FrancophonIA/ELRC3.0 huggingface dataset:
English: • Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula before each zoledronic acid dose.
Croatian: • Prije svake doze zoledronatne kiseline treba izračunati klirens kreatinina na temelju stvarne tjelesne težine koristeći Cockcroft-Gaultovu formulu.
English: Talk to your doctor before you are given Zoledronic acid Teva Generics: - if you are being treated with any other bisphosphonate medicine, since the combined effects of these medicines taken together with Zoledronic acid Teva Generics are unknown.
Croatian: Obavijestite svojeg liječnika prije nego što počnete uzimati Zoledronatnu kiselinu Teva Generics: - ako se liječite drugim bisfosfonatima jer nisu poznati kombinirani učinci tih lijekova i Zoledronatne kiseline Teva Generics.
English: Zoledronic acid Teva Generics has no or negligible influence on the ability to drive and use machines.
Croatian: Zoledronatna kiselina Teva Generics ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone.
Croatian: Zoledronatna kiselina pripada skupini bisfosfonata koji sadržavaju dušik i djeluju prvenstveno na kosti.
English: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
Croatian: Atipični subtrohanterični i dijafizealni prijelomi bedrene kosti prijavljeni su uz terapiju bisfosfonatima, prvenstveno u bolesnika koji se dugotrajno liječe od osteoporoze.
English: Zoledronic acid significantly increased BMD at the lumbar spine, hip, and distal radius relative to treatment with placebo at all timepoints (6, 12, 24 and 36 months).
Croatian: Zoledronatna kiselina je značajno povećala BMD lumbalne kralježnice, kuka i distalnog dijela palčane kosti u usporedbi s liječenjem placebom i to u svim vremenskim točkama (6, 12, 24 i 36 mjeseci).
English: Treatment with zoledronic acid resulted in an increase in BMD of 5.4% at the total hip and 4.3% at the femoral neck over 24 months as compared to placebo.
Croatian: Liječenje zoledronatnom kiselinom rezultiralo je povećanjem BMD-a od 5,4% cijelog kuka i 4,3% vrata bedrene kosti više od 24 mjeseca u usporedbi s placebom.
English: The Marketing Authorisation Holder (MAH) shall ensure that the educational programme implemented for the authorised indications of treatment of osteoporosis in post-menopausal women and in men at increased risk of fracture, including those with a recent low-trauma hip fracture, and treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture is updated.
Croatian: Nositelj odobrenja mora osigurati ažuriranje programa izobrazbe koji se provodi za odobrene indikacije liječenja osteoporoze u postmenopauzalnih žena te u muškaraca s povećanim rizikom od prijeloma, uključujući one s nedavnim prijelomom kuka nakon slabe traume, te liječenja osteoporoze povezane s dugotrajnom sistemskom terapijom glukokortikoidima u postmenopauzalnih žena i u muškaraca s povećanim rizikom od prijeloma.
English: Patients must be appropriately hydrated prior to administration of zoledronic acid.
Croatian: Bolesnici moraju biti prikladno hidrirani prije primjene zoledronatne kiseline.
English: • Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of Zoledronic acid Teva Generics.
Croatian: • Bolesnici, osobito stariji i oni koji primaju diuretsko liječenje, moraju biti prikladno hidrirani prije primjene Zoledronatne kiseline Teva Generics.
English: Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with zoledronic acid (see section 4.3).
Croatian: Postojeća se hipokalcijemija mora prije uvođenja terapije zoledronatnom kiselinom liječiti odgovarajućim unosom kalcija i vitamina D (vidjeti dio 4.3).
English: The rate of atrial fibrillation serious adverse events was increased in patients receiving zoledronic acid (1.3%) (51 out of 3,862) compared with patients receiving placebo (0.6%) (22 out of 3,852).
Croatian: Stopa ozbiljnih štetnih događaja fibrilacije atrija bila je veća u bolesnika koji su primali zoledronatnu kiselinu (1,3%) (51 od 3862) nego u onih koji su primali placebo (0,6%) (22 od 3852).
English: • Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of zoledronic acid.
Croatian: • Bolesnici, osobito stariji i oni koji primaju diuretsko liječenje, moraju biti prikladno hidrirani prije primjene zoledronatne kiseline.
English: Any unused solution should be discarded.
Croatian: Neiskorištenu otopinu treba zbrinuti.
English: Pharmacodynamic effects The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone.
Croatian: Selektivno djelovanje bisfosfonata na kost zasniva se na njihovom visokom afinitetu prema mineraliziranoj kosti.
English: Zoledronic acid (5 mg in 100 ml ready-to-infuse solution) is administered via a vented infusion line and given at a constant infusion rate.
Croatian: Zoledronatna kiselina (5 mg u 100 ml otopine spremne za infuziju) primjenjuje se putem infuzijske cjevčice s odzračivanjem uz konstantnu brzinu infuzije.
English: Bone biopsies were obtained from the iliac crest 1 year after the third annual dose in 152 post-menopausal patients with osteoporosis treated with zoledronic acid (N=82) or placebo (N=70).
Croatian: Godinu dana nakon treće godišnje doze biopsijom su uzeti uzorci iz grebena ilijačne kosti od 152 bolesnice u postmenopauzi s osteoporozom liječene zoledronatnom kiselinom (N=82) ili placebom (N=70).
English: The use of Zoledronic acid Teva Generics in children and adolescents has not been studied.
Croatian: Nije ispitana primjena Zoledronatne kiseline Teva Generics u djece i adolescenata.
English: Table 3 Between treatment comparisons of the incidence of key clinical fracture variables over 3 years
Croatian: Tablica 3 Usporedbe ispitivanih skupina s obzirom na incidenciju ključnih varijabli kliničkih prijeloma tijekom 3 godine
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BAG
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
English: What Zoledronic acid Teva Generics is and what it is used for What you need to know before you are given Zoledronic acid Teva Generics How Zoledronic acid Teva Generics is given Possible side effects
Croatian: Što je Zoledronatna kiselina Teva Generics i za što se koristi Što morate znati prije nego primite Zoledronatnu kiselinu Teva Generics Kako se primjenjuje Zoledronatna kiselina Teva Generics
English: What Zoledronic acid Teva Generics looks like and contents of the pack Zoledronic acid Teva Generics is a clear and colourless solution for infusion.
Croatian: Kako Zoledronatna kiselina Teva Generics izgleda i sadržaj pakovanja Zoledronatna kiselina Teva Generics je bistra i bezbojna otopina za infuziju.
English: Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
Croatian: U tijeku evaluacije bolesnika u kojih se sumnja na atipičan prijelom bedrene kosti mora se razmotriti prekid terapije bisfosfonatima na temelju individualne procjene koristi i rizika.
English: 1 bottle of 100 ml.
Croatian: 1 bočica od 100 ml.
English: Luxembourg/Luxemburg Teva Pharma Belgium S.A. Tél: +32 3 820 73 73
Croatian: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Tél: +32 3 820 73 73
English: The clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Croatian: Procjena liječnika mora se zasnivati na kliničkom statusu svakog pojedinog bolesnika te individualnoj procjeni koristi i rizika.
English: Patients being treated with zoledronic acid should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Croatian: Bolesnici koji se liječe zoledronatnom kiselinom ne smiju se istovremeno liječiti tim lijekovima ili nekim drugim bisfosfonatima jer nisu poznati kombinirani učinci tih lijekova.
English: Ask your doctor, pharmacist or nurse for advice before taking any medicine.
Croatian: Obratite se svomliječniku, ljekarniku ili medicinskoj sestri za savjet prije nego što uzmete bilo koji lijek.
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 primijeni odmah, vrijeme i uvjeti čuvanja lijeka prije uporabe odgovornost su korisnika i normalno ne smiju biti dulji od 24 sata pri 2°C - 8°C.
English: In the single-dose dog infusion studies, 1.0 mg/kg (6 fold the recommended human therapeutic exposure based on AUC) administered over 15 minutes was well tolerated with no renal effects.
Croatian: U ispitivanjima pojedinačne doze infuzijom u pasa, doza od 1,0 mg/kg (šesterostruko viša od preporučene terapijske izloženosti u ljudi bazirano na AUC-u) primijenjena u trajanju od 15 minuta bila je dobro podnesena, bez učinaka na bubrege.
English: Before stopping Zoledronic acid Teva Generics therapy If you are considering stopping Zoledronic acid Teva Generics treatment, please go to your next appointment and discuss this with your doctor.
Croatian: Ako razmišljate o prekidu liječenja Zoledronatnom kiselinom Teva Generics, molimo dođite na sljedeći termin i o toj odluci razgovarate sa svojim liječnikom.
English: Uncommon Influenza, nasopharyngitis
Croatian: Manje često Influenca, nazofaringitis
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 jednom godišnje prije doziranja) i incidencija zatajenja i oštećenja bubrega bile su usporedive u skupini liječenoj zoledronatnom kiselinom i u skupini koja je primala placebo tijekom tri godine.
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 to 8°C.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja lijeka prije uporabe odgovornost su korisnika i normalno ne smiju biti duži od 24 sata na 2 do 8°C.
English: • in adult men at increased risk of fracture.
Croatian: • u žena u postmenopauzi • u odraslih muškaraca s povećanim rizikom od prijeloma.
English: Bone specific alkaline phosphatase (BSAP), serum N-terminal propeptide of type I collagen (P1NP) and serum beta-C-telopeptides (b-CTx) were evaluated in subsets ranging from 517 to 1,246 patients at periodic intervals throughout the study.
Croatian: I (P1NP) i serumski beta-C-telopeptidi (bCTx) u podskupinama u rasponu od 517 do 1246 bolesnica.
English: In the intravenous bolus studies, the doses that were welltolerated decreased with increasing study duration: 0.2 and 0.02 mg/kg daily was well tolerated for 4 weeks in rats and dogs, respectively but only 0.01 mg/kg and 0.005 mg/kg in rats and dogs, respectively, when given for 52 weeks.
Croatian: U ispitivanjima s intravenskom bolus injekcijom doze koje su se dobro podnosile smanjivale su se s povećanjem trajanja ispitivanja: dozu od 0,2 i 0,02 mg/kg na dan dobro su podnosili štakori, odnosno psi tijekom 4 tjedna, no nakon 52 tjedna primjene štakori su podnosili dozu od samo 0,01 mg/kg, a psi samo od 0,005 mg/kg.
English: In the HORIZON-RFT study zoledronic acid treatment significantly increased BMD at the total hip and femoral neck relative to treatment with placebo at all timepoints.
Croatian: U ispitivanju HORIZON-RFT liječenje zoledronatnom kiselinom je značajno povećalo BMD cijelog kuka i vrata bedrene kosti obzirom na placebo u svim vremenskim točkama.
English: Headache, dizziness, sickness, vomiting, diarrhoea, pain in the muscles, pain in the bones and/or joints, pain in the back, arms or legs, flu-like symptoms (e.g. tiredness, chills, joint and muscle pain), chills, feeling of tiredness and lack of interest, weakness, pain, feeling unwell.
Croatian: Glavobolja, omaglica, mučnina, povraćanje, proljev, bol u mišićima, bol u kostima i/ili zglobovima, bol u leđima, rukama ili nogama, simptomi nalik gripi (npr. umor, zimica, bol u zglobovima i mišićima), zimica, osjećaj umora i gubitak interesa, slabost, bol, opće loše osjećanje.
English: Zoledronic acid significantly reduced the mean days of limited activity and the days of bed rest due to back pain by 17.9 days and 11.3 days respectively compared to placebo and significantly reduced the mean days of limited activity and the days of bed rest due to fractures by 2.9 days and 0.5 days respectively compared to placebo (all p<0.01).
Croatian: Zoledronatna kiselina značajno je smanjila srednju vrijednost broja dana s ograničenom aktivnošću za 17,9 dana u usporedbi s placebom, odnosno srednju vrijednost broja dana s ograničenom aktivnošću zbog prijeloma za 2,9 i broja dana provedenih u krevetu zbog prijeloma za 0,5 dana u odnosu na placebo (za sve p<0,01).
English: The usual dose is 5 mg, given to you as one initial infusion into a vein by your doctor or nurse.
Croatian: Uobičajena doza iznosi 5 mg, a daje Vam je liječnik ili medicinska sestra u obliku jedne infuzije u venu.
English: Zoledronic acid-treated patients aged 75 years and older exhibited a 60% reduction in the risk of vertebral fractures compared to placebo patients (p<0.0001).
Croatian: U bolesnica u dobi od 75 godina i više koje su primale zoledronatnu kiselinu zabilježen je smanjen rizik od prijeloma za 60% u usporedbi s bolesnicama koje su primale placebo (p<0,0001).
English: The recommended dose is a single intravenous infusion of 5 mg zoledronic acid.
Croatian: Preporučena doza je jedna intravenska infuzija od 5 mg zoledronatne kiseline.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Bubrežna funkcija
English: Patients who were classified as responders at the end of the 6 month core study were eligible to enter an extended follow-up period.
Croatian: Bolesnici koji su na kraju šestomjesečnog osnovnog kliničkog ispitivanja bili klasificirani kao osobe u kojih je zabilježen terapijski odgovor zadovoljili su kriterije za uključivanje u produljeno razdoblje praćenja.
English: Severe and occasionally incapacitating bone, joint and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including zoledronic acid (see section 4.8).
Croatian: Manje često su zabilježeni teški, a ponekad i onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima u bolesnika koji uzimaju bisfosfonate, uključujući zoledronatnu kiselinu (vidjeti dio 4.8).
English: PHARMACEUTICAL FORM AND CONTENTS Solution for infusion multipack: 5 bottles x 100 ml multipack: 10 bottles x 100 ml
Croatian: OBLIK I SADRŽAJ Otopina za infuziju višestruko pakiranje: 5 vrećicax 100 ml višestruko pakiranje: 10 vrećicax 100 ml
English: Treatment with a 5 mg annual dose of zoledronic acid significantly reduced BSAP by 30% relative to baseline at 12 months which was sustained at 28% below baseline levels at 36 months.
Croatian: Liječenje godišnjom dozom od 5 mg zoledronatne kiseline značajno je smanjilo BSAP za 30% nakon 12 mjeseci u odnosu na početnu vrijednost, a to je smanjenje održano na 28% ispod početnih razina nakon 36 mjeseci.
English: Microcomputed tomography (μCT) analysis demonstrated increased trabecular bone volume and preservation of trabecular bone architecture in patients treated with zoledronic acid compared to placebo.
Croatian: (μCT) pokazala je povećani volumen trabekularne kosti i očuvanje arhitekture trabekularne kosti u bolesnica liječenih zoledronatnom kiselinom u usporedbi s onima koje su primale placebo.
English: - Store below 30°C.
Croatian: - Čuvati na temperaturi ispod 30ºC.
English: MARKETING AUTHORISATION HOLDER Teva B.V.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva B.V.
English: In patients with a recent low-trauma hip fracture, it is recommended to give the zoledronic acid infusion at least two weeks after hip fracture repair (see section 5.1).
Croatian: U bolesnika s nedavnim prijelomom kuka nakon slabe traume preporučuje se primjena infuzije zoledronatne kiseline najmanje dva tjedna nakon oporavka prijeloma kuka (vidjeti dio 5.1).
English: The chance of experiencing these side effects decreases with subsequent doses of Zoledronic acid Teva Generics.
Croatian: Izgledi za razvoj ovih nuspojava smanjuju se sa sljedećim dozama Zoledronatne kiseline
English: The hip fracture event rate was 1.44% for zoledronic acid-treated patients compared to 2.49% for placebo-treated patients.
Croatian: Stopa prijeloma kuka iznosila je 1,44% u bolesnika koji su liječeni zoledronatnom kiselinom u usporedbi s 2,49% u onih koji su primali placebo.
English: In the HORIZON - Pivotal Fracture Trial [PFT] (see section 5.1), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid and placebo, respectively.
Croatian: U ispitivanju HORIZON - (Pivotal Fracture Trial [PFT]) (vidjeti dio 5.1), ukupna incidencija atrijske fibrilacije iznosila je 2,5% (96 od 3862) u bolesnika koji su primali zoledronatnu kiselinu i 1,9% (75
English: 1 bottle of 100 ml
Croatian: 1 bočica od 100 ml
English: The pack sizes of 5 and 10 are only available as multipacks comprising of 5 or 10 packs, each containing 1 bottle.
Croatian: Pakiranja sa 5 i 10 bočica dostupna su samo kao višestruka pakiranja koja sadrže 5 ili 10
English: Uncommonly, cases of osteonecrosis (primarily of the jaw) have been reported, predominantly in cancer patients treated with bisphosphonates, including zoledronic acid.
Croatian: Manje često, zabilježeni su slučajevi osteonekroze (primarno čeljusti), pretežito u bolesnika s rakom liječenih bisfosfonatima, uključujući zoledronatnu kiselinu.
English: Zoledronic acid Teva Generics is supplied in multipacks containing 5 or 10 bags.
Croatian: Zoledronatna kiselina Teva Generics dostupna je u višestrukim pakiranjima sa 5 ili 10 vrećica.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva B.V.
English: Myalgia, arthralgia, bone pain, back pain, pain in extremity
Croatian: Mialgija, artralgija, bol u kostima, bol u leđima, bol u ekstremitetima
English: What Zoledronic acid Teva Generics contains - The active substance is zoledronic acid.
Croatian: Što Zoledronatna kiselina Teva Generics sadrži - Djelatna tvar je zoledronatna kiselina.
English: In patients treated with zoledronic acid, no osteomalacia, marrow fibrosis or woven bone formation was detected.
Croatian: U bolesnica liječenih zoledronatnom kiselinom nisu otkriveni osteomalacija, fibroza srži niti stvaranje ne lamelarne kosti.
English: - After opening the bottle, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
Croatian: Nakon otvaranja bočice, dokazana je kemijska i fizikalna stabilnost u primjeni tijekom 24 sata na temperaturi od 2 do 8°C te na 25ºC.
English: Each bag contains 100 ml of solution.
Croatian: Svaka vrećica sadrži 100 ml otopine.
English: Effect on hip fractures
Croatian: Učinak na prijelom kuka
English: Flu-like symptoms, chills, fatigue, asthenia, pain, malaise, infusion site reaction
Croatian: Simptomi nalik gripi, zimica, umor, astenija, bol, malaksalost, reakcija na mjestu primjene infuzije
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
Croatian: Prijavljeni su rijetki slučajevi zatajenja bubrega koji iziskuju dijalizu i rijetki slučajevi sa smrtnim ishodom u bolesnika s postojećim poremećajem funkcije bubrega ili u bolesnika s drugim rizicima uključujući poodmaklu dob, istovremenu primjenu nefrotoksičnih lijekova, istovremenu primjenu diuretskog liječenja ili dehidraciju u razdoblju nakon infuzije (vidjeti dijelove 4.4 i 4.8 Učinci klase)
English: B-CTx was significantly reduced by 61% below baseline levels at 12 months and was sustained at 55% below baseline levels at 36 months.
Croatian: B-CTx je bio značajno smanjen za 61% ispod početnih razina nakon 12 mjeseci, a to je smanjenje održano na 55% ispod početnih razina nakon 36 mjeseci.
English: 36 months.
Croatian: mjeseci).
English: During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).
Croatian: Nakon stavljanja lijeka na tržište zabilježene su sljedeće nuspojave (učestalost: rijetko): atipični subtrohanterični i dijafizealni prijelomi bedrene kosti (nuspojava kod bisfosfonata).
English: 6.5 Nature and contents of container multilayer polyolefin/styrene-ethylene-butylene (SEB) bag with SFC polypropylene infusion port closed with rubber stopper and snap cap.
Croatian: Višeslojna poliolefin/stiren-etilen-butilen (SEB) vrećica sa SFC polipropilenskim infuzijskim otvorom zatvorenim gumenim čepom i kapicom.
English: For information on the infusion of Zoledronic acid Teva Generics, see section 6.6.
Croatian: Za informacije o infuziji Zoledronatne kiseline Teva Generics vidjeti dio 6.6. 4.3 Kontraindikacije
English: This medicinal product must not be allowed to come into contact with any calcium-containing solutions.
Croatian: Ovaj lijek ne smije doći u dodir s otopinama koje sadrži kalcij.
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 umjereno teške, a povukle su se unutar tri dana od pojave.
English: Skin and subcutaneous tissue disorders Uncommon Rash, hyperhydrosis, pruritus, erythema Musculoskeletal and connective tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva Manje često Osip, hiperhidroza, svrbež, eritem Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: Studies in animals with zoledronic acid have shown reproductive toxicological effects including malformations (see section 5.3).
Croatian: Reproduktivna ispitivanja na životinjama sa zoledronatnom kiselinom pokazala su reproduktivnu toksičnost uključujući pojavu malformacija
English: Treatment with zoledronic acid resulted in a 6.7% increase in BMD at the lumbar spine, 6.0% at the total hip, 5.1% at the femoral neck, and 3.2% at the distal radius over 3 years as compared to placebo.
Croatian: Liječenje zoledronatnom kiselinom dovelo je do porasta BMD-a lumbalne kralježnice od 6,7%, ukupnog BMD-a kuka od 6,0%, BMD-a vrata bedrene kosti od 5,1% i distalnog dijela palčane kosti od 3,2% tijekom 3 godine u usporedbi s placebom.
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: Nakon primjene zoledronatne kiseline zapaženo je oštećenje funkcije bubrega (vidjeti dio 4.8), osobito u bolesnika s prethodnim poremećajem bubrežne funkcije ili u bolesnika s drugim rizicima uključujući poodmaklu dob, istovremenu primjenu nefrotoksičnih lijekova, istovremenu primjenu diuretskog liječenja (vidjeti dio 4.5) ili dehidraciju koja se pojavljuje nakon primjene zoledronatne kiseline.