FRAGMIN SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

DALTEPARIN SODIUM

Dostupné z:

PFIZER CANADA ULC

ATC kód:

B01AB04

INN (Medzinárodný Name):

DALTEPARIN

Dávkovanie:

2500UNIT

Forma lieku:

SOLUTION

Zloženie:

DALTEPARIN SODIUM 2500UNIT

Spôsob podávania:

INTRAVENOUS

Počet v balení:

4ML

Typ predpisu:

Prescription

Terapeutické oblasti:

HEPARINS

Prehľad produktov:

Active ingredient group (AIG) number: 0126861001; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2018-02-22

Súhrn charakteristických

_FRAGMIN (dalteparin sodium) Product Monograph _
_Page 1 of 58_
PRODUCT MONOGRAPH
PR
FRAGMIN

Dalteparin Sodium Injection
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
18 000 IU (anti-factor Xa)/0.72 mL
ANTICOAGULANT/ANTITHROMBOTIC AGENT
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
® Pfizer Health AB
Pfizer Canada Inc., Licensee
©
Pfizer Canada Inc. 2018
Date of Initial Approval:
September 30, 1994
Date of Revision:
October 18, 2018
Submission Control No:
210778
_FRAGMIN (dalteparin sodium) Product Monograph _
_Page 2 of 58_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................23
STORAGE AND STABILITY
....