FrancophonIA/ELRC3.0 huggingface dataset:
English: Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of ONJ.
Croatian: Obratite se odmah Vašem liječniku ili stomatologu ukoliko imate bilo kakvih problema s vašim ustima ili zubima kao što su klimanje zubi, bol ili otekline, ili nezarastanje rana ili iscjedak, jer to mogu biti znakovi ONČ.
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported rarely (may affect up to 1 in 1,000 people) in patients receiving Prolia for osteoporosis.
Croatian: Nuspojava zvana osteonekroza čeljusti (ONČ) (oštećenje kosti čeljusti) je rijetko prijavljivana (može se pojaviti u do 1 na 1000 osoba) u bolesnika koji primaju lijek Prolia za osteoporozu.
English: Women of child-bearing potential should use effective methods of contraception while being treated with Prolia and for at least 5 months after stopping treatment with Prolia.
Croatian: Žene reproduktivne dobi trebaju koristiti učinkovite metode kontracepcije tijekom liječenja lijekom Prolia i najmanje 5 mjeseci nakon prestanka liječenja lijekom Prolia.
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, učinak na limfne čvorove i poremećen poredak zubi je ostao te je u jedne životinje zabilježena minimalna do umjerena mineralizacija u više tkiva (povezanost s liječenjem nije sigurna).
English: In clinical studies, neutralising antibodies have not been observed for denosumab.
Croatian: U kliničkim ispitivanjima nisu otkrivena neutralizirajuća protutijela za denosumab.
English: DO NOT use the pre-filled syringe if the needle cover has been removed.
Croatian: NE koristite napunjenu štrcaljku ako je uklonjen poklopac igle.
English: Whilst being treated with Prolia you may develop a skin infection with symptoms such as a swollen, red area of skin, most commonly in the lower leg, that feels hot and tender (cellulitis), and possibly with symptoms of fever.
Croatian: Tijekom liječenja lijekom Prolia može Vam se pojaviti kožna infekcija sa simptomima kao što su natečeno područje s crvenom kožom, najčešće u području donjeg dijela noge, koje se čini vruće i osjetljivo (celulitis) i možda sa simptomima vrućice.
English: It is unknown whether denosumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se denosumab u majčinom mlijeku u ljudi.
English: At 1 year, the subject incidence of new radiological vertebral fracture was 2.7% (denosumab) versus 3.2% (risedronate).
Croatian: Tijekom 1 godine incidencija novih radioloških vertebralnih fraktura u ispitanika bila je 2,7% (denosumab) u usporedbi s 3,2% (risedronat).
English: Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures.
Croatian: Liječenje osteoporoze u žena u postmenopauzi i u muškaraca s povećanim rizikom od fraktura.
English: Musculoskeletal pain, including severe cases, has been reported in patients receiving Prolia in the post-marketing setting.
Croatian: Mišićno-koštana bol, uključujući i teške slučajeve, zabilježena je u bolesnika koji su primali lijek Prolia nakon stavljanja lijeka u promet.
English: Relative risk reduction (%) (95% CI)
Croatian: Relativno smanjenje rizika (%) (95% CI)
English: Please tell your doctor if you develop any of these symptoms while being treated with Prolia.
Croatian: Molimo obavijestite svog liječnika ako se pojave bilo koji od ovih simptoma dok ste na terapiji lijekom Prolia.
English: ONJ has been reported rarely, in 16 patients, in clinical trials in osteoporosis and in breast or prostate cancer patients receiving hormone ablation including a total of 23,148 patients (see section 4.4).
Croatian: ONČ je rijetko prijavljivana, u 16 bolesnika, u kliničkim ispitivanjima u bolesnika s osteoporozom i u bolesnika s rakom dojke ili prostate koji su primali hormonsku ablacijsku terapiju, a koja su uključivala ukupno 23 148 bolesnika (vidjeti dio 4.4).
English: Discontinuation of Prolia 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.
Croatian: Prekid liječenja lijekom Prolia kod bolesnika za koje se sumnja da imaju atipičnu femoralnu frakturu treba razmotriti na temelju individualne procjene koristi i rizika za svakog pacijenta.
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 muških miševa koji su genetski modificirani da eksprimiraju huRANKL (knock-in miševi), podvrgnutih transkortikalnim frakturama, denosumab je u usporedbi s kontrolom odgodio uklanjanje hrskavice i preoblikovanje frakturnog kalusa, ali nije bilo neželjenih učinaka na biomehaničku snagu.
English: The PRAC considers that due to the fact that fatal cases of hypocalcaemia have been reported for Prolia also during this reporting interval, and there was a timely typical association with Prolia administration, the wording ‘including fatal cases' should be added to the current text regarding hypocalcaemia in section 4.4 of the SmPC.
Croatian: PRAC smatra da zbog činjenice da su smrtni slučajevi hipokalcijemije prijavljivani za lijek Prolia i u ovom izvještajnom razdoblju i da je postojala vremenski tipična povezanost s primjenom lijeka Prolia, tekst “uključujući smrtne slučajeve” treba biti dodan postojećem tekstu u vezi hipokalcijemije u dijelu 4.4 sažetka opisa svojstava lijeka.
English: In another study of cynomolgus monkeys dosed with denosumab throughout pregnancy at AUC exposures 119-fold higher than the human dose (60 mg every 6 months), 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.
Croatian: U drugom ispitivanju u makaki majmuna koji su primili denosumab tijekom trudnoće s AUC izloženosti 119 puta većom od doze u ljudi (60 mg svakih 6 mjeseca), zabilježeno je povećanje mrtvorođenosti i postnatalnog mortaliteta; poremećaj rasta kosti koji rezultira smanjenom snagom kosti, smanjena hematopoeza, poremećaj poretka zubi; nedostatak perifernih limfnih čvorova; smanjen neonatalni rast.
English: There is no experience with overdose in clinical studies.
Croatian: U kliničkim ispitivanjima nije bilo iskustava s predoziranjem.
English: The following risk factors should be considered when evaluating a patient's risk of developing ONJ:
Croatian: Prilikom procjene rizika za razvoj ONČ kod bolesnika, potrebno je uzeti u obzir sljedeće faktore rizika:
English: Bone histology was also evaluated in 17 men with osteoporosis following 1 year treatment with Prolia.
Croatian: Histologija kosti je procijenjena i kod 17 muškaraca s osteoporozom nakon 1 godine liječenja lijekom Prolia.
English: What Prolia is and what it is used for
Croatian: Što je Prolia i za što se koristi
English: Atypical fractures of the femur
Croatian: Atipične frakture femura
English: The risks of developing hypocalcaemia and accompanying parathyroid hormone elevations increase with increasing degree of renal impairment.
Croatian: Rizik razvijanja hipokalcijemije te pratećeg porasta paratireoidnog hormona povećava se s povećanjem stupnja oštećenja bubrega.
English: There are no or limited amount of data from the use of denosumab in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni denosumaba u trudnica ograničeni.
English: Osteonecrosis of the external auditory canal has been reported with denosumab.
Croatian: Osteonekroza vanjskog slušnog kanala je bila prijavljena kod primjene denosumaba.
English: In a study of cynomolgus monkeys dosed with denosumab during the period equivalent to the first trimester at AUC exposures up to 99-fold higher than the human dose (60 mg every 6 months), there was no evidence of maternal or foetal harm.
Croatian: U ispitivanju u makaki majmuna izloženim denosumabu tijekom perioda ekvivalentnog prvom tromjesečju pri AUC izloženosti do 99 puta većoj od doze u ljudi (60 mg svakih 6 mjeseci) nije pokazana štetnost za majku ili fetus.
English: Symptoms include swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin, wheezing or difficulty breathing.
Croatian: Simptomi uključuju oticanje lica, usana, jezika, grla ili drugih dijelova tijela; osip, svrbež ili urtike na koži, piskanje ili otežano disanje.
English: Once removed from the refrigerator, Prolia may be stored at room temperature (up to 25°C) for up to 30 days in the original container.
Croatian: Jednom kada se izvadi iz hladnjaka, Prolia se može čuvati na sobnoj temperaturi (do 25 °C) do 30 dana u originalnom spremniku.
English: Ask your pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte Vašeg ljekarnika kako ukloniti lijekove koji Vam više nisu potrebni.
English: The effect of Prolia on the risk of clinical fractures over 3 years
Croatian: Tablica 3. Učinak lijeka Prolia na rizik kliničkih fraktura kroz 3 godine
English: Talk to your doctor or pharmacist before using Prolia
Croatian: Razgovarajte s svojim liječnikom ili ljekarnikom prije nego počnete primjenjivati lijek Prolia.
English: One pre-filled syringe.
Croatian: Jedna napunjena štrcaljka.
English: • upper respiratory tract infection,
Croatian: • infekcije gornjeg dišnog sustava,
English: Knockout mice (see section 4.6) lacking RANK or RANKL exhibited decreased body weight, reduced bone growth and lack of tooth eruption.
Croatian: U knockout miševa (vidjeti dio 4.6) kojima nedostaje RANK ili RANKL primijećena je smanjena tjelesna težina, smanjen rast kosti i nedostatak izbijanja zuba.
English: Incidence of ONJ was 0.04% at 3 years, 0.06% at 5 years and 0.44% at 10 years of Prolia treatment.
Croatian: Incidencija ONČ bila je 0,04% nakon 3 godine liječenja, 0,06% nakon 5 godina liječenja te 0,44% nakon 10 godina liječenja lijekom Prolia.
English: Two subpopulations were studied: glucocorticoid-continuing (≥ 7.5 mg daily prednisone or its equivalent for ≥ 3 months prior to study enrolment; n = 505) and glucocorticoid-initiating (≥ 7.5 mg daily prednisone or its equivalent for < 3 months prior to study enrolment; n = 290).
Croatian: Ispitane su dvije subpopulacije: bolesnici koji nastavljaju liječenje glukokortikoidima (≥ 7,5 mg prednizona ili ekvivalenta dnevno ≥ 3 mjeseca prije uključivanja u ispitivanje; n = 505) i bolesnici koji počinju liječenje glukokortikoidima (≥ 7,5 mg prednizona ili ekvivalenta dnevno < 3 mjeseca prije uključivanja u ispitivanje; n = 290).
English: It allows continued monitoring of the benefit-risk balance of the medicinal product.
Croatian: Time se omogućuje kontinuirano praćenje omjera koristi i rizika lijeka.
English: • have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction.
Croatian: • imate probleme sa usnom šupljinom ili zubima poput lošeg zdravlja zubi, bolesti desni ili planirano vađenje zuba.
English: MedDRA system organ class Frequency category
Croatian: MedDRA klasifikacija organskog sustava
English: Prolia demonstrated a 40% relative reduction (0.5% absolute risk reduction) in the risk of hip fracture over 3 years (p < 0.05).
Croatian: Prolia je pokazala 40%-tno relativno smanjenje (0,5%-tno smanjenje apsolutnog rizika) rizika frakture kuka tijekom 3 godine (p < 0,05).
English: A decision on whether to abstain from breast-feeding or to abstain from therapy with Prolia should be made, taking into account the benefit of breast-feeding to the newborn/infant and the benefit of Prolia therapy to the woman.
Croatian: Odluku o suzdržavanju od dojenja ili suzdržavanju od terapije lijekom Prolia treba donijeti uzimajući u obzir korist dojenja za novorođenče/dojenče te korist terapije lijekom Prolia za ženu.
English: No dose adjustment is required in patients with renal impairment (see section 4.4 for recommendations relating to monitoring of calcium).
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 4.4 za preporuke vezane uz praćenje razine kalcija).
English: Push the plunger all the way down as far as it will go to inject all the solution.
Croatian: Pritisnite klip do kraja, dokle ide, kako biste injicirali svu otopinu.
English: Open-label extension study in the treatment of postmenopausal osteoporosis A total of 4,550 women (2,343 Prolia & 2,207 placebo) who missed no more than one dose of investigational product in the pivotal study described above and completed the month 36 study visit agreed to enrol in a 7-year, multinational, multicentre, open-label, single-arm extension study to evaluate the long-term safety and efficacy of Prolia.
Croatian: Otvoreni produžetak ispitivanja liječenja postmenopauzalne osteoporoze Ukupno 4550 žena (2343 Prolia i 2207 placebo) koje nisu propustile više od jedne doze ispitivanog lijeka u pivotalnom ispitivanju koje je opisano u prethodnom tekstu i koje su završile posjet u 36. mjesecu ispitivanja pristalo je uključiti se u 7-godišnje, multinacionalno, multicentrično, otvoreno, produljeno ispitivanje na jednoj skupini kako bi se procijenila dugotrajna sigurnost primjene i djelotvornost lijeka Prolia.
English: In the post-marketing setting, rare cases of severe symptomatic hypocalcaemia have been reported predominantly in patients at increased risk of hypocalcaemia receiving Prolia, with most cases occurring in the first weeks of initiating therapy.
Croatian: Nakon stavljanja lijeka u promet zabilježeni su rijetki slučajevi teške simptomatske hipokalcijemije pretežno u bolesnika s povećanim rizikom od hipokalcijemije koji su primali lijek Prolia, a gdje se najveći broj slučajeva pojavio u prvim tjednima od početka liječenja.
English: Prolia is a clear, colourless to slightly yellow solution for injection provided in a ready to use pre-filled syringe.
Croatian: Prolia je bistra, bezbojna do žućkasta otopina za injekcije dostupna u napunjenim štrcaljkama spremnim za upotrebu.
English: Significant increases in BMD at lumbar spine, total hip, femoral neck and hip trochanter were observed by 6 months (p < 0.0001).
Croatian: Značajna povećanja BMD lumbalne kralježnice, cijelog kuka, vrata bedrene kosti i trohantera kuka zabilježena su nakon 6 mjeseci (p<0,0001).
English: Efficacy and safety of Prolia were investigated in 795 patients (70% women and 30% men) aged 20 to 94 years treated with ≥ 7.5 mg daily oral prednisone (or equivalent).
Croatian: Djelotvornost i sigurnost lijeka Prolia ispitivane su u 795 bolesnika (70% žena i 30% muškaraca) u dobi od 20 do 94 godine koji su liječeni s ≥ 7,5 mg oralnog prednizona (ili ekvivalenta) dnevno.
English: In a pooled analysis of data from all phase II and phase III placebo-controlled studies, Influenza-like illness was reported with a crude incidence rate of 1.2% for denosumab and 0.7% for placebo.
Croatian: U združenoj analizi podataka iz svih placebom kontroliranih ispitivanja faze II i faze III, zabilježena je bolest slična gripi sa grubom stopom incidencije od 1,2% za denosumab te 0,7% za placebo.
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: Treatment of bone loss associated with systemic glucocorticoid therapy
Croatian: Liječenje gubitka koštane mase povezano sa sustavnom terapijom glukokortikoidima
English: Taking into account the PRAC Assessment Report on the PSUR(s) for denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer), the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za denosumab (indiciran za liječenje osteoporoze i za liječenje gubitka koštane mase povezano s hormonskom ablacijom kod raka prostate), znanstveni zaključci CHMP-a su sljedeći:
English: For a 60 mg subcutaneous dose, maximum serum denosumab concentrations (Cmax) of 6 mcg/mL (range 1-17 μg/mL) occurred in 10 days (range 2-28 days).
Croatian: Za supkutanu dozu od 60 mg maksimalna koncentracija denosumaba u serumu (Cmax) od 6 µg/ml (raspon 1-17 μg/ml) zabilježena je za 10 dana (raspon 2-28 dana).
English: • To avoid discomfort at the site of injection, allow the pre-filled syringe to reach room temperature (up to 25°C) before injecting and inject slowly.
Croatian: • Kako biste izbjegli nelagodu na mjestu injekcije, prije injiciranja dozvolite da napunjena štrcaljka postigne sobnu temperaturu (do 25 °C) te injicirajte polagano.
English: One pre-filled syringe with automatic needle guard.
Croatian: Jedna napunjena štrcaljka s automatskim štitnikom za iglu.
English: The reduction in the incidence of new vertebral fractures, hip fractures and non-vertebral fractures by Prolia over 3 years were consistent regardless of the 10-year baseline fracture risk.
Croatian: Smanjenje incidencije novih fraktura kralježaka i kuka te nevertebralnih fraktura uzimanjem lijeka Prolia tijekom 3 godine je bilo konzistentno, neovisno o inicijalnom desetogodišnjem riziku za frakturu.
English: • ear infection,
Croatian: • infekcija uha,
English: Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.
Croatian: Javite se svojem liječniku ako osjetite novu ili neobičnu bol u kuku, preponi ili bedru.
English: In a post-hoc analysis in women > 75 years, a 62% relative risk reduction was observed with Prolia (1.4% absolute risk reduction, p < 0.01).
Croatian: U post-hoc analizi u žena > 75 godina zabilježeno je smanjenje relativnog rizika od 62% s lijekom Prolia (1,4%-tno smanjenje apsolutnog rizika, p < 0,01).
English: How do you use the Prolia pre-filled syringe?
Croatian: Kako koristiti napunjenu štrcaljku lijeka Prolia?
English: Declines of serum calcium levels (less than 1.88 mmol/l) were not reported in either the two phase III placebo-controlled clinical trials in patients receiving hormone ablation or the phase III placebo-controlled clinical trial in men with osteoporosis.
Croatian: Sniženje razine kalcija u serumu (manje od 1,88 mmol/l) nije zabilježeno ni u jednom od dva placebom kontrolirana klinička ispitivanja faze III u bolesnika koji su primali hormonsku ablacijsku terapiju, kao ni tijekom placebom kontroliranog kliničkog ispitivanja faze III u muškaraca s osteoporozom.
English: You do not have to remove the air bubble before injecting.
Croatian: Mjehurić zraka ne morate uklanjati prije injiciranja.
English: The needle cover of the pre-filled syringe contains dry natural rubber, which is a derivative of latex (see section 4.4).
Croatian: Poklopac igle napunjene štrcaljke sadrži suhu prirodnu gumu, koja je derivat lateksa (vidjeti dio 4.4).
English: Please tell your doctor immediately if you develop any of these symptoms while being on treatment with Prolia: swollen, red area of skin, most commonly in the lower leg, that feels hot and tender, and possibly with symptoms of fever.
Croatian: Molimo da odmah obavijestite Vašeg liječnika ako se pojave bilo koji od ovih simptoma dok ste na terapiji lijekom Prolia: natečeno, crveno područje kože, najčešće u donjem dijelu noge, koje je vruće i osjetljivo, uz moguće simptome vrućice.
English: Please tell your doctor immediately if you notice any of the following symptoms: spasms, twitches, or cramps in your muscle, and/or numbness or tingling in your fingers, toes or around your mouth, and/or seizures, confusion, or loss of consciousness.
Croatian: Molimo, odmah recite liječniku ukoliko primijetite bilo koji od sljedećih simptoma: spazme, trzanje ili grčeve u mišićima i/ili obamrlost ili trnce u prstima, nožnim prstima ili oko usta, i/ili napadaje, smetenost ili gubitak svijesti.
English: Clinical efficacy and safety in patients with bone loss associated with adjuvant aromatase inhibitor therapy
Croatian: Klinička djelotvornost i sigurnost u bolesnika s gubitkom koštane mase povezana s adjuvantnom terapijom inhibitorom aromataze
English: The safety and efficacy of denosumab have not been studied in patients with hepatic impairment (see section 5.2).
Croatian: Djelotvornost i sigurnost primjene denosumaba nisu ispitivani u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
English: In the osteoporosis clinical trial program, atypical femoral fractures were reported rarely in patients treated with Prolia (see section 4.4).
Croatian: U programu kliničkih ispitivanja osteoporoze atipične frakture femura rijetko su zabilježene u bolesnika liječenih lijekom Prolia (vidjeti dio 4.4).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/618/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/618/001
English: It is important to tell your doctor if you are breast-feeding or plan to do so.
Croatian: Važno je da kažete Vašem liječniku ako dojite ili planirate dojiti.
English: These data indicate that continued treatment with Prolia is required to maintain the effect of the medicinal product.
Croatian: Ti podaci pokazuju da je za održavanje učinka lijeka potrebna stalna terapija lijekom Prolia.
English: Bone turnover markers generally reached pre-treatment levels within 9 months after the last dose.
Croatian: Markeri pregradnje kosti su, općenito, unutar 9 mjeseci od zadnje primijenjene doze dosegli razine vrijednosti prije liječenja.
English: Women with other diseases or on therapies that may affect bone were excluded from this study.
Croatian: Iz ovog ispitivanja su isključene žene s drugim bolestima ili terapijama koje mogu utjecati na kosti.
English: Disposing of used syringes
Croatian: Odlaganje iskorištenih štrcaljki
English: Urinary tract infection Upper respiratory tract infection Diverticulitis1
Croatian: Infekcija urinarnog sustava Infekcija gornjeg dišnog sustava Divertikulitis1
English: Clinical efficacy and safety in men with osteoporosis
Croatian: Klinička djelotvornost i sigurnost u muškaraca s osteoporozom
English: The incidence of diverticulitis was comparable between treatment groups in postmenopausal women or men with osteoporosis and in women undergoing aromatase inhibitor therapy for non-metastatic breast cancer.
Croatian: Incidencija divertikulitisa je bila usporediva u terapijskim skupinama žena u postmenopauzi ili muškaraca s osteoporozom i žena koje primaju terapiju inhibitorima aromataze zbog nemetastazirajućeg raka dojke.
English: • DO NOT put the cover back on used needles.
Croatian: • NEMOJTE stavljati poklopac igle natrag na upotrijebljene štrcaljke.
English: Treatment with Prolia makes bone stronger and less likely to break.
Croatian: Liječenje lijekom Prolia čini kosti jačima i manje lomljivima.
English: Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1).
Croatian: Liječenje gubitka koštane mase povezano s hormonskom ablacijom u muškaraca s rakom prostate koji imaju povećani rizik od fraktura (vidjeti dio 5.1).
English: In addition, as post-marketing experience including multiple cases with positive re-challenge, as well as non-clinical evidence of involvement of the RANK / RANKL signalling pathway in the hair growth cycle support a conclusion that denosumab may be causally associated with the development of alopecia, this new ADR should be added in section 4.8 of the SmPC and the Package Leaflet.
Croatian: Osim toga, budući da iskustva nakon stavljanja lijeka u promet, uključujući višestruke slučajeve nakon ponovnog uvođenja liječenja (pozitivan rechallenge), kao i neklinički dokazi o uključenosti RANK/RANKL signalnog puta u ciklus rasta kose, podržavaju zaključak da denosumab može biti uzročno povezan s razvojem alopecije, ova nova nuspojava treba biti dodana u dio 4.8 sažetka opisa svojstava lijeka i u uputu o lijeku.