BUPRECARE 0.3 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BUPRENORPHINE HYDROCHLORIDE

Available from:

Animalcare Limited

ATC code:

QN02AE01

INN (International Name):

BUPRENORPHINE HYDROCHLORIDE

Dosage:

0.3 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

VPO-Vet.Practitioner Only

Therapeutic group:

Canine, Feline

Therapeutic area:

Buprenorphine

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

2008-05-16

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Buprecare 0.3 mg/ml Solution for Injection for Dogs and Cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each ampoule contains:
Buprenorphine 0.3 mg/ml as buprenorphine hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog
Post-operative analgesia.
Potentiation of the sedative effects of centrally-acting agents.
Cat
Post-operative analgesia.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dog
Post-operative analgesia.
Potentiation of the sedative effects of centrally-acting agents.
Cat
Post-operative analgesia.
4.3 CONTRAINDICATIONS
The product should not be used pre-operatively for caesarean section (see Section 4.7).
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 22/08/2013_
_CRN 7015544_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Buprenorphine may occasionally cause significant respiratory depression and, as with other opioid drugs, care should
be taken when treating animals with impaired respiratory function or animals that are receiving drugs that can cause
respiratory depression.
Buprenorphine should be used with caution in animals with impaired liver function, especially biliary tract disease, as
the substance is metabolised by the liver and its intensity and duration of action may be affected in some animals.
In case of renal, cardiac or hepatic dysfunction, or shock, there may be greater ris