מדינה: סינגפור
שפה: אנגלית
מקור: HSA (Health Sciences Authority)
Human Cytomegalovirus Immunoglobulin in 50mg/ml Human Plasma Protein (IgG ≥ 96%)
GRIFOLS ASIA PACIFIC PTE. LTD.
J06BB09
100 U/ml
INJECTION
Human Cytomegalovirus Immunoglobulin in 50mg/ml Human Plasma Protein (IgG ≥ 96%) 100 U/ml
INTRAVENOUS
Prescription Only
Biotest AG
ACTIVE
2013-12-04
184749 001 INSTRUCTIONS FOR USE Megalotect CP 100 U/ml solution for infusion ACTIVE SUBSTANCE Human cytomegalovirus immunoglobulin for intravenous administration COMPOSITION 1 ml solution contains: - Active substances: Human plasma protein 50 mg Of which immunoglobulin G ≥ 96% Content of antibody to cytomegalovirus 100 U* * Units of the Paul-Ehrlich-Institut reference preparation - Excipients: Glycine and water for injections. The IgG subclass distribution is defined around 65 % IgG1, 30 % IgG2, 3 % IgG3, 2 %, IgG4. The IgA content is ≤ 2 mg/ml. PHARMACEUTICAL FORM Solution for infusion PRESENTATIONS Infusion vial of 10ml Infusion vial of 50ml PHARMACOTHERAPEUTIC GROUP Human cytomegalovirus immunoglobulin for intravenous administration NAME AND ADDRESS OF MANUFACTUREr Biotest Pharma GmbH Landsteinerstraße 5 63303 Dreieich, Germany INDICATIONS Prophylaxis of clinical manifestations of cytomegalovirus infection in pa- tients receiving immunosuppressive therapy, particularly in transplant re- cipients. 184.749.001.indd 1 21.11.13 09:02 CONTRAINDICATIONS Hypersensitivity to any ingredient in Megalotect CP. Hypersensitivity to homologous immunoglobulins, especially in very rare cases of IgA deficiency, when the patient has antibodies against IgA. PREGNANCY AND LACTATION The safety of this product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to preg- nant women and breast-feeding mothers. Clinical experience with immunoglobu- lins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected. Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate. PRECAUTIONS FOR USE Take special care with Megalotect CP - when the infusion ra קרא את המסמך השלם
1 INSTRUCTIONS FOR USE Megalotect CP 100 U/ml solution for infusion ACTIVE SUBSTANCE Human cytomegalovirus immunoglobulin (CMVIG) COMPOSITION One ml contains: Human plasma protein 50mg (of which at least 96 % is immunoglobulin G, with a content of antibodies against cytomegalovirus (CMV) of 100 U*. *Units of the Paul-Ehrlich-Institut reference preparation Distribution of the IgG subclasses (approx.. values): IgG1 65 % IgG2 30 % IgG3 3 % IgG4 2 % The immunoglobin A (IgA) content is ≤ 2000 micrograms/ml. Excipients: Glycine, water for injections. PHARMACEUTICAL FORM Solution for infusion Clear or slightly opalescent and colourless or pale yellow solution with a pH of 5.0 – 5.6 and an osmolality of 250 – 350 mOsm/kg. PRESENTATIONS 10 ml or 50 ml of ready-for-use solution for intravenous infusion in vial (type II glass) with a stopper (bromobutyl) and a cap (aluminium). Each vial with 10ml contains: 500mg human plasma protein (of which at least 96 % is immunoglobulin G), with a content of antibodies against CMV of 1,000 U. Each vial with 50ml contains: 2,500mg human plasma protein (of which at least 96 % is immunoglobulin G), with a content of antibodies against CMV of 5,000 U. PHARMACOTHERAPEUTIC GROUP Human cytomegalovirus immunoglobulin for intravenous administration NAME AND ADDRESS OF MANUFACTURER Biotest Pharma GmbH Landsteinerstraße 5 63303 Dreieich, Germany INDICATIONS Prophylaxis of clinical manifestations of cytomegalovirus infection in patients receiving immunosuppressive therapy, particularly in transplant recipients. The concomitant use of adequate virostatic agents should be considered for CMV-prophylaxis. Biotest logo Bar code 2 CONTRAINDICATIONS • Hypersensitivity to the active substance (human cytomegalovirus immunoglobulin) or to any of the excipients listed above. • Patients with selective IgA deficiency who developed antibodies to IgA, as administering an IgA- containing product can result in anaphylaxis. FERTILITY, PREGNANCY AND LACTATION Pregnancy The safety of this medicinal product קרא את המסמך השלם