natgillin/translations-raw huggingface dataset:
Add-on to metformin (2,000 mg/day) + rosiglitazone (4 mg twice daily) Liraglutide 1.2 mg 177 8.48
Dodatek k zdravljenju z metforminom (2.000 mg/dan) + rosiglitazonom (4 mg dvakrat na dan) liraglutid 1,2 mg liraglutid 1,8 mg placebo
This medicine contains less than 1 mmol sodium (23 mg) per dose.
Zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
• Inflamed gallbladder
• vnetje žolčnika
Victoza 6 mg/ml injection Liraglutide
Victoza 6 mg/ml injekcija liraglutid za subkutano uporabo
1 ml of solution contains 6 mg of liraglutide*.
1 ml raztopine vsebuje 6 mg liraglutida*.
Headache Dizziness
Okvara ledvic
Tmax was delayed by 1.5 h with liraglutide for both compounds.
Čas do največje koncentracije (tmax) se je pri sočasnem zdravljenju z liraglutidom pri obeh učinkovinah podaljšal za 1,5 ure.
In a double-blind study comparing the efficacy and safety of Victoza 1.8 mg versus placebo as add-on to metformin ± insulin in adolescents and children aged 10 years and above with type 2 diabetes, Victoza was superior to placebo treatment in reducing HbA1c after 26 weeks (-1.06, [-1.65, 0.46]).
Izvedli so dvojno slepo študijo za primerjavo učinkovitosti in varnosti 1,8 mg zdravila Victoza v primerjavi s placebom kot dodatka metforminu ± insulinu pri mladostnikih in otrocih, starih 10 let ali več, s sladkorno boleznijo tipa 2; v tej študiji je bilo zdravilo Victoza po 26 tednih superiorno placebu, kar zadeva znižanje HbA1c (-1,06 [-1,65, 0,46]).
Atorvastatin Cmax was decreased by 38% and median tmax was delayed from 1 h to 3 h with liraglutide.
Pri zdravljenju z liraglutidom se je največja koncentracija atorvastatina (Cmax) zmanjšala za 38 %, mediani čas do največje koncentracije (tmax) pa se je podaljšal z 1 na 3 ure.
Liraglutide exposure was lowered by 33%, 14%, 27% and 26% in patients with mild (creatinine clearance, CrCl 50-80 ml/min), moderate (CrCl 30-50 ml/min), and severe (CrCl <30 ml/min) renal impairment and in end-stage renal disease requiring dialysis, respectively.
Pri bolnikih z blago okvaro ledvic (očistek kreatinina 50-80 ml/min) je bila izpostavljenost liraglutidu manjša za 33 %, z zmerno okvaro ledvic (očistek kreatinina 30-50 ml/min)
Hypoglycaemia Anorexia
Bolezni imunskega sistema anafilaktičn a reakcija
In an open label trial comparing the efficacy and safety of liraglutide (1.2 mg and 1.8 mg) and sitagliptin (a DPP-4 inhibitor, 100 mg) in patients inadequately controlled on metformin therapy (mean HbA1c 8.5%), liraglutide at both doses was statistically superior to sitagliptin treatment in reducing HbA1c after 26 weeks (-1.24%, -1.50% vs -0.90%, p<0.0001).
V odprtem preskušanju, ki je primerjalo učinkovitost in varnost liraglutida (1,2 mg in 1,8 mg) in sitagliptina (zaviralca DPP-4, odmerek 100 mg) pri bolnikih, nezadostno urejenih z metforminom (srednji HbA1c 8,5 %), je bil liraglutid v obeh odmerkih statistično superioren v primerjavi s sitagliptinom, kar zadeva znižanje HbA1c po 26 tednih (-1,24 %, -1,50 % v prim.
Liraglutide 1.8 mg 246 8.19
Monoterapija liraglutid 1,2 mg liraglutid 1,8 mg glimepirid 8 mg/dan 248 8,23
HR: 0.87 95% CI [0.78; 0.97]
z -0,88 %, p < 0,0001).
Special populations
Posebne skupine bolnikov
Liraglutide did not change the overall exposure of atorvastatin to a clinically relevant degree following single dose administration of atorvastatin 40 mg.
Liraglutid ni spremenil celotne izpostavljenosti griseofulvinu po enkratnem odmerku 500 mg griseofulvina.
In an open label trial comparing the efficacy and safety of liraglutide 1.8 mg with lixisenatide 20 mcg in 404 patients inadequately controlled on metformin therapy (mean HbA1c 8.4%), liraglutide was superior to lixisenatide in reducing HbA1c after 26 weeks of treatment (-1.83% vs -1.21%, p<0.0001).
V odprtem preskušanju, ki je primerjalo učinkovitost in varnost liraglutida v odmerku 1,8 mg z liksisenatidom v odmerku 20 µg pri 404 bolnikih, nezadostno urejenih pri zdravljenju z metforminom (srednja vrednost HbA1c 8,4 %), se je liraglutid pri zmanjšanju vrednosti HbA1c po 26 tednih zdravljenja izkazal za superiornega v primerjavi z liksisenatidom (-1,83 % v primerjavi z -1,21 %,
Addition of liraglutide resulted in a statistically significantly greater reduction of HbA1c (-0.73% for liraglutide vs -0.40% for comparator) and body weight (-3.03 vs 0.72 kg).
(-0,73 % pri liraglutidu v primerjavi z -0,40 % pri primerjalnem zdravilu) in telesne mase (-3,03 v primerjavi z 0,72 kg).
The incidence of withdrawal due to adverse reactions was 7.8% for liraglutide-treated patients and 3.4% for comparator-treated patients in the long-term controlled trials (26 weeks or longer).
V dolgotrajnih kontroliranih preskušanjih (26 tednov ali dlje) je bilo zaradi neželenih učinkov zdravljenje prekinjeno pri 7,8 % bolnikov, ki so se zdravili z liraglutidom, in pri 3,4 % bolnikov, ki so prejemali primerjalno zdravilo.
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).
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.
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.
bolnikov vsaj enkrat pojavila navzea in pri 7,9 % bolnikov vsaj enkrat driska.
Thyroid disease
Bolezni jeter,
Larger weight reduction was observed with increasing body mass index (BMI) at baseline.
Večje zmanjšanje telesne mase so opazili pri bolnikih, ki so imeli izhodiščno večji indeks telesne mase
Children and adolescents
Za otroke, mlajše od 10
Guideline for titration of insulin glargine
Smernice za prilagajanje odmerka insulina glargin Samoizmerjena glukoza v plazmi na tešče
• Abdominal discomfort
• splošno slabo počutje
More frequent blood testing to determine the ability of your blood to clot may be required.
• varfarin ali druga peroralna zdravila proti strjevanju krvi; opraviti boste morali več preiskav krvi, da se oceni sposobnosti vaše krvi za tvorjenje krvnega strdka.
Posology
ŠKATLA
Read the package leaflet before use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
OTHER SPECIAL WARNINGS, IF NECESSARY
ko je to najprimerneje.
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.
Zelo pogosti sta bili navzea in driska, pogosti pa bruhanje, zaprtost, bolečine v trebuhu in dispepsija.
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%).
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 %).
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.
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.
Few cases of acute pancreatitis (<0.2%) have been reported during long-term, controlled phase 3 clinical trials with Victoza.
V dolgotrajnih, kontroliranih kliničnih preskušanjih faze 3a zdravila Victoza je bilo opisanih le nekaj primerov akutnega pankreatitisa (manj kot 0,2 %).
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.
Če vam je injekcijski peresnik padel na trdo površino ali mislite, da je z njim nekaj narobe,
Non-fatal stroke
Možganska kap brez smrtnega izida
Rate of confirmed hypoglycaemic episodes was higher with liraglutide (0.58 events/patient year) compared to placebo (0.29 events/patient year).
(0,58 dogodka/bolnik-leto) kot s placebom (0,29 dogodka/bolnik-leto).
Do not try to select other doses than 0.6 mg, 1.2 mg or 1.8 mg.
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.
Add-on to metformin (2,000 mg/day) + glimepiride (4 mg/day) Liraglutide 1.8 mg 230 8.3
Dodatek k zdravljenju z metforminom (2.000 mg/dan) + glimepiridom (4 mg/dan) liraglutid 1,8 mg placebo insulin glargin4
The contraceptive effect is therefore anticipated to be unaffected when co-administered with liraglutide.
Zato ni verjetno, da bi sočasno zdravljenje z liraglutidom vplivalo na kontracepcijski učinek.
If you get any side effects, talk to your doctor, pharmacist or nurse.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
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.
Največja koncentracija paracetamola (Cmax) se je zmanjšala za 31 %, mediani čas do največje koncentracije (tmax) pa se je podaljšal za največ 15 min.
Liraglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
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.
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.
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 %
No episodes of severe hypoglycaemia were observed in the trial with liraglutide used as monotherapy.
V preskušanju monoterapije z liraglutidom ni bilo opisanih primerov hude hipoglikemije.
• Painful or swollen tummy (abdomen)
• bolečine ali napihnjenost trebuha • neprijeten občutek v trebuhu
No dose adjustment is recommended for patients with mild or moderate hepatic impairment.
Pri zdravljenju bolnikov z blago ali zmerno okvaro jeter prilagoditev odmerka ni priporočljiva.
• Cases of inflammation of the pancreas (pancreatitis).
To bi lahko bil znak vnetja trebušne slinavke (pankreatitisa).
Disodium phosphate dihydrate Propylene glycol Phenol
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev hidrogenfosfat dihidrat propilenglikol fenol voda za injekcije
Uncommon: may affect up to 1 in 100 people
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
Victoza 6 mg/ml solution for injection in pre-filled pen Liraglutide
Victoza 6 mg/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku liraglutid
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.
5Zdravilo Victoza so kot dodatek k zaviralcu SGLT2 raziskali pri vseh odobrenih odmerkih zaviralca SGLT2.
Flatulence Abdominal distension Gastroesophageal reflux disease Abdominal discomfort Toothache
bolečine v zgornjem delu trebuha, zaprtje, gastritis, napenjanje, napihnjenost trebuha, gastroezofagealna refluksna bolezen,
One pre-filled pen contains 18 mg liraglutide.
En napolnjen injekcijski peresnik vsebuje 18 mg liraglutida.
Significantly more patients achieved HbA1c below 7% with liraglutide compared with exenatide (54.2% vs 43.4%, p=0.0015).
Z liraglutidom je HbA1c pod 7 % doseglo značilno več bolnikov kot z eksenatidom (54,2 % v prim.
Placebo *Superiority (p<0.01) vs active comparator; **Superiority (p<0.0001) vs active comparator; ***Superiority
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
Victoza should not be used if it does not appear clear and colourless or almost colourless.
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.
• Toothache
• omotica
Victoza 6 mg/ml solution for injection in pre-filled pen
Victoza 6 mg/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
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.
26 tednih zdravljenja je povzročil dodatno in statistično značilno znižanje HbA1c (-0,32 %, 95 % IZ:
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.
Največja koncentracija griseofulvina (Cmax) se je povečala za 37 %, medtem ko se mediani čas do največje koncentracije (tmax) ni spremenil.
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.
0,5 % pri placebu z ocenjeno razliko med zdravljenji -0,9 [-1,00; -0,70]95 % IZ.
Increased heart rate
Preiskave povečana koncentracija
• Body weight
• Telesna masa
Inject the dose.
Snemite pokrovček injekcijskega peresnika.
How to store Victoza
Shranjevanje zdravila Victoza
UNIQUE IDENTIFIER - HUMAN READABLE DATA
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC:
The use of Victoza is not recommended if you have severe heart failure.
Uporaba zdravila Victoza ni priporočljiva za bolnike s hudim popuščanjem srca.
Nasopharyngitis Bronchitis
Infekcijske in parazitske bolezni nazofaringitis, bronhitis
Very common Common Uncommon Rare
Zelo redki lipaze*,
Few cases (0.05%) of angioedema have been reported during all long-term clinical trials with Victoza.
(0,05 %) angioedema.
Skin and subcutaneous tissue disorder
Bolezni kože in podkožja izpuščaj urtikarija, pruritus
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.
Bolniki z blago ali zmerno okvaro ledvic (očistek kreatinina 60-90 ml/min oz.
Digoxin median tmax was delayed from 1 h to 1.5 h. No adjustment of digoxin dose is required based on these results.
Mediani čas do največje koncentracije digoksina (tmax) se je pri hkratnem zdravljenju z liraglutidom podaljšal z 1 na 1,5 ure.
(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.
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
Severe hypoglycaemia may occur uncommonly and has primarily been observed when liraglutide is combined with a sulfonylurea (0.02 events/patient year).
Huda hipoglikemija se lahko pojavi občasno, opisana je bila predvsem pri bolnikih, ki so hkrati z liraglutidom prejemali sulfonilsečnino
Common: may affect up to 1 in 10 people
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
With each new pen, check the flow Check the flow before your first injection with each new pen.
Pred injiciranjem zdravila z novim injekcijskim peresnikom vedno preverite pretok.
• Gallstones
• žolčni kamni
One pre-filled pen contains 18 mg liraglutide
En napolnjen injekcijski peresnik vsebuje 18 mg liraglutida,
Your pen comes with 18 mg of liraglutide.
Injekcijski peresnik je napolnjen z 18 mg liraglutida.
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).
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.
• Microvascular evaluation
• Uravnavanje glikemije
The signs include stomach ache, nausea and vomiting.
Bolezni prebavil navzea, driska bruhanje, dispepsija,
Fatigue Injection site reactions
Splošne težave in spremembe na mestu aplikacije utrujenost, reakcije na mestu injiciranja splošno slabo počutje
A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.
• zapora črevesja; huda oblika zaprtja, ki jo spremljajo simptomi, kot so bolečine v trebuhu,
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.
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.
Few cases of anaphylactic reactions with additional symptoms such as hypotension, palpitations, dyspnoea and oedema have been reported with marketed use of Victoza.
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.
Constipation Gastritis
• navaden prehlad
CI: confidence interval
N Povprečna vrednost
Inject your dose
Izbira odmerka
Victoza contains the active substance liraglutide.
Kaj je zdravilo Victoza in za kaj ga uporabljamo Zdravilo Victoza vsebuje učinkovino liraglutid.
Add-on to SGLT2i5 ± metformin (≥1500 mg/day)
≥ 6,7 mmol/l (≥ 120 mg/dl)
Intestinal obstruction
Prekinitev zdravljenja
This summary was last updated in 03-2012.
Povzetek je bil nazadnje posodobljen 03-2012.
As a result, it inhibits the growth of tumour cells and eventually kills them.
Posledica tega je, da zavira rast tumorskih celic in jih nazadnje tudi uniči.
Capecitabine Accord tablets should be swallowed with water within the 30 minutes after a meal.
Tablete zdravila Capecitabine Accord je treba pogoltniti z vodo v 30 minutah po obroku.
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.
To pomeni, da je podobno „referenčnemu zdravilu“, ki vsebuje isto zdravilno učinkovino, vendar je poleg že obstoječih jakosti na voljo tudi v novi jakosti.
The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Accord on 20 April 2012.
Evropska komisija je dovoljenje za promet z zdravilom Capecitabine Accord, veljavno po vsej Evropski uniji, odobrila dne 20. aprila 2012.
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.
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.
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).
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).
For other types of cancer, treatment is stopped if the disease gets worse or the patient cannot tolerate the treatment.
Pri drugih oblikah raka se zdravljenje prekine, če bolezen napreduje ali če bolnik ne prenaša zdravljenja.
The doctor will calculate the number of 150, 300 and 500 mg tablets the patient needs to take.
Zdravnik bo izračunal število 150, 300 in 500 mg tablet, ki jih mora bolnik vzeti.
For more information about treatment with Capecitabine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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.
Because Capecitabine Accord is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Capecitabine Accord biološko enakovredno referenčnemu zdravilo, se šteje, da so koristi in tveganja enaki kot pri referenčnem zdravilu.
This is a summary of the European public assessment report (EPAR) for Capecitabine Accord.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Capecitabine Accord.
What are the benefits and risks of Capecitabine Accord?
Kakšne so koristi in tveganja, povezani z zdravilom Capecitabine Accord?
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.
Kapecitabin je „predzdravilo“, ki se v telesu pretvori v 5-florouracil (5-FU), vendar v večji meri v tumorskih celicah kot v normalnem tkivu.
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.
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.
EPAR summary for the public capecitabine
Povzetek EPAR za javnost kapecitabin
The company provided data from studies to determine that it is bioequivalent to the reference medicine, Xeloda.
Družba je predstavila podatke iz študij, da bi potrdila, da je zdravilo biološko enakovredno referenčnemu zdravilu Xeloda.
While the reference medicine, Xeloda, is available as 150 and 500 mg tables, Capecitabine Accord is also available as 300 mg tablets.
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.