FrancophonIA/ELRC3.0 huggingface dataset:
English: When administered to opioid dependent subjects, naloxone can cause acute withdrawal symptoms in some individuals.
Croatian: Kada se daje ispitanicima koji su ovisni o opioidima, nalokson kod nekih bolesnika može uzrokovati akutne simptome ustezanja.
English: Nyxoid should only be made available once the suitability and competence of an individual to administer naloxone in the appropriate circumstances has been established.
Croatian: Upućivanje bolesnika/korisnika o pravilnoj primjeni Nyxoida Nyxoid bi trebao biti dostupan tek nakon što se utvrdi prikladnost i sposobnost pojedinca da primjeni nalokson u odgovarajućim okolnostima.
English: Very rare: may affect up to 1 in 10,000 people
Croatian: Vrlo rijetko: mogu se javiti u manje od 1 na 10 000 osoba
English: Package leaflet: Information for the user Nyxoid 1.8 mg nasal spray, solution in a single-dose container
Croatian: Uputa o lijeku: Informacije za korisnike Nyxoid 1,8 mg sprej za nos, otopina u jednodoznom spremniku nalokson
English: In pregnant women who have been treated with Nyxoid, the fetus should be monitored for signs of distress.
Croatian: Kod trudnica liječenih Nyxoidom- plod treba motriti zbog moguće pojave znakova distresa.
English: • Feeling sick
Croatian: • Osjećaj mučnine
English: Nyxoid is intended for use in adolescents 14 years and over.
Croatian: Nyxoid je predviđen za primjenu u adolescenata u dobi od 14 i više godina.
English: • Rapid breathing
Croatian: • Ubrzano disanje
English: Peel off the back of the blister from the corner to remove the nasal spray from the container.
Croatian: Kako bi izvadili sprej za nos iz spremnika odljepite stražnju stranu blistera počevši od kuta blistera.
English: • Information on placing the patient into recovery position and administering the second dose, if required, in this position
Croatian: • Informaciju o tome kako upotrijebiti sprej za nos radi pravilne primjene Nyxoida • Informaciju o tome da je bolesnika potrebno postaviti u bočni položaj i dati mu drugu dozu u tom položaju, ako je to potrebno
English: Each pack contains two single-dose nasal sprays.
Croatian: Svako pakiranje sadrži dva jednodozna spreja za nos.
English: Single-dose nasal spray for overdose of opioids (such as heroin) Do not test before use
Croatian: Jednodozni sprej za nos za upotrebu kod predoziranja opioidima (kao što je heroin).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti i izravno preko nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: The pain may increase when you receive Nyxoid.
Croatian: Bol se može povećati kad primite Nyxoid
English: • Slow heart rate
Croatian: • Usporen puls
English: Ιρλανδία Tel +353 1 206 3800
Croatian: Airija Tel +353 1 206 3800
English: Opioid withdrawal syndrome
Croatian: Sindrom ustezanja lijeka
English: Each nasal spray container delivers 1.8 mg of naloxone (as hydrochloride dihydrate)
Croatian: Jedan spremnik spreja za nos isporučuje 1,8 mg naloksona (u obliku naloksonklorid dihidrata)
English: Each nasal spray contains 1.8 mg of naloxone (as hydrochloride dihydrate).
Croatian: Jedan sprej za nos sadrži 1,8 mg naloksona (u obliku naloksonklorid dihidrata).
English: If you are allergic to naloxone or any of the other ingredients of this medicine (listed in section 6).
Croatian: Što morate znati prije nego dobijete Nyxoid Nemojte koristiti Nyxoid ako ste alergični na nalokson ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: • Details of what information needs to be shared when training the patient/carer o how to manage a known or suspected opioid overdosed and how to properly administer Nyxoid o how to minimise the occurrence and severity of the following risks associated with Nyxoid: reappearance of respiratory depression, precipitation of acute opioid withdrawal effect and lack of efficacy due to medication error
Croatian: o kako postupiti u slučaju poznatog slučaja predoziranja opioidima ili u slučaju sumnje na predoziranje i kako odgovarajuće primijeniti Nyxoid o kako smanjiti pojavnost i težinu sljedećih rizika povezanih s lijekom Nyxoid:
English: ADRs are listed below by system organ class and frequency.
Croatian: Neželjene reakcije navedene su u nastavku sukladno klasifikaciji organskih sustava i učestalosti.
English: • Tremor
Croatian: • neraspoloženje
English: Nyxoid 1.8 mg nasal spray, solution in a single-dose container
Croatian: Nyxoid 1,8 mg sprej za nos, otopina u jednodoznom spremniku
English: Tel: +39 02 3182881
Croatian: Mundipharma Pharmaceuticals Srl Tel: +39 02 3182881
English: • Fast heart rate
Croatian: • Ubrzan puls
English: This medicine contains the active substance naloxone.
Croatian: Ovaj lijek sadrži djelatnu tvar nalokson.
English: Nyxoid 1.8 mg nasal spray, solution in a single-dose container naloxone
Croatian: Nyxoid 1,8 mg sprej za nos, otopina u jednodoznom spremniku nalokson
English: • Feeling sick, vomiting, diarrhoea
Croatian: • bolove u tijelu i grčeve u trbuhu • mučninu, povraćanje, proljev
English: • Unpleasant or uncomfortable mood
Croatian: • Nevoljno drhtanje
English: 6.2 Incompatibilities
Croatian: Pročišćena voda 6.2 Inkompatibilnosti
English: Tel: +34 91 3821870
Croatian: Mundipharma Pharmaceuticals, S.L. Tel: +34 91 3821870
English: Vascular disorders Common
Croatian: Tablični prikaz nuspojava
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET
English: The recommended dose is 1.8 mg administered into one nostril (one nasal spray).
Croatian: Odrasli i adolescenti u dobi od 14 i više godina Preporučena doza je 1,8 mg primijenjeno u jednu nosnicu (jedan sprej za nos).
English: Naloxone
Croatian: Tahikardija
English: • severe sleepiness
Croatian: • Suha usta
English: - The other ingredients are trisodium citrate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and purified water.
Croatian: Jedan sprej za nos sadrži 1,8 mg naloksona (u obliku naloksonklorid dihidrata) - Ostali sastojci su natrijev citrat dihidrat, natrijev klorid, kloridna kiselina, natrijev hidroksid i pročišćena voda.
English: Erythema multiforme
Croatian: Vrlo rijetko Multiformni eritem
English: Training will be provided on how to use Nyxoid before it is supplied to you.
Croatian: Vam se propiše i izda lijek bit će Vam pružena obuka o načinu primjene Nyxoida.
English: Mundipharma Oy
Croatian: France MUNDIPHARMA SAS
English: Dizziness, Headache Uncommon Tremor Cardiac disorders Common
Croatian: Manje često Tremor Srčani poremećaji Često
English: E-Mail: office@mundipharma.cz
Croatian: e-mail: mundipharma@mundipharma.bg
English: • Access to a video on how to use Nyxoid The HCP Guidance Document should include:
Croatian: • Pristup videu o primjeni lijeka Nyxoid
English: SIA Inovatīvo biomedicīnas tehnoloģiju institūts Tel: + 37167800810
Croatian: Mundipharma Pharmaceuticals Ltd Τηλ.: +357 22 815656
English: Lay down.
Croatian: Poleći.
English: Mundipharma Gesellschaft m.b.H.
Croatian: Mundipharma DC B.V.
English: How Nyxoid is to be given
Croatian: Kako uzimati Nyxoid
English: info@mundipharma.at
Croatian: info@mundipharma.be
English: MUNDIPHARMA SAS infomed@mundipharma.fr
Croatian: infomed@mundipharma.fr
English: Tel: +43 (0)1 523 25 05-0
Croatian: Mundipharma Gesellschaft m.b.H. Tel: +43 (0)1 523 25 05-0 info@mundipharma.at
English: Tlf: + 354 540 8000
Croatian: Tlf: + 354 540 8000 icepharma@icepharma.is
English: Austria - organizační složka Tel: + 420 222 318 221
Croatian: ТП„Мундифарма медикъл ООД“ Тел.: + 359 2 962 13 56
English: : + 359 2 962 13 56 e-mail: mundipharma@mundipharma.bg
Croatian: Tel: + 420 222 318 221 E-Mail: office@mundipharma.cz
English: Mundipharma Corporation (Ireland) Limited L-Irlanda
Croatian: Mundipharma Corporation (Ireland) Limited Ιρλανδία
English: : +357 22 815656 info@mundipharma.com.cy
Croatian: Tel: + 31 (0)33 450 82 70 info@mundipharma.nl
English: The review of fenspiride was initiated on 14 February 2019 at the request of France, under Article 107i of Directive 2001/83/EC.
Croatian: Ocjenjivanje fenspirida započelo je 14. veljače 2019. na zahtjev Francuske u skladu s člankom 107.i Direktive 2001/83/EZ.
English: The PRAC considered all the available evidence in its review.
Croatian: PRAC je tijekom svojeg pregleda razmotrio sve dostupne dokaze.
English: It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures.
Croatian: Odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene nacionalnim postupcima.
English: In the EU, fenspiride medicines have been authorised via national procedures in Bulgaria, France, Latvia, Lithuania, Poland, Portugal and Romania and are available under various brand names (Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, Еуреспал and Сиресп).
Croatian: Lijekovi koji sadrže fenspirid u EU-u su odobreni putem nacionalnih postupaka u Bugarskoj, Francuskoj, Latviji, Litvi, Poljskoj, Portugalu i Rumunjskoj te su dostupni pod različitim trgovačkim nazivima (Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, Еуреспал i Сиресп).
English: Therefore, the PRAC considered that these medicines should no longer be marketed.
Croatian: Stoga je PRAC zaključio da se te lijekove više ne smije stavljati u promet.
English: The PRAC recommendation was sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted it by consensus on 29 May 2019.
Croatian: Preporuka PRAC-a poslana je Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), koja ju je prihvatila konsenzusom 29. svibnja 2019.
English: • You should stop taking these medicines and contact your doctor or pharmacist for advice on alternative treatments, if needed.
Croatian: • Trebate prekinuti uzimanje tih lijekova i obratiti se svojem liječniku ili ljekarniku za savjet o alternativnim načinima liječenja, ako je potrebno.
English: 1 Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human
Croatian: 1 Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove
English: • If you have any concerns about your medicine, discuss them with your doctor or pharmacist.
Croatian: • Ako ste zabrinuti u pogledu lijeka koji uzimate, razgovarajte sa svojim liječnikom ili ljekarnikom.
English: 29 May 2019 EMA/285298/2019
Croatian: EMA/285298/2019
English: • Return unused medicines to your pharmacy for appropriate disposal.
Croatian: • Vratite neiskorištene lijekove u ljekarnu radi odgovarajućeg zbrinjavanja.
English: Withdrawal of marketing authorisations for fenspiride medicines EMA/285298/2019
Croatian: Povlačenje odobrenja za stavljanje u promet lijekova koji sadrže fenspirid EMA/285298/2019
English: The PRAC recommendation was adopted by the CMDh1 by consensus and will be implemented directly at national level.
Croatian: CMDh1 je konsenzusom prihvatio preporuku PRAC-a te će se ona provesti izravno na nacionalnoj razini.
English: Heart rhythm problems can be serious and occur suddenly, and it is not feasible to identify in advance the patients who may be at risk of these problems with fenspiride.
Croatian: Problemi sa srčanim ritmom mogu biti ozbiljni i pojaviti se iznenada, a nije moguće unaprijed identificirati bolesnike koji bi zbog primjene fenspirida mogli biti izloženi riziku od tih problema.
English: This follows a review that confirmed that these cough medicines could cause heart rhythm problems.
Croatian: To je uslijedilo nakon pregleda kojim je potvrđeno da ti lijekovi za liječenje kašlja mogu izazvati probleme sa srčanim ritmom.
English: The PRAC recommendation will now be implemented by EU Member States, Iceland, Lichtenstein and Norway.
Croatian: Preporuka PRAC-a bit će provedena u državama članicama EU-a, Islandu, Lihtenštajnu i Norveškoj.
English: • Cough medicines containing fenspiride will no longer be marketed in the EU because of data showing a risk of sudden, serious heart rhythm problems.
Croatian: • Lijekovi za liječenje kašlja koji sadrže fenspirid neće se više stavljati u promet u EU-u zbog podataka koji upućuju na rizik od iznenadnih, ozbiljnih problema sa srčanim ritmom.
English: • Given the authorised uses of fenspiride for symptomatic treatment only and the seriousness of the safety concern, the benefit-risk balance of these medicines is negative for the currently authorised uses.
Croatian: • S obzirom na odobrenu primjenu fenspirida samo za simptomatsko liječenje i ozbiljnost razloga za zabrinutost, omjer koristi i rizika tih lijekova je negativan za trenutačno odobrene primjene.
English: Fenspiride medicines are available as syrup or tablets and used in adults and children from the age of 2 years to relieve cough resulting from lung diseases.
Croatian: Lijekovi koji sadrže fenspirid dostupni su u obliku sirupa ili tableta, a primjenjuju se u odraslih i djece u dobi od dvije godine i starije za ublažavanje kašlja prouzročenog bolestima pluća.
English: • The withdrawal of the marketing authorisations of fenspiride medicines is based on case reports and nonclinical studies (including hERG channel binding) that showed that fenspiride can cause QT prolongation and has proarrhythmia potential (could cause triggering or worsening of arrhythmia) with the associated risk of torsades de pointes.
Croatian: • Povlačenje odobrenja za stavljanje u promet lijekova koji sadrže fenspirid temelji se na izvješćima o slučajevima i nekliničkim ispitivanjima (uključujući vezivanje na hERG kanal) koja su pokazala da fenspirid može uzrokovati produljenje QT intervala i ima proaritmijski potencijal (može uzrokovati pojavu ili pogoršanje aritmije) s povezanim rizikom od pojave torsades de pointes.
English: You can check the ingredients of your medicine in the package leaflet accompanying the medicine.
Croatian: Sastojke lijeka koji uzimate možete provjeriti u uputi o lijeku koja je priložena uz lijek.
English: This included cases of QT prolongation and torsades de pointes (abnormalities of the heart's electrical activity that may lead to heart rhythm disturbances) in patients using these medicines, results of laboratory studies, data from published literature and stakeholder input.
Croatian: To uključuje slučajeve produljenja QT intervala i torsades de pointes (abnormalnosti električne aktivnosti srca koje mogu dovesti do poremećaja srčanog ritma) u bolesnika koji se liječe tim lijekovima, rezultate laboratorijskih ispitivanja, podatke iz objavljene literature i informacije dobivene od interesnih skupina.
English: The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Croatian: CMDh je regulatorno tijelo za lijekove koje zastupa države članice Europske unije (EU) te Island, Lihtenštajn i Norvešku.
English: • Patients are only at risk of heart rhythm problems with fenspiride while they are taking these medicines.
Croatian: • Bolesnici su izloženi riziku od problema sa srčanim ritmom koje uzrokuje fenspirid samo dok uzimaju te lijekove.
English: Withdrawal of marketing authorisations for fenspiride medicines
Croatian: Povlačenje odobrenja za stavljanje u promet lijekova koji sadrže fenspirid
English: • Healthcare professionals should no longer prescribe fenspiride medicines and should advise their patients to stop taking fenspiride medicines.
Croatian: • Zdravstveni radnici ne smiju više propisivati lijekove koji sadrže fenspirid te moraju savjetovati bolesnike da prestanu uzimati lijekove koji sadrže fenspirid.
English: In contrast, fenspiride medicines are used to treat non-serious cough.
Croatian: S druge strane, lijekovi koji sadrže fenspirid primjenjuju se za liječenje kašlja koji nije ozbiljan.
English: At that time, the Pharmacovigilance Risk Assessment Committee (PRAC) recommended that supply of fenspiride medicines be suspended as a precautionary measure while the review was ongoing.
Croatian: U to je vrijeme Odbor za procjenu rizika u području farmakovigilancije (PRAC) preporučio da se, kao mjera opreza, obustavi opskrba lijekovima koji sadrže fenspirid dok je ocjenjivanje u tijeku.
English: On 16 May 2019, EMA's safety committee (PRAC) recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU.
Croatian: Odbor EMA-e za procjenu rizika u području farmakovigilancije (PRAC) preporučio je ukidanje odobrenja za stavljanje u promet lijekova koji sadrže fenspirid, pa se stoga ti lijekovi više ne mogu stavljati u promet u EU-u.
English: 00-113 Warsaw Poland
Croatian: 00-113 Warsaw Poljska
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Croatian: POPIS NAZIVA, FARMACEUTSKIH OBLIKA, JAČINA LIJEKOVA, PUTA PRIMJENE, NOSITELJA ODOBRENJA
English: 821 02 Bratislava
Croatian: 821 02 Bratislava Slovačka
English: Trancopal Dolo capsule
Croatian: Trancopal Dolo kapsula
English: MEDA PHARMA S.p.A., Viale Brenta 18, 20139 Milano Italy
Croatian: MEDA PHARMA S.p.A., Viale Brenta 18, 20139 Milano Italija
English: 55218 Ingelheim Germany
Croatian: 55218 Ingelheim Njemačka
English: Dolokadin einmal täglich prolonged release tablet
Croatian: Dolokadin einmal täglich tableta s produljenim oslobađanjem
English: 164,5 mg / 3 ml solution for injection intramuscular use
Croatian: 164,5 mg / 3 ml otopina za injekciju u mišić
English: 61352 Bad Homburg v. d. H. Germany
Croatian: 61352 Bad Homburg v. d. H. Njemačka
English: Trancopal Dolo Suppositorien 150 mg suppository rectal use
Croatian: Trancopal Dolo Suppositorien 150 mg supozitorij rektalno
English: Slovak Republic TEVA Pharmaceuticals Slovakia, s.r.o.
Croatian: TEVA Pharmaceuticals Slovakia, s.r.o.
English: 61352 Bad Homburg Germany
Croatian: 61352 Bad Homburg Njemačka
English: Katadolon Kinderzäpfchen suppository rectal use
Croatian: Katadolon Kinderzäpfchen supozitorij rektalno
English: kabelovny 130, Dolní Mecholupy
Croatian: Ul. kabelovny 130, Dolní Mecholupy
English: Hormosan Pharma GmbH Wilhelmshöher Str. 106 60389 Frankfurt Germany
Croatian: Hormosan Pharma GmbH Wilhelmshöher Str. 106 60389 Frankfurt Njemačka
English: Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany
Croatian: Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Njemačka
English: Flupirtinmaleat Winthrop 400 mg Retardtabletten prolonged release tablet
Croatian: Flupirtinmaleat Winthrop 400 mg Retardtabletten tableta s produljenim oslobađanjem
English: 102 37, Praga 10, Czech Republic
Croatian: 102 37, Praga 10, Češka Republika
English: Katadolon Zäpfchen suppository rectal use
Croatian: Katadolon Zäpfchen supozitorij rektalno
English: Katadolon retard prolonged release tablet
Croatian: Katadolon retard tableta s produljenim oslobađanjem
English: FLUPIZEN 100 mg capsule
Croatian: FLUPIZEN 100 mg kapsula
English: Trancolong prolonged release tablet
Croatian: Trancolong tableta s produljenim oslobađanjem
English: Kabelovny 130 102 37 Praha 10 Czech Republic
Croatian: 102 37 Praha 10 Češka Republika
English: Flupirtinmaleat-ratiopharm 100 mg Hartkapsel ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Croatian: Flupirtinmaleat-ratiopharm 100 mg Hartkapsel ratiopharm GmbH Graf-Arco-Str.
English: Flupirtinmaleat Midas 100 mg Hartkapseln ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Croatian: Flupirtinmaleat Midas 100 mg Hartkapseln ratiopharm GmbH Graf-Arco-Str.
English: MEDA Pharma GmbH & Co. KG Benzstr.
Croatian: MEDA Pharma GmbH & Co.
English: Midas Pharma GmbH Rheinstrasse, 49 55218 Ingelheim Germany
Croatian: Midas Pharma GmbH Rheinstrasse, 49
English: Katadolon S long prolonged release tablet
Croatian: S long tableta s produljenim oslobađanjem
English: Further information can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Dodatne informacije možete pronaći na sljedećoj adresi: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What is Opsiria?
Croatian: Što je Opsiria?
English: Sirolimus has been used for several years to prevent organ rejection following a transplant.
Croatian: Sirolimus se nekoliko godina koristio za sprečavanje odbacivanja organa nakon transplantacije.
English: Withdrawal of the marketing authorisation application for Opsiria (sirolimus)
Croatian: Povlačenje zahtjeva za odobrenje za stavljanje u promet lijeka Opsiria (sirolimus)
English: The inflammation may cause discomfort, pain, blurring of vision, and may lead to partial or complete blindness.
Croatian: Ta upala može prouzročiti nelagodu, bol i zamućenje vida i može dovesti do djelomične ili potpune sljepoće.
English: In addition, the Committee questioned the proposed method of sterilisation of the medicine.
Croatian: Osim toga, Odbor je imao nedoumice u pogledu predložene metode sterilizacije lijeka.
English: The main measure of effectiveness was the number of patients in whom inflammation resolved after 5 months of treatment.
Croatian: Glavno mjerilo učinkovitosti bio je broj bolesnika u kojih je upala izliječena nakon pet mjeseci liječenja.
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 i potrebne su vam dodatne informacije o liječenju, obratite se liječniku koji vas liječi.
English: The data from the clinical study was not sufficient to demonstrate the benefit of Opsiria, particularly in European patients.
Croatian: Podaci dobiveni na temelju kliničkog ispitivanja nisu bili dostatni kako bi se dokazale koristi lijeka Opsiria, osobito u pacijenata iz Europe.
English: On 20 May 2016, Santen Oy officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Opsiria, for the treatment of non-infectious uveitis.
Croatian: Tvrtka Santen Oy je 20. svibnja 2016. službeno obavijestila Odbor za lijekove za humanu uporabu (CHMP) da želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Opsiria za liječenje neinfekcijskog uveitisa.
English: Opsiria is a medicine that contains the active substance sirolimus.
Croatian: Opsiria je lijek koji sadrži djelatnu tvar sirolimus.
English: The application was withdrawn after that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Croatian: Zahtjev je povučen nakon što je CHMP ocijenio dokumentaciju koju je tvrtka dostavila i sastavio popise pitanja.
English: In this study, Opsiria was not compared with any other treatment.
Croatian: U tom ispitivanju lijek Opsiria nije uspoređen niti s jednom drugom terapijom.
English: Opsiria was investigated in one main study in 347 patients with non-infectious uveitis.
Croatian: Lijek Opsiria ispitivan je u jednom glavnom ispitivanju na 347 bolesnika s neinfekcijskim uveitisom.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 May 2016 EMA/358774/2016 EMEA/H/C/003978
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27. svibnja 2016.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Opsiria.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se koristi lijek Opsiria.
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 had some concerns and was of the provisional opinion that Opsiria could not have been approved for the treatment of non-infectious uveitis.
Croatian: Na temelju pregleda podataka i 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 Opsiria za liječenje neinfekcijskog uveitisa.