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:

Ecuphar NV

ATC code:

QN02AE01

INN (International Name):

Buprenorphine hydrochloride

Dosage:

0.3 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

buprenorphine

Authorization status:

Authorised

Authorization date:

2008-05-16

Summary of Product characteristics

Health Products Regulatory Authority
21 March 2019
CRN008XS8
Page 1 of 5
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.
CatPost-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.
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.
Health Products Regulatory Authority
21 March 2019
CRN008XS8
Page 2 of 5
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 risk associated with the use of the product. The
benefit:risk ratio for using the product should be made by the
attending vet. Safety has not been fully evaluated in clinically
compromised cats.
The safety of buprenorphine has not been demonstrated in anim