FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
Slovenian: Victoza prenehajte uporabljati in se nemudoma posvetujte z zdravnikom: hudo in trdovratno bolečino v trebuhu (v predelu želodca), ki lahko izžareva v hrbet, spremlja pa jo lahko tudi siljenje na bruhanje in bruhanje.
English: When combining liraglutide with a sulfonylurea, 9.1% of patients reported at least one episode of nausea and 7.9% of patients reported at least one episode of diarrhoea.
Slovenian: bolnikov vsaj enkrat pojavila navzea in pri 7,9 % bolnikov vsaj enkrat driska.
English: Thyroid disease
Slovenian: Bolezni jeter,
English: Larger weight reduction was observed with increasing body mass index (BMI) at baseline.
Slovenian: Večje zmanjšanje telesne mase so opazili pri bolnikih, ki so imeli izhodiščno večji indeks telesne mase
English: Children and adolescents
Slovenian: Za otroke, mlajše od 10
English: Guideline for titration of insulin glargine
Slovenian: Smernice za prilagajanje odmerka insulina glargin Samoizmerjena glukoza v plazmi na tešče
English: • Abdominal discomfort
Slovenian: • splošno slabo počutje
English: More frequent blood testing to determine the ability of your blood to clot may be required.
Slovenian: • varfarin ali druga peroralna zdravila proti strjevanju krvi; opraviti boste morali več preiskav krvi, da se oceni sposobnosti vaše krvi za tvorjenje krvnega strdka.
English: Posology
Slovenian: ŠKATLA
English: Read the package leaflet before use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
English: OTHER SPECIAL WARNINGS, IF NECESSARY
Slovenian: ko je to najprimerneje.
English: The most frequently reported adverse reactions during clinical trials were gastrointestinal disorders: nausea and diarrhoea were very common, whereas vomiting, constipation, abdominal pain, and dyspepsia were common.
Slovenian: Zelo pogosti sta bili navzea in driska, pogosti pa bruhanje, zaprtost, bolečine v trebuhu in dispepsija.
English: In a double-blind trial comparing the efficacy and safety of liraglutide 1.8 mg versus placebo as addon to insulin and/or OAD in patients with type 2 diabetes and moderate renal impairment, liraglutide was superior to placebo treatment in reducing HbA1c after 26 weeks (-1.05% vs -0.38%).
Slovenian: Uporaba pri bolnikih z okvaro ledvic V dvojno slepem preskušanju, ki je primerjalo učinkovitost in varnost liraglutida v odmerku 1,8 mg in placeba kot dodatka insulinu in/ali peroralnim antidiabetikom pri bolnikih s sladkorno boleznijo tipa 2 in zmerno okvaro ledvic, je bil liraglutid v primerjavi s placebom značilno boljši pri znižanju HbA1c po 26 tednih (-1,05 % v primerjavi z -0,38 %).
English: Ethnic origin had no clinically relevant effect on the pharmacokinetics of liraglutide based on the results of population pharmacokinetic analysis which included patients of White, Black, Asian and Hispanic groups.
Slovenian: Glede na rezultate populacijske farmakokinetične analize, ki je zajela bolnike bele in črne rase ter bolnike iz azijskih in latinskoameriških skupin, etnično poreklo ne vpliva klinično pomembno na farmakokinetiko liraglutida.
English: Few cases of acute pancreatitis (<0.2%) have been reported during long-term, controlled phase 3 clinical trials with Victoza.
Slovenian: V dolgotrajnih, kontroliranih kliničnih preskušanjih faze 3a zdravila Victoza je bilo opisanih le nekaj primerov akutnega pankreatitisa (manj kot 0,2 %).
English: If you have dropped your pen against a hard surface or suspect that something is wrong with it, always put on a new disposable needle and check the flow before you inject.
Slovenian: Če vam je injekcijski peresnik padel na trdo površino ali mislite, da je z njim nekaj narobe,
English: Non-fatal stroke
Slovenian: Možganska kap brez smrtnega izida
English: Rate of confirmed hypoglycaemic episodes was higher with liraglutide (0.58 events/patient year) compared to placebo (0.29 events/patient year).
Slovenian: (0,58 dogodka/bolnik-leto) kot s placebom (0,29 dogodka/bolnik-leto).
English: Do not try to select other doses than 0.6 mg, 1.2 mg or 1.8 mg.
Slovenian: Ne poskušajte izbrati drugih odmerkov kot 0,6 mg, 1,2 mg ali 1,8 mg. Da zagotovite pravilen odmerek, morajo biti številke na zaslonu natančno poravnane s kazalnikom odmerka.
English: Add-on to metformin (2,000 mg/day) + glimepiride (4 mg/day) Liraglutide 1.8 mg 230 8.3
Slovenian: Dodatek k zdravljenju z metforminom (2.000 mg/dan) + glimepiridom (4 mg/dan) liraglutid 1,8 mg placebo insulin glargin4
English: The contraceptive effect is therefore anticipated to be unaffected when co-administered with liraglutide.
Slovenian: Zato ni verjetno, da bi sočasno zdravljenje z liraglutidom vplivalo na kontracepcijski učinek.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Liraglutide did not change the overall exposure of paracetamol following a single dose of 1000 mg. Paracetamol Cmax was decreased by 31% and median tmax was delayed up to 15 min. No dose adjustment for concomitant use of paracetamol is required.
Slovenian: Največja koncentracija paracetamola (Cmax) se je zmanjšala za 31 %, mediani čas do največje koncentracije (tmax) pa se je podaljšal za največ 15 min.
English: Liraglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Liraglutid se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
English: In a 52-week clinical trial, the addition of insulin detemir to liraglutide 1.8 mg and metformin in patients not achieving glycaemic targets on liraglutide and metformin alone resulted in a HbA1c decrease from baseline of 0.54%, compared to 0.20% in the liraglutide 1.8 mg and metformin control group.
Slovenian: 1,8 mg in metforminu pri bolnikih, ki pri zdravljenju samo z liraglutidom in metforminom niso dosegli glikemičnih ciljnih vrednosti, vrednost HbA1c od izhodišča zmanjšala za 0,54 % v primerjavi z 0,20 %
English: No episodes of severe hypoglycaemia were observed in the trial with liraglutide used as monotherapy.
Slovenian: V preskušanju monoterapije z liraglutidom ni bilo opisanih primerov hude hipoglikemije.
English: • Painful or swollen tummy (abdomen)
Slovenian: • bolečine ali napihnjenost trebuha • neprijeten občutek v trebuhu
English: No dose adjustment is recommended for patients with mild or moderate hepatic impairment.
Slovenian: Pri zdravljenju bolnikov z blago ali zmerno okvaro jeter prilagoditev odmerka ni priporočljiva.
English: SN:
Slovenian: Lot:
English: • Cases of inflammation of the pancreas (pancreatitis).
Slovenian: To bi lahko bil znak vnetja trebušne slinavke (pankreatitisa).
English: Disodium phosphate dihydrate Propylene glycol Phenol
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev hidrogenfosfat dihidrat propilenglikol fenol voda za injekcije
English: Uncommon: may affect up to 1 in 100 people
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
English: Victoza 6 mg/ml solution for injection in pre-filled pen Liraglutide
Slovenian: Victoza 6 mg/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku liraglutid
English: 1all patients; 2previous OAD monotherapy; 3previous diet treated patients 5Victoza add-on to SGLT2i was investigated at all approved doses of SGLT2i 4the dosing of insulin glargine was open-labelled and was applied according to Guideline for titration of insulin glargine.
Slovenian: 5Zdravilo Victoza so kot dodatek k zaviralcu SGLT2 raziskali pri vseh odobrenih odmerkih zaviralca SGLT2.
English: Flatulence Abdominal distension Gastroesophageal reflux disease Abdominal discomfort Toothache
Slovenian: bolečine v zgornjem delu trebuha, zaprtje, gastritis, napenjanje, napihnjenost trebuha, gastroezofagealna refluksna bolezen,
English: One pre-filled pen contains 18 mg liraglutide.
Slovenian: En napolnjen injekcijski peresnik vsebuje 18 mg liraglutida.
English: Significantly more patients achieved HbA1c below 7% with liraglutide compared with exenatide (54.2% vs 43.4%, p=0.0015).
Slovenian: Z liraglutidom je HbA1c pod 7 % doseglo značilno več bolnikov kot z eksenatidom (54,2 % v prim.
English: Placebo *Superiority (p<0.01) vs active comparator; **Superiority (p<0.0001) vs active comparator; ***Superiority
Slovenian: Dodatek k zdravljenju z zaviralcem SGLT25 ± metformin (≥ 1.500 mg/dan) liraglutid 1,8 mg placebo *Superiornost (p<0,01) v primerjavi z aktivnim primerjalnim zdravilom; **Superiornost (p<0,0001) v primerjavi z aktivnim primerjalnim zdravilom; ***Superiornost (p<0,001) v primerjavi z aktivnim primerjalnim zdravilom; †Neinferiornost (p<0,0001) v primerjavi z aktivnim primerjalnim zdravilom 1vsi bolniki; 2bolniki, ki so se predhodno zdravili s peroralnimi antidiabetiki; 3bolniki, ki so se predhodno zdravili z dieto
English: Victoza should not be used if it does not appear clear and colourless or almost colourless.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravila Victoza ne smete uporabiti, če raztopina ni bistra in brezbarvna ali skoraj brezbarvna.
English: • Toothache
Slovenian: • omotica
English: Victoza 6 mg/ml solution for injection in pre-filled pen
Slovenian: Victoza 6 mg/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Switching patients from exenatide to liraglutide after 26 weeks of treatment resulted in an additional and statistically significant reduction in HbA1c (-0.32%, 95% CI: -0.41 to -0.24) at week 40, but a formal control group was not available.
Slovenian: 26 tednih zdravljenja je povzročil dodatno in statistično značilno znižanje HbA1c (-0,32 %, 95 % IZ:
English: Liraglutide did not change the overall exposure of griseofulvin following administration of a single dose of griseofulvin 500 mg. Griseofulvin Cmax increased by 37% while median tmax did not change.
Slovenian: Največja koncentracija griseofulvina (Cmax) se je povečala za 37 %, medtem ko se mediani čas do največje koncentracije (tmax) ni spremenil.
English: At week 26, the estimated mean change in HbA1c was -1.4% and -0.5% for liraglutide and placebo, respectively, with an estimated treatment difference of -0.9 [-1.00; -0.70]95% CI.
Slovenian: 0,5 % pri placebu z ocenjeno razliko med zdravljenji -0,9 [-1,00; -0,70]95 % IZ.
English: Increased heart rate
Slovenian: Preiskave povečana koncentracija
English: • Body weight
Slovenian: • Telesna masa
English: Inject the dose.
Slovenian: Snemite pokrovček injekcijskega peresnika.
English: How to store Victoza
Slovenian: Shranjevanje zdravila Victoza
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC:
English: The use of Victoza is not recommended if you have severe heart failure.
Slovenian: Uporaba zdravila Victoza ni priporočljiva za bolnike s hudim popuščanjem srca.
English: Nasopharyngitis Bronchitis
Slovenian: Infekcijske in parazitske bolezni nazofaringitis, bronhitis
English: Very common Common Uncommon Rare
Slovenian: Zelo redki lipaze*,
English: Few cases (0.05%) of angioedema have been reported during all long-term clinical trials with Victoza.
Slovenian: (0,05 %) angioedema.
English: Skin and subcutaneous tissue disorder
Slovenian: Bolezni kože in podkožja izpuščaj urtikarija, pruritus
English: Patients with mild and moderate renal impairment (creatinine clearance 60-90 ml/min and 3059 ml/min, respectively) may experience more gastrointestinal effects when treated with liraglutide.
Slovenian: Bolniki z blago ali zmerno okvaro ledvic (očistek kreatinina 60-90 ml/min oz.
English: Digoxin median tmax was delayed from 1 h to 1.5 h. No adjustment of digoxin dose is required based on these results.
Slovenian: Mediani čas do največje koncentracije digoksina (tmax) se je pri hkratnem zdravljenju z liraglutidom podaljšal z 1 na 1,5 ure.
English: (CrCL 30-59 ml/min, see section 5.1) had 26% lower liraglutide exposure when compared with a separate trial including patients with type 2 diabetes with normal renal function or mild renal impairment.
Slovenian: Podobno so v 26-tedenskem kliničnem preskušanju pri bolnikih s sladkorno boleznijo tipa 2 in zmerno okvaro ledvic (očistek kreatinina 30-59 ml/min, glejte poglavje 5.1) ugotovili 26 % manjšo izpostavljenost liraglutidu kot v ločenem preskušanju, ki je zajelo bolnike s sladkorno boleznijo tipa 2
English: Severe hypoglycaemia may occur uncommonly and has primarily been observed when liraglutide is combined with a sulfonylurea (0.02 events/patient year).
Slovenian: Huda hipoglikemija se lahko pojavi občasno, opisana je bila predvsem pri bolnikih, ki so hkrati z liraglutidom prejemali sulfonilsečnino
English: Common: may affect up to 1 in 10 people
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
English: With each new pen, check the flow Check the flow before your first injection with each new pen.
Slovenian: Pred injiciranjem zdravila z novim injekcijskim peresnikom vedno preverite pretok.
English: • Gallstones
Slovenian: • žolčni kamni
English: One pre-filled pen contains 18 mg liraglutide
Slovenian: En napolnjen injekcijski peresnik vsebuje 18 mg liraglutida,
English: METHOD OF ADMINISTRATION
Slovenian: POSTOPEK UPORABE
English: Your pen comes with 18 mg of liraglutide.
Slovenian: Injekcijski peresnik je napolnjen z 18 mg liraglutida.
English: In an open label trial comparing the efficacy and safety of liraglutide 1.8 mg once daily and exenatide 10 mcg twice daily in patients inadequately controlled on metformin and/or sulfonylurea therapy (mean HbA1c 8.3%), liraglutide was statistically superior to exenatide treatment in reducing HbA1c after 26 weeks (-1.12% vs -0.79%; estimated treatment difference: -0.33; 95% CI: -0.47 to -0.18).
Slovenian: V odprtem preskušanju, ki je primerjala učinkovitost in varnost liraglutida 1,8 mg enkrat na dan in 10mikrogramski odmerek eksenatida dvakrat na dan pri bolnikih, nezadostno urejenih z metforminom in/ali sulfonilsečnino (povprečni HbA1c 8,3 %), se je liraglutid izkazal za superiornega v primerjavi z eksenatidom, kar zadeva znižanje HbA1c po 26 tednih (-1,12 % v prim.
English: • Microvascular evaluation
Slovenian: • Uravnavanje glikemije
English: The signs include stomach ache, nausea and vomiting.
Slovenian: Bolezni prebavil navzea, driska bruhanje, dispepsija,
English: Fatigue Injection site reactions
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost, reakcije na mestu injiciranja splošno slabo počutje
English: A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.
Slovenian: • zapora črevesja; huda oblika zaprtja, ki jo spremljajo simptomi, kot so bolečine v trebuhu,
English: Obesity
Slovenian: Debelost
English: Liraglutide in combination with metformin, glimepiride, metformin and rosiglitazone or SGLT2i ± metformin resulted in a statistically significant greater proportion of patients achieving an HbA1c ≤6.5% at 26 weeks compared with patients receiving these agents alone.
Slovenian: Vrednost HbA1c ≤ 6,5 % je po 26 tednih dosegel značilno večji delež bolnikov, ki so skupaj z metforminom, glimepiridom, metforminom in rosiglitazonom ali zaviralcem SGLT2 ± metformin dobivali liraglutid, kot tistih, ki so dobivali le te učinkovine brez liraglutida.
English: Few cases of anaphylactic reactions with additional symptoms such as hypotension, palpitations, dyspnoea and oedema have been reported with marketed use of Victoza.
Slovenian: Prav tako so po prihodu zdravila Victoza na trg v nekaj primerih poročali o anafilaktični reakciji, ki so jo poleg zgoraj naštetih simptomov spremljali še simptomi, kot so hipertenzija, palpitacije, dispneja in edemi.
English: Constipation Gastritis
Slovenian: • navaden prehlad
English: CI: confidence interval
Slovenian: N Povprečna vrednost
English: Inject your dose
Slovenian: Izbira odmerka
English: Victoza contains the active substance liraglutide.
Slovenian: Kaj je zdravilo Victoza in za kaj ga uporabljamo Zdravilo Victoza vsebuje učinkovino liraglutid.
English: Add-on to SGLT2i5 ± metformin (≥1500 mg/day)
Slovenian: ≥ 6,7 mmol/l (≥ 120 mg/dl)
English: Intestinal obstruction
Slovenian: Prekinitev zdravljenja
English: This summary was last updated in 03-2012.
Slovenian: Povzetek je bil nazadnje posodobljen 03-2012.
English: As a result, it inhibits the growth of tumour cells and eventually kills them.
Slovenian: Posledica tega je, da zavira rast tumorskih celic in jih nazadnje tudi uniči.
English: Capecitabine Accord tablets should be swallowed with water within the 30 minutes after a meal.
Slovenian: Tablete zdravila Capecitabine Accord je treba pogoltniti z vodo v 30 minutah po obroku.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but available at a new strength in addition to existing strengths.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki vsebuje isto zdravilno učinkovino, vendar je poleg že obstoječih jakosti na voljo tudi v novi jakosti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Accord on 20 April 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Capecitabine Accord, veljavno po vsej Evropski uniji, odobrila dne 20. aprila 2012.
English: The full EPAR for Capecitabine Accord 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 Capecitabine Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Capecitabine Accord is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight).
Slovenian: Zdravilo Capecitabine Accord se jemlje dvakrat na dan v odmerkih med 625 in 1 250 mg na kvadratni meter telesne površine (izračunano glede na bolnikovo višino in telesno maso).
English: For other types of cancer, treatment is stopped if the disease gets worse or the patient cannot tolerate the treatment.
Slovenian: Pri drugih oblikah raka se zdravljenje prekine, če bolezen napreduje ali če bolnik ne prenaša zdravljenja.
English: The doctor will calculate the number of 150, 300 and 500 mg tablets the patient needs to take.
Slovenian: Zdravnik bo izračunal število 150, 300 in 500 mg tablet, ki jih mora bolnik vzeti.
English: For more information about treatment with Capecitabine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Capecitabine Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Because Capecitabine Accord is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Capecitabine Accord biološko enakovredno referenčnemu zdravilo, se šteje, da so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This is a summary of the European public assessment report (EPAR) for Capecitabine Accord.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Capecitabine Accord.
English: What are the benefits and risks of Capecitabine Accord?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Capecitabine Accord?
English: Capecitabine is a ‘prodrug' that is converted to 5-fluorouracil (5-FU) in the body, but more is converted in tumour cells than in normal tissues.
Slovenian: Kapecitabin je „predzdravilo“, ki se v telesu pretvori v 5-florouracil (5-FU), vendar v večji meri v tumorskih celicah kot v normalnem tkivu.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Capecitabine Accord.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Capecitabine Accord, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: EPAR summary for the public capecitabine
Slovenian: Povzetek EPAR za javnost kapecitabin
English: The company provided data from studies to determine that it is bioequivalent to the reference medicine, Xeloda.
Slovenian: Družba je predstavila podatke iz študij, da bi potrdila, da je zdravilo biološko enakovredno referenčnemu zdravilu Xeloda.
English: While the reference medicine, Xeloda, is available as 150 and 500 mg tables, Capecitabine Accord is also available as 300 mg tablets.
Slovenian: Referenčno zdravilo Xeloda je na voljo v obliki 150 in 500 mg tablet, zdravilo Capecitabine Accord pa je na voljo tudi v obliki 300 mg tablet.
English: • locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body).
Slovenian: • lokalno napredovalega ali metastatskega raka dojke (raka dojke, ki se je začel širiti na druge dele telesa).
English: Other information about Capecitabine Accord
Slovenian: Druge informacije o zdravilu Capecitabine Accord
English: It can also be used on its own when treatment with both anthracyclines and taxanes (another type of anticancer medicine) has failed or when repeat treatment with anthracyclines is not suitable for the patient.
Slovenian: Lahko se uporablja tudi samostojno, če je bilo zdravljenje z antraciklini in taksani (drugo vrsto zdravila proti raku) neuspešno ali če ponovno zdravljenje z antraciklini za bolnika ni primerno.
English: Full details are available in the summary of product characteristics (also part of the EPAR).
Slovenian: Za podrobnejše informacije glejte povzetek glavnih značilnosti zdravila (prav tako del EPAR).
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za referenčno zdravilo je na voljo na spletni strani agencije.
English: Therefore, the CHMP's view was that, as for Xeloda, the benefit outweighs the identified risk.
Slovenian: Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Xeloda, odtehtajo znana tveganja.
English: The Committee recommended that Capecitabine Accord be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Capecitabine Accord odobri dovoljenje za promet.
English: Capecitabine Accord should only be prescribed by a doctor who is qualified in the use of anticancer medicines.
Slovenian: Zdravilo Capecitabine Accord sme predpisati samo zdravnik, ki je usposobljen za uporabo zdravil proti raku.
English: The CHMP concluded that, in accordance with EU requirements, Capecitabine Accord has been shown to have comparable quality and to be bioequivalent to Xeloda.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Capecitabine Accord primerljivo raven kakovosti kot zdravilo Xeloda ter da mu je biološko enakovredno.
English: Capecitabine Accord is a ‘hybrid generic medicine'.
Slovenian: Zdravilo Capecitabine Accord je „hibridno generično zdravilo“.
English: Capecitabine Accord is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Slovenian: Zdravilo Capecitabine Accord se uporablja z drugimi zdravili proti raku, vključno z zdravilom proti raku, ki vsebuje platino (kot na primer cisplatin);