FrancophonIA/ELRC3.0 huggingface dataset:
English: Nervous system disorders hypo-aesthesia common common common common common headache common uncommon dizziness common insomnia uncommon uncommon uncommon uncommon uncommon
Slovenian: Bolezni živčevja hipestezija pogosti pogosti pogosti pogosti pogosti glavobol pogosti občasni omotica pogosti nespečnost občasni občasni občasni občasni občasni
English: Gastrointestinal disorders flatulence uncommon common
Slovenian: Bolezni prebavil flatulenca občasni pogosti
English: Contents of the pack and other information What Actos contains
Slovenian: Shranjevanje zdravila Actos Vsebina pakiranja in dodatne informacije
English: Contains lactose monohydrate.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje laktozo monohidrat.
English: Heart failure has been experienced commonly (may affect up to 1 in 10 people) in patients taking Actos in combination with insulin.
Slovenian: Pri bolnikih, ki so jemali zdravilo Actos v kombinaciji z insulinom, so pogosto (pri največ 1 od 10 bolnikov) poročali o pojavu srčnega popuščanja.
English: Tel. +370 (5) 2649600
Slovenian: Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600
English: Τηλ: +45 46 77 11 11
Slovenian: Takeda Pharma A/S Τηλ: +45 46 77 11 11
English: Each tablet contains 30 mg pioglitazone (as hydrochloride).
Slovenian: Ena 30-miligramska tableta Actos vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida).
English: Ear and labyrinth disorders vertigo uncommon
Slovenian: Ušesne bolezni, vključno z motnjami labirinta vrtoglavica občasni
English: Each tablet contains 45 mg pioglitazone (as hydrochloride).
Slovenian: Ena 45-miligramska tableta Actos vsebuje 45 mg pioglitazona (v obliki pioglitazonijevega klorida).
English: Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Slovenian: Ena 15-miligramska tableta Actos vsebuje 15 mg pioglitazona (v obliki pioglitazonijevega klorida).
English: − Actos 15 mg tablets are white to off-white, round, convex tablets marked ‘15' on one face and
Slovenian: 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.
English: − The active substance in Actos is pioglitazone.
Slovenian: Kaj vsebuje zdravilo Actos - Zdravilna učinkovina zdravila Actos je pioglitazon.
English: Oedema5
Slovenian: Dybendal Alle 10
English: is reported to result in a 54% decrease in AUC of pioglitazone.
Slovenian: Poročali so, da sočasno dajanje pioglitazona z rifampicinom (induktorjem citokroma P450 2C8) povzroči 54% zmanjšanje AUC pioglitazona.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicant in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila in predlagateljev v državah članicah
English: United Kingdom Kohne Pharma GmbH Schallbruch 1
Slovenian: Združeno kraljestvo Kohne Pharma GmbH Schallbruch 1
English: Dexamed 5 mg comprimidos 5 mg
Slovenian: Dexamed 5 mg comprimidos
English: Capsule, Hard
Slovenian: Kapsula, trda
English: Capsule
Slovenian: Kapsula
English: Annex I List of nationally authorised medicinal products
Slovenian: Priloga I Seznam nacionalno registriranih zdravil
English: Teva Gyógyszergyár Zrt Optalgin
Slovenian: Teva Gyógyszergyár Zrt
English: Parenteral Use
Slovenian: Parenteralna uporaba
English: Rectal Use
Slovenian: Rektalna uporaba
English: Solution For Injection/Infusion
Slovenian: Raztopina za injiciranje/infuzija
English: Syrup
Slovenian: Sirup
English: Film-Coated Tablet
Slovenian: Filmsko obložena tableta
English: Novaminsulfon 1 A Pharma
Slovenian: 1 A Pharma Gmbh Novaminsulfon 1 A Pharma
English: Solution For Injection Intravenous Use
Slovenian: Raztopina za injiciranje Intravenska uporaba
English: Metamizol-Natrium 1 H2o 1a-Pharma
Slovenian: 1 A Pharma Gmbh Metamizol-Natrium 1 H2o 1a-Pharma
English: Metamizol Sintocalmin Metamizole 500mg Tablet
Slovenian: Metamizol Sintocalmin metamizol 500 mg tableta
English: Chemax Pharma Ltd Диалгин Джуниор Metamizole Sodium Monohydrate 250mg
Slovenian: Chemax Pharma Ltd Диалгин Джуниор natrijev metamizolat monohidrat 250 mg vrečica
English: Melting Tablets
Slovenian: Topne tablete
English: Coated Tablet
Slovenian: Obložena tableta
English: Metamizole Sodium 450mg Tablet, Caffeine 50mg Tablet
Slovenian: natrijev metamizolat 450 mg tableta, kofein 50 mg tableta
English: Abz-Pharma Gmbh Novaminsulfon
Slovenian: Ratiopharm Gmbh Novaminsulfon
English: Metamizole Sodium 300mg Tablet, Paracetamol 200mg Tablet, Caffeine 30mg Tablet, Codeine Phosphate 20mg Tablet
Slovenian: Паракофдал natrijev metamizolat 300 mg tableta, paracetamol 200 mg tableta, kofein 30 mg tableta, kodeinijev fosfat 20 mg tableta
English: Hydrochloride 10mg, Metamizole Sodium 1g
Slovenian: Litalgin pitofenonijev hidroklorid 10 mg, natrijev metamizolat 1g
English: Powder For Oral Solution In Sachet
Slovenian: Prašek za peroralno raztopino v vrečici
English: Drotaverine Hydrochloride 40mg Tablet, Metamizole Sodium 400mg Tablet, Caffeine 60mg Tablet
Slovenian: Quarelin drotaverinijev hidroklorid 40 mg tableta, natrijev metamizolat 400 mg tableta, kofein 60 mg tableta
English: Scopolan Compositum Metamizole Sodium 250mg Tablet, Hyoscine Butylbromide 10mg
Slovenian: Scopolan Compositum natrijev metamizolat 250 mg tableta, hioscinijev butilbromid
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
Slovenian: 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
English: Solution For Injection Intramuscular Use
Slovenian: Intramuskularna uporaba
English: Buscapina Compositum Metamizole Sodium 250mg Tablet, Hyoscine Butylbromide 10mg
Slovenian: Buscapina Compositum natrijev metamizolat 250 mg tableta, hioscinijev butilbromid
English: Cyanocobalamin 0.5mg Tablet, Metamizole Sodium 500mg Tablet, Thiamine Nitrate 75mg Tablet, Pyridoxine Hydrochloride 50mg Tablet
Slovenian: Невралгин cianokobolamin 0,5 mg tableta, natrijev metamizolat 500 mg tableta, tiaminijev nitrat 75 mg tableta, piridoksinijev hidroklorid 50 mg tableta
English: Metamizole Sodium Monohydrate 2,5 g/5 ml
Slovenian: Alkagin natrijev metamizolat monohidrat 2,5 g/5 ml
English: Metamizole Sodium 0.5g Suppository, Caffeine And Sodium Benzoate 0.1g Suppository
Slovenian: natrijev metamizolat 0,5 g svečka, kofein in natrijev benzoat 0.1 g svečka
English: Metamizole Sodium 150mg Tablet, Paracetamol 300mg Tablet, Phenobarbital 15mg Tablet, Caffeine 50mg Tablet, Codeine Phosphate Hemihydrate 10mg Tablet
Slovenian: 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
English: Metamizol Kern Pharma Metamizole Magnesium 575mg Capsule
Slovenian: Metamizol Kern Pharma magnezijev metamizolat 575 mg kapsula
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
Slovenian: 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
English: Metamizole Sodium Monohydrate 0.525g/ml
Slovenian: Algocalmin natrijev metamizolat monohidrat 0,525 g/ml
English: Metamizole Sodium Monohydrate 527mg Tablet, Pitofenone Hydrochloride 5.25mg Tablet, Fenpiverinium Bromide 0.1mg Tablet
Slovenian: Algifen natrijev metamizolat monohidrat 527 mg tableta, pitofenonijev hidroklorid 5,25 mg tableta, fenpiverinijev bromid 0,1 mg tableta
English: Pitofenone Hydrochloride 5mg, Metamizole Sodium 500mg
Slovenian: Litalgin pitofenonijev hidroklorid 5 mg, natrijev metamizolat 500 mg
English: Metamizole Sodium 500mg Tablet, Triacetonamine Tosilate 20mg Tablet
Slovenian: Teмпимет natrijev metamizolat 500 mg tableta, triacetonaminejev tozilat 20 mg tableta
English: Metamizol Normon Metamizole Magnesium 2g/5ml
Slovenian: Metamizol Normon magnezijev metamizolat 2 g/5 ml
English: Metamizole Sodium 1g/2ml
Slovenian: Panalgorin natrijev metamizolat 1 g/2ml
English: Thiamine Hydrochloride 38.75mg Tablet, Metamizole Sodium 500mg Tablet, Caffeine 50mg Tablet
Slovenian: Бенлек tiaminijev hidroklorid 38,75 mg tableta, natrijev metamizolat 500 mg tableta, kofein 50 mg tableta
English: Metamizole Sodium Monohydrate 500mg/ml, Pitofenone Hydrochloride 5mg/ml
Slovenian: Algifen Neo natrijev metamizolat monohidrat 500 mg/ml, pitofenonijev hidroklorid 5 mg/ml
English: Metamizole Sodium Monohydrate 25mg Drop
Slovenian: Alvotor natrijev metamizolat monohidrat 25 mg kapljice
English: Metamizole Sodium 0.9g Suppository, Caffeine 0.05g Suppository, Codeine Phosphate Hemihydrate 0.03g Suppository
Slovenian: Suppositorium Analgeticum Forte Fono Vii natrijev metamizolat 0,9 g svečka, kofein 0,05 g svečka, kodeinijev fosfat hemihidrat 0,03 g svečka
English: Metamizole Sodium 500mg
Slovenian: Flamborin natrijev metamizolat 500 mg
English: Metamizol Will-Pharma Metamizole Sodium Monohydrate 500mg/ml
Slovenian: Metamizol Will-Pharma natrijev metamizolat monohidrat 500 mg/ml
English: Hydrochloride 2mg/ml, Fenpiverinium Bromide 0.02mg/ml, Metamizole Sodium 500mg/ml
Slovenian: Pitofenonijev hidroklorid 2 mg/ml, fenpiverinijev bromid 0,02 mg/ml, natrijev metamizolat 500 mg/ml
English: Buscapina Compositum Metamizole Sodium 2.5g/5ml, Hyoscine
Slovenian: Buscapina Compositum natrijev metamizolat 2,5 g/5 ml, hioscinijev butilbromid 0,02 g/5 ml
English: Metamizol Normon Metamizole Magnesium 575mg Capsule
Slovenian: Metamizol Normon magnezijev metamizolat 575 mg kapsula
English: Metamizol Heumann Metamizole Sodium Monohydrate 500mg/ml
Slovenian: Metamizol Heumann natrijev metamizolat monohidrat 500 mg/ml
English: Metamizole Sodium 200mg Suppository
Slovenian: Naturland natrijev metamizolat 200 mg svečka
English: Metamizole Magnesium 2000mg/5ml
Slovenian: Nolotil magnezijev metamizolat 2000 mg/5ml
English: Abc Farmaceutici S.P.A. Metamizolo Sodico Abc Metamizole Sodium 500mg/ml
Slovenian: Metamizolo Sodico Abc natrijev metamizolat 500 mg/ml
English: Metamizole Sodium Monohydrate 500mg Tablet, Pitofenone Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet
Slovenian: Algifen natrijev metamizolat monohidrat 500 mg tableta, pitofenonijev hidroklorid 5 mg tableta, fenpiverinijev bromid 0,1 mg tableta
English: Metamizole Magnesium 575mg Tablet
Slovenian: Metamizol Tarbis magnezijev metamizolat 575 mg tableta
English: Hydrochloride 2mg/ml, Metamizole Sodium 500mg/ml
Slovenian: Litalgin pitofenonijev hidroklorid 2 mg/ml, natrijev metamizolat 500 mg/ml
English: Ratiopharm España S.A. Metamizol Ratiopharm Metamizole Magnesium 575mg Capsule
Slovenian: Metamizol Ratiopharm magnezijev metamizolat 575 mg kapsula
English: Powder For Oral Solution
Slovenian: Prašek za peroralno raztopino
English: Metamizole Sodium 100mg Suppository
Slovenian: Naturland natrijev metamizolat 100 mg svečka
English: Metamizole Sodium Monohydrate 1000mg Sachet
Slovenian: Фрешалгин natrijev metamizolat monohidrat 1000 mg vrečica
English: Hydrochloride 5mg Tablet, Metamizole Sodium 500mg Tablet, Fenpipramide Bromomethylate 0.1mg Tablet
Slovenian: Piafen pitofenonijev hidroklorid 5 mg tableta, natrijev metamizolat 500 mg tableta, fenpipramidijev bromometilat 0,1 mg tableta
English: Metamizole Magnesium 2g/5ml
Slovenian: Nolotil magnezijev metamizolat 2 g/5 ml
English: Metamizol Heumann Metamizole Sodium Monohydrate 500mg
Slovenian: Metamizol Heumann natrijev metamizolat monohidrat 500 mg tableta
English: Laboratorios Cinfa, S.A. Metamizol Cinfa
Slovenian: Laboratorios Cinfa, S.A. Metamizol Cinfa metamizol 575 mg kapsula
English: Metamizole Magnesium Hexahydrate 575mg Capsule
Slovenian: Dolocalma magnezijev metamizolat heksahidrat 575 mg Kapsula
English: Fenpiverinium Bromide 0.1mg/5ml, Metamizole Sodium 2500mg/5ml
Slovenian: Analgin pitofenonijev hidroklorid 10 mg/5 ml, fenpiverinijev bromid 0,1 mg/5ml, natrijev metamizolat 2500 mg/5ml
English: Ratiopharm Gmbh
Slovenian: Ratiopharm Gmbh NovaminsulfonRatiopharm
English: Hydrochloride 5mg/ml, Metamizole Sodium 500mg/ml
Slovenian: Algifen Neo pitofenonijev hidroklorid 5 mg/ml, natrijev metamizolat 500 mg/ml
English: Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet, Metamizole Sodium 500mg Tablet
Slovenian: Спазмоблок pitofenonijev hidroklorid 5mg tableta, fenpiverinijev bromid 0,1 mg tableta, natrijev metamizolat 500 mg tableta
English: Metamizole Magnesium 1000mg Suppository
Slovenian: Algi-Mabo Adultos magnezijev metamizolat 1000 mg svečka
English: Metamizole Sodium 300mg Suppository
Slovenian: Novocalmin natrijev metamizolat 300 mg svečka
English: Темпалгин
Slovenian: Svečka
English: Metamizole Magnesium 575mg Capsule
Slovenian: Nolotil magnezijev metamizolat 575 mg kapsula
English: Metamizole 575mg Capsule
Slovenian: Metamizol Pensa metamizole 575 mg Kapsula
English: Metamizole Sodium Monohydrate 1000mg Suppository
Slovenian: Berlosin natrijev metamizolat monohidrat 1000 mg svečka
English: Metamizole Magnesium 500mg Sachet
Slovenian: Pyralgina Gorączka magnezijev metamizolat 500 mg vrečice
English: Metamizole Magnesium 500mg Capsule
Slovenian: Algi-Mabo magnezijev metamizolat 500 mg kapsula
English: Metamizole Magnesium 2000mg /5ml
Slovenian: Algi-Mabo magnezijev metamizolat 2000 mg /5ml
English: Laboratorios Alter, S.A. Metamizol Alter
Slovenian: Laboratorios Alter, S.A. Metamizol Alter magnezijev metamizolat 575 mg
English: Three of the cases were fatal.
Slovenian: Trije od teh primerov so bili smrtni.
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:
Slovenian: Odgovorite na nekaj vprašanj in nam povejte, kaj menite o tem sporočilu - vzelo vam bo samo nekaj minut vašega časa.
English: The majority of EU patients have been treated in Germany.
Slovenian: Večina bolnikov iz EU se je zdravila v Nemčiji.
English: Tell us how well we did with this information
Slovenian: Povejte nam, kako uporabno je to sporočilo
English: 8 March 2018 EMA/155367/2018
Slovenian: 7. marec 2018 EMA/134289/2018
English: EMA will complete its in-depth review and make public the final outcome.
Slovenian: Agencija EMA bo dokončala svoj podrobni pregled in objavila končni rezultat.
English: Most cases occurred within 8 months of starting treatment.
Slovenian: Večina primerov se je pojavila v osmih mesecih po začetku zdravljenja.
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.
Slovenian: Pregled zdravila Zinbryta se je začel 26. februarja 2018 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: Evidence indicates risk of serious inflammatory brain disorders
Slovenian: Podatki kažejo tveganje za resne možganske vnetne reakcije
English: Consider alternative treatments as appropriate.
Slovenian: Razmislite o morebitnih ustreznih zamenjavah.
English: Patients stopping treatment must be followed up for at least 6 months (see more details below).
Slovenian: Bolnike, ki se prenehajo zdraviti s tem zdravilom, je treba spremljati vsaj šest mesecev (glejte podrobnosti spodaj).
English: Start the survey
Slovenian: Začetek ankete
English: To date over 8,000 patients have been treated with Zinbryta worldwide.
Slovenian: Do zdaj se je po svetu z zdravilom Zinbryta zdravilo več kot 8 000 bolnikov.
English: • Zinbryta will be recalled from pharmacies and hospitals across the EU.
Slovenian: • Zdravilo Zinbryta bo odpoklicano iz lekarn in bolnišnic po vsej Evropski uniji.
English: Zinbryta may also be linked to severe immune reactions affecting several other organs.
Slovenian: Zdravilo Zinbryta je lahko povezano tudi s hudimi imunskimi reakcijami, ki prizadenejo več drugih organov.
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.
Slovenian: Predhodni pregled razpoložljivih podatkov je pokazal, da bi bile lahko imunske reakcije, o katerih so poročali v teh primerih, povezane z uporabo zdravila Zinbryta.
English: Available evidence also indicates that Zinbryta could be linked to other immune-mediated disorders, such as blood dyscrasias, thyroiditis or glomerulonephritis.
Slovenian: Razpoložljivi podatki kažejo tudi, da bi bilo zdravilo Zinbryta lahko povezano z drugimi imunsko povzročenimi boleznimi, kot so krvne diskrazije, tiroiditis ali 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.
Slovenian: 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.
English: Zinbryta was authorised in 2016 for treating relapsing forms of multiple sclerosis.
Slovenian: Zinbryta je zdravilo, ki je bilo odobreno leta 2016 za zdravljenje recidivnih oblik multiple skleroze.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: These reactions can occur for 6 months after treatment has been stopped.
Slovenian: Te reakcije se lahko pojavijo do šest mesecev po prenehanju zdravljenja s tem zdravilom.
English: These could be signs of a reaction to Zinbryta.
Slovenian: Gre lahko za znake reakcije na zdravilo Zinbryta.
English: To date EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed 12 cases of immune-mediated inflammatory disorders, including encephalitis.
Slovenian: Odbor za oceno tveganja na področju farmakovigilance (PRAC) je do zdaj pregledal 12 primerov imunsko povzročenih vnetnih reakcij, vključno z encefalitisom.
English: Healthcare professionals should immediately contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives.
Slovenian: 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.
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.
Slovenian: • Bolnike, ki se prenehajo zdraviti s tem zdravilom, je treba do šest mesecev po zadnjem odmerku zdravila Zinbryta pregledati vsaj enkrat na mesec ali pogosteje, glede na klinično indikacijo.
English: • Advise patients to immediately report symptoms of liver injury such as prolonged fever, severe headache, tiredness, jaundice, nausea or vomiting.
Slovenian: • Bolnikom svetujte, naj simptome okvare jeter, kot so dolgotrajna vročina, hud glavobol, utrujenost, zlatenica, navzeja ali bruhanje, takoj sporočijo.
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.
Slovenian: Pri predhodnem pregledu, ki ga je opravil odbor PRAC leta 2017, je bilo ugotovljeno, da lahko ob jemanju zdravila Zinbryta še do šest mesecev po prenehanju zdravljenja z njim nastane nepredvidljiva in morda tudi smrtna okvara jeter, ter zaključeno, da je treba bolnike po prenehanju zdravljenja s tem zdravilom spremljati.
English: • Do not take another injection of Zinbryta.
Slovenian: • Ne vzemite novega odmerka zdravila Zinbryta.
English: • Your doctor will carry out regular blood tests for up to 6 months after stopping treatment to check for side effects.
Slovenian: • Zdravnik bo do šest mesecev po prenehanju zdravljenja redno opravljal preiskave krvi, da bi prepoznal morebitne neželene učinke.
English: • If you are in a clinical study with Zinbryta, contact the doctor treating you in the study.
Slovenian: • Če ste vključeni v klinično preskušanje zdravila Zinbryta, se posvetujte z zdravnikom, ki vas zdravi v preskušanju.
English: • Contact your patients currently being treated with Zinbryta as soon as possible and stop their treatment.
Slovenian: • Čim prej obvestite bolnike, ki jih zdravite z zdravilom Zinbryta, in jih prenehajte zdraviti z njim.
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.
Slovenian: Evropska agencija za zdravila (EMA) je po prejemu 12 poročil z vsega sveta o resnih možganskih vnetnih reakcijah, vključno z encefalitisom in meningoencefalitisom, priporočila takojšen umik in odpoklic zdravila Zinbryta (daklizumaba beta), ki se uporablja za zdravljenje multiple skleroze.
English: • If you are being treated with Zinbryta, contact your doctor to discuss your treatment.
Slovenian: • Če se zdravite z zdravilom Zinbryta, se posvetujte z zdravnikom glede nadaljnjega zdravljenja.
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.
Slovenian: Priporočilo odbora PRAC za umik in odpoklic zdravila Zinbryta je bilo poslano Evropski komisiji, ki bo sprejela pravno zavezujoči sklep.
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.
Slovenian: Zaradi zaščite zdravja bolnikov agencija priporoča, da se za to zdravilo takoj začasno umakne dovoljenje za promet z zdravilom v EU ter iz lekarn in bolnišnic odpokličejo serije tega zdravila.
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.
Slovenian: • Če imate simptome, kot so dolgotrajna zvišana telesna temperatura, hud glavobol, navzeja
English: No new patients should start treatment with Zinbryta.
Slovenian: Poleg tega se zdravljenje z zdravilom Zinbryta ne sme predpisati nobenemu novemu bolniku.
English: • Do not start any new patients on Zinbryta.
Slovenian: • Zdravila Zinbryta ne smete uvesti pri nobenem novem bolniku.
English: Multiple sclerosis medicine Zinbryta suspended in the EU
Slovenian: Zinbryta, ki se uporablja za zdravljenje multiple skleroze
English: 19 January 2015
Slovenian: 19. januar 2015
English: The areas harmonised include:
Slovenian: Usklajena področja so:
English: The amended information to doctors and patients is available here.
Slovenian: Posodobljeni podatki za zdravnike in bolnike so na voljo tukaj.