FLEBOGAMMA 5 % DIF

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IMMUNOGLOBULINS, NORMAL HUMAN

Available from:

MEDICI MEDICAL LTD, ISRAEL

ATC code:

J06BA02

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

IMMUNOGLOBULINS, NORMAL HUMAN 0.5 G / 10 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

INSTITUTO GRIFOLS S.A.,SPAIN,BARCELONA

Therapeutic group:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

Therapeutic area:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

Therapeutic indications:

Replacement therapy in: Primary immunodeficiency syndromes such as:- congenital agammaglobulinaemia and hypogammaglobulinaemia- common variable immunodeficiency- severe combined immunodeficiency- Wiskott Aldrich syndromeMyeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.Children with congenital AIDS and recurrent infections.Immunomodulation :Idiopathic thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.Guillain Barré Syndrome.Kawasaki disease.Allogeneic bone marrow transplantation

Authorization date:

2020-12-31

Patient Information leaflet

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה
_____ ךיראת
02.11.2014
__________________
______תילגנאב רישכת םש
FLEBOGAMMA 5% DIF
_______םושיר רפסמ
121-04-29877-00
_____________ מ"עב לקידמ י'צידמ___םושירה לעב םש
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
PHARMACEUTIC
AL FORM
Flebogamma
®
5% is a sterile, pasteurised,
50 g/l solution of highly purified intact
human normal immunoglobulin for
intravenous infusion. The solution contains
an immunoglobulin G subclass distribution
that approximates to the distribution found in
normal plasma and contains not more than
0.05 mg/ml IgA. The product is stabilised by
5% D-sorbitol.
Solution for infusion
.
The solution is clear or slightly opalescent and
colourless or pale yellow
.
Flebogamma DIF is isotonic, with an
osmolality from 240 to 370 mOsm/kg.
THERAPEUTIC
INDICATIONS
Flebogamma
®
5% is indicated for
:
Replacement therapy in
:
Primary immunodeficiency syndromes
such as
:
-
congenital agammaglobulinaemia
and hypogammaglobulinaemia
-
common variable immunodeficiency
-
severe combined immunodeficiency
-
Wiskott Aldrich syndrome
Myeloma or chronic lymphocytic
leukaemia with severe secondary
hypogammaglobulinaemia and
recurrent infections
.
Children with congenital AIDS and
recur Immunomodulation
Idiopathic thrombocytopenic purpura
(ITP), in children or adults at high risk
of bleeding or prior to surgery to
correct the platelet count
.
rent infections.
Replacement therapy in
adults, children and
adolescents (2-18 years) in
:
-
Primary immunodeficiency syndromes with
impaired antibody production (see section
_Special warnings and precautions for use_).
-
Hypogammaglobulinaemia and recurrent
bacterial infections in patients with chronic
lymphocytic leukaemia, in whom prophylactic
antibiotics have failed.
-
Hypogammaglobulinaemia and recurrent
bacterial infection

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Flebogamma 5% DIF solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)
One ml contains:
Human normal immunoglobulin ……….. 50 mg
(purity of at least 97% of IgG)
Each vial of 10 ml contains: 0.5 g of human normal immunoglobulin
Each vial of 50 ml contains: 2.5 g of human normal immunoglobulin
Each vial of 100 ml contains: 5 g of human normal immunoglobulin
Each vial of 200 ml contains: 10 g of human normal immunoglobulin
Each vial of 400 ml contains: 20 g of human normal immunoglobulin
Distribution of the IgG subclasses (approx. values):
IgG
1
66.6%
IgG
2
28.5%
IgG
3
2.7%
IgG
4
2.2%
The maximum IgA content is 50 micrograms/ml.
Produced from the plasma of human donors.
Excipient with known effect:
One ml contains 50 mg of sorbitol.
For the full list of excipients, see section 6.1
_._
3.
PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear or slightly opalescent and colourless or pale
yellow.
Flebogamma DIF is isotonic, with an osmolality from 240 to 370
mOsm/kg.
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4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
REPLACEMENT THERAPY IN:
PRIMARY IMMUNODEFICIENCY SYNDROMES SUCH AS:
- CONGENITAL AGAMMAGLOBULINAEMIA AND HYPOGAMMAGLOBULINAEMIA
- COMMON VARIABLE IMMUNODEFICIENCY
- SEVERE COMBINED IMMUNODEFICIENCY
- WISKOTT ALDRICH SYNDROME
MYELOMA OR CHRONIC LYMPHOCYTIC LEUKAEMIA WITH SEVERE SECONDARY
HYPOGAMMAGLOBULINAEMIA AND RECURRENT INFECTIONS.
CHILDREN WITH CONGENITAL AIDS AND RECURRENT INFECTIONS.
IMMUNOMODULATION:
IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP), IN CHILDREN OR ADULTS AT
HIGH RISK OF
BLEEDING OR PRIOR TO SURGERY TO CORRECT THE PLATELET COUNT.
GUILLAIN BARRÉ SYNDROME.
KAWASAKI DISEASE.
ALLOGENEIC BONE MARROW TRANSPLANTATION.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Replacement therapy should be initiated and monitored under the
supervision of a