HYPERTET S/D 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:

1SYRINGE

Prescription type:

Schedule D

Therapeutic area:

SERUMS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2012-02-03

Summary of Product characteristics

PRODUCT MONOGRAPH
HYPERTET
® S/D
TETANUS IMMUNE GLOBULIN (HUMAN)
_SOLVENT/DETERGENT TREATED _
250 UNIT SYRINGES AND VIAL
INJECTABLE SOLUTION
MANUFACTURER’S STANDARD
THERAPEUTIC CLASSIFICATION
PASSIVE IMMUNIZING AGENT
Manufactured by:
Grifols Therapeuctics Inc.
8368 U.S. 70 Bus.Hwy West
Clayton, North Carolina 27250
U.S.A.
Distributed and imported by:
Grifols Canada Ltd.
5060 Spectrum Way, Suite 405
Mississauga, Ontario
L4W 5N5
Control No. : 152494 Date of Approval: February 3, 2012
2
PRODUCT MONOGRAPH
HYPERTET
® S/D
TETANUS IMMUNE GLOBULIN (HUMAN)
SOLVENT/DETERGENT TREATED
250 UNIT SYRINGES AND VIAL
THERAPEUTIC CLASSIFICATION
PASSIVE IMMUNIZING AGENT
INJECTABLE SOLUTION
MANUFACTURER’S STANDARD
ACTION AND CLINICAL PHARMACOLOGY
The occurrence of tetanus in the United States has decreased
dramatically from 560
reported cases in 1947, when national reporting began, to a record low
of 48 reported
cases in 1987.
1
The decline has resulted from widespread use of tetanus toxoid and
improved wound management, including use of tetanus prophylaxis in
emergency
rooms.
2,
3
Tetanus Immune Globulin (Human) - HYPERTET
®
S/D supplies passive immunity to
those individuals who have low or no immunity to the toxin produced by
the tetanus
organism, _Clostridium tetani_. The antibodies act to neutralize the
free form of the
powerful exotoxin produced by this bacterium. Historically, such
passive protection
was provided by antitoxin derived from equine or bovine serum;
however, the foreign
protein in these heterologous products often produced severe allergic
manifestations,
even in individuals who demonstrated negative skin and/or conjunctival
tests prior to
administration. Estimates of the frequency of these foreign protein
reactions following
antitoxin of equine origin varied from 5%–30%.
4 - 7
3
If passive immunization is needed, human tetanus immune globulin (TIG)
is the
product of choice. It provides protection longer than antitoxin of
animal origin and
causes few adverse reactions.
3
Several studies suggest the value of