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Rheumofen 100 mg chewable tablets for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Carprofen …………… ..100 mg
3. PHARMACEUTICAL FORM
White to whitish, single-color, round and flat tablet with a beveled edge and a dividing line of
one side. The tablet can be divided into equal halves.
4. CLINICAL PARTICULARS
4.1 Species for which the VMP is intended
4.2 Indications for use, specifying the target species
To reduce the inflammation and pain caused by musculoskeletal disorders and
degenerative joint disease. As a continuation of parenteral analgesia in management
of postoperative pain.
Do not use in cats.
Do not use in puppies under 4 months of age.
Do not use in case of hypersensitivity to the active substance or to any of them
Do not use in dogs suffering from heart, liver or kidney disease,
where there is a possibility of gastrointestinal ulceration and bleeding, or where there is
doubts about blood dyscrasia.
4.4 Special precautions for use in any animal for which the veterinary medicinal product is intended
See sections 4.3 and 4.5.
4.5 Special precautions for use
Special precautions for use in animals
Use in elderly dogs may lead to additional risk. If so
use can not be avoided, dogs need careful clinical observation.
Avoid use in dehydrated, hypovolaemic or hypotensive dogs, as
as there is a potential risk of increased renal toxicity.
The joint use of potentially nephrotoxic veterinary medicinal products
should be avoided.
NSAIDs may cause phagocytosis suppression and therefore, in the treatment of inflammatory
conditions associated with a bacterial infection must be undertaken appropriately,
concomitant, antibacterial treatment.
Do not use other NSAIDs together or within 24 hours of using this
veterinary medicinal product.
Some NSAIDs can be highly bound to plasma proteins and thus
to compete in connection with other veterinary medicinal products, which are also
high plasma protein binding, which can lead to toxic effects.
Special precautions to be taken by the person administering the veterinary medicinal product to humans
In case of accidental ingestion seek medical advice immediately and show medical advice
provide the package leaflet or product label. After handling the product, wash hands.
4.6 Adverse reactions (frequency and seriousness)
Typical adverse reactions associated with NSAIDs, such as vomiting,
softening of stools / diarrhea, hidden blood in stools, loss of appetite and lethargy.
These adverse reactions occur mainly during the first week of treatment,
in most cases, are transient and disappear after discontinuation of treatment, but in many
rare cases can be serious and fatal.
If adverse reactions occur, the use of the product should be discontinued
you should seek advice from a veterinarian.
As with other NSAIDs, there is a rare risk of kidney or idiosyncratic
hepatic adverse reactions.
4.7 Use during pregnancy, lactation or lay
Laboratory studies in rats and rabbits have demonstrated foetotoxicity of carprofen in rats
doses close to the curative.
The safety of the veterinary medicinal product has not been established during pregnancy
It is not recommended to use it during pregnancy and lactation.
4.8 Interaction with other veterinary medicinal products and other forms
Carprofen should not be co-administered with glucocorticoids. Look. point 4.5.
4.9 Amounts to be administered and administration route
4 mg carprofen / kg body weight / day.
Initial dose of 4 mg carprofen / kg body weight / day given as a single daily dose
or as two equally divided doses. The daily dose may be reduced depending on
The duration of treatment will depend on the response observed. Prolonged
treatment should be performed under close supervision by a veterinarian.
For analgesic and anti-inflammatory, post-operative coverage can be applied
preoperative, parenteral treatment with carprofen injection, followed by administration of
carprofen in the form of tablets at a dose of 4 mg / kg / day for 5 days
Do not exceed the indicated dose.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
There are no signs of toxicity in dogs treated with carprofen at a dose of up to 6 mg / kg
twice daily for 7 consecutive times (3 times the recommended dose)
of 4 mg / kg body weight) and 6 mg / kg body weight once daily for a further 7 days
(1.5 times the recommended dose of 4 mg / kg). There is no specific antidote for overdose with
carprofen, but clinic-based therapy should be undertaken
overdose with NSAIDs.
4.11 Withdrawal period