Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
CYTOMEGALOVIRUS ANTIBODY; HUMAN PLASMA PROTEIN; IMMUNOGLOBULINS, NORMAL HUMAN
KAMADA LTD, ISRAEL
J06BB09
SOLUTION FOR INFUSION
IMMUNOGLOBULINS, NORMAL HUMAN 96 %; HUMAN PLASMA PROTEIN 50 MG/ML; CYTOMEGALOVIRUS ANTIBODY 100 U/ML
I.V
Required
BIOTEST PHARMA GMBH, GERMANY
CYTOMEGALOVIRUS IMMUNOGLOBULIN
Prophylaxis of clinical manifestations of cytomegalovirus infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients.The concomitant use of adequate virostatic agents should be considered for CMV-prophylaxis.
2020-11-30
MEGALOTECT ® CP 1. NAME OF THE MEDICINAL PRODUCT Megalotect CP 100 U/ml solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human cytomegalovirus immunoglobulin (CMVIG) One ml contains: Human plasma protein……......... 50 mg (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 Each vial with 10 ml contains: 500 mg 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 50 ml contains: 2,500 mg human plasma protein (of which at least 96 % is immunoglobulin G), with a content of antibodies against CMV of 5,000 U. Distribution of the IgG subclasses (approx. values): IgG1 65 % IgG2 30 % IgG3 3 % IgG4 2 % The immunoglobulin A (IgA) content is limited to 2,000 micrograms/ml. Produced from the plasma of human donors. For the full list of excipients, see section 6.1. 3. 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. _ _ _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of clinical manifestations of cytomegalovirus infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients. _ _ The concomitant use of adequate virostatic agents should be considered for CMV-prophylaxis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The single dose is 1 ml per kg body weight. Administration should be initiated on the day of transplantation. In case of bone marrow transplantation 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 single doses at 2 to 3 weeks' intervals should be given. _Paediatric population _ The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is give Soma hati kamili