natgillin/translations-raw huggingface dataset:
Following a 6 month period after birth, bone related changes showed recovery and there was no effect on tooth eruption.
Med 6-mesečnim obdobjem po rojstvu so se kostne spremembe popravile in vpliva na izraščanje zob ni bilo.
Patients presenting with such symptoms should be evaluated for an incomplete femoral fracture.
Bolnike s takšnimi simptomi je treba preiskati glede nepopolnega zloma stegnenice.
Tell your doctor if you have or have ever had severe kidney problems, kidney failure or have needed dialysis or are taking medicines called glucocorticoids (such as prednisolone or dexamethasone), which may increase your risk of getting low blood calcium if you do not take calcium supplements.
Zdravniku morate tudi povedati, če imate ali ste kdaj imeli resne težave z ledvicami, ledvično odpoved ali ste potrebovali dializo ali jemljete zdravila, imenovana glukokortikoidi (kot sta prednizolon ali deksametazon), ker to lahko poveča vaše tveganje za pojav nizke vrednosti kalcija v krvi, če ne jemljete dodatkov kalcija.
Put the needle fully into the skin as shown by your doctor or healthcare provider.
Zabodite iglo do konca v kožo, kot vam je pokazal zdravnik ali drugo zdravstveno osebje.
Drug-related hypersensitivity reactions
Z zdravilom povezane preobčutljivostne reakcije
• DO NOT put the cover back on used needles.
• NE nameščajte pokrovčka nazaj na uporabljene igle.
Prolia is not recommended for use in pregnant women and women of child-bearing potential not using contraception.
Zdravila Prolia ni priporočljivo uporabljati pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
In clinical trials, musculoskeletal pain was very common in both denosumab and placebo groups.
V kliničnih preskušanjih je bila mišično-skeletna bolečina zelo pogosta tako v skupini z denosumabom kot v skupini s placebom.
Every 6 months Amgen Europe B.V.
Vsakih 6 mesecev Amgen Europe B.V.
At 2 years, the corresponding numbers were 4.1% versus 5.8% for new radiological vertebral fractures and 5.3% versus 3.8% for non-vertebral fractures.
Po 2 letih sta bili ustrezni števili 4,1 % v primerjavi s 5,8 % za nove radiološke zlome vretenc in 5,3 % v primerjavi s 3,8 % za nevretenčne zlome.
Patients should be advised to seek prompt medical attention if they develop signs or symptoms of cellulitis.
Bolnikom je treba naročiti, naj takoj poiščejo zdravniško pomoč, če se jim pojavijo znaki ali simptomi celulitisa.
Therefore, treatment with denosumab may impair bone growth in children with open growth plates and may inhibit eruption of dentition.
Zdravljenje z denosumabom torej lahko prizadene rast kosti pri otrocih z odprtimi rastnimi ploščicami in lahko zavre izraščanje zob.
Skin infections
Okužbe kože
These could be signs of bone damage in the jaw (osteonecrosis).
To so lahko znaki poškodbe kosti v čeljusti (osteonekroze).
• are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
• jemljete zdravila, ki jih imenujemo kortikosteroidi (kot sta prednizolon ali deksametazon),
The risk of ONJ increases in patients treated for a long time (may affect up to 1 in 200 people if treated for 10 years).
Tveganje za osteonekrozo čeljustnice se poveča pri bolnikih, ki se zdravijo dlje časa (pojavi se lahko pri največ 1 od 200 bolnikov, če so bili zdravljeni 10 let).
Check the appearance of Prolia.
Preverite videz zdravila Prolia.
In order to reduce the risk of developing ONJ, there are some precautions you should take.
Da boste zmanjšali tveganje za nastanek osteonekroze čeljustnice, morate upoštevati nekatere previdnostne ukrepe.
If a dose of Prolia is missed, the injection should be administered as soon as possible.
Če ste izpustili odmerek zdravila Prolia, morate injekcijo dobiti čim prej.
This medicine contains 47 mg sorbitol in each mL of solution.
To zdravilo vsebuje 47 mg sorbitola v vsakem ml raztopine.
The use of Prolia in children and adolescents has not been studied.
Uporaba zdravila Prolia pri otrocih in mladostnikih ni raziskana.
The best places to inject are the top of your thighs and the abdomen.
Najprimernejši mesti za injiciranje sta zgornji del stegen in trebuh.
There was no evidence of maternal harm prior to labour; adverse maternal effects occurred infrequently during labour.
Znakov škodljivosti za samice-matere pred porodom ni bilo; neželeni učinki za samice-matere so se v redkih primerih pojavili med porodom.
MARKETING AUTHORISATION NUMBER(S) EU/1/10/618/001 1 pre-filled syringe (blistered) EU/1/10/618/002 1 pre-filled syringe (unblistered) EU/1/10/618/003 1 pre-filled syringe with automatic needle guard (blistered)
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/10/618/001 1 napolnjena injekcijska brizga (v pretisnem omotu) EU/1/10/618/002 1 napolnjena injekcijska brizga (brez pretisnega omota) EU/1/10/618/003 1 napolnjena injekcijska brizga s ščitnikom igle (v pretisnem omotu)
Long-term antiresorptive treatment (including both denosumab and bisphosphonates) may contribute to an increased risk for adverse outcomes such as osteonecrosis of the jaw and atypical femur fractures due to significant suppression of bone remodelling (see section 4.2).
Dolgoročno antiresorpcijsko zdravljenje (vključno z denosumabom in bisfosfonati) lahko prispeva v povečanemu tveganju za neželene izide, kot na primer osteonekroza čeljustnice in atipični zlomi stegnenice kot posledica signifikantnega zmanjševanja remodeliranja kosti (glejte poglavje 4.2).
• Prolia is given as an injection into the tissue just under the skin (subcutaneous injection).
• Zdravilo Prolia se daje kot injekcija v tkivo tik pod kožo (subkutano injiciranje).
• poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions.
• slabo ustno higieno, periodontalno bolezen, slabo prilegajoče se zobne proteze, že obstoječo zobno bolezen, invazivne zobozdravstvene posege, npr. ekstrakcijo zob.
The pharmacokinetic profile in paediatric populations has not been assessed.
Farmakokinetičnih značilnosti pri pediatrični skupini bolnikov niso ocenjevali.
Concomitant treatment with other denosumab-containing medicinal products Patients being treated with Prolia should not be treated concomitantly with other denosumab-containing medicinal products (for prevention of skeletal related events in adults with bone metastases from solid tumours).
Sočasno zdravljenje z drugimi zdravili, ki vsebujejo denosumab Bolnikov, zdravljenih z zdravilom Prolia, sočasno ne smete zdraviti z drugimi zdravili, ki vsebujejo denosumab (za preprečevanje skeletnih dogodkov pri odraslih s kostnimi metastazami solidnih tumorjev).
Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness.
V vsaki skupini pogostnosti in vsakem organskem sistemu so neželeni učinki navedeni v padajočem zaporedju resnosti pojava.
Musculoskeletal pain leading to discontinuation of study treatment was uncommon.
Mišično-skeletna bolečina, ki bi povzročila prenehanje uporabe preskušanega zdravila, je bila občasna.
Your doctor or healthcare provider will show you or your carer how to use Prolia.
Zdravnik ali drugo zdravstveno osebje bodo vam (ali osebi, ki za vas skrbi) pokazali, kako uporabljati zdravilo Prolia.
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.
Zmanjšanje incidence novih zlomov vretenc, kolkov in nevretenčnih zlomov je bilo z zdravilom Prolia v 3-letnem obdobju dosledno, ne glede na izhodiščno 10-letno tveganje zlomov.
Rarely, allergic reactions may occur in patients receiving Prolia.
Redko se lahko pri bolnikih, ki prejemajo zdravilo Prolia, pojavijo alergijske reakcije.
• potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy.
• moč zdravila, ki zavira resorpcijo kosti (tveganje je večje z zelo močnimi spojinami), pot uporabe (tveganje je večje v primeru parenteralne uporabe) in kumulativni odmerek zdravila,
The primary efficacy variable was percent change in lumbar spine BMD, fracture efficacy was not evaluated.
Primarna spremenljivka učinkovitosti je bil odstotek spremembe mineralne kostne gostote v ledvenem delu hrbtenice, učinkovitost glede zlomov ni bila ocenjena.
The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving denosumab who present with ear symptoms including chronic ear infections.
Na možnost osteonekroze zunanjega slušnega kanala je potrebno pomisliti pri bolnikih, ki prejemajo denosumab in pri katerih se pojavijo simptomi bolezni ušes, vključno s kroničnimi vnetji ušes.
The most common side effects with Prolia (seen in more than one patient in ten) are musculoskeletal pain and pain in the extremity.
Najbolj pogosta neželena učinka zdravila Prolia (pojavila sta se pri več kot enem bolniku od desetih) sta mišično-skeletna bolečina in bolečina v okončini.
Water for injections * Acetate buffer is formed by mixing acetic acid with sodium hydroxide
Voda za injekcije *Acetatni pufer nastane z mešanjem ocetne kisline z natrijevim hidroksidom
Examples of the clinical manifestations of severe symptomatic hypocalcaemia have included QT interval prolongation, tetany, seizures and altered mental status (see section 4.4).
Med kliničnimi manifestacijami hude simptomatske hipokalciemije so bili podaljšanje intervala QT, tetanija, konvulzije in spremenjeno duševno stanje (glejte poglavje 4.4).
• rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions).
• izpuščaj, ki se lahko pojavi na koži, ali razjede v ustih (z zdravilom povezane lihenoidne erupcije).
Disposing of used syringes
Odlaganje uporabljenih brizg
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).
Toda vpliv na bezgavke in neuravnanost zob je ostal, pri eni živali pa so ugotovili minimalno do zmerno mineralizacijo v več tkivih (povezanost z zdravljenjem je negotova).
The risks of developing hypocalcaemia and accompanying parathyroid hormone elevations increase with increasing degree of renal impairment.
Tveganje za pojav hipokalciemije in za spremljajoča zvišanja obščitničnega hormona se povečuje s povečano stopnjo okvare ledvic.
Please tell your doctor immediately if you develop any of these symptoms.
Zdravniku morate takoj povedati, če se vam pojavi kateri koli od teh znakov.
Your carer can also use the outer area of your upper arms.
Oseba, ki za vas skrbi, lahko uporabi tudi zunanjo stran vašega nadlakta.
This indicates that Prolia should not alter the pharmacokinetics of medicinal products metabolised by CYP3A4.
To kaže, da zdravilo Prolia ne bi spremenilo farmakokinetike zdravil, ki se presnavljajo s CYP3A4.
Prolia has not been tested in pregnant women.
Zdravilo Prolia ni preizkušeno pri nosečnicah.
• ear infection,
• okužba ušesa,
After Cmax, serum levels declined with a half-life of 26 days (range 6-52 days) over a period of 3 months (range 1.5-4.5 months).
Po doseženi Cmax je koncentracija v serumu upadala z razpolovnim časom 26 dni (razpon: 6 - 52 dni) v obdobju 3 mesecev (razpon: 1,5 - 4,5 meseca).
For instructions on how to inject Prolia, please read the section at the end of this leaflet.
Za navodila o injiciranju zdravila Prolia preberite poglavje na koncu tega navodila za uporabo.
Patients were randomised (1:1) to receive either Prolia 60 mg subcutaneously once every 6 months or oral risedronate 5 mg once daily (active control) for 2 years.
Bolniki so bili randomizirani (1 : 1) na subkutano prejemanje 60 mg zdravila Prolia enkrat na vsakih šest mesecev ali dveletno peroralno prejemanje 5 mg risedronata enkrat dnevno (aktivna kontrola).
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.
Kliničnih podatkov o sočasni uporabi denosumaba in hormonskega nadomestnega zdravljenja (estrogena) ni, vendar je možnost farmakodinamičnih medsebojnih delovanj predvidoma majhna.
Symptoms of hypocalcaemia in denosumab clinical studies included paraesthesias or muscle stiffness, twitching, spasms and muscle cramps.
Med simptomi hipokalciemije v kliničnih študijah denosumaba so bile parestezije ali togost mišic, trzanje, spazmi in mišični krči.
What Prolia is and what it is used for
Kaj je zdravilo Prolia in za kaj ga uporabljamo
• 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.
• 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.
Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology.
Denosumab je humano monoklonsko protitelo IgG2, pridobljeno v celični liniji sesalcev (celice jajčnikov kitajskega hrčka) s tehnologijo rekombinantne DNA.
This could damage the device.
S tem jo lahko poškodujete.
0-1 year
0-1 leto
Adolescent primates dosed with denosumab at 27 and 150 times (10 and 50 mg/kg dose) the clinical exposure had abnormal growth plates.
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.
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.
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.
What you need to know before you use Prolia
Kaj morate vedeti, preden boste uporabili zdravilo Prolia
Remember: if you have any problems, please ask your doctor or healthcare provider for help and advice.
Ne pozabite: Če imate kakršnekoli težave, prosite za pomoč in nasvet zdravnika ali drugo zdravstveno osebje.
Patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia.
Bolniki s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) ali bolniki na dializi imajo večje tveganje za nastanek hipokalciemije.
The pre-filled syringe may be left outside the refrigerator to reach room temperature.
Napolnjeno injekcijsko brizgo lahko pustite zunaj hladilnika, da doseže sobno temperaturo.
If any patient presents with suspected symptoms of hypocalcaemia during treatment (see section 4.8 for symptoms) calcium levels should be measured.
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.
• cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
• rak, sočasne bolezni (npr. anemijo, koagulopatije, okužbo), kajenje,
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Pokrovček igle na napolnjeni injekcijski brizgi vsebuje suho naravno gumo (derivat lateksa), ki lahko povzroči alergijske reakcije.
The subject incidence of non-vertebral fracture was 4.3% (denosumab) versus 2.5% (risedronate).
Incidenca nevretenčnih zlomov je bila 4,3 % (denosumab) v primerjavi z 2,5 % (risedronat).
If you become pregnant during treatment with Prolia or less than 5 months after stopping treatment with Prolia, please inform your doctor.
Če zanosite med zdravljenjem z zdravilom Prolia ali manj kot 5 mesecev po koncu zdravljenja z zdravilom Prolia, o tem obvestite svojega zdravnika.
Women with other diseases or on therapies that may affect bone were excluded from this study.
V to študijo niso vključili žensk z drugimi boleznimi ali zdravljenji, ki bi lahko vplivala na kosti.
In clinical studies, neutralising antibodies have not been observed for denosumab.
V kliničnih študijah niso ugotovili nevtralizirajočih protiteles proti denosumabu.
Bone histology was also evaluated in 17 men with osteoporosis following 1 year treatment with Prolia.
Histologijo kosti so ocenili tudi pri 17 moških z osteoporozo po 1 letu zdravljenja z zdravilom Prolia.
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.
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.
• upper respiratory tract infection,
• okužba zgornjih dihal,
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).
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).
Patients must be adequately supplemented with calcium and vitamin D (see section 4.4).
Bolniki morajo dobivati zadostne dodatke kalcija in vitamina D (glejte poglavje 4.4).
Prolia significantly reduced the risk of new vertebral fractures at 1, 2 and 3 years (p < 0.0001) (see table 2).
Zdravilo Prolia je znatno zmanjšalo tveganje za nove zlome vretenc po 1, 2 in 3 letih (p < 0,0001) (glejte tabelo 2).
While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Prolia administration.
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.
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.
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.
Your doctor may ask you to undergo a dental examination before you start treatment with Prolia.
Zdravnik vam bo morda naročil, da pred začetkom zdravljenja z zdravilom Prolia opravite zobozdravniški pregled.
• bone loss that results from a reduction in hormone (testosterone) level caused by surgery or treatment with medicines in patients with prostate cancer.
• izgubljanje kostne mase, ki nastane zaradi manjše koncentracije hormonov (testosterona) kot posledica operacije ali zdravljenja z zdravili pri bolnikih z rakom na prostati.
Osteonecrosis of the external auditory canal2
osteonekroza zunanjega slušnega kanala2
Important Before you use a Prolia pre-filled syringe with automatic needle guard, read this important information:
Pred uporabo zdravila Prolia v napolnjeni injekcijski brizgi z avtomatskim ščitnikom igle preberite te pomembne informacije:
There are no or limited amount of data from the use of denosumab in pregnant women.
Podatkov o uporabi denosumaba pri nosečnicah ni oziroma so omejeni.
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.
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.
These data indicate that continued treatment with Prolia is required to maintain the effect of the medicinal product.
Ti podatki kažejo, da je za vzdrževanje učinka zdravila Prolia potrebno stalno zdravljenje.
Push the plunger with a slow constant pressure, always keeping the skin pinched.
S počasnim in stalnim pritiskom potiskajte bat; kožo še naprej držite s prstoma.
Prolia is a clear, colourless to slightly yellow solution for injection provided in a ready to use pre-filled syringe.
Zdravilo Prolia je bistra, brezbarvna do rahlo rumena raztopina za injiciranje, ki je na voljo v napolnjeni injekcijski brizgi, pripravljeni za uporabo.
Patients should be encouraged to report symptoms indicative of hypocalcaemia.
Bolnikom je treba naročiti, naj zdravnika obvestijo o simptomih, ki kažejo na hipokalciemijo.
You should not take Prolia together with another medicine containing denosumab.
Zdravila Prolia ne smete jemati skupaj z drugim zdravilom, ki vsebuje denosumab.
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).
Zavrtje RANK/RANK-liganda (RANKL) je bilo v študijah na živalih povezano z zavrtjem rasti kosti in neizraščanjem zob (glejte poglavje 5.3).
• have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction.
• imate kakšne težave v ustih ali z zobmi kot na primer slabo zdravje zob, bolezen dlesni ali predvideno izdrtje zob,
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.
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.
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.
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.
Rarely, patients receiving Prolia may have low calcium levels in the blood (hypocalcaemia).
Redko imajo lahko bolniki, ki prejemajo zdravilo Prolia, nizko koncentracijo kalcija v krvi (hipokalciemija).
PHARMACEUTICAL FORM AND CONTENTS Solution for injection
FARMACEVTSKA OBLIKA IN VSEBINA Raztopina za injiciranje
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.
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.
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures.
Zdravljenje osteoporoze pri ženskah po menopavzi in pri moških z večjim tveganjem zlomov.
However, due to its character it is unlikely that denosumab has any potential for genotoxicity.
Vendar glede na značilnosti denosumaba ni verjetno, da bi bil genotoksičen.