Buprelieve Multidose 0.3 mg/ml Solution for Injection for Dogs, Cats and Horses

国家: 英国

语言: 英文

来源: VMD (Veterinary Medicines Directorate)

有效成分:

Buprenorphine

可用日期:

Jurox (UK) Limited

ATC代码:

QN02AE01

INN（国际名称）:

Buprenorphine

药物剂型:

Solution for injection

处方类型:

POM-V - Prescription Only Medicine – Veterinarian

治疗组:

Cats, Dogs, Horses

治疗领域:

Neurological Agent analgesic

授权状态:

Authorized

授权日期:

2016-07-06

产品特点

Revised: June 2021
AN: 02143/2020
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Buprelieve Multidose 0.3 mg/ml solution for injection for dogs, cats
and horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Buprenorphine
0.3 mg
as buprenorphine hydrochloride
0.324 mg
EXCIPIENTS
Benzethonium chloride
0.100 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, cats and horses
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Post-operative analgesia in the dog, cat and horse.
Potentiation of the sedative effects of centrally-acting agents in the
dog and
horse.
When used in horses, an intravenous sedative should be administered
within
five minutes prior to injection of buprenorphine.
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 cases of hypersensitivity to the active substance or to
any of the
excipients.
Revised: June 2021
AN: 02143/2020
Page 2 of 9
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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. The benefit-risk
assessment for
using the product should be made by the attending vet. 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.
T