Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
HUMAN PLASMA PROTEIN >95% IMMUNOGLOBULINS IMMUNOGLOBULIN VARICELLA-ZOSTER
Biotest Pharma GmbH
HUMAN PLASMA PROTEIN >95% IMMUNOGLOBULINS IMMUNOGLOBULIN VARICELLA-ZOSTER
5g/1250IU/50 ml %v/v
Solution for Injection
Withdrawn
2008-08-30
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Varitect 25 IU/ml. Solution for Infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human varicella zoster immunoglobulin 1ml solution contains: 1gG subclass distribution: 1gG1 approx. 62.0% 1gG2 approx. 34.0% 1gG3 approx. 0.5% 1gG4 approx. 3.5% 1gA content =5mg For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indications for use 1. Prevention of varicella (chicken pox) for: (a) Children with leukaemia, lymphoma, an immune deficiency or under treatment which weakens the immune response (immunosuppression, long-term treatment with adrenocortical hormones, radiotherapy). (b) Neonates whose mothers contracted chicken pox within 5 days before the birth or shortly afterwards. Time of application: immediately after birth or when the first symptoms appear in the mother. (c) Children suffering from other infectious disease during suspected infection with chicken pox. (d) Pregnant women after suspected infection with the pathogens of chicken pox/zoster, who have not had chicken pox. 2. Treatment of zoster infections in high-risk patients, such as after radiation exposure or treatment with adrenocortical hormones or cytostatic drugs etc. Active substance(s): Human plasma protein 100 mg Thereof immunoglobulin =95 % With antibodies to varicella zoster virus 25 I.U. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/01/2008_ _CRN 2045961_ _page number: 1_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Prevention of chicken pox: 0.2ml – 1 ml ( 5 - 25 I.U.) per kg body weight. In repeated exposure, e.g. household contact, higher doses are preferable. For post-exposure prophylaxis, Varitect s Lees het volledige document