natgillin/translations-raw huggingface dataset:
common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia) 
često (mogu se pojaviti u do 1 na 10 osoba) - infekcija dišnih puteva - poremećen vid - povećanje tjelesne težine - utrnulost manje često (mogu se pojaviti u do 1 na 100 osoba)
A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%). 
Viša stopa prijeloma bila je primijećena u žena koje su uzimale pioglitazon (2,6%) nego usporedni lijek (1,7%).
- if you retain water (fluid retention) or have heart failure problems, in particular if you are over 75 years old. 
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Actos (pogledajte također dio 4.) - ako zadržavate vodu (nakupljanje tekućine) ili imate tegobe s zatajivanjem srca, osobito ako ste stariji od 75 godina.
Actos 30 mg tablets 
Actos 30 mg tablete
common common uncommon macular oedema not known not known not known not known not known 
Poremećaji oka poremećaj vida često često manje često makularni edem nepoznato nepoznato nepoznato nepoznato nepoznato
Takeda Pharma A/S 
Nositelj odobrenja za stavljanje lijeka u promet Takeda Pharma A/S
Actos 45 mg tablets 
Actos 45 mg tablete
Actos 15 mg tablets 
Actos 15 mg tablete
− Actos 45 mg tablets are white to off-white, round, flat tablets marked ‘45' on one face and 
Actos 45 mg tablete su bijele do gotovo bijele boje, okrugle, plosnate s oznakom ‘45' na jednoj strani i ‘ACTOS' na drugoj strani.
1 Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported. 
Nakon stavljanja lijeka na tržište, kod bolesnika koji su liječeni pioglitazonom prijavljeni su slučajevi reakcija preosjetljivosti.
− Actos 30 mg tablets are white to off-white, round, flat tablets marked ‘30' on one face and 
Actos 30 mg tablete su bijele do gotovo bijele boje, okrugle, plosnate s oznakom ‘30' na jednoj strani i ‘ACTOS' na drugoj strani.
Infections and infestations upper respiratory tract infection common common common common common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon 
Infekcije i infestacije infekcije gornjih dišnih puteva često često često često često bronhitis često sinusitis manje često manje često manje često manje često manje često
Read the package leaflet before use. 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati uputu o lijeku.
Each Actos 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride). 
Jedna tableta lijeka Actos od 30 mg sadrži 30 mg pioglitazona (u obliku pioglitazonklorida).
EU/1/00/150/015 EU/1/00/150/016 EU/1/00/150/017 EU/1/00/150/018 EU/1/00/150/019 EU/1/00/150/020 EU/1/00/150/021 EU/1/00/150/022 EU/1/00/150/023 EU/1/00/150/024 EU/1/00/150/025 EU/1/00/150/026 EU/1/00/150/027 EU/1/00/150/028 EU/1/00/150/029 EU/1/00/150/030 
EU/1/00/150/001 EU/1/00/150/002 EU/1/00/150/003 EU/1/00/150/004 EU/1/00/150/005 EU/1/00/150/006 EU/1/00/150/007 EU/1/00/150/008 EU/1/00/150/009 EU/1/00/150/010 EU/1/00/150/011 EU/1/00/150/012 EU/1/00/150/013 EU/1/00/150/014 EU/1/00/150/015 EU/1/00/150/016 EU/1/00/150/017 EU/1/00/150/018 EU/1/00/150/019 EU/1/00/150/020 EU/1/00/150/021 EU/1/00/150/022 EU/1/00/150/023 EU/1/00/150/024 EU/1/00/150/025 EU/1/00/150/026 EU/1/00/150/027 EU/1/00/150/028 EU/1/00/150/029 EU/1/00/150/030
Respiratory, thoracic and mediastinal disorders dyspnoea common 
Poremećaji dišnog sustava, prsišta i sredoprsja dispneja često
Each Actos 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride). 
Jedna tableta lijeka Actos od 45 mg sadrži 45 mg pioglitazona (u obliku pioglitazonklorida).
Each Actos 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride). 
Jedna tableta lijeka Actos od 15 mg sadrži 15 mg pioglitazona (u obliku pioglitazonklorida).
The tablets are white to off-white, round, flat and marked ‘45' on one face and ‘ACTOS' on the other face. 
Tablete su bijele do gotovo bijele boje, okrugle, plosnate i imaju oznaku ‘45' s jedne strane i ‘ACTOS' s druge strane.
Nervous system disorders hypo-aesthesia common common common common common headache common uncommon dizziness common insomnia uncommon uncommon uncommon uncommon uncommon 
Poremećaji živčanog sustava hipoestezija često često često često često glavobolja često manje često omaglica često nesanica manje često manje često manje često manje često manje često
EU/1/00/150/011 14 tablets EU/1/00/150/012 28 tablets EU/1/00/150/022 30 tablets EU/1/00/150/013 50 tablets EU/1/00/150/014 56 tablets EU/1/00/150/023 84 tablets EU/1/00/150/024 90 tablets EU/1/00/150/015 98 tablets EU/1/00/150/029 112 tablets EU/1/00/150/030 196 tablets 
EU/1/00/150/011 14 tableta EU/1/00/150/012 28 tableta EU/1/00/150/022 30 tableta EU/1/00/150/013 50 tableta EU/1/00/150/014 56 tableta EU/1/00/150/023 84 tableta EU/1/00/150/024 90 tableta EU/1/00/150/015 98 tableta EU/1/00/150/029 112 tableta EU/1/00/150/030 196 tableta
The tablets are white to off-white, round, flat and marked ‘30' on one face and ‘ACTOS' on the other face. 
Tablete su bijele do gotovo bijele boje, okrugle, plosnate i imaju oznaku ‘30' s jedne strane i ‘ACTOS' s druge strane.
The tablets are white to off-white, round, convex and marked ‘15' on one face and ‘ACTOS' on the other face. 
Tablete su bijele do gotovo bijele boje, okrugle, konveksne i imaju oznaku ‘15' s jedne strane i ‘ACTOS' s druge strane.
Actos 30 mg tablets pioglitazone 
NAZIV LIJEKA Actos 30 mg tablete pioglitazon
EU/1/00/150/008 14 tablets EU/1/00/150/004 28 tablets EU/1/00/150/019 30 tablets EU/1/00/150/005 50 tablets EU/1/00/150/010 56 tablets EU/1/00/150/020 84 tablets EU/1/00/150/021 90 tablets EU/1/00/150/006 98 tablets EU/1/00/150/027 112 tablets EU/1/00/150/028 196 tablets 
EU/1/00/150/008 14 tableta EU/1/00/150/004 28 tableta EU/1/00/150/019 30 tableta EU/1/00/150/005 50 tableta EU/1/00/150/010 56 tableta EU/1/00/150/020 84 tableta EU/1/00/150/021 90 tableta EU/1/00/150/006 98 tableta EU/1/00/150/027 112 tableta EU/1/00/150/028 196 tableta
EU/1/00/150/007 14 tablets EU/1/00/150/001 28 tablets EU/1/00/150/016 30 tablets EU/1/00/150/002 50 tablets EU/1/00/150/009 56 tablets EU/1/00/150/017 84 tablets EU/1/00/150/018 90 tablets EU/1/00/150/003 98 tablets EU/1/00/150/025 112 tablets EU/1/00/150/026 196 tablets 
EU/1/00/150/007 14 tableta EU/1/00/150/001 28 tableta EU/1/00/150/016 30 tableta EU/1/00/150/002 50 tableta EU/1/00/150/009 56 tableta EU/1/00/150/017 84 tableta EU/1/00/150/018 90 tableta EU/1/00/150/003 98 tableta EU/1/00/150/025 112 tableta EU/1/00/150/026 196 tableta
Actos 45 mg tablets pioglitazone 
NAZIV LIJEKA Actos 45 mg tablete pioglitazon
Lilly Hungária Kft. Tel: +36 1 328 5100 
Tel: + 36 1 328 5100
Contains lactose monohydrate. 
POPIS POMOĆNIH TVARI Sadrži laktozu hidrat.
Actos 15 mg tablets pioglitazone 
NAZIV LIJEKA Actos 15 mg tablete pioglitazon
Avda. 
Nuspojava
− Actos 15 mg tablets are white to off-white, round, convex tablets marked ‘15' on one face and 
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.
It is not known whether pioglitazone is secreted in human milk. 
Nije poznato izlučuje li se pioglitazon u majčino mlijeko pa se stoga pioglitazon ne smije primjenjivati u dojilja.
ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S) 
PRILOG IV. ZNANSTVENI ZAKLJUČCI
Renal and urinary disorders haematuria common glycosuria uncommon proteinuria uncommon 
Poremećaji bubrega i mokraćnog sustava hematurija često glikozurija manje često proteinurija manje često
Neoplasms benign, malignant and unspecified (including cysts and polyps) 
Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) karcinom mokraćnog mjehura manje često manje često manje često manje često manje često
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicant in the Member States 
Popis naziva, farmaceutskih oblika, jačine lijeka, puta primjene i podnositelja zahtjeva u državama članicama
United Kingdom Kohne Pharma GmbH Schallbruch 1 
Ujedinjeno Kraljevstvo Kohne Pharma GmbH Schallbruch 1
Capsule, Hard 
Kapsula, tvrda
Capsule 
Kapsula
Antibiotice Sa 
Antibiotice
Annex I List of nationally authorised medicinal products 
Prilog I Popis naziva lijekova odobrenih nacionalnim postupkom
Tabletta Analgetica Fono Vii 
Tabletata Analgetica Fono Vii
Syrup 
Sirup
Intramuscular Use | Intravenous Use 
Intramuskularno | intravenski
Solution For Injection/Infusion 
Otopina za injekciju/infuziju
Ratiopharm España S.A. Metamizol Ratiopharm Metamizole Magnesium 575mg Capsule 
Ratiopharm España S.A. Metamizol Ratiopharm Metamizolmagnezij 575 mg kapsula
Abc Farmaceutici S.P.A. Metamizolo Sodico Abc Metamizole Sodium 500mg/ml 
Abc Farmaceutici S.P.A. Metamizolo Sodico Abc Metamizolnatrij 500 mg/ml
Sanofi-Aventis Slovakia Sro 
Sanofi-Aventis Slovačka Sro
Chemax Pharma Ltd Диалгин Джуниор Metamizole Sodium Monohydrate 250mg 
Chemax Pharma Ltd Диалгин Джуниор Metamizolnatrij hidrat 250 mg vrećica
Meditop Pharmaceutical Co. Ltd. 
Meditop Pharmaceutical Co.
Metamizol Sintocalmin Metamizole 500mg Tablet 
Metamizol Sintocalmin Metamizol 500 mg tableta
Melting Tablets 
Šumeća tableta
Codeine Phosphate Sesquihydrate 0.03g in form of Codeine Phosphate Hemihydrate 0.02873g, Metamizole Sodium 0.9g, Caffeine And Sodium Benzoate 0.1g / suppository 
Kodeinfosfat seskvihidrat 0,03 g u obliku kodeinfosfat hemihidrata 0,02873 g; metamizolnatrij 0,9 g; kofein i natrijev benzoat 0,1 g / čepić
Solution For Injection Intramuscular Use 
Otopina za injekciju Intramuskularno
Solution For Injection Intravenous Use 
Otopina za injekciju Intravenski
G.L. 
Ltd.
Metamizole Sodium 500mg Tablet, Triacetonamine Tosilate 20mg Tablet 
Metamizolnatrij 500 mg tableta; triacetonamin tosilat 20 mg tableta
Coated Tablet 
Obložena tableta
Powder For Oral Solution In Sachet 
Prašak za oralnu otopinu u vrećici
Metamizole Sodium 300mg Tablet, Paracetamol 200mg Tablet, Caffeine 30mg Tablet, Codeine Phosphate 20mg Tablet 
Metamizolnatrij 300 mg tableta; paracetamol 200 mg tableta; kofein 30 mg tableta; kodeinfosfat 20 mg tableta
Metamizole Sodium 450mg Tablet, Caffeine 50mg Tablet 
Metamizolnatrij 450 mg tableta; kofein 50 mg tableta
Hydrochloride 10mg, Metamizole Sodium 1g 
Pitofenonklorid 10 mg; metamizolnatrij 1 g
Metamizole Sodium 150mg Tablet, Paracetamol 300mg Tablet, Phenobarbital 15mg Tablet, Caffeine 50mg Tablet, Codeine Phosphate Hemihydrate 10mg Tablet 
Metamizolnatrij 150 mg tableta; paracetamol 300 mg tableta; fenobarbital 15 mg tableta; kofein 50 mg tableta; kodeinfosfat hemihidrat 10 mg tableta
Metamizole Sodium 0.9g Suppository, Caffeine 0.05g Suppository, Codeine Phosphate Hemihydrate 0.03g Suppository 
Metamizolnatrij 0,9 g čepić; kofein 0,05 g čepić; kodeinfosfat hemihidrat 0,03 g čepić
Buscapina Compositum Metamizole Sodium 250mg Tablet, Hyoscine Butylbromide 10mg 
Buscapina Compositum Metamizolnatrij 250 mg tableta; hioscinijev butilbromid 10 mg tableta
Metamizole 500mg/ml 
Metamizol 500 mg/ml
Scopolan Compositum Metamizole Sodium 250mg Tablet, Hyoscine Butylbromide 10mg 
Scopolan Compositum Metamizolnatrij 250 mg tableta; hioscinijev butilbromid 10 mg tableta
Metamizol Kern Pharma Metamizole Magnesium 575mg Capsule 
Metamizol Kern Pharma Metamizolmagnezij 575 mg kapsula
Drotaverine Hydrochloride 40mg Tablet, Metamizole Sodium 400mg Tablet, Caffeine 60mg Tablet 
Drotaverinklorid 40 mg tableta; metamizolnatrij 400 mg tableta; kofein 60 mg tableta
Metamizole Sodium Monohydrate 25mg Drop 
Metamizolnatrij hidrat 25 mg kapi
Metamizole Sodium Monohydrate 0.525g/ml 
Metamizolnatrij hidrat 0,525 g/ml
Metamizole Sodium 0.5g Suppository, Caffeine And Sodium Benzoate 0.1g Suppository 
Metamizolnatrij 0,5 g čepić; kofein i natrijev benzoat 0,1 g čepić
Codeine Phosphate Sesquihydrate 0.03g Suppository, Metamizole Sodium 0.09g Suppository, Caffeine And Sodium Benzoate 0.1g Suppository, Codeine Phosphate Hemihydrate 0.02873g Suppository 
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
Metamizole Magnesium 575mg Tablet 
Metamizolmagnezij 575 mg tableta
Pharma Gmbh Metagelan 
G.L. Pharma Gmbh Metagelan
Thiamine Hydrochloride 38.75mg Tablet, Metamizole Sodium 500mg Tablet, Caffeine 50mg Tablet 
Tiaminklorid 38,75 mg tableta; metamizolnatrij 500 mg tableta; kofein 50 mg tableta
Metamizole Magnesium 1000mg Suppository 
Metamizolmagnezij 1000 mg čepić
Metamizole Sodium 1g Suppository 
Metamizolnatrij 1 g čepić
Metamizole Sodium 1g/2ml 
Metamizolnatrij 1 g/2 ml
Metamizol Normon Metamizole Magnesium 2g/5ml 
Metamizol Normon Metamizolmagnezij 2 g/5 ml
Metamizole Sodium Monohydrate 527mg Tablet, Pitofenone Hydrochloride 5.25mg Tablet, Fenpiverinium Bromide 0.1mg Tablet 
Metamizolnatrij hidrat 527 mg tableta; pitofenonklorid 5,25 mg tableta; fenpiverinijev bromid 0,1 mg tableta
Metamizole Magnesium 500mg Capsule 
Metamizolmagnezij 500 mg kapsula
Metamizole Sodium 500mg Sachet, Caffeine 50mg Sachet 
Metamizolnatrij 500 mg vrećica; kofein 50 mg vrećica
Hydrochloride 2mg/ml, Fenpiverinium Bromide 0.02mg/ml, Metamizole Sodium 500mg/ml 
Pitofenonklorid 2 mg/ml; fenpiverinijev bromid 0,02 mg/ml; metamizolnatrij 500 mg/ml
Metamizole Sodium Monohydrate 2,5 g/5 ml 
Metamizolnatrij hidrat 2,5 g/5 ml
Pharma Gmbh Metamilan 
G.L. Pharma Gmbh Metamilan
Metamizole Sodium 200mg Suppository 
Metamizolnatrij 200 mg čepić
Metamizole 575mg Capsule 
Metamizol 575 mg kapsula
Metamizole Sodium Monohydrate 500mg/ml, Pitofenone Hydrochloride 5mg/ml 
Metamizolnatrij hidrat 500 mg/ml; pitofenonklorid 5 mg/ml
Metamizol Will-Pharma Metamizole Sodium Monohydrate 500mg/ml 
Metamizol Will-Pharma Metamizolnatrij hidrat 500 mg/ml
Metamizol Normon Metamizole Magnesium 575mg Capsule 
Metamizol Normon Metamizolmagnezij 575 mg kapsula
Cyanocobalamin 0.5mg Tablet, Metamizole Sodium 500mg Tablet, Thiamine Nitrate 75mg Tablet, Pyridoxine Hydrochloride 50mg Tablet 
Cijanokobalamin 0,5 mg tableta; metamizolnatrij 500 mg tableta; tiaminnitrat 75 mg tableta; piridoksinklorid 50 mg tableta
Hydrochloride 2mg/ml, Fenpiverinium Bromide 0.02mg/ml 
Metamizolnatrij hidrat 0,5 g/ml; pitofenonklorid 2 mg/ml; fenpiverinijev bromid 0,02 mg/ml
Pitofenone Hydrochloride 5mg, Metamizole Sodium 500mg 
Pitofenonklorid 5 mg; metamizolnatrij 500 mg
Metamizole Magnesium 2000mg /5ml 
Metamizolmagnezij 2000 mg/5 ml
Buscapina Compositum Metamizole Sodium 2.5g/5ml, Hyoscine 
Buscapina Compositum Metamizolnatrij 2,5 g/5 ml; hioscinijev butilbromid 0,02 g/5 ml
Metamizole Sodium 100mg Suppository 
Metamizolnatrij 100 mg čepić
Metamizole Magnesium 500mg Sachet 
Metamizolmagnezij 500 mg vrećica
Metamizole Sodium 500g/ml 
Metamizolnatrij 500 g/ml
Metamizol Heumann Metamizole Sodium Monohydrate 500mg/ml 
Metamizol Heumann Metamizolnatrij hidrat 500 mg/ml
Hydrochloride 2mg/ml, Metamizole Sodium 500mg/ml 
Pitofenonklorid 2 mg/ml; metamizolnatrij 500 mg/ml
Metamizole Magnesium 2g/5ml 
Metamizolmagnezij 2 g/5 ml
Powder For Oral Solution 
Prašak za oralnu otopinu
Metamizole Sodium Monohydrate 1000mg Suppository 
Metamizolnatrij hidrat 1000 mg čepić
Fenpiverinium Bromide 0.1mg/5ml, Metamizole Sodium 2500mg/5ml 
Pitofenonklorid 10 mg/5 ml; fenpiverinijev bromid 0,1 mg/5 ml; metamizolnatrij 2500 mg/5 ml
Metamizole Sodium Monohydrate 500mg Tablet, Pitofenone Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet 
Metamizolnatrij hidrat 500 mg tableta; pitofenonklorid 5 mg tableta; fenpiverinijev bromid 0,1 mg tableta
Metamizol Heumann Metamizole Sodium Monohydrate 500mg 
Metamizol Heumann Metamizolnatrij hidrat 500 mg tableta
Laboratorio Stada, S.L. 
Laboratorio Stada, S.L. Metamizol Stada
Granules For Oral Solution 
Granule za oralnu otopinu
Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet, Metamizole Sodium 500mg Tablet 
Pitofenonklorid 5 mg tableta; fenpiverinijev bromid 0,1 mg tableta; metamizolnatrij 500 mg tableta
Hydrochloride 5mg/ml, Metamizole Sodium 500mg/ml 
Pitofenonklorid 5 mg/ml; metamizolnatrij 500 mg/ml
Metamizole Sodium 300mg Suppository 
Metamizolnatrij 300 mg čepić
Metamizole Magnesium Hexahydrate 575mg Capsule 
Metamizolmagnezij heksahidrat 575 mg kapsula
Metamizole Magnesium 575mg Capsule 
Metamizolmagnezij 575 mg kapsula
Metamizole Sodium Monohydrate 1000mg Sachet 
Metamizolnatrij hidrat 1000 mg vrećica
Metamizole Sodium 1000mg Sachet 
Metamizolnatrij 1000 mg vrećica
Hydrochloride 5mg Tablet, Metamizole Sodium 500mg Tablet, Fenpipramide Bromomethylate 0.1mg Tablet 
Pitofenonklorid 5 mg tableta; metamizolnatrij 500 mg tableta; fenpipramid bromometilat 0,1 mg tableta
S.F. 
Sa
Effervescent Tablet 
Oralna otopina
Tell us how well we did with this information 
Recite nam koliko su vam ove informacije bile korisne
Three of the cases were fatal. 
Tri slučaja imala su smrtni ishod.
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: 
Odgovorite na nekoliko pitanja i recite nam što mislite o ovim informacijama - za to će vam biti potrebno samo nekoliko minuta:
The majority of EU patients have been treated in Germany. 
Većina bolesnika u EU-u liječena je u Njemačkoj.
Consider alternative treatments as appropriate. 
Razmotrite prikladne alternativne terapije.
EMA will complete its in-depth review and make public the final outcome. 
EMA će dovršiti svoje dubinsko ispitivanje i objaviti konačni ishod.
Most cases occurred within 8 months of starting treatment. 
Najviše slučajeva pojavilo se u roku od 8 mjeseci od početka liječenja.
Evidence indicates risk of serious inflammatory brain disorders 
Dokazi upućuju na rizik od teških upala mozga
Start the survey 
Započnite s upitnikom
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. 
Ocjenjivanje lijeka Zinbryta započelo je 26. veljače 2018. na zahtjev Europske komisije, u skladu s člankom 20. Uredbe (EZ) br. 726/2004.
8 March 2018 EMA/155367/2018 
EMA/134289/2018
Patients stopping treatment must be followed up for at least 6 months (see more details below). 
Bolesnici čije je liječenje prekinuto moraju se pratiti barem 6 mjeseci (vidjeti više pojedinosti u nastavku).
To date over 8,000 patients have been treated with Zinbryta worldwide. 
Dosad je više od 8 000 bolesnika diljem svijeta liječeno lijekom Zinbryta.
These could be signs of a reaction to Zinbryta. 
To mogu biti znakovi reakcije na lijek Zinbryta.
Zinbryta may also be linked to severe immune reactions affecting several other organs. 
Lijek Zinbryta također može biti povezan s ozbiljnim reakcijama imunosnog sustava koje zahvaćaju brojne druge organe.
Zinbryta was authorised in 2016 for treating relapsing forms of multiple sclerosis. 
Zinbryta je lijek koji je odobren 2016. za liječenje relapsnih oblika multiple skleroze.
Available evidence also indicates that Zinbryta could be linked to other immune-mediated disorders, such as blood dyscrasias, thyroiditis or glomerulonephritis. 
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.
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. 
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.
A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of Zinbryta. 
Prethodno ispitivanje dostupnih dokaza upućuje na to da reakcije imunosnog sustava uočene u prijavljenim slučajevima mogu biti povezane s primjenom lijeka Zinbryta.
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. 
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.
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. 
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.
• 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. 
• 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.
• Your doctor will carry out regular blood tests for up to 6 months after stopping treatment to check for side effects. 
• Vaš će liječnik provoditi redovite krvne testove tijekom 6 mjeseci nakon prekida liječenja kako bi provjerio imate li nuspojave.
• Zinbryta will be recalled from pharmacies and hospitals across the EU. 
• Provest će se povlačenje lijeka Zinbryta iz ljekarni i bolnica diljem EU-a.
To date EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed 12 cases of immune-mediated inflammatory disorders, including encephalitis. 
EMA-in Odbor za procjenu rizika u području farmakovigilancije (PRAC) dosad je ispitao 12 slučajeva imunološki posredovanih upala, uključujući encefalitis.
• Do not take another injection of Zinbryta. 
• Nemojte uzimati daljnje injekcije lijeka Zinbryta.
• Advise patients to immediately report symptoms of liver injury such as prolonged fever, severe headache, tiredness, jaundice, nausea or vomiting. 
• Savjetujte bolesnicima da bez odlaganja prijave simptome oštećenja jetre, kao što su trajna vrućica, teška glavobolja, umor, žutica, mučnina ili povraćanje.
Healthcare professionals should immediately contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives. 
Zdravstveni radnici trebaju bez odlaganja stupiti u kontakt s bolesnicima koji se trenutačno liječe lijekom Zinbryta i prekinuti njihovo liječenje te razmotriti alternative.
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. 
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.
• Contact your patients currently being treated with Zinbryta as soon as possible and stop their treatment. 
• Stupite u kontakt sa svojim bolesnicima koji se već liječe lijekom Zinbryta što je prije moguće i prekinite njihovo liječenje.
• If you are being treated with Zinbryta, contact your doctor to discuss your treatment. 
• Ako se liječite lijekom Zinbryta, obratite se svojem liječniku kako biste razgovarali o vašoj terapiji.
• If you are in a clinical study with Zinbryta, contact the doctor treating you in the study. 
• Ako sudjelujete u kliničkom ispitivanju koje uključuje lijek Zinbryta, obratite se liječniku koji provodi vaše liječenje u ispitivanju.