Land: Armenien
Sprog: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
l-asparaginase
Medac GmbH
l-asparaginase
5000U
powder lyophilized for solution for injection
Prescription
SPC (RUS-Version) Asparaginase 5000/10000 U medac Date of latest revision: 03/2015 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Asparaginase 5000 U medac Asparaginase 10000 U medac Powder for solution for injection Active substance: L-Asparaginase 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial of Asparaginase 5000 (10000) U medac with 21.6 - 24.5 (43.2 – 49.0) mg of powder for solution for injection contains: L-Asparaginase (E. C. 3.5.1.1) 83 (167) µkat, corresponding to 5000 (10000) U. (1 U L-asparaginase releases 1 µmol ammonia from L-asparagine in 1 Minute at 37° C.) 3. PHARMACEUTICAL FORM Powder for solution for injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Asparaginase 5000 (10000) U medac is indicated as a component of an anti-neoplastic combination therapy of acute lymphatic leukaemia (ALL) in children and adults as well as in cases of non-Hodgkin’s lymphomas in childhood. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION To reduce the risk of a possible IgE-mediated hypersensitivity reaction, a prick test (place 1 drop of the ready-to-use solution on the volar side of the forearm using a tube-like instrument and inject into the epidermis through the drop using a sterile syringe. Avoid bleeding. Wipe away the drop of the preparation after 3 minutes. After a further 20 minutes, observe the reaction: if redness and weals develop, refrain from L-asparaginase treatment) or an intracutaneous injection (increasing concentrations in an appropriate dilution) should be carried out before treatment is started or resumed. Since not just IgE-mediated allergic reactions that are detectable by skin testing but also IgG and IgM- mediated sensitisation has been described in the literature, the use of an intravenous test dose before intravenous administration is recommended (1000 U i.v. as a short infusion 1 hour before the beginning of treatment). Unless otherwise prescribed, the mean intravenous daily dose in children and adults in the monotherapy is 200 U per kg body weight (B Læs hele dokumentet