Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
ROPIVACAINE HYDROCHLORIDE
FRESENIUS KABI CANADA LTD
N01BB09
ROPIVACAINE
5MG
SOLUTION
ROPIVACAINE HYDROCHLORIDE 5MG
BLOCK/INFILTRATION
10ML
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0133273003; AHFS:
APPROVED
2015-03-30
_ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION ROPIVACAINE HYDROCHLORIDE INJECTION, USP 2 mg / mL, 5 mg / mL, and 10 mg / mL Local Anesthetic FRESENIUS KABI CANADA LTD. 165 Galaxy Blvd, Suite 100 Toronto, ON M9W 0C8 Date of Revision: September 25, 2023 Submission Control No: 277021 _ _ Ropivacaine Hydrochloride Injection, USP - Product Monograph Page 2 of 42 _ _ RECENT MAJOR LABEL CHANGES Not Applicable TABLE OF CONTENTS 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 .................................................................................................................8 5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..............10 6 WARNINGS AND PRECAUTIONS .............................................................................11 6.1 Special Populations ..................................................................................................16 6.1.1 Pregnant Women .................................................................................................16 6.1.2 Breast-feeding ...................................................................................... Soma hati kamili