Authorisation For The Medicinal Product For Usoumano «Addamel N».

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoumano «Addamel N».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-20&atto.codiceRedazionale=15A00302&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved December 16, 2014 V&A # 2613/2014 of description determines medicine and assigning AIC is authorised the placing on the market of the medicinal product: ADDAMEL N in form and packaging: "7.7 mg/10 ml concentrate for solution for infusion" 20 vials of 10 ml, under the conditions and with the specifications mentioned below: Mah: Fresenius Kabi Italy S.r.l. with registered office and tax domicile in Via Camagre, 41, 37063-Isola della Scala-Verona, Italy packaging: "7.7 mg/10 ml concentrate for solution for infusion" 20 vials of 10 ml AIC # 029231038 (10) 0VW1XY (based on 32) dosage form: concentrate for solution for infusion validity complete appliance: 3 years from date of manufacture period of validity after mixing : from the standpoint of physical chemical product stability after dilution was demonstrated for 24 hours at 25° c. From a microbiological point of view, the product should be used immediately after dilution. Otherwise, the conditions and the shelf life of the diluted solution are under the responsibility of the user and normally should not exceed 24 hours at 2-8° C, unless the mixing is not done in controlled and validated aseptic conditions.
Special precautions for storage: store the medicine in its original packaging to protect it from light. Do not freeze.
Composition: 1 ml concentrate for solution for infusion contains: active ingredient: chromium chloride hexahydrate 5.33 g, copper chloride 0.10 mg, iron chloride hexahydrate 0.54 mg, manganese chloride tetrahydrate 19.8 g, potassium iodide 16.6 g sodium molybdate dihydrate, sodium fluoride 0.21 mg, sodium selenite, 4.85 g, 17.3 g anhydrous zinc chloride 1.05 mg;
Excipients: xylitol, concentrated hydrochloric acid (for pH adjustment), water for injections.
Manufacturer of the active substance: Merck KGaA, Frankfurter Straße 250, D-64293 Darmstadt, Germany, (chromium chloride hexahydrate, copper chloride dihydrate, sodium molybdate dihydrate, zinc manganese chloride tetrahydrate, chloride, iron chloride hexahydrate, potassium iodide, sodium fluoride);
"Sulzbacherstraße" 45 Chemicals and Metals, Selenium retorte GmbH, D-90552, Rothenbach a.d. Pegnitz, Germany (anhydrous sodium selenite);
Manufacturer of the finished product: Fresenius KAbi Norge As, Svinesundsveien, 80, NO-1788, Halden, Norway (production, control, primary and secondary packaging, control and batch release);
Fresenius Kabi Italy Srl, Via Camagre 41, Isola della Scala (VR), Italy (outer packaging).
Medical indications: Addamel N is designated to ensure the basal needs or increase moderately trace elements level in adults and children weighing more than 40 kg in nutrition intravenously.
New listings for the purposes of classification is packaging: "7.7 mg/10 ml concentrate for solution for infusion" 20 vials of 10 ml AIC # 029231038 (10) 0VW1XY (based on 32) new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Classification for the purposes of delivery set: "7.7 mg/10 ml concentrate for solution for infusion" 20 vials of 10 ml AIC # 029231038 (10)-OSP: medicinal products subject to medical prescription, for use exclusively in hospitals or in structure to it comparable standard Correction terms is authorized the rectification of the Standard Terms and/or the description of the following package of medicine ADDAMEL N previously authorized, from: packaging: "concentrate for solution for infusion" 20 vials of 10 ml AIC # 029231026 in packaging: "10 10.3 mg/ml concentrate for solution for infusion" 20 vials of 10 ml AIC # 029231026 Printed cartons of material should be marketed with labels and package leaflets comply with the attached text to the determination, under this extract.
It approved the summary of the product characteristics attached to the assessment, referred to in this excerpt.
In accordance with art. 80 paragraphs 1 and 3 of the Legislative Decree of April 24, 2006, # 219 s and the package leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The mAh avails itself of the complementary use of foreign languages, must give prior notice to the AIFA and keep available the certified translation of German texts and/or in another foreign language. In case of non-compliance with the provisions on the labelling and package leaflet shall apply sanctions under art. 82 of the aforementioned legislative decree.
Periodic safety update reports PSUR-The marketing authorisation holder shall provide periodic safety update reports for this product in accordance with the requirements set out in the list of dates of reference (EURD list) referred to in article 107 c, para. 2010/84/EC Directive 7) and published on the web portal of the European Medicines Agency.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana.