natgillin/translations-raw huggingface dataset:
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.) 
Djelotvornost i sigurnost primjene lijeka Prolia jednom svakih 6 mjeseci tijekom 3 godine ispitivana je u muškaraca s histološki potvrđenim nemetastazirajućim rakom prostate koji su primali ADT (1468 muškaraca u dobi 48-97 godina) koji su imali povećan rizik od fraktura (definirano kao > 70 godina, ili < 70 godina s T-vrijednostima BMD lumbalne kralješnice, cijelog kuka ili vrata femura < -1,0 ili osteoporotična fraktura u anamnezi).
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. 
Infekcije kože zbog kojih je došlo do hospitalizacije u postmenopauzalnih žena s osteoporozom koje su primale placebo zabilježene su u 0,1% (3 od 4041) naspram 0,4% (16 od 4050) kod žena koje su primale lijek Prolia.
DO NOT pick up the pre-filled syringe by the plunger or needle cover. 
NEMOJTE primiti napunjenu štrcaljku za klip ili poklopac igle.
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. 
Simptomi uključuju spazme, trzaje ili grčeve u mišićima i/ili utrnulost ili trnce u prstima, nožnim prstima ili oko usta, i/ili napadaje, smetenost ili gubitak svijesti.
Bone histology in postmenopausal women and men with osteoporosis 
Histologija kosti u žena u postmenopauzi i muškaraca s osteoporozom
There was no evidence of maternal harm prior to labour; adverse maternal effects occurred infrequently during labour. 
Nije bilo dokaza za štetnost po majku prije poroda.
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. 
Bolesnicima koji imaju prateće faktore rizika preporučuje se stomatološki pregled prije terapije denosumabom te provođenje preventivnih stomatoloških zahvata i individualna procjena koristi i rizika.
Osteonecrosis of the jaw1 
Osteonekroza čeljusti1
DO NOT remove the needle cover from the pre-filled syringe until you are ready to inject. 
NEMOJTE uklanjati poklopac igle sa napunjene štrcaljke prije nego što ste spremni za injiciranje.
Clinical efficacy and safety in postmenopausal women with osteoporosis 
Klinička djelotvornost i sigurnost u žena u postmenopauzi s osteoporozom
Effect on vertebral fractures 
Učinci na frakture kralježaka
Efficacy and safety of Prolia administered once every 6 months for 3 years were investigated in postmenopausal women (7,808 women aged 60-91 years, of which 23.6% had prevalent vertebral fractures) with baseline bone mineral density (BMD) T-scores at the lumbar spine or total hip between -2.5 and -4.0 and a mean absolute 10-year fracture probability of 18.60% (deciles: 7.9-32.4%) for major osteoporotic fracture and 7.22% (deciles: 1.4-14.9%) for hip fracture. 
U žena u postmenopauzi ispitivana je djelotvornost i sigurnost lijeka Prolia primjenjivanog jednom svakih šest mjeseci tijekom razdoblja od tri godine (7808 žena u dobi 60-91 godine, od kojih je 23,6% imalo pretežno frakture kralježaka) s početnom mineralnom gustoćom kosti (BMD) lumbalne kralježnice ili cijelog kuka u T-vrijednostima između -2,5 i -4,0 te srednjom apsolutnom vjerojatnošću za frakturu unutar 10 godina od 18,60% (decili: 7,9-32,4%) za veću osteoporotičnu frakturu te 7,22% (decili: 1,4-14,9%) za frakturu kuka.
2 Excludes those of the vertebrae, skull, facial, mandible, metacarpus, and finger and toe phalanges. 
2 Isključuje frakture kralježaka, lubanje, lica, mandibule, metakarpusa te falangi prstiju ruku i nogu.
Drug hypersensitivity1 Anaphylactic reaction1 
Preosjetljivost na lijek1 Anafilaktička reakcija1
The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented. 
Nositelj odobrenja mora osigurati primjenu kartice s podsjetnikom za bolesnika u svezi osteonekroze čeljusti.
Do not put the grey needle cap back on used pre-filled syringes. 
Ne vraćajte sivi zatvarač za iglu na iskorištenu napunjenu štrcaljku.
The solution should not be injected if it contains particles or if it is discoloured or cloudy. 
Ne smijete ju injicirati ako sadrži čestice, ako je zamućena ili ako je promijenila boju.
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. 
Histologija kosti je procijenjena nakon 1 do 3 godine liječenja lijekom Prolia u 62 žene u postmenopauzi s osteoporozom ili smanjenom koštanom masom koje ili prethodno nisu imale terapiju za osteoporozu ili su nakon ranije terapije alendronatom prešle na terapiju lijekom 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). 
Neuravnoteženost nuspojave divertikulitisa zabilježena je u jednom placebom kontroliranom kliničkom ispitivanju faze III, u bolesnika s rakom prostate koji su primali ADT (1,2% denosumab, 0% placebo).
Calcium and Vitamin D supplementation 
Primjeren unos kalcija i vitamina
Lichenoid drug eruptions (e.g. lichen planus-like reactions), have been reported in patients in the postmarketing setting. 
Izbijanje lihenoidnih kožnih promjena uzrokovano lijekom Izbijanje lihenoidnih kožnih promjena uzrokovano lijekom (npr. reakcije nalik na lichen planus) prijavljeno je u bolesnika nakon stavljanja lijeka u promet.
The pharmacokinetics of denosumab is not expected to be affected by hepatic impairment. 
Ne očekuje se da oštećenje jetre utječe na farmakokinetiku denosumaba.
Some people have developed unusual fractures in their thigh bone while being treated with Prolia. 
U nekih osoba pojavili su se neuobičajeni lomovi bedrene kosti tijekom liječenja lijekom Prolia.
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. 
Nakon davanja lijeka Prolia ženama u postmenopauzi s osteoporozom, u dva placebom kontrolirana klinička ispitivanja faze III, približno 0,05% (2 od 4050) bolesnica imalo je sniženje razine kalcija u serumu (manje od 1,88 mmol/l).
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. 
I s iglom promjera 27 G od nehrđajućeg čelika, sa ili bez štitnika za iglu.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL (UNBLISTERED) 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NAPUNJENE ŠTRCALJKE (BEZ BLISTERA)
You must inject the entire content (1 mL) of the Prolia pre-filled syringe and it should be injected once every 6 months as instructed by your doctor. 
Prolia napunjene štrcaljke te je treba injicirati jednom svakih 6 mjeseci kako Vam je propisao liječnik.
No data are available on the effect of denosumab on human fertility. 
Ne postoje podaci o učinku desnosumaba na plodnost kod ljudi.
Effect on bone mineral density 
Učinak na mineralnu gustoću kostiju
The effect of Prolia on the risk of new vertebral fractures 
Tablica 2. Učinak lijeka Prolia na rizik od novih fraktura kralježaka
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. 
U bolesnika koji su uzimali lijek Prolia primijećeni su manje česti slučajevi celulitisa, rijetki slučajevi hipokalcijemije, preosjetljivosti, osteonekroze čeljusti i atipičnih femoralnih fraktura (vidjeti dio 4.4 i dio 4.8 - opis odabranih nuspojava).
How to store Prolia 
Kako čuvati lijek Prolia
In preclinical studies conducted in knockout mice lacking RANK or RANKL, impairment of lymph node formation was observed in the foetus. 
U pretkliničkim ispitivanjima na knockout soju miševa kojima nedostaje RANK ili RANKL u fetusa su zabilježene smetnje u formiranju limfnih čvorova.
Each 1 mL pre-filled syringe contains 60 mg of denosumab (60 mg/mL). 
Jedna napunjena štrcaljka od 1 ml sadrži 60 mg denosumaba (60 mg/ml).
Prolia contains sodium 
Prolia sadrži natrij
Uncommon side effects (may affect up to 1 in 100 people): 
Manje česte nuspojave (mogu se pojaviti u do 1 na 100 osoba):
• Keep used syringes out of the reach and sight of children. 
• Držite upotrijebljene štrcaljke izvan dohvata i pogleda djece.
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) 
U subpopulaciji bolesnika koji počinju liječenje glukokortikoidima lijek Prolia više je povećao BMD lumbalne kralježnice u usporedbi s risedronatom tijekom 1 godine (Prolia 3,1%, risedronat 0,8%; p < 0,001) i 2 godine (Prolia 4,6%, risedronat 1,5%; p < 0,001).
In postmenopausal women Prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures. 
Kod žena u postmenopauzi Prolia značajno umanjuje rizik od fraktura kralježaka, nevertebralnih fraktura te fraktura kuka.
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. 
U bolesnika liječenih lijekom Prolia do 10 godina, BMD je porastao u odnosu na početnu vrijednost u pivotalnom ispitivanju za 21,7% u lumbalnoj kralježnici, 9,2% u cijelom kuku, 9,0% u vratu bedrene kosti, 13,0% u trohanteru i 2,8% u distalnoj trećini radijusa.
It is not known whether Prolia is excreted in breast milk. 
Nije poznato izlučuje li se Prolia u majčino mlijeko.
Major non-vertebral fracture3 
Značajna nevertebralna fraktura3
QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 60 mg of denosumab in 1 mL of solution (60 mg/mL). 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena štrcaljka sadrži 60 mg denosumaba u 1 ml otopine (60 mg/ml).
• fever, vomiting and abdominal pain or discomfort (diverticulitis), 
• vrućica, povraćanje i bol u trbuhu te nelagoda u trbuhu (divertikulitis),
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). 
U subpopulaciji bolesnika koji nastavljaju liječenje glukokortikoidima lijek Prolia više je povećao BMD lumbalne kralježnice u usporedbi s risedronatom tijekom 1 godine (Prolia 3,6%, risedronat 2,0%; p < 0,001) i 2 godine (Prolia 4,5%, risedronat 2,2%; p < 0,001).
Constipation Abdominal discomfort 
Konstipacija Nelagoda u abdomenu
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). 
Prolia je smanjila rizik od nevertebralnih fraktura u žena s inicijalnim BMD vrata femura ≤ -2,5; (35% smanjenje relativnog rizika: 4,1% smanjenje apsolutnog rizika; p < 0,001; eksplorativna analiza).
• The grey needle cap is missing or not securely attached. 
• Ukoliko nema sivog zatvarača za iglu ili nije dobro pričvršćen.
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. 
U ispitivanjima skupina s rakom dojke i rakom prostate kožne infekcije su zabilježene kao teške nuspojave u sličnoj mjeri i za skupine koje su primale placebo (0,6%, 5 od 845) i za skupine koje su primale lijek Prolia (0,6%, 5 od 860).
You should also take calcium and vitamin D supplements while being on treatment with Prolia. 
Dok ste na terapiji lijekom Prolia također biste trebali uzimati dodatke kalcija i vitamina D.
Ear infection 
Infekcija uha
On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies. 
Položite novu napunjenu štrcaljku i ostali pribor na čistu i dobro osvijetljenu radnu površinu.
Next injection Prolia 60 mg injection denosumab SC 
Sljedeća injekcija Prolia 60 mg injekcija denosumab s.c.
It must be a clear, colourless to slightly yellow solution. 
Mora biti bistra, bezbojna do žućkasta tekućina.
In clinical studies, patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis were at greater risk of developing hypocalcaemia in the absence of calcium supplementation. 
U slučaju izostanka nadopune kalcija, bolesnici s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min) ili bolesnici koji su na dijalizi u kliničkim su ispitivanjima imali povećan rizik za razvijanje hipokalcijemije.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 mL pre-filled syringe containing 60 mg of denosumab (60 mg/mL). 
NAVOĐENJE DJELATNE(IH) TVARI Napunjena štrcaljka od 1 ml sadrži 60 mg denosumaba (60 mg/ml).
In postmenopausal women with osteoporosis the pharmacokinetics and pharmacodynamics of denosumab were not altered by previous alendronate therapy, based on data from a transition study (alendronate to denosumab). 
Temeljem podataka iz ispitivanja o prijelazu s jedne terapije na drugu (alendronat u denosumab) u postmenopauzalnih žena s osteoporozom, farmakokinetika i farmakodinamika denosumaba nije se mijenjala zbog ranije terapije alendronatom.
• constipation, 
• zatvor,
Adequate intake of calcium and vitamin D is important in patients with severe renal impairment or receiving dialysis (see section 4.4). 
D je važan za bolesnike s teškim oštećenjem funkcije bubrega ili za bolesnike koji su na dijalizi (vidjeti dio 4.4).
NAME OF THE MEDICINAL PRODUCT Prolia 60 mg solution for injection in pre-filled syringe 
NAZIV LIJEKA Prolia 60 mg otopina za injekciju u napunjenoj štrcaljki
Non-vertebral fracture2 
Klinička fraktura kralježaka Nevertebralna fraktura2
• Before administration, the solution should be inspected. 
• Otopinu treba pregledati prije primjene.
Effect on hip fractures 
Učinak na frakture kuka
Prolia 60 mg solution for injection in pre-filled syringe denosumab 
Prolia 60 mg otopina za injekciju u napunjenoj štrcaljki denosumab
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). 
Kumulativna incidencija novih vertebralnih i nevertebralnih fraktura bila je približno 6,8%, odnosno 13,1% u bolesnika koji su ostali na terapiji denosumabom 10 godina (n = 1278).
Unusual thigh bone fractures 
Neuobičajeni lomovi bedrene kosti
NAME OF THE MEDICINAL PRODUCT Prolia 60 mg injection denosumab 
NAZIV LIJEKA Prolia 60 mg injekcija denosumab
You may have low levels of calcium in your blood while receiving Prolia. 
Tijekom liječenja lijekom Prolia možete imati niske razine kalcija u krvi.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Prolia 60 mg denosumab 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Prolia 60 mg denosumab s.c.
This section contains information on how to use the Prolia pre-filled syringe. 
Upute za injiciranje s Prolia napunjenom štrcaljkom Ovaj dio sadrži informacije o tome kako koristiti Prolia napunjenu štrcaljku.
Prolia increased BMD by 9.2% at the lumbar spine, 6.0% at the total hip, 4.8% at the femoral neck, 7.9% at the hip trochanter, 3.5% at the distal 1/3 radius and 4.1% at the total body over 3 years (all p < 0.0001). 
Prolia je tijekom 3 godine povisila BMD za 9,2% u lumbalnoj kralježnici, 6,0% za cijeli kuk, 4,8% na vratu femura, 7,9% na trohanteru kuka, 3,5% u distalnoj trećini radijusa i 4,1% za cijelo tijelo (za sve p < 0,0001).
• skin condition with itching, redness and/or dryness (eczema), 
• promjene na koži sa svrbežom, crvenilom i/ili suhoćom (ekcem),
Osteonecrosis of the external auditory canal2 
Atipične frakture femura1 Osteonekroza vanjskog slušnog kanala2
• Keep the pre-filled syringe out of the sight and reach of children. 
• Čuvajte napunjenu štrcaljku izvan pogleda i dohvata djece.
Remove the pre-filled syringe from the refrigerator. 
Što treba učiniti prije davanje potkožne injekcije lijeka Prolia Izvadite napunjenu štrcaljku iz hladnjaka.
No accumulation or change in denosumab pharmacokinetics with time was observed upon subcutaneous multiple-dosing of 60 mg once every 6 months. 
Nakon višekratnog supkutanog doziranja od 60 mg jednom svakih 6 mjeseci tijekom vremena nije zabilježeno nakupljanje ili promjena farmakokinetike denosumaba.
Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the tray. 
Uhvatite napunjenu štrcaljku za sigurnosni štitnik kako biste je izvadili iz podloge.
Prolia significantly increased BMD at all clinical sites measured, relative to placebo at 12 months: 4.8% at lumbar spine, 2.0% at total hip, 2.2% at femoral neck, 2.3% at hip trochanter, and 0.9% at distal 1/3 radius (all p < 0.05). 
Prolia je nakon 12 mjeseci značajno povećala BMD u odnosu na placebo na svim kliničkim mjestima mjerenja: 4,8% kod lumbalne kralježnice, 2,0% kod cijelog kuka, 2,2% kod vrata bedrene kosti, 2,3% kod trohantera kuka, te 0,9% kod distalne trećine radijusa (kod svih p<0,05).
How to use Prolia 
Kako primjenjivati lijek Prolia
Step 4: Finish A Discard the used pre-filled syringe and other supplies in a sharps disposal container. 
Odložite iskorištenu napunjenu štrcaljku i ostali pribor u spremnik za odlaganje oštrih predmeta.
Adverse reactions reported in patients with osteoporosis and breast or prostate cancer patients receiving hormone ablation 
Tablica 1. Nuspojave zabilježene u bolesnika s osteoporozom i u bolesnika s rakom dojke ili prostate koji su primali hormonsku ablacijsku terapiju MedDRA klasifikacija organskog sustava
DO NOT shake the pre-filled syringe. 
NE tresite napunjenu štrcaljku.
In the post-marketing setting, rare events of drug-related hypersensitivity, including rash, urticaria, facial swelling, erythema, and anaphylactic reactions have been reported in patients receiving Prolia. 
Nakon stavljanja lijeka u promet u bolesnika koji primaju lijek Prolia zabilježeni su rijetki slučajevi preosjetljivosti povezane s lijekom, uključujući osip, urtikariju, oticanje lica, eritem i anafilaktičke reakcije.
Most of the fractures occurred in the GC-C subpopulation. 
Većina fraktura pojavila se u subpopulaciji bolesnika koji nastavljaju liječenje glukokortikoidima.
An absence of lactation due to inhibition of mammary gland maturation (lobulo-alveolar gland development during pregnancy) was also observed in knockout mice lacking RANK or RANKL. 
U knockout soja miševa kojima nedostaje RANK ili RANKL primijećena je također i odsutnost laktacije zbog inhibicije sazrijevanja mliječne žlijezde (lobulo-alveolarni žljezdani razvoj tijekom trudnoće).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Prolia 60 mg injection denosumab 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Prolia 60 mg injekcija denosumab s.c.
Read all instructions thoroughly before using the pre-filled syringe. 
Prije nego što počnete Prije korištenja napunjene štrcaljke detaljno pročitajte sve upute.
Prolia significantly increased BMD at all clinical sites measured, relative to treatment with placebo at 2 years: 7.6% at lumbar spine, 4.7% at total hip, 3.6% at femoral neck, 5.9% at hip trochanter, 6.1% at distal 1/3 radius and 4.2% at total body (all p < 0.0001). 
Na svim mjerenim mjestima Prolia je u usporedbi s placebom značajno povisila BMD tijekom dvije godine: 7,6% na lumbalnoj kralježnici, 4,7% na cijelom kuku, 3,6% na vratu femura, 5,9% na trohanteru kuka, 6,1% distalne trećine radijusa i 4,2% cijelog tijela (za sve p < 0,0001).
Osteonecrosis of the jaw 
Osteonekroza čeljusti (ONČ)
Patients received calcium (at least 1,000 mg) and vitamin D (at least 800 IU) supplementation daily. 
Bolesnici su dnevno primali dodatke kalcija (barem 1000 mg) i vitamina D (barem 800 IU).
Osteonecrosis of the Jaw (ONJ) ONJ has been reported rarely in patients receiving Prolia for osteoporosis (see section 4.8). 
ONČ je zabilježena u rijetkim slučajevima u bolesnika koji su primali lijek Prolia za liječenje osteoporoze (vidjeti dio 4.8).
Ask your doctor or pharmacist for advice before taking any medicine. 
Prije uzimanja bilo kojeg lijeka, pitajte liječnika ili ljekarnika za savjet.
Finger grips Syringe label Syringe barrel 
Naljepnica na štrcaljki Spremnik štrcaljke Sigurnosni štitnik štrcaljke
GENERAL CLASSIFICATION FOR SUPPLY 
Kategorija učestalosti
Prolia is not recommended for use if you are pregnant. 
Ne preporuča se korištenje lijeka Prolia u trudnoći.
All men received calcium (at least 1,000 mg) and vitamin D (at least 800 IU) supplementation daily. 
Svi muškarci su svakodnevno primali dodatke kalcija (barem 1000 mg) i vitamina D (barem 800 IU).
Belly 
Išijas
Adequate intake of calcium and vitamin D is important in all patients. 
D važan je u svih bolesnika.
Calcium levels were transiently decreased and parathyroid hormone levels transiently increased in ovariectomised monkeys treated with denosumab. 
U majmuna s ovariektomijom koji su tretirani denosumabom zabilježeno je prolazno smanjenje razina kalcija i prolazno povišenje razina paratiroidnog hormona.
All men received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily. 
Svi muškarci svakodnevno su primali dodatke kalcija (barem 1000 mg) i vitamina D (barem 400 IU).
What to do before you give a subcutaneous injection of Prolia 
Što morate znati prije nego počnete primjenjivati lijek Prolia Kako primjenjivati lijek Prolia Moguće nuspojave
Women received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily. 
Žene su dnevno primale dodatke kalcija (barem 1000 mg) i vitamina D (barem 400 IU).
All women received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily. 
Sve žene su svakodnevno primale dodatke kalcija (barem 1 000 mg) i vitamina D (barem 400 IU).
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. 
Slične frakture zabilježene u kombinaciji s bisfosfonatima često su bile obostrane.
Prolia significantly increased BMD at all clinical sites measured, relative to treatment with placebo at 3 years: 7.9% at the lumbar spine, 5.7% at the total hip, 4.9% at the femoral neck, 6.9% at the hip trochanter, 6.9% at the distal 1/3 radius and 4.7% at the total body (all p < 0.0001). 
Prolia je, u usporedbi s placebom, značajno povisila BMD tijekom tri godine: 7,9% na lumbalnoj kralježnici, 5,7% na cijelom kuku, 4,9% na vratu femura, 6,9%
Water for injections * Acetate buffer is formed by mixing acetic acid with sodium hydroxide 
6.1 Popis pomoćnih tvari acetatna kiselina, ledena* natrijev hidroksid (za podešavanje pH)* sorbitol (E420) polisorbat 20 voda za injekcije * Acetatni pufer se stvara miješanjem acetatne kiseline i natrijevog hidroksida 6.2 Inkompatibilnosti
Rarely unusual fractures of the thigh bone may occur in patients receiving Prolia. 
Rijetko, u bolesnika koji primaju lijek Prolia mogu se pojaviti neuobičajeni lomovi bedrene kosti.
Member State EU/EEA 
Država članica EU/EEZ
1 hour 1 hour 
1 sat 1 sat
In particular its activity has been demonstrated against the following micro-organism: 
Naročito je njegova aktivnost dokazana protiv sljedećih mikroorganizama: