FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje zoledronsko kislino za vse skupine pediatrične populacije glede zdravljenja tumorsko povzročene hiperkalciemije in preprečevanja z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: - Thalidomide (a medicine used to treat a certain type of blood cancer involving the bone) or any other medicines which may harm your kidneys.
Slovenian: - Talidomid (zdravilo za zdravljenje določene vrste krvnega raka, ki zajame kosti) ali druga zdravila, ki lahko škodujejo ledvicam.
English: 1.0 mg/dl or 88 micromol/l.
Slovenian: zvišanje za 1,0 mg/dl ali 88 mikromolov/l.
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½ α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Slovenian: Intravensko uporabljena zoledronska kislina se odstranjuje iz telesa v treh fazah: najprej se pojavi hitro dvofazno izginotje iz sistemskega obtoka z razpolovnima časoma t½ α 0,24 ure in t½β 1,87 ure, ki mu sledi dolga eliminacijska faza s terminalnim eliminacijskim razpolovnim časom t½γ 146 ur.
English: If refrigerated, the solution must be allowed to reach room temperature before administration.
Slovenian: Če je raztopina shranjena v hladilniku, je treba pustiti, da pred infundiranjem doseže sobno temperaturo.
English: Intravenous use after dilution.
Slovenian: Intravenska uporaba po razredčenju.
English: Zoledronic acid shows no appreciable binding to plasma proteins and does not inhibit human P450 enzymes in vitro (see section 5.2), but no formal clinical interaction studies have been performed.
Slovenian: Zoledronska kislina ne kaže znatne vezave na plazemske beljakovine in in vitro ne zavira človeških encimov P450 (glejte poglavje 5.2), a formalnih kliničnih študij medsebojnega delovanja niso izvedli.
English: Zoledronic acid Actavis is supplied as a clear and colourless concentrate for solution for infusion (sterile concentrate) in a plastic vial.
Slovenian: Zdravilo Zoledronska kislina Actavis je na voljo kot bister in brezbarven koncentrat za raztopino za infundiranje (sterilen koncentrat) v plastični viali.
English: - Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
Slovenian: - Zdravnik vam bo priporočil, da pred vsakim zdravljenjem s tem zdravilom popijete dovolj vode;
English: It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received zoledronic acid.
Slovenian: Trenutno ni jasno, ali zoledronska kislina povzroča to neredno bitje srca, a če se vam potem, ko ste dobili zoledronsko kislino, pojavijo takšni simptomi, morate to povedati svojemu zdravniku.
English: The reduced doses for patients with renal impairment are expected to achieve the same AUC as that seen in patients with creatinine clearance of 75 ml/min.
Slovenian: Pričakovati je mogoče, da ti manjši odmerki pri bolnikih z okvaro ledvic dosežejo enake AUC, kot so pri bolnikih z očistkom kreatinina 75 ml/min.
English: - if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
Slovenian: - če imate ali ste imeli bolečine, oteklost ali omrtvičenost čeljusti, občutek teže v čeljusti ali majanje zoba.
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic acid Actavis.
Slovenian: - Če zdravilo dobivate za zmanjšanje količine kalcija v krvi, boste praviloma dobili le eno infuzijo zdravila Zoledronska kislina Actavis.
English: Zoledronic acid Actavis is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Slovenian: Zdravilo Zoledronska kislina Actavis ni priporočljivo za bolnike, ki imajo že pred uvedbo zdravljenja hudo okvaro ledvic, ki je za to populacijo bolnikov opredeljena kot CLcr < 30 ml/min.
English: In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Slovenian: V kliničnih študijah so zdravljenje z zoledronsko kislino nadaljevali šele, ko se je koncentracija kreatinina vrnila na raven znotraj 10% od izhodiščne vrednosti (glejte poglavje 4.4).
English: The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06-0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Slovenian: V dolgoročnih živalskih študijah ponavljajočih se parenteralnih odmerkov so bile varnostne meje glede na ledvične učinke ozke, toda kumulativna raven brez neželenih učinkov (NOAEL) v študijah enkratnega odmerka (1,6 mg/kg) in večkratnih odmerkov do en mesec (0,06 do 0,6 mg/kg/dan) niso pokazale ledvičnih učinkov v odmerkih, ki so bili enakovredni največjemu terapevtskemu odmerku za človeka ali večji od njega.
English: Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.
Slovenian: Bolniki morajo dobivati tudi peroralni dodatek 500 mg kalcija in 400 IE vitamina D na dan.
English: From the bone tissue it is released very slowly back into the systemic circulation and eliminated via the kidney.
Slovenian: Iz kostnega tkiva se zelo počasi sprošča nazaj v sistemski obtok in se iz telesa izloča skozi ledvice.
English: • To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Slovenian: • Za preprečevanje zapletov na kosteh, npr. zlomov, pri odraslih bolnikih z metastazami v kosteh (z razširitvijo raka s prvotnega mesta na kosti).
English: The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients.
Slovenian: Neravnovesja, opaženega v tem preskušanju, niso opažali v drugih preskušanjih z zoledronsko kislino, vključno s preskušanji 4 mg zoledronske kisline vsake 3-4 tedne pri onkoloških bolnikih.
English: While being treated with Zoledronic acid Actavis, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Slovenian: V času zdravljenja z zdravilom Zoledronska kislina Actavis morate skrbeti za dobro ustno higieno (kar vključuje redno čiščenje zob) in redno hoditi na rutinske preglede k zobozdravniku.
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer)
Slovenian: Preglednica 3: Rezultati učinkovitosti (drugi parenhimski tumorji razen raka dojke ali prostate)
English: Clinical trial results in the treatment of TIH
Slovenian: Rezultati kliničnih preskušanj v zdravljenju TIH
English: In paediatric patients with severe osteogenesis imperfecta, zoledronic acid seems to be associated with more pronounced risks for acute phase reaction, hypocalcaemia and unexplained tachycardia, in comparison to pamidronate, but this difference declined after subsequent infusions.
Slovenian: Pri pediatričnih bolnikih s hudo osteogenesis imperfecta je zoledronska kislina povezana z večjim tveganjem za reakcijo akutne faze, hipokalciemijo in nepojasnjeno tahikardijo kot uporaba pamidronata, vendar se je z nadaljnjimi infuzijami ta razlika zmanjševala.
English: This condition is known as tumour-induced hypercalcaemia (TIH).
Slovenian: To motnjo imenujemo tumorsko povzročena hiperkalciemija (TIH).
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy)
Slovenian: Preglednica 2: Rezultati učinkovitosti (bolniki z rakom prostate, ki prejemajo hormonsko zdravljenje)
English: - Carefully follow all the other instructions given to you by your doctor, pharmacist or nurse.
Slovenian: - Natančno upoštevajte tudi vsa druga navodila, ki jih dobite od svojega zdravnika, farmacevta ali medicinske sestre.
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders
Slovenian: Preglednica 6: Neželeni učinki, ugotovljeni pri pediatričnih bolnikih s hudo osteogenesis imperfecta1 Bolezni živčevja
English: In clinical studies, zoledronic acid, used as indicated in sections 4.1 and 4.2, has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Slovenian: V kliničnih študijah so zoledronsko kislino, uporabljeno, kot je navedeno v poglavjih 4.1 in 4.2, dajali sočasno s pogosto uporabljanimi zdravili proti raku, diuretiki, antibiotiki in analgetiki, ne da bi prišlo do klinično očitnega medsebojnega delovanja.
English: Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change.
Slovenian: Zoledronska kislina deluje tako, da se veže na kost in upočasni hitrost spreminjanja kosti.
English: Clinical experience with acute overdose of zoledronic acid is limited.
Slovenian: Kliničnih izkušenj z akutnim prevelikim odmerjanjem zoledronske kisline je malo.
English: What Zoledronic acid Actavis is and what it is used for What you need to know before you are given Zoledronic acid Actavis How Zoledronic acid Actavis is used Possible side effects
Slovenian: Kaj je zdravilo Zoledronska kislina Actavis in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Zoledronska kislina Actavis Kako se uporablja zdravilo Zoledronska kislina Actavis Možni neželeni učinki
English: One vial contains 5 ml of solution.
Slovenian: Ena viala vsebuje 5 ml raztopine.
English: Caution is indicated when Zoledronic acid Actavis is used with other potentially nephrotoxic medicinal products.
Slovenian: Previdnost je potrebna, če je zdravilo Zoledronska kislina Actavis uporabljeno skupaj z drugimi potencialno nefrotoksičnimi zdravili.
English: Actavis Italy S.p.A Via Pasteur, 10 20014 Nerviano (MI) Italy
Slovenian: Actavis Italy S.p.A Via Pasteur, 10
English: Thrombocytopenia, leukopenia
Slovenian: Trombocitopenija, levkopenija
English: Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Slovenian: Farmakokinetičnih podatkov o bolnikih s hudo insuficienco ledvic (očistek kreatinina < 30 ml/min) je malo.
English: Median time to SRE (days)
Slovenian: Mediani čas do SRE
English: The dose must be given as a single intravenous infusion over no less than 15 minutes.
Slovenian: Odmerek je treba dati v enkratni intravenski infuziji v času, ki ne sme biti krajši od 15 minut.
English: The active substance in Zoledronic acid Actavis is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Slovenian: Zdravilna učinkovina v zdravilu Zoledronska kislina Actavis je zoledronska kislina, ki spada v skupino snovi, imenovanih difosfonati.
English: - Do not use Zoledronic acid Actavis after the expiry date stated on the vial and carton after EXP. - This medicinal product does not require any specific storage conditions.
Slovenian: - Zdravila Zoledronska kislina Actavis ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP. - To zdravilo ne potrebuje posebnih pogojev za shranjevanje.
English: Prevention of skeletal related events in patients with advanced malignancies involving bone Adults and older people
Slovenian: Preprečevanje z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti Odrasli in starejši bolniki
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when Zoledronic acid Actavis is used in combination with thalidomide.
Slovenian: Pri bolnikih z multiplim mielomom se utegne lahko tveganje za moteno delovanje ledvic poveča, če je zdravilo Zoledronska kislina Actavis uporabljeno v kombinaciji s talidomidom.
English: In the event of hypocalcaemia, calcium gluconate infusions should be administered as clinically indicated.
Slovenian: V primeru hipokalciemije je treba dati infuzijo kalcijevega glukonata, če je to klinično indicirano.
English: Angioneurotic oedema
Slovenian: Angionevrotični edem
English: In the clinical programme patients aged 1 to < 3 years received 0.025 mg/kg zoledronic acid (up to a maximum single dose of 0.35 mg) every 3 months and patients aged 3 to 17 years received 0.05 mg/kg zoledronic acid (up to a maximum single dose of 0.83 mg) every 3 months.
Slovenian: V kliničnem programu so bolniki v starosti od 1 do < 3 leta prejemali 0,025 mg/kg zoledronske kisline (do največ 0,35 mg v enkratnem odmerku) na 3 mesece, bolniki v starosti od 3 do 17 let pa 0,05 mg/kg zoledronske kisline (do največ 0,83 mg v enkratnem odmerku) na 3 mesece.
English: 1Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid as indicated in sections 4.1 and 4.2 (see section 4.8)
Slovenian: Hipofosfatemija 1Neželene učinke s pogostnostjo < 5% so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenimi varnostnimi značilnostmi zoledronske kisline, uporabljene, kot je navedeno v poglavjih 4.1 in 4.2 (glejte poglavje 4.8).
English: Aseptic techniques must be followed during the preparation of the infusion.
Slovenian: Pri pripravi infuzije je treba upoštevati aseptične postopke.
English: Thus these results precluded determining a definitive effect of zoledronic acid on fertility in humans.
Slovenian: Na podlagi teh rezultatov ni mogoče določiti dejanskega vpliva zoledronske kisline na plodnost pri človeku.
English: While the risk is reduced with a dose of 4 mg zoledronic acid administered over 15 minutes, deterioration in renal function may still occur.
Slovenian: Čeprav se tveganje zmanjša, če traja dajanje 4 mg odmerka zoledronske kisline 15 minut, se delovanje ledvic kljub temu lahko poslabša.
English: There was faster normalisation of corrected serum calcium at day 4 for 8 mg zoledronic acid and at day 7 for 4 mg and 8 mg zoledronic acid.
Slovenian: Korigirani serumski kalcij se je hitreje normaliziral 4. dan z 8 mg zoledronske kisline in 7. dan s 4 mg in 8 mg zoledronske kisline.
English: Concentrate for solution for infusion 1 x 5 ml vial
Slovenian: Koncentrat za raztopino za infundiranje 1 x 5 ml viala
English: The type of adverse reactions observed in this population were similar to those previously seen in adults with advanced malignancies involving the bone (see section 4.8).
Slovenian: Vrste neželenih učinkov v tej populaciji so bile podobne tistim pri odraslih z napredovalimi malignimi boleznimi, ki zajamejo kosti (glejte poglavje 4.8).
English: Longer-term repeat administration at doses bracketing the highest intended human therapeutic dose of zoledronic acid produced toxicological effects in other organs, including the gastrointestinal tract, liver, spleen and lungs, and at intravenous injection sites.
Slovenian: Dolgoročno večkratno dajanje v odmerkih okrog največjega terapevtskega odmerka zoledronske kisline za človeka je povzročilo toksične učinke na drugih organih, vključno s prebavili, jetri, vranico in pljuči, in na mestih intravenskega injiciranja.
English: Patients received either 4 mg zoledronic acid or placebo every four weeks for one year.
Slovenian: Bolnice so eno leto na štiri tedne dobivale bodisi 4 mg zoledronske kisline bodisi placebo.
English: In the zoledronic acid-treated group, statistically significant improvement in pain scores (using the Brief Pain Inventory, BPI) was seen at 4 weeks and at every subsequent time point during the study, when compared to placebo (Figure 1).
Slovenian: V skupini, zdravljeni z zoledronsko kislino, so v primerjavi s placebom ugotovili statistično značilno izboljšanje ocene bolečin (z uporabo lestvice BPI - Brief Pain Inventory) po 4 tednih in na vseh nadaljnjih časovnih točkah med študijo (Slika 1).
English: The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Slovenian: Pomembna ugotovljena tveganja med uporabo zoledronske kisline pri odobrenih indikacijah so: okvara delovanja ledvic, osteonekroza čeljustnic, reakcija akutne faze, hipokalciemija, atrijska fibrilacija, anafilaksija, intersticijska bolezen pljuč.
English: Interpretation of the risk of fracture is confounded by the fact that fractures are common events in patients with severe osteogenesis imperfecta as part of the disease process.
Slovenian: Interpretacijo tveganja za zlome otežuje dejstvo, da so pri bolnikih s hudo osteogenesis imperfecta pogosti kot del bolezenskega dogajanja.
English: - Urticaria.
Slovenian: - Koprivnica.
English: - Other medicines that contain zoledronic acid which are used to treat osteoporosis and other noncancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic acid Actavis are unknown.
Slovenian: - druga zdravila, ki vsebujejo zoledronsko kislino, kakršna se uporabljajo za zdravljenje osteoporoze in drugih nerakavih bolezni kosti, ali kakšen drug difosfonat, kajti kombinirani učinki teh zdravil, uporabljenih skupaj z zdravilom Zoledronska kislina Actavis, niso znani.
English: Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Slovenian: Zdravilo Zoledronska kislina Actavis 4 mg/5 ml koncentrat za raztopino za infundiranje, dodatno redčeno v 100 ml (glejte poglavje 6.6), je treba dati v enkratni intravenski infuziji, ki traja najmanj 15 minut.
English: Figure 1: Mean changes from baseline in BPI scores.
Slovenian: Slika 1: Povprečna sprememba ocene BPI od izhodišča.
English: The administration of doses up to 48 mg of zoledronic acid in error has been reported.
Slovenian: Opisana je uporaba odmerkov do 48 mg zoledronske kisline po pomoti.
English: Hyperkalaemia, hypernatraemia
Slovenian: Hiperkaliemija, hipernatremija
English: events (excluding hypercalcaemia and adjusted for prior fracture), divided by the total risk period.
Slovenian: SRE (brez hiperkalciemije in korigiranega na predhodne zlome) in celotnega obdobja tveganja.
English: - The other ingredients are: mannitol, sodium citrate and water for injections.
Slovenian: - Pomožne snovi so: manitol, natrijev citrat in voda za injekcije.
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid Actavis.
Slovenian: Če imate hipokalciemijo, jo je treba odpraviti preden prejmete prvi odmerek zdravila Zoledronska kislina Actavis.
English: Zoledronic acid Actavis should not be used during pregnancy.
Slovenian: Zdravila Zoledronska kislina Actavis se ne sme uporabljati med nosečnostjo.
English: - In vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer drugs, anti-adhesion/invasion activity.
Slovenian: - In vitro: Zavrtje proliferacije osteoblastov, neposredno citostatično in proapoptotično delovanje na tumorske celice, sinergističen citostatični učinek z drugimi zdravili proti raku, anti adhezijsko in anti-invazivno delovanje.
English: - Since no data are available on the compatibility of Zoledronic acid Actavis with other intravenously administered substances, Zoledronic acid Actavis must not be mixed with other medications/substances and should always be given through a separate infusion line.
Slovenian: - Ker podatkov o kompatibilnosti zdravila Zoledronska kislina Actavis z drugimi intravensko uporabljanimi snovmi ni, se zdravila Zoledronska kislina Actavis ne sme mešati z drugimi zdravili/snovmi in ga je vedno treba dati z ločenim infuzijskim sistemom.
English: The pain score for zoledronic acid was consistently below baseline and pain reduction was accompanied by a trend in reduced analgesics score.
Slovenian: Z zoledronsko kislino so bile ocene bolečin ves čas pod izhodiščno vrednostjo, zmanjšanje bolečin je spremljal trend zmanjševanja na lestvici uporabe analgetikov.
English: Your doctor will carry out blood tests before you start treatment with Zoledronic acid Actavis and will check your response to treatment at regular intervals.
Slovenian: Zdravnik vam bo pred začetkom zdravljenja z zdravilom Zoledronska kislina Actavis opravil preiskave krvi in bo v rednih presledkih kontroliral vaš odziv na zdravljenje.
English: - Conjunctivitis.
Slovenian: - Konjunktivitis.
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following Zoledronic acid Actavis dose is recommended (see also section 4.4):
Slovenian: Za bolnike z metastazami v kosteh, ki imajo pred začetkom zdravljenja blago do zmerno okvaro ledvic, ki je za to populacijo bolnikov opredeljena kot CLcr 30-60 ml/min, so priporočljivi naslednji odmerki zdravila Zoledronska kislina Actavis (glejte tudi poglavje 4.4):
English: Patients with TIH and evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with Zoledronic acid Actavis outweighs the possible risk.
Slovenian: Bolnike s TIH in z znaki poslabšanja delovanja ledvic je treba ustrezno oceniti in presoditi, ali možna korist zdravljenja z zdravilom Zoledronska kislina Actavis odtehta možna tveganja.
English: It is an inhibitor of osteoclastic bone resorption.
Slovenian: Zavira osteoklastno resorpcijo kosti.
English: Clear and colourless concentrate for solution for infusion.
Slovenian: Bister in brezbarven koncentrat za raztopino za infundiranje.
English: The onset time is ≤ 3 days post-zoledronic acid infusion (used as indicated in sections 4.1 and 4.2), and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Slovenian: Ti simptomi se pojavijo ≤ 3 dni po infundiranju zoledronske kisline (uporabljene, kot je navedeno v poglavjih 4.1 in 4.2); reakcijo imenujejo tudi "gripozni" simptomi ali "poodmerni" simptomi.
English: - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic acid Actavis every three to four weeks.
Slovenian: - Če zdravilo dobivate za preprečevanje zapletov na kosteh zaradi kostnih metastaz, boste dobivali po eno infuzijo zdravila Zoledronska kislina Actavis na tri do štiri tedne.
English: Upon initiation of treatment in patients with bone metastases with mild to moderate renal impairment, lower doses of zoledronic acid are recommended.
Slovenian: Po uvedbi zdravljenja pri bolnikih z metastazami v kosteh in blago do zmerno okvaro ledvic so priporočljivi nižji odmerki zoledronske kisline.
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as zoledronic acid (see section 4.4).
Slovenian: O osteonekrozi čeljustnic so poročali predvsem pri bolnikih z rakom, zdravljenih z zdravili, ki zavirajo resorpcijo kosti, kakršno je zoledronska kislina (glejte poglavje 4.4).