Buprecare Multidose 0.3 mg/ml Solution for Injection for Dogs and Cats

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Buprenorphine

Disponible depuis:

Animalcare Limited

Code ATC:

QN02AE01

DCI (Dénomination commune internationale):

Buprenorphine

Dosage:

0.3 milligram(s)/millilitre

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

VPO: Veterinary Practitioner Only as defined in relevant national legislation

Groupe thérapeutique:

Cats, Dogs

Domaine thérapeutique:

buprenorphine

indications thérapeutiques:

Neurological Preparations

Statut de autorisation:

Authorised

Date de l'autorisation:

2011-12-16

Résumé des caractéristiques du produit

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.
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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.
Buprenorphine may occasionally cause significant respiratory
depression and, as with other opioid drugs,
care should
be ta