natgillin/translations-raw huggingface dataset:
In a pooled analysis of safety data from trials for the use of zoledronic acid 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 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 %).
Acquired Fanconi syndrome General disorders and administration site conditions Common: 
pridobljen Fanconijev sindrom Splošne težave in spremembe na mestu aplikacije Pogosti:
What Zoledronic Acid Hospira looks like and contents of the pack Zoledronic Acid Hospira is a clear and colourless solution. 
Izgled zdravila Zoledronska kislina in vsebina pakiranja Zdravilo Zoledronska kislina Hospira je bistra in brezbarvna raztopina.
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 raziskav pri bolnikih s tumorsko povzročeno hiperkalciemijo (TIH).
While being treated with Zoledronic Acid Hospira, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. 
V času zdravljenja z zdravilom Zoledronska kislina Hospira morate skrbeti za dobro ustno higieno (kar vključuje redno čiščenje zob) in redno hoditi na rutinske preglede k zobozdravniku.
Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible. 
Razmisliti je treba o začasni prekinitvi zdravljenja z zoledronsko kislino, dokler se stanje ne razreši in dokler se ne zmanjša vpliv prispevajočih dejavnikov tveganja, če je to mogoče doseči.
- Carefully follow all the other instructions given to you by your doctor, nurse or pharmacist. 
- Skrbno se ravnajte tudi po vseh drugih navodilih, ki jih dobite od svojega zdravnika, medicinske sestre ali farmacevta.
The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients. 
Neravnovesja, ki so ga opazili v tem preskušanju, niso opažali v drugih preskušanjih z zoledronsko kislino, vključno s preskušanji z zoledronsko kislino v odmerku 4 mg vsake 3-4 tedne pri onkoloških bolnikih.
Other medicines and Zoledronic Acid Hospira 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 Hospira Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
*Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min). 
*Odmerke so izračunali tako, da so predpostavili ciljno vrednost AUC 0,66 (mg•hr/l) (CLcr=75 ml/min).
It is not known whether zoledronic acid is excreted into human milk. 
Ni znano, ali se zoledronska kislina izloča v materino mleko pri ljudeh.
In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral calcium and/or an intravenous infusion of calcium gluconate. 
Klinično pomembno hipokalciemijo, ki je posledica prevelikega odmerka, lahko odpravimo z dodatkom peroralnega kalcija in/ali intravensko infuzijo kalcijevega glukonata.
Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, intestinal calcium malabsorption). 
Učinkovito je treba zdraviti tudi druge motnje presnove elektrolitov (kot sta zmanjšano delovanje ostanka obščitnice in okvarjena absorpcija kalcija v črevesju).
Population analysis showed that for a patient with creatinine clearance of 20 ml/min (severe renal impairment), or 50 ml/min (moderate impairment), the corresponding predicted clearance of zoledronic acid would be 37% or 72%, respectively, of that of a patient showing creatinine clearance of 84 ml/min. 
Analize na populaciji so pokazale, da bi bil pri bolniku z očistkom kreatinina 20 ml/min (huda ledvična okvara) ali 50 ml/min (zmerna okvara) ustrezni napovedani očistek zoledronske kisline 37 % oziroma 72 % tistega pri bolniku, ki bi imel očistek kreatinina 84 ml/min.
The administration of doses up to 48 mg of zoledronic acid in error has been reported. 
Poročali so o dajanju odmerkov zoledronske kisline do 48 mg po pomoti.
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. 
V študijah faze I za ugotavljanje odmerka pri bolnikih z blago do zmerno hiperkalciemijo, povzročeno s tumorjem (TIH), so bili testirani učinkoviti odmerki v razponu približno 1,2-2,5 mg.
Instructions for preparing reduced doses of Zoledronic Acid Hospira 
Navodila za pripravo zmanjšanih odmerkov zdravila Zoledronska kislina Hospira
Zoledronic acid is not systemically metabolised and does not affect human cytochrome P450 enzymes in vitro (see section 5.2). 
Zoledronska kislina se sistemsko ne presnavlja ter in vitro ne vpliva na encime citokroma P450 pri človeku (glejte poglavje 5.2).
Increases in serum creatinine also occur in some patients with chronic administration of zoledronic acid at recommended doses for prevention of skeletal related events, although less frequently. 
Čeprav redkeje, se zvišanje serumskega kreatinina pojavlja tudi pri nekaterih bolnikih, ki kronično prejemajo zoledronsko kislino v priporočenih odmerkih za preprečevanje z okostjem povezanih dogodkov.
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 ledvice, 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 učinkov na ledvice v odmerkih, ki so bili enakovredni največjemu nameravanemu človeškemu terapevtskemu odmerku ali ki so le-tega presegali.
The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established. 
Varnost in učinkovitost zoledronske kisline pri otrocih in mladostnikih do 18 let nista bili dokazani.
3 PHARMACEUTICAL FORM 
FARMACEVTSKA OBLIKA
Other products containing zoledronic acid as active substance are available for oncology indications. 
Obstajajo druga zdravila, ki vsebujejo učinkovino zoledronska kislina in se uporabljajo za onkološke indikacije.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. 
Pri bolnikih, pri katerih se med difosfonatnim zdravljenjem razvije osteonekroza čeljustnic, lahko stomatološka operacija stanje poslabša.
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. 
Pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov) 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 driska.
If you missed a dose of Zoledronic Acid Hospira Contact your doctor or hospital as soon as possible to re-schedule your appointment. 
Če ste izpustili odmerek zdravila Zoledronska kislina Hospira Čimprej pokličite zdravnika ali v bolnišnico, da se dogovorite za naslednji obisk.
It is given as a single 15-minute intravenous infusion in a separate infusion line. 
Daje se v obliki ene same 15-minutne intravenske infuzije z ločenim infuzijskim sistemom.
To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below. 
Za pripravo zmanjšanih odmerkov za bolnike z izhodiščnim CLcr ≤ 60 ml/min glejte spodnjo preglednico 1.
It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received zoledronic acid. 
Zaenkrat ni jasno, ali to nepravilno bitje srca povzroča zoledronska kislina, kljub temu pa morate zdravniku sporočiti, če pri vas pride do takih simptomov po tem, ko ste prejeli zoledronsko kislino,
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic Acid Hospira. 
Če imate hipokalciemijo, jo je treba odpraviti preden prejmete prvi odmerek zdravila Zoledronska kislina Hospira.
* Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min). 
* Odmerke so izračunali s predvidenim ciljnim AUC 0,66 (mg•hr/l) (CLcr = 75 ml/min).
− Conjunctivitis. 
− konjunktivitis,
The long duration of action of zoledronic acid is attributable to its high binding affinity for the active site of farnesyl pyrophosphate (FPP) synthase and its strong binding affinity to bone mineral. 
Dolgotrajno delovanje zoledronske kisline je mogoče pripisati veliki vezavni afiniteti do aktivnega mesta na farnezil pirofosfat-sintazi in močni vezavni afiniteti do kostnih mineralov.
In the intravenous bolus studies, the doses that were well-tolerated decreased with increasing study duration: 0.2 and 0.02 mg/kg daily was well tolerated for 4 weeks in rats and dogs, respectively but only 0.01 mg/kg and 0.005 mg/kg in rats and dogs, respectively, when given for 52 weeks. 
V študijah z intravenskimi bolusi so se odmerki, ki so jih živali dobro prenašale, zmanjševali s podaljševanjem študije: odmerek 0,2 oziroma 0,02 mg/kg na dan so podgane in psi dobro prenašali 4 tedne, medtem ko so tako podgane kot psi 52 tednov dolgo dajanje zdravila dobro prenašali le v odmerku 0,01 mg/kg oziroma 0,005 mg/kg:
Proportion of patients with SREs (%) 
4 mg placebo delež bolnikov s SRE (%)
The hydration status of patients must be assessed prior to and following administration of zoledronic acid to ensure that they are adequately hydrated. 
Status hidracije bolnikov mora zdravnik oceniti pred in po dajanju zoledronske kisline, da se prepriča, da so ustrezno hidrirani.
Follow carefully all instructions given to you by your doctor or nurse. 
Natančno upoštevajte navodila, ki vam jih je dal vaš zdravnik ali medicinska sestra.
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended. 
Med dejavniki, ki lahko povečajo možnost poslabšanja delovanja ledvic, so dehidracija, predhodna ledvična okvara, večkratni ciklusi zdravljenja z zoledronsko kislino ali drugimi difosfonati, kot tudi sočasna uporaba nefrotoksičnih zdravil ali čas infundiranja, ki je krajši od priporočenega.
** Based on post-marketing reports. 
** na podlagi postmarketinških poročil; pogostnostni ni mogoče oceniti iz razpoložljivih podatkov.
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. 
V kliničnih preskušanjih je bilo 69 bolnikov, pri katerih se je bolezen ponovno pojavila ali pri katerih ni bilo odziva na začetno zdravljenje (zoledronska kislina 4 mg, 8 mg ali pamidronat 90 mg), ponovno zdravljenih z 8 mg zoledronske kisline.
Very Rare (may affect up to 1 in 10,000 people) Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. 
Zelo redki (lahko se pojavijo pri največ 1 od 10.000 bolnikov) V primeru bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte z zdravnikom.
What Zoledronic Acid Hospira is and what it is used for What you need to know before you are given Zoledronic Acid Hospira How Zoledronic Acid Hospira is given Possible side effects 
Kaj je zdravilo Zoledronska kislina Hospira in za kaj ga uporabljamo Kaj morate vedeti, preden vam bodo dali zdravilo Zoledronska kislina Hospira Kako se daje zdravilo Zoledronska kislina Hospira Možni neželeni učinki
Clear and colourless solution. 
bistra in brezbarvna raztopina
In patients with normal renal function, defined as CLcr > 60 ml/min, zoledronic acid 4 mg/100 ml solution for infusion must not be further diluted. 
Pri bolnikih z normalnim delovanjem ledvic, kar je opredeljeno kot CLcr > 60 ml/min, zoledronske kisline 4 mg/100 ml raztopina za infundiranje ni treba dodatno razredčiti.
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 Paget's disease of the bone (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zoledronsko kislino za vse podskupine pediatrične populacije s Pagetovo boleznijo kosti (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Patients should have their serum creatinine levels assessed prior to each dose of zoledronic acid. 
Bolnikom je treba pred vsakim odmerkom zoledronske kisline določiti raven serumskega kreatinina.
Zoledronic acid 4 mg reduced the risk of SREs by 41% in a multiple event analysis (risk ratio=0.59, p=0.019) compared with placebo. 
Pri analizi večkratnih dogodkov se je pokazalo, da je zoledronska kislina 4 mg zmanjšala tveganje za SRE za 41 % (razmerje tveganj = 0,59; p = 0,019) v primerjavi s placebom.
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. 
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).
After first opening: From a microbiological point of view, the product should be used immediately. 
Po prvem odprtju: z mikrobiološkega vidika je treba zdravilo uporabiti takoj.
− if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth. 
− če imate ali ste v preteklosti imeli bolečino, oteklino ali odrevenelost v čeljusti, če čutite težo v čeljusti ali se vam maje zob.
Zoledronic acid must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates. 
Zoledronsko kislino smejo predpisovati in dajati bolnikom samo zdravstveni delavci, ki imajo izkušnje z uporabo intravenskih difosfonatov.
The active substance in Zoledronic Acid Hospira is zoledronic acid, which belongs to a group of substances called bisphosphonates. 
Učinkovina v zdravilu Zoledronska kislina Hospira je zoledronska kislina, ki sodi v skupino snovi, ki se imenujejo difosfonati.
Dystocia was observed at the lowest dose (0.01 mg/kg body weight) tested in rats. 
Distocijo so ugotovili pri najnižjem odmerku (0,01 mg/kg telesne mase), ki so ga preskušali pri podganah.
Longer-term repeat administration at cumulative exposures sufficiently exceeding the maximum intended human exposure produced toxicological effects in other organs, including the gastrointestinal tract and liver, and at the site of intravenous administration. 
Dolgotrajno večkratno dajanje pri kumulativnih izpostavljenostih, ki močno presegajo največjo nameravano izpostavljenost pri človeku, je povzročilo toksikološke učinke v drugih organih, vključno z gastrointestinalnim traktom in jetri, in na mestu intravenske aplikacije.
Abdominal pain Musculoskeletal and connective tissue disorders Common: 
bolečine v trebuhu Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti:
How to store Zoledronic Acid Hospira Contents of the pack and other information 
Shranjevanje zdravila Zoledronska kislina Hospira Vsebina pakiranja in dodatne informacije
Common C-reactive protein increased Uncommon Blood calcium decreased Observed in patients taking concomitant glucocorticosteroids. 
Preiskave pogosti zvišana vrednost C-reaktivnega proteina občasni znižana vrednost kalcija v krvi pri bolnikih, ki so sočasno jemali glukokortikoide.
− Since no data are available on the compatibility of Zoledronic Acid Hospira with other intravenously administered substances, Zoledronic Acid Hospira must not be mixed with other medicinal products/substances and should always be given through a separate infusion line. 
− Ker o združljivosti zdravila Zoledronska kislina Hospira z drugimi intravensko dajanimi snovmi ni na voljo nikakršnih podatkov, zdravila Zoledronska kislina Hospira ne smete mešati z drugimi zdravili ali snovmi in ga moramo vedno dajati po ločenem infuzijskem sistemu.
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid and other bisphosphonates as well as use of other nephrotoxic medicinal products. 
Med dejavniki, ki utegnejo zvečati možnost poslabšanja ledvične funkcije so dehidracija, že obstoječa ledvična okvara, več ciklov zdravljenja z zoledronsko kislino in drugimi difosfonati, pa tudi uporaba drugih nefrotoksičnih zdravil.
The use of Zoledronic Acid Hospira 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 Hospira pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 35 ml/min) je kontraindicirana zaradi povečanega tveganja za odpoved pri tej populaciji.
p-value Median time to SRE (days) 
mediana časa do SRE (dnevi)
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 z znaki poslabšanja ledvične funkcije, moramo ustrezno ovrednotiti in pri tem pretehtati, ali možna korist zdravljenja z zoledronsko kislino odtehta morebitno tveganje.
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. 
Bolniki z normalnim delovanjem ledvic (opredeljeno kot CLcr > 60 ml/min), lahko zoledronsko kislino 4 mg/100 ml raztopino za infundiranje prejmejo neposredno brez nadaljnje priprave.
− Low level of magnesium and potassium in the blood. 
− nizki koncentraciji magnezija in kalija v krvi.
It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic Acid Hospira, as directed by your healthcare provider. 
Pomembno je, da v nekaj urah pred prejemom zdravila Zoledronska kislina Hospira popijete vsaj 2 kozarca tekočine (na primer vode), kakor vam naroči zdravstveni delavec, s katerim sodelujete.
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 je pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 35 ml/min) kontraindicirana zaradi povečanega tveganja za odpoved ledvic pri tej populaciji.
Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline. 
Zdravljenje z zoledronsko kislino se sme spet začeti šele, ko se serumski kreatinin vrne na vrednost, ki ni za več kot 10% večja od izhodiščne.
It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Zoledronic Acid Hospira. 
Zaenkrat ni jasno, ali to nepravilno bitje srca povzroča zdravilo Zoledronska kislina Hospira, kljub temu pa morate zdravniku sporočiti, če pri vas pride do takih simptomov po prejemu zdravila Zoledronska kislina Hospira.
Zoledronic acid treatment should be resumed at the same dose as that given prior to treatment interruption. 
Zdravljenje z zoledronsko kislino je treba spet začeti z enakim odmerkom, kot ga je bolnik prejemal pred prekinitvijo zdravljenja.
Solution for infusion 4 mg/100 ml 
raztopina za infundiranje 4 mg/100 ml
In a large clinical trial, local reactions at the infusion site, such as redness, swelling and/or pain, were reported (0.7%) following the administration of zoledronic acid. 
V obsežnem kliničnem preskušanju so po odmerjanju zoledronske kisline poročali o lokalnih reakcijah, kot so rdečina, oteklina in/ali bolečina (0,7 %).
For atrial fibrillation serious adverse events the pooled incidences were 1.3% for zoledronic acid and 0.8% for placebo. 
Združeni incidenci atrijske fibrilacije, ki so jo opredelili kot resen neželen učinek, sta bili 1,3 % pri zoledronski kislini in 0,8 % pri placebu.
Your doctor can recommend a mild pain reliever such as ibuprofen or paracetamol to reduce these side effects. 
Za ublažitev teh neželenih učinkov vam zdravnik lahko svetuje blago zdravilo proti bolečinam, kot sta ibuprofen ali paracetamol.
− if you are allergic (hypersensitive) to zoledronic acid, another bisphosphonate (the group of substances to which zoledronic acid belongs), or any of the other ingredients of Zoledronic Acid Hospira. 
− če ste alergični (preobčutljivi) na zoledronsko kislino, drug difosfonat (skupina snovi, ki ji pripada zoledronska kislina) ali katerokoli sestavino zdravila Zoledronska kislina Hospira
Concentrate for solution for infusion 4 mg/5 ml 
koncentrat za raztopino za infundiranje 4 mg/5 ml
− Sleepiness 
− zaspanost,
Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) 
− intersticijska bolezen pljuč (vnetje tkiva okoli pljučnih mešičkov),