natgillin/translations-raw huggingface dataset:
Clinical characteristics of these cases were similar between treatment groups.
Klinične značilnosti teh primerov so bile med zdravljenimi skupinami podobne.
Based on best response
Na podlagi najboljšega odziva 190
Within these active-controlled clinical trials, safety was evaluated in 5,931 patients.
V okviru teh kliničnih študij, kontroliranih z učinkovino, so varnost ocenjevali pri 5.931 bolnikih.
The median duration of response was not estimable (four patients experienced disease progressions following an objective response).
Mediana trajanje odziva ni bilo ocenljivo (štirim bolnikom je bolezen napredovala po objektivnem odzivu).
The overall incidence of clinically significant hypocalcaemia was 9%.
Celotna incidenca klinično pomembne hipokalciemije je bila 9 %.
This includes medicines obtained without a prescription.
To vključuje zdravila, ki ste jih dobili brez recepta.
Events have occurred during treatment and up to 9 months after treatment was discontinued (see section 4.4).
Dogodki so se pojavili med zdravljenjem in do 9 mesecev po prenehanju zdravljenja (glejte poglavje 4.4).
1 CI = Exact Confidence Interval
1 IZ = eksaktni interval zaupanja
Increasing body weight was associated with decreases in systemic exposure, and vice versa.
Povečevanje telesne mase je bilo povezano z zmanjšanjem sistemske izpostavljenosti in obratno.
Number of patients with an objective response
Število bolnikov z objektivnim odzivom
It is important to tell your doctor if you are pregnant, think you may be pregnant, or plan to get pregnant.
Pomembno je, da zdravniku poveste, če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev.
Problems with your mouth, teeth or jaw
Težave z usti, zobmi ali čeljustjo
Upon enrolment of 305 patients in studies 5 and 6 a retrospective independent review of radiographic imaging data was performed.
Potem, ko je bilo v študiji 5 in 6 vključenih 305 bolnikov, je bil opravljen retrospektiven, neodvisen pregled podatkov radiografskih slikanj.
No overall differences in safety or efficacy were observed between geriatric patients and younger patients.
V celoti niso ugotovili razlik v varnosti in učinkovitosti med geriatričnimi bolniki in mlajšimi.
Of the remaining 15 patients, 10 (67%) radiographic measurements showed no progression of the target lesion.
Pri preostalih 15 bolnikih 10 (67 %) radiografskih meritev ni pokazalo napredovanja ciljne lezije.
RANKL exists as a transmembrane or soluble protein.
RANKL obstaja kot transmembranska ali topna beljakovina.
For instructions for use, handling and disposal see section 6.6.
Za navodila glede uporabe, ravnanja z zdravilom in odstranjevanja glejte poglavje 6.6.
Efficacy results from study 4 are presented in figure 2 and table 3.
Rezultati učinkovitosti iz študije 4 so prikazani na sliki 2 in preglednici 3.
An investigator assessment reported that all 18 adolescent patients had a best response of stable disease or better (complete response in 2 patients, partial response in 8 patients, and stable disease in 8 patients).
Ocena raziskovalcev je navajala, da je imelo vseh 18 mladostnikov kot najboljši odziv stabilno bolezen ali boljši (popolni odziv pri 2 bolnikih, delni odziv pri 8 bolnikih in stabilna bolezen pri 8 bolnikih).
• The entire contents of the vial should be injected.
• Injicirajte celotno vsebino viale.
One hundred and ninety had at least 1 evaluable time point response and were included in the analysis (table 4).
Stodevetdeset jih je imelo vsaj 1 ocenljivo časovno točko odziva in so bili vključeni v analizo (preglednica 4).
Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Bolniki z redko prirojeno motnjo intolerance za fruktozo ne smejo uporabljati tega zdravila.
Each pack contains one, three or four single use vials.
Eno pakiranje vsebuje eno, tri ali štiri viale za enkratno uporabo.
Overall safety profile is consistent in all approved indications for XGEVA.
Celoten varnostni profil je skladen med vsemi odobrenimi indikacijami za zdravilo XGEVA.
N = number of subjects randomised
N = Število randomiziranih preiskovancev
• Before receiving treatment, tell your doctor/nurse (healthcare professional) if you have any problems with your mouth or teeth.
• Preden dobite zdravilo, morate zdravniku ali medicinski sestri (zdravstvenemu delavcu) povedati, če imate kakšne težave v ustih ali z zobmi.
Based on these limited data, the adverse event profile appeared to be similar to adults.
Na podlagi teh omejenih podatkov se zdijo značilnosti neželenih dogodkov podobne kot pri odraslih.
22.14 (14.26, NE)
22,14 (14,26, NO)
It is important to try to prevent osteonecrosis of the jaw developing as it may be a painful condition that can be difficult to treat.
Pomembno si je prizadevati, da bi preprečili nastanek osteonekroze čeljustnice, ker gre za stanje, ki lahko boli in ga je težko zdraviti.
Following subcutaneous administration, bioavailability was 62%.
Po subkutani uporabi je bila biološka uporabnost 62 %.
All 20 patients (100%) with histology assessments responded.
Odzvalo se je vseh 20 bolnikov (100 %), ki so imeli opravljeno histološko oceno.
22.8 (14.7, NE)
22,8 (14,7, NO)
Between weeks 9 and 49, median trough levels varied by less than 9%.
Med 9. in 49. tednom je mediana najnižja koncentracija variirala za manj kot 9 %.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine, since it contains sorbitol (E420).
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se z njim posvetujte, preden vzamete to zdravilo, ker vsebuje sorbitol (E420).
Patients should be monitored for radiological signs of malignancy, new radiolucency or osteolysis.
Bolnike je treba kontrolirati glede radioloških znakov malignosti, nove radiolucentnosti ali osteolize.
The primary and secondary endpoints evaluated the occurrence of one or more skeletal related events (SREs).
Primarni in sekundarni opazovani dogodek sta ocenjevala pojav enega ali več skeletnih dogodkov (SRE - Skeletal Related Events).
Patients with giant cell tumour of bone should be evaluated at regular intervals to determine whether they continue to benefit from treatment.
Bolnike z gigantocelularnim kostnim tumorjem je treba v rednih presledkih ocenjevati, da bi ugotovili, ali jim zdravljenje še koristi.
RANKL is essential for the formation, function and survival of osteoclasts, the sole cell type responsible for bone resorption.
RANKL je nujen za nastajanje, delovanje in preživetje osteoklastov, edine vrste celic, odgovorne za resorpcijo kosti.
Low calcium in the blood may also lead to a change in heart rhythm called QT prolongation, which is seen by electrocardiogram (ECG).
Nizek kalcij v krvi lahko povzroči spremembo srčnega ritma, imenovano podaljšanje QT, ki je vidna na elektrokardiogramu (EKG).
Response criteria included elimination of giant cells based on histopathology or lack of progression by radiography.
Merila odziva so vključevala odpravo celic velikank na podlagi histopatološkega pregleda ali odsotnost radiografskega napredovanja.
Study 2**
Študija 2**
The median time to response was 3.1 months (95% CI: 2.89, 3.65).
Mediani čas do odziva je bil 3,1 meseca (95 % IZ: 2,89, 3,65).
Number of patients evaluable for response
Število bolnikov, pri katerih je bilo mogoče oceniti odziv
• a bisphosphonate
• z bisfosfonatom.
Kaplan-Meier plots of time to first on-study SRE
Kaplan-Meierjevi prikazi časa do prvega SRE med študijo
Secondary outcome measures included superiority of time to first SRE, superiority of time to first and subsequent SRE, and overall survival.
Med sekundarnimi merami izida so bili superiornost časa do prvega skeletnega dogodka, superiornost časa do prvega in nadaljnjih skeletnih dogodkih in celokupno preživetje.
• low phosphate levels in the blood (hypophosphataemia),
• nizka koncentracija fosfata v krvi (hipofosfatemija),
NR 33.2
ND 33,2
HCM = hypercalcaemia of malignancy
HCM (hypercalcaemia of malignancy) = hiperkalciemija zaradi malignoma
Difference in median time (months)
Razlika v mediana času (meseci)
Regular monitoring of calcium levels is especially important in these patients.
Pri takšnih bolnikih so redne kontrole koncentracije kalcija posebej pomembne.
If you are being treated for giant cell tumour of bone, you will receive an additional dose 1 week and 2 weeks after the first dose.
Če se zdravite zaradi gigantocelularnega kostnega tumorja, boste dobili dodaten odmerek 1 teden in 2 tedna po prvem odmerku.
• removal of a tooth,
• izdrtje zoba,
Osteonecrosis of the jaw can also occur after stopping treatment.
Osteonekroza čeljustnice se lahko pojavi tudi po končanju zdravljenja.
• While being treated, you should maintain good oral hygiene and receive routine dental check-ups.
• Med zdravljenjem morate vzdrževati dobro ustno higieno in opravljati redne zobozdravniške preglede.
Consequently, osteolysis is reduced and proliferative tumour stroma is replaced with non-proliferative, differentiated, densely woven new bone.
Posledično se osteoliza zmanjša in proliferacijsko tumorsko stromo nadomesti neproliferacijsko, diferencirano, gosto novo kostno tkivo.
XGEVA is a clear, colourless to slightly yellow solution.
Zdravilo XGEVA je bistra, brezbarvna do rahlo rumena raztopina.
XGEVA has no or negligible influence on the ability to drive and use machines.
Zdravilo XGEVA nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
There is no experience with overdose in clinical studies.
Izkušenj s prevelikim odmerjanjem iz kliničnih študij ni.
Any effects of XGEVA are likely to be greater during the second and third trimesters of pregnancy since monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester.
Za vse učinke zdravila XGEVA je verjetno, da so večji v drugem ali tretjem trimesečju nosečnosti, kajti monoklonska protitelesa prehajajo skozi placento linearno, kot napreduje nosečnost, s tem da jih največja količina preide v tretjem trimesečju.
No dose adjustment is required in elderly patients.
Starejšim bolnikom odmerka ni treba prilagoditi.
In patients whose disease is controlled by XGEVA, the effect of interruption or cessation of treatment has not been evaluated, however limited data in these patients does not indicate a rebound effect upon cessation of treatment.
Pri bolnikih, ki imajo bolezen z zdravilom XGEVA obvladano, niso ocenili učinka prekinitve ali prenehanja zdravljenja, toda omejeni podatki pri teh bolnikih ne kažejo povratnega učinka po prenehanju zdravljenja.
It is especially important that you tell your doctor if you are being treated with
Posebej pomembno je, da zdravniku poveste, če se zdravite:
If hypocalcaemia occurs while receiving XGEVA, additional calcium supplementation and additional monitoring may be necessary.
Če se med prejemanjem zdravila XGEVA pojavi hipokalciemija, je lahko potrebno dodatno dodajanje kalcija in dodatne kontrole.
1 single use vial 3 single use vials 4 single use vials
1 viala za enkratno uporabo 3 viale za enkratno uporabo 4 viale za enkratno uporabo
Severe, untreated hypocalcaemia (see section 4.4).
Huda, nezdravljena hipokalciemija (glejte poglavje 4.4).
Calcium and vitamin D supplementation
Dodajanje kalcija in vitamina D
What XGEVA is and what it is used for
Kaj je zdravilo XGEVA in za kaj ga uporabljamo
Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids.
Pričakovati je, da njegova presnova in izločanje potekata po poteh očistka imunoglobulinov, ki vodijo v razgradnjo do majhnih peptidov in posameznih aminokislin.
Monitoring of calcium levels should be conducted (i) prior to the initial dose of XGEVA, (ii) within two weeks after the initial dose, (iii) if suspected symptoms of hypocalcaemia occur (see section 4.8 for symptoms).
Kontrolo koncentracije kalcija je treba izvesti (i) pred prvim odmerkom zdravila XGEVA, (ii) v dveh tednih po prvem odmerku, (iii) če se pojavijo simptomi, sumljivi za hipokalciemijo (za simptome glejte poglavje 4.8).
Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness.
V vsaki skupini pogostnosti in vsakem organskem sistemu so neželeni učinki navedeni po padajoči resnosti.
Tell your doctor if you have or have had severe kidney problems, kidney failure or have needed dialysis, which may increase your risk of getting low blood calcium, especially if you do not take calcium supplements.
Zdravniku morate tudi povedati, če imate ali ste kdaj imeli hude težave z ledvicami, ledvično odpoved ali ste potrebovali dializo; vse to lahko poveča vaše tveganje za pojav nizke koncentracije kalcija v krvi, še posebej, če ne jemljete dodatkov kalcija.
• poor oral hygiene, periodontal disease, poorly fitting dentures, pre-existing dental disease, invasive dental procedures (e.g. tooth extractions).
• slabo ustno higieno, periodontalno bolezen, slabo prilegajoče se zobne proteze, že obstoječo zobno bolezen, invazivne zobozdravstvene posege (npr. ekstrakcije zob).
Once your vial has been left to reach room temperature (up to 25°C), it must be used within 30 days.
Ko viala enkrat doseže sobno temperaturo (do 25 °C), jo morate uporabiti v 30 dneh.
Proportion of subjects without SRE
Delež bolnikov brez SRE
Of the 35 patients included in the efficacy analysis, 85.7% (95% CI: 69.7, 95.2) had a treatment response to XGEVA.
Od 35 bolnikov, vključenih v analizo učinkovitosti, se jih je 85,7 % (95 % IZ: 69,7, 95,2) odzvalo na zdravljenje z zdravilom XGEVA.
No dose adjustment is required in patients with renal impairment (see section 4.4 for recommendations relating to monitoring of calcium, 4.8 and 5.2).
Bolnikom z okvaro ledvic odmerka ni treba prilagoditi (glejte poglavje 4.4 za priporočila o kontrolah kalcija, 4.8 in 5.2).
In studies of denosumab (60 mg, n = 55 and 120 mg, n = 32) in patients without advanced cancer but with varying degrees of renal function, including patients on dialysis, the degree of renal impairment had no effect on the pharmacokinetics of denosumab; thus dose adjustment for renal impairment is not required.
V študijah z denosumabom (60 mg, n = 55, in 120 mg, n = 32) pri bolnikih brez napredovalega raka, a z različno stopnjo delovanja ledvic, vključno z bolniki na dializi, stopnja okvare ledvic ni vplivala na farmakokinetiko denosumaba, zato bolnikom z okvaro ledvic odmerka ni treba prilagoditi.
After treatment is discontinued, monitor patients for signs and symptoms of hypercalcaemia, consider periodic assessment of serum calcium and re-evaluate the patient's calcium and vitamin D supplementation requirements (see section 4.8).
Po prenehanju zdravljenja spremljajte bolnike glede znakov in simptomov hiperkalciemije, razmislite o rednem preverjanju serumskega kalcija ter ponovno opredelite bolnikove potrebe po dodajanju kalcija in vitamina D (glejte poglavje 4.8).
Effect on pain
Vpliv na bolečino
• allergic reactions (e.g. wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin).
• alergijske reakcije (npr. piskajoče dihanje ali oteženo dihanje; oteklost obraza, ustnic, jezika, grla ali drugih delov telesa; izpuščaj, srbenje ali koprivnica na koži).
The non-linearity is likely due to a saturable target-mediated elimination pathway of importance at low concentrations.
Nelinearnost je verjetno posledica saturabilne, s ciljem posredovane poti odstranjevanja, ki je pomembna pri nizkih koncentracijah.
Examples of clinical manifestations of severe symptomatic hypocalcaemia have included QT interval prolongation, tetany, seizures and altered mental status (including coma) (see section 4.4).
Med kliničnimi manifestacijami hude simptomatske hipokalciemije so bili podaljšanje intervala QT, tetanija, konvulzije in spremenjeno duševno stanje (vključno s komo) (glejte poglavje 4.4).
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.