natgillin/translations-raw huggingface dataset:
Clinical efficacy and safety in adults and skeletally mature adolescents with giant cell tumour of bone
Klinička djelotvornost i sigurnost u odraslih i koštano sazrelih adolescenata s gigantocelularnim tumorom kosti
The median time to ONJ was 18.7 months (range: 1 - 44).
Medijan vremena do ONČ iznosio je 18,7 mjeseci (raspon: 1 - 44).
Upon enrolment of 282 patients, in Study 6 cohorts 1 and 2 combined, a clinically meaningful reduction in worst pain (i.e. ≥ 2-point decrease from baseline) was reported for 31.4% of patients at risk (i.e. those who had a worst pain score of ≥ 2 at baseline) within 1 week of treatment, and ≥ 50% at week 5.
Prilikom uključivanja 282 bolesnika u Ispitivanje 6, u kohorte 1 i 2 zajedno, zabilježeno je klinički značajno smanjenje najjače boli (tj. smanjenje od ≥ 2 boda u odnosu na početnu vrijednost) u 31,4% bolesnika s rizikom (tj. kod kojih je početni rezultat najjače boli bio ≥ 2) unutar 1 tjedna liječenja, te ≥ 50% u 5. tjednu.
The safety and efficacy of XGEVA have not been established in paediatric patients (age < 18) other than skeletally mature adolescents with giant cell tumour of bone.
Sigurnost i djelotvornost lijeka XGEVA nisu ustanovljene kod pedijatrijskih bolesnika (u dobi < 18) osim kod koštano sazrelih adolescenata s gigantocelularnim tumorom kosti.
• high calcium levels in the blood (hypercalcaemia) after stopping treatment in patients with giant cell tumour of the bone,
• visoke razine kalcija u krvi (hiperkalcijemija) nakon prestanka liječenja u bolesnika s gigantocelularnim tumorom kosti,
Musculoskeletal pain leading to discontinuation of study treatment was uncommon.
Slučajevi kada je mišićno-koštana bol dovela do prekida liječenja u ispitivanju bili su manje česti.
Calcium and vitamin D supplementation
Nadomjestak kalcija i vitamina D
MARKETING AUTHORISATION NUMBER(S) EU/1/11/703/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/703/001
In this study, 1,718 multiple myeloma patients with at least one bone lesion were randomised to receive 120 mg XGEVA subcutaneously every 4 weeks (Q4W) or 4 mg zoledronic acid intravenously (IV) every 4 weeks (dose-adjusted for renal function).
U ovom ispitivanju, 1718 bolesnika s dijagnozom multiplog mijeloma s najmanje jednom koštanom lezijom randomizirano je za primanje 120 mg lijeka XGEVA supkutano svaka 4 tjedna ili 4 mg zoledronatne kiseline intravenski svaka 4 tjedna (doza prilagođena za funkciju bubrega).
HR (95% CI) / RRR (%) Superiority p-value
HR (95% CI) / RRR p-vrijednost za superiornost
In a phase III trial in patients with non-metastatic prostate cancer (a patient population for which XGEVA is not indicated), with longer treatment exposure of up to 7 years, the patient-year adjusted incidence of confirmed ONJ was 1.1% during the first year of treatment, 3.0% in the second year, and 7.1% per year thereafter.
U ispitivanju faze III na skupini bolesnika s ne-metastatskim rakom prostate (populacija bolesnika za koju XGEVA nije indicirana), s dužim izlaganjem liječenju u trajanju do 7 godina, incidencija prilagođena prema bolesnik-godini za potvrđenu ONČ iznosila je 1,1% tijekom prve godine liječenja, 3,0% u drugoj godini i 7,1% po godini nakon toga.
• spasms, twitches, cramps in your muscles, numbness or tingling in your fingers, toes or around your mouth and/or seizures, confusion or loss of consciousness.
• spazme, trzanje mišića, grčeve u mišićima, obamrlost ili trnce u prstima ruku ili nogu ili oko usta i/ili napadaje, smetenost ili gubitak svijesti.
Overall survival was longer for XGEVA in non-small cell lung cancer (hazard ratio [95% CI] of 0.79 [0.65, 0.95]; n = 702) and longer for zoledronic acid in multiple myeloma (hazard ratio [95% CI] of 2.26 [1.13, 4.50]; n = 180) and similar between XGEVA and zoledronic acid in other tumour types (hazard ratio [95% CI] of 1.08 (0.90, 1.30); n = 894).
Ukupno preživljenje bilo je dulje za lijek XGEVA kod raka pluća nemalih stanica (omjer hazarda [95% CI] od 0,79 [0,65; 0,95]; n = 702), dulje za zoledronatnu kiselinu kod multiplog mijeloma (omjer hazarda [95% CI] od 2,26 [1,13; 4,50]; n = 180) i slično za lijek XGEVA i zoledronatnu kiselinu kod drugih tipova tumora (omjer hazarda [95% CI] of 1,08 (0,90; 1,30); n = 894).
Some people have developed unusual fractures in their thigh bone while being treated with XGEVA.
Kod nekih ljudi dolazi do neuobičajenih prijeloma bedrene kosti tijekom liječenja lijekom XGEVA.
Musculoskeletal pain1
Mišićnokoštana bol1
In preclinical studies knockout mice lacking RANK or RANKL had an absence of lactation due to inhibition of mammary gland maturation (lobulo-alveolar gland development during pregnancy) and exhibited impairment of lymph node formation.
U nekliničkim ispitivanjima kod knockout miševa bez RANK ili RANKL izostala je laktacija zbog inhibicije sazrijevanja mliječnih žlijezda (razvoj lobulo-alveolarne žlijezde u trudnoći) i utvrđeno je oštećenje formiranja limfnih čvorova.
The highest incidence of hypocalcaemia was observed in a phase III trial in patients with multiple myeloma.
Najveća incidencija hipokalcijemije opažena je u kliničkom ispitivanju faze III u bolesnika s multiplim mijelomom.
Treatment of skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity: the posology is the same as in adults.
Liječenje koštano sazrelih adolescenata s gigantocelularnim tumorom kosti koji je neresektabilan ili gdje kirurška resekcija može rezultirati teškim morbiditetom: doziranje je isto kao u odraslih.
How to store XGEVA
Kako čuvati lijek XGEVA
In phase III clinical trials of patients with advanced malignancies involving bone, median uNTx/Cr reductions of approximately 80% were maintained through 49 weeks of XGEVA treatment (120 mg every Q4W).
U kliničkim ispitivanjima faze III u bolesnika s uznapredovalim malignim bolestima koje zahvaćaju kosti, medijan smanjenja uNTx/Cr od otprilike 80% zadržan je tijekom 49 tjedana liječenja lijekom XGEVA (120 mg svaka 4 tjedna).
XGEVA 120 mg solution for injection denosumab
XGEVA 120 mg otopina za injekciju denosumab
Patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia.
Bolesnici s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) ili bolesnici koji su na dijalizi imaju povećan rizik za razvoj hipokalcijemije.
Tooth extraction
Vađenje zuba
2 RECIST 1.1: Modified Response Evaluation Criteria in Solid Tumours to evaluate tumour burden based on computed tomography (CT)/magnetic resonance imaging (MRI) 3 EORTC: Modified European Organisation for Research and Treatment of Cancer criteria to evaluate metabolic response using fluorodeoxyglucose positron emission tomography (FDG-PET) 4 Density/Size: Modified Inverse Choi criteria to evaluate tumour size and density using Hounsfield units based on CT/MRI
3 EORTC: Modified European Organization for Research and Treatment of Cancer criteria - Izmijenjeni kriteriji Europske organizacije za istraživanje i liječenje raka za procjenu metaboličkog odgovora uz korištenje pozitronske emisijske tomografije s fluorodeoksiglukozom (FDG-PET) 4 Gustoća/veličina: Izmijenjeni inverzni kriterij po Choi-u za procjenu veličine i gustoće tumora uz korištenje Hounsfield-ovih jedinica, temeljeno na CT/MRI
In a clinical study in patients without advanced cancer, 19% of patients with severe renal impairment (creatinine clearance < 30 mL/min) and 63% of patients receiving dialysis developed hypocalcaemia despite calcium supplementation.
U kliničkom ispitivanju kod bolesnika bez uznapredovalog raka, kod 19% bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) i kod 63% bolesnika na dijalizi zabilježena je hipokalcijemija, iako su primali nadomjestak kalcija.
Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Liječenje odraslih i koštano sazrelih adolescenata s gigantocelularnim tumorom kosti koji je neresektabilan ili gdje kirurška resekcija može rezultirati teškim morbiditetom.
Please tell your doctor immediately if you have spasms, twitches, or cramps in your muscles, and/or numbness or tingling in your fingers, toes or around your mouth and/or seizures, confusion or loss of consciousness while being treated with XGEVA.
Obavezno se obratite svom liječniku ako primijetite spazme, trzanje ili grčeve u mišićima i/ili obamrlost ili trnce u prstima ruku, nogu ili oko usta i/ili napadaje, smetenost ili gubitak svijesti tijekom liječenja lijekom XGEVA.
ONJ has been reported commonly in patients receiving XGEVA (see section 4.8).
ONČ je prijavljena često u bolesnika koji su primali lijek XGEVA (vidjeti dio 4.8).
This medicine contains less than 1 mmol sodium (23 mg) per 120 mg, i.e. essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) u 120 mg, odnosno zanemarive količine natrija.
In the clinical trial programme, atypical femoral fractures have been reported uncommonly in patients treated with XGEVA and the risk increased with longer duration of treatment.
U programu kliničkih ispitivanja u bolesnika liječenih lijekom XGEVA manje često su zabilježene atipične femoralne frakture , a rizik se povećavao s duljinom trajanja liječenja.
In patients whose disease is controlled by XGEVA, the effect of interruption or cessation of treatment has not been evaluated, however limited data in these patients does not indicate a rebound effect upon cessation of treatment.
Nije se vršila procjena učinka prekida ili obustave liječenja kod bolesnika kod kojih je bolest kontrolirana lijekom XGEVA, međutim, ograničeni podaci u tih bolesnika ne ukazuju na povratni (engl. rebound) učinak nakon obustave liječenja.
At the completion of the double-blind treatment phase of this trial, the patient-year adjusted incidence (number of events per 100 patient years) of confirmed ONJ in the XGEVA group (median exposure of 19.4 months; range 1 - 52), was 2.0% during the first year of treatment, 5.0% in the second year, and 4.5% per year thereafter.
Po završetku dvostruko slijepe faze liječenja u ovom ispitivanju, incidencija prilagođena prema bolesnik-godini (broj događaja na 100 bolesnik-godina) za potvrđenu ONČ u skupini bolesnika koji su primali lijek XGEVA (medijan izloženosti od 19,4 mjeseci; raspon: 1 - 52) iznosila je 2,0% tijekom prve godine liječenja, 5,0% u drugoj godini i 4,5% po godini nakon toga.
Elderly patients (age ≥ 65) No dose adjustment is required in elderly patients (see section 5.2).
Prilagodba doze nije potrebna kod starijih bolesnika (vidjeti dio 5.2).
In a combined pre-specified analysis from studies 1, 2 and 3, overall survival was similar between XGEVA and zoledronic acid (hazard ratio and 95% CI 0.99 [0.91, 1.07]).
ispitivanja 1, 2, 3 ukupno preživljenje bilo je slično kod lijeka XGEVA i zoledronatne kiseline (omjer hazarda i 95% CI 0,99 [0,91; 1,07]).
In three phase III active-controlled clinical trials in patients with advanced malignancies involving bone, hypocalcaemia was reported in 9.6% of patients treated with XGEVA and 5.0% of patients treated with zoledronic acid.
U tri aktivno kontrolirana klinička ispitivanja faze III u bolesnika s uznapredovalim malignim bolestima koje zahvaćaju kosti, hipokalcijemija je zabilježena u 9,6% bolesnika koji su primali lijek XGEVA i u 5,0% bolesnika koji su primali zoledronatnu kiselinu.
In another study of cynomolgus monkeys dosed with denosumab throughout pregnancy at systemic exposures 12-fold higher than the human dose, there were increased stillbirths and postnatal mortality; abnormal bone growth resulting in reduced bone strength, reduced haematopoiesis, and tooth malalignment; absence of peripheral lymph nodes; and decreased neonatal growth.
U drugom ispitivanju na cynomolgus majmunima koji su tijekom gestacije bili izloženi dozama denosumaba koje rezultiraju 12 puta većom sistemskom izloženošću od preporučene doze za ljude, zabilježeno je povećanje broja mrtvorođenčadi i postnatalne smrtnosti; abnormalan rast kostiju koji je rezultirao smanjenom čvrstoćom kostiju, smanjenom hematopoezom i poremećajem rasporeda zuba; nedostatkom perifernih limfnih čvorova i smanjenim neonatalnim rastom.
The risk of developing hypocalcaemia and accompanying elevations in parathyroid hormone increases with increasing degree of renal impairment.
Rizik od razvoja hipokalcijemije, te pratećeg porasta paratiroidnog hormona povećava se s povećanjem stupnja oštećenja bubrega.
- The active substance is denosumab.
Što XGEVA sadrži - Djelatna tvar je denosumab.
You should also take calcium and vitamin D supplements while being treated with XGEVA unless you have an excess of calcium in the blood.
D tijekom liječenja lijekom XGEVA osim ako imate višak kalcija u krvi.
The solution may contain trace amounts of translucent to white proteinaceous particles.
Otopina može sadržavati tragove prozirnih do bijelih proteinskih čestica.
The recommended dose of XGEVA is 120 mg administered once every 4 weeks, as a single injection under the skin (subcutaneous).
Preporučena doza lijeka XGEVA je 120 mg primijenjeno svaka 4 tjedna u obliku jedne injekcije pod kožu (potkožno).
A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with denosumab.
Prije liječenja denosumabom preporuča se obaviti stomatološki pregled s preventivnim stomatološkim liječenjem i individualnu procjenu koristi i rizika.
The patient-year adjusted overall incidence (number of events per 100 patient years) of confirmed ONJ was 1.1% during the first year of treatment, 3.7% in the second year and 4.6% per year thereafter.
Sveukupna prilagođena incidencija prema bolesnik-godini (broj događaja na 100 bolesnik-godina) za potvrđenu ONČ iznosila je 1,1% tijekom prve godine liječenja, 3,7% u drugoj godini i 4,6% po godini nakon toga.
XGEVA is not recommended in paediatric patients (age < 18) other than skeletally mature adolescents with giant cell tumour of bone (see section 4.4).
Ne preporučuje se primjena lijeka XGEVA u pedijatrijskih bolesnika (u dobi < 18) osim kod koštano sazrelih adolescenata s gigantocelularnim tumorom kosti (vidjeti dio 4.4).
In two phase II single-arm clinical trials in patients with giant cell tumour of bone, ONJ occurred in 2.3% (12 of 523) of patients treated with XGEVA (median overall exposure of 20.3 months; range: 0 - 83.4).
U dva klinička ispitivanja faze II na jednoj skupini bolesnika s gigantocelularnim tumorom kosti, ONČ se pojavila u 2,3% (12 od 523) bolesnika liječenih lijekom XGEVA (medijan ukupne izloženosti od 20,3 mjeseca, raspon: 0 - 83,4).
Unusual thigh bone fractures
Neuobičajeni prijelomi bedrene kosti
In subjects with giant cell tumour of bone who received 120 mg every 4 weeks with a loading dose on days 8 and 15, steady-state levels were achieved within the first month of treatment.
U ispitanika s gigantocelularnim tumorom kosti koji su primali 120 mg svaka 4 tjedna, s udarnom dozom 8. i 15. dana, razine stanja dinamičke ravnoteže postignute su unutar prvog mjeseca liječenja.
It may contain trace amounts of clear to white particles.
Može sadržavati prozirne do bijele čestice u tragovima.
Adverse reactions reported in patients with advanced malignancies involving bone, multiple myeloma, or with giant cell tumour of bone MedDRA system organ class Frequency category
Tablica 1. Nuspojave zabilježene u bolesnika s uznapredovalim malignim bolestima koje zahvaćaju kosti, s multiplim mijelomom ili s gigantocelularnim tumorom kosti MedDRA klasifikacija organskih sustava
Clinical efficacy and safety in patients with bone metastases from solid tumours
Klinička djelotvornost i sigurnost u bolesnika s koštanim metastazama solidnih tumora
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.7 mL
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
Hypocalcaemia was reported in 16.9% of patients treated with XGEVA and 12.4% of patients treated with zoledronic acid.
Hipokalcijemija je prijavljena u 16,9% bolesnika koji su primali lijek XGEVA i u 12,4% bolesnika koji su primali zoledronatnu kiselinu.
71.6% (95% CI: 64.6, 77.9) of patients (table 4) assessed by any of the modalities, with the majority of responses defined by a reduction in fluorodeoxyglucose PET activity or increase in density measured in CT/HU, only 25.1% of the patients had a response per RECIST.
Sveukupno, lijek XGEVA je postigao objektivni odgovor u liječenju tumora kod 71,6% (95% CI: 64,6; 77,9) bolesnika (tablica 4) procijenjen na jedan od nekoliko načina, a najviše odgovora je definirano kroz smanjenje aktivnosti fluorodeoksiglukoze mjerene PET-om ili kroz povećanje izmjerene gustoće na CT/HU, a samo je 25,1% bolesnika imalo odgovor prema Kriterijima za procjenu terapijskog odgovora kod solidnih tumora (engl.
The pharmacokinetics of denosumab is not expected to be affected by hepatic impairment.
Ne očekuje se da bi oštećenje jetre utjecalo na farmakokinetiku denosumaba.
Hypercalcaemia following treatment discontinuation in patients with giant cell tumour of bone and in patients with growing skeletons
Hiperkalcijemija nakon prekida liječenja u bolesnika s gigantocelularnim tumorom kosti i bolesnika sa skeletom u razdoblju rasta
Accompanying increases in parathyroid hormone have also been observed in patients receiving XGEVA with severe renal impairment or receiving dialysis.
Također je primijećen porast razine paratiroidnog hormona kod bolesnika s teškim oštećenjem funkcije bubrega ili koji su na dijalizi i koji su primali lijek XGEVA.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION XGEVA 120 mg injection denosumab
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA XGEVA 120 mg injekcija denosumab s.c.
Giant cell tumour of bone
Gigantocelularni tumor kosti
Osteonecrosis of the jaw (ONJ)
Osteonekroza čeljusti (ONČ)
In Study 6, XGEVA has been evaluated in a subset of 18 adolescent patients (aged 13-17 years) with giant cell tumour of bone who had reached skeletal maturity defined by at least 1 mature long bone (e.g. closed epiphyseal growth plate of the humerus) and body weight ≥ 45 kg. An objective response was observed for four of six evaluable adolescents in an interim analysis of Study 6.
6 na podskupini od 18 adolescentnih bolesnika (13-17 godina starosti) s gigantocelularnim tumorom kosti, a koji su dosegli zrelost koštanog sustava što je definirano s barem jednom zrelom dugom kosti (primjerice zatvorena epifizna ploča rasta humerusa) i tjelesnom težinom ≥ 45 kg.
There is no need for renal monitoring with XGEVA dosing.
Nije potrebno pratiti funkciju bubrega prilikom doziranja lijeka XGEVA.
In the double-blind treatment phase of this trial, ONJ was confirmed in 5.9% of patients treated with XGEVA (median exposure of 19.4 months; range 1 52) and in 3.2% of patients treated with zoledronic acid.
U dvostruko slijepoj fazi liječenja u ovom ispitivanju, ONČ je potvrđena u 5,9% bolesnika liječenih lijekom XGEVA (medijan izloženosti od 19,4 mjeseci; raspon: 1 - 52) i u 3,2% bolesnika liječenih zoledronatnom kiselinom.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 120 mg denosumaba u 1,7 ml otopine (70 mg/ml).
In a clinical study of patients without advanced cancer with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis, there was a greater risk of developing hypocalcaemia in the absence of calcium supplementation.
U kliničkom ispitivanju kod bolesnika koji nisu bolovali od uznapredovalog raka, a imali su teško oštećenje bubrega (klirens kreatinina < 30 ml/min) ili su bili na dijalizi, postojao je povećan rizik za razvoj hipokalcijemije ako nije primijenjen nadomjestak kalcija.
The safety and efficacy of XGEVA was studied in two phase II open-label, single-arm trials (studies 5 and 6) that enrolled 529 patients with giant cell tumour of bone that was either unresectable or for which surgery would be associated with severe morbidity.
Sigurnost i djelotvornost lijeka XGEVA ispitana je u dva otvorena klinička ispitivanja faze II na jednoj skupini bolesnika (ispitivanja 5 i 6) koja su uključila 529 bolesnika s gigantocelularnim
XGEVA was studied in an open-label trial that enrolled 18 skeletally mature adolescents with giant cell tumour of bone.
Provedeno je otvoreno ispitivanje lijeka XGEVA na 18 koštano sazrelih adolescenata s gigantocelularnim tumorom kosti.
What XGEVA contains
XGEVA sadrži natrij
Patients with prior history of ONJ or osteomyelitis of the jaw, an active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or any planned invasive dental procedure, were not eligible for inclusion in these studies.
Bolesnici s anamnezom ONČ-a ili osteomijelitisa čeljusti, s aktivnom bolešću zubi ili čeljusti koja zahtijeva oralnu operaciju, oni s nezacijeljenom stomatološkom/oralnom operacijom ili koji planiraju invazivne stomatološke zahvate nisu bili prikladni za uključivanje u ova ispitivanja.
In the primary double blind treatment phases of four phase III active-controlled clinical trials in patients with advanced malignancies involving bone, new primary malignancy was reported in 54/3691 (1.5%) of patients treated with XGEVA (median exposure of 13.8 months; range: 1.0-51.7) and 33/3688 (0.9%) of patients treated with zoledronic acid (median exposure of 12.9 months; range:
U primarnim dvostruko slijepim fazama liječenja u četiri aktivno kontrolirana klinička ispitivanja faze III u bolesnika s uznapredovalim malignim bolestima koje zahvaćaju kosti nova primarna maligna bolest prijavljena je u 54 od 3691 (1,5%) bolesnika koji su primali lijek XGEVA (medijan izloženosti od 13,8 mjeseci, raspon: 1,0 - 51,7) i u 33 od 3688 (0,9%) bolesnika koji su primali zoledronatnu kiselinu (medijan izloženosti od 12,9 mjeseci, raspon: 1,0 - 50,8).
You may have low levels of calcium in your blood.
Možda Vam je razina kalcija u krvi snižena.
The use of XGEVA has not been studied in children and adolescents with other cancers that have spread to bone.
Primjena lijeka XGEVA u djece i adolescenata koji boluju od drugih oblika raka koji su se proširili na kosti nije ispitana.
First SRE Median time (months)
Prvi SRE Medijan vremena (mjeseci)
Each vial contains 120 mg of denosumab in 1.7 mL of solution (corresponding to 70 mg/mL).
Jedna bočica sadrži 120 mg denosumaba u 1,7 ml otopine (što odgovara 70 mg/ml).
MARKETING AUTHORISATION NUMBER(S) EU/1/11/703/001 1 single use vial EU/1/11/703/002 4 single use vials EU/1/11/703/003 3 single use vials
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/703/001 1 bočica za jednokratnu upotrebu
Lichenoid drug eruptions (e.g. lichen planus-like reactions), have been reported in patients in the postmarketing setting.
Izbijanje lihenoidnih kožnih promjena uzrokovano lijekom Izbijanje lihenoidnih kožnih promjena uzrokovano lijekom (npr. reakcije nalik na lihen planus) prijavljeno je u bolesnika nakon stavljanja lijeka u promet.
The highest incidence of ONJ was observed in a phase III trial in patients with multiple myeloma.
Najveća incidencija ONČ opažena je u kliničkom ispitivanju faze III u bolesnika s multiplim mijelomom.
NAME OF THE MEDICINAL PRODUCT XGEVA 120 mg solution for injection
NAZIV LIJEKA XGEVA 120 mg otopina za injekciju
In the primary treatment phases of three phase III active-controlled clinical trials in patients with advanced malignancies involving bone, ONJ was confirmed in 1.8% of patients treated with XGEVA (median exposure of 12.0 months; range: 0.1 - 40.5) and 1.3% of patients treated with zoledronic acid.
U primarnim fazama liječenja u tri aktivno kontrolirana klinička ispitivanja faze III u bolesnika s uznapredovanim malignim bolestima koje zahvaćaju kosti, ONČ je potvrđena u 1,8% bolesnika koji su primali lijek XGEVA (medijan izloženosti od 12,0 mjeseci, raspon: 0,1 - 40,5) i u 1,3% bolesnika koji su primali zoledronatnu kiselinu.
Hypercalcaemia following treatment discontinuation in patients with giant cell tumour of bone3
Hiperkalcijemija nakon prekida liječenja u bolesnika s gigantocelularnim tumorom kosti3