FrancophonIA/ELRC3.0 huggingface dataset:
English: Fatigue, oedema peripheral, application site papules, application site anaesthesia, application site erythema, application site irritation, application site pain, application site pustules
Croatian: Umor, periferni edem, papule na mjestu primjene, anestezija na mjestu primjene, eritem na mjestu primjene, nadraženost na mjestu primjene, bol na mjestu primjene, pustule na mjestu primjene
English: Rash, dry skin, rash pruritic
Croatian: Osip, suha koža, svrbež s osipom
English: HOW TO USE KENTERA
Croatian: Kako primjenjivati Kenteru
English: Daily nocturia episodes Baseline
Croatian: P-vrijednost naspram placeba Dnevne epizode nikturije
English: The expression of CYP3A and CYP3A4 may vary by as much as 40 fold due to genetic polymorphism.
Croatian: Ekspresija CYP3A i CYP3A4
English: Oxybutynin administered orally is metabolised primarily by the cytochrome P450 enzyme systems, particularly CYP3A4, found mostly in the liver and gut wall.
Croatian: Peroralno primijenjen oksibutinin metabolizira se prvenstveno preko sustava enzima citokroma P450,
English: The multidose container is comprised of an outer bottle with a pouch liner, a metering pump and a cap.
Croatian: Višedozni spremnik s odmjernom pumpicom sastoji se od vanjske boce sa zaštitnom vrećicom,
English: Physical activity subscale
Croatian: Ograničenja djelatnosti Tjelesna ograničenja
English: Hepatic impairment
Croatian: - bolno gutanje
English: The difference in AUC and Cmax of oxybutynin and the active metabolite N-desethyloxybutynin following transdermal administration of Kentera on either the abdomen, upper arms/shoulders and thighs is not clinically relevant.
Croatian: N-desetiloksibutinina nakon transdermalne primjene Kentere na abdomen, nadlakticu/rame i bedro nije klinički značajna.
English: Psychiatric and central nervous system (CNS) anticholinergic events like sleep disorders (e.g. insomnia) and cognitive disorders have been associated with oxybutynin use, especially in elderly patients.
Croatian: S uporabom oksibutinina, osobito u starijih bolesnika, povezani su psihijatrijski događaji i događaji u središnjem živčanom sustavu (SŽS) vezani uz antikolinergički mehanizam kao što su poremećaji spavanja (npr. nesanica) i kognitivni poremećaji.
English: Rare side effects - panic reaction - mental confusion - hallucinations - disorientation - memory impairment - loss of memory - abnormal tiredness - poor concentration
Croatian: - gubitak pamćenja - abnormalni umor - loša koncentracija.
English: Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Kentera.
Croatian: Prije početka liječenja Kenterom potrebno je procijeniti ostale uzroke čestog mokrenja (zatajenje srca ili bubrežna bolest).
English: Change from baseline P-value vs. placebo
Croatian: P-vrijednost naspram placeba
English: Discard empty multidose containers in accordance with local requirements.
Croatian: Prazne višedozne spremnike s odmjernom pumpicom zbrinite sukladno lokalnim propisima.
English: Sími: + 354 550 3300
Croatian: Tel: +351 21 4329 500
English: Talk to your doctor before using Kentera if you are pregnant, might be pregnant or are planning to become pregnant.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete Kenteru.
English: - Are above 65 years old - Chronic dry mouth that has resulted in periodontal disease or oral fungal infections - Nerve disorder that affects involuntary body functions including heart rate, blood pressure,
Croatian: - kronično suha usta što je rezultiralo parodontozom ili gljivičnim infekcijama usne šupljine - živčani poremećaj koji zahvaća tjelesne funkcije koje nisu kontrolirane voljom, uključujući brzinu rada srca, krvni tlak, znojenje i probavu
English: Because Kentera may produce drowsiness, somnolence, or blurred vision, patients should be advised to exercise caution when driving or using machinery.
Croatian: Budući da Kentera može izazvati omamljenost, pospanost ili zamagljeni vid, potrebno je obavijestiti bolesnike da budu oprezni kad voze ili rade na strojevima.
English: The anticholinergic activity of oxybutynin is increased by concurrent use of other anticholinergics or medicinal products with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian medicinal products (e.g. biperiden, levodopa), antihistamines, antipsychotics (e.g. phenothiazines, butyrophenones, clozapine), quinidine, tricyclic antidepressants, atropine and related compounds like atropinic antispasmodics, and dipyridamole.
Croatian: - ketokonazol, itrakonazol ili flukonazol (primjenjuju se u liječenju gljivičnih infekcija) - makrolidni antibiotik eritromicin (primjenjuje se u liječenju bakterijskih infekcija) - biperiden, levodopa ili amantadin (primjenjuju se u liječenju Parkinsonove bolesti) - antihistaminici (primjenjuju se u liječenju alergija poput peludne groznice) - fenotiazini, butirofenon ili klozapin (primjenjuju se za liječenje duševne bolesti)
English: Do not use Kentera after the expiry date which is stated on the sachet and the carton after EXP.
Croatian: Kentera se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vrećici i kutiji iza „Rok valjanosti“.
English: Common side effects: - redness or rash at the site of patch application - dry mouth - constipation - diarrhoea - upset stomach - stomach pain - headache or sleepiness - urinary tract infections - blurred vision - dizziness
Croatian: - crvenilo ili osip na mjestu primjene flastera - suha usta - zatvor - proljev - nadražen želudac - bol u želucu - glavobolja ili pospanost
English: BEFORE YOU USE KENTERA Do not use Kentera
Croatian: PRIJE NEGO POČNETE PRIMJENJIVATI KENTERU
English: anorexia, vomiting, reflux oesophagitis, decreased sweating, heat stroke, decreased lacrimation, mydriasis, tachycardia, arrhythmia, nightmares, restlessness, convulsion, intraocular hypertension and induction of glaucoma, paranoia, photosensitivity, erectile dysfunction.
Croatian: toplinski udar, smanjeno suzenje, midrijaza, tahikardija, aritmija, noćne more, nemir, konvulzije,
English: Kentera 90.7 mg/g gel in sachet oxybutynin
Croatian: Kentera 90,7 mg/g gel u vrećici oksibutinin
English: Mean and median change from baseline for incontinence episodes, urinary frequency, and urinary void volume at Week 12 (LOCF)
Croatian: učestalost mokrenja i volumen izmokrenog urina u 12. tjednu (LOCF (Last Observation Carried Forward) metoda)
English: Hydroxypropylcellulose Sodium hydroxide (for pH-adjustment) Purified water
Croatian: 6.1 Popis pomoćnih tvari etanol (96-postotni) glicerol hidroksipropilceluloza natrijev hidroksid (za podešavanje pH)
English: General health perception Incontinence impact Symptom severity Role limitations Physical limitations Social limitations Personal relationships Emotions
Croatian: Utjecaj inkontinencije Težina simptoma
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Srednja vrijednost (SD)
English: - Atropine and other anticholinergic medicines (used in the treatment of stomach disorders such as irritable bowel syndrome).
Croatian: - triciklički antidepresivi (primjenjuju se u liječenju depresije) - dipiridamol (primjenjuje se za liječenje problema zgrušavanja krvi) - atropin i drugi antikolinergički lijekovi (primjenjuju se u liječenju probavnih poremećaja poput sindroma iritabilnog crijeva).
English: Uncommon side effects - bladder infection - anxiety - confusion - nervousness - agitation - difficulty in sleeping - low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm
Croatian: - poteškoće sa spavanjem - niske razine kalija, što može prouzročiti mišićnu slabost, trzanje ili abnormalni srčani ritam - osjećaj zabrinutosti
English: STORING KENTERA
Croatian: ŠTO JE KENTERA
English: Because Kentera may cause drowsiness, somnolence, or blurred vision, patients should be advised to exercise caution when driving or using machinery (see section 4.7).
Croatian: Budući da Kentera može prouzročiti omamljenost, somnolenciju, ili zamagljeni vid, potrebno je obavijestiti bolesnike da budu oprezni kad voze ili rade na strojevima (vidjeti dio 4.7).
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: A PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Kentera transdermalni flaster, gel i gel u vrećici:
English: Kentera 90.7 mg/g gel in sachet
Croatian: Kentera 90,7 mg/g gel u vrećici
English: Because Kentera may cause drowsiness, somnolence, or blurred vision, patients should be advised to exercise caution when driving or using machinery (see section 4.5).
Croatian: Budući da Kentera može prouzročiti omamljenost, somnolenciju, ili zamagljeni vid, potrebno je upozoriti bolesnike da budu oprezni kad voze ili rade na strojevima (vidjeti dio 4.5).
English: - Biperiden, levodopa, or amantadine (used to treat Parkinson's disease).
Croatian: - ketokonazol, itrakonazol ili flukonazol (primjenjuju se u liječenju gljivičnih infekcija) - makrolidni antibiotik eritromicin (primjenjuje se u liječenju bakterijskih infekcija) - biperiden, levodopa ili amantadin (primjenjuju se u liječenju Parkinsonove bolesti)
English: Innova Pharma S.p.A. Tel: +39 02 48787.1
Croatian: Tel: +39 02 48787.1
English: Each metered dose of 1 gram of gel contains 90.7 mg of oxybutynin resulting in a nominal delivery of approximately 4 mg/day.
Croatian: Jedna odmjerena doza od 1 gram gela sadrži 90,7 mg oksibutinina, što rezultira nominalnom primjenom od približno 4 mg/dan.
English: Each sachet of 1 gram of gel contains 90.7 mg of oxybutynin resulting in a nominal delivery of approximately 4 mg/day.
Croatian: Jedna vrećica s 1 gramom gela sadrži 90,7 mg oksibutinina, što rezultira nominalnom isporukom od približno 4 mg/dan.
English: Be sure all of it sticks to your skin, even around the edges.
Croatian: Provjerite je li flaster u cijelosti zalijepljen za kožu,
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom proizvodu dostupne su na web stranici Europske agencije za lijekove (EMA) http://www.ema.europa.eu.
English: - Bend the patch back over itself.
Croatian: - Presavijte iskorišteni flaster na pola.
English: Each metered dose of 1 gram of gel contains 90.7 mg of oxybutynin (as 100 mg oxybutynin hydrochloride) resulting in a nominal delivery of approximately 4 mg/day.
Croatian: Jedna odmjerena doza od 1 grama gela sadrži 90,7 mg oksibutinina (u obliku 100 mg oksibutininklorida), što rezultira nominalnom isporukom od približno 4 mg/dan.
English: The approved application sites for Kentera are the shaded areas shown in Figure A. These are the abdomen (stomach area), upper arms/shoulder, and thigh.
Croatian: To su abdomen (područje trbuha), nadlaktice/rame i bedro.
English: THE MARKETING AUTHORISATION HOLDER
Croatian: Nositelj odobrenja za stavljanje lijeka u promet
English: Each sachet of 1 gram of gel contains 90.7 mg of oxybutynin (as 100 mg oxybutynin hydrochloride) resulting in a nominal delivery of approximately 4 mg/day.
Croatian: Jedna vrećica s 1 gramom gela sadrži 90,7 mg oksibutinina (u obliku 100 mg oksibutininklorida), što rezultira nominalnom isporukom od približno 4 mg/dan.
English: For transdermal use only.
Croatian: Samo za primjenu kroz kožu.
English: Talk to your doctor or pharmacist if you have any questions on the use of this medical product.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku.
English: The usual dose is one sachet applied once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs, which delivers 4 mg of oxybutynin in 24 hours.
Croatian: nadlaktice/ramena ili bedra, koja isporučuje 4 mg oksibutinina tijekom 24 sata.
English: Each metered dose of 1 gram of gel contains 90.7 mg oxybutynin (as hydrochloride) resulting in a nominal delivery of approximately 4 mg/day.
Croatian: Jedna odmjerena doza od 1 gram gela sadrži 90,7 mg oksibutinina (u obliku oksibutininklorida), što rezultira nominalnom isporukom od približno 4 mg/dan.
English: Each sachet of 1 gram of gel contains 90.7 mg of oxybutynin (as hydrochloride) resulting in a nominal delivery of approximately 4 mg/day.
Croatian: Jedna vrećica s gelom od 1 grama sadrži 90,7 mg oksibutinina (u obliku oksibutininklorida), što rezultira nominalnom isporukom od približno 4 mg/dan.
English: Read package leaflet before use.
Croatian: NAČIN PRIMJENE LIJEKA Prije primjene pročitati Uputu o lijeku.
English: If you have any of the following: - Liver problems - Kidney problems - Difficulty urinating - Intestinal blockage - Bloody stools - Generalized muscle weakness - Painful swallowing
Croatian: - oticanje krvnih žila oko anusa - osip - suha koža - osip koji svrbi - bolno ili teško mokrenje
English: Apply immediately upon removal from sachet.
Croatian: Primijenite odmah nakon vađenja iz vrećice.
English: uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Croatian: - Rijetko (javlja se kod 1 do 10 na 10 000 korisnika) - Vrlo rijetko (javlja se kod manje od 1 na 10 000 korisnika)
English: Rebetol is taken with food each day in two divided doses (morning and evening).
Croatian: Rebetol se uzima s hranom svaki dan u dvjema odvojenim dozama (ujutro i navečer).
English: The full EPAR for Rebetol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito izvješće EPAR za lijek Rebetol nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Some studies also looked at signs of improvement of the condition of the liver.
Croatian: U nekim su ispitivanjima također promatrani znakovi poboljšanja stanja jetre.
English: It is available as capsules (200 mg) and as an oral solution (40 mg/ml).
Croatian: Dostupan je u obliku kapsula (200 mg) te kao oralna otopina (40 mg/ml).
English: This summary was last updated in 10-2015.
Croatian: Sažetak je posljednji put ažuriran: 10.2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rebetol on 7 May 1999.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Rebetol vrijedi na prostoru Europske unije od 7. svibnja 1999.
English: What measures are being taken to ensure the safe and effective use of Rebetol?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Rebetol?
English: Rebetol has also been studied in 177 children and adolescents aged between three and 17 years who had not been treated before.
Croatian: Osim toga, Rebetol je ispitan na 177 djece i adolescenata u dobi od 3 do 17 godina koji nisu prethodno bili liječeni.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom need to be adjusted for patients who experience side effects.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Rebetol on its own has no effect on eliminating the hepatitis C virus from the body.
Croatian: Rebetol sam po sebi nema učinka na uklanjanje virusa hepatitisa C iz organizma.
English: Other information about Rebetol
Croatian: Ostale informacije o lijeku Rebetol
English: Children above 3 years of age and adolescents who weigh less than 47 kg or who cannot swallow capsules should take the oral solution at a dose of 15 mg per kilogram body weight a day.
Croatian: Djeca u dobi od 3 ili više godina i adolescenti tjelesne težine manje od 47 kg ili koji ne mogu progutati kapsule trebaju uzimati oralnu otopinu u dozi od 15 mg po kilogramu tjelesne težine dnevno.
English: Rebetol has been studied in a total of over 6,000 adults who had not been treated before, including 328 patients with cirrhosis and 507 patients also infected with HIV.
Croatian: Rebetol je ispitan na više od ukupno 6000 odraslih koji prethodno nisu bili liječeni, uključujući 328 bolesnika s cirozom i 507 bolesnika koji su također zaraženi HIV-om.
English: Haemolytic anaemia (anaemia caused by abnormal breakdown of red blood cells) is a common side effect (seen in between 1 and 10 patients in 100), usually during the first few weeks of treatment.
Croatian: Hemolitička anemija (anemija uzrokovana abnormalnim raspadanjem crvenih krvnih stanica) uobičajena je nuspojava (uočena u između 1 i 10 na 100 bolesnika) koja se javlja tijekom prvih tjedana liječenja.
English: It has also been studied in 1,699 adults whose disease had come back after previous treatment or whose previous treatment had failed.
Croatian: Nadalje, ispitan je na 1699 bolesnika kojima se bolest vratila nakon prethodnog liječenja ili čije je prethodno liječenje bilo neuspješno.
English: The main measure of effectiveness in these studies was the number of patients who had no detectable hepatitis C virus in their blood 24 weeks after the end of the treatment and could therefore be considered to be cured.
Croatian: Glavna mjera učinkovitosti u ovim ispitivanjima bio je broj bolesnika koji nisu imali mjerljivu koncentraciju virusa hepatitisa C u krvi 24 tjedna nakon završetka terapije, zbog čega su se mogli smatrati izliječenima.
English: This is a summary of the European public assessment report (EPAR) for Rebetol.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Rebetol.
English: Rebetol is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply.
Croatian: Smatra se da Rebetol interferira s proizvodnjom ili djelovanjem DNK i RNK virusa, koji su nužni kako bi virusi preživjeli i umnožavali se.
English: Triple therapy led to a 30% increase in the number of previously untreated early responders who were cured after six months.
Croatian: Trostruka terapija dovela je do 30 %-tnog povećanja broja prethodno neliječenih ispitanika koji su rano odgovorili na liječenje, a koji su izliječeni nakon šest mjeseci.
English: A risk management plan has been developed to ensure that Rebetol is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Rebetol.
English: What is the risk associated with Rebetol?
Croatian: Koji su rizici povezani s lijekom Rebetol?
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 Rebetol.
Croatian: Objašnjava kako je Odbor za lijekove za primjenu kod ljudi (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Rebetol.
English: For more information about treatment with Rebetol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Rebetol pročitajte u uputi lijeka (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: In most of the studies, the main measure of effectiveness was the amount of virus in the blood before and after six months or a year of treatment, and at ‘follow-up', six months later.
Croatian: U većini je ispitivanja glavna mjera djelotvornosti bila količina virusa u krvi prije i nakon šest mjeseci ili jedne godine liječenja te tijekom praćenja nakon liječenja, šest mjeseci kasnije.
English: In children weighing between 47 and 65 kg the dose ranges from 3 to 4 capsules.
Croatian: U djece tjelesne težine između 47 i 65 kg doza se kreće od 3 do 4 kapsule.
English: The haemolytic anaemia may affect a patient's heart function and lead to abnormal test values for substances such as uric acid and bilirubin in the blood.
Croatian: Hemolitička anemija može utjecati na bolesnikovu funkciju srca te uzrokovati abnormalne rezultate ispitivanja vrijednosti tvari kao što su urična kiselina i bilirubin u krvi.
English: There are several other side effects of Rebetol, some of which are very common (occurring in more than 1 in 10 patients).
Croatian: Rebetol, od kojih su neke vrlo česte (pojavljuju se kod više od 1 u 10 bolesnika).
English: The duration of treatment depends on the patient's condition and response to treatment, and ranges from six months to a year.
Croatian: Trajanje liječenja ovisi o stanju i reakciji bolesnika na terapiju i traje od šest mjeseci do jedne godine.
English: What is Rebetol?
Croatian: Što je Rebetol?
English: Why has Rebetol been approved?
Croatian: Zašto je Rebetol odobren?
English: The dose of Rebetol is based on the patient's body weight, and ranges from five to six capsules a day in adults.
Croatian: Doza lijeka Rebetol ovisi o tjelesnoj težini bolesnika i kreće se od pet do šest kapsula dnevno u odraslih.
English: Combination treatment including Rebetol was effective in around a quarter of the adults whose disease had come back after previous treatment or whose previous treatment did not work, and over half of the children and adolescents treated.
Croatian: Kombinirana terapija koja je uključivala Rebetol bila je učinkovita u otprilike četvrtine odraslih čija se bolest vratila nakon prethodnog liječenja ili čije prethodno liječenje nije postiglo rezultate te u više od pola djece i adolescenata koji su primali terapiju.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rebetol, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za lijek Rebetol uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Rebetol is a medicine that contains the active substance ribavirin.
Croatian: Rebetol je lijek koji sadrži djelatnu tvar ribavirin.
English: The CHMP decided that Rebetol's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor (CHMP) je odlučio da koristi lijeka Rebetol nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Treatment with Rebetol should be started and monitored by a doctor who has experience in the management of long-term hepatitis C.
Croatian: Liječenje lijekom Rebetol mora započeti i nadzirati liječnik iskusan u liječenju kroničnog hepatitisa C.
English: It can also be used in previously untreated patients aged three years and over whose livers are working properly.
Croatian: Također se može koristiti u djece u dobi od tri ili više godina čija jetra ne funkcionira ispravno.
English: Rebetol must not be used in patients with severe heart disease and blood disorders such as thalassaemia and sickle cell anaemia or in pregnant or breast-feeding women.
Croatian: Rebetol ne smiju uzimati bolesnici s ozbiljnim srčanim tegobama i poremećajem krvne slike, kao što su talasemija i anemija srpastih stanica, te žene koje su trudne ili koje doje.
English: The active substance in Rebetol, ribavirin, is an antiviral belonging to the class ‘nucleoside analogues'.
Croatian: Ribavirin, djelatna tvar lijeka Rebetol, je antivirotik koji pripada skupini analoga nukleozida.
English: Additional data from the published literature show the positive effects of ribavirin-containing medicines when taken in different combinations, including combinations with peginterferon alfa-2a and a class of medicines known as direct acting antivirals (or DAAs).
Croatian: Dodatni podaci iz objavljene literature ukazuju na pozitivne učinke lijekova koji sadrže ribavirin kada se uzimaju u različitim kombinacijama, uključujući kombinacije s peginterferonom alfa-2a i razredom lijekova poznatih kao antivirotici koji djeluju direktno.