FrancophonIA/ELRC3.0 huggingface dataset:
English: < Lansoprazol-CT and associated names (see Annex I) 15 mg , gastro-resistant capsules, hard > Lansoprazol
Slovenian: Lansoprazol-CT in povezana imena (glejte Dodatek I) 15 mg, trde gastrorezistentne kapsule lansoprazol
English: A poor metaboliser would have more marked effects than an extensive metaboliser.
Slovenian: Pri osebah s slabšo presnovo so učinki bolj izraziti kot pri osebah z boljšo presnovo.
English: ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Slovenian: ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Nemčija
English: NAME OF THE MEDICINAL PRODUCT < Lansoprazol-CT and associated names (see Annex I) 30 mg , gastro-resistant capsules, hard > lansoprazole
Slovenian: IME ZDRAVILA Lansoprazol-CT in povezana imena (glejte Dodatek I) 30 mg trde gastrorezistentne kapsule
English: Dosage adjustment is not necessary in patients with renal insufficiency.
Slovenian: Pri bolnikih z okvaro delovanja ledvic prilagoditev odmerka ni potrebna.
English: GENERAL CLASSIFICATION FOR SUPPLY [to be completed nationally]
Slovenian: NAČIN IZDAJANJA ZDRAVILA [Podatke je treba dopolniti v posameznih državah]
English: A daily dose of 30 mg should not be exceeded.
Slovenian: Odmerkov, večjih od 30 mg dnevno, ne smete preseči.
English: The recommended dose is 1 capsule once daily (equivalent to 30 mg lansoprazole) for 4 weeks.
Slovenian: Priporočeni odmerek je 1 kapsuli enkrat dnevno (kar ustreza 30 mg lansoprazola), 4 tedne.
English: Pancreatitis, candidiasis of oesophagus and glossitis.
Slovenian: Pankreatitis, kandidiaza ezofagusa in glositis.
English: The recommended dose is 2 capsules once daily (equivalent to 30 mg lansoprazole) for 2 weeks.
Slovenian: Priporočeni odmerek je 2 kapsuli enkrat dnevno (kar ustreza 30 mg lansoprazola), 2 tedna.
English: General disorders Common:
Slovenian: Splošne motnje Pogosti:
English: The recommended dose is 2 capsules once daily (equivalent to 30 mg lansoprazole) for 4 weeks.
Slovenian: Priporočeni odmerek je 2 kapsuli enkrat dnevno (kar ustreza 30 mg lansoprazola), 4 tedne.
English: The recommended dose is 1 capsule once daily (equivalent to 30 mg lansoprazole) for 2 weeks.
Slovenian: Priporočeni odmerek je 1 kapsuli enkrat dnevno (kar ustreza 30 mg lansoprazola), 2 tedna.
English: Eye and taste disorders
Slovenian: Očesne bolezni in motnje okušanja
English: Please consult your doctor before taking Lansoprazol-CT if you know that you are intolerant to certain sugars.
Slovenian: Če veste, da nekaterih sladkorjev ne prenašate, se pred jemanjem zdravila Lansoprazol-CT posvetujte z zdravnikom.
English: Co-administered medicinal products
Slovenian: Sočasno uporabljeno zdravilo
English: Caution and monitoring of phenytoin plasma concentrations is advised when initiating and ending lansoprazole treatment.
Slovenian: Ob začetku in koncu zdravljenja z lansoprazolom se priporočata previdnost in nadzorovanje koncentracije fenitoina v plazmi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each gastro-resistant capsule contains 15 mg lansoprazole
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka gastrorezistentna kapsula vsebuje 15 mg lansoprazola.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each gastro-resistant capsule contains 30 mg lansoprazole
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka gastrorezistentna kapsula vsebuje 30 mg lansoprazola.
English: An interval of at least 1 hour before or after should be allowed between administration of lansoprazole and antacids and sucralfate.
Slovenian: Med jemanjem lansoprazola in anatacidov ter sukralfata mora preteči najmanj 1 ura.
English: Caution and increased monitoring frequency is advised when initiating or ending lansoprazole cotreatment in patients treated with warfarin.
Slovenian: Ob začetku in koncu sočasnega zdravljenja z lansoprazolom in varfarinom se priporočata previdnost in pogostejši nadzor.
English: Not applicable
Slovenian: NAVODILO ZA UPORABO
English: muscle and joint pain
Slovenian: Bolečine v mišicah in sklepih
English: Carbamazepine (medicine used in the treatment of fits) Caution is urged if carbamazepine and lansoprazole are used simultaneously.
Slovenian: Pri sočasni uporabi karbamazepina in lansoprazola morate biti zelo previdni.
English: 1 After reconstitution, 1 dose (0.2 ml) contains:
Slovenian: Po rekonstituciji en odmerek (0,2 ml) vsebuje:
English: fluorescent focus units
Slovenian: fluorescentna fokusna enota.
English: produced in VERO cells by reverse genetic technology.
Slovenian: pridobljen v celicah VERO s tehnologijo reverzne genetike.
English: propagated in fertilised hens' eggs from healthy chicken flocks.
Slovenian: razmnožen v oplojenih kokošjih jajcih zdravih piščančjih jat.
English: Pack size sprayer (glass) in trays sprayer (glass) in a tri-fold carton
Slovenian: Velikost pakiranja nosnik (steklo) v posodicah nosnik (steklo) v kartonu s tremi pregibi
English: 1 (live attenuated) of the following four strains
Slovenian: Novi virus gripe 1 (živ oslabljen) naslednjih štirih sevov
English: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Switzerland/3330/2017, MEDI 307134)
Slovenian: A/Brisbane/02/2018 (H1N1)pdm09-podoben sev (A/Switzerland/3330/2017, MEDI 307134)
English: It is used in adults, usually when other medicines or treatments have failed or cannot be used, for the treatment of the following diseases:
Slovenian: Uporablja se pri odraslih, običajno takrat, ko druga zdravila ali načini zdravljenja niso bili uspešni ali jih ni mogoče uporabljati, za zdravljenje naslednjih bolezni:
English: Flixabi infliximab
Slovenian: Flixabi infliksimab
English: The full EPAR for Flixabi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Flixabi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Flixabi is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Slovenian: To pomeni, da je podobno biološkemu zdravilu (t.i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: This is a summary of the European public assessment report (EPAR) for Flixabi.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Flixabi.
English: What measures are being taken to ensure the safe and effective use of Flixabi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Flixabi?
English: For further information see the summary of product characteristics (also part of the EPAR).
Slovenian: Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: Flixabi is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary.
Slovenian: Zdravilo Flixabi se pri revmatoidnem artritisu običajno daje v odmerku 3 mg na kilogram telesne mase, vendar se odmerek po potrebi lahko poveča.
English: All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.
Slovenian: Pri vseh bolnikih je treba preverjati, ali med infuzijo in še najmanj eno do dve uri po njej ni prišlo do pojava kakršnih koli reakcij.
English: Flixabi is given as an infusion lasting one or two hours.
Slovenian: Zdravilo Flixabi se daje z infuzijo v trajanju ene ali dveh ur.
English: Flixabi is also used in patients aged between 6 and 17 years with severe Crohn's disease or ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Slovenian: Zdravilo Flixabi se uporablja tudi pri bolnikih v starosti med 6 in 17 let z resno Crohnovo boleznijo ali ulceroznim kolitisom, kadar se na druga zdravila ali načine zdravljenja niso odzvali ali kadar jih ne smejo prejemati.
English: The most common side effects with Flixabi (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper-respiratory-tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Slovenian: Najpogostejši neželeni učinki zdravila Flixabi (opaženi pri več kot enem bolniku od 10) so virusne okužbe (na primer gripa ali herpes), glavobol, okužbe zgornjih dihal (prehladi), sinusitis (vnetje sinusov), navzeja (slabost), bolečine v trebuhu, reakcije, povezane z infuzijo, in bolečine.
English: The main measure of effectiveness was the proportion of patients who achieved at least a 20% reduction in ACR scores (a measure of painful, swollen joints and other symptoms) after 30 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih je po 30 tednih zdravljenja prišlo do najmanj 20odstotnega zmanjšanja rezultata ACR (merilo za boleče, otekle sklepe in druge simptome).
English: By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of these diseases.
Slovenian: Z zaviranjem TNF-alfa infliksimab izboljša vnetna stanja in druge simptome teh bolezni.
English: Results of this study showed that Flixabi was as effective as Remicade in reducing symptoms of rheumatoid arthritis: 64% of those treated with Flixabi (148 of 231 patients) had at least a 20% reduction in ACR scores, compared with 66% of those given Remicade (163 out of 247).
Slovenian: Rezultati te študije so pokazali, da je zdravilo Flixabi pri zmanjševanju simptomov revmatoidnega artritisa enako učinkovito kot zdravilo Remicade: prišlo je do vsaj 20-odstotnega zmanjšanja rezultata ACR pri 64 % bolnikov, ki so prejeli zdravilo Flixabi (148 od 231), in pri 66 % bolnikov, ki so prejeli zdravilo Remicade (163 od 247).
English: To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Flixabi or the infusion time may be slowed down.
Slovenian: Za zmanjšanje tveganja za pojav reakcij, povezanih z infuzijo, lahko bolniki pred zdravljenjem z zdravilom Flixabi ali med njim prejemajo druga zdravila ali pa se hitrost infuzije upočasni.
English: In particular, information will be provided for doctors who intend to prescribe the medicine to children with Crohn's disease or ulcerative colitis, to explain that these patients may be at an increased risk of developing infections and to remind of the importance of keeping vaccinations up to date.
Slovenian: Zdravniki, ki nameravajo predpisovati zdravilo otrokom s Crohnovo boleznijo ali ulceroznim kolitisom, bodo prejeli še posebne informacije, v katerih bo pojasnjeno, da pri teh bolnikih obstaja povečano tveganje za okužbe, opozorjeni pa bodo tudi na pomembnost rednega cepljenja.
English: In addition, the company that markets Flixabi will provide an alert card for patients and educational material for prescribers, summarising the safety information about the medicine.
Slovenian: Poleg tega bo podjetje, ki trži zdravilo Flixabi, priskrbelo opozorilno kartico za bolnike in izobraževalno gradivo za predpisovalce, kjer bodo navedene informacije o varnosti zdravila.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Flixabi has been shown to have a comparable quality, safety and effectiveness to Remicade.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je zdravilo Flixabi po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Remicade.
English: A risk management plan has been developed to ensure that Flixabi is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Flixabi je bil pripravljen načrt obvladovanja tveganj.
English: Flixabi must also not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).
Slovenian: Ne sme se uporabljati pri bolnikih s tuberkulozo, drugimi hudimi okužbami ali zmernim do hudim srčnim popuščanjem (nezmožnostjo srca, da črpa dovolj krvi po telesu).
English: What are the risks associated with Flixabi?
Slovenian: Kakšna tveganja so povezana z zdravilom Flixabi?
English: Therefore, the CHMP's view was that, as for Remicade, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Remicade odtehtajo znana tveganja.
English: TNF-alpha is involved in causing inflammation and is found at high levels in patients with the diseases that Flixabi is used to treat.
Slovenian: TNF-alfa sodeluje pri povzročanju vnetij in je prisoten v visokih koncentracijah pri bolnikih z boleznimi, za katere se zdravilo Flixabi uporablja.
English: Other information about Flixabi
Slovenian: Druge informacije o zdravilu Flixabi
English: Flixabi was also compared with Remicade in one main study involving 584 patients with moderate to severe rheumatoid arthritis who had received previous treatment with methotrexate.
Slovenian: Zdravilo Flixabi so z zdravilom Remicade primerjali tudi v glavni študiji, ki je vključevala 584 bolnikov z zmernim do hudim revmatoidnim artritisom, ki so se predhodno zdravili z metotreksatom.
English: Flixabi is used with methotrexate (a medicine that acts on the immune system);
Slovenian: Zdravilo Flixabi se uporablja skupaj z metotreksatom (zdravilom, ki učinkuje na imunski sistem);
English: What benefits of Flixabi have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Flixabi izkazalo v študijah?
English: What is Flixabi and what is it used for?
Slovenian: Kaj je zdravilo Flixabi in za kaj se uporablja?
English: The active substance in Flixabi, infliximab, is a monoclonal antibody (a type of protein) that has been designed to attach to a protein called tumour necrosis factor-alpha (TNF-alpha) and block its activity.
Slovenian: Zdravilna učinkovina zdravila Flixabi, infliksimab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da se pritrdi na beljakovino, imenovano tumorje nekrotizirajoči faktor alfa (TNFalfa), in zavira njeno delovanje.
English: For more information about treatment with Flixabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Flixabi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Flixabi treatment should be started and supervised by a specialist doctor who has experience in the diagnosis and treatment of the diseases that Flixabi is used to treat.
Slovenian: Zdravljenje z zdravilom Flixabi lahko uvede in nadzoruje le zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolezni, za katere se uporablja zdravilo Flixabi.
English: For practical information about using Flixabi, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Flixabi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: • Crohn's disease (a disease causing inflammation of the gut), when the disease is moderate to severe or causes fistulae (abnormal passageways between the gut and other organs);
Slovenian: • Crohnove bolezni (bolezni, ki povzroča vnetje črevesja), kadar je bolezen zmerno do močno izražena ali pa prihaja do fistulizacije (nenormalnih prehodov med črevesjem in drugimi organi);
English: It is not intended to provide practical advice on how to use Flixabi.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Flixabi, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Flixabi must not be used in patients who are hypersensitive (allergic) to infliximab, mouse proteins or any of the other ingredients of Flixabi.
Slovenian: Zdravila Flixabi ne smejo jemati osebe, ki so preobčutljive za (alergične na) infliksimab, mišje beljakovine ali na katero koli drugo sestavino zdravila.
English: The Committee recommended that Flixabi be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Flixabi izda dovoljenje za promet.
English: For the full list of all side effects reported with Flixabi, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Flixabi, glejte navodilo za uporabo.
English: Why is Flixabi approved?
Slovenian: Zakaj je bilo zdravilo Flixabi odobreno?
English: Studies were carried out to show that Flixabi is comparable to Remicade, including a study to show that it produces similar levels of the active substance in the body to Remicade.
Slovenian: Opravljene so bile študije za dokazovanje primerljivosti zdravila Flixabi in zdravila Remicade, vključno s študijo za dokazovanje, da zdravilo Flixabi v telesu proizvede podobno raven zdravilne učinkovine kot zdravilo Remicade.
English: Flixabi contains the active substance infliximab and is a ‘biosimilar medicine'.
Slovenian: Zdravilo Flixabi vsebuje zdravilno učinkovino infliksimab in je „podobno biološko zdravilo“.
English: Flixabi is an anti-inflammatory medicine.
Slovenian: Zdravilo Flixabi je protivnetno zdravilo.
English: • rheumatoid arthritis (an immune-system disease causing inflammation of the joints).
Slovenian: • revmatoidnega artritisa (bolezni imunskega sistema, ki povzroča vnetje sklepov).
English: The reference medicine for Flixabi is Remicade.
Slovenian: Referenčno zdravilo za zdravilo Flixabi je zdravilo Remicade.
English: How does Flixabi work?
Slovenian: Kako zdravilo Flixabi deluje?
English: • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
Slovenian: • ankilozirajočega spondilitisa (bolezni, ki povzroča vnetje in bolečine v sklepih v hrbtenici);
English: • psoriasis (a disease causing red, scaly patches on the skin).
Slovenian: • psoriaze (bolezni, ki povzroča nastajanje rdečih in luskastih zaplat na koži).
English: How is Flixabi used?
Slovenian: Kako se zdravilo Flixabi uporablja?
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
Slovenian: • psoriatičnega artritisa (bolezni, ki povzroča nastajanje rdečih in luskastih zaplat na koži in vnetje sklepov);
English: This may take about 10 minutes.
Slovenian: To lahko traja okoli 10 minut.
English: • Then drink it straight away.
Slovenian: • Potem takoj popijte.
English: It may harm them,
Slovenian: Če driska postane huda,
English: Some cases have been fatal.
Slovenian: Nekaj primerov je bilo smrtnih.
English: Then take the next dose at the normal time.
Slovenian: Potem vzemite naslednji odmerek ob običajnem času.
English: 7 day schedule:
Slovenian: 7-dnevna shema:
English: N=Number of events/number of randomised patients
Slovenian: n = število dogodkov/število randomiziranih bolnikov
English: • If you are sensitive to the sun.
Slovenian: • če ste občutljivi za sonce.
English: 31.3% of patients had stable disease for at least 8 weeks.
Slovenian: 31,3 % bolnikov je imelo stabilno bolezen vsaj 8 tednov.
English: Date of latest renewal: 15 January 2019
Slovenian: Datum zadnjega podaljšanja: 15. januar 2019
English: You should have these tests:
Slovenian: Te preiskave morate opraviti:
English: These do not usually cause symptoms but your doctor may want to monitor them.
Slovenian: Ponavadi ne povzročajo simptomov, vendar jih bo zdravnik morda želel spremljati;
English: This section includes only data derived from completed studies where patient exposure is known.
Slovenian: To poglavje vključuje le podatke, pridobljene iz dokončanih študij, pri katerih je izpostavljenost bolnikov znana.
English: 19.3 months
Slovenian: 19,3 mesecev
English: No other liquids should be used.
Slovenian: Drugih tekočin se ne sme uporabljati.
English: Only use water, do not use any other liquids.
Slovenian: Uporabljajte samo vodo in ne kakšnih drugih tekočin.
English: • If you start taking medicines that affect your heart
Slovenian: • Če začnete jemati zdravila, ki vplivajo na srce.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 February 2012
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 17. februar 2012
English: Most (95% of the patients) had metastatic disease.
Slovenian: Večina (95 % bolnikov) je imela metastatsko bolezen.
English: • Put the tablet into the water.
Slovenian: • Dajte tableto v vodo.
English: 52/100 80.4 months a Overall response rate = complete + partial responses.
Slovenian: 52/100 80,4 mesecev a Celotni delež odziva = popolni + delni odziv.
English: RET mutation status in Study 58
Slovenian: Status mutacije RET v Študiji 58
English: 3Q 2020
Slovenian: Do datuma 3Q 2020
English: • The recommended dose is 300 mg each day.
Slovenian: • Priporočeni odmerek je 300 mg vsak dan.
English: The total daily dose in children must not exceed 300 mg.
Slovenian: Celoten dnevni odmerek pri otrocih ne sme presegati 300 mg.
English: • Every 3 months thereafter
Slovenian: • nato pa vsake 3 mesece.
English: The primary efficacy outcome was ORR according to RECIST v 1.0.
Slovenian: Primarni izid učinkovitosti je bil ORR po RECIST v 1.0.
English: Dose reduction (mg) c
Slovenian: Zmanjšanje odmerka (mg)c
English: This is seen on an electrocardiogram (ECG).
Slovenian: Ta je opazna na elektrokardiogramu (EKG).
English: • Take Caprelsa about the same time each day.
Slovenian: • Zdravilo Caprelsa vzemite vsak dan ob približno istem času.
English: This is because Caprelsa may harm an unborn child.
Slovenian: To pa zato, ker zdravilo Caprelsa lahko škoduje nerojenemu otroku.
English: Tell your doctor or pharmacist if you are taking any of the following medicines:
Slovenian: Povejte svojemu zdravniku ali farmacevtu, če jemljete katero od naslednjih zdravil:
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Slovenian: Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okvirju izvesti naslednje ukrepe:
English: The tablet is to be dropped in water, without crushing, stirred until dispersed (approximately 10 minutes) and the resultant dispersion swallowed immediately.
Slovenian: Tableto je treba dati v vodo brez, da bi jo zdrobili, mešati, dokler se ne dispergira (približno 10 minut) in dobljeno disperzijo takoj popiti.
English: • Stroke or other conditions where the brain may not get enough blood.
Slovenian: • možganska kap ali druga stanja, pri katerih možgani ne prejmejo dovolj krvi;
English: • Sensitivity of the skin to sunlight.
Slovenian: • občutljivost kože za sončno svetlobo.
English: • Severe skin reactions affecting large areas of your body.
Slovenian: • hude kožne reakcije, ki prizadenejo obsežne predele telesa.
English: This can cause sunburn.
Slovenian: Posledica so lahko sončne opekline.
English: Disease Control Rate including best response or Stable Disease >24 weeks was 75.0%.
Slovenian: Delež obvladanja bolezni, vključno z najboljšim odzivom ali s stabilno boleznijo > 24 tednov, je bil 75,0 %.
English: The recommended dose is 300 mg once a day, taken with or without food at about the same time each day.
Slovenian: Priporočeni odmerek je 300 mg enkrat na dan, ki ga bolnik vzame s hrano ali brez nje in vsak dan ob približno istem času.
English: Patients with documented RET mutation (n=187)
Slovenian: Bolniki z dokazano mutacijo RET (n = 187)
English: The objective response rate observed was 43.8%, all of which were partial responses.
Slovenian: Ugotovljeni delež objektivnega odziva je bil 43,8 %; v vseh primerih je šlo za delen odziv.