NUBAIN INJECTION 10MG/ML SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

NALBUPHINE HYDROCHLORIDE

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

N02AF02

INN (International Name):

NALBUFINE

복용량:

10MG

약제 형태:

SOLUTION

구성:

NALBUPHINE HYDROCHLORIDE 10MG

관리 경로:

INTRAMUSCULAR

패키지 단위:

5X1ML

처방전 유형:

Schedule G (CDSA IV)

치료 영역:

OPIATE PARTIAL AGONISTS

제품 요약:

Active ingredient group (AIG) number: 0114464001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2001-12-04

제품 특성 요약

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PRODUCT MONOGRAPH
©
NUBAIN
(NALBUPHINE HYDROCHLORIDE)
INJECTION, 10 MG/ML
OPIOID ANALGESIC
ADJUNCT ANESTHETIC
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, Quebec, J4B 7K8
Date of Revision:
April 3, 2018
Submission Control No: 213120
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................. 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
..............................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................
4
ADVERSE REACTIONS
.............................................................................................
12
DRUG INTERACTIONS
.............................................................................................
14
DOSAGE AND ADMINISTRATION
.........................................................................
15
OVERDOSAGE
...........................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 19
STORAGE AND STABILITY
.....................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
.................................................................. 20
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 21
PART II: SCIENTIFIC INFORMATION
................................................................... 22
PHARMACEUTICAL INFORMATION
.....................................................................
22
CLINICAL TRIALS
.....................................................................................................
23
TOXICOLOGY
...........................................