natgillin/translations-raw huggingface dataset:
Zoledronic acid Teva Generics must not be allowed to come into contact with any calcium-containing solutions. 
Ne smete dovoliti, da bi zdravilo Zoledronska kislina Teva Generics prišla v stik z raztopino, ki vsebuje kalcij.
Zoledronic acid significantly decreased the incidence of one or more new vertebral fractures over three years and as early as the one year timepoint (see Table 2). 
Učinek na morfometrično opredeljene zlome vretenc Zoledronska kislina je statistično značilno znižalo incidenco enega ali več novih zlomov vretenc tako v obdobju treh let kot tudi že po enem letu opazovanja (glejte preglednico 2).
Efficacy was demonstrated if non-inferiority to risedronate was shown sequentially with respect to the percentage change in lumbar spine BMD at 12 months relative to baseline in the treatment and prevention subpopulations, respectively. 
Učinkovitost je bila dokazana, če se je pokazalo, da zoledronska kislina ni bila slabše od risedronata glede odstotne spremembe mineralne gostote kosti ledvene hrbtenice po 12 mesecih v primerjavi z izhodiščno vrednostjo, in sicer posebej v podskupini za zdravljenje in posebej v podskupini za preprečevanje osteoporoze.
Women of childbearing potential Zoledronic acid is not recommended in women of childbearing potential. 
Ženske v rodni dobi Uporaba zoledronske kisline ni priporočena pri ženskah v rodni dobi.
It is supplied in multipacks containing 5 or 10 bags. 
Na voljo je v skupnem pakiranju po 5 ali 10 vreč.
For osteoporosis, Zoledronic acid Teva Generics works for one year. 
Za zdravljenje osteoporoze deluje zdravilo Zoledronska kislina Teva Generics eno leto.
Uncommon Influenza, nasopharyngitis 
Preglednica 1 Infekcijske in parazitske bolezni občasni gripa, nazofagitis
Tetracycline label was detectable in all but one of 82 biopsies obtained from patients on zoledronic acid. 
Označevanje s tetraciklini je bilo mogoče odkriti v vseh 82 biopsijskih vzorcih bolnic, ki so bile zdravljene z zoledronsko kislino z izjemo enega vzorca.
Concomitant osteoporosis therapy included: calcitonin, raloxifene, tamoxifen, hormone replacement therapy, tibolone; but excluded other bisphosphonates. 
Sočasno zdravljenje osteoporoze je vključevalo: kalcitonin, raloksifen, tamoksifen,
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. 
Po odmerjanju zoledronske kisline so opažali okvare ledvic (glejte poglavje 4.8), zlasti pri bolnikih s predhodno ledvično disfunkcijo ali z drugimi dejavniki tveganja, kar vključuje višjo starost bolnika, sočasno uporabo nefrotoksičnih zdravil, diuretičnega zdravljenja (glejte poglavje 4.5) ali dehidracijo po odmerjanju zoledronske kisline.
Clinical efficacy in osteoporosis associated with long-term systemic glucocorticoid therapy The efficacy and safety of zoledronic acid in the treatment and prevention of osteoporosis associated with long-term systemic glucocorticoid therapy were assessed in a randomised, multicentre, double-blind, stratified, active-controlled study of 833 men and women aged 18-85 years (mean age for men 56.4 years; for women 53.5 years) treated with > 7.5 mg/day oral prednisone (or equivalent). 
Klinična učinkovitost pri osteoporozi zaradi dolgotrajnega zdravljenja s sistemskimi glukokortikoidi Učinkovitost in varnost zdravila pri zdravljenju in preprečevanju osteoporoze, do katere pride zaradi dolgotrajnega zdravljenja s sistemskimi glukokortikoidi, so ocenjevali v randomizirani, multicentrični, dvojno slepi, stratificirani, aktivno kontrolirani študiji z 833 moškimi in ženskami, starimi od 18 do 85
- if you have had sections of your intestine removed. 
- če so vam odstranili dele črevesa.
Special populations (see section 4.2) 
Posebne skupine bolnikov (glejte poglavje 4.2) Okvara ledvic
85% of patients were bisphosphonate-naïve. 
85 % bolnic prej še ni prejemalo difosfonatov.
There was no progressive reduction of bone turnover markers with repeated annual dosing. 
Pri ponovljenem odmerjanju enkrat letno ni prišlo do progresivnega zniževanja vrednosti označevalcev pregradnje kosti.
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. 
Zdravljenje z zoledronsko kislino je v obdobju 3 let zvečalo mineralno gostoto kosti ledvene hrbtenice za 6,7 %, celotnega kolka za 6,0 %, vratu stegnenice za 5,1 % in distalnega dela koželjnice za 3,2 % v primerjavi s placebom.
Tel/Tél: +32 3 820 73 73 
/S.A./AG Tel/Tél: +32 3 820 73 73
Clinical efficacy in the treatment of Paget's disease of the bone Zoledronic acid was studied in male and female patients aged above 30 years with primarily mild to moderate Paget's disease of the bone (median serum alkaline phosphatase level 2.6-3.0 times the upper limit of the age-specific normal reference range at the time of study entry) confirmed by radiographic evidence. 
Klinična učinkovitost pri zdravljenju Pagetove bolezni kosti Zoledronsko kislino so proučevali pri bolnicah in bolnikih, starejših od 30 let, z rentgenološko potrjeno primarno blago do zmerno Pagetovo boleznijo kosti (mediana aktivnost alkalne fosfataze v serumu je bila 2,6 do 3-krat večja od zgornje meje starostno specifičnega normalnega referenčnega območja v času vstopa v študijo).
Renal failure requiring dialysis or with a fatal outcome has rarely occurred in patients with underlying renal impairment or with any of the risk factors described above. 
Pri bolnikih s predhodno okvaro ledvic ali s katerim od zgoraj navedenih dejavnikov tveganja je redko prišlo do ledvične odpovedi, zaradi katere bi bila potrebna dializa ali bi se končala s smrtjo.
Zoledronic acid Teva Generics has no or negligible influence on the ability to drive and use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Zoledronska kislina Teva Generics nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Any unused solution should be discarded. 
Morebitno neuporabljeno raztopino zavrzite.
No dose adjustment is necessary in patients with creatinine clearance ≥ 35 ml/min. 
Za bolnike z očistkom kreatinina ≥ 35 ml/min ni potrebno prilagajanje odmerjanja.
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. 
V študiji HORIZON - študiji pomembnih zlomov (Pivotal Fracture Trial [PFT], glejte poglavje 5.1) je bila skupna incidenca atrijske fibrilacije pri bolnikih, ki so prejemali zoledronsko kislino, 2,5 % (pri 96 od 3.862 bolnikov), pri bolnikih, ki so prejemali placebo, pa 1,9 % (pri 75 od 3.852 bolnikov).
The inter- and intra-subject variation for plasma clearance of zoledronic acid was shown to be 36% and 34%, respectively. 
Pokazali so, da je variabilnost plazemskega očistka zoledronske kisline med preiskovanci 36 %, pri posameznem preiskovancu pa 34 %.
Osteonecrosis of the jaw has been reported in patients treated with zoledronic acid. 
O osteonekrozi čeljusti so poročali pri bolnikih, ki so prejemali zolendronsko kislino.
There was no accumulation of the active substance in plasma after multiple doses given every 28 days. 
Po večkratnih odmerkih zdravila, danih vsakih 28 dni, se zdravilna učinkovina ni kopičila v plazmi.
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Samo za enkratno uporabo.
Paget's disease of the bone 
Pagetova bolezen kosti
België/Belgique/Belgien Teva Pharma Belgium N.V. Tel/Tél: +32 3 820 73 73 
Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73
• Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula before each zoledronic acid dose. 
• Pred vsakim odmerjanjem zoledronske kisline je treba izračunati očistek kreatinina glede na dejansko telesno maso po Cockcroft-Gaultovi formuli.
Rare (may affect up to 1 in 1,000 people) 
Redki (pojavijo se lahko pri največ 1 od 1. 000 bolnikov):
The majority of patients continued to receive glucocorticoids for the one year duration of the trial. 
Bolniki so v letu, ko je potekala študija, večinoma nadaljevali zdravljenje z glukokortikoidi.
The use of zoledronic acid in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population. 
Uporaba zoledronske kisline pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 35 ml/min) je kontraindicirana zaradi povečanega tveganja za odpoved pri tej populaciji.
Your doctor may advise you to take calcium and vitamin D supplements (e.g. tablets) for at least the first ten days after being given Zoledronic acid Teva Generics. 
Mogoče vam bo zdravnik svetoval, da vsaj prvih deset dni po prejemu zdravila Zoledronska kislina Teva Generics jemljete dodatke kalcija in vitamina D (na primer v obliki tablet).
MARKETING AUTHORISATION NUMBER(S) EU/1/14/912/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/912/001
It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic acid Teva Generics, as directed by your healthcare provider. 
Pomembno je, da v nekaj urah pred prejemom zdravila Zoledronska kislina Teva Generics popijete vsaj en ali dva kozarca tekočine (na primer vode), kakor vam naroči zdravstveni delavec, s katerim sodelujete.
Zoledronic acid Teva Generics is not recommended for anyone under 18 years of age. 
Otroci in mladostniki Uporaba zdravila Zoledronska kislina Teva Generics ni priporočljiva pri starosti pod 18 let.
Follow carefully all instructions given to you by your doctor or nurse. 
Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika ali medicinske sestre.
The use of Zoledronic acid Teva Generics in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population. 
Uporaba zdravila Zoledronska kislina Teva Generics je pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 35 ml/min) kontraindicirana zaradi povečanega tveganja za odpoved ledvic pri tej populaciji.
B-CTx was significantly reduced by 61% below baseline levels at 12 months and was sustained at 55% below baseline levels at 36 months. 
Vrednosti beta C-telopeptida so se po 12 mesecih statistično značilno znižale za 61 % od izhodiščnih vrednosti, znižanje se je po 36 mesecih ohranilo na vrednosti 55 % pod izhodiščnimi vrednostmi.
Not known (frequency cannot be estimated from the available data) Severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and throat, decreased blood pressure, dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea. 
Hude alergijske reakcije, vključno z omotičnostjo in oteženim dihanjem, otekanje predvsem v obraz in grlo oziroma žrelo, znižan krvni tlak, dehidracija zaradi simptomov po odmerjanju, kot so zvišana telesna temperatura, bruhanje in diareja.
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). 
Eno leto po tretjem letnem odmerku so 152 postmenopavzalnim bolnicam z osteoporozo, ki so se zdravile z zoledronsko kislino (N=82) oziroma s placebom (N=70), opravili biopsijo kosti iz grebena črevnice (crista iliaca).
• Reminder card with the following key messages: o Need to calculate creatinine clearance based on actual body weight using the CockcroftGault formula before each treatment with Zoledronic acid Teva Generics o Contraindication in patients with creatinine clearance < 35 ml/min o Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity o Need to ensure appropriate hydration of the patient especially those at an advanced age and those receiving diuretic therapy o Need to infuse Zoledronic acid Teva Generics slowly over a period of no less than 15 minutes o Once-yearly dosing regime o Adequate calcium and vitamin D intake are recommended in association with zoledronic acid administration o Need for appropriate physical activity, non-smoking and healthy diet 
• Opomnik z naslednjimi ključnimi sporočili: Potreba izračuna očistka kreatinina glede na dejansko telesno maso po Cockcroft-Gaultovi formuli pred vsakim zdravljenjem z zdravilom Zoledronska kislina Teva Generics o kontraindikacija pri bolnikih z očistkom kreatinina < 35 ml/min, o kontraindikacije med nosečnostjo in dojenjem zaradi možne teratogenosti,
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. 
V celotnem poteku študije so podskupinam, ki so zajemale od 517 do 1.246 bolnic, v rednih intervalih pregledovali kostno specifično alkalno fosfatazo (bone specific alkaline phosphatase - BSAP), Nkončni propeptid kolagena tipa I (N-terminal propeptide of type I collagen - P1NP) v serumu in beta C-telopeptide (b-CTx).
Pharmacodynamic effects The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone. 
Difosfonati delujejo selektivno na kosti zaradi svoje velike afinitete do mineralizirane kosti.
All women received 1,000 to 1,500 mg elemental calcium and 400 to 1,200 IU of vitamin D supplements daily. 
Vse ženske so prejemale dodatke 1.000 do 1.500 mg elementarnega kalcija in vitamina D v odmerkih 400 do 1.200 i.e. dnevno.
Tell your dentist immediately if you experience such symptoms. 
Če pride do navedenih simptomov, takoj obvestite svojega zobozdravnika.
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. 
- če se zdravite z zdravilom, ki vsebuje kateri koli drug difosfonat, saj skupni učinki jemanja teh zdravil skupaj z zdravilom Zoledronska kislina Teva Generics niso znani.
Not known** Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects) 
neznana** osteonekroza čeljusti (glejte poglavji 4.4
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. 
Večplastna, vreča iz poliolefin/stiren-etilen-butilena (SEB) z SFC propilenskim nastavkom za infundiranje, zaprtim z gumijastim zamaškom in snemno zaporko.
Zoledronic acid Teva Generics contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodium-free.” 
Zdravilo Zoledronska kislina Teva Generics vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 ml, kar v bistvu pomeni »brez natrija«.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/912/004 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/912/004
Zoledronic acid is contraindicated during breast-feeding (see section 4.3). 
Uporaba zoledronske kisline v času dojenja je kontraindicirana (glejte poglavje 4.3).
All participants received 1,000 mg elemental calcium plus 400 to 1,000 IU vitamin D supplementation per day. 
Vsi bolniki so prejemali dodatke 1.000 mg elementarnega kalcija in 400 do 1.000 i.e. vitamina D na dan.
Small observed increases in AUC(0-24hr), by about 30% to 40% in mild to moderate renal impairment, compared to a patient with normal renal function, and lack of accumulation of drug with multiple doses irrespective of renal function, suggest that dose adjustments of zoledronic acid in mild (Clcr = 50-80 ml/min) and moderate renal impairment down to a creatinine clearance of 35 ml/min are not necessary. 
Majhno zvečanje AUC(0-24hr) za okrog 30 do 40 %, ki so ga opazili pri bolnikih z blago do zmerno ledvično okvaro v primerjavi z bolniki z normalnim ledvičnim delovanjem, in odsotnost kopičenja zdravila ob večkratnih odmerkih, ne glede na ledvično delovanje,
PHARMACEUTICAL FORM AND CONTENTS Solution for infusion multipack: 5 bottles x 100 ml multipack: 10 bottles x 100 ml 
raztopina za infundiranje skupno pakiranje: 5 plastenk x 100 ml skupno pakiranje: 10 plastenk x 100 ml intravenska uporaba
In the intravenous infusion studies, renal tolerability of zoledronic acid was established in rats when given 0.6 mg/kg as 15-minute infusions at 3-day intervals, six times in total (for a cumulative dose that corresponded to AUC levels about 6 times the human therapeutic exposure) while five 15-minute infusions of 0.25 mg/kg administered at 2-3-week intervals (a cumulative dose that corresponded to 7 times the human therapeutic exposure) were well tolerated in dogs. 
Subkronična in kronična toksičnost V študijah z intravenskim infundiranjem so dokazali ledvično prenosljivost za zoledronsko kislino pri podganah, ki so jim dajali odmerek 0,6 mg/kg v 15-minutnih infuzijah v 3-dnevnih presledkih (kumulativni odmerek je ustrezal ravnem AUC, ki so bile približno 6-krat večje od terapevtske izpostavljenosti pri človeku).
This resulted in exaggerated pharmacological effects considered related to the compound's inhibition of skeletal calcium mobilisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study. 
To je v obdobju okrog poroda povzročalo hipokalciemijo (kar je značilno za celo skupino difosfonatov), distocijo in predčasno prekinitev študije.
Zoledronic acid Teva Generics contains the active substance zoledronic acid. 
Zdravilo Zoledronska kislina Teva Generics vsebuje zdravilno učinkovino zoledronsko kislino.
MARKETING AUTHORISATION HOLDER Teva B.V. 
Imetnik dovoljenja za promet z zdravilom Teva B.V.
• Key signs and symptoms of serious adverse events 
• ključne znake in simptome resnih neželenih dogodkov, • navodila o tem, kdaj je treba poiskati zdravniško pomoč.
4.1 Therapeutic indications 
4.1 Terapevtske indikacije Zdravljenje osteoporoze
It comes in a polyolefin/styrene-ethylene-butylene (SEB) foil bag with a foil over pouch. 
Pakirana je v 100 ml večplastno, vrečo iz poliolefin/stiren-etilen-butilena (SEB) obdano s folijsko vrečo.
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. 
Zdravljenje z zoledronsko kislino je po 24 mesecih v primerjavi s placebom povzročilo povečanje mineralne gostote kosti celotnega kolka za 5,4 % in vratu stegnenice za 4,3 %.
P1NP was significantly reduced by 61% below baseline levels at 12 months and was sustained at 52% below baseline levels at 36 months. 
Vrednosti N-končnega propeptida kolagena tipa I so se po 12 mesecih statistično značilno znižale za 61 % od izhodiščnih vrednosti, znižanje se je po 36 mesecih ohranilo na vrednosti 52 % pod izhodiščnimi vrednostmi.
Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic acid Teva Generics. 
Zdravnik mora pred vsakim odmerkom zdravila Zoledronska kislina Teva Generics opraviti krvne preiskave, da preveri delovanje vaših ledvic (raven kreatinina).
Approximately 42% of patients had a femoral neck BMD T-score below -2.5 and approximately 45% of the patients had a femoral neck BMD T-score above -2.5. zoledronic acid was administered once a year, until at least 211 patients in the study population had confirmed clinical fractures. 
Približno 42 % bolnikov je imelo vrednost T mineralne gostote kosti vratu stegnenice pod -2,5 in približno 45 % bolnikov je imelo vrednost T mineralne gostote kosti vratu stegnenice nad -2,5.
For information on the infusion of zoledronic acid, see section 6.6. 
Za informacije o infundiranju zoledronske kisline glejte poglavje 6.6. 4.3 Kontraindikacije
The incidence of fractures was 8 for zoledronic acid-treated patients versus 7 for risedronate-treated patients (p=0.8055). 
skupini z zoledronsko kislino je bila incidenca zlomov 8 v primerjavi z incidenco 7 v skupini z risedronatom (p=0,8055).
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 patients studied. 
Ledvični očistek je znašal 75 ± 33 % očistka kreatinina, ki je pri 64 proučevanih bolnikih pokazal srednjo vrednost
Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C and 25ºC. 
Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
The pack sizes of 5 and 10 are only available as multipacks comprising of 5 or 10 packs, each containing 1 bottle. 
Na voljo je v pakiranjih po 1, 5 in 10 plastenk.V pakiranjih po 5 in 10 plastenk je vsaka plastenka posebej pakirana v zunanjo ovojnino
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. 
• Dodatni ukrepi za zmanjševanje tveganj Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo izobraževalni program, ki ga je izvajal za odobrene indikacije zdravljenja osteoporoze pri postmenopavzalnih ženskah in pri moških s povečanim tveganjem za zlome, vključno s tistimi z nedavnim zlomom kolka po lažji poškodbi,
Description of selected adverse reactions 
Opis izbranih neželenih učinkov Učinki po skupinah:
You must not be given Zoledronic acid Teva Generics if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, ne smete dobiti zdravila
Adequate calcium and vitamin D intake are recommended in association with zoledronic acid administration. 
Skupaj z dajanjem zoledronske kisline se priporoča zadostno uživanje kalcija in vitamina D.
The percentage of patients who experienced adverse reactions was lower in a smaller study (19.5%, 10.4%, 10.7% after the first, second and third infusion, respectively), where prophylaxis against adverse reactions was used. 
V manjši študiji, v kateri so uporabljali profilakso proti neželenim učinkom, so bili deleži vseh bolnikov, pri katerih je prišlo do neželenih učinkov, nižji, in sicer po prvi infuziji 19,5 %, po drugi infuziji 10,4 %, po tretji infuziji pa 10,7 %.
Patients must be appropriately hydrated prior to administration of zoledronic acid. 
Preden bolniki dobijo zoledronsko kislino, morajo biti primerno hidrirani.
• Patient information pack 
• Komplet podatkov o zdravilu za bolnika
Renal impairment has been observed in patients after a single administration. 
Po prejemu enkratnega odmerka so pri bolnikih opazili okvaro ledvic.
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). 
Skupaj z dajanjem zoledronske kisline je priporočeno zadostno uživanje kalcija in vitamina D. Poleg tega je zelo priporočljivo bolnikom s Pagetovo boleznijo zagotoviti zadostno dodajanje kalcija, ki ustreza vsaj 500 mg elementarnega kalcija, dvakrat na dan vsaj 10 dni po uporabi zoledronske kisline (glejte poglavje 4.2).