FrancophonIA/ELRC3.0 huggingface dataset:
English: NovoThirteen was investigated in a main study involving 41 adults and children above 6 years of age with congenital factor XIII A-subunit deficiency who had been treated in the past with medicines containing factor XIII.
Croatian: NovoThirteen je ispitan u jednom glavnom ispitivanju koje je obuhvatilo 41 odraslu osobu i djecu stariju od 6 godina s prirođenim nedostatkom faktora XIII podjedinice
English: What benefit has NovoThirteen shown during the studies?
Croatian: Koje su koristi lijeka NovoThirteen dokazane u ispitivanjima?
English: Why has NovoThirteen been approved?
Croatian: Zašto je lijek NovoThirteen odobren?
English: During the long-term study, no bleeding episodes were observed in children below 6 years of age treated with NovoThirteen.
Croatian: Tijekom dugoročnog ispitivanja, u djece mlađe od 6 godina starosti liječene lijekom NovoThirteen nisu uočene epizode krvarenja.
English: What is NovoThirteen used for?
Croatian: Za što se NovoThirteen koristi?
English: How is NovoThirteen used?
Croatian: Kako se NovoThirteen koristi?
English: NovoThirteen works by providing the factor XIII A-subunit, which helps to prevent bleeding in these patients.
Croatian: Djelatna tvar lijeka NovoThirteen, katridekakog, strukturno je ista kao humani faktor XIII podjedinice A. NovoThirteen djeluje tako što osigurava faktor XIII podjedinice A, što pomaže pri sprječavanju krvarenja u ovih bolesnika.
English: How does NovoThirteen work?
Croatian: Kako djeluje NovoThirteen?
English: Patients with congenital factor XIII A-subunit deficiency do not have enough of the factor XIII A-subunit, or it does not work correctly, which makes them prone to bleeding.
Croatian: Bolesnici oboljeli od prirođenog nedostatka faktora XIII podjedinice A nemaju dovoljno faktora XIII podjedinice
English: A specific component of factor XIII called the A-subunit is involved in stabilising blood clots and increasing the strength of the clot.
Croatian: A uključena je u stabiliziranje ugrušaka krvi i povećava snagu ugruška.
English: How has NovoThirteen been studied?
Croatian: Kako se lijek NovoThirteen ispitivao?
English: The recommended dose is one tablet once a week.
Croatian: Preporučena doza je jedna tableta jedanput na tjedan.
English: This summary was last updated in 08-2014.
Croatian: Ovaj sažetak je posljednji put ažuriran: 08.2014.
English: The name of the medicine was changed to Vantavo on 26 March 2010.
Croatian: Naziv lijeka promijenjen je u Vantavo 26. ožujka 2010.
English: This authorisation was based on the authorisation granted to Fosavance in 2005 (‘informed consent').
Croatian: Odobrenje se temeljilo na odobrenju izdanom za lijek Fosavance iz 2005. godine („informirana suglasnost”).
English: The full EPAR for Vantavo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Vantavo nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Vantavo reduces the risk of broken bones in the spine and the hip.
Croatian: Vantavo smanjuje rizik od slomljenih kostiju u kralježnici i kuku.
English: Other information about Vantavo:
Croatian: Ostale informacije o lijeku Vantavo:
English: Gradually, the bones become thin and fragile, and more likely to break.
Croatian: Kosti postepeno postaju tanje i krhkije, te su frakture izglednije.
English: The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink, or other medicines (including antacids, calcium supplements and vitamins).
Croatian: Bolesnice trebaju uzeti jednu tabletu s punom čašom vode (no ne mineralne vode), najmanje 30 minuta prije unosa bilo kakve hrane, pića ili drugih lijekova (uključujući antacide, dodatke kalcija i vitamine).
English: Alendronic acid is a bisphosphonate that has been used in osteoporosis since the mid-1990s.
Croatian: Alendronatna kiselina je bifosfat koji se koristi za liječenje osteoporoze od sredine 1990-ih.
English: What measures are being taken to ensure the safe and effective use of Vantavo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vantavo?
English: the day, which should be at least 30 minutes after taking the tablet.
Croatian: prvog unosa hrane u danu, što mora biti najmanje 30 minuta nakon unosa tablete.
English: Vitamin D3 is a nutrient that is found in some foods, but is also made in the skin through exposure to natural sunlight.
Croatian: Vitamin D3 je nutrijent koji je prisutan u određenim namirnicama, no proizvodi ga i koža prilikom izlaganja prirodnoj sunčevoj svjetlosti.
English: Vitamin D3, along with other forms of vitamin D, is required for calcium absorption and normal bone formation.
Croatian: Vitamin D3, zajedno s drugim oblicima vitamina D, potreban je za apsorpciju kalcija i normalno formiranje kostiju.
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 Vantavo.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i preporuke o uvjetima primjene lijeka Vantavo.
English: For more information about treatment with Vantavo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Vantavo pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: The information presented by the company from earlier studies and the published literature showed that the dose of alendronic acid included in Vantavo was the same as the dose needed to prevent bone loss.
Croatian: Informacije koje je tvrtka dostavila iz prethodnih ispitivanja i objavljene literature dokazuju da je doza alendronatne kiseline koja je uključena u lijek Vantavo ista kao doza potrebna za sprječavanje gubitka kostiju.
English: Why has Vantavo been approved?
Croatian: Zašto je Vantavo odobren?
English: The tablet should be swallowed whole and not crushed, chewed or allowed to dissolve in the mouth.
Croatian: Tableta se mora progutati cijela i ne smije se drobiti, žvakati niti cuclati.
English: Vantavo must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low blood calcium levels), or who cannot stand or sit upright for at least 30 minutes.
Croatian: Vantavo se ne smije primjenjivati u bolesnica koje imaju anomalije ezofagusa, koje imaju hipokalcemiju (nisku koncentraciju kalcija u krvi), odnosno koje ne mogu stajati niti sjediti uspravno najmanje 30 minuta.
English: A risk management plan has been developed to ensure that Vantavo is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Vantavo.
English: Because alendronic acid and vitamin D3 are already used separately in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets.
Croatian: Budući da se alendronatna kiselina i vitamin D3 već koriste zasebno u odobrenim lijekovima u EU-u, tvrtka je dostavila podatke prikupljene u ranijim ispitivanjima i iz objavljene literature za žene koje su u postmenopauzi te koje uzimaju alendronatnu kiselinu i vitamin D kao zasebne tablete.
English: It slows the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Croatian: Usporava djelovanje osteoklasta, stanica uključenih u razgradnju koštanog tkiva.
English: Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Vantavo.
Croatian: Budući da bolesnice koje boluju od osteoporoze možda neće dobiti dovoljnu količinu vitamina D3 izlaganjem sunčevoj svjetlosti, ovaj je vitamin uključen u lijek Vantavo.
English: The additional studies showed that including vitamin D3 in the same tablet with alendronic acid could increase vitamin D levels.
Croatian: Dodatna su ispitivanja pokazala da uključivanje vitamina D3 u istu tabletu s alendronatnom kiselinom može povećati koncentraciju vitamina D.
English: The European Commission granted a marketing authorisation valid throughout the EU for Alendronate Sodium And Colecalciferol, MSD on 16 October 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Alendronate Sodium And Kolekalciferol, MSD na snazi u Europskoj uniji od 16. listopada 2009.
English: It is intended for long-term use.
Croatian: Lijek je indiciran za dugoročnu primjenu.
English: What is the risk associated with Vantavo?
Croatian: Koji su rizici povezani s lijekom Vantavo?
English: The CHMP decided that Vantavo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Vantavo nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The most common side effects with Vantavo include abdominal pain (stomach ache), dyspepsia (heartburn), oesophageal (gullet) ulcers, dysphagia (difficulty swallowing), abdominal distension (swollen tummy) and acid regurgitation.
Croatian: Najčešće nuspojave lijeka Vantavo uključuju abdominalnu bol (bol u želucu), dispepsiju (žgaravicu), ezofagealne ulkuse (ulkuse jednjaka), disfagiju (poteškoće pri gutanju), abdominalnu distenziju (nateknuti želudac) i regurgitaciju želučane kiseline.
English: 1 Previously known as Alendronate Sodium And Colecalciferol, MSD.
Croatian: 1 Ranije poznat pod nazivima Alendronate Sodium And Colecalciferol, MSD.
English: It is available as tablets (70 mg alendronic acid and 2,800 international units [IU] colecalciferol; 70 mg alendronic acid and 5,600 IU colecalciferol).
Croatian: Dostupan je u tabletama (70 mg alendronatne kiseline i 2 800 međunarodnih jedinica [IU] kolekalciferola; 70 mg alendronatne kiseline i 5 600 IU kolekalciferola).
English: The main measure of effectiveness was the reduction in the number of patients with low vitamin D levels after 15 weeks.
Croatian: Glavna mjera djelotvornosti bilo je smanjenje broja bolesnica s niskim koncentracijama vitamina
English: Vantavo (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels.
Croatian: Vantavo (sadrži 2 800 ili 5 600 IU kolekalciferola) koristi se za liječenje osteoporoze (bolesti koja čini kosti lomljivima) u žena u postmenopauzi i s rizikom od nedostatka vitamina D.
English: This document is a summary of the European Public Assessment Report (EPAR) for Vantavo.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Vantavo.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vantavo, 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 Vantavo nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnice trebaju pridržavati.
English: To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Vantavo's ability to increase vitamin D levels.
Croatian: U prilog primjeni kombinacije alendronatne kiseline i vitamina D3 u istoj tableti, tvrtka je također provela ispitivanje u 717 bolesnica s osteoporozom, uključujući 682 žena u postmenopauzi kako bi dokazala sposobnost lijeka Vantavo povećanja koncentracija vitamina D.
English: Blocking the action of these cells leads to less bone loss.
Croatian: Inhibirajući djelovanje ovih stanica usporava gubitak kostiju.
English: What is Vantavo?
Croatian: Što je Vantavo?
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.
Croatian: Osteoporoza je češća u žena u postmenopauzi, kada se razine ženskog hormona estrogena snižavaju.
English: Patients received either Vantavo 70 mg/2,800 IU or alendronic acid only once a week.
Croatian: Bolesnice su primale Vantavo jačine 70 mg/2 800 IU ili alendronatnu kiselinu samo jednom tjedno.
English: Vantavo 70 mg/5,600 IU is for use in patients who are not taking vitamin D supplements.
Croatian: Vantavo 70 mg/5 600 IU indiciran je za primjenu u bolesnica koji ne uzimaju dovoljne količine vitamina D.
English: This study was extended in 652 patients for a further 24 weeks to compare the effects of continuing with Vantavo 70 mg/2,800 IU on its own or adding 2,800 IU vitamin D3 (equivalent to using Vantavo 70 mg/5,600 IU).
Croatian: Ovo je ispitivanje također prošireno na 652 bolesnica tijekom daljnja 24 tjedan kako bi se usporedilo djelovanje nastavka terapije s Vantavo 70 mg/2 800 IU kao monoterapije ili dodavanjem 2 800 IU vitamina D3 (ekvivalenta primjene lijeka Vantavo 70 mg/5 600 IU).
English: In the extension study, similar numbers of patients taking Vantavo 70 mg/2,800 IU and Vantavo 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Vantavo 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.
Croatian: U proširenom ispitivanju, sličan broj bolesnica koje su uzimale lijekove Vantavo od 70 mg/2 800 IU i Vantavo 70 mg/5 600 IU imalo je nisku koncentraciju vitamina D (nižu od 6%), no bolesnice koje su uzimale lijek Vantavo 70 mg/5 600 IU imale su veće povećanje u koncentracijama vitamina
English: Vantavo is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Croatian: Vantavo je lijek koji sadrži dvije djelatne tvari: alendronatnu kiselinu i kolekalciferol (vitamin D3).
English: Vantavo contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Croatian: Vantavo sadrži dvije djelatne tvari: alendronatnu kiselinu i kolekalciferol (vitamin D3).
English: What is Vantavo used for?
Croatian: Za što se Vantavo koristi?
English: Vantavo alendronic acid and colecalciferol
Croatian: alendronatna kiselina i kolekalciferol
English: Patients should also take calcium supplements if they are not getting enough calcium from their diet. For more information, see the package leaflet.
Croatian: Bolesnice moraju uzimati dodatne količine kalcija ukoliko je unos hranom nedovoljan.
English: What benefit has Vantavo shown during the studies?
Croatian: Koje su koristi lijeka Vantavo utvrđene u ispitivanjima?
English: For the full list of all side effects reported with Vantavo, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Vantavo potražite u uputi o lijeku.
English: How is Vantavo used?
Croatian: Kako se Vantavo koristi?
English: How has Vantavo been studied?
Croatian: Kako je Vantavo ispitivan?
English: How does Vantavo work?
Croatian: Kako djeluje Vantavo?
English: After 15 weeks, fewer patients had low vitamin D levels when they took Vantavo 70 mg/2,800 IU (11%) than when they took alendronic acid only (32%).
Croatian: D ako su uzimali Vantavo 70 mg/2 800 IU (11%) u odnosu na monoterapiju alendronatnom kiselinom (32%).
English: Further information on Keytruda can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/keytruda.
Croatian: Više informacija o lijeku Keytruda dostupno je na internetskim stranicama Agencije:ema.europa.eu/medicines/human/EPAR/keytruda.
English: When it is given with other cancer medicines, the dose is always 200 mg every three weeks.
Croatian: Kada se daje s drugim lijekovima protiv raka, doza je uvijek 200 mg svaka tri tjedna.
English: What is Keytruda and what is it used for?
Croatian: Što je Keytruda i za što se koristi?
English: Keytruda received a marketing authorisation valid throughout the EU on 17 July 2015.
Croatian: Lijek Keytruda dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 17. srpnja 2015.
English: The medicine can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in the treatment of cancer.
Croatian: Lijek se izdaje samo na recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju raka.
English: Keytruda can delay worsening of melanoma and improve survival.
Croatian: Keytruda može odgoditi pogoršanje melanoma i poboljšati preživljenje.
English: What measures are being taken to ensure the safe and effective use of Keytruda?
Croatian: Koje se mjere poduzimaju da bi se osigurala sigurna i učinkovita primjena lijeka Keytruda?
English: The average time that patients lived without their disease getting worse again was around 11 months.
Croatian: Prosječno trajanje razdoblja tijekom kojega su bolesnici živjeli bez ponovnog pogoršanja bolesti bilo je oko 11 mjeseci.
English: In addition, the company will provide the final results of studies with Keytruda to confirm the longterm benefits of the medicine.
Croatian: Osim toga, tvrtka će dostaviti konačne rezultate ispitivanja provedenih s lijekom Keytruda kako bi potvrdila dugoročnu korist od lijeka.
English: The company that markets Keytruda will provide patients with an information pack and alert card to inform them about the risks of potential immune-related side effects and give instructions on when to contact their doctor if they experience symptoms.
Croatian: Tvrtka koja stavlja lijek Keytruda u promet osigurat će bolesnicima informativni paket i karticu s upozorenjima, u kojima će ih obavijestiti o rizicima od potencijalnih nuspojava povezanih s imunosnim sustavom i dati upute o tome kada se obratiti liječniku ako dođe do nuspojava.
English: Keytruda is mainly used for cancers that are advanced, have spread to other parts of the body (metastatic) or are not responding to other treatments.
Croatian: Keytruda se uglavnom koristi za liječenje raka koji je uznapredovao, proširio se na druge dijelove tijela (metastazirao) ili ne reagira na druge terapije.
English: When Keytruda is given alone the dose is either 200 mg every three weeks or 400 mg every six weeks.
Croatian: Kada se Keytruda daje kao monoterapija, doza je 200 mg svaka tri tjedna ili 400 mg svakih šest tjedana.
English: The doctor may delay doses if certain side effects occur or stop treatment altogether if side effects are severe.
Croatian: Liječnik može odgoditi primjenu doze ako nastupe određene nuspojave ili u potpunosti prekinuti terapiju ako su nuspojave teške.
English: The European Medicines Agency decided that Keytruda'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 od lijeka Keytruda nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Side effects reported with Keytruda are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Keytruda pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Keytruda 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 Keytruda također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: Some cancers can make a protein (PD-L1) that combines with PD-1 to switch off the activity of certain cells of the immune system (the body's natural defences) preventing them from attacking the cancer.
Croatian: Neke vrste raka mogu proizvesti bjelančevinu (PD-L1) koja se kombinira s receptorom PD-1 i time prekida aktivnost određenih stanica imunosnog sustava (prirodne obrane tijela) te ih sprječava da napadnu rak.
English: By blocking PD-1, pembrolizumab stops the cancer switching off these immune cells, thereby increasing the immune system's ability to kill the cancer cells.
Croatian: Inhibirajući PD-1 pembrolizumab zaustavlja rak pri isključivanju tih imunosnih stanica i time povećava sposobnost imunosnog sustava da uništava stanice raka.
English: In some patients, tumours have to produce a high level of PD-L1 for the medicine to be effective.
Croatian: Kod nekih bolesnika tumori moraju proizvoditi visoke razine bjelančevine PD-L1 da bi lijek bio učinkovit.
English: Moreover, the company will carry out analyses to better understand which patients are likely to benefit most from treatment with Keytruda.
Croatian: Tvrtka će usto provesti i analize da bi se bolje razumjelo koji će bolesnici imati najveće koristi od terapije lijekom Keytruda.
English: Other information about Keytruda
Croatian: Ostale informacije o lijeku Keytruda
English: Keytruda partially or completely clears cancer cells in classical Hodgkin lymphoma that has not improved or had returned after treatment with brentuximab vedotin, with or without an autologous stem cell transplantation.
Croatian: Keytruda djelomično ili potpuno uništava stanice raka u slučaju klasičnog Hodgkinova limfoma kod kojeg nije vidljivo poboljšanje ili ako se bolest vratila nakon terapije brentuksimab vedotinom, uz autolognu transplantaciju matičnih stanica ili bez nje.
English: Keytruda did not delay worsening of the disease compared with the other cancer medicines (time to disease worsening was 2 and 3 months respectively).
Croatian: Lijek Keytruda nije odgodio pogoršanje bolesti u usporedbi s drugim lijekovima protiv raka (razdoblje do pogoršanja bolesti trajalo je dva, odnosno tri mjeseca).
English: Why is Keytruda authorised in the EU?
Croatian: Zašto je lijek Keytruda odobren u EU-u?
English: What are the risks associated with Keytruda?
Croatian: Koji su rizici povezani s lijekom Keytruda?
English: An overview of Keytruda and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Keytruda i zašto je odobren u EU-u
English: As for all medicines, data on the use of Keytruda are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Keytruda kontinuirano se prate.
English: At 18 months, 81% of the patients given the combination were alive, compared with 71% in the sunitinib group.
Croatian: Nakon 18 mjeseci 81 % bolesnika koji su primali kombinaciju tih lijekova bilo je još živo, u usporedbi sa 71 % bolesnika u skupini koja je primala sunitinib.
English: Keytruda is given as an infusion (drip) into a vein.
Croatian: Keytruda se daje intravenskom infuzijom (ukapavanjem).
English: A study looked at 542 patients previously treated with platinum-based medicines who received either Keytruda or another cancer medicine chosen by the doctor (paclitaxel, docetaxel or vinflunine).
Croatian: Ispitivanje je obuhvatilo 542 bolesnika prethodno liječena lijekovima na bazi platine, koji su primali lijek Keytruda ili drugi lijek protiv raka prema izboru liječnika (paklitaksel, docetaksel ili vinflunin).
English: A third study in 1,019 patients who had had surgery and who were at high risk for their cancer coming back compared Keytruda to placebo (a dummy treatment).
Croatian: U trećem ispitivanju na 1 019 bolesnika koji su imali kirurški zahvat i koji su bili izloženi velikom riziku od povratka raka, lijek Keytruda uspoređen je s placebom (prividnim liječenjem).
English: Keytruda is also effective in combination treatment of a type of NSCLC known as ‘non-squamous' cancer, based on the type of cancer cells involved.
Croatian: Lijek Keytruda učinkovit je i u kombiniranom liječenju vrste raka pluća nemalih stanica koji se naziva „neskvamozni” rak na temelju vrste prisutnih stanica raka.