IGANTET INJECTION 250 iuml

Country: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

ANTITETANUS IMMUNOGLOBULIN (HUMAN)

Доступно од:

GRIFOLS ASIA PACIFIC PTE. LTD.

АТЦ код:

J06BB02

Дозирање:

250 iu/ml

Фармацеутски облик:

INJECTION

Састав:

ANTITETANUS IMMUNOGLOBULIN (HUMAN) 250 iu/ml

Пут администрације:

INTRAMUSCULAR

Тип рецептора:

Prescription Only

Произведен од:

INSTITUTO GRIFOLS, S.A.

Статус ауторизације:

ACTIVE

Датум одобрења:

2004-06-24

Информативни летак

HUMAN ANTITETANUS IMMUNOGLOBULIN
Solution for injection in pre-filled syringe
COMPOSITION
250 I.U.
500 I.U.
- Active ingredient:
Human antitetanus immunoglobulin
250 I.U.
500 I.U.
(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
I.U. of human antitetanus
immunoglobulin.
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.
HOLDER OF THE MARKETING AUTHORISATION 
Instituto Grifols, S.A.
Can Guasch, 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 immunoglobulins is likely to develop in the very rare
cases of IgA deficiency, when
the patient has antibodies against IgA.
Patients should be observed for at least 20 minutes after
administration.
When medicinal products prep

Карактеристике производа

HUMAN ANTITETANUS IMMUNOGLOBULIN
Solution for injection in pre-filled syringe
COMPOSITION
250 I.U.
500 I.U.
- Active ingredient:
Human antitetanus immunoglobulin
250 I.U.
500 I.U.
(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
I.U. of human antitetanus
immunoglobulin.
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.
HOLDER OF THE MARKETING AUTHORISATION
Instituto Grifols, S.A.
Can Guasch, 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 immunoglobulins is likely to develop in the very rare
cases of IgA deficiency, when
the patient has antibodies against IgA.
Patients should be observed for at least 20 minutes after
administration.
When medicinal products prepared from human blood or p