HYPERRAB SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

RABIES IMMUNOGLOBULIN (HUMAN)

Dostupné s:

GRIFOLS THERAPEUTICS LLC

ATC kód:

J06BB05

INN (Mezinárodní Name):

RABIES IMMUNOGLOBULIN

Dávkování:

300UNIT

Léková forma:

SOLUTION

Složení:

RABIES IMMUNOGLOBULIN (HUMAN) 300UNIT

Podání:

INTRAMUSCULAR

Jednotky v balení:

15G/50G

Druh předpisu:

Schedule D

Terapeutické oblasti:

SERUMS

Přehled produktů:

Active ingredient group (AIG) number: 0110666003; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2019-03-13

Charakteristika produktu

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_HYPERRAB® (Rabies Immunoglobulin [Human]) _
_Page 1 of 17_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
HYPERRAB®
Rabies Immunoglobulin [Human]
Injectable Solution, 300 IU per mL
For infiltration and intramuscular injection
Manufacturer’s Standard
Passive Immunizing Agent
ATC: J06BB05
Manufactured by:
Grifols Therapeutics LLC
8368 U.S. 70 Bus. Hwy West
Clayton, North Carolina
27520
U.S.A.
Imported and Distributed by:
Grifols Canada Ltd.
5060 Spectrum Way, Suite 405
Mississauga, Ontario
L4W 5N5
Date of Initial
Authorization:
July 3, 1975
Date of Revision:
[TBD]
Submission Control Number: 247808 Date of Approval: March 19, 2021
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_HYPERRAB® (Rabies Immunoglobulin [Human]) _
_Page 2 of 17_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.4
Administration.....................................................................................................5
5
OVERDOSAGE
...........