FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of post-dose symptoms occurring within the first three days after administration of Zoledronic Acid Hospira can be reduced with the administration of paracetamol or ibuprofen shortly following Zoledronic Acid Hospira administration.
Croatian: Incidencija simptoma koji se javljaju u prva tri dana nakon primjene doze Zoledronatne kiseline Hospira mogu se smanjiti uzimanjem paracetamola ili ibuprofena nedugo nakon uzimanja Zoledronatne kiseline Hospira.
English: The main molecular target of zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase.
Croatian: Glavni molekularni cilj zoledronatne kiseline u osteoklastu je enzim farnezil pirofosfat sintaza.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane prema padajućoj ozbiljnosti.
English: In clinical studies, zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Croatian: U kliničkim ispitivanjima zoledronatna kiselina primjenjivala se istodobno s uobičajeno primijenjenim antitumorskim lijekovima, diureticima, antibioticima i analgeticima bez klinički vidljivih interakcija.
English: In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Croatian: U kliničkim je ispitivanjima liječenje zoledronatnom kiselinom nastavljeno tek kad se razina kreatinina vratila na vrijednosti unutar 10% početne vrijednosti (vidjeti dio 4.4).
English: − Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with zoledronic acid.
Croatian: - Ispitivanja s nekoliko vrsta infuzijskih linija od polivinilklorida, polietilena i polipropilena nisu pokazala inkompatibilnost sa zoledronatnom kiselinom.
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
Croatian: Zbog brzog nastupa učinka zoledronatne kiseline na pregradnju kostiju može se razviti prolazna hipokalcemija, ponekad simptomatska, koja se može razviti i obično je najviša unutar prvih 10 dana nakon infuzije zoledronatne kiseline (vidjeti dio 4.8).
English: In the clinical trials, renal deterioration was defined as follows:
Croatian: U kliničkim je ispitivanjima pogoršanje funkcije bubrega bilo definirano na sljedeći način:
English: Since zoledronic acid is not metabolised in humans and the substance was found to have little or no capacity as a direct-acting and/or irreversible metabolism-dependent inhibitor of P450 enzymes, zoledronic acid is unlikely to reduce the metabolic clearance of substances which are metabolised via the cytochrome P450 enzyme systems.
Croatian: Budući da se zoledronatna kiselina ne metabolizira u ljudi, a da je utvrđeno da ima malu ili nikakvu sposobnost da, djelujući direktno i/ili kao ireverzibilni inhibitor ovisan o metabolizmu, inhibira P450 enzime, nije vjerojatno da će zoledronatna kiselina smanjiti metabolički klirens tvari koje se metaboliziraju preko enzimskog sustava citokroma P450.
English: The majority of these reactions occur within the first three days following zoledronic acid administration.
Croatian: Većina tih nuspojava pojavila se unutar prva tri dana nakon primjene zoledronatne kiseline.
English: The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone.
Croatian: Selektivno djelovanje bisfosfonata na kost temelji se njihovom visokom afinitetu za mineraliziranu kost.
English: Treatment of Paget's disease of the bone in adults.
Croatian: Liječenje Pagetove bolesti kostiju u odraslih.
English: The majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Croatian: Većina prijavljenih slučajeva odnosila se na onkološke bolesnike nakon vađenja zuba ili drugih stomatoloških operacija.
English: Zoledronic acid 8 mg (N=90)
Croatian: zoledronatna kiselina 8 mg (n=90)
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, produženi period remisije opažen je u bolesnika koji su dobro reagirali na liječenje.
English: • Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula before each Zoledronic Acid Hospira dose.
Croatian: • potrebno je izračunati klirens kreatinina na temelju stvarne tjelesne težine pomoću CockcroftGault formule prije svake doze Zoledronatne kiseline Hospira
English: 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.
Croatian: Produljenje trajanja infuzije s 5 na 15 minuta prouzročilo je 30%-tno sniženje koncentracije zoledronatne kiseline na kraju infuzije, ali nije imalo nikakvog učinka na područje ispod krivulje koncentracije u plazmi naspram vremena mjerenja.
English: It is given as a single 15-minute intravenous infusion in a separate infusion line.
Croatian: Primjenjuje se kao jednokratna 15-minutna intravenska infuzija kroz zasebnu infuzijsku liniju.
English: Teratogenicity was observed in rats at doses 0.2 mg/kg and was manifested by external, visceral and skeletal malformations.
Croatian: Teratogenost je opažena u štakora pri dozama ≥ 0,2 mg/kg, a izražavala se vanjskim i visceralnim malformacijama te malformacijama skeleta.
English: Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.
Croatian: Bolesnicima također treba davati oralni nadomjestak kalcija od 500 mg i 400 IU vitamina
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 koji su postigli terapijski odgovor 6 mjeseci nakon liječenja zoledronatnom kiselinom, a koji su kasnije doživjeli relaps bolesti tijekom produljenog perioda praćenja, ponovno su liječeni zoledronatnom kiselinom, a srednje vrijeme od početnog liječenja do ponovnog liječenja bilo je 6,5 godina.
English: From the bone tissue it is released very slowly back into the systemic circulation and eliminated via the kidney.
Croatian: Iz koštanog tkiva se otpušta vrlo sporo natrag u sistemsku cirkulaciju i eliminira putem bubrega.
English: The recommended dose is a single intravenous infusion of 5 mg zoledronic acid.
Croatian: Preporučena doza je jednokratna intravenska infuzija 5 mg zoledronatne kiseline.
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 prijavljene su lokalne reakcije na mjestu primjene infuzije (0,7%), kao što su crvenilo, oticanje i/ili bol, nakon primjene zoledronatne kiseline.
English: Zoledronic Acid Hospira, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Croatian: Zoledronatnu kiselinu Hospira, dodatno razrijeđenu u 100 ml (vidjeti dio 6.6), treba primijeniti kao jednokratnu intravensku infuziju u trajanju od najmanje 15 minuta.
English: Other products containing zoledronic acid as active substance are available for oncology indications.
Croatian: Ostali lijekovi koji sadrže zoledronatnu kiselinu kao djelatnu tvar dostupni su za onkološke indikacije.
English: In patients with Paget's disease, symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth have been reported.
Croatian: U bolesnika s Pagetovom bolešću prijavljeni su simptomi uzrokovani niskom razinom kalcija u krvi, kao što su grčevi mišića ili utrnutost ili trnci, osobito u području oko usta.
English: Your doctor will advise you and decide how long you should be treated with Zoledronic Acid Hospira.
Croatian: Liječnik će Vam dati savjet i odlučiti koliko dugo biste se trebali liječiti Zoledronatnom kiselinom Hospira.
English: Healthcare professionals are advised not to dispose of unused Zoledronic Acid Hospira via the domestic sewage system.
Croatian: Zdravstvenim radnicima se savjetuje da ne bacaju neiskorištenu Zoledronatnu kiselinu Hospira u otpadne vode.
English: The following are the important identified risks with zoledronic acid in the approved indications:
Croatian: Utvrđeni su sljedeći važni rizici primjene zoledronatne kiseline u odobrenim indikacijama:
English: Very common (may affect more than 1 in 10 people):− Low level of phosphate in the blood.
Croatian: Vrlo često (može se javiti u do 1 na 10 osoba): - niska razina fosfata u krvi.
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 da predoziranje dovodi do klinički značajne hipokalcemije, suprotni učinak se može postići nadomještanjem oralnog kalcija i/ili intravenskom infuzijom kalcijevog glukonata.
English: − Keep Zoledronic Acid Hospira out of the reach and sight of children.
Croatian: - Zoledronatnu kiselinu Hospira čuvajte izvan pogleda i dohvata djece.
English: Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Croatian: Moguće nuspojave zoledronatne kiseline na plodnost ispitane su na roditeljskoj i F1 generaciji štakora.
English: Arthritis and joint swelling as a symptom of acute phase reaction
Croatian: artritis i oticanje zglobova kao simptomi reakcije akutne faze
English: It comes in 100 ml plastic bags as a readyto-use solution for infusion.
Croatian: Isporučuje se u plastičnim vrećicama od 100 ml kao otopina za infuziju spremna za uporabu.
English: - Pregnancy and breast-feeding (see section 4.6).
Croatian: - Trudnoća i dojenje (vidjeti dio 4.6).
English: CARTON FOR 1 BAG AS UNIT PACK
Croatian: KUTIJA ZA 1 VREĆICU KAO JEDINIČNO PAKIRANJE
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 je bila povezana s oštećenjem bubrega koje se očitovalo kao slabljenje bubrežne funkcije (npr. povišeni kreatinin u serumu) i u rijetkim slučajevima kao akutno zatajenje bubrega.
English: Zoledronic acid should not be used during pregnancy.
Croatian: Zoledronatna kiselina ne smije se primjenjivati tijekom trudnoće.
English: Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Croatian: Na temelju pregleda kliničkih i postmarketinških ispitivanja, postoji dovoljno dokaza koji podupiru povezanost liječenja zoledronatnom kiselinom i prijavljenih slučajeva hipokalcemije i posljedičnog razvoja srčane aritmije.
English: − The diluted Zoledronic Acid Hospira infusion solution should be used immediately in order to avoid microbial contamination.
Croatian: - Razrijeđena otopina za infuziju Zoledronatne kiseline Hospira mora se primjeniti odmah da bi se izbjeglo mikrobno zagađenje.
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: Prijelomi nastaju nakon minimalne traume ili bez ikakve traume, pri čemu neki bolesnici osjete bol u bedru ili preponama, a na radiološkim slikama često su prisutni znakovi stresnog prijeloma tjednima ili mjesecima prije nego što nastane potpuni prijelom bedrene kosti.
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when zoledronic acid is used in combination with thalidomide.
Croatian: U bolesnika s multiplim mijelomom, rizik od poremećaja funkcije bubrega može biti povećan kad se primjenjuje zoledronatna kiselina u kombinaciji s talidomidom.
English: Of the 153 zoledronic acid-treated patients and 115 risedronate-treated patients who entered an extended observation study, after a median 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 medijana trajanja praćenja od 3,8 godina, računato od vremena doziranja, stopa bolesnika koji su završili produljeni period praćenja zbog potrebe za ponovnim liječenjem (klinička procjena) bila je veća za risedronat (48 bolesnika ili 41,7%) naspram zoledronatne kiseline (11 bolesnika ili 7,2%).
English: − For single use only.
Croatian: Samo za jednokratnu primjenu.
English: Patients who have received doses higher than those recommended (see section 4.2) should be carefully monitored, since renal function impairment (including renal failure) and serum electrolyte (including calcium, phosphorus and magnesium) abnormalities have been observed.
Croatian: Bolesnike koji su primili više doze od preporučenih (vidjeti dio 4.2) treba pažljivo pratiti budući da su primijećena oštećenja bubrega (uključujući zatajenje bubrega) i poremećaji serumskih elektrolita (uključujući kalcij, fosfor i magnezij).
English: The incidence of these reactions decreased markedly with subsequent annual doses of zoledronic acid.
Croatian: Incidencija tih nuspojava značajno se smanjila s narednim godišnjim dozama zoledronatne kiseline.
English: Median time to onset of the first SRE was not reached in the zoledronic acid -treated arm at the end of the study and was significantly prolonged compared to placebo (p=0.007).
Croatian: Medijan vremena do nastupa prvog koštanog događaja nije dosegnut u skupini liječenoj zoledronatnom kiselinom do kraja ispitivanja i bio je značajno dulji naspram placeba (p=0,007).
English: Pharmacokinetic/pharmacodynamic relationships
Croatian: Odnos farmakokinetika/farmakodinamika
English: Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
Croatian: konvulzije, hipoestezija i tetanija (zbog hipokalcemije)
English: - 4.4 ml for 3.5 mg dose - 4.1 ml for 3.3 mg dose - 3.8 ml for 3.0 mg dose
Croatian: - 4,4 ml za dozu od 3,5 mg - 4,1 ml za dozu od 3,3 mg - 3,8 ml za dozu od 3,0 mg
English: Adverse reactions, such as dizziness and somnolence, may have influence on the ability to drive or use machines, therefore caution should be exercised with the use of zoledronic acid along with driving and operating of machinery.
Croatian: Nuspojave poput omaglice i somnolencije mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima te je stoga potreban oprez kad se tijekom primjene zoledronatne kiseline upravlja vozilima i radi sa strojevima.
English: Elevated bone turnover is a characteristic of Paget's disease of the bone.
Croatian: Povećana pregradnja kosti je osobina Pagetove bolesti kostiju.
English: Other medicines and Zoledronic Acid Hospira 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 Hospira Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Croatian: Nuspojave u tablici 1 su navedene prema klasifikaciji organskih sustava prema MedDRA-i i učestalosti.
English: Episcleritis
Croatian: episkleritis
English: Furthermore, there is evidence of an association between hypocalcaemia and secondary neurological events reported in these cases including; convulsions, hypoaesthesia and tetany (see section 4.4).
Croatian: Nadalje, postoji dokaz povezanosti hipokalcemije i posljedičnih neuroloških događaja uključujući konvulzije, hipoesteziju i tetaniju (vidjeti dio 4.4).
English: What Zoledronic Acid Hospira looks like and contents of the pack Zoledronic Acid Hospira is supplied as a liquid concentrate (referred to as a ‘concentrate for solution for infusion' or ‘sterile concentrate') in a vial.
Croatian: Kako Zoledronatna kiselina Hospira izgleda i sadržaj pakiranja Zoledronatna kiselina Hospira je tekući koncentrat (koji se naziva "koncentrat za otopinu za infuziju" ili "sterilni koncentrat") u bočici.
English: The mechanism behind the increased incidence of atrial fibrillation is unknown.
Croatian: Nije poznat mehanizam u pozadini povećane incidencije fibrilacije atrija.
English: Clinical experience with acute overdose of zoledronic acid is limited.
Croatian: Kliničko iskustvo s akutnim predoziranjem zoledronatnom kiselinom je ograničeno.
English: Zoledronic Acid Hospira works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
Croatian: Zoledronatna kiselina djeluje tako što vraća proces preoblikovanja kosti u normalu, osiguravajući stvaranje normalne kosti, čime kosti postaju snažnije.
English: Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with Zoledronic Acid Hospira.
Croatian: Dodatno, bilo je sporadičnih prijava osteonekroze drugih anatomskih mjesta, uključujući kuk i bedrenu kost, koje su bile prijavljene pretežno u odraslih bolesnika oboljelih od raka liječenih Zoledronatnom kiselinom Hospira.
English: Within three days after zoledronic acid administration, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Croatian: Unutar tri dana nakon primjene zoledronatne kiseline često je prijavljena reakcija akutne faze sa simptomima koji uključuju bol u kostima, vrućicu, umor, artralgiju, mialgiju, tresavicu i artritis s posljedičnim oticanjem zglobova; ti se simptomi obično povuku unutar nekoliko dana (vidjeti opis odabranih nuspojava).
English: Untreated hypercalcaemia patients generally have some degree of renal function impairment, therefore careful renal function monitoring should be considered.
Croatian: Bolesnici s neliječenom hiperkalcijemijom najčešće imaju neki stupanj oštećenja funkcije bubrega pa je stoga potrebno razmotriti pažljivo praćenje funkcije bubrega.
English: These could be signs of bone damage in the jaw (osteonecrosis).
Croatian: To mogu biti znakovi oštećenja kosti u čeljusti (osteonekroze).
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 Hospira, as directed by your healthcare provider.
Croatian: Važno je za Vas da pijete barem 2 čaše tekućine (npr. vode), unutra nekoliko sati prije primanja Zoledronatne kiseline Hospira, prema uputama svog zdravstvenog radnika.
English: - Zoledronic Acid Hospira is ready for use.
Croatian: - Zoledronatna kiselina Hospira je spremna za primjenu.
English: Zoledronic Acid Hospira is not recommended for anyone under 18 years of age.
Croatian: Zoledronatna kiselina Hospira ne preporučuje se osobama mlađim od 18 godina.
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 temelju laboratorijske procjene, prolazne asimptomatske razine kalcija ispod normalnog referentnog raspona (manje od 2,10 mmol/1) javile su se u 2,3% bolesnika liječenih zoledronatnom kiselinom u velikom kliničkom ispitivanju, naspram 21% bolesnika liječenih zoledronatnom kiselinom u kliničkim ispitivanjima Pagetove bolesti.
English: Before receiving Zoledronic Acid Hospira, tell your doctor, pharmacist or nurse if - you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction; - you do not receive routine dental care or have not had a dental check-up for a long time; - you are a smoker (as this may increase the risk of dental problems); - you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders); - you are taking medicines called corticosteroids (such as prednisolone or dexamethasone) - you have cancer.
Croatian: Prije liječenja Zoledronatnom kiselinom Hospira, recite svom liječniku, ljekarniku ili medicinskoj sestri ako: - imate problema s ustima ili zubima poput loše oralne higijene, bolesti desni ili kirurških zahvata zuba - ne primate rutinsku stomatološku skrb ili niste dugo bili na pregledu kod zubara - ste pušač (to može povećati rizik razvoja stomatoloških problema) - ste prethodno liječeni s bisfosfonatima (koji se primjenjuju za liječenje ili sprječavanje poremećaja kosti) - uzimate lijekove koji se zovu kortikosteroidi (poput prednizolona ili deksametazona) - imate rak.
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]) objedinjena incidencija fibrilacije atrija bila je usporediva kod zoledronatne kiseline (2,6%) i placeba (2, 1%).
English: Caution is indicated when zoledronic acid is used with other potentially nephrotoxic medicinal products.
Croatian: Oprez je indiciran kad se zoledronatna kiselina primjenjuje s drugim potencijalno nefrotoksičnim lijekovima.
English: Adverse reactions, such as dizziness, may affect the ability to drive or use machines.
Croatian: Nuspojava kao što je omaglica može utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: p-value Median time to SRE (days)
Croatian: p-vrijednost medijan vremena do koštanog događaja (dani)
English: Zoledronic acid has been associated with reports of renal dysfunction.
Croatian: Zoledronatna kiselina povezuje se s prijavama disfunkcije bubrega.
English: In paediatric patients with severe osteogenesis imperfecta, zoledronic acid seems to be associated with more pronounced risks for acute phase reaction, hypocalcaemia and unexplained tachycardia, in comparison to pamidronate, but this difference declined after subsequent infusions.
Croatian: Čini se da je u pedijatrijskih bolesnika s teškim oblikom osteogenesis imperfecta zoledronatna kiselina povezana s izraženijim rizikom od reakcije akutne faze, hipokalcemije i neobjašnjene tahikardije u odnosu na pamidronat, ali ta se razlika smanjila nakon narednih infuzija.
English: The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established.
Croatian: Sigurnost i djelotvornost primjene zoledronatne kiseline u djece u dobi od 1 do 17 godina nije ustanovljena.