HEPARIN SODIUM INJECTION USP SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

HEPARIN SODIUM

Tilgjengelig fra:

PFIZER CANADA ULC

ATC-kode:

B01AB01

INN (International Name):

HEPARIN

Dosering :

1000UNIT

Legemiddelform:

SOLUTION

Sammensetning:

HEPARIN SODIUM 1000UNIT

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

2ML/25X2ML

Resept typen:

Ethical

Terapeutisk område:

HEPARINS

Produkt oppsummering:

Active ingredient group (AIG) number: 0104596004; AHFS:

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2016-03-15

Preparatomtale

PRODUCT MONOGRAPH
HEPARIN SODIUM INJECTION USP
FOR INTRAVENOUS OR SUBCUTANEOUS USE
1000 USP UNITS PER ML (PRESERVATIVE FREE)
1000 USP UNITS PER ML
5 000 USP UNITS PER ML
10 000 USP UNITS PER ML
ANTICOAGULANT
Pfizer Canada Inc.
17300 Trans Canada Highway
Kirkland, Quebec
H9J 2M5
Control No.:
185186
Date of Revision: May 20, 2015
Date of Approval: July 15, 2015
_ _
Heparin Sodium Injection_ _USP _ _
Page 2 of 25_ _
Pfizer Canada Inc.
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
..................................................................................................9
DRUG INTERACTIONS
................................................................................................11
DOSAGE AND ADMINISTRATION
...........................................................................13
OVERDOSAGE
...............................................................................................................16
ACTIONS AND CLINICAL PHARMACOLOGY
......................................................17
STORAGE AND
STABILITY........................................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................18
PART II: SCIENTIFIC INFORMATION
................................................................................20
PHARMACEUTICAL INFORMATION
......................................................................20
CLINICAL TRIALS
.....................................................................................