Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
IMMUNOGLOBULINS, NORMAL HUMAN
KAMADA LTD, ISRAEL
J06BA02
SOLUTION FOR INFUSION
IMMUNOGLOBULINS, NORMAL HUMAN 5 G / 100 ML
I.V
Required
BIO PRODUCTS LABORATORY LIMITED (BPL), UK
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
Replacement therapy in adults, and children and adolescents in:- Primary immunodeficiency syndromes with impaired antibody production - 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- Congenital AIDS with recurrent bacterial infectionsImmunomodulation in adults, and children and adolescents in:- 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
2016-01-31
HEAD OFFICE 2 Holzman St., Science Park, P.O. Box 4081, Rehovot, 7670402, Israel | Tel. +972-8-9406472 | Fax. +972-89406473 PLANT Kibbutz Beit Kama, M.P Negev 8532500, Israel | Tel. +972-8-9913111 | Fax. +972-8-9912083 טסוגוא 8 201 ,ה/דבכנ ת/חקור ,ה/אפור :רישכתה רובע ,ןלהל טרופמכ עדימ ןוכדיע לע עידוהל תשקבמ עדהמק תרבח GAMMAPLEX ; סקלפאמג SOLUTION FOR INFUSION, I.V. ןוישירל םאתהב םיליעפ םיביכרמ : IMMUNOGLOBULIN NORMAL HUMAN 5g/100 ml :היוותה REPLACEMENT THERAPY IN ADULTS, AND CHILDREN AND ADOLESCENTS 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 - Congenital AIDS with recurrent bacterial infections IMMUNOMODULATION IN ADULTS, AND CHILDREN AND ADOLESCENTS IN: - 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 יונישה תוהמ םי : סב אפורל ןולעה ןוכדיע ףיע SPECIAL WARNINGS AND PRECAUTIONS FOR USE 4.4 :)בוהצב תשגדומ הרמחה( Transfusion related acute lung injuries (TRALI) There have been reports of TRALI i.e. noncardiogenic pulmonary oedema, in patients administered IVIg products. :תואירבה דרשמ רתאבש תופורתה רגאמב םוסרפל חלשנ ןכדועמה אפורל ןולעה HTTPS://WWW.OLD.HEALTH.GOV.IL/UNITS/PHARMACY/TRUFOT/INDEX.ASP , לעבל הינפ י"ע ספדומ ולבקל ןתינו המק תרבח ,םושירה 'לט( מ"עב עד 08-9406472 .) ,הכרבב ,לדונ הנינפ הנוממ תחקור Citiți documentul complet
_ _ _ _ _Page 1 of 15 _ GAMMAPLEX ® SOLUTION FOR INFUSION 1. NAME OF THE MEDICINAL PRODUCT Gammaplex ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Gammaplex 5 % w/v, solution for infusion. Human normal immunoglobulin (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 (approximate values): IgG1 62 % IgG2 31 % IgG3 6 % IgG4 1 % The maximum IgA content is 10 micrograms / ml. Produced from the plasma of human donors. For the full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Gammaplex is a colourless sterile solution for intravenous infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS REPLACEMENT THERAPY IN ADULTS, AND CHILDREN AND ADOLESCENTS 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 - Congenital AIDS with recurrent bacterial infections _ _ _ _ _Page 2 of 15 _ IMMUNOMODULATION IN ADULTS, AND CHILDREN AND ADOLESCENTS IN: - 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 monitored under the supervision of a physician experienced in the treatment of immunodeficiency. Treatment at home should be similarly supervised, with the patient fully assessed and trained in hospital prior to self-infusion at home. Posology The dose and dose regimen is depende Citiți documentul complet