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

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: VMD (Veterinary Medicines Directorate)

Thành phần hoạt chất:

Buprenorphine

Sẵn có từ:

VetViva Richter GmbH

Mã ATC:

QN02AE01

INN (Tên quốc tế):

Buprenorphine

Dạng dược phẩm:

Solution for injection

Loại thuốc theo toa:

POM-V - Prescription Only Medicine – Veterinarian

Nhóm trị liệu:

Cats, Dogs

Khu trị liệu:

Neurological Agent analgesic

Tình trạng ủy quyền:

Authorized

Ngày ủy quyền:

2011-10-12

Đặc tính sản phẩm

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