BUPRECARE MULTIDOSE 0.3 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

BUPRENORPHINE (AS BUPRENORPHINE HYDROCHLORIDE PH.EUR.)

MAH:

Animalcare Limited

ATC_code:

QN02AE01

INN:

BUPRENORPHINE (AS BUPRENORPHINE HYDROCHLORIDE PH.EUR.)

dosage:

0.3

pharmaceutical_form:

Solution for Injection

prescription_type:

VPO-Vet.Practitioner Only

therapeutic_group:

Canine, Feline

therapeutic_area:

Buprenorphine

therapeutic_indication:

Neurological Preparations

authorization_status:

Authorised

authorization_date:

2011-12-16

SPC

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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 24/11/2016_
_CRN 7025298_
_page number: 1_
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 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 an