FrancophonIA/ELRC3.0 huggingface dataset:
English: Domperidone Domperidona Gamir 1 mg/ml suspensión oral
Italian: Domperidona Gamir 1 mg/ml suspensión oral
English: Via Ippolito Rossellini 12 20124 Milano Italy
Italian: PENSA PHARMA S.P.A. Via Ippolito Rossellini 12 20124 Milano Italy
English: 92654 Boulogne Cedex France
Italian: 92517 Boulogne Billancourt Cedex France
English: 1MG/ML
Italian: Motilium-1mg/ml
English: Luxembourg Johnson & Johnson Consumer N.V. Antwerpseweg 15-17
Italian: Lussemburgo Johnson & Johnson Consumer N.V.
English: Domperidone Motilium zetpillen voor kinderen 30 mg
Italian: Motilium zetpillen voor kinderen 30 mg
English: Domperidone Motilium 60mg Suppositories
Italian: Motilium 60mg Suppositories
English: Domperidone COSTI
Italian: Costi
English: 60 mg suppository rectal use
Italian: 60 mg supposta uso rettale
English: Wrexham Industrial Estate Wrexham LL13 9UF
Italian: Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom domperidone maleate Domperidone 10mg Tablets
English: Domperidon AbZ 10 mg Filmtabletten
Italian: Domperidonemaleat Domperidon AbZ 10 mg Filmtabletten
English: Domperidon ratiopharm 10 mg Filmtabletten
Italian: Domperidonemaleat Domperidon-ratiopharm 10 mg Filmtabletten
English: Germany domperidone DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible
Italian: DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible
English: Domperidone Domperidon JJC zetpillen voor zuigelingen 10 mg
Italian: Domperidon JJC zetpillen voor zuigelingen 10 mg
English: H-2045 Törökbálint Hungary domperidone Motilium 10 mg filmtabletta
Italian: H-2045 Törökbálint Hungary
English: Domperidone Domperidon JJC filmomhulde tabletten 10 mg
Italian: Domperidon JJC filmomhulde tabletten 10 mg
English: Slovak Republic Medochemie Ltd. 1-10 Constantinoupoleos St. P.O.
Italian: 1-10 Constantinoupoleos St. P.O.
English: Domperidone Domperidon JJC zetpillen voor kinderen 30 mg
Italian: Domperidon JJC zetpillen voor kinderen 30 mg
English: Domperidone Domperidon JJC zetpillen voor volwassenen 60 mg
Italian: Domperidon JJC zetpillen voor volwassenen 60 mg
English: 10 mg suppository rectal use
Italian: 10 mg supposta uso rettale
English: 10 mg effervescent granules
Italian: 10 mg granuli effervescenti
English: Domperidon-CT 10 mg Filmtabletten
Italian: Domperidonemaleat Domperidon-CT 10 mg Filmtabletten
English: Domperidone Motilium 30 mg Suppositories
Italian: Motilium 30 mg Suppositories
English: 1 mg/ml suspension
Italian: 1 mg/ml sospensione orale
English: Domperidona Pensa 10 mg comprimidos EFG
Italian: Domperidone maleate Domperidona Pensa 10 mg comprimidos EFG
English: Domidon 10 mg Filmtabletten
Italian: Domperidonemaleat Domidon 10 mg Filmtabletten
English: 1 mg/ml oral suspension oral use
Italian: 1 mg/ml sospensione uso orale
English: 30 mg suppository rectal use
Italian: 30 mg supposta uso rettale
English: Domperidone Motilium 10 mg Suppositories
Italian: Motilium 10 mg Suppositories
English: SUBSTIPHARM 8, rue Bellini 75116 Paris France domperidone DOMPERIDONE GERDA 10 mg, comprimé pelliculé
Italian: SUBSTIPHARM 8, rue Bellini 75116 Paris France
English: Domperidone DOMERID 10mg Tablets.
Italian: DOMERID 10mg Tablets.
English: DOMPERIDONE ANGENERICO
Italian: Domperidone Maleato DOMPERIDONE ANGENERICO
English: Domperidone Domperidone instant EG
Italian: Domperidone maleate Domperidone EG
English: Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris domperidone DOMPERIDONE ZENTIVA 10 mg, comprimé orodispersible
Italian: Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris
English: Domperidone Domperidon Bellwood 10 mg, tabletten
Italian: Domperidon Bellwood 10 mg, tabletten
English: Via Pavia 6 20136 Milano Italy
Italian: CRINOS S.P.A. Via Pavia 6 20136 Milano Italy
English: Domperidone Domperidon Actavis 10 mg, omhulde tabletten
Italian: Domperidon Actavis 10 mg, omhulde tabletten
English: Domperidone Domperidon Sandoz 10 mg, tabletten
Italian: Domperidon Sandoz 10 mg, tabletten
English: Domperidone Motilium filmomhulde tabletten 10 mg
Italian: Motilium filmomhulde tabletten 10 mg
English: Austria domperidone Motilium 60 mgZäpfchen
Italian: Motilium 60 mgZäpfchen
English: Domperidone Nauzelin 1 mg/ml suspensión oral
Italian: Nauzelin 1 mg/ml suspensión oral
English: MEDICAMENT 10 mg, comprimé orodispersible
Italian: OROPERIDYS 10 mg, comprimé orodispersible
English: Domperidone Domperidon STADA 10 mg tabletten
Italian: Domperidonemaleat Domperidon STADA 10 mg Tabletten
English: Domperidone PERIDON
Italian: Domperidona Labesfal
English: 10 mg dispersible tablet
Italian: 10 mg compressa dispersibile
English: Domperidone Domperidon PCH 10, filmomhulde tabletten 10 mg
Italian: Domperidon PCH 10, filmomhulde tabletten 10 mg
English: Domperidone Domperidon Faribérica 10 mg, tabletten
Italian: Domperidon Faribérica 10 mg, tabletten
English: ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon domperidone DOMPERIDONE ARROW 10 mg, comprimé pelliculé
Italian: ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon
English: Austria domperidone Motilium 30 mgZäpfchen
Italian: Motilium 30 mgZäpfchen
English: LABORATORI ALTER S.R.L.
Italian: LABORATORI ALTER S.R.L. Via Egadi 7
English: 5 mg effervescent granules
Italian: 5 mg granulato effervescente
English: Domperidone Domperidon 10 PCH, filmomhulde tabletten 10 mg
Italian: Domperidon 10 PCH, filmomhulde tabletten 10 mg
English: 4230 Skaelskoer Denmark domperidone Domperidon "Alternova"
Italian: 4230 Skaelskoer Denmark
English: Rua Alto do Montijo, 13 - 1º DtoEdifício Monsanto 2790-012 Portela de Carnaxide Portugal domperidone Domperidona Germed
Italian: Rua Alto do Montijo, 13 - 1º DtoEdifício Monsanto
English: 20 mg effervescent granules
Italian: 20 mg granulato effervescente
English: Domperidone Domperidon 10 mg Pharmachemie, tabletten
Italian: Domperidon 10 mg Pharmachemie, tabletten
English: Domperidone Motilium 1 mg/ ml suspensión oral
Italian: Motilium 1 mg/ ml suspensión oral
English: Germany domperidone DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé
Italian: DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé
English: Domperidone Motilium instant
Italian: Motilium instant
English: Domperidone Motilium
Italian: Domperidone maleate Motilium
English: Domperidone DOMPERIDONE ABC 10 mg tablet
Italian: DOMPERIDONE ABC 10 mg compressa
English: Domperidone Domperidon CF 10 mg, tabletten
Italian: Domperidon CF 10 mg, tabletten
English: 49, avenue Georges Pompidou 92300 Levallois-Perret France domperidone DOMPERIDONE SANDOZ 10 mg, comprimé orodispersible
Italian: 49, avenue Georges Pompidou 92300 Levallois-Perret France
English: United Kingdom domperidone maleate
Italian: United Kingdom domperidone maleate Motilium 10
English: Via Cantù 11
Italian: Laarstraat 16
English: 92787 Issy-les-Moulineaux Cedex domperidone MOTILIUM 10 mg, comprimé pelliculé
Italian: 92787 Issy-les-Moulineaux Cedex
English: Domperidon-TEVA 10 mg Filmtabletten
Italian: Domperidonemaleat Domperidon-TEVA 10 mg Filmtabletten
English: Belgium Eurogenerics N.V. Heizel Esplanade b22
Italian: Heizel Esplanade b22 1020 Brussels Belgium
English: Domperidon beta 10 mg Tabletten
Italian: Domperidonemaleat Domperidon beta 10 mg Tabletten
English: Domperidone Kruidvat Domperidon 10 mg, tabletten
Italian: Kruidvat Domperidon 10 mg, tabletten
English: Domperidom Hexal 10 mg Tabletten
Italian: Domperidonemaleat Domperidom Hexal 10 mg Tabletten
English: Domperidone Domperidon Accord 10 mg, tabletten
Italian: Domperidon Accord 10 mg, tabletten
English: Domperidone Domperidon Actavis 10 mg, tabletten
Italian: Domperidon Actavis 10 mg, tabletten
English: 75116 Paris domperidone DOMPERIDONE SGPHARM 20 mg, comprimé pelliculé sécable.
Italian: DOMPERIDONE SGPHARM 20 mg, comprimé pelliculé sécable.
English: Domperidone Domperidon Actavis 10 mg tablet
Italian: Domperidon Actavis 10 mg tablets
English: Via Manunzio 7
Italian: DOC GENERICI S.R.L. Via Manunzio 7
English: Domperidone Domperidon Mylan 10 mg, tabletten
Italian: Domperidon Mylan 10 mg, tabletten
English: 5 mg chewable tablet
Italian: 5 mg compressa masticabile
English: Domperidone Maleato
Italian: Domperidone Maleato PERMOTIL
English: Domperidone Domperidon Mdq 10 mg, tabletten
Italian: Domperidon Mdq 10 mg, tabletten
English: Domperidone EG-10 10 mg tablet
Italian: Domperidone EG-10 10 mg compressa
English: Domperidone Motilium Tropfen 10 mg oral drops, suspension
Italian: 10 mg gocce orali, sospensione
English: Domperidone Domperidon Pharmacin 10 mg, tabletten
Italian: Domperidon Pharmacin 10 mg, tabletten
English: Domperidone Motilium 1mg/ml Oral Suspension
Italian: Domperidone 1mg/ml Oral Suspension
English: 15, boulevard Charles de Gaulle 92700 Colombes France domperidone DOMPERIDONE BIOGARAN 10 mg,
Italian: 15, boulevard Charles de Gaulle 92700 Colombes France
English: Austria domperidone Motilium 10 mgZäpfchen
Italian: Motilium 10 mgZäpfchen
English: 75116 Paris domperidone DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable
Italian: DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable
English: Domperidone mylan 10 mg film-coated tablet
Italian: Domperidona Mylan 10 mg compressa filmrivestita
English: Domperidone Domperidon Kela 10 mg, tabletten
Italian: Domperidon Kela 10 mg, tabletten
English: Limassol CY-3505 Cyprus domperidone Costi 10mg Film coated tablets
Italian: Limassol CY-3505 Cyprus
English: Domperidone Domperidon Sofar 10 mg, tabletten
Italian: Domperidon Sofar 10 mg, tabletten
English: Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal domperidone Domperidona Ratiopharm
Italian: Lagoas Park, Edifício 5 A, Piso 2
English: 75116 Paris domperidone DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.
Italian: DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.
English: Domperidone Domperidon 10 mg PCH, tabletten
Italian: Domperidon 10 mg PCH, tabletten
English: Domperidon Accord 10 mg Tabletten
Italian: Domperidonemaleat Domperidon Accord 10 mg Tabletten
English: Belgium Kela Pharma nv Industriepark 68
Italian: Kela Pharma nv Industriepark 68 9100 Sint-Niklaas Belgium
English: Domperidone Oroperidys
Italian: OROPERIDYS
English: Domperidone Tablets 10mg
Italian: OROPERIDYS ORODISPERSIBLE TABLETS 10MG
English: 10 mg coated tablet
Italian: Costi 10mg Film coated tablets
English: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE MYLAN 10 mg, comprimé pelliculé
Italian: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
English: Domperidon AL 10 mg Tabletten
Italian: Domperidon 10 mg tabletten
English: Motilium Instants 10 mg orodispersible tablet oral use
Italian: Motilium Instant-10 10 mg compressa orodispersibile
English: Domperidone GERDI
Italian: Domperidona GP
English: Via Winckelmann 1 20146 Milano Italy
Italian: PIERRE FABRE PHARMA S.R.L. Via Winckelmann 1 20146 Milano Italy
English: DOMPERIDONE OROPERIDYS 10 mg 10 mg orodispersible tablet oral use
Italian: OROPERIDYS 10 mg 10 mg compressa orodispersibile
English: 3460 Birkeroed Denmark domperidone Motilium
Italian: 3460 Birkeroed
English: 2730-055 Barcarena Portugal domperidone Motilium
Italian: 2790-012 Portela de Carnaxide Portugal
English: Domperidone DOMPERIDONE SANDOZ
Italian: Domperidona Baldacci
English: Einnehmen
Italian: RIGES
English: Domperidone Domperidon 10 mg, tabletten
Italian: Domperidon 10 mg, tabletten
English: Hungary domperidone Domperidon-EP 10 mg tabletta
Italian: Domperidon-EP 10 mg tabletta
English: 10 mg orodispersible tablet oral use
Italian: Oroperidys 10 mg orodispersible tablets
English: Domperitop
Italian: Domstal
English: Samenwerkende
Italian: NEOPERIDYS
English: Healthypharm B.V. Nieuwe Donk 3
Italian: Healthypharm B.V.
English: Belgium domperidone Domperidone EG-10 10 mg orodispersible tablet oral use
Italian: Domperidone EG-10 10 mg compressa orodispersibile
English: 92787 Issy-les-Moulineaux Cedex domperidone MOTILIUM 10 mg, granulés effervescents en sachet-dose
Italian: MOTILIUM 10 mg, granulés effervescents en sachet-dose
English: Austria domperidone Motilium 1 mg/mlSuspension zum
Italian: Motilium 1 mg/mlSuspension zum Einnehmen
English: Domperidone DOMPERIDONE FG 10 mg tablet
Italian: DOMPERIDONE FG 10 mg compressa
English: 20 mg orodispersible tablet oral use
Italian: 20 mg compressa orodispersibile
English: Domperidone OROPERIDYS 10 mg 10 mg tablet
Italian: OROPERIDYS 10 mg 10 mg compressa
English: Domperidon teva 10 mg film-coated tablet
Italian: DOMPERIDONE TEVA 10 mg, comprimé pelliculé
English: 2770-229 Paço de Arcos Portugal domperidone Domperidona Ciclum 10 mg tablet
Italian: 2770-229 Paço de Arcos Portugal
English: DOMPERIDONE MOTILIUM 10 mg 10 mg film-coated tablet
Italian: Domperidona Generis 10 mg compressa filmrivestita
English: Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal domperidone Domperidona Generis
Italian: Portogallo Generis Farmacêutica, S.A. Rua João de Deus, 19
English: 92931 Paris La Défense Cedex France domperidone DOMPERIDONE TEVA 10 mg, comprimé orodispersible
Italian: 92931 Paris La Défense Cedex France
English: 10 mg/10 ml suspension
Italian: DOMPERIDONE GERMED 10 mg/10 ml sospensione uso orale
English: Ireland domperidone maleate
Italian: Domperidone maleate Domperitop
English: ZYLINDERAMPULLEN
Italian: VASOKONSTRIKTORZYLINDERAMPULLEN
English: 3% without vasoconstrictor
Italian: 3% senza vasocostrittore
English: Dental use Perineural use Submucosal use Infiltration
Italian: Uso dentale Uso perineurale Uso sottomucosale Infiltrazione
English: Dental use Perineural use
Italian: Uso dentale Uso perineurale
English: Gingival use
Italian: Uso gengivale
English: Infiltration Perineural use
Italian: Infiltrazione Uso perineurale
English: SCANDONEST 30 MG/ML, SOLUTION INJECTABLE À USAGE DENTAIRE
Italian: MG/ML, SOLUTION INJECTABLE À USAGE DENTAIRE
English: Perineural use Infiltration
Italian: Uso perineurale Infiltrazione
English: Perineural use
Italian: Uso perineurale
English: The company stated that it intended to stop the development of the medicine, but that it plans to work with doctors, patients and local regulatory authorities to allow currently treated patients to access the remaining supply of Kyndrisa.
Italian: La ditta ha dichiarato di voler interrompere lo sviluppo del medicinale, ma ha l'intenzione di lavorare con medici, pazienti e autorità di regolamentazione locali per consentire ai pazienti attualmente trattati di accedere alle forniture rimanenti di Kyndrisa.
English: EMA/430531/2016 Rev 1 EMEA/H/C/003846
Italian: EMA/430531/2016
English: Kyndrisa is a medicine that contains the active substance drisapersen.
Italian: Kyndrisa è un medicinale contenente il principio attivo drisapersen.
English: It causes progressive weakness and loss of muscle function, and usually leads to death in adolescence or early adulthood.
Italian: Questa malattia causa progressiva debolezza e perdita della funzionalità muscolare e solitamente porta alla morte in età adolescenziale o nella prima età adulta.
English: The Committee considered that data from the clinical studies did not sufficiently demonstrate a beneficial effect of Kyndrisa: the main study did not show any benefit in patients with the condition, while two other studies failed to consistently show a beneficial effect.
Italian: Il comitato ha ritenuto che i dati degli studi clinici non dimostrassero in modo sufficiente un beneficio di Kyndrisa: lo studio principale non mostrava nessun beneficio nei pazienti affetti dalla malattia, mentre gli altri due studi non erano riusciti a dimostrare un effetto benefico consistente.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Kyndrisa did not outweigh its risks.
Italian: Pertanto, al momento del ritiro della domanda, il CHMP riteneva che i benefici di Kyndrisa non fossero superiori ai suoi rischi.
English: The studies compared the effects of Kyndrisa with placebo (a dummy treatment) and the main measure of effectiveness was the change in the distance the patient could walk in six minutes after 24 or 48 weeks of treatment.
Italian: Gli studi hanno messo a confronto gli effetti di Kyndrisa con un placebo (un trattamento fittizio); i principali parametri di efficacia erano i cambiamenti nella distanza che il paziente era in grado di percorrere in sei minuti dopo 24 o 48 settimane di trattamento.
English: Further, the safety profile of the medicine was not considered satisfactory, particularly because of the risk of persisting reactions at the injection site (such as swelling, inflammation and ulceration) which could have a negative impact on quality of life, and the risk of thrombocytopenia (low blood platelet counts) which could put patients at risk of serious bleeding complications.
Italian: Inoltre, il profilo di sicurezza del medicinale non è stato ritenuto soddisfacente, soprattutto a causa del rischio di reazioni persistenti in sede di iniezione (come tumefazione, infiammazione e ulcerazione) che potrebbero avere un impatto negativo sulla qualità della vita, e del rischio di trombocitopenia (conta delle piastrine bassa) che potrebbe porre i pazienti a rischio di serie complicazioni emorragiche.
English: What is Kyndrisa?
Italian: Che cos'è Kyndrisa?
English: This technology enables the protein-making apparatus in cells to skip some areas of the dystrophin gene and allow the production of a shortened but partially working dystrophin protein.
Italian: Questa tecnologia consente all'apparato che produce la proteina nelle cellule di saltare alcune aree del gene della distrofina permettendo la produzione di una proteina distrofina più corta, ma parzialmente funzionante.
English: On 31 May 2016, BioMarin International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kyndrisa, for the treatment of Duchenne muscular dystrophy.
Italian: Il 31 maggio 2016 la ditta BioMarin International Limited ha notificato ufficialmente al comitato per i medicinali per uso umano (CHMP) la sua intenzione di ritirare la domanda di autorizzazione all'immissione in commercio per Kyndrisa, per il trattamento della distrofia muscolare di Duchenne.
English: Kyndrisa was investigated in three studies in a total of 290 patients with Duchenne muscular dystrophy.
Italian: Kyndrisa è stato valutato nell'ambito di tre studi condotti su un totale di 290 pazienti affetti da distrofia muscolare di Duchenne.
English: What was Kyndrisa expected to be used for?
Italian: Per che cosa avrebbe dovuto essere usato Kyndrisa?
English: Duchenne muscular dystrophy is a serious genetic disease, which mainly affects boys and is usually diagnosed before the age of 6.
Italian: La distrofia muscolare di Duchenne è una malattia genetica grave che colpisce soprattutto i bambini di sesso maschile e generalmente viene diagnosticata prima dei 6 anni.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it would not be able to address the CHMP concerns regarding the results of the clinical studies within the expected timeframe.
Italian: Nella lettera di notifica all'Agenzia del ritiro della domanda, la ditta ha affermato che non sarebbe in grado di rispondere ai dubbi del CHMP riguardanti i risultati degli studi clinici nel tempo previsto.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some important unresolved issues.
Italian: Dopo la valutazione da parte del CHMP delle risposte della ditta all'ultima serie di domande, alcuni problemi erano rimasti irrisolti.
English: Kyndrisa was expected to be used for the treatment of Duchenne muscular dystrophy in patients aged 5 years and older who are able to walk and whose disease is due to certain genetic mutations (defects) that can be treated with ‘exon 51 skipping technology'.
Italian: Kyndrisa avrebbe dovuto essere usato per il trattamento della distrofia muscolare di Duchenne nei pazienti deambulanti a partire dai 5 anni di età la cui malattia è dovuta a certe mutazioni genetiche (difetti) che possono essere trattate con la “tecnologia di salto dell'esone 51”.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Kyndrisa could not have been approved for the treatment of Duchenne muscular dystrophy.
Italian: In base all'esame dei dati e delle risposte fornite dalla ditta agli elenchi di domande poste dal CHMP, al momento del ritiro della domanda, il CHMP aveva alcuni dubbi ed era provvisoriamente del parere che Kyndrisa non potesse essere autorizzato per il trattamento della distrofia muscolare di Duchenne.
English: Kyndrisa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 27 February 2009 for Duchenne muscular dystrophy.
Italian: Kyndrisa è stato qualificato come “medicinale orfano” (medicinale utilizzato nelle malattie rare) il 27 febbraio 2009 per la distrofia muscolare di Duchenne.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 June 2016
Italian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 giugno 2016 EMA/430531/2016 EMEA/H/C/003846
English: Duchenne muscular dystrophy is caused by mutations in the gene for the protein dystrophin, which lead to the production of a non-functional dystrophin.
Italian: La distrofia muscolare di Duchenne è causata da mutazioni del gene che codifica per la proteina distrofina, che portano alla produzione di distrofina non funzionale.
English: This medicine works by ‘exon 51 skipping
Italian: la “tecnologia del salto dell'esone 51”.
English: How is Kyndrisa expected to work?
Italian: Come avrebbe dovuto agire Kyndrisa?
English: OPEN HERE LIFT HERE
Italian: APRIRE QUI SOLLEVARE QUI
English: How much and when to inject
Italian: Quanto e quando iniettare
English: 22014 Incheon Republic of Korea
Italian: 22014 Incheon Repubblica di Corea
English: Date of first authorisation: 28 March 2019
Italian: Data della prima autorizzazione: 28 marzo 2019
English: HIT-6 total
Italian: HIT-6 totale
English: Important information:
Italian: Informazioni importanti:
English: MIDAS total
Italian: MIDAS totale
English: Do not remove pressure until the 3 steps below are complete.
Italian: Non togliere la pressione finché non sono stati completati i 3 passaggi seguenti.
English: Two dosing options are available:
Italian: Sono disponibili due opzioni di somministrazione:
English: Your doctor will discuss and decide with you the most appropriate dosing schedule.
Italian: Il medico discuterà e deciderà con lei il programma di somministrazione più appropriato.
English: d) Wash your hands with soap and water and dry well with a clean towel.
Italian: d) Lavarsi le mani con acqua e sapone e asciugarle bene con un asciugamano pulito.
English: ATC code: Not yet assigned.
Italian: Codice ATC: non ancora assegnato.
English: No safety data are available in these patients.
Italian: Non sono disponibili dati di sicurezza in questi pazienti.
English: One of these 6 patients developed neutralising antibodies.
Italian: Uno di questi 6 pazienti ha sviluppato anticorpi neutralizzanti.
English: The treatment benefit should be assessed within 3 months after initiation of treatment.
Italian: Il beneficio del trattamento va valutato entro 3 mesi dopo l'inizio della terapia.
English: More than 1,400 patients were treated for at least 12 months.
Italian: Più di 1.400 pazienti sono stati trattati per almeno 12 mesi.
English: The safety and efficacy of AJOVY in children and adolescents below the age of 18 years have not yet been established.
Italian: La sicurezza e l'efficacia di AJOVY nei bambini e negli adolescenti di età inferiore a 18 anni non sono state ancora stabilite.
English: The expiration date has passed.
Italian: La data di scadenza è passata.
English: Other medicines and AJOVY
Italian: Altri medicinali e AJOVY
English: c) Remove the needle from your skin.
Italian: c) Rimuovere l'ago dalla pelle.
English: Make sure the name AJOVY appears on the label.
Italian: Assicurarsi che il nome AJOVY compaia sull'etichetta.
English: You wait another 10 seconds (to make sure all of the medicine is injected).
Italian: Attendere ancora 10 secondi (per assicurarsi che tutto il farmaco sia stato iniettato).