국가: 이스라엘
언어: 영어
출처: Ministry of Health
IMMUNOGLOBULINS, NORMAL HUMAN
CSL BEHRING LTD., ISRAEL
J06BA02
SOLUTION FOR INFUSION
IMMUNOGLOBULINS, NORMAL HUMAN 100 G/L
I.V
Required
CSL BEHRING AG, SWITZERLAND
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
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
2016-06-30
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 전체 문서 읽기
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) 전체 문서 읽기