BUPAQ 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 (AS HYDROCHLORIDE) PH.EUR.

Available from:

Richter Pharma AG

ATC code:

QN02AE01

INN (International Name):

BUPRENORPHINE (AS HYDROCHLORIDE) PH.EUR.

Dosage:

0.3 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

VPO-Vet.Practitioner Only

Therapeutic group:

Canine, Feline

Therapeutic area:

Buprenorphine

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

2011-10-21

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bupaq Multidose 0.3 mg/ml Solution for Injection for Dogs and Cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Buprenorphine (as 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 to almost 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 use in case of hypersensitivity to the active substance or to any of the excipients.
Do not administer by the intrathecal or peridural route.
Do not use pre-operatively for Caesarian section (see section 4.7).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 14/10/2016_
_CRN 7022734_
_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 cause 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.
In case 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.
Buprenorphi