FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: 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.
English: 2 Excludes those of the vertebrae, skull, facial, mandible, metacarpus, and finger and toe phalanges.
Croatian: 2 Isključuje frakture kralježaka, lubanje, lica, mandibule, metakarpusa te falangi prstiju ruku i nogu.
English: Drug hypersensitivity1 Anaphylactic reaction1
Croatian: Preosjetljivost na lijek1 Anafilaktička reakcija1
English: The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Croatian: Nositelj odobrenja mora osigurati primjenu kartice s podsjetnikom za bolesnika u svezi osteonekroze čeljusti.
English: Do not put the grey needle cap back on used pre-filled syringes.
Croatian: Ne vraćajte sivi zatvarač za iglu na iskorištenu napunjenu štrcaljku.
English: The solution should not be injected if it contains particles or if it is discoloured or cloudy.
Croatian: Ne smijete ju injicirati ako sadrži čestice, ako je zamućena ili ako je promijenila boju.
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: Calcium and Vitamin D supplementation
Croatian: Primjeren unos kalcija i vitamina
English: Lichenoid drug eruptions (e.g. lichen planus-like reactions), have been reported in patients in the postmarketing setting.
Croatian: 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.
English: The pharmacokinetics of denosumab is not expected to be affected by hepatic impairment.
Croatian: Ne očekuje se da oštećenje jetre utječe na farmakokinetiku denosumaba.
English: Some people have developed unusual fractures in their thigh bone while being treated with Prolia.
Croatian: U nekih osoba pojavili su se neuobičajeni lomovi bedrene kosti tijekom liječenja lijekom Prolia.
English: 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.
Croatian: 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).
English: One mL solution in a single use pre-filled syringe made from type I glass with stainless steel 27 gauge needle, with or without needle guard.
Croatian: I s iglom promjera 27 G od nehrđajućeg čelika, sa ili bez štitnika za iglu.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL (UNBLISTERED)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NAPUNJENE ŠTRCALJKE (BEZ BLISTERA)
English: 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.
Croatian: Prolia napunjene štrcaljke te je treba injicirati jednom svakih 6 mjeseci kako Vam je propisao liječnik.
English: No data are available on the effect of denosumab on human fertility.
Croatian: Ne postoje podaci o učinku desnosumaba na plodnost kod ljudi.
English: Effect on bone mineral density
Croatian: Učinak na mineralnu gustoću kostiju
English: The effect of Prolia on the risk of new vertebral fractures
Croatian: Tablica 2. Učinak lijeka Prolia na rizik od novih fraktura kralježaka
English: 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.
Croatian: 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).
English: How to store Prolia
Croatian: Kako čuvati lijek Prolia
English: In preclinical studies conducted in knockout mice lacking RANK or RANKL, impairment of lymph node formation was observed in the foetus.
Croatian: U pretkliničkim ispitivanjima na knockout soju miševa kojima nedostaje RANK ili RANKL u fetusa su zabilježene smetnje u formiranju limfnih čvorova.
English: Each 1 mL pre-filled syringe contains 60 mg of denosumab (60 mg/mL).
Croatian: Jedna napunjena štrcaljka od 1 ml sadrži 60 mg denosumaba (60 mg/ml).
English: Prolia contains sodium
Croatian: Prolia sadrži natrij
English: Uncommon side effects (may affect up to 1 in 100 people):
Croatian: Manje česte nuspojave (mogu se pojaviti u do 1 na 100 osoba):
English: • Keep used syringes out of the reach and sight of children.
Croatian: • Držite upotrijebljene štrcaljke izvan dohvata i pogleda djece.
English: 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)
Croatian: 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).
English: In postmenopausal women Prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures.
Croatian: Kod žena u postmenopauzi Prolia značajno umanjuje rizik od fraktura kralježaka, nevertebralnih fraktura te fraktura kuka.
English: 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.
Croatian: 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.
English: It is not known whether Prolia is excreted in breast milk.
Croatian: Nije poznato izlučuje li se Prolia u majčino mlijeko.
English: Major non-vertebral fracture3
Croatian: Značajna nevertebralna fraktura3
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 60 mg of denosumab in 1 mL of solution (60 mg/mL).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena štrcaljka sadrži 60 mg denosumaba u 1 ml otopine (60 mg/ml).
English: • fever, vomiting and abdominal pain or discomfort (diverticulitis),
Croatian: • vrućica, povraćanje i bol u trbuhu te nelagoda u trbuhu (divertikulitis),
English: 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).
Croatian: 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).
English: Constipation Abdominal discomfort
Croatian: Konstipacija Nelagoda u abdomenu
English: In women with baseline femoral neck BMD ≤ -2.5, Prolia reduced the risk of non-vertebral fracture (35% relative risk reduction, 4.1% absolute risk reduction, p < 0.001, exploratory analysis).
Croatian: 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).
English: • The grey needle cap is missing or not securely attached.
Croatian: • Ukoliko nema sivog zatvarača za iglu ili nije dobro pričvršćen.
English: 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.
Croatian: 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).
English: You should also take calcium and vitamin D supplements while being on treatment with Prolia.
Croatian: Dok ste na terapiji lijekom Prolia također biste trebali uzimati dodatke kalcija i vitamina D.
English: Ear infection
Croatian: Infekcija uha
English: On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies.
Croatian: Položite novu napunjenu štrcaljku i ostali pribor na čistu i dobro osvijetljenu radnu površinu.
English: Next injection Prolia 60 mg injection denosumab SC
Croatian: Sljedeća injekcija Prolia 60 mg injekcija denosumab s.c.
English: It must be a clear, colourless to slightly yellow solution.
Croatian: Mora biti bistra, bezbojna do žućkasta tekućina.
English: 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.
Croatian: 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.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 mL pre-filled syringe containing 60 mg of denosumab (60 mg/mL).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Napunjena štrcaljka od 1 ml sadrži 60 mg denosumaba (60 mg/ml).
English: 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).
Croatian: 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.
English: • constipation,
Croatian: • zatvor,
English: Adequate intake of calcium and vitamin D is important in patients with severe renal impairment or receiving dialysis (see section 4.4).
Croatian: D je važan za bolesnike s teškim oštećenjem funkcije bubrega ili za bolesnike koji su na dijalizi (vidjeti dio 4.4).
English: NAME OF THE MEDICINAL PRODUCT Prolia 60 mg solution for injection in pre-filled syringe
Croatian: NAZIV LIJEKA Prolia 60 mg otopina za injekciju u napunjenoj štrcaljki
English: Non-vertebral fracture2
Croatian: Klinička fraktura kralježaka Nevertebralna fraktura2
English: • Before administration, the solution should be inspected.
Croatian: • Otopinu treba pregledati prije primjene.
English: Effect on hip fractures
Croatian: Učinak na frakture kuka
English: Prolia 60 mg solution for injection in pre-filled syringe denosumab
Croatian: Prolia 60 mg otopina za injekciju u napunjenoj štrcaljki denosumab
English: Fracture incidence was evaluated as a safety endpoint but efficacy in fracture prevention cannot be estimated due to high number of discontinuations and open-label design The cumulative incidence of new vertebral and non-vertebral fractures were approximately 6.8% and 13.1% respectively, in patients who remained on denosumab treatment for 10 years (n = 1,278).
Croatian: 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).
English: Unusual thigh bone fractures
Croatian: Neuobičajeni lomovi bedrene kosti
English: NAME OF THE MEDICINAL PRODUCT Prolia 60 mg injection denosumab
Croatian: NAZIV LIJEKA Prolia 60 mg injekcija denosumab
English: You may have low levels of calcium in your blood while receiving Prolia.
Croatian: Tijekom liječenja lijekom Prolia možete imati niske razine kalcija u krvi.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Prolia 60 mg denosumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Prolia 60 mg denosumab s.c.
English: This section contains information on how to use the Prolia pre-filled syringe.
Croatian: Upute za injiciranje s Prolia napunjenom štrcaljkom Ovaj dio sadrži informacije o tome kako koristiti Prolia napunjenu štrcaljku.
English: 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).
Croatian: 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).
English: • skin condition with itching, redness and/or dryness (eczema),
Croatian: • promjene na koži sa svrbežom, crvenilom i/ili suhoćom (ekcem),
English: Osteonecrosis of the external auditory canal2
Croatian: Atipične frakture femura1 Osteonekroza vanjskog slušnog kanala2
English: • Keep the pre-filled syringe out of the sight and reach of children.
Croatian: • Čuvajte napunjenu štrcaljku izvan pogleda i dohvata djece.
English: Remove the pre-filled syringe from the refrigerator.
Croatian: Što treba učiniti prije davanje potkožne injekcije lijeka Prolia Izvadite napunjenu štrcaljku iz hladnjaka.
English: No accumulation or change in denosumab pharmacokinetics with time was observed upon subcutaneous multiple-dosing of 60 mg once every 6 months.
Croatian: Nakon višekratnog supkutanog doziranja od 60 mg jednom svakih 6 mjeseci tijekom vremena nije zabilježeno nakupljanje ili promjena farmakokinetike denosumaba.
English: Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the tray.
Croatian: Uhvatite napunjenu štrcaljku za sigurnosni štitnik kako biste je izvadili iz podloge.
English: 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).
Croatian: 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).
English: How to use Prolia
Croatian: Kako primjenjivati lijek Prolia
English: Step 4: Finish A Discard the used pre-filled syringe and other supplies in a sharps disposal container.
Croatian: Odložite iskorištenu napunjenu štrcaljku i ostali pribor u spremnik za odlaganje oštrih predmeta.
English: Adverse reactions reported in patients with osteoporosis and breast or prostate cancer patients receiving hormone ablation
Croatian: 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
English: DO NOT shake the pre-filled syringe.
Croatian: NE tresite napunjenu štrcaljku.
English: 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.
Croatian: 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.
English: Most of the fractures occurred in the GC-C subpopulation.
Croatian: Većina fraktura pojavila se u subpopulaciji bolesnika koji nastavljaju liječenje glukokortikoidima.
English: 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.
Croatian: 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).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Prolia 60 mg injection denosumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Prolia 60 mg injekcija denosumab s.c.
English: Read all instructions thoroughly before using the pre-filled syringe.
Croatian: Prije nego što počnete Prije korištenja napunjene štrcaljke detaljno pročitajte sve upute.
English: 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).
Croatian: 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).
English: Osteonecrosis of the jaw
Croatian: Osteonekroza čeljusti (ONČ)
English: Patients received calcium (at least 1,000 mg) and vitamin D (at least 800 IU) supplementation daily.
Croatian: Bolesnici su dnevno primali dodatke kalcija (barem 1000 mg) i vitamina D (barem 800 IU).
English: Osteonecrosis of the Jaw (ONJ) ONJ has been reported rarely in patients receiving Prolia for osteoporosis (see section 4.8).
Croatian: ONČ je zabilježena u rijetkim slučajevima u bolesnika koji su primali lijek Prolia za liječenje osteoporoze (vidjeti dio 4.8).
English: Ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Prije uzimanja bilo kojeg lijeka, pitajte liječnika ili ljekarnika za savjet.
English: Finger grips Syringe label Syringe barrel
Croatian: Naljepnica na štrcaljki Spremnik štrcaljke Sigurnosni štitnik štrcaljke
English: GENERAL CLASSIFICATION FOR SUPPLY
Croatian: Kategorija učestalosti
English: Prolia is not recommended for use if you are pregnant.
Croatian: Ne preporuča se korištenje lijeka Prolia u trudnoći.
English: All men received calcium (at least 1,000 mg) and vitamin D (at least 800 IU) supplementation daily.
Croatian: Svi muškarci su svakodnevno primali dodatke kalcija (barem 1000 mg) i vitamina D (barem 800 IU).
English: Belly
Croatian: Išijas
English: Adequate intake of calcium and vitamin D is important in all patients.
Croatian: D važan je u svih bolesnika.
English: Calcium levels were transiently decreased and parathyroid hormone levels transiently increased in ovariectomised monkeys treated with denosumab.
Croatian: U majmuna s ovariektomijom koji su tretirani denosumabom zabilježeno je prolazno smanjenje razina kalcija i prolazno povišenje razina paratiroidnog hormona.
English: All men received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily.
Croatian: Svi muškarci svakodnevno su primali dodatke kalcija (barem 1000 mg) i vitamina D (barem 400 IU).
English: What to do before you give a subcutaneous injection of Prolia
Croatian: Što morate znati prije nego počnete primjenjivati lijek Prolia Kako primjenjivati lijek Prolia Moguće nuspojave
English: Women received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily.
Croatian: Žene su dnevno primale dodatke kalcija (barem 1000 mg) i vitamina D (barem 400 IU).
English: All women received calcium (at least 1,000 mg) and vitamin D (at least 400 IU) supplementation daily.
Croatian: Sve žene su svakodnevno primale dodatke kalcija (barem 1 000 mg) i vitamina D (barem 400 IU).
English: 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.
Croatian: Slične frakture zabilježene u kombinaciji s bisfosfonatima često su bile obostrane.
English: 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).
Croatian: 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%
English: Water for injections * Acetate buffer is formed by mixing acetic acid with sodium hydroxide
Croatian: 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
English: Rarely unusual fractures of the thigh bone may occur in patients receiving Prolia.
Croatian: Rijetko, u bolesnika koji primaju lijek Prolia mogu se pojaviti neuobičajeni lomovi bedrene kosti.
English: Member State EU/EEA
Croatian: Država članica EU/EEZ
English: 1 hour 1 hour
Croatian: 1 sat 1 sat
English: In particular its activity has been demonstrated against the following micro-organism:
Croatian: Naročito je njegova aktivnost dokazana protiv sljedećih mikroorganizama:
English: If no improvement is noted within 48 hours, the diagnosis should be confirmed.
Croatian: Ako nema poboljšanja nakon 48 sati, potrebno je potvrditi dijagnozu.
English: Absorption: Several studies have been conducted.
Croatian: Apsorpcija: Provedeno je nekoliko ispitivanja.
English: It is believed to affect protein synthesis.
Croatian: Vjeruje se da utječe na sintezu proteina.
English: • Avoid contact with skin and eyes.
Croatian: • Izbjegavajte kontakt s kožom i očima.
English: The treatment appears to be intended to be preventive, which is not in line with the principles of prudent use of antibiotics.
Croatian: Čini se kako je namjera liječenja prevencija, što nije u skladu s načelima oprezne uporabe antibiotika.
English: 8 hours 8 hours
Croatian: 8 sati 8 sati
English: 1000 Brussel
Croatian: 1000 Brussel BELGIJA
English: • Withdrawal period.
Croatian: • Razdoblje povlačenja.
English: Once broached use within 28 days.
Croatian: Nakon što se otvori, upotrijebiti u roku od 28 dana.
English: 4600 Wels AUSTRIA
Croatian: 4600 Wels AUSTRIJA