البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
DALTEPARIN SODIUM
PFIZER CANADA ULC
B01AB04
DALTEPARIN
3500UNIT
SOLUTION
DALTEPARIN SODIUM 3500UNIT
INTRAVENOUS
0.28ML
Prescription
HEPARINS
Active ingredient group (AIG) number: 0126861004; AHFS:
MARKETED
2015-03-25
_Product Monograph _ _Fragmin (dalteparin sodium injection) _ _Page 1 of 58_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR FRAGMIN ® Dalteparin Sodium for subcutaneous injection or intravenous infusion SOLUTION 10 000 IU (anti-factor Xa)/1 mL, Ampoule 25 000 IU (anti-factor Xa)/mL 3.8 mL, Multi-Dose Vial PREFILLED SYRINGE WITH SAFETY NEEDLE DEVICE 2 500 IU (anti-factor Xa)/0.2 mL 3500 IU (anti-factor Xa)/0.28 mL 5 000 IU (anti-factor Xa)/0.2 mL 7 500 IU (anti-factor Xa)/0.3 mL 10 000 IU (anti-factor Xa)/0.4 mL 12 500 IU (anti-factor Xa)/0.5 mL 15 000 IU (anti-factor Xa)/0.6 mL 16 500 IU (anti-factor Xa)/0.66 mL 18 000 IU (anti-factor Xa)/0.72 mL Professed standard ANTICOAGULANT/ANTITHROMBOTIC AGENT (ATC CODE: B01AB04) Pfizer Canada ULC 17,300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 ®Pfizer Health AB Pfizer Canada ULC, Licensee © Pfizer Canada ULC 2022 Date of Initial Authorization: SEP 30, 1994 Date of Revision: DEC 29, 2022 Submission Control Number: 266850 _ _ _Product Monograph _ _Fragmin (dalteparin sodium injection) _ _Page 2 of 58_ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, 1.2 Pediatrics 07/2020 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 07/2020 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 07/2020 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 07/2020 7 WARNINGS AND PRECAUTIONS, General 07/2020 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 07/2020 7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics 07/2020 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 5 1 INDICATIONS .............................................................................................................. 5 1.1 Pediatrics .................................................... اقرأ الوثيقة كاملة