Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
HUMAN PLASMA PROTEIN >90% GAMMA GLOBULIN
Baxalta Innovations GmbH
J06BA; J06BA02
HUMAN PLASMA PROTEIN >90% GAMMA GLOBULIN
0.5 g/30 m gram(s)/millilitre
Powder and solvent for solution for infusion
Intravenous use
vials of 5.0 g and 10.0 g
Product subject to prescription which may not be renewed (A)
immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration
Immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm.
Primary immunodeficiency syndromes (PID): Congenital agammaglobulinaemia and hypogammaglobulinaemia Common variable immunodeficiencies Severe combined immunodeficiencies Wiskott Aldrich syndrome Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections Children with congenital AIDS and recurrent infections
Not marketed
1998-05-01
PACKAGE LEAFLET: INFORMATION FOR THE USER GAMMAGARD S/D 5.0 G / 10.0 G POWDER AND SOLVENT FOR SOLUTION FOR INFUSION Human normal immunoglobulin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What GAMMAGARD S/D is and what it is used for 2. What you need to know before you use GAMMAGARD S/D 3. How to use GAMMAGARD S/D 4. Possible side effects 5. How to store GAMMAGARD S/D 6. Contents of the pack and other information The information on Gammagard S/D in the following sections applies to both adults and children. 1. WHAT GAMMAGARD S/D IS AND WHAT IT IS USED FOR GAMMAGARD S/D belongs to a class of medications called immunoglobulins. These medicines contain human antibodies, which are present in human blood. Antibodies help your body to fight infections. Medicines like GAMMAGARD S/D are used if you do not have enough antibodies in your blood. These patients tend to get frequent infections. GAMMAGARD S/D can also be used if you need additional antibodies to cure certain inflammatory disorders (autoimmune diseases). GAMMAGARD S/D IS USED FOR TREATMENT OF PATIENTS WHO DO NOT HAVE SUFFICIENT ANTIBODIES (REPLACEMENT THERAPY). THERE ARE FOUR GROUPS: 1. Patients with inborn lack of antibodies (primary immunodeficiency syndromes (PID)) such as: – congenital agammaglobulinemia or hypogammaglobulinemia – common variable immunodeficiency – severe combined immunodeficiencies – Wiskott Aldrich syndrome 2. Patients with a lack of antibody production and recurrent infections (myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinemia) 3. Children who suffer from inborn AIDS and get frequent infections 4. Premature children with low bi Læs hele dokumentet
Health Products Regulatory Authority 22 October 2021 CRN00C3Z8 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gammagard S/DHuman Normal Immunoglobulin for Intravenous Administration Powder and solvent for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT Human Normal Immunoglobulin (IVIg) QUANTITATIVE COMPOSITION Human Normal Immunoglobulin for Intravenous Administration, Gammagard S/D, may be reconstituted with solvent [Water for Injections] to a 5% (50 mg/mL) solution or a 10% (100 mg/mL) solution of protein of which at least 90% is gamma globulin. Maximum immunoglobulin A (IgA) content: not more than 3 microgram per mL in a 5% solution. Produced from the plasma of human donors. Excipients with known effect: In grams per 100 mL reconstituted product, at 5 %: Sodium Chloride 0.9 Glucose Monohydrate 1.7 For the full list of excipients, see section 6.1. IGG SUBCLASSES Distribution of IgG subclasses: IgG1 ≥ 56.9% IgG2 ≥ 16.0% IgG3 ≥ 3.3% IgG4 ≥ 0.3% 3 PHARMACEUTICAL FORM Powder and solvent for solution for infusion. p.H. of reconstituted product is 6.4 – 7.2. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS REPLACEMENT THERAPY Primary immunodeficiency syndromes (PID): Congenital agammaglobulinaemia and hypogammaglobulinaemia Common variable immunodeficiencies Severe combined immunodeficiencies Wiskott Aldrich syndrome Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections Children with congenital AIDS and recurrent infections IMMUNOMODULATORY EFFECTIdiopathic thrombocytopenic purpura (ITP) in adults or children at high risk of bleeding or prior to surgery to correct the platelet count.Allogeneic bone marrow transplantationKawasaki syndromeGuillain-Barré 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. Health Products Regulatory Læs hele dokumentet