FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Slučajevi osteonekroze čeljusti (vidjeti dio 4.4 i dio 4.8 - opis izdvojenih nuspojava) opaženi su često u bolesnika koji uzimaju lijek XGEVA.
English: There is no experience with overdose in clinical studies.
Croatian: U kliničkim ispitivanjima nema iskustva s predoziranjem.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „EXP“/„Rok valjanosti“.
English: 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.
Croatian: Vrijeme do smanjenja osjeta boli (odnosno ≥ 2 boda smanjenja od početne vrijednosti u rezultatu za najveću bol prema Kratkom upitniku o boli, BPI-SF) bilo je slično za denosumab i zoledronatnu kiselinu u svakom od ispitivanja i u integriranoj analizi.
English: Women should be advised not to become pregnant during and for at least 5 months after treatment with XGEVA.
Croatian: Žene se mora savjetovati da ne zatrudne za vrijeme i barem 5 mjeseci po završetku liječenja lijekom XGEVA.
English: HCM = hypercalcaemia of malignancy
Croatian: HCM = hiperkalcijemija maligne bolesti
English: Increased osteoclast activity, stimulated by RANKL, is a key mediator of bone destruction in metastatic bone disease and multiple myeloma.
Croatian: Pojačana aktivnost osteoklasta, stimulirana RANKL-om ključni je posrednik u uništavanju kosti kod metastatskih bolesti kosti i multiplog mijeloma.
English: Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.
Croatian: Obavijestite svog liječnika ukoliko osjetite novu ili neobičnu bol u kuku, preponama ili bedru.
English: 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.
Croatian: Dodatno praćenje razine kalcija potrebno je razmotriti tijekom terapije u bolesnika s čimbenicima rizika za hipokalcijemiju ili ukoliko postoji indikacija temeljena na kliničkom statusu bolesnika.
English: 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.
Croatian: Populacijska analiza farmakokinetike nije pokazala klinički značajne promjene u sistemskoj izloženosti denosumabu u stanju dinamičke ravnoteže s obzirom na dob (18 do 87 godina), rasu/etničku pripadnost (sudjelovali crnci, latinoamerikanci, azijati i bijelci), spol, tipove solidnih tumora ili u bolesnika s multiplim mijelomom.
English: XGEVA is not recommended for use in pregnant women and women of child-bearing potential not using contraception.
Croatian: Primjena lijeka XGEVA se ne preporučuje u trudnica i žena u reproduktivnoj dobi koje ne koriste kontracepciju.
English: Pre-existing hypocalcaemia must be corrected prior to initiating therapy with XGEVA.
Croatian: Prethodno postojeća hipokalcijemija mora biti korigirana prije početka liječenja lijekom XGEVA.
English: Your doctor should delay the start of your treatment if you have unhealed wounds in your mouth from dental procedures or oral surgery.
Croatian: Vaš liječnik treba odgoditi početak liječenja ukoliko u ustima imate nezacijeljene rane od stomatoloških zahvata ili oralnog kirurškog zahvata.
English: 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.
Croatian: Budući da je biološka aktivnost denosumaba u životinja specifična kod nehumanih primata, korištene su procjene genetski modificiranih (knockout) miševa ili drugi biološki inhibitori RANK/RANKL puta, kao što su OPG-Fc i RANK-Fc, za procjenu farmakodinamičkih svojstava denosumaba na modelima glodavaca.
English: During denosumab treatment, patients should be advised to report new or unusual thigh, hip, or groin pain.
Croatian: Tijekom liječenja denosumabom bolesnike treba savjetovati da prijave novu ili neobičnu bol u području bedara, kuka ili prepona.
English: treatment with denosumab may impair bone growth in children with open growth plates and may inhibit eruption of dentition.
Croatian: Dakle liječenje denosumabom može narušiti rast kostiju u djece s otvorenim pločama rasta te može inhibirati izbijanje zuba.
English: Unhealed lesions from dental or oral surgery.
Croatian: Nezacijeljene lezije nakon stomatološkog ili oralnog kirurškog zahvata.
English: 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).
Croatian: Prevencija koštanih događaja (patološke frakture, zračenje kosti, kompresija leđne moždine ili operacija kosti) u odraslih s uznapredovalim malignim bolestima koje zahvaćaju kosti (vidjeti dio 5.1).
English: • poor oral hygiene, periodontal disease, poorly fitting dentures, pre-existing dental disease, invasive dental procedures (e.g. tooth extractions).
Croatian: • lošu oralnu higijenu, bolesti parodonta, slabo prijanjajuće zubne proteze, postojeće dentalne bolesti, invazivne stomatološke zahvate (npr. vađenje zuba).
English: Denosumab is composed solely of amino acids and carbohydrates as native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms.
Croatian: Denosumab je sastavljen isključivo od aminokiselina i ugljikohidrata kao prirodni imunoglobulin te je mala vjerojatnost za njegovu eliminaciju putem jetrenih metaboličkih mehanizama.
English: If hypocalcaemia occurs while receiving XGEVA, additional calcium supplementation and additional monitoring may be necessary.
Croatian: U slučaju pojave hipokalcijemije tijekom primjene lijeka XGEVA, može biti nužna dodatna primjena nadomjestaka kalcija i dodatno praćenje.
English: Proportion (%) (95% CI)1
Croatian: Udio (%) (95% CI)1
English: 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.
Croatian: U Kohorti 1 (bolesnici s kirurški neizlječivom bolesti) medijan vremena do napredovanja bolesti nije dosegnut, kod 21 od 258 liječenih bolesnika zabilježeno je napredovanje bolesti.
English: In Cohort 2 (patients with surgically salvageable disease whose planned surgery was associated with severe morbidity), 209 of the 228 evaluable patients treated with XGEVA had not undergone surgery by month 6.
Croatian: U Kohorti 2 (bolesnici s kirurški izlječivom bolesti čija je planirana operacija povezana s teškim morbiditetom), 209 od 228 procjenjivih bolesnika liječenih lijekom XGEVA nije podvrgnuto operaciji u periodu od 6 mjeseci.
English: Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti i klasifikacije organskih sustava nuspojave su navedene prema padajućoj ozbiljnosti.
English: 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.
Croatian: Nuspojava zvana osteonekroza čeljusti (oštećenje kosti čeljusti) je često prijavljivana (može se pojaviti u do 1 na 10 osoba) u bolesnika koji primaju XGEVA injekcije za stanja povezana s rakom.
English: Temporary interruption of XGEVA treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Croatian: Potrebno je razmotriti privremeni prekid liječenja lijekom XGEVA dok se stanje ne riješi ili se dodatni čimbenici rizika ne ublaže, gdje je moguće.
English: Symptoms of hypocalcaemia in clinical studies included paraesthesias or muscle stiffness, twitching, spasms and muscle cramps.
Croatian: Simptomi hipokalcijemije u kliničkim ispitivanjima uključivali su paresteziju ili ukočenost mišića, trzanje, spazme i grčeve mišića.
English: 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.
Croatian: U skupini bolesnika u kojih je potvrđena ONČ, većina (81% u obje skupine bolesnika) je provodila lošu oralnu higijenu, prethodno su im vađeni zubi i/ili su koristili zubne proteze.
English: Study 5 enrolled 37 adult patients with histologically confirmed unresectable or recurrent giant cell tumour of bone.
Croatian: Ispitivanje 5 uključilo je 37 odraslih bolesnika s histološki potvrđenim neresektabilnim ili rekurentnim gigantocelularnim tumorom kosti.
English: An SRE was defined as any of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.
Croatian: SRE je definiran kao bilo koje od sljedećeg: patološka fraktura (kralježnička ili ne-kralježnička), terapija zračenjem kosti (uključujući primjenu radioizotopa), operacija kosti ili kompresija leđne moždine.
English: 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.
Croatian: Za klasifikaciju nuspojava temeljenih na stopi incidencija u četiri klinička ispitivanja faze III, dva klinička ispitivanja faze II i nakon stavljanja lijeka u promet (vidjeti tablicu 1) korištena je sljedeća konvencija: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: 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.
Croatian: Maligna bolest kod gigantocelularnog tumora kosti ili progresija u metastatsku bolest nije čest događaj i poznati je rizik u bolesnika s gigantocelularnim tumorom kosti.
English: Talk to your doctor before using XGEVA.
Croatian: Obratite se Vašem liječniku prije nego počnete primjenjivati lijek XGEVA.
English: 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).
Croatian: XGEVA je smanjila rizik od pojave SRE i pojave multiplih SRE (prvih i sljedećih) u bolesnika s koštanim metastazama solidnih tumora (vidjeti tablicu 2).
English: 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.
Croatian: Denosumab je humano monoklonsko protutijelo (IgG2) koje cilja i veže se s jakim afinitetom i specifičnošću za RANKL sprečavajući da dođe do interakcije RANKL/RANK koja rezultira smanjenjem broja i funkcije osteoklasta time smanjujući resorpciju kosti i rakom izazvanu destrukciju kosti.
English: XGEVA contains sorbitol
Croatian: XGEVA sadrži sorbitol
English: What XGEVA is and what it is used for What you need to know before you use XGEVA How to use XGEVA
Croatian: Što je XGEVA i za što se koristi Što morate znati prije nego počnete primjenjivati lijek XGEVA Kako primjenjivati lijek XGEVA Moguće nuspojave
English: Do not inject the solution if it is cloudy or discoloured.
Croatian: Nemojte injicirati otopinu ako je mutna ili je promijenila boju.
English: 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):
Croatian: Molimo odmah obavijestite svog liječnika ako primijetite bilo koji od sljedećih simptoma tijekom liječenja lijekom XGEVA (mogu se pojaviti u više od 1 na 10 osoba):
English: 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.
Croatian: Bolesnici koji su na kemoterapiji i/ili radioterapiji, koji uzimaju steroide ili antiangiogene lijekove (koriste se za liječenje raka), koji su podvrgnuti stomatološkom kirurškom zahvatu, koji ne posjećuju redovito stomatologa, imaju bolest desni ili koji su pušači, imaju potencijalno veći rizik od razvoja osteonekroze čeljusti.
English: 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.
Croatian: Nakon stavljanja lijeka u promet zabilježena je teška simptomatska hipokalcijemija (uključujući i smrtne slučajeve) gdje se većina slučajeva pojavila u prvim tjednima od početka terapije.
English: 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.
Croatian: Smanjen rast kostiju, promjene u pločama rasta i narušeno izbijanja zuba također su primijećeni u ispitivanjima novorođenih štakora koji su primali RANKL inhibitore, a ove su promjene bile djelomično reverzibilne nakon prestanka davanja RANKL inhibitora.
English: In male mice genetically engineered to express huRANKL (knock-in mice), which were subjected to a transcortical fracture, denosumab delayed the removal of cartilage and remodelling of the fracture callus compared to control, but biomechanical strength was not adversely affected.
Croatian: U mužjaka miševa genetski modificiranih za ekspresiju huRANKL (knock-in miševi) koji su bili podvrgnuti transkortikalnoj frakturi denosumab je odgodio uklanjanje hrskavice i remodeliranje frakturnog kalusa u usporedbi s kontrolom, ali biomehanička snaga nije bila smanjena.
English: First and subsequent SRE Mean number of events/patient Rate ratio (95% CI) Skeletal morbidity rate per year
Croatian: Srednja vrijednost broja događaja/bolesnik Omjer stopa (95% CI) Stopa skeletalnog morbiditeta po godini
English: Inhibition of RANK/RANK ligand (RANKL) in animal studies has been coupled to inhibition of bone growth and lack of tooth eruption, and these changes were partially reversible upon cessation of RANKL inhibition (see section 5.3).
Croatian: Inhibicija RANK/RANK liganda (RANKL) u ispitivanjima na životinjama povezana je s inhibicijom rasta kostiju i izostankom izbijanja zubi, a ove su promjene bile djelomično reverzibilne nakon prestanka RANKL inhibicije (vidjeti dio 5.3).
English: 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.
Croatian: Uz pomoć svog liječnika odlučit ćete hoćete li prestati dojiti ili ćete prestati primjenjivati lijek XGEVA, uzimajući u obzir koristi od dojenja za dijete i korist od primjene lijeka XGEVA za majku.
English: 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).
Croatian: Početna pred-terapijska upotreba analgetika u kohorti 1 i kohorti 2 je graduirana na skali od sedam točaka, gdje je 74,8 % bolesnika prijavilo nikakvu ili blagu upotrebu analgetika (tj. analgetičko bodovanje ≤ 2) i 25,2 % bolesnika koristilo je snažne opioidne lijekove (analgetičko bodovanje 3 do 7).
English: However, the effects on lymph nodes and tooth malalignment persisted, and minimal to moderate mineralisation in multiple tissues was seen in one animal (relation to treatment uncertain).
Croatian: Međutim, ostao je učinak na limfne čvorove i poremećen raspored zuba te je zamijećena minimalna do umjerena mineralizacija u više tkiva kod jedne životinje (povezanost s liječenjem nije utvrđena).
English: 1.7 mL solution in a single use vial (type I glass) with stopper (fluoropolymer coated elastomeric) and seal (aluminium) with flip-off cap.
Croatian: 1,7 ml otopine u bočici za jednokratnu uporabu (staklo tip I) s čepom (elastomer obložen fluoropolimerom) i aluminijskim prstenom s „flip-off“ kapicom.
English: 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.
Croatian: Sve bolesnike treba poticati na održavanje dobre higijene usne šupljine, odlazak na redovite stomatološke preglede i da odmah prijave bilo kakve simptome vezane uz usnu šupljinu kao što su klimanje zubi, bol ili oticanje, ili nezarastanje rana ili iscjedak tijekom liječenja denosumabom.
English: • 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.
Croatian: • Odmah se obratite svom liječniku i stomatologu ako primijetite bilo kakve probleme s usnom šupljinom ili zubima kao što su klimanje zubi, bol ili oticanje, nezarastanje rana ili iscjedak, jer to mogu biti znakovi osteonekroze čeljusti.
English: Your doctor may recommend a dental examination before you start treatment with XGEVA.
Croatian: Vaš liječnik može preporučiti stomatološki pregled prije početka liječenja lijekom XGEVA.
English: Osteonecrosis of the external auditory canal3,4
Croatian: Osteonekroza vanjskog slušnog kanala3,4
English: 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.
Croatian: XGEVA je procijenjena u međunarodnom, randomiziranom (1:1), dvostruko slijepom, aktivno kontroliranom ispitivanju lijeka XGEVA u usporedbi sa zoledronatnom kiselinom u bolesnika s novom dijagnozom multiplog mijeloma, ispitivanju 4.
English: Clinical efficacy in patients with multiple myeloma
Croatian: Klinička djelotvornost u bolesnika s multiplim mijelomom
English: In clinical studies, neutralising antibodies have not been observed for denosumab.
Croatian: U kliničkim ispitivanjima nije zabilježeno stvaranje neutralizirajućih protutijela na denosumab.
English: 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.
Croatian: Žene reproduktivne dobi trebaju koristiti učinkovite metode kontracepcije tijekom liječenja lijekom XGEVA i najmanje 5 mjeseci nakon prestanka liječenja lijekom XGEVA.
English: In the post-marketing setting, severe symptomatic hypocalcaemia (including fatal cases) has been reported (see section 4.8), with most cases occurring in the first weeks of initiating therapy, but can occur later.
Croatian: Nakon puštanja lijeka u promet zabilježena je teška simptomatska hipokalcijemija (uključujući i smrtne slučajeve) (vidjeti dio 4.8), gdje se većina slučajeva pojavila u prvim tjednima nakon početka liječenja, iako se mogu pojaviti i kasnije.
English: 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.
Croatian: Kada je kod ovih modela OPG-Fc kombiniran s hormonskom terapijom (tamoksifen) ili kemoterapijom (docetaksel), postojala je dodatna inhibicija rasta koštanog tumora kod raka dojke, prostate i pluća.
English: 1 single use vial 3 single use vials 4 single use vials
Croatian: 1 bočica za jednokratnu upotrebu 3 bočice za jednokratnu upotrebu 4 bočice za jednokratnu upotrebu
English: The decreases in serum calcium were generally appropriately managed by calcium and vitamin D supplementation.
Croatian: Smanjenja razine kalcija u serumu općenito su se uspješno liječila nadomjestkom kalcija i vitamina D.
English: Study 1*
Croatian: Ispitivanje 1*
English: XGEVA is used in adults with advanced cancer to prevent serious complications caused by bone metastasis (e.g. fracture, pressure on the spinal cord or the need to receive radiation therapy or surgery).
Croatian: XGEVA se primjenjuje u odraslih osoba koje boluju od uznapredovalog raka za sprečavanje ozbiljnih komplikacija uzrokovanih koštanim metastazama (primjerice, prijelom kosti, pritisak na leđnu moždinu ili potreba za terapijom zračenjem ili operacijom).
English: No data are available on the effect of denosumab on human fertility.
Croatian: Nema podataka o učincima denosumaba na plodnost u ljudi.
English: Most subjects were receiving or had received chemotherapy.
Croatian: Većina je bolesnika paralelno primala ili je ranije primala kemoterapiju.
English: XGEVA has been administered in clinical studies using doses up to 180 mg every 4 weeks and 120 mg weekly for 3 weeks.
Croatian: XGEVA je u kliničkim ispitivanjima primjenjivana u dozama do 180 mg svaka 4 tjedna i 120 mg tjedno tijekom 3 tjedna.
English: Anaphylactic reaction1
Croatian: Anafilaktička reakcija1
English: Disease progression and overall survival with bone metastases from solid tumours
Croatian: Progresija bolesti i ukupno preživljenje s koštanim metastazama solidnih tumora
English: 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.
Croatian: XGEVA sadrži denosumab, protein (monoklonsko protutijelo) koji usporava razaranje kosti uzrokovano širenjem raka na kosti (koštane metastaze) ili gigantocelularnim tumorom kosti.
English: 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):
Croatian: Molimo odmah obavijestite svog liječnika ili stomatologa ako primijetite bilo koji od sljedećih simptoma tijekom liječenja lijekom XGEVA ili nakon prestanka liječenja (mogu se pojaviti u do 1 na 10 osoba):
English: In two phase II single-arm clinical trials in patients with giant cell tumour of bone, hypocalcaemia was reported in 5.7% of patients.
Croatian: U dva klinička ispitivanja faze II na jednoj skupini bolesnika s gigantocelularnim tumorom kosti, hipokalcijemija je prijavljena u 5,7% bolesnika.
English: 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.
Croatian: Bolesnici u ispitivanju faze II koji su bili podvrgnuti kompletnoj resekciji gigantocelularnog tumora kosti, primali su terapiju dodatnih 6 mjeseci nakon operacije sukladno protokolu ispitivanja.
English: The vial may be left outside the refrigerator to reach room temperature (up to 25°C) before injection.
Croatian: Bočicu možete ostaviti izvan hladnjaka kako bi prije injiciranja postigla sobnu temperaturu (do 25°C).
English: Atypical femoral fracture1
Croatian: Atipična femoralna fraktura1
English: If you are nursing during treatment with XGEVA, please inform your doctor.
Croatian: Ako dojite tijekom liječenja s lijekom XGEVA molimo Vas obavijestite svog liječnika o tome.
English: Study 3*
Croatian: Ispitivanje 3*