HYPERTET (tetanus immune globulin- human injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Human Clostridium Tetani Toxoid Immune Globulin (UNII: V4SWI4RF4J) (Human Clostridium Tetani Toxoid Immune Globulin - UNII:V4SWI4RF4J)

Available from:

GRIFOLS USA, LLC

INN (International Name):

Human Clostridium Tetani Toxoid Immune Globulin

Composition:

Human Clostridium Tetani Toxoid Immune Globulin 250 [iU] in 1 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

HyperTET is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus.(8,9,16) A thorough attempt must be made to determine whether a patient has completed primary vaccination. Patients with unknown or uncertain previous vaccination histories should be considered to have had no previous tetanus toxoid doses. Persons who had military service since 1941 can be considered to have received at least one dose, and although most of them may have completed a primary series of tetanus toxoid, this cannot be assumed for each individual. Patients who have not completed a primary series may require tetanus toxoid and passive immunization at the time of wound cleaning and debridement.(3) The following table is a summary guide to tetanus prophylaxis in wound management: None known.

Product summary:

HyperTET is supplied in 250 unit prefilled disposable syringes with attached needles. HyperTET contains no preservative and is not made with natural rubber latex.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

HYPERTET- TETANUS IMMUNE GLOBULIN (HUMAN) INJECTION
GRIFOLS USA, LLC
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TETANUS IMMUNE GLOBULIN (HUMAN)
HYPERTET
250 UNITS
DESCRIPTION
Tetanus Immune Globulin (Human) — HyperTET is a clear or slightly
opalescent, and
colorless or pale yellow sterile solution of human tetanus immune
globulin for
intramuscular administration. HyperTET contains no preservative.
HyperTET is
prepared from pools of human plasma collected from healthy donors by a
combination
of cold ethanol fractionation, caprylate precipitation and filtration,
caprylate incubation,
anion exchange chromatography, nanofiltration and low pH incubation.
HyperTET
consists of a 15% to 18% protein solution at a pH of 4.1 to 4.8 in
0.16 M to 0.26 M
glycine. The product is standardized against the U.S. Standard
Antitoxin and the U.S.
Control Tetanus Toxin and contains not less than 250 tetanus antitoxin
units per 1 mL.
When medicinal biological products are administered, the risk of
infectious diseases due
to transmission of pathogens cannot be totally excluded. However, in
the case of
products prepared from human plasma, the risk of transmission of
pathogens is
reduced by epidemiological surveillance of the donor population and
selection of
individual donors by medical interview; testing of individual
donations and plasma pools;
and the presence in the manufacturing processes of steps with
demonstrated capacity
to inactivate/remove pathogen.
In the manufacturing process of HyperTET, there are several steps with
the capacity for
viral inactivation or removal.(1) The main steps of the manufacturing
process that
contribute to the virus clearance capacity are as follows:
Caprylate precipitation/depth filtration
Caprylate incubation
Depth filtration
Column chromatography
Nanofiltration
Low pH final container incubation
To provide additional assurance of the pathogen safety of the final
product, the capacity
of the HyperTET manufacturing process to remove and/or inactivate
viruses has been
demonstrated by laboratory spiking studies on a scaled down process