FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no clinical data on the co-administration of denosumab and hormone replacement therapy (oestrogen), however the potential for a pharmacodynamic interaction is considered to be low.
Slovenian: Kliničnih podatkov o sočasni uporabi denosumaba in hormonskega nadomestnega zdravljenja (estrogena) ni, vendar je možnost farmakodinamičnih medsebojnih delovanj predvidoma majhna.
English: Symptoms of hypocalcaemia in denosumab clinical studies included paraesthesias or muscle stiffness, twitching, spasms and muscle cramps.
Slovenian: Med simptomi hipokalciemije v kliničnih študijah denosumaba so bile parestezije ali togost mišic, trzanje, spazmi in mišični krči.
English: What Prolia is and what it is used for
Slovenian: Kaj je zdravilo Prolia in za kaj ga uporabljamo
English: • osteoporosis in women after the menopause (postmenopausal) and men who have an increased risk of fracture (broken bones), reducing the risk of spinal, non-spinal and hip fractures.
Slovenian: • osteoporozo pri ženskah po menopavzi (postmenopavzalno) in moških, ki imajo povečano tveganje zlomov (zlomljenih kosti), tako da se zmanjša tveganje zlomov hrbtenice, nehrbteničnih zlomov in zlomov kolka.
English: Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology.
Slovenian: Denosumab je humano monoklonsko protitelo IgG2, pridobljeno v celični liniji sesalcev (celice jajčnikov kitajskega hrčka) s tehnologijo rekombinantne DNA.
English: This could damage the device.
Slovenian: S tem jo lahko poškodujete.
English: Diverticulitis
Slovenian: Divertikulitis
English: 0-1 year
Slovenian: 0-1 leto
English: Adolescent primates dosed with denosumab at 27 and 150 times (10 and 50 mg/kg dose) the clinical exposure had abnormal growth plates.
Slovenian: Pri adolescentnih primatih, ki so dobivali denosumab v odmerkih 27- in 150-kratne (odmerek 10 in 50 mg/kg) klinične izpostavljenosti, so ugotovili nenormalne rastne ploščice.
English: Major osteoporotic fracture4 *p ≤ 0.05; **p = 0.0106 (secondary endpoint included in multiplicity adjustment), ***p ≤ 0.0001 + Event rates based on Kaplan-Meier estimates at 3 years.
Slovenian: Hujši osteoporotični zlom4 *p ≤ 0,05; **p = 0,0106 (sekundarna končna točka, vključena v korekcijo za multipla testiranja), ***p ≤ 0,0001 + Pogostnost dogodkov na podlagi Kaplan-Meierjevih ocen po 3 letih.
English: What you need to know before you use Prolia
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Prolia
English: Remember: if you have any problems, please ask your doctor or healthcare provider for help and advice.
Slovenian: Ne pozabite: Če imate kakršnekoli težave, prosite za pomoč in nasvet zdravnika ali drugo zdravstveno osebje.
English: Patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia.
Slovenian: Bolniki s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) ali bolniki na dializi imajo večje tveganje za nastanek hipokalciemije.
English: The pre-filled syringe may be left outside the refrigerator to reach room temperature.
Slovenian: Napolnjeno injekcijsko brizgo lahko pustite zunaj hladilnika, da doseže sobno temperaturo.
English: If any patient presents with suspected symptoms of hypocalcaemia during treatment (see section 4.8 for symptoms) calcium levels should be measured.
Slovenian: Če se med zdravljenjem kateremu koli bolniku pojavijo simptomi, ki so sumljivi za hipokalciemijo (glejte poglavje 4.8 za simptome), je treba izmeriti koncentracijo kalcija.
English: • cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Slovenian: • rak, sočasne bolezni (npr. anemijo, koagulopatije, okužbo), kajenje,
English: The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Slovenian: Pokrovček igle na napolnjeni injekcijski brizgi vsebuje suho naravno gumo (derivat lateksa), ki lahko povzroči alergijske reakcije.
English: The subject incidence of non-vertebral fracture was 4.3% (denosumab) versus 2.5% (risedronate).
Slovenian: Incidenca nevretenčnih zlomov je bila 4,3 % (denosumab) v primerjavi z 2,5 % (risedronat).
English: If you become pregnant during treatment with Prolia or less than 5 months after stopping treatment with Prolia, please inform your doctor.
Slovenian: Če zanosite med zdravljenjem z zdravilom Prolia ali manj kot 5 mesecev po koncu zdravljenja z zdravilom Prolia, o tem obvestite svojega zdravnika.
English: Women with other diseases or on therapies that may affect bone were excluded from this study.
Slovenian: V to študijo niso vključili žensk z drugimi boleznimi ali zdravljenji, ki bi lahko vplivala na kosti.
English: In clinical studies, neutralising antibodies have not been observed for denosumab.
Slovenian: V kliničnih študijah niso ugotovili nevtralizirajočih protiteles proti denosumabu.
English: Bone histology was also evaluated in 17 men with osteoporosis following 1 year treatment with Prolia.
Slovenian: Histologijo kosti so ocenili tudi pri 17 moških z osteoporozo po 1 letu zdravljenja z zdravilom Prolia.
English: Thirteen of these ONJ cases occurred in postmenopausal women with osteoporosis during the phase III clinical trial extension following treatment with Prolia for up to 10 years.
Slovenian: Trinajst od teh primerov osteonekroze čeljustnice se je pojavilo pri ženskah po menopavzi z osteoporozo med podaljšanjem kliničnega preskušanja III. faze po zdravljenju z zdravilom Prolia do 10 let.
English: • upper respiratory tract infection,
Slovenian: • okužba zgornjih dihal,
English: Atypical femoral fractures have also been reported in patients with certain co-morbid conditions (e.g. vitamin D deficiency, rheumatoid arthritis, hypophosphatasia) and with use of certain pharmaceutical agents (e.g. bisphosphonates, glucocorticoids, proton pump inhibitors).
Slovenian: O atipičnih zlomih stegnenice so poročali tudi pri bolnikih z določenimi sočasnimi bolezenskimi stanji (npr. s pomanjkanjem vitamina D, revmatoidnim artritisom, hipofosfatazijo) in med uporabo določenih zdravil (npr. bisfosfonatov, glukokortikoidov, zaviralcev protonske črpalke).
English: Patients must be adequately supplemented with calcium and vitamin D (see section 4.4).
Slovenian: Bolniki morajo dobivati zadostne dodatke kalcija in vitamina D (glejte poglavje 4.4).
English: Prolia significantly reduced the risk of new vertebral fractures at 1, 2 and 3 years (p < 0.0001) (see table 2).
Slovenian: Zdravilo Prolia je znatno zmanjšalo tveganje za nove zlome vretenc po 1, 2 in 3 letih (p < 0,0001) (glejte tabelo 2).
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Prolia administration.
Slovenian: Med zdravljenjem je izvajanje invazivnih zobozdravniških posegov dovoljeno le po skrbnem razmisleku in se jim je treba izogniti v bližini termina za odmerjanje zdravila Prolia.
English: Histomorphometry findings in the extension study in postmenopausal women with osteoporosis showed that the antiresorptive effects of Prolia, as measured by activation frequency and bone formation rates, were maintained over time.
Slovenian: Histomorfometrični izsledki v podaljšanju študije pri ženskah po menopavzi, ki so imele osteoporozo, so pokazali, da so se antiresorpcijski učinki zdravila Prolia, merjeni s pogostnostjo aktivacije in hitrostjo tvorbe kosti, ohranili skozi čas.
English: Your doctor may ask you to undergo a dental examination before you start treatment with Prolia.
Slovenian: Zdravnik vam bo morda naročil, da pred začetkom zdravljenja z zdravilom Prolia opravite zobozdravniški pregled.
English: • bone loss that results from a reduction in hormone (testosterone) level caused by surgery or treatment with medicines in patients with prostate cancer.
Slovenian: • izgubljanje kostne mase, ki nastane zaradi manjše koncentracije hormonov (testosterona) kot posledica operacije ali zdravljenja z zdravili pri bolnikih z rakom na prostati.
English: Osteonecrosis of the external auditory canal2
Slovenian: osteonekroza zunanjega slušnega kanala2
English: Important Before you use a Prolia pre-filled syringe with automatic needle guard, read this important information:
Slovenian: Pred uporabo zdravila Prolia v napolnjeni injekcijski brizgi z avtomatskim ščitnikom igle preberite te pomembne informacije:
English: There are no or limited amount of data from the use of denosumab in pregnant women.
Slovenian: Podatkov o uporabi denosumaba pri nosečnicah ni oziroma so omejeni.
English: At the end of each dosing interval, CTX reductions were partially attenuated from maximal reduction of ≥ 87% to approximately ≥ 45% (range 45-80%), reflecting the reversibility of Prolia's effects on bone remodelling once serum levels diminish.
Slovenian: Na koncu posameznega intervala odmerjanja je znižanje koncentracije CTX deloma izzvenelo (od največjega znižanja ≥ 87 % na približno ≥ 45 % [razpon: 45 do 80 %]), kar kaže na to, da so vplivi zdravila Prolia na remodeliranje kosti po znižanju koncentracije v serumu reverzibilni.
English: These data indicate that continued treatment with Prolia is required to maintain the effect of the medicinal product.
Slovenian: Ti podatki kažejo, da je za vzdrževanje učinka zdravila Prolia potrebno stalno zdravljenje.
English: Push the plunger with a slow constant pressure, always keeping the skin pinched.
Slovenian: S počasnim in stalnim pritiskom potiskajte bat; kožo še naprej držite s prstoma.
English: Prolia is a clear, colourless to slightly yellow solution for injection provided in a ready to use pre-filled syringe.
Slovenian: Zdravilo Prolia je bistra, brezbarvna do rahlo rumena raztopina za injiciranje, ki je na voljo v napolnjeni injekcijski brizgi, pripravljeni za uporabo.
English: Patients should be encouraged to report symptoms indicative of hypocalcaemia.
Slovenian: Bolnikom je treba naročiti, naj zdravnika obvestijo o simptomih, ki kažejo na hipokalciemijo.
English: You should not take Prolia together with another medicine containing denosumab.
Slovenian: Zdravila Prolia ne smete jemati skupaj z drugim zdravilom, ki vsebuje denosumab.
English: Inhibition of RANK/RANK ligand (RANKL) in animal studies has been coupled to inhibition of bone growth and lack of tooth eruption (see section 5.3).
Slovenian: Zavrtje RANK/RANK-liganda (RANKL) je bilo v študijah na živalih povezano z zavrtjem rasti kosti in neizraščanjem zob (glejte poglavje 5.3).
English: • have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction.
Slovenian: • imate kakšne težave v ustih ali z zobmi kot na primer slabo zdravje zob, bolezen dlesni ali predvideno izdrtje zob,
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.
Slovenian: Odprta podaljšana študija pri zdravljenju pomenopavzalne osteoporoze Skupaj 4.550 žensk (2.343 prejemnic zdravila Prolia in 2.207 prejemnic placeba), ki v zgoraj opisani ključni študiji niso izpustile več kot enega odmerka raziskovanega zdravila, in so zaključile obisk študije v 36. mesecu, je privolilo v sodelovanje v nadaljevalni 7-letni multinacionalni, multicentrični, odprti študiji z enim krakom za oceno dolgoročne varnosti in učinkovitosti zdravila Prolia.
English: Using a sensitive immunoassay < 1% of patients treated with denosumab for up to 5 years tested positive for non neutralising binding antibodies with no evidence of altered pharmacokinetics, toxicity, or clinical response.
Slovenian: Uporaba občutljivega imunskega testa je pokazala pozitiven izvid za nenevtralizirajoča protitelesa pri < 1 % bolnikov, ki so se zdravili z denosumabom v obdobju do 5 let; pri tem ni bilo nobenih znakov sprememb farmakokinetike, toksičnosti ali kliničnega odziva.
English: Rarely, patients receiving Prolia may have low calcium levels in the blood (hypocalcaemia).
Slovenian: Redko imajo lahko bolniki, ki prejemajo zdravilo Prolia, nizko koncentracijo kalcija v krvi (hipokalciemija).
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Raztopina za injiciranje
English: 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 Prolia.
Slovenian: 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 Prolia.
English: Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures.
Slovenian: Zdravljenje osteoporoze pri ženskah po menopavzi in pri moških z večjim tveganjem zlomov.
English: However, due to its character it is unlikely that denosumab has any potential for genotoxicity.
Slovenian: Vendar glede na značilnosti denosumaba ni verjetno, da bi bil genotoksičen.
English: At 1 year, the subject incidence of new radiological vertebral fracture was 2.7% (denosumab) versus 3.2% (risedronate).
Slovenian: Po 1 letu je bila incidenca novih radioloških zlomov vretenc 2,7 % (denosumab) v primerjavi s 3,2 % (risedronat).
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).
Slovenian: O osteonekrozi čeljustnice so poročali redko, in sicer pri 16 bolnikih v kliničnih preskušanjih pri osteoporozi in raku dojke ali prostate pri bolnikih, zdravljenih z ablacijo hormonov, ki so vključevala skupno 23.148 bolnikov (glejte poglavje 4.4).
English: Prolia contains sorbitol
Slovenian: Zdravilo Prolia vsebuje sorbitol
English: EU/1/10/618/002
Slovenian: EU/1/10/618/001 EU/1/10/618/002 EU/1/10/618/003
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.
Slovenian: V študiji opic cynomolgus, ki so prejemale denosumab med obdobjem, ki ustreza prvemu trimesečju nosečnosti, tako, da je bila izpostavljenost glede na AUC 99-krat večja kot odmerek pri človeku (60 mg vsakih 6 mesecev), ni bilo znakov škodljivosti za mater ali plod.
English: In an interaction study, Prolia did not affect the pharmacokinetics of midazolam, which is metabolised by cytochrome P450 3A4 (CYP3A4).
Slovenian: V študiji o medsebojnem delovanju zdravilo Prolia ni vplivalo na farmakokinetiko midazolama, ki se presnavlja s citokromom P450 3A4 (CYP3A4).
English: To get the most benefit from your treatment, it is important to use Prolia for as long as your doctor prescribes it for you.
Slovenian: Da vam bo zdravljenje čim bolj koristilo, morate zdravilo Prolia uporabljati toliko časa, kot vam predpiše zdravnik.
English: These changes were partially reversible in this model when dosing with RANKL inhibitors was discontinued.
Slovenian: Pri tem modelu so bile te spremembe po prenehanju odmerjanja zaviralcev RANKL delno reverzibilne.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Prolia in all subsets of the paediatric population in the treatment of bone loss associated with sex hormone ablative therapy, and in subsets of the paediatric population below the age of 2 in the treatment of osteoporosis.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Prolia za vse podskupine pediatrične populacije za zdravljenje izgubljanja kostnine, povezanega s terapevtsko ablacijo spolnih hormonov, in za podskupine pediatrične populacije, mlajše od 2 let, za zdravljenje osteoporoze (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The safety and efficacy of denosumab have not been studied in patients with hepatic impairment (see section 5.2).
Slovenian: Okvara jeter Varnost in učinkovitost denosumaba pri bolnikih z okvaro jeter nista raziskani (glejte poglavje 5.2).
English: Absolute risk reduction (%) (95% CI)
Slovenian: Absolutno zmanjšanje tveganja (%) (95 % IZ)
English: It is not known whether Prolia is excreted in breast milk.
Slovenian: Ni znano, ali se zdravilo Prolia izloča v materino mleko.
English: It is unknown whether denosumab is excreted in human milk.
Slovenian: Ni znano, ali se denosumab pri človeku izloča v materino mleko.
English: Maternal mammary gland development was normal.
Slovenian: Razvoj mlečnih žlez pri samicah-materah je bil normalen.
English: Upon re-initiation, reductions in CTX by denosumab were similar to those observed in patients initiating primary denosumab treatment.
Slovenian: Po ponovni uvedbi zdravljenja z denosumabom je bilo znižanje koncentracije CTX podobno kot pri bolnikih, ki so prvič začeli z zdravljenjem z denosumabom.
English: On the basis of the scientific conclusions for denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer) is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za denosumab (indiciran za osteoporozo in izgubljanje kostne mase, povezane z ablacijo hormonov pri raku na prostati) odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravila, ki vsebuje denosumab (indiciran za osteoporozo in izgubljanje kostne mase, povezane z ablacijo hormonov pri raku na prostati) nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
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.
Slovenian: Simptomi vključujejo otekanje obraza, ustnic, jezika, grla ali drugih delov telesa, izpuščaj, srbenje ali koprivnico na koži, piskajoče dihanje ali oteženo dihanje.
English: In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.
Slovenian: Pri moških z rakom na prostati, ki prejemajo zdravljenje z ablacijo hormonov, zdravilo Prolia znatno zmanjša tveganje zlomov vretenc.
English: If you forget to use Prolia
Slovenian: Če ste pozabili uporabiti zdravilo Prolia
English: Prolia treatment rapidly reduced the rate of bone turnover, reaching a nadir for the bone resorption marker serum type 1 C-telopeptides (CTX) (85% reduction) by 3 days, with reductions maintained over the dosing interval.
Slovenian: Zdravljenje z zdravilom Prolia je hitro zmanjšalo hitrost prenove kostnega tkiva, kar je razvidno iz koncentracije serumskega označevalca resorpcije kosti, C-telopeptida (CTX) tipa 1, ki je v 3 dneh dosegla najnižjo vrednost (85-odstotno znižanje), znižanje pa se je ohranilo v celotnem odmernem intervalu.
English: Incidence of ONJ was 0.04% at 3 years, 0.06% at 5 years and 0.44% at 10 years of Prolia treatment.
Slovenian: Incidenca osteonekroze čeljustnice je bila 0,04 % po 3 letih zdravljenja, 0,06 % po 5 letih zdravljenja in 0,44 % po 10 letih zdravljenja z zdravilom Prolia.
English: No data are available on the effect of denosumab on human fertility.
Slovenian: Podatkov o vplivu denosumaba na plodnost pri človeku ni.
English: In a prospectively planned exploratory analysis, significant increases in BMD were observed at the lumbar spine, total hip, femoral neck and the hip trochanter 1 month after the initial dose.
Slovenian: V prospektivno načrtovani eksploratorni analizi so ugotovili znatno povečanje mineralne kostne gostote v ledvenem delu hrbtenice, celotnem kolku, vratu stegnenice in kolčnem trohantru 1 mesec po začetnem odmerku.
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Prolia or after stopping treatment.
Slovenian: Zdravniku in zobozdravniku takoj povejte, če se vam takšni znaki pojavijo med zdravljenjem z zdravilom Prolia ali po končanju zdravljenja.
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.
Slovenian: V drugi študiji opic cynomolgus, ki so med nosečnostjo prejemale toliko denosumaba, da je bila izpostavljenost glede na AUC 119-krat večja kot z odmerkom za človeka (60 mg vsakih 6 mesecev), so ugotovili več mrtvorojenosti in večjo poporodno umrljivost, nenormalno rast kosti, ki je povzročila manjšo moč kosti, zmanjšano hematopoezo in neuravnanost zob, odsotnost perifernih bezgavk in upočasnjeno neonatalno rast.
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.
Slovenian: Vsem bolnikom je treba naročiti, da morajo vzdrževati dobro ustno higieno, redno opravljati zobozdravniške preglede in med zdravljenjem z denosumabom nemudoma obvestiti zdravnika, če se pojavi kakršen koli simptom v ustih, na primer majanje zob, bolečina ali oteklina, rana, ki se ne celi, ali izcedek.
English: Denosumab has been administered in clinical studies using doses up to 180 mg every 4 weeks (cumulative doses up to 1,080 mg over 6 months), and no additional adverse reactions were observed.
Slovenian: Izkušenj s prevelikim odmerjanjem iz kliničnih študij ni. Denosumab so v kliničnih študijah uporabljali v odmerkih do 180 mg na 4 tedne (kumulativni odmerki do 1.080 mg v 6 mesecih) in ob tem niso ugotovili nobenih dodatnih neželenih učinkov.
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.
Slovenian: Pri mišjih samcih z genskoinženirsko doseženim izraženjem huRANKL (t. i. knock-in miši), ki so jim povzročili transkortikalni zlom, je denosumab v primerjavi s primerjalnimi živalmi upočasnil odstranjevanje hrustanca in preoblikovanje kalusa, biomehanična čvrstost pa ni bila prizadeta.
English: It is important that you or your carer do not give the injection unless training from your doctor or healthcare provider has been received.
Slovenian: Pomembno je, da vi ali oseba, ki za vas skrbi, ne injicirate zdravila, dokler vas tega ne nauči zdravnik ali drugo zdravstveno osebje.
English: Where should you give the injection?
Slovenian: Kam injicirati zdravilo?
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.
Slovenian: Takoj se posvetujte z zdravnikom in zobozdravnikom, če se vam pojavijo težave z usti ali zobmi, kot so majanje zob, bolečina ali oteklina, razjede, ki se ne celijo, ali izcedek, saj so to lahko znaki osteonekroze čeljustnice.