FrancophonIA/ELRC3.0 huggingface dataset:
English: In genetically engineered mice in which RANKL has been turned off by gene removal (a “knockout mouse”), studies suggest absence of RANKL (the target of denosumab see section 5.1) during pregnancy may interfere with maturation of the mammary gland leading to impaired lactation post-partum (see section 5.3).
Slovenian: Študije na genetsko spremenjenih miših (t.i. »knockout miši«), pri katerih je RANKL izključen z odstranitvijo gena, kažejo, da lahko odsotnost RANKL-a (ki je cilj denosumaba, glejte poglavje 5.1) med nosečnostjo moti dozorevanje mlečnih žlez in po skotitvi okvari laktacijo (glejte poglavje 5.3).
English: If you stop using Prolia
Slovenian: Če ste prenehali uporabljati zdravilo Prolia
English: Fracture incidence was evaluated as a safety endpoint but efficacy in fracture prevention cannot be estimated due to high number of discontinuations and open-label design The cumulative incidence of new vertebral and non-vertebral fractures were approximately 6.8% and 13.1% respectively, in patients who remained on denosumab treatment for 10 years (n = 1,278).
Slovenian: Incidenca zlomov je bila ocenjena kot končna točka varnosti, učinkovitosti v preprečevanju zlomov pa ni možno oceniti zaradi visokega števila prekinitev in odprtega tipa študije.Pri bolnicah, ki so prejemale zdravljenje z denosumabom 10 let (n = 1.278) je bila kumulativna incidenca novih vretenčnih zlomov približno 6,8 %, novih nevretenčnih zlomov pa približno 13,1 %.
English: For a 60 mg subcutaneous dose, maximum serum denosumab concentrations (Cmax) of 6 mcg/mL (range 1-17 μg/mL) occurred in 10 days (range 2-28 days).
Slovenian: Pri dajanju subkutanega odmerka 60 mg je denosumab dosegel najvišjo koncentracijo v serumu (Cmax) 6 mcg/ml (razpon: 1-17 µg/ml) v 10 dneh (razpon: 2-28 dni).
English: • To avoid discomfort at the site of injection, allow the pre-filled syringe to reach room temperature (up to 25°C) before injecting and inject slowly.
Slovenian: • Za preprečitev nelagodja na mestu dajanja je treba zagotoviti, da napolnjena injekcijska brizga pred injiciranjem doseže sobno temperaturo (do 25 °C), zdravilo pa je treba injicirati počasi.
English: Adequate intake of calcium, vitamin D and regular monitoring of calcium is especially important in these patients, see above.
Slovenian: Pri takšnih bolnikih so posebno pomembni ustrezno uživanje kalcija in vitamina D ter redne kontrole kalcija, glejte zgoraj.
English: In single and repeated dose toxicity studies in cynomolgus monkeys, denosumab doses resulting in 100 to 150 times greater systemic exposure than the recommended human dose had no impact on cardiovascular physiology, male or female fertility, or produced specific target organ toxicity.
Slovenian: Odmerki denosumaba, ki so povzročili od 100- do 150-krat večjo sistemsko izpostavljenost kot priporočeni odmerek za človeka, v študijah toksičnosti enkratnega in ponavljajočih se odmerkov pri opicah cynomolgus niso vplivali na kardiovaskularno fiziologijo ali na plodnost samcev in samic; prav tako niso povzročili specifičnih toksičnih učinkov na ciljnih organih.
English: • bone loss that results from long-term treatment with glucocorticoids in patients who have an increased risk of fracture.
Slovenian: • izgubljanje kostne mase, ki nastane zaradi dolgotrajnega glukokortikoidnega zdravljenja, pri bolnikih, ki imajo povečano tveganje zlomov.
English: The needle cover of the pre-filled syringe contains dry natural rubber, which is a derivative of latex (see section 4.4).
Slovenian: Ščitnik igle na napolnjeni injekcijski brizgi vsebuje suho naravno gumo, ki je derivat lateksa (glejte poglavje 4.4).
English: Treatment of bone loss associated with systemic glucocorticoid therapy
Slovenian: Zdravljenje izgubljanja kostne mase, povezanega s sistemskim glukokortikoidnim zdravljenjem
English: 4 Includes clinical vertebral, hip, forearm, and humerus fractures, as defined by the WHO.
Slovenian: 4 Vključuje klinične zlome vretenc, kolka, podlakta in nadlahtnice, kot jih opredeljuje Svetovna zdravstvena organizacija.
English: Your doctor will give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Prolia.
Slovenian: Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni pred in med zdravljenjem z zdravilom Prolia.
English: Two subpopulations were studied: glucocorticoid-continuing (≥ 7.5 mg daily prednisone or its equivalent for ≥ 3 months prior to study enrolment; n = 505) and glucocorticoid-initiating (≥ 7.5 mg daily prednisone or its equivalent for < 3 months prior to study enrolment; n = 290).
Slovenian: Študija je vključevala dve subpopulaciji: bolnike, ki so zdravljenje s prednizonom ali njegovim ekvivalentom nadaljevali (≥ 7,5 mg prednizona dnevno ali ekvivalent tri mesece ali več pred vključitvijo v študijo; n = 505), in bolnike, ki so glukokortikoidno zdravljenje začeli (≥ 7,5 mg prednizona dnevno ali ekvivalent manj kot tri mesece pred vključitvijo v študijo; n = 290).
English: The recommended dose is one pre-filled syringe of 60 mg administered once every 6 months, as a single injection under the skin (subcutaneous).
Slovenian: Priporočeni odmerek je ena napolnjena injekcijska brizga s 60 mg, ki se vsakih 6 mesecev daje kot enkratna injekcija pod kožo (subkutano).
English: In the post-marketing setting, rare cases of severe symptomatic hypocalcaemia have been reported predominantly in patients at increased risk of hypocalcaemia receiving Prolia, with most cases occurring in the first weeks of initiating therapy.
Slovenian: V obdobju trženja zdravila so pretežno pri bolnikih s povečanim tveganjem za hipokalciemijo, ki so dobivali zdravilo Prolia, poročali o redkih primerih hude simptomatske hipokalciemije, večina primerov se je pojavila v prvih tednih po uvedbi zdravljenja.
English: Women should be advised not to become pregnant during and for at least 5 months after treatment with Prolia.
Slovenian: Ženskam je treba naročiti, da med zdravljenjem z zdravilom Prolia in vsaj še 5 mesecev po zdravljenju ne smejo zanositi.
English: Clinical efficacy and safety in patients with bone loss associated with androgen deprivation
Slovenian: Klinična učinkovitost in varnost pri bolnikih z izgubljanjem kostnine, povezanim z odtegnitvijo androgenov
English: The effect of Prolia on the risk of clinical fractures over 3 years
Slovenian: Tabela 3: Vpliv zdravila Prolia na tveganje kliničnih zlomov v 3-letnem obdobju
English: Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1).
Slovenian: Zdravljenje izgubljanja kostne mase, povezanega z ablacijo hormonov pri moških z rakom na prostati, ki imajo večje tveganje zlomov (glejte poglavje 5.1).
English: In clinical studies examining the effects of discontinuation of Prolia, BMD returned to approximately pre-treatment levels and remained above placebo within 18 months of the last dose.
Slovenian: V kliničnih študijah, ki so raziskovale učinke prenehanja zdravljenja z zdravilom Prolia, se je vrednost mineralne kostne gostote v 18 mesecih po zadnjem odmerku vrnila na približno enako raven kot pred zdravljenjem ter ostala višja kot pri uporabi placeba.
English: However, the trend is not considered clinically important, since pharmacodynamic effects based on bone turnover markers and BMD increases were consistent across a wide range of body weight.
Slovenian: Vendar ta trend ne velja za klinično pomembnega: farmakodinamični učinki, ocenjeni z označevalci presnove kostnega tkiva in povečanja mineralne kostne gostote, so bili namreč primerljivi pri zelo različnih telesnih masah.
English: Do not use Prolia
Slovenian: Ne uporabljajte zdravila Prolia
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP. Rok uporabnosti se izteče na zadnji dan navedenega meseca.
English: One mL solution in a single use pre-filled syringe made from type I glass with stainless steel 27 gauge needle, with or without needle guard.
Slovenian: En mililiter raztopine v napolnjeni injekcijski brizgi za enkratno uporabo, izdelani iz stekla tipa I in opremljeni z nerjavno jekleno iglo številka 27, s ščitnikom igle ali brez njega.
English: Remove the needle and let go of the skin.
Slovenian: Izvlecite iglo in kožo spustite.
English: • fever, vomiting and abdominal pain or discomfort (diverticulitis),
Slovenian: • zvišana telesna temperatura, bruhanje in bolečine ali nelagodje v trebuhu (divertikulitis),
English: - The active substance is denosumab.
Slovenian: - Zdravilna učinkovina je denosumab.
English: • skin condition with itching, redness and/or dryness (eczema),
Slovenian: • kožno obolenje s srbenjem, pordelostjo in/ali suhostjo (ekcem),
English: Relative risk reduction (%) (95% CI)
Slovenian: Relativno zmanjšanje tveganja (%) (95 % IZ)
English: Significant increases in BMD at lumbar spine, total hip, femoral neck and hip trochanter were observed by 6 months (p < 0.0001).
Slovenian: Značilno povečanje mineralne kostne gostote v ledvenem delu hrbtenice, celotnem kolku, stegneničnem vratu in kolčnem trohantru so opažali pri 6 mesecih (p < 0,0001).
English: In dose ranging studies, denosumab exhibited non-linear, dose-dependent pharmacokinetics, with lower clearance at higher doses or concentrations, but approximately dose-proportional increases in exposures for doses of 60 mg and greater.
Slovenian: Rezultati študij za določanje optimalnih odmerkov so pokazali nelinearno od odmerka odvisno farmakokinetiko denosumaba, z očistkom, ki je bil manjši pri višjih odmerkih oziroma koncentracijah zdravila, izpostavljenost zdravilu pri odmerjanju 60 mg ali več pa se je povečevala približno sorazmerno z višino odmerka.
English: LIST OF EXCIPIENTS Acetic acid, glacial, sodium hydroxide, sorbitol (E420), polysorbate 20, water for injections.
Slovenian: SEZNAM POMOŽNIH SNOVI Ledocet, natrijev hidroksid, sorbitol (E420), polisorbat 20, voda za injekcije.
English: - The other ingredients are acetic acid, glacial, sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections.
Slovenian: - Pomožne snovi so ledocet, natrijev hidroksid, sorbitol (E420), polisorbat 20 in voda za injekcije.
English: Efficacy and safety of Prolia were investigated in 795 patients (70% women and 30% men) aged 20 to 94 years treated with ≥ 7.5 mg daily oral prednisone (or equivalent).
Slovenian: Učinkovitost in varnost zdravila Prolia so proučevali pri 795 bolnikih (70 % žensk in 30 % moških), starih od 20 do 94 let, zdravljenih s 7,5 mg ali več peroralnega prednizona (ali ekvivalenta) dnevno.
English: Knockout mice (see section 4.6) lacking RANK or RANKL exhibited decreased body weight, reduced bone growth and lack of tooth eruption.
Slovenian: Knockout miši (glejte poglavje 4.6) brez RANK oz. RANKL so imele manjšo telesno maso, upočasnjeno rast kosti in niso jim izrasli zobje.
English: • Tell your doctor if you have an allergy to latex (the needle cap 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 derivat lateksa).
English: No dose adjustment is required in patients with renal impairment (see section 4.4 for recommendations relating to monitoring of calcium).
Slovenian: Bolnikom z okvaro ledvic odmerka ni treba prilagoditi (za priporočila o spremljanju kalcija glejte poglavje 4.4).
English: Adequate intake of calcium and vitamin D is important in patients with severe renal impairment or receiving dialysis (see section 4.4).
Slovenian: Zadostno uživanje kalcija in vitamina D je pomembno za vse bolnike s hudo okvaro ledvic in za bolnike na dializi (glejte poglavje 4.4).
English: The solution should not be injected if it contains particles or if it is discoloured or cloudy.
Slovenian: Raztopine ne smete injicirati, če vsebuje delce, če je obarvana ali motna.
English: This medicine contains less than 1 mmol sodium (23 mg) per 60 mg, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 60 mg, kar v bistvu pomeni 'brez natrija'.
English: In a post-hoc analysis in women > 75 years, a 62% relative risk reduction was observed with Prolia (1.4% absolute risk reduction, p < 0.01).
Slovenian: V post hoc analizi pri ženskah, starih > 75 let, so pri zdravljenju z zdravilom Prolia ugotovili 62 % relativno zmanjšanje tveganja (1,4 % absolutno zmanjšanje tveganja, p < 0,01).
English: Clear, colourless to slightly yellow solution.
Slovenian: Bistra, brezbarvna do rahlo rumena raztopina.
English: Prolia demonstrated a significant relative risk reduction of new vertebral fractures: 85% (1.6% absolute risk reduction) at 1 year, 69% (2.2% absolute risk reduction) at 2 years and 62% (2.4% absolute risk reduction) at 3 years (all p < 0.01).
Slovenian: Pri zdravljenju z zdravilom Prolia se je izkazalo znatno relativno zmanjšanje novih zlomov vretenc: 85 % (1,6 % absolutno zmanjšanje tveganja ) po 1 letu, 69 % (2,2 % absolutno zmanjšanje tveganja) po 2 letih in 62 % (2,4 % absolutno zmanjšanje tveganja) po 3 letih (vsi p < 0,01).
English: Lichenoid drug eruptions
Slovenian: Z zdravilom povezane lihenoidne erupcije
English: Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).
Slovenian: Zdravljenje izgubljanja kostne mase, povezanega z dolgotrajnim sistemskim glukokortikoidnim zdravljenjem pri odraslih bolnikih, ki imajo večje tveganje zlomov (glejte poglavje 5.1).
English: Tél: +33 (0)9 69 363 363
Slovenian: Amgen S.A.S Tél: +33 (0)9 69 363 363
English: Patients receiving Prolia may develop skin infections (predominantly cellulitis) leading to hospitalisation (see section 4.8).
Slovenian: Pri bolnikih, ki dobivajo zdravilo Prolia, se lahko pojavijo okužbe kože (predvsem celulitis), ki zahtevajo bolnišnično zdravljenje (glejte poglavje 4.8).
English: Once removed from the refrigerator, Prolia may be stored at room temperature (up to 25°C) for up to 30 days in the original container.
Slovenian: Ko vzamete zdravilo Prolia iz hladilnika, ga lahko shranjujete pri sobni temperaturi (do 25 °C ) do 30 dni v originalnem vsebniku.
English: Push the plunger all the way down as far as it will go to inject all the solution.
Slovenian: Potisnite bat povsem do konca, dokler gre, da boste injicirali vso raztopino.
English: In addition, Prolia demonstrated a significantly greater mean percent increase in BMD from baseline compared to risedronate at the total hip, femoral neck, and hip trochanter.
Slovenian: Poleg tega je zdravilo Prolia pokazalo značilno večje povečanje povprečnega odstotka MKG od izhodiščne vrednosti v primerjavi z risedronatom pri celotnem kolku, stegneničnem vratu in kolčnem trohantru.
English: In women with baseline femoral neck BMD ≤ -2.5, Prolia reduced the risk of non-vertebral fracture (35% relative risk reduction, 4.1% absolute risk reduction, p < 0.001, exploratory analysis).
Slovenian: Pri ženskah, ki so imele izhodiščno mineralno kostno gostoto stegneničnega vratu ≤ -2,5, je zdravilo Prolia zmanjšalo tveganje nevretenčnih zlomov (35 % relativno zmanjšanje tveganja; 4,1 % absolutno zmanjšanje tveganja, p < 0,001, eksploratorna analiza).
English: In neonatal rats, inhibition of RANKL (target of denosumab therapy) with high doses of a construct of osteoprotegerin bound to Fc (OPG-Fc) was associated with inhibition of bone growth and tooth eruption.
Slovenian: Pri novoskotenih podganah je bilo zavrtje RANKL (ki je cilj zdravljenja z denosumabom) z velikimi odmerki skupka osteoprotegerina, vezanega na Fc (OPG-Fc), povezano z zavrtjem rasti kosti in izraščanja zob.
English: Rarely, patients receiving Prolia may develop pain in the mouth and/or jaw, swelling or non-healing of sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Slovenian: Redko se lahko bolnikom, ki prejemajo zdravilo Prolia, pojavijo bolečine v ustih in/ali čeljusti, oteklost ali razjede v ustih ali na čeljusti, ki se ne celijo, izcedek, omrtvičenost ali občutek teže v čeljusti, ali majanje zoba.
English: Prolia demonstrated a 40% relative reduction (0.5% absolute risk reduction) in the risk of hip fracture over 3 years (p < 0.05).
Slovenian: Pri zdravljenju z zdravilom Prolia se je izkazalo 40 % relativno zmanjšanje (0,5 % absolutno zmanjšanje) tveganja zloma kolka v 3-letnem obdobju (p < 0,05).
English: 1 Includes clinical vertebral fractures and non-vertebral fractures.
Slovenian: 1 Vključuje klinične zlome vretenc in nevretenčne zlome.
English: DO NOT use any Prolia that is left in the syringe.
Slovenian: NE uporabljajte preostanka zdravila Prolia, ki ostane v brizgi.
English: Discontinuation of Prolia therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient based on an individual benefit-risk assessment.
Slovenian: Pri bolnikih, pri katerih obstaja sum na atipičen zlom stegnenice, je treba razmisliti o prenehanju uporabe zdravila Prolia ob vrednotenju bolnika glede na individualno oceno koristi in tveganja.
English: Most of the fractures occurred in the GC-C subpopulation.
Slovenian: Večina zlomov se je pojavila v subpopulaciji, ki je glukokortikoidno zdravljenje nadaljevala.
English: In preclinical bone quality studies in monkeys on long-term denosumab treatment, decreases in bone turnover were associated with improvement in bone strength and normal bone histology.
Slovenian: V predkliničnih študijah kakovosti kosti pri opicah, ki so dolgoročno dobivale denosumab, je bilo zmanjšanje kostne prenove povezano z večjo čvrstostjo kosti in njihovo normalno histologijo.
English: Your carer can also use the outer area of your upper arm. Each pack of Prolia contains a reminder card with stickers that can be removed from the carton.
Slovenian: Vsako pakiranje zdravila Prolia vsebuje opomnilno kartico z nalepkami, ki jih je mogoče odstraniti s škatle.
English: What Prolia is and what it is used for What you need to know before you use Prolia How to use Prolia
Slovenian: Kaj je zdravilo Prolia in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Prolia Kako uporabljati zdravilo Prolia Možni neželeni učinki
English: In phase III placebo-controlled clinical trials, the overall incidence of skin infections was similar in the placebo and the Prolia groups: in postmenopausal women with osteoporosis (placebo [1.2%, 50 out of 4,041] versus Prolia [1.5%, 59 out of 4,050]); in men with osteoporosis (placebo [0.8%, 1 out of 120] versus Prolia [0%, 0 out of 120]); in breast or prostate cancer patients receiving hormone ablation (placebo [1.7%, 14 out of 845] versus Prolia [1.4%, 12 out of 860]).
Slovenian: V kliničnih, s placebom kontroliranih preskušanjih III. Faze, je bila skupna incidenca okužb kože pri ženskah po menopavzi z osteoporozo primerljva pri skupinah s placebom in z zdravilom Prolia (placebo: 1,2 %, 50 od 4.041; zdravilo Prolia: 1,5 %, 59 od 4.050); pri moških z osteoporozo (placebo: 0,8 %, 1 od 120; zdravilo Prolia: 0 %, 0 od 120); pri bolnicah oz. bolnikih z rakom na dojki ali na prostati, zdravljenih z ablacijo hormonov (placebo: 1,7 %, 14 od 845; zdravilo Prolia: 1,4 %, 12 od 860).
English: During denosumab treatment, patients should be advised to report new or unusual thigh, hip, or groin pain.
Slovenian: Bolnikom je treba naročiti, da morajo med zdravljenjem z denosumabom zdravniku poročati o novi ali nenavadni bolečini v stegnu, kolku ali dimljah.
English: Further, post-marketing experience including multiple cases with positive re-challenge supports the conclusion that denosumab may be causally associated with the development of lichenoid drug reactions, and this new ADR should be added in section 4.8 of the SmPC and the Package Leaflet.
Slovenian: Poleg tega izkušnje v obdobju trženja zdravila, ki vključujejo več pozitivnih primerov po ponovni uvedbi zdravljenja, potrjujejo ugotovitev, da je denosumab lahko vzročno povezan z razvojem z zdravilom povezanih lihenoidnih reakcij, zato je potrebno ta nov neželen učinek zdravila dodati v poglavje 4.8 Povzetka glavnih značilnosti zdravila in v Navodilo za uporabo.
English: The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months into the thigh, abdomen or upper arm.
Slovenian: Priporočeni odmerek zdravila Prolia je 60 mg enkrat na 6 mesecev v enkratni subkutani injekciji v stegno, trebuh ali zgornji del roke.
English: Contact your doctor if you experience new or unusual pain in your hip, groin or thigh as this may be an early indication of a possible fracture of the thigh bone.
Slovenian: Posvetujte se z zdravnikom, če se vam med zdravljenjem z zdravilom Prolia pojavi nova ali neobičajna bolečina v kolku, dimljah ali stegnu, kajti to je lahko zgoden znak možnega zloma stegnenice.
English: • pain, tingling or numbness that moves down your leg (sciatica),
Slovenian: • bolečine, mravljinčenje ali omrtvelost, ki se širi navzdol po nogi (išias),
English: One pre-filled syringe with automatic needle guard.
Slovenian: Ena napolnjena injekcijska brizga z avtomatičnim ščitnikom za iglo.
English: No data is available in patients with long-term systemic glucocorticoid therapy and severe renal impairment (GFR < 30 ml/min).
Slovenian: Za bolnike, ki prejemajo dolgotrajno sistemsko glukokortikoidno zdravljenje in imajo hudo okvaro ledvic (GFR < 30 ml/min), podatki niso na voljo.
English: • Talk to your doctor if you have ear pain, discharge from the ear and/or an ear infection.
Slovenian: • V primeru pojava bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte z zdravnikom.
English: Fifty-three percent (53%) of patients had no measurable amounts of denosumab detected at 6 months post-dose.
Slovenian: Šest mesecev po odmerku pri triinpetdesetih odstotkih (53 %) bolnikov niso zaznali merljive koncentracije denosumaba.
English: Please tell your doctor if you develop any of these symptoms while being treated with Prolia.
Slovenian: Zdravniku povejte, če se vam med zdravljenjem z zdravilom Prolia pojavi kateri koli od teh simptomov.
English: Clinical efficacy and safety in patients with bone loss associated with adjuvant aromatase inhibitor therapy
Slovenian: Klinična učinkovitost in varnost pri bolnicah z izgubljanjem kostnine, povezanim z adjuvantnim zdravljenjem z zaviralcem aromataze
English: Effect on Bone Mineral Density (BMD)
Slovenian: Vpliv na mineralno kostno gostoto (MKG)
English: After the menopause, oestrogen level drops which may cause bones to become thin and fragile.
Slovenian: Po menopavzi se koncentracija estrogena zmanjša, kar lahko povzroči krhke kosti z manjšo kostno maso.
English: Whilst being treated with Prolia you may develop a skin infection with symptoms such as a swollen, red area of skin, most commonly in the lower leg, that feels hot and tender (cellulitis), and possibly with symptoms of fever.
Slovenian: Med zdravljenjem z zdravilom Prolia se lahko pojavi okužba kože s simptomi, kot je otekel, pordel predel kože, najpogosteje nastane na goleni, ki je vroč in občutljiv (celulitis) in ga lahko spremljajo znaki zvišane telesne temperature.
English: DO NOT leave the syringe exposed to direct sunlight.
Slovenian: NE izpostavljajte brizge neposredni sončni svetlobi.
English: Atypical femoral fractures may occur with little or no trauma in the subtrochanteric and diaphyseal regions of the femur.
Slovenian: Atipični zlomi stegnenice se lahko pojavijo že ob majhni poškodbi ali celo brez poškodbe, in sicer v subtrohanternem in diafiznem predelu stegnenice.
English: How to use Prolia
Slovenian: Kako uporabljati zdravilo Prolia
English: Skin infections leading to hospitalisation were reported in 0.1% (3 out of 4,041) of postmenopausal women with osteoporosis receiving placebo versus 0.4% (16 out of 4,050) of women receiving Prolia.
Slovenian: Okužbe kože, ki so zahtevale sprejem v bolnišnico, so pri ženskah po menopavzi z osteoporozo zabeležili pri 0,1 % (3 od 4.041) uporabnic placeba in 0,4 % (16 od 4.050) uporabnic zdravila Prolia.