FrancophonIA/ELRC3.0 huggingface dataset:
English: Tetracycline label was detectable in all but one of 82 biopsies obtained from patients on zoledronic acid.
Croatian: Tetraciklinsko obilježavanje otkriveno je kod svih osim jednog od 82 uzorka uzetih biopsijom od bolesnica na zoledronatnoj kiselini.
English: After 6 months, zoledronic acid showed 96% (169/176) and 89% (156/176) response and serum alkaline phosphatase (SAP) normalisation rates compared to 74% (127/171) and 58% (99/171) for risedronate (all p<0.001).
Croatian: Nakon 6 mjeseci pri primjeni zoledronatne kiseline zabilježen je odgovor od 96% (169/176) te normalizacija razina alkalne fosfataze u serumu od 89% (156/176) u usporedbi sa 74% (127/171), odnosno 58% (99/171) pri primjeni risedronata (sve p<0,001).
English: Efficacy was demonstrated if non-inferiority to risedronate was shown sequentially with respect to the percentage change in lumbar spine BMD at 12 months relative to baseline in the treatment and prevention subpopulations, respectively.
Croatian: Djelotvornost je bila postignuta ako sekvencijski nije ustanovljena inferiornost u odnosu na risedronat s obzirom na postotak promjene BMD-a lumbalne kralježnice nakon 12 mjeseci u odnosu na početne vrijednosti u liječenju i u odnosu na prevenciju u subpopulacijama.
English: Adverse reactions, such as dizziness, may affect the ability to drive or use machines, though no studies on this effect with zoledronic acid have been performed.
Croatian: Nuspojave, kao što je omaglica, mogu utjecati na sposobnost upravljanja vozilima i rada na strojevima, premda nisu provedena ispitivanja ovog učinka sa zoledronatnom kiselinom.
English: It belongs to a group of medicines called bisphosphonates and is used to treat post-menopausal women and adult men with osteoporosis or osteoporosis caused by treatment with steroids, and Paget's disease of the bone in adults.
Croatian: Pripada skupini lijekova koji se nazivaju bisfosfonati i koristi se za liječenje žena u postmenopauzi i odraslih muškaraca s osteoporozom ili za liječenje osteoporoze izazvane liječenjem steroidima te za liječenje
English: Zoledronic acid demonstrated a consistent effect over 3 years, resulting in a 41% reduction in the risk of hip fractures (95% CI, 17% to 58%).
Croatian: Zoledronatna kiselina pokazala je konzistentne učinke tijekom 3 godine, što je dovelo do smanjenja rizika od prijeloma kuka za 41% (95% CI, 17% do 58%).
English: 85% of patients were bisphosphonate-naïve.
Croatian: 85% bolesnica do tada nije primalo bisfosfonate.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Croatian: Farmakoterapijska skupina: lijekovi za liječenje bolesti kostiju, bisfosfonati, ATK oznaka: M05BA08 Mehanizam djelovanja
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Croatian: Nuspojave navedene u Tablici 1 poredane su po klasifikaciji organskih sustava prema MedDRA-i i po kategoriji učestalosti.
English: Re-treatment of Paget's disease: After initial treatment with zoledronic acid in Paget's disease an extended remission period is observed in responding patients.
Croatian: Ponovno liječenje Pagetove bolesti: nakon početnog liječenja Pagetove bolesti zoledronatnom kiselinom zapaženo je produljeno razdoblje remisije u bolesnika koji su odgovorili na liječenje.
English: • in adult men at increased risk of fracture, including those with a recent low-trauma hip fracture.
Croatian: • u žena u postmenopauzi • u odraslih muškaraca s povećanim rizikom od prijeloma, uključujući one koji su nedavno imali prijelom kuka nakon slabe traume.
English: Teva Santé Tél: +33 1 55 91 7800
Croatian: Tél: +33 1 55 91 7800
English: Your doctor should do a blood test to check your kidney function before each dose of Zoledronic acid Teva Generics.
Croatian: Liječnik Vam mora napraviti krvnu pretragu kako bi Vam provjerio bubrežnu funkciju prije svake doze Zoledronatne kiseline Teva Generics.
English: In another study in men (study CZOL446M2308) an annual infusion of zoledronic acid was non-inferior to weekly alendronate for the percentage change in lumbar spine BMD at month 24 relative to baseline.
Croatian: U drugom ispitivanju u muškaraca (ispitivanje CZOL446M2308) godišnja infuzija zoledronatne kiseline nije bila lošija od tjedne primjena alendronata s obzirom na postotak promjene BMD-a lumbalne kralježnice nakon 24 mjeseca u odnosu na početne vrijednosti.
English: Of the 153 zoledronic acid-treated patients and 115 risedronate-treated patients who entered an extended observation study, after a mean duration of follow-up of 3.8 years from time of dosing, the proportion of patients ending the Extended Observation Period due to the need for re-treatment (clinical judgment) was higher for risedronate (48 patients, or 41.7%) compared with zoledronic acid (11 patients, or 7.2%).
Croatian: Od 153 bolesnika liječenih zoledronatnom kiselinom i 115 bolesnika liječenih risedronatom, koji su ušli u produljenu studiju praćenja, nakon srednjeg trajanja praćenja od 3,8 godina, računato od vremena doziranja, udio bolesnika koji su završili produljeno razdoblje praćenja zbog potrebe za ponovnim liječenjem (klinička procjena) bio je viši u skupini koja je primala risedronat (48 bolesnika, odnosno 41,7%) nego u onoj koja je primala zoledronatnu kiselinu (11 bolesnika, odnosno 7,2%).
English: For osteoporosis, Zoledronic acid Teva Generics works for one year.
Croatian: U slučaju osteoporoze, Zoledronatna kiselina Teva Generics djeluje tijekom godine dana.
English: In a large clinical trial, local reactions at the infusion site, such as redness, swelling and/or pain, were reported (0.7%) following the administration of zoledronic acid.
Croatian: U velikom kliničkom ispitivanju zabilježene su (0,7%) lokalne reakcije na mjestu infuzije, kao što su crvenilo, oticanje i/ili bol nakon primjene zoledronatne kiseline.
English: België/Belgique/Belgien Teva Pharma Belgium N.V. Tel/Tél: +32 3 820 73 73
Croatian: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73
English: The pack sizes of 5 and 10 bottles are only available in multipacks.
Croatian: Pakiranja sa 5 i 10 bočica dostupna su samo kao višestruka pakiranja
English: In both women and men, Zoledronic acid Teva Generics strengthens the bone and therefore makes it less likely to break.
Croatian: I u žena i u muškaraca Zoledronatna kiselina Teva Generics jača kost i na taj način smanjuje vjerojatnost posljedičnog prijeloma.
English: In the Paget's disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all of whom it resolved.
Croatian: U kliničkim ispitivanjima Pagetove bolesti u otprilike 1% bolesnika opažena je simptomatska hipokalcijemija, koja se kod svih povukla.
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known
Croatian: Kategorije učestalosti određene su na sljedeći način: vrlo često (≥1/10) često (≥1/100 do <1/10) manje često (≥1/1000 do <1/100) rijetko (≥1/10 000 do <1/1000) vrlo rijetko
English: In the three-year osteoporosis study standing height was measured annually using a stadiometer.
Croatian: U trogodišnjem ispitivanju osteoporoze, jednom na godinu mjerena je visina u stojećem položaju uz pomoć stadiometra.
English: Zoledronic acid Teva Generics must not be mixed or given intravenously with any other medicinal product and must be given through a separate vented infusion line at a constant infusion rate.
Croatian: Zoledronatna kiselina Teva Generics ne smije se miješati niti primjenjivati intravenski s drugim lijekovima te se mora dati putem zasebne infuzijske cjevčice s odzračivanjem uz konstantnu brzinu infuzije.
English: Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy
Croatian: Liječenje osteoporoze povezane s dugotrajnim liječenjem sistemskim glukokortikoidima
English: Zoledronic acid Teva Generics is supplied in packs of 1, 5 or 10 bottles.
Croatian: Zoledronatna kiselina Teva Generics dostupna je u pakiranjima sa 1, 5 ili 10 bočica.
English: In patients with renal impairment, the systemic exposure to concomitant medicinal products that are primarily excreted via the kidney may increase.
Croatian: U bolesnika s oštećenjem bubrega, može se povećati sistemska izloženost istovremeno primijenjenim lijekovima koji se primarno izlučuju putem bubrega.
English: In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between zoledronic acid (2.6%) and placebo (2.1%).
Croatian: U ispitivanjima osteoporoze (PFT, HORIZON - Recurrent Fracture Trial [RFT]) ukupna incidencija fibrilacije atrija bila je usporediva kod zoledronatne kiseline (2,6%) i placeba (2,1%).
English: Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound drugs are therefore unlikely.
Croatian: Zoledronatna kiselina se ne veže u velikoj mjeri na proteine plazme (veže se otprilike 43-55%) pa zbog toga interakcije nastale istiskivanjem lijekova koji se u velikoj mjeri vežu za proteine nisu vjerojatne.
English: All patients received adequate supplementation with vitamin D and calcium in the post-menopausal osteoporosis trial, the prevention of clinical fractures after hip fracture trial, and the Paget's disease trials (see also section 4.2).
Croatian: Svi su bolesnici primili odgovarajući dodatak vitamina D i kalcija u ispitivanju osteoporoze u postmenopauzi, prevenciji kliničkih prijeloma nakon ispitivanja prijeloma kuka te ispitivanjima Pagetove bolesti (vidjeti također dio 4.2).
English: • A single dose of zoledronic acid should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2).
Croatian: • Jednokratna doza zoledronatne kiseline ne smije biti veća od 5 mg, a trajanje infuzije treba biti najmanje 15 minuta (vidjeti dio 4.2).
English: Concomitant osteoporosis therapy included: calcitonin, raloxifene, tamoxifen, hormone replacement therapy, tibolone; but excluded other bisphosphonates.
Croatian: Istodobna terapija osteoporoze uključivala je: kalcitonin, raloksifen, tamoksifen, hormonsko nadomjesno liječenje i tibolon, međutim, isključeni su ostali bisfosfonati.
English: How to store Zoledronic acid Teva Generics Contents of the pack and other information
Croatian: Kako čuvati Zoledronatnu kiselinu Teva Generics Sadržaj pakiranja i druge informacije
English: Zoledronic acid Teva Generics may also cause other side effects Very common (may affect more than 1 in 10 people) Fever
Croatian: Zoledronatna kiselina Teva Generics može uzrokovati i druge nuspojave Vrlo često (mogu se javiti u više od 1 na 10 osoba)
English: These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture.
Croatian: Ti prijelomi nastaju nakon minimalne traume ili bez nje, a neki bolesnici osjete bol u bedru ili preponi, često praćenu radiološkim prikazom stres prijeloma i to tjednima, odnosno mjesecima prije potpunog prijeloma bedrene kosti.
English: Solution for infusion multipack: 5 bags x 100 ml multipack: 10 bags x 100 ml
Croatian: Višestruko pakovanje: 5 bočica x 100 ml Višestruko pakovanje: 10 bočica x 100 ml
English: Before you receive dental treatment or undergo dental surgery, tell your dentist you are receiving treatment with Zoledronic acid Teva Generics.
Croatian: Prije nego što započnete liječenje kod zubara ili ako idete na stomatološki kirurški zahvat, obavijestite svog zubara da se liječite Zoledronatnom kiselinom Teva
English: - Do not use this medicine if you notice any discolouration or particles in the solution.
Croatian: - Ovaj lijek se ne smije upotrijebiti ako primijetite promjenu boje otopine ili čestice u otopini.
English: Clinical efficacy in the treatment of osteoporosis in patients at increased risk of fracture after a recent hip fracture (RFT)
Croatian: Klinička djelotvornost u liječenju osteoporoze u bolesnika s povećanim rizikom za prijelom nakon nedavnog prijeloma kuka
English: Ask your doctor, pharmacist or nurse for advice before taking this medicine.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri za savjet prije nego što uzmete ovaj lijek.
English: The incidence of post-dose symptoms occuring within the first three days after administration of zoledronic acid can be reduced with the administration of paracetamol or ibuprofen shortly following zoledronic acid administration.
Croatian: Incidencija simptoma nakon doze koji se javljaju u roku od prva tri dana nakon primjene zoledronatne kiseline može se smanjiti primjenom paracetamola ili ibuprofena ubrzo nakon primjene zoledronatne kiseline.
English: Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/l) occurred in 2.3% of zoledronic acid-treated patients in a large clinical trial compared to 21% of zoledronic acid-treated patients in the Paget's disease trials.
Croatian: Na osnovi laboratorijske procjene prolazne asimptomatske razine kalcija ispod normalnog referentnog raspona (manje od 2,10 mmol/l) zabilježene su u 2,3% bolesnika liječenih zoledronatnom kiselinom u velikom kliničkom ispitivanju u usporedbi sa 21% bolesnika liječenih zoledronatnom kiselinom u kliničkim ispitivanjima Pagetove bolesti.
English: Hypocalcaemia
Croatian: Hipokalcijemija
English: The incidence of these reactions decreased markedly with subsequent annual doses of zoledronic acid.
Croatian: Incidencija tih nuspojava značajno se smanjila sa sljedećim godišnjim dozama zoledronatne kiseline.
English: Days of disability
Croatian: Broj dana fizičke onesposobljenosti
English: Vitamin D levels were not routinely measured but a loading dose of vitamin D (50,000 to 125,000 IU orally or via the intramuscular route) was given to the majority of patients 2 weeks prior to infusion.
Croatian: D nisu se rutinski mjerile, ali većina bolesnika je primila dodatnu dozu vitamina D (50 000 do 125 000 IU peroralno ili intramuskularno) 2 tjedna prije infuzije.
English: The zoledronic acid group revealed approximately 2.5 mm less height loss compared to placebo (95% CI: 1.6 mm, 3.5 mm) [p<0.0001].
Croatian: Skupina na zoledronatnoj kiselini pokazala je otprilike 2,5 mm manji gubitak tjelesne visine u usporedbi s placebom (95% CI: 1,6 mm, 3,5 mm) [p<0,0001].
English: Zoledronic acid is not metabolised and is excreted unchanged via the kidney.
Croatian: Zoledronatna kiselina se ne metabolizira te se izlučuje nepromijenjena putem bubrega.
English: Uncommon Lethargy, paraesthesia, somnolence, tremor, syncope, dysgeusia
Croatian: Manje često Letargija, parestezija, somnolencija, tremor, sinkopa, disgeusija
English: The incidence of fractures was 8 for zoledronic acid-treated patients versus 7 for risedronate-treated patients (p=0.8055).
Croatian: Incidencija prijeloma bila je 8 bolesnika liječenih zoledronatnom kiselinom naspram 7 bolesnika liječenih risedronatom (p=0,8055).
English: Pliva Ljubljana d.o.o.
Croatian: Pliva Hrvatska d.o.o. Tel.
English: Zoledronic acid has been associated with renal impairment manifested as deterioration in renal function (i.e. increased serum creatinine) and in rare cases acute renal failure.
Croatian: Zoledronatna kiselina bila je povezana s oštećenjem funkcije bubrega koje se očitovalo kao slabljenje bubrežne funkcije (npr. povišena razina kreatinina u serumu) i u rijetkim slučajevima kao akutno zatajenje bubrega.
English: Six patients who achieved therapeutic response 6 months after treatment with zoledronic acid and later experienced disease relapse during the extended follow-up period were re-treated with zoledronic acid after a mean time of 6.5 years from initial treatment to re-treatment.
Croatian: Šest bolesnika u kojih je postignut terapijski odgovor nakon 6 mjeseci liječenja zoledronatnom kiselinom i u kojih je kasnije tijekom razdoblja praćenja zabilježen relaps, ponovo su liječeni zoledronatnom kiselinom nakon srednjeg vremena od 6,5 godina nakon početnog do ponovnog liječenja.
English: Zoledronic acid treatment rapidly reduced the rate of bone turnover from elevated post-menopausal levels with the nadir for resorption markers observed at 7 days, and for formation markers at 12 weeks.
Croatian: Liječenje zoledronatnom kiselinom dovelo je do brzog smanjenja stope pregradnje kosti s povišenih razina u postmenopauzi, pri čemu je najniža vrijednost markera resorpcije opažena 7. dana, a markera izgradnje kosti u 12. tjednu.
English: Clinical efficacy in the treatment of post-menopausal osteoporosis (PFT) The efficacy and safety of zoledronic acid 5 mg once a year for 3 consecutive years were demonstrated in post-menopausal women (7,736 women aged 65-89 years) with either: a femoral neck bone mineral density (BMD) with a T-score ≤ -1.5 and at least two mild or one moderate existing vertebral fracture(s); or a femoral neck BMD T-score ≤ -2.5 with or without evidence of existing vertebral fracture(s).
Croatian: Djelotvornost i sigurnost primjene zoledronatne kiseline u dozi od 5 mg jednom na godinu tijekom tri uzastopne godine dokazane su kod žena u postmenopauzi (7736 žena u dobi od 65 do 89 godina) s jednim od dva uvjeta: BMD T-vrijednost vrata bedrene kosti ≤ -1,5 te najmanje dva blaga ili jedan umjereno teški postojeći vertebralni prijelom; ili BMD T-vrijednost vrata bedrene kosti ≤ -2,5 sa znakovima postojećeg(ih) vertebralnog(ih) prijeloma ili bez njih.
English: • A single dose of Zoledronic acid Teva Generics should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2).
Croatian: • Jednokratna doza Zoledronatne kiseline Teva Generics ne smije biti veća od 5 mg, a trajanje infuzije treba biti najmanje 15 minuta (vidjeti dio 4.2).
English: It is unknown whether zoledronic acid is excreted into human milk.
Croatian: Nije poznato izlučuje li se zoledronatna kiselina u majčino mlijeko.
English: In clinical trials in osteoporosis, approximately 0.2% of patients had notable declines of serum calcium levels (less than 1.87 mmol/l) following zoledronic acid administration.
Croatian: Otprilike 0,2% bolesnika u kliničkom ispitivanju osteoporoze imalo je značajan pad razina kalcija u serumu (manje od 1,87 mmol/l) nakon primjene zoledronatne kiseline.
English: Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Croatian: Rijetko može doći do neuobičajenih prijeloma bedrene kosti, posebno u bolesnika na dugotrajnoj terapiji radi osteoporoze.
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: (≥1/100 do <1/10), manje često (≥1/1000 do <1/100), rijetko (≥1/10 000 do <1/1000), vrlo rijetko
English: - The other ingredients are mannitol, sodium citrate and water for injections.
Croatian: - Drugi sastojci su manitol, natrijev citrat i voda za injekcije.
English: - Severe renal impairment with creatinine clearance < 35 ml/min (see section 4.4).
Croatian: - Teško oštećenje funkcije bubrega s klirensom kreatinina < 35 ml/min (vidjeti dio 4.4).
English: You must not be given Zoledronic acid Teva Generics:
Croatian: Ne smijete primati Zoledronatnu kiselinu Teva Generics:
English: Therefore, interactions resulting from displacement of highly proteinbound drugs are unlikely.
Croatian: Zbog toga, interakcije nastale istiskivanjem lijekova koji su u velikoj mjeri vezani na proteine nisu vjerojatne.
English: In the intravenous infusion studies, renal tolerability of zoledronic acid was established in rats when given 0.6 mg/kg as 15-minute infusions at 3-day intervals, six times in total (for a cumulative dose that corresponded to AUC levels about 6 times the human therapeutic exposure) while five 15-minute infusions of 0.25 mg/kg administered at 2-3-week intervals (a cumulative dose that corresponded to 7 times the human therapeutic exposure) were well tolerated in dogs.
Croatian: U ispitivanjima s intravenskom infuzijom bubrežna podnošljivost zoledronatne kiseline utvrđena je u štakora koji su dobivali 0,6 mg/kg u obliku 15-minutne infuzije u intervalima od tri dana, ukupno šest puta (čime se dobila kumulativna doza koja je odgovarala AUC razinama koje su bile otprilike šesterostruko veće od terapijske izloženosti u ljudi), dok su psi dobro podnosili pet 15-minutnih infuzija u dozi od 0,25 mg/kg koje su primjenjivane u intervalima od 2-3 tjedna (kumulativna doza je odgovarala sedmerostrukoj terapijskoj izloženosti u ljudi).
English: Uncommon Insomnia
Croatian: Manje često Insomnija
English: Patients with hepatic impairment No dose adjustment is required (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu (vidjeti dio 5.2).
English: Zoledronic acid is contraindicated during pregnancy (see section 4.3).
Croatian: Trudnoća Zoledronatna kiselina je kontraindicirana tijekom trudnoće (vidjeti dio 4.3).
English: Zoledronic acid Teva Generics must not be allowed to come into contact with any calcium-containing solutions.
Croatian: Zoledronatna kiselina Teva Generics ne smije doći u kontakt s otopinama koje sadržavaju kalcij.
English: Small observed increases in AUC(0-24hr), by about 30% to 40% in mild to moderate renal impairment, compared to a patient with normal renal function, and lack of accumulation of drug with multiple doses irrespective of renal function, suggest that dose adjustments of zoledronic acid in mild (Clcr = 50-80 ml/min) and moderate renal impairment down to a creatinine clearance of 35 ml/min are not necessary.
Croatian: Mala zapažena povećanja AUC(024hr) vrijednosti za oko 30% do 40% u slučaju blagog do umjerenog oštećenja bubrega u usporedbi s bolesnikom s normalnom funkcijom bubrega te pomanjkanje nakupljanja lijeka pri višestrukim dozama, bez obzira na bubrežnu funkciju, navode na zaključak da nije potrebno prilagođavati dozu zoledronatne kiseline u slučaju blagog (Clcr = 50-80 ml/min) i umjerenog oštećenja bubrega s klirensom kreatinina većim od 35 ml/min.
English: Renal failure requiring dialysis or with a fatal outcome has rarely occurred in patients with underlying renal impairment or with any of the risk factors described above.
Croatian: Zatajenje bubrega koje iziskuje dijalizu ili je završilo smrću rijetko se pojavilo u bolesnika s već postojećim oštećenjem bubrega ili bilo kojim od prethodno opisanih čimbenika rizika.
English: It is supplied in multipacks containing 5 or 10 bags.
Croatian: Dostupna je u višestrukim pakovanjima sa 5 ili 10 vrećica.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in Paget's disease of the bone, osteoporosis in post-menopausal women at an increased risk of fracture, osteoporosis in men at increased risk of fracture and prevention of clinical fractures after a hip fracture in men and women (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži zoledronatnu kiselinu u svim podskupinama pedijatrijske populacije u liječenju Pagetove bolesti kosti, liječenju osteoporoze u žena u postmenopauzi s povećanim rizikom od prijeloma, liječenju osteoporoze u muškaraca s povećanim rizikom od prijeloma i prevenciji kliničkih prijeloma nakon prijeloma kuka u muškaraca i žena (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: There was a transient increase in serum creatinine observed within 10 days in 1.8% of zoledronic acid-treated patients versus 0.8% of placebo-treated patients.
Croatian: Zapaženo je prolazno povećanje kreatinina u serumu unutar 10 dana u 1,8% bolesnika liječenih zoledronatnom kiselinom te u 0,8% bolesnika koji su primali placebo.
English: Table 4 Between treatment comparisons of the incidence of key clinical fracture variables
Croatian: Tablica 4 Usporedbe incidencije ključnih varijabli kliničkog prijeloma između liječenja