Buprecare Multidose 0.3 mg/ml Solution for Injection for Dogs and Cats
Pays: Autriche
Langue: anglais
Source: HMA (Heads of Medicines Agencies)
Résumé des caractéristiques du produit
(SPC)
09-07-2013
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Ingrédients actifs:
buprenorphine hydrochloride 0.32 mg
Disponible depuis:
Animalcare Limited
Code ATC:
QN02AE01
forme pharmaceutique:
Solution for injection
Groupe thérapeutique:
buprenorphine
Domaine thérapeutique:
Cats, Dogs
Date de l'autorisation:
2008-02-15
Résumé des caractéristiques du produit
Revised: June 2013
AN. 00507/2012
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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
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
Revised: June 2013
AN. 00507/2012
Page 2 of 6
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 ac
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