FrancophonIA/ELRC3.0 huggingface dataset:
English: These provisional measures are without prejudice to the outcome of the ongoing review under Article 20 procedure.
Croatian: Te privremene mjere ne dovode u pitanje ishod procjene u tijeku na temelju postupka iz članka 20.
English: • Furthermore, PRAC recommended that a healthcare professional communication should be disseminated to inform healthcare professionals about the precautionary measures, awaiting the outcome of the full review of Esmya.
Croatian: • Štoviše, PRAC je preporučio proširenje komunikacije sa liječnicima kako bi bili obaviješteni o mjerama opreza dok se čeka rezultat cjelokupne procjene lijeka Esmya.
English: • During the ongoing review of safety and efficacy data in relation to the overall risk of liver injury with Esmya, the PRAC reviewed all data currently available from post-marketing settings and from clinical trials as well as the responses provided by the marketing authorisation holder on cases of serious liver injury reported with Esmya.
Croatian: • Tijekom pregleda podataka o sigurnosti i djelotvornosti povezanih s ukupnim rizikom od oštećenja jetre nakon primjene lijeka Esmya, PRAC je pregledao sve podatke koji su trenutačno dostupni iz izvješća nakon odobrenja lijeka i kliničkih ispitivanja, kao i odgovore koje je dostavio nositelj odobrenja za stavljanje u promet u pogledu slučajeva ozbiljnog oštećenja jetre prijavljenih nakon primjene lijeka Esmya.
English: Patients who develop transaminase levels > 2 times the upper level of normal during Esmya treatment should stop treatment and be closely monitored.
Croatian: U bolesnika s razinom transaminaze koja je 2 puta veća od gornje granice normalne razine, tijekom terapije lijekom Esmya treba odmah prekinuti liječenje i pažljivo ih pratiti.
English: The provisional measures proposed by PRAC also include the limitation of use of the medicinal product in patients that are currently under therapeutic treatment.
Croatian: Privremene mjere koje predlaže PRAC uključuju i ograničenu primjenu lijeka na bolesnike koji trenutačno primaju terapiju.
English: In view of the above, the Committee considers that the benefit-risk balance of Esmya remains favourable subject to the agreed provisional measures.
Croatian: S obzirom na prethodno navedeno, Odbor smatra da omjer koristi i rizika za lijek Esmya ostaje povoljan uz uvjet dogovorenih privremenih mjera.
English: In view of the seriousness of the cases, the PRAC considered that provisional measures are now needed to minimise this risk and protect patients, while the review is ongoing and a thorough assessment of all available data related to the benefit-risk of Esmya is performed.
Croatian: Uzimajući u obzir ozbiljnost slučajeva, PRAC smatra da je potrebno uvesti privremene mjere za smanjenje rizika i zaštitu bolesnika, dok je procjena u tijeku i dok se izvršava temeljita procjena svih dostupnih podataka povezanih s omjerom koristi i rizika lijeka Esmya.
English: Nevertheless, the review of cumulatively reported post-marketing cases does not allow a firm conclusion at this stage.
Croatian: Bez obzira na to, procjena ukupno zabilježenih slučajeva nakon izdavanja odobrenja za stavljanje lijeka u promet trenutačno ne omogućuje donošenje konkretnog zaključka.
English: The therapeutic indication for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age was based on results from another study providing data for up to 4 intermittent treatment courses of 3 months each with ulipristal acetate along with data for repeated treatment courses from the previous studies.
Croatian: Terapijska indikacija za isprekidano liječenje umjerenih do ozbiljnih simptoma mioma maternice u odraslih žena reproduktivne dobi temelji se na rezultatima drugog ispitivanja s podatcima o 4 isprekidane terapije ulipristal acetatom, od kojih svaka traje 3 mjeseca, kao i s podatcima o ponovljenoj terapiji iz prethodnih ispitivanja.
English: The clinical efficacy of ulipristal acetate in the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age was based on short-term studies demonstrating the ability of the active substance to reduce fibroid-related bleeding, anaemia and fibroid size if administered in a daily dose of 5 mg for up to three months.
Croatian: Klinička djelotvornost ulipristal acetata pri preoperativnom liječenju umjerenih do ozbiljnih simptoma mioma maternice u odraslih žena reproduktivne dobi temelji se na kratkoročnim ispitivanjima u kojima se pokazuje sposobnost djelatne tvari da smanji krvarenja povezana s miomom, anemiju i veličinu mioma ako se primjenjuje u dozi od 5 mg dnevno do tri mjeseca.
English: In addition, several other cases of hepatic impairment associated with the use of the product were reported.
Croatian: Nadalje, zabilježeno je još nekoliko slučajeva oštećenja jetre povezanih s primjenom lijeka.
English: Given the estimated exposure to Esmya of approximately 175,000 patient years, the number of cases of subacute severe liver impairment leading to liver transplantation with Esmya appears higher than expected, although background incidence on drug induced liver injury is uncertain.
Croatian: Uzimajući u obzir procijenjenu izloženost lijeku Esmya od približno 175.000 bolesnika u odnosu na godine liječenja, broj slučajeva subakutnog ozbiljnog oštećenja jetre koje dovodi do transplantacije jetre nakon primjene lijeka Esmya čini se višim od očekivanoga, iako prethodna učestalost ozljede jetre nakon primjene lijekova nije sigurna.
English: Patients exhibiting signs and symptoms suggestive of liver injury should promptly contact a healthcare professional.
Croatian: Bolesnike koji pokazuju znakove i simptome koji upućuju na oštećenje jetre potrebno je odmah uputiti liječniku.
English: PRAC reviewed all data currently available from post-marketing settings and from clinical trials as well as the responses provided by the marketing authorisation holder on cases of serious liver injury reported with Esmya.
Croatian: PRAC je pregledao sve podatke koji su trenutačno dostupni iz izvješća nakon odobrenja lijeka i kliničkih ispitivanja, kao i odgovore koje je dostavio nositelj odobrenja za stavljanje u promet u pogledu slučajeva ozbiljnog oštećenja jetre prijavljenih nakon primjene lijeka Esmya.
English: In addition, several cases of hepatic injury in patients using Esmya were reported.
Croatian: Nadalje, zabilježeno je nekoliko slučajeva ozljede jetre u bolesnika koji su primali lijek Esmya.
English: With regards to patients under intermittent treatment, the use of the medicinal product should not be repeated in patients who have finalised a previous treatment course.
Croatian: U pogledu bolesnika koji primaju isprekidano liječenje, primjena lijeka ne bi se trebala ponavljati u bolesnika koji su dovršili prethodnu terapiju.
English: • The PRAC noted that four cases of acute liver failure leading to liver transplantation including one with fatal outcome have been reported with Esmya.
Croatian: • PRAC je zaključio da su zabilježena četiri slučaja akutnog zatajenja jetre koje je dovelo do transplantacije jetre, uključujući jedan sa smrtnim ishodom nakon primjene lijeka Esmya.
English: The above provisional measures should be reflected in the terms of the marketing authorisation, including the product information of Esmya, and communicated to HCPs via a DHPC.
Croatian: Prethodno navedene privremene mjere trebaju se odražavati u uvjetima za odobrenje za stavljanje lijeka u promet, uključujući informacije o lijeku Esmya.
English: In patients suffering from heavy menstrual bleeding associated with uterine fibroids, repeated 3-month treatment courses with ulipristal acetate provide a medical alternative to surgery and have the potential to reduce the need for surgical intervention.
Croatian: U bolesnica koje pate od teškog menstrualnog krvarenja povezanog s miomima maternice, ponovljena mjesečna terapija svaka tri mjeseca lijekom ulipristal acetat služi kao medicinska alternativa operaciji te može smanjiti potrebu za kirurškim zahvatom.
English: Follow-up information on this case was also reviewed by the PRAC, as well as additional information provided by the Marketing Authorisation Holder while the review was ongoing.
Croatian: PRAC je pregledao i popratne informacije o tom slučaju, kao i dodatne informacije koje je dostavio nositelj odobrenja za stavljanje lijeka u promet tijekom pregleda.
English: Four cases of serious liver injury leading to a hepatic transplantation were reported since the marketing authorisation of Esmya.
Croatian: Zabilježena su četiri slučaja ozbiljne ozljede jetre koja je dovela do transplantacije jetre nakon izdavanja odobrenja za stavljanje lijeka Esmya u promet.
English: With regards to patients under intermittent treatment, the use of the medicinal product should be discontinued in patients who have finalised a previous treatment course.
Croatian: U pogledu bolesnika koji primaju isprekidano liječenje, primjena lijeka treba se prekinuti u bolesnika koji su dovršili prethodnu terapiju.
English: In post-marketing settings, a total of four cases of acute liver failure leading to liver transplantation including one with fatal outcome have been reported in patients exposed to Esmya.
Croatian: Nakon izdavanja odobrenja za stavljanje lijeka u promet zabilježena su ukupno četiri slučaja akutnog zatajenja jetre koje je dovelo do transplantacije jetre, uključujući jedan sa smrtnim ishodom u bolesnika koji su primali lijek Esmya.
English: Healthcare Professionals (HCPs) should be informed of the cases of liver injury and hepatic failure reported with the use of Esmya in post-marketing experience.
Croatian: Liječnici trebaju biti obaviješteni o slučajevima ozljede jetre i zatajenja jetre koji su zabilježeni s lijekom Esmya nakon puštanja lijeka u promet.
English: No information on hepatic events is currently included in the Product Information of Esmya.
Croatian: U informacijama o lijeku Esmya trenutačno nema informacija o oštećenjima jetre.
English: • A heart attack within the last four weeks.
Croatian: • Srčani udar u roku posljednjih četiri tjedna.
English: In some cases you may have to stop taking one of the medicines.
Croatian: U nekim slučajevima možda će biti potrebno prestati uzimati jedan od lijekova.
English: You must tell your doctor if you think you are (or might become) pregnant.
Croatian: Potrebno je obavijestiti liječnika ako mislite da ste (ili biste mogli postati) trudni.
English: This leaflet was last revised in
Croatian: Ova Uputa je posljednji puta revidirana u
English: Try to take the tablet at the same time each day.
Croatian: Pokušajte uzeti tabletu u isto vrijeme svaki dan.
English: See section 3.
Croatian: Pogledajte dio 3.
English: It is important that you take Onduarp every day until your doctor tells you otherwise.
Croatian: Važno je uzimati Onduarp svaki dan, dok Vam liječnik drugačije ne propiše.
English: Weight increased, weight decreased
Croatian: Porast težine, smanjena težina
English: Cumulative urinary excretion is <1 % of dose.
Croatian: Kumulativna urinarna ekskrecija je <1% doze.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i ostali oblici interakcija
English: If these effects are not treated they could be fatal.
Croatian: Ako se ovi učinci ne liječe, mogu imati fatalan ishod.
English: Additional information on individual components
Croatian: Dodatni podaci o pojedinim komponentama
English: If you take more Onduarp than you should
Croatian: Ako uzmete više Onduarpa nego što biste trebali
English: The tablets should be swallowed with some water or other non-alcoholic drink.
Croatian: Tablete se gutaju s malo vode ili drugog bezalkoholnog pića.
English: No new or more severe adverse reactions were observed.
Croatian: Nisu primijećene nove ili teže nuspojave.
English: Treatment of essential hypertension in adults:
Croatian: Liječenje esencijalne hipertenzije kod odraslih osoba:
English: Do not take a double dose to make up for forgotten individual doses.
Croatian: Ne uzimajte dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Grapefruit and grapefruit juice
Croatian: Grejp i sok od grejpa
English: You can take Onduarp with or without food.
Croatian: Možete uzimati Onduarp sa ili bez hrane.
English: It is recommended to take Onduarp with some liquid.
Croatian: Preporučuje se uzimati Onduarp s malo tekućine.
English: Therefore, the combination should be administered with caution, especially in the elderly.
Croatian: Stoga se kombinacija primjenjuje s oprezom, osobito kod starijh osoba.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Croatian: Bolesnika se mora pažljivo nadzirati, a liječenje mora biti simptomatsko i suportivno.
English: • Erythromycin (antibiotic).
Croatian: • Eritromicin (antibiotik).
English: Signs and symptoms of overdose are expected to be in line with exaggerated pharmacological effects.
Croatian: Očekuje se da znakovi i simptomi predoziranja odgovaraju prekomjernim farmakološkim učincima.
English: Onduarp with food and drink
Croatian: Uzimanje Onduarpa s hranom i pićem
English: What Onduarp is and what it is used for
Croatian: Što je Onduarp i za što se koristi
English: • if you suffer from severe low blood pressure (including shock).
Croatian: • ako patite od izrazito niskog krvnog tlaka (uključujući šok).
English: Your doctor may need to change the dose of these other medicines or take other precautions.
Croatian: Liječnik će možda promijeniti doze drugih lijekova ili primijeniti druge mjere opreza.
English: However, no adverse events attributable to such interaction have been reported.
Croatian: Međutim, nisu prijavljene nuspojave koje se mogu pripisati takvim interakcijama.
English: There are usually no symptoms of high blood pressure before damage occurs.
Croatian: Obično se simptomi visokog krvnog tlaka ne pojavljuju prije nego što dođe do oštećenja.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Za sve dodatne informacije o ovom lijeku, molimo, kontaktirajte lokalnog predstavnika nositelja odobrenja za stavljanje gotovog lijeka u promet.
English: This applies especially to the medicines listed below taken at the same time with Onduarp:
Croatian: Ovo se osobito odnosi na u nastavku navedene lijekove koji se uzimaju istovremeno uz Onduarp:
English: The inhibitory effect is maintained over 24 hours and still measurable up to 48 hours.
Croatian: Inhibicijski učinak se održava tijekom 24 sata, a može se još uvijek izmjeriti do 48 sati.
English: If you do not take your tablet on one day, take your normal dose on the next day.
Croatian: Ako ne uzmete tabletu jedan dan, sljedeći dan primijenite redovitu dozu.
English: Treatment can be continued once blood pressure has been stabilised.
Croatian: Liječenje se može nastaviti nakon stabilizacije krvnog tlaka.
English: Dyspnoea, rhinitis
Croatian: Dispneja, rinitis
English: Therefore, caution should be recommended when driving a car or using machines.
Croatian: Stoga se preporučuje oprez prilikom upravljanja automobilom ili strojem.
English: Little information is available in the very elderly patients.
Croatian: Dostupno je malo podataka za vrlo stare bolesnike.
English: Paediatric population (age below 18 years) No pharmacokinetic data are available in the paediatric population.
Croatian: Pedijatrijska populacija (dob ispod 18 godina starosti) Nisu dostupni farmakokinetički podaci za pedijatrijsku populaciju.
English: • Raised aldosterone levels (which lead to water and salt retention in the body along with imbalance of various blood minerals).
Croatian: • Povišene vrijednosti aldosterona (što dovodi do zadržavanja vode i soli u tijelu uz poremećenu ravnotežu raznih minerala u krvi).
English: The volume of distribution of amlodipine is approximately 21 l/kg.
Croatian: Volumen distribucije amlodipina je oko 21 l/kg.
English: Onduarp contains sorbitol.
Croatian: Onduarp sadrži sorbitol.
English: The pharmacokinetics of telmisartan do not differ in young and elderly patients.
Croatian: Farmakokinetika telmisartana ne razlikuje se između mlađih i starijih bolesnika.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali, ili biste mogli uzimati neke druge lijekove.
English: • Shock (including cardiogenic shock)
Croatian: ● Šok (uključujući kardiogeni šok)
English: If you experience these side effects, do not drive or use machines.
Croatian: Ako osjećate ove nuspojave, nemojte upravljati vozilima ili strojevima.
English: This means that both of these active substances work together to help stop your blood vessels tightening.
Croatian: To znači da obje ove djelatne tvari djeluju zajedno kako bi pomogle zaustaviti stezanje Vaših krvnih žila.
English: Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Croatian: Stoga je redovno mjerenje krvnog tlaka važno kako bismo znali je li u granicama normale.
English: Concomitant use requiring caution
Croatian: Istovremena primjena koja zahtijeva oprez
English: Absolute bioavailability has been estimated to be between 64 and 80%.
Croatian: Apsolutna bioraspoloživost je procijenjena na između 64 i 80%.
English: Talk to your doctor before taking Onduarp:
Croatian: Posavjetujte se s liječnikom prije nego počnete uzimati Onduarp:
English: Plasma concentrations were higher in females than in males, without relevant influence on efficacy.
Croatian: Koncentracije u plazmi bile su više kod žena nego kod muškaraca, bez relevantnog utjecaja na djelotvornost.
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 o povećanom teratogenom riziku nakon izloženosti ACE inhibitorima tijekom prvog tromjesečja trudnoće nisu konačni; međutim, ne može se isključiti malo povećanje rizika.
English: However, there may be a risk of prolonged delivery.
Croatian: Međutim, može postojati rizik od produljenog porođaja.
English: Serum electrolytes and creatinine should be monitored frequently.
Croatian: Serumski elektroliti i kreatinin moraju se često pratiti.
English: If patients experience these adverse reactions, they should avoid potentially hazardous tasks such as driving or using machines.
Croatian: Ako bolesnici imaju ove nuspojave, moraju izbjegavati potencijalno rizične radnje kao što su upravljanje vozilima ili strojevima.
English: Children and adolescents The use of Onduarp in children and adolescents up to the age of 18 years is not recommended.
Croatian: Djeca i adolescenti Primjena Onduarpa kod djece i adolescenata do 18 godina starosti se ne preporučuje.
English: Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid glycoprotein.
Croatian: Telmisartan se u velikoj mjeri veže na proteine plazme (>99,5%), uglavnom albumin i alfa-1 kiseli glikoprotein.
English: Telmisartan has been studied in a large outcome study in 25,620 patients with high cardiovascular risk (ONTARGET).
Croatian: Telmisartan je ispitivan u velikoj studiji ishoda na 25 620 ispitanika s visokim kardiovaskularnim rizikom (ONTARGET).
English: After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 3 hours.
Croatian: Nakon prve doze telmisartana, antihipertenzivni učinak postupno postaje vidljiv u roku 3 sata.
English: What Onduarp is and what it is used for What you need to know before you take Onduarp How to take Onduarp
Croatian: Što je Onduarp i za što se koristi Što morate znati prije nego počnete uzimati Onduarp Kako uzimati Onduarp
English: However, the clinical relevance of this finding is uncertain.
Croatian: Međutim, klinički značaj ovog otkrića je neizvjestan.
English: • Simvastatin to treat elevated levels of cholesterol.
Croatian: • Simvastatin za liječenje povišenih vrijednosti kolesterola.
English: You might experience low blood pressure and rapid heart beat.
Croatian: Možda ćete imati niski krvni tlak ili ubrzane otkucaje srca.
English: Studies with telmisartan in animals have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja telmisartana na životinjama su pokazala reproduktivnu toksičnost (vidjeti dio 5.3).
English: Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su razvrstane prema nazivima učestalosti uz uporabu sljedeće konvencije: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥ 1/1000 do < 1/100); rijetko (≥ 1/10 000 do < 1/1000; vrlo rijetko (<1/10 000); nije poznato (ne može se utvrditi iz dostupnih podataka).
English: Some side effects can be serious and need immediate medical attention:
Croatian: Neke nuspojave mogu biti teške te zahtijevati trenutno medicinsko zbrinjavanje:
English: ketoconazole).
Croatian: (npr. ketokonazol).
English: There is no linear relationship between doses and plasma levels.
Croatian: Ne postoji linearan odnos između doza i vrijednosti u plazmi.
English: In vitro studies have shown that approximately 97.5 % of circulating amlodipine is bound to plasma proteins in hypertensive patients.
Croatian: In vitro studije su pokazale da se oko 97,5% amlodipina u cirkulaciji veže na proteine plazme kod hipertenzivnih bolesnika.
English: Onduarp is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Croatian: Onduarp se ne preporučuje u ranoj trudnoći, te se ne smije primjenjivati kada ste trudni dulje od 3 mjeseca, jer može izazvati teško oštećenje bebe kada se primjenjuje nakon trećeg mjeseca trudnoće.
English: If you forget to take a dose, take it as soon as you remember and then carry on as before.
Croatian: Ako zaboravite uzeti dozu, uzmite ju čim se sjetite, te nastavite po redovnom režimu doziranja.
English: • if you are allergic to other medicines of the dihydropyridine type (one type of calcium channel blocker).
Croatian: • ako ste alergični na druge lijekove tipa dihidropiridina (jedan tip blokatora kalcijevih kanala).
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Croatian: Pretklinički podaci ne otkrivaju poseban rizik za ljude na osnovi konvencionalnih studija farmakološke sigurnosti, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog potencijala.
English: Supportive treatment should be instituted.
Croatian: Potrebno je suportivno liječenje.
English: Furthermore, orthostatic hypotension may be aggravated by alcohol.
Croatian: Nadalje, ortostatska hipotenzija se može pogoršati uzimanjem alkohola.
English: Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Croatian: Prijavljena je izražena i vjerojatno produljena sistemska hipotenzija, uključujući i šok s fatalnim ishodom.
English: The mean steady state apparent volume of distribution (Vdss) is approximately 500 l.
Croatian: Prosječni prividni volumen distribucije u stanju dinamičke ravnoteže (Vdss) je približno 500 l.
English: In two corresponding open-label long-term follow up studies performed over a further 6 months the effect of Onduarp was maintained over the trial period.
Croatian: U dvjema podudarnim, otvorenim, dugotrajnim studijama praćenja, provođenim tijekom daljnjih 6 mjeseci, učinak Onduarpa bio je održavan tijekom razdoblja ispitivanja.
English: Interactions linked to telmisartan
Croatian: Interakcije povezane s telmisartanom
English: There is no evidence of clinically relevant accumulation of telmisartan taken at the recommended dose.
Croatian: Ne postoje dokazi klinički relevantnog nakupljanja telmisartana uzetog u preporučenoj dozi.