FrancophonIA/ELRC3.0 huggingface dataset:
English: Quality of life was improved significantly with Circadin 2 mg compared to placebo.
Slovenian: V skupini, ki je jemala zdravilo Circadin 2 mg se je kakovost življenja pomembno izboljšala v primerjavi s tisto, ki je jemala placebo.
English: The active substance of Circadin, melatonin, belongs to a natural group of hormones produced by the body.
Slovenian: Kaj je zdravilo Circadin in za kaj ga uporabljamo Zdravilna učinkovina zdravila Circadin, melatonin, sodi v skupino naravnih hormonov, ki jih izloča telo.
English: Therefore, Circadin is not recommended for use in patients with autoimmune diseases.
Slovenian: Zato se uporaba zdravila Circadin pri bolnikih z avtoimunimi boleznimi ne priporoča.
English: What Circadin looks like and contents of the pack Circadin 2 mg prolonged-release tablets are available as white to off-white round bi-convex shaped tablets.
Slovenian: Circadin 2 mg tablete s podaljšanim sproščanjem so bele do umazano bele okrogle tablete bikonveksne oblike.
English: Ammonio methacrylate copolymer type B Calcium hydrogen phosphate dihydrate Lactose monohydrate Silica, colloidal anhydrous Talc
Slovenian: 6.1 Seznam pomožnih snovi amonijev metakrilat, kopolimer (vrsta B) kalcijev hidrogenfosfat dihidrat laktoza monohidrat brezvoden koloiden silicijev dioksid smukec magnezijev stearat
English: How to take Circadin
Slovenian: Kako jemati zdravilo Circadin
English: Modifications in diurnal functioning did not occur with Circadin 2 mg.
Slovenian: Pri jemanju zdravila Circadin 2 mg niso opazili sprememb funkcioniranja v vsakodnevnem življenju.
English: What you need to know before you take Circadin
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Circadin Ne jemljite zdravila Circadin
English: NAME OF THE MEDICINAL PRODUCT Circadin 2 mg prolonged-release tablets
Slovenian: IME ZDRAVILA Circadin 2 mg tablete s podaljšanim sproščanjem
English: Melatonin metabolism is known to decline with age.
Slovenian: Znano je, da z leti presnova melatonina upada.
English: Circadin contains lactose monohydrate.
Slovenian: Zdravilo Circadin vsebuje laktozo monohidrat.
English: • Disorientation
Slovenian: • motena orientacija
English: MEDICE Arzneimittel Pütter GmbH & Co. KG Tel: +49 (0)2371 9370 info@medice.de
Slovenian: KG Tel: +49 (0)2371 9370 info@medice.de
English: There is no experience of the use of Circadin in patients with liver impairment.
Slovenian: Izkušenj z uporabo zdravila Circadin pri bolnikih z okvaro jeter ni.
English: In addition, patients' self-reported quality of sleep, number of awakenings and morning alertness significantly improved with Circadin compared to placebo.
Slovenian: Poleg tega poročila bolnikov kažejo na pomembno izboljšavo kakovosti spanja in jutranje budnosti v skupini z zdravilom Circadin v primerjavi s tisto s placebom.
English: Sími: +354 535 7000
Slovenian: Vistor hf. Simi: +354 535 7000
English: • Feeling your heartbeat
Slovenian: • razbijanje srca
English: No clinical data exist concerning the use of Circadin in individuals with autoimmune diseases.
Slovenian: V zvezi z uporabo zdravila Circadin pri posameznikih z avtoimunimi boleznimi ni kliničnih podatkov.
English: Hepatic enzyme increased, blood electrolyes abnormal, laboratory test abnormal
Slovenian: Preiskave abnormalni testi delovanja jeter, povečanje telesne mase povečanje jetrnega encima, nenormalni elektroliti v krvi,
English: In an outpatient study with 2 week run-in baseline period with placebo, a randomised, double blind, placebo controlled, parallel group treatment period of 3 weeks and 2 week withdrawal period with placebo, the rate of patients who showed a clinically significant improvement in both quality of sleep and morning alertness was 47% in the Circadin group as compared to 27% in the placebo group.
Slovenian: V ambulantni študiji primerjave s placebom, randomizirani, dvojno slepi, s placebom kontrolirani, z dvotedenskim uvajalnim obdobjem, s 3-tedenskim trajanjem in dvotedenskim obdobjem odtegnitve, je bil odstotek bolnikov, ki so pokazali klinično pomembno izboljšanje tako v kakovosti spanja kot jutranji budnosti 47 % v skupini, ki je jemala zdravilo Circadin, v primerjavi s 27 % v skupini, ki je jemala placebo.
English: Priapism, prostatitis Galactorrhoea
Slovenian: Motnje reprodukcije in dojk menopavzni sindrom priapizem, prostatitis galaktoreja
English: − Benzodiazepines and non-benzodiazepine hypnotics (medicines used to induce sleep such as zaleplon, zolpidem and zopiclone)
Slovenian: - benzodiazepini in nebenzoidazepinski hipnotiki (zdravila za uspavanje, kot so zaleplon, zopidem in zopiklon).
English: Somnolence was the most reported adverse event.
Slovenian: Najpogosteje navedeni neželeni učinek je bila somnolenca.
English: • psoriasis
Slovenian: • luskavica
English: Circadin with food, drink and alcohol
Slovenian: Zdravilo Circadin skupaj s hrano, pijačo in alkoholom Zdravilo Circadin vzemite po tem, ko ste zaužili hrano.
English: How to store Circadin
Slovenian: Shranjevanje zdravila Circadin
English: NAME OF THE MEDICINAL PRODUCT Circadin 2 mg prolonged-release tablets melatonin
Slovenian: IME ZDRAVILA Circadin 2 mg tablete s podaljšanim sproščanjem melatonin
English: Temmler Pharma GmbH & Co. KG Temmlerstrasse 2
Slovenian: Odgovoren za sproščanje serije v EGP: Temmler Pharma GmbH & Co.
English: Hypertriglyceridaemia, hypocalcaemia, hyponatraemia
Slovenian: Presnovne in prehranske motnje hipertrigliceridemija, hipokalciemija,
English: Therefore, Circadin is not recommended for use in patients with hepatic impairment.
Slovenian: Zato uporaba zdravila Circadin pri bolnikih z okvaro jeter ni priporočljiva.
English: Herpes zoster
Slovenian: Infekcijske in parazitske bolezni herpes zoster
English: Mood altered, aggression, agitation, crying, stress symptoms, disorientation, early morning awakening, libido increased, depressed mood, depression
Slovenian: Psihiatrične motnje razdražljivost, nervoza, nemirnost, nespečnost, nenavadne sanje, nočne more, anksioznost nihanje v razpoloženju nasilnost, razburjenost, jokanje, simptomi stresa, dezorientiranost, zgodnje jutranje zbujanje, povečan libido, depresivno razpoloženje,
English: • Visual impairment
Slovenian: • slabši vid • zamegljen vid
English: Gastro-oesophageal reflux disease, gastrointestinal disorder, oral mucosal blistering, tongue ulceration, gastrointestinal upset, vomiting, bowel sounds abnormal, flatulence, salivary hypersecretion, halitosis, abdominal discomfort, gastric disorder, gastritis
Slovenian: gastrointestinalne motnje, bruhanje, nenormalni črevesni zvoki, napenjanje, povečano izločanje sline, ustni zadah, nelagodje v trebuhu, želodčne motnje,
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER STRIP
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2 mg melatonin.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 2 mg melatonina.
English: Pain in extremity Arthritis, muscle spasms, neck pain, night cramps
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečina v okončinah artritis, mišični spazmi, bolečine v vratu, nočni krči
English: Hypersensitivity reaction
Slovenian: Bolezni imunskega sistema preobčutljivostn e reakcije
English: Package Leaflet: Information for the patient Circadin 2 mg prolonged-release tablets Melatonin
Slovenian: Navodilo za uporabo Circadin 2 mg tablete s podaljšanim sproščanjem melatonin
English: Breastfeeding
Slovenian: gastritis
English: Name and address of the manufacturers responsible for batch release
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serije Temmler Pharma GmbH & Co.
English: Hypertension
Slovenian: palpitacije
English: Glycosuria, proteinuria
Slovenian: Frosst Ibérica, S.A.
English: Syncope, memory impairment, disturbance in attention, dreamy state, restless legs syndrome, poor quality sleep, paraesthesia
Slovenian: Bolezni živčevja migrena, glavobol, letargija, psihomotorična hiperaktivnost, vrtoglavica, zaspanost sinkopa, težave s spominom, motnje pozornosti, zaspanost , sindrom nemirnih nog, šibek spanec, parestezija
English: Menopausal symptoms
Slovenian: hiponatriemija
English: See Section 4.
Slovenian: - Navodilo shranite.
English: Asthenia, chest pain Fatigue, pain, thirst
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija, bolečina v prsih utrujenost, bolečina, žeja
English: Leukopenia, thrombocytopenia
Slovenian: Bolezni jeter, žolčnika in žolčevodov hiperbilirubinemija
English: LIST OF EXCIPIENTS Contains lactose monohydrate See leaflet for further information
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje laktozo monohidrat.
English: Prolonged-release tablets 20 tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Tablete s podaljšanim sproščanjem20 tablet 21 tablet 30 tablet 7 tablet
English: Migraine, headache, lethargy, psychomotor hyperactivity, dizziness, somnolence
Slovenian: Bolezni sečil glikozurija, proteinurija poliurija, hematurija, nokturija
English: Eczema, erythema, hand dermatitis, psoriasis, rash generalised, rash pruritic, nail disorder
Slovenian: Bolezni kože in podkožja dermatitis, nočno potenje, pruritus, izpuščaj, generalizirani pruritus, suha koža ekcemi, eritem, dermatitis rok, psoriaza, generalizirani osip, pruritični osip, motnje nohtov angioedem, edem v ustih, edem jezika
English: Abdominal pain, abdominal pain upper, dyspepsia, mouth ulceration, dry mouth, nausea
Slovenian: Bolezni prebavil bolečine v trebuhu, bolečine v zgornjem delu trebuha, dispepsija, razjede v ustih, suha usta, navzea gastro-ezofagealna refluksna bolezen,
English: Gastrointestinal disorders
Slovenian: nenormalni laboratorijski testi
English: Date of first authorisation: 20 April 2012 Date of latest renewal: 09th January 2017
Slovenian: Datum prve odobritve: 20. april 2012 Datum zadnjega podaljšanja: 09. januar 2017
English: See Table 7 for treatment regimens.
Slovenian: Glejte preglednico 7 za sheme zdravljenja.
English: • Take the tablets morning and evening as prescribed by your doctor.
Slovenian: • Tablete jemljite zjutraj in zvečer, kot vam jih je predpisal zdravnik.
English: • are or become dehydrated
Slovenian: • ste ali postajate dehidrirani,
English: • Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow them whole with water.
Slovenian: • Tablete zaužijte v 30 minutah po koncu obroka (zajtrka in večerje); tablete pogoltnite cele z vodo.
English: Not all pack sizes may be marketed.
Slovenian: Na tržišču morda ni na voljo vseh velikosti pakiranja.
English: • have a history of eye problems as you may need extra monitoring of your eyes
Slovenian: • ste v preteklosti imeli bolezni oči, ker boste morda potrebovali dodatne kontrole oči.
English: • if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na kapecitabin ali katerokoli sestavino tega zdravila (navedene v poglavju 6).
English: DPD deficiency: DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines.
Slovenian: Pomanjkanje DPD: pomanjkanje DPD je redko prirojeno stanje, ki navadno ne povzroča težav z zdravjem, razen če prejmete določena zdravila.
English: Do not throw away any medicines via wastewater or household waste.
Slovenian: Nobenih zdravil ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: Also ou need to be particularly careful if you are taking any of the following:
Slovenian: Posebno previdni morate biti tudi pri uporabi:
English: • specific changes in the electrocardiogram (QT prolongation)
Slovenian: • specifične spremembe v elektrokardiogramu (podaljševanje intervala QT),
English: Capecitabine Accord tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken).
Slovenian: Tablete zdravila Kapecitabin Accord se običajno jemljejo 14 dni, čemur sledi 7-dnevni premor (ko se tablet ne jemlje).
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovenian: Pred začetkom jemanja natančno preberite navodilo, ker vsebuje pomembne podatke!
English: Parameter: Overall Survival
Slovenian: Parameter: Celokupno preživetje
English: Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.
Slovenian: Vaš zdravnik vam bo povedal, kolikšen odmerek morate jemati, kdaj ga vzeti in kako dolgo bo zdravljenje trajalo.
English: This medicine does not require any special storage conditions.
Slovenian: Za shranjevanje zdravila niso potrebni posebni pogoji shranjevanja.
English: Accord Healthcare Limited, Sage house, 319 Pinner Road, Harrow HA1 4HF, United Kingdom
Slovenian: Accord Healthcare Limited, Sage house, 319 Pinner Road, Harrow HA1 4HF, Velika Britanija
English: • have brain diseases (for example cancer that has spread to the brain) or nerve damage
Slovenian: • imate možgansko bolezen (na primer raka, ki se širi v možgane) ali poškodbo živcev
English: Body System Very Common
Slovenian: Organski sistem Zelo pogosti
English: • if you previously have had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines such as fluorouracil),
Slovenian: • če ste že imeli hujšo reakcijo na zdravljenje s fluoropirimidinom (skupino zdravil proti raku, kot je na primer fluorouracil),
English: In animal studies effects on fertility were observed (see section 5.3)
Slovenian: V študijah na živalih so ugotovili vpliv na plodnost (glejte poglavje 5.3).
English: Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali boste morda jemali katero koli zdravilo.
English: 5-Fluorouracil: intravenous bolus injection immediately after leucovorin
Slovenian: 5-fluorouracil:intravensko injekcija v bolusu neposredno po levkovorinu
English: Capecitabine Accord may be used either alone or in combination with other medicines.
Slovenian: Zdravilo Kapecitabin Accord se lahko uporablja samostojno ali v kombinaciji z drugimi zdravili.
English: Contact your doctor immediately if you are concerned about any of the side effects or if you notice any additional side effects not listed in the leaflet (see section 4 Possible side effects.
Slovenian: Nemudoma obvestite zdravnika, če vas skrbi kateri koli od neželenih učinkov ali če opazite kateri koli dodatni neželeni učinek, ki ni naveden v tem navodilu (glejte poglavje 4 Možni neželeni učinki).
English: The dose of Capecitabine Accord is based on your body surface area.
Slovenian: Odmerek zdravila Kapecitabin Accord je določen glede na vašo telesno površino.
English: *According to the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) or the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
Slovenian: * Glede na skupne kriterije toksičnosti skupine za klinična preskušanja Kanadskega državnega inštituta za raka (NCIC CTG - National Cancer Institute of Canada Clinical Trial Group) (različica 1) ali skupne kriterije za terminologijo neželenih učinkov (CTCAE - Common Terminology Criteria for Adverse Events) programa za vrednotenje zdravljenja raka državnega inštituta za raka ZDA, različica 4.
English: • jaundice (yellowing of skin and eyes)
Slovenian: • zlatenica (porumenelost kože in oči),
English: • a medicine to treat cancer (interferon alpha)
Slovenian: • zdravila za zdravljenje raka (interferon alfa)
English: Furthermore, Capecitabine Accord is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Slovenian: Zdravilo Kapecitabin Accord se uporablja tudi za preprečevanje novega pojava raka debelega črevesa po kompletni odstranitvi tumorja z operacijo.
English: • Hypersensitivity to capecitabine or to any of the excipients listed in section 6.1 or fluorouracil,
Slovenian: • Preobčutljivost na kapecitabin, katero koli pomožno snov, navedeno v poglavju 6.1, ali fluorouracil.
English: Finally, β-ureido-propionase cleaves FUPA to α-fluoro-β-alanine (FBAL) which is cleared in the urine.
Slovenian: Na koncu β-ureido-propionaza cepi FUPA v α-fluoro-β alanin (FBAL), ki se izloči z urinom.
English: • certain types of arrhythmias (including ventricular fibrillation, torsade de pointes, and bradycardia)
Slovenian: • določene tipe aritmije (vključno z ventrikularno fibrilacijo, torsade de pointes in bradikardijo).
English: Body surface area (m2)
Slovenian: Telesna površina (m2 )
English: • have severe skin reaction
Slovenian: • imate hudo kožno reakcijo.
English: Aluminium/aluminium blisters This medicinal product does not require any special storage conditions.
Slovenian: Aluminijevi/aluminijevi pretisni omoti Za shranjevanje zdravila niso potrebni posebni pogoji shranjevanja.
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, pyrimidine analogues, ATC code: L01BC06
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje novotvorb, antimetaboliti, analogi pirimidina, oznaka ATC: L01BC06.
English: Recommended posology (see section 5.1)
Slovenian: Priporočeno odmerjanje (glejte poglavje 5.1)
English: What Capecitabine Accord is and what it is used for
Slovenian: Kaj je zdravilo Kapecitabin Accord in za kaj ga uporabljamo
English: Interrupt until resolved to grade 0-1 75%
Slovenian: • Stopnja 3 1. pojav prekinitev, dokler ni dosežena stopnja 0−1 75 %
English: The capecitabine pivotal studies included females of childbearing potential and males only if they agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a reasonable period thereafter.
Slovenian: V ključnih študijah s kapecitabinom so sodelovale ženske v rodni dobi in moški, če so se strinjali, da bodo uporabljali sprejemljivo metodo kontracepcije, da bi preprečili nosečnost v času študije in primernim obdobjem po njej.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing capecitabine in all subsets of the paediatric population in adenocarcinoma of the colon and rectum, gastric adenocarcinoma and breast carcinoma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje kapecitabin, za vse podskupine pediatrične populacije z adenokarcinomom kolona in rektuma, želodčnim adenokarcinomom in rakom dojk (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: If you take more Capecitabine Accord than you should, contact your doctor as soon as possible before taking the next dose.
Slovenian: Če ste vzeli večji odmerek zdravila Kapecitabin Accord, kot bi smeli, se takoj posvetujte z zdravnikom, še preden boste zaužili naslednjega.
English: Cytochrome P-450 2C9 substrates
Slovenian: Substrati citokroma P-450 2C9:
English: Other medicines and Capecitabine Accord
Slovenian: Druga zdravila in Kapecitabin Accord
English: Progression-free Survival after 6 months
Slovenian: Preživetje brez napredovanja bolezni po 6 mesecih ITT
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: PRILOGA II A. IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
English: Ethnic factors: Following oral administration of 825 mg/m2 capecitabine twice daily for 14 days, Japanese patients (n=18) had about 36% lower Cmax and 24% lower AUC for capecitabine than Caucasian patients (n=22).
Slovenian: Etnični dejavniki: po peroralnem dajanju 825 mg/m2 kapecitabina dvakrat na dan 14 dni so japonski bolniki (n = 18) imeli približno 36 % nižjo Cmax in 24 % nižjo AUC kapecitabina kakor kavkaški bolniki (n = 22).
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: Natisnjena navodila za uporabo zdravila morajo vsebovati ime in naslov imetnika dovoljenja za izdelavo zdravila, odgovornega za sprošanje serije.
English: Capecitabine Accord is not indicated in children and adolescent.
Slovenian: Zdravilo Kapecitabin Accord ni namenjeno otrokom in mladostnikom.
English: - first-line treatment of advanced gastric cancer in combination with a platinum based regimen (see section 5.1).
Slovenian: - prvo linijo zdravljenja napredovalega raka želodca v kombinaciji s shemo na osnovi platine (glejte poglavje 5.1);
English: You should take Capecitabine Accord no later than 30 minutes after meals.
Slovenian: Zdravilo Kapecitabin Accord morate vzeti najpozneje 30 minut po obroku.
English: Severe skin reactions
Slovenian: Hude kožne reakcije:
English: What you need to know before you take Capecitabine Accord Do not take Capecitabine Accord
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Kapecitabin Accord Ne jemljite zdravila Kapecitabin Accord:
English: The median follow up at the time of the primary analyses in the intent-to-treat population was 2.1 years; data from analyses following an additional 6 months of follow up are also included in Table 10.
Slovenian: Mediana spremljanja v času primarne analize v populaciji, ki so jo nameravali zdraviti, je bila 2,1 leta; podatki iz analize po dodatnih 6 mesecih spremljanja so prav tako vključeni v preglednico 10.
English: There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with Capecitabine Accord.
Slovenian: Obstajajo dokazi, da je dekspantenol učinkovit pri preprečevanju sindroma roka-noga pri bolnikih, zdravljenih z zdravilom Kapecitabin Accord.
English: If unscheduled laboratory assessments during a treatment cycle show that the neutrophil count drops below 1.0 x 109/L or that the platelet count drops below 75 x 109/L, treatment with capecitabine should be interrupted.
Slovenian: Če laboratorijski izvid med ciklom zdravljenja pokaže, da se je število nevtrofilcev znižalo pod 1,0 x 109/l ali da se je število trombocitov znižalo pod 75 x 109/l, je treba zdravljenje s kapecitabinom prekiniti.
English: Dehydration may cause acute renal failure, especially in patients with pre-existing compromised renal function or when capecitabine is given concomitantly with known nephrotoxic drugs.
Slovenian: Dehidracija lahko povzroči akutno ledvično odpoved, še posebno pri bolnikih z že obstoječim okrnjenim delovanjem ledvic ali kadar kapecitabin dajemo sočasno z nefrotoksičnimi zdravili.
English: Capecitabine can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
Slovenian: Zdravilo Kapecitabin Accord lahko izzove hude kožne reakcije, kot sta Stevens-Johnsonov sindrom in toksična epidermalna nekroliza.
English: • have imbalances of ions in your blood (electrolyte imbalances, seen in test)
Slovenian: • imate ionsko neravnovesje v krvi (neravnovesje elektrolitov, razvidno iz preiskav),
English: Capecitabine Accord with food and drink
Slovenian: Jemanje zdravila Kapecitabin Accord skupaj s hrano in pijačo
English: Capecitabine should be permanently discontinued in patients who experience a severe skin reaction during treatment.
Slovenian: Zdravilo Kapecitabin Accord je treba trajno ukiniti pri bolnikih, pri katerih se med zdravljenjem pojavi huda kožna reakcija.
English: For patients 60 years of age or more, a starting dose reduction of capecitabine to 75% (950 mg/m2 twice daily) is recommended.
Slovenian: Za bolnike, stare 60 let ali več, je priporočljivo začetni odmerek zdravila kapecitabin zmanjšati na 75 % (950 mg/m2 dvakrat na dan).