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Date: Thursday, April 25, 2024 19:59

Description: Krka Logo
Release 3.480
Rycarfa 20mg, 50mg, 100mg Tablets for Dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Oral: Other NSAIDs
Active ingredient: Carprofen
Product:Rycarfa 20mg, 50mg, 100mg Tablets for Dogs
Product index: Rycarfa 20mg, 50mg, 100mg Tablets for Dogs
Incorporating:
Presentation
Round, dark brown, marbled tablets with visible darker spots, one-side scored and bevel-edged. The tablet can be divided into equal halves.
Description: Rycarfa composisiont
Uses
Reduction of inflammation and pain caused by musculoskeletal disorders and degenerative joint disease. As a follow up to parenteral analgesia in the management of post operative pain.
Dosage and administration
FOR ORAL ADMINISTRATION.
2 to 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 or in two equally divided doses may, subject to clinical response, be reduced after 7 days to 2 mg carprofen/kg bodyweight/day given as a single dose.
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 may be followed with Carprofen tablets at 4 mg/kg/day for up to 5 days.
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.
Contra-indications, warnings, etc
Do not use in cats.
Do not use in pregnant or lactating bitches.
Do not use in dogs less than 4 months of age.
Do not use in case of hypersensitivity to 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 gastrointestinal ulceration or bleeding, or where there is evidence of a blood dyscrasia.
There is no specific antidote for carprofen overdosage but general supportive therapy, as applied to clinical overdosage with NSAIDs should be applied.
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.
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.
Typical undesirable effects associated with NSAIDs such as vomiting, soft faeces/diarrhoea, 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.
As with other NSAIDs there is a risk of rare renal or idiosyncratic hepatic adverse events.
Overdose
Although studies investigating the safety of carprofen at overdose have been performed, 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 4mg/kg) and 6mg/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 applied.
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.
Interactions
Do not administer other NSAIDs and glucocorticoids concurrently or within 24 hours of administration of the product. Carprofen is highly bound to plasma proteins and may compete with other highly bound drugs, which can lead to toxic effects.
Concurrent administration of potential nephrotoxic drugs should be avoided.
Environmental Safety
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Pharmaceutical precautions
Store in the original packaging in order to protect from light and moisture.
Shelf-life of unopened package: 3 years.
Return any halved tablet to the opened blister and use within 24 hours.
Legal category
Legal category: POM-V
Packaging quantities
Aluminium blisters of 10 tablets. Packaged into boxes of 100.
Marketing Authorisation Holder (if different from distributor)
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Further information
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids.
ATCvet code: QM01AE91
Carprofen possesses anti-inflammatory, analgesic and antipyretic activity. Like most other NSAID’s, carprofen is an inhibitor of the enzyme cyclo-oxygenase of the arachidonic acid cascade.
However, the inhibition of prostaglandin synthesis by carprofen is slight in relation to its anti-inflammatory and analgesic potency. The precise mode of action of carprofen is not clear.
Carprofen is a chiral drug with the S(+) enantiomer being more active than the R(-) enantiomer. There is no chiral inversion between the enantiomers in-vivo.
Carprofen is well absorbed after oral administration (90%) and is highly protein bound. Peak plasma concentrations are achieved between 1 h and 3 h after administration. Carprofen is characterized by a half-life of approximately 10 hours in dogs. Carprofen is eliminated in dogs primarily by means of biotransformation in the liver, followed by rapid excretion of the resulting metabolites in faeces (70-80%) and urine (10-20%). Some enterohepatic circulation has been detected.
Marketing Authorisation Number
Rycarfa 20mg Tablets for Dogs Vm 01656/4069
Rycarfa 50mg Tablets for Dogs Vm 01656/4070
Rycarfa 100mg Tablets for Dogs Vm01656/4071
Significant changes
GTIN
GTIN description:Rycarfa 20mg Tablets for Dogs (100 tablets)
GTIN:03838989723811
GTIN description:Rycarfa 50mg Tablets for Dogs (100 tablets)
GTIN:03838989723804
GTIN description:Rycarfa 100mg Tablets for Dogs (100 tablets)
GTIN:03838989723828