FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with 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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z 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).
English: Zometa treatment should be resumed at the same dose as that given prior to treatment interruption.
Slovenian: Zdravljenje z zdravilom Zometa je treba spet začeti z enakim odmerkom kot ga je bolnik prejemal pred prekinitvijo zdravljenja.
English: Anxiety, sleep disturbance
Slovenian: anksioznost, motnje spanja redki:
English: Women of child-bearing potential should be advised to avoid becoming pregnant.
Slovenian: Ženskam v rodni dobi je treba naročiti, naj pazijo, da ne bodo zanosile.
English: The frequencies for each of these identified risks are shown in Table 1.
Slovenian: Pogostnosti vsakega od navedenih ugotovljenih tveganj so prikazane v preglednici 1.
English: - In vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer drugs, anti-adhesion/invasion activity.
Slovenian: - In vitro: Inhibicijo proliferacije osteoblastov, neposredno citostatično in pro-apoptotično aktivnost pri tumorskih celicah, sinergističen citostatični učinek z drugimi zdravili proti raku, anti-adhezijsko in anti-invazijsko aktivnost.
English: Patients whose blood calcium levels are not too high will also be prescribed calcium and vitamin D supplements to be taken each day.
Slovenian: Bolnikom, ki nimajo previsoke koncentracije kalcija v krvi, bo zdravnik predpisal nadomestke kalcija in vitamina D, ki jih bodo jemali vsak dan.
English: In Phase I dose finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2-2.5 mg.
Slovenian: 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.
English: The study treatment period was 12 months preceded by a 4- to 9-week screening period during which vitamin D and elemental calcium supplements were taken for at least 2 weeks.
Slovenian: Obdobje zdravljenja v študiji je trajalo 12 mesecev, pred tem so imeli bolniki 4- do 9-tedensko obdobje presejanja (screening), v katerem so bolniki vsaj 2 tedna jemali vitamin D in nadomestke z elementarnim kalcijem.
English: The effects of intravenous zoledronic acid in the treatment of paediatric patients (age 1 to 17 years) with severe osteogenesis imperfecta (types I, III and IV) were compared to intravenous pamidronate in one international, multicentre, randomised, open-label study with 74 and 76 patients in each treatment group, respectively.
Slovenian: Delovanje intravenske zoledronske kisline pri zdravljenju pediatričnih bolnikov (starih od 1 leta do 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.
English: Hyperkalaemia, hypernatraemia
Slovenian: hiperkaliemija, hipernatriemija
English: In the event of hypocalcaemia, calcium gluconate infusions should be administered as clinically indicated.
Slovenian: V primeru hipokalciemije je treba dati infuzijo kalcijevega glukonata v skladu s klinično indikacijo.
English: The reduced doses for patients with renal impairment are expected to achieve the same AUC as that seen in patients with creatinine clearance of 75 ml/min.
Slovenian: Pričakuje se, da bodo zmanjšani odmerki pri bolnikih z ledvičnimi okvarami dosegli iste AUC, kot jih vidimo pri bolnikih z očistkom kreatinina 75 ml/min.
English: Hypophosphataemia 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 Zometa (see section 4.8)
Slovenian: hipofosfatemija Neželene učinke s pogostnostjo < 5 % so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenim varnostnim profilom zdravila Zometa (glejte poglavje 4.8).
English: Zoledronic acid shows no appreciable binding to plasma proteins and does not inhibit human P450 enzymes in vitro (see section 5.2), but no formal clinical interaction studies have been performed.
Slovenian: Zoledronska kislina ne kaže znatne vezave na plazemske beljakovine in ne zavira humanih encimov P450 in vitro (glejte poglavje 5.2), niso pa izvedli formalnih kliničnih študij medsebojnega delovanja.
English: The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with Zometa (zoledronic acid) 4 mg every 3-4 weeks in oncology patients.
Slovenian: Neravnovesja, ki so ga opažali v tem preskušanju, niso opažali v drugih preskušanjih z zoledronsko kislino, vključno s preskušanji z zdravilom Zometa (zoledronsko kislino) v odmerku 4 mg vsake 3-4 tedne pri onkoloških bolnikih.
English: In clinical studies, Zometa has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Slovenian: V kliničnih študijah so zdravilo Zometa dajali sočasno z običajno uporabljanimi zdravili proti raku, diuretiki, antibiotiki in analgetiki, ne da bi prišlo do klinično očitnega medsebojnega delovanja.
English: If your level of calcium falls too low, you may have to be given supplemental calcium by infusion.
Slovenian: Če se vam koncentracija kalcija preveč zniža, vam bodo morda morali nadomeščati kalcij z infuzijo.
English: Single and multiple 5- and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients with bone metastases yielded the following pharmacokinetic data, which were found to be dose independent.
Slovenian: Pri posameznih in večkratnih 5-minutnih in 15-minutnih infuzijah 2, 4, 8 in 16 mg zoledronske kisline pri 64 bolnikih z zasevki v kosteh so dobili spodnje farmakokinetične podatke, za katere so ugotovili, da so neodvisni od odmerka.
English: Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
Slovenian: hipertenzija, hipotenzija, atrijska fibrilacija, hipotenzija, ki povzroči sinkopo ali cirkulacijski kolaps redki:
English: Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change.
Slovenian: Zoledronska kislina deluje tako, da se pripne na kost in upočasni hitrost spreminjanja kosti.
English: Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
Slovenian: huda alergijska reakcija: zadihanost, otekanje zlasti v obraz in žrelo oziroma grlo.
English: Patients who have received doses higher than those recommended (see section 4.2) should be carefully monitored, since renal function impairment (including renal failure) and serum electrolyte (including calcium, phosphorus and magnesium) abnormalities have been observed.
Slovenian: Bolnike, ki so dobili večje odmerke od priporočenih (glejte poglavje 4.2), je treba skrbno spremljati, saj so opažali slabše delovanje ledvic (vključno z ledvično odpovedjo) in nepravilnosti elektrolitov v serumu (vključno s kalcijem, fosforjem in magnezijem).
English: Estimated treatment effects on BMD were similar, but the trial design was not sufficiently robust to establish non-inferior efficacy for zoledronic acid.
Slovenian: Ocenjeni učinki zdravljenja na mineralno gostoto kosti so bili podobni pri obeh učinkovinah, vendar zasnova preskušanja ni bila dovolj robustna, da bi lahko potrdili ne-inferiorno učinkovitost zoledronske kisline.
English: After initiating the infusion of zoledronic acid, the plasma concentrations of zoledronic acid rapidly increased, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak prior to the second infusion of zoledronic acid on day 28.
Slovenian: Po začetku infuzije zoledronske kisline so se plazemske koncentracije zoledronske kisline hitro zvišale, dosegle ob koncu obdobja infuzije vrh, ki mu je sledilo hitro znižanje na < 10 % najvišje koncentracije po 4 urah in na < 1 % najvišje koncentracije po 24 urah, čemur je sledilo dolgotrajno obdobje zelo nizkih koncentracij, ki pred drugo infuzijo zoledronske kisline na 28. dan niso presegle 0,1 % maksimalne koncentracije.
English: 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.
Slovenian: 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.
English: Clinical studies in tumour-induced hypercalcaemia (TIH) demonstrated that the effect of zoledronic acid is characterised by decreases in serum calcium and urinary calcium excretion.
Slovenian: Klinične študije hiperkalciemije, povzročene s tumorjem (TIH), so pokazale, da je za učinek zoledronske kisline značilno znižanje serumskega kalcija in zmanjšanje izločanja kalcija z urinom.
English: What Zometa is and what it is used for What you need to know before you are given Zometa How Zometa is used
Slovenian: Kaj je zdravilo Zometa in za kaj ga uporabljamo Kaj morate vedeti, preden vam bodo dali zdravilo Zometa Kako se zdravilo Zometa uporablja Možni neželeni učinki
English: Multi-packs containing 4 (4x 1) or 5 (5x 1) bottles.
Slovenian: Skupno pakiranje vsebuje 4 (4x 1) ali 5 (5x 1) plastenk.
English: Hypocalcaemia is an important identified risk with Zometa in the approved indications.
Slovenian: Hipokalciemija predstavlja pomembno tveganje, ki ga opažajo pri uporabi zdravila Zometa za odobrene indikacije.
English: If a lower dose of Zometa is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Slovenian: Če je potreben manjši odmerek zdravila Zometa, najprej odvzemite ustrezni volumen, kot je navedeno spodaj, in ga nato dodatno razredčite s 100 ml infuzijske raztopine.
English: VIAL LABEL
Slovenian: NALEPKA VIALE
English: - Carefully follow all the other instructions given to you by your doctor, pharmacist or nurse.
Slovenian: - Skrbno se ravnajte tudi po vseh drugih navodilih, ki jih dobite od svojega zdravnika, farmacevta ali medicinske sestre.
English: Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Slovenian: Osteonekrozo so zelo redko opažali tudi na drugih kosteh in ne le na čeljustnici, še posebej na kolku in stegnu.
English: Instructions for preparing reduced doses of Zometa:
Slovenian: Navodila za pripravo zmanjšanih odmerkov zdravila Zometa:
English: Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Slovenian: Študije razmnoževanja na živalih z zoledronsko kislino so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zometa and inform your doctor about your dental treatment.
Slovenian: - če si zdravite zobe ali če boste imeli zobozdravstveno operacijo, povejte svojemu zobozdravniku, da se zdravite z zdravilom Zometa in obvestite svojega zdravnika o zdravljenju zob.
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when Zometa is used in combination with thalidomide.
Slovenian: Pri bolnikih z multiplim mielomom se utegne zvečati tveganje za disfunkcijo ledvic, kadar zdravilo Zometa uporabljamo v kombinaciji s talidomidom.
English: The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg zoledronic acid every 3 to 4 weeks.
Slovenian: Priporočeni odmerek za preprečevanje z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti, je 4 mg zoledronske kisline vsake 3 do 4 tedne.
English: 1 bottle, 100 ml
Slovenian: 1 plastenka, 100 ml
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zometa.
Slovenian: Če imate hipokalciemijo, jo je treba odpraviti preden prejmete prvi odmerek zdravila Zometa.
English: In paediatric patients with severe osteogenesis imperfecta, zoledronic acid seems to be associated with more pronounced risks for acute phase reaction, hypocalcaemia and unexplained tachycardia, in comparison to pamidronate, but this difference declined after subsequent infusions.
Slovenian: Kaže, da je pri pediatričnih bolnikih s hudo obliko osteogenesis imperfecta uporaba zoledronske kisline povezana z večjim tveganjem za reakcijo akutne faze, hipokalciemijo in nepojasnjeno tahikardijo kot uporaba pamidronata, vendar se je z nadaljnjimi infuzijami ta razlika zmanjševala.
English: Additional information on handling of Zometa, including guidance on preparation of reduced doses, is provided in section 4.2.
Slovenian: Nadaljnje informacije o ravnanju z zdravilom Zometa, vključno z navodili za pripravo nižjih odmerkov, so navedene v poglavju 4.2.
English: 1 bottle
Slovenian: 1 plastenka
English: Do not use Zometa after the expiry date stated on the pack.
Slovenian: - Zdravilo Zometa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.
Slovenian: Bolniki morajo prejeti tudi peroralni dodatek 500 mg kalcija in 400 i.e. vitamina D na dan.
English: 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.
Slovenian: Pri bolnikih, ki se zdravijo s kemoterapijo in/ali obsevanjem, ki jemljejo steroide, imajo zobozdravstveno operacijo, ki nimajo redne zobozdravstvene oskrbe, ki imajo obolenje dlesni, ki kadijo ali ki so se v preteklosti zdravili z difosfonati (uporabljajo se za zdravljenje ali preprečevanje obolenj kosti), je lahko tveganje za pojav osteonekroze čeljustnic večje.
English: The frequencies for each of these identified risks are shown in Table 2.
Slovenian: Pogostnosti vsakega od navedenih ugotovljenih tveganj so prikazane v preglednici 2.
English: • To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Slovenian: • preprečevanje zapletov na kosteh, na primer zlomov, pri odraslih bolnikih z metastazami v kosteh (z razširitvijo raka s prvotnega mesta na kosti),
English: The following properties have been demonstrated in preclinical studies: - In vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
Slovenian: V predkliničnih raziskavah so dokazali sledeče lastnosti: - In vivo: Inhibicijo osteoklastne resorpcije kosti, ki spremeni mikrookolje kostnega mozga, tako da je le-to manj ugodno za rast tumorskih celic, protiangiogeno aktivnost in protibolečinsko aktivnost.
English: This condition is known as tumour-induced hypercalcaemia (TIH).
Slovenian: To stanje imenujemo tumorsko povzročena hiperkalciemija (TIH).
English: In the clinical programme patients aged 1 to < 3 years received 0.025 mg/kg zoledronic acid (up to a maximum single dose of 0.35 mg) every 3 months and patients aged 3 to 17 years received 0.05 mg/kg zoledronic acid (up to a maximum single dose of 0.83 mg) every 3 months.
Slovenian: V kliničnem programu so bolniki v starosti od 1 leta do < 3 leta prejeli 0,025 mg/kg zoledronske kisline (do največ 0,35 mg v enkratnem odmerku) vsake 3 mesece, bolniki v starosti od 3 do 17 let pa so prejeli 0,05 mg/kg zoledronske kisline (do največ 0,83 mg v enkratnem odmerku) vsake 3 mesece.
English: Median time to onset of the first SRE was not reached in the zoledronic acid-treated arm at the end of the study and was significantly prolonged compared to placebo (p=0.007).
Slovenian: V skupini, zdravljeni z zoledronsko kislino, mediana časa do pojava prvega SRE ob koncu študije še ni bila dosežena, bila je signifikantno podaljšana v primerjavi s placebom (p=0,007).
English: Powder vial: 6 ml colourless glass vial, hydrolytic glass type I (Ph.
Slovenian: Viala s praškom: 6-mililitrska viala iz brezbarvnega stekla, hidrolitično steklo razreda I (Ph.
English: 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.
Slovenian: 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.
English: - Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Slovenian: - 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.
English: Your doctor will carry out blood tests before you start treatment with Zometa and will check your response to treatment at regular intervals.
Slovenian: Preden začnete zdravljenje z zdravilom Zometa, vam bo zdravnik opravil preiskave krvi in v rednih presledkih preverjal vaš odziv na zdravljenje.
English: The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid-treated group versus 49.6% in the placebo group (p=0.003).
Slovenian: Delež bolnic z vsaj enim SRE (razen hiperkalciemije) je bil v skupini, zdravljeni z zoledronsko kislino 29,8 % v primerjavi s skupino s placebom, kjer je bil 49,6 % (p=0,003).
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so razvrščeni glede na pogostnost, najprej najpogostejši, in to po naslednjem dogovoru: zelo pogosti (1/10), pogosti (1/100 do <1/10), občasni (1/1.000 do <1/100), redki (1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: There were no statistically significant differences between the two zoledronic acid doses.
Slovenian: Med obema odmerkoma zoledronske kisline ni bilo statistično značilnih razlik.
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½ 0.24 and t½ 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½ 146 hours.
Slovenian: Intravensko dana zoledronska kislina se odstranjuje iz telesa s trifaznim procesom: hitro dvofazno izginotje iz sistemskega krvnega obtoka z razpolovnima časoma t1/2 0,24 ure in t1/2 1,87 ure, ki mu sledi dolga eliminacijska faza s terminalnim eliminacijskim razpolovnim časom t1/2 146 ur.
English: The interpatient variability in pharmacokinetic parameters for zoledronic acid was high, as seen with other bisphosphonates.
Slovenian: Variabilnost farmakokinetičnih parametrov zoledronske kisline med posameznimi bolniki je bila velika, podobno kot pri drugih difosfonatih.
English: The active substance in Zometa is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Slovenian: Zdravilna učinkovina v zdravilu Zometa je zoledronska kislina, ki sodi v skupino snovi, ki se imenujejo difosfonati.
English: Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Slovenian: Razmisliti je treba o začasni prekinitvi zdravljenja z zoledronsko kislino, dokler se stanje ne razreši in dokler se ne zmanjša vpliv vpletenih dejavnikov tveganja, če je to mogoče doseči.
English: Thus these results precluded determining a definitive effect of zoledronic acid on fertility in humans.
Slovenian: Na podlagi teh rezultatov ni mogoče določiti dejanskega vpliva zoledronske kisline na plodnost pri ljudeh.
English: Zoledronic acid was teratogenic in the rat at subcutaneous doses  0.2 mg/kg.
Slovenian: Zoledronska kislina je bila teratogena pri podganah pri subkutanih odmerkih  0,2 mg/kg.
English: 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 5000 ng/ml.
Slovenian: 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.
English: In the zoledronic acid-treated group, statistically significant improvement in pain scores (using the Brief Pain Inventory, BPI) was seen at 4 weeks and at every subsequent time point during the study, when compared to placebo (Figure 1).
Slovenian: V skupini, zdravljeni z zoledronsko kislino, so opažali statistično značilno izboljšanje na bolečinskih lestvicah (uporabili so Brief Pain Inventory, BPI) po 4 tednih in ob vseh nadaljnjih terminih primerjave s placebom v študiji (slika 1).
English: Multipack (5x1 bottle)
Slovenian: skupno pakiranje (5x1 steklenica)
English: Zometa treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Slovenian: Zdravljenje z zdravilom Zometa pri bolnikih s TIH, ki imajo tudi težko ledvično okvaro, lahko pride v poštev šele po oceni nevarnosti in koristnih učinkov zdravljenja.
English: Zoledronic acid belongs to the class of bisphosphonates and acts primarily on bone.
Slovenian: Zoledronska kislina pripada skupini difosfonatov in deluje primarno na kost.
English: Solvent for Zometa Water for injections 5 ml
Slovenian: vehikel za Zometo voda za injekcije 5 ml