natgillin/translations-raw huggingface dataset:
- The other ingredients are acetic acid, glacial, sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections. 
- Pomožne snovi so ledocet, natrijev hidroksid, sorbitol (E420), polisorbat 20 in voda za injekcije.
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). 
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.
Knockout mice (see section 4.6) lacking RANK or RANKL exhibited decreased body weight, reduced bone growth and lack of tooth eruption. 
Knockout miši (glejte poglavje 4.6) brez RANK oz. RANKL so imele manjšo telesno maso, upočasnjeno rast kosti in niso jim izrasli zobje.
• Tell your doctor if you have an allergy to latex (the needle cap on the pre-filled syringe contains a derivative of latex). 
• Zdravniku morate povedati, če ste alergični na lateks (pokrovček igle na napolnjeni injekcijski brizgi vsebuje derivat lateksa).
No dose adjustment is required in patients with renal impairment (see section 4.4 for recommendations relating to monitoring of calcium). 
Bolnikom z okvaro ledvic odmerka ni treba prilagoditi (za priporočila o spremljanju kalcija glejte poglavje 4.4).
Adequate intake of calcium and vitamin D is important in patients with severe renal impairment or receiving dialysis (see section 4.4). 
Zadostno uživanje kalcija in vitamina D je pomembno za vse bolnike s hudo okvaro ledvic in za bolnike na dializi (glejte poglavje 4.4).
The solution should not be injected if it contains particles or if it is discoloured or cloudy. 
Raztopine ne smete injicirati, če vsebuje delce, če je obarvana ali motna.
This medicine contains less than 1 mmol sodium (23 mg) per 60 mg, that is to say essentially ‘sodiumfree'. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 60 mg, kar v bistvu pomeni 'brez natrija'.
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). 
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).
Clear, colourless to slightly yellow solution. 
Bistra, brezbarvna do rahlo rumena raztopina.
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). 
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).
Lichenoid drug eruptions 
Z zdravilom povezane lihenoidne erupcije
Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1). 
Zdravljenje izgubljanja kostne mase, povezanega z dolgotrajnim sistemskim glukokortikoidnim zdravljenjem pri odraslih bolnikih, ki imajo večje tveganje zlomov (glejte poglavje 5.1).
Patients receiving Prolia may develop skin infections (predominantly cellulitis) leading to hospitalisation (see section 4.8). 
Pri bolnikih, ki dobivajo zdravilo Prolia, se lahko pojavijo okužbe kože (predvsem celulitis), ki zahtevajo bolnišnično zdravljenje (glejte poglavje 4.8).
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. 
Ko vzamete zdravilo Prolia iz hladilnika, ga lahko shranjujete pri sobni temperaturi (do 25 °C ) do 30 dni v originalnem vsebniku.
Push the plunger all the way down as far as it will go to inject all the solution. 
Potisnite bat povsem do konca, dokler gre, da boste injicirali vso raztopino.
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. 
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.
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). 
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).
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. 
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.
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. 
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.
Prolia demonstrated a 40% relative reduction (0.5% absolute risk reduction) in the risk of hip fracture over 3 years (p < 0.05). 
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).
1 Includes clinical vertebral fractures and non-vertebral fractures. 
1 Vključuje klinične zlome vretenc in nevretenčne zlome.
DO NOT use any Prolia that is left in the syringe. 
NE uporabljajte preostanka zdravila Prolia, ki ostane v brizgi.
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. 
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.
Most of the fractures occurred in the GC-C subpopulation. 
Večina zlomov se je pojavila v subpopulaciji, ki je glukokortikoidno zdravljenje nadaljevala.
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. 
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.
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. 
Vsako pakiranje zdravila Prolia vsebuje opomnilno kartico z nalepkami, ki jih je mogoče odstraniti s škatle.
What Prolia is and what it is used for What you need to know before you use Prolia How to use Prolia 
Kaj je zdravilo Prolia in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Prolia Kako uporabljati zdravilo Prolia Možni neželeni učinki
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]). 
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).
During denosumab treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. 
Bolnikom je treba naročiti, da morajo med zdravljenjem z denosumabom zdravniku poročati o novi ali nenavadni bolečini v stegnu, kolku ali dimljah.
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. 
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.
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. 
Priporočeni odmerek zdravila Prolia je 60 mg enkrat na 6 mesecev v enkratni subkutani injekciji v stegno, trebuh ali zgornji del roke.
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. 
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.
• pain, tingling or numbness that moves down your leg (sciatica), 
• bolečine, mravljinčenje ali omrtvelost, ki se širi navzdol po nogi (išias),
One pre-filled syringe with automatic needle guard. 
Ena napolnjena injekcijska brizga z avtomatičnim ščitnikom za iglo.
No data is available in patients with long-term systemic glucocorticoid therapy and severe renal impairment (GFR < 30 ml/min). 
Za bolnike, ki prejemajo dolgotrajno sistemsko glukokortikoidno zdravljenje in imajo hudo okvaro ledvic (GFR < 30 ml/min), podatki niso na voljo.
• Talk to your doctor if you have ear pain, discharge from the ear and/or an ear infection. 
• V primeru pojava bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte z zdravnikom.
Fifty-three percent (53%) of patients had no measurable amounts of denosumab detected at 6 months post-dose. 
Šest mesecev po odmerku pri triinpetdesetih odstotkih (53 %) bolnikov niso zaznali merljive koncentracije denosumaba.
Please tell your doctor if you develop any of these symptoms while being treated with Prolia. 
Zdravniku povejte, če se vam med zdravljenjem z zdravilom Prolia pojavi kateri koli od teh simptomov.
Clinical efficacy and safety in patients with bone loss associated with adjuvant aromatase inhibitor therapy 
Klinična učinkovitost in varnost pri bolnicah z izgubljanjem kostnine, povezanim z adjuvantnim zdravljenjem z zaviralcem aromataze
Effect on Bone Mineral Density (BMD) 
Vpliv na mineralno kostno gostoto (MKG)
After the menopause, oestrogen level drops which may cause bones to become thin and fragile. 
Po menopavzi se koncentracija estrogena zmanjša, kar lahko povzroči krhke kosti z manjšo kostno maso.
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. 
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.
DO NOT leave the syringe exposed to direct sunlight. 
NE izpostavljajte brizge neposredni sončni svetlobi.
Atypical femoral fractures may occur with little or no trauma in the subtrochanteric and diaphyseal regions of the femur. 
Atipični zlomi stegnenice se lahko pojavijo že ob majhni poškodbi ali celo brez poškodbe, in sicer v subtrohanternem in diafiznem predelu stegnenice.
How to use Prolia 
Kako uporabljati zdravilo Prolia
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. 
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.
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). 
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 %).
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.) 
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).
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. 
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.
What Prolia looks like and contents of the pack 
Izgled zdravila Prolia in vsebina pakiranja
Clinical efficacy and safety in postmenopausal women with osteoporosis 
Klinična učinkovitost in varnost pri ženskah po menopavzi z osteoporozo
Your doctor has prescribed a Prolia pre-filled syringe for injection into the tissue just under the skin (subcutaneous). 
Zdravnik vam je predpisal zdravilo Prolia v napolnjeni injekcijski brizgi, da si ga boste injicirali tik pod kožo (subkutano).
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. 
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.
Prolia contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, in order to treat bone loss and osteoporosis. 
Denosumab je beljakovina (monoklonsko protitelo), ki ovira delovanje neke druge beljakovine in tako zdravi izgubljanje kostne mase in osteoporozo.
How do you use the Prolia pre-filled syringe? 
Kako uporabiti napolnjeno injekcijsko brizgo zdravila Prolia?
Clinical efficacy and safety in men with osteoporosis 
Klinična učinkovitost pri moških z osteoporozo
• constipation, 
• zaprtost,
In postmenopausal women Prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures. 
Pri ženskah po menopavzi zdravilo Prolia znatno zmanjša tveganje zlomov vretenc, nevretenčnih zlomov in zlomov kolka.
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. 
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.
Find a comfortable, well-lit, clean surface and put all the equipment within reach. 
Poiščite primerno, dobro osvetljeno, čisto površino.
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. 
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.
Please tell your doctor if you have an allergy to latex (the needle cover on the pre-filled syringe contains a derivative of latex). 
Zdravniku morate povedati, če ste alergični na lateks (pokrovček igle na napolnjeni injekcijski brizgi vsebuje lateksno snov).
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: 
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:
Prolia increased lumbar spine BMD from baseline in 94.7% of men at 1 year. 
Zdravilo Prolia je po 1 letu v primerjavi z izhodiščem povečalo mineralno kostno gostoto v ledvenem delu hrbtenice pri 94,7 % moških.
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. 
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).
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. 
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.
If you have questions about how to inject, please ask your doctor or healthcare provider for assistance. 
Če imate vprašanja o injiciranju zdravila, se za pomoč obrnite na zdravnika ali drugo zdravstveno osebje.
It must be a clear, colourless to slightly yellow solution. 
Biti mora bistra, brezbarvna do rahlo rumena raztopina.
DO NOT use the pre-filled syringe if the needle cover has been removed. 
NE uporabite napolnjene injekcijske brizge, če je bil njen pokrovček odstranjen.
The incidence of hip fracture was 1.2% in the placebo group compared to 0.7% in the Prolia group at 3 years. 
Po 3 letih je bila incidenca zloma kolka v skupini s placebom 1,2 % in v skupini z zdravilom Prolia 0,7 %.
In the osteoporosis clinical trial program, atypical femoral fractures were reported rarely in patients treated with Prolia (see section 4.4). 
V programu kliničnih preskušanj pri osteoporozi so pri bolnikih, zdravljenih z zdravilom Prolia, redko poročali o atipičnih zlomih stegnenice (glejte poglavje 4.4).
Each pack contains one pre-filled syringe. 
Eno pakiranje vsebuje eno napolnjeno injekcijsko brizgo.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
Pharmacotherapeutic group: Drugs for the treatment of bone diseases - Other drugs affecting bone structure and mineralisation, ATC code: M05BX04 
Farmakoterapevtska skupina: Zdravila za zdravljenje bolezni kosti - druga zdravila z učinkom na strukturo in mineralizacijo kosti.
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). 
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.).
Treatment with Prolia makes bone stronger and less likely to break. 
Zdravljenje z zdravilom Prolia okrepi kosti in zmanjša verjetnost zlomov.
Each pack contains one pre-filled syringe with a needle guard. 
Eno pakiranje vsebuje eno napolnjeno injekcijsko brizgo s ščitnikom za iglo.
The following risk factors should be considered when evaluating a patient's risk of developing ONJ: 
Pri ocenjevanju bolnikovega tveganja za nastanek osteonekroze čeljustnice je treba upoštevati naslednje dejavnike tveganja:
Bone histology in postmenopausal women and men with osteoporosis 
Histologija kosti pri ženskah po menopavzi in moških z osteoporozo
Denosumab is composed solely of amino acids and carbohydrates as native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms. 
Denosumab je naraven imunoglobulin in je tako sestavljen zgolj iz aminokislin in ogljikovih hidratov.
Effect on bone mineral density 
Vpliv na mineralno kostno gostoto
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. 
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.
Atypical femoral fractures have been reported in patients receiving denosumab (see section 4.8). 
Pri bolnikih, ki so prejemali denosumab, so poročali o atipičnih zlomih stegnenice (glejte poglavje 4.8).
Denosumab pharmacokinetics were not affected by the formation of binding antibodies to denosumab and were similar in men and women. 
Nastajanje protiteles, ki se vežejo na denosumab, ni vplivalo na farmakokinetične lastnosti zdravila, ki so bile pri ženskah in moških podobne.
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. 
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.