FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Capecitabine SUN is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Xeloda.
Croatian: Budući da je Kapecitabin SUN generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje da je lijek bioekvivalentan referentnom lijeku, Xeloda.
English: Full details are available in the summary of product characteristics (also part of the EPAR).
Croatian: Više detalja dostupno je u sažetku opisa svojstva lijeka (također dio EPAR-a).
English: Capecitabine SUN
Croatian: Kapecitabin SUN
English: As a result, it blocks the growth of tumour cells and eventually kills them.
Croatian: Rezultat toga je da 5-FU blokira rast stanica tumora te ih naposljetku uzrokuje smrt stanica.
English: Capecitabine SUN is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Croatian: Kapecitabin SUN koristi se u kombinaciji s docetakselom (drugim antikancerogenim lijekom) nakon neuspješne terapije antraciklinima (drugi tip antikancerogenog lijeka).
English: • colon (large bowel) cancer.
Croatian: • karcinoma kolona (debelog crijeva).
English: Capecitabine SUN is an anticancer medicine that contains the active substance capecitabine.
Croatian: Kapecitabin SUN je antikancerogeni lijek koji sadrži djelatnu tvar kapecitabin.
English: Why has Capecitabine SUN been approved?
Croatian: Zašto je Kapecitabin SUN odobren?
English: Capecitabine SUN is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Croatian: Kapecitabin SUN koristi se za kombiniranu terapiju zajedno s drugim antikancerogenim lijekovima, uključujući antikancerogene lijekove koji sadrže platinu, poput cisplatina;
English: It can also be used on its own when treatment with both anthracyclines and taxanes (another type of anticancer medicine) has failed or when repeat treatment with anthracyclines is not suitable for the patient.
Croatian: Kapecitabin SUN može se koristiti za monoterapiju ako liječenja antraciklinima i taksanima (drugi tip antikancerogenog lijeka) nisu bila uspješna ili ako ponovljeno liječenje antraciklinima nije primjereno za bolesnika.
English: The active substance in Capecitabine SUN, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Croatian: Djelatna tvar Kapecitabina SUN, kapecitabin, citotoksičan je lijek (lijek koji uzrokuje smrt stanica koje se dijele, poput stanica karcinoma), a ubraja se u grupu „antimetabolitika”.
English: Capecitabine SUN is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Croatian: Kapecitabin SUN koristi se za kombiniranu terapiju zajedno s drugim antikancerogenim lijekovima ili monoterapiju u bolesnika nakon operacije karcinoma debelog crijeva „stadija III” ili „stadij C” prema Dukesovoj klasifikaciji;
English: How does Capecitabine SUN work?
Croatian: Kako djeluje Kapecitabin SUN?
English: How is Capecitabine SUN used?
Croatian: Kako se Kapecitabin SUN koristi?
English: Capecitabine SUN is used with or without other anticancer medicines;
Croatian: Kapecitabin SUN koristi se za kombiniranu terapiju zajedno s drugim antikancerogenim lijekovima ili monoterapiju;
English: How has Capecitabine SUN been studied?
Croatian: Kako se Kapecitabin SUN ispitivao?
English: 31 March 2016
Croatian: 31. ožujka 2016.
English: This section should also include literature case reports and review.
Croatian: Ovaj dio treba uključivati izvješća i pregled slučajeva iz literature.
English: • submit the PSUR within 90 days following the DLP of 31 December
Croatian: • dostaviti PSUR u roku od 90 dana nakon DLP-a od 31. prosinca 2015.
English: Furthermore the discussion on the adverse events in this group should be compared with the pattern of adverse events in other age groups.
Croatian: Nadalje, rasprava o nuspojavama u toj skupini treba se usporediti s obrascem nuspojava u drugim dobnim skupinama.
English: • discuss the usage in elderly, taking into account the naturally lower level of testosterone in this age group of patients.
Croatian: • raspraviti primjenu u starijih osoba, uzimajući u obzir prirodno niže razine testosterona u toj dobnoj skupini bolesnika.
English: The spontaneous reports shall not be presented as a listing of the individual cases, but rather as a general discussion of the aggregated cases, and include all relevant information, e.g. time to onset (when available), haematocrit/haemoglobin level (when available), indication, age, confounding factors and other.
Croatian: Spontana izvješća ne dostavljaju se kao popis individualnih slučajeva, već kao općenita rasprava agregiranih slučajeva, te uključuju sve relevantne informacije, primjerice vrijeme do nastupanja (ako je dostupno), razine hematokrita/ hemoglobina (ako je dostupno), indikaciju, dob, doprinoseće čimbenike i drugo.
English: • monitor cardiovascular risk (including literature review, clinical trials data and all other relevant data) and discuss the finding in the next PSUR.
Croatian: • pratiti kardiovaskularni rizik (uključujući i pregled literature, podatke o kliničkim ispitivanjima i sve druge relevantne podatke) i raspraviti nalaze u sljedećem PSUR-u.
English: National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Croatian: Nadležna državna tijela države(a) članice(a) ili referentne(ih) države(a) članice(a), gdje je to primjenjivo, osigurati će ispunjavanje sljedećih uvjeta od strane nositelja odobrenja:
English: Annex IV Conditions to the marketing authorisations
Croatian: Dodatak IV Uvjeti odobrenja za stavljanje lijeka u promet
English: • report on venous thrombolic events (VTE) including deep venous thrombosis (VTE) and pulmonary embolism (PE) in a separate section in the next PSUR.
Croatian: • izvijestiti o vensko trombotičkim događajima (VTE) uključujući duboku vensku trombozu (VTE) i pulmonalnu emboliju (PE) u zasebnim dijelovima sljedećeg PSUR-a.
English: The Marketing Authorisation Holders of testosterone-containing medicinal products should, with the next PSUR:
Croatian: Nositelji odobrenja stavljanje u promet lijeka koji sadrži testosteron trebaju sa sljedećim PSUR-om:
English: • discuss a possible mechanism of VTE and the potential association between CV/VTE events and testosterone levels (whether low or high levels compared to eugonadal level may contribute to the risk), and discuss if the information should be included in the product information.
Croatian: • raspraviti mogući mehanizam VTE-a i potencijalne veze između događaja CV-a/VTE-a i razine testosterona (može doprinijeti riziku bez obzira je li riječ o niskim ili visokim razinama u usporedbi s eugonadnim razinama) i raspraviti trebaju li se te informacije uključiti u informacije o lijeku.
English: The effect of each infusion lasts for a year or more.
Croatian: Djelovanje svake infuzije traje otprilike godinu dana ili dulje.
English: This summary was last updated in 03-2014.
Croatian: Sažetak je posljednji put obnovljen 03.2014.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila taj lijek da bi preporučila njegovo odobrenje u EU-u te uvjete za njegovu primjenu.
English: Gradually, the bones become thin and fragile, and more likely to fracture.
Croatian: Kosti postepeno postaju tanje i krhkije, te su frakture izglednije.
English: In Paget's disease, the bone breaks down more quickly, and when it grows back, it is weaker than normal.
Croatian: U slučaju Pagetove bolesti, kosti pucaju brže, a kada ponovno narastu slabije su od normalnih.
English: This leads to less bone loss in osteoporosis and less disease activity in Paget's disease.
Croatian: Ovo uzrokuje manji gubitak kosti u slučaju osteoporoze i manju aktivnost bolesti u slučaju Pagetove bolesti.
English: Patients must have adequate fluids before and after treatment, and should receive adequate supplements of vitamin D and calcium.
Croatian: Bolesnici moraju primati odgovarajuće količine tekućina prije i nakon liječenja te trebaju primati odgovarajuće nadomjeske vitamina D i kalcija.
English: This can be repeated once a year in patients being treated for osteoporosis.
Croatian: Infuzija se može ponoviti jednom godišnje u bolesnika koji se liječe od osteoporoze.
English: The full EPAR and risk management plan summary for Zoledronic acid Teva Generics can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za zoledronatnu kiselinu Teva Generics može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a disease where the normal process of bone growth is altered.
Croatian: Ovo je bolest u slučaju koje je izmijenjen normalan postupak rasta kostiju.
English: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Croatian: Osteoporoza nastupa kada ne raste dovoljna količina nove kosti koja bi zamijenila prirodno puknutu kost.
English: It is used in patients who are at risk of fractures (broken bones) and in patients whose osteoporosis is linked to long-term treatment with glucocorticoids (a type of steroid).
Croatian: Koristi se u bolesnika koji su izloženi riziku od fraktura (slomljenih kostiju) i u bolesnika čija je osteoporoza povezana s dugotrajnom terapijom glukokortikoida (tipom steroida).
English: It is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men.
Croatian: Koristi se za liječenje osteoporoze (bolesti koja čini kosti lomljivima) u žena koje su prošle menopauzu i u muškaraca.
English: In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall.
Croatian: Osteoporoza je češća u žena nakon menopauze, kada se razine ženskog hormona estrogena snižavaju.
English: It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Croatian: Zaustavlja djelovanje osteoklasta, stanica u tijelu koje su uključene u razgradnju koštanog tkiva.
English: Zoledronic acid Teva Generics is given as an infusion lasting at least 15 minutes.
Croatian: Zoledronatna kiselina Teva Generics primjenjuje se kao infuzija koja traje najmanje 15 minuta.
English: Zoledronic acid Teva Generics is also used to treat Paget's disease of the bone in adults.
Croatian: Zoledronatna kiselina Teva Generics koristi se također za liječenje Pagetove bolesti kostiju u odraslih osoba.
English: This means that Zoledronic acid Teva Generics is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aclasta.
Croatian: To znači da je zoledronatna kiselina Teva Generics sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) naziva Aclasta.
English: Osteoporosis can also occur in both sexes as a side effect of glucocorticoid treatment.
Croatian: Osteoporoza može također nastupiti u oba spola kao nuspojava liječenja glukokorticoidom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Teva Generics on 27 March 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za zoledronatnu kiselinu Teva Generics vrijedi na prostoru Europske unije od 27. ožujka 2014.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Teva Generics.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za zoledronatnu kiselinu Teva Generics.
English: No additional studies were needed as Zoledronic acid Teva Generics is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Aclasta.
Croatian: Nisu bila potrebna dodatna ispitivanja budući da je zoledronatna kiselina Teva Generics generički lijek koji se primjenjuje infuzijom i sadrži istu djelatnu tvar kao i referentni lijek, Aclasta.
English: In the treatment of Paget's disease, Zoledronic acid Teva Generics must only be used by a doctor who has experience in the treatment of the disease.
Croatian: Za potrebe liječenja Pagetove bolesti, zoledronatnu kiselinu Teva Generics smije primjenjivati samo liječnik koji ima iskustva u liječenju ove bolesti.
English: Zoledronic acid Teva Generics is a medicine that contains zoledronic acid (5mg).
Croatian: Zoledronatna kiselina Teva Generics je lijek koji sadrži zoledronatnu kiselinu (5mg).
English: Zoledronic acid Teva Generics is available as a solution for infusion (drip) into a vein; the medicine can only be obtained with a prescription.
Croatian: Zoledronatna kiselina Teva Generics dostupna je kao otopina za infuziju (drip) u venu; ovaj se lijek izdaje samo na liječnički recept.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva Generics, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za zoledronatnu kiselinu Teva Generics uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za referenti lijek može se naći na internetskim stranicama Agencije.
English: For more information on generic medicines, see the question-and-answer document here.
Croatian: Više informacija o biosličnim lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zoledronic acid Teva Generics has been shown to be comparable to Aclasta.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je da je zoledronatna kiselina Teva Generics dokazano usporediva lijeku Aclasta u skladu sa zahtjevima EU.
English: For more information about treatment with Zoledronic acid Teva Generics, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju zoledronatnom kiselinom Teva Generics pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Because Zoledronic acid Teva Generics is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je zoledronatna kiselina Teva Generics generički lijek, smatra se da su koristi i rizici od ovog lijeka isti kao oni referentnog lijeka.
English: What are the benefits and risks of Zoledronic acid Teva Generics?
Croatian: Koje su koristi i rizici povezani sa zoledronatnom kiselinom Teva Generics?
English: What measures are being taken to ensure the safe and effective use of Zoledronic acid Teva Generics?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena zoledronatne kiseline Teva Generics?
English: It is not intended to provide practical advice on how to use Zoledronic acid Teva Generics.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Zoledronatna kiselina Teva Generics.
English: A risk management plan has been developed to ensure that Zoledronic acid Teva Generics is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena zoledronatne kiseline Teva Generics.
English: Zoledronic acid Teva Generics zoledronic acid
Croatian: Zoledronatna kiselina Teva Generics zoledronatna kiselina
English: Zoledronic acid Teva Generics is a ‘generic medicine'.
Croatian: Zoledronatna kiselina Teva Generics je „generički lijek”.
English: Other information about Zoledronic acid Teva Generics
Croatian: Ostale informacije o zoledronatnoj kiselini Teva Generics
English: What is Zoledronic acid Teva Generics and what is it used for?
Croatian: Što je zoledronatna kiselina Teva Generics i za što se koristi?
English: Zoledronic acid Teva Generics is usually given, but additional infusions can be considered if the patient's disease comes back.
Croatian: Za potrebe liječenja Pagetove bolesti, uobičajena je samo jedna infuzija zoledronatne kiseline Teva Generics, no dodatne se infuzije mogu uzeti u obzir ako se bolest bolesnika ponovno pojavi.
English: The active substance in Zoledronic acid Teva Generics, zoledronic acid, is a bisphosphonate.
Croatian: Djelatna tvar u lijeku Zoledronatna kiselina Teva Generics, zoledronatna kiselina, je bifosfonat.
English: For practical information about using Zoledronic acid Teva Generics, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju zoledronatne kiseline Teva Generics pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Why is Zoledronic acid Teva Generics approved?
Croatian: Zašto je zoledronatna kiselina Teva Generics odobrena?
English: How does Zoledronic acid Teva Generics work?
Croatian: Kako djeluje zoledronatna kiselina Teva Generics?
English: How has Zoledronic acid Teva Generics been studied?
Croatian: Kako se ispitivala zoledronatna kiselina Teva Generics?
English: How is Zoledronic acid Teva Generics used?
Croatian: Kako se zoledronatna kiselina Teva Generics koristi?
English: Therefore, the CHMP's view was that, as for Aclasta, the benefit outweighs the identified risk.
Croatian: Stoga je CHMP mišljenja da, kao i u slučaju lijeka Aclasta, koristi od lijeka Zoledronatna kiselina Teva Generics nadmašuju s njim povezane rizike i preporučilo je njegovo odobrenje za korištenje u Europskoj uniji.
English: Median (90% Prediction Interval)*
Croatian: Medijan (90%-tni interval predviđanja)*
English: The relative importance of these pathways is unknown.
Croatian: Relativna važnost tih putova nije poznata.
English: • Take it with or without food.
Croatian: • Možete ga uzeti s hranom ili bez nje.
English: CMV is a virus that a lot of people have without knowing.
Croatian: CMV je virus koji mnogi ljudi imaju, a da toga nisu ni svjesni.
English: Take your next dose at the usual time.
Croatian: Uzmite sljedeću dozu u uobičajeno vrijeme.
English: • you take either of these medicines:
Croatian: • ako uzimate bilo koji od ovih lijekova:
English: Normally, CMV just stays in their body and it does not hurt them.
Croatian: CMV se obično samo zadržava u tijelu i ne uzrokuje nikakvu štetu.
English: (The net effect is not known).
Croatian: (Neto učinak nije poznat.)
English: Each vial is packaged in a carton.
Croatian: Svaka je bočica pakirana u kutiju.
English: If you experience any of these effects, do not drive or use machines until the effect wears off.
Croatian: Ako se pojavi bilo koji od tih učinaka, nemojte upravljati vozilima niti raditi sa strojevima dok se ti učinci ne povuku.
English: The categories of failure are mutually exclusive and based on the hierarchy of categories in the order listed.
Croatian: Kategorije neuspjeha međusobno su isključive, a temelje se na hijerarhiji kategorija prema navedenom redoslijedu.
English: Haploidentical donor
Croatian: Haploidentičan donor
English: # (see section 4.4).
Croatian: # (vidjeti dio 4.4).
English: Parameter n (%)
Croatian: Parametar n (%)
English: PREVYMIS is not for use in children and adolescents under 18 years old.
Croatian: PREVYMIS nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
English: • Take PREVYMIS at the same time every day.
Croatian: • Uzmite PREVYMIS svakoga dana u isto vrijeme.
English: Immunosuppressive Regimen
Croatian: Imunosupresivni režim
English: The tablet should be swallowed whole and may be taken with or without food.
Croatian: Tabletu treba progutati cijelu, a može se uzeti s hranom ili bez nje.
English: General information
Croatian: Opće informacije
English: 2220 Heist-op-den-Berg
Croatian: 2220 Heist-op-den-Berg BELGIJA
English: Additional blood tests may be needed to monitor the following medicinal products:
Croatian: Možda će biti potrebne dodatne krvne pretrage za praćenje razina sljedećih lijekova:
English: You will get PREVYMIS once a day.
Croatian: PREVYMIS ćete primati jedanput na dan.
English: What PREVYMIS is and what it is used for 2.
Croatian: Što je PREVYMIS i za što se koristi 2.
English: The full induction effect can be expected after 10-14 days of letermovir treatment.
Croatian: Puni indukcijski učinak može se očekivati nakon 10 - 14 dana liječenja letermovirom.
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) or very rare (< 1/10,000).
Croatian: Učestalost je definirana kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) ili vrlo rijetko (< 1/10 000).
English: Also tell your doctor if you are taking any of the following medicines.
Croatian: Isto tako, obavijestite svog liječnika ako uzimate neki od sljedećih lijekova.
English: Opioid agonists Examples: alfentanil, fentanyl
Croatian: Opioidni agonisti Primjeri: alfentanil, fentanil
English: EC50 values for these mutations are 13- to 8,262-fold higher than those for the wild-type reference virus.
Croatian: Vrijednosti EC50 za te mutacije su 13 do 8262 puta veće od onih za referentni virus divljeg tipa.
English: You will get PREVYMIS as an infusion (drip) into a vein and it will take about 1 hour.
Croatian: PREVYMIS ćete primiti kao infuziju (drip) u venu, a primjena će trajati približno 1 sat.
English: The inter-individual variability for CL is estimated to be 24.6%.
Croatian: Procijenjena interindividualna varijabilnost klirensa iznosi 24,6%.
English: The potential interaction between letermovir and these medicinal products have not been investigated.
Croatian: Moguće interakcije između letermovira i tih lijekova nisu ispitane.
English: Cross-resistance is not likely with medicinal products with a different mechanism of action.
Croatian: Nije vjerojatna križna rezistencija s lijekovima koji imaju drugačiji mehanizam djelovanja.
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 25 °C and for 48 hours at 2 to 8 °C.
Croatian: Dokazana je kemijska i fizikalna stabilnost pripremljenog lijeka tijekom 48 sati na temperaturi od 25°C te tijekom 48 sati na temperaturi od 2°C do 8°C.
English: Effect on concentration Mean ratio (90 % confidence interval) for AUC, Cmax (likely mechanism of action)
Croatian: Učinak na koncentraciju Omjer srednjih vrijednosti (90%-tni interval pouzdanosti) za AUC, Cmax (vjerojatan mehanizam djelovanja)
English: • you are allergic to letermovir or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na letermovir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: • If you are not sure what to do, call your doctor or pharmacist.
Croatian: • Ako niste sigurni što učiniti, nazovite svog liječnika ili ljekarnika.
English: The median time to starting letermovir was 9 days after transplantation.
Croatian: Medijan vremena do početka liječenja letermovirom bio je 9 dana nakon transplantacije.
English: The net effect in vivo on the other listed enzymes and transporters is not known.
Croatian: Neto učinak in vivo na druge navedene enzime i prijenosnike nije poznat.
English: Difference (95% CI) p-value
Croatian: Razlika (95% CI) p-vrijednost