FrancophonIA/ELRC3.0 huggingface dataset:
English: 15, boulevard Charles de Gaulle 92700 Colombes France domperidone DOMPERIDONE BIOGARAN 20 mg, comprimé pelliculé sécable.
Croatian: 15, boulevard Charles de Gaulle 92700 Colombes France domperidon DOMPERIDONE BIOGARAN 20 mg, comprimé pelliculé sécable.
English: Johnson & Johnson Consumer B.V. Rooseveltweg 15
Croatian: Nizozemska Johnson & Johnson Consumer B.V.
English: Domperidone Domperidon Accord 10 mg, tabletten
Croatian: Domperidon Domperidon Accord 10 mg, tabletten
English: Domperidone Domperidon Sandoz 10 mg, tabletten
Croatian: Domperidon Domperidon Sandoz 10 mg, tabletten
English: Stada Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany
Croatian: Nizozemska Stada Arzneimittel AG Stadastrasse 2-18
English: 2770-229 Paço de Arcos Portugal domperidone Domperidona Ciclum 10 mg tablet
Croatian: Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal domperidon Domperidona Ciclum 10 mg tableta
English: Domperidone Domperidon Actavis 10 mg, omhulde tabletten
Croatian: Domperidon Domperidon Actavis 10 mg, omhulde tabletten
English: 92517 Boulogne Billancourt Cedex France domperidone DOMPERIDONE EG 10 mg, comprimé pelliculé
Croatian: 92517 Boulogne Billancourt Cedex France domperidon DOMPERIDONE EG 10 mg, comprimé pelliculé
English: Domperidone Domperidon STADA 10 mg tabletten
Croatian: Domperidon Domperidon STADA 10 mg tabletten
English: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE MYLAN 20 mg, comprimé pelliculé sécable.
Croatian: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidon DOMPERIDONE MYLAN 20 mg, comprimé pelliculé sécable.
English: Domperidone Domperidon PCH 10, filmomhulde tabletten 10 mg
Croatian: Domperidon Domperidon PCH 10, filmomhulde tabletten 10 mg
English: 15, boulevard Charles de Gaulle 92700 Colombes France domperidone DOMPERIDONE BIOGARAN 10 mg,
Croatian: 15, boulevard Charles de Gaulle 92700 Colombes France domperidon DOMPERIDONE BIOGARAN 10 mg,
English: 15, boulevard Charles de Gaulle 92700 Colombes France domperidone DOMPERIDONE ALMUS 10 mg, comprimé pelliculé
Croatian: 15, boulevard Charles de Gaulle 92700 Colombes France domperidon DOMPERIDONE ALMUS 10 mg, comprimé pelliculé
English: Domperidone Domperidon Faribérica 10 mg, tabletten
Croatian: Domperidon Domperidon Faribérica 10 mg, tabletten
English: Domperidone Domperidon Bellwood 10 mg, tabletten
Croatian: Domperidon Domperidon Bellwood 10 mg, tabletten
English: Via Pavia 6 20136 Milano Italy
Croatian: CRINOS S.P.A. Via Pavia 6 20136 Milano Italy
English: Domperidone Domperidon 10 PCH, filmomhulde tabletten 10 mg
Croatian: Domperidon Domperidon 10 PCH, filmomhulde tabletten 10 mg
English: 49, avenue Georges Pompidou 92300 Levallois-Perret France domperidone DOMPERIDONE SANDOZ 10 mg, comprimé pelliculé
Croatian: 49, avenue Georges Pompidou 92300 Levallois-Perret France domperidon DOMPERIDONE SANDOZ 10 mg, comprimé pelliculé
English: QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE QUALIMED 10 mg,
Croatian: QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France domperidon DOMPERIDONE QUALIMED 10 mg, comprimé pelliculé
English: 75116 Paris domperidone DOMPERIDONE SGPHARM 20 mg, comprimé pelliculé sécable.
Croatian: France domperidon DOMPERIDONE SGPHARM 20 mg, comprimé pelliculé sécable.
English: 10 mg suppository rectal use
Croatian: 10 mg čepić rektalno
English: Domperidone Domperidon 10 mg Pharmachemie, tabletten
Croatian: Domperidon Domperidon 10 mg Pharmachemie, tabletten
English: 20 mg orodispersible tablet oral use
Croatian: 20 mg raspadljiva tableta za usta
English: Domperidone Domperidon 10 mg tabletten
Croatian: Domperidon Domperidon 10 mg tabletten
English: Domperidone Kruidvat Domperidon 10 mg, tabletten
Croatian: Domperidon Kruidvat Domperidon 10 mg, tabletten
English: 30 mg suppository rectal use
Croatian: 30 mg čepić rektalno
English: Domperidone Domperidon CF 10 mg, tabletten
Croatian: Domperidon Domperidon CF 10 mg, tabletten
English: 10 mg dispersible tablet
Croatian: 10 mg raspadljiva tableta za usta
English: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE MYLAN 10 mg, comprimé orodispersible
Croatian: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidon DOMPERIDONE MYLAN 10 mg, comprimé orodispersible
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone PERIDYS 1 mg/ml, suspension buvable
Croatian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon PERIDYS 1 mg/ml, suspension buvable
English: 75116 Paris domperidone DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.
Croatian: France domperidon DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.
English: Domperidone DOMPERIDONE FG 10 mg tablet
Croatian: Domperidon DOMPERIDONE FG 10 mg tableta
English: 1MG/ML
Croatian: ORAL SUSPENSION 1MG/ML
English: Domperidone mylan 10 mg film-coated tablet
Croatian: Domperidone mylan 10 mg filmom obložena tableta
English: Domperidone Domperidon Mylan 10 mg, tabletten
Croatian: Domperidon Domperidon Mylan 10 mg, tabletten
English: 5 mg chewable tablet
Croatian: 5 mg šumeća tableta
English: Domperidone Domperidon Mdq 10 mg, tabletten
Croatian: Domperidon Domperidon Mdq 10 mg, tabletten
English: DOMPERIDONE MOTILIUM 10 mg 10 mg film-coated tablet
Croatian: DOMPERIDON MOTILIUM 10 mg 10 mg filmom obložena tableta
English: Domperidone Domperidon Actavis 10 mg, tabletten
Croatian: Domperidon Domperidon Actavis 10 mg, tabletten
English: Domperidone EG 10 mg tablet
Croatian: Domperidone EG 10 mg tableta
English: Domperidone Domperidon Pharmacin 10 mg, tabletten
Croatian: Domperidon Domperidon Pharmacin 10 mg, tabletten
English: Belgium Pierre Fabre Médicament 45 place Abel Gance
Croatian: Španjolska Pierre Fabre Médicament 45 place Abel Gance
English: Domperidone Domperidon Actavis 10 mg tablet
Croatian: Domperidon Domperidon Actavis 10 mg tableta
English: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE MYLAN 10 mg, comprimé pelliculé
Croatian: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidon DOMPERIDONE MYLAN 10 mg, comprimé pelliculé
English: Domperidone Domperidon Kela 10 mg, tabletten
Croatian: Domperidon Domperidon Kela 10 mg, tabletten
English: 92931 Paris La Défense Cedex France domperidone DOMPERIDONE TEVA 20 mg, comprimé pelliculé sécable
Croatian: 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France domperidon DOMPERIDONE TEVA 20 mg, comprimé pelliculé sécable
English: Domperidone DOMPERIDONE EG 10 mg tablet
Croatian: Domperidon DOMPERIDONE EG 10 mg tableta
English: DOMPERIDONE OROPERIDYS 10 mg 10 mg orodispersible tablet oral use
Croatian: DOMPERIDON OROPERIDYS 10 mg 10 mg raspadljiva tableta za usta
English: Domperidone Domperidon Sofar 10 mg, tabletten
Croatian: Domperidon Domperidon Sofar 10 mg, tabletten
English: Domperidone Domperidon 10 mg PCH, tabletten
Croatian: Domperidon Domperidon 10 mg PCH, tabletten
English: 92931 Paris La Défense Cedex France domperidone DOMPERIDONE TEVA 10 mg, comprimé orodispersible
Croatian: 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France domperidon DOMPERIDONE TEVA 10 mg, comprimé orodispersible
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone PERIDYS 10 mg, comprimé pelliculé
Croatian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon PERIDYS 10 mg, comprimé pelliculé
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone BIPERIDYSFLASH 20 mg, comprimé orodispersible
Croatian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon BIPERIDYSFLASH 20 mg, comprimé orodispersible
English: Rua Manuel Ribeiro de Pavia, 11º - Venda Nova 2700-547 Amadora Portugal domperidone Cinet
Croatian: Rua Manuel Ribeiro de Pavia, 1 - 1ºVenda Nova
English: B-2340, Beerse Belgium domperidone MOTILIUM ORAL SUSPENSION
Croatian: B-2340, Beerse Belgium domperidon MOTILIUM
English: 92931 Paris La Défense Cedex France domperidone DOMPERIDONE TEVA 10 mg, comprimé pelliculé
Croatian: 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France domperidon DOMPERIDONE TEVA 10 mg, comprimé pelliculé
English: Domperidone Maleato
Croatian: Domperidone Maleat
English: Domperidone DOMPERIDONE DR. REDDY'S
Croatian: Domperidon DOMPERIDONE DR.
English: Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris domperidone DOMPERIDONE ZENTIVA 10 mg, comprimé orodispersible
Croatian: Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone DOMPERIDONE PIERRE FABRE 20 mg, comprimé pelliculé sécable
Croatian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon DOMPERIDONE PIERRE FABRE 20 mg, comprimé pelliculé sécable
English: Janssen-Cilag Kft. Tó park
Croatian: Janssen-Cilag Kft.
English: Domperidone Domperidon 10 mg, tabletten
Croatian: Domperidon Domperidon 10 mg, tabletten
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone BIPERIDYS 20 mg, comprimé pelliculé sécable
Croatian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon BIPERIDYS 20 mg, comprimé pelliculé sécable
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone DOMPERIDONE PIERRE FABRE 10 mg, comprimé orodispersible
Croatian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon DOMPERIDONE PIERRE FABRE 10 mg, comprimé orodispersible
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone DOMPERIDONE PIERRE FABRE
Croatian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon OROPERIDYS
English: 10 mg orodispersible tablet oral use
Croatian: 10 mg tableta za oralnu suspenziju
English: Burton Upon Trent, Staffordshire DE14 2WX
Croatian: Focus Pharmaceuticals Limited Unit 5, Faraday Court First Avenue, Centrum 100 Burton Upon Trent, Staffordshire DE14 2WX
English: Healthypharm B.V. Nieuwe Donk 3
Croatian: Nizozemska Healthypharm B.V.
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone Oroperidys 10 mg orodispersible tablets
Croatian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon Oroperidys 10 mg orodispersible tablets
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone OROPERIDYS 10 mg, comprimé orodispersible
Croatian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon OROPERIDYS 10 mg, comprimé orodispersible
English: Domperidon teva 10 mg film-coated tablet
Croatian: Domperidon DOMPERIDONE TEVA 10 mg filmom obložena tableta
English: ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon domperidone DOMPERIDONE ARROW 10 mg, comprimé pelliculé
Croatian: ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon
English: 1 mg/ml oral suspension oral use
Croatian: 1 mg/ml oralna suspenzija kroz usta
English: Avda.
Croatian: Str.
English: Takeda GmbH Byk-Gulden-Str. 2 78467 Konstanz Germany
Croatian: 2 78467 Konstanz Germany
English: Pharmachemie B.V. Swensweg 5
Croatian: GERMED PHARMA S.P.A. Via Cantù 11
English: Belgium Eurogenerics N.V. Heizel Esplanade b22
Croatian: Heizel Esplanade b22 1020 Brussels Belgium
English: Portugal domperidone Domperidona Mylan 10 mg film-coated tablet
Croatian: Portugal domperidon Domperidona Wynn 10 mg tableta
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone Oroperidys 10 mg 10 mg orodispersible tablet oral use
Croatian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidon Oroperidys 10 mg 10 mg raspadljiva tableta za usta
English: Dubrova 308 52220 Labin Croatia
Croatian: Apolonia d.o.o. Dubrova 308 52220 Labin Croatia
English: Orchard Business Centre St Barnabas Close Allington Maidstone Kent ME16 OJZ England
Croatian: St Barnabas Close Allington Maidstone Kent ME16 OJZ England
English: ZYLINDERAMPULLEN
Croatian: VASOKONSTRIKTORZYLINDERAMPULLEN
English: Septodont Ltd Unit R & S
Croatian: Septodont Ltd Unit R & S Orchard Business Centre
English: John Tsaprazis SA 157 Michalakopoulou Str. 11527, Athens Greece
Croatian: John Tsaprazis SA 157 Michalakopoulou Str.
English: 87 Avenue de la Constitution B-1083 Brussel Belgium
Croatian: Septodont NV-SA Grondwetlaan 87 Avenue de la Constitution B-1083 Brussel Belgium
English: Dental use Perineural use Submucosal use Infiltration
Croatian: Dentalno Perineuralno Submukozno Infiltracijom
English: Septodont GmbH Felix-Wankel-Str. 9
Croatian: Septodont GmbH Felix-Wankel-Str. 9 53859 NiederkasselMondorf
English: 3% without vasoconstrictor
Croatian: 3% without vasoconstrictor Otopina za injekciju Dentalno
English: Infiltration Perineural use
Croatian: Infiltracijom Perineuralno
English: Perineural use Submucosal use
Croatian: Perineuralno Submukozno
English: SCANDONEST 30 MG/ML, SOLUTION INJECTABLE À USAGE DENTAIRE
Croatian: MG/ML, SOLUTION INJECTABLE À USAGE DENTAIRE
English: Dental use Perineural use
Croatian: Dentalno Perineuralno
English: Laboratoires Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-des-Fossés France
Croatian: Laboratoires Septodont 58, rue du Pont de Créteil
English: Spécialités Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-des-Fossés France
Croatian: Spécialités Septodont 58, rue du Pont de Créteil
English: Laboratoires Septodont 58, rue du Pont de Créteil 94107 Saint-Maur-des-Fossés Cedex
Croatian: 94107 Saint-Maur-desFossés Cedex France
English: technology'.
Croatian: Ta tehnologija
English: EMA/430531/2016 Rev 1 EMEA/H/C/003846
Croatian: EMA/430531/2016 EMEA/H/C/003846
English: In addition, the Committee questioned the proposed method of sterilisation of the medicine.
Croatian: Osim toga, Odbor je doveo u pitanje predloženu metodu sterilizacije lijeka.
English: What is Kyndrisa?
Croatian: Što je Kyndrisa?
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ako sudjelujete u kliničkom ispitivanju te vam je potrebno više informacija o liječenju, obratite se liječniku koji vam daje terapiju.
English: It causes progressive weakness and loss of muscle function, and usually leads to death in adolescence or early adulthood.
Croatian: Ta bolest uzrokuje progresivno slabljenje i gubitak funkcije mišića i obično dovodi do smrti u adolescenciji ili ranoj odrasloj dobi.
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.
Croatian: Tvrtka je navela da namjerava prekinuti razvoj lijeka, ali da namjerava, u suradnji s liječnicima, bolesnicima i lokalnim regulatornim tijelima, bolesnicima koji se trenutačno liječe omogućiti pristup preostalim zalihama lijeka Kyndrisa.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some important unresolved issues.
Croatian: Nakon što je CHMP ocijenio odgovore proizvođača na posljednji popis pitanja, još su uvijek postojala neka važna neriješena pitanja.
English: Kyndrisa is a medicine that contains the active substance drisapersen.
Croatian: Kyndrisa je lijek koji sadrži djelatnu tvar drisapersen.
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.
Croatian: Nadalje, sigurnosni profil lijeka nije se smatrao zadovoljavajućim, osobito zbog rizika od dugotrajnih reakcija na mjestu ubrizgavanja (kao što su oticanje, upala i ulceracije), što bi moglo negativno utjecati na kvalitetu života, te zbog rizika od trombocitopenije (niskog broja trombocita), zbog čega bolesnici mogu biti u opasnosti od teških komplikacija povezanih s krvarenjem.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Croatian: Zahtjev je povučen nakon što je CHMP ocijenio inicijalnu dokumentaciju koju je tvrtka dostavila i sastavio popise pitanja.
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.
Croatian: U ispitivanjima su učinci lijeka Kyndrisa uspoređeni s placebom (slijepo liječenje), a glavno mjerilo djelotvornosti bila je promjena u udaljenosti koju bolesnik može prohodati u roku od šest minuta nakon 24 tjedna ili 48 tjedana liječenja.
English: Withdrawal of the marketing authorisation application for Kyndrisa (drisapersen)
Croatian: Povlačenje zahtjeva za davanje odobrenja za stavljanje u promet lijeka Kyndrisa (drisapersen)
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.
Croatian: Dana 31. svibnja 2016. tvrtka BioMarin International Limited službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) da želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Kyndrisa za liječenje Duchenneove mišićne distrofije.
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'.
Croatian: Lijek Kyndrisa trebao se koristiti za liječenje Duchenneove mišićne distrofije u bolesnika u dobi od 5 ili više godina koji mogu hodati i čija je bolest uzrokovana određenim genskim mutacijama (oštećenjima) koje se mogu liječiti „tehnologijom preskakanja egzona 51”.
English: Duchenne muscular dystrophy is a serious genetic disease, which mainly affects boys and is usually diagnosed before the age of 6.
Croatian: Duchenneova mišićna distrofija teška je genska bolest koja većinom pogađa dječake i za koju se dijagnoza obično uspostavlja prije navršene 6. godine.
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.
Croatian: omogućuje da stanični aparat za izradu proteina preskoči određena područja gena distrofina i omogući proizvodnju skraćenog, ali djelomično funkcionalnog proteina distrofina.
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.
Croatian: U svom dopisu kojim obavješćuje Agenciju o povlačenju zahtjeva tvrtka je navela da ne može odgovoriti na probleme za koje CHMP smatra da postoje u vezi s rezultatima kliničkih ispitivanja u očekivanom roku.
English: Kyndrisa was investigated in three studies in a total of 290 patients with Duchenne muscular dystrophy.
Croatian: Lijek Kyndrisa ispitan je u okviru triju ispitivanja na ukupno 290 bolesnika s Duchenneovom mišićnom distrofijom.
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.
Croatian: Duchenneovu mišićnu distrofiju uzrokuju mutacije gena za protein distrofin koje dovode do proizvodnje nedjelotvornog distrofina.
English: What was Kyndrisa expected to be used for?
Croatian: Za što se lijek Kyndrisa trebao koristiti?
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.
Croatian: Na temelju pregleda podataka te odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost i bio je privremenog mišljenja da nije moguće dati odobrenje za lijek Kyndrisa za liječenje Duchenneove mišićne distrofije.
English: Withdrawal of the marketing authorisation application for Kyndrisa (drisapersen) EMA/430531/2016
Croatian: (drisapersen) EMA/430531/2016
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Kyndrisa did not outweigh its risks.
Croatian: Sukladno navedenome, u vrijeme povlačenja CHMP je smatrao da koristi od lijeka Kyndrisa ne nadmašuju s njim povezane rizike.
English: This medicine works by ‘exon 51 skipping
Croatian: Lijek djeluje s pomoću „tehnologije preskakanja egzona 51”.
English: How is Kyndrisa expected to work?
Croatian: Kako je lijek Kyndrisa trebao djelovati?
English: Kyndrisa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 27 February 2009 for Duchenne muscular dystrophy.
Croatian: Lijek Kyndrisa označen je kao lijek za liječenje rijetkih bolesti 27. veljače 2009. za liječenje Duchenneove mišićne distrofije.
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.
Croatian: U glavnom se ispitivanju nije pokazala nikakva korist u bolesnika s tim stanjem, dok se u drugim dvama ispitivanjima korisnost lijeka nije uspjela dokazati na dosljedan način.
English: 22014 Incheon Republic of Korea
Croatian: 22014 Incheon Republika Koreja
English: Important information:
Croatian: Važne informacije:
English: Date of first authorisation: 28 March 2019
Croatian: Datum prvog odobrenja: 28. ožujka 2019.
English: How much and when to inject
Croatian: Koliko i kada ubrizgati
English: Your doctor will discuss and decide with you the most appropriate dosing schedule.
Croatian: Vaš će liječnik s Vama raspraviti i odlučiti koji je raspored doziranja najprikladniji.
English: d) Wash your hands with soap and water and dry well with a clean towel.
Croatian: d) Operite ruke sapunom i vodom i dobro ih obrišite čistim ručnikom.
English: Do not remove pressure until the 3 steps below are complete.
Croatian: Nemojte prestati pritiskati sve dok nisu završena sva 3 koraka navedena u nastavku.
English: One of these 6 patients developed neutralising antibodies.
Croatian: Jedan od tih 6 bolesnika razvio je neutralizirajuća protutijela.
English: c) Remove the needle from your skin.
Croatian: c) Izvucite iglu iz kože.
English: The treatment benefit should be assessed within 3 months after initiation of treatment.
Croatian: Korist od liječenja treba procijeniti unutar 3 mjeseca od početka liječenja.
English: Make sure the name AJOVY appears on the label.
Croatian: Budite sigurni da je naziv AJOVY vidljiv na naljepnici.
English: Intrinsic and extrinsic factors
Croatian: Intrinzični i ekstrinzični faktori
English: The safety and efficacy of AJOVY in children and adolescents below the age of 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka AJOVY u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: Two dosing options are available:
Croatian: Postoje dvije moguće preporučene opcije doziranja:
English: AJOVY is not recommended for children and adolescents below the age of 18 years because it has not been studied in this age group.
Croatian: AJOVY se ne preporučuje za djecu i adolescente mlađe od 18 godina jer nije ispitan u toj dobnoj skupini.
English: − Wait 10 seconds to allow the skin to dry before injecting.
Croatian: − Pričekajte 10 sekundi kako bi se koža osušila prije ubrizgavanja.
English: Not all pack sizes may be available in your country.
Croatian: U Vašoj državi možda nisu dostupne sve veličine pakiranja.