HYPERTET SD

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TETANUS IMMUNE GLOBULIN (S/D TREATED)

Available from:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC code:

J06BB02

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

TETANUS IMMUNE GLOBULIN (S/D TREATED) 250 U/ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

GRIFOLS THERAPEUTICS LLC., USA

Therapeutic group:

TETANUS IMMUNOGLOBULIN

Therapeutic area:

TETANUS IMMUNOGLOBULIN

Therapeutic indications:

Immunity against Tetanus toxin. Treatment of active cases of Tetanus.

Authorization date:

2023-07-31

Summary of Product characteristics

1
HYPERTET
® S/D
TETANUS IMMUNE GLOBULIN (S/D TREATED)
250 U/ML, I.M_ _
THERAPEUTIC INDICATIONS AND USAGE
HyperTET S/D is indicated for immunity against Tetanus toxin. It is
also
indicated for treatment of active cases of tetanus.
1,2,3
DESCRIPTION
Tetanus Immune Globulin (Human) - HyperTET
®
S/D treated with
solvent/detergent is a colorless to pale yellow or pink sterile
solution of
tetanus hyperimmune immune globulin for intramuscular administration;
it is
preservative-free, in a latex-free delivery system. HyperTET S/D is
prepared
by cold ethanol fractionation from the plasma of donors immunized with
tetanus toxoid. The immune globulin is isolated from solubilized Cohn
Fraction
II. The Fraction II solution is adjusted to a final concentration of
0.3% tri-n-
butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of
solvent (TNBP) and detergent (sodium cholate), the solution is heated
to 30ºC
and maintained at that temperature for not less than 6 hours. After
the viral
inactivation step, the reactants are removed by precipitation,
filtration and
finally ultrafiltration and diafiltration. HyperTET S/D is formulated
as a 15-18%
protein solution at a pH of 6.4-7.2 in 0.21-0.32 M glycine. HyperTET
S/D is
then incubated in the final container for 21-28 days at 20-27ºC. 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
container.
The removal and inactivation of spiked model enveloped and
non-enveloped
viruses during the manufacturing process for HyperTET S/D has been
validated in laboratory studies. Human Immunodeficiency Virus, Type 1
(HIV-
1), was chosen as the relevant virus for blood products; Bovine Viral
Diarrhea
Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus
(PRV) was chosen to model Human Herpes viruses and other large
enveloped DNA viruses; and Reo virus type 3 (Reo) was chosen to model
non-enveloped viruses and for its resistance to physical and chemical
inactiva