FrancophonIA/ELRC3.0 huggingface dataset:
English: - Zoledronic Acid Hospira 4 mg/100 ml solution for infusion can be used immediately without further preparation for patients with normal renal function.
Croatian: - Zoledronatna kiselina Hospira 4 mg/100 ml otopina za infuziju može se upotrijebiti odmah bez dodatne pripreme za bolesnike s normalnom funkcijom bubrega.
English: In clinical trials in osteoporosis, the change in creatinine clearance (measured annually prior to dosing) and the incidence of renal failure and impairment was comparable for both the zoledronic acid and placebo treatment groups over three years.
Croatian: U kliničkim ispitivanjima osteoporoze, promjena klirensa kreatinina (mjerenog godišnje prije doziranja) i incidencija zatajenja i oštećenja bubrega bile su usporedive u skupini liječenoj zoledronatnom kiselinom i skupini koja je primala placebo tijekom tri godine.
English: Zoledronic acid is not systemically metabolised and does not affect human cytochrome P450 enzymes in vitro (see section 5.2).
Croatian: Zoledronatna kiselina se ne metabolizira sistemski niti utječe na ljudski citokrom enzim P450 in vitro (vidjeti dio 5.2).
English: The highest non-lethal single intravenous dose was 10 mg/kg body weight in mice and 0.6 mg/kg in rats.
Croatian: Najviša jednokratna intravenska doza bez letalnog učinka iznosila je 10 mg/kg tjelesne težine u miševa i 0,6 mg/kg u štakora.
English: − Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Croatian: - uočeno je da se također vrlo rijetko pojavila i na drugim kostima osim čeljusti, naročito na kuku ili bedrima.
English: The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥ 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
Croatian: Preporučena doza kod hiperkalcijemije (serumski kalcij korigiran za albumin ≥ 12,0 mg/dl ili 3,0 mmol/l) je jednokratna doza od 4 mg zoledronatne kiseline.
English: The onset time is 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Croatian: Vrijeme nastupa je ≤ 3 dana nakon infuzije zoledronatne kiseline, a reakcije se još zovu “simptomi nalik gripi” ili “simptomi nakon doziranja”.
English: This adverse drug reaction consists of a constellation of symptoms that includes fever, myalgia, headache, extremity pain, nausea, vomiting, diarrhoea, arthralgia and arthritis with subsequent joint swelling.
Croatian: Ova nuspojava sastoji se od konstelacije simptoma koji uključuju vrućicu, mialgiju, glavobolju, bol u ekstremitetima, mučninu, povraćanje, proljev, artralgiju i artritis s posljedičnim oticanjem zglobova.
English: Upon initiation of treatment in patients with bone metastases with mild to moderate renal impairment, lower doses of zoledronic acid are recommended.
Croatian: Nakon početka liječenja bolesnika s koštanim metastazama i blagim do umjerenim oštećenjem bubrega preporučuju se niže doze zoledronatne kiseline.
English: The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Croatian: Prvo randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje uspoređivalo je zoledronatnu kiselinu u dozi od 4 mg s placebom u prevenciji koštanih događaja u bolesnika s rakom prostate.
English: In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
Croatian: U kliničkim ispitivanjima provedenima u bolesnika s hiperkalcijemijom izazvanom tumorom, cjelokupni sigurnosni profil bio je sličan po vrsti i težini u sve tri liječene skupine (zoledronatna kiselina u dozi od 4 mg i 8 mg i pamidronat u dozi od 90 mg).
English: The frequencies for each of these identified risks are shown in Table 1.
Croatian: Učestalosti svakog pojedinog utvrđenog rizika navedene su u Tablici 1.
English: Longer-term repeat administration at doses bracketing the highest intended human therapeutic dose of zoledronic acid produced toxicological effects in other organs, including the gastrointestinal tract, liver, spleen and lungs, and at intravenous injection sites.
Croatian: Dugotrajna ponovna primjena doza koje se približavaju najvišoj terapijskoj dozi zoledronatne kiseline za ljude proizvela je toksikološke učinke u drugim organima, uključujući gastrointestinalni trakt, jetru, slezenu i pluća te promjene na mjestu primjene intravenske injekcije.
English: The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients.
Croatian: Opažena neravnoteža u ovom ispitivanju nije bila opažena u drugim ispitivanjima zoledronatne kiseline, uključujući ispitivanja zoledronatne kiseline u dozi od 4 mg primijenjene svaka 3-4 tjedna u onkoloških bolesnika.
English: The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid -treated group versus 49.6% in the placebo group (p=0.003).
Croatian: Udio bolesnika s barem jednim koštanim događajem (isključujući hiperkalcemiju) bio je 29,8% u skupini liječenoj zoledronatnom kiselinom naspram 49,6% u placebo skupini (p=0,003).
English: The chance of experiencing these side effects decreases with subsequent doses of Zoledronic Acid Hospira.
Croatian: Izgledi za pojavu ovih nuspojava smanjuju se sa sljedećim dozama Zoledronatne kiseline Hospira.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika i normalno ne smiju biti dulji od 24 sata pri 2
English: Pharmacodynamic effects
Croatian: Farmakodinamički učinci:
English: Zoledronic acid 4 mg (N=86)
Croatian: 10. dan zoledronatna kiselina 4 mg (n=86)
English: Zoledronic acid is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Croatian: Zoledronatna kiselina je kontraindicirana u bolesnika s klirensom kreatinina < 35 ml/min (vidjeti dijelove 4.3 i 4.4).
English: Patients must be assessed prior to administration of zoledronic acid to ensure that they are adequately hydrated.
Croatian: Bolesnici moraju biti pregledani prije primjene zoledronatne kiseline kako bi se potvrdilo da su odgovarajuće hidrirani.
English: In the clinical programme patients aged 1 to < 3 years received 0.025 mg/kg zoledronic acid (up to a maximum single dose of 0.35 mg) every 3 months and patients aged 3 to 17 years received 0.05 mg/kg zoledronic acid (up to a maximum single dose of 0.83 mg) every 3 months.
Croatian: Bolesnici uključeni u klinički program u dobi od 1 do < 3 godine primali su 0,025 mg/kg zoledronatne kiseline (do najviše jednokratne doze od 0,35 mg) svaka 3 mjeseca, a bolesnici u dobi od 3 do 17 godina primali su 0,05 mg/kg zoledronatne kiseline (do najviše jednokratne doze od 0,83 mg) svaka 3 mjeseca.
English: If any of these apply to you, tell your doctor straight away.
Croatian: Ako se bilo što od navednog odnosi na vas, odmah se obratite svom liječniku.
English: The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg zoledronic acid every 3 to 4 weeks.
Croatian: Preporučena doza za prevenciju koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti je 4 mg zoledronatne kiseline svaka 3 do 4 tjedna.
English: The effects of intravenous zoledronic acid in the treatment of paediatric patients (age 1 to 17 years) with severe osteogenesis imperfecta (types I, III and IV) were compared to intravenous pamidronate in one international, multicentre, randomised, open-label study with 74 and 76 patients in each treatment group, respectively.
Croatian: Učinci intravenski primijenjene zoledronatne kiseline u liječenju pedijatrijskih bolesnika (u dobi od 1 do 17 godina) s teškim oblikom osteogenesis imperfecta (tipovi I, III i IV) usporedili su se s učincima intravenski primijenjenog pamidronata u jednom međunarodnom, multicentričnom, randomiziranom ispitivanju otvorenog tipa u svakoj liječenoj skupini, jednoj sa 74 i drugoj sa 76 bolesnika.
English: Day 10
Croatian: 4. dan
English: In patients with normal renal function, defined as CLcr > 60 ml/min, zoledronic acid 4 mg/100 ml solution for infusion must not be further diluted.
Croatian: U bolesnika s normalnom funkcijom bubrega, koja se definira kao CLcr > 60 ml/min, zoledronatna kiselina 4 mg/100 ml otopina za infuziju ne smije se dodatno razrijediti.
English: Acquired Fanconi syndrome General disorders and administration site conditions Common:
Croatian: stečeni Fanconijev sindrom Opći poremećaji i reakcije na mjestu primjene često:
English: Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal dysfunction or additional risk factors (e.g. advanced age, oncology patients with chemotherapy, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, severe dehydration), the majority of whom received a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
Croatian: Oštećenje bubrega je opaženo nakon primjene zoledronatne kiseline, osobito u bolesnika s prijašnjom disfunkcijom bubrega ili dodatnim faktorima rizika (npr. poodmakla dob, onkološki bolesnici na kemoterapiji, istodobna primjena nefrotoksičnih lijekova, istodobna diuretska terapija, teška dehidracija), od kojih je većina primala dozu od 4 mg svaka 3-4 tjedna, no opaženo je i u bolesnika nakon jednokratne primjene.
English: What you need to know before you are given Zoledronic Acid Hospira
Croatian: Što morate znati prije nego počnete primjenjivati Zoledronatnu kiselinu Hospira
English: Fracture adverse events of long bones in the lower extremities were reported in approximately 24% (femur) and 14% (tibia) of zoledronic acid-treated patients vs 12% and 5% of pamidronate-treated patients with severe osteogenesis imperfecta, regardless of disease type and causality but overall incidence of fractures was comparable for the zoledronic acid and pamidronate-treated patients: 43% (32/74) vs 41% (31/76).
Croatian: Nuspojava prijeloma dugih kostiju donjih ekstremiteta bila je prijavljena u približno 24% (bedrena kost) i 14% (goljenična kost) bolesnika liječenih zoledronatnom kiselinom naspram 12% odnosno 5% u bolesnika s teškim oblikom osteogenesis imperfecta liječenih pamidronatom, bez obzira na tip bolesti i uzrok, no ukupna incidencija prijeloma bila je slična u bolesnika liječenih zoledronatnom kiselinom i onih liječenih pamidronatom: 43% (32/74) naspram 41% (31/76).
English: Zoledronic Acid Hospira must not be allowed to come into contact with any calcium-containing solutions.
Croatian: Zoledronatna kiselina Hospira ne smije doći u kontakt s otopinama koje sadrže kalcij.
English: Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Croatian: Kad je moguće, treba uzeti u obzir privremeni prekid liječenja zoledronatnom kiselinom dok se stanje ne popravi i pripadajući čimbenici rizika ublaže.
English: Instructions for preparing reduced doses of Zoledronic Acid Hospira
Croatian: Upute za pripremu sniženih doza Zoledronatne kiseline Hospira
English: 6 ml, type I clear glass vial or 5 ml plastic vial, stoppered with a fluoropolymer-coated halo-butyl closure and sealed with an aluminium seal and flip-off top.
Croatian: I od 6 ml ili plastična bočica od 5 ml, zatvorene halobutilnim čepom obloženim flourpolimerom, aluminijskim prstenom i ˝flip-off˝ poklopcem.
English: The majority of these reactions were mild to moderate and resolved within three days of the event onset.
Croatian: Te nuspojave su većinom bile blage do umjerene, a povukle su se unutar tri dana od pojave.
English: If you experience any of the above side effects, you should contact your doctor immediately.
Croatian: Ako imate bilo koji od gore navedenih nuspojava, odmah se obratite svom liječniku.
English: The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost zoledronatne kiseline u djece i adolescenata ispod 18 godina nisu ustanovljene.
English: The administration of doses up to 48 mg of zoledronic acid in error has been reported.
Croatian: Prijavljena je primjena doza zoledronatne kiseline do 48 mg zbog pogreške.
English: Psychiatric disorders Uncommon: Anxiety, sleep disturbance Rare:
Croatian: anksioznost, poremećaj spavanja rijetko:
English: Investigations Very common:
Croatian: Pretrage vrlo često:
English: Zoledronic Acid Hospira should be given as a single intravenous infusion in no less than 15 minutes.
Croatian: Zoledronatnu kiselinu Hospira treba primijeniti kao jednokratnu intravensku infuziju u trajanju od najmanje 15 minuta.
English: This medicine contains 16 mmol (or 360 mg) sodium per dose.
Croatian: Ovaj lijek sadrži 16 mmol natrija (360 mg) po dozi.
English: - Do not use this medicine after the expiry date which is stated on the carton and bag.
Croatian: - Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici.
English: For atrial fibrillation serious adverse events the pooled incidences were 1.3% for zoledronic acid and 0.8% for placebo.
Croatian: Objedinjena incidencija ozbiljnih štetnih događaja fibrilacije atrija bila je 1,3% za zoledronatnu kiselinu i 0,8% za placebo.
English: Caution is indicated when zoledronic acid is administered in conjunction with medicinal products that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration) (see section 4.4).
Croatian: Potreban je oprez kada se zoledronatna kiselina primjenjuje zajedno s lijekovima koji mogu značajno utjecati na funkciju bubrega (npr. aminoglikozidi ili diuretici koji mogu uzrokovati dehidraciju) (vidjeti dio 4.4).
English: In patients who show evidence of renal deterioration during treatment, zoledronic acid should be withheld.
Croatian: U bolesnika u kojih se pojave znakovi pogoršanja funkcije bubrega tijekom liječenja, treba prekinuti primjenu zoledronatne kiseline.
English: * Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Croatian: * Doze su izračunate za ciljnu AUC od 0,66 (mg•hr/l) (CLcr = 75 ml/min).
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži zoledronatnu kiselinu u svim podskupinama pedijatrijske populacije u liječenju hiperkalcijemije izazvane tumorom i prevenciji događaja povezanih s koštanim sustavom u bolesnika s uznapredovalom zloćudnom bolešću koja zahvaća kosti (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below.
Croatian: Za pripremu sniženih doza za bolesnike s početnim CLcr ≤ 60 ml/min, vidjeti Tablicu 1 niže.
English: Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Croatian: Zoledronatna kiselina se ne preporučuje za bolesnike koje prije početka terapije imaju teško oštećenje bubrega koje se za ovu populaciju definira kao klirens kreatinina < 30 ml/min.
English: The pain score for zoledronic acid was consistently below baseline and pain reduction was accompanied by a trend in reduced analgesics score.
Croatian: Rezultat na ljestvici bola za zoledronatnu kiselinu bio je dosljedno ispod početne razine, a smanjenje boli bilo je praćeno trendom smanjenja bodova za analgetike.
English: In view of the potential impact of zoledronic acid on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum creatinine 400 µmol/l or 4.5 mg/dl for patients with TIH and 265 µmol/l or 3.0 mg/dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/min), the use of zoledronic acid is not recommended in patients with severe renal impairment.
Croatian: S obzirom na mogući utjecaj zoledronatne kiseline na funkciju bubrega, nedostatak kliničkih podataka o sigurnosti u bolesnika s teškim oštećenjem bubrega (u kliničkim ispitivanjima definiranim kao kreatinin u serumu ≥ 400 μmol/l ili ≥ 4,5 mg/dl u bolesnika s hiperkalcijemijom izazvanom tumorom odnosno ≥ 265 μmol/l ili ≥ 3,0 mg/dl u bolesnika s rakom i koštanim metastazama) na početku liječenja i ograničene farmakokinetičke podatke u bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) na početku liječenja, ne preporučuje se primjena zoledronatne kiseline u bolesnika s teškim oštećenjem bubrega.
English: − To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Hospira concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Croatian: Da bi pripremili otopinu za infuziju koja sadrži 4 mg zoledronatne kiseline, dodatno razrijedite koncentrat Zoledronatne kiseline Hospira (5,0 ml) sa 100 ml otopine za infuziju koja ne sadrži kalcij niti druge dvovalentne katione.
English: Zoledronic acid treatment should be resumed at the same dose as that given prior to treatment interruption.
Croatian: Liječenje zoledronatnom kiselinom treba nastaviti istom dozom koja se primjenjivala prije prekida liječenja.
English: Caution is advised when Zoledronic Acid Hospira is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Croatian: Preporuča se oprez kad se zoledronatna kiselina primjenjuje s antiangiogenim lijekovima jer je primijećena povećana incidencija osteonekroze čeljusti u bolesnika koji su istodobno liječeni ovim lijekovima.
English: The use of Zoledronic Acid Hospira in children and adolescents has not been studied.
Croatian: Primjena Zoledronatne kiseline Hospira u djece i adolescenata nije ispitivana.
English: In addition, 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 administration (see section 4.2).
Croatian: Uz to, u bolesnika s Pagetovom bolesti, strogo se preporuča osigurati adekvatnu nadoknadu kalcija od najmanje 500 mg elementarnog kalcija dvaput dnevno tijekom najmanje 10 dana nakon primjene zoledronatne kiseline (vidjeti dio 4.2).
English: Nervous system disorders Common:
Croatian: Poremećaji živčanog sustava često:
English: In Phase I dose finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2-2.5 mg.
Croatian: U ispitivanjima faze I, određivanja doze u bolesnika s blagom do umjerenom hiperkalcijemijom izazvanom tumorom, djelotvorne ispitivane doze bile su u rasponu od približno 1,2 do 2,5 mg.
English: Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid.
Croatian: Pogoršanje funkcije bubrega koje napreduje do zatajenja bubrega i dijalize, prijavljeno je u bolesnika nakon početne doze ili jednokratne doze od 4 mg zoledronatne kiseline.
English: It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Zoledronic Acid Hospira.
Croatian: Trenutačno je nejasno uzrokuje li zoledronatna kiselina nepravilan srčani ritam, ali trebate to prijaviti svom liječniku ako primijetite takve simptome nakon uzimanja Zoledronatne kiseline Hospira.
English: Zoledronic Acid Hospira must not be mixed or given intravenously with any other medicinal products.
Croatian: Zoledronatna kiselina Hospira se ne smije miješati niti davati intravenski s bilo kojim drugim lijekom.
English: − Since no data are available on the compatibility of Zoledronic Acid Hospira with other intravenously administered substances, Zoledronic Acid Hospira must not be mixed with other medicinal products/substances and should always be given through a separate infusion line.
Croatian: - Budući da nema dostupnih podataka o kompatibilnosti Zoledronatne kiseline Hospira s drugim tvarima za intravensku primjenu, Zoledronatna kiselina Hospira ne smije se miješati s drugim lijekovima/tvarima i uvijek se mora primjenjivati kroz zasebnu infuzijsku liniju.
English: Concentrate for solution for infusion 4 mg/5 ml
Croatian: koncentrat za otopinu za infuziju 4 mg/5 ml
English: Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline.
Croatian: S primjenom zoledronatne kiseline smije se nastaviti tek kad se kreatinin u serumu vrati na vrijednosti unutar 10% početne vrijednosti.
English: - Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Croatian: - Liječenje odraslih bolesnika s hiperkalcijemijom izazvanom tumorom.
English: Hypophosphataemia
Croatian: hipofosfatemija
English: Blood creatinine and blood urea increased, hypocalcaemia Uncommon: Hypomagnesaemia, hypokalaemia Rare:
Croatian: povišeni kreatinin i urea u krvi, hipokalcemija manje često:
English: The SRE rate (events/person year) was 0.628 for zoledronic acid and 1.096 for placebo.
Croatian: Stopa koštanih događaja (događaja po osobi/godini) iznosila je 0,628 u skupini koja je primala zoledronatnu kiselinu i 1,096 u placebo skupini.
English: The frequencies for each of these identified risks are shown in Table 2.
Croatian: Učestalosti svakog pojedinog utvrđenog rizika navedene su u Tablici 2.
English: Uncommon: Thrombocytopenia, leukopenia Rare:
Croatian: trombocitopenija, leukopenija rijetko:
English: Do not mix Zoledronic Acid Hospira concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Croatian: Nemojte miješati koncentrat Zoledronatne kiseline Hospira s otopinama koje sadrže kalcij ili druge dvovalentne katione kao što je otopina Ringerovog laktata.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Croatian: Ako se ne upotrijebi odmah, vrijeme i uvjeti čuvanja prije upotrebe su odgovornost korisnika i ne bi trebali biti dulji od 24 sata na 2°8° C.
English: There was faster normalisation of corrected serum calcium at day 4 for 8 mg zoledronic acid and at day 7 for 4 mg and 8 mg zoledronic acid.
Croatian: Bila je brža normalizacija korigiranog kalcija u serumu 4. dana kod doze zoledronatne kiseline od 8 mg i 7. dana kod doze zoledronatne kiseline od 4 i 8 mg.