Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
HUMAN PLASMA PROTEIN >95% IMMUNOGLOBULINS IMMUNOGLOBULIN CYTOMEGALOVIRUS
Biotest Pharma GmbH
50 Units/ml
Solution for Infusion
1995-04-21
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Megalotect 50 U/ml Solution for Infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin (IVIg) with antibodies to cytomegalovirus. 3 PHARMACEUTICAL FORM Solution for Infusion. The solution is clear to slightly opalescent and colourless to pale yellow. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of clinical manifestations of cytomegalovirus infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology:_ As a rule doses containing 50 units of (PEI) per kg body weight should be administered. Administration should be initiated on the day of transplantation or the day prior to this (bone marrow transplantation). 1 ml contains: _Active substance:_ Human plasma protein 100.0 mg thereof immunoglobulin G (IgG) 95.0 % with antibodies to cytomegalovirus 50.0 U* *Units of the Paul-Ehrlich-Institut reference preparation Distribution of IgG subclasses: IgG1 ca. 62.0 % IgG2 ca. 34.0 % IgG3 ca. 0.5 % IgG4 ca. 3.5 % Immunoglobulin A (IgA) content max.5.0 mg/ml _Excipients_ Sodium chloride 155.0 micromol For full list of excipients, see section 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/01/2008_ _CRN 2045854_ _page number: 1_ An initiation of prophylaxis up to 10 days before transplantation can also be envisaged, particularly in CMV sero- positive patients. A total of at least 6 doses at 2 to 3 weeks’ intervals should be given. _Method of administration:_ Megalotect should be infused intravenously at a rate of max. 20 drops (1 ml) per minute. 4.3 CONTRAINDICATIONS Megalotect is contra-indicated in patients who are in Lire le document complet