natgillin/translations-raw huggingface dataset:
If you experience this side effect, talk to your doctor as soon as possible. 
Če opazite ta neželeni učinek, se čim prej posvetujte s svojim zdravnikom.
Takeda Pharma A/S 
Imetnik dovoljenja za promet z zdravilom Takeda Pharma A/S
- you are breast-feeding or if you are planning to breast-feed your baby. 
- če dojite ali nameravate dojiti.
Lactose monohydrate Magnesium stearate 
6.1 Seznam pomožnih snovi kalcijev karmelozat hiproloza laktoza monohidrat magnezijev stearat
Localised swelling (oedema) has also been experienced very commonly (may affect more than 1 in 10 people) in patients taking Actos in combination with insulin. 
Pri bolnikih, ki so jemali zdravilo Actos v kombinaciji z insulinom, so zelo pogosto (pri več kot 1 od 10 bolnikov) poročali o lokalnem otekanju (edemih).
Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Actos. 
Pri bolnikih, ki so jemali zdravilo Actos, so občasno (pri največ 1 od 100 bolnikov) poročali o pojavu raka sečnega mehurja.
Actos tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. 
Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
− Actos 45 mg tablets are white to off-white, round, flat tablets marked ‘45' on one face and 
- Tablete zdravila Actos 45 mg so bele do sivobele barve, okrogle, ploščate, z oznako ‘45' na eni in ‘ACTOS' na drugi strani.
Pioglitazone should be discontinued if any deterioration in cardiac status occurs. 
Če se pojavi kakršno koli poslabšanje srčnega statusa, je treba zdravljenje s pioglitazonom ukiniti.
− Actos 30 mg tablets are white to off-white, round, flat tablets marked ‘30' on one face and 
- Tablete zdravila Actos 30 mg so bele do sivobele barve, okrogle, ploščate, z oznako ‘30' na eni in ‘ACTOS' na drugi strani.
A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥ 8.0% after the first six months of therapy). 
Za oceno časa do neuspeha zdravljenja (definirano kot pojav HbA1c ≥ 8,0% po prvih šest mesecih zdravljenja) so klinično preskušanje pioglitazona v primerjavi z gliklazidom kot monoterapiji podaljšali na dve leti.
Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible. 
Prav tako se čim prej posvetujte s svojim zdravnikom, če ste imeli zamegljen vid že prej, pa se vam je stanje poslabšalo.
NAME OF THE MEDICINAL PRODUCT 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
Foetal growth restriction was apparent in animal studies with pioglitazone. 
V študijah s pioglitazonom na živalih so opažali zastoj rasti plodu.
How to store Actos 
Shranjevanje zdravila Actos
The tablets are white to off-white, round, flat and marked ‘45' on one face and ‘ACTOS' on the other face. 
Tablete so bele ali skoraj bele barve, okrogle, ploščate, z oznako ‘45' na eni in ‘ACTOS' na drugi strani.
Each Actos 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride). 
Actos 30 mg tablete Ena tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida).
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/1/00/150/001 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
Weight gain 
PRETISNI OMOT
If you stop using Actos, your blood sugar may go up. 
Če zdravilo Actos prenehate jemati, se lahko raven krvnega sladkorja zviša, zato se pred prekinitvijo zdravljenja najprej posvetujte z zdravnikom.
The tablets are white to off-white, round, flat and marked ‘30' on one face and ‘ACTOS' on the other face. 
Tablete so bele ali skoraj bele barve, okrogle, ploščate, z oznako ‘30' na eni in ‘ACTOS' na drugi strani.
Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Actos and have also been reported in male patients (frequency cannot be estimated from the available data) taking Actos. 
O zlomih so poročali tudi pri bolnikih, ki so se zdravili z zdravilom Actos (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
Neoplasms benign, malignant and unspecified (including cysts and polyps) 
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) rak sečnega mehurja občasni občasni občasni občasni občasni
Each Actos 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride). 
Actos 45 mg tablete Ena tableta vsebuje 45 mg pioglitazona (v obliki pioglitazonijevega klorida).
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 tablet EU/1/00/150/012 28 tablet EU/1/00/150/022 30 tablet EU/1/00/150/013 50 tablet EU/1/00/150/014 56 tablet EU/1/00/150/023 84 tablet EU/1/00/150/024 90 tablet EU/1/00/150/015 98 tablet EU/1/00/150/029 112 tablet EU/1/00/150/030 196 tablet
Actos 30 mg tablets pioglitazone 
IME ZDRAVILA Actos 30 mg tablete pioglitazon
The tablets are white to off-white, round, convex and marked ‘15' on one face and ‘ACTOS' on the other face. 
Tablete so bele ali skoraj bele barve, okrogle, izbočene, z oznako ‘15' na eni in ‘ACTOS' na drugi strani.
This leaflet was last approved in Other sources of information 
Navodilo je bilo nazadnje revidirano
Actos 45 mg tablets pioglitazone 
IME ZDRAVILA Actos 45 mg tablete pioglitazon
Each Actos 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride). 
Actos 15 mg tablete Ena tableta vsebuje 15 mg pioglitazona (v obliki pioglitazonijevega klorida).
Actos 15 mg tablets pioglitazone 
IME ZDRAVILA Actos 15 mg tablete pioglitazon
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 tablet EU/1/00/150/001 28 tablet EU/1/00/150/016 30 tablet EU/1/00/150/002 50 tablet EU/1/00/150/009 56 tablet EU/1/00/150/017 84 tablet EU/1/00/150/018 90 tablet EU/1/00/150/003 98 tablet EU/1/00/150/025 112 tablet EU/1/00/150/026 196 tablet
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 tablet EU/1/00/150/004 28 tablet EU/1/00/150/019 30 tablet EU/1/00/150/005 50 tablet EU/1/00/150/010 56 tablet EU/1/00/150/020 84 tablet EU/1/00/150/021 90 tablet EU/1/00/150/006 96 tablet EU/1/00/150/027 112 tablet EU/1/00/150/028 196 tablet
Renal and urinary disorders haematuria common glycosuria uncommon proteinuria uncommon 
Bolezni sečil hematurija pogosti glikozurija občasni proteinurija občasni
Nervous system disorders hypo-aesthesia common common common common common headache common uncommon dizziness common insomnia uncommon uncommon uncommon uncommon uncommon 
Bolezni živčevja hipestezija pogosti pogosti pogosti pogosti pogosti glavobol pogosti občasni omotica pogosti nespečnost občasni občasni občasni občasni občasni
Gastrointestinal disorders flatulence uncommon common 
Bolezni prebavil flatulenca občasni pogosti
Contents of the pack and other information What Actos contains 
Shranjevanje zdravila Actos Vsebina pakiranja in dodatne informacije
Contains lactose monohydrate. 
SEZNAM POMOŽNIH SNOVI Vsebuje laktozo monohidrat.
Heart failure has been experienced commonly (may affect up to 1 in 10 people) in patients taking Actos in combination with insulin. 
Pri bolnikih, ki so jemali zdravilo Actos v kombinaciji z insulinom, so pogosto (pri največ 1 od 10 bolnikov) poročali o pojavu srčnega popuščanja.
Each tablet contains 30 mg pioglitazone (as hydrochloride). 
Ena 30-miligramska tableta Actos vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida).
Ear and labyrinth disorders vertigo uncommon 
Ušesne bolezni, vključno z motnjami labirinta vrtoglavica občasni
Each tablet contains 45 mg pioglitazone (as hydrochloride). 
Ena 45-miligramska tableta Actos vsebuje 45 mg pioglitazona (v obliki pioglitazonijevega klorida).
Each tablet contains 15 mg of pioglitazone (as hydrochloride). 
Ena 15-miligramska tableta Actos vsebuje 15 mg pioglitazona (v obliki pioglitazonijevega klorida).
− Actos 15 mg tablets are white to off-white, round, convex tablets marked ‘15' on one face and 
Izgled zdravila Actos in vsebina pakiranja - Tablete zdravila Actos 15 mg so bele do sivobele barve, okrogle, izbočene, z oznako ‘15' na eni in ‘ACTOS' na drugi strani.
− The active substance in Actos is pioglitazone. 
Kaj vsebuje zdravilo Actos - Zdravilna učinkovina zdravila Actos je pioglitazon.
Oedema5 
Dybendal Alle 10
is reported to result in a 54% decrease in AUC of pioglitazone. 
Poročali so, da sočasno dajanje pioglitazona z rifampicinom (induktorjem citokroma P450 2C8) povzroči 54% zmanjšanje AUC pioglitazona.
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicant in the Member States 
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila in predlagateljev v državah članicah
United Kingdom Kohne Pharma GmbH Schallbruch 1 
Združeno kraljestvo Kohne Pharma GmbH Schallbruch 1
Capsule, Hard 
Kapsula, trda
Annex I List of nationally authorised medicinal products 
Priloga I Seznam nacionalno registriranih zdravil
Parenteral Use 
Parenteralna uporaba
Rectal Use 
Rektalna uporaba
Solution For Injection/Infusion 
Raztopina za injiciranje/infuzija
Film-Coated Tablet 
Filmsko obložena tableta
Solution For Injection Intravenous Use 
Raztopina za injiciranje Intravenska uporaba
Metamizol Sintocalmin Metamizole 500mg Tablet 
Metamizol Sintocalmin metamizol 500 mg tableta
Chemax Pharma Ltd Диалгин Джуниор Metamizole Sodium Monohydrate 250mg 
Chemax Pharma Ltd Диалгин Джуниор natrijev metamizolat monohidrat 250 mg vrečica
Melting Tablets 
Topne tablete
Metamizole Sodium 450mg Tablet, Caffeine 50mg Tablet 
natrijev metamizolat 450 mg tableta, kofein 50 mg tableta
Abz-Pharma Gmbh Novaminsulfon 
Ratiopharm Gmbh Novaminsulfon
Metamizole Sodium 300mg Tablet, Paracetamol 200mg Tablet, Caffeine 30mg Tablet, Codeine Phosphate 20mg Tablet 
Паракофдал natrijev metamizolat 300 mg tableta, paracetamol 200 mg tableta, kofein 30 mg tableta, kodeinijev fosfat 20 mg tableta
Hydrochloride 10mg, Metamizole Sodium 1g 
Litalgin pitofenonijev hidroklorid 10 mg, natrijev metamizolat 1g
Powder For Oral Solution In Sachet 
Prašek za peroralno raztopino v vrečici
Drotaverine Hydrochloride 40mg Tablet, Metamizole Sodium 400mg Tablet, Caffeine 60mg Tablet 
Quarelin drotaverinijev hidroklorid 40 mg tableta, natrijev metamizolat 400 mg tableta, kofein 60 mg tableta
Scopolan Compositum Metamizole Sodium 250mg Tablet, Hyoscine Butylbromide 10mg 
Scopolan Compositum natrijev metamizolat 250 mg tableta, hioscinijev butilbromid
Codeine Phosphate Sesquihydrate 0.03g in form of Codeine Phosphate Hemihydrate 0.02873g, Metamizole Sodium 0.9g, Caffeine And Sodium Benzoate 0.1g / suppository 
Suppositorium Analgeticum Forte Fono Vii kodeinijev fosfat seskvihidrat 0,03 g v obliki kodeinijevega fosfat hemihidrata 0,02873 g, natrijev metamizolat 0,9 g, kofein in natrijev benzoat 0,1 g / svečka
Solution For Injection Intramuscular Use 
Intramuskularna uporaba
Buscapina Compositum Metamizole Sodium 250mg Tablet, Hyoscine Butylbromide 10mg 
Buscapina Compositum natrijev metamizolat 250 mg tableta, hioscinijev butilbromid
Cyanocobalamin 0.5mg Tablet, Metamizole Sodium 500mg Tablet, Thiamine Nitrate 75mg Tablet, Pyridoxine Hydrochloride 50mg Tablet 
Невралгин cianokobolamin 0,5 mg tableta, natrijev metamizolat 500 mg tableta, tiaminijev nitrat 75 mg tableta, piridoksinijev hidroklorid 50 mg tableta
Metamizole Sodium Monohydrate 2,5 g/5 ml 
Alkagin natrijev metamizolat monohidrat 2,5 g/5 ml
Metamizole Sodium 0.5g Suppository, Caffeine And Sodium Benzoate 0.1g Suppository 
natrijev metamizolat 0,5 g svečka, kofein in natrijev benzoat 0.1 g svečka
Metamizole Sodium 150mg Tablet, Paracetamol 300mg Tablet, Phenobarbital 15mg Tablet, Caffeine 50mg Tablet, Codeine Phosphate Hemihydrate 10mg Tablet 
Седалгин-Нео natrijev metamizolat 150 mg tableta, paracetamol 300 mg tableta, fenobarbital 15 mg tableta, kofein 50 mg tableta, kodeinijev fosfat hemihidrat 10 mg tableta
Metamizol Kern Pharma Metamizole Magnesium 575mg Capsule 
Metamizol Kern Pharma magnezijev metamizolat 575 mg kapsula
Codeine Phosphate Sesquihydrate 0.03g Suppository, Metamizole Sodium 0.09g Suppository, Caffeine And Sodium Benzoate 0.1g Suppository, Codeine Phosphate Hemihydrate 0.02873g Suppository 
kodeinijev fosfat seskvihidrat 0,03 g svečka, natrijev metamizolat 0.09 g svečka, kofein in natrijev benzoat 0,1 g svečka, kodeinijev fosfat hemihidrat 0,02873 g svečka
Metamizole Sodium Monohydrate 0.525g/ml 
Algocalmin natrijev metamizolat monohidrat 0,525 g/ml
Metamizole Sodium Monohydrate 527mg Tablet, Pitofenone Hydrochloride 5.25mg Tablet, Fenpiverinium Bromide 0.1mg Tablet 
Algifen natrijev metamizolat monohidrat 527 mg tableta, pitofenonijev hidroklorid 5,25 mg tableta, fenpiverinijev bromid 0,1 mg tableta
Pitofenone Hydrochloride 5mg, Metamizole Sodium 500mg 
Litalgin pitofenonijev hidroklorid 5 mg, natrijev metamizolat 500 mg
Metamizole Sodium 500mg Tablet, Triacetonamine Tosilate 20mg Tablet 
Teмпимет natrijev metamizolat 500 mg tableta, triacetonaminejev tozilat 20 mg tableta
Metamizol Normon Metamizole Magnesium 2g/5ml 
Metamizol Normon magnezijev metamizolat 2 g/5 ml
Metamizole Sodium 1g/2ml 
Panalgorin natrijev metamizolat 1 g/2ml
Thiamine Hydrochloride 38.75mg Tablet, Metamizole Sodium 500mg Tablet, Caffeine 50mg Tablet 
Бенлек tiaminijev hidroklorid 38,75 mg tableta, natrijev metamizolat 500 mg tableta, kofein 50 mg tableta
Metamizole Sodium Monohydrate 500mg/ml, Pitofenone Hydrochloride 5mg/ml 
Algifen Neo natrijev metamizolat monohidrat 500 mg/ml, pitofenonijev hidroklorid 5 mg/ml
Metamizole Sodium Monohydrate 25mg Drop 
Alvotor natrijev metamizolat monohidrat 25 mg kapljice
Metamizole Sodium 0.9g Suppository, Caffeine 0.05g Suppository, Codeine Phosphate Hemihydrate 0.03g Suppository 
Suppositorium Analgeticum Forte Fono Vii natrijev metamizolat 0,9 g svečka, kofein 0,05 g svečka, kodeinijev fosfat hemihidrat 0,03 g svečka
Metamizole Sodium 500mg 
Flamborin natrijev metamizolat 500 mg
Metamizol Will-Pharma Metamizole Sodium Monohydrate 500mg/ml 
Metamizol Will-Pharma natrijev metamizolat monohidrat 500 mg/ml
Hydrochloride 2mg/ml, Fenpiverinium Bromide 0.02mg/ml, Metamizole Sodium 500mg/ml 
Pitofenonijev hidroklorid 2 mg/ml, fenpiverinijev bromid 0,02 mg/ml, natrijev metamizolat 500 mg/ml
Buscapina Compositum Metamizole Sodium 2.5g/5ml, Hyoscine 
Buscapina Compositum natrijev metamizolat 2,5 g/5 ml, hioscinijev butilbromid 0,02 g/5 ml
Metamizol Normon Metamizole Magnesium 575mg Capsule 
Metamizol Normon magnezijev metamizolat 575 mg kapsula
Metamizol Heumann Metamizole Sodium Monohydrate 500mg/ml 
Metamizol Heumann natrijev metamizolat monohidrat 500 mg/ml
Metamizole Sodium 200mg Suppository 
Naturland natrijev metamizolat 200 mg svečka
Metamizole Magnesium 2000mg/5ml 
Nolotil magnezijev metamizolat 2000 mg/5ml
Abc Farmaceutici S.P.A. Metamizolo Sodico Abc Metamizole Sodium 500mg/ml 
Metamizolo Sodico Abc natrijev metamizolat 500 mg/ml
Metamizole Sodium Monohydrate 500mg Tablet, Pitofenone Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet 
Algifen natrijev metamizolat monohidrat 500 mg tableta, pitofenonijev hidroklorid 5 mg tableta, fenpiverinijev bromid 0,1 mg tableta
Metamizole Magnesium 575mg Tablet 
Metamizol Tarbis magnezijev metamizolat 575 mg tableta
Hydrochloride 2mg/ml, Metamizole Sodium 500mg/ml 
Litalgin pitofenonijev hidroklorid 2 mg/ml, natrijev metamizolat 500 mg/ml
Ratiopharm España S.A. Metamizol Ratiopharm Metamizole Magnesium 575mg Capsule 
Metamizol Ratiopharm magnezijev metamizolat 575 mg kapsula
Powder For Oral Solution 
Prašek za peroralno raztopino
Metamizole Sodium 100mg Suppository 
Naturland natrijev metamizolat 100 mg svečka
Metamizole Sodium Monohydrate 1000mg Sachet 
Фрешалгин natrijev metamizolat monohidrat 1000 mg vrečica
Hydrochloride 5mg Tablet, Metamizole Sodium 500mg Tablet, Fenpipramide Bromomethylate 0.1mg Tablet 
Piafen pitofenonijev hidroklorid 5 mg tableta, natrijev metamizolat 500 mg tableta, fenpipramidijev bromometilat 0,1 mg tableta
Metamizole Magnesium 2g/5ml 
Nolotil magnezijev metamizolat 2 g/5 ml
Metamizol Heumann Metamizole Sodium Monohydrate 500mg 
Metamizol Heumann natrijev metamizolat monohidrat 500 mg tableta
Laboratorios Cinfa, S.A. Metamizol Cinfa 
Laboratorios Cinfa, S.A. Metamizol Cinfa metamizol 575 mg kapsula
Metamizole Magnesium Hexahydrate 575mg Capsule 
Dolocalma magnezijev metamizolat heksahidrat 575 mg Kapsula
Fenpiverinium Bromide 0.1mg/5ml, Metamizole Sodium 2500mg/5ml 
Analgin pitofenonijev hidroklorid 10 mg/5 ml, fenpiverinijev bromid 0,1 mg/5ml, natrijev metamizolat 2500 mg/5ml
Ratiopharm Gmbh 
Ratiopharm Gmbh NovaminsulfonRatiopharm
Hydrochloride 5mg/ml, Metamizole Sodium 500mg/ml 
Algifen Neo pitofenonijev hidroklorid 5 mg/ml, natrijev metamizolat 500 mg/ml
Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet, Metamizole Sodium 500mg Tablet 
Спазмоблок pitofenonijev hidroklorid 5mg tableta, fenpiverinijev bromid 0,1 mg tableta, natrijev metamizolat 500 mg tableta
Metamizole Magnesium 1000mg Suppository 
Algi-Mabo Adultos magnezijev metamizolat 1000 mg svečka
Metamizole Sodium 300mg Suppository 
Novocalmin natrijev metamizolat 300 mg svečka
Темпалгин 
Svečka
Metamizole Magnesium 575mg Capsule 
Nolotil magnezijev metamizolat 575 mg kapsula
Metamizole 575mg Capsule 
Metamizol Pensa metamizole 575 mg Kapsula
Metamizole Sodium Monohydrate 1000mg Suppository 
Berlosin natrijev metamizolat monohidrat 1000 mg svečka
Metamizole Magnesium 500mg Sachet 
Pyralgina Gorączka magnezijev metamizolat 500 mg vrečice
Metamizole Magnesium 500mg Capsule 
Algi-Mabo magnezijev metamizolat 500 mg kapsula
Metamizole Magnesium 2000mg /5ml 
Algi-Mabo magnezijev metamizolat 2000 mg /5ml
Laboratorios Alter, S.A. Metamizol Alter 
Laboratorios Alter, S.A. Metamizol Alter magnezijev metamizolat 575 mg
Three of the cases were fatal. 
Trije od teh primerov so bili smrtni.
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 nekaj vprašanj in nam povejte, kaj menite o tem sporočilu - vzelo vam bo samo nekaj minut vašega časa.
The majority of EU patients have been treated in Germany. 
Večina bolnikov iz EU se je zdravila v Nemčiji.
Tell us how well we did with this information 
Povejte nam, kako uporabno je to sporočilo
8 March 2018 EMA/155367/2018 
7. marec 2018 EMA/134289/2018
EMA will complete its in-depth review and make public the final outcome. 
Agencija EMA bo dokončala svoj podrobni pregled in objavila končni rezultat.
Most cases occurred within 8 months of starting treatment. 
Večina primerov se je pojavila v osmih mesecih po začetku zdravljenja.
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. 
Pregled zdravila Zinbryta se je začel 26. februarja 2018 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
Evidence indicates risk of serious inflammatory brain disorders 
Podatki kažejo tveganje za resne možganske vnetne reakcije
Consider alternative treatments as appropriate. 
Razmislite o morebitnih ustreznih zamenjavah.
Patients stopping treatment must be followed up for at least 6 months (see more details below). 
Bolnike, ki se prenehajo zdraviti s tem zdravilom, je treba spremljati vsaj šest mesecev (glejte podrobnosti spodaj).
Start the survey 
Začetek ankete
To date over 8,000 patients have been treated with Zinbryta worldwide. 
Do zdaj se je po svetu z zdravilom Zinbryta zdravilo več kot 8 000 bolnikov.
• Zinbryta will be recalled from pharmacies and hospitals across the EU. 
• Zdravilo Zinbryta bo odpoklicano iz lekarn in bolnišnic po vsej Evropski uniji.
Zinbryta may also be linked to severe immune reactions affecting several other organs. 
Zdravilo Zinbryta je lahko povezano tudi s hudimi imunskimi reakcijami, ki prizadenejo več drugih organov.
A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of Zinbryta. 
Predhodni pregled razpoložljivih podatkov je pokazal, da bi bile lahko imunske reakcije, o katerih so poročali v teh primerih, povezane z uporabo zdravila Zinbryta.
Available evidence also indicates that Zinbryta could be linked to other immune-mediated disorders, such as blood dyscrasias, thyroiditis or glomerulonephritis. 
Razpoložljivi podatki kažejo tudi, da bi bilo zdravilo Zinbryta lahko povezano z drugimi imunsko povzročenimi boleznimi, kot so krvne diskrazije, tiroiditis ali 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. 
Pregled opravlja Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj glede zdravil za uporabo v humani medicini in ki bo podal več priporočil.
Zinbryta was authorised in 2016 for treating relapsing forms of multiple sclerosis. 
Zinbryta je zdravilo, ki je bilo odobreno leta 2016 za zdravljenje recidivnih oblik multiple skleroze.
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. 
Družba, ki trži zdravilo Zinbryta (Biogen Idec Ltd), je že prostovoljno zahtevala odvzem dovoljenja za promet z zdravilom in agencijo EMA obvestilo o nameri za ustavitev kliničnih preskušanj.
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. 
Po pregledu učinkov tega zdravila na jetra, opravljenem leta 2017, je bila njegova uporaba omejena na bolnike, ki so preskusili vsaj dve drugi imunomodulirajoči zdravili in jih ni bilo mogoče zdraviti z nobenim drugim zdravilom proti multipli sklerozi.
These reactions can occur for 6 months after treatment has been stopped. 
Te reakcije se lahko pojavijo do šest mesecev po prenehanju zdravljenja s tem zdravilom.
These could be signs of a reaction to Zinbryta. 
Gre lahko za znake reakcije na zdravilo Zinbryta.
To date EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed 12 cases of immune-mediated inflammatory disorders, including encephalitis. 
Odbor za oceno tveganja na področju farmakovigilance (PRAC) je do zdaj pregledal 12 primerov imunsko povzročenih vnetnih reakcij, vključno z encefalitisom.
Healthcare professionals should immediately contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives. 
Zdravstveni delavci morajo stopiti v stik z bolniki, ki se trenutno zdravijo z zdravilom Zinbryta, ter jih takoj prenehati zdraviti z njim in razmisliti o drugih možnostih zdravljenja.