Buprecare
Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
09-07-2013
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Active ingredient:
buprenorphine hydrochloride 0.3 mg/ml
Available from:
Animalcare Limited
ATC code:
QN02AE01
Pharmaceutical form:
Solution for injection
Therapeutic group:
buprenorphine
Therapeutic area:
Cats, Dogs
Authorization date:
2011-09-28
Summary of Product characteristics
New – AN 02194/2006 28/05/08
Page 1 of 6
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Buprecare 0.3 mg/ml Solution for Injection for Dogs and Cats (UK, BE, FR, IE, LU, NL, ES)
Buprenovet 0.3 mg/ml Solution for Injection for Dogs and Cats (AT, DE)
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
Dogs and cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Post-operative analgesia in the cat and dog.
Potentiation of the sedative effects of centrally acting agents in the dog.
4.3
CONTRAINDICATIONS
The product should not be used pre-operatively for caesarean section (see Section 4.7).
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.
As buprenorphine is metabolised by the liver, its intensity and duration of action may be affected in
animals with impaired liver function.
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 ha
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