natgillin/translations-raw huggingface dataset:
• Treatment with Iclusig should be stopped if a complete haematologic response has not occurred by three months. 
• Zdravljenje z zdravilom Iclusig je treba prekiniti, v kolikor v treh mesecih ne pride do popolnega hematološkega odziva.
The review followed a previous assessment of clinical trial data which indicated that cases of blood clots and blockages in the arteries or veins were occurring at a higher rate than was observed at the time of the medicine's initial authorisation. 
Pregled je sledil predhodni oceni podatkov iz kliničnih preizkušanj, ki so kazali, da je do primerov krvnih strdkov in zapor arterij ali ven prihajalo pogosteje, kot je bilo opaženo ob izdaji prvotnega dovoljenja za promet.
Additionally, healthcare professionals should stop Iclusig if a complete response has not occurred within three months of treatment, and should monitor patients for high blood pressure or signs of heart problems. 
Poleg tega bi morali zdravstveni delavci zdravljenje z zdravilom Iclusig prekiniti, v kolikor po treh mesecih zdravljenja ne pride do popolnega odziva, ter spremljati, ali se pri bolnikih pojavijo visok krvni tlak ali znaki težav s srcem.
During its review, the PRAC assessed available data on the nature, frequency and severity of blood clots or blockage of the arteries or veins and considered the potential mechanism for these side effects. 
V okviru pregleda je odbor PRAC ocenil razpoložljive podatke o značaju, pogostnosti in resnosti krvnih strdkov in zapor arterij ali ven ter obravnaval morebitne mehanizme za razvoj teh neželenih učinkov.
• Treatment with Iclusig will usually be stopped if there is insufficient beneficial response within three months, or if you develop heart or circulatory problems during treatment. 
• Zdravljenje z zdravilom Iclusig se navadno prekine, če v treh mesecih ne pride do zadostnega koristnega odziva ali se med zdravljenjem pojavijo težave s srcem ali obtočili.
The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations. 
Opravil ga je Odbor za oceno tveganja na področju farmakovigilance (PRAC), pristojni odbor za ocenjevanje vprašanj glede varnosti zdravil za uporabo v humani medicini, ki je nato oblikoval niz priporočil.
• Iclusig is a medicine used for the treatment of leukaemia, a type of cancer that affects white blood cells. 
• Zdravilo Iclusig se uporablja za zdravljenje levkemije, vrste raka, ki prizadene bele krvničke.
The PRAC also sought the advice of a group of experts in oncology before finalising its recommendations, which have now been endorsed by the Agency's Committee for Medicinal Products for Human Use (CHMP) in its final opinion. 
Odbor PRAC se je pred dokončanjem svojih priporočil posvetoval s skupino izvedencev na področju onkologije, ta priporočila pa je nato v svojem končnem mnenju podprl Odbor za zdravila v humani medicini (CHMP) pri agenciji.
Iclusig is a medicine used to treat adults with the following types of leukaemia (cancer of the white blood cells): 
Zdravilo Iclusig se uporablja za zdravljenje odraslih z naslednjimi vrstami levkemije (raka belih krvničk):
Ponatinib works by blocking a tyrosine kinase (an enzyme) called Bcr-Abl, which is found in some receptors on the surface of the cancer cells where it is involved in stimulating the cells to divide uncontrollably. 
Ponatinib deluje tako, da zavira tirozin-kinazo (encim), imenovano Bcr-Abl, ki se nahaja v nekaterih receptorjih na površini rakavih celic, kjer sodeluje pri spodbujanju njihovega nenadzorovanega razmnoževanja.
The available evidence shows that the risk of blood vessel blockage with Iclusig is likely to be doserelated, however the data are insufficient to formally recommend the use of lower doses of Iclusig, and there is a risk that lower doses might not be as effective in all patients and in long-term treatment. 
Razpoložljivi dokazi kažejo, da je tveganje za zaporo žil ob uporabi zdravila Iclusig verjetno povezano z odmerkom, vendar podatki ne zadostujejo, da bi uradno priporočili uporabo nižjih odmerkov zdravila Iclusig, poleg tega pa obstaja tveganje, da nižji odmerki ne bi bili tako učinkoviti pri vseh bolnikih in pri dolgotrajnem zdravljenju.
Dose modifications or treatment interruption (temporary or permanent) should be considered to manage treatment toxicity. 
Za obvladovanje toksičnosti zdravljenja je treba pretehtati prilagoditev odmerka ali prekinitev zdravljenja (začasno ali trajno).
• The risk of vascular occlusive events with Iclusig is likely to be dose-related; however, the currently available data on the dose-efficacy and dose-toxicity relationship are not sufficient to make a formal recommendation on dose reduction, and there is a risk that lower doses might have reduced efficacy. 
• Tveganje dogodkov žilne okluzije pri uporabi zdravila Iclusig je verjetno povezano z odmerkom, vendar pa trenutno razpoložljivi podatki o razmerju med odmerkom in učinkovitostjo ter odmerkom in toksičnostjo ne zadostujejo za uradno priporočilo o zmanjšanju odmerkov; poleg tega obstaja pri manjših odmerkih tveganje zmanjšane učinkovitosti.
The European Medicines Agency (EMA) has concluded its review of the benefits and risks of Iclusig (ponatinib), a medicine used for the treatment of leukaemia (cancer of the white blood cells), and has recommended strengthened warnings in the product information aimed at minimising the risk of blood clots and blockages in the arteries. 
Evropska agencija za zdravila je 23. oktobra 2014 zaključila pregled koristi in tveganj, povezanih z zdravilom Iclusig (ponatinib), ki se uporablja za zdravljenje levkemije (raka belih krvničk), in priporočila okrepitev opozoril v informacijah o zdravilu, namenjenih zmanjšanju tveganja za nastanek krvnih strdkov in zaporo arterij.
Iclusig is authorised for use in patients with chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia (ALL) who cannot take or tolerate several other medicines of the same class (known as ‘tyrosine-kinase inhibitors'). 
Zdravilo Iclusig je odobreno za uporabo pri bolnikih s kronično mieloično levkemijo (KML) in akutno limfoblastno levkemijo (ALL), ki ne morejo jemati več drugih zdravil istega razreda (znanih pod imenom „zaviralci tirozin-kinaze“) oziroma teh zdravil ne prenašajo.
Iclusig is used in patients who cannot tolerate or do not respond to dasatinib or nilotinib (other medicines for the treatment of leukaemia) and for whom subsequent treatment with imatinib is not considered appropriate. 
Zdravilo Iclusig se uporablja pri bolnikih, ki ne prenašajo desatiniba ali nilotiniba (drugih zdravil za zdravljenje levkemije) oziroma se nanju ne odzivajo ali za katere nadaljnje zdravljenje z imatinibom ne velja za primerno.
The active substance in Iclusig, ponatinib, belongs to a group of medicines called ‘tyrosine-kinase inhibitors'. 
Zdravilna učinkovina zdravila Iclusig, ponatinib, spada v skupino zdravil, imenovanih zaviralci tirozinkinaze.
The company that markets Iclusig will provide healthcare professionals with educational material highlighting important risks for which monitoring and/or dose adjustments are recommended and including available data on the relationship between dose of Iclusig and risk of blood vessel blockage. 
Družba, ki trži zdravilo Iclusig, bo zdravstvenim delavcem zagotovila izobraževalno gradivo, ki bo izpostavilo pomembna tveganja, za katera se priporoča spremljanje in/ali prilagoditev odmerka, ter vključevalo razpoložljive podatke o razmerju med odmerkom zdravila Iclusig in tveganjem za zaporo žil.
• Safety and efficacy data concerning dose reduction following major cytogenetic response in chronic phase CML patients have been included in the SmPC, to provide information to the prescriber and to facilitate an individual assessment of the benefit-risk balance of Iclusig with regards to dose reduction. 
• V povzetek glavnih značilnosti zdravila so bili vključeni podatki o varnosti in učinkovitosti ob zmanjšanju odmerka pri bolnikih s KML v kronični fazi po velikem citogenetskem odzivu, da bi zagotovili informacije za zdravnike, ki predpisujejo zdravilo, ter olajšali individualno oceno razmerja med koristmi in tveganji zdravila Iclusig ob zmanjšanju odmerka.
A study on the safety and benefits of Iclusig is also planned, to help clarify if lower doses of the medicine would carry a lower risk of blood clots or blockages of the blood vessels while still having a beneficial effect in patients with chronic phase CML. 
Načrtovana je tudi študija o varnosti in koristih zdravila Iclusig, da bi pojasnili, ali bi bilo pri nižjih odmerkih tveganje krvnih strdkov in zapor žil manjše, pri čemer pa bi zdravilo še vedno imelo koristen učinek za bolnike s KML v kronični fazi.
A dose-ranging study will be conducted in patients with chronic phase CML in order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reduction after achieving major cytogenetic response. 
Pri bolnikih s KML v kronični fazi bo izvedena študija z različnimi odmerki, v kateri bo določen optimalni začetni odmerek zdravila Iclusig ter opredeljena varnost in učinkovitost zdravila Iclusig po zmanjšanju odmerka, ko je bolnik dosegel velik citogenetski odziv.
The material will also provide the available evidence regarding the safety and efficacy of ponatinib when dose is reduced in patients with chronic phase CML who have achieved major cytogenetic response. 
V gradivu bodo prav tako zagotovljeni razpoložljivi dokazi glede varnosti in učinkovitosti ponatiniba ob zmanjšanju odmerka pri bolnikih s KML v kronični fazi, ki so dosegli velik citogenetski odziv.
The product information will be updated with strengthened warnings about the risks with Iclusig, and to also provide healthcare professionals with the latest evidence in case they wish to consider reducing the dose of Iclusig in patients with ‘chronic phase' CML who are responding well to treatment, and who might be at particular risk of blood vessel blockage. 
Informacije o zdravilu so bile posodobljene z okrepljenimi opozorili glede tveganj pri uporabi zdravila Iclusig in z namenom, da bi zdravstvenim delavcem zagotovili najnovejše dokaze v pomoč pri presoji morebitnega zmanjšanja odmerka zdravila Iclusig pri bolnikih s KML v kronični fazi, ki se dobro odzivajo na zdravljenje in pri katerih je tveganje za zaporo žil morda posebej visoko.
• The benefit-risk balance of Iclusig remains positive in all authorised indications, and the starting dose remains 45 mg per day. 
• Razmerje med koristmi in tveganji zdravila Iclusig ostaja pozitivno za vse odobrene indikacije, začetni odmerek pa ostaja 45 mg na dan. Pred začetkom zdravljenja z zdravilom Iclusig je treba oceniti kardiovaskularno stanje bolnika ter ga med samim zdravljenjem redno spremljati.
However, the Committee noted that many patients required reductions in their dose and recommended that the company should study whether starting at lower doses would still be effective but would have fewer side effects. 
Kljub temu je odbor izpostavil, da je bilo treba pri mnogih bolnikih zmanjšati odmerek, in priporočil, naj družba prouči, ali bi bila uvedba zdravila z manjšimi odmerki še vedno učinkovita in bi imela manj neželenih učinkov.
This means that there is more evidence to come about the medicine, which the company is required to provide. 
To pomeni, da se o njem pričakujejo dodatni dokazi, ki jih mora zagotoviti družba.
The side effects were considered manageable and were acceptable, compared with the limited other treatment options available. 
Neželeni učinki so bili v primerjavi z drugimi omejenimi razpoložljivimi možnostmi zdravljenja obvladljivi in sprejemljivi.
The European Commission granted a marketing authorisation valid throughout the European Union for Cometriq on 21 March 2014. 
Evropska komisija je dovoljenje za promet z zdravilom Cometriq, veljavno po vsej Evropski uniji, izdala 21. marca 2014.
The recommended dose is 140 mg once a day, taken as one 80-mg and three 20-mg capsules. 
Priporočeni odmerek je 140 mg enkrat na dan, kar vključuje eno 80-miligramsko in tri 20-miligramske kapsule.
By blocking the activity of these receptors in cancer cells, the medicine reduces the growth and spread of the cancer. 
Z zaviranjem dejavnosti teh receptorjev v rakavih celicah zdravilo zmanjša rast in širjenje raka.
Cometriq is available as capsules (20 and 80 mg). 
Zdravilo Cometriq je na voljo v obliki kapsul (20 in 80 mg).
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cometriq's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Cometriq večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Cometriq. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cometriq.
What measures are being taken to ensure the safe and effective use of Cometriq? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cometriq?
Patients should not eat for at least two hours before and one hour after their dose of Cometriq. 
Bolniki vsaj dve uri pred odmerjanjem zdravila in eno uro po njem ne smejo uživati hrane.
Treatment is continued until the patient no longer benefits from it or side effects become unacceptable. 
Zdravljenje traja, dokler bolnik od njega nima več kliničnih koristi ali dokler neželeni učinki ne postanejo nesprejemljivi.
The summary of the opinion of the Committee for Orphan Medicinal Products for Cometriq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Cometriq je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
A risk management plan has been developed to ensure that Cometriq is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Cometriq je bil pripravljen načrt obvladovanja tveganj.
Since Cometriq has been granted a conditional approval, the company that markets Cometriq will provide information from a study comparing the safety and effectiveness of different doses of Cometriq, and its benefit in patients lacking the RET gene mutation or whose cancer has changes in another family of genes called RAS. 
Ker je zdravilo Cometriq pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, zagotovila informacije iz študije, ki bo primerjala varnost in učinkovitost različnih odmerkov zdravila Cometriq, ter informacije o njegovi koristi pri bolnikih brez mutacije gena RET ali s spremembami druge družine genov, imenovanih RAS.
Because the number of patients with medullary thyroid cancer is low, the disease is considered ‘rare', and Cometriq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 February 
Ker je bolnikov z medularnim rakom ščitnice malo, velja ta bolezen za redko, zato je bilo zdravilo Cometriq 6. februarja 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
It is used to treat adults with medullary thyroid cancer, a type of cancer originating in the cells in the thyroid gland that produce the hormone calcitonin. 
Uporablja se za zdravljenje medularnega raka ščitnice, vrste raka, ki izvira iz celic v ščitnici, ki proizvajajo hormon kalcitonin.
Cometriq should be used with care in patients taking certain other medicines that affect the way it is broken down in the body. 
Zdravilo Cometriq je treba uporabljati previdno pri bolnikih, ki jemljejo nekatera druga zdravila, ki vplivajo na način njegove razgradnje v telesu.
Other information about Cometriq 
Druge informacije o zdravilu Cometriq
These enzymes can be found in certain receptors (such as VEGF, MET and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels to supply the cancer. 
Ti encimi so prisotni v nekaterih receptorjih (kot so receptorji VEGF, MET in RET) v rakavih celicah, v katerih spodbujajo številne procese, vključno z delitvijo celic in rastjo novih žil, ki oskrbujejo raka.
For the full list of all side effects and restrictions with Cometriq, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Cometriq glejte navodilo za uporabo.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cometriq, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Cometriq in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For more information about treatment with Cometriq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Cometriq preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The benefits of Cometriq may be smaller for patients whose cancer does not have a mutation in a gene called the ‘re-arranged during transfection' (RET) gene, and this should be taken into account when deciding whether to start treatment. 
Koristi zdravila so lahko manjše pri bolnikih, ki nimajo mutacije gena, imenovanega gen RET (rearranged during transfection - prerazporejen med transfekcijo), kar je treba upoštevati pri odločanju o uvedbi zdravljenja.
Cometriq can only be obtained with a prescription and treatment should only be started by a doctor who has experience in using cancer medicines. 
Izdaja zdravila Cometriq je le na recept, zdravljenje z njim pa sme uvesti samo zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
What is Cometriq and what is it used for? 
Kaj je zdravilo Cometriq in za kaj se uporablja?
The full EPAR and risk management plan summary for Cometriq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Cometriq sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cometriq has been shown to be effective in one main study involving 330 adults with medullary thyroid cancer that could not be treated with surgery and was extensive or had spread to other parts of the body. 
Učinkovitost zdravila Cometriq so dokazali v eni glavni študiji, v katero je bilo vključenih 330 odraslih bolnikov z medularnim rakom ščitnice, ki ga ni bilo mogoče zdraviti s kirurškim posegom in je bil obsežen ali se je razširil na druge dele telesa.
Cometriq had shown a benefit in patients with advanced medullary thyroid cancer unsuitable for surgery, who have few other treatment options. 
Zdravilo Cometriq je pokazalo koristi pri bolnikih z napredovalim medularnim rakom ščitnice, neprimernih za kirurški poseg, ki imajo na voljo malo drugih možnosti zdravljenja.
Why is Cometriq approved? 
Zakaj je bilo zdravilo Cometriq odobreno?
What benefits of Cometriq have been shown in studies? 
Kakšne koristi je zdravilo Cometriq izkazalo v študijah?
Cometriq is used when the cancer cannot be removed by surgery and has progressed or spread to other parts of the body. 
Zdravilo se uporablja, kadar raka ni mogoče odstraniti s kirurškim posegom in je napredoval ali se razširil na druge dele telesa.
What are the risks associated with Cometriq? 
Kakšna tveganja so povezana z zdravilom Cometriq?
It is not intended to provide practical advice on how to use Cometriq. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The active substance in Cometriq, cabozantinib, is a tyrosine kinase inhibitor. 
Zdravilna učinkovina v zdravilu Cometriq, kabozantinib, je zaviralec tirozin-kinaze.
Cometriq was given once a day in an initial dose of 140 mg (reduced if necessary due to side effects) and compared with placebo (a dummy treatment). 
Zdravilo se je dajalo enkrat na dan, pri čemer je bil začetni odmerek 140 mg (ki se je zaradi neželenih učinkov po potrebi zmanjšal), in se je primerjalo s placebom (zdravilom brez zdravilne učinkovine).
For practical information about using Cometriq, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Cometriq naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The most common side effects with Cometriq (which may affect more than 2 in 10 people) are diarrhoea, palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome, which involves rash and numbness on the palms and soles), loss of weight, loss of appetite, nausea (feeling sick), tiredness, taste disturbances, changes in hair colour, hypertension (high blood pressure), inflammation of the mucosa (moist tissue that lines certain body cavities) including stomatitis (inflammation of the lining of the mouth), constipation, vomiting, weakness, and changes in the sound of the voice. 
Najpogostejši neželeni učinki zdravila Cometriq (ki lahko prizadenejo več kot 2 osebi od 10) so driska, sindrom palmarno-plantarne eritrodisestezije (sindrom dlani in stopal, ki vključuje izpuščaj in otrplost v dlaneh in stopalih), izguba telesne mase, izguba teka, navzeja (slabost), utrujenost, motnje okušanja, spremembe barve las, hipertenzija (visok krvni tlak), vnetje sluznice (vlažnega tkiva, s katerim so obložene nekatere telesne votline), vključno s stomatitisom (vnetjem ustne sluznice), zaprtost, bruhanje, šibkost in spremembe glasu.
The most common abnormal results in laboratory blood tests were increased liver enzymes such as aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP), low white cell counts (lymphopenia or neutropenia), thrombocytopenia (low blood-platelet counts), hypocalcaemia (low blood calcium levels), hypophosphataemia (low blood levels of phosphates), hypomagnesaemia (low blood magnesium levels), hypokalaemia (low blood potassium levels) and hyperbilirubinaemia (increased amounts of bilirubin, a breakdown product of red blood cells). 
Najpogostejši nenormalni izvidi laboratorijskih krvnih preiskav so povišana raven jetrnih encimov, kot so aspartat-aminotransferaza (AST), alanin-aminotransferaza (ALT) in alkalna fosfataza (ALP), nizko število belih krvničk (limfopenija ali nevtropenija), trombocitopenija (nizko število trombocitov), hipokalciemija (nizka raven kalcija v krvi), hipofosfatemija (nizka raven fosfatov), hipomagneziemija (nizka raven magnezija v krvi), hipokaliemija (nizka raven kalija v krvi) in hiperbilirubinemija (povišana raven bilirubina, ki se tvori ob razgradnji rdečih krvnih celic).
What information is still awaited for Cometriq? 
Katere informacije o zdravilu Cometriq še pričakujemo?
Cometriq is a cancer medicine that contains the active substance cabozantinib. 
Cometriq je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino kabozantinib.
Cometriq has been given ‘conditional approval'. 
Zdravilo Cometriq je pridobilo pogojno dovoljenje za promet.
The most common serious side effects are pneumonia, inflammation of the mucosa, hypocalcaemia (low calcium levels in the blood), dysphagia (difficulty swallowing), dehydration, pulmonary embolism (blood clots in the vessels supplying the lungs), and hypertension. 
Najpogostejši resni neželeni učinki so pljučnica, vnetje sluznice, hipokalciemija (nizka raven kalcija v krvi), disfagija (težave pri požiranju), dehidracija, pljučna embolija (krvni strdki v žilah, ki oskrbujejo pljuča) in hipertenzija.
The dose may need to be reduced or stopped temporarily 
Zaradi neželenih učinkov bo morda treba zmanjšati odmerek ali začasno prekiniti odmerjanje, predvsem v prvih osmih tednih zdravljenja.
How does Cometriq work? 
Kako zdravilo Cometriq deluje?