HyperTET SD Injection 250 units

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

TETANUS IMMUNE GLOBULIN (HUMAN)

Available from:

GRIFOLS ASIA PACIFIC PTE. LTD.

ATC code:

J06BB02

Dosage:

250 units

Pharmaceutical form:

INJECTION

Composition:

TETANUS IMMUNE GLOBULIN (HUMAN) 250 units

Administration route:

INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Grifols Therapeutics LLC

Authorization status:

ACTIVE

Authorization date:

1998-02-26

Patient Information leaflet

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08941121 (Rev. September 2012)
TETANUS IMMUNE GLOBULIN (HUMAN)
HyperTET® S/D
SOLVENT/DETERGENT TREATED
250 UNITS
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 30°C 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 20–27°C. 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 inactivation. Significant
removal of model enveloped and non

Summary of Product characteristics

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3052632 (Rev. 6/2018)
TETANUS IMMUNE GLOBULIN
(
HUMAN
)
HyperTET
®
S/D
SOLVENT/DETERGENT TREATED
250 UNITS
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 30°C 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 20–27°C. 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 inactivation. Significant removal
of model enveloped and non-enveloped
viruses is achieved at two steps in the C