FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredients are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate (type A), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171), iron oxide red (E172).
Croatian: - Drugi sastojci su manitol (E421), mikrokristalična celuloza, hidroksipropilceluloza, natrijev škroboglikolat (vrsta A), magnezijev stearat, hipromeloza, makrogol 400, titanijev dioksid (E171), željezov oksid, crveni (E172).
English: Brintellix 20 mg/ml oral drops, solution
Croatian: NAZIV LIJEKA Brintellix 20 mg/ml oralne kapi, otopina
English: - The other ingredients are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate (type A), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171), iron oxide yellow (E172).
Croatian: - Drugi sastojci su manitol (E421), mikrokristalična celuloza, hidroksipropilceluloza, natrijev škroboglikolat (vrsta A), magnezijev stearat, hipromeloza, makrogol 400, titanijev dioksid (E171), željezov oksid, žuti (E172).
English: CARTON AND LABEL FOR BOTTLE NAME OF THE MEDICINAL PRODUCT
Croatian: KUTIJA I NALJEPNICA ZA BOCU
English: Multipack containing 126 (9 x 14) and 490 (5 x (98x1)) film-coated tablets.
Croatian: Višestruko pakiranje sadrži 126 (9 x 14) i 490 (5 x (98x1)) filmom obloženih tableta.
English: Dizziness Not known * Serotonin Syndrome
Croatian: Serotoninski sindrom
English: Τηλ.
Croatian: Brintellixom.
English: Brintellix 20 mg film-coated tablets EU/1/13/891/027-035
Croatian: Brintellix 20 mg filmom obložene tablete EU/1/13/891/027-035
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172)
Croatian: Titanijev dioksid (E171) Željezov oksid, crveni (E172) Željezov oksid, žuti (E172)
English: Brintellix 5 mg tablet vortioxetine
Croatian: Brintellix 5 mg tableta vortioxetinum
English: Brintellix 20 mg film-coated tablets
Croatian: Brintellix 20 mg filmom obložene tablete
English: Brintellix 15 mg film-coated tablets EU/1/13/891/018-026
Croatian: Brintellix 15 mg filmom obložene tablete EU/1/13/891/018-026
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Croatian: Titanijev dioksid (E171) Željezov oksid, žuti (E172)
English: Multipack containing 490 (5 x (98x1)) film-coated tablets.
Croatian: Višestruko pakiranje sadrži 490 (5 x (98x1)) filmom obloženih tableta.
English: Brintellix 5 mg film-coated tablets EU/1/13/891/001-007
Croatian: Brintellix 5 mg filmom obložene tablete EU/1/13/891/001-007
English: Lundbeck Slovensko s.r.o.
Croatian: Lundbeck España S.A.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKIH PAKIRANJA OMOTANIH
English: Angioedema, Urticaria Rash
Croatian: Angioedem, urtikarija, osip
English: Microcrystalline cellulose Hydroxypropylcellulose Sodium starch glycolate (type A) Magnesium stearate
Croatian: Natrijev škroboglikolat (vrsta A) Magnezijev stearat
English: - sumatriptan and similar medicines to Brintellix with active substance names ending in “triptans” (used to treatmigraine).
Croatian: - sumatriptan i lijekovi slični Brintellixu s imenima djelatnih tvari koja završavaju na “triptani”
English: Brintellix 10 mg film-coated tablets EU/1/13/891/008-017
Croatian: Brintellix 10 mg filmom obložene tablete EU/1/13/891/008-017
English: Depending on individual patient response, a dose adjustment may be considered if a broad cytochrome P450 inducer (e.g., rifampicin, carbamazepine, phenytoin) is added to vortioxetine treatment (see section 4.2).
Croatian: Ovisno o individualnom odgovoru bolesnika, može se razmotriti prilagodba doze ako se induktor širokog spektra citokroma P450 (npr. rifampicin, karbamazepin, fenitoin) doda liječenju vortioksetinom (vidjeti dio 4.2).
English: Following a single dose of 10 mg vortioxetine, renal impairment estimated using the Cockcroft-Gault formula (mild, moderate, or severe; n=8 per group) caused modest exposure increases (up to 30%), compared to healthy matched controls.
Croatian: Nakon pojedinačne doza od 10 mg vortioksetina, oštećenje bubrega procijenjeno pomoću Cockcroft-Gault formule (blago, umjereno ili teško; n=8 po skupini) prouzročilo je skromno povećanje izloženosti (do 30%), u usporedbi sa zdravim podudarnim kontrolama.U bolesnika sa završnim stadijem bolesti bubrega, samo je mali udio vortiksetina bio izgubljen tijekom dijalize (AUC i Cmax bili su 13% odnosno 27% niži; n=8) nakon primjene pojedinačne doze vortioksetina od 10 mg.
English: Brintellix 10 mg film-coated tablets
Croatian: Brintellix 10 mg filmom obložene tablete
English: Lundbeck Hungaria Kft. Tel: +36 1 4369980
Croatian: Lundbeck Croatia d.o.o. Tel.: + 385 1 6448263
English: Brintellix 15 mg film-coated tablets
Croatian: Brintellix 15 mg filmom obložene tablete
English: Brintellix 5 mg film-coated tablets
Croatian: Brintellix 5 mg filmom obložene tablete
English: Seizures
Croatian: NUSPOJAVA
English: Multipacks: 490 (5 packs of 98 x 1) film-coated tablets.
Croatian: Višestruka pakiranja: 490 (5 pakiranja od 98 x 1) filmom obloženih tableta.
English: Multipack: 490 (5 packs of 98 x 1) film-coated tablets.
Croatian: Višestruko pakiranje: 490 (5 pakiranja od 98 x 1) filmom obloženih tableta.
English: - medicines known to cause low sodium level.
Croatian: Lijekovi koji snižavaju prag napadaja
English: Haemorrhage
Croatian: Hiponatremija
English: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 20 mg vortioxetine.
Croatian: Svaka filmom obložena tableta sadrži vortioksetinbromid u količini koja odgovara 20 mg vortioksetina (vortioxetinum).
English: Brintellix 15 mg film-coated tablets vortioxetine
Croatian: Brintellix 15 mg filmom obložene tablete vortioxetinum
English: Package leaflet: Information for the patient Brintellix 20 mg film-coated tablets vortioxetine
Croatian: Uputa o lijeku: Informacije za bolesnika Brintellix 20 mg filmom obložene tablete vortioksetin (vortioxetinum)
English: Each film-coated tablet contains 20 mg vortioxetine (as hydrobromide).
Croatian: Svaka filmom obložena tableta sadrži 20 mg vortioksetina (u obliku vortioksetinbromida).
English: Depending on individual patient response, a dose adjustment of vortioxetine may be considered if a broad cytochrome P450 inducer (e.g., rifampicin, carbamazepine, phenytoin) is added to vortioxetine treatment (see section 4.5).
Croatian: Ovisno o individualnom odgovoru bolesnika, može se razmotriti prilagodba doze vortioksetina ako se liječenju vortioksetinom doda induktor širokog spektra citokroma P450 (npr. rifampicin, karbamazepin, fenitoin) (vidjeti dio 4.5).
English: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 10 mg vortioxetine.
Croatian: Svaka filmom obložena tableta sadrži vortioksetinbromid u količini koja odgovara 10 mg vortioksetina (vortioxetinum).
English: EU/1/13/891/040 126 film-coated tablets (9 packs of 14) EU/1/13/891/033 490 film-coated tablets (5 packs of 98x1)
Croatian: EU/1/13/891/040 126 filmom obloženih tableta (9 pakiranja od 14) EU/1/13/891/033 490 filmom obloženih tableta (5 pakiranja od 98 x 1)
English: Vascular disorders
Croatian: Hidroksipropilbetadeks
English: Following intake of dosages several times higher than the prescribed dose, fits (seizures) and a rare condition called serotonin syndrome have been reported.
Croatian: Bilo je prijavljenih slučajeva napadaja i rijetkog stanja poznatog kao serotoninski sindrom nakon uzimanja doza nekoliko puta većih od propisane.
English: Yellow, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “10” on the other side.
Croatian: Žuta, filmom obložena tableta, bademastog oblika (5 x 8,4 mm) s utisnutim „TL” na jednoj strani i “10” na drugoj strani.
English: Red, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “20” on the other side.
Croatian: Crvena, filmom obložena tableta, bademastog oblika (5 x 8,4 mm) s utisnutim „TL” na jednoj strani i “20” na drugoj strani.
English: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 15 mg vortioxetine.
Croatian: Svaka filmom obložena tableta sadrži vortioksetinbromid u količini koja odgovara 15 mg vortioksetina (vortioxetinum).
English: Package leaflet: Information for the patient Brintellix 10 mg film-coated tablets vortioxetine
Croatian: Uputa o lijeku: Informacije za bolesnika Brintellix 10 mg filmom obložene tablete vortioksetin (vortioxetinum)
English: Package leaflet: Information for the patient Brintellix 15 mg film-coated tablets vortioxetine
Croatian: Uputa o lijeku: Informacije za bolesnika Brintellix 15 mg filmom obložene tablete vortioksetin (vortioxetinum)
English: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5 mg vortioxetine.
Croatian: Svaka filmom obložena tableta sadrži vortioksetinbromid u količini koja odgovara 5 mg vortioksetina (vortioxetinum).
English: EU/1/13/891/018 14 film-coated tablets EU/1/13/891/019 28 film-coated tablets EU/1/13/891/020 56 film-coated tablets EU/1/13/891/021 98 film-coated tablets EU/1/13/891/022 56x1 film-coated tablets EU/1/13/891/023 98x1 film-coated tablets EU/1/13/891/025 100 film-coated tablets EU/1/13/891/026 200 film-coated tablets
Croatian: EU/1/13/891/018 14 filmom obloženih tableta EU/1/13/891/019 28 filmom obloženih tableta EU/1/13/891/020 56 filmom obloženih tableta EU/1/13/891/021 98 filmom obloženih tableta EU/1/13/891/022 56 x 1 filmom obloženih tableta EU/1/13/891/023 98 x 1 filmom obloženih tableta EU/1/13/891/025 100 filmom obloženih tableta EU/1/13/891/026 200 filmom obloženih tableta
English: Orange, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “15” on the other side.
Croatian: Narančasta, filmom obložena tableta, bademastog oblika (5 x 8,4 mm) s utisnutim „TL” na jednoj strani i “15” na drugoj strani.
English: Package leaflet: Information for the patient Brintellix 5 mg film-coated tablets vortioxetine
Croatian: Uputa o lijeku: Informacije za bolesnika Brintellix 5 mg filmom obložene tablete vortioksetin (vortioxetinum)
English: Brintellix film-coated tablets 10 mg are available in blister packs of 7, 14, 28, 56, 56 x 1, 98, 98 x 1, 126 (9x14), 490 (5 x (98x1)) tablets and in tablet containers of 100 and 200 tablets.
Croatian: Brintellix filmom obložene tablete 10 mg dostupne su u blister pakiranjima od 7, 14, 28, 56, 98, 56 x 1, 98 x 1, 126 (9x14), 490 (5 x (98x1)) tableta te u spremnicima za tablete od 100 i 200 tableta.
English: EU/1/13/891/001 14 film-coated tablets EU/1/13/891/002 28 film-coated tablets EU/1/13/891/003 56 x 1 film-coated tablets EU/1/13/891/004 98 x 1 film-coated tablets EU/1/13/891/006 100 film-coated tablets EU/1/13/891/007 200 film-coated tablets EU/1/13/891/037 98 film-coated tablets
Croatian: EU/1/13/891/001 14 filmom obloženih tableta EU/1/13/891/002 28 filmom obloženih tableta EU/1/13/891/003 56 x 1 filmom obloženih tableta EU/1/13/891/004 98 x 1 filmom obloženih tableta EU/1/13/891/006 100 filmom obloženih tableta EU/1/13/891/007 200 filmom obloženih tableta EU/1/13/891/037 98 filmom obloženih tableta
English: Contents of the pack and other information What Brintellix contains
Croatian: Što Brintellix sadrži
English: EU/1/13/891/008 7 film-coated tablets EU/1/13/891/009 14 film-coated EU/1/13/891/010 28 film-coated tablets EU/1/13/891/011 56 film-coated tablets EU/1/13/891/012 98 film-coated tablets EU/1/13/891/013 56x1 film-coated tablets EU/1/13/891/014 98x1 film-coated tablets EU/1/13/891/016 100 film-coated tablets EU/1/13/891/017 200 film-coated tablets
Croatian: EU/1/13/891/008 7 filmom obloženih tableta EU/1/13/891/009 14 filmom obloženih tableta EU/1/13/891/010 28 filmom obloženih tableta EU/1/13/891/011 56 filmom obloženih tableta EU/1/13/891/012 98 filmom obloženih tableta EU/1/13/891/013 56 x 1 filmom obloženih tableta EU/1/13/891/014 98 x 1 filmom obloženih tableta EU/1/13/891/016 100 filmom obloženih tableta EU/1/13/891/017 200 filmom obloženih tableta
English: Close monitoring for Serotonin Syndrome is necessary if used concomitantly (see section 4.4).
Croatian: Ako se ovi lijekovi primjenjuju istodobno, pažljivo praćenje je nužno zbog moguće pojave serotoninskog sindroma (vidjeti dio 4.4).
English: Brintellix film-coated tablets 5 mg are available in blister packs of 14, 28, 98, 56x1, 98x1, 126 (9x14) 490 (5x(98x1)) tablets and in tablet containers of 100 and 200 tablets.
Croatian: Brintellix filmom obložene tablete 5 mg dostupne su u blister pakiranjima od 14, 28, 98, 56x1, 98x1, 126 (9x14), 490 (5x(98x1)) tableta te u spremnicima za tablete od 100 i 200 tableta.
English: latvia@lundbeck.com
Croatian: Nederland Lundbeck B.V.
English: Brintellix 5 mg film-coated tablets Vortioxetine
Croatian: Brintellix 5 mg filmom obložene tablete vortioxetinum
English: Yellow, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “10” on the other side.
Croatian: Žuta filmom obložena tableta bademastog oblika (tableta), 5 x 8,4 mm, s oznakom “TL” na jednoj strani i “10” na drugoj strani.
English: EU/1/13/891/027 14 film-coated tablets EU/1/13/891/028 28 film-coated tablets EU/1/13/891/029 56 film-coated tablets EU/1/13/891/030 98 film-coated tablets EU/1/13/891/031 56x1 film-coated tablets EU/1/13/891/032 98x1 film-coated tablets EU/1/13/891/034 100 film-coated tablets EU/1/13/891/035 200 film-coated tablets
Croatian: EU/1/13/891/027 14 filmom obloženih tableta EU/1/13/891/028 28 filmom obloženih tableta EU/1/13/891/029 56 filmom obloženih tableta EU/1/13/891/030 98 filmom obloženih tableta EU/1/13/891/031 56 x 1 filmom obloženih tableta EU/1/13/891/032 98 x 1 filmom obloženih tableta EU/1/13/891/034 100 filmom obloženih tableta EU/1/13/891/035 200 filmom obloženih tableta
English: Depending on individual patient response, a lower dose of vortioxetine may be considered if strong CYP2D6 inhibitor (e.g., bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment (see section 4.2).
Croatian: Ovisno o indivudualnom odgovoru bolesnika, može se razmotriti niža doza vortioksetina ako će se snažni inhibitori CYP2D6 (npr. bupropion, kinidin, fluoksetin, paroksetin) dodati liječenju vortioksetinom (vidjeti dio 4.2).
English: Brintellix film-coated tablets 15 mg are available in blister packs of 14, 28, 56, 56 x 1, 98, 98 x 1, 490 (5 x (98x1)) tablets and in tablet containers of 100 and 200 tablets.
Croatian: Brintellix filmom obložene tablete 15 mg dostupne su u blister pakiranjima od 14, 28, 56, 98, 56 x 1, 98 x 1, 490 (5 x (98x1)) tableta te u spremnicima za tablete od 100 i 200 tableta.
English: Each film-coated tablet contains 10 mg vortioxetine (as hydrobromide).
Croatian: Svaka filmom obložena tableta sadrži 10 mg vortioksetina (u obliku vortioksetinbromida).
English: Each film-coated tablet contains 5 mg vortioxetine (as hydrobromide).
Croatian: Svaka filmom obložena tableta sadrži 5 mg vortioxetinum (u obliku vortioksetinbromida).
English: Each film-coated tablet contains 15 mg vortioxetine (as hydrobromide).
Croatian: Svaka filmom obložena tableta sadrži 15 mg vortioxetinum (u obliku vortioksetinbromida).
English: Brintellix film-coated tablets 20 mg are available in blister packs of 14, 28, 56, 56x1, 98, 98x1, 126 (9x14), 490 (5x(98x1)) tablets and in tablet containers of 100, 200 tablets.
Croatian: Brintellix filmom obložene tablete 20 mg dostupne su u blister pakiranjima od 14, 28, 56, 98, 56 x 1, 98 x 1, 126 (9x14), 490 (5x( 98x1)) tableta te u spremnicima za tablete od 100 i 200 tableta.
English: Lundbeck B.V. Tel: +31 20 697 1901
Croatian: Tel: +31 20 697 1901
English: - have a severe kidney disease.. - have a severe liver disease or a liver disease called cirrhosis.
Croatian: - ste imali maniju. - imate sklonost lakom nastajanju krvarenja ili modrica. - imate nisku razinu natrija u krvi. - ste u dobi od 65 godina ili stariji. - imate tešku bolest bubrega. - imate tešku bolest jetre ili bolest jetre koja se zove ciroza.
English: Pink, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “5” on the other side.
Croatian: Roza, filmom obložena tableta, bademastog oblika (5 x 8,4 mm) s utisnutim „TL“ na jednoj strani i “5” na drugoj strani.
English: Red, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “20” on the other side.
Croatian: Crvena filmom obložena tableta bademastog oblika (tableta), 5 x 8,4 mm, s oznakom “TL” na jednoj strani i “20” na drugoj strani.
English: Brintellix 20 mg tablet vortioxetine
Croatian: Brintellix 20 mg tableta vortioxetinum NAZIV NOSITELJA
English: Depending on individual patient response, a lower dose of vortioxetine may be considered if a strong CYP2D6 inhibitor (e.g. bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment (see section 4.5).
Croatian: Ovisno o individualnom odgovoru bolesnika, može se razmotriti niža doza vortioksetina ako se liječenju vortioksetinom dodaju snažni inhibitori CYP2D6 (npr. bupropion, kinidin, fluoksetin, paroksetin) (vidjeti dio 4.5).
English: Pink, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “5” on the other side.
Croatian: Roza filmom obložena tableta bademastog oblika (tableta), 5 x 8,4 mm, s oznakom “TL” na jednoj strani i “5” na drugoj strani.
English: In elderly healthy subjects (aged ≥65 years; n=20), the exposure to vortioxetine increased up to 27%
Croatian: U starijih zdravih ispitanika (u dobi ≥ 65 godina; n=20), izloženost vortioksetinu povećala se do 27% (Cmax i AUC) u usporedbi s mladim zdravim kontrolnim ispitanicima (u dobi ≤45 godina) nakon višekratnih doza od 10 mg/dan.
English: Orange, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “15” on the other side.
Croatian: Narančasta filmom obložena tableta bademastog oblika (tableta), 5 x 8,4 mm, s oznakom “TL” na jednoj strani i “15” na drugoj strani.
English: Česká republika Lundbeck Česká republika s.r.o.
Croatian: Magyarország Lundbeck Hungaria Kft.
English: For elderly people 65 years of age or older the starting dose is 5 mg vortioxetine taken once daily.
Croatian: ≥ 65 godina kod doza ≥ 10 mg vortioksetina jednom dnevno.
English: Lundbeck S.A. Tél: +32 2 535 7979
Croatian: Lundbeck Hellas A.E Τηλ.: +357 22490305
English: EU/1/13/891/038 126 film-coated tablets (9 packs of 14) EU/1/13/891/005 490 film-coated tablets (5 packs of 98x1)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/891/038 126 filmom obloženih tableta (9 pakiranja od 14) EU/1/13/891/005 490 filmom obloženih tableta (5 pakiranja od 98 x 1) 13.
English: EU/1/13/891/039 126 film-coated tablets (9 packs of 14) EU/1/13/891/015 490 film-coated tablets (5 packs of 98x1).
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/891/039 126 filmom obloženih tableta (9 pakiranja od 14) EU/1/13/891/015 490 filmom obloženih tableta (5 pakiranja od 98 x 1) 13.
English: Each film-coated tablet contains 5 mg vortioxetine (as hydrobromide)
Croatian: Svaka filmom obložena tableta sadrži 5 mg vortioxetinum (u obliku vortioksetinbromida) POPIS POMOĆNIH TVARI
English: MA (EU) Number Name
Croatian: Broj (EU) odobrenja Naziv
English: Strength Pharmaceutical Form Route of Administration Immediate Packaging
Croatian: Jačina Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja
English: Pack size
Croatian: 84 kapsule
English: 1 For more information see here.
Croatian: 1 Više informacija potražite ovdje.
English: The review of Zydelig has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Croatian: Ocjenjivanje lijeka Zydelig započeto je 11. ožujka 2016. na zahtjev Europske komisije, u skladu s člankom 20. Uredbe (EZ) br. 726/2004.
English: It is only used in combination with rituximab.
Croatian: Primjenjuje se samo u kombinaciji s rituksimabom.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23. ožujka 2016.
English: To ensure that the medicine is used as safely as possible changes have been made to the way the medicine is used:
Croatian: Kako bi se osiguralo da se lijek upotrebljava na što sigurniji način, uvedene su promjene u pogledu toga kako će se lijek upotrebljavati:
English: EMA recommends new safety measures for Zydelig
Croatian: EMA preporučuje nove sigurnosne mjere za lijek Zydelig
English: Other excess deaths related mainly to respiratory events.
Croatian: Ostali prekomjerni smrtni slučajevi uglavnom su povezani s respiratornim problemima.
English: However, these studies did not use the medicine in the same way as currently authorised.
Croatian: Međutim, u tim se ispitivanjima lijek nije primijenjivao na način kako je trenutačno odobreno.
English: In the EU, Zydelig is authorised for the treatment of:
Croatian: U EU-u lijek Zydelig odobren je za liječenje:
English: If you are taking Zydelig and have any questions or concerns speak to your doctor or pharmacist.
Croatian: Ako uzimate lijek Zydelig i imate bilo kakvih pitanja ili nedoumica, obratite se svom liječniku ili ljekarniku.
English: • You should not stop Zydelig before speaking to your doctor.
Croatian: • Liječenje lijekom Zydelig ne smijete prekidati prije nego što razgovarate sa svojim liječnikom.
English: Once the PRAC review is concluded any further recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt a final opinion.
Croatian: Nakon što PRAC dovrši ocjenjivanje sve daljnje preporuke bit će proslijeđene Odboru za lijekove za humanu uporabu (CHMP), odgovornome za pitanja koja se odnose na lijekove za humanu uporabu, koji će usvojiti konačno mišljenje.
English: 18 March 2016 EMA/201814/2016
Croatian: EMA/309645/2016
English: While the review is ongoing the PRAC has made a set of provisional recommendations to protect public health.
Croatian: Postupak ocjenjivanja i dalje je u tijeku i stoga je PRAC donio niz privremenih preporuka radi zaštite javnog zdravlja.
English: The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Croatian: Završna faza postupka ocjenjivanja lijeka jest donošenje zakonski obvezujuće odluke Europske komisije primjenjive u svim državama članicama EU-a.
English: Healthcare professionals will be informed in writing about the precautionary measures to be taken.
Croatian: Zdravstveni su djelatnici pisanim putem obaviješteni o mjerama opreza koje je potrebno poduzeti.
English: These are provisional recommendations which the PRAC has issued, as a precaution, to protect patients while the medicine is being reviewed.
Croatian: Ovo su privremene preporuke koje je PRAC izdao kao mjeru opreza radi zaštite bolesnika dok je lijek u postupku ocjenjivanja.
English: In case of neutropenia your doctor may stop your treatment with Zydelig.
Croatian: U slučaju neutropenije liječnik može prekinuti vaše liječenje lijekom Zydelig.
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using the cancer medicine Zydelig (idelalisib) to ensure that it continues to be used as safely as possible.
Croatian: EMA-in Odbor za procjenu rizika u području farmakovigilancije (PRAC) izdao je 17. ožujka 2016. privremene savjete za liječnike i bolesnike koji upotrebljavaju lijek za liječenje raka Zydelig (idelalisib) kako bi se osiguralo da se lijek i dalje upotrebljava na što sigurniji način.
English: • Studies in non-Hodgkin lymphoma included patients with disease characteristics different from those covered by the currently approved indication and investigated a combination of medicines not currently approved.
Croatian: • Ispitivanja na bolesnicima s ne-Hodgkinovim limfom uključivala su bolesnike čija je bolest imala drukčije karakteristike od onih koje su obuhvaćene trenutačno odobrenom indikacijom i istraživanje kombinacije lijekova koji trenutačno nisu odobreni.