Buprecare Multidose 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:

2011-12-16

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 Multidose 0.3 mg/ml Solution for Injection for Dogs and Cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Buprenorphine (as buprenorphine hydrochloride) 0.3 mg
EXCIPIENTS
Chlorocresol 1.35 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats
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
Do not administer by the intrathecal or peridural route.
Do not use 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
Use of the veterinary medicinal product in the below circumstances
should only be in accordance with the benefit/risk
assessment by the responsible veterinarian.
Health Products Regulatory Authority
21 March 2019
CRN008XS8
Page 2 of 5
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 cases of renal, cardiac or hepatic dysfunction, or shock, there may
be greater risk associated with the use of the product.
Safety has not been fully evaluated in clinically compromised cats.
The safety of bup