PRIVIGEN

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

IMMUNOGLOBULINS, NORMAL HUMAN

זמין מ:

CSL BEHRING LTD., ISRAEL

קוד ATC:

J06BA02

טופס פרצבטיות:

SOLUTION FOR INFUSION

הרכב:

IMMUNOGLOBULINS, NORMAL HUMAN 100 G/L

מסלול נתינה (של תרופות):

I.V

סוג מרשם:

Required

תוצרת:

CSL BEHRING AG, SWITZERLAND

קבוצה תרפויטית:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

איזור תרפויטי:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

סממני תרפויטית:

Replacement therapy in• Primary immunodeficiency syndromes (PID) 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 infectionsImmunomodulation• Immune thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgical interventions to correct the platelet count• Guillain-Barré syndrome• Kawasaki disease• Chronic inflammatory demyelinating polyneuropathy (CIDP)Allogeneic bone marrow transplantation

תאריך אישור:

2016-06-30

עלון מידע

2019 רבמטפס
PRIVIGEN
ןגיווירפ
Active ingredient:
HUMAN NORMAL IMMUNOGLOBULIN 100 G/L
:ליעפ רמוח
Solution for I.V. Infusion
הסימת
ידירו ךות ןתמל היזופניאל
ןלהל
חסונ
היוותהה
:רישכתל רשואמה
Replacement therapy in
•
_Primary immunodeficiency syndromes_ _(PID)_ 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
•
_Immune thrombocytopenic purpura (ITP) in children or adults at high
risk of bleeding or prior to _
_surgical interventions to correct the platelet count _
•
_Guillain-Barré syndrome _
•
_Kawasaki disease _
•
_Chronic inflammatory demyelinating polyneuropathy (CIDP) _
Allogeneic bone marrow transplantation
,ה/דבכנ ת/חקור ,ה/אפור
•
ולעה
ן
אפורל
ןכדוע
ב
ילוי
2019
הווהמה יונישב
הרמחה
.
•
ולעב
ן
םניאש םיפסונ םייוניש
םיווהמ
רמחה
תו
.
:אפורל ןולעב ירקיעה ןוכדעה
4.8 UNDESIRABLE EFFECTS
MEDDRA SYSTEM ORGAN CLASS
(SOC)
ADVERSE DRUG REACTION
FREQUENCY
Blood and lymphatic
system disorders
Anaemia, haemolysis
(including haemolytic anaemia)
leukopenia
Anisocytosis (including
microcytosis),
thrombocytosis
Decreased neutrophil count
Unknown
ולעה
ן
אפורל
נ
.תואירבה דרשמ רתאבש תופורתה רגאמל
ותאלעה ךרוצל תואירבה דרשמל חלש
לבקל ןתינ
הז ןולע
די לע ספדומ
י
הינפ
הרישי
:םושירה לעבל
סקידמנג
חר ,
םינושארה תיב
12
,
תוישעת קראפ
רפח קמע
3877701
.
:ןופלט
04-6341766
.
,הכרבב
רלדירפ תירוד
חקור
ת
הנוממ
סקידמנג

מאפייני מוצר

1. NAME OF THE MEDICINAL PRODUCT
Privigen
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin
(IVIg)*.
One ml contains:
Human normal immunoglobulin 100 mg
(purity of at least 98% IgG)
Each vial of 25 ml solution contains: 2.5 g human normal
immunoglobulin
Each vial of 50 ml solution contains: 5 g human normal immunoglobulin
Each vial of 100 ml solution contains: 10 g human normal
immunoglobulin
*Produced from the plasma of human donors.
Excipients with known effects:_ _
Privigen contains approximately 250 mmol/L of L-proline.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear to slightly opalescent and colorless to pale
yellow. Privigen is isotonic, with
an approximate osmolality of 320 mOsmol/kg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Replacement therapy in
•
_Primary immunodeficiency syndromes_ _(PID)_ 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
•
_Immune thrombocytopenic purpura (ITP) in children or adults at high
risk of bleeding or prior _
_to surgical interventions to correct the platelet count _
•
_Guillain-Barré syndrome _
•
_Kawasaki disease _
•
_Chronic inflammatory demyelinating polyneuropathy (CIDP) _
Allogeneic bone marrow transplantation
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_DOSAGE _
The dosage and dosage regimen is dependent on the indication. In
replacement therapy the dosage
may need to be individualized for each patient depending on the
clinical response. The following
dosage regimens are given as a guideline.
Replacement therapy in primary immunodeficiency syndromes
The dosage regimen should achieve a trough IgG level (measured before
the next infusion)