FrancophonIA/ELRC3.0 huggingface dataset:
English: In a single phase III placebo-controlled clinical trial in patients with prostate cancer receiving ADT an imbalance in diverticulitis adverse events was observed (1.2% denosumab, 0% placebo).
Slovenian: V enem samem s placebom kontroliranem kliničnem preskušanju III. faze pri bolnikih z rakom prostate, zdravljenih z ADT, so ugotovili razliko v pojavnosti neželenega učinka divertikulitisa (denosumab 1,2 %, placebo 0 %).
English: Efficacy and safety of Prolia once every 6 months for 3 years were investigated in men with histologically confirmed non-metastatic prostate cancer receiving ADT (1,468 men aged 48-97 years) who were at increased risk of fracture (defined as > 70 years, or < 70 years with a BMD T-score at the lumbar spine, total hip, or femoral neck < -1.0 or a history of an osteoporotic fracture.)
Slovenian: Učinkovitost in varnost zdravila Prolia, uporabljenega enkrat na 6 mesecev v obdobju 3 let, so raziskovali pri moških s histološko potrjenim nemetastatskim rakom prostate, zdravljenih z ADT (1.468 moških, starih od 48 do 97 let), ki so imeli večje tveganje zlomov (kar je bilo opredeljeno kot starost > 70 let ali starost < 70 let in T-vrednost mineralne kostne gostote v ledvenem delu hrbtenice, celotnem kolku ali stegneničnem vratu < -1,0 ali anamneza osteoporotičnega zloma).
English: The PRAC considers that due to the fact that fatal cases of hypocalcaemia have been reported for Prolia also during this reporting interval, and there was a timely typical association with Prolia administration, the wording ‘including fatal cases' should be added to the current text regarding hypocalcaemia in section 4.4 of the SmPC.
Slovenian: Zaradi dejstva, da so v tem obdobju poročanja o varnosti zdravila Prolia poročali o smrtnih primerih hipokalciemije in da je obstajala značilna časovna povezava z dajanjem zdravila Prolia, odbor PRAC meni, da je potrebno k obstoječemu besedilu glede hipokalciemije v poglavju 4.4.
English: What Prolia looks like and contents of the pack
Slovenian: Izgled zdravila Prolia in vsebina pakiranja
English: Clinical efficacy and safety in postmenopausal women with osteoporosis
Slovenian: Klinična učinkovitost in varnost pri ženskah po menopavzi z osteoporozo
English: Your doctor has prescribed a Prolia pre-filled syringe for injection into the tissue just under the skin (subcutaneous).
Slovenian: Zdravnik vam je predpisal zdravilo Prolia v napolnjeni injekcijski brizgi, da si ga boste injicirali tik pod kožo (subkutano).
English: Please tell your doctor immediately if you notice any of the following symptoms: spasms, twitches, or cramps in your muscle, and/or numbness or tingling in your fingers, toes or around your mouth, and/or seizures, confusion, or loss of consciousness.
Slovenian: Zdravniku morate takoj povedati, če opazite katerega koli od naslednjih znakov: spazme, trzanje ali krče v mišicah in/ali omrtvičenost ali mravljinčenje v prstih rok ali nog ali okrog ust in/ali napade krčev, zmedenost ali izgubite zavest.
English: Prolia contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, in order to treat bone loss and osteoporosis.
Slovenian: Denosumab je beljakovina (monoklonsko protitelo), ki ovira delovanje neke druge beljakovine in tako zdravi izgubljanje kostne mase in osteoporozo.
English: How do you use the Prolia pre-filled syringe?
Slovenian: Kako uporabiti napolnjeno injekcijsko brizgo zdravila Prolia?
English: Clinical efficacy and safety in men with osteoporosis
Slovenian: Klinična učinkovitost pri moških z osteoporozo
English: • constipation,
Slovenian: • zaprtost,
English: In postmenopausal women Prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures.
Slovenian: Pri ženskah po menopavzi zdravilo Prolia znatno zmanjša tveganje zlomov vretenc, nevretenčnih zlomov in zlomov kolka.
English: Women of child-bearing potential should use effective methods of contraception while being treated with Prolia and for at least 5 months after stopping treatment with Prolia.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z zdravilom Prolia in vsaj še 5 mesecev po koncu zdravljenja s tem zdravilom uporabljati učinkovito kontracepcijsko zaščito.
English: Find a comfortable, well-lit, clean surface and put all the equipment within reach.
Slovenian: Poiščite primerno, dobro osvetljeno, čisto površino.
English: Efficacy and safety of Prolia once every 6 months for 2 years were investigated in women with non-metastatic breast cancer (252 women aged 35-84 years) and baseline BMD T-scores between -1.0 to -2.5 at the lumbar spine, total hip or femoral neck.
Slovenian: Učinkovitost in varnost zdravila Prolia enkrat na 6 mesecev v obdobju 2 let so raziskovali pri ženskah z nemetastatskim rakom dojke (252 žensk, starih od 35 do 84 let) in izhodiščno T-vrednostjo mineralne kostne gostote med -1,0 do -2,5 v ledvenem delu hrbtenice, celotnem kolku ali stegneničnem vratu.
English: Please tell your doctor if you have an allergy to latex (the needle cover on the pre-filled syringe contains a derivative of latex).
Slovenian: Zdravniku morate povedati, če ste alergični na lateks (pokrovček igle na napolnjeni injekcijski brizgi vsebuje lateksno snov).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer), the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za denosumab (indiciran za osteoporozo in izgubljanje kostne mase, povezane z ablacijo hormonov pri raku na prostati) je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Prolia increased lumbar spine BMD from baseline in 94.7% of men at 1 year.
Slovenian: Zdravilo Prolia je po 1 letu v primerjavi z izhodiščem povečalo mineralno kostno gostoto v ledvenem delu hrbtenice pri 94,7 % moških.
English: Uncommon cases of cellulitis, rare cases of hypocalcaemia, hypersensitivity, osteonecrosis of the jaw and atypical femoral fractures (see section 4.4 and section 4.8 - description of selected adverse reactions) have been observed in patients taking Prolia.
Slovenian: Pri bolnikih, ki uporabljajo zdravilo Prolia, so opazili občasne primere celulitisa, redke primere hipokalciemije, preobčutljivosti, osteonekroze čeljustnice ter atipičnih zlomov stegnenice (glejte poglavje 4.4 in poglavje 4.8 - opis izbranih neželenih učinkov).
English: Similar fractures reported in association with bisphosphonates are often bilateral; therefore the contralateral femur should be examined in denosumab-treated patients who have sustained a femoral shaft fracture.
Slovenian: opisani v zvezi z bisfosfonati, so pogosto obojestranski, zato je treba pri bolnikih, ki se zdravijo z denosumabom in so imeli zlom srednjega dela stegnenice, opraviti tudi pregled druge stegnenice.
English: If you have questions about how to inject, please ask your doctor or healthcare provider for assistance.
Slovenian: Če imate vprašanja o injiciranju zdravila, se za pomoč obrnite na zdravnika ali drugo zdravstveno osebje.
English: It must be a clear, colourless to slightly yellow solution.
Slovenian: Biti mora bistra, brezbarvna do rahlo rumena raztopina.
English: DO NOT use the pre-filled syringe if the needle cover has been removed.
Slovenian: NE uporabite napolnjene injekcijske brizge, če je bil njen pokrovček odstranjen.
English: The incidence of hip fracture was 1.2% in the placebo group compared to 0.7% in the Prolia group at 3 years.
Slovenian: Po 3 letih je bila incidenca zloma kolka v skupini s placebom 1,2 % in v skupini z zdravilom Prolia 0,7 %.
English: In the osteoporosis clinical trial program, atypical femoral fractures were reported rarely in patients treated with Prolia (see section 4.4).
Slovenian: V programu kliničnih preskušanj pri osteoporozi so pri bolnikih, zdravljenih z zdravilom Prolia, redko poročali o atipičnih zlomih stegnenice (glejte poglavje 4.4).
English: Each pack contains one pre-filled syringe.
Slovenian: Eno pakiranje vsebuje eno napolnjeno injekcijsko brizgo.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases - Other drugs affecting bone structure and mineralisation, ATC code: M05BX04
Slovenian: Farmakoterapevtska skupina: Zdravila za zdravljenje bolezni kosti - druga zdravila z učinkom na strukturo in mineralizacijo kosti.
English: All women in the extension study were to receive Prolia 60 mg every 6 months, as well as daily calcium (at least 1 g) and vitamin D (at least 400 IU).
Slovenian: V nadaljevalni študiji naj bi vse ženske prejele zdravilo Prolia 60 mg vsakih 6 mesecev, tako kot tudi dnevno kalcij (vsaj 1 g) in vitamin D (vsaj 400 i.e.).
English: Treatment with Prolia makes bone stronger and less likely to break.
Slovenian: Zdravljenje z zdravilom Prolia okrepi kosti in zmanjša verjetnost zlomov.
English: Each pack contains one pre-filled syringe with a needle guard.
Slovenian: Eno pakiranje vsebuje eno napolnjeno injekcijsko brizgo s ščitnikom za iglo.
English: The following risk factors should be considered when evaluating a patient's risk of developing ONJ:
Slovenian: Pri ocenjevanju bolnikovega tveganja za nastanek osteonekroze čeljustnice je treba upoštevati naslednje dejavnike tveganja:
English: Bone histology in postmenopausal women and men with osteoporosis
Slovenian: Histologija kosti pri ženskah po menopavzi in moških z osteoporozo
English: Denosumab is composed solely of amino acids and carbohydrates as native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms.
Slovenian: Denosumab je naraven imunoglobulin in je tako sestavljen zgolj iz aminokislin in ogljikovih hidratov.
English: Effect on bone mineral density
Slovenian: Vpliv na mineralno kostno gostoto
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with denosumab in patients with concomitant risk factors.
Slovenian: Za bolnike s sočasnimi dejavniki tveganja je pred zdravljenjem z denosumabom priporočljiv zobozdravstveni pregled, vključno s preventivno zobozdravstveno oskrbo ter individualno oceno koristi in tveganja.
English: Atypical femoral fractures have been reported in patients receiving denosumab (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali denosumab, so poročali o atipičnih zlomih stegnenice (glejte poglavje 4.8).
English: Denosumab pharmacokinetics were not affected by the formation of binding antibodies to denosumab and were similar in men and women.
Slovenian: Nastajanje protiteles, ki se vežejo na denosumab, ni vplivalo na farmakokinetične lastnosti zdravila, ki so bile pri ženskah in moških podobne.
English: In addition, as post-marketing experience including multiple cases with positive re-challenge, as well as non-clinical evidence of involvement of the RANK / RANKL signalling pathway in the hair growth cycle support a conclusion that denosumab may be causally associated with the development of alopecia, this new ADR should be added in section 4.8 of the SmPC and the Package Leaflet.
Slovenian: Izkušnje v obdobju trženja zdravila, ki vključujejo več pozitivnih primerov po ponovni uvedbi zdravljenja, kot tudi predklinični dokazi o vključenosti signalne poti RANK / RANKL v cikel rasti las potrjujejo tudi sklep, da je denosumab lahko vzročno povezan z razvojem alopecije, zato je potrebo ta nov neželen učinek dodati v poglavje 4.8 Povzetka glavnih značilnosti zdravila in v Navodilo za uporabo.
English: Your pre-filled syringe may be left outside the refrigerator to reach room temperature (up to 25°C) before injection.
Slovenian: Pred injiciranjem lahko napolnjeno injekcijsko brizgo pustite zunaj hladilnika, da doseže sobno temperaturo (do 25 °C).
English: DO NOT remove the needle cover from the pre-filled syringe until you are ready to inject.
Slovenian: NE odstranite pokrovčka igle z napolnjene injekcijske brizge, dokler niste pripravljeni za injiciranje.
English: You may notice a small air bubble in the pre-filled syringe.
Slovenian: V napolnjeni injekcijski brizgi boste morda opazili majhen zračni mehurček.
English: In preclinical studies conducted in knockout mice lacking RANK or RANKL, impairment of lymph node formation was observed in the foetus.
Slovenian: V predkliničnih študijah pri knockout miših brez RANK ali RANKL, so ugotovili motnjo razvoja bezgavk pri plodu.
English: Your doctor may decide that it is best for you or a carer to inject Prolia.
Slovenian: Zdravnik lahko presodi, da je najbolje, če si zdravilo Prolia injicirate sami oz. vam ga injicira oseba, ki za vas skrbi.
English: Please tell your doctor immediately if you develop any of these symptoms while being on treatment with Prolia: swollen, red area of skin, most commonly in the lower leg, that feels hot and tender, and possibly with symptoms of fever.
Slovenian: Zdravniku morate nemudoma povedati, če se vam med zdravljenjem z zdravilom Prolia pojavi kateri od naslednjih simptomov: otekel, pordel predel kože, najpogosteje nastane na goleni, ki je vroč in občutljiv in ga lahko spremljajo znaki zvišane telesne temperature.
English: In two phase III placebo-controlled clinical trials in postmenopausal women with osteoporosis, approximately 0.05% (2 out of 4,050) of patients had declines of serum calcium levels (less than 1.88 mmol/l) following Prolia administration.
Slovenian: V dveh kliničnih, s placebom kontroliranih preskušanjih III. faze pri ženskah po menopavzi z osteoporozo so po uporabi zdravila Prolia ugotovili zmanjšanje koncentracije kalcija (manj kot 1,88 mmol/l) pri približno 0,05 % (2 od 4.050) bolnic.
English: Clinical monitoring of calcium levels is recommended before each dose and, in patients predisposed to hypocalcaemia within two weeks after the initial dose.
Slovenian: Hipokalciemijo je treba še pred začetkom zdravljenja odpraviti z zadostnim uživanjem kalcija in vitamina D. Priporočljivo je klinično spremljanje koncentracije kalcija pred vsakim odmerkom, in pri bolnikih, ki so nagnjeni k hipokalciemiji, v dveh tednih po prvem odmerku.
English: Atypical femoral fractures1
Slovenian: atipični zlomi stegnenice1
English: The effect of Prolia on the risk of new vertebral fractures
Slovenian: Tabela 2: Vpliv zdravila Prolia na tveganje novih zlomov vretenc
English: If you are breast-feeding during Prolia treatment, please inform your doctor.
Slovenian: Če med zdravljenjem z zdravilom Prolia dojite, o tem obvestite zdravnika.
English: Bone histology was evaluated in 62 postmenopausal women with osteoporosis or with low bone mass who were either naïve to osteoporosis therapies or had transitioned from previous alendronate therapy following 1-3 years treatment with Prolia.
Slovenian: Po 1 do 3 letih zdravljenja z zdravilom Prolia so histološko ocenili kosti pri 62 ženskah po menopavzi z osteoporozo ali majhno kostno maso, ki se še niso zdravile za osteoporozo ali ki so prešle s predhodnega zdravljenja z alendronatom.
English: The pharmacokinetics of denosumab is not expected to be affected by hepatic impairment.
Slovenian: Ni pričakovati, da bi okvara jeter vplivala na farmakokinetiko denosumaba.
English: Finger grips Syringe label Syringe barrel
Slovenian: Oprijemalo za prste Nalepka brizge Valj brizge Varnostni ščitnik brizge Varnostna vzmet igle
English: 2 Excludes those of the vertebrae, skull, facial, mandible, metacarpus, and finger and toe phalanges.
Slovenian: 2 Izključuje zlome vretenc, lobanje, obraza, spodnje čeljusti, metakarpalne zlome in zlome prstnic na rokah in nogah.
English: REMINDER STICKERS TEXT (included in pack)
Slovenian: BESEDILO ZA OPOZORILNE NALEPKE (priložene v pakiranju)
English: Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption in cortical and trabecular bone.
Slovenian: Preprečitev medsebojnega delovanja RANKL/RANK zavre nastajanje, delovanje in preživetje osteoklastov.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 60 mg of denosumab in 1 mL of solution (60 mg/mL).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 60 mg denosumaba v 1 ml raztopine (60 mg/ml).
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported rarely (may affect up to 1 in 1,000 people) in patients receiving Prolia for osteoporosis.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Prolia za osteoporozo, so redko (pojavi se pri do 1 od 1.000 bolnikov) poročali o neželenem učinku, ki ga imenujemo osteonekroza čeljustnice (odmiranje kosti v čeljusti).
English: Each 1 mL pre-filled syringe contains 60 mg of denosumab (60 mg/mL).
Slovenian: Ena 1 ml napolnjena injekcijska brizga vsebuje 60 mg denosumaba (60 mg/ml).
English: Effect on vertebral fractures
Slovenian: Vpliv na zlome kolkov
English: Prolia significantly increased BMD at all clinical sites measured, versus placebo at 1, 2 and 3 years.
Slovenian: Zdravljenje z zdravilom Prolia je v primerjavi s placebom po 1, 2 in 3 letih znatno povečalo mineralno kostno gostoto na vseh merjenih kliničnih mestih.
English: A decision on whether to abstain from breast-feeding or to abstain from therapy with Prolia should be made, taking into account the benefit of breast-feeding to the newborn/infant and the benefit of Prolia therapy to the woman.
Slovenian: Pri tem je treba upoštevati korist dojenja za novorojenčka/dojenčka in korist zdravljenja z zdravilom Prolia za žensko.
English: The start of treatment/new treatment course should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Slovenian: Pri bolnikih, ki imajo odprte lezije mehkih tkiv v ustih, je treba začetek zdravljenja/nov ciklus zdravljenja odložiti.
English: Adverse reactions reported in patients with osteoporosis and breast or prostate cancer patients receiving hormone ablation
Slovenian: Tabela 1: Neželeni učinki, poročani pri bolnicah in bolnikih z osteoporozo ter bolnicah z rakom na dojki ali bolnikih z rakom na prostati, ki so se zdravili z ablacijo hormonov
English: Osteonecrosis of the external auditory canal has been reported with denosumab.
Slovenian: Pri zdravljenju z denosumabom so poročali o osteonekrozi zunanjega slušnega kanala.
English: Patients treated with Prolia should be given the package leaflet and the patient reminder card.
Slovenian: Bolniki, zdravljeni z zdravilom Prolia, morajo dobiti navodilo za uporabo in opozorilno kartico za bolnika.
English: In the glucocorticoid-initiating subpopulation, Prolia demonstrated a greater increase in lumbar spine BMD compared to risedronate at 1 year (Prolia 3.1%, risedronate 0.8%; p < 0.001) and 2 years (Prolia 4.6%, risedronate 1.5%; p < 0.001)
Slovenian: V subpopulaciji, ki je glukokortikoidno zdravljenje začela, je zdravilo Prolia povzročilo večje povečanje MKG v ledvenem delu hrbtenice v primerjavi z risedronatom po 1 letu (zdravilo Prolia 3,1 %, risedronat 0,8 %, p < 0,001) in po 2 letih (zdravilo Prolia 4,6 %, risedronat 1,5 %, p < 0,001).
English: In a pooled analysis of data from all phase II and phase III placebo-controlled studies, Influenza-like illness was reported with a crude incidence rate of 1.2% for denosumab and 0.7% for placebo.
Slovenian: in III. faze je bila gripi podobna bolezen opisana z okvirno stopnjo incidence 1,2 % za denosumab in 0,7 % za placebo.
English: In this study, foetal lymph nodes were not examined.
Slovenian: V tej študiji niso pregledali bezgavk pri plodih.
English: Symptoms include spasms, twitches, or cramps in your muscles, and/or numbness or tingling in your fingers, toes or around your mouth and/or seizures, confusion, or loss of consciousness.
Slovenian: Znaki tega so spazmi, trzljaji ali krči v mišicah in/ali omrtvelost ali mravljinčenje v prstih rok ali nog ali okoli ust in/ali napadi krčev, zmedenost ali izguba zavesti.
English: The incidence of diverticulitis was comparable between treatment groups in postmenopausal women or men with osteoporosis and in women undergoing aromatase inhibitor therapy for non-metastatic breast cancer.
Slovenian: V terapevtskih skupinah žensk po menopavzi ali moških z osteoporozo in žensk, ki so se zdravile z zaviralcem aromataze zaradi nemetastatskega raka dojke, je bila incidenca divertikulitisa primerljiva.
English: Osteonecrosis of the jaw
Slovenian: Osteonekroza čeljustnice
English: In patients treated with Prolia for up to 10 years, BMD increased from the pivotal study baseline by 21.7% at the lumbar spine, 9.2% at the total hip, 9.0% at the femoral neck, 13.0% at the trochanter and 2.8% at the distal 1/3 radius.
Slovenian: Bolnicam, ki so se zdravile z zdravilom Prolia do 10 let, se je mineralna gostota kosti v primerjavi z mineralno gostoto na začetku ključne študije povečala za 21,7 % v ledveni hrbtenici, 9,2 % v celotnem kolku, 9,0 % v vratu stegnenice, 13,0 % v trohantru in 2,8 % v distalni tretjini koželjnice.
English: Any clinical fracture1
Slovenian: Katerikoli klinični zlom1
English: Lichenoid drug eruptions (e.g. lichen planus-like reactions), have been reported in patients in the postmarketing setting.
Slovenian: V obdobju trženja zdravila so pri bolnikih poročali o z zdravilom povezanih lihenoidnih erupcijah (npr. reakcijah, podobnih lichen planus).
English: Next injection Prolia 60 mg injection denosumab SC
Slovenian: Naslednje injiciranje Prolia 60 mg injekcija denosumab s.c.
English: In the glucocorticoid-continuing subpopulation, Prolia demonstrated a greater increase in lumbar spine BMD compared to risedronate at 1 year (Prolia 3.6%, risedronate 2.0%; p < 0.001) and 2 years (Prolia 4.5%, risedronate 2.2%; p < 0.001).
Slovenian: V subpopulaciji, ki je glukokortikoidno zdravljenje nadaljevala, je zdravilo Prolia povzročilo večje povečanje MKG v ledvenem delu hrbtenice v primerjavi z risedronatom po 1 letu (zdravilo Prolia 3,6 %, risedronat 2,0 %, p < 0,001) in po 2 letih (zdravilo Prolia 4,5 %, risedronat 2,2 %, p < 0,001).
English: Skin infections reported as serious adverse reactions were similar in the placebo (0.6%, 5 out of 845) and the Prolia (0.6%, 5 out of 860) groups in the breast and prostate cancer studies.
Slovenian: Okužbe kože, opisane kot resni neželeni učinki, so bile v skupinah bolnikov z rakom na dojki ali na prostati med uporabo placeba podobno pogoste (0,6 %, 5 od 845) kot med uporabo zdravila Prolia (0,6 %, 5 od 860).
English: Surgery or medicines that stop the production of oestrogen or testosterone used to treat patients with breast or prostate cancer can also lead to bone loss.
Slovenian: Izgubljanje kostne mase lahko povzročijo tudi operacija ali zdravila, ki preprečijo nastajanje estrogena ali testosterona in se uporabljajo za zdravljenje raka na dojki ali raka na prostati.
English: Prolia is used to treat:
Slovenian: Z zdravilom Prolia zdravimo:
English: One pre-filled syringe.
Slovenian: Ena napolnjena injekcijska brizga.
English: Disinfect the skin by using an alcohol wipe.
Slovenian: Uporabite alkoholni zloženec in z njim razkužite kožo.
English: No accumulation or change in denosumab pharmacokinetics with time was observed upon subcutaneous multiple-dosing of 60 mg once every 6 months.
Slovenian: Po večkratnem subkutanem dajanju 60 mg vsakih 6 mesecev niso opazili kopičenja ali sprememb farmakokinetike denosumaba skozi čas.
English: You should also take calcium and vitamin D supplements while being on treatment with Prolia.
Slovenian: Med zdravljenjem z zdravilom Prolia morate jemati dodatke kalcija in vitamina D. Zdravnik se bo o tem pogovoril z vami.
English: • Before administration, the solution should be inspected.
Slovenian: • Raztopino je treba pred injiciranjem pregledati.