ROPIVACAINE HYDROCHLORIDE INJECTION USP SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ROPIVACAINE HYDROCHLORIDE

제공처:

PFIZER CANADA ULC

ATC 코드:

N01BB09

INN (국제 이름):

ROPIVACAINE

복용량:

10MG

약제 형태:

SOLUTION

구성:

ROPIVACAINE HYDROCHLORIDE 10MG

관리 경로:

EPIDURAL

패키지 단위:

10ML/20ML

처방전 유형:

Ethical

치료 영역:

LOCAL ANESTHETICS

제품 요약:

Active ingredient group (AIG) number: 0133273005; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2022-10-01

제품 특성 요약

_Product Monograph – Ropivacaine Hydrochloride Injection USP _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ROPIVACAINE HYDROCHLORIDE INJECTION USP
Parenteral sterile solution
2 mg / mL ropivacaine hydrochloride per flexible container
5 mg / mL and 10 mg / mL ropivacaine hydrochloride per vial
Local Anaesthetic
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision:
May 19, 2020
Submission Control No: 236564
_ _
_Product Monograph – Ropivacaine Hydrochloride Injection USP _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
Warnings and Precautions (6)
10/2018
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
4
1.2
Geriatrics
...............................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
DOSAGE AND ADMINISTRATION
................................................................................
5
3.1
Dosing Considerations
...........................................................................................
5
3.2
Recommended Dose and Dosage Adjustment
....................................................... 6
4
OVERDOSAGE
...............................................................................................................
7
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
......................... 9
6