natgillin/translations-raw huggingface dataset:
- 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.
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.