FrancophonIA/ELRC3.0 huggingface dataset:
English: In over half of these patients other treatments for psoriasis had failed or the patients could not receive them.
Croatian: Kod više od polovice bolesnika druge terapije za psorijazu prethodno nisu bile uspješne ili ih oni nisu mogli primiti.
English: The patient material will also include details of how Stelara should be injected under the skin.
Croatian: Materijali za bolesnike također će sadržavati informacije o načinu ubrizgavanja lijeka Stelara pod kožu.
English: What benefits of Stelara have been shown in studies?
Croatian: Koje su koristi lijeka Stelara dokazane u ispitivanjima?
English: It is not intended to provide practical advice on how to use Stelara.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Stelara.
English: • moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin).
Croatian: • umjerene do teške plak psorijaze (bolesti koja na koži uzrokuje crvenkasta žarišta koja se ljušte).
English: Therefore, the CHMP decided to restrict the use of the medicine in moderate to severe plaque psoriasis to patients aged 12 years and above in whom other treatments had failed or who could not receive them.
Croatian: Stoga je CHMP odlučio ograničiti primjenu lijeka u liječenju umjerene do teške plak psorijaze na bolesnike u dobi od 12 godina ili starije kod kojih druge terapije nisu bile uspješne ili su bile kontraindicirane.
English: The side effects of the medicine were considered tolerable and manageable.
Croatian: Nuspojave lijeka smatraju se podnošljivima i moguće ih je kontrolirati.
English: Patients or their caregivers may inject Stelara under the skin once they have been trained, if their doctor thinks that this is appropriate.
Croatian: Nakon što prođu obuku, bolesnici ili njihovi njegovatelji mogu sami davati injekcije lijeka Stelara pod kožu ako liječnik smatra da je to primjereno.
English: An additional study involved 110 children with moderate to severe plaque psoriasis aged between 12 and 18 years.
Croatian: Dodatno ispitivanje obuhvatilo je 110 djece u dobi od 12 do 18 godina s umjerenim do teškim oblikom plak psorijaze.
English: In Crohn's disease, the effects of Stelara in reducing symptoms in patients in whom other treatments had failed or who could not receive them were considered important, also given the unmet medical need of these patients.
Croatian: U slučaju Crohnove bolesti učinci lijeka Stelara na ublažavanje simptoma u bolesnika kod kojih druge terapije nisu bile uspješne ili su bile kontraindicirane smatraju se važnima, uzimajući u obzir i nezadovoljenu medicinsku potrebu tih pacijenata.
English: After 44 weeks of starting treatment by injection under the skin, 53% of patients on Stelara every 8 weeks and 49% of patients on Stelara every 12 weeks had a significant reduction in symptoms of Crohn's disease, compared with 36% of patients on placebo.
Croatian: Nakon 44 tjedna od početka terapije injekcijom pod kožu u 53 % bolesnika koji su primali lijek Stelara svakih 8 tjedana i 49 % onih koji su lijek primali svakih 12 tjedana značajno su ublaženi simptomi Crohnove bolesti, u usporedbi s 36 % bolesnika koji su primali placebo.
English: • moderately to severely active Crohn's disease (a disease causing inflammation of the gut) in adults whose condition has not responded well enough to other treatments for Crohn's disease or who cannot receive such treatments.
Croatian: • umjereno do teškog oblika aktivne Crohnove bolesti (upalne bolesti crijeva) u odraslih osoba koje nisu zadovoljavajuće odgovorile na druge terapije za Crohnovu bolest ili koje ne mogu primati te terapije.
English: The children received placebo or Stelara and the main measure of effectiveness was the number of patients who responded to treatment after 12 weeks as shown by an improvement in symptom scores.
Croatian: Djeca su dobila placebo ili lijek Stelara, a glavna mjera djelotvornosti bio je broj bolesnika koji su odgovorili na terapiju nakon 12 tjedna, što je vidljivo na temelju boljih rezultata simptoma.
English: The full EPAR for Stelara can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Stelara nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Više informacija o liječenju lijekom Stelara pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: How is Stelara used?
Croatian: Kako se Stelara koristi?
English: In around 69% of children (25 out of 36) who received Stelara responded, compared with 5% of patients receiving placebo (2 out of 37).
Croatian: Oko 69 % djece (25 od 36) koja su primala lijek Stelara odgovorilo je na terapiju, u usporedbi s 5 % bolesnika koji su primili placebo (2 od 37).
English: For adults with psoriatic arthritis who have not responded well to DMARDs the CHMP noted the limited treatments available and considered that Stelara would be of benefit in these patients.
Croatian: CHMP je zaključio da su odraslim osobama s psorijatičnim artritisom koje nisu adekvatno odgovorile na DMARD-ove dostupne ograničene mogućnosti liječenja i smatra da bi lijek Stelara bio koristan za te bolesnike.
English: Stelara contains the active substance ustekinumab.
Croatian: Stelara sadrži djelatnu tvar ustekinumab.
English: In the treatment of active psoriatic arthritis, Stelara was compared with placebo in two main studies involving a total of 927 adults with the condition who did not have an adequate response with previous treatments.
Croatian: U liječenju aktivnog psorijatičnog artritisa lijek Stelara uspoređen je s placebom u dvama glavnim ispitivanjima koja su obuhvatila ukupno 927 odraslih osoba koje nisu odgovarajuće odgovorile na prethodne terapije.
English: For practical information about using Stelara, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Stelara pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: • active psoriatic arthritis (inflammation of the joints associated with psoriasis) in adults, when the condition has not responded well enough to other treatments called disease-modifying antirheumatic drugs' (DMARDs).
Croatian: • aktivnog psorijatičnog artritisa (upale zglobova povezane s psorijazom) u odraslih osoba kada reakcija na druge lijekove, i to nebiološke antireumatske lijekove koji modificiraju tijek bolesti (DMARD-ovi), nije bila odgovarajuća.
English: The CHMP considered that studies had shown that Stelara was effective in the treatment of adults and children over 12 years of age with moderate to severe plaque psoriasis.
Croatian: CHMP je smatrao da su ispitivanja pokazala kako je lijek Stelara djelotvoran u liječenju umjerene do teške plak psorijaze u odraslih osoba i djece starije od 12 godina.
English: For the full list of restrictions please see the package leaflet.
Croatian: Potpuni popis ograničenja potražite u uputi o lijeku.
English: Looking at the results of the two main studies in adults taken together, around 69% of the patients receiving Stelara responded to treatment after 12 weeks, compared with around 3% of the patients receiving placebo.
Croatian: Promatrajući zajedno rezultate dvaju glavnih ispitivanja među odraslim osobama, otprilike 69 % bolesnika koji su primali lijek Stelara odgovorilo je na terapiju nakon 12 tjedana, u usporedbi s otprilike 3 % bolesnika koji su primili placebo.
English: The active substance in Stelara, ustekinumab, is a monoclonal antibody.
Croatian: Djelatna tvar lijeka Stelara, ustekinumab, monoklonsko je protutijelo.
English: In the treatment of Crohn's disease, Stelara (concentrate for infusion) was compared with placebo in two main studies involving 1,369 patients with moderately to severely active disease.
Croatian: U liječenju Crohnove bolesti lijek Stelara (koncentrat za infuziju) uspoređen je s placebom u dvama glavnim ispitivanjima koja su obuhvatila 1 369 pacijenata s umjerenim do teškim oblikom aktivne bolesti.
English: In both studies the main measure of effectiveness was the number of patients who responded to treatment after 24 weeks as shown by an improvement in symptom scores.
Croatian: U oba ispitivanja glavna mjera djelotvornosti bio je broj bolesnika koji su odgovorili na terapiju nakon 24 tjedna, što je vidljivo na temelju boljih rezultata simptoma.
English: How does Stelara work?
Croatian: Kako djeluje Stelara?
English: In the treatment of moderate to severe plaque psoriasis, Stelara has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,996 adults with the condition.
Croatian: U liječenju umjerene do teške plak psorijaze lijek Stelara uspoređen je s placebom (prividnim liječenjem) u dvama glavnim ispitivanja kojima je obuhvaćeno ukupno 1 996 odraslih osoba s tim stanjem.
English: In the first study, around 34% patients who received Stelara (at a dose calculated based on bodyweight) responded to treatment compared with 21% of patients who were given placebo.
Croatian: U prvom ispitivanju oko 34 % bolesnika koji su primili lijek Stelara (u dozi utvrđenoj na temelju tjelesne težine) odgovorilo je na terapiju, u usporedbi s 21 % bolesnika koji su primili placebo.
English: In the first study, around 42% of those given Stelara 45 mg and 50% of those given 90 mg responded, compared with around 23% of those given placebo.
Croatian: U prvom ispitivanju, otprilike 42 % bolesnika koji su primili lijek Stelara u dozi od 45 mg i 50 % bolesnika koji su primili dozu od 90 mg odgovorilo je na terapiju, u usporedbi s otprilike 23 % bolesnika koji su primili placebo.
English: For the full list of all side effects reported with Stelara, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih prilikom primjene lijeka Stelara potražite u uputi o lijeku.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stelara have also been included in the summary of product characteristics and the package leaflet.
Croatian: U sažetku opisa svojstava lijeka i uputi o lijeku također se nalaze preporuke i mjere opreza za sigurnu i učinkovitu primjenu lijeka Stelara kojih se zdravstveni radnici i bolesnici trebaju pridržavati.
English: These cytokines are involved in inflammation and other processes that are important in psoriasis, psoriatic arthritis and Crohn's disease.
Croatian: Ustekinumab se vezuje na dva citokina (glasničke molekule) u imunosnom sustavu, i to na interleukin 12 i interleukin 23. Ti citokini sudjeluju u upalnim i drugim procesima značajnima za psorijazu, psorijatični artritis i Crohnovu bolest.
English: In the second study, around 44% of those given either dose of Stelara responded, compared with around 20% of those given placebo.
Croatian: U drugom ispitivanju, otprilike 44 % bolesnika koji su primili jednu od dviju doza lijeka Stelara odgovorilo je na terapiju, u usporedbi s otprilike 20 % bolesnika koji su primili placebo.
English: and the remainder in the faeces.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI
English: CoAprovel should be taken at least one hour before or four hours after these medications;
Croatian: CoAprovel se mora uzeti najmanje jedan sat prije ili 4 sata poslije tih lijekova;
English: Older people
Croatian: Starije osobe
English: What CoAprovel is and what it is used for
Croatian: Što je CoAprovel i za što se koristi
English: See also information under the heading “Do not take CoAprovel”.
Croatian: Vidjeti također informacije pod naslovom „Nemojte uzimati CoAprovel“.
English: Other medicines and CoAprovel
Croatian: Drugi lijekovi i CoAprovel
English: While this is not documented with CoAprovel, a similar effect should be anticipated.
Croatian: Iako to nije dokumentirano za CoAprovel, može se očekivati sličan učinak.
English: It may harm them, even if their signs of illness are the same as yours.
Croatian: CoAprovel se ne preporučuje uzimati u ranoj trudnoći, a ne smije se uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi Vašem djetetu primjenjujete li ga u tom razdoblju (vidjeti dio o trudnoći).
English: depression, sleep disturbances
Croatian: depresija, poremećaji spavanja
English: Children should not take CoAprovel
Croatian: Djeca ne smiju uzimati CoAprovel
English: If possible, another class of diuretics should be used;
Croatian: Ako je moguće, treba primjenjivati diuretike iz neke druge skupine;
English: The study recruited 58% males.
Croatian: Ispitivanje je uključivalo 58% muškaraca.
English: It is important that you continue to take CoAprovel until your doctor tells you otherwise.
Croatian: Važno je da kontinuirano uzimate CoAprovel sve dok Vam liječnik ne odredi drugačije.
English: Date of first authorisation: 15 October 1998 Date of latest renewal: 15 October 2008
Croatian: Datum posljednje obnove: 15. listopada 2008.
English: At the time of Commission Decision.
Croatian: U vrijeme donošenja Odluke Komisije
English: 63.09 17404 Riells i Viabrea (Girona) - Spain
Croatian: 63.09 17404 Riells i Viabrea (Girona) Španjolska
English: sexual dysfunction, libido changes
Croatian: seksualna disfunkcija, promjene libida
English: At least 61% of the oral dose is eliminated unchanged within 24 hours.
Croatian: Najmanje 61% peroralno primijenjene doze eliminira se nepromijenjeno unutar 24 sata.
English: CoAprovel is not recommended for use in children and adolescents because the safety and efficacy have not been established.
Croatian: Ne preporučuje se primjena lijeka CoAprovel u djece i adolescenata jer sigurnost i djelotvornost nisu utvrđene.
English: Children and adolescents CoAprovel should not be given to children and adolescents (under 18 years).
Croatian: Djeca i adolescenti CoAprovel se ne smije davati djeci i adolescentima (mlađima od 18 godina).
English: Your doctor will normally advise you to stop taking CoAprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of CoAprovel.
Croatian: Vaš će Vam liječnik obično preporučiti da prestanete koristiti CoAprovel prije nego što zatrudnite ili čim saznate da ste trudni te će Vam savjetovati da uzmete neki drugi lijek umjesto lijeka CoAprovel.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, ovaj lijek može uzrokovati nuspojave iako se neće javiti kod svakoga.
English: Since CoAprovel contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Croatian: Budući da CoAprovel sadrži hidroklorotiazid, ne preporučuje se tijekom prvog tromjesečja trudnoće.
English: if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Croatian: ako ste imali rak kože ili ako Vam se pojavi neočekivana lezija (promjena) na koži tijekom liječenja.
English: The MAH shall complete, within the stated timeframe, the below measures:
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere:
English: What CoAprovel is and what it is used for What you need to know before you take CoAprovel How to take CoAprovel
Croatian: Što je CoAprovel i za što se koristi Što morate znati prije nego počnete uzimati CoAprovel Kako uzimati CoAprovel
English: If you accidentally miss a daily dose, just take the next dose as normal.
Croatian: Ako slučajno zaboravite uzeti dnevnu dozu, samo uzmite sljedeću dozu kao što to obično i činite.
English: CoAprovel should not be given to children under 18 years of age.
Croatian: CoAprovel ne smiju uzimati djeca mlađa od 18 godina.
English: Your doctor will instruct you how to switch from the previous treatment to CoAprovel.
Croatian: Liječnik će Vas uputiti kako prijeći s prethodnog liječenja na CoAprovel.
English: What CoAprovel contains
Croatian: Što CoAprovel sadrži
English: Such conditions should be corrected before initiating therapy with CoAprovel.
Croatian: Takva stanja treba korigirati prije započinjanja terapije lijekom CoAprovel.
English: What you need to know before you take CoAprovel
Croatian: Što morate znati prije nego počnete uzimati CoAprovel
English: 2112 Veresegyhaz Hungary
Croatian: 2112 Veresegyhaz Mađarska
English: If you forget to take CoAprovel
Croatian: Ako ste zaboravili uzeti CoAprovel
English: Protect your skin from sun exposure and UV rays while taking CoAprovel
Croatian: Zaštitite svoju kožu od izlaganja suncu i UV zrakama za vrijeme uzimanja lijeka CoAprovel
English: The mean age of patients was 52.5 years, 13% were ≥ 65 years of age, and just 2% were ≥ 75 years of age.
Croatian: Srednja dob bolesnika bila je 52,5 godina; 13% ispitanika bilo je u dobi od 65 godina ili više, a samo 2% u dobi od 75 godina ili više.
English: Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Croatian: Ograničena akumulacija irbesartana (< 20%) zabilježena je u plazmi nakon primjene ponovljenih doza jedanput na dan.
English: If CoAprovel is used during breast feeding, doses should be kept as low as possible.
Croatian: Ako se CoAprovel primjenjuje tijekom dojenja, njegove doze trebaju biti što je moguće niže.
English: 2112 Veresegyház - Hungary
Croatian: 2112 Veresegyház - Mađarska
English: The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Croatian: Glavni cirkulirajući metabolit je irbesartan glukuronid (oko 6%).
English: * These limits are not applicable for batches where more than one of the above N-nitrosamines has been identified simultaneously; such batches should be rejected.
Croatian: * Te granične vrijednosti nisu primjenjive za serije gdje je utvrđeno istodobno postojanje više od jednog od prethodno navedenih N-nitrozamina; takve serije treba odbaciti.
English: 2) After the transitional period of 2 years, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented.
Croatian: 2) Nakon prijelaznog razdoblja od dvije godine potrebno je primijeniti graničnu vrijednost za tvari NDMA i NDEA od najviše 0,03 ppm.
English: You should discontinue CoAprovel treatment and seek medical attention.
Croatian: Prestanite uzimati CoAprovel i zatražite liječničku pomoć.
English: Irbesartan AUC and Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18-40 years).
Croatian: Vrijednosti AUC i Cmax irbesartana također su bile nešto veće u starijih (≥ 65 godina) nego u mlađih bolesnika (18 do 40 godina).
English: CoAprovel can be taken once daily, with or without food.
Croatian: CoAprovel se može uzimati jedanput na dan, s hranom ili bez nje.
English: respiratory distress (including pneumonitis and pulmonary oedema)
Croatian: respiratorni distres (uključujući pneumonitis i plućni edem)
English: In long-term follow-up studies, the effect of irbesartan/hydrochlorothiazide was maintained for over one year.
Croatian: U dugoročnim ispitivanjima praćenja, učinak kombinacije irbesartan/hidroklorotiazid održao se kroz više od godinu dana.
English: When necessary, CoAprovel may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
Croatian: Kada je potrebno, CoAprovel se može primjenjivati s drugim antihipertenzivnim lijekom (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
English: Please see section 2 “CoAprovel contains lactose”.
Croatian: Vidjeti dio 2., „ CoAprovel sadrži laktozu“.
English: Epidemiological studies have shown that long term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.
Croatian: Epidemiološka su ispitivanja pokazala da dugoročno liječenje hidroklorotiazidom smanjuje rizik od kardiovaskularnog morbiditeta i mortaliteta.
English: 56 x 1 tablets
Croatian: 56 x 1 tableta
English: dyspepsia, dysgeusia
Croatian: dispepsija, disgeuzija
English: Alcohol: potentiation of orthostatic hypotension may occur;
Croatian: Alkohol: može se pojaviti izraženija ortostatska hipotenzija;
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Croatian: Epidemiološki podaci koji se odnose na rizik od teratogenog učinka nakon primjene ACE inhibitora tijekom prvog tromjesečja trudnoće nisu bili dostatni za donošenje zaključaka; međutim manji porast rizika ne može se isključiti.
English: There is no difference in response to CoAprovel, regardless of age or gender.
Croatian: Ne postoji razlika u terapijskom odgovoru bolesnika na CoAprovel s obzirom na dob ili spol.
English: CoAprovel with food and drink CoAprovel can be taken with or without food.
Croatian: CoAprovel s hranom i pićem CoAprovel se može uzeti s hranom ili bez nje.
English: The primary treatment is to discontinue drug intake as rapidly as possible.
Croatian: Primarno liječenje je prestanak primjene lijeka što je prije moguće.
English: Hydrochlorothiazide is 68% protein-bound in the plasma, and its apparent volume of distribution is 0.83-1.14 l/kg.
Croatian: Za proteine u plazmi veže se 68% hidroklorotiazida, a njegov prividni volumen distribucije iznosi 0,83-1,14 l/kg.
English: Primary aldosteronism: patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Croatian: Primarni aldosteronizam: bolesnici s primarnim aldosteronizmom općenito ne reagiraju na antihipertenzivne lijekove koji djeluju putem inhibicije renin-angiotenzinskog sustava.
English: Another study showed a possible association between lip cancer (SCC) and exposure to HCTZ: 633 cases of lip-cancer were matched with 63,067 population controls, using a risk-set sampling strategy.
Croatian: Druga studija pokazala je moguću povezanost između raka usana (SCC) i izlaganja hidroklorotiazidu: 633 slučaja raka usana usklađeno je s 63 067 kontrola u populaciji, primjenom strategije uzorkovanja iz rizične skupine (engl. risk-set sampling).
English: Food does not affect the bioavailability of CoAprovel.
Croatian: Hrana ne utječe na bioraspoloživost lijeka CoAprovel.
English: All of these changes were considered to be caused by the pharmacological action of irbesartan.
Croatian: Sve navedene promjene smatraju se uzrokovanim farmakološkim djelovanjem irbesartana.
English: Thiazides in high doses causing intense diuresis can inhibit the milk production.
Croatian: Tiazidi u visokim dozama koje uzrokuju intenzivnu diurezu mogu inhibirati proizvodnju mlijeka.
English: If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere (npr. laktozu), obratite se liječniku prije uzimanja ovog lijeka.
English: No specific information is available on the treatment of overdose with CoAprovel.
Croatian: Nema dostupnih specifičnih podataka o liječenju predoziranja lijekom CoAprovel.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: One study included a population comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively.
Croatian: Jedna studija uključila je populaciju koja se sastojala od 71 533 slučaja BCC-a i 8 629 slučajeva SCC-a usklađenih s 1 430 833, odnosno 172 462 kontrola u populaciji.
English: If you get any of the above symptoms or get short of breath, stop taking CoAprovel and contact your doctor immediately.
Croatian: Ako dobijete neki od tih simptoma ili ako imate nedostatak zraka, prestanite uzimati CoAprovel i odmah se obratite svome liječniku.
English: jaundice hepatitis, abnormal liver function
Croatian: hepatitis, abnormalna funkcija jetre
English: Risk factors for developing acute angleclosure glaucoma may include a history of sulfonamide or penicillin allergy (see section 4.8).
Croatian: Faktori rizika za razvoj akutnog glaukoma zatvorenog kuta mogu uključivati alergiju na sulfonamid ili penicilin u povijesti bolesti (vidjeti dio 4.8).