FRAGMIN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DALTEPARIN SODIUM

Available from:

PFIZER CANADA ULC

ATC code:

B01AB04

INN (International Name):

DALTEPARIN

Dosage:

10000UNIT

Pharmaceutical form:

SOLUTION

Composition:

DALTEPARIN SODIUM 10000UNIT

Administration route:

INTRAVENOUS

Units in package:

5 X 0.4ML

Prescription type:

Prescription

Therapeutic area:

HEPARINS

Product summary:

Active ingredient group (AIG) number: 0126861002; AHFS:

Authorization status:

MARKETED

Authorization date:

2011-02-01

Summary of Product characteristics

_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
....................................................