Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
IMMUNOGLOBULINS, NORMAL HUMAN
CSL BEHRING LTD., ISRAEL
J06BA01
SOLUTION FOR INJECTION
IMMUNOGLOBULINS, NORMAL HUMAN 160 MG/ML
I.M, S.C
Required
CSL BEHRING GmbH, GERMANY
IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASCULAR ADM.
IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASCULAR ADM.
Substitution in - Primary antibody deficiency syndromes resulting from defective antibody synthesis. - Protracted transitory hypogammaglobulinaemia especially in premature infants .Prophylaxis of hepatitis A- Before exposure- Within 2 weeks after exposure בקשה לתוספת התוויה 28/4/2019Indications for subcutaneous administration (SCIg)Replacement therapy in adults, children and adolescents (0-18 years) in: • Primary immunodeficiency syndromes with impaired antibody production (see section 4.4).• Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated.• Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients • Hypogammaglobulinaemia in patients pre- and post- allogeneic haematopoietic stem cell transplantation (HSCT)Indications for intramuscular administration (IMIg)Hepatitis A prophylaxisIn adults and children and adolescents (0-18 years)• Pre-exposure prophylaxis, preferably in combination with vaccination, in unvaccinated individuals travelling in less than 2 weeks to areas of hepatitis A risk.• Post-exposure prophylaxis in unvaccinated individuals within 2 weeks of hepatitis A virus (HAV) exposure.Consideration should also be given to other official guidance on the appropriate use in hepatitis A prophylaxis. For long term hepatitis A prophylaxis, vaccination is recommended. הערה: הבקשה הינה בהתאם לנוהל EMA (25.2.15)- Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration
2022-05-31
Page 1 of 12 BERIGLOBIN P 1. NAME OF THE MEDICINAL PRODUCT Beriglobin ® P Solution for injection for subcutaneous or intramuscular administration 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin One ml contains: Human normal immunoglobulin 160 mg (of which at least 95 % IgG) Each prefilled syringe of 2 ml contains: 320 mg of human normal immunoglobulin. Each prefilled syringe of 5 ml contains 800 mg of human normal immunoglobulin. Antibodies to hepatitis A virus at least 100 IU/ml Distribution of IgG subclasses: IgG 1 ca. 61 % IgG 2 ca. 28 % IgG 3 ca. 5 % IgG 4 ca. 6 % The maximum IgA content is 1700 micrograms/ml. Produced from the plasma of human donors. Excipients with known effects: Sodium (as chloride and hydroxide): 0.8 to 1.6 mg/ml. For the full list of excipients, see 6.1 3. PHARMACEUTICAL FORM Solution for injection for subcutaneous or intramuscular administration. Beriglobin P is a clear solution. The colour can vary from colourless to pale-yellow up to light brown during shelf life. Page 2 of 12 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Substitution in - Primary antibody deficiency syndromes resulting from defective antibody synthesis. - Protracted transitory hypogammaglobulinaemia especially in premature infants Prophylaxis of hepatitis A - Before exposure - Within 2 weeks after exposure 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The dosage and intervals of infusion are dependent on the indication. _SUBSTITUTION IN ANTIBODY DEFICIENCY SYNDROME _ The product should be administered via the subcutaneous route. The dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline The dosage regimen using the subcutaneous route should achieve a sustained plasma level of IgG. A loading dose of at least 0.2 to 0.5 g/kg (1.3 to 3.1 ml/kg) body weight - divided over several days with a maximal daily dose of 0.1 to 0.15 g/kg body weight and as indicated by the treating phy Prečítajte si celý dokument