Vetergesic Multidose, 0.3 mg/ml, solution for injection for dogs and cats

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Buprenorphine hydrochloride

Tersedia dari:

Ceva Santé Animale

Kode ATC:

QN02AE01

INN (Nama Internasional):

Buprenorphine hydrochloride

Dosis:

0.3 milligram(s)/millilitre

Bentuk farmasi:

Solution for injection

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Kelompok Terapi:

Cats, Dogs

Area terapi:

buprenorphine

Indikasi Terapi:

Neurological Preparations

Status otorisasi:

Authorised

Tanggal Otorisasi:

2012-08-17

Karakteristik produk

Health Products Regulatory Authority
13 August 2018
CRN000YV9
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetergesic Multidose, 0.3 mg/ml, solution for injection for dogs and
cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml solution for injection contains:
ACTIVE SUBSTANCE:
Buprenorphine
0.3 mg
As Buprenorphine hydrochloride
0.324 mg
EXCIPIENT:
Chlorocresol
1.35 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution for injection
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 Caesarian section (see Section 4.7).
Do not use in animals with known hypersensitivity to the active
substance or to any
of the excipients.
Health Products Regulatory Authority
13 August 2018
CRN000YV9
Page 2 of 8
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
I) 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.
The safety of buprenorphine has not been demonstrated in animals