FRAXIPARINE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NADROPARIN CALCIUM

Available from:

ASPEN PHARMACARE CANADA INC.

ATC code:

B01AB06

INN (International Name):

NADROPARIN

Dosage:

9500UNIT

Pharmaceutical form:

SOLUTION

Composition:

NADROPARIN CALCIUM 9500UNIT

Administration route:

INTRAVENOUS

Units in package:

0.2ML

Prescription type:

Prescription

Therapeutic area:

HEPARINS

Product summary:

Active ingredient group (AIG) number: 0131662001; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-04-20

Summary of Product characteristics

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