natgillin/translations-raw huggingface dataset:
Denosumab displayed non-linear pharmacokinetics with dose over a wide dose range, but approximately dose-proportional increases in exposure for doses of 60 mg (or 1 mg/kg) and higher. 
Farmakokinetika denosumaba je bila v širokem razponu odmerkov nelinearna, a povečanja izpostavljenosti so bila približno odmerku sorazmerna za odmerke 60 mg (ali 1 mg/kg) in večje.
Each 1.7 mL of solution contains 78 mg sorbitol (E420). 
1,7 ml raztopine vsebuje 78 mg sorbitola (E420).
Controlled clinical studies of XGEVA in patients with advanced malignancies involving bone over age 65 revealed similar efficacy and safety in older and younger patients. 
Kontrolirane klinične študije zdravila XGEVA pri bolnikih nad 65. letom starosti z napredovanimi malignomi, ki so zajeli kosti, so pri starejših in mlajših bolnikih pokazale podobno učinkovitost in varnost.
A population pharmacokinetic analysis did not indicate clinically significant changes in the systemic exposure of denosumab at steady-state with respect to age (18 to 87 years), race/ethnicity (Blacks, Hispanics, Asians and Caucasians explored), gender or solid tumour types or patients with multiple myeloma. 
Populacijska farmakokinetična analiza ni pokazala klinično pomembnih sprememb sistemske izpostavljenosti denosumabu v stanju dinamičnega ravnovesja glede na starost (od 18 do 87 let), raso/etnično pripadnost (raziskani črnci, hispani, azijci in belci), spol ali vrsto solidnega tumorja ali bolnikov z diseminiranim plazmocitomom.
Temporary interruption of XGEVA treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible. 
Razmisliti je treba o začasnem prenehanju zdravljenja z zdravilom XGEVA, dokler se to stanje ne razreši in se sovpleteni dejavniki tveganja ublažijo, če je mogoče.
Hypocalcaemia can be severe and symptomatic (see section 4.8 - description of selected adverse reactions). 
Hipokalciemija je lahko huda in simptomatska (glejte poglavje 4.8 Opis izbranih neželenih učinkov).
• new or unusual pain in your hip, groin or thigh (this may be an early indication of a possible fracture of the thigh bone), 
• nova ali neobičajna bolečina v kolku, dimljah ali stegnu (to je lahko zgoden znak možnega zloma stegnenice),
In the post-marketing setting, severe symptomatic hypocalcaemia (including fatal cases) has been reported, with most cases occurring in the first weeks of initiating therapy. 
V obdobju trženja zdravila so poročali o hudi simptomatski hipokalciemiji (vključno s smrtnimi primeri), večina primerov se je pojavila v prvih tednih po uvedbi zdravljenja.
XGEVA is not recommended for use in pregnant women and women of child-bearing potential not using contraception. 
Zdravila XGEVA ni priporočljivo uporabljati pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
XGEVA has not been tested in pregnant women. 
Zdravilo XGEVA ni preizkušeno pri nosečnicah.
treatment with denosumab may impair bone growth in children with open growth plates and may inhibit eruption of dentition. 
Zdravljenje z denosumabom torej lahko prizadene rast kosti pri otrocih z odprtimi rastnimi ploščicami in lahko zavre izraščanje zob.
Among subjects with confirmed ONJ, most (81% in both treatment groups) had a history of tooth extraction, poor oral hygiene, and/or use of a dental appliance. 
Med bolniki s potrjeno osteonekrozo čeljustnice, je imela večina (81 % v obeh terapevtskih skupinah) anamnezo ekstrakcije zoba, slabe ustne higiene in/ali uporabe zobne proteze.
Symptoms of hypocalcaemia in clinical studies included paraesthesias or muscle stiffness, twitching, spasms and muscle cramps. 
Simptomi hipokalciemije v kliničnih študijah so vključevali parestezije ali otrdelost mišic, trzanje, spazme in mišične krče.
• bone, joint, and/or muscle pain which is sometimes severe, 
• bolečina v kosteh, sklepih in/ali mišicah, ki je včasih huda,
The use of XGEVA has not been studied in children and adolescents with other cancers that have spread to bone. 
Uporaba zdravila XGEVA ni raziskana pri otrocih in mladostnikih z drugimi vrstami raka, ki so se razširili v kosti.
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 
2 RECIST 1.1: Prilagojena merila RECIST (Response Evaluation Criteria in Solid Tumours) za oceno bremena tumorja na podlagi računalniške tomografije (CT)/magnetnoresonančnega slikanja (MRI) 3 EORTC: Prilagojena merila EORTC (European Organisation for Research and Treatment of Cancer) za oceno presnovnega odziva z uporabo pozitronske emisijske tomografije s fluorodeoksiglukozo (FDG-PET) 4 Gostota/velikost: Prilagojena inverzna Choieva merila za oceno velikosti in gostote tumorja z uporabo Hounsfieldovih enot na podlagi CT/MRI
** Including NSCLC, renal cell cancer, colorectal cancer, small cell lung cancer, bladder cancer, head and neck cancer, GI/genitourinary cancer and others, excluding breast and prostate cancer. 
** Vključno z nedrobnoceličnim pljučnim rakom, rakom ledvičnih celic, kolorektalnim rakom, drobnoceličnim pljučnim rakom, rakom mehurja, rakom glave in vratu, rakom gastrointestinalnega/genitourinarnega sistema in drugimi, izključujoč raka dojke in raka prostate.
The number of patients across both study arms with ISS stage I, stage II, and stage III at diagnosis were 32.4%, 38.2%, and 29.3%, respectively. 
V obeh študijskih skupinah je bil delež bolnikov, ki so imeli ob diagnozi stadij I po ISS 32,4 %, stadij II 38,2 % in stadij III 29,3 %.
Elderly patients (age ≥ 65) No dose adjustment is required in elderly patients (see section 5.2). 
Starejši bolniki (stari ≥ 65 let) Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
It is not known whether XGEVA is excreted in breast milk. 
Ni znano, ali se zdravilo XGEVA izloča v materino mleko.
The time to pain improvement (i.e. ≥ 2-point decrease from baseline in BPI-SF worst pain score) was similar for denosumab and zoledronic acid in each study and the integrated analyses. 
Čas do zmanjšanja bolečine (tj. zmanjšanje za ≥ 2 točki v primerjavi z izhodiščem po BPI-SF skali najslabše ocene bolečin) je bil z denosumabom in zoledronsko kislino podoben v vsaki študiji zase in v skupnih analizah.
Hypocalcaemia can occur at any time during therapy with XGEVA. 
Hipokalciemija se lahko pojavi kadarkoli med zdravljenjem z zdravilom XGEVA.
• If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with XGEVA. 
• Če se trenutno zdravite pri zobozdravniku ali imate predviden kirurški poseg v ustni votlini (npr. izdrtje zob), obvestite svojega zdravnika o zobnem zdravljenju, svojemu zobozdravniku pa povejte, da se zdravite z zdravilom XGEVA.
INFORMATION IN BRAILLE xgeva 
PODATKI V BRAILLOVI PISAVI xgeva
Additional monitoring of calcium level should be considered during therapy in patients with risk factors for hypocalcaemia, or if otherwise indicated based on the clinical condition of the patient. 
O dodatnih kontrolah koncentracije kalcija med zdravljenjem je treba razmisliti pri bolnikih, ki imajo dejavnike tveganja za hipokalciemijo, ali če so takšne kontrole sicer umestne glede na bolnikovo klinično stanje.
The European Medicines Agency has waived the obligation to submit the results of studies with XGEVA in all subsets of the paediatric population in the prevention of skeletal related events in patients with bone metastases and subsets of the paediatric population below the age of 12 in the treatment of giant cell tumour of bone (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom XGEVA za vse skupine pediatričnih bolnikov za preprečevanje skeletnih dogodkov pri bolnikih s kostnimi metastazami in za skupine pediatrične populacije, mlajše od 12 let, za zdravljenje gigantocelularnega kostnega tumorja (za podatke o uporabi pri pediatričnih bolnikih glejte poglavje 4.2).
The primary outcome measure was demonstration of non-inferiority of time to first on study skeletal related event (SRE) as compared to zoledronic acid. 
Primarna mera izida je bil dokaz neinferiornosti časa do prvega skeletnega dogodka med študijo v primerjavi z zoledronsko kislino.
This medicinal product contains sorbitol. 
Zdravilo vsebuje sorbitol.
If the level of calcium in your blood is low, your doctor may decide to give you calcium supplements before you start treatment with XGEVA. 
Če imate nizko koncentracijo kalcija v krvi, se zdravnik lahko odloči za dajanje dodatkov kalcija še pred začetkom zdravljenja z zdravilom XGEVA.
In subjects who discontinued 120 mg every 4 weeks, the mean half-life was 28 days (range 14 to 55 days). 
Pri preiskovancih, ki so prenehali prejemati 120 mg na 4 tedne, je bil povprečni razpolovni čas 28 dni (razpon: od 14 do 55 dni).
In 190 subjects evaluable for objective tumour response, 55 subjects had giant cell tumour of bone surgery, out of which 40 subjects had complete resections. 
Od 190 bolnikov, ocenljivih glede objektivnega odziva tumorja, jih je 55 imelo kirurški poseg gigantocelularnega kostnega tumorja, od teh pa 40 popolno resekcijo.
Talk to your doctor before using XGEVA. 
Pogovorite se z zdravnikom, preden dobite zdravilo XGEVA.
Study 5 enrolled 37 adult patients with histologically confirmed unresectable or recurrent giant cell tumour of bone. 
Študija 5 je zajela 37 odraslih bolnikov s histološko potrjenim inoperabilnim ali recidivnim gigantocelularnim kostnim tumorjem.
Other medicines and XGEVA 
Druga zdravila in zdravilo XGEVA
Density/Size4 
Gostota/velikost4
Malignancy in giant cell tumour of bone or progression to metastatic disease is an infrequent event and a known risk in patients with giant cell tumour of bone. 
Malignost pri gigantocelularnem kostnem tumorju ali napredovanje do metastatske bolezni je redek dogodek in je znano tveganje pri bolnikih z gigantocelularnim kostnim tumorjem.
You should not take XGEVA together with other medicines containing denosumab or bisphosphonates. 
Zdravila XGEVA ne smete jemati skupaj z drugimi zdravili, ki vsebujejo denosumab, ali z bisfosfonati.
Superiority p-value 
Vrednosti p za superiornost
Adolescent primates dosed with denosumab at 2.7 and 15 times (10 and 50 mg/kg dose) the clinical exposure had abnormal growth plates. 
Pri adolescentnih primatih, ki so dobivali denosumab v odmerkih 2,7- in 15-kratne (odmerek 10 in 50 mg/kg) klinične izpostavljenosti, so ugotovili nenormalne rastne ploščice.
Most subjects were receiving or had received chemotherapy. 
Večina bolnikov je trenutno ali pred tem prejemala kemoterapijo.
Clinically significant hypercalcaemia after treatment discontinuation has been reported in the post-marketing setting in paediatric patients (see section 4.4). 
O klinično pomembni hiperkalciemiji po prenehanju zdravljenja so v obdobju trženja poročali pri pediatričnih bolnikih (glejte poglavje 4.4).
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1). 
Preprečevanje skeletnih dogodkov (patoloških zlomov, obsevanja kosti, kompresije hrbtenjače ali operacije kosti) pri odraslih z napredovanimi malignomi, ki zajamejo kosti (glejte poglavje 5.1).
If you become pregnant during treatment with XGEVA or less than 5 months after stopping treatment with XGEVA, please inform your doctor. 
Če zanosite med zdravljenjem z zdravilom XGEVA ali manj kot 5 mesecev po koncu zdravljenja z zdravilom XGEVA, o tem obvestite svojega zdravnika.
Monitoring of calcium levels and adequate intake of calcium and vitamin D is especially important in patients with renal impairment (see section 4.4). 
Kontrole koncentracije kalcija in ustrezen vnos kalcija in vitamina D so posebej pomembni za bolnike z okvaro ledvic (glejte poglavje 4.4).
Increased osteoclast activity, stimulated by RANKL, is a key mediator of bone destruction in metastatic bone disease and multiple myeloma. 
Povečana aktivnost osteoklastov, ki jo spodbuja RANKL, je ključni posrednik razgradnje kosti pri metastatski bolezni kosti in diseminiranem plazmocitomu.
In studies demonstrating superiority of XGEVA to zoledronic acid, patients were offered open-label XGEVA in a pre-specified 2-year extension treatment phase. 
V študijah, ki so pokazale superiornost zdravila XGEVA pred zoledronsko kislino, so bolnikom ponudili odprto uporabo zdravila XGEVA v vnaprej opredeljeni fazi 2-letnega podaljšanega zdravljenja.
Unhealed lesions from dental or oral surgery. 
Nezaceljene lezije po zobnih ali ustnih kirurških posegih.
Excipient with known effects 
Pomožne snovi z znanim učinkom
These could be signs that you have low calcium levels in the blood. 
To so lahko znaki, da imate nizko koncentracijo kalcija v krvi.
While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to XGEVA administration. 
Med zdravljenjem je izvajanje invazivnih zobozdravniških posegov dovoljeno le po skrbnem razmisleku in se jim je treba izogniti v bližini termina za odmerjanje zdravila XGEVA.
In Cohort 1 (patients with surgically unsalvageable disease), median time to disease progression was not reached, 21 of the 258 treated patients had disease progression. 
V 1. kohorti (bolniki s kirurško nerešljivo boleznijo) mediani čas do napredovanja bolezni ni bil dosežen, bolezen je napredovala pri 21 od 258 zdravljenih bolnikov.
XGEVA is a solution for injection (injection). 
Zdravilo XGEVA je raztopina za injiciranje (injekcija).
Lichenoid drug eruptions 
Lihenoidne erupcije zdravila
• The vial should not be re-entered. 
• V vialo se ne sme poseči več kot enkrat.
• rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions). 
• izpuščaj na koži ali razjede v ustih (lihenoidne erupcije zdravila).
Study 3 prostate cancer 
Študija 3: rak prostate
Study 3* 
Študija 3*
What XGEVA is and what it is used for What you need to know before you use XGEVA How to use XGEVA 
Kaj je zdravilo XGEVA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo XGEVA Kako uporabljati zdravilo XGEVA Možni neželeni učinki
The cumulative incidence at one year was 1.1 % for denosumab and 0.6 % for zoledronic acid, respectively. 
Kumulativna incidenca je pri enem letu znašala 1,1 % za denosumab in 0,6 % za zoledronsko kislino.
• Before administration, the XGEVA solution should be inspected visually. 
• Pred uporabo je treba raztopino zdravila XGEVA vizualno pregledati.
Do not inject the solution if it is cloudy or discoloured. 
Raztopine ne smete dajati, če je motna ali obarvana.
The alterations were not considered clinically-relevant, since pharmacodynamic effects based on bone turnover markers were consistent across a wide range of body weight. 
Teh sprememb niso ocenili za klinično pomembne, ker so bili farmakodinamski učinki, ocenjeni z označevalci presnove kostnega tkiva, podobni pri zelo različnih telesnih masah.
This study did not control for prognostic factors and anti-neoplastic treatments. 
V študiji ni bilo prilagoditve ("kontrole") za prognostične dejavnike in antineoplastična zdravljenja.
4 Class effect 
4 Učinek skupine.
In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take: 
Da boste zmanjšali tveganje za nastanek osteonekroze čeljustnice, morate upoštevati nekatere previdnostne ukrepe.
Study 6 enrolled 507 adult or skeletally mature adolescents with giant cell tumour of bone and evidence of measurable active disease. 
Študija 6 je zajela 507 odraslih ali skeletno dozorelih mladostnikov z gigantocelularnim kostnim tumorjem in znaki merljive aktivne bolezni.
Proportion (%) (95% CI)1 
Delež (%) (95 % IZ) 1
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. 
Po vključitvi 282 bolnikov, kombinirano v 1. in 2. kohorto študije 6, so o klinično pomembnem zmanjšanju najhujše bolečine (tj. ≥ 2 točki manjše od izhodišča) poročali pri 31,4 % bolnikov s tveganjem (tj. tistih, ki so imeli izhodiščno oceno najhujše bolečine ≥ 2) v 1. tednu zdravljenja in ≥ 50 % v 5. tednu.
Pre-existing hypocalcaemia must be corrected prior to initiating therapy with XGEVA. 
Obstoječo hipokalciemijo je treba odpraviti še pred začetkom zdravljenja z zdravilom XGEVA.
Study 1* 
Študija 1*
The following convention has been used for the classification of the adverse reactions based on incidence rates in four phase III, two phase II clinical studies and post-marketing experience (see table 1): very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data. 
faze in iz izkušenj v obdobju trženja zdravila (glejte tabelo 1), je uporabljen naslednji dogovor: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in pogostnost neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
The median number of doses administered was 16 for XGEVA and 15 for zoledronic acid. 
Mediano število uporabljenih odmerkov zdravila XGEVA je bilo 16 in zoledronske kisline 15.
In clinical trials, XGEVA has been administered in combination with standard anti-cancer treatment and in subjects previously receiving bisphosphonates. 
V kliničnih preskušanjih so zdravilo XGEVA dajali v kombinaciji s standardnim zdravljenjem proti raku in preiskovancem, ki so predhodno prejemali bisfosfonate.
Patients undergoing chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medicines (used to treat cancer), undergoing dental surgery, who do not receive routine dental care, have gum disease or who are smokers, may have a higher risk of developing osteonecrosis of the jaw. 
Bolniki, ki prejemajo kemoterapijo in/ali radioterapijo, jemljejo steroide ali antiangiogena zdravila (uporabljajo se za zdravljenje raka), imajo zobozdravstven kirurški poseg, niso deležni redne zobozdravstvene oskrbe, imajo bolezen dlesni ali so kadilci, imajo lahko večje tveganje za nastanek osteonekroze čeljustnice.
Since the biological activity of denosumab in animals is specific to nonhuman primates, evaluation of genetically engineered (knockout) mice or use of other biological inhibitors of the RANK/RANKL pathway, such as OPG-Fc and RANK-Fc, were used to evaluate the pharmacodynamic properties of denosumab in rodent models. 
Ker je biološka aktivnost denosumaba pri živalih specifična za ne-humane primate, so za oceno farmakodinamičnih lastnosti denosumaba pri glodalcih uporabili genetsko spremenjene ("knockout") miši ali druge biološke zaviralce poti RANK/RANKL poti, npr. OPG-Fc in RANK-Fc.
Once removed from the refrigerator, XGEVA may be stored at room temperature (up to 25°C) for up to 30 days in the original container. 
Ko vzamete zdravilo XGEVA iz hladilnika, ga lahko shranjujete pri sobni temperaturi (do 25 °C ) do 30 dni v originalnem vsebniku.
The risk of developing hypocalcaemia and accompanying elevations in parathyroid hormone increases with increasing degree of renal impairment. 
Tveganje za pojav hipokalciemije in spremljajočega zvišanja paratiroidnega hormona se povečuje s povečano stopnjo okvare ledvic.
Baseline pre-treatment analgesic use in cohort 1 and cohort 2 was graded on a seven point scale, where 74.8% of patients reported no or mild analgesic use (i.e. analgesic score ≤ 2) and 25.2% of patients used strong opioids (i.e. analgesic score 3 to 7). 
Izhodiščno uporabo analgetikov pred zdravljenjem so v 1. in 2. kohorti ocenjevali na sedemstopenjski lestvici, pri čemer je 74,8 % bolnikov poročalo, da analgetikov niso uporabljali ali so uporabljali blage (tj. ocena analgetikov ≤ 2), 25,2 % bolnikov pa je uporabljalo močne opioide (tj. ocena analgetikov 3 do 7).
XGEVA has been administered in clinical studies using doses up to 180 mg every 4 weeks and 120 mg weekly for 3 weeks. 
Zdravilo XGEVA so v kliničnih študijah uporabljali v odmerkih do 180 mg na 4 tedne in 120 mg na teden 3 tedne.
First and subsequent SRE Mean number of events/patient Rate ratio (95% CI) Skeletal morbidity rate per year 
Prvi in nadaljnji skeletni dogodki Povprečno število dogodkov/bolnika Razmerje deležev (95 % IZ) Deleže skeletne obolevnosti na leto
Zoledronic Acid (N = 859) 
Zoledronska kislina (N = 859)
In a mouse model of mammary tumour induction, RANK-Fc reduced hormone-induced proliferation in mammary epithelium and delayed tumour formation. 
V mišjem modelu indukcije mamarnih tumorjev je RANK-Fc zmanjšal hormonsko izzvano proliferacijo mamarnega epitelija in je zakasnil nastanek tumorjev.
A post-hoc analysis in study 2 (patients with other solid tumours or multiple myeloma) examined overall survival for the 3 tumour types used for stratification (non-small cell lung cancer, multiple myeloma, and other). 
Post hoc analiza v študiji 2 (bolniki z drugimi solidnimi tumorji ali diseminiranim plazmocitomom) je raziskala celokupno preživetje pri 3 vrstah tumorjev, uporabljenih za stratifikacijo (nedrobnocelični pljučni rak, diseminirani plazmocitom in drugi).
When OPG-Fc was combined with hormonal therapy (tamoxifen) or chemotherapy (docetaxel) in these models, there was additive inhibition of skeletal tumour growth in breast, and prostate or lung cancer respectively. 
Če je bil OPG-Fc v teh modelih kombiniran s hormonskim zdravljenjem (tamoksifen) ali kemoterapijo (docetaksel), so ugotovili dodatno zavrtje skeletne tumorske rasti pri raku dojke, prostate in pljuč.
Patients being treated with XGEVA should not be treated concomitantly with other denosumab containing medicinal products (for osteoporosis indications). 
Bolniki, zdravljeni z zdravilom XGEVA, sočasno ne smejo prejemati drugih zdravil, ki vsebujejo denosumab (za indikacije pri osteoporozi).
It may contain trace amounts of clear to white particles. 
Vsebuje lahko sledove prosojnih do belih delcev.
Clear, colourless to slightly yellow solution and may contain trace amounts of translucent to white proteinaceous particles. 
Bistra, brezbarvna do rahlo rumena raztopina, ki lahko vsebuje sledove prosojnih do belih beljakovinskih delcev.
In patients with giant cell tumour of bone, denosumab binds to RANK ligand, significantly reducing or eliminating osteoclast-like giant cells. 
Pri bolnikih z gigantocelularnim kostnim tumorjem se denosumab veže na RANK-ligand in znatno zmanjša ali odstrani osteoklastom podobne gigantske celice.
Low calcium levels in the blood 
Nizka koncentracija kalcija v krvi
High calcium levels in the blood after stopping treatment with XGEVA Some patients with giant cell tumour of the bone have developed high calcium levels in the blood weeks to months after stopping treatment. 
Visoka raven kalcija v krvi po prenehanju zdravljenja z zdravilom XGEVA Pri nekaterih bolnikih z gigantocelularnim kostnim tumorjem so se visoke ravni kalcija v krvi pojavljale še tedne do mesece po prenehanju zdravljenja.
HR (95% CI) / RRR (%) 
HR (95 % IZ) / RRR (%)
• Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw. 
• Takoj se posvetujte z zdravnikom in zobozdravnikom, če se vam med zdravljenjem ali potem, ko je zdravnik končal vaše zdravljenje, pojavijo težave z usti ali zobmi, kot so majanje zob, bolečina ali oteklina, razjede, ki se ne celijo, ali izcedek, saj so to lahko znaki osteonekroze čeljustnice.