Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
HUMAN PLASMA PROTEIN >95% IMMUNOGLOBULINS IMMUNOGLOBULIN VARICELLA-ZOSTER
Biotest Pharma GmbH
Solution for Injection
1995-04-21
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Varitect 25 IU/ml Solution for Infusion. Human Varicella Immunoglobulin for Intravenous Administration. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human varicella zoster immunoglobulin 1 ml solution contains: Active substance 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 1. Prophylaxis of varicella after exposure for: o Children with negative history of varicella who are receiving immunosuppressive, cytostatic or radiotherapy or suffer from hereditary immunodeficiences; o Immunocompromised adults who, after careful evaluation are believed susceptible and have had significant exposure; o Newborns of mothers who develop chicken pox within 5 days before and 2 days after delivery; o Premature infants whose mothers have negative histories of varicella, as long as they require hospital care; o Premature infants of less than 28 weeks of gestation or with a birth weight of 1000 g or less, regardless of maternal varicella history; 2. Adjuvant therapy of severe or complicated varicella zoster in immunocompromised patients or newborns at risk of dissemination. 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-expos Pročitajte cijeli dokument