natgillin/translations-raw huggingface dataset:
If you feel dizzy while taking Zoledronic acid Teva Generics, do not drive or use machines until you feel better. 
Ako osjećate omaglicu dok uzimate Zoledronatnu kiselinu Teva Generics, nemojte upravljati vozilima ili strojevima dok se ne budete osjećali bolje.
Pharmachemie B.V. Swensweg 5 
Pharmachemie B.V. sweg 5
Repeat dosing did not lead to further reduction of bone turnover markers. 
Ponovljeno doziranje nije dovelo do dodatnog smanjenja markera koštane pregradnje.
Many patients with osteoporosis have no symptoms but they are still at risk of breaking bones because osteoporosis has made their bones weaker. 
Mnogi bolesnici s osteoporozom nemaju simptome, ali su svejedno izloženi riziku od loma kostiju jer je osteoporoza oslabila njihove kosti.
Histomorphometric analysis showed a 63% reduction in bone turnover. 
Histomorfometrijska analiza pokazala je smanjenje koštane pregradnje od 63%.
It is normal that old bone is removed and is replaced with new bone material. 
Normalno je da se stara kost razgrađuje i da se obnavlja novim koštanim tkivom.
Thus these results precluded determining a definitive effect of zoledronic acid on fertility in humans. 
Stoga su ti rezultati spriječili utvrđivanje definitivnog učinka zoledronatne kiseline na plodnost u ljudi.
The symptoms are usually mild to moderate and go away within three days. 
Simptomi su obično blagi do umjereno teški i nestaju unutar tri dana.
Not known** Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects) 
Nije poznato** Osteonekroza čeljusti (vidjeti dijelove 4.4 i 4.8 Učinci klase)
Physicians should consider clinical monitoring for these patients. 
Liječnici moraju procijeniti potrebu za kliničkim praćenjem u tih bolesnika.
- if you have severe kidney problems. 
- ako imate teških problema s bubrezima.
These results were consistent with biochemical marker evidence of normalisation of bone turnover. 
Ti su rezultati bili u skladu s biokemijskim markerima koji su pokazali normalizaciju koštane pregradnje.
Placebo (N = 1,062) event rate 
Placebo (N=1062) stopa događaja
This is especially important for the elderly and for patients receiving diuretic therapy. 
To je osobito važno za starije osobe i bolesnike koji primaju diuretsku terapiju.
The primary efficacy variable was the incidence of clinical fractures over the duration of the study. 
Primarna varijabla djelotvornosti bila je incidencija kliničkih prijeloma tijekom trajanja ispitivanja.
Uncommon (may affect up to 1 in 100 people) Skin reactions such as redness. 
Manje često (mogu se javiti u do 1 na 100 osoba) Kožne reakcije poput crvenila.
The patient information pack should be provided and contain the following key messages: 
Potrebno je napraviti informativni paket za bolesnika u kojem će biti navedene sljedeće ključne poruke:
During this entire time period bone turnover markers were within the pre-menopausal range at the end of each year. 
Tijekom čitavog razdoblja markeri koštane pregradnje bili su unutar premenopauzalnog raspona na kraju svake godine.
Patients should be informed about symptoms of hypocalcaemia and receive adequate clinical monitoring during the period of risk. 
Bolesnike je potrebno obavijestiti o simptomima hipokalcijemije te ih tijekom razdoblja rizika odgovarajuće klinički pratiti.
If you experience any of the above side effects, you should contact your doctor immediately. 
Ako primijetite bilo koju od navedenih nuspojava, odmah se obratite svom liječniku.
As with other bisphosphonates, the retention time of zoledronic acid in bones is very long. 
Kao i u slučaju ostalih bisfosfonata, vrijeme zadržavanja zoledronatne kiseline u kostima je vrlo dugo.
Gödöllő 2100 
Gödöllő 2100 Mađarska
Effect on all clinical fractures 
Učinak na sve kliničke prijelome
These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare. 
Ti poprečni ili kratki kosi prijelomi mogu nastati bilo gdje na bedrenoj kosti, od neposredno ispod malog trohantera do neposredno iznad suprakondilarnog dijela.
• Monitoring of serum creatinine should be considered in at-risk patients. 
• Praćenje kreatinina u serumu potrebno je uzeti u obzir u bolesnika s rizikom.
In Paget's disease, bone remodelling is too rapid and new bone is formed in a disordered fashion, which makes it weaker than normal. 
Kod Pagetove bolesti, preoblikovanje kosti je prebrzo te se nova kost stvara na poremećen način, čime postaje slabija nego normalno.
INFORMATION FOR THE HEALTHCARE PROFESSIONAL 
INFORMACIJE ZA ZDRAVSTVENE DJELATNIKE
• Transient increase in serum creatinine may be greater in patients with underlying impaired renal function. 
• Prolazni porast kreatinina u serumu može biti veći u bolesnika koji imaju predležeću oštećenu funkciju bubrega.
Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, intestinal calcium malabsorption). 
Ostali poremećaji metabolizma minerala također se moraju učinkovito liječiti (npr. smanjenje zalihe paratireoidnih žlijezda, intestinalna malapsorpcija kalcija).
Following the menopause bone loss occurs, bones become weaker and break more easily. 
Nakon menopauze dolazi do gubitka kosti, kosti postaju slabije i lakše se lome.
Increasing the infusion time from 5 to 15 minutes caused a 30% decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve. 
Povećanje vremena infuzije sa 5 na 15 minuta uzrokovalo je 30% smanjenje koncentracije zoledronatne kiseline na kraju infuzije, ali nije imalo učinka na površinu ispod krivulje plazmatske koncentracije u odnosu na vrijeme.
While on treatment, these patients should avoid invasive dental procedures if possible. 
Ako je moguće, ovi bolesnici moraju izbjegavati invazivne stomatološke zahvate tijekom liječenja.
The study was not designed to measure significant differences in hip fracture, but a trend was seen towards reduction in new hip fractures. 
Ispitivanje nije bilo osmišljeno tako da mjeri značajne razlike prijeloma kuka, ali je zapažen trend smanjenja novih prijeloma kuka.
There was no accumulation of the active substance in plasma after multiple doses given every 28 days. 
Nije bilo nakupljanja zoledronatne kiseline u plazmi nakon višestrukih doza lijeka davanih svakih 28 dana.
The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of zoledronic acid on an individual patient basis, particularly after 5 or more years of use. 
Potrebu za nastavkom liječenja potrebno je ponovno procijeniti periodički na osnovi odnosa koristi i potencijalnih rizika zoledronatne kiseline u svakog pojedinačnog bolesnika, a posebno nakon 5 ili više godina primjene.
Bone biopsy results showed bone of normal quality with no evidence of impaired bone remodelling and no evidence of mineralisation defects. 
Rezultati biopsije kosti pokazali su kost normalne kvalitete, bez znakova oštećenog remodeliranja kosti kao i bez dokaza o mineralizacijskim defektima.
The early disposition phases (α and β, with t½ values above) presumably represent rapid uptake into bone and excretion via the kidneys. 
Rane faze dispozicije (α i β, s prije navedenim t½ vrijednostima) vjerojatno predstavljaju brz koštani unos i izlučivanje putem bubrega.
Swelling, redness, pain and itching to the eyes or eye sensitivity to light. 
Oticanje, crvenilo, bol i svrbež očiju ili osjetljivost očiju na svjetlost.
Paget's disease 
Pagetova bolest
Any clinical fracture (1) 
Bilo koji klinički prijelom (1)
Effect on bone mineral density (BMD) 
Učinci na mineralnu gustoću kosti (BMD)
Decreased circulating levels of sex hormones, mainly oestrogens converted from androgens, also play a role in the more gradual bone loss observed in men. 
Sniženje razine spolnih hormona u cirkulaciji, prvenstveno estrogena koji su nastali od androgena, također ima ulogu u postupnijem gubitku kosti zamijećenom u muškaraca.
This uptake into bone is common for all bisphosphonates and is presumably a consequence of the structural analogy to pyrophosphate. 
Taj je unos u koštano tkivo zajednički za sve bisfosfonate i vjerojatno je posljedica strukturalne analogije s pirofosfatima.
All cause mortality was 10% (101 patients) in the zoledronic acid-treated group compared to 13% (141 patients) in the placebo group. 
Smrtnost zbog svih uzroka bila je 10% (101 bolesnik) u skupini liječenih zoledronatnom kiselinom u usporedbi s 13% (141 bolesnik) u placebo skupini.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. 
U bolesnika koji razviju osteonekrozu čeljusti tijekom liječenja bisfosfonatima, stomatološka operacija mogla bi pogoršati stanje.
It is an inhibitor of osteoclast-mediated bone resorption. 
Ona je inhibitor osteoklastične resorpcije kosti.
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. 
Zoledronatnu kiselinu Teva Generics ne smijete primati ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete.
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. 
Liječnik Vam može savjetovati da uzimate nadomjestke kalcija i vitamina D (na primjer tablete) najmanje prvih deset dana nakon primjene Zoledronatne kiseline Teva Generics.
Teratogenicity was observed in rats at doses ≥ 0.2 mg/kg and was manifested by external, visceral and skeletal malformations. 
Teratogenost je zapažena u štakora pri dozama od ≥ 0,2 mg/kg, a izražavala se vanjskim i visceralnim malformacijama te malformacijama skeleta.
- if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6). 
- ako ste alergični na zoledronatnu kiselinu, druge bisfosfonate ili na bilo koju pomoćnu tvar ovog lijeka (navedeni u dijelu 6).
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). 
Zoledronatna kiselina značajno je smanjila incidenciju jednog ili više novih vertebralnih prijeloma tijekom tri godine i najranije već tijekom prve godine (vidjeti Tablicu 2).
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. 
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.
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. 
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.
• Contraindication in pregnancy and in breast-feeding women 
• Kontraindikacija u trudnica i u dojilja
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. 
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.
Swelling and/or pain at the infusion site may occur. 
Može doći do oticanja i/ili boli na mjestu primjene infuzije.
Very common Fever Common 
Vrlo često Vrućica Često
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). 
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).
Five of the 6 patients had SAP within the normal range at month 6 (Last Observation Carried Forward, LOCF). 
Pet od 6 bolesnika imalo je SAP s normalnim rasponom nakon 6 mjeseci (uz posljednje zapažanje prenijeto dalje, engl.
Treatment of osteoporosis 
Liječenje osteoporoze
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. 
Za liječenje Pagetove bolesti, zoledronatnu kiselinu smiju propisivati samo liječnici koji imaju iskustva u liječenju Pagetove bolesti kosti.
It comes in a clear plastic bottle. 
Lijek je dostupan u prozirnim plastičnim bočicama.
Zoledronic acid Teva Generics is not recommended for anyone under 18 years of age. 
Zoledronatna kiselina Teva Generics ne preporuča se osobama mlađima od 18 godina.
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. 
Tijekom prvih 24 sata, 39 ± 16% od primijenjene doze nađeno je u mokraći, dok je ostatak uglavnom ostao vezan na koštano tkivo.
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. 
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.
Your doctor will advise you and decide how long you should be treated with Zoledronic acid Teva Generics. 
On će Vam dati savjet i odlučiti koliko dugo biste se trebali liječiti Zoledronatnom kiselinom Teva Generics.
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. 
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.
The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established. 
Nisu utvrđene sigurnost i djelotvornost zoledronatne kiseline u djece i adolescenata ispod 18 godina.
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. 
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.
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. 
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.
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. 
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.
Thereafter bone markers stabilised within the pre-menopausal range. 
Nakon toga su se koštani markeri stabilizirali unutar premenopauzalnog raspona.
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. 
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.
Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential. 
Zoledronatna kiselina se u provedenim ispitivanjima mutagenosti nije pokazala mutagenom, dok ispitivanje karcinogenosti nije dalo nikakve dokaze o karcinogenom potencijalu.
It is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor. 
Važno je uzimati nadomjestke kalcija i vitamina D (na primjer tablete) prema uputama liječnika.
Cyclic Olefin Polymer (COP) plastic bottle, fitted with a chlorobutyl/butyl rubber stopper and aluminium cap fitted with violet plastic flip off disc. 
Plastična bočica od cikloolefinskog polimera (COP) s klorobutil/butilnim gumenim čepom i aluminijskom kapicom s ljubičastim plastičnim flip off diskom.
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). 
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).
Zoledronic acid Teva Generics works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone. 
Zoledronatna kiselina Teva Generics djeluje tako što vraća proces preoblikovanja kosti u normalu osiguravajući stvaranje normalne kosti, čime kosti postaju snažnije.
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. 
Većina nuspojava, poput vrućice i zimice, bolova u mišićima ili zglobovima te glavobolje, javlja se unutar prva tri dana nakon primjene doze Zoledronatne kiseline
Effect on morphometric vertebral fractures 
Učinak na morfometrijske vertebralne prijelome
From a microbiological point of view, the product should be used immediately. 
S mikrobiološkog stajališta, lijek treba odmah primijeniti.
The medicinal product must not be mixed or given intravenously with any other medicinal products. 
Ovaj lijek ne smije se miješati ili primjenjivati intravenski s drugim lijekovima.
It is prudent to avoid dental surgery as recovery may be prolonged (see section 4.4). 
Razborito je izbjegavati stomatološke operacije jer bi oporavak mogao biti produljen (vidjeti dio 4.4).
The following precautions should be taken into account to minimise the risk of renal adverse reactions: 
Sljedeće mjere opreza treba uzeti u obzir kako bi se smanjio rizik za bubrežne nuspojave:
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. 
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.
Other products containing zoledronic acid as active substances are available for oncology indications. 
Ostali lijekovi koji sadrže zoledronatnu kiselinu kao djelatnu tvar dostupni su za onkološke indikacije.
The infusion time must not be less than 15 minutes. 
Trajanje infuzije ne smije biti kraće od 15 minuta.
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. 
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.
Summary of vertebral fracture efficacy at 12, 24 and 36 months 
Tablica 2 Sažetak djelotvornosti s obzirom na vertebralne prijelome u 12., 24. i 36. mjesecu Ishod
Many of the reported cases have been associated with dental procedures such as tooth extraction. 
Mnogo prijavljenih slučajeva je bilo povezano sa stomatološkim zahvatima, kao što je vađenje zuba.
The main molecular target of zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase. 
Glavna molekularna meta zoledronatne kiseline u osteoklastu je enzim farnezil pirofosfat sintaza.
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. 
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.
Patients were stratified with respect to duration of glucocorticoid use prior to randomisation (≤ 3 months versus > 3 months). 
Bolesnici su stratificirani s obzirom na duljinu primjene glukokortikoida prije randomizacije (≤ 3 mjeseca u odnosu na > 3 mjeseca).
Uncommon Hypertension, flushing Not known** Hypotension (some of the patients had underlying risk factors) 
Nije poznato** Hipotenzija (neki od bolesnika s predležećim rizičnim faktorima)
Frequency cannot be estimated from available data. 
Učestalost se ne može procijeniti na osnovi raspoloživih podataka.
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. 
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.
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. 
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.
From the bone tissue it is released very slowly back into the systemic circulation and eliminated via the kidney. 
Iz koštanog tkiva otpušta se vrlo polako natrag u sustavnu cirkulaciju i izlučuje putem bubrega.
If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time. 
Ako se podnošenje periodičkog izvješća o neškodljivosti (PSUR) podudara s nadopunama Plana (RMP), dokumenti mogu biti podneseni istodobno.
The study was not powered to show a reduction in clinical fractures compared to risedronate. 
Ispitivanje nije bilo pokrenuto da pokaže smanjenje kliničkih prijeloma u usporedbi s risedronatom.
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. 
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.