OCTAGAM

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

IMMUNOGLOBULINS, NORMAL HUMAN

Commercializzato da:

DOVER MEDICAL & SCIENTIFIC EQUIPMENT LTD, ISRAEL

Codice ATC:

J06BA02

Forma farmaceutica:

SOLUTION FOR INFUSION

Composizione:

IMMUNOGLOBULINS, NORMAL HUMAN 50 MG/ML

Via di somministrazione:

I.V

Tipo di ricetta:

Required

Prodotto da:

OCTAPHARMA PHARMAZ. PROD. m.b.H, AUSTRIA

Gruppo terapeutico:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

Area terapeutica:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

Indicazioni terapeutiche:

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

Data dell'autorizzazione:

2015-03-31

Foglio illustrativo

ילוי
2019
ה/דבכנ ת/חקור
,הדבכנ ה/אפור
רישכתל אפורל ןולע ןוכדע : ןודנה
, SOLUTION FOR I.V. INFUSION
OCTAGAM
היזופניאל הסימת ,םגאטקוא
ידירו ךות ןתמל
רישכתל אפורל ןולעב םינוכדע לע עידוהל
תשקבמ מ"עב יעדמו יאופר רושכמ רבוד תרבח
Octagam
.
:רישכתב ליעפה רמוחה
Human normal immunoglobulin 50 mg/ml
:רישכתל תרשואמה היוותהה
_REPLACEMENT THERAPY IN: _
Primary immunodeficiency syndromes such as:

congenital agammaglobulinaemia and hypogammaglobulinaemia

common variable immunodeficiency

severe combined immunodeficiency

Wiskott Aldrich syndrome

Myeloma or chronic lymphatic leukaemia with severe secondary
Hypogammaglobulinaemia and recurrent infections

Children with congenital AIDS and recurrent bacterial infections
_Immunomodulatory effect: _

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 _
ןכדוע ילארשיה ןולעה
לירפאב
2019
.הינטירבב רשואמה ןולע יפ לע
הרמחה הווהמה ןוכדע השענ םהב םיפיעס
םיניוצמ וז העדוהב
-
שגדומ
בוהצב
.
םינולעב
.הרמחה םיווהמ םניאש םיפסונ םינוכדע
םימייק
.תואירבה דרשמ ידי לע רשואש יפכ אפורל
ןולעב ןייעל שי הפורתה לע אלמ עדימל
ולעה
ן
כדועמה
ן
לשנ
ח
םוסרפל
רגאמב
תופורתה
רתאבש
דרשמ לש טנרטניאה
:תואירבה
https://data.health.gov.il/drugs/index.html#/byDrug
ולעה תא לבקל ןתינ
ספדומ ן
:םושירה לעבל היינפ י"ע
תולעמה ,מ"עב יעדמו יאופר רושכמ רבוד
11
,
.הילצרה
: ןופלט
09-9514545
ס הקבר ,בר דובכב
םינול
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Scheda tecnica

This leaflet format has been determined by the Ministry of Health and
the content has been checked
and approved in
April 2019
SUMMARY OF THE PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
OCTAGAM
50 mg/ml solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)
One ml contains :
Human normal immunoglobulin* 50 mg
* corresponding to the total protein content of which at least 95% is
human Immunoglobulin
G
Maximum IgA content: 200 micrograms/ml
Each bottle of 50 ml contains 2.5g of human normal immunoglobulin.
Each bottle of 100 ml contains 5g of human normal immunoglobulin.
Each bottle of 200 ml contains 10g of human normal immunoglobulin.
Produced from plasma of human donors.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_REPLACEMENT THERAPY IN: _
Primary immunodeficiency syndromes such as:
o
congenital agammaglobulinaemia and hypogammaglobulinaemia
o
common variable immunodeficiency
o
severe combined immunodeficiency
o
Wiskott Aldrich syndrome
•
Myeloma or chronic lymphatic leukaemia with severe secondary
Hypogammaglobulinaemia and recurrent infections
•
Children with congenital AIDS and recurrent bacterial infections
_Immunomodulatory effect: _
•
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
_POSOLOGY _
_ _
The dose and dosage regimen is dependant on the indication.
In
replacement
therapy
the
dosage
may
need
to
be
individualised
for
each
patient
dependant on the pharmacokinetic and clinical response.
The following dosage regimens are given as a guideline.
Replacement therapy in primary immunodeficiency syndromes:
•
The dosage regimen should achieve a trough level of IgG (measured
before the next
infusion) of at least 4.0 - 6.0 g