natgillin/translations-raw huggingface dataset:
• bowel obstruction, collection of fluid in the abdomen, inflammation of the small or large intestine, the stomach or the oesophagus, pain in the lower abdomen, abdominal discomfort, 
• zaprtje črevesja, zbiranje tekočine v trebuhu, vnetje debelega ali tankega črevesja, želodca ali požiralnika, bolečine v spodnjem delu trebuha, slabo počutje v spodnjem delu trebuha, zgaga (dviganje hrane iz želodca), kri v blatu
• blood infection, urinary tract infection, infection of the skin, infections in the nose and throat, 
• zastrupitev krvi, vnetje sečnega trakta, okužbe kože, okužbe nosu in grla, glivične okužbe (vključno z okužbami ust), gripa, gastroenteritis, zobni absces
Diabetes, Hypokalaemia, Appetite disorder, Malnutrition, Hypertriglycerida emia 
Presnovne in prehranske motnje anoreksija dehidracija, zmanjšanje telesne mase sladkorna bolezen, hipokaliemija, motnje apetita, podhranjenost, hipertrigliceridemija
skin loss, skin inflammation, nail disorder 
razbarvanje kože, izgubo kože, vnetje kože, spremembe na nohtih
Talk to your doctor or pharmacist before taking Capecitabine Teva - if you know that you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD) - if you have liver or kidney diseases - if you have or had heart problems (for example an irregular heartbeat or pains to the chest, jaw and back brought on by physical effort and due to problems with the blood flow to the heart) - if you have brain diseases (for example, cancer that has spread to the brain, or nerve damage 
- če imate ali ste imeli druge bolezni, kot so težave s srcem (na primer nereden srčni utrip ali bolečine v prsih, čeljusti ali hrbtu, ki se pojavijo zaradi fizičnega napora in problemi s tokom krvi v srce).
INFORMATION IN BRAILLE Capecitabine Teva 150 mg film-coated tablets 
PODATKI V BRAILLOVI PISAVI Kapecitabin Teva 150 mg filmsko obložene tablete
Capecitabine Teva 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine. 
Kapecitabin Teva 500 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 500 mg kapecitabina.
NAME OF THE MEDICINAL PRODUCT Capecitabine Teva 150 mg film-coated tablets capecitabine 
IME ZDRAVILA Kapecitabin Teva 150 mg filmsko obložene tablete kapecitabin
Hepatic failure (rare), Cholestatic hepatitis (rare) 
žolčnika in žolčevodov hiperbilirubinemija, nenormalni testi jetrne funkcije zlatenica odpoved jeter (redki), holestatični hepatitis (redki)
Table 4 Summary of related ADRs reported in patients treated with capecitabine monotherapy Body System Very Common All grades 
Preglednica 4 Povzetek z zdravljenjem povezanih neželenih učinkov, o katerih so poročali pri bolnikih, zdravljenih v monoterapiji s kapecitabinom.
P=0.30 
12,1 meseca p = 0,30
Table 8 Key efficacy results for AIO KRK study XELOX + bevacizumab 
Preglednica 8 Glavni rezultati o učinkovitosti za študijo AIO KRK
Oval biconvex light peach film-coated tablets with inscription “C” on one side and “500” on the other side. 
Kapecitabin Teva 500 mg filmsko obložene tablete Ovalne, bikonveksne filmsko obložene tablete, svetlo breskove barve z oznako »C« na eni strani in »500« na drugi strani.
Oval biconvex light peach film-coated tablets with inscription “C” on one side and “150” on the other side. 
Kapecitabin Teva 150 mg filmsko obložene tablete Ovalne, bikonveksne filmsko obložene tablete, svetlo breskove barve z oznako »C« na eni strani in »150« na drugi strani.
- Capecitabine Teva 150 mg film-coated tablets 
- Kapecitabin Teva 150 mg filmsko obložene tablete
How to store Capecitabine Teva 
Shranjevanje zdravila Kapecitabin Teva
In combination with other medicines the usual dose for adults may be less than 1250 mg/m2 of body surface area, and you may need to take the tablets over a different time period (e.g. every day, with no rest period). 
V kombinaciji z drugimi zdravili je lahko običajni odmerek za odrasle manjši od 1.250 mg/m2 telesne površine.
You must not breast-feed if you are taking Capecitabine Teva and for 2 weeks after the last dose. 
Med zdravljenjem z zdravilom Kapecitabin Teva in še 2 tedna po zadnjem odmerku zdravila ne smete dojiti.
Capecitabine Teva 150 mg film-coated tablets 
Kapecitabin Teva 150 mg filmsko obložene tablete
5 mg/kg intravenous 30-90 mins 
5 mg/kg intravensko
• fluid collection in the kidneys, increased frequency of urination during the night, incontinence, 
• zadrževanje tekočin v ledvicah, povečano uriniranje ponoči, inkontinenco, kri v urinu, povečanje kreatina v krvi (znak nedelovanja ledvic)
NAME OF THE MEDICINAL PRODUCT Capecitabine Teva 150 mg film-coated tablets Capecitabine Teva 500 mg film-coated tablets 
Kapecitabin Teva 150 mg filmsko obložene tablete Kapecitabin Teva 500 mg filmsko obložene tablete
Neurotoxicity, Tremor, Neuralgia, 
glavobol nevtrotoksičnost, tremor, nevralgija, preobčutljivostne reakcije, hipestezija
Vaginal haemorrhage 
Okvare ledvic
In this trial, 1987 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3week cycles for 24 weeks) or 5-FU and leucovorin (Mayo Clinic regimen: 20 mg/m2 leucovorin IV followed by 425 mg/m2 intravenous bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks). 
V tem preskušanju so randomizirali 1.987 bolnikov v zdravljenje s kapecitabinom (1.250 mg/m dvakrat na dan 2 tedna, sledil je enotedenski premor, dobili so 3-tedenske cikle v 24 tednih) ali s 5-FU in levkovorinom (shema Mayo:
Very Common All grades 
Zelo pogosti
XELOX/XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017) 
Preglednica 7 Glavni rezultati o učinkovitosti za analizo ne-inferiornosti v študiji NO16966 OSNOVNA ANALIZA XELOX/XELOX + P/ XELOX + BEVACIZUMAB (EPP*: N=967; ITT**: N=1.017)
QUALITATIVE AND QUANTITATIVE COMPOSITION Capecitabine Teva 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine. 
Kapecitabin Teva 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg kapecitabina.
Pulmonary embolism, Pneumothorax, Haemoptysis, Asthma, Dyspnoea exertional 
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja, epistaksa, kašelj, rinoreja pljučna embolija, pnevmotoraks, hemoptiza, astma, dispneja ob naporu
Capecitabine Teva 150 mg film-coated tablets Each film-coated tablet contains 15.6 mg lactose. 
Ena filmsko obložena tableta vsebuje 15,6 mg laktoze.
If you forget to take Capecitabine Teva 
Če ste pozabili vzeti zdravilo Kapecitabin Teva Ne zaužijte izpuščenega odmerka.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 500 mg capecitabine. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 500 mg kapecitabina.
• vein inflammation 
• mišični krči
There are no side effects caused by stopping treatment with capecitabine. 
Če ste prenehali jemati zdravilo Kapecitabin Teva Po prenehanju zdravljenja s kapecitabinom se ne pojavijo neželeni učinki.
Common side-effects (may affect up to 1 in 10 people) include: 
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) vključujejo:
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 150 mg capecitabine. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 150 mg kapecitabina.
• vertigo, ear pain 
• vrtoglavica, bolečine v ušesih
Jaundice 
Driska
Pyrexia, Weakness, +Lethargy, Temperature intolerance 
Splošne težave in spremembe na mestu aplikacije pireksija, šibkost, +letargija,
For the capecitabine dose of 1000 mg/m2 twice daily on days 1 to 14 every 3 
V zdravljenje s kapecitabinom (1.000 mg/m dvakrat na dan dva tedna, čemur je sledil
Hypertension, 
Bolezni jeter,
Tinnitus, Hypoacusis 
vključno z motnjami labirinta tinitus, hipakuza
Pharyngolaryngeal pain, Dysphonia 
Psihiatrične motnje motnje spanja, tesnoba
Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopeni a, Leukopenia, Haemolytic anaemia, 
Bolezni krvi in limfatičnega sistema nevtropenija, anemija febrilna nevtropenija, pancitopenija, granulocitopenija, trombocitopenija, levkopenija, hemolitična anemija, zvišano internacionalno normalizirano razmerje/podaljšan protrombinski čas
Central or peripheral nervous system disease 
- če imate jetrno ali ledvično bolezen.
Capecitabine Teva contains lactose. 
Zdravilo Kapecitabin Teva vsebuje laktozo
(neuropathy) - if you have calcium imbalances (seen in blood tests) - if you have diabetes - if you cannot keep food or water in your body because of severe nausea and vomiting - if you have diarrhoea - if you are, or become dehydrated - if you have imbalances of ions in your blood (electrolyte imbalances, seen in tests) - if you have a history of eye problems as you may need extra monitoring of your eyes - if you have a severe skin reaction 
- če imate neravnovesje ionov v krvi (elektrolitsko neravnovesje, vidno v testih).
Package leaflet: Information for the user Capecitabine Teva 150 mg film-coated tablets Capecitabine Teva 500 mg film-coated tablets capecitabine 
Kapecitabin Teva 150 mg filmsko obložene tablete Kapecitabin Teva 500 mg filmsko obložene tablete kapecitabin
- ECF: epirubicin (50 mg/m2 as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m2 as a two hour infusion on day 1 every 3 weeks) and 5-FU (200 mg/m2 daily given by continuous infusion via a central line). 
1. dan vsake 3 tedne) in 5-FU (200 mg/m na dan v kontinuirani infuziji skozi centralni venski kateter); - ECX: epirubicin (50 mg/m2 kot bolus 1. dan vsake 3 tedne), cisplatin (60 mg/m2 v 2-urni infuziji 1. dan vsake 3 tedne) in kapecitabin (625 mg/m dvakrat na dan neprekinjeno); - EOF: epirubicin (50 mg/m2 kot bolus 1. dan vsake 3 tedne), oksaliplatin (130 mg/m2 v 2-urni infuziji 1. dan vsake tri tedne) in 5-FU (200 mg/m2 na dan v kontinuirani infuziji skozi centralni venski kateter); - EOX: epirubicin (50 mg/m2 kot bolus 1. dan vsake 3 tedne), oksaliplatin (130 mg/m2 v 2-urni infuziji 1. dan vsake tri tedne) in kapecitabin (625 mg/m2 dvakrat na dan neprekinjeno).
Rash, Alopecia, Erythema, Dry skin, Pruritus, Skin hyperpigmentatio n, Rash macular, Skin desquamation, Dermatitis, Pigmentation disorder, Nail disorder 
Bolezni kože in podkožja alopecija, spremembe na nohtih hiperhidroza, eritematozni izpuščaj, urtikarija, nočno znojenje
The marketing authorisation was renewed on 10 February 2002 and on 10 February 2007. 
Dovoljenje za promet je bilo podaljšano dne 10. februarja 2002 in 10. februarja 2007.
The only difference between the two vaccines is the amount of vaccine in each vial or syringe. 
Edina razlika med obema cepivoma je količina cepiva v vsaki viali ali injekcijski brizgi.
The additional studies showed that the presence of antibodies was maintained for at least four years. 
Dodatne študije so pokazale, da ostanejo protitelesa v telesu prisotna vsaj štiri leta.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Če potrebujete več informacij o svojem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
It is used in infants, children and adolescents aged between one and 15 years who are not already immune to these two diseases and who are at risk of contracting both of them. 
Uporablja se pri dojenčkih, otrocih in mladostnikih, starih med enim in 15 leti, ki še niso imuni na ta dva virusa in pri katerih obstaja tveganje, da se okužijo z njima.
Two studies were carried out in a total of 180 children and adolescents, all of whom received Twinrix Paediatric. 
Dve študiji so izvedli pri skupno 180 otrocih in mladostnikih, ki so vsi prejemali zdravilo Twinrix Paediatric.
All children had satisfactory antibody levels to hepatitis A by two months, and almost 100% had protective levels of antibodies to hepatitis B by six months (just before the third vaccine dose). 
Vsi otroci so imeli zadovoljive ravni protiteles na virus hepatitisa A po dveh mesecih, skoraj 100 % otrok pa je imelo zaščitne ravni protiteles proti virusu hepatitisa B po šestih mesecih (neposredno pred tretjim odmerkom cepiva).
In the future, the immune system will be able to make antibodies more quickly when it is exposed to the viruses. 
V prihodnosti lahko imunski sistem ob izpostavitvi virusom hitreje ustvari protitelesa.
Further studies looked at the persistence of antibody levels after vaccination. 
V nadaljnjih študijah so opazovali ohranjanje ravni protiteles po cepljenju.
Twinrix Paediatric is identical to the vaccine Twinrix Adult, which has been available in the European Union (EU) since 1996. 
Zdravilo Twinrix Paediatric je identično cepivu Twinrix Adult, ki je v Evropski uniji (EU) na voljo od leta 1996.
The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins. 
Površinski antigeni virusa hepatitisa B se izdelujejo z metodo, ki se imenuje „tehnologija rekombinantne DNA“: proizvajajo jih kvasovke, ki so prejele gen (DNA), zaradi katerega lahko tvorijo te beljakovine.
The main measure of effectiveness was the proportion of the children who had developed protective levels of antibodies to hepatitis A and hepatitis B. 
Glavno merilo učinkovitosti je bil delež otrok, pri katerih se je pojavila zaščitna raven protiteles za virusa hepatitisa A in hepatitisa B.
It is recommended that individuals who receive the first dose should complete all three doses of Twinrix Paediatric. 
Priporočeno je, da posamezniki, ki prejmejo prvi odmerek, prejmejo vse tri odmerke zdravila Twinrix Paediatric.
The recommended vaccination schedule for Twinrix Paediatric is three doses with a gap of one month between the first two doses and a gap of five months between the second and third. 
Priporočena shema cepljenja z zdravilom Twinrix Paediatric vključuje tri odmerke, dane v presledku enega meseca med prvima dvema odmerkoma, in presledku petih mesecev med drugim in tretjim odmerkom.
Levels of antibodies to both hepatitis A and B increased after the third dose of the vaccine. 
Ravni protiteles proti hepatitisu A in hepatitisu B so se povečale po tretjemu odmerku cepiva.
It should be given by injection into the muscle of the upper arm or the thigh. 
Zdravilo se daje z injekcijsko brizgo v mišico nadlakti ali stegno.
The studies showed that Twinrix Paediatric produced an immune response that was at least as good as that seen during studies of Twinrix Adult. 
Študije so pokazale, da je zdravilo Twinrix Paediatric povzročilo imunski odziv, ki je bil vsaj tako dober kot tisti, ki so ga opazili pri uporabi zdravila Twinrix Adult.
The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Paediatric's benefits are greater than its risks for use in non-immune infants, children and adolescents from one year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Twinrix Paediatric za uporabo pri neimunih dojenčkih, otrocih in mladostnikih, starih od enega leta do vključno 15 let, pri katerih obstaja tveganje za okužbo s hepatitisom A in hepatitisom B, večje od z njim povezanih tveganj.
Twinrix Paediatric should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic). 
Zdravila Twinrix Paediatric ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) katero koli od zdravilnih učinkovin, katero koli od drugih sestavin zdravila ali neomicin (antibiotik).
Twinrix Paediatric should be postponed in patients with a severe sudden fever. 
Dajanje zdravila Twinrix Paediatric je treba pri bolnikih s hudo nenadno vročino odložiti na pozneje.
Because Twinrix Paediatric and Twinrix Adult contain identical ingredients, some of the data used to support the use of Twinrix Adult were used to support the use of Twinrix Paediatric. 
Ker vsebujeta zdravili Twinrix Paediatric in Twinrix Adult iste sestavine, so nekatere podatke v podporo zdravilu Twinrix Adult uporabili za zdravilo Twinrix Paediatric.
Twinrix Paediatric is a vaccine, which is available as a suspension for injection. 
Zdravilo Twinrix Paediatric je cepivo, ki je na voljo v obliki suspenzije za injiciranje.
The active substances in Twinrix Paediatric and Twinrix Adult have been available in the EU for a number of years in separate vaccines: Havrix Adult for protection against hepatitis A and Engerix-B for protection against hepatitis B. 
Zdravilne učinkovine cepiv Twinrix Paediatric in Twinrix Adult so v EU na voljo že mnogo let kot samostojna cepiva: Havrix Adult za zaščito proti virusu hepatitisa A in Engerix-B za zaščito proti virusu hepatitisa B.
The European Commission granted a marketing authorisation valid throughout the EU to GlaxoSmithKline Biologicals s.a. for Twinrix Paediatric on 10 February 1997. 
Evropska komisija je dovoljenje za promet z zdravilom Twinrix Paediatric, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s.a. dne 10. februarja 1997.
Other information about Twinrix Paediatric: 
Druge informacije o zdravilu Twinrix Paediatric:
Twinrix Paediatric is used to protect against hepatitis A and hepatitis B infection (diseases that affect the liver). 
Zdravilo Twinrix Paediatric se uporablja za zaščito pred okužbo z virusom hepatitisa A in hepatitisa B (bolezni, ki vplivata na jetra).
The most common side effect with Twinrix Paediatric (seen in more than 1 in 10 doses of the vaccine) is pain and redness at the injection site. 
Najpogostejši neželeni učinki, ki so povezani z zdravilom Twinrix Paediatric (opaženi pri več kot enem bolniku od 10) sta bolečina in rdečina na mestu vboda.
Twinrix Paediatric is a vaccine. 
Zdravilo Twinrix Paediatric je cepivo.
A booster dose of Twinrix Paediatric, or of a separate hepatitis A or B vaccine may be given, according to official recommendations. 
Poživitveni odmerek zdravila Twinrix Paediatric ali ločenega cepiva proti virusu hepatitisa A ali B lahko zdravnik da skladno z uradnimi priporočili.
What benefit has Twinrix Paediatric shown during the studies? 
Kakšne koristi je zdravilo Twinrix Paediatric izkazalo med študijami?
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TWINRIX PAEDIATRIC EPAR summary for the public 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) TWINRIX PAEDIATRIC
For the full list of all side effects reported with Twinrix Paediatric, see the Package Leaflet. 
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Twinrix Paediatric, glejte Navodilo za uporabo.
The Committee recommended that Twinrix Paediatric be given marketing authorisation. 
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Twinrix Paediatric.
It is available in a 0.5 ml vial and in a 0.5 ml prefilled syringe. 
Kot zdravilno učinkovino vsebuje inaktivirane (mrtve) viruse hepatitisa A in dele virusa hepatitisa B. Na voljo je v obliki 0,5 ml vial in 0,5 ml napolnjenih injekcijskih brizg.
What is the risk associated with Twinrix Paediatric? 
Kakšna tveganja so povezana z zdravilom Twinrix Paediatric?
Why has Twinrix Paediatric been approved? 
Zakaj je bilo zdravilo Twinrix Paediatric odobreno?
Twinrix Paediatric contains small amounts of inactivated hepatitis A viruses and the ‘surface antigen' (proteins from the surface) of the hepatitis B virus. 
Zdravilo Twinrix Paediatric vsebuje majhne količine inaktiviranih virusov hepatitisa A in „površinskih antigenov“ (beljakovin na površini) virusa hepatitisa B. Kadar oseba prejme cepivo, imunski sistem prepozna viruse in površinske beljakovine kot „tuje“ ter začne proti njim tvoriti protitelesa.
The full EPAR for Twinrix Paediatric can be found here. 
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Twinrix Paediatric je na voljo tukaj.
What is Twinrix Paediatric? 
Kaj je zdravilo Twinrix Paediatric?
How has Twinrix Paediatric been studied? 
Kako je bilo zdravilo Twinrix Paediatric raziskano?
What is Twinrix Paediatric used for? 
Za kaj se zdravilo Twinrix Paediatric uporablja?
How is Twinrix Paediatric used? 
Kako se zdravilo Twinrix Paediatric uporablja?
How does Twinrix Paediatric work? 
Kako zdravilo Twinrix Paediatric deluje?
What measures are being taken to ensure the safe and effective use of Ocaliva? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ocaliva?
Ocaliva received a marketing authorisation valid throughout the EU on 12 December 2016. 
Za zdravilo Ocaliva je bilo 12. decembra 2016 izdano dovoljenje za promet, veljavno po vsej EU.
Ocaliva (obeticholic acid) 
Ocaliva (obetiholna kislina)
The European Medicines Agency therefore decided that Ocaliva's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Ocaliva večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Why is Ocaliva authorised in the EU? 
Zakaj je bilo zdravilo Ocaliva odobreno v EU?
Further information on Ocaliva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije za zdravilo Ocaliva so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended starting dose is 5 mg once a day or 5 mg once a week, depending on the patient's degree of liver impairment (which should be determined before starting treatment with Ocaliva). 
Priporočeni začetni odmerek je 5 mg enkrat na dan ali 5 mg enkrat na teden, odvisno od stopnje okvare bolnikovih jeter (kar se določi pred začetkom zdravljenja z zdravilom Ocaliva).
In the majority of cases seen, itching occurred within the first month of treatment and tended to resolve over time while continuing treatment. 
V večini primerov se je srbenje pojavilo v prvem mesecu zdravljenja in je sčasoma z nadaljnjim zdravljenjem izzvenelo.
This may lead to scarring and liver failure, and may increase the risk of liver cancer. 
To lahko privede do brazgotinjenja in odpovedi jeter ter poveča tveganje za raka jeter.
What is Ocaliva and what is it used for? 
Kaj je zdravilo Ocaliva in za kaj se uporablja?
Itching is also the most common side effect that can lead to discontinuation of treatment. 
Srbenje je tudi najpogostejši neželeni učinek, ki lahko privede do prekinitve zdravljenja.
The study showed that Ocaliva was more effective than placebo at reducing the blood levels of bilirubin and ALP: levels decreased by the required amount in 47% (34 out of 73) of patients treated with Ocaliva 10 mg and in 46% (32 out of 70) of patients treated with increasing doses of Ocaliva (from 5 mg up to 10 mg), compared with 10% (7 out of 73) of patients on placebo. 
Študija je pokazala, da je zdravilo Ocaliva učinkovitejše od placeba pri zniževanju ravni bilirubina in ALP v krvi: raven se je znižala za potrebno količino pri 47 % (34 od 73) bolnikov, zdravljenih z zdravilom Ocaliva v odmerku 10 mg, in pri 46 % (32 od 70) bolnikov, zdravljenih z naraščajočimi odmerki zdravila Ocaliva (od 5 mg do 10 mg), v primerjavi z 10 % (7 od 73) bolnikov, ki so prejemali placebo.
As for all medicines, data on the use of Ocaliva is continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ocaliva stalno spremljajo.
However, the clinical benefits of Ocaliva need to be demonstrated in further studies. 
Kljub temu je treba klinične koristi zdravila Ocaliva dokazati z nadaljnjimi študijami.
Since Ocaliva has been granted a conditional authorisation, the company that markets Ocaliva will provide additional data from two studies to confirm the effectiveness and safety of the medicine. 
Ker je zdravilo Ocaliva pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, zagotovila dodatne podatke iz dveh študij in tako potrdila učinkovitost in varnost zdravila.
Patients with primary biliary cholangitis have limited treatment options. 
Bolniki s primarnim biliarnim holangitisom imajo omejene možnosti zdravljenja.