FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness was a change of FEV1 (the maximum volume of air a person can breathe out in 1 second).
Croatian: Glavno mjerilo učinkovitosti bila je promjena funkcije FEV1 (maksimalan volumen zraka koji osoba može izdahnuti u jednoj sekundi).
English: Prevention of rejection
Croatian: Sprječavanje odbacivanja organa
English: Rapamune is available as an oral solution (1 mg/ml) and tablets (0.5, 1 and 2 mg).
Croatian: Rapamune je dostupan kao oralna otopina (1 mg/ml) i tablete (0,5 mg, 1 mg i 2 mg).
English: What is Rapamune and what is it used for?
Croatian: Što je Rapamune i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Rapamune?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Rapamune?
English: For more information about using Rapamune, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Rapamune, pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: The doctor will adjust the dose to achieve appropriate levels of sirolimus in the patient's blood.
Croatian: Liječnik će prilagoditi dozu u svrhu postizanja odgovarajuće razine sirolimusa u krvi bolesnika.
English: To prevent organ rejection, the first dose is usually 6 mg given soon after the transplantation followed by 2 mg once a day.
Croatian: Kako bi se spriječilo odbacivanje organa, prva doza od najčešće 6 mg daje se ubrzo nakon presađivanja organa, nakon čega se daje doza od 2 mg jedanput dnevno.
English: Rapamune received a marketing authorisation valid throughout the EU on 14 March 2001.
Croatian: Lijek Rapamune je dobio odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 14. ožujka 2001.
English: Side effects reported with Rapamune are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Rapamune pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Patients allergic to peanut or soya must not take Rapamune oral solution because the solution contains soya oil.
Croatian: Bolesnici alergični na kikiriki i soju ne smiju uzimati oralnu otopinu lijeka Rapamune jer otopina sadržava sojino ulje.
English: Other information about Rapamune
Croatian: Ostale informacije o lijeku Rapamune
English: To treat patients with S-LAM, the dose of Rapamune is 2 mg daily and after 10 to 20 days the doctor will adjust the dose to achieve appropriate levels of sirolimus in the patient's blood.
Croatian: Za liječenje bolesnika koji boluju od S-LAM-a, doza lijeka Rapamune iznosi 2 mg dnevno, a nakon 10 do 20 dana liječnik će prilagoditi dozu u svrhu postizanja odgovarajućih razina sirolimusa u krvi bolesnika.
English: It is recommended that Rapamune is used with ciclosporin and corticosteroids (other medicines to prevent organ rejection) for two to three months.
Croatian: Preporuča se da se Rapamune primjenjuje s ciklosporinom i kortikosteroidima (drugim lijekovima za sprječavanje odbacivanja organa) tijekom razdoblja od dva do tri mjeseca.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rapamune have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Rapamune nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The active substance in Rapamune, sirolimus, is an immunosuppressant (a medicine that reduces the activity of the immune system).
Croatian: Djelatna tvar lijeka Rapamune, sirolimus, je imunosupresiv (lijek koji smanjuje aktivnost imunosnog sustava).
English: Two additional studies looked at Rapamune as continuing treatment for up to 5 years in 765 patients who were able to stop ciclosporin after 2 to 3 months.
Croatian: U dvama dodatnim ispitivanjima lijek Rapamune promatran je u kontekstu nastavka liječenja do tijekom najdulje pet godina 765 bolesnika koji su mogli prestati uzimati ciklosporin nakon 2 do 3 mjeseca.
English: In the body, sirolimus attaches to a protein inside cells to make a ‘complex'.
Croatian: Sirolimus se u tijelu prvo veže na protein koji se nalazi unutar stanica kako bi se stvorio „kompleks”.
English: Since mTOR is involved in the multiplication of activated T-lymphocytes (white blood cells that are responsible for attacking the transplanted organ), Rapamune reduces the number of these cells, reducing the risk of organ rejection.
Croatian: Budući da je mTOR uključen u umnožavanje aktiviranih T-limfocita (bijelih krvnih stanica koje su odgovorne za napadanje transplantiranog organa), Rapamune smanjuje broj tih stanica, čime ujedno smanjuje i rizik od odbacivanja organa.
English: FEV1 improved by an average of 1 ml per month in patients treated with Rapamune compared with a worsening by 12 ml per month in patients receiving placebo.
Croatian: FEV1 se poboljšao u prosjeku za 1 ml mjesečno u bolesnika koji su liječeni lijekom Rapamune u usporedbi s pogoršanjem za 12 ml mjesečno u bolesnika koji su primali placebo.
English: Rapamune can then be used for continuing treatment with corticosteroids, but only if ciclosporin treatment can be stopped.
Croatian: Potom se Rapamune može primjenjivati za nastavak liječenja zajedno s kortikosteroidima, no samo ako se terapija ciklosporinom može prekinuti.
English: Why is Rapamune authorised in the EU?
Croatian: Zašto je lijek Rapamune odobren u EU-u?
English: Rapamune is also used for treating patients with sporadic lymphangioleiomyomatosis (S-LAM) with moderate lung disease or worsening lung function.
Croatian: Rapamune se također koristi za liječenje bolesnika sa sporadičnom limfangiolejomiomatozom (S-LAM) s umjerenom bolesti pluća ili pogoršavanjem funkcije pluća.
English: The Agency noted that no medicinal product has been approved for the treatment of S-LAM and Rapamune's effect on lung function is considered important.
Croatian: Agencija je primijetila da nijedan lijek nije odobren za liječenje S-LAM-a, a učinak lijeka Rapamune na funkciju pluća smatra se značajnim.
English: As for all medicines, data on the use of Rapamune are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Rapamune kontinuirano se prate.
English: All patients were also treated with ciclosporin and corticosteroids and were at low to moderate risk of rejection.
Croatian: Svi su bolesnici također bili liječeni ciklosporinom i kortikosteroidima i imali su niski do umjereni rizik od odbacivanja organa.
English: An overview of Rapamune and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Rapamune i zašto je odobren u EU-u
English: In S-LAM, mTOR is overactive, causing excessive multiplication of cells that cause the disease.
Croatian: Kod S-LAM-a mTOR je pretjerano aktivan, što uzrokuje pretjerano umnožavanje stanica koje uzrokuju bolest.
English: Rapamune treatment should be started by and remain under the guidance of a doctor who is a qualified specialist in transplantation.
Croatian: Liječenje lijekom Rapamune treba započeti i održavati pod nadzorom liječnik koji je kvalificirani liječnik specijalist za transplantaciju.
English: In the second study, treatment failed in 30% (68 out of 277) of the patients adding Rapamune, compared with 48% (62 out of 130) of those adding placebo.
Croatian: U drugom ispitivanju liječenje je bilo neuspješno u 30 % (68 od 277) bolesnika koji su dodali lijek Rapamune, u usporedbi s 48 % (62 od 130) bolesnika koji su dodali placebo.
English: Rapamune was more effective than placebo in improving lung function in a study involving 81 patients with S-LAM.
Croatian: Rapamune je bio učinkovitiji od placeba u poboljšanju plućne funkcije u ispitivanju koje je obuhvaćalo 81 bolesnika sa S-LAM-om.
English: What are the risks associated with Rapamune?
Croatian: Koji su rizici povezani s lijekom Rapamune?
English: In the first study, treatment failed in 19% (53 out of 284) of the patients adding Rapamune after 6 months, compared with 32% (52 out of 161) of those adding azathioprine.
Croatian: U prvom ispitivanju liječenje je bilo neuspješno u 19 % (53 od 284 bolesnika) bolesnika koji su dodali Rapamune nakon šest mjeseci, u usporedbi s 32 % (52 od 161) bolesnika koji su dodali azatioprin.
English: The European Medicines Agency considered that Rapamune is effective for the prevention of rejection of a transplanted kidney in patients at low to moderate risk of rejection.
Croatian: Europska agencija za lijekove zaključila je kako je lijek Rapamune učinkovit u sprječavanju odbacivanja presađenog bubrega u bolesnika s niskim do umjerenim rizikom od odbacivanja.
English: Rapamune was more effective than placebo (a dummy treatment) or azathioprine (another immunosuppressive medicine) in two main studies involving a total of 1,295 patients who were having a kidney transplant.
Croatian: Lijek Rapamune je bio učinkovitiji od placeba (prividno liječenje) ili azatioprina (koji je također imunosupresivan lijek) u dvama glavnim ispitivanjima koja su obuhvaćala ukupno 1 295 bolesnika s presađenim bubregom.
English: Rapamune was effective in helping the new kidney to survive, with an improvement in how well it worked and an improvement in blood pressure when ciclosporin treatment was stopped.
Croatian: Rapamune je učinkovito pomogao u preživljenju novog bubrega uz poboljšanje funkcije novog bubrega i poboljšanje u krvnom tlaku kada je prekinuto liječenje ciklosporinom.
English: S-LAM is a rare lung disease that causes worsening symptoms such as shortage of breath and occurs mainly in women who are at an age when they can have children.
Croatian: S-LAM je rijetka bolest pluća koja uzrokuje pogoršanje simptoma kao što je nedostatak zraka i javlja se većinom u žena reproduktivne dobi.
English: By blocking mTOR, Rapamune reduces the multiplication of these cells.
Croatian: Rapamune blokira djelovanje mTOR-a i time smanjuje množenje tih stanica.
English: How is Rapamune used?
Croatian: Kako se Rapamune koristi?
English: It is used in adults who are at a low to moderate risk of rejection.
Croatian: Primjenjuje se u odraslih bolesnika s niskim do umjerenim rizikom odbacivanja organa.
English: The Agency decided that Rapamune's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Agencija je zaključila da koristi lijeka Rapamune nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: What benefits of Rapamune have been shown in studies?
Croatian: Koje su koristi od lijeka Rapamune utvrđene u ispitivanjima?
English: Rapamune is a medicine used to prevent the body from rejecting a newly transplanted kidney.
Croatian: Rapamune je lijek koji se koristi za profilaksu odbacivanja nedavno transplantiranog bubrega.
English: This complex then blocks another protein called ‘mammalian target of rapamycin' (mTOR).
Croatian: Taj kompleks zatim inhibira protein naziva ciljna molekula rapamicina u sisavaca (engl. mammalian Target Of Rapamycin, mTOR).
English: Rapamune contains the active substance sirolimus.
Croatian: Rapamune sadržava djelatnu tvar sirolimus.
English: How does Rapamune work?
Croatian: Kako djeluje Rapamune?
English: For the full list of side effects and restrictions of Rapamune, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja za lijek Rapamune potražite u uputi o lijeku.
English: (Invented) Name Strength
Croatian: (Zaštićen) Naziv
English: Tibolona Aristo
Croatian: Tibolona Aristo 2,5 mg
English: Tibolon Aristo
Croatian: Tibolon Aristo 2,5 mg
English: This overview was last updated in 09-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 09-2018.
English: Further information on Xofigo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Xofigo možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 1 See outcome of safety review carried out in 2018 here.
Croatian: 1 Ishod sigurnosnog pregleda provedenog 2018. godine dostupan je ovdje.
English: This may limit the damage to nearby healthy tissues.
Croatian: To može ograničiti oštećenje okolnog zdravog tkiva.
English: The bones in the body take up radium in the same way as calcium.
Croatian: Kosti u tijelu apsorbiraju radij na isti način kao i kalcij.
English: It should be used only for patients who have had at least two previous treatments for prostate cancer or who cannot receive other treatments.
Croatian: Treba se primjenjivati samo u bolesnika koji su prethodno primili najmanje dvije terapije za liječenje raka prostate ili ne mogu primiti druge terapije.
English: Patients were given up to 6 injections at 1-month intervals and were followed up for 3 years from the first injection.
Croatian: Bolesnici su primili do šest injekcija u intervalima od jednog mjeseca i praćeni su tijekom razdoblja od tri godine nakon prve injekcije.
English: The medicine is slowly injected into a vein usually for up to one minute.
Croatian: Lijek se polako primjenjuje injekcijom u venu, najčešće u trajanju do jedne minute.
English: Patients given Xofigo lived on average for 14.9 months, compared with 11.3 months for those given placebo.
Croatian: Bolesnici koji su primili lijek Xofigo živjeli su u prosjeku 14,9 mjeseci, u usporedbi s 11,3 mjeseca u bolesnika koji su primili placebo.
English: Xofigo received a marketing authorisation valid throughout the EU on 13 November 2013.
Croatian: Lijek Xofigo dobio je odobrenje za stavljanje lijeka u promet koje vrijedi na prostoru EU-a od 13. studenoga 2013.
English: What is Xofigo and what is it used for?
Croatian: Što je Xofigo i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Xofigo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Xofigo?
English: Other information about Xofigo
Croatian: Ostale informacije o lijeku Xofigo
English: Xofigo (radium-223 dichloride)
Croatian: Xofigo (radij-223 diklorid)
English: For more information about using Xofigo, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Xofigo pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Side effects reported with Xofigo are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Xofigo pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The company that markets Xofigo will have to conduct studies to further characterise the safety profile of the medicine, in particular with regard to the risk of fractures and the risk of new metastases that do not affect the bone in patients treated with Xofigo.
Croatian: Tvrtka koja stavlja lijek Xofigo u promet morat će provesti ispitivanja kako bi se dodatno opisao sigurnosni profil lijeka, posebno u vezi s rizikom od prijeloma i rizikom od novih metastaza koje ne zahvaćaju kosti u bolesnika liječenih lijekom Xofigo.
English: Why is Xofigo authorised in the EU?
Croatian: Zašto je lijek Xofigo odobren u EU-u?
English: The most serious side effects were thrombocytopenia and neutropenia (low levels of neutrophils, a type of white blood cell that fights infection).
Croatian: Najozbiljnije su nuspojave trombocitopenija i neutropenija (niske razine neutrofila, vrste bijelih krvnih stanica koje se bore protiv infekcija).
English: The radioactive radium builds up in bone tissues where the cancer has spread, and the alpha particles destroy surrounding cancer cells and help to control the associated symptoms.
Croatian: Radioaktivni radij nakuplja se u koštanom tkivu na koje se rak proširio, a alfa čestice ubijaju okolne stanice raka i pomažu pri kontroli povezanih simptoma.
English: Xofigo must not be used with the medicine abiraterone acetate and the corticosteroids prednisone or prednisolone.
Croatian: Xofigo se ne smije primjenjivati u kombinaciji s abirateronacetatom i kortikosteroidima prednizonom ili prednizolonom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xofigo have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Xofigo nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Xofigo is a radiopharmaceutical (a medicine containing a radioactive substance) that is used to treat adults with cancer of the prostate (a gland of the male reproductive system).
Croatian: Xofigo je radiofarmak (lijek koji sadrži radioaktivnu tvar) i koristi se za liječenje odraslih osoba s rakom prostate (žlijezda muškog reproduktivnog sustava).
English: What are the risks associated with Xofigo?
Croatian: Koji su rizici povezani s lijekom Xofigo?
English: As for all medicines, data on the use of Xofigo are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Xofigo kontinuirano se prate.
English: The most common side effects with Xofigo (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), vomiting, thrombocytopenia (low blood-platelet counts) and bone fractures.
Croatian: Najčešće nuspojave lijeka Xofigo (koje se mogu javiti u više od 1 na 10 osoba) jesu proljev, mučnina, povraćanje, trombocitopenija (smanjen broj trombocita) i prijeloma kostiju.
English: An overview of Xofigo and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Xofigo i zašto je odobren u EU-u
English: Xofigo is used when castration (to stop the production of male hormones) by surgery or with medicines does not work, and when the cancer has spread to the bones (bone metastases) and is causing symptoms such as pain, but has not spread to other internal organs.
Croatian: Xofigo se primjenjuje ako kirurška ili medicinska kastracija (radi zaustavljanja stvaranja muških hormona) ne djeluje te ako se rak proširio na kosti (metastaze u kostima) i uzrokuje simptome, na primjer bol, no nije metastazirao na druge unutarnje organe.
English: Xofigo can only be obtained with a prescription and should only be handled and given by someone who is authorised to use radioactive medicines and after evaluation of the patient by a qualified doctor.
Croatian: Xofigo se izdaje samo na liječnički recept i njime smiju rukovati i primjenjivati ga samo osobe ovlaštene za rukovanje s radiofarmacima, i to nakon što kvalificirani liječnik procijeni bolesnika.
English: Xofigo was compared with placebo (a dummy treatment) as an addition to standard care in a main study involving 921 men with cancer of the prostate that had spread to the bones and for which suppression of male hormones using medicines or surgery did not work.
Croatian: Xofigo je uspoređen s placebom (prividno liječenje) kao dodatak standardnom liječenju u glavnom ispitivanju kojim je bio obuhvaćen 921 muškarac s rakom prostate koji se proširio na kosti i koji je rezistentan na supresiju muških hormona primjenom lijekova ili kirurškog zahvata.
English: The dose of Xofigo is calculated to provide a specific dose of radioactivity based on the patient's body weight.
Croatian: Doza lijeka Xofigo izračunava se na temelju tjelesne težine bolesnika kako bi se dobila specifična doza radioaktivnosti.
English: Xofigo has been shown to prolong life and delaying signs and symptoms of progressive disease.
Croatian: Dokazano je da se primjenom lijeka Xofigo produljuje život i odgađaju simptomi progresivne bolesti.
English: The European Medicines Agency decided that Xofigo's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Xofigo nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The active substance in Xofigo, radium-223, emits short-range radiation known as alpha particles.
Croatian: Djelatna tvar u lijeku Xofigo, radij-223, odašilje zračenje kratkog dometa poznatog pod nazivom alfa čestice.
English: Xofigo is used on its own or in combination with a medicine known as an ‘LHRH analogue'.
Croatian: Xofigo se primjenjuje kao monoterapija ili u kombinaciji s lijekom poznatim pod nazivom „LHRHanalog”.
English: Xofigo contains the active substance radium-223 dichloride.
Croatian: Xofigo sadrži djelatnu tvar radij-223 diklorid.
English: Injections are repeated every 4 weeks for a total of 6 injections.
Croatian: Terapija se primjenjuje u 6 injekcija u vremenskim razmacima od 4 tjedna.
English: How does Xofigo work?
Croatian: Kako djeluje Xofigo?
English: How is Xofigo used?
Croatian: Kako se Xofigo koristi?
English: What benefits of Xofigo have been shown in studies?
Croatian: Koje su koristi od lijeka Xofigo utvrđene u ispitivanjima?
English: Xofigo can increase the risk of having fractures.
Croatian: Primjenom lijeka Xofigo može se povećati rizik od prijeloma.
English: Regarding its safety, several measures have been put in place to minimise the risks of the medicine such as bone fractures1 The radiation emitted by Xofigo has a shorter range than the radiation of currently available radiopharmaceuticals.
Croatian: U pogledu sigurnosti lijeka, uvedeno je nekoliko mjera kojima se smanjuju rizici lijeka kao što su prijelomi kostiju1.
English: For the full list of side effects of Xofigo, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Xofigo potražite u uputi o lijeku.
English: The signs and symptoms of progressive disease such as bone pain also took longer to develop in patients given Xofigo.
Croatian: Osim toga, u bolesnika koji su primali lijek Xofigo proteklo je više vremena do pojave znakova i simptoma progresivne bolesti kao što je bol u kostima.
English: You have been prescribed CRESTOR because:
Croatian: Vam je propisan zato što:
English: • You have a high cholesterol level.
Croatian: • imate visoku razinu kolesterola.
English: Take your dose once a day.
Croatian: Dozu treba uzeti jednom dnevno.
English: Children younger than 6 years
Croatian: Djeca mlađa od 6 godina
English: Your doctor may increase your dose to find the right amount of CRESTOR for you.
Croatian: Liječnik Vam može povećati dozu kako bi pronašao odgovarajuću dozu CRESTORA za Vas.
English: This trial (n=176) was not suited for comparison of rare adverse drug events.
Croatian: Ova studija (n = 176) nije bila pogodna za usporedbu rijetkih štetnih događaja.
English: The usual start dose is 5 mg.
Croatian: Uobičajena početna doza je 5 mg.
English: These changes were each in the direction of improved lipid responses and were sustained over 2 years.
Croatian: Sve su te promjene ukazivale na poboljšanje lipidnih odgovora te su se održale tijekom 2 godine.
English: This means you are at risk from a heart attack or stroke.
Croatian: To znači da ste izloženi riziku za nastanak srčanog ili moždanog udara.
English: Treatment of hypercholesterolaemia
Croatian: Liječenje hiperkolesterolemije
English: Rosuvastatin exposure was predictable with respect to dose and time over a 2-year period.
Croatian: Izloženost rosuvastatinu bila je predvidljiva s obzirom na dozu i vrijeme tijekom 2-godišnjeg razdoblja.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Informacije o lijeku mogu naknadno revidirati nadležna tijela država članica u suradnji s referentnom državom članicom, ako je potrebno, sukladno postupcima propisanima u poglavlju 4. glave III Direktive 2001/83/EZ.
English: Crestor is used in adults, adolescents and children 6 years or older to treat high cholesterol.
Croatian: Crestor se koristi kod odraslih, adolescenata i djece u dobi od 6 ili više godina za liječenje visokog kolesterola.