Carprogesic 20 mg Tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carprofen

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QM01AE91

INN (International Name):

Carprofen

Dosage:

20 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

carprofen

Authorization status:

Authorised

Authorization date:

2006-12-08

Summary of Product characteristics

Health Products Regulatory Authority
07 February 2019
CRN008TK5
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Carprogesic 20 mg Tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Carprofen 20 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablets:
A white/off white circular tablet with a break line on one face and
“20” scored on the
opposing face.
The tablets can be divided into equal halves.
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
musculoskeletal 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 pregnant or lactating bitches.
Do not use in puppies 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.
Health Products Regulatory Authority
07 February 2019
CRN008TK5
Page 2 of 5
Do not use in animals suffering from hemorrhagic syndrome.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Refer to statements under 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, such 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.
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.
Refer to section 4.8.
SPECIAL P