País: Canadá
Idioma: inglés
Fuente: Health Canada
ROPIVACAINE HYDROCHLORIDE
FRESENIUS KABI CANADA LTD
N01BB09
ROPIVACAINE
7.5MG
SOLUTION
ROPIVACAINE HYDROCHLORIDE 7.5MG
NERVE BLOCK
10ML/20ML
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0133273004; AHFS:
CANCELLED PRE MARKET
2023-03-10
_ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION ROPIVACAINE HYDROCHLORIDE INJECTION, USP 2 mg / mL, 5 mg / mL, 7.5 mg / mL and 10 mg / mL Local Anesthetic FRESENIUS KABI CANADA LTD. 165 Galaxy Blvd, Suite 100 Toronto, ON M9W 0C8 Date of Revision: October 7, 2019 Submission Control No: 228440 _ _ Ropivacaine Hydrochloride Injection, USP - Product Monograph Page 2 of 41 _ _ RECENT MAJOR LABEL CHANGES Warnings and Precautions (6) 10/2018 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 1 INDICATIONS ...........................................................................................................3 1.1 Pediatrics ........................................................................................................... 3 1.2 Geriatrics ........................................................................................................... 3 2 CONTRAINDICATIONS ...........................................................................................3 3 DOSAGE AND ADMINISTRATION .......................................................................4 3.1 Dosing Considerations ...................................................................................... 4 3.2 Recommended Dose and Dosage Adjustment .................................................. 5 4 OVERDOSAGE ...........................................................................................................7 5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .........9 6 WARNINGS AND PRECAUTIONS .......................................................................10 6.1 Special Populations ......................................................................................... 14 6.1.1 Pregnant Women............................................................................................. 15 6.1.2 Breast-feeding ................................................................................................. 15 6.1.3 Pediatrics .................. Leer el documento completo