FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials, where patients suffering from primary insomnia received Circadin 2 mg every evening for 3 weeks, benefits were shown in treated patients compared to placebo in sleep latency (as measured by objective and subjective means) and in subjective quality of sleep and daytime functioning (restorative sleep) with no impairment of vigilance during the day.
Croatian: U kliničkim ispitivanjima u kojima su bolesnici s primarnom nesanicom primali Circadin u dozi od 2 mg svake večeri tijekom 3 tjedna, Circadin je u liječenih bolesnika, u usporedbi s onima koji su primali placebo, imao korisne učinke u smislu vremena do usnivanja (mjereno objektivnim i subjektivnim metodama), subjektivne kvalitete sna te dnevnog funkcioniranja (okrepljujući san) bez smanjene budnosti tijekom dana.
English: The excretion of the metabolite is completed within 12 hours after ingestion.
Croatian: Metaboliti se potpuno izluče unutar 12 sati nakon peroralne primjene.
English: RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux
English: - The other ingredients are ammonio methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), talc and magnesium stearate.
Croatian: - Drugi sastojci su amonio-metakrilat kopolimer vrste B, kalcijev hidrogenfosfat dihidrat, laktoza hidrat, silicijev dioksid, koloidni, bezvodni, talk, magnezijev stearat.
English: How to take Circadin
Croatian: Kako uzimati Circadin
English: Visual acuity reduced, vision blurred, lacrimation increased
Croatian: Poremećaji oka smanjena oštrina vida, zamagljen vid, pojačano suzenje
English: There was also a reduction in sleep latency with active treatment (61 minutes) compared to placebo (77 minutes) after 13 weeks of double-blind treatment, without causing earlier wake-up time.
Croatian: Nakon 13 tjedana dvostruko slijepog liječenja kod primjene aktivnog liječenja došlo je i do skraćenja vremena latencije sna u sudionika (61 minuta) u usporedbi s primjenom placeba (77 minuta), bez uzrokovanja ranijeg vremena buđenja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 2 mg melatonin.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta s produljenim oslobađanjem sadrži 2 mg melatonina.
English: Published data demonstrates markedly elevated endogenous melatonin levels during daytime hours due to decreased clearance in patients with hepatic impairment.
Croatian: Objavljeni podaci pokazuju da su u bolesnika s oštećenjem jetre razine endogenog melatonina značajno povišene tijekom dnevnih sati zbog smanjenog klirensa.
English: If you suffer from continued drowsiness, then you should consult your doctor.
Croatian: Ako ste stalno pospani, potražite savjet liječnika.
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.
Croatian: Circadin 2 mg tablete s produljenim oslobađanjem dostupne su kao bijele do gotovo bijele okrugle bikonveksne tablete.
English: Herpes zoster
Croatian: Infekcije i infestacije herpes zoster
English: Tfno: +34 91 7711500
Croatian: EXELTIS HEALTHCARE, S.L. Tfno: +34 91 7711500
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svojem liječniku ili ljekarniku.
English: At 3 months, about an extra 10% of responders were seen in the Circadin treated group.
Croatian: Nakon 3 mjeseca u skupini liječenih Circadinom bilo je 10% više bolesnika koji su odgovorili na liječenje.
English: For melatonin, no clinical data on exposed pregnancies are available.
Croatian: Nema dostupnih kliničkih podataka o utjecaju melatonina na trudnoću.
English: Therefore, Circadin is not recommended for use in patients with autoimmune diseases.
Croatian: Stoga se ne preporučuje primjena Circadina u bolesnika s autoimunim bolestima.
English: Circadin contains lactose monohydrate.
Croatian: Circadin sadrži laktozu hidrat.
English: Shingles, high level of fatty molecules in the blood, low serum calcium levels in the blood, low sodium levels in the blood, altered mood, aggression, agitation, crying, stress symptoms, early morning awakening, increased sex drive, depressed mood, memory impairment, disturbance in attention, dreamy state, restless legs syndrome, poor quality sleep, ‘pins and needles' feeling, watery eyes, dizziness when standing or sitting, hot flushes, acid reflux, stomach disorder, blistering in the mouth, tongue ulceration, stomach upset, vomiting, abnormal bowel sounds, wind, excess saliva production, bad breath, abdominal discomfort, gastric disorder, inflammation of the stomach lining, eczema, skin rash, hand dermatitis, itchy rash, nail disorder, arthritis, muscle spasms, neck pain, night cramps, prolonged erection that might be painful, inflammation of the prostate gland, tiredness, pain, thirst, passing large volumes of urine, urinating during the night, increased liver enzymes, abnormal blood electrolytes and abnormal laboratory tests.
Croatian: herpes zoster, povišena razina masnoća u krvi, smanjena razina kalcija u serumu, smanjena razina natrija u krvi, promjena raspoloženja, agresivnost, uznemirenost, plačljivost, simptomi stresa, ranojutarnje buđenje, pojačani spolni nagon, loše raspoloženje, oslabljeno pamćenje, poremećaj pozornosti, stanje sanjivosti, sindrom nemirnih nogu, slaba kakvoća sna, trnci, suzenje očiju, omaglica pri stajanju ili sjedenju, navale vrućine, vraćanje želučane kiseline, poremećaji u trbuhu, mjehurići na sluznici usta, ulceracije (oštećenja) na jeziku, probavne tegobe, povraćanje, glasan rad crijeva, vjetrovi, pretjerano stvaranje sline, neugodan zadah iz usta, nelagoda u trbuhu, želučani poremećaji, upala sluznice želuca, ekcem, kožni osip, dermatitis na rukama, osip sa svrbežom, promjene na noktima, artritis, grčevi mišića, bol u vratu, noćni grčevi, produljeno trajanje erekcije koje može biti bolno, upala prostate, umor, bol, žeđanje, pojačano izlučivanje mokraće, mokrenje tijekom noći, povišenje jetrenih enzima, poremećeni elektroliti u krvi i poremećeni rezultati laboratorijskih testova.
English: In addition, quality of sleep and morning alertness significantly improved with Circadin compared to placebo.
Croatian: Uz to su kakvoća sna i jutarnja budnost bile značajno bolje u skupini koja je primala Circadin u usporedbi sa skupinom koja je primala placebo.
English: Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraine, headache, lethargy (tiredness, lack of energy), restlessness associated with increased activity, dizziness, tiredness, high blood pressure, upper abdominal pain, indigestion, mouth ulceration, dry mouth, nausea, changes in the composition of your blood which could cause yellowing of the skin or eyes, inflammation of the skin, night sweats, itching, rash, dry skin, pain in extremities, menopausal symptoms, feeling of weakness, excretion of glucose in the urine, excess proteins in the urine, abnormal liver function and weight increase.
Croatian: razdražljivost, nervoza, nemir, nesanica, neuobičajeni snovi, noćne more, tjeskoba, migrena, glavobolja, letargija (umor, nedostatak energije), nemir povezan s pojačanom aktivnošću, omaglica, umor, povišeni krvni tlak, bol u gornjem trbuhu, loša probava, ulceracije (oštećenja) sluznice usta, suha usta, mučnina, promjene u sastavu krvi koje mogu prouzročiti žutilo kože ili očiju, upala kože, noćno znojenje, svrbež, osip, suhoća kože, bol u udovima, simptomi menopauze, osjećaj slabosti, izlučivanje glukoze u urinu, povišena razina proteina u urinu, poremećena funkcija jetre i povećanje tjelesne težine.
English: How to store Circadin
Croatian: Kako čuvati Circadin
English: Polyuria, haematuria, nocturia
Croatian: proteinurija poliurija, hematurija, nokturija
English: Patients had a significantly decreased total excretion of 6-sulfatoxymelatonin compared with controls.
Croatian: Ukupno izlučivanje 6-sulfatoksimelatonina bilo je značajno manje u bolesnika s cirozom nego u kontrolnih ispitanika.
English: Caution should be used when melatonin is administered to such patients.
Croatian: Melatonin se u ovih bolesnika mora primjenjivati s oprezom.
English: There is no experience of the use of Circadin in patients with liver impairment.
Croatian: Nema iskustva s primjenom Circadina u bolesnika s oštećenjem jetre.
English: Ammonio methacrylate copolymer type B Calcium hydrogen phosphate dihydrate Lactose monohydrate Silica, colloidal anhydrous Talc
Croatian: 6.1 Popis pomoćnih tvari amonio-metakrilat kopolimer vrste B kalcijev hidrogenfosfat dihidrat laktoza hidrat silicijev dioksid, koloidni, bezvodni talk magnezijev stearat
English: In a polysomnographic (PSG) study with a run-in of 2 weeks (single-blind with placebo treatment), followed by a treatment period of 3 weeks (double-blind, placebo-controlled, parallel group design) and a 3-week withdrawal period, sleep latency (SL) was shortened by 9 minutes compared to placebo.
Croatian: U polisomnografskom (PSG) ispitivanju uz uvodno liječenje u trajanju od 2 tjedna (jednostruko slijepo s placebom), nakon kojeg je uslijedilo razdoblje liječenja od 3 tjedna (dvostruko slijepo, placebom kontrolirano ispitivanje na usporednim skupinama) te 3-tjedno razdoblje ustezanja, vrijeme do nastupa sna bilo je skraćeno za 9 minuta u usporedbi s placebom.
English: Each prolonged-release tablet contains 2 mg melatonin.
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 2 mg melatonina.
English: Package Leaflet: Information for the patient Circadin 2 mg prolonged-release tablets Melatonin
Croatian: Uputa o lijeku: Informacije za bolesnika Circadin 2 mg tablete s produljenim oslobađanjem melatonin
English: • Melatonin has been observed to induce CYP3A in vitro at supra-therapeutic concentrations.
Croatian: • Primijećeno je da melatonin u koncentracijama višim od terapijskih inducira CYP3A in vitro.
English: • Severe chest pain due to angina
Croatian: • jaka bol u grudima uzrokovana anginom
English: MEDICE Arzneimittel Pütter GmbH & Co. KG Tel: +49 (0)2371 9370 info@medice.de
Croatian: KG Tel: +49 (0)2371 9370 info@medice.de
English: PHARMACEUTICAL FORM Prolonged-release tablet.
Croatian: OBLIK Tableta s produljenim oslobađanjem.
English: NAME OF THE MEDICINAL PRODUCT Circadin 2 mg prolonged-release tablets
Croatian: NAZIV LIJEKA Circadin 2 mg tablete s produljenim oslobađanjem
English: In a second outpatient study with two week run in baseline period with placebo and a randomised, double blind, placebo controlled, parallel group treatment period of 3 weeks, the rate of patients who showed a clinically significant improvement in both quality of sleep and morning alertness was 26% in the Circadin group as compared to 15% in the placebo group.
Croatian: U drugom ispitivanju u ambulantnih bolesnika, koje se sastojalo od 2 tjedna uvodnog liječenja placebom i 3 tjedna randomiziranog, dvostruko slijepog, placebom kontroliranog ispitivanja na usporednim skupinama, postotak bolesnika koji su pokazali klinički značajno poboljšanje u kvaliteti sna i jutarnjoj budnosti iznosio je 26% u skupini koja je primala Circadin, u usporedbi s 15% u skupini koja je primala placebo.
English: • Visual impairment
Croatian: • oštećenje vida • zamagljen vid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2 mg melatonin.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 2 mg melatonina.
English: • Presence of red blood cells in the urine
Croatian: • pojava eritrocita u urinu
English: − Adrenergic agonists/antagonists (such as certain types of medicines used to control blood pressure by constricting blood vessels, nasal decongestants, blood pressure lowering medicines), opiate agonists/antagonists (such as medicinal products used in the treatment of drug addiction), prostaglandin inhibitors (such as nonsteroidal anti-inflammatory medicines), antidepressant medication, tryptophan and alcohol.
Croatian: - Fluvoksamin (upotrebljava se za liječenje depresije i opsesivno kompulzivnog poremećaja), psoraleni (primjenjuju se u liječenju poremećaja kože, npr. psorijaze), cimetidin (primjenjuje se za liječenje želučanih tegoba, primjerice čireva), kinoloni i rifampicin (primjenjuju se u liječenju bakterijskih infekcija), estrogeni (primjenjuju se u kontracepciji ili zamjenskoj hormonalnoj terapiji) i karbamazepin (primjenjuje se u liječenju epilepsije). - adrenergički agonisti/antagonisti (poput određenih vrsta lijekova koji kontroliraju krvni tlak sužavanjem krvnih žila, nazalnih dekongestata, lijekova za snižavanje krvnog tlaka), opijatski agonisti/antagonist (poput lijekova koji se primjenjuju u liječenju ovisnosti o drogama), inhibitora prostaglandina (poput nesteroidnih protuupalnih lijekova), antidepresiva, triptofana i alkohola.
English: Hypertension
Croatian: hiponatremija
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.
Croatian: U ispitivanju u ambulantnih bolesnika, koje se sastojalo od 2 tjedna uvodnog liječenja placebom, 3 tjedna randomiziranog, dvostruko slijepog, placebom kontroliranog ispitivanja na usporednim skupinama te razdoblja ustezanja s placebom u trajanju od 2 tjedna, postotak bolesnika koji su pokazali klinički značajno poboljšanje u kvaliteti sna i jutarnjoj budnosti iznosio je 47% u skupini koja je primala Circadin, u usporedbi s 27% u skupini koja je primala placebo.
English: Concomitant administration resulted in increased impairment of attention, memory and co-ordination compared to zolpidem alone.
Croatian: Pozornost, pamćenje i koordinacija bili su jače narušeni u slučaju kad se lijek primjenjivao istodobno sa zolpidemom, nego kad se zolpidem primjenjivao sam.
English: Therefore, Circadin is not recommended for use in patients with hepatic impairment.
Croatian: Stoga se ne preporučuje primjena Circadina u bolesnika s oštećenjem jetre.
English: Mood altered, aggression, agitation, crying, stress symptoms, disorientation, early morning awakening, libido increased, depressed mood, depression
Croatian: Psihijatrijski poremećaji razdražljivost, nervoza, nemir, insomnija, neuobičajeni snovi, noćne more, anksioznost promjena raspoloženja, agresivnost, agitacija, plačljivost, simptomi stresa, dezorijentacija, preuranjeno buđenje, pojačan libido, depresivno raspoloženje,
English: Rationale for use
Croatian: Opravdanost primjene
English: Hot flush
Croatian: Hipertenzija navale vrućine
English: Τηλ: +30 210 6387800gr.info@takeda.com
Croatian: TAKEDA ΕΛΛΑΣ Α.Ε. Τηλ: +30 210 6387800 gr.info@takeda.com
English: The use of Circadin is not known to cause any withdrawal effects after treatment completion.
Croatian: Nakon završetka liječenja Circadinom nije poznato da su nastupili simptomi ustezanja.
English: NAME OF THE MEDICINAL PRODUCT Circadin 2 mg prolonged-release tablets melatonin
Croatian: NAZIV LIJEKA Circadin 2 mg tablete s produljenim oslobađanjem melatonin
English: Hepatic enzyme increased, blood electrolyes abnormal, laboratory test abnormal
Croatian: Pretrage poremećeni rezultati jetrenih proba, povećanje tjelesne težine povišenje jetrenih enzima, promijenjeni nalazi elektrolita u krvi, poremećeni rezultati laboratorijskih pretraga
English: • Melatonin does not induce CYP1A enzymes in vitro at supra-therapeutic concentrations.
Croatian: • Primijećeno je da melatonin u koncentracijama višim od terapijskih ne inducira enzime CYP1A in vitro.
English: patients in the active group and by 77% in the placebo group.
Croatian: Štetne događaje nastale tijekom liječenja prijavilo je 85 % bolesnika u skupini koja je primala aktivno liječenje i 77 % bolesnika u skupini koja je primala placebo.
English: Temmler Pharma GmbH & Co. KG Temmlerstrasse 2
Croatian: Temmlerstrasse 2
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
Croatian: gastrointestinalni nadražaj, povraćanje, abnormalni probavni zvukovi, flatulencija, pojačana salivacija,
English: Prolonged-release tablets 20 tablets
Croatian: OBLIK I SADRŽAJ Tablete s produljenim oslobađanjem20 tableta 21 tableta 30 tableta 7 tableta
English: Dermatitis, night sweats, pruritus, rash, pruritus generalised, dry skin
Croatian: Poremećaji kože i potkožnog tkiva dermatitis, noćno znojenje, pruritus, osip, generalizirani pruritus, suha koža ekcem, eritem, dermatitis šake, psorijaza, generalizirani osip, osip sa svrbežom,
English: Breastfeeding
Croatian: parestezije
English: Pain in extremity Arthritis, muscle spasms, neck pain, night cramps
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva bolovi u udovima artritis, grčevi u mišićima, bol u vratu, noćni grčevi
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji bubrega i mokraćnog sustava glukozurija,
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Circadin može uzrokovati pospanost.
English: Asthenia, chest pain Fatigue, pain, thirst
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija, bol u prsima umor, bol, žeđ
English: EXP
Croatian: KG
English: Migraine, headache, lethargy, psychomotor hyperactivity, dizziness, somnolence
Croatian: Poremećaji živčanog sustava migrena, glavobolja, letargija,
English: Abdominal pain, abdominal pain upper, dyspepsia, mouth ulceration, dry mouth, nausea
Croatian: neugodan zadah iz usta, nelagoda u abdomenu, želučani poremećaj, gastritis
English: In addition, patients' self-reported quality of sleep, number of awakenings and morning alertness significantly improved with Circadin compared to placebo.
Croatian: Uz to, ispitanici koji su uzimali Circadin u usporedbi s onima koji su uzimali placebo naveli su značajno poboljšanje kvalitete sna, manje prekida sna i veću jutarnju budnost.
English: Reproductive system and breast disorders
Croatian: Poremećaji reproduktivnog sustava i dojki simptomi menopauze prijapizam,
English: Angioedema, oedema of mouth, tongue oedema
Croatian: promjene na noktima angioedem, edem usta, edem jezika
English: • are or become dehydrated
Croatian: • ste ili postajete dehidrirani
English: This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines.
Croatian: To je vrlo važno jer istovremeno uzimanje više lijekova može pojačati ili oslabiti učinak lijeka.
English: Lutomierska 50,95-200 Pabianice, Poland
Croatian: Lutomierska 50,95-200 Pabianice, Poljska.
English: OTHER SPECIAL WARNING (S), IF NECESSARY
Croatian: DRUGA POSEBNA UPOZORENJA (AKO JE POTREBNO)
English: • Take the tablets morning and evening as prescribed by your doctor.
Croatian: • Tablete uzimajte ujutro i navečer, kako Vam je propisao liječnik.
English: Check with your doctor or pharmacist if you are not sure.
Croatian: Posavjetujte se s vašim liječnikom ili ljekarnikom ako niste sigurni.
English: Date of first authorisation: 20 April 2012 Date of latest renewal: 09th January 2017
Croatian: Datum posljednje obnove: 09. siječanj 2017
English: • Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow them whole with water.
Croatian: • Tablete uzimajte najkasnije 30 minuta nakon što završite s jelom (doručkom i večerom) i progutajte ih cijele, s vodom.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Ovaj lijek uvijek uzimajte točno onako kako vam je rekao vaš liječnik ili ljekarnik.
English: Also ou need to be particularly careful if you are taking any of the following:
Croatian: Također, trebate biti posebno oprezni ako uzimate neki od ovih lijekova:
English: • loss of appetite (anorexia)
Croatian: • Gubitak apetita (anoreksija)
English: If you take more Capecitabine Accord than you should, contact your doctor as soon as possible before taking the next dose.
Croatian: Ako uzmete više Kapecitabina Accord nego što ste trebali obratite se svom liječniku čim prije, prije uzimanja sljedeće doze.
English: Careful monitoring during the first cycle of treatment is recommended for all patients.
Croatian: Pažljivo promatranje tijekom prvog ciklusa liječenja se preporučuje za sve bolesnike.
English: Tell your doctor immediately if you experience any of these symptoms.
Croatian: Odmah obavijestite svog liječnika ako imate bilo koji od ovih simptoma.
English: Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Prije početka liječenja obavijestite svog liječnika ili ljekarnika ukoliko uzimate ili ste nedavno uzimali ili biste mogli uzeti bilo koje druge lijekove.
English: • bruising or reaction at the injection site (caused by medicines given by injection at the same time)
Croatian: • modrice ili reakcija na mjestu injekcije (uzrokovana lijekovima koje se daju putem injekcija u isto vrijeme)
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.
Croatian: Pomanjkanje DPD: Pomanjkanje DPD je rijetko stanje prisutno kod rođenja koje inače nije povezano sa zdravstvenim problemima osim u slučaju uzimanja nekih lijekova.
English: • have a history of eye problems as you may need extra monitoring of your eyes
Croatian: • ste ranije imali očnih tegoba jer će vam možda biti potrebna dodatna kontrola očiju
English: Do not drive if you feel dizzy, nauseous or tired after taking this medicine.
Croatian: Nemojte voziti ako osjećate omaglicu, mučninu ili umor nakon uzimanja ovog lijeka.
English: ITT 95% CI
Croatian: 95% CI
English: STOP taking Capecitabine Accord immediately and contact your doctor if any of these symptoms occur:
Croatian: Odmah PRESTANITE uzimati Kapecitabin Accord i obratite se liječniku ako se pojave neki od ovih simptoma:
English: If you take more Capecitabine Accord than you should
Croatian: Ako uzmete više Kapecitabina Accord nego što ste trebali
English: Capecitabine Accord with food and drink
Croatian: Kapecitabin Accord s hranom i pićem
English: • Infection: if you experience signs of infection caused by bacteria or virus, or other organisms.
Croatian: • upala: ako primijetite znakove upale uzrokovane bakterijom ili virusom, ili drugim organizmima.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, i ovaj lijek može izazvati nuspojave, iako se one ne javljaju kod svih osoba.
English: What Capecitabine Accord is and what it is used for
Croatian: Što je Kapecitabin Accord i za što se koristi
English: In addition to the above, when capecitabine is used alone, the very common side effects which may affect more than 1 in 10 people are:
Croatian: Dodatno na gore navedeno, kada se kapecitabin koristi sam, vrlo česte nuspojave koje se mogu javiti u više od 1 na 10 osoba su:
English: Capecitabine Accord may be used either alone or in combination with other medicines.
Croatian: Kapecitabin Accord se može primijeniti samostalno ili u kombinaciji s drugim lijekovima.
English: Severe and/or Lifethreatening (grade 3-4) or considered medically relevant
Croatian: Teške i/ili po život opasne (3. do 4.stupanj) ili one koje se smatraju medicinski značajnima
English: Body Surface Area (m2 )
Croatian: Površina tijela (m2)
English: • if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični (preosjetljivi) na kapecitabin ili bilo koji drugi sastojak ovog lijeka (navedeni u dijelu 6).
English: Capecitabine is contraindicated during pregnancy.
Croatian: Kapecitiabin je kontraindiciran tijekom trudnoće.