IGANTET ANTI-TETANUS IMMUNOGLOBULIN GRIFOLS INJECTION 250 IUml

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

HUMAN ANTI-TETANUS IMMUNOGLOBULIN

Available from:

GRIFOLS MALAYSIA SDN. BHD.

INN (International Name):

HUMAN ANTI-TETANUS IMMUNOGLOBULIN

Units in package:

250 INTERNATIONAL UNITS->1000; 500 INTERNATIONAL UNITS->1000; 2ml mL

Manufactured by:

INSTITUTO GRIFOLS S.A.

Summary of Product characteristics

Id2181-P1
25/10/2023
Color references
P-287
Background
White
Size | Structure (mm)
150 x 340
HUMAN ANTITETANUS IMMUNOGLOBULIN
Solution for injection in pre-filled syringe
Composition
250 IU
500 IU
- Active ingredient:
Human antitetanus immunoglobulin
250 IU
500 IU
(Human protein
160 mg
320 mg)
(Human immunoglobulin percentage
≥ 95% Ig
≥ 95% Ig)
- Excipients:
Glycine, Sodium chloride
Water for injection q.s.
1 ml
2 ml
Pharmaceutical form and content
Solution for injection in pre-filled syringe containing 250 or 500 IU
of human antitetanus immunoglobulin.
Clear or slightly opalescent, colourless or pale-yellow or light-brown
liquid; during storage it may show formation of slight
turbidity or a small amount of visible particulate matter.
Activity
Igantet
®
is a solution for injection of human antitetanus immunoglobulin that
contains antibodies to tetanus toxin and
that has been subjected to a pasteurisation process. It is prepared
from pooled donors’ plasma containing specific
antibodies against the toxin of Clostridium tetani.
Manufacturer
Instituto Grifols, S.A.
Can Guasc, 2 - Parets del Vallès
08150 Barcelona - SPAIN
Therapeutic indications
- Prophylaxis in persons with recent injuries that might be
contaminated with tetanus spores and who did not receive
vaccination in the previous 10 years or whose prior vaccination
regimen was incomplete or is unknown.
- Treatment of clinically manifest tetanus.
Contraindications
The lethal risk associated with tetanus rules out any potential
contraindication (see item corresponding to Precautions).
Precautions
Do not give this product intravascularly (risk of shock). Injections
have to be made intramuscularly, and care should be
taken to draw back the plunger of the syringe before injection in
order to be certain that the needle is not in a blood vessel.
True allergic responses to human antitetanus immunoglobulin given in
the prescribed intramuscular manner are rare. In
the case of shock, treatment should follow the guidelines of shock
therapy.
Intolerance to immunogl