HYPERTET SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TETANUS IMMUNOGLOBULIN (HUMAN)

Available from:

GRIFOLS THERAPEUTICS LLC

ATC code:

J06BB02

INN (International Name):

TETANUS IMMUNOGLOBULIN

Dosage:

250UNIT

Pharmaceutical form:

SOLUTION

Composition:

TETANUS IMMUNOGLOBULIN (HUMAN) 250UNIT

Administration route:

INTRAMUSCULAR

Units in package:

15G/50G

Prescription type:

Schedule D

Therapeutic area:

SERUMS

Product summary:

Active ingredient group (AIG) number: 0133051001; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-09-10

Summary of Product characteristics

_ _
_HYPERTET_
_®_
_ (Tetanus Immunoglobulin [Human]) _
_ _
_Page 1 of 17_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
HYPERTET®
Tetanus Immunoglobulin (Human)
250 antitoxin unit (AU) pre-filled syringes
Solution for Intramuscular Injection
Manufacturer’s Standard
Passive Immunizing Agent
ATC Code: J06BB02
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:
December 31, 1959
Date of Revision:
September 8, 2021
Submission Control Number: 249214
_ _
_ _
_ _
_HYPERTET_
_®_
_ (Tetanus Immunoglobulin [Human]) _
_Page 2 of 17_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
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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
4.1
Dosing Considerations
.......................................................................................
5
4.2