natgillin/translations-raw huggingface dataset:
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). 
Pri bolnikih, ki so bili stari 75 let ali starejši in so prejemali zoledronsko kislino, je bilo tveganje za zlome vretenc za 60 % manjše v primerjavi z bolniki, ki so prejemali placebo (p < 0,0001).
Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, including zoledronic acid (see section 4.4). 
O osteonekrozi čeljustnic so poročali predvsem pri bolnikih z rakom, zdravljenih z zdravili, ki zavirajo resorpcijo kosti, vključno z zoledronsko kislino (glejte poglavje 4.4).
The patient educational material should contain the following key messages: 
Pripraviti je treba Komplet podatkov o zdravilu za bolnika, ki mora vsebovati naslednja ključna sporočila:
Not known (frequency cannot be estimated from the available data) Pain in the mouth, and/or jaw, swelling or non-healing sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth; these could be signs of bone damage in the jaw (osteonecrosis). 
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) Bolečine v ustih in/ali čeljustnic, oteklina ali slabo celjenje ranic v ustni votlini ali čeljustnic, vnetje, odrevenelost ali občutek pritiska v čeljustnic ali majanje zoba so lahko znaki odmiranja kosti v čeljustnic (osteonekroze).
Zoledronic acid Teva Pharma is supplied in packs of 1 bottle and multipacks of 5 (5 x 1) or 10 (10 x 1) bottles. 
Zoledronska kislina Teva Pharma je na voljo v posamičnih pakiranjih po 1 plastenko in skupnih pakiranjih po 5 (5 x 1) ali 10 (10 x 1) plastenk.
Pharmacodynamic effects The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone. 
Farmakodinamični učinki Difosfonati delujejo selektivno na kosti zaradi svoje velike afinitete do mineralizirane kosti.
Excipients: Mannitol, sodium citrate and water for injections. 
Pomožne snovi: manitol, natrijev citrat in voda za injekcije.
The hip fracture event rate was 1.44% for zoledronic acidtreated patients compared to 2.49% for placebo-treated patients. 
Delež zlomov kolka je bil 1,44 % v skupini z zoledronsko kislino v primerjavi z 2,49 % v skupini s placebom.
The recommended dose is a single intravenous infusion of 5 mg Zoledronic acid Teva Pharma. 
Priporočeni odmerek je ena intravenska infuzija s 5 mg zdravila Zoledronska kislina Teva Pharma.
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. 
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) 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.
- The other ingredients are mannitol, sodium citrate and water for injections. 
- Druge sestavine zdravila so: manitol, natrijev citrat in voda za injekcije.
Osteonecrosis of the external auditory canal† (bisphosphonate class adverse reaction) 
zelo redki osteonekroza zunanjega slušnega kanala† (neželeni učinek skupine disfosfonatov)
Zoledronic acid Teva Pharma contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodium-free.” 
Zdravilo Zoledronska kislina Teva Pharma vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 ml, kar v bistvu pomeni »brez natrija«.
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 Teva Pharma administration (see section 4.4). 
Pri bolnikih s Pagetovo boleznijo je zelo priporočeno zadostno dodajanje kalcija, ki ustreza vsaj 500 mg elementarnega kalcija, in sicer dvakrat na dan vsaj 10 dni po uporabi zdravila Zoledronska kislina Teva Pharma (glejte poglavje 4.4).
Your doctor may ask you to undergo a dental examination before you start treatment with Zoledronic acid Teva Pharma. 
Zdravnik vas bo verjetno prosil, da pred začetkom zdravljenja z zdravilom Zoledronska kislina Teva Pharma opravite zobozdravstveni pregled.
Zoledronic acid Teva Pharma is administered via a vented infusion line and given slowly at a constant infusion rate. 
Zdravilo Zoledronska kislina Teva Pharma se aplicira prek infuzijskega sistema s prezračevanjem in sicer počasi s stalno hitrostjo infundiranja.
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, doubleblind, 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 let (s povprečno starostjo 56,4 leta pri moških in 53,5 let pri ženskah), ki so peroralno jemali več kot 7,5 mg prednizona na dan (ali ekvivalent).
Uncommon Influenza, nasopharyngitis 
Infekcijske in parazitske bolezni gripa, nazofaringitis
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodium-free.” 
Pomožne snovi To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 ml, kar v bistvu pomeni “brez natrija”.
Table 2 Summary of vertebral fracture efficacy at 12, 24 and 36 months Outcome 
Preglednica 2 Pregled učinkovitosti glede zlomov vretenc po 12, 24 in 36 mesecih Izid absolutno znižanje odstotka zlomov % (IZ)
Solution for infusion Multipack: 5 bottles of 100 ml Multipack: 10 bottles of 100 ml 
raztopina za infundiranje Skupno pakiranje: 5 plastenk po 100 ml Skupno pakiranje: 10 plastenk po 100 ml
Cyclic olefin polymer (COP) plastic bottle, fitted with a chlorobutyl/butyl rubber stopper and aluminium cap fitted with violet plastic flip off disc. 
Plastenka iz cikloolefinskega polimera z zamaškom iz klorobutila/butila in pečatom iz aluminija z vijolično plastično dvižno zaporko.
Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. 
Pri zdravljenju z disfosfonati so poročali o osteonekrozi zunanjega slušnega kanala, večinoma pri dolgoročnem zdravljenju.
You must not be given Zoledronic acid Teva Pharma: 
Zdravila Zoledronska kislina Teva Pharma ne smete dobiti:
Zoledronic acid Teva Pharma is contraindicated during pregnancy (see section 4.3). 
Uporaba zdravila Zoledronska kislina Teva Pharma v nosečnosti je kontraindicirana (glejte poglavje 4.3).
Zoledronic acid Teva Pharma must not be allowed to come into contact with any calcium-containing solutions. 
Ne smete dovoliti, da bi zdravilo Zoledronska kislina Teva Pharma prišla v stik z raztopino, ki vsebuje kalcij.
- Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients, listed in section 6.1. 
- Preobčutljivost na zdravilno učinkovino, katerega od difosfonatov ali katero koli pomožno snov, navedeno v poglavju 6.1.
Zoledronic acid Teva Pharma with food and drink Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic acid Teva Pharma, as directed by your doctor. 
Zdravilo Zoledronska kislina Teva Pharma s hrano in pijačo Poskrbite, da boste pred zdravljenjem z zdravilom Zoledronska kislina Teva Pharma in po njem pili dovolj tekočine (vsaj en do dva kozarca), kot vam bo naročil zdravnik.
For osteoporosis, Zoledronic acid Teva Pharma works for one year. 
Za zdravljenje osteoporoze deluje zdravilo Zoledronska kislina Teva Pharma eno leto.
- Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients listed in section 6.1. 
- Preobčutljivost na zdravilno učinkovino, katerega od difosfonatov ali katero koli pomožno snov navedeno v poglavju 6.1.
- if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na zoledronsko kislino, druge difosfonate ali katero koli sestavino zdravila
Patients treated with Zoledronic acid Teva Pharma should be given the package leaflet and the patient reminder card. 
Bolnikom, ki prejemajo zdravilo Zoledronska kislina Teva Pharma, je treba izročiti Navodilo za uporabo in Opozorilno kartico za bolnika.
• Zoledronic acid Teva Pharma should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5). 
• Pri sočasni uporabi zdravila Zoledronska kislina Teva Pharma z drugimi zdravili, ki lahko vplivajo na delovanje ledvic, je potrebna previdnost (glejte poglavje 4.5).
After opening: 24 hours at 2°C - 8°C 
EXP: Po odprtju: 24 ur pri 2 °C - 8 °C.
The following should be considered when evaluating a patient's risk of developing ONJ: - Potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy. 
Za oceno tveganja za razvoj osteonekroze čeljustnic pri bolniku je treba upoštevati naslednje dejavnike: - moč delovanja zdravila, ki zavira resorpcijo kosti (tveganje je večje pri močnejših zdravilih),
Caution is indicated when Zoledronic acid Teva Pharma is administered in conjunction with medicinal products that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration) (see section 4.4). 
Kadar uporabljamo zdravilo Zoledronska kislina Teva Pharma skupaj z zdravili, ki lahko znatno vplivajo na delovanje ledvic (npr. z aminoglikozidi ali diuretiki, ki lahko povzročijo dehidracijo), je potrebna previdnost (glejte poglavje 4.4).
• Patient reminder card on osteonecrosis of the jaw 
• Opozorilno kartico za bolnika z opozorili glede osteonekroze čeljustnic.
Component of a multipack, can't be sold separately. 
raztopina za infundiranje Ena plastenka s 100 ml. Del skupnega pakiranja - ne more se prodajati ločeno.
In the subpopulation of patients receiving glucocorticoids for more than 3 months prior to randomisation, zoledronic acid increased lumbar spine BMD by 4.06% versus 2.71% for risedronate (mean difference: 1.36%; p<0.001). 
V podskupini bolnikov, ki so prejemali glukokortikoide več kot 3 mesece pred randomizacijo, je zoledronska kislina povečala mineralno gostoto kosti ledvene hrbtenice za 4,06 % v primerjavi z 2,71 % pri uporabi risedronata (z razliko povprečij: 1,36 %; p < 0,001).
In patients with a recent low trauma hip fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first zoledronic acid infusion. 
Pri bolnikih z nedavnim zlomom kolka po lažji poškodbi je pred prvo infuzijo zoledronske kisline priporočen večji začetni odmerek vitamina D 50.000 do 125.000 i.e. peroralno ali intramuskularno.
After opening: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C and 25ºC. 
Po odpiranju: Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
Table 4 Between treatment comparisons of the incidence of key clinical fracture variables Outcome 
Preglednica 4 Primerjava incidenc ključnih kliničnih zlomov med obema načinoma
MARKETING AUTHORISATION NUMBER(S) EU/1/12/772/005 1 bottle 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/772/005 1 plastenka
What Zoledronic acid Teva Pharma looks like and contents of the pack Zoledronic acid Teva Pharma is a clear and colourless solution. 
Izgled zdravila Zoledronska kislina Teva Pharma in vsebina pakiranja Zdravilo Zoledronska kislina Teva Pharma je bistra brezbarvna raztopina.
ONJ has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis (see section 4.8). 
O osteonekrozi čeljustnic so po začetku trženja zdravila poročali pri bolnikih, ki so zaradi osteoporoze prejemali zdravilo Zoledronska kislina Teva Pharma (glejte poglavje 4.8).
The chance of experiencing these side effects decreases with subsequent doses of Zoledronic acid Teva Pharma. 
Verjetnost, da pride do teh neželenih učinkov, se pri nadaljnjih odmerjanjih zdravila Zoledronska kislina Teva Pharma zmanjšuje.
The incidence of fractures was 8 for zoledronic acid-treated patients versus 7 for risedronate-treated patients (p=0.8055). 
V skupini z zoledronsko kislino je bila incidenca zlomov 8 v primerjavi z incidenco 7 v skupini z risedronatom (p = 0,8055).
• Patient educational material 
• Komplet podatkov o zdravilu za bolnika
Solution for infusion 1 bag of 100 ml. 
raztopina za infundiranje Ena plastenka s 100 ml.
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 Pharma, as directed by your healthcare provider. 
Pomembno je, da v nekaj urah pred prejemom zdravila Zoledronska kislina Teva Pharma popijete vsaj 2 kozarca tekočine (na primer vode), kakor vam naroči zdravstveni delavec, s katerim sodelujete.
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, swelling and/or pain at the infusion site. 
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov Glavobol, omotičnost, slabost, bruhanje, driska, bolečine v mišicah, bolečine v kosteh in/ali sklepih, bolečine v hrbtu, rokah ali nogah, gripi podobni simptomi (na primer utrujenost, mrazenje, bolečine v sklepih in mišicah), mrazenje, občutek utrujenosti in pomanjkanje zanimanja, šibkost, bolečine, slabo počutje, otekanje in/ali bolečina na mestu infundiranja.
At least one new vertebral fracture (0-1 year) 
vsaj en nov zlom vretenca (v prvem letu)
In the subpopulation of patients that had received glucocorticoids for 3 months or less prior to randomisation, zoledronic acid increased lumbar spine BMD by 2.60% versus 0.64% for risedronate (mean difference: 1.96%; p<0.001). 
V podskupini bolnikov, ki so prejemali glukokortikoide 3 mesece ali manj pred randomizacijo, je zoledronska kislina povečala mineralno gostoto kosti ledvene hrbtenice za 2,60 % v primerjavi z 0,64 % pri uporabi risedronata (z razliko povprečij: 1,96 %; p < 0,001).
Table 3 Between treatment comparisons of the incidence of key clinical fracture variables over 3 years 
Preglednica 3 Primerjava incidenc ključnih kliničnih zlomov med obema načinoma
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 Pharma. 
Mogoče vam bo zdravnik svetoval, da vsaj prvih deset dni po prejemu zdravila Zoledronska kislina Teva Pharma jemljete dodatke kalcija in vitamina D (na primer v obliki tablet).
- Zoledronic acid Teva Pharma 5 mg solution for infusion is ready for use. 
- Zdravilo Zoledronska kislina Teva Pharma 5 mg raztopina za infundiranje v vialah je že pripravljena za uporabo.
It comes in a polyolefin/styreneethylene-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.
A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Zoledronic acid Teva Pharma in patients with concomitant risk factors. 
Pri bolnikih s spremljajočimi dejavniki tveganja je pred začetkom zdravljenja z zdravilom Zoledronska kislina Teva Pharma priporočeno opraviti zobozdravniški pregled z ustreznimi preventivnimi zobozdravstvenimi ukrepi in oceniti razmerje med koristmi in tveganji pri vsakem posameznem bolniku.
- After opening the bag, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC. 
- Po odprtju vreče sta kemična in fizikalna stabilnost med uporabo dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
Each bag contains 100 ml of solution. 
Vsaka vreča vsebuje 100 ml raztopine.
Not known** Renal impairment. 
neznana**
Zoledronic acid Teva Pharma is contraindicated during breast-feeding (see section 4.3). 
Uporaba zdravila Zoledronska kislina Teva Pharma v času dojenja je kontraindicirana (glejte poglavje 4.3).
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.
Zoledronic acid (N=3,875) event rate 
Zoledronska kislina (N=1.065) delež dogodkov (%)
What Zoledronic acid Teva Pharma contains - The active substance is zoledronic acid. 
Kaj vsebuje zdravilo Zoledronska kislina Teva Pharma - Zdravilna učinkovina je zoledronska kislina.
• Transient increase in serum creatinine may be greater in patients with underlying impaired renal 
• Pri bolnikih s predhodno zmanjšanim delovanjem ledvic je lahko prehodno zvišanje koncentracije kreatinina v serumu bolj izrazito.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. 
Druga zdravila in zdravilo Zoledronska kislina Teva Pharma Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
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). 
Poleg tega je v primerjavi s placebom statistično značilno znižala povprečno število dni z omejeno aktivnostjo zaradi zlomov za 2,9 dni in število dni, v katerih je zaradi zlomov potreben počitek v postelji, za 0,5 dni (v vseh primerih p < 0,01).
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. 
Zdravljenje z odmerkom zoledronske kisline 5 mg na leto je statistično značilno znižalo vrednosti kostno specifične alkalne fosfataze po 12 mesecih za 30 % glede na izhodišče.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena plastenka s 100 ml raztopine vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
Puh/Tel: +358 20 180 5900 
Sími: +358 20 180 5900
At least one new vertebral fracture (0-2 year) 
vsaj en nov zlom vretenca (v prvih dveh letih)
At least one new vertebral fracture (0-3 year) 
vsaj en nov zlom vretenca (v prvih treh letih)
Cases of ONJ have been reported in the postmarketing setting for Zoledronic acid Teva Pharma. 
O osteonekrozi čeljustnic so poročali tudi v okviru uporabe v času trženja zdravila Zoledronska kislina Teva Pharma.
Zoledronic acid Teva Pharma contains the active substance zoledronic acid. 
Zdravilo Zoledronska kislina Teva Pharma vsebuje zdravilno učinkovino zoledronsko kislino.
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 Teva Pharma administration (see section 4.2). 
Skupaj z dajanjem zdravila Zoledronska kislina Teva Pharma 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 zdravila Zoledronska kislina Teva Pharma (glejte poglavje 4.2).
How to prepare and administer Zoledronic acid Teva Pharma 
Kako pripraviti in dati bolniku zdravilo Zoledronska kislina Teva Pharma
- Do not use this medicine after the expiry date which is stated on the carton and bag after EXP. - Store below 30°C. 
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na vreči poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
- After opening the bottle, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC. 
- Po odprtju plastenke sta kemična in fizikalna stabilnost med uporabo dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
The increases in BMD were significantly greater in the zoledronic acid-treated group at the lumbar spine and femoral neck at 12 months compared to risedronate (all p<0.03). 
Po 12 mesecih je bilo povečanje mineralne gostote kosti ledvene hrbtenice in vratu stegnenice statistično značilno večje v skupini bolnikov, ki so prejemali zoledronsko kislino, v primerjavi s tistimi, ki so prejemali risedronat (vse vrednosti p < 0,03).
Solution for infusion 
Način uporabe intravenska uporaba
Measurement of serum calcium before infusion of Zoledronic acid Teva Pharma is recommended for patients with Paget´s disease. 
Bolnikom s Pagetovo boleznijo je priporočljivo izmeriti vrednost kalcija v serumu pred infuzijo zdravila Zoledronska kislina Teva Pharma.
How Zoledronic acid Teva Pharma is given 
Kako se daje zdravilo Zoledronska kislina Teva Pharma
Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic acid Teva Pharma. 
Zdravnik mora pred vsakim odmerkom zdravila Zoledronska kislina Teva Pharma opraviti krvne preiskave, da preveri delovanje vaših ledvic (raven kreatinina).
Vitamin D levels were not routinely measured but a loading dose of vitamin D (50,000 to 125,000 IU orally or via the intramuscular route) was given to the majority of patients 2 weeks prior to infusion. 
Zoledronsko kislino so prejemali enkrat na leto, dokler ni vsaj pri 211 bolnikih v študiji prišlo do dokazanega kliničnega zloma. Koncentracij vitamina D niso merili rutinsko, vendar je večina bolnikov 2 tedna pred infuzijo prejela večji začetni odmerek vitamina D (50.000 do 125.000 i.e. peroralno ali intramuskularno).
Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. 
Redki: pojavijo se lahko pri največ 1 od 1. 000 bolnikov Redko se lahko pojavijo neobičajni zlomi stegnenice, še posebno pri bolnikih, ki so na dolgotrajnem zdravljenju osteoporoze.
EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles EU/1/12/772/005 1 bottle 
EU/1/12/772/001 skupno pakiranje po 5 plastenk EU/1/12/772/002 skupno pakiranje po 10 plastenk EU/1/12/772/005 1 plastenka
QUALITATIVE AND QUANTITATIVE COMPOSITION Each bag contains 5 mg zoledronic acid (as monohydrate). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena vreča vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
- Do not use this medicine after the expiry date which is stated on the carton and bag after EXP. 
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in
• Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of Zoledronic acid Teva Pharma. 
• Pred odmerjanjem zdravila Zoledronska kislina Teva Pharma morajo biti bolniki, zlasti starejši in tisti, ki jemljejo diuretike, primerno hidrirani.