natgillin/translations-raw huggingface dataset:
Patients in the phase II study who underwent complete resection of giant cell tumour of bone did receive an additional 6 months of treatment following the surgery as per study protocol. 
V študiji faze II so v skladu s protokolom študije bolniki z opravljeno popolno resekcijo gigantocelularnega kostnega tumorja po kirurškem posegu prejemali zdravljenje dodatnih 6 mesecev.
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. 
V klinični študiji pri bolnikih brez napredovanega raka in s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) ali bolnikih na dializi, je bilo tveganje za pojav hipokalciemije večje v odsotnosti dodatkov kalcija.
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. 
Zdravniku morate takoj povedati, če imate med zdravljenjem z zdravilom XGEVA spazme, trzanje ali krče v mišicah in/ali omrtvičenost ali mravljinčenje v prstih rok ali nog ali okrog ust in/ali napade krčev, zmedenost ali izgubite zavest.
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. 
V preskušanju III. faze pri bolnikih z nemetastatskim rakom prostate (populacija bolnikov za katere zdravilo XGEVA ni indicirano) med dolgotrajnejšo izpostavljenostjo zdravilu do 7 let je bila za bolnik-leto korigirana incidenca potrjene osteonekroze čeljustnice 1,1 % prvo leto zdravljenja, 3,0 % drugo leto zdravljenja in zatem 7,1 % na leto.
Women should be advised not to become pregnant during and for at least 5 months after treatment with XGEVA. 
Ženskam je treba naročiti, da med zdravljenjem z zdravilom XGEVA in vsaj še 5 mesecev po zdravljenju ne smejo zanositi.
• 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. 
• spazmi, trzanje, krči v mišicah, omrtvičenost ali mravljinčenje v prstih rok ali nog ali okrog ust in/ali napadi krčev, zmedenost ali izguba zavesti.
Supplementation with calcium and vitamin D is required in all patients unless hypercalcaemia is present (see section 4.2). 
Vsi bolniki morajo prejemati dodatek kalcija in vitamina D, razen če ima bolnik hiperkalciemijo (glejte poglavje 4.2).
XGEVA will be injected into your thigh, abdomen or upper arm. 
Zdravilo XGEVA vam bodo injicirali v stegno, trebuh ali nadlaket.
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. 
Ob dokončanju dvojno slepe faze zdravljenja v tem preskušanju je bila na bolnik-leto preračunana pojavnost (število dogodkov na 100 bolnik-let) potrjene osteonekroze čeljustnice v skupini z zdravilom XGEVA (mediana izpostavljenost 19,4 meseca, razpon od 1 do 52) 2,0 % v prvem letu zdravljenja, 5,0 % v drugem letu in 4,5 % v letu pozneje.
The median time to ONJ was 20.6 months (range: 4 - 53). 
Mediana čas do osteonekroze čeljustnice je bil 20,6 meseca (razpon: 4 - 53).
EU/1/11/703/002 
EU/1/11/703/001 EU/1/11/703/002 EU/1/11/703/003
ONJ was confirmed in 6.9% of patients with breast cancer and prostate cancer during the extension treatment phase. 
Osteonekroza čeljustnice je bila med podaljšano fazo zdravljenja potrjena pri 6,9 % bolnic z rakom dojke in bolnikov z rakom prostate.
XGEVA 120 mg solution for injection denosumab 
XGEVA 120 mg raztopina za injiciranje 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. 
Med zdravljenjem z zdravilom XGEVA morate jemati dodatke kalcija in vitamina D, razen če imate preveč kalcija v krvi.
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. 
V drugi študiji na opicah cynomolgus, ki so med nosečnostjo prejemale toliko denosumaba, da je bila sistemska izpostavljenost 12-krat višja kot z odmerkom za človeka, so ugotovili več mrtvorojenosti in večjo poporodno umrljivost, nenormalno rast kosti, ki je povzročila manjšo moč kosti, zmanjšano hematopoezo in neuravnanost zob, odsotnost perifernih bezgavk in upočasnjeno neonatalno rast.
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. 
V programu kliničnih preskušanj so pri bolnikih, zdravljenih z zdravilom XGEVA, občasno poročali o atipičnih zlomih stegnenice, tveganje pa se je povečalo z daljšim časom trajanja zdravljenja.
• A 27 gauge needle is recommended for the administration of denosumab. 
• Za dajanje denosumaba je priporočljivo uporabiti iglo številka 27.
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. 
V treh kliničnih preskušanjih III. faze, kontroliranih z učinkovino, pri bolnikih z napredovanimi malignomi, ki so zajeli kosti, so poročali o hipokalciemiji pri 9,6 % bolnikov, ki so prejemali zdravilo XGEVA, in pri 5,0 % bolnikov, ki so prejemali zoledronsko kislino.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/703/001 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/703/001 - 1 viala za enkratno uporabo
NR 25.2 
ND 25,2 19,0
The risk of developing hypocalcaemia during XGEVA treatment is greater with increasing degree of renal impairment. 
Tveganje za pojav hipokalciemije je med zdravljenjem z zdravilom XGEVA večje z napredujočo stopnjo okvare ledvic.
Efficacy and safety of 120 mg XGEVA SC every 4 weeks or 4 mg zoledronic acid (dose-adjusted for reduced renal function) IV every 4 weeks were compared in three randomised, double-blind, 
Učinkovitost in varnost 120 mg zdravila XGEVA s.c. na 4 tedne ali 4 mg zoledronske kisline (odmerek prilagojen na zmanjšano delovanje ledvic) i.v.
The median time to ONJ was 19.4 months (range: 11 - 40). 
Mediani čas do osteonekroze čeljustnice je bil 19,4 meseca (razpon: 11 - 40).
Your healthcare professional will not administer XGEVA to you if you have unhealed wounds from dental or oral surgery. 
Zdravnik vam zdravila XGEVA ne bo injiciral, če imate nezaceljene rane po zobnih ali ustnih kirurških posegih.
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). 
Celokupno preživetje je bilo z zdravilom XGEVA daljše pri nedrobnoceličnem pljučnem raku (razmerje ogroženosti [95 % IZ] 0,79 [0,65, 0,95], n = 702), z zoledronsko kislino daljše pri diseminiranem plazmocitomu (razmerje ogroženosti [95 % IZ] 2,26 [1,13, 4,50], n = 180) in podobno z zdravilom XGEVA in zoledronsko kislino pri drugih vrstah tumorjev (razmerje ogroženosti [95 % IZ] 1,08 (0,90, 1,30), n = 894).
Dmab = Denosumab 120 mg Q4W 
Dmab = Denosumab 120 mg na 4 tedne
In single and repeated dose toxicity studies in cynomolgus monkeys, denosumab doses resulting in 2.7 to 15 times greater systemic exposure than the recommended human dose had no impact on cardiovascular physiology, male or female fertility, or produced specific target organ toxicity. 
Odmerki denosumaba, ki so povzročili od 2,7- do 15-krat večjo sistemsko izpostavljenost od priporočenega odmerka za človeka, v študijah toksičnosti enkratnega in ponavljajočih se odmerkov pri opicah cynomolgus niso vplivali na kardiovaskularno fiziologijo ali na reprodukcijsko sposobnost samcev in samic; prav tako niso povzročili specifičnih toksičnih učinkov na ciljnih organih.
Some people have developed unusual fractures in their thigh bone while being treated with XGEVA. 
Pri nekaterih ljudeh so se med zdravljenjem z zdravilom XGEVA pojavili neobičajni zlomi stegnenice.
Hypocalcaemia was reported in 16.9% of patients treated with XGEVA and 12.4% of patients treated with zoledronic acid. 
O hipokalciemiji so poročali pri 16,9 % bolnikih, zdravljenih z zdravilom XGEVA, in pri 12,4 % bolnikih, zdravljenih z zoledronsko kislino.
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. 
V predkliničnih študijah knockout miši brez RANK ali RANKL niso imele laktacije zaradi zavrtja dozorevanja mlečnih žlez (razvoj lobulo-alveolarnih žlez med brejostjo) in so imele okvarjeno nastajanje bezgavk.
Reduced bone growth, altered growth plates and impaired tooth eruption were also seen in studies of neonatal rats administered RANKL inhibitors, and these changes were partially reversible when dosing of RANKL inhibitor was discontinued. 
V študijah novorojenih podgan, ki so prejemale zaviralce RANKL, so ugotovili tudi zmanjšano kostno rast, spremenjene rastne ploščice in pomanjkanje izraščanja zob; te spremembe so bile delno reverzibilne, ko se je prekinila uporaba zaviralca RANKL.
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. 
Pri preiskovancih z gigantocelularnim kostnim tumorjem, ki so dobivali 120 mg na 4 tedne in polnilni odmerek 8. in 15. dan, je bila koncentracija v stanju dinamičnega ravnovesja dosežena v prvem mesecu zdravljenja.
Anaphylactic reaction1 
redki anafilaktična reakcija1
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 120 mg denosumaba v 1,7 ml raztopine (70 mg/ml).
Each vial contains 120 mg of denosumab in 1.7 mL of solution (corresponding to 70 mg/mL). 
Ena viala vsebuje 120 mg denosumaba v 1,7 ml raztopine (kar ustreza 70 mg/ml).
Using a sensitive immunoassay < 1% of patients treated with denosumab for up to 3 years tested positive for non neutralising binding antibodies with no evidence of altered pharmacokinetics, toxicity, or clinical response. 
bolnikov, ki so se zdravili z denosumabom v obdobju do 3 let, pri tem pa ni bilo nobenih znakov sprememb farmakokinetike, toksičnosti ali kliničnega odziva.
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). 
V tej študiji so 1.718 bolnikov z diseminiranim plazmocitomom z vsaj eno kostno lezijo randomizirali na prejemanje 120 mg zdravila XGEVA subkutano na 4 tedne ali 4 mg zoledronske kisline intravensko (i.v.)
• Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. 
• V primeru pojava bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte z zdravnikom.
XGEVA should be administered under the responsibility of a healthcare professional. 
Zdravilo XGEVA mora aplicirati zdravstveni delavec.
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 excluded from the clinical trials. 
Bolniki z anamnezo osteonekroze čeljustnice ali osteomielitisa čeljustnice, aktivno zobno ali čeljustno boleznijo, ki zahteva kirurški poseg v ustih, nezaceljenim stanjem po zobnem/ustnem kirurškem posegu ali katerim koli načrtovanim invazivnim zobozdravstvenim posegom niso bili vključeni v klinična preskušanja.
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. 
V klinični študiji pri bolnikih brez napredovalega raka se je hipokalciemija kljub dodajanju kalcija pojavila pri 19 % bolnikov s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) in pri 63 % bolnikov na dializi.
Pharmacotherapeutic group: Drugs for treatment of bone diseases - other drugs affecting bone structure and mineralisation, ATC code: M05BX04 
Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti - druga zdravila z učinkom na strukturo in mineralizacijo kosti.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION XGEVA 120 mg injection denosumab 
IME ZDRAVILA IN POT(I) UPORABE XGEVA 120 mg injekcija denosumab s.c.
The highest incidence of hypocalcaemia was observed in a phase III trial in patients with multiple myeloma. 
Največjo pojavnost hipokalciemije so opažali v preskušanju III. faze pri bolnikih z diseminiranim plazmocitomom.
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: 
V fazah dvojno slepega primarnega zdravljenja v štirih kliničnih preskušanjih III. faze, kontroliranih z učinkovino, pri bolnikih z napredovanimi malignomi, ki so zajeli kosti, so novonastale primarne malignome potrdili pri 54/3691 (1,5 %) bolnikov, zdravljenih z zdravilom XGEVA (mediana izpostavljenost 13,8 meseca; razpon: 1,0 - 51,7) in 33/3688 (0,9 %) bolnikov, zdravljenih z zoledronsko kislino (mediana izpostavljenost 12,9 meseca; razpon: 1,0 - 50,8).
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. 
V dvojno slepi fazi zdravljenja v tem preskušanju je bila osteonekroza čeljustnice potrjena pri 5,9 % bolnikov, zdravljenih z zdravilom XGEVA (mediana izpostavljenost 19,4 meseca; razpon od 1 do 52), in pri 3,2 % bolnikov, zdravljenih z zoledronsko kislino.
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). 
faze z eno samo skupino pri bolnikih z gigantocelularnim kostnim tumorjem se je osteonekroza čeljustnice pojavila pri 2,3 % (12 od 523) bolnikov, zdravljenih z zdravilom XGEVA (mediana celotna izpostavljenost 20,3 meseca, razpon: 0 - 83,4).
Denosumab is composed solely of amino acids and carbohydrates as native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms. 
Denosumab je kot naraven imunoglobulin sestavljen zgolj iz aminokislin in ogljikovih hidratov.
Clinical efficacy in patients with multiple myeloma 
Klinična učinkovitost pri bolnikih z diseminiranim plazmocitomom
You should take calcium and vitamin D supplements while being treated with XGEVA unless your blood calcium is high. 
Med zdravljenjem z zdravilom XGEVA morate prejemati dodatke kalcija in vitamina D, razen če imate visoko koncentracijo kalcija v krvi.
active-controlled studies, in IV-bisphosphonate naïve patients with advanced malignancies involving bone: adults with breast cancer (study 1), other solid tumours or multiple myeloma (study 2), and castrate-resistant prostate cancer (study 3). 
na 4 tedne so primerjali v treh randomiziranih, dvojno slepih, z učinkovino kontroliranih študijah bolnikov, ki še niso dobivali intravenskega bisfosfonata in so imeli napredovane malignome, ki so zajeli kosti: odrasle z rakom dojke (študija 1), drugimi solidnimi tumorji ali diseminiranim plazmocitomom (študija 2) in proti kastraciji odpornim rakom prostate (študija 3).
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. 
V fazi primarnega zdravljenja v treh kliničnih preskušanjih III. faze, kontroliranih z učinkovino, pri bolnikih z napredovanimi malignomi, ki so zajeli kosti, so osteonekrozo čeljustnice potrdili pri 1,8 % bolnikov, zdravljenih z zdravilom XGEVA (mediana izpostavljenost 12,0 mesecev; razpon: 0,140,5), in pri 1,3 % bolnikov, zdravljenih z zoledronsko kislino.
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. 
Zdravljenje odraslih bolnikov in skeletno dozorelih mladostnikov z gigantocelularnim kostnim tumorjem, ki ni operabilen, ali pri katerem bi kirurška odstranitev verjetno povzročila hudo obolevnost.
NAME OF THE MEDICINAL PRODUCT XGEVA 120 mg solution for injection 
IME ZDRAVILA XGEVA 120 mg raztopina za injiciranje
Atypical femoral fracture1 
občasni atipični zlom stegnenice1
In clinical trials, the incidence of ONJ was higher with longer duration of exposure; ONJ has also been diagnosed after stopping treatment with XGEVA with the majority of cases occurring within 5 months after the last dose. 
Osteonekrozo čeljustnice so ugotavljali tudi po prenehanju zdravljenja z zdravilom XGEVA, in sicer se je večina teh primerov pojavila v 5 mesecih po zadnjem odmerku.
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti dispneja
How to store XGEVA 
Kako uporabljati zdravilo XGEVA
Lichenoid drug eruptions (e.g. lichen planus-like reactions), have been reported in patients in the postmarketing setting. 
V obdobju trženja zdravila so pri bolnikih poročali o lihenoidnih erupcijah zdravila (npr. reakcije, podobne lichen planusu).
Giant cell tumour of bone 
Gigantocelularni kostni tumor
A grade 4 decrease in serum calcium levels was experienced in 0.6% of patients treated with XGEVA and 0.2% of patients treated with zoledronic acid (see section 4.4). 
Znižanje koncentracije kalcija v serumu 4. stopnje se je pojavilo pri 0,6 % bolnikov, zdravljenih z zdravilom XGEVA, in pri 0,2 % bolnikov, zdravljenih z zoledronsko kislino (glejte poglavje 4.4).
In the post-marketing setting, musculoskeletal pain, including severe cases, has been reported in patients receiving XGEVA. 
Med obdobjem trženja zdravila so pri bolnikih, ki so dobivali zdravilo XGEVA, poročali o mišično-skeletni bolečini, vključno s hudimi primeri.
Patients treated with XGEVA should be given the package leaflet and the patient reminder card. Prevention of skeletal related events in adults with advanced malignancies involving bone The recommended dose is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm. 
Preprečevanje skeletnih dogodkov pri odraslih z napredovanimi malignomi, ki zajamejo kosti Priporočeni odmerek je 120 mg enkrat na 4 tedne v enkratni subkutani injekciji v stegno, trebuh ali nadlaket.
There were no clinically-relevant alterations in trough serum concentration and pharmacodynamics of denosumab (creatinine adjusted urinary N-telopeptide, uNTx/Cr) by concomitant chemotherapy and/or hormone therapy or by previous intravenous bisphosphonate exposure. 
Sočasna kemoterapija in/ali hormonsko zdravljenje ali predhodna intravenska izpostavljenost bisfosfonatom niso klinično pomembno spremenili najmanjše koncentracije denosumaba v serumu in farmakodinamike denosumaba (N-telopeptid v urinu, prilagojen na kreatinin, uNTx/Cr).
NR = not reached; NA = not available; HCM = hypercalcaemia of malignancy; SMR = skeletal morbidity rate; HR = Hazard Ratio; RRR = Relative Risk Reduction †Adjusted p-values are presented for Studies 1, 2 and 3 (first SRE and first and subsequent SRE endpoints); *Accounts for all skeletal events over time; only events occurring ≥ 21 days after the previous event are counted. 
ND = ni doseženo, NP = ni podatka, HKM = hiperkalciemija zaradi malignoma, DSO = stopnja skeletne obolevnosti, HR = razmerje ogroženosti (HR - Hazard Ratio), RRR = zmanjšanje relativnega tveganja (RRR - Relative Risk Reduction).
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. 
faze z eno samo skupino (študiji 5 in 6), ki sta zajeli 529 bolnikov z gigantocelularnim kostnim tumorjem, ki je bil inoperabilen, ali je bil takšen, da bi kirurški poseg spremljala huda obolevnost.
The following risk factors should be considered when evaluating a patient's risk of developing ONJ: 
Pri ocenjevanju bolnikovega tveganja za pojav osteonekroze čeljustnice je treba upoštevati naslednje dejavnike tveganja:
Combined advanced cancer 
Kombinirano napredovani rak zdravilo XGEVA
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. 
Odmerjanje za zdravljenje skeletno dozorelih mladostnikov z gigantocelularnim kostnim tumorjem, ki ni operabilen, ali pri katerem bi kirurška odstranitev verjetno povzročila hudo obolevnost, je enako kot za odrasle.
XGEVA reduced the risk of developing a SRE, and developing multiple SREs (first and subsequent) in patients with bone metastases from solid tumours (see table 2). 
Zdravilo XGEVA je bolnikom s kostnimi metastazami solidnih tumorjev zmanjšalo tveganje za pojav SRE in pojav (prvih ali nadaljnjih) multiplih SRE (glejte preglednico 2).
Denosumab 120 mg Q4W Zoledronic Acid 4 mg Q4W 
Denosumab 120 mg na 4 tedne Zoledronska kislina 4 mg na 4 tedne
A side effect called osteonecrosis of the jaw (bone damage in the jaw) has been reported commonly (may affect up to 1 in 10 people) in patients receiving XGEVA injections for cancer-related conditions. 
Pri bolnikih, ki so dobivali injekcije zdravila XGEVA zaradi bolezni, povezanih z rakom, so pogosto (pojavi se pri do 1 od 10 oseb) poročali o neželenem učinku, ki ga imenujemo osteonekroza čeljustnice (odmiranje kosti v čeljusti).
- if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6). 
Kaj morate vedeti, preden boste uporabili zdravilo XGEVA Ne uporabljajte zdravila XGEVA: - če ste alergični na denosumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
NR NR NR NR NR 28.6 
ND ND ND ND ND 28,6
First radiation to bone Hazard ratio (95% CI) 
Prvo obsevanje kosti Razmerje ogroženosti (95 % IZ)
There is no need for renal monitoring with XGEVA dosing. 
Med odmerjanjem zdravila XGEVA kontroliranje ledvic ni potrebno.
Non-inferiority / Superiority p-values 
Vrednosti p za neinferiornost / superiornost Delež bolnikov (%)
In the post-marketing setting, events of hypersensitivity, including rare events of anaphylactic reactions, have been reported in patients receiving XGEVA. 
Z zdravilom povezane preobčutljivostne reakcije V obdobju trženja zdravila so pri bolnikih, ki prejemajo zdravilo XGEVA, poročali o primerih preobčutljivosti, vključno z redkimi primeri anafilaktičnih reakcij.