FrancophonIA/ELRC3.0 huggingface dataset:
English: Interstitial Lung Disease (ILD)
Slovenian: Bolezni imunskega sistema pogosti intersticijska bolezen pljuč*
English: • Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Progression free survival (PFS) as assessed by an IRC according to IWCLL criteria indicated a 78% statistically significant reduction in the risk of death or progression for patients in the IMBRUVICA
Slovenian: Po podatkih o preživetju brez napredovanja bolezni, ki jih je ocenila neodvisna komisija za pregled podatkov (IRC) po kriterijih IWCLL, je v skupini z zdravilom IMBRUVICA prišlo do 78-odstotnega statistično značilnega znižanja tveganja za smrt ali napredovanje bolezni.
English: • Mantle cell lymphoma (MCL), a type of cancer affecting the lymph nodes, when the disease has come back or has not responded to treatment.
Slovenian: Za kaj uporabljamo zdravilo IMBRUVICA Uporabljamo ga za zdravljenje naslednjih krvnih rakov pri odraslih: - Limfom plaščnih celic (MCL - mantle cell lymphoma) (to je vrsta raka, ki prizadene bezgavke) pri bolnikih, pri katerih se je bolezen ponovila ali niso odgovorili na zdravljenje.
English: Atrial fibrillation Uncommon Ventricular tachyarrhythmia
Slovenian: Srčne bolezni pogosti atrijska fibrilacija občasni ventrikularna tahiaritmija
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (30 days)
Slovenian: ZGIBANKA 140 MG TABLETE (30 dni)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (28 days)
Slovenian: ZGIBANKA 140 MG TABLETE (28 dni)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg tablets ibrutinib
Slovenian: IMBRUVICA 560 mg tablete ibrutinib
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg tablets ibrutinib
Slovenian: IMBRUVICA 420 mg tablete ibrutinib
English: The dose of ibrutinib should be reduced to 280 mg once daily (two capsules) when used concomitantly with moderate CYP3A4 inhibitors.
Slovenian: Pri sočasni uporabi z zmernimi zaviralci CYP3A4 je treba odmerek ibrutiniba zmanjšati na 280 mg na dan (dve kapsuli).
English: Febrile neutropenia Leukocytosis Lymphocytosis
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti nevtropenija trombocitopenija pogosti febrilna nevtropenija levkocitoza limfocitoza redki sindrom levkostaze
English: Figure 3: Kaplan-Meier curve of OS (ITT Population) in Study PCYC-1115-CA
Slovenian: Slika 3: Kaplan-Meierjeva krivulja OS (populacija ITT) v študiji PCYC-1115-CA
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg tablets ibrutinib
Slovenian: IMBRUVICA 280 mg tablete ibrutinib
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Slovenian: 14 filmsko obloženih tablet
English: Second restart at 420 mg daily restart at 280 mg daily
Slovenian: prvič ponovna uvedba s 560 mg na dan ponovna uvedba s 420 mg na dan drugič ponovna uvedba s 420 mg na dan ponovna uvedba z 280 mg na dan tretjič ponovna uvedba z 280 mg na dan ponovna uvedba s 140 mg na dan četrtič ukinitev zdravljenja z zdravilom IMBRUVICA
English: • temporary episode of neurologic dysfunction caused by loss of blood flow, stroke.
Slovenian: težave pri požiranju ali dihanju, srbeč izpuščaj (koprivnico) - vnetje podkožnega maščevja - začasna epizoda nevrološke disfunkcije, ki jo povzroči izguba pretoka krvi, možganska kap
English: Atrial fibrillation, atrial flutter and cases of ventricular tachyarrhythmia have been reported in patients treated with IMBRUVICA.
Slovenian: Pri bolnikih, ki so jemali zdravilo IMBRUVICA, so poročali o primerih atrijske fibrilacije, atrijske undulacije in ventrikularne tahiaritmije.
English: Titanium dioxide (E171) Black iron oxide (E172) Red iron oxide (E172)
Slovenian: IMBRUVICA 280 mg filmsko obložene tablete makrogol polivinilalkohol smukec titanov dioksid (E171) črni železov oksid (E172) rdeči železov oksid (E172)
English: Metabolism and nutrition disorders
Slovenian: zeliščna zdravila in prehranske nadomestke.
English: CI=confidence interval; HR=hazard ratio; CR=complete response; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response IRC evaluated, median follow-up 18.4 months.
Slovenian: (Overall Response Rate) = celokupni delež odgovora, OS (overall survival) = celokupno preživetje, PFS (Progression Free Survival) = preživetje brez napredovanja bolezni, PR (partial response) = delni odgovor ocenjeno s strani IRC, mediano spremljanje 18,4 mesece Mediana celokupnega preživetja ni bila dosežena pri nobeni od obeh skupin; p < 0,005 za OS.
English: Drug-drug interactions
Slovenian: Prilagajanje odmerkov
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/945/001 (90 hard capsules) EU/1/14/945/002 (120 hard capsules)
Slovenian: EU/1/14/945/001 (90 trdih kapsul) EU/1/14/945/002 (120 trdih kapsul)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg film-coated tablets ibrutinib
Slovenian: IMBRUVICA 420 mg filmsko obložene tablete ibrutinib
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja zelo pogosti izpuščaj*
English: Mildly decreased trabecular and cortical bone was seen in female rats administered ≥100 mg/kg/day (AUC exposure margin of 20.3-fold).
Slovenian: Pri podganjih samicah, ki so jim dajali odmerke ≥ 100 mg/kg/dan (z mejo izpostavljenosti, ki je bila 20,3-kratnik AUC) so opazili nekoliko zmanjšan volumen trabekularne in kortikalne kostnine.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg tablets ibrutinib
Slovenian: IMBRUVICA 140 mg tablete ibrutinib
English: QUALITATIVE AND QUANTITATIVE COMPOSITION IMBRUVICA 140 mg film-coated tablets Each film-coated tablet contains 140 mg of ibrutinib.
Slovenian: IMBRUVICA 140 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 140 mg ibrutiniba.
English: Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172)
Slovenian: IMBRUVICA 560 mg filmsko obložene tablete makrogol polivinilakohol smukec titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172)
English: IMBRUVICA contains lactose
Slovenian: Zdravilo IMBRUVICA vsebuje laktozo
English: IMBRUVICA Hard Capsules Janssen Pharmaceutica NV Turnhoutseweg 30
Slovenian: IMBRUVICA trde kapsule Janssen-Cilag International NV Turnhoutseweg 30
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg film-coated tablets ibrutinib
Slovenian: IMBRUVICA 140 mg filmsko obložene tablete ibrutinib
English: Figure 6: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1112- CA
Slovenian: Slika 6: Kaplan-Meierjeva krivulja PFS (populacija z namenom zdravljenja, angl. ITT population) v študiji PCYC-1112- CA
English: Grade ≥3
Slovenian: Stopnje ≥3 (%)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg film-coated tablets ibrutinib
Slovenian: IMBRUVICA 560 mg filmsko obložene tablete ibrutinib
English: • if you are taking a herbal medicine called St. John's Wort, used for depression.
Slovenian: - če za zdravljenje depresije uporabljate zdravilo rastlinskega izvora s šentjanževko.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg film-coated tablets ibrutinib
Slovenian: IMBRUVICA 280 mg filmsko obložene tablete ibrutinib
English: Ibrutinib has a pH dependent solubility, with lower solubility at higher pH. A lower Cmax was observed in fasted healthy subjects administered a single 560 mg dose of ibrutinib after taking omeprazole at 40 mg once daily for 5 days (see section 5.2).
Slovenian: Pri zdravih teščih osebah, ki so prejele enkratni 560 mg odmerek ibrutiniba po jemanju 40 mg omeprazola enkrat na dan, 5 dni (glejte poglavje 5.2), so opazili nižjo vrednost Cmax.
English: Response Rate (CR, VGPR, PR) Median duration of response, months (range)
Slovenian: Delež odgovora (CR, VGPR, PR)
English: Tests and check-ups before and during treatment Tumour lysis syndrome (TLS): Unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have happened during treatment of cancer and sometimes even without treatment.
Slovenian: Sindrom razpada tumorja (TLS-Tumour lysis syndrome): nenormalne koncentracije biokemijskih parametrov, ki jih povzroči hitro razpadanje rakavih celic.
English: • if you have ever had or might now have a hepatitis B infection.
Slovenian: - če ste kdaj bili ali ste morda zdaj okuženi z virusom hepatitisa B. Zdravilo IMBRUVICA namreč lahko povzroči ponovno aktivacijo hepatitisa B. Pred začetkom zdravljenja bo zdravnik skrbno pregledal bolnike glede znakov te okužbe.
English: Angioedema Panniculitis
Slovenian: Shranjevanje zdravila IMBRUVICA
English: Figure 2: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1115-CA
Slovenian: Slika 2: Kaplan-Meierjeva krivulja PFS (populacija z namenom zdravljenja (ITT-Intention To Treat Population)) v študiji PCYC-1115-CA
English: Cases of ILD have been reported in patients treated with IMBRUVICA.
Slovenian: Intersticijska bolezen pljuč (ILD-Interstitial Lung Disease) Pri bolnikih, ki so jemali zdravilo IMBRUVICA so poročali o primerih ILD.
English: Fourth discontinue IMBRUVICA
Slovenian: ukinitev zdravljenja z zdravilom IMBRUVICA
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg hard capsules
Slovenian: IMBRUVICA 140 mg trde kapsule
English: Ibrutinib has no genotoxic properties when tested in bacteria, mammalian cells or in mice.
Slovenian: Pri testiranju na bakterijskih in sesalskih celicah ter na miših ibrutinib ni kazal genotoksičnih lastnosti.
English: PHARMACEUTICAL FORM AND CONTENTS 90 capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA
English: The CR rate according to IWCLL criteria was 16.2% in the IMBRUVICA arm versus 3.0% in the chlorambucil arm. At the time of long-term follow-up, a total of 73 subjects (54.9%) originally randomized to the chlorambucil arm subsequently received ibrutinib as cross-over treatment.
Slovenian: V času pregleda po dolgotrajnem zdravljenju je skupno 73 preiskovancev (54,9%), ki so bili sprva randomizirani v skupino s klorambucilom, kasneje prejemalo ibrutinib v okviru navzkrižnega zdravljenja.
English: Consider the risks and benefits of anticoagulant or antiplatelet therapy when co-administered with IMBRUVICA.
Slovenian: Pri sočasni uporabi zdravila IMBRUVICA z antikoagulanti ali protitrombocitnimi zdravili je treba pretehtati tveganja in koristi teh zdravljenj.
English: EU/1/14/945/009 - 28 tablets (2 wallet packs of 14) EU/1/14/945/010 - 30 tablets (3 wallet packs of 10)
Slovenian: EU/1/14/945/009 (28 tablet) EU/1/14/945/010 (30 tablet)
English: EU/1/14/945/012 - 28 tablets (2 wallet packs of 14) EU/1/14/945/006 - 30 tablets (3 wallet packs of 10)
Slovenian: EU/1/14/945/012 (28 tablet) EU/1/14/945/006 (30 tablet)
English: EU/1/14/945/007 - 28 tablets (2 wallet packs of 14) EU/1/14/945/008 - 30 tablets (3 wallet packs of 10)
Slovenian: EU/1/14/945/007 (28 tablet) EU/1/14/945/008 (30 tablet)
English: Tumour lysis syndrome
Slovenian: Sindrom razpada tumorja
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 140 MG CAPSULE
Slovenian: NALEPKA NA PLASTENKI 140 MG KAPSULE
English: EU/1/14/945/011 - 28 tablets (2 wallet packs of 14) EU/1/14/945/005 - 30 tablets (3 wallet packs of 10)
Slovenian: EU/1/14/945/011 (28 tablet) EU/1/14/945/005 (30 tablet)
English: Median (95% CI), months
Slovenian: HR (95% IZ) TTnT mediana (95% IZ), meseci ni dosežena
English: The Kaplan-Meier curve for PFS is shown in Figure 6.
Slovenian: Na Sliki 6 je prikazana Kaplan-Meierjeva krivulja PFS.
English: Progression-free survival (PFS) was assessed by IRC according to IWCLL criteria indicated a 77% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. With a median follow-up time on study of 31 months, the median PFS was not reached in the IMBRUVICA+obinutuzumab arm and was 19 months in the chlorambucil+obinutuzumab arm. Efficacy results for Study PCYC-1130-CA are shown in Table 5 and the Kaplan-Meier curve for PFS is shown in Figure 5.
Slovenian: Z medianim trajanjem spremljanja bolnikov v študiji 31 mesecev v skupini z zdravilom IMBRUVICA in obinutuzumabom mediana vrednost PFS ni bila dosežena, v skupini s klorambucilom in obinutuzumabom pa je bila 19 mesecev.
English: • if you have irregular heart beat or have a history of irregular heart beat or severe heart failure, or if you feel any of the following: shortness of breath, weakness, dizziness, light-headedness, fainting or near fainting, chest pain or swollen legs
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - hude okužbe celega telesa (sepsa) - okužba sečil - krvavitve iz nosu, majhne rdeče ali vijolične pike, ki nastanejo zaradi krvavitve pod kožo - kri v trebuhu, črevesju, blatu ali urinu, močnejše menstrualne krvavitve ali krvavitev iz rane, ki je ne morete ustaviti - hitro bitje srca, izpuščeni posamezni srčni utripi, šibak ali neenakomeren pulz, omotica,
English: • allergic reaction, sometimes severe, that may include a swollen face, lip, mouth, tongue or throat, difficulty swallowing or breathing, itchy rash (hives)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - odpoved jeter - hude glivične okužbe - zmedenost, glavobol z oteženim govorom ali občutkom omedlevice - to so lahko znaki resne notranje krvavitve v možganih - alergijska reakcija, včasih huda, ki lahko vključuje oteklost obraza, ustnic, ust, jezika ali grla,
English: • If you are not sure, talk to your doctor, pharmacist or nurse about when to take your next dose.
Slovenian: - Če niste prepričani, kdaj morate vzeti naslednji odmerek, se posvetujte z zdravnikom,
English: Onychoclasis
Slovenian: Citopenije
English: Progression free survival (PFS) as assessed by IRC according to International Workshop on CLL (IWCLL) criteria indicated an 84% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. Efficacy results for Study PCYC-1115-CA are shown in Table 4 and the Kaplan-Meier curves for PFS and OS are shown in Figures 2 and 3, respectively.
Slovenian: Podatki o preživetju brez napredovanja bolezni (PFS- Progression free survival), ki jih je ocenila IRC glede na kriterije mednarodnega seminarja za KLL (IWCLL - International Workshop on CLL) so pokazali 84% statistično značilno zmanjšanje tveganja za smrt ali napredovanje bolezni v skupini, ki je prejemala zdravilo IMBRUVICA.
English: Also tell your doctor if you take any of the following medicines - The effects of IMBRUVICA or other medicines may be influenced if you take IMBRUVICA together with any of the following medicines:
Slovenian: Poleg tega zdravniku povejte, če jemljete katero od naslednjih zdravil - na učinke zdravila IMBRUVICA ali drugih zdravil lahko vpliva sočasno jemanje zdravila IMBRUVICA s katerim koli od naslednjih zdravil: - zdravila, ki jih imenujemo antibiotiki in jih uporabljamo za zdravljenje bakterijskih okužb klaritromicin, telitromicin, ciprofloksacin, eritromicin ali rifampicin - zdravila proti glivičnim okužbam - posakonazol, ketokonazol, itrakonazol, flukonazol ali vorikonazol - zdravila, ki jih uporabljamo pri okužbi z virusom humane imunske pomanjkljivosti (HIV)
English: Hepatic impairment
Slovenian: Huda bolezen srca
English: Swallow the tablet whole.
Slovenian: Tablete je treba pogoltniti cele z vodo.
English: Analysis of OS demonstrated a 57% statistically significant reduction in the risk of death for patients in the IMBRUVICA arm. Efficacy results for Study PCYC-1112-CA are shown in Table 7.
Slovenian: Analiza OS je pri bolnikih v skupini z zdravilom IMBRUVICA pokazala 57-odstotno statistično značilno znižanje tveganja za smrt.
English: Very common Haemorrhage Bruising Hypertension
Slovenian: Presnovne in prehranske motnj pogosti sindrom razpada tumorja hiperurikemija
English: • blood thinners such as warfarin, heparin or other medicines for blood clots
Slovenian: Mednje sodijo: - acetilsalicilna kislina in nesteroidna protivnetna zdravila, kot sta ibuprofen in naproksen - zdravila, ki zavirajo strjevanje krvi, kot so varfarin, heparin in druga zdravila, ki delujejo proti nastanku krvnih strdkov - prehranski nadomestki, ki lahko povečajo možnost krvavitve, kot so ribje olje, vitamin E ali laneno seme
English: EU/1/14/945/010 (30 tablets)
Slovenian: EU/1/14/945/010
English: Uncommon Angioedema Panniculitis
Slovenian: pogosti urtikarija eritem lomljenje nohtov občasni angioedem panikulitis*
English: EU/1/14/945/006 (30 tablets)
Slovenian: EU/1/14/945/006
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Slovenian: peroralna uporaba Pred uporabo preberite priloženo navodilo!
English: EU/1/14/945/005 (30 tablets)
Slovenian: EU/1/14/945/005
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/12/763/001 Ecansya
Slovenian: Velikost pakiranja pretisni omot (alu/alu)
English: 1 bottle + 1 oral syringe 10 ml
Slovenian: 1 steklenička + 1 peroralna brizga 10 ml
English: EU Number
Slovenian: Številka EU Izmišljeno ime Jakost
English: This overview was last updated in 07-2018.
Slovenian: Pregled je bil nazadnje posodobljen 07-2018.
English: Histamine is a substance occurring naturally in the body that is involved in many processes.
Slovenian: Histamin je snov, ki je naravno prisotna v telesu, in je vpletena v številne procese.
English: This means that it changes the activity of the immune system (the body's natural defences).
Slovenian: To pomeni, da spreminja delovanje imunskega sistema (naravnega obrambnega mehanizma telesa).
English: The European Medicines Agency decided that Ceplene's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Ceplene večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: It is used during the patients' first ‘remission' (a period without symptoms of the disease after the first course of treatment).
Slovenian: Uporablja se pri bolnikih med „prvo remisijo“ (obdobjem brez simptomov bolezni po prvem krogu zdravljenja).
English: This can increase the length of time the patient stays in remission.
Slovenian: S tem se podaljša čas, ko bolnik ostane v remisiji.
English: What measures are being taken to ensure the safe and effective use of Ceplene?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ceplene?
English: Ceplene received a marketing authorisation valid throughout the EU on 7 October 2008.
Slovenian: Za zdravilo Ceplene je bilo 7. oktobra 2008 izdano dovoljenje za promet, veljavno po vsej EU.
English: It is available as a solution for injection under the skin.
Slovenian: Na voljo je v obliki raztopine za injiciranje pod kožo.
English: Other information about Ceplene
Slovenian: Druge informacije o zdravilu Ceplene
English: An overview of Ceplene and why it is authorised in the EU
Slovenian: Pregled zdravila Ceplene in zakaj je odobreno v EU
English: Ceplene must not be used in patients who have severe heart problems or in women who are pregnant or breastfeeding.
Slovenian: Zdravilo Ceplene se ne sme uporabljati pri bolnikih, ki imajo resne težave s srcem, ali pri ženskah, ki so noseče ali dojijo.
English: As for all medicines, data on the use of Ceplene are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ceplene stalno spremljajo.
English: AML is rare, and Ceplene was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 April 2005.
Slovenian: AML je redka bolezen, zdravilo Ceplene pa je bilo 11. aprila 2005 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Ceplene has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Ceplene je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
English: Further information on Ceplene can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Ceplene so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Ceplene and what is it used for?
Slovenian: Kaj je zdravilo Ceplene in za kaj se uporablja?
English: Depending on the patient's response to treatment and side effects, the treatment may have to be suspended or the dose adjusted.
Slovenian: Glede na bolnikov odziv na zdravljenje in neželene učinke se lahko zdravljenje prekine ali pa se odmerek prilagodi.
English: Between each cycle there should be a treatment-free period of 3 weeks.
Slovenian: En cikel traja 3 tedne, med vsakim ciklom pa mora biti obdobje 3 tednov brez zdravljenja.
English: Side effects reported with Ceplene are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Ceplene, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What benefit of Ceplene have been shown in studies?
Slovenian: Kakšne koristi zdravila Ceplene so se pokazale v študijah?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ceplene have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ceplene upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The recommended dose of Ceplene is one injection twice a day, one to three minutes after an interleukin-2 injection.
Slovenian: Priporočeni odmerek zdravila Ceplene je ena injekcija dvakrat dnevno, od ene do treh minut po injekciji interlevkina-2.
English: What are the risks associated with Ceplene?
Slovenian: Kakšna tveganja so povezana z zdravilom Ceplene?
English: For more information about using Ceplene, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Ceplene glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The effectiveness of Ceplene has been studied in one main study involving 320 adults with AML who were in remission following leukaemia treatment.
Slovenian: Učinkovitost zdravila Ceplene so preučevali v eni glavni študiji, v kateri je sodelovalo 320 odraslih bolnikov z AML, ki so bili v remisiji po zdravljenju levkemije.
English: This is because it has not been possible to obtain complete information about Ceplene due to the rarity of the disease.
Slovenian: To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
English: Ceplene (histamine dihydrochloride)
Slovenian: Ceplene (histaminijev diklorid)
English: The company that markets Ceplene will provide yearly updates on the safety and effectiveness of Ceplene in combination with interleukin-2 in AML patients in first remission.
Slovenian: Podjetje, ki trži zdravilo Ceplene, bo zagotovilo letne posodobitve glede varnosti in učinkovitosti zdravila Ceplene v kombinaciji z interlevkinom-2 pri bolnikih z AML v prvi remisiji.
English: Why has Ceplene been approved?
Slovenian: Zakaj je bilo zdravilo Ceplene odobreno?
English: Ceplene can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in the treatment of AML.
Slovenian: Predpisovanje in izdaja zdravila Ceplene je le na recept, dajati pa ga je treba pod nadzorom zdravnika z izkušnjami z zdravljenjem AML.
English: For patients who were into their first remission the combination of Ceplene and interleukin-2 was more effective than no treatment in increasing the time until AML came back or the patient died from any cause: the average time without disease increased from 291 days with no treatment to 450 days after treatment with Ceplene and interleukin-2.
Slovenian: Kombinacija zdravila Ceplene in interlevkina-2 je bila pri bolnikih v prvi remisiji v primerjavi z bolniki brez zdravljenja učinkovitejša pri podaljšanju časa, ko se bolezen AML ponovi ali bolnik iz katerega koli razloga umre: povprečni čas brez bolezni se je podaljšal z 291 dni (brez zdravljenja) na 450 dni (po zdravljenju z zdraviloma Ceplene in interlevkin-2).