FrancophonIA/ELRC3.0 huggingface dataset:
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (StevensJohnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis).
Slovenian: široko razširjen izpuščaj z mehurčki in luščenjem kože, še posebej okoli ust, nosu, oči in v predelu spolovil (Stevens-Johnsonov sindrom) in hujša oblika, ki povzroči luščenje kože na več kot 30 % telesne površine (toksična epidermalna nekroliza).
English: In adults, levetiracetam efficacy has been demonstrated in 3 double-blind, placebo-controlled studies at 1000 mg, 2000 mg, or 3000 mg/day, given in 2 divided doses, with a treatment duration of up to 18 weeks.
Slovenian: Dopolnilno zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih, otrocih in dojenčkih od 1 meseca starosti, z epilepsijo Pri odraslih je bila učinkovitost levetiracetama dokazana v 3 dvojno slepih, s placebom nadzorovanih študijah s 1000 mg, 2000 mg ali 3000 mg/dan, razdeljenih na dva odmerka, ter s trajanjem zdravljenja do 18 tednov.
English: With continued long-term treatment, 11.4 % of the patients were seizure-free for at least 6 months and 7.2 % were seizure-free for at least 1 year.
Slovenian: nadaljevanjem dolgotrajnega zdravljenja je bilo 11,4 % bolnikov brez napada vsaj 6 mesecev, 7,2 % pa jih je bilo brez napada vsaj 1 leto.
English: Excipient with known effect: Each film-coated tablet contains 0.06 mg colouring agent tartrazine (E102).
Slovenian: Pomožna snov z znanim učinkom: Ena filmsko obložena tableta vsebuje 0,06 mg barvila tartrazin
English: Levetiracetam Teva 1000 mg film-coated tablets Hypromellose 6 cp, Titanium dioxide (E171), Macrogol 3350
Slovenian: Levetiracetam Teva 1000 mg filmsko obložene tablete hipromeloza 6 cp, titanov dioksid (E171), makrogol 3350
English: (3)A 15 mg/kg loading dose is recommended on the first day of treatment with levetiracetam.
Slovenian: (3)Prvi dan zdravljenja z levetiracetamom je priporočljiv začetni odmerek 15 mg/kg.
English: Tablet coating: hypromellose 6 cp, titanium dioxide (E171), macrogol 3350, colourants*
Slovenian: Obloga tablete: hipromeloza 6 cp, titanov dioksid (E171), makrogol 3350, barvila*
English: Uncommon: may affect up to 1 in 100 people
Slovenian: Občasni: pojavijo se pri 1 od 100 oseb
English: Dosing adjustment for adult and adolescent patients weighing more than 50 kg with impaired renal function:
Slovenian: Prilagoditev odmerjanja pri odraslih in mladostnikih s telesno maso, večjo kot 50 kg, z okvarjenim delovanjem ledvic: skupina očistek kreatinina
English: (2)A 10.5 mg/kg loading dose is recommended on the first day of treatment with levetiracetam.
Slovenian: (2)Prvi dan zdravljenja z levetiracetamom je priporočljiv začetni odmerek 10,5 mg/kg.
English: Levetiracetam Teva 1000 mg film-coated tablets Each film-coated tablet contains 1000 mg levetiracetam.
Slovenian: Levetiracetam Teva 1000 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 1000 mg levetiracetama.
English: Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugs.
Slovenian: ki se sočasno zdravijo z obema učinkovinama, je potrebno skrbno spremljanje koncentracije metotreksata in levetiracetama v krvi.
English: Contact your doctor if you have missed one or more doses.
Slovenian: Če ste pozabili vzeti zdravilo Levetiracetam Teva Če ste pozabili vzeti enega ali več odmerkov, se posvetujte s svojim zdravnikom.
English: 750 mg film-coated tablets: iron oxide yellow (E172), iron oxide red (E172) and sunset yellow FCF (E110).
Slovenian: 750 mg filmsko obložene tablete: rumeni železov oksid (E172), rdeči železov oksid (E172) in oranžno FCF (E110)
English: The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications.
Slovenian: Ti podatki so dopolnjeni s podatki iz ustreznih odprtih, razširjenih študij o uporabi levetiracetama ter s postmarketinškimi podatki.Varnostni profil levetiracetama je v splošnem podoben v vseh starostnih skupinah (odrasli in pediatrični bolniki) in pri vseh odobrenih indikacijah za zdravljenje epilepsije.
English: Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Slovenian: Dopolnilno zdravljenje miokloničnih napadov pri odraslih in mladostnikih od 12. leta starosti z juvenilno mioklonično epilepsijo
English: Croscarmellose sodium Magnesium stearate
Slovenian: Jedro tablete koruzni škrob povidon premreženi natrijev karmelozat magnezijev stearat
English: Adverse reactions reported in clinical studies (adults, adolescents, children and infants > 1 month) and from post-marketing experience are listed in the following table per System Organ Class and per frequency.
Slovenian: starejši od 1 meseca) in v postmarketinškem obdobju, so navedeni v spodnji preglednici po organskih sistemih in pogostnosti.
English: Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose.
Slovenian: Zdravnik bo glede na starost, telesno maso in odmerek predpisal najprimernejšo farmacevtsko obliko zdravila, ki vsebuje levetiracetam.
English: This medicinal product contains colouring agent sunset yellow (E110) which may cause allergic reactions.
Slovenian: Zdravilo vsebuje barvilo oranžno FCF (E110), ki lahko povzroči alergijske reakcije.
English: • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Slovenian: primarno generaliziranih tonično-kloničnih napadov pri odraslih in mladostnikih od 12. leta starosti z idiopatsko generalizirano epilepsijo.
English: Psychiatric disorders
Slovenian: psihotične motnje,
English: The patients were randomized to carbamazepine CR 400 - 1200 mg/day or levetiracetam 1000 - 3000 mg/day, the duration of the treatment was up to 121 weeks depending on the response.
Slovenian: Bolniki so randomizirano prejemali 400-1200 mg karbamazepina z nadzorovanim sproščanjem (CR) na dan ali 1000-3000 mg levetiracetama na dan,
English: Contact your doctor if you took more tablets than you should.Your doctor will establish the best possible treatment of overdose.
Slovenian: Če ste vzeli več tablet kot bi morali, se posvetujte s svojim zdravnikom.
English: Levetiracetam Teva 250 mg film-coated tablets Each film-coated tablet contains 250 mg levetiracetam.
Slovenian: Levetiracetam Teva 250 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 250 mg levetiracetama.
English: Levetiracetam Teva 500 mg contains Tartrazine
Slovenian: Levetiracetam Teva 500 mg vsebuje barvilo tartrazin
English: 3.5 to 10.5 mg/kg twice daily
Slovenian: 3,5 do 10,5 mg/kg dvakrat na dan
English: The NOAEL (No Observed Adverse Effect Level) was 3600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m2
Slovenian: Odmerek, pri katerem ni mogoče opaziti neželenih učinkov (NOAEL), je bil pri brejih podganah 3.600 mg/kg/dan (12-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2) in pri zarodkih 1200 mg/kg/dan.
English: This medicinal product contains colouring agent tartrazine E 102 (see leaflet for further information).
Slovenian: Zdravilo vsebuje barvilo tartrazin E102 (opozorila in druge pomožne snovi so navedene v navodilu za uporabo).
English: Levetiracetam Teva 1000 mg film-coated tablets EU/1/11/701/022
Slovenian: Levetiracetam Teva 1000 mg filmsko obložene tablete EU/1/11/701/022
English: basis) and 1200 mg/kg/day for foetuses.
Slovenian: 1800 mg/kg/dan.
English: 3.5 to 7 mg/kg twice daily
Slovenian: 3,5 do 7 mg/kg dvakrat na dan
English: Following repeated oral dose administration (20 to 60 mg/kg/day) to epileptic children (4 to 12 years), levetiracetam was rapidly absorbed.
Slovenian: Po uporabi večkratnih peroralnih odmerkov (od 20 do 60 mg/kg/dan) pri otrocih z epilepsijo (od 4 do
English: This medicinal product contains colouring agent sunset yellow E 110 (see leaflet for further information).
Slovenian: Zdravilo vsebuje barvilo oranžno FCF E110 (opozorila in druge pomožne snovi so navedene v navodilu za uporabo).
English: 7 to 14 mg/kg twice daily
Slovenian: 7 do 14 mg/kg dvakrat na dan
English: 7 to 21 mg/kg twice daily
Slovenian: 7 do 21 mg/kg dvakrat na dan
English: • Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
Slovenian: • Odmer pri odraslih in mladostnikih (od 12 do 17 let), težkih 50 kg ali več: Običajni odmerek: med 1000 mg in 3000 mg na dan.
English: Hypromellose 6 cp, Titanium dioxide (E171), Macrogol 3350, Indigotine (E132), Brilliant blue FCF (E133)
Slovenian: Levetiracetam Teva 250 mg filmsko obložene tablete hipromeloza 6 cp, titanov dioksid (E171), makrogol 3350, indigotin (E132), briljantno modro FCF (E133)
English: Talk to your doctor before taking Levetiracetam Teva
Slovenian: Pred začetkom jemanja zdravila Levetiracetam Teva se posvetujte z zdravnikom
English: Levetiracetam Teva 750 mg contains Sunset Yellow
Slovenian: Levetiracetam Teva 750 mg vsebuje barvilo oranžno
English: Levetiracetam Teva 750 mg film-coated tablets EU/1/11/701/015
Slovenian: Levetiracetam Teva 750 mg filmsko obložene tablete EU/1/11/701/015
English: Levetiracetam Teva 500 mg film-coated tablets EU/1/11/701/008
Slovenian: Levetiracetam Teva 500 mg filmsko obložene tablete EU/1/11/701/008
English: • in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Slovenian: miokloničnih napadov pri odraslih in mladostnikih od 12. leta starosti z juvenilno mioklonično epilepsijo.
English: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam).
Slovenian: Pri bolnikih, ki so se zdravili z antiepileptiki (vključno z levetiracetamom), so poročali o samomoru, poskusu samomora, samomorilnem razmišljanju in vedenju.
English: No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 generation.
Slovenian: Pri podganah, starševska in F1 generacija, pri odmerkih do 1800 mg/kg/dan (6-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2 ali na osnovno izpostavljenost) niso opazili neželenih učinkov na plodnost samcev ali samic ali na razmnoževanje.
English: Levetiracetam Teva 750 mg film-coated tablets
Slovenian: Levetiracetam Teva 750 mg filmsko obložene tablete
English: Levetiracetam Teva 750 mg film-coated tablets levetiracetam
Slovenian: Levetiracetam Teva 750 mg filmsko obložene tablete levetiracetam
English: Levetiracetam Teva 250 mg film-coated tablets EU/1/11/701/001
Slovenian: Levetiracetam Teva 250 mg filmsko obložene tablete EU/1/11/701/001
English: Hypromellose 6 cp, Titanium dioxide (E171), Macrogol 3350, Iron oxide yellow (E172), Iron oxide red (E172), Sunset yellow FCF (E110)
Slovenian: Levetiracetam Teva 750 mg filmsko obložene tablete hipromeloza 6 cp, titanov dioksid (E171), makrogol 3350, rumeni železov oksid (E172), rdeči železov oksid (E172), oranžno FCF (E110)
English: Levetiracetam Teva 250 mg film-coated tablets
Slovenian: Levetiracetam Teva 250 mg filmsko obložene tablete
English: Levetiracetam Teva 1,000 mg film-coated tablets levetiracetam
Slovenian: Levetiracetam Teva 1000 mg filmsko obložene tablete levetiracetam
English: Hypromellose 6 cp, Titanium dioxide (E171), Macrogol 3350, Indigotine (E132), Tartrazine (E102), Iron oxide yellow (E172)
Slovenian: Levetiracetam Teva 500 mg filmsko obložene tablete hipromeloza 6 cp, titanov dioksid (E171), makrogol 3350, indigotin (E132), tartrazin (E102), rumeni železov oksid (E172)
English: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state , panic attack, affect lability/mood swings, agitation
Slovenian: nenormalno vedenje, halucinacije, jeza, stanje zmedenosti,, napad panike,
English: Levetiracetam Teva 500 mg film-coated tablets levetiracetam
Slovenian: Levetiracetam Teva 500 mg filmsko obložene tablete levetiracetam
English: Respiratory,
Slovenian: Ušesne bolezni,
English: Infants 6 to 23 months, children and adolescents weighing less than 50 kg
Slovenian: 12 do 17 let), težke manj kot 50 kg
English: Levetiracetam Teva 250 mg film-coated tablets levetiracetam
Slovenian: Levetiracetam Teva 250 mg filmsko obložene tablete levetiracetam
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja ovojnina
English: Levetiracetam Teva 1,000 mg film-coated tablets
Slovenian: Levetiracetam Teva 1.000 mg filmsko obložene tablete
English: Pancytopenia, neutropenia, agranulocytosis
Slovenian: driska, dispepsija, bruhanje, navzea pankreatitis
English: Levetiracetam Teva 500 mg film-coated tablets
Slovenian: Levetiracetam Teva 500 mg filmsko obložene tablete
English: 10 to 30 mg/kg twice daily
Slovenian: 10 do 30 mg/kg dvakrat na dan blaga ledvična okvara
English: 10 to 20 mg/kg twice daily
Slovenian: 10 do 20 mg/kg dvakrat na dan zmerna ledvična okvara
English: Completed suicide, personality disorder, thinking abnormal, delirium
Slovenian: čustvena labilnost/nihanja v razpoloženju, agitacija samomor, osebnostne motnje, motnje mišljenja, delirij
English: Levetiracetam Teva 1000 mg film-coated tablets
Slovenian: Levetiracetam Teva 1000 mg filmsko obložene tablete
English: 5 to 15 mg/kg twice daily
Slovenian: 5 do 15 mg/kg dvakrat na dan huda ledvična okvara
English: Blue, oblong shaped, film-coated tablets, scored on one side and debossed with "9" on one side of the score and with "3" on the other side of the score.
Slovenian: Modra, podolgovata, filmsko obložena tableta z zarezo na eni strani z vtisnjeno oznako “9˝ na eni strani in ˝3” na drugi strani zareze, ter z vtisnjeno oznako “7285˝ na drugi strani tablete.
English: EU/1/11/701/022 30 film-coated tablets EU/1/11/701/023 50 film-coated tablets EU/1/11/701/024 50x1 film-coated tablet EU/1/11/701/025 60 film-coated tablets EU/1/11/701/026 100 film-coated tablets EU/1/11/701/027 120 film-coated tablets EU/1/11/701/028 200 film-coated tablets EU/1/11/701/032 20 film-coated tablets
Slovenian: EU/1/11/701/022 30 filmsko obloženih tablet EU/1/11/701/023 50 filmsko obloženih tablet EU/1/11/701/024 50x1 filmsko obložena tableta EU/1/11/701/025 60 filmsko obloženih tablet EU/1/11/701/026 100 filmsko obloženih tablet EU/1/11/701/027 120 filmsko obloženih tablet EU/1/11/701/028 200 filmsko obloženih tablet EU/1/11/701/032 20 filmsko obloženih tablet
English: EU/1/11/701/001 30 film-coated tablets EU/1/11/701/002 50 film-coated tablets EU/1/11/701/003 50x1 film-coated tablet EU/1/11/701/004 60 film-coated tablets EU/1/11/701/005 100 film-coated tablets EU/1/11/701/006 120 film-coated tablets EU/1/11/701/007 200 film-coated tablets EU/1/11/701/029 20 film-coated tablets
Slovenian: EU/1/11/701/001 30 filmsko obloženih tablet EU/1/11/701/002 50 filmsko obloženih tablet EU/1/11/701/003 50x1 filmsko obložena tableta EU/1/11/701/004 60 filmsko obloženih tablet EU/1/11/701/005 100 filmsko obloženih tablet EU/1/11/701/006 120 filmsko obloženih tablet EU/1/11/701/007 200 filmsko obloženih tablet EU/1/11/701/029 20 filmsko obloženih tablet
English: EU/1/11/701/008 30 film-coated tablets EU/1/11/701/009 50 film-coated tablets EU/1/11/701/010 50x1 film-coated tablet EU/1/11/701/011 60 film-coated tablets EU/1/11/701/012 100 film-coated tablets EU/1/11/701/013 120 film-coated tablets EU/1/11/701/014 200 film-coated tablets EU/1/11/701/030 20 film-coated tablets
Slovenian: EU/1/11/701/008 30 filmsko obloženih tablet EU/1/11/701/009 50 filmsko obloženih tablet EU/1/11/701/010 50x1 filmsko obložena tableta EU/1/11/701/011 60 filmsko obloženih tablet EU/1/11/701/012 100 filmsko obloženih tablet EU/1/11/701/013 120 filmsko obloženih tablet EU/1/11/701/014 200 filmsko obloženih tablet EU/1/11/701/030 20 filmsko obloženih tablet
English: EU/1/11/701/015 30 film-coated tablets EU/1/11/701/016 50 film-coated tablets EU/1/11/701/017 50x1 film-coated tablet EU/1/11/701/018 60 film-coated tablets EU/1/11/701/019 100 film-coated tablets EU/1/11/701/020 120 film-coated tablets EU/1/11/701/021 200 film-coated tablets EU/1/11/701/031 20 film-coated tablets
Slovenian: EU/1/11/701/015 30 filmsko obloženih tablet EU/1/11/701/016 50 filmsko obloženih tablet EU/1/11/701/017 50x1 filmsko obložena tableta EU/1/11/701/018 60 filmsko obloženih tablet EU/1/11/701/019 100 filmsko obloženih tablet EU/1/11/701/020 120 filmsko obloženih tablet EU/1/11/701/021 200 filmsko obloženih tablet EU/1/11/701/031 20 filmsko obloženih tablet
English: White, oblong shaped, film-coated tablets, scored on one side and debossed with "9" on one side of the score and with "3" on the other side of the score.
Slovenian: Bela, podolgovata, filmsko obložena tableta z zarezo na eni strani z vtisnjeno oznako “9˝ na eni strani in ˝3” na drugi strani zareze, ter z vtisnjeno oznako “7493˝ na drugi strani tablete.
English: Orange, oblong shaped, film-coated tablets, scored on one side and debossed with "9" on one side of the score and with "3" on the other side of the score.
Slovenian: Oranžna, podolgovata, filmsko obložena tableta z zarezo na eni strani z vtisnjeno oznako “9˝ na eni strani in ˝3” na drugi strani zareze, ter z vtisnjeno oznako “7287˝ na drugi strani tablete.
English: Yellow, oblong shaped, film coated tablets, scored on one side and debossed with "9" one side of the score and with "3" on the other side of the score.
Slovenian: Rumena, podolgovata, filmsko obložena tableta z zarezo na eni strani z vtisnjeno oznako “9˝ na eni strani in ˝3” na drugi strani zareze, ter z vtisnjeno oznako “7286˝ na drugi strani tablete.
English: Thrombocytopenia, leukopenia
Slovenian: UAB Sicor Biotech filiāle Latvijā
English: Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention
Slovenian: Bolezni živčevja somnolenca, glavobol konvulzije, motnje ravnotežja, omotica, letargija, tremor amnezija, oslabljen spomin, poslabšana koordinacija/ataksija, parestezija, motnje pozornosti horeoatetoza, diskinezija, hiperkinezija, motnje hoje, encefalopatija
English: Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more
Slovenian: Dopolnilno zdravljenje za odrasle (≥ 18 let) in mladostnike (od 12 do 17 let), težke 50 kg in več Začetni terapevtski odmerek je 500 mg dvakrat na dan. Z njim se lahko začne prvi dan zdravljenja.
English: An oral solution is the preferred formulation for use in this population.
Slovenian: Pri tej populaciji se priporoča uporaba peroralne raztopine.
English: CLcr (ml/min/1.73 m2 = Height (cm) x ks____
Slovenian: (ml/min/1,73m odmerjanje in pogostnost(1)
English: However, the longterm effects of the medicine will need to be further investigated.
Slovenian: Vendar pa bo treba dolgoročne učinke zdravila nadalje raziskati.
English: It is available as tablets (5, 10, 15 and 20 mg).
Slovenian: Na voljo je v obliki tablet (5, 10, 15 in 20 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jakavi on 23 August 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Jakavi, veljavno po vsej Evropski uniji, izdala 23. avgusta 2012.
English: Jakavi ruxolitinib
Slovenian: Jakavi ruksolitinib
English: What measures are being taken to ensure the safe and effective use of Jakavi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Jakavi?
English: If the treatment is not considered effective enough, the dose can be increased by 5 mg up to 25 mg twice a day.
Slovenian: Če se zdravljenje ne zdi dovolj učinkovito, se lahko odmerek poveča za 5 mg do 25 mg dvakrat na dan.
English: The full EPAR for Jakavi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Jakavi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: With regard to safety, the Committee considered that the risk of infections is acceptable but should be monitored further, while other known risks, such as bleeding or a reduction in blood cell counts, can be appropriately managed.
Slovenian: V zvezi z varnostjo je menil, da je tveganje okužb sprejemljivo, vendar ga je treba še naprej nadzirati, druga znana tveganja, kot so krvavitev ali zmanjšanje števila krvnih celic, pa je mogoče ustrezno obravnavati.
English: Other information about Jakavi
Slovenian: Druge informacije o zdravilu Jakavi
English: The main measure of effectiveness was the proportion of patients whose spleen had reduced in size by at least 35%, measured after six months in the first study and after one year in the second study.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih se je velikost vranice zmanjšala za vsaj 35 %, izmerjeno po šestih mesecih v prvi študiji, in po enem letu v drugi študiji.
English: This is a summary of the European public assessment report (EPAR) for Jakavi.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Jakavi.
English: Jakavi is used to treat the following conditions:
Slovenian: Zdravilo Jakavi se uporablja za zdravljenje naslednjih bolezni:
English: What benefit has Jakavi shown during the studies?
Slovenian: Kakšne koristi je zdravilo Jakavi izkazalo med študijami?
English: In polycythaemia vera treatment should also be stopped when haemoglobin levels are very low.
Slovenian: Pri pravi policitemiji je treba zdravljenje prekiniti, kadar so ravni hemoglobina zelo nizke.
English: For more information about treatment with Jakavi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Jakavi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: These blood cells migrate to organs including the spleen, causing them to become enlarged.
Slovenian: Te krvne celice potujejo do organov, vključno z vranico, ki se zaradi tega povečajo.
English: A risk management plan has been developed to ensure that Jakavi is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Jakavi je bil pripravljen načrt obvladovanja tveganj.
English: The CHMP decided that Jakavi's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Jakavi večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: The second study compared Jakavi with the best available treatment, which included different types of medicines such as anti-cancer agents, hormones and immunosuppressants.
Slovenian: V drugi študiji so zdravilo Jakavi primerjali z najboljšo razpoložljivo obliko zdravljenja, ki vključuje različne vrste zdravil, kot so zdravila proti raku, hormoni in imunosupresivi.
English: In polycythaemia vera, the company will extend the main study to provide long-term data on the safety and effectiveness of Jakavi.
Slovenian: V zvezi s pravo policitemijo bo družba podaljšala glavno študijo, da bo zbrala dolgoročne podatke o varnosti in učinkovitosti zdravila Jakavi.
English: What is the risk associated with Jakavi?
Slovenian: Kakšna tveganja so povezana z zdravilom Jakavi?
English: Treatment should be stopped if the patient's blood levels of platelets or neutrophils (a type of white blood cell) fall below certain thresholds, or if no improvement in spleen size or symptoms is seen after six months.
Slovenian: Zdravljenje je treba prekiniti, če se vrednosti krvnih ploščic ali nevtrofilcev (vrste belih krvnih celic) v bolnikovi krvi znižajo pod določeno vrednost ali če se velikost vranice ali simptomi po šestih mesecih zdravljenja ne izboljšajo.