FrancophonIA/ELRC3.0 huggingface dataset:
English: How to prepare and administer Zoledronic Acid Teva - To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Teva concentrate (5 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Croatian: Kako pripremiti i primijeniti Zoledronatnu kiselinu Teva - Da biste pripremili otopinu za infuziju koja sadrži 4 mg zoledronatne kiseline, dodatno razrijedite koncentrat Zoledronatne kiseline Teva (5 ml) sa 100 ml otopine za infuziju koja ne sadrži kalcij niti druge dvovalentne katione.
English: Zoledronic Acid Teva can be given to people aged 65 years and over.
Croatian: Bolesnici u dobi od 65 ili više godina Zoledronatna kiselina Teva može se davati osobama u dobi od 65 ili više godina.
English: When initiating treatment with Zoledronic Acid Teva in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Croatian: Kad se počinje liječenje Zoledronatnom kiselinom Teva u bolesnika s multiplim mijelomom ili solidnim tumorom koji je metastazirao u kosti, potrebno je odrediti vrijednosti kreatinina u serumu i klirens kreatinina (CLcr).
English: Patients with TIH and evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with Zoledronic Acid Teva outweighs the possible risk.
Croatian: Bolesnike s hiperkalcemijom izazvanom tumorom i dokazanim pogoršanjem funkcije bubrega treba procijeniti na odgovarajući način i pritom razmotriti jesu li moguće koristi od liječenja Zoledronatnom kiselinom Teva veće od mogućih rizika.
English: This resulted in exaggerated pharmacological effects considered to be related to the compound's inhibition of skeletal calcium metabolisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
Croatian: Rezultati su pokazali pojačane farmakološke učinke za koje se smatra da su povezani s inhibicijom metabolizma kalcija u kostima koju taj spoj izaziva, s posljedičnom hipokalcemijom u vrijeme parturicije, što je učinak razreda bisfosfonata, s distocijom i ranim prekidom ispitivanja.
English: In a pooled analysis of safety data from zoledronic acid registration trials 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 primjene zoledronatne kiseline iz registracijskih ispitivanja za sprječavanje koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti, učestalost štetnih događaja oštećenja funkcije bubrega za koje se sumnjalo da su povezani sa zoledronatnom kiselinom (nuspojave) bila je sljedeća: multipli mijelom (3,2%), karcinom prostate (3,1%), karcinom dojke (4,3%), tumor pluća i drugi solidni tumori (3,2%).
English: Patients must be assessed prior to administration of Zoledronic Acid Teva to ensure that they are adequately hydrated.
Croatian: Bolesnici moraju biti pregledani prije primjene Zoledronatne kiseline Teva kako bi se potvrdilo da su odgovarajuće hidrirani.
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients)
Croatian: Tablica 4: Rezultati djelotvornosti (u bolesnika s karcinomom dojke i multiplim mijelomom)
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) iznosio je 29,8% u skupini liječenoj zoledronatnom kiselinom i 49,6% u skupini koja je primala placebo (p=0,003).
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Croatian: Tablica 3: Rezultati djelotvornosti (solidni tumori osim karcinoma dojke i prostate) Bilo koji koštani događaj
English: Instructions for preparing reduced doses of Zoledronic Acid Teva: Withdraw the appropriate volume of the liquid concentrate, as follows: - 4.4 ml for 3.5 mg dose
Croatian: Upute za pripremu sniženih doza Zoledronatne kiseline Teva Izvucite sljedeći odgovarajući volumen tekućeg koncentrata: - 4,4 ml za dozu od 3,5 mg
English: Warnings and precautions Talk to your doctor before you are given Zoledronic Acid Teva: - if you have or have had a kidney problem.
Croatian: Obratite se svom liječniku prije nego primite Zoledronatnu kiselinu Teva: - ako imate ili ste imali tegobe s bubrezima.
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 putem zasebne infuzijske linije.
English: What Zoledronic Acid Teva is and what it is used for What you need to know before you are given Zoledronic Acid Teva How Zoledronic Acid Teva is given Possible side effects
Croatian: Što je Zoledronatna kiselina Teva i za što se koristi Što morate znati prije nego primite Zoledronatnu kiselinu Teva Kako primjenjivati Zoledronatnu kiselinu Teva
English: Hypocalcaemia has been reported in patients treated with Zoledronic Acid Teva.
Croatian: Hipokalcemija je zabilježena u bolesnika liječenih Zoledronatnom kiselinom Teva.
English: Placebo Δ Zoledronic acid 
Croatian: Placebo Δ Zoledronatna kiselina 
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Croatian: Srčane aritmije i neurološki štetni događaji (uključujući konvulzije, hipoesteziju i tetaniju) zabilježeni su sekundarno uz slučajeve teške hipokalcemije.
English: The active substance is zoledronic acid.
Croatian: - Djelatna tvar je zoledronatna kiselina.
English: - Sleepiness.
Croatian: - Pospanost.
English: Zoledronic Acid Teva is contraindicated in breast-feeding women (see section 4.3).
Croatian: Zoledronatna kiselina Teva kontraindicirana je u dojilja (vidjeti dio 4.3).
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 skupine simptoma koja uključuje vrućicu, mialgiju, glavobolju, bol u ekstremitetima, mučninu, povraćanje, proljev, artralgiju i artritis s posljedičnim oticanjem zglobova.
English: Table 5: Proportion of complete responders by day in the combined TIH studies Day 4
Croatian: Tablica 5: Udio ispitanika s potpunim odgovorom prema danima u kombiniranim ispitivanjima liječenja hiperkalcemije izazvane tumorom
English: - The total time between dilution, storage in the refrigerator and end of administration must not exceed 24 hours.
Croatian: Ukupno vrijeme od razrjeđenja i čuvanja u hladnjaku do završetka primjene ne smije biti dulje od
English: Prilaz baruna Filipovića 25
Croatian: PLIVA Hrvatska d.o.o. Prilaz baruna Filipovića 25, 10 000 Zagreb
English: - High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation,
Croatian: - Visoki krvni tlak, nedostatak zraka, omaglica, tjeskoba, poremećaji spavanja, promjena osjeta okusa, drhtavica, trnci ili utrnulost šaka ili stopala, proljev, zatvor, bol u trbuhu, suha usta.
English: LIST OF EXCIPIENTS Excipients: mannitol, sodium citrate and water for injections.
Croatian: Pomoćne tvari: manitol, natrijev citrat i voda za injekcije.
English: Manufacturer Pharmachemie B.V. Swensweg 5
Croatian: Proizvođač Pharmachemie B.V.
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: Čimbenici koji mogu povećati mogućnost pogoršanja funkcije bubrega uključuju dehidraciju, prethodno postojeće oštećenje funkcije bubrega, višestruke cikluse liječenja zoledronatnom kiselinom i drugim bisfosfonatima, kao i uzimanje drugih nefrotoksičnih lijekova.
English: Acute renal failure, haematuria, proteinuria Acquired Fanconi syndrome
Croatian: oštećenje funkcije bubrega akutno zatajenje bubrega, hematurija, proteinurija stečeni Fanconijev sindrom
English: EXP Use immediately after dilution.
Croatian: Primijeniti odmah nakon razrjeđivanja.
English: Common (may affect up to 1 in 10 people): - Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Croatian: Odmah obavijestite svog liječnika o svakoj sljedećoj ozbiljnoj nuspojavi: Često (mogu se javiti u do 1 na 10 osoba): - Teško oštećenje funkcije bubrega (obično će ga utvrditi liječnik pomoću određenih specifičnih krvnih pretraga).
English: - Zoledronic acid must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Croatian: - Zoledronatnu kiselinu Teva smiju davati samo zdravstveni radnici iskusni u davanju bisfosfonata intravenskim putem, tj. u venu.
English: - Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Croatian: - Nepravilan srčani ritam (fibrilacija atrija) opažen je u bolesnica koje su primale zoledronatnu kiselinu zbog osteoporoze u postmenopauzi.
English: - In vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer medicinal products, anti-adhesion/invasion activity.
Croatian: − in vitro: inhibicija proliferacije osteoblasta, izravno citostatsko i proapoptotsko djelovanje na tumorske stanice, sinergistički citostatski učinak s drugim antitumorskim lijekovima,
English: Patients being treated with Zoledronic acid Teva should not be treated with such medicinal products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Croatian: Teva ne smiju se istovremeno liječiti takvim lijekovima ili bilo kojim drugim bisfosfonatom, budući da nisu poznati kombinirani učinci tih lijekova.
English: Common (may affect up to 1 in 10 people): - Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Croatian: Često (mogu se javiti u do 1 na 10 osoba): - Glavobolja i sindrom nalik gripi koji se sastoji od vrućice, umora, slabosti, omamljenosti, zimice i bolova u kostima, zglobovima i/ili mišićima.
English: Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
Croatian: hipertenzija, hipotenzija, fibrilacija atrija, hipotenzija s posljedičnom sinkopom ili cirkulacijskim kolapsom bradikardija, srčana aritmija (uslijed hipokalcemije)
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Zoledronic Acid Teva.
Croatian: Tijekom liječenja Zoledronatnom kiselinom Teva sve bolesnike se mora poticati da održavaju dobru oralnu higijenu, redovito odlaze na stomatološke kontrole i odmah prijave bilo koji oralni simptom kao što je pomičnost zuba, bol ili oticanje, ili ranice koje ne cijele ili iscjedak.
English: - Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Croatian: 4.1 Terapijske indikacije - Sprječavanje koštanih događaja (patološki prijelomi, kompresija kralježaka, zračenje ili kirurški zahvat na kosti ili hiperkalcemija izazvana tumorom) u odraslih bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti.
English: Zoledronic Acid Teva should only be resumed when serum creatinine returns to within 10% of baseline.
Croatian: S primjenom Zoledronatne kiseline Teva smije se nastaviti tek kad se kreatinin u serumu vrati na vrijednosti unutar 10% početne vrijednosti.
English: 45.3% (p=0.104) 82.6% (p=0.005)* 88.4% (p=0.002)*
Croatian: Zoledronatna kiselina 4 mg (N=86) 45,3% (p=0,104) 82,6% (p=0,005)* 88,4% (p=0,002)* Zoledronatna kiselina 8 mg (N=90) 55,6% (p=0,021)* 83,3% (p=0,010)* 86,7% (p=0,015)* Pamidronat 90 mg (N=99)
English: - Skin reactions (redness and swelling) at the infusion site, rash, itching.
Croatian: - Kožne reakcije (crvenilo i oticanje) na mjestu primjene infuzije, osip, svrbež.
English: Patients treated with Zoledronic Acid Teva should be given the package leaflet and the patient reminder card.
Croatian: Bolesnicima koji se liječe Zoledronatnom kiselinom Teva potrebno je dati uputu o lijeku i karticu-podsjetnik za bolesnika.
English: The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 cancer patients studied.
Croatian: Bubrežni klirens zoledronatne kiseline korelirao je s klirensom kreatinina, s time da je bubrežni klirens predstavljao 75±33% klirensa kreatinina, koji je prosječno iznosio 84 ± 29 ml/min (raspon od 22 do 143 ml/min) u 64 uključena onkološka bolesnika.
English: Proportion of patients with SREs (%) p-value
Croatian: Udio bolesnika s koštanim događajem (%)
English: In a third phase III randomised, double-blind trial, 4 mg zoledronic acid 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 trećem 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 karcinomom dojke i najmanje jednom koštanom lezijom.
English: The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Croatian: Stopa fibrilacije atrija kao ozbiljna štetnog događaja bila je 1,3% (51 od 3862) u bolesnica koje su primale zoledronatnu kiselinu u dozi od 5 mg i 0,6% (22 od 3852) u bolesnica koje su primale placebo.
English: Acute phase reaction, pain
Croatian: pireksija, umor reakcija akutne faze, bol
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, zabilježeno je u bolesnika nakon početne doze ili jednokratne doze od 4 mg zoledronatne kiseline.
English: Angioneurotic oedema
Croatian: reakcija preosjetljivosti angioneurotski edem
English: Do not mix Zoledronic Acid Teva concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Croatian: Nemojte miješati koncentrat Zoledronatne kiseline Teva s otopinama koje sadrže kalcij ili druge dvovalentne katione kao što je Ringerova otopina s laktatom.
English: Caution is advised when Zoledronic Acid Teva 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: Savjetuje se oprez tijekom istovremene primjene Zoledronatne kiseline Teva i antiangiogenih lijekova jer je u bolesnika koji su istovremeno liječeni tim lijekovima zabilježena povećana incidencija osteonekroze čeljusti.
English: In patients who show evidence of renal deterioration during treatment, Zoledronic Acid Teva should be withheld.
Croatian: U bolesnika u kojih se pojave znakovi pogoršanja funkcije bubrega tijekom liječenja treba prekinuti primjenu Zoledronatne kiseline Teva.
English: Additional information on handling on Zoledronic Acid Teva, including guidance on preparation of reduced doses, is provided in section 4.2.
Croatian: Dodatne informacije o rukovanju Zoledronatnom kiselinom Teva, uključujući upute za pripremu sniženih doza, nalaze se u dijelu 4.2. Tijekom pripreme infuzije moraju se koristiti aseptičke tehnike.
English: - Confusion.
Croatian: - Smetenost.
English: In clinical trials 69 patients who relapsed or were refractory to initial treatment (zoledronic acid 4 mg, 8 mg or pamidronate 90 mg) were retreated with 8 mg zoledronic acid.
Croatian: U kliničkim je ispitivanjima 69 bolesnika s relapsom ili bolešću otpornom na početno liječenje (zoledronatna kiselina u dozi od 4 mg, 8 mg ili pamidronat u dozi od 90 mg) bilo liječeno
English: Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Teva and will check your response to treatment at regular intervals.
Croatian: Prije nego što počnete primati Zoledronatnu kiselinu Teva, liječnik će Vam napraviti krvne pretrage i u redovitim vremenskim razmacima provjeravati Vaš odgovor na liječenje.
English: Zoledronic Acid Teva must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Croatian: Zoledronatnu kiselinu Teva bolesnicima smiju propisivati i primjenjivati samo liječnici s iskustvom u intravenskoj primjeni bisfosfonata.
English: Thrombocytopenia, leukopenia
Croatian: anemija trombocitopenija, leukopenija pancitopenija
English: Clinical studies in tumour-induced hypercalcaemia (TIH) demonstrated that the effect of zoledronic acid is characterised by decreases in serum calcium and urinary calcium excretion.
Croatian: Rezultati kliničkih ispitivanja liječenja hiperkalcemije izazvane tumorom Klinička ispitivanja liječenja hiperkalcemije izazvane tumorom pokazala su da je učinak zoledronatne kiseline obilježen smanjenjem kalcija u serumu i smanjenim izlučivanjem kalcija mokraćom.
English: No dose adjustment is necessary in TIH patients with serum creatinine < 400 μmol/l or < 4.5 mg/dl (see section 4.4).
Croatian: Nije potrebna prilagodba doze u bolesnika s hiperkalcemijom izazvanom tumorom i vrijednostima kreatinina u serumu manjima od 400 μmol/l ili 4,5 mg/dl (vidjeti dio 4.4).
English: In an in vitro study, zoledronic acid showed low affinity for the cellular components of human blood, with a mean blood to plasma concentration ratio of 0.59 in a concentration range of 30 ng/ml to 5000 ng/ml.
Croatian: U in vitro ispitivanu, zoledronatna kiselina je pokazala niski afinitet za humane krvne stanice, uz srednju vrijednost omjera koncentracije krvi prema plazmi od 0,59 za raspon koncentracije od
English: Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
Croatian: hiperestezija, tremor, somnolencija konvulzije, hipoestezija i tetanija (sekundarno uz hipokalcemiju)
English: Diluted Solution - The readily prepared Zoledronic Acid Teva infusion solution should preferably be used immediately.
Croatian: - Pripremljenu otopinu za infuziju Zoledronatne kiseline Teva treba po mogućnosti odmah primijeniti.
English: Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
Croatian: mučnina, povraćanje, smanjeni apetit proljev, zatvor, bol u abdomenu, dispepsija, stomatitis, suha usta
English: Other medicines and Zoledronic Acid Teva Tell your doctorif you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Croatian: astenija, periferni edemi, reakcije na mjestu primjene injekcije (uključujući bol, nadraženost, oteklinu i otvrdnuće), bol u prsištu, povećanje tjelesne težine, anafilaktična reakcija/šok, urtikarija artritis i oticanje zglobova kao simptomi reakcije akutne faze
English: - History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures
Croatian: - Bolest zuba u anamnezi, loša oralna higijena, periodontalna bolest, invazivni stomatološki zahvati (npr. vađenje zuba) i slabo pričvršćene zubne proteze.
English: Pam 90 mg zoledronic acid 4 mg
Croatian: 90 mg zoledronatna kiselina 4 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 (see section 4.4).
Croatian: Propadanje funkcije bubrega, koje napreduje do zatajenja bubrega i dijalize, zabilježeno je u bolesnika nakon početne ili jednokratne doze zoledronatne kiseline od 4 mg (vidjeti dio 4.4).
English: Zoledronic Acid Teva treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Croatian: Liječenje bolesnika Zoledronatnom kiselinom Teva s hiperkalcemijom izazvanom tumorom koji imaju i teško oštećenje funkcije bubrega dolazi u obzir tek nakon procjene rizika i koristi od liječenja.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
English: - Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) - Flu-like symptoms including arthritis and joint swelling - Painful redness and/or swelling of the eye.
Croatian: - Intersticijska bolest pluća (upala tkiva oko alveola) - Simptomi nalik gripi uključujući artritis i oticanje zglobova.
English: Unopened Vial - Keep Zoledronic Acid Teva out of the reach and sight of children.
Croatian: Kako čuvati Zoledronatnu kiselinu Teva Lijek čuvajte izvan pogleda i dohvata djece.
English: Patients were evenly distributed between zoledronic acid-treated and placebo groups.
Croatian: Bolesnici su bili ravnomjerno raspodijeljeni u skupinu koja je primala zoledronatnu kiselinu i skupinu koja je primala placebo.
English: 0.5 mg/dl or 44 μmol/l; - For patients with an abnormal baseline creatinine (> 1.4 mg/dl or > 124 μmol/l), an increase of
Croatian: − povišenje vrijednosti kreatinina za 0,5 mg/dl ili 44 μmol/l, u bolesnika s normalnom početnom vrijednošću kreatinina u serumu (manjom od 1,4 mg/dl ili 124 μmol/l),
English: Uncommon: Rare:
Croatian: Manje često: Rijetko:
English: Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza "Rok valjanosti".
English: The withdrawn amount of concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Croatian: Izvučenu količinu koncentrata treba dodatno razrijediti u 100 ml sterilne otopine za injekciju natrijevog klorida od 9 mg/ml (0,9%) ili 5%-tne m/V otopine glukoze.
English: How Zoledronic Acid Teva is given - Zoledronic Acid Teva is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Croatian: - Zoledronatna kiselina Teva daje se u venu kao infuzija (drip) u trajanju od najmanje 15 minuta i mora se primijeniti kao jednokratna intravenska otopina kroz zasebnu infuzijsku liniju.
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. • Dojenje (vidjeti dio 4.6).