natgillin/translations-raw huggingface dataset:
0.5 mg/dl or 44 µmol/l; 
zvišanje za 0,5 mg/dl ali 44 µmol/l;
Patients receiving zoledronic acid 4 mg reported less increase in pain than those receiving placebo, and the difference reached significance at months 3, 9, 21 and 24. 
so poročali o manjšem porastu bolečin kot tisti, ki so dobivali placebo, ta razlika pa je dosegla statistično značilnost v 3., 9., 21. in 24. mesecu.
Healthcare professionals are advised not to dispose of unused Zoledronic acid medac via the domestic sewage system. 
Zdravstvenim delavcem svetujemo, da neporabljenega zdravila Zoledronska kislina medac ne izlijejo v gospodinjske odplake.
Zoledronic acid treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment. 
Zdravljenje z zoledronsko kislino pri bolnikih s TIH, ki imajo tudi težko ledvično okvaro, lahko pride v poštev šele po oceni nevarnosti in koristnih učinkov zdravljenja.
After first opening: Chemical and physical in-use stability has been demonstrated for 4 days at 2 - 8°C and 25°C. 
Po prvem odprtju: dokazana je bila 4-dnevna kemična in fizična stabilnost razredčenega zdravila pri 2-8 °C in 25 °C.
There are no site specific risk factors for osteonecrosis apart from additional oral risk factors for osteonecrosis of the jaw. 
Dejavniki tveganja za osteonekrozo niso specifični glede na lokacijo z izjemo dodatnih oralnih dejavnikov tveganja za osteonekrozo čeljustnice.
• Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate. 
• potentnost difosfonatov (večje tveganje pri visoko potentnih učinkovinah), pot uporabe (večje tveganje pri parenteralni uporabi) in kumulativni odmerek difosfonata.
Increasing the infusion time from 5 to 15 minutes caused a 30 % decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve. 
Podaljšanje časa infundiranja s 5 na 15 minut je povzročilo 30-odstotno znižanje koncentracije zoledronske kisline ob koncu infuzije, ni pa vplivalo na površino pod krivuljo plazemske koncentracije proti času.
Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have a higher risk of developing osteonecrosis of the jaw. 
Pri bolnikih, ki se zdravijo s kemoterapijo in/ali obsevanjem, jemljejo steroide, imajo operativen poseg na zobeh, niso deležni redne zobozdravstvene oskrbe, imajo bolezen dlesni, kadijo ali so se prej zdravili z difosfonati (ki se uporabljajo za zdravljenje ali preprečevanje bolezni kosti), je lahko tveganje nastanka osteonekroze čeljustnic večje.
Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose 
Odvzemite ustrezni volumen potrebnega koncentrata, kot sledi: 4,4 ml za odmerek 3,5 mg,
• Breast-feeding (see section 4.6). 
• Dojenje (glejte poglavje 4.6)
- 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. 
• Preprečevanje z okostjem povezanih dogodkov (patološki zlomi, spinalna kompresija, obsevanje ali operacija kosti ali tumorsko povzročena hiperkalciemija) pri odraslih bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti.
- Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh. 
- Osteonekrozo so zelo redko opažali tudi na drugih kosteh in ne le na čeljustnici, še posebej na kolku in stegnu.
Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours. 
Intravensko dana zoledronska kislina se odstranjuje iz telesa s trifaznim procesom: hitro dvofazno izginotje iz sistemskega krvnega obtoka z razpolovnima časoma t1/2α 0,24 ure in t1/2β 1,87 ure, ki mu sledi dolga eliminacijska faza s terminalnim eliminacijskim razpolovnim časom t1/2γ 146 ur.
Therefore, the product information should be updated to reflect in sections 4.4 and 4.8 of the SmPC a warning on osteonecrosis of other anatomical sites and add this adverse reaction with a frequency very rare. 
Informacije o zdravilu je zato treba posodobiti z vključitvijo opozorila o pojavu osteonekroze na drugih anatomskih lokacijah in dodatkom tega neželenega učinka s pogostnostjo zelo redek v poglavji 4.4 in 4.8 povzetka glavnih značilnosti zdravila.
The cases from safety database did report multiple risk factors including underlying malignancy, bone metastases; concomitant therapy with steroids, angiogenesis inhibitors, radiotherapy but the exact underlying cause for the osteonecrosis was not ascertained. 
Primeri iz podatkovne baze o varnosti zdravila kažejo več dejavnikov tveganja vključno z osnovno rakavo boleznijo, kostnimi zasevki, sočasnim zdravljenjem s steroidi, zaviralci angiogeneze ali radioterapijo, vendar pa natančen vzrok za pojav osteonekroze ni ugotovljen.
- have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth. 
- imate ali ste imeli bolečino, oteklino ali odrevenelost čeljusti, občutek pritiska v čeljusti ali če se vam maje zob.
Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3). 
Študije razmnoževanja pri živalih z zoledronsko kislino so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
• From a microbiological point of view, the solution for infusion should be used immediately, after first opening. 
• Z mikrobiološkega stališča je raztopino za infundiranje najbolje uporabiti takoj po prvem odpiranju.
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje zoledronsko kislino za vse podskupine pediatrične populacije glede zdravljenja tumorsko povzročene hiperkalciemije in preprečevanja z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
On the basis of the scientific conclusions for zoledronic acid (indicated for cancer and fractures) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing zoledronic acid (indicated for cancer and fractures) is unchanged subject to the proposed changes to the product information 
Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za zoledronsko kislino (indicirano za zdravljenje raka in zlomov) odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) zoledronsko kislino (indicirano za zdravljenje raka in zlomov) nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Furthermore, there is evidence of an association between hypocalcaemia and secondary neurological events reported in these cases including convulsions, hypoaesthesia and tetany (see section 4.4). 
Poleg tega obstajajo dokazi o povezanosti hipokalciemije in posledičnih nevroloških dogodkov, o katerih so poročali v teh primerih in so vključevali konvulzije, hipestezijo in tetanijo (glejte poglavje 4.4).
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of a condition called osteonecrosis of the jaw. 
Takoj obvestite zdravnika in zobozdravnika, če se pri vas pojavijo kakršne koli težave v zvezi z usti ali zobmi, na primer majanje zob, bolečina ali otekanje, neceljenje ran ali izcedek, ker so to lahko znaki stanja, ki se imenuje osteonekroza čeljustnic.
*Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min). 
* Odmerke so izračunali tako, da so predpostavili tarčno AUC 0,66 (mg•hr/l) (CLcr=75 ml/min).
- 4.1 ml for 3.3 mg dose 
4,1 ml za odmerek 3,3 mg,
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 5,000 ng/ml. 
V študiji in vitro je imela zoledronska kislina nizko afiniteto za celične sestavine humane krvi, pri čemer je znašala povprečna vrednost razmerja med koncentracijo v krvi in koncentracijo v plazmi 0,59 v razponu koncentracij od 30 ng/ml do 5.000 ng/ml.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06 - 0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose. 
Varno območje, glede na učinke na ledvici, je bilo v dolgoročnih študijah večkratnih parenteralnih odmerkov na živalih ozko, vendar kumulativne koncentracije brez neželenih učinkov (NOAEL) pri enkratnih odmerkih (1,6 mg/kg) in pri do en mesec trajajočih študijah večkratnih odmerkov (0,060,6 mg/kg/dan) niso kazale na učinke na ledvici v odmerkih, ki so bili enakovredni največjemu nameravanemu človeškemu terapevtskemu odmerku ali ki so le-tega presegali.
What you need to know before you are given Zoledronic acid medac 
Kaj morate vedeti, preden vam bodo dali zdravilo Zoledronska kislina medac
Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible. 
Začasna prekinitev zdravljenja z zoledronsko kislino pride v poštev, dokler se stanje ne razreši in se dejavniki tveganja, ki prispevajo z razvoju bolezni, ne ublažijo, če je to mogoče.
− 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. 
- In vitro: inhibicijo proliferacije osteoblastov, neposredno citostatično in pro-apoptotično aktivnost pri tumorskih celicah, sinergističen citostatični učinek z drugimi zdravili proti raku,
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid medac. 
Če imate hipokalciemijo, jo je treba odpraviti preden prejmete prvi odmerek zdravila Zoledronska kislina medac.
The analysis of the individual safety reports from clinical trials, spontaneous reports and literature retrieved 62 cases of osteonecrosis of other anatomical sites in association with zoledronic acid, with the majority of events occurring in the hip/femur (46). 
Analiza posameznih poročil o varnosti iz kliničnih študij, spontanih poročil in literature je razkrila 62 primerov osteonekroze v povezavi z zoledronsko kislino na drugih anatomskih lokacijah.
• Since no data are available on the compatibility of Zoledronic acid medac with other intravenously administered substances, Zoledronic acid medac must not be mixed with other medications/substances and should always be given through a separate infusion line. 
• Ker o združljivosti zdravila Zoledronska kislina medac z drugimi intravensko dajanimi snovmi ni na voljo nikakršnih podatkov, zdravila Zoledronska kislina medac ne smete mešati z drugimi zdravili ali snovmi in jo morate vedno dajati po ločenem infuzijskem sistemu.
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 outweighs the possible risk. 
Bolnike s tumorsko povzročeno hiperkalciemijo (TIH) in znaki poslabšanja ledvične funkcije, moramo ustrezno ovrednotiti in pri tem pretehtati, ali možna korist zdravljenja z zoledronsko kislino odtehta možno tveganje.
The following risk factors should be considered when evaluating an individual's risk of developing ONJ: 
Pri oceni tveganja za razvoj osteonekroze čeljustnic pri posamezniku je treba upoštevati naslednje dejavnike tveganja:
To assess the effects of 4 mg zoledronic acid versus pamidronate 90 mg, the results of two pivotal multicentre studies in patients with TIH were combined in a pre-planned analysis. 
Za oceno učinkov 4 mg zoledronske kisline v primerjavi s pamidronatom 90 mg so v vnaprej načrtovani analizi združili rezultate dveh ključnih multicentričnih študij pri bolnikih s tumorsko povzročeno hiperkalciemijo (TIH).
The solution must be allowed to reach 20°C to 23.5°C before administration. 
Pred dajanjem mora raztopina doseči temperaturo med 20 °C in 23,5 °C.
Withdraw an appropriate volume of the solution needed, as follows: - 4.4 ml for 3.5 mg dose 
Odvzemite ustrezni volumen potrebne raztopine, kot sledi: 4,4 ml za odmerek 3,5 mg,
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%). 
V združeni analizi podatkov o varnosti zdravila iz registracijskih preskušanj zoledronske kisline pri preprečevanju z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajemajo kosti, so bile pogostnosti neželenih dogodkov, ki so vključevali okvaro ledvic in pri katerih je obstajal sum, da so povezani z zoledronsko kislino (torej neželenih učinkov), naslednje: multipli mielom (3,2 %), rak prostate (3,1 %), rak dojke (4,3 %), tumor na pljučih in drugi čvrsti tumorji (3,2 %).
- 3.8 ml for 3.0 mg dose 
3,8 ml za odmerek 3,0 mg.
METHOD AND ROUTE(S) OF ADMINISTRATION Dilute before use. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo razredčite.
• Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking. 
• rak, sočasne druge bolezni (npr. anemija, koagulopatije, infekcija), kajenje.
- Treatment of adult patients with tumour-induced hypercalcaemia (TIH). 
• Zdravljenje odraslih bolnikov s tumorsko povzročeno hiperkalciemijo (TIH - tumour-induced hypercalcaemia).
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. 
17 let) s hudo obliko osteogenesis imperfecta (tipov I, III in IV) so primerjali z intravenskim pamidronatom v eni mednarodni, multicentrični, randomizirani, odprti študiji s 74 oziroma 76 bolniki v vsaki od zdravljenih skupin.
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially ‘sodiumfree'. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, tj. zdravilo je v bistvu "brez natrija".
The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs. 
Rezultati so dokazali, da je zoledronska kislina 4 mg pokazala učinkovitost za preprečevanje z okostjem povezanih dogodkov (SRE), ki je bila primerljiva z učinkovitostjo 90 mg pamidronata.
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. 
Preden začnete zdravljenje z zdravilom Zoledronska kislina medac, vam bo zdravnik opravil preiskave krvi in v rednih presledkih preverjal vaš odziv na zdravljenje.
- Difficulty in breathing with wheezing or coughing. 
- oteženo dihanje s piskanjem ali kašljem,
Anxiety, sleep disturbance Confusion 
anksioznost, motnje spanja redki:
The plasma protein binding is low, with the unbound fraction ranging from 60% at 2 ng/ml to 77% at 2,000 ng/ml of zoledronic acid. 
Vezava na beljakovine v plazmi je majhna, tako da nevezana frakcija predstavlja od 60 % pri koncentraciji zoledronske kisline 2 ng/ml do 77 % pri koncentraciji 2.000 ng/ml.
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. 
Kemična in fizična stabilnost med uporabo je bila dokazana za steklenice, infuzijske vrečke in infuzijske linije iz polivinilklorida, polietilena in polipropilena (napolnjene z 9 mg/ml (0,9-odstotno) raztopino natrijevega klorida za injekcije ali 5 % m/v raztopino glukoze) za 96 ur pri 2 do 8 °C in 25 °C.
The primary endpoint of the study was the percent change from baseline in lumbar spine bone mineral density (BMD) after 12 months of treatment. 
Primarni cilj opazovanja v študiji je bila odstotna sprememba mineralne gostote kosti ledvenega dela hrbtenice po 12 mesecih zdravljenja glede na izhodišče.
• For single use only. 
• Zdravilo je namenjeno samo za enkratno uporabo.
The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients. 
V prvi randomizirani, dvojno slepi raziskavi, kontrolirani s placebom, so primerjali zoledronsko kislino 4 mg s placebom za preprečevanje z okostjem povezanih dogodkov (SRE - skeletal related event) pri bolnikih z rakom prostate.
Caution is advised when bisphosphonates are administered with aminoglycosides, calcitonin or loop diuretics, since these agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required (see section 4.4). 
Kadar difosfonate dajemo sočasno z aminoglikozidi, kalcitoninom ali diuretiki Henlejeve zanke je priporočljiva previdnost, ker utegnejo imeti te učinkovine aditiven učinek, kar bi imelo za posledico nižje koncentracije serumskega kalcija za dalj časa, kot je potrebno (glejte poglavje 4.4).
Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications. 
Hipokalciemija predstavlja pomembno tveganje, ki ga opažajo pri uporabi zdravila zoledronska kislina za odobrene indikacije.
What Zoledronic acid medac is and what it is used for What you need to know before you are given Zoledronic acid medac How Zoledronic acid medac is used Possible side effects 
Kaj je zdravilo Zoledronska kislina medac in za kaj ga uporabljamo Kaj morate vedeti, preden vam bodo dali zdravilo Zoledronska kislina medac Kako uporabljati zdravilo Zoledronska kislina medac
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. 
Bolniki, ki prejemajo zdravilo Zoledronska kislina medac, ne smejo sočasno prejemati takih zdravil ali katerega koli od drugih difosfonatov, saj učinki kombinacije navedenih učinkovin niso znani.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING (WITHOUT BLUE BOX) CARTON FOR 1 BOTTLE AS PART OF A MULTIPACK COMPRISING 4 BOTTLES CARTON FOR 1 BOTTLE AS PART OF A MULTIPACK COMPRISING 10 BOTTLES 
PODATKI NA ZUNANJI OVOJNINI (BREZ PODATKOV ZA “BLUE BOX”) ŠKATLA ZA 1 STEKLENICO KOT DEL SKUPNEGA PAKIRANJA S 4 STEKLENICAMI ŠKATLA ZA 1 STEKLENICO KOT DEL SKUPNEGA PAKIRANJA Z 10 STEKLENICAMI
Zoledronic acid does not inhibit human P450 enzymes in vitro, shows no biotransformation and in animal studies < 3 % of the administered dose was recovered in the faeces, suggesting no relevant role of liver function in the pharmacokinetics of zoledronic acid. 
Zoledronska kislina in vitro ne zavira humanih encimov s P450, ne kaže biotransformacije, v raziskavah na živalih pa so iz blata prestregli < 3 % danega odmerka, kar kaže, da funkcija jeter nima pomembne vloge v farmakokinetiki zoledronske kisline.
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) 
hipofosfatemija Neželene učinke s pogostnostjo < 5 % so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenim varnostnim profilom zoledronske kisline (glejte poglavje 4.8).
Very rare (may affect up to 1 in 10,000 people): - As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia. 
Zelo redki (lahko se pojavijo pri največ 1 od 10.000 bolnikov): - zaradi nizke vrednosti kalcija: napadi krčev, otrplost in tetanija (zaradi hipokalciemije).
- Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ). 
- antiangiogena zdravila (uporabljamo jih pri zdravljenju raka), ker kombinacijo le-teh z zdravilom Zoledronska kislina medac povezujejo s povečanim tveganjem za osteonekrozo čeljustnic.
Hypomagnesaemia, hypokalaemia Hyperkalaemia, hypernatraemia 
hiperkaliemija, hipernatriemija
In use stability: Chemical and physical in-use stability after dilution has been demonstrated for 24 hours at 2-8°C and 25°C. 
Stabilnost med uporabo: dokazana je bila 24-urna kemična in fizična stabilnost razredčenega zdravila pri 2-8 °C in 25 °C.
Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes. 
Zdravilo Zoledronska kislina medac 4 mg/5 ml koncentrat za raztopino za infundiranje, nadaljnje razredčeno v 100 ml (glejte poglavje 6.6), je treba dajati v obliki ene same intravenske infuzije, ki traja najmanj 15 minut.
Taking into account the PRAC Assessment Report on the PSUR(s) for zoledronic acid (indicated for cancer and fractures), the scientific conclusions of CHMP are as follows: 
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za zoledronsko kislino (indicirano za zdravljenje raka in zlomov) je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Rare (may affect up to 1 in 1,000 people): - Slow heart beat. 
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - počasno bitje srca,
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). 
- preprečevanje zapletov na kosteh, na primer zlomov, pri odraslih bolnikih z metastazami v kosteh (z razširitvijo raka s prvotnega mesta na kosti),
Instructions for preparing reduced doses of zoledronic acid 
Navodila za pripravo zmanjšanih odmerkov zoledronske kisline:
Median time to SRE (days) 
čas v študiji (tedni)
• The solution containing zoledronic acid must not be further diluted or mixed with other infusion solutions. 
• Raztopine, ki vsebuje zoledronsko kislino, ne smete nadalje redčiti ali mešati z drugimi infuzijskimi raztopinami.
The hydration status of patients must be assessed prior to and following administration of Zoledronic acid medac to ensure that they are adequately hydrated. 
Status hidracije bolnikov mora zdravnik oceniti pred in po dajanju zdravila Zoledronska kislina medac, da se prepriča, da so ustrezno hidrirani.