FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 Adverse events occurring with frequencies < 5 % were medically assessed and it was shown that these cases are consistent with the well-established safety profile of zoledronic acid (see section 4.8)
Croatian: 1 Nuspojave koje nastaju učestalošću < 5% bile su medicinski procijenjene i pokazalo se da su u skladu s dobro utvrđenim sigurnosnim profilom zoledronatne kiseline (vidjeti dio 4.8).
English: - have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
Croatian: - osjećate ili ste osjećali bol, oticanje ili utrnulost čeljusti, težinu u čeljusti ili klimanje zuba.
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 otopinama za infuziju.
English: 3.0 mg* *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min).
Croatian: 3,0 mg* *Doze su izračunate uz pretpostavku da je ciljni AUC 0,66 (mg•h/l) (klirens kreatinina = 75 ml/min).
English: Zoledronic acid medac contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially ‘sodium-free'.
Croatian: Natrij Zoledronatna kiselina medac sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: • The solution containing Zoledronic acid medac is given as a single 15-minute intravenous infusion.
Croatian: • Otopina koja sadrži Zoledronatnu kiselinu medac daje se kao jednokratna 15-minutna intravenska infuzija.
English: • Studies with glass bottles, several types of infusion bags and infusion lines made from polyvinylchloride, polyethylene and polypropylene (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution) showed no incompatibility with zoledronic acid.
Croatian: • Ispitivanja sa staklenim bocama, nekoliko vrsta infuzijskih vrećica i infuzijskih linija napravljenih od polivinilklorida, polietilena i polipropilena (napunjenih otopinom za injekciju natrijevog klorida od 9 mg/ml (0,9%) ili 5% w/v otopine glukoze) pokazala su da nema inkompatibilnosti sa zoledronatnom kiselinom.
English: Zoledronic acid medac can be given to people aged 65 years and over.
Croatian: Bolesnici u dobi od 65 ili više godina Zoledronatna kiselina medac može se davati osobama u dobi od 65 ili više godina.
English: • Zoledronic acid medac 4 mg/100 ml solution for infusion can be used immediately without further preparation for patients with normal renal function.
Croatian: • Zoledronatna kiselina medac 4 mg/100 ml otopina za infuziju može se odmah primijeniti bez dodatne pripreme kod bolesnika s normalnom funkcijom bubrega.
English: 1 bottle of 100 ml.
Croatian: 1 boca od 100 ml.
English: The solution must be allowed to reach 20°C to 23.5°C before administration.
Croatian: Otopina se prije primjene mora ostaviti da dosegne temperaturu od 20°C do 23,5°C.
English: • To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Croatian: • Da biste pripremili otopinu za infuziju koja sadrži 4 mg zoledronatne kiseline, dodatno razrijedite koncentrat (5,0 ml) sa 100 ml otopine za infuziju koja ne sadrži kalcij niti druge dvovalentne katione
English: What Zoledronic acid medac looks like and contents of the pack Zoledronic acid medac is supplied as a concentrate for solution for infusion in a 5 ml plastic vial made of clear, colourless plastic (cycloolefine copolymer) with rubber stopper (type I bromobutyl) and sealed with flip-off seal (aluminium and polypropylene).
Croatian: Kako Zoledronatna kiselina medac izgleda i sadržaj pakiranja Zoledronatna kiselina medac isporučuje se kao koncentrat za otopinu za infuziju u plastičnoj bočici od 5 ml napravljenoj od prozirne, bezbojne plastike (cikloolefinski kopolimer) s gumenim čepom (brombutil tipa I) i zatvorenoj „flip-off“ poklopcem (od aluminija i polipropilena).
English: 1 bottle of 100 ml
Croatian: 1 boca od 100 ml
English: Patients should be adequately supplemented with calcium and vitamin D.
Croatian: Bolesnicima je potrebno davati odgovarajuće nadomjeske kalcija i vitamina D.
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic acid medac.
Croatian: - Ako se liječite zbog snižavanja količine kalcija u krvi, obično ćete dobiti samo jednu infuziju
English: Patients being treated with Zoledronic acid medac should not be treated with such medicinal products concomitantly or any other bisphosphonate, since the combined effects of these agents are unknown.
Croatian: Bolesnici koji se liječe zoledronatnom kiselinom medac ne smiju se istovremeno liječiti takvim lijekovima ili bilo kojim drugim bisfosfonatom, budući da nisu poznati kombinirani učinci tih lijekova.
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, antiadhesion/invasion activity.
Croatian: - in vitro: inhibicija proliferacije osteoblasta, izravno citostatsko i proapoptotsko djelovanje na tumorske stanice, sinergistički citostatski učinak s drugim antitumorskim lijekovima,
English: - Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Croatian: Liječenje odraslih bolesnika s hiperkalcemijom izazvanom tumorom.
English: If the solution is not used immediately, storage prior to use is the responsibility of the user and should be in a refrigerator at 2 °C - 8 °C.
Croatian: Ako se otopinu ne primijeni odmah, čuvanje prije primjene odgovornost je korisnika a treba je čuvati u hladnjaku na temperaturi od 2°C - 8°C.
English: Placebo Zoledronic acid 4 mg
Croatian: Placebo Zoledronatna kiselina 4 mg
English: The frequencies for each of these identified risks are shown in Table 2.
Croatian: Učestalost svakog pojedinog utvrđenog rizika navedena je u tablici 2.
English: - Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Croatian: - rijetko može nastati neobičan prijelom bedrene kosti osobito u bolesnika koji se dugotrajno liječe zbog osteoporoze.
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to zoledronic acid administration.
Croatian: Invazivne stomatološke zahvate za vrijeme liječenja treba provoditi samo nakon pažljive procjene i izbjegavati neposredno prije ili poslije liječenja zoledronatnom kiselinom.
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 dvije terapijske skupine, jedne sa 74 i druge sa 76 bolesnika.
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders
Croatian: Tablica 6: Nuspojave primijećene u pedijatrijskih bolesnika s teškim oblikom osteogenesis imperfecta1
English: • Zoledronic acid medac 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 medac 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: For instructions on the dilution of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o razrjeđivanju lijeka prije primjene, vidjeti dio 6.6.
English: Zoledronic acid medac contains sodium
Croatian: Zoledronatna kiselina medac sadrži natrij
English: Instructions for preparing reduced doses of Zoledronic acid medac
Croatian: Upute za pripremu sniženih doza Zoledronatne kiseline medac
English: • From a microbiological point of view, the diluted solution for infusion should be used immediately.
Croatian: • S mikrobiološkog stanovišta, razrijeđena otopina za infuziju treba se odmah primijeniti.
English: Your doctor will carry out blood tests before you start treatment with Zoledronic acid medac and will check your response to treatment at regular intervals.
Croatian: Prije nego što počnete primati Zoledronatnu kiselinu medac, liječnik će Vam napraviti krvne pretrage i u redovitim vremenskim razmacima provjeravati Vaš odgovor na liječenje.
English: • The readily prepared Zoledronic acid medac infusion solution should preferably be used immediately.
Croatian: • Pripremljenu otopinu za infuziju Zoledronatne kiseline medac treba po mogućnosti odmah primijeniti.
English: Zoledronic acid medac 4 mg/100 ml solution for infusion should be given as a single intravenous infusion in no less than 15 minutes.
Croatian: Zoledronatnu kiselinu medac 4 mg/100 ml otopinu za infuziju treba dati kao jednokratnu intravensku infuziju u trajanju od najmanje 15 minuta.
English: After first opening: Chemical and physical in-use stability has been demonstrated for 4 days at 2 - 8°C and 25°C.
Croatian: Nakon prvog otvaranja: dokazana kemijska i fizikalna stabilnost iznosi 4 dana na temperaturi od
English: It is used: - to prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Croatian: - sprječavanje koštanih komplikacija, npr. prijeloma, u odraslih bolesnika s koštanim metastazama (širenje raka iz primarnog mjesta u kosti).
English: Nausea, vomiting, decreased appetite Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
Croatian: mučnina, povraćanje, smanjeni apetit proljev, zatvor, bolovi u trbuhu, dispepsija, stomatitis, suha usta
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 versus 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) versus 41% (31/76).
Croatian: Nuspojava prijeloma dugih kostiju nogu bila je zabilježena 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: Pamidronate 90 mg
Croatian: 90 mg
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 medac.
Croatian: Tijekom liječenja Zoledronatnom kiselinom medac sve bolesnike treba poticati da održavaju dobru oralnu higijenu, redovito odlaze na stomatološke preglede i odmah prijave svaki oralni simptom, kao što je pomičnost zuba, bol ili oticanje, ili ranice koje ne cijele ili iscjedak.
English: To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below.
Croatian: Da biste pripremili snižene doze za bolesnike s početnim klirensom kreatinina ≤ 60 ml/min, poslužite se tablicom 1 niže.
English: Zoledronic acid medac 4 mg/100 ml solution for infusion must not be mixed with other infusion solutions and should be administered as a single intravenous solution in a separate infusion line.
Croatian: Zoledronatna kiselina medac 4 mg/100 ml otopina za infuziju ne smije se miješati s drugim otopinama za infuziju i treba se primijeniti kao jednokratna intravenska otopina kroz posebnu infuzijsku liniju.
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing) Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Croatian: vrućica, sindrom sličan gripi (uključujući umor, tresavicu, malaksalost i crvenilo uz osjećaj vrućine) astenija, periferni edemi, reakcije na mjestu primjene injekcije (uključujući bol, nadraženost, oteklinu i otvrdnuće), bol u prsištu, povećanje tjelesne težine, anafilaktična reakcija/šok, urtikarija
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 ne preporučuje se u bolesnika koji prije početka liječenja imaju teško oštećenje funkcije bubrega, koje se u ove populacije definira kao klirens kreatinina manji od 30 ml/min.
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 klirens kreatinina veći od 60 ml/min) zoledronatna kiselina 4 mg/100 ml otopina za infuziju može se primijeniti izravno bez ikakvog dodatnog razrjeđivanja.
English: Chemical and physical in-use stability has been demonstrated for glass bottles, polyethylene, polyvinylchloride and polypropylene infusion lines and infusion bags (prefilled with sodium chloride 9 mg/ml (0.9 %) solution for injection or 5 % w/v glucose solution) for 96 hours at 2-8°C and 25°C.
Croatian: Dokazana kemijska i fizikalna stabilnost u staklenim bocama, polietilenskim, polivinilkloridnim i polipropilenskim infuzijskim linijama i infuzijskim vrećicama (napunjene otopinom za injekciju natrijevog klorida od 9 mg/ml (0,9%) ili 5% w/v otopinom glukoze) iznosi 96 sati na temperaturi od
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 koji uključuju vrućicu, mialgiju, glavobolju, bol u ekstremitetima, mučninu, povraćanje, proljev, artralgiju i artritis s posljedičnim oticanjem zglobova.
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) - niska razina kalcija u krvi.
English: Zoledronic acid recommended dose*
Croatian: Preporučena doza zoledronatne kiseline*
English: Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline (see section 4.2).
Croatian: S primjenom zoledronatne kiseline smije se nastaviti tek kad se kreatinin u serumu vrati na vrijednosti unutar 10% početne vrijednosti (vidjeti dio 4.2).
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: 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: - Increased sweating.
Croatian: - povećanje tjelesne težine - pojačano znojenje
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid medac or after stopping treatment - Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Croatian: Ako osjetite ove simptome za vrijeme ili nakon prestanka liječenja Zoledronatnom kiselinom medac, odmah obavijestite svog liječnika ili zubara. - nepravilan srčani ritam (fibrilacija atrija) opažen je u bolesnica koje su primale zoledronatnu kiselinu zbog postmenopauzalne osteoporoze.
English: The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth, except in medical emergency situations.
Croatian: Osim u hitnim slučajevima, u bolesnika s nezacijeljenim otvorenim lezijama mekih tkiva u ustima treba odgoditi početak liječenja ili novi ciklus liječenja.
English: The following risk factors should be considered when evaluating an individual's risk of developing ONJ:
Croatian: Kada se procjenjuje rizik od razvoja osteonekroze čeljusti u neke osobe, potrebno je u obzir uzeti sljedeće čimbenike rizika:
English: Replace with the following volume of sterile sodium chloride 9 mg/ml (0.9%), or 5% glucose solution for injection (ml)
Croatian: Zamijenite sljedećim volumenom sterilne otopine natrijevog klorida od 9 mg/ml (0,9%) ili 5% otopinom glukoze za injekciju (ml)
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: Ako osjetite bol, slabost ili nelagodu u natkoljenici, kuku ili preponama, odmah se javite liječniku, jer to mogu biti rani znakovi mogućeg prijeloma bedrene kosti
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: • Keep Zoledronic acid medac out of the sight and reach of children.
Croatian: Kako čuvati Zoledronatnu kiselinu medac • Ovaj lijek čuvajte izvan pogleda i dohvata djece.
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 s 8 mg zoledronatne kiseline.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 1 BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA 1 BOČICU
English: Zoledronic acid medac treatment should be resumed at the same dose as that given prior to treatment interruption.
Croatian: Liječenje Zoledronatnom kiselinom medac treba nastaviti istom dozom koja se davala prije prekida liječenja.
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer)
Croatian: Tablica 3: Rezultati djelotvornosti (solidni tumori osim karcinoma dojke i prostate)
English: One bottle contains 4 mg zoledronic acid.
Croatian: Jedna bočica sadrži 4 mg zoledronatne kiseline.
English: Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia.
Croatian: Nepravilan rad srca (srčane aritmije), napadaji, grčevi i trzanje mišića (tetanija) zabilježeni su kao posljedica teške hipokalcemije.
English: Table 7: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders Common:
Croatian: Tablica 7: Nuspojave primijećene u pedijatrijskih bolesnika s teškim oblikom osteogenesis imperfecta1
English: Zoledronic acid 4 mg
Croatian: Zoledronatna kiselina 4 mg
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 metastazama u kostima koji prije početka liječenja imaju blago do umjereno oštećenje funkcije bubrega, definirano u ove populacije kao klirens kreatinina od 30 do 60 ml/min, preporučuje se sljedeća doza zoledronatne kiseline (vidjeti također dio 4.4):
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).
English: Rare: Very rare:
Croatian: Manje često: Vrlo rijetko:
English: It is especially important that you tell your doctor if you are also taking: - Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Croatian: Osobito je važno da obavijestite liječnika ako uzimate: - aminoglikozide (lijekovi za liječenje teških infekcija), kalcitonin (vrsta lijeka za liječenje post-menopauzalne osteoporoze i hiperkalcemije), diuretike Henleove petlje (vrsta lijekova za liječenje visokog krvnog tlaka ili edema) ili druge lijekove koji snizuju razinu kalcija, budući da kombinacija ovih lijekova s bisfosfonatima može dovesti do preniskih razina kalcija u krvi - talidomid (lijek za liječenje određenih vrsta raka krvi koji zahvaća kost) ili neke druge lijekove koji mogu oštetiti bubrege - druge lijekove koji također sadrže zoledronatnu kiselinu i koriste se za liječenje osteoporoze i drugih bolesti kostiju koje nisu uzrokovane rakom ili bilo koji drugi bisfosfonat, budući da kombinirani učinci ovih lijekova kad se uzimaju zajedno sa Zoledronatnom kiselinom medac nisu poznati
English: Figure 1: Mean changes from baseline in BPI scores.
Croatian: Slika 1: Prosječna promjena rezultata na ljestvici bola (BPI) u odnosu na početnu vrijednost.
English: Tachycardia
Croatian: urtikarija
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 hiperkalcemijom izazvanom tumorom, djelotvorne ispitivane doze kretale su se u rasponu od približno 1,2 do 2,5 mg.
English: In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), 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 5 mg and placebo, respectively.
Croatian: U jednom randomiziranom, dvostruko slijepom, kontroliranom ispitivanju u trajanju od 3 godine u kojem se ocjenjivala djelotvornost i sigurnost zoledronatne kiseline u dozi od 5 mg jedanput godišnje u usporedbi s placebom u liječenju postmenopauzalne osteoporoze (PMO), ukupna incidencija fibrilacije atrija iznosila je 2,5% (96 od 3862) u bolesnica koje su primale zoledronatnu kiselinu u dozi od 5 mg i 1,9% (75 od 3852) u onih koje su primale placebo.