natgillin/translations-raw huggingface dataset:
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. 
Molimo, odmah recite liječniku ukoliko primijetite bilo koji od sljedećih simptoma: spazme, trzanje ili grčeve u mišićima i/ili obamrlost ili trnce u prstima, nožnim prstima ili oko usta, i/ili napadaje, smetenost ili gubitak svijesti.
Clinical efficacy and safety in patients with bone loss associated with adjuvant aromatase inhibitor therapy 
Klinička djelotvornost i sigurnost u bolesnika s gubitkom koštane mase povezana s adjuvantnom terapijom inhibitorom aromataze
The safety and efficacy of denosumab have not been studied in patients with hepatic impairment (see section 5.2). 
Djelotvornost i sigurnost primjene denosumaba nisu ispitivani u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
In the osteoporosis clinical trial program, atypical femoral fractures were reported rarely in patients treated with Prolia (see section 4.4). 
U programu kliničkih ispitivanja osteoporoze atipične frakture femura rijetko su zabilježene u bolesnika liječenih lijekom Prolia (vidjeti dio 4.4).
MARKETING AUTHORISATION NUMBER(S) EU/1/10/618/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/618/001
It is important to tell your doctor if you are breast-feeding or plan to do so. 
Važno je da kažete Vašem liječniku ako dojite ili planirate dojiti.
These data indicate that continued treatment with Prolia is required to maintain the effect of the medicinal product. 
Ti podaci pokazuju da je za održavanje učinka lijeka potrebna stalna terapija lijekom Prolia.
Bone turnover markers generally reached pre-treatment levels within 9 months after the last dose. 
Markeri pregradnje kosti su, općenito, unutar 9 mjeseci od zadnje primijenjene doze dosegli razine vrijednosti prije liječenja.
Women with other diseases or on therapies that may affect bone were excluded from this study. 
Iz ovog ispitivanja su isključene žene s drugim bolestima ili terapijama koje mogu utjecati na kosti.
Disposing of used syringes 
Odlaganje iskorištenih štrcaljki
Urinary tract infection Upper respiratory tract infection Diverticulitis1 
Infekcija urinarnog sustava Infekcija gornjeg dišnog sustava Divertikulitis1
Clinical efficacy and safety in men with osteoporosis 
Klinička djelotvornost i sigurnost u muškaraca s osteoporozom
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. 
Incidencija divertikulitisa je bila usporediva u terapijskim skupinama žena u postmenopauzi ili muškaraca s osteoporozom i žena koje primaju terapiju inhibitorima aromataze zbog nemetastazirajućeg raka dojke.
• DO NOT put the cover back on used needles. 
• NEMOJTE stavljati poklopac igle natrag na upotrijebljene štrcaljke.
Treatment with Prolia makes bone stronger and less likely to break. 
Liječenje lijekom Prolia čini kosti jačima i manje lomljivima.
Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). 
Liječenje gubitka koštane mase povezano s hormonskom ablacijom u muškaraca s rakom prostate koji imaju povećani rizik od fraktura (vidjeti dio 5.1).
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. 
Osim toga, budući da iskustva nakon stavljanja lijeka u promet, uključujući višestruke slučajeve nakon ponovnog uvođenja liječenja (pozitivan rechallenge), kao i neklinički dokazi o uključenosti RANK/RANKL signalnog puta u ciklus rasta kose, podržavaju zaključak da denosumab može biti uzročno povezan s razvojem alopecije, ova nova nuspojava treba biti dodana u dio 4.8 sažetka opisa svojstava lijeka i u uputu o lijeku.
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). 
Ispitivanja na genetički izmijenjenom soju miševa kojima je RANKL isključen uklanjanjem gena (“knockout” soju miševa) pokazuju da odsustvo RANKL-a (ciljno mjesto denosumaba, vidjeti dio 5.1) tijekom trudnoće može utjecati na sazrijevanje mliječne žlijezde, što može dovesti do oslabljene laktacije u postpartalnom razdoblju (vidjeti dio 5.3).
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. 
U neonatalnih štakora je inhibicija RANKL (ciljno mjesto denosumab terapije) s visokim dozama spoja osteoprotegerina vezanog za Fc (OPG-Fc) povezana s inhibicijom koštanog rasta i nicanja zuba.
• osteoporosis in women after the menopause (postmenopausal) and men who have an increased risk of fracture (broken bones), reducing the risk of spinal, non-spinal and hip fractures. 
• Osteoporoze u žena nakon menopauze (postmenopauza) i muškaraca koji imaju povećani rizik od prijeloma kosti, smanjujući rizik od prijeloma kralježaka, kuka te nevertebralnih prijeloma.
Symptoms of hypocalcaemia in denosumab clinical studies included paraesthesias or muscle stiffness, twitching, spasms and muscle cramps. 
Simptomi hipokalcijemije u kliničkim ispitivanjima s denosumabom uključivali su paresteziju ili ukočenost mišića, trzanje, spazme i grčeve mišića.
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. 
Nadalje, iskustvo nakon stavljanja lijeka u promet, uključujući višestruke slučajeve nakon ponovnog uvođenja liječenja (pozitivan rechallenge), podržava zaključak da denosumab može biti uzročno povezan s razvojem lihenoidnih reakcija na lijek, a ova nova nuspojava treba biti dodana u dio 4.8 sažetka opisa svojstava lijeka i u uputu o lijeku.
If you forget to use Prolia 
Ako ste zaboravili primijeniti lijek Prolia
• bone loss that results from long-term treatment with glucocorticoids in patients who have an increased risk of fracture. 
• Gubitka koštane mase koji je rezultat dugotrajnog liječenja glukokortikoidima u bolesnika koji imaju povećani rizik od fraktura.
What you need to know before you use Prolia 
Što morate znati prije nego počnete primjenjivati lijek Prolia
Adequate intake of calcium, vitamin D and regular monitoring of calcium is especially important in these patients, see above. 
D te redovito praćenje razine kalcija posebno su važni u ovih bolesnika, vidjeti gore navedeno.
Any clinical fracture1 
Bilo koja klinička fraktura1
The recommended dose is one pre-filled syringe of 60 mg administered once every 6 months, as a single injection under the skin (subcutaneous). 
Uobičajena doza je jedna napunjena štrcaljka od 60 mg primijenjena jednom svakih 6 mjeseci, kao pojedinačna injekcija pod kožu (supkutano).
The subject incidence of non-vertebral fracture was 4.3% (denosumab) versus 2.5% (risedronate). 
Incidencija novih radioloških nevertebralnih fraktura u ispitanika bila je 4,3% (denosumab) u usporedbi s 2,5% (risedronat).
The management plan of the patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ. 
Treba izraditi plan zbrinjavanja za bolesnike koji razviju ONČ, u bliskoj suradnji između liječnika i stomatologa, odnosno oralnog kirurga koji ima iskustva s ONČ.
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). 
Prolia je značajno smanjila relativan rizik novih fraktura kralježaka: 85% (1,6% smanjenje apsolutnog rizika) tijekom 1 godine, 69% (2,2% smanjenje apsolutnog rizika) tijekom 2 godine i 62% (2,4% smanjenje apsolutnog rizika) tijekom 3 godine (za sve p < 0,01).
Histomorphometry findings in the extension study in postmenopausal women with osteoporosis showed that the antiresorptive effects of Prolia, as measured by activation frequency and bone formation rates, were maintained over time. 
Nalazi histomorfometrije u produžetku ispitivanja u postmenopauzalnih žena s osteoporozom su pokazali da su antiresorptivni učinci lijeka Prolia, mjereni pomoću učestalosti aktivacije i stopa formacije kosti, održani tijekom vremena.
The data in Table 1 below describe adverse reactions reported from Phase II and III clinical trials in patients with osteoporosis and breast or prostate cancer patients receiving hormone ablation; and/or spontaneous reporting. 
Podaci u Tablici 1 u nastavku opisuju nuspojave zabilježene u kliničkim ispitivanjima faze II i III u bolesnika s osteoporozom i bolesnika s rakom dojke ili prostate koji su primali hormonsku ablacijsku terapiju; i/ili zabilježene u sklopu spontane prijave nuspojave.
Clinical efficacy and safety in patients with bone loss associated with androgen deprivation 
Klinička djelotvornost i sigurnost u bolesnika s gubitkom koštane mase povezanog s deprivacijom androgena
Fifty-three percent (53%) of patients had no measurable amounts of denosumab detected at 6 months post-dose. 
6 mjeseci nakon doze 53% bolesnika nije imalo mjerljive količine denosumaba.
All patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling or non-healing of sores or discharge during treatment with denosumab. 
Sve bolesnike za vrijeme terapije denosumabom treba poticati na održavanje dobre oralne higijene, odlazak na redovite stomatološke preglede i da bez odlaganja prijave bilo kakve simptome vezane uz usnu šupljinu kao što su klimanje zubi, bol ili oticanje ili nezarastanje rana ili iscjedak.
Inhibition of RANK/RANK ligand (RANKL) in animal studies has been coupled to inhibition of bone growth and lack of tooth eruption (see section 5.3). 
U ispitivanjima na životinjama inhibicija RANK/RANK liganda (RANKL) bila je povezana s inhibicijom rasta kosti i nedostatkom nicanja zubi (vidjeti dio 5.3).
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). 
Istodobno liječenje ostalim lijekovima koji sadrže denosumab Tijekom liječenja lijekom Prolia bolesnici ne smiju istodobno uzimati druge lijekove koji sadrže denosumab (za prevenciju koštanih događaja u odraslih s koštanim metastazama solidnih tumora).
The incidence of hip fracture was 1.2% in the placebo group compared to 0.7% in the Prolia group at 3 years. 
Tijekom 3 godine incidencija frakture kuka bila je 1,2% u skupini koja je primala placebo u usporedbi s 0,7% u skupini koja je primala lijek Prolia.
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. 
U pretkliničkim ispitivanjima kvalitete kosti u majmuna pri dugoročnoj terapiji denosumabom smanjenje pregradnje kosti povezano je s poboljšanjem koštane čvrstoće i normalnom histologijom kosti.
Each pack contains one pre-filled syringe. 
Jedno pakiranje sadrži jednu napunjenu štrcaljku.
On the basis of the scientific conclusions for denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer) is unchanged subject to the proposed changes to the product information. 
Na temelju znanstvenih zaključaka za denosumab (indiciran za liječenje osteoporoze i za liječenje gubitka koštane mase povezano s hormonskom ablacijom kod raka prostate), CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) denosumab (indiciran za liječenje osteoporoze i za liječenje gubitka koštane mase povezano s hormonskom ablacijom kod raka prostate) nepromijenjen, uz predložene izmjene informacija o lijeku.
If you stop using Prolia 
Ako prestanete primjenjivati lijek Prolia
Musculoskeletal pain leading to discontinuation of study treatment was uncommon. 
Slučajevi kad je mišićno-koštana bol dovela do prekida terapije u ispitivanju bili su manje česti.
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. 
Svako pakiranje lijeka Prolia sadrži karticu s podsjetnikom s naljepnicama koje se mogu ukloniti s kutije.
Administration should be performed by an individual who has been adequately trained in injection techniques. 
Injekcije bi trebala davati osoba primjereno obučena za davanje injekcija.
Hypocalcaemia must be corrected by adequate intake of calcium and vitamin D before initiating therapy. 
Prije započinjanja terapije hipokalcijemija se mora korigirati odgovarajućim unosom kalcija i vitamina D.
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. 
Rijetko, bolesnici koji primaju lijek Prolia mogu razviti bol u ustima i/ili čeljusti, oticanje ili rane koje ne cijele u ustima ili čeljusti, iscjedak, utrnulost ili osjećaj težine u čeljusti, ili gubitak zuba.
Please tell your doctor if you have an allergy to latex (the needle cover on the pre-filled syringe contains a derivative of latex). 
Molimo recite liječniku ako ste alergični na lateks (poklopac igle na napunjenoj štrcaljki sadrži derivat lateksa).
Your pre-filled syringe may be left outside the refrigerator to reach room temperature (up to 25°C) before injection. 
Napunjenu štrcaljku možete ostaviti izvan hladnjaka kako bi prije injiciranja dostigla sobnu temperaturu (do 25 °C).
What Prolia is used for 
Za što se Prolia koristi
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]). 
Ukupna incidencija kožnih infekcija u placebom kontroliranim kliničkim ispitivanjima faze III bila je slična u skupinama s placebom i lijekom Prolia: u žena u postmenopauzi s osteoporozom (placebo [1,2%, 50 od 4041] naspram lijeka Prolia [1,5%, 59 od 4050]); u muškaraca s osteoporozom (placebo [0,8%, 1 od 120] naspram lijeka Prolia [0%, 0 od 120]); u bolesnika s rakom dojke ili prostate koji primaju hormonsku ablacijsku terapiju (placebo [1,7%, 14 od 845] naspram Prolia [1,4%, 12 od 860]).
3 Includes pelvis, distal femur, proximal tibia, ribs, proximal humerus, forearm, and hip. 
3 Uključuje zdjelicu, distalni femur, proksimalnu tibiju, rebra, proksimalni humerus, podlakticu i kuk.
LIST OF EXCIPIENTS Acetic acid, glacial, sodium hydroxide, sorbitol (E420), polysorbate 20, water for injections. 
POPIS POMOĆNIH TVARI Ledena acetatna kiselina, natrijev hidroksid, sorbitol (E420), polisorbat 20, voda za injekcije.
Patients should be advised to seek prompt medical attention if they develop signs or symptoms of cellulitis. 
Bolesnike treba savjetovati da u slučaju znakova ili simptoma celulitisa odmah zatraže medicinsku pomoć.
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. 
Javite se svojem liječniku ako osjetite novu ili neobičnu bol u kuku, preponi ili bedru jer to može biti rani znak mogućeg prijeloma bedrene kosti.
- The other ingredients are acetic acid, glacial, sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections. 
- Pomoćne tvari su ledena acetatna kiselina, natrijev hidroksid, sorbitol (E420), polisorbat 20 i voda za injekcije.
4 Includes clinical vertebral, hip, forearm, and humerus fractures, as defined by the WHO. 
4 Uključuje kliničke frakture kralježaka, kuka, podlaktice i humerusa, prema definiciji SZO.
No specific study in patients with hepatic impairment was performed. 
Nisu provođena pojedinačna ispitivanja na bolesnicima s oštećenjem funkcije jetre.
Patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia. 
Bolesnici s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min) ili bolesnici koji su na dijalizi imaju povećan rizik za razvoj hipokalcijemije.
If you are breast-feeding during Prolia treatment, please inform your doctor. 
Ako dojite tijekom liječenja lijekom Prolia, molimo Vas obavijestite Vašeg liječnika o tome.
The mean lumbar spine BMD T-score at the end of the study was1.3 in patients treated for 10 years. 
Srednja T-vrijednost BMD lumbalne kralježnice na kraju ispitivanja bila je -1,3 u bolesnika liječenih 10 godina.
Denosumab pharmacokinetics were not affected by the formation of binding antibodies to denosumab and were similar in men and women. 
Stvaranje protutijela koja se vežu za denosumab nije utjecalo na farmakokinetiku denosumaba i bilo je slično u muškaraca i žena.
Hypocalcaemia1 
Hipokalcijemija1
The use of Prolia in children and adolescents has not been studied. 
Primjena lijeka Prolia u djece i adolescenata nije bilo ispitivana.
In a prospectively planned exploratory analysis, significant increases in BMD were observed at the lumbar spine, total hip, femoral neck and the hip trochanter 1 month after the initial dose. 
U prospektivnoj planiranoj eksploratornoj analizi jedan mjesec nakon inicijalne doze zabilježen je značajan porast BMD-a na lumbalnoj kralježnici, cijelom kuku, vratu femura i trohanteru kuka.
Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1). 
Liječenje gubitka koštane mase povezano s dugotrajnom sustavnom terapijom glukokortikoidima u odraslih bolesnika koji imaju povećani rizik od fraktura (vidjeti dio 5.1).
• Tell your doctor if you have an allergy to latex (the needle cap on the pre-filled syringe contains a derivative of latex). 
• Obavijestite svog liječnika ukoliko ste alergični na lateks (zatvarač igle na napunjenoj štrcaljki sadrži derivat lateksa).
This medicine contains less than 1 mmol sodium (23 mg) per 60 mg, that is to say essentially ‘sodiumfree'. 
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po 60 mg, tj. zanemarive količine natrija.
Each pack contains one pre-filled syringe with a needle guard. 
Jedno pakiranje sadrži jednu napunjenu štrcaljku sa štitnikom za iglu.
Prolia contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, in order to treat bone loss and osteoporosis. 
Prolia sadrži denosumab, bjelančevinu (monoklonsko protutijelo) koja sprječava djelovanje jedne druge bjelančevine kako bi se liječio gubitak koštane mase i osteoporoza.
Pinch (without squeezing) the skin between your thumb and forefinger. 
Uhvatite (bez stiskanja) kožu palcem i kažiprstom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S NAPUNJENOM ŠTRCALJKOM
Re-initiation of Prolia resulted in gains in BMD similar to those when Prolia was first administered. 
Ponovno uvođenje lijeka Prolia rezultiralo je porastom BMD koji je bio sličan onome kada je Prolia uvedena po prvi puta.
Do not use Prolia 
Nemojte primjenjivati lijek Prolia
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. 
Preporučena doza lijeka Prolia je 60 mg primijenjeno u obliku jedne supkutane injekcije u bedro, trbuh ili nadlakticu jednom u svakih 6 mjeseci.
Patients treated with Prolia should be given the package leaflet and the patient reminder card. 
Bolesnicima koji su liječeni lijekom Prolia treba dati uputu o lijeku i karticu s podsjetnikom za bolesnika.
Uncommonly, patients receiving Prolia may develop skin infections (predominantly cellulitis). 
Manje često, bolesnici koji primaju lijek Prolia mogu razviti kožne infekcije (najčešće celulitis).
Rarely, allergic reactions may occur in patients receiving Prolia. 
Rijetko, u bolesnika koji primaju lijek Prolia mogu se pojaviti alergijske reakcije.
Rare Rare 
Rijetko Rijetko
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERED PRE-FILLED SYRINGE 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAPUNJENA ŠTRCALJKA U BLISTERU
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL WITH OR WITHOUT NEEDLE GUARD (BLISTERED) 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA NAPUNJENOJ ŠTRCALJKI SA ILI BEZ ŠTITNIKA ZA IGLU (U BLISTERU)
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. 
Uz to, lijek Prolia imao je značajno veće prosječno povećanje postotka BMD-a od početne vrijednosti u usporedbi s risedronatom na cijelom kuku, vratu femura i trohanteru kuka.
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). 
Sve žene u produžetku ispitivanja trebale su primati lijek Prolia 60 mg svakih 6 mjeseci, kao i svakodnevno kalcij (barem 1 g) i vitamin D (barem 400 IU).
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. 
Djelotvornost i sigurnost lijeka Prolia primjenjivanog jednom svakih 6 mjeseci tijekom 2 godine ispitivane su u žena s nemetastazirajućim rakom dojke (252 žene u dobi 35-84 godine) s početnim BMD T-vrijednostima između -1,0 i -2,5 na lumbalnoj kralježnici, cijelom kuku ili vratu femura.
Elderly (age ≥ 65) No dose adjustment is required in elderly patients. 
Nije potrebna prilagodba doze u starijih bolesnika.
Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject. 
Ne uklanjajte sivi zatvarač igle s napunjene štrcaljke sve dok niste spremni injicirati.
Do not inject the solution if it contains particles, or is cloudy or discoloured. 
Nemojte injicirati otopinu ako sadrži čestice ili je zamućena ili je promijenila boju.
Prolia significantly increased BMD at all clinical sites measured, versus placebo at 1, 2 and 3 years. 
Na svim mjerenim mjestima Prolia je u usporedbi s placebom značajno povisila BMD tijekom jedne, dvije i tri godine.