FrancophonIA/ELRC3.0 huggingface dataset:
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide black (E172)
Croatian: poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, crni (E172)
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 150 mg/850 mg film-coated tablets
Croatian: NAZIV LIJEKA Vokanamet 150 mg/850 mg filmom obložene tablete
English: Dual therapy with metformin (26 weeks)
Croatian: Usporedba s glimepiridom kao dvojnom terapijom s metforminom (52 tjedna)
English: Patients (%) achieving HbA1c < 7% 43.2b
Croatian: Bolesnici (%) koji su postigli HbA1c < 7% 43,2 b
English: Mean percent changes from baseline in creatinine were 2.8% and 4.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 1.5% for placebo.
Croatian: k Srednje vrijednosti postotka promjene kreatinina u odnosu na početnu bila je 2,8% i 4,0% za kanagliflozin od 100 mg odnosno 300 mg u usporedbi s 1,5% za placebo.
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 50 mg/1000 mg film-coated tablets
Croatian: NAZIV LIJEKA Vokanamet 50 mg/1000 mg filmom obložene tablete
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 150 mg/1000 mg film-coated tablets
Croatian: NAZIV LIJEKA Vokanamet 150 mg/1000 mg filmom obložene tablete
English: ● a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017
Croatian: 7,5 događaja/1000 bolesnik-godini, dijeta sama 12,7 događaja/1,000 bolesnik-godini, p=0,017
English: Titanium dioxide (E171)) Iron oxide yellow (E172) Iron oxide red (E172)
Croatian: poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 50 mg/850 mg film-coated tablets
Croatian: NAZIV LIJEKA Vokanamet 50 mg/850 mg filmom obložene tablete
English: Mean changes from baseline in haematocrit were 2.4% and 2.5% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.0% for placebo.
Croatian: j Srednje vrijednosti promjene hematokrita u odnosu na početnu bila je 2.4% i 2,5% za kanagliflozin od 100 mg odnosno 300 mg u usporedbi s 0,0% za placebo.
English: • St. John's wort (a herbal medicine used to treat depression)
Croatian: ● gospina trava (biljni lijek za liječenje depresije)
English: ● a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021)
Croatian: /1,000 bolesnik-godini u odnosu na samu dijetu 20,6 događaja/1000 bolesnik-godini, (p=0,011), i naspram skupina s kombinacijom sulfonilureje i s inzulinom u monoterapiji 18,9 događaja/1000 bolesnik-godini (p=0,021)
English: Other side effects when taking canagliflozin alone: Very common
Croatian: Ostale nuspojave kada se kanagliflozin uzima samostalno:
English: respectively, compared to 0.6% for placebo.
Croatian: mg odnosno 300 mg u usporedbi s 0,6% za placebo.
English: Iodinated contrast agents
Croatian: Primjena jodnih kontrastnih sredstava
English: Combinations requiring precautions for use
Croatian: Upozorenja i mjere opreza
English: j Mean changes from baseline in haematocrit were 2.4% and 2.5% for canagliflozin 100 mg and 300 mg, respectively,
Croatian: j Srednje vrijednosti promjene hematokrita u odnosu na početnu bila je 2.4% i 2,5% za kanagliflozin od 100 mg odnosno
English: Film-coating: - 50 mg/850 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Croatian: 50 mg/850 mg: makrogol (3350) poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, crni (E172)
English: ● a significant reduction of the absolute risk of any diabetesrelated complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patientyears), p=0.0034
Croatian: Prikazana je analiza rezultata za pretile bolesnike liječene metforminom nakon neuspjeha liječenja samo dijetom: ● značajna redukcija apsolutnog rizika za pojavu bilo koje komplikacije povezane s dijabetesom u skupini s metforminom (29,8 događaja/1000 bolesnik-godini) u odnosu na samu dijetu (43,3 događaja/1000 bolesnik-godini), p=0,0023, te u odnosu na skupinu s kombinacijom sulfonilureje i inzulinom u monoterapiji (40,1 događaja/1000 bolesnik-godini), p=0,0034
English: In patients ≥ 75 years of age, the incidences were 4.9%
Croatian: Za bolesnike na diureticima Henleove petlje, incidencije su bile 3,2%
English: Baseline (mean) in kg % change from baseline (adjusted mean)
Croatian: Početna (srednja) vrijednost u kg % promjene od početne vrijednosti (prilagođena srednja vrijednost)
English: ● a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Croatian: 11 događaja/1000 bolesnik-godini, dijeta sama 18 događaja/1000 bolesnik-godini, (p=0,01).
English: Baseline (mean) in kg % change from baseline (adjusted mean) -4.2 Difference from glimepiride (adjusted mean) (95% CI)
Croatian: Početna (srednja) vrijednost u kg % promjene u odnosu na početnu vrijednost (prilagođena srednja vrijednost) Razlika u odnosu na glimepirid
English: For patients on loop diuretics, the incidences were 3.2% on canagliflozin 100 mg once daily and 8.8% on canagliflozin 300 mg once daily compared to 4.7% in the control group.
Croatian: uz kanagliflozin od 100 mg jedanput na dan i 8,8% uz kanagliflozin od 300 mg jedanput na dan u usporedbi s 4,7% u kontrolnoj skupini.
English: 150 mg/850 mg:
Croatian: 150 mg/850 mg: makrogol (3350)
English: • insulin or a sulphonylurea (such as glimepiride or glipizide) for diabetes - your doctor may want to reduce your dose in order to avoid your blood sugar level from getting too low (hypoglycaemia)
Croatian: ● inzulin ili sulfonilureju (poput glimepirida ili glipizida) za liječenje šećerne bolest - liječnik će
English: 150 mg/1000 mg:
Croatian: 150 mg/1000 mg: makrogol (3350)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 850 mg of metformin hydrochloride.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 50 mg kanagliflozina i sadrži 850 mg metforminklorida.
English: Patients with renal impairment
Croatian: Bolesnici starosti
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin, and 850 mg of metformin hydrochloride.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 150 mg kanagliflozina i sadrži 850 mg metforminklorida.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 1000 mg of metformin hydrochloride.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 50 mg kanagliflozina i sadrži 1000 mg metforminklorida.
English: Administration of iodinated contrast agent
Croatian: Kontrastna sredstva na bazi joda
English: respectively, compared to 1.5% for placebo.
Croatian: 100 mg odnosno 300 mg u usporedbi s 1,5% za placebo.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin, and 1000 mg of metformin hydrochloride.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 150 mg kanagliflozina i sadrži 1000 mg metforminklorida.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/918/010 (20 tablets) EU/1/14/918/011 (60 tablets) EU/1/14/918/012 (180 tablets)
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/918/010 (20 tableta)
English: 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Croatian: Uzimanje lijekaVokanamet mora se prekinuti prije ili za vrijeme ispitivanja, te se ne smije ponovno uvoditi dok nije prošlo 48 sati, te jedino nakon što se ponovnom procijenjenom funkcijom bubrega ustanovi da je ona normalna (vidjeti dio 4.5).
English: The dose of glucose-lowering therapy with Vokanamet should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability, using the recommended daily dose of 100 mg or 300 mg canagliflozin and not exceeding the maximum recommended daily dose of metformin orally.
Croatian: Doza lijeka Vokanamet u terapiji snižavanja šećera mora se odrediti za svakog bolesnika ponaosob na temelju dosadašnje terapije, učinkovitosti i podnošljivosti, uz primjenu preporučene dnevne doze od
English: 50 mg/1000 mg:
Croatian: 50 mg/1000 mg: makrogol (3350)
English: The primary assessment of safety and tolerability was conducted in a pooled analysis (N=2,313) of four 26-week placebo-controlled clinical studies (monotherapy and add-on therapy with metformin,
Croatian: Krvni tlak Analizom četiri 26-tjedna, placebom-kontrolirana ispitivanja (N=2313), liječenje kanagliflozinom od
English: on canagliflozin 100 mg once daily and 8.7% on canagliflozin 300 mg once daily compared to 2.6% in the control group (see sections 4.2 and 4.4).
Croatian: 100 mg jedanput na dan i 8,1% uz kanagliflozin od 300 mg jedanput na dan u usporedbi s 2,6% u kontrolnoj skupini.
English: Baseline (mean) in kg % change from baseline (adjusted mean) -2.1 Difference from placebo (adjusted mean) (95% CI)
Croatian: Početna (srednja) vrijednost u kg % promjene u odnosu na početnu vrijednost (prilagođena srednja vrijednost) Razlika u odnosu na sitagliptin
English: The dose of glucose-lowering therapy with Vokanamet should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability, while using the recommended daily dose of 100 mg or 300 mg canagliflozin and not exceeding the maximum recommended daily dose of metformin orally.
Croatian: 100 mg ili 300 mg kanagliflozina i bez prekoračenja maksimalne preporučene dnevne doze metformina, peroralno.
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Croatian: poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, žuti (E172) 6.2 Inkompatibilnosti
English: Tablet core
Croatian: Bubrežna funkcija
English: Reporting of side effects
Croatian: ● prijelom kosti
English: In this pooled analysis, patients on loop diuretics, patients with a baseline eGFR 30 mL/min/1.73 m2 to
Croatian: U ovoj udruženoj analizi, bolesnici na diureticima Henleove petlje, bolesnici s početnom vrijednosti eGFR 30 mL/min/1,73 m2 do < 60 mL/min/1,73 m2 i bolesnici starosti ≥ 75 godina imali su općenito veće incidencije ovih nuspojava.
English: m Mean percent changes from baseline in blood potassium were 0.5% and 1.0% for canagliflozin 100 mg and 300 mg,
Croatian: m Srednje vrijednosti postotka promjene kalija u krvi u odnosu na početnu bila je 0,5% i 1,0% za kanagliflozin od 100
English: Following administration of a single oral [14C]canagliflozin dose to healthy subjects, 41.5%, 7.0%, and
Croatian: Nakon primjene jedne oralne doze [14C]kanagliflozina u zdravih ispitanika, 41,5%; 7,0% i 3,2% primijenjene radioaktivne doze se ponovno našlo u stolici kao kanagliflozin, kao hidroksilirani odnosno O-glukuronidni metabolit.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/918/007 (20 tablets) EU/1/14/918/008 (60 tablets) EU/1/14/918/009 (180 tablets)
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/918/007 (20 tableta)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/918/004 (20 tablets) EU/1/14/918/005 (60 tablets) EU/1/14/918/006 (180 tablets)
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/918/004 (20 tableta)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/918/001 (20 tablets) EU/1/14/918/002 (60 tablets) EU/1/14/918/003 (180 tablets)
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/918/001 (20 tableta)
English: For 31 patients their disease got worse during treatment.
Croatian: U 31 bolesnika bolest se pogoršala tijekom liječenja.
English: Further information on Xgeva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Više informacija o lijeku Xgeva nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Of the remainder, 84 were able to have less extensive surgery than previously planned.
Croatian: U preostala 84 bolesnika bilo je moguće provesti manje opsežan kirurški zahvat nego što je to prethodno planirano.
English: Prevention of bone complications
Croatian: Sprječavanje koštanih komplikacija
English: What is Xgeva and what is it used for?
Croatian: Što je Xgeva i za što se koristi?
English: A response to treatment was defined as elimination of at least 90% of the giant cells or no progression of the condition after 25 weeks of treatment.
Croatian: Odgovor na liječenje definiran je kao eliminacija najmanje 90 % gigantskih stanica ili zaustavljanje napredovanja tumora 25 tjedana nakon liječenja.
English: In patients with giant cell tumour of bone, 120 mg is injected under the skin once a week for 3 weeks, and then once every 4 weeks.
Croatian: U bolesnika s gigantocelularnim tumorom kosti, 120 mg lijeka ubrizgava se pod kožu jedanput tjedno tijekom tri tjedna, a zatim jedanput svaka četiri tjedna.
English: What measures are being taken to ensure the safe and effective use of Xgeva?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Xgeva?
English: By attaching to RANKL and blocking it, denosumab reduces the formation and activity of the osteoclasts.
Croatian: Vezujući se na RANKL i blokirajući ga, denosumab smanjuje stvaranje i aktivnost osteoklasta.
English: About 20% of patients were able to have complete surgical removal of the cancer.
Croatian: U otprilike 20 % bolesnika bilo je moguće potpuno odstraniti rak kirurškim zahvatom.
English: This protein activates osteoclasts, the cells in the body that are involved in breaking down bone tissue.
Croatian: Taj protein aktivira osteoklaste, stanice u tijelu koje su uključene u razgradnju koštanog tkiva.
English: This reduces the loss of bone, making fractures and other serious bone complications less likely.
Croatian: Time se smanjuje gubitak kostiju, pa i vjerojatnost pojave fraktura i ozbiljnih koštanih komplikacija.
English: The first study involved 37 patients, 86 % of whom responded to treatment with Xgeva.
Croatian: Prvo je ispitivanje obuhvatilo 37 bolesnika, od kojih je 86 % odgovorilo na liječenje lijekom Xgeva.
English: Other information about Xgeva
Croatian: Ostale informacije o lijeku Xgeva
English: In patients with giant cell tumour of bone, Xgeva was effective in controlling the disease.
Croatian: U bolesnika s gigantocelularnim tumorom kosti, Xgeva je bio djelotvoran u kontroliranju bolesti.
English: In the second study which involved 507 patients treatment with Xgeva prevented surgery in about half (109 of 225) of the group in whom surgery would have resulted in complications.
Croatian: U drugom ispitivanju koje je uključivalo 507 bolesnika, liječenje lijekom Xgeva spriječilo je kirurški zahvat u otprilike polovice osoba (109 od 225) u skupini bolesnika u kojih bi kirurški zahvat rezultirao komplikacijama.
English: Treatment of giant cell tumour of bone
Croatian: Liječenje gigantocelularnog tumora kosti
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xgeva 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 Xgeva također se nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Xgeva received a marketing authorisation valid throughout the EU on 13 July 2011.
Croatian: Lijek Xgeva dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji od 13. srpnja 2011.
English: The third study involved 1,776 patients with advanced solid tumours in various parts of the body or with multiple myeloma (a cancer of the bone marrow).
Croatian: Treće je ispitivanje obuhvatilo 1776 bolesnika s uznapredovalim solidnim tumorima u različitim dijelovima tijela ili s multiplim mijelomom (rak koštane moždine).
English: Side effects reported with Xgeva are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Xgeva pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Xgeva can only be obtained with a prescription.
Croatian: Xgeva se izdaje samo na liječnički recept.
English: Why is Xgeva authorised in the EU?
Croatian: Zašto je lijek Xgeva odobren u EU-u?
English: The active substance in Xgeva, denosumab, is a monoclonal antibody which has been designed to recognise and attach to a protein called RANKL.
Croatian: Djelatna tvar lijeka Xgeva, denosumab, monoklonsko je protutijelo koje je namijenjeno prepoznavanju i vezivanju na protein pod nazivom RANKL.
English: As for all medicines, data on the use of Xgeva are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Xgeva kontinuirano se prate.
English: What are the risks associated with Xgeva?
Croatian: Koji su rizici povezani s lijekom Xgeva?
English: Xgeva contains the active substance denosumab.
Croatian: Xgeva sadrži djelatnu tvar denosumab.
English: It is used in patients who cannot be treated by surgery or in whom surgery is likely to cause complications.
Croatian: Koristi se u bolesnika s tumorom koji se ne može kirurški odstraniti ili u kojih bi kirurški zahvat vjerojatno prouzročio komplikacije.
English: An overview of Xgeva and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Xgeva i zašto je odobren u EU-u
English: Two main studies looked at the effect of Xgeva in adults or full-grown adolescents with giant cell tumour of bone that was unsuitable for surgery or in whom surgery would have resulted in severe complications like amputation of a limb.
Croatian: U dvama glavnim ispitivanjima istraživalo se djelovanje lijeka Xgeva u odraslih osoba ili potpuno zrelih adolescenata s gigantocelularnim tumorom kosti koji nisu bili pogodni za kirurški zahvat ili u kojih bi kirurški zahvat prouzročio ozbiljne komplikacije, poput amputacije uda.
English: The company that markets Xgeva will provide a card to inform patients about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they have symptoms.
Croatian: Tvrtka koja stavlja lijek Xgeva u promet osigurat će karticu za bolesnike s informacijama o riziku od osteonekroze čeljusti i uputama da se obrate svom liječniku ako budu imali simptome.
English: The Agency noted that there is a need for an effective treatment for bone disease in advanced cancer, particularly for patients with kidney problems since currently available treatments can be toxic for the kidneys.
Croatian: Agencija je navela da postoji potreba za djelotvornim liječenjem koštane bolesti u slučaju uznapredovalog raka, posebice u bolesnika s oštećenjem bubrega jer dostupne terapije mogu biti toksične za bubrege.
English: The first study involved 2,046 patients with breast cancer and the second study involved 1,901 men with prostate cancer which did not respond to hormonal treatment.
Croatian: Prvo je ispitivanje obuhvatilo 2046 bolesnica s rakom dojke, a drugo je ispitivanje obuhvatilo 1901 muškarca s rakom prostate koji nije reagirao na hormonsku terapiju.
English: Xgeva must not be used in patients with wounds from dental or mouth surgery have not yet healed, or in people with severe, untreated hypocalcaemia.
Croatian: Xgeva se ne smije primjenjivati u bolesnika kojima još nisu zacijelile rane nastale nakon dentalnih ili oralnih kirurških zahvata, ni u osoba s ozbiljnom, neliječenom hipokalcemijom.
English: These complications include fractures (breaks in the bone), spinal compression (pressure on the spinal cord caused by damage to the surrounding bone), or bone problems requiring radiotherapy (treatment with radiation) or surgery.
Croatian: Te komplikacije uključuju frakture (prijelomi kostiju), kompresiju leđne moždine (pritisak na leđnu moždinu uzrokovan oštećenjem okolne kosti) ili tegobe s kostima koje iziskuju radioterapiju (liječenje zračenjem) ili kirurški zahvat.
English: To prevent bone complications in cancer that has spread to the bone, 120 mg is given once every 4 weeks as a single injection under the skin in the thigh, abdomen (belly) or upper arm.
Croatian: Za prevenciju koštanih komplikacija u slučaju raka koji se proširio na kost, 120 mg lijeka daje se jedanput svaka četiri tjedna u obliku jednokratne potkožne injekcije u bedro, abdomen (trbuh) ili nadlakticu.
English: In another study involving 1,718 patients with newly diagnosed multiple myeloma, Xgeva was as effective as zoledronic acid in delaying the patients' first skeletal-related event.
Croatian: U drugom ispitivanju koje je obuhvatilo 1718 bolesnika s novodijagnosticiranim multiplim mijelomom, lijek Xgeva bio je jednako djelotvoran kao i zoledronska kiselina u odgađanju prvog koštanog događaja u bolesnika.
English: All the studies looked at the risk of patients having a first ‘skeletal-related event' (such as a fracture, pressure on the spinal cord or the need for radiotherapy or surgery to the bone) during the study period by measuring how long it took for this event to happen.
Croatian: U svim ispitivanjima istražen je rizik od prvog koštanog događaja u bolesnika (poput frakture, pritiska na leđnu moždinu ili potrebe za radioterapijom ili kirurškim zahvatom na kosti) tijekom trajanja ispitivanja mjerenjem razdoblja potrebnog za pojavljivanje ovog događaja.
English: Other common side effects (seen in up to 1 patient in 10) are development of another form of cancer in patients with advanced cancer, hypophosphataemia (low levels of phosphate in the blood), excessive sweating, tooth loss and osteonecrosis in the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth and loose teeth).
Croatian: Ostale česte nuspojave (zabilježene u 1 na 10 bolesnika) su razvoj druge vrste raka u bolesnika s uznapredovalim stadijem raka, hipofosfatemija (niske razine fosfata u krvi), prekomjerno znojenje, gubitak zubi i osteonekroza čeljusti (oštećenje kosti čeljusti koje za posljedicu može imati bolove, rane u usnoj šupljini i klimanje zubi).
English: For more information about using Xgeva, see the package leaflet or contact a doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Xgeva pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The Agency considered that Xgeva was effective in preventing bone-related events and was less toxic to the kidneys and easier to use than existing treatments.
Croatian: Agencija je zaključila da je lijek Xgeva djelotvoran u sprječavanju koštanih događaja te da je manje toksičan za bubrege i jednostavnije se primjenjuje od postojećih načina liječenja.
English: For patients with giant cell tumour of bone the possibility of complete surgical removal of the tumour after treatment and the reduction in extent of the surgery in some patients were considered clinically important.
Croatian: U slučaju bolesnika s gigantocelularnim tumorom kosti zaključeno je da postoji klinički značajna mogućnost potpunog kirurškog uklanjanja tumora nakon liječenja i smanjenje razmjera kirurškog zahvata u pojedinih bolesnika.
English: The most common side effects with Xgeva (seen in more than 1 patient in 10) are hypocalcaemia (low levels of calcium in the blood), pain in the muscles and bones, dyspnoea (difficulty breathing) and diarrhoea.
Croatian: Najčešće nuspojave lijeka Xgeva (zabilježene u više od 1 na 10 bolesnika) su hipokalcemija (niska razina kalcija u krvi), bol u mišićima i kostima, dispneja (poteškoće pri disanju) i proljev.