Authorisation For The Medicinal Product For Usoumano «Pseudoneb»

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-04&atto.codiceRedazionale=15A01476&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 16, 2015 V&A # 286/2015 of description determines medicine and assigning AIC is authorised the placing on the market of the medicinal product: PSEUDONEB in form and packaging: "1 million IU powder for solution for injection, infusion or by inhalation" 10 glass vials, "2 million IU powder for solution for injection, infusion or by inhalation" 10 conditions and glass vials with the specifications mentioned below : Mah: Forest Laboratories UK Limited, with registered office and tax domicile in Riverbridge House Anchor Boulevard, Crossways Business Park, Dartford, Kent DA2 6SL, United Kingdom packaging: "1 million IU powder for solution for injection, infusion or by inhalation" AIC glass vials 10 n° 037023013 (10) 139V95 (based on 32) packaging: "2 million IU powder for solution for injection, infusion or by inhalation" AIC glass vials 10 n° 037023025 (10) 139V9K (based on 32) Form Pharmaceutics: powder for solution for injection, infusion or by inhalation validity complete appliance: before opening: 3 years reconstituted solutions: solution for infusion or injection: chemical and physical in-use stability has been demonstrated for 28 days at a temperature of 4° c.
From a microbiological point of view, the solution should be used immediately. If that doesn't happen, the user is responsible of the period and the storage conditions of the product before use, which should not normally exceed 24 hours at a temperature between 2 and 8° C unless the reconstitution and dilution does not occur under aseptic conditions, controlled and validated.
Solutions for spraying: spraying solutions have similar stability in use and should be treated as above. To the patients-administering the antibiotic for nebulization should be advised to use the solutions immediately after preparation. If that's not possible, solutions must not be kept in the fridge for longer than 24 hours.
Special precautions for storage: do not store above 25° c. Keep the vials in the outer carton in order to protect from light.
Incompatibility: avoid mixing infusions, injections and sprays with sodium colistemato solutions.
Composition: each vial contains: active ingredient: 1 million International unit of Colistimethate sodium Manufacturer of the finished product: Penn Pharmaceutical Services Limited, Units 23-24, Tafarnaubach Industrial Estate, Tredegar, Gwent, NP223AA, United Kingdom (secondary packaging and batch release);
Medical indications: Pseudoneb is indicated for the treatment of the following infections, where sensitivity tests show that are caused by susceptible bacteria: inhalation Treatment of pulmonary infection by Pseudomonas aeruginosa in patients with cystic fibrosis (CF).
Intravenous administration for the treatment of serious infections caused by Gram negative bacteria, including lower respiratory tract and urinary tract, whereas the most commonly used antibacterial agents can be contraindicated or ineffective due to bacterial resistance.
New listings for the purposes of classification is packaging: "1 million IU powder for solution for injection, infusion or by inhalation" AIC glass vials 10 # 037023013 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).
Packaging: "2 million IU powder for solution for injection, infusion or by inhalation" AIC glass vials 10 # 037023025 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: "1 million IU powder for solution for injection, infusion or by inhalation" AIC glass vials 10 n° 037023013-RNRL medicinal products subject to medical prescription, to be renewed from time to time, be sold to the public on prescription of hospitals or specialists-regional hospitals for cystic fibrosis and internist, infectious disease specialist, pulmonologist, pediatrician.
Packaging: "2 million IU powder for solution for injection, infusion or by inhalation" AIC glass vials 10 n° 037023025-RNRL medicinal products subject to medical prescription, to be renewed from time to time, be sold to the public on prescription of hospitals or specialists-regional hospitals for cystic fibrosis and internist, infectious disease specialist, pulmonologist, pediatrician.
Packaging of printed 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-

At the time of granting the authorisation, the submission of the periodic safety update reports not required for this product. However, the marketing authorisation holder shall submit periodic safety update reports for this product if the product is listed as reference dates (EURD list) under art. 107 quater, para. 7 of Directive 2010/84/EC 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.