Buprevet 0.3 mg/ml Solution for Injection for Dogs and Cats

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Buprenorphine

Διαθέσιμο από:

Richter Pharma AG

Φαρμακολογική κατηγορία (ATC):

QN02AE01

INN (Διεθνής Όνομα):

Buprenorphine

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Cats, Dogs

Θεραπευτική περιοχή:

Neurological Agent analgesic

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2017-01-27

Αρχείο Π.Χ.Π.

Revised: April 2020
AN: 01936/2019
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Buprevet 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
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 cases 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.
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.
Revised: April 2020
AN: 01936/2019
Page 2 of 6
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 age.
Repeat administration earlier than the recommended repeat interval
suggested in
section 4.9 is not recommended.
Long-term safety of buprenorphine in cats has not been investigated
beyond 5
consecuti