FrancophonIA/ELRC3.0 huggingface dataset:
English: Actos 45 mg tablets pioglitazone
Croatian: NAZIV LIJEKA Actos 45 mg tablete pioglitazon
English: Lilly Hungária Kft. Tel: +36 1 328 5100
Croatian: Tel: + 36 1 328 5100
English: Contains lactose monohydrate.
Croatian: POPIS POMOĆNIH TVARI Sadrži laktozu hidrat.
English: Actos 15 mg tablets pioglitazone
Croatian: NAZIV LIJEKA Actos 15 mg tablete pioglitazon
English: Τηλ: +45 46 77 11 11
Croatian: Takeda Pharma A/S Τηλ: +45 46 77 11 11
English: Eli Lilly Nederland B.V. Tel: +31 (0) 30 60 25 800
Croatian: Tel: + 31 (0) 30 60 25 800
English: Avda.
Croatian: Nuspojava
English: − Actos 15 mg tablets are white to off-white, round, convex tablets marked ‘15' on one face and
Croatian: Kako Actos izgleda i sadržaj pakiranja Actos 15 mg tablete su bijele do gotovo bijele boje, okrugle, konveksne s oznakom ‘15' na jednoj strani i ‘ACTOS' na drugoj strani.
English: It is not known whether pioglitazone is secreted in human milk.
Croatian: Nije poznato izlučuje li se pioglitazon u majčino mlijeko pa se stoga pioglitazon ne smije primjenjivati u dojilja.
English: ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
Croatian: PRILOG IV. ZNANSTVENI ZAKLJUČCI
English: Renal and urinary disorders haematuria common glycosuria uncommon proteinuria uncommon
Croatian: Poremećaji bubrega i mokraćnog sustava hematurija često glikozurija manje često proteinurija manje često
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) karcinom mokraćnog mjehura manje često manje često manje često manje često manje često
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicant in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačine lijeka, puta primjene i podnositelja zahtjeva u državama članicama
English: United Kingdom Kohne Pharma GmbH Schallbruch 1
Croatian: Ujedinjeno Kraljevstvo Kohne Pharma GmbH Schallbruch 1
English: Dexamed 5 mg comprimidos 5 mg
Croatian: Dexamed 5 mg comprimidos
English: Capsule, Hard
Croatian: Kapsula, tvrda
English: Capsule
Croatian: Kapsula
English: Antibiotice Sa
Croatian: Antibiotice
English: Annex I List of nationally authorised medicinal products
Croatian: Prilog I Popis naziva lijekova odobrenih nacionalnim postupkom
English: Tabletta Analgetica Fono Vii
Croatian: Tabletata Analgetica Fono Vii
English: Syrup
Croatian: Sirup
English: Intramuscular Use | Intravenous Use
Croatian: Intramuskularno | intravenski
English: Solution For Injection/Infusion
Croatian: Otopina za injekciju/infuziju
English: Ratiopharm España S.A. Metamizol Ratiopharm Metamizole Magnesium 575mg Capsule
Croatian: Ratiopharm España S.A. Metamizol Ratiopharm Metamizolmagnezij 575 mg kapsula
English: Abc Farmaceutici S.P.A. Metamizolo Sodico Abc Metamizole Sodium 500mg/ml
Croatian: Abc Farmaceutici S.P.A. Metamizolo Sodico Abc Metamizolnatrij 500 mg/ml
English: Sanofi-Aventis Slovakia Sro
Croatian: Sanofi-Aventis Slovačka Sro
English: Chemax Pharma Ltd Диалгин Джуниор Metamizole Sodium Monohydrate 250mg
Croatian: Chemax Pharma Ltd Диалгин Джуниор Metamizolnatrij hidrat 250 mg vrećica
English: Meditop Pharmaceutical Co. Ltd.
Croatian: Meditop Pharmaceutical Co.
English: Metamizol Sintocalmin Metamizole 500mg Tablet
Croatian: Metamizol Sintocalmin Metamizol 500 mg tableta
English: Melting Tablets
Croatian: Šumeća tableta
English: Codeine Phosphate Sesquihydrate 0.03g in form of Codeine Phosphate Hemihydrate 0.02873g, Metamizole Sodium 0.9g, Caffeine And Sodium Benzoate 0.1g / suppository
Croatian: Kodeinfosfat seskvihidrat 0,03 g u obliku kodeinfosfat hemihidrata 0,02873 g; metamizolnatrij 0,9 g; kofein i natrijev benzoat 0,1 g / čepić
English: Solution For Injection Intramuscular Use
Croatian: Otopina za injekciju Intramuskularno
English: Solution For Injection Intravenous Use
Croatian: Otopina za injekciju Intravenski
English: G.L.
Croatian: Ltd.
English: Metamizole Sodium 500mg Tablet, Triacetonamine Tosilate 20mg Tablet
Croatian: Metamizolnatrij 500 mg tableta; triacetonamin tosilat 20 mg tableta
English: Coated Tablet
Croatian: Obložena tableta
English: Powder For Oral Solution In Sachet
Croatian: Prašak za oralnu otopinu u vrećici
English: Metamizole Sodium 300mg Tablet, Paracetamol 200mg Tablet, Caffeine 30mg Tablet, Codeine Phosphate 20mg Tablet
Croatian: Metamizolnatrij 300 mg tableta; paracetamol 200 mg tableta; kofein 30 mg tableta; kodeinfosfat 20 mg tableta
English: Metamizole Sodium 450mg Tablet, Caffeine 50mg Tablet
Croatian: Metamizolnatrij 450 mg tableta; kofein 50 mg tableta
English: Hydrochloride 10mg, Metamizole Sodium 1g
Croatian: Pitofenonklorid 10 mg; metamizolnatrij 1 g
English: Metamizole Sodium 150mg Tablet, Paracetamol 300mg Tablet, Phenobarbital 15mg Tablet, Caffeine 50mg Tablet, Codeine Phosphate Hemihydrate 10mg Tablet
Croatian: Metamizolnatrij 150 mg tableta; paracetamol 300 mg tableta; fenobarbital 15 mg tableta; kofein 50 mg tableta; kodeinfosfat hemihidrat 10 mg tableta
English: Metamizole Sodium 0.9g Suppository, Caffeine 0.05g Suppository, Codeine Phosphate Hemihydrate 0.03g Suppository
Croatian: Metamizolnatrij 0,9 g čepić; kofein 0,05 g čepić; kodeinfosfat hemihidrat 0,03 g čepić
English: Buscapina Compositum Metamizole Sodium 250mg Tablet, Hyoscine Butylbromide 10mg
Croatian: Buscapina Compositum Metamizolnatrij 250 mg tableta; hioscinijev butilbromid 10 mg tableta
English: Metamizole 500mg/ml
Croatian: Metamizol 500 mg/ml
English: Scopolan Compositum Metamizole Sodium 250mg Tablet, Hyoscine Butylbromide 10mg
Croatian: Scopolan Compositum Metamizolnatrij 250 mg tableta; hioscinijev butilbromid 10 mg tableta
English: Metamizol Kern Pharma Metamizole Magnesium 575mg Capsule
Croatian: Metamizol Kern Pharma Metamizolmagnezij 575 mg kapsula
English: Drotaverine Hydrochloride 40mg Tablet, Metamizole Sodium 400mg Tablet, Caffeine 60mg Tablet
Croatian: Drotaverinklorid 40 mg tableta; metamizolnatrij 400 mg tableta; kofein 60 mg tableta
English: Metamizole Sodium Monohydrate 25mg Drop
Croatian: Metamizolnatrij hidrat 25 mg kapi
English: Metamizole Sodium Monohydrate 0.525g/ml
Croatian: Metamizolnatrij hidrat 0,525 g/ml
English: Metamizole Sodium 0.5g Suppository, Caffeine And Sodium Benzoate 0.1g Suppository
Croatian: Metamizolnatrij 0,5 g čepić; kofein i natrijev benzoat 0,1 g čepić
English: Codeine Phosphate Sesquihydrate 0.03g Suppository, Metamizole Sodium 0.09g Suppository, Caffeine And Sodium Benzoate 0.1g Suppository, Codeine Phosphate Hemihydrate 0.02873g Suppository
Croatian: Kodeinfosfat seskvihidrat 0,03 g čepić; metamizolnatrij 0,09 g čepić; kofein i natrijev benzoat 0,1 g čepić; kodeinfosfat hemihidrat 0,02873 g čepić
English: Metamizole Magnesium 575mg Tablet
Croatian: Metamizolmagnezij 575 mg tableta
English: Pharma Gmbh Metagelan
Croatian: G.L. Pharma Gmbh Metagelan
English: Thiamine Hydrochloride 38.75mg Tablet, Metamizole Sodium 500mg Tablet, Caffeine 50mg Tablet
Croatian: Tiaminklorid 38,75 mg tableta; metamizolnatrij 500 mg tableta; kofein 50 mg tableta
English: Metamizole Magnesium 1000mg Suppository
Croatian: Metamizolmagnezij 1000 mg čepić
English: Metamizole Sodium 1g Suppository
Croatian: Metamizolnatrij 1 g čepić
English: Metamizole Sodium 1g/2ml
Croatian: Metamizolnatrij 1 g/2 ml
English: Metamizol Normon Metamizole Magnesium 2g/5ml
Croatian: Metamizol Normon Metamizolmagnezij 2 g/5 ml
English: Metamizole Sodium Monohydrate 527mg Tablet, Pitofenone Hydrochloride 5.25mg Tablet, Fenpiverinium Bromide 0.1mg Tablet
Croatian: Metamizolnatrij hidrat 527 mg tableta; pitofenonklorid 5,25 mg tableta; fenpiverinijev bromid 0,1 mg tableta
English: Metamizole Magnesium 500mg Capsule
Croatian: Metamizolmagnezij 500 mg kapsula
English: Heumann Pharma Gmbh & Co. Generica Kg
Croatian: Heumann Pharma Gmbh & Co.
English: Metamizole Sodium 500mg Sachet, Caffeine 50mg Sachet
Croatian: Metamizolnatrij 500 mg vrećica; kofein 50 mg vrećica
English: Hydrochloride 2mg/ml, Fenpiverinium Bromide 0.02mg/ml, Metamizole Sodium 500mg/ml
Croatian: Pitofenonklorid 2 mg/ml; fenpiverinijev bromid 0,02 mg/ml; metamizolnatrij 500 mg/ml
English: Metamizole Sodium Monohydrate 2,5 g/5 ml
Croatian: Metamizolnatrij hidrat 2,5 g/5 ml
English: Pharma Gmbh Metamilan
Croatian: G.L. Pharma Gmbh Metamilan
English: Metamizole Sodium 200mg Suppository
Croatian: Metamizolnatrij 200 mg čepić
English: Metamizole 575mg Capsule
Croatian: Metamizol 575 mg kapsula
English: Metamizole Sodium Monohydrate 500mg/ml, Pitofenone Hydrochloride 5mg/ml
Croatian: Metamizolnatrij hidrat 500 mg/ml; pitofenonklorid 5 mg/ml
English: Metamizol Will-Pharma Metamizole Sodium Monohydrate 500mg/ml
Croatian: Metamizol Will-Pharma Metamizolnatrij hidrat 500 mg/ml
English: Metamizol Normon Metamizole Magnesium 575mg Capsule
Croatian: Metamizol Normon Metamizolmagnezij 575 mg kapsula
English: Cyanocobalamin 0.5mg Tablet, Metamizole Sodium 500mg Tablet, Thiamine Nitrate 75mg Tablet, Pyridoxine Hydrochloride 50mg Tablet
Croatian: Cijanokobalamin 0,5 mg tableta; metamizolnatrij 500 mg tableta; tiaminnitrat 75 mg tableta; piridoksinklorid 50 mg tableta
English: Hydrochloride 2mg/ml, Fenpiverinium Bromide 0.02mg/ml
Croatian: Metamizolnatrij hidrat 0,5 g/ml; pitofenonklorid 2 mg/ml; fenpiverinijev bromid 0,02 mg/ml
English: Pitofenone Hydrochloride 5mg, Metamizole Sodium 500mg
Croatian: Pitofenonklorid 5 mg; metamizolnatrij 500 mg
English: Metamizole Magnesium 2000mg /5ml
Croatian: Metamizolmagnezij 2000 mg/5 ml
English: Buscapina Compositum Metamizole Sodium 2.5g/5ml, Hyoscine
Croatian: Buscapina Compositum Metamizolnatrij 2,5 g/5 ml; hioscinijev butilbromid 0,02 g/5 ml
English: Metamizole Sodium 100mg Suppository
Croatian: Metamizolnatrij 100 mg čepić
English: Metamizole Magnesium 500mg Sachet
Croatian: Metamizolmagnezij 500 mg vrećica
English: Metamizole Sodium 500g/ml
Croatian: Metamizolnatrij 500 g/ml
English: Metamizol Heumann Metamizole Sodium Monohydrate 500mg/ml
Croatian: Metamizol Heumann Metamizolnatrij hidrat 500 mg/ml
English: Hydrochloride 2mg/ml, Metamizole Sodium 500mg/ml
Croatian: Pitofenonklorid 2 mg/ml; metamizolnatrij 500 mg/ml
English: Metamizole Magnesium 2g/5ml
Croatian: Metamizolmagnezij 2 g/5 ml
English: Powder For Oral Solution
Croatian: Prašak za oralnu otopinu
English: Metamizole Sodium Monohydrate 1000mg Suppository
Croatian: Metamizolnatrij hidrat 1000 mg čepić
English: Fenpiverinium Bromide 0.1mg/5ml, Metamizole Sodium 2500mg/5ml
Croatian: Pitofenonklorid 10 mg/5 ml; fenpiverinijev bromid 0,1 mg/5 ml; metamizolnatrij 2500 mg/5 ml
English: Metamizole Sodium Monohydrate 500mg Tablet, Pitofenone Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet
Croatian: Metamizolnatrij hidrat 500 mg tableta; pitofenonklorid 5 mg tableta; fenpiverinijev bromid 0,1 mg tableta
English: Metamizol Heumann Metamizole Sodium Monohydrate 500mg
Croatian: Metamizol Heumann Metamizolnatrij hidrat 500 mg tableta
English: Laboratorio Stada, S.L.
Croatian: Laboratorio Stada, S.L. Metamizol Stada
English: Granules For Oral Solution
Croatian: Granule za oralnu otopinu
English: Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet, Metamizole Sodium 500mg Tablet
Croatian: Pitofenonklorid 5 mg tableta; fenpiverinijev bromid 0,1 mg tableta; metamizolnatrij 500 mg tableta
English: Hydrochloride 5mg/ml, Metamizole Sodium 500mg/ml
Croatian: Pitofenonklorid 5 mg/ml; metamizolnatrij 500 mg/ml
English: Metamizole Sodium 300mg Suppository
Croatian: Metamizolnatrij 300 mg čepić
English: Metamizole Magnesium Hexahydrate 575mg Capsule
Croatian: Metamizolmagnezij heksahidrat 575 mg kapsula
English: Metamizole Magnesium 575mg Capsule
Croatian: Metamizolmagnezij 575 mg kapsula
English: Metamizole Sodium Monohydrate 1000mg Sachet
Croatian: Metamizolnatrij hidrat 1000 mg vrećica
English: Metamizole Sodium 1000mg Sachet
Croatian: Metamizolnatrij 1000 mg vrećica
English: Hydrochloride 5mg Tablet, Metamizole Sodium 500mg Tablet, Fenpipramide Bromomethylate 0.1mg Tablet
Croatian: Pitofenonklorid 5 mg tableta; metamizolnatrij 500 mg tableta; fenpipramid bromometilat 0,1 mg tableta
English: S.F.
Croatian: Sa
English: Effervescent Tablet
Croatian: Oralna otopina
English: Tell us how well we did with this information
Croatian: Recite nam koliko su vam ove informacije bile korisne
English: Three of the cases were fatal.
Croatian: Tri slučaja imala su smrtni ishod.
English: Please tell us what you think about this information by answering a few questions - it will only take a couple of minutes of your time:
Croatian: Odgovorite na nekoliko pitanja i recite nam što mislite o ovim informacijama - za to će vam biti potrebno samo nekoliko minuta:
English: The majority of EU patients have been treated in Germany.
Croatian: Većina bolesnika u EU-u liječena je u Njemačkoj.
English: Consider alternative treatments as appropriate.
Croatian: Razmotrite prikladne alternativne terapije.
English: EMA will complete its in-depth review and make public the final outcome.
Croatian: EMA će dovršiti svoje dubinsko ispitivanje i objaviti konačni ishod.
English: Most cases occurred within 8 months of starting treatment.
Croatian: Najviše slučajeva pojavilo se u roku od 8 mjeseci od početka liječenja.
English: Evidence indicates risk of serious inflammatory brain disorders
Croatian: Dokazi upućuju na rizik od teških upala mozga
English: Start the survey
Croatian: Započnite s upitnikom
English: The review of Zinbryta was initiated following a request from the European Commission on 26 February 2018, under Article 20 of Regulation (EC) No 726/2004.
Croatian: Ocjenjivanje lijeka Zinbryta započelo je 26. veljače 2018. na zahtjev Europske komisije, u skladu s člankom 20. Uredbe (EZ) br. 726/2004.
English: 8 March 2018 EMA/155367/2018
Croatian: EMA/134289/2018
English: Patients stopping treatment must be followed up for at least 6 months (see more details below).
Croatian: Bolesnici čije je liječenje prekinuto moraju se pratiti barem 6 mjeseci (vidjeti više pojedinosti u nastavku).
English: To date over 8,000 patients have been treated with Zinbryta worldwide.
Croatian: Dosad je više od 8 000 bolesnika diljem svijeta liječeno lijekom Zinbryta.
English: These could be signs of a reaction to Zinbryta.
Croatian: To mogu biti znakovi reakcije na lijek Zinbryta.
English: Zinbryta may also be linked to severe immune reactions affecting several other organs.
Croatian: Lijek Zinbryta također može biti povezan s ozbiljnim reakcijama imunosnog sustava koje zahvaćaju brojne druge organe.
English: Zinbryta was authorised in 2016 for treating relapsing forms of multiple sclerosis.
Croatian: Zinbryta je lijek koji je odobren 2016. za liječenje relapsnih oblika multiple skleroze.
English: Available evidence also indicates that Zinbryta could be linked to other immune-mediated disorders, such as blood dyscrasias, thyroiditis or glomerulonephritis.
Croatian: Dostupni dokazi također ukazuju na to da se lijek Zinbryta može povezati s drugim imunološki posredovanim poremećajima, kao što su diskrazija krvi, tiroiditis ili glomerulonefritis.
English: The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.
Croatian: Prvotno ocjenjivanje provodi Odbor za procjenu rizika u području farmakovigilancije (PRAC), odbor odgovoran za ocjenu sigurnosnih pitanja u pogledu lijekova za humanu uporabu, koji će iznijeti skup preporuka.
English: A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of Zinbryta.
Croatian: Prethodno ispitivanje dostupnih dokaza upućuje na to da reakcije imunosnog sustava uočene u prijavljenim slučajevima mogu biti povezane s primjenom lijeka Zinbryta.
English: The company that markets Zinbryta (Biogen Idec Ltd) has already voluntarily requested a withdrawal of the medicine's marketing authorisation and has informed EMA of its intention to stop clinical studies.
Croatian: Tvrtka koja je stavila lijek Zinbryta u promet (Biogen Idec Ltd) već je dobrovoljno zatražila povlačenje odobrenje za stavljanje lijeka u promet i obavijestila je EMA-u o svojoj namjeri prekidanja kliničkih ispitivanja.
English: Following a 2017 review of the medicine's effects on the liver, the use of the medicine was restricted to patients who have tried at least two other disease-modifying treatments and cannot be treated with any other multiple sclerosis treatments.
Croatian: Nakon ispitivanja učinaka lijeka na jetru koje je provedeno 2017., primjena lijeka ograničena je na bolesnike koji su prethodno pokušali barem dvije druge terapije koje mijenjaju tijek bolesti i koji se ne mogu liječiti nijednim drugim lijekom za multiplu sklerozu.
English: • Patients stopping treatment should be monitored at least monthly and more frequently as clinically indicated for up to 6 months after the last dose of Zinbryta.
Croatian: • Bolesnike čije je liječenje prekinuto valja nadzirati barem na mjesečnoj osnovi te češće, kako je klinički indicirano tijekom najviše 6 mjeseci nakon primjene posljednje doze lijeka Zinbryta.
English: • Your doctor will carry out regular blood tests for up to 6 months after stopping treatment to check for side effects.
Croatian: • Vaš će liječnik provoditi redovite krvne testove tijekom 6 mjeseci nakon prekida liječenja kako bi provjerio imate li nuspojave.
English: • Zinbryta will be recalled from pharmacies and hospitals across the EU.
Croatian: • Provest će se povlačenje lijeka Zinbryta iz ljekarni i bolnica diljem EU-a.
English: To date EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed 12 cases of immune-mediated inflammatory disorders, including encephalitis.
Croatian: EMA-in Odbor za procjenu rizika u području farmakovigilancije (PRAC) dosad je ispitao 12 slučajeva imunološki posredovanih upala, uključujući encefalitis.
English: • Do not take another injection of Zinbryta.
Croatian: • Nemojte uzimati daljnje injekcije lijeka Zinbryta.
English: • Advise patients to immediately report symptoms of liver injury such as prolonged fever, severe headache, tiredness, jaundice, nausea or vomiting.
Croatian: • Savjetujte bolesnicima da bez odlaganja prijave simptome oštećenja jetre, kao što su trajna vrućica, teška glavobolja, umor, žutica, mučnina ili povraćanje.
English: Healthcare professionals should immediately contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives.
Croatian: Zdravstveni radnici trebaju bez odlaganja stupiti u kontakt s bolesnicima koji se trenutačno liječe lijekom Zinbryta i prekinuti njihovo liječenje te razmotriti alternative.
English: On 6 March 2018, the European Medicines Agency (EMA) recommended the immediate suspension and recall of the multiple sclerosis medicine Zinbryta (daclizumab beta) following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis.
Croatian: Europska agencija za lijekove (EMA) preporučila je trenutačnu obustavu i povlačenje s tržišta lijeka Zinbryta (daklizumab beta) za multiplu sklerozu nakon 12 prijavljenih slučajeva teških upala mozga diljem svijeta, uključujući encefalitis i meningoencefalitis.
English: • Contact your patients currently being treated with Zinbryta as soon as possible and stop their treatment.
Croatian: • Stupite u kontakt sa svojim bolesnicima koji se već liječe lijekom Zinbryta što je prije moguće i prekinite njihovo liječenje.
English: • If you are being treated with Zinbryta, contact your doctor to discuss your treatment.
Croatian: • Ako se liječite lijekom Zinbryta, obratite se svojem liječniku kako biste razgovarali o vašoj terapiji.
English: • If you are in a clinical study with Zinbryta, contact the doctor treating you in the study.
Croatian: • Ako sudjelujete u kliničkom ispitivanju koje uključuje lijek Zinbryta, obratite se liječniku koji provodi vaše liječenje u ispitivanju.
English: A previous PRAC review in 2017 found that unpredictable and potentially fatal immune-mediated liver injury can occur with Zinbryta for up to 6 months after stopping treatment and concluded that patients stopping treatment should be followed up.
Croatian: PRAC je u prethodnom ispitivanju provedenom 2017. utvrdio da kod uzimanja lijeka Zinbryta može doći do nepredvidivog imunološki posredovanog oštećenja jetre koje može dovesti do smrtnog ishoda i zaključio je da valja pratiti bolesnike kod kojih je prekinuto liječenje.
English: No new patients should start treatment with Zinbryta.
Croatian: Ne smije se započinjati liječenje novih bolesnika lijekom Zinbryta.
English: The PRAC's recommendation to suspend Zinbryta and recall the product was sent to the European Commission, which issued a legally binding decision on 8 March 2018.
Croatian: Preporuka PRAC-a o obustavi lijeka Zinbryta i povlačenju proizvoda s tržišta šalje se Europskoj komisiji radi donošenja pravno obvezujuće odluke.
English: • Do not start any new patients on Zinbryta.
Croatian: • Nemojte započinjati liječenje novih bolesnika lijekom Zinbryta.
English: These reactions can occur for 6 months after treatment has been stopped.
Croatian: mjeseci nakon prekida liječenja.
English: To protect patients' health, the marketing authorisation in the EU of Zinbryta is now suspended and batches are to be recalled from pharmacies and hospitals.
Croatian: Radi zaštite zdravlja bolesnika EMA preporučuje trenutačnu obustavu odobrenja za stavljanje lijeka u promet u EU-u i povlačenje serija lijeka iz ljekarni i bolnica.
English: • Tell your doctor immediately if you have or experience symptoms such as persistent high temperature, severe headache, nausea (feeling sick), tiredness, yellowing of the skin or eyes and vomiting.
Croatian: teška glavobolja, mučnina (slabost), umor, žutilo kože ili očiju i povraćanje.
English: Multiple sclerosis medicine Zinbryta suspended in the EU
Croatian: EMA preporučuje trenutačnu obustavu i povlačenje s tržišta lijeka Zinbryta za multiplu sklerozu
English: 19 January 2015
Croatian: 19. siječnja 2015.
English: Other changes
Croatian: Druge izmjene
English: The areas harmonised include:
Croatian: Usklađena područja uključuju:
English: Nasonex and associated names are currently marketed in the following Member States of the EU: Austria, Belgium, Bulgaria, Croatia, Cyprus1, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.
Croatian: Nasonex i povezani nazivi trenutno su odobreni za stavljanje u promet u sljedećim državama članicama EU-a: Austriji, Belgiji, Bugarskoj, Hrvatskoj, Cipru1, Češkoj, Danskoj, Estoniji, Finskoj, Francuskoj, Njemačkoj, Grčkoj, Mađarskoj, Irskoj, Italiji, Latviji, Litvi, Luksemburgu, Malti, Nizozemskoj, Poljskoj, Portugalu, Rumunjskoj, Slovačkoj, Sloveniji, Španjolskoj, Švedskoj i Ujedinjenoj Kraljevini, te na Islandu i u Norveškoj.
English: The European Commission issued an EU-wide legally binding decision to implement these changes on 19 January 2015.
Croatian: Europska komisija izdala je pravno obvezujuću odluku na razini EU-a za provedbu ove izmjene dana 19. siječnja 2015.
English: What is Nasonex?
Croatian: Što je Nasonex?
English: Why was Nasonex reviewed?
Croatian: Zašto je Nasonex pregledan?
English: The CHMP agreed to that Nasonex must not be used in:
Croatian: CHMP je suglasan da se Nasonex ne smije koristiti u:
English: The CHMP also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation), 4.8 (side effects) and 5.1 (pharmacodynamic properties).
Croatian: CHMP je također uskladio druge dijelove sažetka opisa svojstava proizvoda, uključujući dijelove 4.4. (posebna upozorenja i mjere opreza za), 4.6. (plodnost, trudnoća i dojenje), 4.8. (nuspojave) i 5.1. (farmakodinamička svojstva).