effects.
Oral use.
Osteoarthritis:
Administer 5 mg per kg bodyweight once daily as presented in the table below.
Tablets can be administered with or without food.
Duration of treatment will be dependent on the response observed. As field studies were limited to 90
days, longer-term treatment should be considered carefully and regular monitoring undertaken by the
veterinarian.
Relief
of post-operative pain
Administer 5 mg per kg bodyweight once daily as presented in the table below for up to 3 days as
needed, starting approximately 2 hours prior to surgery.
Following orthopaedic surgery and depending on the response observed, treatment using the same
daily dosing schedule may be continued after the first 3 days, upon judgement of the attending
veterinarian.
Body weight (kg)
Number of chewable tablets by size
mg/kg range
57
mg
227
mg
3 – 5.5
0.5
5.2 – 9.5
5.6 – 10
1
5.7 – 10.2
10.1 – 15
1.5
5.7 – 8.5
15.1 – 22
0.5
5.2 – 7.5
22.1 – 45
1
5.0 – 10.3
45.1 – 68
1.5
5.0 – 7.5
68.1 – 90
2
5.0 – 6.7
In dogs ten weeks of age at the start of treatment at dose rates equal or greater to 25 mg/kg/day (5
times the recommended dose) for three months, the following signs of toxicity were observed:
bodyweight loss, poor appetite, changes in the liver (accumulation of lipid), brain (vacuolisation),
duodenum (ulcers) and death. At dose rates equal or greater to 15 mg/kg/day (3 times the
recommended dose) for six months, similar clinical signs were observed, albeit that the severity and
frequency were less and duodenal ulcers were absent.
In those target animal safety studies, clinical signs of toxicity were reversible in some dogs following
cessation of therapy.
4
In dogs seven months of age at the start of treatment at dose rates greater than or equal to
25 mg/kg/day (5 times the recommended dose) for six months, gastrointestinal adverse effects, i.e.
vomiting were observed.
Overdose studies were not conducted in animals over 14 months of age.
If clinical signs of overdosing are observed, discontinue treatment.
Not applicable.
5.
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids.
ATCvet code: QM01AH90
5.1 Pharmacodynamic properties
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which
acts by selective inhibition of cyclooxygenase-2 (COX-2) – mediated prostaglandin synthesis.
Cyclooxygenase is responsible for generation of prostaglandins. COX-2 is the isoform of the enzyme
that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be
primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Coxibs therefore display analgesic, anti-inflammatory and antipyretic properties. COX-2 is also
thought to be involved in ovulation, implantation and closure of the ductus arteriosus, and central
nervous system functions (fever induction, pain perception and cognitive function). In
in-vitro
canine
whole blood assays, firocoxib exhibits approximately 380-fold selectivity for COX-2 over COX-1.
The concentration of firocoxib required to inhibit 50% of the COX-2 enzyme (i.e., the IC
50
) is
0.16 (± 0.05) µM, whereas the IC
50
for COX-1 is 56 (± 7) µM.
5.2 Pharmacokinetic particulars
Following oral administration in dogs at the recommended dose of 5 mg per kg of bodyweight,
firocoxib is rapidly absorbed and the time to maximal concentration (T
max
) is 1.25 (± 0.85) hours. The
peak concentration (C
max
) is 0.52 (± 0.22) g/ml (equivalent to approximately 1.5 µM), area under the
curve (AUC 0-24) is 4.63 (1.91) µg xhr/ml, and oral bioavailability is 36.9 (20.4) percent. The
elimination half-life (t
½
) is 7.59 (± 1.53) hours. Firocoxib is approximately 96% bound to plasma
proteins. Following multiple oral administrations, the steady state is reached by the third daily dose.
Firocoxib is metabolised predominantly by dealkylation and glucuronidation in the liver. Elimination
is principally in the bile and gastrointestinal tract.
6.
6.1 List of excipients
Lactose Monohydrate
Microcrystalline Cellulose
Chartor Hickory Smoke Flavour
Hydroxypropyl Cellulose
Croscarmellose Sodium
Magnesium Stearate
Caramel E150d
Silica, colloidal anhydrous
Iron Oxides
5
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Half tablets should be returned to the original market container and may be stored for up to 7 days
6.4 Special precautions for storage
Do not store above 30°C.
Store in the original package.
6.5 Nature and composition of immediate packaging
Previcox tablets are supplied in carton boxes containing blisters (transparent PVC /aluminium foil and
paper backing).
The chewable tablets are available in the following pack sizes:
57 mg: 1 carton box containing one blister of 10 tablets
1 carton box containing three blisters of 10 tablets each
1 carton box containing eighteen blisters of 10 tablets each
227 mg: 1 carton box containing one blister of 10 tablets
1
carton
box
containing
three
blisters
of
10
tablets
each
1 carton box containing eighteen blisters of 10 tablets each
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 veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
MERIAL
29 avenue Tony Garnier
FR-69007 Lyon
France.
8.
EU/2/04/045/001-6
9.
13/09/2004
6
01/2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMA)
http://www.ema.europa.eu
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
7
1.
Previcox 8.2 mg/g oral paste for horses.
2.
Each syringe contains 7.32 g of paste and delivers:
Firocoxib 8.2 mg/g
For a full list of excipients, see section 6.1.
3.
Oral paste.
White to off-white paste.
4.
Horses.
4.2 Indications for use specifying the target species
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated
lameness in horses
.
Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic,
cardiac or renal function and bleeding disorders.
Do not use in breeding, pregnant or lactating animals.
Do not use concomitantly with corticosteroids or other NSAIDs.
None.
Do not use in animals less than 10 weeks. If side effects occur, treatment should be discontinued and
the advice of a veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or
hypotensive animal, as there may be potential risk of increased renal toxicity. Concurrent
administration of potentially nephrotoxic drugs should be avoided.
The recommended treatment dose and duration should not be exceeded.
8
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
Avoid contact with eyes and skin. If it occurs, rinse affected area immediately with water.
Wash hands after use of the product.
Women of child-bearing age should avoid contact with, or wear disposable gloves, when
administering the product.
Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be
observed in treated animals. Typically, these lesions are mild and resolve without treatment, but oral
lesions may be associated with salivation and labial and tongue oedema.
No data is available in horses. However, studies with laboratory animals have shown embryo-
foetotoxicity, malformations, delayed parturition and decreased pup survival. Therefore, do not use in
breeding, pregnant or lactating animals.
Other NSAIDs, diuretic and substances with high protein binding may compete for binding and lead to
toxic effects. Do not use concomitantly with corticosteroids or other NSAIDs.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse
effects and a treatment-free period with such products should therefore be observed. The treatment-
free period should take into account the pharmacological properties of the products used previously.
Concomitant treatment with molecules displaying action on renal flow (e.g. diuretics) should be
subject to clinical monitoring. Concurrent administration of potentially nephrotoxic drugs should be
avoided as there might be an increased risk of renal toxicity.
Oral use.
Administer 0.1 mg firocoxib per kg bodyweight, once daily. Duration of treatment will be dependent
on the response observed, but should not exceed 14 days
.
To administer Previcox at the dose of 0.1 mg firocoxib/kg, set the syringe plunger to the appropriate
dose division for the horse’s weight. Each full dose division on the syringe plunger delivers sufficient
firocoxib to treat 100 kg body weight. The contents of one syringe will treat horses weighing up to
600 kg. To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid
overdosing.
To deliver firocoxib at the appropriate dosage, unlock the knurled ring on the syringe plunger by
rotating it ¼ turn and slide it along the plunger shaft to the appropriate dose division for the horse’s
weight. Rotate the plunger ring ¼ turn to lock it in place and ensure it is locked.
Make sure the horse’s mouth contains no feed. Remove the cover from the tip of the syringe. Insert the
syringe tip into the horse’s mouth at the interdental space and deposit the paste on the base of the
tongue.
9
Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be
observed in treated animals when administered the recommended treatment dose. Typically, these
lesions are mild and resolve without treatment, but oral lesions may be associated with salivation and
labial and tongue oedema. The incidence of oral/skin lesions increases with increasing dose.
At high dosages and prolonged treatment (3 times the recommended dose for 42 consecutive days and
2.5 times the recommended dose for 92 consecutive days administered once daily) mild to moderate
renal lesions were observed. If clinical signs occur, treatment should be discontinued and symptomatic
treatment initiated.
4.11 Withdrawalperiod
Meat and offal: 26 days
Do not use in mares producing milk for human consumption.
5.
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, ATC vet
code: QM01AH90.
5.1 Pharmacodynamic properties
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which
acts by selective inhibition of cyclooxygenase-2 (COX-2)-mediated prostaglandin synthesis.
Cyclooxygenase is responsible for generation of prostaglandins. COX-2 is the isoform of the enzyme
that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be
primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Coxibs therefore display analgesic, anti-inflammatory, and antipyretic properties. COX-2 is also
thought to be involved in ovulation, implantation and closure of the ductus arteriosus, and central
nervous system functions (fever induction, pain perception, and cognitive function). “In “
in vitro
”
equine whole blood assays, firocoxib exhibits 222 to 643 fold selectivity for COX-2 over COX-1. The
concentration of firocoxib required to inhibit 50% of the COX-2 enzyme (i.e., the IC50) is 0.0369 to
0.12 μM, whereas the IC50 for COX-1 is 20.14 to 33.1 μM
.
5.2 Pharmacokinetic particulars
Following oral administration in horses at the recommended dose of 0.1 mg per kg of bodyweight,
firocoxib is rapidly absorbed, and the time to maximal concentration (T
max
) is 3.9 (± 4.4) hours. The
peak concentration (C
max
) is 0.075 (± 0.033) µg/ml (equivalent to approximately 0.223 µM), area
under the curve (AUC
0-24
) is 0.96 (± 0.26) µg x hr/ml, and oral bioavailability is 79 (± 31) percent.
The elimination half-life (t
½
) after a single dose is 29.6 (± 7.5) hours and 50.6 hours after 14 days of
dosing. Firocoxib is approximately 97% bound to plasma proteins. Following multiple oral
administrations, the steady state is reached by approximately the eighth daily dose. Firocoxib is
metabolised predominantly by dealkylation and glucuronidation in the liver. Elimination is principally
in the excreta (primarily the urine), with some biliary excretion also observed.
6.
6.1 List of excipients
Titanium dioxide (E 171)
Glycerol triacetate
10
Silica, colloidal anhydrous
Magnesium carbonate, heavy
Macrogol 300
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf life after first opening the syringe: 3 months
6.4 Special precautions for storage
Replace cap after use.
This medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Pre-filled oral syringes made of polypropylene, with a polyethylene cap, a rubber rod tip, and a
polypropylene plunger rod.
Each syringe contains a net weight of 7.32 g of oral paste and is labelled in 100 kg dosing increments.
Each syringe is packaged in an individual carton box.
6.6
Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
MERIAL
29 avenue Tony Garnier
FR-69007 Lyon
France.
8. MARKETING AUTHORISATION NUMBER
EU/2/04/045/007
13/09/2004
10/04/2008
11
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 (EMA)
http://www.ema.europa.eu/
12
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
13
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Merial S.A.S.
4 Chemin de Calquet
31300 Toulouse
France
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
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
In accordance with Council Regulation (EEC) No 2377/90, as amended and in accordance with Article
34.4b of Regulation (EC) No 726/2004 of 31 March 2004.
Firocoxib is included in Annex I of Council Regulation (EEC) No 2377/90 in accordance with the
following table:
Pharmacologically
active substance(s)
Marker
residue
Animal
species
MRLs
Target
tissues
Other provisions
Firocoxib
Firocoxib
Equidae
10 μg/kg
15 μg/kg
60 μg/kg
10 μg/kg
Muscle
Fat
Liver
Kidney
14
ANNEX III
LABELLING AND PACKAGE LEAFLET
15
A. LABELLING
16
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton Box labelling
1.
Previcox 57 mg chewable tablets for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Firocoxib 57 mg
3.
Chewable tablet
4.
PACKAGE SIZE
10 tablets
30 tablets
180 tablets
5.
Dogs
6.
Pain and inflammation associated with osteoarthritis.
Peri-operative pain management.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Administer 5 mg per kg bodyweight once daily.
8.
Not applicable
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
17
10. EXPIRY DATE
EXP {month/year}
Half tablets should be returned to the original market container and may be stored for up to 7 days
11. SPECIAL STORAGE CONDITIONS
Do not store above 30°C.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
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.
MERIAL, 29 avenue Tony Garnier, FR-69007 Lyon, France
EU/2/04/045/001 10 tablets
EU/2/04/045/002 30 tablets
EU/2/04/045/005 180 tablets
17. MANUFACTURER’S BATCH NUMBER
Lot
18
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton Box labelling
1.
Previcox 227 mg chewable tablets for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Firocoxib 227 mg
3.
Chewable tablet
4.
PACKAGE SIZE
10 tablets
30 tablets
180 tablets
5.
Dogs
6.
Pain and inflammation associated with osteoarthritis.
Peri-operative pain management.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Administer 5 mg per kg bodyweight once daily.
8.
Not applicable
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
19
10. EXPIRY DATE
EXP {month/year}
Half tablets should be returned to the original market container and may be stored for up to 7 days
11. SPECIAL STORAGE CONDITIONS
Do not store above 30°C.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
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.
MERIAL, 29 avenue Tony Garnier, FR-69007 Lyon, France
EU/2/04/045/003 10 tablets
EU/2/04/045/004 30 tablets
EU/2/04/045/006 180 tablets
17. MANUFACTURER’S BATCH NUMBER
Lot
20
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
{NATURE/TYPE}
1.
Previcox 57 mg chewable tablets
Firocoxib
2.
MERIAL
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot
21/33
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
{NATURE/TYPE}
1.
Previcox 227 mg chewable tablets
Firocoxib
2.
MERIAL
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot
22
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton box labelling
1.
Previcox 8.2 mg/g oral paste for horses.
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Firocoxib 8.2 mg/g
3.
Oral paste.
4.
PACKAGE SIZE
1 syringe.
5.
Horses.
6.
INDICATION(S)
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated
lameness in horses
.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
8.
Withdrawal period: Meat and offal: 26 days.
Do not use in mares producing milk for human consumption.
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
23
10. EXPIRY DATE
EXP {month/year}
Once broached, use within 3 months.
11. SPECIAL STORAGE CONDITIONS
This medicinal product does not require any special storage conditions. Replace cap after use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS , IF ANY
Read the package leaflet before use.
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.
MERIAL, 29 avenue Tony Garnier, FR-69007 Lyon, France.
EU/2/04/045/007
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
24
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Syringe labelling
1.
Previcox 8.2 mg/g oral paste for horses
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Firocoxib 8.2 mg/g
3.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
7.32 g of oral paste
4.
ROUTE(S) OF ADMINISTRATION
Oral use.
5.
Withdrawal period: Meat and offal: 26 days.
Do not use in mares producing milk for human consumption.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Once broached, use within 3 months.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET
Previcox 57 mg chewable tablets for dogs
Previcox 227 mg chewable tablets for dogs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
:
MERIAL, 29 avenue Tony Garnier, FR-69007 Lyon, France
Manufacturer for the batch release
:
MERIAL, 4 Chemin du Calquet, FR-31300 Toulouse, France
2.
Previcox 57 mg chewable tablets for dogs
Previcox 227 mg chewable tablets for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each tablet contains:
Firocoxib 57 mg
Firocoxib 227 mg
Iron oxides (E172)
Caramel (E150d)
4.
For the relief of pain and inflammation associated with osteoarthritis in dogs.
For the relief of post-operative pain and inflammation associated with soft-tissue and orthopaedic
surgery in dogs.
5.
Do not use in pregnant or lactating bitches.
Laboratory studies in rabbits have shown evidence of maternotoxic and foetotoxic effects at dose rates
approximating the recommended treatment dose for the dog.
Do not use in animals less than 10 weeks of age or less than 3 kg bodyweight.
Do not use in animals suffering from gastrointestinal bleeding, blood dyscrasia or haemorrhagic
disorders.
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs
(NSAID).
6.
ADVERSE REACTIONS*
Emesis and diarrhoea have occasionally been reported. These reactions are generally of a transitory
nature and are reversible when the treatment is stopped. Renal and/or hepatic disorders have been
reported in very rare cases in dogs administered the recommended treatment dose
.
Rarely, nervous
system disorders have been reported in treated dogs
27
If adverse reactions like vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss,
anorexia, lethargy, degradation of renal or hepatic biochemistry parameters occur, use of the product
should be stopped and the advice of a veterinarian should be sought. As with other NSAIDs, serious
adverse effects can occur and, in very rare cases, may be fatal.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
* The frequency of possible adverse effects is defined using the following convention:
Rare (affects 1 to 10 animals in 10,000)
Very rare (affects less than 1 animal in 10,000)
7.
Dogs.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
5 mg/kg once daily.
For the reduction of post-operative pain and inflammation, the animals can be dosed starting
approximately 2 hours before surgery for up to 3 consecutive days as needed. Following orthopaedic
surgery and depending on the response observed, treatment using the same daily dosing schedule may
be continued after the first 3 days, upon judgement of the attending veterinarian.
For oral use as per table below.
Body weight (kg)
Number of chewable tablets by size
57
mg
227
mg
3 – 5.5
0.5
5.6 – 10
1
10.1 – 15
1.5
15.1 – 22
0.5
22.1 – 45
1
45.1 – 68
1.5
68.1 – 90
2
9.
ADVICE ON CORRECT ADMINISTRATION
Tablets can be administered with or without food. Do not exceed the recommended dose.
Duration of treatment will be dependent on the response observed. As field studies were limited to 90
days, longer-term treatment should be considered carefully and regular monitoring undertaken by the
veterinarian.
10. WITHDRAWAL PERIOD
Not applicable
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
28
Do not store above 30°C.
In order to protect from moisture, store in the original package.
Do not use after the expiry date stated on the label
Half tablets should be returned to the original market container and may be stored for up to 7 days
12. SPECIAL WARNING(S)
Use in very young animals, or animals with suspected or confirmed impairment of renal, cardiac or
hepatic function may involve additional risk. If such use cannot be avoided, those dogs require careful
veterinary monitoring. Appropriate laboratory testing is recommended prior to treatment in order to
detect subclinical (asymptomatic) renal or hepatic disorders that may predispose to adverse effects.
Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a risk of increased
renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided.
Use this product under strict veterinary monitoring where there is a risk of gastro-intestinal bleeding,
or if the animal previously displayed intolerance to NSAIDs. The treatment should be discontinued if
any of these signs are observed: repeated diarrhoea, vomiting, faecal occult blood, sudden weight loss,
anorexia, lethargy, degradation of renal or hepatic biochemistry parameters.
As anaesthetic drugs may affect renal perfusion, the use of parenteral fluids during surgery should be
considered to decrease potential renal complications when using NSAIDs peri-operatively.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse
effects and accordingly a treatment-free period with such drugs should be observed for at least 24
hours before the commencement of treatment with Previcox. The treatment-free period, however,
should take into account the pharmacokinetic properties of the products used previously.
Previcox must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Gastrointestinal tract ulceration may be exacerbated by corticosteroids in animals given non-steroidal
anti-inflammatory drugs.
Concomitant treatment with molecules displaying action on renal flow, e.g. diuretics or Angiotensin
Converting Enzyme (ACE) inhibitors, should be subject to clinical monitoring. Concurrent
administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk
for renal toxicity. Concurrent use of other active substances that have a high degree of protein binding
may compete with firocoxib for binding and thus lead to toxic effects.
In case of accidental ingestion, seek medical advice immediately and show the package insert or the
label to the physician.
Wash hands after use of the product.
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 local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
01/2010
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu
15. OTHER INFORMATION
29
Mode of action:
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of
cyclooxygenase-2 (COX-2) – mediated prostaglandin synthesis. COX-2 is the isoform of the enzyme
that has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain,
inflammation, and fever. In
in-vitro
canine whole blood assays, firocoxib exhibited approximately
380-fold selectivity for COX-2 over COX-1.
Previcox Chewable tablets are scored to facilitate accurate dosing and contain caramel and smoke
flavours to facilitate administration to dogs. Not all pack sizes may be marketed.
The chewable tablets are available in the following pack sizes:
57 mg: 1 carton box containing one blister of 10 tablets
1 carton box containing three blisters of 10 tablets each
1 carton box containing eighteen blisters of 10 tablets each
227 mg: 1 carton box containing one blister of 10 tablets
1
box
containing
three
blisters
of
10
tablets
each
1 carton box containing eighteen blisters of 10 tablets each
30
carton
PACKAGE LEAFLET
Previcox 8.2 mg/g oral paste for horses
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Marketing authorisation holder
:
MERIAL, 29 avenue Tony Garnier, 69007 Lyon, France.
Manufacturer for the batch release
:
MERIAL, 4 chemin du Calquet, FR-31300 Toulouse, France.
2.
Previcox 8.2 mg/g oral paste for horses.
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Firocoxib 8.2 mg/g
4.
INDICATIONS
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated
lameness in horses
.
5.
Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic,
cardiac or renal function and bleeding disorders.
Do not use in breeding, pregnant or lactating animals.
Do not use concomitantly with corticosteroids or other NSAIDs.
6.
ADVERSE REACTIONS
Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be
observed in treated animals. Typically, these lesions are mild and resolve without treatment, but oral
lesions may be associated with salivation and labial and tongue oedema.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Horses.
8.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
0.1 mg firocoxib per kg bodyweight, once daily for up to 14 days.
31
Oral use.
9.
ADVICE ON CORRECT ADMINISTRATION
To administer Previcox at the dose of 0.1 mg firocoxib/kg, set the syringe plunger to the appropriate
dose division for the horse’s weight. Each full dose division on the syringe plunger delivers sufficient
firocoxib to treat 100 kg body weight. The contents of one syringe will treat horses weighing up to
600 kg.
To deliver firocoxib at the appropriate dosage, unlock the knurled ring on the syringe plunger by
rotating it ¼ turn and slide it along the plunger shaft to the appropriate dose division for the horse’s
weight. Rotate the plunger ring ¼ turn to lock it in place and ensure it is locked.
Make sure the horse’s mouth contains no feed. Remove the cover from the tip of the syringe. Insert the
syringe tip into the horse’s mouth at the interdental space and deposit the paste on the base of the
tongue.
10. WITHDRAWAL PERIOD
Withdrawal period: Meat and offal: 26 days.
Do not use in mares producing milk for human consumption.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Replace cap after use.
Do not use after the expiry date stated on the label.
Shelf-life after first opening the syringe: 3 months.
12. SPECIAL WARNINGS
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be
sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there may be potential
risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be
avoided.
Do not use in animals less than 10 weeks.
The recommended treatment dose and duration should not be exceeded.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
Avoid contact with eyes and skin. If it occurs, rinse affected area immediately with water.
Wash hands after use of the product.
Pregnant women should avoid contact with the medicinal product.
Other NSAIDs, diuretic and substances with high protein binding may compete for binding and lead to
toxic effects. Do not use concomitantly with corticosteroids or other NSAIDs.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse
effects and a treatment-free period with such products should therefore be observed. The treatment-
free period should take into account the pharmacological properties of the products used previously.
32
Concomitant treatment with molecules displaying action on renal flow (e.g. diuretics) should be
subject to clinical monitoring. Concurrent administration of potentially nephrotoxic drugs should be
avoided as there might be an increased risk of renal toxicity.
No data on use during pregnancy is available in horses. Therefore, do not use in breeding, pregnant or
lactating animals.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
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
Detailed information on this product is available on the website of the European Medicines Agency
15. OTHER INFORMATION
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which
acts by selective inhibition of cyclooxygenase-2 (COX-2)-mediated prostaglandin synthesis.
Each syringe is packaged in an individual carton box.
33
Source: European Medicines Agency
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