FrancophonIA/ELRC3.0 huggingface dataset:
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit-risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Effect on all clinical fractures Prolia significantly reduced fractures across all fracture types/groups (see table 3).
Slovenian: Učinek na vse klinične zlome Zdravilo Prolia je znatno zmanjšalo število zlomov po vseh vrstah/skupinah (glejte tabelo 3).
English: It is important to try to prevent ONJ developing as it may be a painful condition that can be difficult to treat.
Slovenian: Pomembno si je prizadevati, da bi preprečili nastanek osteonekroze čeljustnice, ker gre za stanje, ki lahko boli in ga je težko zdraviti.
English: In a study of 55 patients with varying degrees of renal function, including patients on dialysis, the degree of renal impairment had no effect on the pharmacokinetics of denosumab.
Slovenian: V študiji 55 bolnikov z različno stopnjo delovanja ledvic, vključno z bolniki na dializi, stopnja okvare ledvic ni vplivala na farmakokinetiko denosumaba.
English: The optimal total duration of antiresorptive treatment for osteoporosis (including both denosumab and bisphosphonates) has not been established.
Slovenian: Optimalno trajanje antiresorpcijskega zdravljenja osteoporoze (vključno z denosumabom in bisfosfonati) še ni bilo potrjeno.
English: Proportion of women with fracture (%)+
Slovenian: Delež žensk z zlomom (%)+
English: Problems with your mouth, teeth or jaw
Slovenian: Težave z usti, zobmi ali čeljustnico
English: Please talk to your doctor before you consider stopping the treatment.
Slovenian: Posvetujte se z zdravnikom, preden se odločite za prenehanje zdravljenja.
English: Calcium and Vitamin D supplementation
Slovenian: Dodajanje kalcija in vitamina D
English: Age (28-87 years), race and disease state (low bone mass or osteoporosis; prostate or breast cancer) do not appear to significantly affect the pharmacokinetics of denosumab.
Slovenian: Kaže, da starost (28 - 87 let), rasa in stanje bolezni (majhna kostna masa ali osteoporoza; rak na prostati ali dojki) ne vplivajo pomembno na farmakokinetiko denosumaba.
English: DO NOT touch the needle or push the plunger.
Slovenian: NE dotikajte se igle in ne pritiskajte bata.
English: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Slovenian: Upoštevati je treba aditivni učinek sočasnega dajanja zdravil, ki vsebujejo sorbitol (ali fruktozo), in prehranskega vnosa sorbitola (ali fruktoze).
English: These effects were sustained with continued treatment.
Slovenian: Ti vplivi so se med nadaljevanjem zdravljenja ohranili.
English: A trend was observed between higher body weight and lower exposure based on AUC and Cmax.
Slovenian: Opazili so povezanost med večjo telesno maso in manjšo izpostavljenostjo, ocenjeno z AUC in Cmax.
English: Elderly (age ≥ 65) No dose adjustment is required in elderly patients.
Slovenian: Starejši (stari ≥ 65 let) Starejšim bolnikom odmerka ni treba prilagoditi.
English: Many patients with osteoporosis have no symptoms, but they are still at risk of breaking bones, especially in the spine, hips and wrists.
Slovenian: Številni bolniki z osteoporozo nimajo simptomov, a jih kljub temu ogrožajo zlomi kosti, zlasti hrbtenice, kolkov in zapestij.
English: The following convention has been used for the classification of the adverse reactions (see table 1): very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Za razvrstitev neželenih učinkov (glejte tabelo 1) je uporabljen naslednji dogovor: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: You must inject the entire content (1 mL) of the Prolia pre-filled syringe and it should be injected once every 6 months as instructed by your doctor.
Slovenian: Injicirati morate celotno vsebino (1 ml) napolnjene injekcijske brizge Prolia in injicirati jo morate enkrat vsakih 6 mesecev, kot vam je naročil zdravnik.
English: Following subcutaneous administration of a 1.0 mg/kg dose, which approximates the approved 60 mg dose, exposure based on AUC was 78% as compared to intravenous administration at the same dose level.
Slovenian: Po subkutanem dajanju odmerka 1,0 mg/kg, ki približno ustreza odobrenemu odmerku 60 mg, je bila izpostavljenost ocenjena na podlagi AUC 78 % tiste po intravenskem dajanju enakega odmerka.
English: While being treated, you should maintain good oral hygiene and receive routine dental check-ups.
Slovenian: Med zdravljenjem morate vzdrževati dobro ustno higieno in opravljati redne zobozdravniške preglede.
English: Subjects with an eGFR < 30 mL/min/1.73 m2 were excluded from the study.
Slovenian: Preiskovanci z ocenjeno hitrostjo glomerularne filtracije < 30 ml/min/1,73 m2 so bili izključeni iz študije.
English: What Prolia is and how it works
Slovenian: Kaj je zdravilo Prolia in kako deluje
English: • if you have low calcium levels in the blood (hypocalcaemia).
Slovenian: • če imate nizko koncentracijo kalcija v krvi (hipokalciemijo).
English: Injecting the solution with the air bubble is harmless.
Slovenian: Injiciranje raztopine z mehurčkom zraka je neškodljivo.
English: Bone turnover markers generally reached pre-treatment levels within 9 months after the last dose.
Slovenian: Označevalci prenove kosti so na splošno dosegli raven, kakršna je bila pred zdravljenjem, v 9 mesecih po zadnjem odmerku.
English: It can also occur in patients receiving glucocorticoids.
Slovenian: Pojavi se lahko tudi pri bolnikih, ki prejemajo glukokortikoide.
English: Only use each pre-filled syringe for one injection.
Slovenian: Vsako napolnjeno injekcijsko brizgo uporabite samo za eno injiciranje.
English: Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Slovenian: Med možne dejavnike tveganja za osteonekrozo zunanjega slušnega kanala spadajo uporaba steroidov in kemoterapija in/ali lokalni dejavniki tveganja, kot sta okužba ali poškodba.
English: No specific study in patients with hepatic impairment was performed.
Slovenian: Specifičnih študij pri bolnikih z okvaro jeter ni bilo.
English: A no observed adverse effect level for reproductive effects was not established.
Slovenian: Ravni odmerka brez ugotovljenih neželenih učinkov niso ugotovili.
English: • Belly, except for a 5 cm (2-inch) area right around your belly button.
Slovenian: • trebuh, razen v predelu 5 cm okrog popka.
English: Efficacy and safety of Prolia once every 6 months for 1 year were investigated in 242 men aged 31-84 years.
Slovenian: Učinkovitost in varnost zdravila Prolia, uporabljenega enkrat na 6 mesecev v obdobju 1 leta, so raziskali pri 242 moških, starih od 31 do 84 let.
English: • Inject the entire contents of the pre-filled syringe.
Slovenian: • Injicirajte celotno vsebino napolnjene injekcijske brizge.
English: Bone biopsy results showed bone of normal architecture and quality with no evidence of mineralisation defects, woven bone or marrow fibrosis.
Slovenian: Rezultati biopsije kosti so pokazali normalno kostno arhitekturo in kakovost, brez znakov mineralizacijskih defektov, prepletene kostnine ali fibroze kostnega mozga.
English: Any effects of Prolia are likely to be greater during the second and third trimesters of pregnancy since monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester.
Slovenian: Za vse učinke zdravila Prolia je verjetno, da so večji v drugem ali tretjem trimesečju nosečnosti, kajti monoklonska protitelesa prehajajo skozi placento linearno, kot napreduje nosečnost, s tem da jih največja količina preide v tretjem trimesečju.
English: Prolia has no or negligible influence on the ability to drive and use machines.
Slovenian: Prolia ne vpliva ali pa le zanemarljivo vpliva na sposobnost vožnje in upravljanja strojev.
English: • bone, joint, and/or muscle pain which is sometimes severe, • arm or leg pain (pain in extremity).
Slovenian: • bolečina v kosteh, sklepih in/ali mišicah, ki je včasih huda, • bolečina v rokah ali nogah (bolečina v udih).
English: Other medicines and Prolia
Slovenian: Druga zdravila in zdravilo Prolia
English: In the post-marketing setting, severe symptomatic hypocalcaemia (including fatal cases) has been reported (see section 4.8), with most cases occurring in the first weeks of initiating therapy, but it can occur later.
Slovenian: V obdobju trženja zdravila so poročali o hudi simptomatski hipokalciemiji (vključno s smrtnimi primeri) (glejte poglavje 4.8), večina primerov se je pojavila v prvih tednih po uvedbi zdravljenja, a pojavi se lahko tudi pozneje.
English: • concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck.
Slovenian: • sočasna zdravljenja: kortikosteroide, kemoterapijo, zaviralce angiogeneze, radioterapijo glave in vratu,
English: Once your syringe has been left to reach room temperature (up to 25°C), it must be used within 30 days.
Slovenian: Ko brizga enkrat doseže sobno temperaturo (do 25 °C), jo morate uporabiti v 30 dneh.
English: A total of 2,626 subjects (58% of the women included in the extension study i.e. 34% of the women included in the pivotal study) completed the extension study.
Slovenian: Podaljšanje študije je dokončalo skupaj 2.626 bolnic (58 % žensk, vključenih v podaljšanje študije, to je 34 % žensk, ki so bile vključene v ključno študijo).
English: • have previously been treated with a bisphosphonate (used to treat or prevent bone disorders).
Slovenian: • ste predhodno dobivali zdravilo iz skupine bisfosfonatov (uporabljajo se za zdravljenje ali preprečevanje kostnih bolezni),
English: DO NOT warm it in any other way, for example, in a microwave or in hot water.
Slovenian: NE ogrevajte zdravila kako drugače, npr. v mikrovalovni pečici ali vroči vodi.
English: INFORMATION IN BRAILLE Prolia
Slovenian: PODATKI V BRAILLOVI PISAVI Prolia
English: In general, monoclonal antibodies are not eliminated via hepatic metabolic mechanisms.
Slovenian: Na splošno se monoklonska protitelesa ne odstranijo z jetrnimi presnovnimi mehanizmi.
English: Following a 6 month period after birth, bone related changes showed recovery and there was no effect on tooth eruption.
Slovenian: Med 6-mesečnim obdobjem po rojstvu so se kostne spremembe popravile in vpliva na izraščanje zob ni bilo.
English: Patients presenting with such symptoms should be evaluated for an incomplete femoral fracture.
Slovenian: Bolnike s takšnimi simptomi je treba preiskati glede nepopolnega zloma stegnenice.
English: 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.
Slovenian: 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.
English: Put the needle fully into the skin as shown by your doctor or healthcare provider.
Slovenian: Zabodite iglo do konca v kožo, kot vam je pokazal zdravnik ali drugo zdravstveno osebje.
English: Drug-related hypersensitivity reactions
Slovenian: Z zdravilom povezane preobčutljivostne reakcije
English: • DO NOT put the cover back on used needles.
Slovenian: • NE nameščajte pokrovčka nazaj na uporabljene igle.
English: Prolia is not recommended for use in pregnant women and women of child-bearing potential not using contraception.
Slovenian: Zdravila Prolia ni priporočljivo uporabljati pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: In clinical trials, musculoskeletal pain was very common in both denosumab and placebo groups.
Slovenian: V kliničnih preskušanjih je bila mišično-skeletna bolečina zelo pogosta tako v skupini z denosumabom kot v skupini s placebom.
English: Every 6 months Amgen Europe B.V.
Slovenian: Vsakih 6 mesecev Amgen Europe B.V.
English: 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.
Slovenian: 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.
English: Patients should be advised to seek prompt medical attention if they develop signs or symptoms of cellulitis.
Slovenian: Bolnikom je treba naročiti, naj takoj poiščejo zdravniško pomoč, če se jim pojavijo znaki ali simptomi celulitisa.
English: Therefore, treatment with denosumab may impair bone growth in children with open growth plates and may inhibit eruption of dentition.
Slovenian: Zdravljenje z denosumabom torej lahko prizadene rast kosti pri otrocih z odprtimi rastnimi ploščicami in lahko zavre izraščanje zob.
English: Skin infections
Slovenian: Okužbe kože
English: These could be signs of bone damage in the jaw (osteonecrosis).
Slovenian: To so lahko znaki poškodbe kosti v čeljusti (osteonekroze).
English: • are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
Slovenian: • jemljete zdravila, ki jih imenujemo kortikosteroidi (kot sta prednizolon ali deksametazon),
English: 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).
Slovenian: 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).
English: Check the appearance of Prolia.
Slovenian: Preverite videz zdravila Prolia.
English: In order to reduce the risk of developing ONJ, there are some precautions you should take.
Slovenian: Da boste zmanjšali tveganje za nastanek osteonekroze čeljustnice, morate upoštevati nekatere previdnostne ukrepe.
English: If a dose of Prolia is missed, the injection should be administered as soon as possible.
Slovenian: Če ste izpustili odmerek zdravila Prolia, morate injekcijo dobiti čim prej.
English: This medicine contains 47 mg sorbitol in each mL of solution.
Slovenian: To zdravilo vsebuje 47 mg sorbitola v vsakem ml raztopine.
English: The use of Prolia in children and adolescents has not been studied.
Slovenian: Uporaba zdravila Prolia pri otrocih in mladostnikih ni raziskana.
English: The best places to inject are the top of your thighs and the abdomen.
Slovenian: Najprimernejši mesti za injiciranje sta zgornji del stegen in trebuh.
English: Polysorbate 20
Slovenian: Polisorbat 20
English: There was no evidence of maternal harm prior to labour; adverse maternal effects occurred infrequently during labour.
Slovenian: Znakov škodljivosti za samice-matere pred porodom ni bilo; neželeni učinki za samice-matere so se v redkih primerih pojavili med porodom.
English: 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)
Slovenian: 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)
English: 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).
Slovenian: 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).
English: • Prolia is given as an injection into the tissue just under the skin (subcutaneous injection).
Slovenian: • Zdravilo Prolia se daje kot injekcija v tkivo tik pod kožo (subkutano injiciranje).
English: • poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions.
Slovenian: • slabo ustno higieno, periodontalno bolezen, slabo prilegajoče se zobne proteze, že obstoječo zobno bolezen, invazivne zobozdravstvene posege, npr. ekstrakcijo zob.
English: The pharmacokinetic profile in paediatric populations has not been assessed.
Slovenian: Farmakokinetičnih značilnosti pri pediatrični skupini bolnikov niso ocenjevali.
English: 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).
Slovenian: 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).
English: Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V vsaki skupini pogostnosti in vsakem organskem sistemu so neželeni učinki navedeni v padajočem zaporedju resnosti pojava.
English: Musculoskeletal pain leading to discontinuation of study treatment was uncommon.
Slovenian: Mišično-skeletna bolečina, ki bi povzročila prenehanje uporabe preskušanega zdravila, je bila občasna.
English: Your doctor or healthcare provider will show you or your carer how to use Prolia.
Slovenian: Zdravnik ali drugo zdravstveno osebje bodo vam (ali osebi, ki za vas skrbi) pokazali, kako uporabljati zdravilo Prolia.
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.
Slovenian: 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.
English: Rarely, allergic reactions may occur in patients receiving Prolia.
Slovenian: Redko se lahko pri bolnikih, ki prejemajo zdravilo Prolia, pojavijo alergijske reakcije.
English: • 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.
Slovenian: • 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,
English: The primary efficacy variable was percent change in lumbar spine BMD, fracture efficacy was not evaluated.
Slovenian: Primarna spremenljivka učinkovitosti je bil odstotek spremembe mineralne kostne gostote v ledvenem delu hrbtenice, učinkovitost glede zlomov ni bila ocenjena.
English: 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.
Slovenian: 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.
English: The most common side effects with Prolia (seen in more than one patient in ten) are musculoskeletal pain and pain in the extremity.
Slovenian: Najbolj pogosta neželena učinka zdravila Prolia (pojavila sta se pri več kot enem bolniku od desetih) sta mišično-skeletna bolečina in bolečina v okončini.
English: Water for injections * Acetate buffer is formed by mixing acetic acid with sodium hydroxide
Slovenian: Voda za injekcije *Acetatni pufer nastane z mešanjem ocetne kisline z natrijevim hidroksidom
English: Examples of the clinical manifestations of severe symptomatic hypocalcaemia have included QT interval prolongation, tetany, seizures and altered mental status (see section 4.4).
Slovenian: Med kliničnimi manifestacijami hude simptomatske hipokalciemije so bili podaljšanje intervala QT, tetanija, konvulzije in spremenjeno duševno stanje (glejte poglavje 4.4).
English: • rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions).
Slovenian: • izpuščaj, ki se lahko pojavi na koži, ali razjede v ustih (z zdravilom povezane lihenoidne erupcije).
English: Disposing of used syringes
Slovenian: Odlaganje uporabljenih brizg
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).
Slovenian: 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).
English: The risks of developing hypocalcaemia and accompanying parathyroid hormone elevations increase with increasing degree of renal impairment.
Slovenian: Tveganje za pojav hipokalciemije in za spremljajoča zvišanja obščitničnega hormona se povečuje s povečano stopnjo okvare ledvic.
English: Please tell your doctor immediately if you develop any of these symptoms.
Slovenian: Zdravniku morate takoj povedati, če se vam pojavi kateri koli od teh znakov.
English: Your carer can also use the outer area of your upper arms.
Slovenian: Oseba, ki za vas skrbi, lahko uporabi tudi zunanjo stran vašega nadlakta.
English: This indicates that Prolia should not alter the pharmacokinetics of medicinal products metabolised by CYP3A4.
Slovenian: To kaže, da zdravilo Prolia ne bi spremenilo farmakokinetike zdravil, ki se presnavljajo s CYP3A4.
English: Prolia has not been tested in pregnant women.
Slovenian: Zdravilo Prolia ni preizkušeno pri nosečnicah.
English: • ear infection,
Slovenian: • okužba ušesa,
English: 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).
Slovenian: 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).
English: For instructions on how to inject Prolia, please read the section at the end of this leaflet.
Slovenian: Za navodila o injiciranju zdravila Prolia preberite poglavje na koncu tega navodila za uporabo.
English: 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.
Slovenian: 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).