FrancophonIA/ELRC3.0 huggingface dataset:
English: Torisel is available as a concentrate and solvent that are made up into a solution for infusion (drip) into a vein.
Croatian: Lijek Torisel dostupan je kao koncentrat i otapalo za pripremu otopine za infuziju (drip) u venu.
English: How does Torisel work?
Croatian: Kako djeluje Torisel?
English: In advanced renal cell carcinoma, a main study involving 626 patients with poor prognosis found Torisel more effective than interferon alfa (another medicine used in the treatment of cancer) at prolonging patients' survival.
Croatian: Kod uznapredovalog raka bubrežnih stanica, u glavnom ispitivanju koje je obuhvatilo 626 bolesnika s lošim prognozama utvrđeno je da je Torisel djelotvorniji od interferona alfa (drugog lijeka protiv raka) u produljenju preživljenja bolesnika.
English: An overview of Torisel and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Torisel i razlozima njegova odobrenja u EU-u
English: In mantle cell lymphoma, Torisel was found more effective than alternative cancer medicines (such as gemcitabine or fludarabine) in a main study involving 162 patients whose disease had come back after previous treatment or in whom other treatments had not worked.
Croatian: Kod limfoma plaštenih stanica utvrđeno je da je lijek Torisel djelotvorniji od drugih lijekova protiv raka(kao što su gemcitabin ili fludarabin) u jednom glavnom ispitivanju koje je obuhvatilo 162 bolesnika čija se bolest vratila nakon prethodne terapije ili u kojih druge terapije nisu djelovale.
English: The most serious side effects of Torisel are allergic (hypersensitivity) reactions, serious reactions that occur during the infusion or soon afterwards, infections, lung disorders including pneumonitis (inflammation of the lungs) and pulmonary embolism (blood clot in the lung), bleeding in the brain, kidney failure, tearing (perforation) of the intestine, complications affecting the healing of wounds, hyperglycaemia (high blood sugar), thrombocytopenia (low levels of platelets), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and hyperlipaemia (high blood levels of a type of fat).
Croatian: Ozbiljne nuspojave lijeka Torisel jesu alergijske reakcije (reakcije preosjetljivosti), ozbiljne reakcije koje se javljaju tijekom infuzije ili nedugo nakon nje, infekcije, poremećaji funkcije pluća, uključujući pneumonitis (upalu pluća) i plućnu emboliju (krvni ugrušak u plućima), krvarenje u mozgu, zatajenje bubrega, laceracija (perforacija) crijeva, komplikacije pri zacjeljivanju rana, hiperglikemija (visoka razina šećera u krvi), trombocitopenija (niska razina krvnih pločica), neutropenija (niska razina neutrofila, vrste bijelih krvnih stanica koje se bore protiv infekcije) i hiperlipemija (visoka razina vrste masnoće u krvi).
English: What benefits of Torisel have been shown in studies?
Croatian: Koje su koristi od lijeka Torisel utvrđene u ispitivanjima?
English: • advanced renal cell carcinoma (a kidney cancer).
Croatian: • uznapredovalog raka bubrežnih stanica (rak bubrega).
English: Patients receiving Torisel alone survived 10.9 months on average compared with 7.3 months in those receiving interferon alfa alone.
Croatian: Bolesnici koji su primali lijek Torisel kao monoterapiju u prosjeku su živjeli 10,9 mjeseci u usporedbi s 7,3 mjeseci u bolesnika koji su primali interferon alfu kao monoterapiju.
English: Patients receiving the lower dose of Torisel in combination with interferon alfa survived for a similar time (8.4 months) as those taking interferon alfa alone.
Croatian: Razdoblje preživljenja u bolesnika koji su primali nižu dozu lijeka Torisel u kombinaciji s interferonom alfa bilo je slično (8,4 mjeseca) kao u bolesnika koji su primali interferon alfa kao monoterapiju.
English: The active substance in Torisel, temsirolimus blocks a protein called ‘mammalian target of rapamycin' (mTOR).
Croatian: Djelatna tvar lijeka Torisel, temsirolimus, lijek je protiv raka koji onemogućuje djelovanje bjelančevine naziva „ciljna molekula rapamicina u sisavaca” (mTOR).
English: For the full list of side effects of Torisel, see the package leaflet.
Croatian: Potpuni popis nuspojava lijeka Torisel potražite u uputi o lijeku.
English: Strength Pharmaceutical form
Croatian: Farmaceutski oblik Put primjene Unutarnje pakiranje
English: 4 vials + 4 ampoules
Croatian: 4 bočice + 4 ampule
English: 10 (10x 1+1) vials + ampoules (multi-pack)
Croatian: 10 (10x 1+1) bočica + ampula (višestruko pakiranje)
English: 10 (10x1) vials (multi-pack)
Croatian: 10 (10x1) bočica (višestruko pakiranje)
English: 1 vial + 1 ampoule
Croatian: 1 bočica + 1 ampula
English: 4 vials
Croatian: 4 bočice
English: The patients were treated for up to 23 months.
Croatian: Bolesnici su liječeni do najviše 23 mjeseca.
English: Forsteo teriparatide
Croatian: Forsteo teriparatid
English: This summary was last updated in 05-2016.
Croatian: Ovaj sažetak je posljednji put ažuriran u 05.2016.
English: The full EPAR for Forsteo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Forsteo nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Forsteo must not be used in children or in young adults whose bones are not yet fully mature, or during pregnancy or breastfeeding.
Croatian: Forsteo ne smiju uzimati djeca ili mlađe odrasle osobe čije kosti još nisu potpuno razvijene ili tijekom trudnoće ili dojenja.
English: Forsteo has been studied in three main studies.
Croatian: Forsteo je ispitivan u trima glavnim ispitivanjima.
English: It also reduced the risk of non-vertebral fractures by 62%, but did not reduce the risk of hip fractures.
Croatian: Također je smanjio rizik od nevertebralnih prijeloma za 62 %, ali nije smanjio rizik od prijeloma kuka.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Forsteo on 10 June 2003.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Forsteo na snazi u Europskoj uniji od 10. lipnja 2003.
English: • men who are at an increased risk of fractures;
Croatian: • u muškaraca s povećanim rizikom od prijeloma;
English: The main measure of effectiveness was the number of new vertebral fractures at the end of the study, although the study also looked at non-vertebral fractures.
Croatian: Glavna mjera učinkovitosti bio je broj novih vertebralnih prijeloma na kraju ispitivanja, iako su se ispitivanjem također proučavali nevertebralni prijelomi.
English: A user manual is available for the pen.
Croatian: Dostupan je priručnik za korisnike brizgalice.
English: What measures are being taken to ensure the safe and effective use of Forsteo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Forsteo?
English: What is the risk associated with Forsteo?
Croatian: Koji su rizici povezani s lijekom Forsteo?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Forsteo have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza koje zdravstveni djelatnici i bolesnici trebaju poštovati radi sigurne i učinkovite uporabe proizvoda Forsteo nalaze se u sažetku opisa svojstava proizvoda i u uputi o proizvodu.
English: The recommended dose is 20 micrograms of Forsteo given once a day as an injection under the skin of the thigh or abdomen (tummy).
Croatian: Preporučena doza je 20 mikrograma lijeka Forsteo jedanput na dan injekcijom ispod kože bedra ili abdomena (trbuha).
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 Forsteo.
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 Forsteo.
English: For more information about treatment with Forsteo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Forsteo pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: It is available as a solution for injection in prefilled pens (one 2.4 ml prefilled pen contains 600 micrograms of teriparatide).
Croatian: Dostupan je u obliku otopine za injekciju unaprijed napunjenim brizgalicama (jedna unaprijed napunjena brizgalica od 2,4 ml sadrži 600 mikrograma teriparatida).
English: Forsteo must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease.
Croatian: Forsteo ne smiju uzimati bolesnici koji boluju od drugih bolesti kostiju kao što su Pagetova bolest, rak kostiju ili metastaze u kostima (rak koji se proširio na kosti), u bolesnika koji su liječeni zračenjem koje obuhvaća kosti ili u bolesnika koji boluju od hiperkalcemije (visoka razina kalcija u krvi), u bolesnika s neobjašnjeno visokim razinama alkalne fosfataze (enzim) ili teške bolesti bubrega.
English: This is a summary of the European public assessment report (EPAR) for Forsteo.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Forsteo.
English: The most common side effect with Forsteo (seen in more than 1 patient in 10) is pain in the arms or legs.
Croatian: Najčešća nuspojava lijeka Forsteo (uočena u više od 1 na 10 osoba) je bol u rukama ili nogama.
English: The CHMP concluded that Forsteo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je zaključio da koristi od lijeka Forsteo nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Other information about Forsteo
Croatian: Ostale informacije o lijeku Forsteo
English: Forsteo is used for the treatment of osteoporosis (a disease that makes bones fragile) in the following groups:
Croatian: Forsteo se koristi za liječenje osteoporoze (bolesti koja kosti čini krhkima) u sljedećih skupina:
English: In the study in men, Forsteo increased bone density in the spine by about 6% after an average of almost 12 months.
Croatian: U ispitivanju koje je obuhvaćalo muškarce Forsteo je povećao gustoću kostiju kralježnice za otprilike 6 % nakon prosječno gotovo 12 mjeseci.
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 terapije glukokortikoidima.
English: The studies also showed that the benefits of Forsteo treatment continued to increase for up to two years, with further increases in bone density.
Croatian: Ispitivanjima je također pokazano da su se koristi liječenja lijekom Forsteo nastavile povećavati do najviše dvije godine uz dodatna povećanja gustoće kostiju.
English: Forsteo reduced the risk of developing a new vertebral fracture over 19 months by 65% compared with placebo.
Croatian: Forsteo je smanjio rizik od nastanka novog vertebralnog prijeloma tijekom 19 mjeseci za 65 % u usporedbi s placebom.
English: What is Forsteo used for?
Croatian: Za što se Forsteo koristi?
English: The first study involved 1,637 women with osteoporosis who had been through the menopause (average age: 69.5 years), in which Forsteo was compared with placebo (a dummy treatment) for an average of 19 months.
Croatian: Prvim je ispitivanjem obuhvaćeno 1 637 žena s osteoporozom koje su bile u postmenopauzi (prosječna dob: 69,5 godina), u kojem je Forsteo uspoređivan s placebom (prividno liječenje) tijekom otprilike 19 mjeseci.
English: Why has Forsteo been approved?
Croatian: Zašto je lijek Forsteo odobren?
English: What is Forsteo?
Croatian: Što je Forsteo?
English: • men and women who are at an increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid).
Croatian: • u muškaraca i žena s povećanim rizikom od prijeloma zbog dugotrajne terapije glukokortikoidima
English: Forsteo was more effective than placebo in reducing vertebral fractures: 5% of the women who received Forsteo had a new fracture during the study, compared with 14% in the group who received placebo.
Croatian: Forsteo je bio djelotvorniji od placeba u smanjenju vertebralnih prijeloma: 5 % žena koje su primale lijek Forsteo imalo je novi prijelom tijekom ispitivanja, u usporedbi s 14 % u grupi koja je primala placebo.
English: The active substance in Forsteo, teriparatide, is identical to part of the human parathyroid hormone.
Croatian: Djelatna tvar u lijeku Forsteo, teriparatid, identična je dijelu humanog paratiroidnog hormona.
English: The study included 429 women and men who had osteoporosis and had been taking glucocorticoids for at least three months.
Croatian: Ispitivanjem je obuhvaćeno 429 žena i muškaraca s osteoporozom i koji su uzimali glukokortikoide tijekom posljednja tri mjeseca.
English: The third study compared the effects of Forsteo and alendronate (another medicine used to treat osteoporosis) on spine bone density over three years.
Croatian: U trećem su ispitivanju uspoređeni učinci lijeka Forsteo i alendronata (drugog lijeka koji se koristi za liječenje osteoporoze) na gustoću kosti kralježnice tijekom razdoblja od tri godine.
English: In the study of patients taking glucocorticoids, Forsteo was more effective than alendronate: after 18 months, patients receiving Forsteo had a 7% increase in bone density in the spine, compared with 3% in those receiving alendronate.
Croatian: U ispitivanju bolesnika koji su uzimali glukokortikoide, Forsteo je bio učinkovitiji od alendronata: bolesnici koji su primali Forsteo nakon 18 mjeseci imali su povećanje gustoće kostiju kralježnice od 7 % u usporedbi s 3 % u bolesnika koji su primali alendronat.
English: Forsteo is a medicine that contains the active substance teriparatide.
Croatian: Forsteo je lijek koji sadrži djelatnu tvar teriparatid.
English: The second study looked at the use of Forsteo in 437 men with osteoporosis, comparing its effect on the density of bones in the spine with that of placebo.
Croatian: U drugom je ispitivanju proučavana primjena lijeka Forsteo u 437 muškaraca s osteoporozom, uspoređujući učinak lijeka na gustoću kostiju u kralježnici s učinkom placeba.
English: What benefit has Forsteo shown during the studies?
Croatian: Koje su koristi lijeka Forsteo utvrđene u ispitivanjima?
English: An additional study looked at the effects of Forsteo on bone density over two years in 234 women who had been through the menopause.
Croatian: U dodatnom su ispitivanju tijekom dvije godine proučavani učinci lijeka Forsteo na gustoću kostiju u 234 žene u postmenopauzi.
English: Patients may inject themselves once they have been trained.
Croatian: Ako prođu odgovarajuću obuku, bolesnici si mogu samostalno injicirati lijek Forsteo.
English: • women who have been through the menopause.
Croatian: • u žena u postmenopauzi.
English: In these patients, Forsteo has been shown to significantly reduce vertebral (spine) and non-vertebral fractures (broken bones), but not those of the hip;
Croatian: (spinalne) i nevertebralne prijelome (slomljene kosti), no ne i prijelom kuka;
English: Only one two-year course of Forsteo should be given to a patient in their lifetime.
Croatian: Tijekom života bolesnik ne smije primiti više od jednog dvogodišnjeg ciklusa liječenja lijekom Forsteo.
English: For the full list of all side effects reported with Forsteo, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene pri primjeni lijeka Forsteo potražite u uputi o lijeku.
English: How does Forsteo work?
Croatian: Kako djeluje Forsteo?
English: Patients should receive calcium and vitamin D supplements if they do not get enough from their diet. Forsteo can be used for up to two years.
Croatian: Bolesnici trebaju primati nadomjeske kalcija i vitamina
English: This could be dangerous to yourself or others.
Croatian: To bi moglo biti opasno za Vas ili za druge osobe.
English: CI: 95% confidence interval.
Croatian: CI: 95% interval pouzdanosti.
English: You may then hear or feel a click.
Croatian: Možda ćete čuti ili osjetiti ‘klik'.
English: • turn you on your side
Croatian: • okrenuti Vas na bok
English: This is normal and does not affect your dose.
Croatian: To je normalno i ne utječe na Vašu dozu.
English: Before first use
Croatian: Prije prve uporabe
English: ATC code: A10AE06.
Croatian: ATK oznaka: A10AE06.
English: Your medicine might be harmful to their health.
Croatian: Vaš bi lijek mogao naškoditi njihovu zdravlju.
English: • you suddenly feel unwell with sweating
Croatian: • odjednom se osjećate loše i znojite se
English: This is especially important if you take more than one type of insulin.
Croatian: To je posebno važno ako primjenjujete više od jedne vrste inzulina.
English: • how much Tresiba you will need each day
Croatian: • koliko će Vam lijeka Tresiba biti potrebno svaki dan
English: 6 seconds
Croatian: 6 sekundi
English: • Do not leave the pen in a car or other place where it can get too hot or too cold.
Croatian: • Ne ostavljajte brizgalicu u vozilu ili na drugom mjestu gdje može biti prevruće ili prehladno.
English: Component of a multipack, cannot be sold separately
Croatian: Sastavni dio višestrukog pakiranja, ne može se prodavati odvojeno.
English: • Get medical help straight away.
Croatian: • Odmah zatražite medicinsku pomoć.
English: 4 Episodes from week 16 in each treatment period
Croatian: 4 Epizode iz 16. tjedna u svakom razdoblju liječenja
English: • thiazides, for high blood pressure or if your body keeps too much water (water retention).
Croatian: • tiazide, za visoki krvni tlak ili ako Vaše tijelo zadržava previše vode (nakupljanje vode).
English: • beta-blockers, for high blood pressure.
Croatian: • beta-blokatore, za visoki krvni tlak.
English: If you have poor eyesight, please see section 3.
Croatian: Ako slabo vidite, pogledajte dio 3.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Croatian: To može predstavljati rizik u situacijama u kojima su takve sposobnosti vrlo važne (primjerice, upravljanje vozilima ili rad sa strojevima).
English: If you drink alcohol, your need for insulin may change.
Croatian: Ako pijete alkohol, Vaša potreba za inzulinom može se promijeniti.
English: After first opening: Use within 8 weeks
Croatian: Nakon prvog otvaranja: upotrijebiti unutar 8 tjedana.
English: Dose counter stopped: 52 units left
Croatian: Brojčanik doze se zaustavio: preostalo 52 jedinice
English: Tresiba which has been frozen must not be used.
Croatian: Tresiba koja je bila zamrznuta se ne smije primijeniti.
English: It might lead to cross-infection.
Croatian: To može dovesti do križne infekcije.
English: For more information, see ‘serious allergic reaction' above.
Croatian: Za dodatne informacije pročitajte ‘ozbiljna alergijska reakcija' u tekstu iznad.
English: What Tresiba is and what it is used for
Croatian: Što je Tresiba i za što se koristi
English: These reactions are usually mild and transitory and they normally disappear during continued treatment.
Croatian: Te reakcije su obično blage i prolazne te normalno nestaju tijekom daljnjeg liječenja.
English: • anabolic steroids, such as testosterone
Croatian: • anaboličke steroide, poput testosterona
English: Date of latest renewal: 21 September 2017
Croatian: Datum posljednje obnove odobrenja: 21. rujna 2017.
English: Tresiba helps your body reduce your blood sugar level.
Croatian: Tresiba pomaže Vašem tijelu sniziti razinu šećera u krvi.
English: This medicinal product must not be mixed with any other medicinal products.
Croatian: Ovaj lijek se ne smije miješati s drugim lijekovima.
English: • Leave the needle under the skin for at least 6 seconds to make sure you get your full dose.
Croatian: • Zadržite iglu pod kožom najmanje 6 sekundi kako biste bili sigurni da ste primili cijelu dozu.
English: If you try to put it back on, you may accidentally stick yourself with the needle.
Croatian: Ako ga pokušate vratiti, možete se slučajno ubosti na iglu.
English: Swelling around your joints: When you first start using your medicine, your body may keep more water than it should.
Croatian: Oticanje oko zglobova: Kada prvi puta počnete primjenjivati ovaj lijek, Vaše tijelo može zadržavati više vode nego bi trebalo.
English: Safety and efficacy have been demonstrated in a long term trial in children aged 1 to less than 18 years.
Croatian: Sigurnost i djelotvornost dokazane su u dugotrajnom ispitivanju u djece u dobi od 1 do manje od 18 godina.
English: Patients should be instructed to always use a new needle.
Croatian: Bolesnike treba uputiti da uvijek upotrijebe novu iglu.
English: Subsequently, dosage should be adjusted individually.
Croatian: Nakon toga dozu treba individualno prilagoditi.
English: All cause death
Croatian: Smrt zbog bilo kojeg uzroka
English: Usually, the first symptoms of hyperglycaemia develop gradually over a period of hours or days.
Croatian: Obično se prvi simptomi hiperglikemije javljaju postupno tijekom nekoliko sati ili dana.
English: After delivery, insulin requirements usually return rapidly to pre-pregnancy values.
Croatian: Nakon poroda, potrebe za inzulinom se obično brzo vraćaju na vrijednosti prije trudnoće.
English: • sulfonamides, for infections
Croatian: • sulfonamide, za infekcije
English: Patients must be advised to take precautions to avoid hypoglycaemia while driving.
Croatian: Bolesnicima treba savjetovati da poduzmu mjere kako bi izbjegli hipoglikemiju tijekom vožnje.
English: If necessary, clean it with mild detergent on a moistened cloth.
Croatian: Ako je potrebno, očistite je vlažnom krpicom s blagim deterdžentom.
English: CV: Cardiovascular.
Croatian: KV: kardiovaskularni.
English: Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Croatian: Prilagodba doze može biti potrebna ako bolesnik pojača tjelesnu aktivnost, promijeni uobičajenu prehranu ili tijekom istodobne bolesti.
English: • If you are given glucagon, you will need sugar or a sugary snack as soon as you come round.
Croatian: • Ako ste dobili glukagon, trebat ćete uzeti šećer ili međuobrok bogat šećerom čim dođete sebi.
English: This medicinal product can be used in adolescents and children from the age of 1 year (see section 5.1).
Croatian: Ovaj lijek se može koristiti u adolescenata i djece u dobi od navršene 1 godine (vidjeti dio 5.1).
English: Tresiba with alcohol
Croatian: Tresiba s alkoholom
English: Insulin requirements usually decrease in the first trimester and increase subsequently during the second and third trimesters.
Croatian: Potrebe za inzulinom obično se smanjuju tijekom prvog tromjesečja te naknadno povećavaju u drugom i trećem tromjesečju trudnoće.
English: How to inject
Croatian: Kako injicirati
English: 3 Select your dose
Croatian: 3 Odaberite svoju dozu
English: The half-life of Tresiba is approximately 25 hours independent of dose.
Croatian: Poluvijek lijeka Tresiba iznosi približno 25 sati neovisno o dozi.
English: Never use a bent or damaged needle.
Croatian: Nikada ne koristite savijenu ili oštećenu iglu.
English: This medicinal product is for use by one person only.
Croatian: Ovaj lijek namijenjen je uporabi samo jedne osobe.
English: Do not inject it into a vein or muscle.
Croatian: Nemojte injicirati lijek u venu ili mišić.
English: • Always keep your pen and needles out of sight and reach of others, especially children.
Croatian: • Brizgalicu i igle uvijek čuvajte izvan pogleda i dohvata drugih, osobito djece.
English: Flexibility in dosing time
Croatian: Fleksibilno vrijeme doziranja
English: Contents of the pack and other information What Tresiba contains
Croatian: Sadržaj pakiranja i druge informacije Što Tresiba sadrži