COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Rocuronio Strides Arcolab International». (13A09656)
Estratto determinazione n. 1033/2013 del 19 novembre 2013 Medicinale: ROCURONIO STRIDES ARCOLAB INTERNATIONAL. Titolare A.I.C.: Strides Arcolab International Limited - Unit 4 - Metro Centre, Tolpits Lane - Watford Hertfordshire WD 189 SS - Regno Unito. Confezione: «10 mg/ml soluzione iniettabile o per infusione» 10 flaconcini in vetro da 5 ml - A.I.C. n. 041945015 (in base 10) 1801XR (in base 32). Forma farmaceutica: Soluzione iniettabile/per infusione. Composizione: ogni ml di soluzione iniettabile o per infusione contiene: principio attivo: 10 mg di rocuronio bromuro. Ogni flaconcino con 5 ml contiene 50 mg di rocuronio bromuro;
eccipienti: acetato di sodio triidrato, acido acetico glaciale (per l'aggiustamento del pH), cloruro di sodio, idrossido di sodio (per l'aggiustamento del pH), acqua per soluzioni iniettabili. Produzione, testing, assembling, confezionamento primario e secondario: Agila Specialties Private Limited (sterile Product Division) Opp. IIM, Bilekahalli, Bannerghatta road, Bangalore - 560 076 India. Produzione principio attivo: Sicor de Mexico S.A de C.V. Av. San Rafael No. 35, Parque Industrial Lerma, Lerma, Edo, de Mexico, C.P 52000 - Messico. Rilascio e controllo lotti: Pharmadox Healthcare Ltd KW20A Kordin Industrial Park, Paola PLA 3000 Malta. Indicazioni terapeutiche: Rocuronio Strides Arcolab International e' indicato nei pazienti adulti e pediatrici (da neonati a termine ad adolescenti, da 0 a
18 anni) come coadiuvante all'anestesia generale per agevolare l'intubazione tracheale durante l'induzione di routine a sequenza rapida e per procurare il rilassamento della muscolatura scheletrica durante gli interventi chirurgici. Negli adulti rocuronio bromuro e' inoltre indicato per facilitare l'intubazione tracheale durante l'induzione a sequenza rapida e come coadiuvante nelle unita' di terapia intensiva (UTI) per agevolare l'intubazione e la ventilazione meccanica. Classificazione. Le confezioni di cui all'art...
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