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1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Carprodyl Quadri 120 mg chewable tablets for dogs

Carprodyl vet. 120 mg chewable tablets for dogs (FI, SE, DK)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

One tablet contains:

Carprofen ....................................................... 120 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Chewable tablet.

Clover-shaped scored beige tablet

The tablet can be divided into four equal parts.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs.

4.2 Indications for use, specifying the target species

In the dog:

Reduction of inflammation and pain caused by musculo-skeletal disorders and degenerative joint disease.

As a follow-up to parenteral analgesia in the management of post-operative pain.

4.3 Contraindications

Do not use in pregnant and lactating bitches.

Do not use in dogs aged less than 4 months in the absence of specific data.

Do not use in cats.

Do not use in dogs, suffering from cardiac, hepatic or renal disease, when there is a possibility of gastrointestinal ulceration or bleeding or where there is evidence of blood dyscrasia.

Do not use in case of hypersensitivity to the active substance, to other NSAID and to any of the excipients.

4.4 Special warnings for each target species

See sections 4.3 and 4.5.

4.5 Special precautions for use Special precautions for use in animals

Use in dogs less than 6 weeks of age, or in aged dogs, may involve additional risk. If such a use cannot be avoided, 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.

Concurrent administration of potential nephrotoxic drugs should be avoided. NSAID can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infection, appropriate concurrent antimicrobial therapy should be instigated.

As with other NSAID, photodermatitis during treatment with carprofen has been observed in laboratory animals and in humans. These skin reactions have never been observed in dogs.

Do not administer other NSAID concurrently or within 24 hours of each other. Some NSAID may be highly bound to plasma proteins and compete with other highly bound drugs, which can lead to toxic effects.

Due to the good palatability of the tablet, they should be stored in a safe place out of the reach of animals. Intake of dose exceeding the recommended number of tablets may lead to severe adverse effects. If this is the case, seek veterinary assistance immediately.

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 to the physician. Wash hands after handling the product.

4.6 Adverse reactions (frequency and seriousness)

Typical undesirable effects associated with NSAID, such as vomiting, soft faeces/diarrhea, faecal occult blood, loss of appetite and lethargy have been reported. These adverse reactions generally occur within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, use of the product should be stopped and the advice of a veterinarian should be sought.

As with other NSAID there is a risk of rare renal or idiosyncratic hepatic adverse events.

4.7 Use during pregnancy and lactation

Studies in laboratory species (rat and rabbit) have shown evidence of foetotoxic effects of carprofen at doses close to the therapeutic dose. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Do not use in pregnant or lactating bitches. For breeding animals, do not use during reproduction period.

4.8 Interaction with other medicinal products and other forms of interaction

Carprofen is highly bound to plasma proteins and compete with other highly bound drugs, which can increase their respective toxic effects.

Do not use this veterinary medicinal drug concurrently with other NSAID or with glucocorticoids.

Concurrent administration of potentially nephrotoxic drugs (e.g. aminogylcoside antibiotics) should be avoided.

Refers also to section 4.5

4.9 Amounts to be administered and administration route

For oral administration.

4 mg carprofen per kg bodyweight per day.

An initial dose of 4 mg carprofen per kg bodyweight per day given as a single daily dose. The analgesic effect from each dose persists for at least 12 hours.

The daily dose may be reduced, 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 and anti-inflammatory cover post-operatively parenteral preoperative treatment with an injectable carprofen may be followed with carprofen tablets at 4 mg/kg/day for 5 days. Do not exceed the stated dose.

Tablets can be broken as follows: Put the tablet on a flat surface, with its scored side facing the surface (convex face up).

With the tip of forefinger, exert a slight vertical pressure on the middle of the tablet to break it into halves. In order to obtain quarters, then exert a slight pressure on the middle of one half with forefinger.

Each chewable tablet can be quartered for accurate dosing according to the individual body weight of the animal.

Number of tablets per day

Dog weight (kg)

¼

 7.5

 14.5

 21

 30

 37.5

 45

 52.5

 60

< 14.4

< 20.9

< 29.9

< 37.4

< 44.9

< 52.4

< 59.9

< 70

½

¾

1

1 ¼

1 ½

1 ¾

2

The chewable tablets are flavoured and are accepted by dogs. The chewable tablets can be administered with or without food.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Bibliographic data report that carprofen is well tolerated in dogs at twice the recommended dosage for 42 days.

There is no specific antidote to carprofen but general supportive therapy as applied to clinical overdose with NSAIDs should be applied.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

ATCvet code: QM01AE91

Pharmacotherapeutic group: anti-inflammatory, NSAID, aryl proprionic acids

5.1 Pharmacodynamic properties

Carprofen is a non-steroidal anti-inflammatory drug (NSAID), of the 2-aryl propionic acid class and possesses anti-inflammatory, analgesic and antipyretic activities. The mechanism of action of carprofen, is not well known. However, it was shown that the inhibition of the cyclo-oxygenase enzyme by carprofen is relatively weak at the recommended dosage. Moreover, it was shown that carprofen doesn’t inhibit the generation of thromboxane (TX) B2 in dog clotting blood and neither prostaglandin (PG) E2 nor 12-hydroxyeicosatetraenoic acid (HETE) in inflammatory exudate are inhibited. This suggests the mechanism of action of carprofen is not the inhibition of the eicosanoids. Some authors suggested an activity of carprofen on one or numerous inflammatory mediators not yet identified but no clinical evidence could be shown.

Carprofen exists in two enantiomeric forms, R(-)-carprofen and S(+)-carprofen and the racemic form is the one marketed. Laboratory animal studies suggest that the S(+) enantiomer possesses greater anti-inflammatory potency.

Ulcerogenic potential of carprofen has been shown in the rodents but not in the dogs.

5.2 Pharmacokinetic particulars

After a single oral administration of 4 mg of carprofen per kg of bodyweight in dog, the time to obtain a maximum plasmatic concentration of 23µg/ml is about 2 hours. The oral bioavailability is more than 90% of the total dose. Carprofen is more than 98% bound to plasma proteins and its volume of distribution is low.

Carprofen is excreted in the bile with 70 % of an intra-venous dose of carprofen being eliminated in the faeces, mainly as the glucuronide conjugate. Carprofen undergoes an enantioselective enterohepatic cycle in dog, with only the S(+) enantiomer being significantly recycled. The plasmatic clearance of the S(+) carprofen is about twice that of the R(-) carprofen. The biliary clearance of S(+) carprofen seems to be subject to stereoselectivity too as it is about three times higher than that of R(-) carprofen.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Pig liver flavour

Yeast,

Croscarmellose sodium,

Copovidone,

Magnesium stearate,

Anhydrous colloidal silica,

Microcrystalline cellulose, Lactose monohydrate.

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 immediate packaging:

72 hours

6.4. Special precautions for storage

Do not store above 30°C Protect from light.

Divided tablets should be stored in the blister pack. Any divided tablet portions remaining after 72 hours should be discarded.

6.5 Nature and composition of immediate packaging

Blister complex: PVDC-PVC/Aluminium heat sealed blisters with 6 tablets / blister.

Cardboard box with 2 blisters of 6 tablets.

Cardboard box with 20 blisters of 6 tablets.

Cardboard box with 40 blisters of 6 tablets.

Cardboard box with 80 blisters of 6 tablets.

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. MARKETING AUTHORISATION HOLDER

Ceva Animal Health Ltd

Unit 3, Anglo Office Park

White Lion Road

Amersham

Buckinghamshire

HP7 9FB

  1. MARKETING AUTHORISATION NUMBER

Vm 15052/4093

  1. DATE OF FIRST AUTHORISATION

4 February 2010

10. DATE OF REVISION OF THE TEXT

October 2016

Approved: 20 October 2016

Presentation

Carprodyl® F tablets are scored, circular beige tablets containing as active ingredient 20 mg, 50 mg or 100 mg carprofen.

Uses

For analgesia and reduction of inflammation caused by musculo-skeletal disorders and degenerative joint disease of the dog. Carprodyl® F tablets can also be used as a follow-up to parenteral analgesia in the management of post-operative pain in dogs.

Dosage and administration

For oral administration. The tablets are flavoured and are readily consumed by most dogs when offered. An initial dose of 4 mg carprofen/kg bodyweight/day is recommended to be given as a single dose or in two equally divided doses. Subject to clinical response the dose may be reduced. To extend analgesic and anti-inflammatory cover post operatively, parenteral therapy with carprofen injection may be followed with carprofen tablets at 4mg/kg/day for up to 5 days.

Duration of treatment will be dependent upon the response seen. Long-term treatment should be under regular veterinary supervision. Do not exceed stated dose.

Contra-indications, warnings, etc

The elimination time of NSAIDs, including carprofen, in the cat is longer than in the dog and the therapeutic index is narrower. Consequently, do not use in cats.

Do not use in pregnant or lactating bitches.

Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.

Do not use in dogs suffering from cardiac, hepatic or renal disease, where there is a possibility of gastro-intestinal ulceration or bleeding or where there is evidence of a blood dyscrasia or hypersensitivity to the product. Do not use in puppies less than 4 months of age.

Special precautions for use in animals

Use in aged dogs may involve additional risk. If such a use cannot be avoided, dogs may require careful clinical management. Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided.

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.

Do not administer other NSAIDs concurrently or within 24 hours. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs, which can lead to toxic effects.

Response to long-term treatment should be monitored at regular intervals by a veterinary surgeon.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

In the event of accidental ingestion of the tablets, seek medical advice and show the doctor the package leaflet. Wash hands after handling the product.

Adverse reactions

Typical undesirable effects associated with NSAIDs, such as vomiting, soft faeces/diarrhea, faecal occult blood, loss of appetite and lethargy have been reported. These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal. Rare cases of gastrointestinal bleeding are reported. If adverse reactions occur, use of the product should be stopped and the advice of a veterinarian should be sought. As with other NSAIDs there is a rare risk of renal or idiosyncratic hepatic adverse events.

Overdose

No signs of toxicity appeared when dogs were treated with carprofen at levels up to 6 mg/kg twice daily for 7 days (3 times the recommended dose rate of 4 mg/kg) and 6 mg/kg once daily for a further 7 days (1.5 times the recommended dose rate of 4 mg/kg). There is no specific antidote for carprofen overdosage but general supportive therapy, as applied to clinical overdosage with NSAIDs, should be given. Due to the flavourings in the tablets, store in a secure location. Severe adverse reactions may occur if large quantities are ingested. If you suspect that your dog has consumed tablets above the labelled dose, contact your veterinarian.

Interaction with other medicinal products and other forms of interaction

Carprofen must not be administered with glucocorticoids.

For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

This medicinal product does not require any special temperature storage conditions

Store tablets and half-tablets in the original blister in order to protect from light.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

Box containing 2 blisters of 10 tablets

Box containing 10 blisters of 10 tablets

Box containing 20 blisters of 10 tablets

Box containing 50 blisters of 10 tablets

Not all pack sizes may be marketed.

Further information

Carprofen is a non-steroidal anti-inflammatory drug (NSAID) of the 2-aryl propionic acid class and possesses anti-inflammatory, analgesic and antipyretic activities.

The mechanism of action of carprofen, like other NSAIDs, is believed to be associated with the inhibition of cyclo-oxygenase activity.

Two unique cyclo-oxygenases have been described in mammals. The constitutive cyclo-oxygenase, COX-1, synthesizes prostaglandins necessary for normal gastrointestinal and renal function. The inducible cyclo-oxygenase, COX-2, generates prostaglandins involved in inflammation. Inhibition of COX-1 is thought to be associated with gastrointestinal and renal toxicity while inhibition of COX-2 provides anti-inflammatory activity. In an in-vitro study, using canine cell cultures, carprofen demonstrated selective inhibition of COX-2 versus COX-1. Clinical relevance of these data has not be shown.

Carprofen has also been shown to inhibit the release of several prostaglandins in two inflammatory cell systems: rat polymorphonuclear leukocytes (PMN) and human rheumatoid synovial cells, indicating inhibition of acute (PMN system) and chronic (synovial cell system) inflammatory reactions.

Several studies have demonstrated that carprofen has modulatory effects on both humoral and cellular immune responses. Carprofen also inhibits the production of osteoclast-activating factor (OAF), PGE1 and PGE2 by its inhibitory effect on prostaglandin biosynthesis.

After oral administration, carprofen is well absorbed in the dogs. Following the administration of the product tablets in dogs, a mean Cmax (maximum concentration in serum) of 6.1 mg/L and 3.6 mg/L was achieved at approximately 1 hour for Carprofen R(-) and Carprofen S(+), respectively. For both enantiomers, the mean half-life was approximately 9 hours. The analgesic effect from each dose persists for at least 12 hours.

Carprofen has a small volume of distribution and a low systemic clearance. It is highly bound to plasma protein. Carprofen is metabolised in the liver by conjugation and oxidation. The excretion of the glucuronide conjugate is mainly faecal after biliary excretion.

Marketing authorisation number

Carprodyl® F 20 mg - Vm 15052/4033

Carprodyl® F 50 mg - Vm 15052/4034

Carprodyl® F 100 mg - Vm 15052/4035

GTIN

Carprodyl F 100mg:

03411111879022

Carprodyl F 50mg:

03411111878995

Carprodyl F 20mg:

03411111878438

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