PASTEURISED HUMAN IMMUNOGLOBULIN GRIFOLS FOR INJECTION 160 mgml

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

IMMUNOGLOBULIN (POLYVALENT) (HUMAN)

Tilgjengelig fra:

GRIFOLS ASIA PACIFIC PTE. LTD.

ATC-kode:

J06BA02

Dosering :

160 mg/ml

Legemiddelform:

INJECTION

Sammensetning:

IMMUNOGLOBULIN (POLYVALENT) (HUMAN) 160 mg/ml

Administreringsrute:

INTRAMUSCULAR

Resept typen:

Prescription Only

Produsert av:

INSTITUTO GRIFOLS SA

Autorisasjon status:

ACTIVE

Autorisasjon dato:

2000-01-19

Informasjon til brukeren

HUMAN POLYVALENT IMMUNOGLOBULIN
Solution for injection
COMPOSITION
2 ml
5 ml
- Active ingredient:
Human polyvalent immunoglobulin
320 mg
800 mg
(Human protein
288-352 mg
720-880 mg)
(Human immunoglobulin percentage
≥ 95% Ig
≥ 95% Ig)
- Excipients:
Glycine, Sodium chloride
Water for injection q.s.
2 ml
5 ml
PHARMACEUTICAL FORM AND CONTENT
Solution for injection containing 2 or 5 ml of human polyvalent
immunoglobulin 16% solution.
ACTIVITY
Pasteurised Human Immunoglobulin Grifols is a solution for injection
of human polyvalent
immunoglobulin that contains mainly immunoglobulin G (IgG), having a
broad spectrum of
antibodies against various infectious agents, and that has been
subjected to a pasteurisation
process. 
This product is obtained from human plasma tested and found
non-reactive for hepatitis B
surface antigen (HBsAg) and negative for antibodies to HCV and
antibodies to HIV-1 and HIV-2.
HOLDER OF THE MARKETING AUTHORISATION
Instituto Grifols, S.A.
Can Guasch, 2 - Parets del Vallès
08150 Barcelona - SPAIN
THERAPEUTIC INDICATIONS 
-
Hepatitis  A  prophylaxis  before  exposure  in  the  case  of  travellers  going  to  endemic
hepatitis A areas or in persons exposed less than 1 week previously.
-
Measles prophylaxis or attenuation in persons exposed less than 1 week previously, if specific
measles immunoglobulin is not available.
-
Rubella prophylaxis in pregnant susceptible women within 72 hours of exposure, if specific
rubella immunoglobulin is not available.
This  treatment  could  remove  the  symptoms  suffered  by  the  mother  without  preventing  the
infection or viremia which could be masked.
-
Replacement  therapy  for  patients  with  antibody  deficiency  syndromes  resulting  from
defective antibody synthesis, whether primary or secondary.
CONTRAINDICATIONS
Intolerance to homologous immunoglobulins.
Allergic response related to any of the components.
Pasteuri

Preparatomtale

HUMAN POLYVALENT IMMUNOGLOBULIN
Solution for injection
COMPOSITION
2 ml
5 ml
- Active ingredient:
Human polyvalent immunoglobulin
320 mg
800 mg
(Human protein
288-352 mg
720-880 mg)
(Human immunoglobulin percentage
≥
95% Ig
≥
95% Ig)
- Excipients:
Glycine, Sodium chloride
Water for injection q.s.
2 ml
5 ml
PHARMACEUTICAL FORM AND CONTENT
Solution for injection containing 2 or 5 ml of human polyvalent
immunoglobulin 16% solution.
ACTIVITY
Pasteurised Human Immunoglobulin Grifols is a solution for injection
of human polyvalent
immunoglobulin that contains mainly immunoglobulin G (IgG), having a
broad spectrum of
antibodies against various infectious agents, and that has been
subjected to a pasteurisation
process.
This product is obtained from human plasma tested and found
non-reactive for hepatitis B
surface antigen (HBsAg) and negative for antibodies to HCV and
antibodies to HIV-1 and HIV-2.
HOLDER OF THE MARKETING AUTHORISATION
Instituto Grifols, S.A.
Can Guasch, 2 - Parets del Vallès
08150 Barcelona - SPAIN
THERAPEUTIC INDICATIONS
-
Hepatitis A prophylaxis before exposure in the case of travellers
going to endemic
hepatitis A areas or in persons exposed less than 1 week previously.
-
Measles prophylaxis or attenuation in persons exposed less than 1 week
previously, if specific
measles immunoglobulin is not available.
-
Rubella prophylaxis in pregnant susceptible women within 72 hours of
exposure, if specific
rubella immunoglobulin is not available.
This treatment could remove the symptoms suffered by the mother
without preventing the
infection or viremia which could be masked.
-
Replacement
therapy
for
patients
with
antibody
deficiency
syndromes
resulting
from
defective antibody synthesis, whether primary or secondary.
CONTRAINDICATIONS
Intolerance to homologous immunoglobulins.
Allergic response related to any of the components.
Pasteurised Human Immunoglobulin Grifols should not be administered to
patients suffering
from
severe
thrombocytopenia
or
any
coagulation
disorder
that
would
contraindicate
intramu