FrancophonIA/ELRC3.0 huggingface dataset:
English: You must not be given Zoledronic acid Teva Generics if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Croatian: Zoledronatnu kiselinu Teva Generics ne smijete primati ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete.
English: Your doctor may advise you to take calcium and vitamin D supplements (e.g. tablets) for at least the first ten days after being given Zoledronic acid Teva Generics.
Croatian: Liječnik Vam može savjetovati da uzimate nadomjestke kalcija i vitamina D (na primjer tablete) najmanje prvih deset dana nakon primjene Zoledronatne kiseline Teva Generics.
English: Teratogenicity was observed in rats at doses ≥ 0.2 mg/kg and was manifested by external, visceral and skeletal malformations.
Croatian: Teratogenost je zapažena u štakora pri dozama od ≥ 0,2 mg/kg, a izražavala se vanjskim i visceralnim malformacijama te malformacijama skeleta.
English: - if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na zoledronatnu kiselinu, druge bisfosfonate ili na bilo koju pomoćnu tvar ovog lijeka (navedeni u dijelu 6).
English: Zoledronic acid significantly decreased the incidence of one or more new vertebral fractures over three years and as early as the one year timepoint (see Table 2).
Croatian: Zoledronatna kiselina značajno je smanjila incidenciju jednog ili više novih vertebralnih prijeloma tijekom tri godine i najranije već tijekom prve godine (vidjeti Tablicu 2).
English: The most frequent finding in the repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound's pharmacological antiresorptive activity.
Croatian: Najčešći nalaz u ispitivanjima s ponovljenim dozama bio je povećano primarno spongiozno tkivo u metafizama dugih kostiju kod životinja u razvoju i to pri gotovo svim dozama, odnosno nalaz koji je odražavao farmakološko antiresorpcijsko djelovanje kemijskog spoja.
English: In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral calcium and/or an intravenous infusion of calcium gluconate.
Croatian: U slučaju predoziranja koje dovodi do klinički značajne hipokalcijemije, obrat se može postići oralnom primjenom kalcija u obliku dodatka prehrani i/ili intravenskom infuzijom kalcijevog glukonata.
English: • Contraindication in pregnancy and in breast-feeding women
Croatian: • Kontraindikacija u trudnica i u dojilja
English: It is currently unclear whether Zoledronic acid Teva Generics causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Zoledronic acid Teva Generics.
Croatian: Trenutačno nije jasno uzrokuje li Zoledronatna kiselina Teva Generics te nepravilne otkucaje srca, ali morate se javiti liječniku ako osjetite takve simptome nakon što primite Zoledronatnu kiselinu Teva Generics.
English: Swelling and/or pain at the infusion site may occur.
Croatian: Može doći do oticanja i/ili boli na mjestu primjene infuzije.
English: Very common Fever Common
Croatian: Vrlo često Vrućica Često
English: The mean time of ending the Extended Observation Period due to the need for Paget's re-treatment from the initial dose was longer for zoledronic acid (7.7 years) than for risedronate (5.1 years).
Croatian: Srednje vrijeme završetka produljenog razdoblja praćenja zbog potrebe za ponovnim liječenjem Pagetove bolesti nakon početne doze bilo je duže u slučaju zoledronatne kiseline (7,7 godina) nego risedronata (5,1 godina).
English: Five of the 6 patients had SAP within the normal range at month 6 (Last Observation Carried Forward, LOCF).
Croatian: Pet od 6 bolesnika imalo je SAP s normalnim rasponom nakon 6 mjeseci (uz posljednje zapažanje prenijeto dalje, engl.
English: Treatment of osteoporosis
Croatian: Liječenje osteoporoze
English: For the treatment of Paget's disease, zoledronic acid should be prescribed only by physicians with experience in the treatment of Paget's disease of the bone.
Croatian: Za liječenje Pagetove bolesti, zoledronatnu kiselinu smiju propisivati samo liječnici koji imaju iskustva u liječenju Pagetove bolesti kosti.
English: It comes in a clear plastic bottle.
Croatian: Lijek je dostupan u prozirnim plastičnim bočicama.
English: Zoledronic acid Teva Generics is not recommended for anyone under 18 years of age.
Croatian: Zoledronatna kiselina Teva Generics ne preporuča se osobama mlađima od 18 godina.
English: Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
Croatian: Tijekom prvih 24 sata, 39 ± 16% od primijenjene doze nađeno je u mokraći, dok je ostatak uglavnom ostao vezan na koštano tkivo.
English: Other medicines and Zoledronic acid Teva Generics Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Zoledronatna kiselina Teva Generics Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate ili ste nedavno uzeli ili biste mogli uzeti primijeniti bilo koje druge lijekove.
English: Your doctor will advise you and decide how long you should be treated with Zoledronic acid Teva Generics.
Croatian: On će Vam dati savjet i odlučiti koliko dugo biste se trebali liječiti Zoledronatnom kiselinom Teva Generics.
English: Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
Croatian: Obratite se svom liječniku ako osjetite bol, slabost ili nelagodu u bedru, kuku ili preponama jer to mogu biti rani znakovi mogućeg prijeloma bedrene kosti.
English: The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established.
Croatian: Nisu utvrđene sigurnost i djelotvornost zoledronatne kiseline u djece i adolescenata ispod 18 godina.
English: The efficacy of one infusion of 5 mg zoledronic acid versus daily doses of 30 mg risedronate for 2 months was demonstrated in two 6-month comparative trials.
Croatian: Djelotvornost jedne infuzije od 5 mg zoledronatne kiseline u odnosu na dnevne doze od 30 mg risedronata za 2 mjeseca bila je pokazana u dva šestomjesečna usporedna ispitivanja.
English: Ninety-five percent of the patients received their infusion two or more weeks after the hip fracture repair and the median timing of infusion was approximately six weeks after the hip fracture repair.
Croatian: Devedesetpet posto bolesnika je primilo svoju infuziju dva ili više tjedana nakon oporavka prijeloma kuka, a medijan vremena infuzije bio je približno šest tjedana nakon oporavka prijeloma kuka.
English: The percentage of patients who experienced adverse reactions was lower in a smaller study (19.5%, 10.4%, 10.7% after the first, second and third infusion, respectively), where prophylaxis against adverse reactions was used.
Croatian: Postotak bolesnika koji su imali nuspojave bio je niži u manjoj studiji (19,5%, 10,4%, 10,7% nakon prve, druge, odnosno treće infuzije) kad je bila korištena profilaksa protiv nuspojava kako je opisno u daljnjem tekstu.
English: Thereafter bone markers stabilised within the pre-menopausal range.
Croatian: Nakon toga su se koštani markeri stabilizirali unutar premenopauzalnog raspona.
English: Single and multiple 5 and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients yielded the following pharmacokinetic data, which were found to be dose independent.
Croatian: Jednostruke i višestruke infuzije od 2, 4, 8 i 16 mg zoledronatne kiseline u trajanju od 5 i 15 minuta primijenjene u 64 bolesnika s koštanim metastazama dale su sljedeće farmakokinetičke podatke za koje je ustanovljeno da nisu ovisni o dozi.
English: Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Croatian: Zoledronatna kiselina se u provedenim ispitivanjima mutagenosti nije pokazala mutagenom, dok ispitivanje karcinogenosti nije dalo nikakve dokaze o karcinogenom potencijalu.
English: It is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor.
Croatian: Važno je uzimati nadomjestke kalcija i vitamina D (na primjer tablete) prema uputama liječnika.
English: Cyclic Olefin Polymer (COP) plastic bottle, fitted with a chlorobutyl/butyl rubber stopper and aluminium cap fitted with violet plastic flip off disc.
Croatian: Plastična bočica od cikloolefinskog polimera (COP) s klorobutil/butilnim gumenim čepom i aluminijskom kapicom s ljubičastim plastičnim flip off diskom.
English: Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of zoledronic acid (see section 4.8).
Croatian: Zbog brzog nastupa učinka zoledronatne kiseline na pregradnju kosti, može se razviti prolazna hipokalcijemija, koja je katkada simptomatska, a obično je najjača unutar prvih 10 dana nakon infuzije zoledronatne kiseline (vidjeti dio 4.8).
English: Zoledronic acid Teva Generics works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
Croatian: Zoledronatna kiselina Teva Generics djeluje tako što vraća proces preoblikovanja kosti u normalu osiguravajući stvaranje normalne kosti, čime kosti postaju snažnije.
English: The majority of the side effects, such as fever and chills, pain in the muscles or joints, and headache, occur within the first three days following the dose of Zoledronic acid Teva Generics.
Croatian: Većina nuspojava, poput vrućice i zimice, bolova u mišićima ili zglobovima te glavobolje, javlja se unutar prva tri dana nakon primjene doze Zoledronatne kiseline
English: Effect on morphometric vertebral fractures
Croatian: Učinak na morfometrijske vertebralne prijelome
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek treba odmah primijeniti.
English: The medicinal product must not be mixed or given intravenously with any other medicinal products.
Croatian: Ovaj lijek ne smije se miješati ili primjenjivati intravenski s drugim lijekovima.
English: It is prudent to avoid dental surgery as recovery may be prolonged (see section 4.4).
Croatian: Razborito je izbjegavati stomatološke operacije jer bi oporavak mogao biti produljen (vidjeti dio 4.4).
English: The following precautions should be taken into account to minimise the risk of renal adverse reactions:
Croatian: Sljedeće mjere opreza treba uzeti u obzir kako bi se smanjio rizik za bubrežne nuspojave:
English: The long duration of action of zoledronic acid is attributable to its high binding affinity for the active site of farnesyl pyrophosphate (FPP) synthase and its strong binding affinity to bone mineral.
Croatian: Dugo trajanje učinka zoledronatne kiseline pripisuje se njenom visokom afinitetu vezanja na aktivno mjesto farnezil pirofosfat (FPP) sintaze i njenom afinitetu snažnog vezanja na mineral kosti.
English: Other products containing zoledronic acid as active substances are available for oncology indications.
Croatian: Ostali lijekovi koji sadrže zoledronatnu kiselinu kao djelatnu tvar dostupni su za onkološke indikacije.
English: The infusion time must not be less than 15 minutes.
Croatian: Trajanje infuzije ne smije biti kraće od 15 minuta.
English: In a large clinical trial in 7,736 patients, osteonecrosis of the jaw has been reported in one patient treated with zoledronic acid and one patient treated with placebo.
Croatian: U velikom kliničkom ispitivanju sa 7736 bolesnika, osteonekroza čeljusti zabilježena je u jednog bolesnika liječenog zoledronatnom kiselinom i u jednog bolesnika koji je primao placebo.
English: Summary of vertebral fracture efficacy at 12, 24 and 36 months
Croatian: Tablica 2 Sažetak djelotvornosti s obzirom na vertebralne prijelome u 12., 24. i 36. mjesecu Ishod
English: Many of the reported cases have been associated with dental procedures such as tooth extraction.
Croatian: Mnogo prijavljenih slučajeva je bilo povezano sa stomatološkim zahvatima, kao što je vađenje zuba.
English: The main molecular target of zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase.
Croatian: Glavna molekularna meta zoledronatne kiseline u osteoklastu je enzim farnezil pirofosfat sintaza.
English: For the treatment of post-menopausal osteoporosis, osteoporosis in men and the treatment of osteoporosis associated with long-term systemic glucocorticoid therapy, the recommended dose is a single intravenous infusion of 5 mg zoledronic acid administered once a year.
Croatian: Za liječenje osteoporoze u postmenopauzi, osteoporoze u muškaraca i liječenje osteoporoze povezane s dugotrajnim liječenjem sistemskim glukokortikoidima, preporučena doza je jednokratna intravenska infuzija od 5 mg zoledronatne kiseline primijenjena jedanput u godini dana.
English: Patients were stratified with respect to duration of glucocorticoid use prior to randomisation (≤ 3 months versus > 3 months).
Croatian: Bolesnici su stratificirani s obzirom na duljinu primjene glukokortikoida prije randomizacije (≤ 3 mjeseca u odnosu na > 3 mjeseca).
English: Uncommon Hypertension, flushing Not known** Hypotension (some of the patients had underlying risk factors)
Croatian: Nije poznato** Hipotenzija (neki od bolesnika s predležećim rizičnim faktorima)
English: Frequency cannot be estimated from available data.
Croatian: Učestalost se ne može procijeniti na osnovi raspoloživih podataka.
English: Before you receive treatment with Zoledronic acid Teva Generics, tell your doctor if you have (or have had) pain, swelling or numbness in your gums, jaw or both, if your jaw feels heavy, or if you have lost a tooth.
Croatian: Prije nego što počnete liječenje Zoledronatnom kiselinom Teva Generics obavijestite svog liječnika ako Vas bole (ili su Vas boljele) ili Vam otiču ili trnu desni, čeljust ili oboje, odnosno ako osjećate težinu u čeljusti ili ako ste izgubili zub.
English: Not known (frequency cannot be estimated from the available data) Pain in the mouth, teeth and jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) Bol u ustima, zubima i čeljusti, oticanje ili ranice u ustima, utrnulost ili osjećaj težine u čeljusti, klimanje zuba.
English: From the bone tissue it is released very slowly back into the systemic circulation and eliminated via the kidney.
Croatian: Iz koštanog tkiva otpušta se vrlo polako natrag u sustavnu cirkulaciju i izlučuje putem bubrega.
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: Ako se podnošenje periodičkog izvješća o neškodljivosti (PSUR) podudara s nadopunama Plana (RMP), dokumenti mogu biti podneseni istodobno.
English: The study was not powered to show a reduction in clinical fractures compared to risedronate.
Croatian: Ispitivanje nije bilo pokrenuto da pokaže smanjenje kliničkih prijeloma u usporedbi s risedronatom.
English: The incidence of clinical fractures, including vertebral, non-vertebral and hip fractures, was evaluated in 2,127 men and women aged 50-95 years (mean age 74.5 years) with a recent (within 90 days) low-trauma hip fracture who were followed for an average of 2 years on study medication.
Croatian: Incidencija kliničkih prijeloma, uključujući vertebralne prijelome, nevertebralne prijelome i prijelome kuka, bila je procijenjena u 2127 muškaraca i žena u dobi od 50 do 95 godina (srednja dob 74,5 godina) s nedavnim (unutar 90 dana) prijelomom kuka nakon slabe traume koji su praćeni u prosjeku 2 godine tijekom liječenja ispitivanim lijekom.
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Croatian: Intravenski primijenjena zoledronatna kiselina eliminirana je procesom u 3 faze: brzo dvofazno nestajanje iz sustavne cirkulacije, s poluvijekom od t½α 0,24 i t½β 1,87 sati, nakon čega slijedi faza duge eliminacije sa završnim poluvijekom eliminacije od t½y 146 sati.
English: The highest non-lethal single intravenous dose was 10 mg/kg body weight in mice and 0.6 mg/kg in rats.
Croatian: U miševa je najviša neletalna pojedinačna intravenska doza bila 10 mg/kg tjelesne težine, a u štakora 0,6 mg/kg.
English: Frequency categories are defined using the following convention: very common (≥1/10); common
Croatian: Kategorije učestalosti određene su na sljedeći način: vrlo često (≥1/10), često
English: No teratological or embryo/foetal effects were observed in rabbits, although maternal toxicity was marked at 0.1 mg/kg due to decreased serum calcium levels.
Croatian: U kunića nisu zapaženi teratološki ili embrio/fetalni učinci, iako je toksičnost za majku bila izrazita pri dozi od 0,1 mg/kg zbog smanjenih razina kalcija u serumu.
English: Your doctor, pharmacist or nurse knows how to store Zoledronic acid Teva Generics properly.
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra znaju kako pravilno čuvati Zoledronatnu kiselinu Teva
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: Sav neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno lokalnim propisima.
English: This includes e.g. Zometa or Aclasta (medicines that also contain zoledronic acid and are used to treat the same disease or osteoporosis and other non-cancer diseases of the bone).
Croatian: Ti lijekovi uključuju primjerice Zometu ili Aclastu (lijekovi koji također sadrže zoledronatnu kiselinu i primjenjuju se za liječenje iste bolesti ili osteoporoze i drugih nekancerogenih bolesti kostiju).
English: * Common in Paget's disease only.
Croatian: * Često samo pri Pagetovoj bolesti.
English: Bone histology was evaluated in 7 patients with Paget's disease 6 months after treatment with 5 mg zoledronic acid.
Croatian: Histologija kostiju procijenjena je u 7 bolesnika s Pagetovom bolešću 6 mjeseci nakon liječenja sa 5 mg zoledronatne kiseline.
English: At 24 months a similar significant increase of 3.6% in total hip BMD was observed for patients treated with zoledronic acid as compared to the effects observed in post-menopausal women in the HORIZON-PFT study.
Croatian: Nakon 24 mjeseca zapaženo je slično značajno povećanje od 3,6% BMD-a cijelog kuka u bolesnika liječenih zoledronatnom kiselinom u usporedbi s učincima zapaženima u žena u postmenopauzi u ispitivanju HORIZON-PFT.
English: C-reactive protein increased Uncommon Blood calcium decreased
Croatian: Povišen C-reaktivni protein Manje često Snižen kalcij u krvi
English: There was no progressive reduction of bone turnover markers with repeated annual dosing.
Croatian: Nije opaženo progresivno smanjenje markera koštane pregradnje nakon ponovljene godišnje primjene.
English: The optimal duration of bisphosphonate treatment for osteoporosis has not been established.
Croatian: Nije utvrđeno optimalno trajanje liječenja bisfosfonatima u bolesnika s osteoporozom.
English: Women who were evaluated for the incidence of vertebral fractures did not receive concomitant osteoporosis therapy, which was allowed for women contributing to the hip and all clinical fracture evaluations.
Croatian: Žene koje su analizirane s obzirom na incidenciju vertebralnih prijeloma nisu primale istodobnu terapiju za osteoporozu, koja je bila dopuštena kod žena koje su sudjelovale u ispitivanju prijeloma kuka i svih kliničkih prijeloma.
English: The risk reduction was 51% in bisphosphonate-naïve patients and 42% in patients allowed to take concomitant osteoporosis therapy.
Croatian: Sniženje rizika iznosilo je 51% u bolesnika koji ranije nisu dobivali bisfosfonate i 42% u bolesnika kojima je bilo dopušteno istovremeno uzimati lijekove za liječenje osteoporoze.
English: • Reminder card with the following key messages: o Need to calculate creatinine clearance based on actual body weight using the CockcroftGault formula before each treatment with Zoledronic acid Teva Generics o Contraindication in patients with creatinine clearance < 35 ml/min o Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity o Need to ensure appropriate hydration of the patient especially those at an advanced age and those receiving diuretic therapy o Need to infuse Zoledronic acid Teva Generics slowly over a period of no less than 15 minutes o Once-yearly dosing regime o Adequate calcium and vitamin D intake are recommended in association with zoledronic acid administration o Need for appropriate physical activity, non-smoking and healthy diet
Croatian: • Podsjetnik na kojem su navedene sljedeće ključne poruke: o Potreba izračunavanja klirensa kreatinina na temelju stvarne tjelesne težine korištenjem Cockcroft-Gaultove formule prije svakog liječenja Zoledronatnom kiselinom Teva Generics o Kontraindikacija u bolesnika s klirensom kreatinina <35 ml/min o Kontraindikacija u trudnica i u dojilja zbog potencijalne teratogenosti o Potreba da se osigura odgovarajuća hidracija bolesnika, osobito onih starije dobi i onih koji primaju terapiju diureticima o Potreba za primjenom infuzije Zoledronatne kiseline Teva generics polako tijekom razdoblja koje ne traje manje od 15 minuta o Režim doziranja jednom godišnje o Preporučuje se odgovarajući unos kalcija i vitamina D uz primjenu zoledronatne kiseline o Potreba za primjerenom fizičkom aktivnošću, nepušenjem i zdravom prehranom
English: • Contraindication in patients with severe kidney problems
Croatian: • Kontraindikacija u bolesnika s teškim bubrežnim tegobama
English: Longer-term repeat administration at cumulative exposures sufficiently exceeding the maximum intended human exposure produced toxicological effects in other organs, including the gastrointestinal tract and liver, and at the site of intravenous administration.
Croatian: Dugotrajna ponovljena primjena pri kumulativnim izloženostima koje su dovoljno prekoračivale najveću planiranu izloženost u ljudi izazvala je toksične učinke na drugim organima, uključujući probavni sustav i jetru, kao i na mjestu primjene.
English: It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic acid Teva Generics, as directed by your healthcare provider.
Croatian: Važno je da popijete najmanje 2 čaše tekućine (kao što je voda), unutar nekoliko sati prije primanja Zoledronatne kiseline Teva Generics, prema uputama zdravstvenog djelatnika.
English: Effect on all clinical fractures The incidence rates of key clinical fracture variables are presented in Table 4.
Croatian: Učinak na sve kliničke prijelome Stope incidencije ključnih varijabli kliničkih prijeloma prikazane su u Tablici 4.
English: After initiation of the zoledronic acid infusion, plasma concentrations of the active substance increased rapidly, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak levels.
Croatian: Nakon početka primjene infuzije zoledronatne kiseline, koncentracija zoledronatne kiseline u plazmi naglo se povećala, dosegnuvši vršnu koncentraciju na kraju infuzije, nakon čega je uslijedio brzi pad do <10% od vršne koncentracije nakon 4 sata te <1% od vršne koncentracije nakon 24 sata, s posljedičnim produženim razdobljem vrlo niskih koncentracija koje nisu prelazile 0,1% vršne koncentracije.
English: Treatment of Paget's disease of the bone in adults.
Croatian: Liječenje Pagetove bolesti kosti u odraslih.