国: カナダ
言語: 英語
ソース: Health Canada
ROPIVACAINE HYDROCHLORIDE
PFIZER CANADA ULC
N01BB09
ROPIVACAINE
10MG
SOLUTION
ROPIVACAINE HYDROCHLORIDE 10MG
EPIDURAL
10ML/20ML
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0133273005; AHFS:
CANCELLED POST MARKET
2022-10-01
_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 完全なドキュメントを読む