natgillin/translations-raw huggingface dataset:
In subjects with advanced cancer, who received multiple doses of 120 mg every 4 weeks an approximate 2-fold accumulation in serum denosumab concentrations was observed and steady-state was achieved by 6 months, consistent with time-independent pharmacokinetics.
Pri preiskovancih z napredovalim rakom, ki so dobili večkratne odmerke 120 mg na 4 tedne so ugotovili približno 2-kratno kopičenje koncentracije denosumaba v serumu; stanje dinamičnega ravnovesja je bilo doseženo do 6 meseca, kar se sklada s farmakokinetiko, neodvisno od časa.
Patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia.
Bolniki s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) ali bolniki na dializi imajo večje tveganje za pojav hipokalciemije.
XGEVA was evaluated in an international, randomised (1:1), double-blind, active-controlled study comparing XGEVA with zoledronic acid in patients with newly diagnosed multiple myeloma, study 4.
Zdravilo XGEVA so ocenili v mednarodni, randomizirani (1:1), dvojno slepi, z učinkovino kontrolirani študiji, ki je primerjala zdravilo XGEVA z zoledronsko kislino pri bolnikih z novodiagnosticiranim diseminiranim plazmocitomom, študija 4.
Based on duration of exposure, there are insufficient data in giant cell tumour of bone patients to assess risk of ONJ beyond 2 years.
Glede na trajanje izpostavljenosti pri bolnikih z gigantocelularnim kostnim tumorjem ni dovolj podatkov za oceno tveganja za osteonekrozo čeljustnice v obdobju nad 2 leti.
The trials in patients with breast or prostate cancer included an XGEVA extension treatment phase (median overall exposure of 14.9 months; range: 0.1 - 67.2).
Preskušanja pri bolnicah z rakom dojke ali bolnikih z rakom prostate so obsegala podaljšano fazo zdravljenja z zdravilom XGEVA (mediana celotna izpostavljenost 14,9 meseca; razpon: 0,1 - 67,2).
The vial may be left outside the refrigerator to reach room temperature (up to 25°C) before injection.
Pred injiciranjem lahko vialo pustite zunaj hladilnika, da doseže sobno temperaturo (do 25 °C).
All patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with denosumab.
Vsem bolnikom je treba naročiti, da morajo med zdravljenjem z denosumabom vzdrževati dobro ustno higieno, redno opravljati zobozdravniške preglede in nemudoma obvestiti zdravnika, če se pojavi kakršen koli simptom v ustih, na primer majanje zob, bolečina, oteklina, rana, ki se ne celi, ali izcedek.
Study 2 other solid tumours** or multiple myeloma
Študija 2: drugi solidni tumorji** ali diseminirani plazmocitom
You may have low levels of calcium in your blood.
Morda imate nizko koncentracijo kalcija v krvi.
Please tell your doctor immediately if you develop any of these symptoms while being treated with XGEVA (may affect more than 1 in 10 people):
Zdravniku morate takoj povedati, če se vam med zdravljenjem z zdravilom XGEVA pojavi kateri od naslednjih simptomov (lahko se pojavijo pri več kot 1 od 10 bolnikov):
The recommended dose of XGEVA is 120 mg administered once every 4 weeks, as a single injection under the skin (subcutaneous).
Priporočeni odmerek zdravila XGEVA je 120 mg, ki ga prejmete enkrat na 4 tedne v obliki enkratne injekcije pod kožo (subkutano).
Patients being treated with XGEVA should not be treated concomitantly with bisphosphonates.
Bolniki, zdravljeni z zdravilom XGEVA, sočasno ne smejo prejemati bisfosfonatov.
Your healthcare professional will not administer XGEVA to you if you have a very low level of calcium in your blood which has not been treated.
Zdravnik vam zdravila XGEVA ne bo injiciral, če imate zelo nizko koncentracijo kalcija v krvi in to stanje ni bilo zdravljeno.
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).
V kliničnih preskušanjih III. faze bolnikov z napredovanimi malignomi, ki so zajele kosti, se je mediana znižanja uNTx/Cr približno 80 % ohranilo v 49 tednih zdravljenja z zdravilom XGEVA (120 mg na vsake 4 tedne).
Neonatal RANK/RANKL knockout mice exhibited decreased body weight, reduced bone growth, altered growth plates and lack of tooth eruption.
Novoskotene RANK/RANKL knockout miši so imele manjšo telesno maso, upočasnjeno rast kosti, spremenjene rastne ploščice in niso jim izrasli zobje.
Clinically significant hypercalcaemia has also been reported in this patient group weeks to months following treatment discontinuation.
Tudi v tej skupini bolnikov so poročali o klinično pomembni hiperkalciemiji še tedne do mesece po prenehanju zdravljenja.
Similar fractures reported in association with bisphosphonates are often bilateral; therefore the contralateral femur should be examined in denosumab-treated patients who have sustained a femoral shaft fracture.
Podobni zlomi, opisani v zvezi z bisfosfonati, so pogosto obojestranski, zato je treba pri bolnikih, ki se zdravijo z denosumabom in so imeli zlom srednjega dela stegnenice, opraviti tudi pregled druge stegnenice.
1.7 mL solution in a single use vial (type I glass) with stopper (fluoropolymer coated elastomeric) and seal (aluminium) with flip-off cap.
1,7 ml raztopine v viali (iz stekla tipa I) za enkratno uporabo z zamaškom (elastomeren, prekrit s fluoropolimerom) in tesnilom (aluminij) s snemno zaporko.
This medicine contains less than 1 mmol sodium (23 mg) per 120 mg, i.e. essentially ‘sodium-free'.
Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na 120 mg, kar pomeni, da je praktično "brez natrija".
In a study of cynomolgus monkeys dosed with denosumab during the period equivalent to the first trimester of pregnancy, denosumab doses resulting in 9 times greater systemic exposure than the recommended human dose did not induce maternal toxicity or foetal harm during a period equivalent to the first trimester, although foetal lymph nodes were not examined.
V študiji na opicah cynomolgus, ki so prejemale denosumab med obdobjem, ki ustreza prvemu trimesečju nosečnosti, odmerki denosumaba, ki so povzročili 9-krat večjo sistemsko izpostavljenost kot priporočeni odmerek za človeka, niso povzročili maternalne toksičnosti ali škode za plod med obdobjem, ustreznim prvemu trimesečju, vendar pa niso raziskali bezgavk plodov.
Osteonecrosis of the external auditory canal3,4
pogostnost neznana osteonekroza zunanjega slušnega kanala3, 4
Efficacy results for XGEVA compared to zoledronic acid in patients with newly diagnosed multiple myeloma
Rezultati učinkovitosti zdravila XGEVA v primerjavi z zoledronsko kislino pri bolnikih z novodiagnosticiranim diseminiranim plazmocitomom
• high calcium levels in the blood (hypercalcaemia) after stopping treatment in patients with giant cell tumour of the bone,
• visoka raven kalcija v krvi (hiperkalciemija) po prenehanju zdravljenja pri bolnikih z gigantocelularnim kostnim tumorjem,
XGEVA is not recommended in patients with growing skeletons (see section 4.2).
Zdravilo XGEVA ni priporočljivo pri bolnikih, ki se jim skelet še razvija (glejte poglavje 4.2).
Denosumab 120 mg Q4W (N = 859) Zoledronic Acid 4 mg Q4W (N = 859)
Denosumab 120 mg na 4 tedne (N = 859) Zoledronska kislina 4 mg na 4 tedne (N = 859)
XGEVA was studied in an open-label trial that enrolled 18 skeletally mature adolescents with giant cell tumour of bone.
Zdravilo XGEVA so raziskali v odprtem preskušanju, ki je zajelo 18 skeletno dozorelih mladostnikov z gigantocelularnim kostnim tumorjem.
Kaplan-Meier plot for time to first on-study SRE in patients with newly diagnosed multiple myeloma
Kaplan-Meierjevi prikaz časa do prvega skeletnega dogodka med študijo pri bolnikih z novodiagnosticiranim diseminiranim plazmocitomom
Disease progression was similar between XGEVA and zoledronic acid in all three studies and in the pre-specified analysis of all three studies combined.
Napredovanje bolezni in celokupno preživetje pri bolnikih s kostnimi metastazami solidnih tumorjev Napredovanje bolezni je bilo podobno pri zdravilu XGEVA in zoledronski kislini v vseh treh študijah in v vnaprej opredeljeni analizi vseh treh študij skupaj.
Your doctor may recommend a dental examination before you start treatment with XGEVA.
Zdravnik vam bo morda svetoval, da pred začetkom zdravljenja z zdravilom XGEVA opravite zobozdravniški pregled.
If you are nursing during treatment with XGEVA, please inform your doctor.
Če med zdravljenjem z zdravilom XGEVA dojite, o tem obvestite zdravnika.
The recommended dose of XGEVA is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm with additional 120 mg doses on days 8 and 15 of treatment of the first month of therapy.
Priporočeni odmerek zdravila XGEVA je 120 mg enkrat na 4 tedne v enkratni subkutani injekciji v stegno, trebuh ali nadlaket ter dodaten odmerek 120 mg 8. in 15. dan zdravljenja v prvem mesecu terapije.
First SRE or HCM Median time (months)
Prvi skeletni dogodek ali HCM Mediani čas (meseci)
Please tell your doctor and dentist immediately if you experience any of these symptoms while being treated with XGEVA or after stopping treatment (may affect up to 1 in 10 people):
Zdravniku in zobozdravniku morate takoj povedati, če se vam med zdravljenjem z zdravilom XGEVA ali po končanju vašega zdravljenja, pojavi kateri od naslednjih simptomov (lahko se pojavijo pri največ 1 od 10 bolnikov):
Overall of 225 patients for whom giant cell tumours of bone surgery (excluding lung metastases only) was planned, 109 had no surgery performed and 84 underwent a less morbid procedure than planned at baseline.
V celoti ni imelo opravljenega kirurškega posega 109 od 225 bolnikov, pri katerih je bil načrtovan kirurški poseg gigantocelularnega kostnega tumorja (izključujoč samo metastaze na pljučih), 84 bolnikov pa je imelo opravljen manj težaven kirurški poseg, kot je bil sprva načrtovan.
New primary malignancy
pogosti novonastali primarni malignom1
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.
V celoti je zdravilo XGEVA doseglo objektiven odziv tumorja v 71,6 % (95 % IZ: 64,6, 77,9) bolnikov (preglednica 4) ocenjen na vse načine, pri čemer je bila večina odzivov opredeljena z zmanjšanjem aktivnosti PET s fluorodeoksiglukozo ali s povečanjem gostote, izmerjene na CT/HU, le 25,1 % bolnikov je imelo odziv po RECIST.
In subjects with multiple myeloma who received 120 mg every 4 weeks, median trough levels varied by less than 8% between months 6 and 12.
Pri bolnikih z diseminiranim plazmocitomom, ki so prejemali 120 mg na 4 tedne, se je mediana najnižja koncentracija od 6. do 12. meseca razlikovala za manj kot 8 %.
First SRE Median time (months)
Prvi SRE Mediana čas (meseci)
XGEVA contains denosumab, a protein (monoclonal antibody) that works to slow down bone destruction caused by cancer spreading to the bone (bone metastasis) or by giant cell tumour of bone.
Denosumab je beljakovina (monoklonsko protitelo), ki deluje tako, da upočasni razgradnjo kosti, nastalo zaradi širjenja raka v kost (kostne metastaze) ali zaradi gigantocelularnega kostnega tumorja.
Discontinuation of XGEVA therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient based on an individual benefit-risk assessment.
Pri bolnikih, pri katerih obstaja sum na atipičen zlom stegnenice, je treba razmisliti o prenehanju uporabe zdravila XGEVA ob vrednotenju bolnika glede na individualno oceno koristi in tveganja.
XGEVA zoledronic acid
zoledronska kislina
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
Neželeni učinki, poročani pri bolnikih z napredovanimi malignomi, ki so zajeli kosti, diseminiranim plazmocitomom ali z gigantocelularnim kostnim tumorjem Organski sistem po MedDRA Kategorija pogostnosti
No treatment-related pattern in individual cancers or cancer groupings was apparent.
Pri posameznih rakih ali skupinah rakov ni bilo mogoče razbrati nobenega vzorca, povezanega z zdravljenjem.
NR 26.4
ND 26,4 20,6
XGEVA is not recommended for children and adolescents under 18 years of age except for adolescents with giant cell tumour of the bone whose bones have stopped growing.
Uporaba zdravila XGEVA ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let, razen pri mladostnikih, ki imajo gigantocelularni kostni tumor in so jim kosti že nehale rasti.
- Your doctor will give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with XGEVA.
Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni pred in med zdravljenjem z zdravilom XGEVA.
XGEVA is not recommended in paediatric patients (age < 18) other than skeletally mature adolescents with giant cell tumour of bone (see section 4.4).
Zdravilo XGEVA ni priporočljivo za pediatrične bolnike (stare < 18 let) z izjemo skeletno dozorelih mladostnikov z gigantocelularnim kostnim tumorjem (glejte poglavje 4.4).
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.
V študiji 6 so zdravilo XGEVA ocenjevali v podskupini 18 mladostnikov (starih 13 - 17 let) z gigantocelularnim kostnim tumorjem, ki so že dosegli kostno zrelost, opredeljeno kot vsaj 1 zrela dolga kost (npr. zaprta epifizna rastna ploščica nadlahtnice) in so imeli telesno maso ≥ 45 kg.
The median time to ONJ was 18.7 months (range: 1 - 44).
Mediani čas do osteonekroze čeljustnice je bil 18,7 meseca (razpon: od 1 do 44).
The solution may contain trace amounts of translucent to white proteinaceous particles.
Raztopina lahko vsebuje sledove prosojnih do belih beljakovinskih delcev.
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.
Varnost in učinkovitost zdravila XGEVA pri pediatričnih bolnikih (starih < 18 let) še nista bili dokazani z izjemo skeletno dozorelih mladostnikov z gigantocelularnim kostnim tumorjem.
Objective treatment response in patients with giant cell tumour of bone
Objektivni odziv na zdravljenje pri bolnikih z gigantocelularnim kostnim tumorjem
XGEVA contains sorbitol
Zdravilo XGEVA vsebuje sorbitol
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.
Celotna, za bolnik-leta korigirana incidenca (število dogodkov na 100 bolnik-let) potrjene osteonekroze čeljustnice je bila 1,1 % v prvem letu zdravljenja, 3,7 % v drugem letu in 4,6 % na leto pozneje.
In two phase II single-arm clinical trials in patients with giant cell tumour of bone, hypocalcaemia was reported in 5.7% of patients.
faze z eno samo skupino pri bolnikih z gigantocelularnim kostnim tumorjem so poročali o hipokalciemiji pri 5,7 % bolnikov.
Hypercalcaemia following treatment discontinuation in patients with giant cell tumour of bone and in patients with growing skeletons
Hiperkalciemija po prenehanju zdravljenja bolnikov z gigantocelularnim kostnim tumorjem in pri bolnikih s še razvijajočim se skeletom
A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with denosumab.
Pred zdravljenjem z denosumabom je priporočljivo opraviti zobozdravstveni pregled in preventivno zobozdravstveno oskrbo ter individualno oceno koristi in tveganja.
Women of child-bearing potential should use effective methods of contraception while being treated with XGEVA and for at least 5 months after stopping treatment with XGEVA.
Ženske v rodni dobi morajo med zdravljenjem z zdravilom XGEVA in vsaj še 5 mesecev po koncu zdravljenja s tem zdravilom uporabljati učinkovito kontracepcijsko zaščito.
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.