Country: Canada
Language: English
Source: Health Canada
TINZAPARIN SODIUM
LEO PHARMA INC
B01AB10
TINZAPARIN
20000UNIT
SOLUTION
TINZAPARIN SODIUM 20000UNIT
SUBCUTANEOUS
0.5ML
Prescription
HEPARINS
Active ingredient group (AIG) number: 0124929003; AHFS:
APPROVED
2010-10-14
_ _ _innohep® (tinzaparin sodium) Product Monograph, version 8.0 _ _Page 1 of 45_ PRODUCT MONOGRAPH PR INNOHEP® tinzaparin sodium Sterile solution for SC injection MULTI-DOSE VIAL 10,000 anti-Xa IU/mL 20,000 anti-Xa IU/mL PRE-FILLED SYRINGE WITH SAFETY NEEDLE DEVICE 2,500 anti-Xa IU/0.25 mL 3,500 anti-Xa IU/0.35 mL 4,500 anti-Xa IU/0.45 mL 8,000 anti-Xa IU/0.4 mL 10,000 anti-Xa IU/0.5 mL 12,000 anti-Xa IU/0.6 mL 14,000 anti-Xa IU/0.7 mL 16,000 anti-Xa IU/0.8 mL 18,000 anti-Xa IU/0.9 mL Ph. Eur. Anticoagulant / Antithrombotic LEO Pharma Inc Thornhill, ON L3T 7W8 www.leo-pharma.com/canada Date of Revision: Date of Approval: MAY 26, 2017 Submission Control No: 202366 ® Registered trademark of LEO Pharma A/S used under license by LEO Pharma Inc., Thornhill, ON eDoc-000592317 - Version 5.0 _ _ _innohep® (tinzaparin sodium) Product Monograph, version 8.0 _ _Page 2 of 45_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................5 ADVERSE REACTIONS ..................................................................................................14 DRUG INTERACTIONS ..................................................................................................19 DOSAGE AND ADMINISTRATION ..............................................................................20 OVERDOSAGE ................................................................................................................26 ACTION AND CLINICAL PHARMACOLOGY ............................................................26 STORAGE AND STABILITY ..................... Read the complete document