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

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Buprenorphine hydrochloride

থেকে পাওয়া:

VetViva Richter GmbH

এটিসি কোড:

QN02AE01

INN (আন্তর্জাতিক নাম):

Buprenorphine hydrochloride

ফার্মাসিউটিকাল ফর্ম:

Solution for injection

প্রেসক্রিপশন টাইপ:

POM: Prescription Only Medicine as defined in relevant national legislation

থেরাপিউটিক এলাকা:

buprenorphine

অনুমোদন তারিখ:

2011-10-21

পণ্য বৈশিষ্ট্য

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bupaq Multidose 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
EXCIPIENTS:
Chlorocresol
1.35 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 case 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
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 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.
3
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.
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 saf