FrancophonIA/ELRC3.0 huggingface dataset:
English: In a pooled analysis of safety data from trials for the use of zoledronic acid 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 zoledronic acid (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 iz ispitivanja primjene zoledronatne kiseline za prevenciju koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti, sumnjalo se da je učestalost štetnih događaja oštećenja bubrega povezanih sa zoledronatnom kiselinom (nuspojave) bila sljedeća: multipli mijelom (3,2%), rak prostate (3,1%), rak dojke (4,3%), rak plućni i drugi solidni tumori (3,2%).
English: - The unopened bag does not require any special storage conditions.
Croatian: - Neotvorena vrećica ne zahtijeva posebne uvjete čuvanja.
English: Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8 Class effects)
Croatian: Prijavljeni su rijetki slučajevi zatajenja bubrega koji iziskuju dijalizu i rijetki slučajevi sa smrtnim ishodom u bolesnika s postojećom disfunkcijom bubrega ili drugim faktorima rizika kao što su: poodmakla dob, istodobna primjena nefrotoksičnih lijekova, istodobna primjena diuretske terapije ili dehidracija u razdoblju nakon infuzije (vidjeti dijelove 4.4 i 4.8 učinci skupine).
English: - Severe renal impairment with creatinine clearance < 35 ml/min (see section 4.4).
Croatian: - Teško oštećenje bubrega s klirensom kreatinina < 35 ml/min (vidjeti dio 4.4).
English: Flu-like symptoms including arthritis and joint swelling.
Croatian: - simptomi nalik gripi, uključujući artritis i oticanje zglobova.
English: •Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar, druge bisfosfonate ili neku od pomoćnih tvari navedenih u dijelu 6.1.
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 naspram bolesnika koji su primali pamidronat.
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 uvođenja infuzije zoledronatne kiseline, koncentracije djelatne tvari u plazmi brzo su se povećavale, pri čemu su vršnu vrijednost postigle na kraju perioda infuzije, nakon čega je slijedio brzi pad na < 10% vršne vrijednosti nakon 4 sata, zatim na < 1% vršne vrijednosti nakon 24 sata, s produljenim periodom vrlo niskih koncentracija koje nisu prelazile 0,1% vršnih razina.
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Croatian: Aritmije srca i neurološke nuspojave (uključujući konvulzije, hipoesteziju i tetaniju) prijavljeni su kao posljedica hipokalcemije.
English: Adjusted dose (mg zoledronic acid) *
Croatian: Prilagođena doza (mg zoledronatne kiseline)*
English: Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja utjecaja zoledronatne kiseline na reproduktivnost životinja pokazala su da postoji reproduktivna toksičnost (vidjeti dio 5.3).
English: Hypersensitivity reactions including rare cases of bronchoconstriction, urticaria and angioedema, and very rare cases of anaphylactic reaction/shock
Croatian: Poremećaji imunološkog sustava nepoznato** reakcija preosjetljivosti, uključujući rijetke slučajeve bronhokonstrikcije, urtikarije, angioedem i vrlo rijetko anafilaktičku reakciju/šok
English: What Zoledronic Acid Hospira is and what it is used for
Croatian: Što je Zoledronatna kiselina Hospira i za što se koristi
English: The active substance in Zoledronic Acid Hospira is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Croatian: Djelatna tvar u Zoledronatnoj kiselini Hospira je zoledronatna kiselina, koja pripada skupini tvari koje se zovu bisfosfonati.
English: The use of Zoledronic Acid Hospira in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
Croatian: Primjena Zoledronatne kiseline Hospira u bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 35 ml/min) je kontraindicirana zbog povećanog rizika od zatajenja bubrega u ovoj populaciji.
English: You will be given adequate calcium and vitamin D supplements.
Croatian: Dobit ćete odgovarajuće nadomjestke kalcija i vitamina D.
English: After initiating the infusion of zoledronic acid, the plasma concentrations of zoledronic acid rapidly increased, 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 prior to the second infusion of zoledronic acid on day 28.
Croatian: Nakon početka infuzije zoledronatne kiseline, koncentracija zoledronatne kiseline u plazmi brzo se povisila i postigla vršnu vrijednost na kraju razdoblja infuzije, nakon čega je uslijedilo brzo sniženje na < 10% vršne vrijednosti nakon 4 sata te < 1% vršne vrijednosti nakon 24 sata, s narednim produljenim razdobljem vrlo niskih koncentracija koje nisu prelazile 0,1% vršne vrijednosti prije druge infuzije zoledronatne kiseline 28. dana.
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 se zoledronatna kiselina u dozi od 4 mg s pamidronatom u dozi od 90 mg svaka 3 do 4 tjedna u bolesnika s multiplim mijelomom ili rakom dojke i najmanje jednom koštanom lezijom.
English: Solution for infusion 4 mg/100 ml
Croatian: otopina za infuziju 4 mg/100 ml
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 > 60 ml/min) zoledronatna kiselina 4 mg/100 ml otopina za infuziju može se primijeniti izravno bez ikakvog dodatnog razrjeđivanja.
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: The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06-0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Croatian: Dugotrajna ispitivanja ponovljenih parenteralnih doza u životinja pokazala su uzak raspon sigurnosti s obzirom na učinke na bubrege, ali najviša kumulativna doza koja ne uzrokuje oštećenje (NOAEL) u ispitivanjima jednostruke doze (1,6 mg/kg) i višestrukih doza u trajanju do jednog mjeseca (0,060,6 mg/kg/dan) nije imala učinke na bubrege pri dozama jednakima ili višima od najviše terapijske doze za ljude.
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 liječniku ako osjetite bol, slabost ili nelagodu u Vašem bedru, kuku ili preponama, jer to može biti rani znak mogućeg prijeloma bedrene kosti.
English: Renal impairment has been observed in patients after a single administration, renal failure requiring dialysis or with a fatal outcome has rarely occurred in patients with underlying renal impairment or with any of the risk factors described above.
Croatian: Zatajenje bubrega koje zahtijeva dijalizu ili koje je imalo smrtni ishod u rijetkim slučajevima se pojavilo u bolesnika s podležećim oštećenjem bubrega ili s bilo kojim gore opisanim faktorima rizika.
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight.
Croatian: Ukupan tjelesni klirens je 5,04 ± 2,5 1/h, neovisno o dozi te na njega ne utječe spol, dob, rasa ili tjelesna težina.
English: Remove the volume of Zoledronic Acid Hospira solution indicated from the bag prior to administration.
Croatian: Izvucite navedeni volumen Zoledronatne kiseline Hospira iz vreće prije primjene.
English: Placebo Zoledronic Acid
Croatian: Placebo Zoledronatna kiselina
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid and other bisphosphonates as well as use of other nephrotoxic medicinal products.
Croatian: Faktori koji mogu povećati mogućnost pogoršanja funkcije bubrega uključuju dehidraciju, prethodno postojeće oštećenje bubrega, višestruke cikluse liječenja zoledronatnom kiselinom i drugim bisfosfonatima kao i primjenu drugih nefrotoksičnih lijekova.
English: Table 7: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta Nervous system disorders
Croatian: Tablica 7: Nuspojave opažene u pedijatrijskih bolesnika s teškim oblikom osteogenesis imperfecta Poremećaji živčanog sustava često:
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 ponovljenih doza bio je povećana primarna spongioza u metafizama dugih kostiju životinja u razvoju kod gotovo svih doza, što je odraz farmakološkog antiresorptivne aktivnosti tvari.
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta Nervous system disorders
Croatian: Tablica 6: Nuspojave opažene u pedijatrijskih bolesnika s teškim oblikom osteogenesis imperfecta Poremećaji živčanog sustava često:
English: Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change.
Croatian: Zoledronatna kiselina djeluje tako što se spaja na kost i usporava brzinu pregradnje kosti.
English: * Includes vertebral and non-vertebral fractures
Croatian: * Uključuje prijelome kralježaka i drugih kostiju.
English: Patients must be maintained well hydrated prior to and following administration of Zoledronic Acid Hospira.
Croatian: Bolesnici moraju biti dobro hidrirani prije i nakon primjene Zoledronatne kiseline Hospira.
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended.
Croatian: Faktori koji mogu povećati potencijal propadanja funkcije bubrega uključuju dehidraciju, postojeće oštećenje bubrega, višestruke cikluse primjene zoledronatne kiseline ili drugih bisfosfonata kao i istodobnu primjenu nefrotoksičnih lijekova ili kraće trajanje infuzije od trenutno preporučenog.
English: The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.
Croatian: Pri donošenju odluke da se liječe bolesnici s koštanim metastazama radi prevencije koštanih događaja, treba uzeti u obzir da učinak liječenja nastupa nakon 2-3 mjeseca.
English: Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic Acid Hospira, as directed by your doctor.
Croatian: Zoledronatna kiselina Hospira sa hranom i pićem Svakako pijte dovoljno tekućine (barem jednu ili dvije čaše) prije i nakon liječenja Zoledronatnom kiselinom Hospira, kako Vas je uputio Vaš liječnik.
English: Zoledronic Acid Recommended Dose* 4.0 mg zoledronic acid
Croatian: Preporučena doza zoledronatne kiseline* 4,0 mg zoledronatne kiseline
English: - Zoledronic Acid Hospira 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: - Zoledronatna kiselina Hospira 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: 100 ml polypropylene bags with a polypropylene twist-off port fitted with a cap, with a polyester/polypropylene overwrap
Croatian: Polipropilenske vrećice od 100 ml s polipropilenskim zatvaračem s pričvršćenim poklopcem s poliesterskim/polipropilenskim omotom.
English: The following properties have been demonstrated in preclinical studies:
Croatian: U nekliničkim ispitivanjima pokazala je sljedeća svojstva:
English: In patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Zoledronic Acid Hospira administration (see section 4.4).
Croatian: U bolesnika s Pagetovom bolešću, snažno se preporučuje osigurati uzimanje odgovarajućeg nadomjestka kalcija, koji odgovara količini od najmanje 500 mg elementarnog kalcija, dvaput dnevno, tijekom najmanje 10 dana nakon primjene Zoledronatne kiseline Hospira (vidjeti dio 4.4).
English: Zoledronic acid was studied in male and female patients aged above 30 years with primarily mild to moderate Paget's disease of the bone (median serum alkaline phosphatase level 2.6-3.0 times the upper limit of the age-specific normal reference range at the time of study entry) confirmed by radiographic evidence.
Croatian: Zoledronatna kiselina je ispitivana u bolesnika oba spola koji su bili stariji od 30 godina i u kojih je radiološki potvrđena primarno blaga do umjerena Pagetova bolest kosti (u vrijeme ulaska u kliničko ispitivanje medijan razine alkalne fosfataze u serumu bio je 2,6 - 3,0 puta veći od gornje granice normalnog referentnog raspona specifičnog za tu dob).
English: The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Croatian: Nositelj odobrenja mora osigurati uvođenje kartice-podsjetnika za bolesnika u svezi osteonekroze čeljusti.
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: It is unknown whether zoledronic acid is excreted into human milk.
Croatian: Nepoznato je izlučuje li se zoledronatna kiselina u majčino mlijeko.
English: Renal impairment has been observed following the administration of zoledronic acid (see section 4.8), especially in patients with pre-existing renal dysfunction or other risks including advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy (see section 4.5), or dehydration occurring after zoledronic acid administration.
Croatian: Opaženo je oštećenje bubrega nakon primjene zoledronatne kiseline (vidjeti dio 4.8) pogotovo u bolesnika s postojećom disfunkcijom bubrega i drugim rizicima, uključujući uznapredovalu dob, istodobnu primjenu nefrotoksičnih lijekova i istodobnu primjenu diuretske terapije (vidjeti dio 4.5) ili dehidracije nakon primjene zoledronatne kiseline.
English: Your doctor should do a blood test to check your kidney function before each dose of Zoledronic Acid Hospira.
Croatian: Vaš liječnik bi trebao napraviti pretrage krvi kako bi provjerio Vašu funckiju bubrega prije svake doze Zoledronatne kiseline Hospira.
English: Uncommon: Blurred vision, scleritis and orbital inflammation Rare:
Croatian: zamagljen vid, skleritis i upala orbite rijetko:
English: Zoledronic Acid Hospira (5 mg in 100 ml ready-to-infuse solution) is administered via an infusion line and given at a constant infusion rate.
Croatian: Zoledronatnu kiselinu Hospira (5 mg/100 ml otopina spremna za infuziju) treba primijeniti putem infuzijske linije konstantnom brzinom infuzije.
English: In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking zoledronic acid.
Croatian: U razdoblju nakon stavljanja lijeka u promet prijavljeni su jaki i ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima u bolesnika koji su uzimali zoledronatnu kiselinu
English: The use of zoledronic acid in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
Croatian: Primjena zoledronatne kiseline u bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 35 ml/min), kontraindicirana je zbog povećanog rizika od zatajenja bubrega u toj populaciji.
English: Abdominal pain Musculoskeletal and connective tissue disorders Common:
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva često:
English: Eye disorders Common:
Croatian: Poremećaji oka često:
English: The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Croatian: Rezultati su pokazali usporednu djelotvornost zoledronatne kiseline u dozi od 4 mg i 90 mg pamidronata u prevenciji koštanih događaja.
English: Caution is advised when Zoledronic acid is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Croatian: Savjetuje se oprez kod primjene zoledronatne kiseline s lijekovima za koje je poznato da uzrokuju hipokalcemiju budući da mogu imati sinergistički učinak s posljedičnom teškom hipokalcemijom (vidjeti dio 4.5).
English: In the pooled results, a similar decrease in pain severity and pain interference scores relative to baseline were observed over 6 months for zoledronic acid and risedronate.
Croatian: Kada su rezultati bili objedinjeni, nakon 6 mjeseci opaženo je slično sniženje u težini boli i zbrojeva interferencije boli u odnosu na početne vrijednosti za zoledronatnu kiselinu i risedronat.
English: Studies in animals with zoledronic acid have shown reproductive toxicological effects including malformations (see section 5.3).
Croatian: Ispitivanja utjecaja zoledronatne kiseline na reproduktivnost životinja pokazala su da postoji reproduktivna toksičnost uključujući malformacije (vidjeti dio 5.3).
English: - if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid Hospira and inform your doctor about your dental treatment.
Croatian: - ako se liječite kod zubara ili trebate ići na zubarski kirurški zahvat, obavijestite svog zubara da se liječite Zoledronatnom kiselinom Hospira i obavijestite svog liječnika o Vašem liječenju kod zubara.
English: Caution is advised when bisphosphonates are administered with aminoglycosides, calcitonin or loop diuretics since these agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required (see section 4.4).
Croatian: Savjetuje se oprez kod primjene bisfosfonata s aminoglikozidima, kalcitoninom ili diureticima Henleove petlje budući da tijekom duljeg razdoblja ti lijekovi mogu imati aditivan učinak i sniziti razinu kalcija u serumu kroz dulje razdoblje nego što je potrebno (vidjeti dio 4.4).
English: Single and multiple 5- and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients with bone metastases yielded the following pharmacokinetic data, which were found to be dose independent.
Croatian: Jednokratne i višekratne infuzije zoledronatne kiseline u dozi od 2, 4, 8 i 16 mg u trajanju od 5 i 15 minuta u 64 bolesnika s koštanim metastazama dale su sljedeće farmakokinetičke podatke, za koje se pokazalo da ne ovise o dozi.
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 zoledronic acid dose is recommended (see also section 4.4):
Croatian: U bolesnika s koštanim metastazama koji prije početka terapije imaju blago do umjereno oštećenje bubrega koje se za ovu populaciju definira kao CLcr od 30 do 60 ml/min, preporučuje se sljedeća doza zoledronatne kiseline (vidjeti također dio 4.4):
English: In a second study including solid tumours other than breast or prostate cancer, zoledronic acid 4 mg significantly reduced the proportion of patients with an SRE, delayed the median time to first SRE by > 2 months, and reduced the skeletal morbidity rate.
Croatian: U drugom ispitivanju u bolesnika sa solidnim tumorima, izuzev raka dojke ili prostate, zoledronatna kiselina u dozi od 4 mg značajno je smanjila udio bolesnika s koštanim događajima, produljila medijan vremena do prvog koštanog događaja za > 2 mjeseca i smanjila stopu koštanog pobola.
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 infuzijskim otopinama.
English: − The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Croatian: - Otopina koja sadrži zoledronatnu kiselinu daje se kao jednokratna 15-minutna intravenska infuzija kroz zasebnu infuzijsku liniju.
English: − Do not use Zoledronic Acid Hospira after the expiry date stated on the pack.
Croatian: - Zoledronatna kiselina Hospira se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju.
English: Each pack contains one bag which contains 4 mg of zoledronic acid.
Croatian: Svako pakiranje sadrži jednu vrećicu sa 4 mg zoledronatne kisline.
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic Acid Hospira.
Croatian: Vaš liječnik može preporučiti pregled kod zubara prije nego počnete liječenje Zoledronatnom kiselinom Hospira.
English: Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia.
Croatian: Nepravilan rad srca (srčana aritmija), napadaji, grčevi i trzanje mišića (tetanija) prijavljeni su kao posljedica teške hipokalcemije.
English: Patients must be appropriately hydrated prior to administration of Zoledronic Acid Hospira.
Croatian: Bolesnici moraju biti prikladno hidrirani prije primjene Zoledronatne kiseline Hospira.