Rheumofen 50 mg Carprofen chewable tablets for dogs 1 blister /10 tablets/

1. NAME

Rheumofen 50 mg chewable tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active Substance:

Carprofen …………… ..50 mg

3. PHARMACEUTICAL FORM

Tablet.

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

Dogs.

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.

4.3 Contraindications

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

excipients.

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.

See 4.7.

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 an 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

animals

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 rarely a 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

lactation.

It is not recommended to use it during pregnancy and lactation.

4.8 Interaction with other veterinary medicinal products and other forms

interaction

Carprofen should not be co-administered with glucocorticoids. Look. point 4.5.

4.9 Amounts to be administered and administration route

Orally.

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

clinical response.

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

consecutive 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

Not applicable.