Austiofen 100 mg Tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carprofen

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QM01AE91

INN (International Name):

Carprofen

Dosage:

100 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

carprofen

Therapeutic indications:

N.S.A.I.D.

Authorization status:

Authorised

Authorization date:

2006-06-02

Summary of Product characteristics

Health Products Regulatory Authority
12 November 2019
CRN0095GQ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Austiofen 100 mg Tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
Carprofen 100.0 mg/tablet
EXCIPIENTS
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
A white to off white round shape tablets with a cross breakline on one
side. The tablets can be divided into halves or quarters.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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 cats.
Do not use in pups 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 gastro-intestinal ulceration or
bleeding, or where there is evidence of a blood dyscrasia.
Refer to section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Refer to Sections 4.3 and 4.5
4.5 SPECIAL PRECAUTIONS FOR USE
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 potential 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 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.
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