Country: Malta
Language: English
Source: Medicines Authority
IMMUNOGLOBULIN G, HUMAN
Octapharma (IP) Limited
J06BA01
IMMUNOGLOBULIN G, HUMAN
SOLUTION FOR INJECTION
IMMUNOGLOBULIN G, HUMAN 165 mg/ml
POM
IMMUNE SERA AND IMMUNOGLOBULINS
Authorised
2011-05-16
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER GAMMANORM, 165 MG/ML, SOLUTION FOR INJECTION 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 or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Gammanorm is and what it is used for 2. What do you need to know before you use Gammanorm 3. How to use Gammanorm 4. Possible side effects 5. How to store Gammanorm 6. Contents of the pack and other information _ _ 1. WHAT GAMMANORM IS AND WHAT IT IS USED FOR Gammanorm is an immunoglobulin and contains antibodies against bacteria and viruses. Antibodies protect the body and increase its resistance to infections. The purpose of this treatment is to attain normal antibody levels. Gammanorm is used as replacement therapy in adults, children and adolescents (0-18 years) in: Patients who are born with a reduced ability or inability to produce immunoglobulins (primary immunodeficiencies). Patients with chronic lymphocytic leukaemia, a certain kind of blood cancer that leads to a lack of antibodies and to recurrent infections, when antibiotics have failed or may not be given. Patients with multiple myeloma, another kind of blood cancer that leads to a lack of antibodies and to recurrent infections Patients with lack of antibodies and recurrent infections before and after a haematopoietic stem cell transplantation 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GAMMANORM DO NOT USE GAMMANORM: - if you are allergic to human normal immunoglobulin or any of the other ingredients of this medicine (listed in section 6). - Read the complete document
Page 1 of 11 SUMMARY OF THE PRODUCT CHARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT GAMMANORM, 165 mg/mL, solution for injection 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Human normal immunoglobulin (SCIg/IMIg) One mL contains: Human normal immunoglobulin 165 mg (purity of at least 95 % IgG) Each vial of 6 mL contains: 1 g of human normal immunoglobulin. Each vial of 10 mL contains: 1.65 g of human normal immunoglobulin. Each vial of 12 mL contains: 2 g of human normal immunoglobulin. Each vial of 20 mL contains: 3.3 g of human normal immunoglobulin. Each vial of 24 mL contains: 4 g of human normal immunoglobulin. Each vial of 48 mL contains: 8 g of human normal immunoglobulin. Distribution of the IgG subclasses (approx. values): IgG 1 ……….. 59% IgG 2 ……….. 36% IgG 3 ……….. 4.9% IgG 4 …………0.5% The maximum IgA content is 82.5 micrograms/mL Produced from the plasma of human donors. Excipients with known effects: This medicinal product contains 4.35 mmol (or 100 mg) sodium per dose (40 ml). For the full list of excipients, see section 6.1. 3 P HARMACEUTICAL F ORM Solution for injection The liquid preparation is clear or slightly opalescent and colourless or pale yellow or light-brown. 4 C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Indications for subcutaneous administration (SCIg) Replacement therapy in adults, children and adolescents (0-18 years) in: Primary immunodeficiency syndromes such with impaired antibody production (see section 4.4) Page 2 of 11 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- allogenic haematopoietic stem cell transplantation (HSCT) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Replacement therapy should be initiated and monitored under the supervision of a physician e Read the complete document