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Date: Saturday, October 12, 2024 9:13

Release 2.121
Carprieve 50 mg Tablets for Dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Oral: Other NSAIDs
Active ingredient: Carprofen
Product:Carprieve 50mg Tablets for Dogs
Product index: Carprieve Tablets 50 mg
Incorporating:
Qualitative and quantitative composition
Each tablet contains:
Active Substance:
Carprofen
50 mg
Excipients:
For a full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Tablet.
A white/off white circular tablet of diameter 8 mm, 50 embossed on one side and a single break line on the other side.
Clinical particulars
Target species
Dogs
Indications for use, specifying the target species
For analgesia and reduction of chronic inflammation, for example in degenerative joint disease, in dogs.
Carprieve Tablets can also be used in the management of post-operative pain.
Contraindications
The use of Carprieve Tablets is contraindicated in the cat, and the inadvertent administration of oral carprofen tablets may induce life-threatening conditions in this species.
Do not exceed the stated dose.
Do not administer NSAIDs concurrently or within 24 hours of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs, which can lead to toxic effects.
Do not use in dogs suffering from cardiac, hepatic or renal disease, where there is a possibility of gastrointestinal ulceration or bleeding, or where there is evidence of a blood dyscrasia or hypersensitivity to the product.
Special Warnings for each target species
Use in dogs less than 6 weeks of age, or in aged animals, may involve additional risk. If such use cannot be avoided, such dogs may require a reduced dosage and careful clinical management.
Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk of increased renal toxicity.
NSAIDs can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infection, appropriate concurrent antimicrobial therapy should be instigated.
Special precautions for use
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
None.
Adverse reactions (frequency and seriousness)
None.
Use during pregnancy, lactation or lay
In the absence of any specific studies in pregnant bitches such use is not indicated.
Interaction with other medicinal products and other forms of interaction
Do not administer NSAIDs concurrently or within 24 hours of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs, which can lead to toxic effects.
Concurrent administration of potential nephrotoxic drugs should be avoided.
Amounts to be administered and administration route
For oral administration.
An initial dose of 2 to 4 mg carprofen/kg bodyweight/day is recommended to be given in 2 equally divided doses. The dose may be reduced to 2 mg carprofen/kg bodyweight/day administered as a single daily dose after 7 days, subject to clinical response.
Duration of treatment will be dependent upon the response seen. Long term treatment should be under regular veterinary supervision.
To extend analgesic cover post-operatively, parenteral administration of carprofen, may be followed with Carprieve Tablets.
Overdose (symptoms, emergency procedures, antidotes), if necessary
There is no specific antidote for carprofen overdosage but general supportive therapy as applied to clinical overdosage with NSAIDs should be applied.
Withdrawal period
Not applicable.
Pharmacological particulars
Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug
ATC Vet Code: QM01AE91
Pharmacodynamic properties
Carprofen, (±)-6-chloro-α-methylcarbazole-2-acetic acid, is a non-steroidal anti-inflammatory drug (NSAID). It is a derivative of phenylpropionic acid and a member of the arylpropionic acid class of NSAIDs. As a representative of the 2-arylpropionic family, it contains a chiral center at C2 of the propionic moiety and therefore, exists in 2 sterioisomeric forms, the (+)-S and (-)-R enantiomers.
Pharmacokinetic properties
Following oral administration of 4mg carprofen/kg to dogs, peak plasma concentrations (mean Cmax = 28.51 μg/ml) were achieved in 4 hours.
Absorption of carprofen is rapid and complete in the dog. The volume of distribution is small with the highest drug concentrations occurring in plasma. Ratios of tissue to plasma concentration are less than one, which is consistent with a high level of binding of carprofen to plasma proteins.
Pharmaceutical particulars
List of excipients
Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Poly-vinyl pyrrolidone K 30
Sodium laurilsulfate
Magnesium stearate
Purified water
Incompatibilities
None.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale:
Tubs: 36 months
Blister strips: 24 months
Special precautions for storage
Do not store above 25°C.
Store in a dry place.
Protect from light.
Nature and composition of immediate packaging
Carprieve Tablets are supplied in:
Polypropylene Snap Secure Tubs, containing 100 or 500 tablets, sealed with a white Polyethylene Snap Secure Cap.
Alu/Alu blister strips of 2 x 5 tablets.
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 material should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
Norbrook Laboratories Limited, Station Works, Newry, Co. Down, BT35 6JP Northern Ireland
Marketing Authorisation Number
Vm 02000/4221
Significant changes
Date of the first authorisation or date of renewal
5th September 2003/ 5th September 2008
Date of revision of the text
January 2009
Any other information
Nil.
Legal category
Legal category: POM-V
GTIN
GTIN description:Carprieve 50mg Tablets
GTIN:5023534008293
GTIN description:Carprieve 50mg (100 Pack)
GTIN:5023534008316
GTIN description:Carprieve 50mg (500 Tablets)
GTIN:5023534008309
GTIN description:Carprieve 50mg (500 Pack)
GTIN:5023534008323