Buprefelican Multidose 0.3 mg/ml solution for injection for dogs and cats

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Buprenorphine hydrochloride

Disponibil de la:

Le Vet Beheer B.V.

Codul ATC:

QN02AE01

INN (nume internaţional):

Buprenorphine hydrochloride

Dozare:

0.3 milligram(s)/millilitre

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupul Terapeutică:

Cats, Dogs

Zonă Terapeutică:

buprenorphine

Indicații terapeutice:

Neurological Preparations

Statutul autorizaţiei:

Authorised

Data de autorizare:

2015-11-27

Caracteristicilor produsului

Health Products Regulatory Authority
20 November 2020
CRN009RQW
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Buprefelican Multidose 0.3 mg/ml solution for injection for dogs and
cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH ML CONTAINS:
ACTIVE SUBSTANCE:
Buprenorphine 0.3 mg
(Equivalent to buprenorphine hydrochloride 0.324 mg)
EXCIPIENTS:
Chlorocresol 1.35 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Post-operative analgesia in the dog and cat.
Potentiation of the sedative effects of centrally acting agents in the
dog.
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 known cases of hypersensitivity to the active substance
or any of the excipients.
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.
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.
Health Products Regulatory Authority
20 November 2020
CRN009RQW
Page 2 of 5
The safety of buprenorphine has not been demonstrated in animals less
than 7 weeks of age.
Repeat administration earlier than the recommended repeat interval
suggested