Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
NADROPARIN CALCIUM
ASPEN PHARMACARE CANADA INC.
B01AB06
NADROPARIN
9500UNIT
SOLUTION
NADROPARIN CALCIUM 9500UNIT
INTRAVENOUS
0.3ML
Prescription
HEPARINS
Active ingredient group (AIG) number: 0131662001; AHFS:
APPROVED
2015-03-05
_Pr_ _FRAXIPARINE_ _® _ _& _ _Pr_ _FRAXIPARINE_ _®_ _ FORTE (_nadroparin calcium injection_) _ _Page 1 of 50_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR FRAXIPARINE ® nadroparin calcium injection (9,500 anti-Xa IU/mL) 0.2 mL, 0.3 mL, 0.4 mL, 0.6 mL and 1.0 mL prefilled syringes PR FRAXIPARINE ® FORTE nadroparin calcium injection (19,000 anti-Xa IU/mL) 0.6 mL, 0.8 mL and 1.0 mL prefilled syringes Manufactures Standard Topical Anesthetic for Dermal Analgesia Aspen Pharmacare Canada Inc 8 – 1155 North Service Road West Oakville, ON L6M 3E3 Date of Initial Approval: February 05, 1998 Date of Revision: July 8, 2022 Submission Control Number: 260986 Trademarks are owned by or licensed to the Aspen Group of companies. _Product Monograph Master Template _ _Template Date: September 2020 _ _Pr_ _FRAXIPARINE_ _® _ _& _ _Pr_ _FRAXIPARINE_ _®_ _ FORTE (_ nadroparin calcium injection _) _ _Page 2 of 50_ RECENT MAJOR LABEL CHANGES 1 Indications (Removed) 06/2016 1 Indications, 1.2 Geriatrics (Removed) 06/2016 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment (Removed) 09/2017 Patient Medication Information (Removed) 09/2017 11 Storage, Stability and Disposal (Removed) 02/2018 7 Warnings and Precautions 09/2021 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES..............................................................................................2 TABLE OF CONTENTS ................................................................................................................2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................4 1 INDICATIONS ................................................................................................................4 1.1 Pediatrics (<18 years of age): ...............................................................................4 1.2 Geriatrics (≥ 65 years of age): ...............................................................................4 2 CONTRAINDICATIONS ................ Aqra d-dokument sħiħ