Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Human normal immunoglobulin
TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
J06BA02
100mg/ml
INFUSION, SOLUTION
Human normal immunoglobulin 100mg/ml
INTRAVENOUS
Prescription Only
Baxalta Belgium Manufacturing SA
ACTIVE
2010-05-21
Page 1 of 15 BAXTER KIOVIG NAME OF THE MEDICINAL PRODUCT KIOVIG 100 mg/ml solution for infusion QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Human normal immunoglobulin (IVIg)..............................................100 mg* *corresponding to human protein content, of which at least 98% is IgG One vial of 10 ml contains: 1 g One vial of 25 ml contains: 2.5 g One vial of 50 ml contains: 5 g One vial of 100 ml contains: 10 g One vial of 200 ml contains: 20 g One vial of 300ml contains: 30g Distribution of IgG subclasses: IgG1 ≥ 56.9% IgG2 ≥ 26.6% IgG3 ≥ 3.4% IgG4 ≥ 1.7% Maximum immunoglobulin A (IgA) content: 0.14 milligram per ml. Excipient: Glycine For a full list of excipients, see ‘List of excipients’. PHARMACEUTICAL FORM Solution for infusion The solution is clear or slightly opalescent and colourless or pale yellow. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Replacement therapy in Primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogamma-globulinaemia - common variable immunodeficiency - severe combined immunodeficiency - Wiskott Aldrich syndrome Myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary hypogamma- globulinaemia and recurrent infections. Children with congenital AIDS and recurrent infections. Page 2 of 15 Immunomodulation - Idiopathic thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count. - Guillain Barré syndrome - Kawasaki disease Allogeneic bone marrow transplantation POSOLOGY AND METHOD OF ADMINISTRATION Replacement therapy should be initiated and monitored under a physician experienced in the treatment of immunodeficiency. POSOLOGY The dose and dosage regimen are dependent on the indication. In replacement therapy the dosage may need to be individualised fo Read the complete document
Page 1 of 15 BAXALTA KIOVIG NAME OF THE MEDICINAL PRODUCT KIOVIG 100 mg/ml solution for infusion QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Human normal immunoglobulin (IVIg)..............................................100 mg* *corresponding to human protein content, of which at least 98 % is IgG One vial of 10 ml contains: 1 g One vial of 25 ml contains: 2.5 g One vial of 50 ml contains: 5 g One vial of 100 ml contains: 10 g One vial of 200 ml contains: 20 g One vial of 300ml contains: 30g Distribution of IgG subclasses: IgG1 ≥ 56.9% IgG2 ≥ 26.6% IgG3 ≥ 3.4% IgG4 ≥ 1.7% Maximum immunoglobulin A (IgA) content: 0.14 milligram per ml. Excipient: Glycine For a full list of excipients, see ‘List of excipients’. PHARMACEUTICAL FORM Solution for infusion The solution is clear or slightly opalescent and colourless or pale yellow. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Replacement therapy in Primary immunodeficiency syndromes such as: - congenital agammaglob ulinaemia and hypogamma-globulinaemia - common variable immunodeficiency - severe combined immunodeficienc y - Wiskott Aldrich syndrome Myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary hypogamma- globulinaemia and recurrent infections. Children with congenital AIDS and recurrent infections. Page 2 of 15 Immunomodulation - Idiopathic thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count. - Guillain Barré syndrome - Kawasaki disease - Multifocal Motor Neuropathy (MMN) Allogeneic bone marrow transplantation POSOLOGY AND METHOD OF ADMINISTRATION Replacement therapy should be initiated and monitored under a physician experienced in the treatment of immunodeficiency. POSOLOGY The dose and dosage regimen are dependent on the indication. In replacement therapy the dosage may need to be individualised for each patient depending on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline. Replacement therapy in Read the complete document