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

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Buprenorphine

Tersedia dari:

Ecuphar NV

Kode ATC:

QN02AE01

INN (Nama Internasional):

Buprenorphine

Bentuk farmasi:

Solution for injection

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Cats, Dogs

Area terapi:

Neurological Agent analgesic

Status otorisasi:

Authorized

Tanggal Otorisasi:

2011-12-12

Karakteristik produk

Revised: August 2022
AN: 01024/2022
Page 1 of 7
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.
Revised: August 2022
AN: 01024/2022
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 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 and duration of action may be affected in some animals.
In cases 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.
The safety of buprenorphine has not been demonstrated in animal