HYPERHEP B S/D SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

HEPATITIS B IMMUNOGLOBULIN (HUMAN)

Disponible des:

GRIFOLS THERAPEUTICS LLC

Codi ATC:

J06BB04

Designació comuna internacional (DCI):

HEPATITIS B IMMUNOGLOBULIN

Dosis:

220UNIT

formulario farmacéutico:

SOLUTION

Composición:

HEPATITIS B IMMUNOGLOBULIN (HUMAN) 220UNIT

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

5ML

tipo de receta:

Schedule D

Área terapéutica:

SERUMS

Resumen del producto:

Active ingredient group (AIG) number: 0114080002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2012-02-02

Fitxa tècnica

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PRODUCT MONOGRAPH
HYPERHEP B® S/D
Hepatitis B Immune Globulin (Human)
_Solvent/Detergent Treated _
_ _
Injectable Solution,

220 IU/mL
Manufacturer’s Standard
Passive Immunizing Agent
Manufactured by:
Grifols Therapeutics Inc.
8368 U.S. 70 Bus. HwyWest
Clayton, North Carolina
27520
U.S.A.
Distributed and Imported by:
Grifols Canada Ltd.
5060 Spectrum Way
Suite 405
Mississauga, Ontario
L4W 5N5
Date of Revision:
Submission Control No: 152142 Date of Approval: February 2, 2012
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
DESCRIPTION....................................................................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................12
PART II: SCIENTIFIC INFORMATION
......................................