Land: Singapur
Sprache: Englisch
Quelle: HSA (Health Sciences Authority)
COAGULATION FACTOR VIII (HUMAN)
WELLCHEM PHARMACEUTICALS PTE LTD
B02BD02
250 iu/5 ml
INJECTION, POWDER, FOR SOLUTION
COAGULATION FACTOR VIII (HUMAN) 250 iu/5 ml vial
INTRAVENOUS
Prescription Only
OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES MBH
ACTIVE
2004-02-06
INSTRUCTIONS FOR USE (Summary of Product Characteristics) 1 NAME OF THE MEDICINAL PRODUCT OCTAGAM® 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 ACTIVE INGREDIENTS Human normal immunoglobulin (IVIg) 2.2 QUANTITATIVE COMPOSITION: 1 ml solution contains: Protein 50 mg of which ≥ 95% is human Immunoglobulin G IgA ≤ 0.2 mg Distribution of IgG subclasses: IgG 1 ca. 60 % IgG 2 ca. 32 % IgG 3 ca. 7 % IgG 4 ca. 1 % For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _4.1.1 Replacement therapy in:_ • Primary immunodefi ciency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodefi ciency - severe combined immunodefi ciency - Wiskott Aldrich syndrome • Myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections • Children with congenital AIDS and recurrent infections. _4.1.2 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 _4.1.3 Allogeneic bone marrow transplantation_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _4.2.1 Posology_ The dose and dosage regimen is dependant on the indication. In replacement therapy the dosage may need to be individualised for each patient dependant on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline: Replacement therapy in primary immunodefi ciency syndromes: • The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 4.0 – 6.0 g/l. Three to six months are required after the initiation of therapy for equilibration to occur. The recommended starting dose is 0.4 - 0.8 g/kg, followed by at least 0.2 g/kg every Lesen Sie das vollständige Dokument
_ _ _ _ _1_ _20170202_120_50IU_spc_SG_05.04_en.doc_ _ _ INSTRUCTIONS FOR USE (SUMMARY OF PRODUCT CHARACTERISTICS) 1 NAME OF THE MEDICINAL PRODUCT OCTANATE 250 IU powder and solvent for solution for injection Human Coagulation Factor VIII, freeze-dried OCTANATE 500 IU powder and solvent for solution for injection Human Coagulation Factor VIII, freeze-dried 2 COMPOSITION OCTANATE 250 IU i s presented as pow der a nd s olvent f or s olution for injection c ontaining nominally 250 IU human coagulation factor VIII per vial. T h e p r o d u c t c o n t a i n s a p p r o x i m a t e l y 5 0 I U * p e r m l h u m a n c o a g u l a t i o n f a c t o r V I I I w h e n reconstituted with 5 ml of solvent. OCTANATE 500 IU i s pr esented a s pow der a nd s olvent f or s olution for i njection c ontaining nominally 500 IU human coagulation factor VIII per vial. T h e p r o d u c t c o n t a i n s a p p r o x i m a t e l y 5 0 I U * p e r m l h u m a n c o a g u l a t i o n f a c t o r V I I I w h e n reconstituted with 10 ml of solvent. For excipients, see 6.1. * T h e p o t e n c y ( I U ) i s d e t e r m i n e d u s i n g t h e E u r o p e a n P h a r m a c o p o e i a c h r o m o g e n i c a ssay. The mean specific a c t i v i t y o f OCTANATE is ≥ 100 IU/mg protein. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. A white or pale yellow powder or friable solid. The solvent is a clear, colourless solution. _ _ _ _ _2_ _20170202_120_50IU_spc_SG_05.04_en.doc_ _ _ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment a nd pr ophylaxis of bl eeding i n pa tients w ith h aemophilia A (congenital f actor V III deficiency). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. The dosage and duration of the substitution therapy depend on the severity of factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition. The number of units o f f actor V III Lesen Sie das vollständige Dokument