GAMASTAN SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

IMMUNOGLOBULIN (HUMAN)

Disponibil de la:

GRIFOLS THERAPEUTICS LLC

Codul ATC:

J06BA01

INN (nume internaţional):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASC. ADM

Dozare:

18%

Forma farmaceutică:

SOLUTION

Compoziție:

IMMUNOGLOBULIN (HUMAN) 18%

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Schedule D

Zonă Terapeutică:

SERUMS

Rezumat produs:

Active ingredient group (AIG) number: 0106267001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2019-03-13

Caracteristicilor produsului

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Page 1 of 16
PRODUCT MONOGRAPH
GAMASTAN®
Immunoglobulin (Human)
_ _
Injectable Solution, 15-18% Protein
Manufacturer’s Standard
Passive Immunizing Agent
Manufactured by:
Grifols Therapeutics LLC
8368 U.S. 70 Bus. Hwy West
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 Initial Approval:
June 12, 1974
Submission Control No: 218627 Date of Revision:
March 13, 2019
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Page 2 of 16
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
DESCRIPTION....................................................................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................11
PART II: SCIENTIFIC INFORMATION
.................................................................