FrancophonIA/ELRC3.0 huggingface dataset:
English: For major depression, Duloxetine Lilly has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients.
Croatian: U slučaju teškog depresivnog poremećaja Duloxetine Lilly je uspoređen s placebom (prividnim liječenjem) u osam glavnih ispitivanja koja su obuhvatila 2 544 bolesnika.
English: In patients who respond to Duloxetine Lilly, treatment should continue for several months, to prevent the disorder coming back.
Croatian: U bolesnika koji odgovaraju na lijek Duloxetine Lilly liječenje treba nastaviti tijekom nekoliko mjeseci kako bi se spriječio relaps.
English: For practical information about using Duloxetine Lilly, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Duloxetine Lilly pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Duloxetine Lilly used?
Croatian: Kako se Duloxetine Lilly koristi?
English: What benefits of Duloxetine Lilly have been shown in studies?
Croatian: Koje su koristi lijeka Duloxetine Lilly utvrđene u ispitivanjima?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duloxetine Lilly on 8 December 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Duloxetine Lilly na snazi u Europskoj uniji od <datum izdavanja odobrenja za stavljanje u promet>.
English: For the full list of all side effects reported with Duloxetine Lilly, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Duloxetine Lilly potražite u uputi o lijeku.
English: ‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Croatian: Duloxetine Lilly dostupan je kao gastrorezistentne kapsule (30 mg i 60 mg). „Gastrorezistentno” znači da sadržaj kapsula prolazi kroz želudac bez razgradnje sve dok ne stigne u crijeva.
English: How does Duloxetine Lilly work?
Croatian: Kako djeluje Duloxetine Lilly?
English: The full EPAR for Bondronat can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Bondronat nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was based on the number of new bone complications.
Croatian: Glavno mjerilo djelotvornosti temeljilo se na broju novih koštanih komplikacija.
English: About three-quarters responded to a 4-mg dose.
Croatian: Otprilike tri četvrtine je odgovorilo na dozu od 4 mg.
English: Bondronat is used in adults in the following ways:
Croatian: Primjenjuje se u odraslih osoba na sljedeće načine:
English: The patient should not lie down for one hour after taking the tablet.
Croatian: Bolesnik ne smije leći najmanje jedan sat nakon što je uzeo tablete.
English: Other information about Bondronat
Croatian: Ostale informacije o lijeku Bondronat
English: Bondronat reduced the risk of having a skeletal event by about 40% compared with placebo.
Croatian: Bondronat je smanjio rizik od koštanih događaja za otprilike 40% u usporedbi s placebom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bondronat on 25 June 1996.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Bondronat na snazi u Europskoj uniji od 25. lipnja 1996.
English: The medicine can only be obtained with a prescription.
Croatian: Ovaj lijek izdaje se samo na liječnički recept.
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein, and as tablets (50 mg).
Croatian: Dostupan je kao koncentrat za pripremu otopine za infuziju (drip) u venu i kao tablete (50 mg).
English: The infusion will normally bring the blood calcium level down to normal levels within a week.
Croatian: Infuzijom se razina kalcija u krvi obično snižava na normalne razine u roku od tjedan dana.
English: Bondronat must not be used in people with hypocalcaemia.
Croatian: Bondronat se ne smije koristiti u osoba s hipokalcemijom.
English: Bondronat treatment should only be started by a doctor who has experience in the treatment of cancer.
Croatian: Terapiju lijekom Bondronat mora započeti liječnik koji ima iskustva u liječenju raka.
English: What measures are being taken to ensure the safe and effective use of Bondronat?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Bondronat?
English: Bondronat was not compared with any other treatments in these studies.
Croatian: Bondronat nije uspoređen ni s jednom drugom terapijom u tim ispitivanjima.
English: Bondronat was more effective than placebo in preventing bone complications.
Croatian: Bondronat je bio djelotvorniji od placeba u sprječavanju koštanih komplikacija.
English: Bondronat ibandronic acid
Croatian: Bondronat ibandronatna kiselina
English: This is a summary of the European public assessment report (EPAR) for Bondronat.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Bondronat.
English: The tablets must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit up for at least an hour.
Croatian: Tablete se ne smiju koristiti u bolesnika koji imaju abnormalan ezofagus ili koji ne mogu stajati, odnosno uspravno sjediti najmanje sat vremena.
English: The tablet should be taken after the patient has not eaten anything for at least six hours overnight and at least 30 minutes before the first food or drink of the day.
Croatian: Tablete se uvijek trebaju uzimati natašte, nakon što bolesnik nije jeo preko noći najmanje šest sati, te najmanje 30 minuta prije prvog obroka ili pića tog dana.
English: The main measure of effectiveness was the change in blood calcium levels.
Croatian: Glavno mjerilo djelotvornosti bila je promjena u koncentracijama kalcija u krvi.
English: It took longer for patients on Bondronat infusions or tablets to develop a new bone complication (50 to 76 weeks) than for patients on placebo (33 to 48 weeks).
Croatian: Bolesnicima koji su uzimali infuziju ili tablete lijeka Bondronat trebalo je više vremena da razviju nove koštane komplikacije (50 do 76 tjedana) u odnosu na bolesnike koji su primali placebo (33 do 48 tjedana).
English: These included spine fractures, fractures outside the spine and any bone complications that needed treatment with radiotherapy or surgery.
Croatian: Te su komplikacije obuhvaćale frakture kralježnice, frakture izvan kralježnice i sve koštane komplikacije koje su zahtijevale dodatnu radioterapiju ili kirurški zahvat.
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 Bondronat.
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 Bondronat.
English: In the prevention of skeletal events in patients with breast cancer and bone metastases, Bondronat has been compared with placebo (a dummy treatment) in three main studies lasting two years: one with the infusions in 466 patients and two with the tablets in a total of 846 patients.
Croatian: U prevenciji koštanih događaja u bolesnika s rakom dojke i metastazama u kostima, Bondronat je uspoređen s placebom (prividnim liječenjem) u tri glavna ispitivanja koja su trajala dvije godine: jedno s infuzijom u 466 bolesnika i dva s tabletama kod ukupno 846 bolesnika.
English: About a half to two-thirds of the patients responded to a 2-mg dose of Bondronat, with blood calcium levels returning to within the normal range.
Croatian: Otprilike polovica do dvije trećine bolesnika odgovorila je na dozu lijeka Bondronat od 2 mg tako što su se koncentracije kalcija u krvi vratile na normalne vrijednosti.
English: This leads to less bone loss.
Croatian: To rezultira smanjenjem gubitka koštane mase.
English: For more information about treatment with Bondronat, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Bondronat pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: In the treatment of hypercalcaemia caused by tumours, Bondronat is given over 2 hours as an infusion of either 2 or 4 mg, depending on how severe the hypercalcaemia is.
Croatian: Za potrebe liječenja hiperkalcemije koju uzrokuju tumori, Bondronat se primjenjuje tijekom 2 sata kao infuzija od 2 ili 4 mg, ovisno o tome koliko je hiperkalcemija ozbiljna.
English: In addition, the company that markets Bondronat will provide a card to inform patients receiving Bondronat infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Croatian: Osim toga, tvrtka koja lijek Bondronat stavlja u promet osigurat će bolesnicima koji primaju lijek putem infuzije karticu s informacijama o riziku od osteonekroze čeljusti i uputama o tome da se obrate svom liječniku ako uoče naznačene simptome.
English: Patients with tumours can have high levels of calcium in their blood, released from the bones.
Croatian: Bolesnici s tumorima mogu imati visoku razinu kalcija u krvi koji se oslobađa iz kostiju.
English: It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Croatian: Ona blokira aktivnost osteoklasta, stanica u tijelu koje su uključene u razgradnju koštanog tkiva.
English: • as an infusion to treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
Croatian: • kao infuzija za liječenje hiperkalcemije (visokih razina kalcija u krvi) koju uzrokuju tumori.
English: A risk management plan has been developed to ensure that Bondronat is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Bondronat.
English: • as an infusion or as a tablet to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone);
Croatian: • kao infuzija ili tablete za sprječavanje „koštanih događaja” (fraktura [slomljenih kostiju] ili koštanih komplikacija koje zahtijevaju liječenje) u bolesnika s rakom dojke i koštanim metastazama (ako se rak proširio u kosti);
English: Bondronat has also been studied in the treatment of hypercalcaemia caused by tumours in three fourweek studies involving a total of 343 patients.
Croatian: Bondronat je također ispitan u terapiji hiperkalcemije uzrokovane tumorima u tri četverotjedna ispitivanja koja su obuhvatila ukupno 343 bolesnika.
English: Bondronat was also effective in treating hypercalcaemia caused by tumours.
Croatian: Bondronat je također bio djelotvoran u liječenju hiperkalcemije uzrokovane tumorima.
English: Patients with moderate or severe kidney problems should receive Bondronat infusions at a lower dose over an hour, or the tablet every two days or every week.
Croatian: Bolesnici s umjerenim ili ozbiljnim problemima s bubrezima trebaju primiti infuziju lijeka Bondronat u manjim dozama tijekom sat vremena ili kao tablete svaka dva dana ili svaki tjedan.
English: In the prevention of skeletal events, Bondronat is either given as a 6-mg infusion lasting at least 15 minutes every three to four weeks, or as one tablet once a day.
Croatian: Za sprječavanje koštanih događaja Bondronat se primjenjuje kao infuzija od 6 mg koja traje najmanje 15 minuta svaka tri do četiri tjedna ili kao jedna tableta jednom na dan.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bondronat, 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 Bondronat nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The most serious side effects with Bondronat are anaphylactic reaction (severe allergic reaction), atypical fractures of the femur (an unusual type of fracture of the bone of the upper leg), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth), and eye inflammation.
Croatian: Najteže su nuspojave zabilježene pri primjeni lijeka Bondronat anafilaktička reakcija (teška alergijska reakcija), atipični prijelomi femura (neobičan oblik prijeloma natkoljenice), osteonekroza čeljusti (oštećenje kosti čeljusti koje može dovesti do boli, ranica u ustima ili pomicanja zubi) i upala oka.
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Croatian: Smanjenje gubitka koštane mase pomaže u tome da kosti budu manje lomljive, što je korisno u sprječavanju fraktura u bolesnika s rakom i koštanim metastazama.
English: For the full list of all side effects and restrictions reported with Bondronat, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja prijavljenih s lijekom Bondronat potražite u uputi o lijeku.
English: The CHMP decided that Bondronat's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi lijeka Bondronat nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: What is the risk associated with Bondronat?
Croatian: Koji su rizici povezani s lijekom Bondronat?
English: The most common side effects with Bondronat infusions are a rise in body temperature, hypocalcaemia (low blood calcium levels), asthenia (weakness) and headache.
Croatian: Najčešće nuspojave prijavljene s infuzijom lijeka Bondronat su povišenje tjelesne temperature, hipokalcemija (niske razine kalcija u krvi), astenija (slabost) i glavobolja.
English: What benefit has Bondronat shown during the studies?
Croatian: Koje su koristi lijeka Bondronat dokazane u ispitivanjima?
English: The most common side effects with the tablets are hypocalcaemia and dyspepsia (heartburn).
Croatian: Najčešće nuspojave s tabletama su hipokalcemija i dispepsija (žgaravica).
English: where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used).
Croatian: Lijek treba uzeti s punom čašom obične vode (u područjima sa tvrdom vodom, gdje tekuća voda sadrži veliku količinu otopljenog kalcija, može se koristiti voda iz boce s niskom koncentracijom minerala).
English: Bondronat is a medicine that contains the active substance ibandronic acid.
Croatian: Bondronat je lijek koji sadrži ibandronatnu kiselinu kao djelatnu tvar.
English: Why has Bondronat been approved?
Croatian: Zašto je lijek Bondronat odobren?
English: What is Bondronat used for?
Croatian: Za što se Bondronat koristi?
English: What is Bondronat?
Croatian: Što je Bondronat?
English: The active substance in Bondronat, ibandronic acid, is a bisphosphonate.
Croatian: Djelatna tvar u lijeku Bondronat, ibandronatna kiselina, pripada skupini lijekova koji se nazivaju bisfosfonati.
English: How is Bondronat used?
Croatian: Kako se Bondronat koristi?
English: How does Bondronat work?
Croatian: Kako djeluje Bondronat?
English: By preventing the breakdown of bones, Bondronat also helps to reduce the amount of calcium released into the blood.
Croatian: Bondronat također doprinosi snižavanju količine kalcija koja se oslobađa u krv time što sprječava razgradnju kostiju.
English: How has Bondronat been studied?
Croatian: Kako je Bondronat ispitivan?
English: Intravenous use vial (glass) 12 (12x1) vials (multipack)
Croatian: 12 (12x1) bočica (višestruko pakiranje)
English: (Invented) name Strength Pharmaceutical form
Croatian: Doza Farmaceutski oblik Put primjene
English: Immediate Packaging
Croatian: Unutarnje pakovanje Veličina pakovanja
English: Strength Pharmaceutical Form
Croatian: Farmaceutski oblik Put primjene Unutarnje pakiranje
English: 2 sets of constituents
Croatian: Staklene bočice 2 kompleta sastojaka
English: 1 set of constituents
Croatian: Staklene bočice 1 komplet sastojaka
English: The infusion should last three hours.
Croatian: Infuzija mora trajati tri sata.
English: It is designed for long-term use.
Croatian: Namijenjen je za dugotrajnu primjenu.
English: This summary was last updated in 09-2016.
Croatian: Sažetak je posljednji put ažuriran u 09.2016.
English: These measurements were taken at the start of the study and after a year of treatment.
Croatian: Vrijednosti su izmjerene na početku ispitivanja i nakon godinu dana terapije.
English: Elaprase has been authorised under ‘exceptional circumstances'.
Croatian: Lijek Elaprase odobren je u „iznimnim okolnostima”.
English: At the start of the study, the patients could walk an average of around 395 metres in six minutes.
Croatian: Na početku ispitivanja bolesnici su prosječno mogli prehodati oko 395 metara u šest minuta.
English: Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Croatian: Europska agencija za lijekove svake godine pregledava sve nove dostupne informacije te se ovaj sažetak po potrebi ažurira.
English: Elaprase is given every week, as an infusion into a vein, at a dose of 0.5 mg per kilogram body weight.
Croatian: Elaprase se primjenjuje svaki tjedan kao intravenska infuzija u dozi od 0,5 mg po kilogramu tjelesne težine.
English: The CHMP concluded that the improvements shown in the study, even if limited, represent a clinical benefit in the treatment of Hunter syndrome.
Croatian: CHMP je zaključio da poboljšanja koja su dokazana tijekom ispitivanja, iako ograničena, predstavljaju kliničku korist u liječenju Hunterova sindroma.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Elaprase on 8 January 2007.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Elaprase na snazi u Europskoj uniji od 8. siječnja 2007.
English: This causes a wide range of symptoms, particularly difficulty breathing and difficulty walking.
Croatian: To uzrokuje različite simptome, a napose otežano disanje i otežano hodanje.
English: Without treatment, these symptoms become more severe over time.
Croatian: Ako se ne liječe, ti se simptomi s vremenom pogoršavaju.
English: After a year, the patients receiving Elaprase could walk a further 43 metres on average, and the patients receiving placebo could walk a further 8 metres.
Croatian: Nakon godinu dana bolesnici koji su primali lijek Elaprase mogli su prosječno prehodati 43 metra više, dok su pacijenti koji su primali placebo hodali 8 metara više.
English: The main measures of effectiveness were lung function (‘forced vital capacity', the maximum amount of air the patient could breathe out), and the distance the patients could walk in six minutes, which measures the combined effects of the illness on the heart, lungs, joints and other organs.
Croatian: Glavne mjere djelotvornosti bile su funkcija pluća („forsirani vitalni kapacitet”, tj. maksimalna količina zraka koju bolesnik može izdahnuti) i udaljenost koju je bolesnik mogao prehodati u šest minuta, čime se mjere kombinirani učinci bolesti na srce, pluća, zglobove i ostale organe.
English: Since patients with Hunter syndrome cannot break these substances down, the GAGs gradually build up in most of the organs in the body and damage them.
Croatian: Budući da osobe oboljele od Hunterova sindroma ne mogu razgraditi te tvari, one se postupno nagomilavaju u većini tjelesnih organa i oštećuju ih.
English: What measures are being taken to ensure the safe and effective use of Elaprase?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Elaprase?
English: The main study of Elaprase involved 96 male patients aged between 5 and 31 years, and compared it with placebo (a dummy treatment).
Croatian: Glavnim ispitivanjem lijeka Elaprase bilo je obuhvaćeno 96 bolesnih muškaraca u dobi od pet do 31 godine, a lijek je uspoređen s placebom (prividnim liječenjem).
English: This is a summary of the European public assessment report (EPAR) for Elaprase.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Elaprase.
English: For more information about treatment with Elaprase, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Elaprase pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The full EPAR for Elaprase can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Elaprase nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that because Hunter syndrome is rare, it has not been possible to obtain complete information about Elaprase.
Croatian: To znači da zbog činjenice da je Hunterov sindrom rijetka bolest nije bilo moguće dobiti potpune informacije o lijeku Elaprase.
English: However, as long as the patient does not develop infusion reactions (rash, itching, fever, headache, high blood pressure or flushing), the duration of the infusion can be gradually reduced to one hour.
Croatian: Međutim, ako bolesnik nema reakcije na infuziju (osip, svrbež, groznicu, glavobolju, visoki krvni tlak ili crvenilo), trajanje infuzije može se postupno skratiti na jedan sat.
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 Elaprase.
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 Elaprase.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Elaprase can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Elaprase možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Croatian: Dostupan je kao koncentrat od kojeg se priprema otopina za intravensku infuziju (drip).
English: Elaprase is used to treat patients with Hunter syndrome.
Croatian: Elaprase se koristi za liječenje bolesnika s Hunterovim sindromom.
English: Supplying the enzyme will help to break down GAGs and stop them building up in body tissue, thereby helping to improve the symptoms of the disease.
Croatian: Isporuka enzima pomoći će pri razgradnji GAG-ova i zaustaviti njihovo nakupljanje u tjelesnim tkivima, čime se ublažavaju simptomi bolesti.
English: Elaprase improved lung function and the walking ability of the patients.
Croatian: Primjenom lijeka Elaprase poboljšala se funkcija pluća i sposobnost hodanja bolesnika.
English: Other information about Elaprase
Croatian: Ostale informacije o lijeku Elaprase
English: Hunter syndrome, which is also known as mucopolysaccharidosis II, is a rare, inherited disease that primarily affects male patients.
Croatian: Hunterov sindrom, koji je poznat i pod nazivom mukopolisaharidoza II, rijetka je nasljedna bolest od koje prvenstveno obolijevaju muškarci.