FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between Zometa therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Croatian: Na temelju pregleda slučajeva iz kliničkih ispitivanja i nakon stavljanja lijeka u promet postoji dovoljno dokaza o povezanosti između liječenja Zometom, zabilježenih događaja hipokalcemije i razvoja srčane aritmije kao njene posljedice.
English: Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change.
Croatian: Zoledronatna kiselina djeluje tako da se spaja na kost i usporava brzinu pregradnje kosti.
English: Blurred vision, scleritis and orbital inflammation
Croatian: Zamagljen vid, skleritis i upala orbite
English: Zometa 4 mg/100 ml solution for infusion contains 4 mg zoledronic acid in 100 ml of infusion solution for immediate use in patients with normal renal function.
Croatian: Zometa 4 mg/100 ml otopina za infuziju sadrži 4 mg zoledronatne kiseline u 100 ml otopine za infuziju za neposrednu primjenu u bolesnika s normalnom funkcijom bubrega.
English: Zometa must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Croatian: Zometu smiju davati samo zdravstveni djelatnici iskusni u davanju bisfosfonata intravenskim putem, tj. u venu.
English: In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Croatian: U randomiziranom, dvostruko slijepom, kontroliranom ispitivanju u trajanju od 3 godine u kojem se ocjenjivala djelotvornost i sigurnost zoledronatne kiseline u dozi od 5 mg jedanput godišnje u usporedbi s placebom u liječenju postmenopauzalne osteoporoze (PMO), ukupna incidencija fibrilacije atrija iznosila je 2,5% (96 od 3862) u bolesnica koje su primale zoledronatnu kiselinu u dozi od 5 mg i 1,9% (75 od 3852) u onih koje su primale placebo.
English: Zometa is supplied as a unit pack containing one bottle or as multipacks comprising 4 or 5 cartons, each containing 1 bottle.
Croatian: Zometa se isporučuje kao jedinično pakiranje koje sadrži jednu bocu ili kao višestruko pakiranje koje sadrži 4 ili 5 kutija, od kojih svaka sadrži 1 bocu.
English: Zometa 4 mg/100 ml solution for infusion must not be mixed with other infusion solutions and should be administered as a single intravenous solution in a separate infusion line.
Croatian: Zometa 4 mg/100 ml otopina za infuziju ne smije se miješati s drugim otopinama za infuziju i treba se primijeniti kao jednokratna intravenska otopina kroz posebnu infuzijsku liniju.
English: One vial with 5 ml concentrate for solution for infusion Component of a multipack comprising ten packs, each containing one vial
Croatian: Jedna bočica s 5 ml koncentrata za otopinu za infuziju Sastavni dio višestrukog pakiranja koje se sastoji od deset pakiranja, od kojih svako sadrži po jednu bočicu
English: Caution is advised when Zometa is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Croatian: Savjetuje se oprez kada se Zometa primjenjuje s antiangiogenim lijekovima, budući da je uočeno povećanje incidencije osteonekroze čeljusti u bolesnika koji se istodobno liječe tim lijekovima.
English: Vial: 5-ml plastic vial made of clear, colourless cycloolefine copolymer with fluoropolymer-coated bromobutyl rubber stopper and aluminium cap with plastic flip-off component.
Croatian: Bočica: plastična bočica od 5 ml izrađena od prozirnog, bezbojnog cikloolefinskog kopolimera s bromobutilnim gumenim čepom obloženim fluoropolimerom i aluminijskom kapicom s plastičnim „flip-off“ dijelom.
English: In a pooled analysis of safety data from Zometa registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to Zometa (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
Croatian: U analizi objedinjenih podataka o sigurnosti primjene Zomete iz registracijskih ispitivanja za sprječavanje koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti, sumnjalo se da je učestalost štetnih događaja oštećenja funkcije bubrega povezana sa Zometom (nuspojava) na sljedeći način: multipli mijelom (3,2%), karcinom prostate (3,1%), karcinom dojke (4,3%), karcinom pluća i drugi solidni tumori (3,2%).
English: High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation, abdominal pain, dry mouth.
Croatian: Visok krvni tlak, nedostatak zraka, omaglica, tjeskoba, poremećaji spavanja, promjena osjeta okusa, drhtavica, trnci ili utrnulost šaka ili stopala, proljev, zatvor, bol u trbuhu, suha usta.
English: Zometa should only be resumed when serum creatinine returns to within 10% of baseline.
Croatian: S primjenom Zomete smije se nastaviti tek kad se kreatinin u serumu vrati na vrijednosti unutar 10% početne vrijednosti.
English: Patients should be adequately supplemented with calcium and vitamin D.
Croatian: Bolesnicima je potrebno davati odgovarajuće nadomjestke kalcija i vitamina D.
English: Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Croatian: Bol u ustima, zubima i/ili čeljusti, oteklina ili ranice u ustima ili čeljusti koje ne cijele, iscjedak, utrnulost ili osjećaj težine u čeljusti, klimanje zuba.
English: The solution containing zoledronic acid must not be further diluted or mixed with other infusion solutions.
Croatian: Otopina koja sadrži zoledronatnu kiselinu ne smije se dodatno razrjeđivati niti miješati s drugim otopinama za infuziju.
English: Instructions for preparing reduced doses of Zometa
Croatian: Upute za pripremu sniženih doza Zomete
English: In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
Croatian: U kliničkim ispitivanjima provedenima u bolesnika s hiperkalcemijom izazvanom tumorom, cjelokupni sigurnosni profil bio je sličan po vrsti i težini u sve tri terapijske skupine (zoledronatna kiselina u dozi od 4 mg i 8 mg i pamidronat u dozi od 90 mg).
English: The multiple event analysis revealed a significant risk reduction of 16% in patients treated with zoledronic acid 4 mg in comparison with patients receiving pamidronate.
Croatian: Analiza višestrukih događaja pokazala je značajno smanjenje rizika za 16% u bolesnika liječenih zoledronatnom kiselinom u dozi od 4 mg u usporedbi s bolesnicima koji su primali pamidronat.
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of Zometa or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended.
Croatian: Čimbenici koji mogu povećati mogućnost propadanja funkcije bubrega uključuju dehidraciju, postojeće oštećenje funkcije bubrega, višestruke cikluse primanja Zomete ili drugih bisfosfonata, kao i istodobnu primjenu nefrotoksičnih lijekova ili kraće trajanje infuzije od trenutno preporučenog.
English: In patients with mild to moderate renal impairment, reduced Zometa doses are recommended (see section “Posology” above and section 4.4).
Croatian: U bolesnika s blagim do umjerenim oštećenjem funkcije bubrega preporučuju se snižene doze Zomete (vidjeti dio “Doziranje” iznad i dio 4.4).
English: Additional information on handling of Zometa, including guidance on preparation of reduced doses, is provided in section 4.2.
Croatian: Dodatne informacije o rukovanju Zometom, uključujući upute za pripremu sniženih doza, nalaze se u dijelu 4.2.
English: In patients with mild to moderate renal impairment, reduced doses should be prepared as instructed below.
Croatian: U bolesnika s blagim do umjerenim oštećenjem funkcije bubrega, potrebno je pripremiti snižene doze prema uputama koje slijede.
English: Hypomagnesaemia, hypokalaemia
Croatian: Hipomagnezemija, hipokalemija
English: If a lower dose of Zometa is required, first withdraw the appropriate volume of the reconstituted solution (4 mg/5 ml) as indicated below and then dilute it further with 100 ml of infusion solution.
Croatian: Ako je potrebna niža doza Zomete, prvo izvucite odgovarajući volumen rekonstruirane otopine (4 mg/5 ml), kako je navedeno niže, i potom ga dodatno razrijedite sa 100 ml otopine za infuziju.
English: EU/1/01/176/001 1 vial and 1 ampoule EU/1/01/176/002 4 vials and 4 ampoules
Croatian: EU/1/01/176/001 1 bočica i 1 ampula EU/1/01/176/002 4 bočice i 4 ampule
English: It also contains mannitol and sodium citrate.
Croatian: Također sadrži manitol i natrijev citrat.
English: Additional information on handling of Zometa, including guidance on the preparation of reduced doses using the Zometa ready-to-use bottle, is provided in section 4.2.
Croatian: Dodatne informacije o rukovanju Zometom, uključujući upute za pripremu sniženih doza korištenjem boce Zomete spremne za uporabu, nalaze se u dijelu 4.2.
English: In the zoledronic acid-treated group, statistically significant improvement in pain scores (using the Brief Pain Inventory, BPI) was seen at 4 weeks and at every subsequent time point during the study, when compared to placebo (Figure 1).
Croatian: Brief Pain Inventory - BPI) nakon 4 tjedna i pri svakom sljedećem mjerenju tijekom ispitivanja u usporedbi s placebom (Slika 1).
English: Day 10
Croatian: Dan 10
English: To prepare an infusion solution containing 4 mg zoledronic acid, add 5 ml of water for injections from the ampoule supplied in the pack to the vial containing the Zometa powder under aseptic conditions.
Croatian: Za pripremu otopine za infuziju koja sadrži 4 mg zoledronatne kiseline, u aseptičkim uvjetima dodati 5 ml vode za injekcije iz ampule koja se nalazi u pakiranju u bočicu koja sadrži Zometa prašak.
English: For storage conditions of the reconstituted solution for infusion, see section 6.3.
Croatian: Uvjete čuvanja rekonstituirane otopine za infuziju vidjeti u dijelu 6.3.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Croatian: Za upute o rekonstituciji i razrjeđivanju lijeka prije primjene vidjeti dio 6.6.
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of Zometa and other bisphosphonates as well as use of other nephrotoxic medicinal products.
Croatian: Čimbenici koji mogu povećati mogućnost pogoršanja funkcije bubrega uključuju dehidraciju, postojeće oštećenje funkcije bubrega, višestruke cikluse liječenja Zometom i drugim bisfosfonatima, kao i uzimanje drugih nefrotoksičnih lijekova.
English: It is given as a single 15-minute intravenous infusion in a separate infusion line.
Croatian: Otopina se daje kao jednokratna 15-minutna intravenska infuzija kroz zasebnu infuzijsku liniju.
English: Adjusted dose (mg zoledronic acid in 100 ml)
Croatian: Prilagođena doza (mg zoledronatne kiseline u 100 ml)
English: Skin reactions (redness and swelling) at the infusion site, rash, itching.
Croatian: Kožne reakcije (crvenilo i oticanje) na mjestu primjene infuzije, osip, svrbež.
English: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Croatian: Astenija, periferni edem, reakcija na mjestu primjene injekcije (uključujući bol, nadraženost, oteklinu, otvrdnuće), bol u prsištu, povećanje tjelesne težine, anafilaktička reakcija/šok, urtikarija
English: The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Croatian: Prvo randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje uspoređivalo je zoledronatnu kiselinu u dozi od 4 mg s placebom u sprječavanju koštanih događaja u bolesnika s karcinomom prostate.
English: Zometa 4 mg powder and solvent for solution for infusion, reconstituted and further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Croatian: Zometa 4 mg prašak i otapalo za otopinu za infuziju, rekonstituiran i dodatno razrijeđen u 100 ml (vidjeti dio 6.6), potrebno je dati kao jednokratnu intravensku infuziju u trajanju od najmanje 15 minuta.
English: The frequencies for each of these identified risks are shown in Table 2.
Croatian: Učestalost svakog pojedinog utvrđenog rizika navedeni su u Tablici 2.
English: In clinical trials 69 patients who relapsed or were refractory to initial treatment (zoledronic acid 4 mg, 8 mg or pamidronate 90 mg) were retreated with 8 mg zoledronic acid.
Croatian: U kliničkim je ispitivanjima 69 bolesnika s relapsom ili bolešću otpornom na početno liječenje (zoledronatna kiselina u dozi od 4 mg, 8 mg ili pamidronat u dozi od 90 mg) bilo liječeno zoledronatnom kiselinom u dozi od 8 mg.
English: Unit packs containing 1 or 4 vials and 1 or 4 ampoules of water for injections, respectively.
Croatian: Jedinična pakiranja sadrže 1 ili 4 bočice, i 1 ili 4 ampule vode za injekcije.
English: Pam 90 mg zoledronic acid 4 mg
Croatian: Pam 90 mg zoledronatna kiselina 4 mg
English: The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Croatian: Stopa fibrilacije atrija kao ozbiljnog štetnog događaja bila je 1,3% (51 od 3862) bolesnica koje su primale zoledronatnu kiselinu u dozi od 5 mg i 0,6% (22 od 3852) bolesnica koje su primale placebo.
English: Date of first authorisation: 24.03.2003 Date of latest renewal: 20.03.2006
Croatian: Datum prvog odobrenja: 24.03.2003.
English: Table 1 Preparation of reduced doses of Zometa 4 mg/100 ml solution for infusion
Croatian: Tablica 1 Priprema sniženih doza Zometa 4 mg/100 ml otopine za infuziju
English: The powder must first be reconstituted in the vial using 5 ml water for injections from the ampoule supplied.
Croatian: Prašak se prvo mora rekonstituirati u bočici s 5 ml vode za injekcije iz priložene ampule.
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following Zometa dose is recommended (see also section 4.4):
Croatian: U bolesnika s metastazama u kostima koji prije početka liječenja imaju blago do umjereno oštećenje funkcije bubrega, koje se u ove populacije definira kao CLcr od 30 do 60 ml/min, preporučuje se sljedeća doza Zomete (vidjeti također dio 4.4):
English: Patients with TIH and evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with Zometa outweighs the possible risk.
Croatian: Bolesnike s hiperkalcemijom izazvanom tumorom i dokazanim pogoršanjem funkcije bubrega treba procijeniti na odgovarajući način i pritom razmotriti jesu li moguće koristi od liječenja Zometom veće od mogućih rizika.
English: Table 7 Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta
Croatian: Tablica 7 Nuspojave primijećene u pedijatrijskih bolesnika s teškim oblikom osteogenesis imperfecta
English: FOLDING BOX - INTERMEDIATE CONTAINER OF MULTIPACK (WITHOUT BLUE BOX)
Croatian: KUTIJA - SPREMNIK MEĐUPAKIRANJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: Table 6 Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta
Croatian: Tablica 6 Nuspojave primijećene u pedijatrijskih bolesnika s teškim oblikom osteogenesis imperfecta
English: This medicinal product must not be allowed to come into contact with any calcium-containing solutions and it must not be mixed or given intravenously with any other medicinal product in the same infusion line.
Croatian: Lijek ne smije doći u dodir s otopinama koje sadrže kalcij i ne smije se miješati ni davati intravenski ni s jednim drugim lijekom kroz istu infuzijsku liniju.
English: If your level of calcium falls too low, you may have to be given supplemental calcium by infusion.
Croatian: Ako Vam razina kalcija padne na prenisku vrijednost, možda ćete infuzijom primiti nadomjestak kalcija.
English: Sleepiness.
Croatian: Pospanost.
English: The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75  33% of the creatinine clearance, which showed a mean of 84  29 ml/min (range 22 to 143 ml/min) in the 64 cancer patients studied.
Croatian: Bubrežni klirens zoledronatne kiseline korelirao je s klirensom kreatinina, s time da je bubrežni klirens predstavljao 75±33% klirensa kreatinina, koji je prosječno iznosio 84±29 ml/min (raspon od 22 do 143 ml/min) u 64 uključena onkološka bolesnika.
English: Flu-like symptoms including arthritis and joint swelling.
Croatian: Simptomi nalik gripi uključujući artritis i oticanje zglobova.
English: Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
Croatian: Proljev, zatvor, bol u trbuhu, dispepsija, stomatitis, suha usta
English: In a third phase III randomised, double-blind trial, zoledronic acid 4 mg or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
Croatian: U randomiziranom, dvostruko slijepom ispitivanju faze III uspoređivala su se 4 mg zoledronatne kiseline s pamidronatom u dozi od 90 mg svaka 3 do 4 tjedna u bolesnika s multiplim mijelomom ili karcinomom dojke i najmanje jednom koštanom lezijom.
English: No dose adjustment is necessary in TIH patients with serum creatinine < 400 µmol/l or < 4.5 mg/dl (see section 4.4).
Croatian: Nije potrebna prilagodba doze u bolesnika s hiperkalcemijom izazvanom tumorom i vrijednostima kreatinina u serumu <400 μmol/l ili <4,5 mg/dl (vidjeti dio 4.4).
English: Zoledronic acid 4 mg reduced the risk of SREs by 41% in a multiple event analysis (risk ratio=0.59, p=0.019) compared with placebo.
Croatian: Prema analizi višestrukih događaja, zoledronatna kiselina u dozi od 4 mg smanjila je rizik od koštanog događaja za 41% (omjer rizika=0,59, p=0,019) u usporedbi s placebom.
English: Conjunctivitis.
Croatian: Konjunktivitis.
English: As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Croatian: Kao posljedica niskih razina kalcija: nepravilni otkucaji srca (srčana artimija, uslijed hipokalcemije).
English: Zometa 4 mg concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Croatian: Zometa 4 mg koncentrat za otopinu za infuziju, dodatno razrijeđenu u 100 ml (vidjeti dio 6.6), potrebno je dati kao jednokratnu intravensku infuziju u trajanju od najmanje 15 minuta.
English: The following adverse reactions, listed in Table 1, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Croatian: Sljedeće nuspojave navedene u Tablici 1, prikupljene su iz kliničkih ispitivanja i prijava nakon stavljanja lijeka u promet, uglavnom kod kroničnog liječenja s 4 mg zoledronatne kiseline:
English: Mutagenicity and carcinogenic potential
Croatian: Mutagenost i kancerogenost
English: To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zometa concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Croatian: Da biste pripremili otopinu za infuziju koja sadrži 4 mg zoledronatne kiseline, dodatno razrijedite koncentrat Zomete (5,0 ml) sa 100 ml otopine za infuziju koja ne sadrži kalcij niti druge dvovalentne katione.
English: The following adverse reactions, listed in Table 2, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Croatian: Sljedeće nuspojave navedene u Tablici 2, prikupljene su iz kliničkih ispitivanja i prijava nakon stavljanja lijeka u promet, uglavnom kod kroničnog liječenja s 4 mg zoledronatne kiseline:
English: For intravenous use only
Croatian: Samo za primjenu u venu
English: FOLDING BOX FOR 1 VIAL AS UNIT PACK (INCLUDING BLUE BOX) FOLDING BOX FOR 4 VIALS AS UNIT PACK (INCLUDING BLUE BOX)
Croatian: KUTIJA ZA 1 BOČICU KAO JEDINIČNO PAKIRANJE (UKLJUČUJUĆI PLAVI OKVIR) KUTIJA ZA 4 BOČICE KAO JEDINIČNO PAKIRANJE (UKLJUČUJUĆI PLAVI OKVIR)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer then 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja otopine prije primjene odgovornost su korisnika i ne bi trebali biti dulji od 24 sata na temperaturi od 2°C-8°C, osim ako se razrjeđenje provelo u kontroliranim i validiranim aseptičkim uvjetima.
English: Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid (see section 4.4).
Croatian: Propadanje funkcije bubrega, koje napreduje do zatajenja bubrega i dijalize, zabilježeno je u bolesnika i nakon početne jednokratne doze zoledronatne kiseline od 4 mg (vidjeti dio 4.4).
English: In patients who show evidence of renal deterioration during treatment, Zometa should be withheld.
Croatian: U bolesnika u kojih se pojave znakovi pogoršanja funkcije bubrega tijekom liječenja treba prekinuti primjenu Zomete.
English: For patients with normal renal function (defined as CLcr > 60 ml/min), zoledronic acid 4 mg/100 ml solution for infusion may be administered directly without any further preparation.
Croatian: U bolesnika s normalnom funkcijom bubrega (definiranom kao CLcr veći od 60 ml/min) zoledronatna kiselina 4 mg/100 ml otopina za infuziju može se primijeniti izravno bez ikakvog dodatnog razrjeđivanja.
English: Clinical trial results in the prevention of skeletal related events in patients with advanced malignancies involving bone
Croatian: Rezultati kliničkih ispitivanja u sprječavanju koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti
English: Zometa 4 mg/100 ml solution for infusion should be given as a single intravenous infusion in no less than 15 minutes.
Croatian: Zometa 4 mg/100 ml otopinu za infuziju potrebno je dati kao jednokratnu intravensku infuziju u trajanju od najmanje 15 minuta.
English: Musculoskeletal pain
Croatian: Mišićno-koštani bolovi
English: Population analysis showed that for a patient with creatinine clearance of 20 ml/min (severe renal impairment), or 50 ml/min (moderate impairment), the corresponding predicted clearance of zoledronic acid would be 37% or 72%, respectively, of that of a patient showing creatinine clearance of 84 ml/min.
Croatian: Populacijska analiza pokazala je da bi odgovarajući predviđeni klirens zoledronatne kiseline kod bolesnika s klirensom kreatinina od 20 ml/min (teško oštećenje funkcije bubrega) bio 37%, a kod bolesnika s klirensom kreatinina od 50 ml/min (umjereno oštećenje) 72% onoga kakav postoji kod bolesnika s klirensom kreatinina od 84 ml/min.
English: The active substance of Zometa is zoledronic acid.
Croatian: Djelatna tvar Zometa je zoledronatna kiselina.