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

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Buprenorphine

Dostępny od:

VetViva Richter GmbH

Kod ATC:

QN02AE01

INN (International Nazwa):

Buprenorphine

Forma farmaceutyczna:

Solution for injection

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

Cats, Dogs

Dziedzina terapeutyczna:

Neurological Agent analgesic

Status autoryzacji:

Authorized

Data autoryzacji:

2011-10-12

Charakterystyka produktu

Revised: January 2023
AN: 02966/20022
Page 1 of 7
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.
Revised: January 2023
AN: 02966/2022
Page 2 of 7
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.
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 action may be affected in such animals.
The safety of buprenorphine has not been demonstrated in animals less
than 7
weeks of