VIGAM LIQUID 5G/100ML SOLUTION FOR INTRAVENOUS INFUSION

Country: Ċipru

Lingwa: Grieg

Sors: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Ingredjent attiv:

IMMUNOGLOBULIN HUMAN NORMAL

Disponibbli minn:

BIO PRODUCTS LABORATORY LIMITED (0000009242) DAGGER LANE, ELSTREE, HERTFORDSHIRE, WD6 3BX

Kodiċi ATC:

J06BA02

INN (Isem Internazzjonali):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Dożaġġ:

5G/100ML

Għamla farmaċewtika:

SOLUTION FOR INTRAVENOUS INFUSION

Kompożizzjoni:

IMMUNOGLOBULIN HUMAN NORMAL (8000012671) 5% W/V

Rotta amministrattiva:

INTRAVENOUS USE

Tip ta 'preskrizzjoni:

Εθνική Διαδικασία

Żona terapewtika:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Sommarju tal-prodott:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 50ML (200016001) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 200 ml (200016002) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 100ML (200016003) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή

Karatteristiċi tal-prodott

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
_Vigam Liquid_
_PL 08801/0040_
1.
NAME OF THE MEDICINAL PRODUCT
Vigam
Liquid is a 5 % w/v normal immunoglobulin sterile liquid.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg) (IVIg)
One ml contains:
Human normal immunoglobulin 50 mg
(Purity of at least 95% IgG)
Each 2.5 g vial of 50 mL contains: 2.5 g of Human normal
immunoglobulin.
Each 5 g vial of 100 mL contains: 5 g of Human normal immunoglobulin.
Each 10 g vial of 200 mL contains: 10 g of Human normal
immunoglobulin.
Distribution of the IgG subclasses is similar to plasma (approximate
values):
IgG1: 64 %
IgG2: 29 %
IgG3: 6 %
IgG4: 1 %
The maximum IgA content is 14 micrograms/ml.
Produced from the plasma of human donors.
Excipient(s):
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Vigam
Liquid is a sterile liquid for intravenous administration which varies
from colourless to
pale amber or pale green.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Replacement therapy in adults, and children and adolescents (0-18
years) in:

Primary immunodeficiency syndromes with impaired antibody production
(see section
4.4).

Hypogammaglobulinaemia and recurrent bacterial infections in patients
with chronic
lymphocytic leukaemia, in whom prophylactic antibiotics have failed.

Hypogammaglobulinaemia and recurrent bacterial infections in plateau
phase multiple
myeloma patients who have failed to respond to pneumococcal
immunisation.

Hypogammaglobulinaemia in patients after allogeneic haematopoietic
stem cell
transplantation (HSCT).

Congenital AIDS and recurrent bacterial infections
Immunomodulation in adults, and children and adolescents (0-18 years)
in:
2
_Vigam Liquid_
_PL 08801/0040_

Primary immune thrombocytopenia (ITP), in patients at high risk of
bleeding or prior to
surgery to correct the platelet count

Guillain Barré Syndrome

Kawasaki disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Replacement therapy should be initiated and monitore