natgillin/translations-raw huggingface dataset:
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.
A grade 3 decrease in serum calcium levels was experienced in 2.5% of patients treated with XGEVA and 1.2% of patients treated with zoledronic acid.
Znižanje koncentracije kalcija v serumu 3. stopnje se je pojavilo pri 2,5 % bolnikov, zdravljenih z zdravilom XGEVA, in pri 1,2 % bolnikov, zdravljenih z zoledronsko kislino.
In phase II clinical studies of patients with advanced malignancies involving bone, subcutaneous (SC) dosing of XGEVA administered either every 4 weeks (Q4W) or every 12 weeks resulted in a rapid reduction in markers of bone resorption (uNTx/Cr, serum CTx), with median reductions of approximately 80% for uNTx/Cr occurring within 1 week regardless of prior bisphosphonate therapy or baseline uNTx/Cr level.
faze pri bolnikih z napredovalimi malignomi, ki so zajeli kosti, je subkutana (s.c.) uporaba zdravila XGEVA, aplicirana bodisi na 4 tedne bodisi na 12 tednov, povzročila hitro znižanje označevalcev resorpcije kosti (uNTx/kreatinin, serumski CTx).
Cases of osteonecrosis of the jaw (see sections 4.4 and section 4.8 - description of selected adverse reactions) have been commonly observed in patients taking XGEVA.
Pri bolnikih, ki prejemajo zdravilo XGEVA, so pogosto opazili primere osteonekroze čeljustnice (glejte poglavje 4.4 in poglavje 4.8 - Opis izbranih neželenih učinkov).
Your doctor will then help you decide whether to stop breast-feeding or whether to stop taking XGEVA, considering the benefit of breast-feeding to the baby and the benefit of XGEVA to the mother.
Na podlagi upoštevanja koristi dojenja za otroka in koristi zdravljenja z zdravilom XGEVA za mater vam bo zdravnik pomagal pri odločitvi, ali prenehati z dojenjem ali prenehati z jemanjem zdravila XGEVA.
The decreases in serum calcium were generally appropriately managed by calcium and vitamin D supplementation.
Znižanje kalcija v serumu so na splošno ustrezno odpravili z dodatki kalcija in vitamina D. Najbolj pogosti neželeni učinki zdravila XGEVA so mišično-skeletne bolečine.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 120 mg denosumaba v 1,7 ml raztopine (70 mg/ml).
XGEVA contains sodium
Zdravilo XGEVA vsebuje natrij
ONJ has been reported commonly in patients receiving XGEVA (see section 4.8).
Pri bolnikih, zdravljenih z zdravilom XGEVA, so o osteonekrozi čeljustnice poročali pogosto (glejte poglavje 4.8).
In studies 1, 2 and 3, overall survival was balanced between XGEVA and zoledronic acid in patients with advanced malignancies involving bone: patients with breast cancer (hazard ratio and 95% CI was 0.95 [0.81, 1.11]), patients with prostate cancer (hazard ratio and 95% CI was 1.03 [0.91, 1.17]), and patients with other solid tumours or multiple myeloma (hazard ratio and 95% CI was 0.95 [0.83, 1.08]).
(razmerje ogroženosti in 95 % IZ 0,95 [0,81, 1,11]), bolniki z rakom prostate (razmerje ogroženosti in 95 % IZ 1,03 [0,91, 1,17]) in bolniki z drugimi solidnimi tumorji ali diseminiranim plazmocitomom (razmerje ogroženosti in 95 % IZ 0,95 [0,83, 1,08]).
N = Number of subjects randomised * = Statistically significant for superiority; ** = Statistically significant for non-inferiority
ZA = Zoledronska kislina 4 mg na 4 tedne N = Število randomiziranih preiskovancev * = Statistično značilno za superiornostf; ** = Statistično značilno za neinferiornost
Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.
Če se vam pojavi nova ali neobičajna bolečina v kolku, dimljah ali stegnu, se posvetujte z zdravnikom.
Hypocalcaemia1, 2
Presnovne in prehranske motnje zelo pogosti hipokalciemija1, 2
• persistent pain in the mouth and/or jaw, and/or swelling or non-healing of sores in the mouth or jaw, discharge, numbness or feeling of heaviness in the jaw, or loosening of a tooth could be signs of bone damage in the jaw (osteonecrosis).
• trajna bolečina v ustih in/ali čeljustnici, in/ali oteklost ali neceljenje razjed v ustih ali čeljustnici,
Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing the RANKL/RANK interaction from occurring and resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction.
Tako prepreči pojav interakcije RANKL/RANK ter zmanjša število in delovanje osteoklastov, s čimer zmanjša resorpcijo kosti in z rakom povzročeno razgradnjo kosti.
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.
Za vključitev v te študije niso bili primerni bolniki s predhodno anamnezo osteonekroze čeljustnice ali osteomielitisa čeljustnice, aktivno zobno ali čeljustno boleznijo, ki je zahtevala kirurški poseg v ustih, nezaceljenim stanjem po zobnem/ustnem kirurškem posegu ali katerim koli načrtovanim invazivnim zobozdravstvenim posegom.
First radiation to bone Median time (months)
Vrednosti p za superiornost Prvo obsevanje kosti Mediana čas (meseci)
The start of treatment/new treatment course should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Pri bolnikih, ki imajo nezaceljene lezije mehkih tkiv v ustih, je treba začetek zdravljenja/nov ciklus zdravljenja odložiti.
Clinically significant hypercalcaemia requiring hospitalisation and complicated by acute renal injury has been reported in XGEVA-treated patients with giant cell tumour of bone weeks to months following treatment discontinuation.
Pri bolnikih z gigantocelularnim kostnim tumorjem, ki so bili zdravljeni z zdravilom XGEVA, so še tedne do mesece po prenehanju zdravljenja poročali o klinično pomembni hiperkalciemiji, pri kateri je bilo potrebno bolnišnično zdravljenje in se je zapletla z akutno okvaro ledvic.
Rare side effects (may affect up to 1 in 1,000 people):
Redki neželeni učinki (lahko se pojavijo pri največ 1 od 1.000 bolnikov)
Hypercalcaemia following treatment discontinuation in patients with giant cell tumour of bone3
pogosti hipofosfatemija občasni hiperkalciemija po prenehanju zdravljenja pri bolnikih z gigantocelularnim kostnim tumorjem3
A grade 3 decrease in serum calcium levels was experienced in 1.4% of patients treated with XGEVA and 0.6% of patients treated with zoledronic acid.
Znižanje koncentracije kalcija v serumu 3. stopnje se je pojavilo pri 1,4 % bolnikov, zdravljenih z zdravilom XGEVA, in pri 0,6 % bolnikov, zdravljenih z zoledronsko kislino.
• To avoid discomfort at the site of injection, allow the vial to reach room temperature (up to
• Za preprečitev nelagodja na mestu dajanja je treba zagotoviti, da viala pred injiciranjem doseže sobno temperaturo (do 25 °C), zdravilo pa je treba injicirati počasi.
A grade 4 decrease in serum calcium levels was experienced in 0.4% of patients treated with XGEVA and 0.1% of patients treated with zoledronic acid.
Znižanje koncentracije kalcija v serumu 4. stopnje se je pojavilo pri 0,4 % bolnikov, zdravljenih z zdravilom XGEVA, in pri 0,1 % bolnikov, zdravljenih z zoledronsko kislino.
- If you get any side effects, talk to your doctor, pharmacist or nurse.
- Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.