FrancophonIA/ELRC3.0 huggingface dataset:
English: Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose acetylsalicylic acid or other active substances likely to increase gastrointestinal risk (see below and section 4.5).
Slovenian: Za te bolnike in tudi za bolnike, ki morajo sočasno jemati nizke odmerke acetilsalicilne kisline ali drugih zdravil, ki utegnejo povečati gastrointestinalno tveganje, je priporočljivo kombinirano zdravljenje z zaščitnimi sredstvi (kot so npr. mizoprostol ali zaviralci protonske črpalke) (glejte spodaj in poglavje 4.5).
English: Xefo and associated names (see Annex I) 8 mg powder and solvent for solution for injection [See Annex I - To be completed nationally]
Slovenian: Xefo in povezana imena (glejte Dodatek I) 8 mg prašek in vehikel za raztopino za injiciranje [Glejte Dodatek I - Izpolni država članica]
English: Some patients may need further 8 mg within the first day of treatment Xefo 8 mg powder for solution for injection must be dissolved with the accompanying 2 ml solvent for solution for injection before use
Slovenian: Pred uporabo je treba zdravilo Xefo 8 mg prašek za raztopino za injiciranje raztopiti s priloženima 2 ml vehikla za raztopino za injiciranje.
English: WHAT XEFO IS AND WHAT IT IS USED FOR Xefo is a non-steroidal anti-inflammatory drug and antirheumatic drug (NSAID) of the oxicam class.
Slovenian: Xefo je nesteroidno protivnetno zdravilo in antirevmatično zdravilo iz razreda oksikamov.
English: If you take more Xefo Rapid than you should Please contact your doctor or the pharmacist if you have taken more Xefo Rapid than prescribed.
Slovenian: Če ste vzeli večji odmerek zdravila Xefo Rapid, kot bi smeli Če ste vzeli večji odmerek zdravila Xefo Rapid, kot je predpisan, obvestite svojega zdravnika ali farmacevta.
English: Excipients: Lactose 90 mg For a full list of excipients, see section 6.1.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 8 mg lornoksikama Pomožne snovi: laktoza 90 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Xefo and associated names (see Annex I) 8 mg powder for solution for injection [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Xefo in povezana imena (glejte Dodatek I) 8 mg prašek za raztopino za injiciranje [Glejte Dodatek I - Izpolni država članica] Lornoksikam i.v.
English: Xefo film-coated tablets are supplied for oral use and should be taken with a sufficient quantity of liquid.
Slovenian: Zdravilo Xefo filmsko obložene tablete je namenjeno peroralni uporabi in ga mora bolnik vzeti z dovolj tekočine.
English: Blister: Do not store above 30 °C
Slovenian: Pretisni omot: Shranjujte pri temperaturi do 30 °C.
English: Ear and labyrinth disorders Uncommon: Vertigo, tinnitus.
Slovenian: Ušesne bolezni, vključno z motnjami labirinta Občasni: vrtoglavica, tinitus.
English: LIST OF EXCIPIENTS Lactose monohydrate For other excipients, see package leaflet
Slovenian: SEZNAM POMOŽNIH SNOVI laktoza monohidrat
English: PHARMACEUTICAL FORM Film-coated tablet
Slovenian: Filmsko obložena tableta.
English: Amber glass, class III (hydrolytic) with aluminium screw cap closures.
Slovenian: Vsebnik za tablete: steklo (tipa III) jantarne barve z aluminijastim navojnim pokrovčkom.
English: Cellulose, microcrystalline Sodium hydrogen carbonate Calcium hydrogen phosphate, anhydrous Low substituted hydroxypropylcellulose Hydroxypropylcellulose Calcium stearate
Slovenian: 6.1 Seznam pomožnih snovi Sredica: celuloza, mikrokristalinična natrijev hidrogenkarbonat kalcijev hidrogenfosfat, brezvodni nizkosubstituirana hidroksipropilceluloza hidroksipropilceluloza kalcijev stearat Film: titanov dioksid (E171) smukec propilenglikol hipromeloza
English: Uncommon: Flushing, oedema.
Slovenian: Občasni: oblivanje, edem.
English: Xefo Rapid film-coated tablets are supplied for oral administration and should be taken with a sufficient quantity of liquid.
Slovenian: Zdravilo Xefo Rapid filmsko obložene tablete je namenjeno peroralni uporabi in ga mora bolnik vzeti z dovolj tekočine.
English: - if you suffer from thrombocytopenia - if you are hypersensitive to other NSAIDs including acetylsalicylic acid - if you suffer from severe heart failure - if you suffer from gastro-intestinal bleeding, cerebrovascular bleeding or other bleeding disorders - if you have a history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy - if you suffer from an active or have a history of recurrent peptic ulcer - if you suffer from severe liver impairment - if you suffer form severe renal impairment - if you are in the last three months of your pregnancy
Slovenian: Ne uporabljajte zdravila Xefo - če ste alergični na (preobčutljivi za) lornoksikam ali katerokoli sestavino zdravila Xefo - prašek in vehikel za raztopino za injiciranje, - če imate trombocitopenijo, - če ste preobčutljivi za druga nesteroidna protivnetna zdravila, vključno z acetilsalicilno kislino, - če imate hudo srčno popuščanje, - če imate krvavitev v prebavilih, cerebrovaskularno krvavitev ali druge bolezni s krvavitvijo, - če ste kdaj imeli krvavitev ali perforacijo v prebavilih, povezano s predhodnim zdravljenjem z nesteroidnimi protivnetnimi zdravili, - če imate ali ste kdaj imeli rekurentno peptično razjedo, - če imate hudo okvaro jeter, - če imate hudo okvaro ledvic, - če ste v zadnjem tromesečju nosečnosti.
English: Adverse events
Slovenian: Neželeni učinki
English: If you take more Xefo than you should Please contact your doctor or the pharmacist if you have received more Xefo than prescribed.
Slovenian: Če ste uporabili večji odmerek zdravila Xefo, kot bi smeli Če ste prejeli večji odmerek zdravila Xefo, kot je predpisan, obvestite svojega zdravnika ali farmacevta.
English: If you suffer from blood coagulation disorder, impaired liver function, such as liver cirrhosis, are elderly or you will be treated with Xefo for more than 3 months, your doctor may monitor you by laboratory test on a frequent basis.
Slovenian: Zdravnik bo morda spremljal vaše zdravljenje z rednimi laboratorijskimi preiskavami, če imate motnjo strjevanja krvi, okvarjeno ledvično funkcijo, npr. jetrno cirozo, če ste starostnik ali če se boste zdravili z zdravilom Xefo dlje kot 3 mesece.
English: Xefo Rapid film-coated tablets are supplied for oral use and should be taken before meals with a glass quantity of liquid.
Slovenian: Jemanje zdravila Xefo Rapid skupaj s hrano in pijačo Zdravilo Xefo Rapid filmsko obložene tablete je namenjeno peroralni uporabi in ga morate vzeti pred obrokom z zadostno količino tekočine.
English: If you take more Xefo than you should Please contact your doctor or the pharmacist if you have taken more Xefo than prescribed.
Slovenian: Če ste vzeli večji odmerek zdravila Xefo, kot bi smeli Če ste vzeli večji odmerek zdravila Xefo, kot je predpisan, obvestite svojega zdravnika ali farmacevta.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 8 mg lornoxicam.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 8 mg lornoksikama.
English: Lornoxicam “Nycomed” 8 mg Film-coated tablet
Slovenian: Lornoxicam „Nycomed“
English: Xefo Rapid and associated names (see Annex I) 8 mg film-coated tablets [see Annex I - to be completed nationally]
Slovenian: Xefo Rapid in povezana imena (glejte Dodatek I) 8 mg filmsko obložene tablete [Glejte Dodatek I - Izpolni država članica]
English: Xefo and associated names (see Annex I) 8 mg film-coated tablets [see Annex I - To be completed nationally]
Slovenian: Xefo in povezana imena (glejte Dodatek I) 8 mg filmsko obložene tablete [Glejte Dodatek I - Izpolni država članica]
English: Indication lornoxicam dose
Slovenian: STEKLENA VIALA ZA PRAŠEK LORNOXICAM
English: Propylene glycol
Slovenian: AMPULA ZA VEHIKEL
English: Xefo film-coated tablets are supplied for oral use and should be taken before meals with a sufficient quantity of liquid.
Slovenian: Jemanje zdravila Xefo skupaj s hrano in pijačo Zdravilo Xefo filmsko obložene tablete je namenjeno peroralni uporabi in ga morate vzeti pred obrokom z zadostno količino tekočine.
English: The justification for combining data from lornoxicam administered p.o. and i.m.
Slovenian: Utemeljitev za združitev podatkov o peroralno in intramuskularno dajanem lornoksikamu v 3. metaanalizi ni prepričljiva.
English: Lornoxicam caused renal toxicity and gastrointestinal ulceration single- and repeat-dose toxicity studies in several species.
Slovenian: V študijah toksičnosti pri enem odmerku in ponavljajočih se odmerkih na več živalskih vrstah je lornoksikam povzročil toksične učinke na ledvice in razjede v prebavilih.
English: Oral
Slovenian: Sklepi
English: If you suffer from blood coagulation disorder, impaired liver function, are elderly or you will be treated with Xefo Rapid for more than 3 months, your doctor may monitor you by laboratory test on a frequent basis.
Slovenian: Zdravnik bo morda spremljal vaše zdravljenje z rednimi laboratorijskimi preiskavami, če imate motnjo strjevanja krvi, okvarjeno ledvično funkcijo, npr. jetrno cirozo, če ste starostnik ali če se boste zdravili z zdravilom Xefo Rapid dlje kot 3 mesece.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 8 mg lornoxicam.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 8 mg lornoksikama.
English: Always take Xefo Rapid exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Xefo Rapid natančno upoštevajte zdravnikova navodila.
English: Eye disorders Uncommon: Conjuctivitis Rare: Visual disturbances.
Slovenian: Očesne bolezni Občasni: konjuktivitis.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: Izgled zdravila Xefo in vsebina pakiranja
English: 6.1 List of excipients Powder:
Slovenian: 6.1 Seznam pomožnih snovi Prašek: manitol trometamol dinatrijev edetat
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE FOR SOLVENT
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.
Slovenian: V zvezi z zdravljenjem z NSAID so poročali o edemih, hipertenziji in srčnem popuščanju.
English: Pharmacodynamic properties - Section 5.1
Slovenian: Terapevtske indikacije - poglavje 4.1 SPC
English: If you suffer from blood coagulation disorder, impaired liver function, are elderly or you will be treated with Xefo for more than 3 months, your doctor may have to monitor you by laboratory test on a frequent basis.
Slovenian: Zdravnik bo morda spremljal vaše zdravljenje z rednimi laboratorijskimi preiskavami, če imate motnjo strjevanja krvi, okvarjeno ledvično funkcijo, če ste starostnik ali če se boste zdravili z zdravilom Xefo dlje kot 3 mesece.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 4 mg lornoxicam
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 4 mg lornoksikama.
English: Other information about Sileo:
Slovenian: Druge informacije o zdravilu Sileo:
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Sileo on 10 June 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Sileo, veljavno po vsej Evropski uniji, odobrila dne 10/06/2015.
English: If symptoms occur, the advice of a doctor should be sought.
Slovenian: Če se pojavijo simptomi, se je treba posvetovati z zdravnikom.
English: The dose to be given depends on the dog's bodyweight.
Slovenian: Odmerek, ki ga je treba dati, je odvisen od telesne mase psa.
English: The affected person should not drive as sedation and changes in blood pressure may occur.
Slovenian: Prizadeta oseba ne sme voziti, saj se lahko pojavijo sedacija in spremembe krvnega tlaka.
English: If the noise continues and the dog shows signs of anxiety and fear again, further doses can be given at intervals of two hours, up to a total of 5 times during each event.
Slovenian: Če hrup ne preneha in pes ponovno kaže znake tesnobe in strahu, je mogoče dati dodatne odmerke v presledku dveh ur, vendar največ 5 odmerkov med posameznim dogodkom.
English: Typical signs of anxiety and fear in dogs include panting, trembling, pacing, seeking people, hiding or trying to escape, refusal to eat and inappropriate urination or defaecation.
Slovenian: Značilni znaki tesnobe in strahu pri psih vključujejo sopenje, tresenje, sprehajanje gor in dol, zatekanje k ljudem, skrivanje ali poskuse pobega, zavračanje hrane in neprimerno uriniranje ali iztrebljanje.
English: What benefit has Sileo shown during the studies?
Slovenian: Kakšne koristi je zdravilo Sileo izkazalo med študijami?
English: What is the risk associated with Sileo?
Slovenian: Kakšna tveganja so povezana z zdravilom Sileo?
English: 72% (64 of 89) of the Sileo-treated dogs were scored excellent or good for behaviour compared to 37% (34 of 93) of the group given dummy treatment.
Slovenian: Z oceno odlično ali dobro so ocenili vedenje 72 % (64 od 89) psov, ki so prejeli zdravilo Sileo, v primerjavi s 37 % (34 od 93) psov v skupini, ki je prejela zdravilo brez zdravilne učinkovine.
English: Since noradrenaline is involved in maintaining alertness and arousal, reducing its release reduces the severity of acute anxiety and fear associated with noise.
Slovenian: Noradrenalin sodeluje pri ohranjanju budnosti in vznemirjenosti, zato zmanjšanje njegovega sproščanja zmanjša stopnjo akutne tesnobe in strahu, povezanih s hrupom.
English: The two main measures of effectiveness were the owner's assessment of the dog's behaviour at least two hours after the last dose compared to the previous year and the score given by the owner for signs of anxiety and fear after treatment.
Slovenian: Glavni merili učinkovitosti sta bili lastnikova ocena vedenja psa najmanj dve uri po zadnjem odmerku v primerjavi s prejšnjim letom ter lastnikova ocena znakov tesnobe in strahu po zdravljenju.
English: Dexmedetomidine hydrochloride
Slovenian: Deksmedetomidinijev klorid
English: The active substance in Sileo, dexmedetomidine hydrochloride, is a type of sedative medicine called an alpha-2 adrenoceptor agonist.
Slovenian: Zdravilna učinkovina v zdravilu Sileo, deksmedetomidinijev klorid, je vrsta pomirjevala, ki ga imenujemo agonist adrenergičnih receptorjev alfa-2.
English: In case of skin contact the exposed skin should be washed immediately after exposure with large amounts of water and contaminated clothes should be removed.
Slovenian: Če zdravilo pride v stik s kožo, je treba izpostavljeno kožo takoj sprati z velikimi količinami vode in odstraniti kontaminirana oblačila.
English: The CVMP concluded that the benefits of Sileo exceed the risks for the approved indication and recommended that Sileo be given a marketing authorisation.
Slovenian: Odbor CVMP je zaključil, da so koristi zdravila Sileo večje od z njim povezanih tveganj za odobreno indikacijo, in priporočil, da se zanj izda dovoljenje za promet.
English: Contact with skin, eye, lips or the inside of the mouth or nostrils should be avoided.
Slovenian: Preprečiti je treba stik s kožo, očmi, ustnicami in notranjostjo ust ali nosnic.
English: The oral syringe should be returned to the outer carton immediately after each use for child safety.
Slovenian: Brizgo za peroralno dajanje je treba zaradi varnosti otrok po vsaki uporabi takoj pospraviti nazaj v zunanjo škatlo.
English: An initial dose is given either when the dog first shows signs of anxiety or when the owner detects a typical stimulus such as the sound of fireworks or thunder.
Slovenian: Začetni odmerek je treba dati bodisi takrat, ko pes kaže prve znake tesnobe, ali takrat, ko lastnik opazi značilne pojave, ki pri psu izzovejo tesnobo, na primer zvok ognjemeta ali groma.
English: Sileo is a veterinary medicine that contains dexmedetomidine hydrochloride.
Slovenian: Sileo je zdravilo za uporabo v veterinarski medicini, ki vsebuje deksmedetomidinijev klorid.
English: Why has Sileo been approved?
Slovenian: Zakaj je bilo zdravilo Sileo odobreno?
English: It is available as an oromucosal gel (a gel applied to the lining of the mouth).
Slovenian: Na voljo je v obliki oralnega gela (gela, ki se nanese na ustno sluznico).
English: Sileo must not be used in dogs with severe disorders of the heart and blood vessels, with severe disease such as kidney or liver failure or in dogs if unexpectedly sedated from a previous dose.
Slovenian: Zdravilo Sileo se ne sme uporabljati pri psih, ki imajo hude bolezni srca in krvnih žil ali hudo bolezen, kot je odpoved ledvic ali jeter, ter pri psih, ki so nepričakovano sedirani zaradi prejšnjega odmerka.
English: Score good for behaviour indicated only mild and short-lived signs of fear and anxiety shown by the dog whilst score excellent for behaviour indicated no signs shown.
Slovenian: Ocena vedenja dobro je pomenila, da je pes kazal zgolj blage in prehodne znake strahu in tesnobe, medtem ko je ocena vedenja odlično pomenila, da se niso pojavili nobeni znaki.
English: Pregnant women should avoid contact with the product as uterine contractions and reduced blood pressure of the unborn baby may occur after exposure to dexmedetomidine.
Slovenian: Nosečnice se morajo izogibati stiku z zdravilom, saj se lahko po izpostavljenosti deksmedetomidinu pojavijo kontrakcije maternice in znižan krvni tlak nerojenega otroka.
English: Sileo is used in dogs to reduce acute anxiety and fear associated with noise.
Slovenian: Zdravilo Sileo se uporablja pri psih za zmanjšanje akutne tesnobe in strahu, povezanih s hrupom.
English: In case of contact with the eye or inside of the mouth, the area should be rinsed abundantly with fresh water.
Slovenian: Če zdravilo pride v stik z očmi ali notranjostjo ust, je treba predel izprati z obilo sveže vode.
English: For a full list of all restrictions and side-effects reported with Sileo, see the package leaflet.
Slovenian: Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Sileo, glejte navodilo za uporabo.
English: What is Sileo used for?
Slovenian: Za kaj se zdravilo Sileo uporablja?
English: Sedation, vomiting and urinary incontinence may also occur in less than 10 in 100 dogs.
Slovenian: Prav tako se pri manj kot 10 psih od 100 lahko pojavijo tudi sedacija, bruhanje in urinarna inkontinenca.
English: If Sileo is accidentally ingested or if there is prolonged contact with the eyes, lips or the inside of the mouth or nostrils medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Slovenian: V primeru nenamernega zaužitja zdravila Sileo ali daljšega stika z očmi, ustnicami ali notranjostjo ust ali nosnic se je treba takoj posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali nalepko.
English: Short-lived paleness of the lining of the mouth and gums at the application site may occur in less than 10 in 100 dogs due to a temporary localised narrowing of the blood vessels.
Slovenian: Pri manj kot 10 psih od 100 se lahko pojavi prehodna bledica ustne sluznice in dlesni na mestu dajanja zdravila, ki je posledica začasnega lokaliziranega zoženja krvnih žil.
English: How has Sileo been studied?
Slovenian: Kako je bilo zdravilo Sileo raziskano?
English: Sileo-treated dogs also had significantly lower scores for signs of anxiety and fear than the dogs given dummy treatment.
Slovenian: Psi, ki so jim dali zdravilo Sileo, so prejeli tudi znatno nižje ocene za znake tesnobe in strahu kot psi, ki so jim dali zdravilo brez zdravilne učinkovine.
English: How does Sileo work?
Slovenian: Kako zdravilo Sileo deluje?
English: What is Sileo?
Slovenian: Kaj je zdravilo Sileo?
English: Impermeable disposable gloves should be worn when handling Sileo.
Slovenian: Pri rokovanju z zdravilom Sileo je treba nositi nepropustne rokavice za enkratno uporabo.
English: The effectiveness of Sileo was investigated in a field study involving dogs exposed to fireworks noise at New Year's Eve. Sileo was given to 89 dogs and 93 dogs received a dummy treatment.
Slovenian: Učinkovitost zdravila Sileo so proučevali v terenski študiji, v katero so vključili pse, izpostavljene hrupu ob ognjemetu na novoletni večer.
English: Sileo is applied to the lining of the dog's mouth between the cheek and gum from the pre-filled oral syringe.
Slovenian: Zdravilo Sileo je treba nanesti z napolnjeno brizgo za peroralno dajanje na ustno sluznico psa med licem in dlesnijo.
English: Immediate packaging Pack size blister (PVC/PE/PVDC/alu) 294 (3x98) tablets (multipack)
Slovenian: Pot uporabe Stična ovojnina
English: The doctor should consider stopping treatment if the level of white cells in the blood does not return to normal within three months.
Slovenian: Zdravnik mora razmisliti o ukinitvi zdravljenja, če se število belih krvnih celic v treh mesecih ne povrne na normalno raven.
English: What measures are being taken to ensure the safe and effective use of Iclusig?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Iclusig?
English: Iclusig is available as tablets (15 mg, 30 mg and 45 mg).
Slovenian: Zdravilo Iclusig je na voljo v obliki tablet (15, 30 in 45 mg).
English: It is used to treat adults with the following types of leukaemia (cancer of the white blood cells):
Slovenian: Uporablja se za zdravljenje odraslih z naslednjimi vrstami levkemije (raka belih krvnih celic):
English: Further information on Iclusig can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Iclusig so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Medicines Agency decided that Iclusig'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 Iclusig večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The results of the study showed that treatment with Iclusig led to clinically relevant responses in all groups of patients:
Slovenian: Rezultati študije so pokazali, da je zdravljenje z zdravilom Iclusig vodilo do klinično pomembnih odzivov pri vseh skupinah bolnikov:
English: Further information on the orphan designations can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CML; ALL).
Slovenian: Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (KML, ALL).
English: Other information about Iclusig
Slovenian: Druge informacije o zdravilu Iclusig
English: As for all medicines, data on the use of Iclusig are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Iclusig stalno spremljajo.
English: These diseases are rare, and Iclusig was designated an ‘orphan medicine' (a medicine used in rare diseases) on 2 February 2010.
Slovenian: Ti bolezni sta redki, zato je bilo zdravilo Iclusig 2. februarja 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Iclusig received a marketing authorisation valid throughout the EU on 1 July 2013.
Slovenian: Za zdravilo Iclusig je bilo 1. julija 2013 izdano dovoljenje za promet, veljavno po vsej EU.
English: • chronic myeloid leukaemia (CML) in its different stages known as chronic, accelerated and blast phases;
Slovenian: • kronično mieloidno levkemijo (KML) v različnih fazah, znanih pod imeni kronična, pospešena in blastna faza;
English: An overview of Iclusig and why it is authorised in the EU
Slovenian: Pregled zdravila Iclusig in zakaj je odobreno v EU
English: What is Iclusig and what is it used for?
Slovenian: Kaj je zdravilo Iclusig in za kaj se uporablja?
English: In the study, Iclusig was not compared with another treatment.
Slovenian: V študiji zdravila Iclusig niso primerjali z nobeno drugo obliko zdravljenja.