BUPAQ MULTIDOSE 0.3 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

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Download 제품 특성 요약 (SPC)
29-10-2016

유효 성분:

BUPRENORPHINE (AS HYDROCHLORIDE) PH.EUR.

제공처:

Richter Pharma AG

ATC 코드:

QN02AE01

INN (국제 이름):

BUPRENORPHINE (AS HYDROCHLORIDE) PH.EUR.

복용량:

0.3 Mg/Ml

약제 형태:

Solution for Injection

처방전 유형:

VPO-Vet.Practitioner Only

치료 그룹:

Canine, Feline

치료 영역:

Buprenorphine

치료 징후:

Neurological Preparations

승인 상태:

Authorised

승인 날짜:

2011-10-21

제품 특성 요약

                                SUMMARY OF PRODUCT CHARACTERISTICS
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 14/10/2016_
_CRN 7022734_
_page number: 1_
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.
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.
Buprenorphi
                                
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