HEPARIN SODIUM INJECTION USP SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Last ned Preparatomtale (SPC)
24-08-2016

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:

10ML/25X10ML

Resept typen:

Ethical

Terapeutisk område:

HEPARINS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2017-09-27

Preparatomtale

                                PRODUCT MONOGRAPH
HEPARIN SODIUM INJECTION USP
FOR INTRAVENOUS OR SUBCUTANEOUS USE
1000 USP UNITS PER ML
10 000 USP UNITS PER ML
ANTICOAGULANT
Pfizer Canada Inc.
17300 Trans Canada Highway
Kirkland, Quebec
H9J 2M5
Control No.:
193940
Date of Approval: August 10, 2016
_ _
_ _
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
...............................................................................................................17
ACTIONS AND CLINICAL PHARMACOLOGY
......................................................17
STORAGE AND
STABILITY........................................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................19
PART II: SCIENTIFIC INFORMATION
................................................................................20
PHARMACEUTICAL INFORMATION
......................................................................20
CLINICAL TRIALS
........................................................................................................21
REFERENCES
.........................................................
                                
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Preparatomtale Preparatomtale fransk 10-08-2016

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