FrancophonIA/ELRC3.0 huggingface dataset:
English: Gender No dose adjustment is necessary according to gender.
Croatian: Dozu nije potrebno prilagođavati prema spolu bolesnika.
English: Nausea* Constipation* Diarrhoea*
Croatian: - Zatvor - Glavobolja - Proljev - Omaglica
English: Apealea (paclitaxel)
Croatian: Apealea (paklitaksel)
English: Further information on Apealea can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/apealea.
Croatian: Više informacija o lijeku Apealea nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/apealea.
English: It belongs to the group of cancer medicines known as the ‘taxanes'.
Croatian: On pripada skupini lijekova pod nazivom „taksani”.
English: The dose of Apealea is 250 mg per square metre (calculated based on height and body weight) and is given by infusion over about 1 hour, once every 3 weeks, for 6 cycles of treatment.
Croatian: Doza lijeka Apealea iznosi 250 mg po kvadratnom metru (izračunana na temelju tjelesne visine i težine) i daje se infuzijom u trajanju od sat vremena, jedanput svaka tri tjedna u šest ciklusa terapije.
English: The average length of time that patients lived without their disease coming back yet again was 10.3 months with Apealea, and 10.1 months with conventional paclitaxel.
Croatian: Prosječno vrijeme preživljenja bolesnica bez ponovnog pojavljivanja bolesti iznosilo je 10,3 mjeseca s lijekom Apealea i 10,1 mjesec s konvencionalnim paklitakselom.
English: The most common side effects with Apealea (which may affect more than 1 in 10 people) are neutropenia (low numbers of white blood cells called neutrophils), stomach and gut disorders such as diarrhoea, nausea (feeling sick) and vomiting, peripheral neuropathy (nerve damage in hands and feet), joint and muscle pain, and reactions such as redness, soreness and inflammation of the veins at the site of infusion.
Croatian: Najčešće nuspojave lijeka Apealea (mogu se pojaviti u više od 1 na 10 bolesnika) su neutropenija (nizak broj bijelih krvnih stanica pod nazivom neutrofili), poremećaji želuca i crijeva kao što su proljev, mučnina (slabost) i povraćanje, periferna neuropatija (oštećenje živaca u rukama i stopalima), bol u zglobovima i mišićima i reakcije poput crvenila, boli i upale vena na mjestu infuzije.
English: The European Medicines Agency considered that Apealea was as effective as conventional paclitaxel, and could be a valuable alternative in combination with carboplatin.
Croatian: Europska agencija za lijekove smatrala je da je Apealea jednako djelotvorna kao i konvencionalni paklitaksel te da se može smatrati dostojnom alternativom u kombinaciji s karboplatinom.
English: Other information about Apealea
Croatian: Ostale informacije o lijeku Apealea
English: While the new formulation might be associated with more infusion site reactions, and studies suggested stronger effects on blood cells and the gut, these were considered manageable and the overall benefits and risks are consistent with those of other paclitaxel medicines.
Croatian: Premda se nova formulacija može povezati s više reakcija na mjestu infuzije te ispitivanja pokazuju snažnije djelovanje na krvne stanice i crijeva, te se nuspojave mogu kontrolirati, a ukupne koristi i rizici u skladu su s koristima i rizicima drugih lijekova s paklitakselom.
English: Apealea (paclitaxel) EMA/791927/2018
Croatian: Apealea (paklitaksel) EMA/653818/2018
English: For more information about using Apealea, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Apealea pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: The medicine can only be obtained with a prescription and should be given under the supervision of a specialist in the treatment of cancer.
Croatian: Lijek se izdaje samo na liječnički recept, a liječenje se provodi pod nadzorom liječnika specijalista u liječenju raka.
English: What is Apealea and what is it used for?
Croatian: Što je Apealea i za što se primjenjuje?
English: Supportive data from the study showed that the average time that patients lived after treatment was 25.7 months among those given Apealea and 24.8 months for those given conventional paclitaxel.
Croatian: Potkrepljujući podatci iz ispitivanja pokazali su da je prosječno vrijeme preživljenja nakon liječenja iznosilo 25,7 mjeseci za bolesnice koje su primile lijek Apealea i 24,8 mjeseci za bolesnice koje su primile konvencionalni paklitaksel.
English: Apealea has been shown to be as effective as a conventional formulation of paclitaxel in one main study involving further treatment of 789 women whose ovarian, fallopian tube or peritoneal cancer had come back.
Croatian: Lijek Apealea pokazao se jednako djelotvornim kao konvencionalna formulacija paklitaksela u jednom glavnom ispitivanju koje je obuhvaćalo daljnje liječenje 789 žena kod kojih su se vratili rak jajnika, jajovoda ili peritoneuma.
English: Side effects reported with Apealea are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Apealea pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What measures are being taken to ensure the safe and effective use of Apealea?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Apealea?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Apealea 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 Apealea nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: By keeping this structure intact the cells cannot divide and they eventually die.
Croatian: Budući da struktura ostaje cjelovita, stanice se ne mogu dijeliti te naposljetku odumiru.
English: An overview of Apealea and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Apealea i zašto je odobren u EU-u
English: Apealea must not be used in patients who are breast feeding or those who already have low levels of neutrophils in the blood.
Croatian: Apealea se ne smije primjenjivati u onih bolesnica koje doje ili u onih koje imaju nisku razinu neutrofila u krvi.
English: stage of cell division in which the cell's internal ‘skeleton' is dismantled to allow the cell to divide.
Croatian: koje se unutarnji „kostur” stanice raspada kako bi se stanica mogla razdijeliti.
English: Apealea is a cancer medicine used to treat women with cancer of the ovary or surrounding structures (the fallopian tube that connects the ovary to the womb, or the peritoneum, the membrane that lines the abdomen).
Croatian: Apealea je lijek protiv raka koji se primjenjuje za liječenje raka jajnika ili okolnih struktura u žena (jajovoda koji povezuje jajnik s maternicom ili peritoneuma, ovojnice koja obavija abdomen).
English: As for all medicines, data on the use of Apealea are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Apealea kontinuirano se prate.
English: The Agency therefore decided that Apealea's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Stoga je Agencija zaključila da koristi od lijeka Apealea nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Apealea is available as a powder to make up a solution for infusion (drip) into a vein.
Croatian: Lijek Apealea dostupan je kao prašak za pripremu otopine za infuziju (drip) u venu.
English: The active substance in Apealea, paclitaxel, is a cancer medicine that has been used in the EU for many years.
Croatian: Djelatna tvar u lijeku Apealea, paklitaksel, lijek je protiv raka koji se dugi niz godina primjenjuje u EUu.
English: Apealea is given along with a platinum-based medicine, carboplatin, to patients whose disease responds to platinum-based cancer medicines and has come back after initial treatment.
Croatian: Apealea se daje u kombinaciji s karboplatinom, lijekom na bazi platine, bolesnicama kod kojih je zabilježen odgovor na lijekove protiv raka na bazi platine i kod kojih se bolest vratila nakon početne terapije.
English: Why is Apealea authorised in the EU?
Croatian: Zašto je lijek Apealea odobren u EU-u?
English: What are the risks associated with Apealea?
Croatian: Koji su rizici povezani s lijekom Apealea?
English: Doses may be delayed or reduced by the doctor, or treatment may be stopped, if severe side effects occur; doses should also be reduced in patients with moderate or severe reduction in liver function.
Croatian: Liječnik može smanjiti ili odgoditi dozu ili prekinuti terapiju ako se pojave ozbiljne nuspojave.
English: The paclitaxel in Apealea is formulated in tiny particles, called micelles, to help it dissolve in the infusion solvent.
Croatian: Paklitaksel u lijeku Apealea nalazi se u obliku sitnih čestica zvanih micele kako bi se pospješilo njegovo otapanje u otopini za infuziju.
English: What benefits of Apealea have been shown in studies?
Croatian: Koje su koristi od lijeka Apealea utvrđene u ispitivanjima?
English: How does Apealea work?
Croatian: Kako djeluje Apealea?
English: Patients are also treated with a platinum-based medicine, carboplatin.
Croatian: Bolesnicama se daje i karboplatin, lijek na bazi platine.
English: Patients also received a platinum-based cancer medicine, carboplatin.
Croatian: Bolesnice su također primile karboplatin, lijek protiv raka na bazi platine.
English: How is Apealea used?
Croatian: Kako se Apealea primjenjuje?
English: Paclitaxel blocks a
Croatian: Paklitaksel blokira fazu diobe stanica tijekom
English: Apealea contains the active substance paclitaxel.
Croatian: Lijek Apealea sadrži djelatnu tvar paklitaksel.
English: For the full list of side effects of Apealea, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Apealea potražite u uputi o lijeku.
English: -1 Lyophilisate and solvent for oculonasal suspension
Croatian: - 1 Liofilizat i otapalo za okulonazalnu suspenziju
English: Lyophilisate: 1,000 doses
Croatian: Liofilizat: 1000doza
English: Solvent: 35 ml
Croatian: Otapalo: 35 ml
English: -1 Live avian infectious bronchitis virus, strain D388: 104.0 - 105.5 EID50*/dose * 50% egg infective dose
Croatian: -1 Živi atenuirani infektivni virus bronhitisa, soj D388: 104.0 - 105.5
English: 10 lyophilisate cups + 10 solvent vials
Croatian: 10 čašica liofilizata + 10 bočica otapala
English: Packaging Content Package size Withdrawal period
Croatian: Način primjene Pakovanje Sadržaj
English: EMA/483954/2014
Croatian: EU/2/14/174/003
English: Chicken Oculonasal use Lyophilisate: cup (Alu/PP);
Croatian: Liofilizat : (Alu/PP); Otapalo : bočica (LDPE)
English: EU (MA) number Invented name
Croatian: Izmišlje ni naziv
English: 10 cups
Croatian: Nula dana
English: However, sexual stimulation is still needed.
Croatian: No, još je uvijek potrebna seksualna stimulacija.
English: The main measure of effectiveness was the improvement in symptoms after 12 weeks.
Croatian: Glavna mjera djelotvornosti bilo je poboljšanje u simptomima nakon 12 tjedana.
English: The full EPAR for Cialis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Cialis nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A doctor should consider the potential risks of sexual activity in men who have cardiovascular disease.
Croatian: Liječnik treba razmotriti potencijalne rizike seksualne aktivnosti u muškaraca koji boluju od kardiovaskularne bolesti.
English: It is available as tablets (2.5, 5, 10 and 20 mg).
Croatian: Dostupan je u obliku tableta (2,5 mg, 5 mg, 10 mg i 20 mg).
English: Cialis can be used at a lower dose once a day in men who intend to use it frequently (twice a week or more), based on the doctor's judgement.
Croatian: Cialis se može koristiti u manjim dozama jednom na dan u muškaraca koji namjeravaju lijek koristiti često (dva puta na tjedan ili češće), na temelju odluke liječnika.
English: For Cialis to be effective in this condition, sexual stimulation is required.
Croatian: Kako bi Cialis bila djelotvorna, potrebna je seksualna stimulacija.
English: The dose is 5 mg once a day, but can be lowered to 2.5 mg once a day depending on how well it is tolerated.
Croatian: Doza iznosi 5 mg jednom na da, no može se smanjiti na 2,5 mg jednom na dan ovisno o tome koliko se dobro podnosi.
English: Patients with severe liver problems or kidney problems should not take more than 10 mg in one dose.
Croatian: Bolesnici s ozbiljnim problemima jetre ili problemima bubrega ne smiju uzimati više od 10 mg u jednoj dozi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cialis on 12 November 2002.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Cialis na snazi u Europskoj uniji od 12. studenog 2002.
English: The maximum recommended dosing frequency is once per day, but continuous daily use of 10 or 20 mg Cialis is not recommended.
Croatian: Maksimalna preporučena učestalost doziranja je jednom na dan, no kontinuirana dnevna uporaba od 10 ili 20 mg lijeka Cialis nije preporučena.
English: Once-a-day dosing is not recommended in patients with severe kidney problems, and should only be prescribed to patients with liver problems after a careful evaluation of the benefits and risks of taking the medicine.
Croatian: Doziranje jednom na dan se ne preporučuje u bolesnika s ozbiljnim problemima u funkciji bubrega, i treba se propisivati samo bolesnicima s problemima s jetrom nakon pažljive ocjene koristi i rizika uzimanja lijeka.
English: For treating erectile dysfunction, the recommended dose of Cialis is 10 mg taken ‘on demand' at least 30 minutes before sexual activity.
Croatian: Za liječenje erektile disfunkcije, preporučena doza lijeka Cialis iznosi 10 mg i uzima se "prema potrebi" najmanje 30 minuta prije seksualne aktivnosti.
English: What measures are being taken to ensure the safe and effective use of Cialis?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Cialis?
English: Because Cialis has not been studied in patients who have had a heart attack within the last three months or a stroke within the last six months, or those who have high blood pressure or heart disorders (irregular heart beat), these men should not use the medicine.
Croatian: Budući da lijeka Cialis nije ispitan u bolesnika koji su imaju infarkt miokarda unutar posljednja tri mjeseca ili moždani udar unutar posljednjih šest mjesece ili onih koji su imali visoki krvni tlak ili srčane poremećaje (nepravilne otkucaje srca), ovi muškarci ne smiju uzimati lijek.
English: This is a summary of the European public assessment report (EPAR) for Cialis.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Cialis.
English: Cialis is used to treat men with erectile dysfunction (sometimes called impotence) when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity.
Croatian: Cialis se koristi za liječenje odraslih muškaraca s erektilnom disfunkcijom (koja se ponekad naziva impotencija), kada ne mogu postići ili održati ukrućeni penis (erekciju) dostatan za zadovoljavajuću seksualnu aktivnost.
English: Other information about Cialis
Croatian: Ostale informacije o lijeku Cialis
English: This may reduce the problems with the flow of urine which are symptoms of benign prostatic hyperplasia.
Croatian: Ovo može smanjiti probleme s protokom urina koji su simptomi benigne prostatične hiperplazije.
English: Cialis was significantly more effective than placebo in all studies in erectile dysfunction.
Croatian: Cialis je bio značajno djelotvorniji od placeba u svim ispitivanjima erektilne disfunkcije.
English: For more information about treatment with Cialis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Cialis pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Patients taking Cialis once a day at doses of 2.5 or 5 mg also reported improved erections compared with those taking placebo.
Croatian: Bolesnici koji su uzimali Cialis jednom na dan u dozi od 2,5 ili 5 mg također su prijavili poboljšane erekcije u usporedbi s onima koji su uzimali placebo.
English: Overall, in the studies of general populations, 81% of patients reported that Cialis ‘on demand' improved their erections as compared to 35% of those taking placebo.
Croatian: Ukupno u svim ispitivanjima provedenima na općoj populaciji, 81% bolesnika prijavilo je da je Cialis "prema potrebi" poboljšao njihovu erekciju u usporedbi s 35% onih koji su uzimali placebo.
English: For one of the questionnaires, where the maximum score is 30, patients who recorded scores of about 15 before treatment, recorded scores of 22.6 or 25 after receiving Cialis 10 mg or 20 mg, respectively.
Croatian: U jednom od upitnika u kojem je maksimalan rezultat 30, bolesnici koji su zabilježili rezultat od otprilike 15 prije terapije, zabilježili su rezultat od 22,6 ili 25 nakon primanja terapije lijekom Cialis 10 mg odnosno 20 mg.
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 Cialis.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Cialis
English: For treating men with benign prostatic hyperplasia, or men with both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day.
Croatian: U slučaju terapije muškaraca s benignom prostatičnom hiperplazijom, ili muškaraca s benignom prostatičnom hiperplazijom i erektilnom disfunkcijom, preporučena doza iznosi 5 mg jednom na dan.
English: A risk management plan has been developed to ensure that Cialis is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Cialis.
English: Cialis, when taken ‘on demand' before sexual activity, has been studied in six main studies including 1,328 patients with erectile dysfunction.
Croatian: Cialis, kada se uzima "prema potrebi" prije seksualne aktivnosti, ispitan je u šest glavnih ispitivanja koja su obuhvatila 1.328 bolesnika s erektilnom disfunkcijom.
English: Cialis must not be used where sexual activity is inadvisable (e.g. in men with heart disease).
Croatian: Lijek Cialis ne smije se koristiti u slučaju kad se seksualne aktivnosti ne preporučuju (kao što je slučaj kod muškaraca s teškom bolesti srca).
English: Cialis must not be taken with nitrates (a type of medicine used for angina) or medicines of the class ‘guanylate cyclase stimulators' such as riociguat (a medicine for high blood pressure in the vessels supplying the lungs, known as pulmonary hypertension).
Croatian: Cialis se ne smije primjenjivati s nitratima (tipom lijeka koji se koristi za anginu) ili lijekovima klase "stimulatori guanilat ciklaze" poput riociguata (lijeka za visoki krvni tlak u krvnim žilama koje opskbrljuju pluća, poznat pod nazivom pulmonalna hipertenzija).
English: By blocking the breakdown of cGMP, Cialis restores erectile function.
Croatian: Blokadom razgradnje cGMP-a Cialis ponovno uspostavlja erektilnu funkciju.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection.
Croatian: Tijekom normalne seksualne stimulacije cGMP se proizvodi u penisu, gdje uzrokuje opuštanje mišića u spužvastom tkivu penisa (corpora cavernosa), što dozvoljava protok krvi u korporu stvarajući erekciju.
English: Cialis is a medicine containing the active substance tadalafil.
Croatian: Cialis je lijek koji sadrži djelatnu tvar tadalafil.
English: The most common side effects with Cialis are headache, dyspepsia (indigestion), back pain and myalgia (muscle pain), which are more common at higher doses.
Croatian: Najčešće nuspojave lijeka Cialis su glavobolja, dispepsija (indigestija), bolna leđa i mijalgija (mišićna bol), koji su uobičajeniji u većim dozama.
English: In all studies, the effects of Cialis were compared with those of placebo (a dummy treatment), and the main measure of effectiveness was the ability to get and maintain an erection.
Croatian: U svim ispitivanjima, djelovanje lijeka Cialis uspoređeno je s liječenjem s placebom (prividnim liječenjem), a glavna mjera djelotvornosti bila je sposobnost da se postigne i zadrži erekcija.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cialis, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Cialis nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The active substance of Cialis, tadalafil, belongs to a group of medicines called 'phosphodiesterase type 5 (PDE5) inhibitors'.
Croatian: Tadalafil, djelatni sastojak lijeka Cialis, pripada skupini lijekova zvanih inhibitori fosfodiesteraze tipa 5 (PDE5).
English: By blocking the phosphodiesterase enzyme and preventing the breakdown of cGMP, Cialis also improves the blood flow to, and relaxes the muscles of, the prostate and bladder.
Croatian: Inhibirajući enzim fosfodijesteraze i sprječavajući razgradnju cGMP-a, Cialis također poboljšava dotok krvi do te opušta mišiće prostate i mjehura.
English: Four main studies comparing Cialis with placebo were carried out in 1,500 patients with the condition, including some who also had erectile dysfunction.
Croatian: Četiri glavna ispitivanja koja su usporedila Cialis s placebom provedena su na 1.500 bolesnika sa stanjem, uključujući pojedine koji su imali erektilnu disfunkciju.
English: What is Cialis?
Croatian: Što je Cialis?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom medicine should be taken around the same time every day and the appropriateness of the once-a-day dosing should be re-assessed regularly.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: What is the risk associated with Cialis?
Croatian: Koji su rizici povezani s lijekom Cialis?
English: The CHMP decided that Cialis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Cialis nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Why has Cialis been approved?
Croatian: Zašto je Cialis odobren?
English: Cialis given at a dose of 5 mg was also more effective than placebo in all the studies in patients with benign prostatic hyperplasia, with the results showing a significant improvement in symptoms after 12 weeks compared with placebo.
Croatian: Kada se Cialis primjenjivao u dozi od 5 mg bio je djelotvorniji u odnosu na placebo u svim ispitivanjima u bolesnika s benignom prostatičnom hiperplazijom, s rezultatom značajnog poboljšanja u simptomima nakon 12 tjedana u usporedbi s placebom.
English: It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Croatian: Djeluje tako da blokira enzim fofodiesteraze, koji inače rastvara tvar poznatu pod nazivom ciklički gvanozin-monofosfat (cGMP).
English: Cialis has also been studied in patients with benign prostatic hyperplasia.
Croatian: Cialis je također ispitan u bolesnika s benignom prostatičnom hiperplazijom.