Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
IMMUNOGLOBULINS, NORMAL HUMAN
CSL BEHRING LTD., ISRAEL
J06BA01
SOLUTION FOR INFUSION
IMMUNOGLOBULINS, NORMAL HUMAN 200 MG / 1 ML
S.C
Required
CSL BEHRING AG, SWITZERLAND
IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASCULAR ADM.
Replacement therapy in adults and children in primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency and Wiskott-Aldrich syndrome - IgG subclass deficiencies with recurrent infectionsReplacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
2020-05-04
PATIENT LEAFLET IN ACCORDANCE WITH PHARMACIST’S REGULATIONS (PREPARATIONS) 1986 The medicine is marketed according to doctor’s prescription only. HIZENTRA, 200 MG/ML SOLUTION FOR SUBCUTANEOUS INFUSION IN VIAL HIZENTRA, 200 MG/ML SOLUTION FOR SUBCUTANEOUS INFUSION IN PRE-FILLED SYRINGE Human normal immunoglobulin (SCIg = Subcutaneous Immunoglobulin) COMPOSITION The ACTIVE SUBSTANCE is human normal immunoglobulin. One ml contains 200 mg of human normal immunoglobulin, of which at least 98% is immunoglobulin type G (IgG). The approximate percentage of IgG subclasses is as follows: IgG1 69 % IgG2 26 % IgG3 3 % IgG4 2 % This medicine contains trace amounts of IgA (not more than 50 micrograms /ml). Hizentra is essentially sodium free. OTHER INGREDIENTS (EXCIPIENTS) See section 6. - READ THE LEAFLET CAREFULLY UNTIL THE END BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or the pharmacist. - This medicine was prescribed for you. Do not pass it on to others. It may harm them even if their medical condition seems similar to yours. 1. WHAT HIZENTRA IS USED FOR? Hizentra is used in the treatment of adults and children: 1. Who are born with a reduced ability or inability to produce immunoglobulins (primary immunodeficiencies). This includes conditions such as: • low immunoglobulin levels (hypogammaglobulinaemia) or absence of immunoglobulins (agammaglobulinaemia) in the blood • combination of low immunoglobulin levels, frequent infections and inability to produce adequate amounts of antibodies after vaccination (common variable immunodeficiency) • combination of low level or absence of immunoglobulins and absence or non-functional immune cells (severe combined immunodeficiency and Wiskott- Aldrich syndrome) • lack of certain immunoglobulin G subclasses causing recurrent infections. 2. Treatment of low immunoglobulin levels (Hypogammaglobulinaemia ) and recurrent infections in patients with chronic lymphocytic leukaemia (CLL Pročitajte cijeli dokument
1. NAME OF THE MEDICINAL PRODUCT Hizentra 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Immunoglobulin normal Human (SCIg) One ml contains: Human normal immunoglobulin ....................................................................................................200 mg (purity: at least 98% is immunoglobulin type G (IgG)) Vials Each vial of 5 ml solution contains: 1 g of human normal immunoglobulin Each vial of 10 ml solution contains: 2 g of human normal immunoglobulin Each vial of 20 ml solution contains: 4 g of human normal immunoglobulin Each vial of 50 ml solution contains: 10 g of human normal immunoglobulin Pre-filled syringes Each pre-filled syringe of 5 ml solution contains: 1 g human normal immunoglobulin Each pre-filled syringe of 10 ml solution contains: 2 g human normal immunoglobulin Distribution of the IgG subclasses (approx. values): IgG1 ............ 69 % IgG2 ............ 26 % IgG3 ............ 3 % IgG4 2 % The maximum IgA content is 50 micrograms/ml. Produced from the plasma of human donors. Excipients with known effects Hizentra contains approximately 250 mmol/L of L-proline. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for subcutaneous infusion. The solution is clear and pale-yellow or light-brown. Hizentra has an approximate osmolality of 380 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Replacement therapy in adults and children in primary immunodeficiency syndromes such as: − congenital agammaglobulinaemia and hypogammaglobulinaemia − common variable immunodeficiency − severe combined immunodeficiency and Wiskott-Aldrich syndrome − IgG subclass deficiencies with recurrent infections Replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology for adults and children The dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response and serum IgG trough levels. Pročitajte cijeli dokument