Pays: Canada
Langue: anglais
Source: Health Canada
ENOXAPARIN SODIUM
FRESENIUS KABI CANADA LTD
B01AB05
ENOXAPARIN
120MG
SOLUTION
ENOXAPARIN SODIUM 120MG
INTRAVENOUS
15G/50G
Prescription
Active ingredient group (AIG) number: 0131860002; AHFS:
APPROVED
2022-10-26
_Product Monograph Master Template _ _Template Date: September 2020 _ _ELONOX and ELONOX HP, (enoxaparin sodium) _ _Page 1 of 81_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ELONOX Enoxaparin sodium Solution for Injection, 100 mg/mL, Subcutaneous or Intravenous Use 30 mg/0.3 mL 40 mg/0.4 mL 60 mg/0.6 mL 80 mg/0.8 mL 100 mg/mL Pre-filled syringes PR ELONOX HP Enoxaparin sodium Solution for Injection, 150 mg/mL, Subcutaneous or Intravenous Use 120 mg/0.8 mL 150 mg/mL Pre-filled syringes USP ATC Code: B01AB05 Anticoagulant/Antithrombotic Agent Fresenius Kabi Canada Ltd. 165 Galaxy Blvd, Suite 100 Toronto Ontario Canada M9W 0C8 Date of Initial Authorization: October 26, 2022 Submission Control Number: 243026 _Product Monograph Master Template _ _Template Date: September 2020 _ _ELONOX and ELONOX HP, (enoxaparin sodium) _ _Page 2 of 81_ RECENT MAJOR LABEL CHANGES N/A TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. 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 ................................................................................................. 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 4.1 Dosing Considerations .............................. Lire le document complet