Niuliva Solution For Infusion 250 I.U.ml

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

Human antihepatitis B immunoglobulin

Disponible desde:

GRIFOLS ASIA PACIFIC PTE. LTD.

Código ATC:

J06BB04

Dosis:

250 I.U./ml

formulario farmacéutico:

INJECTION, SOLUTION

Composición:

Human antihepatitis B immunoglobulin 250 I.U./ml

Vía de administración:

INTRAVENOUS

tipo de receta:

Prescription Only

Fabricado por:

INSTITUTO GRIFOLS, S.A.

Estado de Autorización:

ACTIVE

Fecha de autorización:

2011-12-30

Información para el usuario

Niuliva
®
 250 I.U./ml 
Solution for infusion
Human antiHepatitiS B immunogloBulin
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human antihepatitis B immunoglobulin.
the percentage of igg subclasses, which is determined by immunonephelometry, is approximately 74.3% igg
1
, 
22.1% igg
2
, 1.99% igg
3
 and 1.61% igg
4
.
Human protein content is 50 g/l of which at least 97% is igg.
the  content  of  human  antihepatitis  B  immunoglobulin  is  250  i.u./ml  (600  i.u./2.4  ml,  1,000  i.u./4  ml,  
5,000 i.u./20 ml and 10,000 i.u./40 ml).
Contains trace amounts of iga (lower than 0.05 mg/ml).
excipient:
D-sorbitol content is 50 g/l.
For full list of excipients, see section “list of excipients”.
PHARMACEUTICAL FORM
Solution for infusion.
the solution is clear or slightly opalescent and colourless or pale yellow.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
niuliva
®
 is indicated for:
PREVENTION OF HEPATITIS B VIRUS RE-INFECTION AFTER LIVER TRANSPLANTATION FOR HEPATITIS B INDUCED LIVER FAILURE 
DURING THE MAINTENANCE PHASE IN NON REPLICATOR PATIENTS.
IMMUNOPROPHYLAXIS OF HEPATITIS B
-  in  case  of  accidental  exposure  in  non-immunised  subjects  (including  persons  whose  vaccination  is 
incomplete or status unknown).
-  in haemodialysed patients, until vaccination has become effective.
-  in the newborn of a hepatitis B virus carrier-mother.
-  in  subjects  who  did  not  show  an  immune  response  (no  measurable  antihepatitis  B  antibodies)  after 
vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected 
with hepatitis B.
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
PREVENTION OF HEPATITIS B VIRUS RE-INFECTION AFTER LIVER TRANSPLANTATION FOR HEPATITIS B INDUCED LIVER FAILURE 
DURING TH

Ficha técnica

Niuliva
®
250 I.U./ml
Solution for infusion
Human antiHepatitiS B immunogloBulin
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human antihepatitis B immunoglobulin.
the percentage of igg subclasses, which is determined by
immunonephelometry, is approximately 74.3% igg
1
,
22.1% igg
2
, 1.99% igg
3
and 1.61% igg
4
.
Human protein content is 50 g/l of which at least 97% is igg.
the content of human antihepatitis B immunoglobulin is 250 i.u./ml
(600 i.u./2.4 ml, 1,000 i.u./4 ml,
5,000 i.u./20 ml and 10,000 i.u./40 ml).
Contains trace amounts of iga (lower than 0.05 mg/ml).
excipient:
D-sorbitol content is 50 g/l.
For full list of excipients, see section “list of excipients”.
PHARMACEUTICAL FORM
Solution for infusion.
the solution is clear or slightly opalescent and colourless or pale
yellow.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
niuliva
®
is indicated for:
PREVENTION OF HEPATITIS B VIRUS RE-INFECTION AFTER LIVER
TRANSPLANTATION FOR HEPATITIS B INDUCED LIVER FAILURE
DURING THE MAINTENANCE PHASE IN NON REPLICATOR PATIENTS.
IMMUNOPROPHYLAXIS OF HEPATITIS B
-
in case of accidental exposure in non-immunised subjects (including
persons whose vaccination is
incomplete or status unknown).
-
in haemodialysed patients, until vaccination has become effective.
-
in the newborn of a hepatitis B virus carrier-mother.
-
in subjects who did not show an immune response (no measurable
antihepatitis B antibodies) after
vaccination and for whom a continuous prevention is necessary due to
the continuous risk of being infected
with hepatitis B.
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
PREVENTION OF HEPATITIS B VIRUS RE-INFECTION AFTER LIVER
TRANSPLANTATION FOR HEPATITIS B INDUCED LIVER FAILURE
DURING THE MAINTENANCE PHASE IN NON REPLICATOR PATIENTS:
in adults:
2,000 - 10,000 i.u./month to maintain antibody levels above 100 - 150
i.u./l in HBV-Dna negative patients.
IMMUNOPROPHYLAXIS OF HEPATITIS B:
-
prevention of hepatitis B in case of accidental exposure in
non-immunised subjects:
at least 500 i.u., depending on the int