FrancophonIA/ELRC3.0 huggingface dataset:
English: How often Zoledronic Acid Hospira is given - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic Acid Hospira every three to four weeks.
Slovenian: Kako pogosto se daje zdravilo Zoledronska kislina Hospira - Če prejemate zdravilo za preprečevanje zapletov na kosteh zaradi kostnih metastaz, boste prejeli eno infuzijo zdravila Zoledronska kislina Hospira vsake tri do štiri tedne.
English: Treatment of Paget's disease of the bone in adults.
Slovenian: Zdravljenje Pagetove bolezni kosti pri odraslih.
English: How much Zoledronic Acid Hospira is given - The usual single dose given is 4 mg. - If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
Slovenian: Koliko zdravila Zoledronska kislina Hospira se daje - Običajni posamezni odmerek je 4 mg. - Če imate težave z ledvicami, vam bo zdravnik dal manjši odmerek, ki bo odvisen od tega, kako hude so vaše težave z ledvicami.
English: Re-treatment consists of an additional intravenous infusion of 5 mg zoledronic acid after an interval of one year or longer from initial treatment in patients who have relapsed.
Slovenian: Ponovno zdravljenje pomeni dodatno intravensko infundiranje 5 mg zoledronske kisline po enoletnem ali daljšem intervalu od začetnega zdravljenja pri bolnikih, pri katerih se je bolezen ponovila.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem,ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: The majority of the side effects, such as fever and chills, pain in the muscles or joints, and headache, occur within the first three days following the dose of Zoledronic Acid Hospira.
Slovenian: Večina neželenih učinkov, kot so vročina z mrzlico, bolečine v mišicah in sklepih in glavobol, nastopi v prvih treh dneh po odmerku zdravila Zoledronska kislina Hospira.
English: The mean time of ending the Extended Observation Period due to the need for Paget's re-treatment from the initial dose was longer for zoledronic acid (7.7 years) than for risedronate (5.1 years).
Slovenian: Povprečen čas od začetnega zdravljenja do prekinitve sodelovanja v podaljšanem obdobju opazovanja zaradi potrebe po ponovnem zdravljenju Pagetove bolezni je bil daljši pri uporabi zoledronske kisline (7,7 let) kot pri uporabi risedronata (5,1 let).
English: While the risk is reduced with a dose of zoledronic acid administered over 15 minutes, deterioration in renal function may still occur.
Slovenian: Čeprav se tveganje zmanjša, če odmerek zoledronske kisline dajemo več kot 15 minut, lahko kljub temu nastopi poslabšanje ledvične funkcije.
English: - 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: - 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: - Do not use this medicine after the expiry date which is stated on the carton and bag.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na vreči.
English: Teratogenicity was observed in rats at doses 0.2 mg/kg and was manifested by external, visceral and skeletal malformations.
Slovenian: Teratogenost so ugotovili pri podganah v odmerkih ≥0,2 mg/kg, ki se je kazala v obliki zunanjih, visceralnih in skeletnih malformacij.
English: Zoledronic acid has been associated with reports of renal dysfunction.
Slovenian: Zoledronsko kislino povezujejo s poročili o disfunkciji ledvic.
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Slovenian: Neželeni učinki v preglednici 1 so razvrščeni glede na organski sistem po MedDRA klasifikaciji in glede na kategorijo pogostnosti.
English: The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
Slovenian: Možnost osteonekroze zunanjega slušnega kanala je treba upoštevati pri bolnikih, ki prejemajo difosfonate in pri katerih se pojavljajo simptomi bolezni ušesa, vključno s kroničnimi vnetji ušesa.
English: Zoledronic acid 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 zoledronsko kislino pri bolnikih s TIH, ki imajo tudi hudo ledvično okvaro, lahko pride v poštev šele po oceni tveganj in koristi zdravljenja.
English: Hypersensitivity reactions including rare cases of bronchoconstriction, urticaria and angioedema, and very rare cases of anaphylactic reaction/shock
Slovenian: preobčutljivostne reakcije, vključno z redkimi primeri bronhokonstrikcije, urtikarije in angioedema in z zelo redkimi primeri anafilaktične reakcije/šoka
English: † Identified in post-marketing experience.
Slovenian: † ugotovljeno z izkušnjami v obdobju po prihodu zdravila na trg.
English: For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: Statistically significant differences are marked (*p<0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
Slovenian: Statistično pomembne razlike so označene (*p < 0,05) za primerjavo med obema vrstama zdravljenja (4 mg zoledronska kislina v primerjavi s placebom)
English: In patients with renal impairment, the systemic exposure to concomitant medicinal products that are primarily excreted via the kidney may increase.
Slovenian: Pri bolnikih z okvaro ledvic lahko pride do povečane sistemske izpostavljenosti sočasnim zdravilom, ki se izločajo predvsem preko ledvic.
English: Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with zoledronic acid (see section 4.3).
Slovenian: Že obstoječo hipokalciemijo je treba zdraviti z zadostnim vnosom kalcija in vitamina D še pred uvedbo zdravljenja z zoledronsko kislino (glejte poglavje 4.3).
English: − Low level of calcium in the blood.
Slovenian: − nizka raven kalcija v krvi.
English: Zoledronic acid 4 mg significantly reduced the proportion of patients experiencing at least one skeletal related event (SRE), delayed the median time to first SRE by > 5 months, and reduced the annual incidence of events per patient - skeletal morbidity rate.
Slovenian: Zoledronska kislina 4 mg je pomembno zmanjšala delež bolnikov, ki so doživeli vsaj po en SRE, odložila mediano časa nastopa prvega SRE za > 5 mesecev in zmanjšala letno incidenco dogodkov na bolnika - stopnjo obolevnosti skeleta.
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when zoledronic acid is used in combination with thalidomide.
Slovenian: Pri bolnikih z multiplim mielomom se utegne zvečati tveganje za disfunkcijo ledvic, kadar zoledronsko kislino uporabljamo v kombinaciji s talidomidom.
English: Musculoskeletal pain
Slovenian: Mišičnoskeletna bolečina
English: Low levels of phosphate in the blood.
Slovenian: Nizke vrednosti fosfatov v krvi.
English: The majority of these reactions were mild to moderate and resolved within three days of the event onset.
Slovenian: Večina teh učinkov je bila blagih do zmernih, izzveneli so v treh dneh po nastopu.
English: Special populations (see section 4.2)
Slovenian: Posebne skupine bolnikov (glejte poglavje 4.2)
English: Elevated bone turnover is a characteristic of Paget's disease of the bone.
Slovenian: Povečana kostna premena je značilnost Pagetove bolezni kosti.
English: − Blurred vision, tearing of the eye, eye sensitivity to light.
Slovenian: − zamegljen vid, solzenje oči, občutljivost na svetlobo,
English: − Hypersensitivity reactions.
Slovenian: − preobčutljivostne reakcije,
English: - In vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer medicinal products, 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: 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.
Slovenian: Intravensko dana zoledronska kislina se odstranjuje iz telesa s trifaznim procesom: hitro dvofazno izginotje iz sistemskega krvnega obtoka z razpolovnima časoma t½α 0,24 in t½β 1,87 ure, ki mu sledi dolga eliminacijska faza s terminalnim eliminacijskim razpolovnim časom t½γ 146 ur.
English: If you experience any of the above side effects, you should contact your doctor immediately.
Slovenian: Če opazite katerega od zgoraj navedenih neželenih učinkov, takoj obvestite svojega zdravnika.
English: No teratological or embryo/foetal effects were observed in rabbits, although maternal toxicity was marked at 0.1 mg/kg due to decreased serum calcium levels.
Slovenian: Pri kuncih niso opazili teratogenih učinkov ali učinkov na zarodek ali plod, čeprav je bila toksičnost za mater pri odmerku 0,1 mg/kg znatna zaradi znižanih koncentracij kalcija v serumu.
English: Zoledronic acid 8 mg (N=90)
Slovenian: Zoledronska kislina 8 mg (n = 90)
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Slovenian: Skupni telesni očistek je 5,04 ± 2,5 l/h, je neodvisen od odmerka in nanj ne vplivajo spol, starost, rasa in telesna masa.
English: The main molecular target of zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase.
Slovenian: Najbolj pomemebno molekularno ciljno mesto zoledronske kisline v osteoklastu je encim farnezil pirofosfat-sintaza.
English: Zoledronic Acid Hospira is not recommended for anyone under 18 years of age.
Slovenian: Zdravilo Zoledronska kislina Hospira ni priporočljivo za nikogar, ki je star manj kot 18 let.
English: Your doctor will advise you and decide how long you should be treated with Zoledronic Acid Hospira.
Slovenian: Zdravnik vam bo svetoval in presodil, kako dolgo vas je treba zdraviti z zdravilom Zoledronska kislina Hospira.
English: Healthcare professionals are advised not to dispose of unused Zoledronic Acid Hospira via the domestic sewage system.
Slovenian: Zdravstvenim delavcem se odsvetuje odstranjevanje neuporabljenega zdravila Zoledronska kislina Hospira prek gospodinjskega kanalizacijskega sistema.
English: When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Slovenian: Pri uvajanju zdravljenja z zoledronsko kislino pri bolnikih z multiplim mielomom ali metastatičnimi kostnimi lezijami zaradi čvrstih tumorjev je treba določiti serumski kreatinin in očistek kreatinina (CLcr).
English: Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and binding is concentration independent.
Slovenian: Zoledronska kislina se ne veže v veliki meri na beljakovine plazme (vezana je približno v 43-55 %), vezava pa je neodvisna od koncentracije.
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight.
Slovenian: Celotni sistemski očistek je 5,04 ± 2,5 l/h, je neodvisen od odmerka in nanj ne vplivajo spol, starost, rasa ali telesna masa.
English: − The diluted Zoledronic Acid Hospira infusion solution should be used immediately in order to avoid microbial contamination.
Slovenian: − Razredčeno raztopino za infundiranje zdravila Zoledronska kislina Hospira je treba uporabiti takoj, da se prepreči mikrobna kontaminacija.
English: Five of the 6 patients had SAP within the normal range at month 6 (Late Observation Carried Forward, LOCF).
Slovenian: Pri petih od teh šestih bolnikov je bila vrednost alkalne fosfataze v serumu po 6 mesecih v okviru normalnih vrednosti (po principu zadnje izmerjene vrednosti prenesene naprej (Last Observation Carried Forward, LOCF)).
English: Re-treatment of Paget's disease: After initial treatment with zoledronic acid in Paget's disease, an extended remission period is observed in responding patients.
Slovenian: Ponovno zdravljenje Pagetove bolezni: Po začetnem zdravljenju Pagetove bolezni z zoledronsko kislino so pri bolnikih, ki se odzovejo na zdravljenje, opazili dolgotrajne remisije.
English: Zoledronic Acid Hospira, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Slovenian: Zdravilo Zoledronska kislina Hospira, nadaljnje razredčeno v 100 ml (glejte poglavje 6.6), je treba dati v obliki ene intravenske infuzije, ki traja najmanj 15 minut.
English: There were no statistically significant differences between the two zoledronic acid doses.
Slovenian: Med obema odmerkoma zoledronske kisline ni bilo statistično pomembnih razlik.
English: The use of Zoledronic Acid Hospira in children and adolescents has not been studied.
Slovenian: Uporabe zdravila Zoledronska kislina Hospira pri otrocih in mladostnikih niso preučili.
English: In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between zoledronic acid (2.6%) and placebo (2.1%).
Slovenian: V preskušanjih osteoporoze (v PFT, v študiji HORIZON - študiji ponovnih zlomov (Recurrent Fracture Trial [RFT]) sta bili združeni incidenci atrijske fibrilacije primerljivi med zoledronsko kislino (2,6 %) in placebom (2,1 %).
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: For the treatment of Paget's disease, zoledronic acid should be prescribed only by physicians with experience in the treatment of Paget's disease of the bone.
Slovenian: Za zdravljenje Pagetove bolezni smejo zoledronsko kislino predpisovati samo zdravniki, ki imajo izkušnje z zdravljenjem Pagetove bolezni kosti.
English: Before receiving Zoledronic Acid Hospira, tell your doctor, pharmacist or nurse if - you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction; - you do not receive routine dental care or have not had a dental check-up for a long time; - you are a smoker (as this may increase the risk of dental problems); - you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders); - you are taking medicines called corticosteroids (such as prednisolone or dexamethasone) - you have cancer.
Slovenian: Preden prejmete zdravilo Zoledronska kislina Hospira, povejte zdravniku, farmacevtu ali medicinski sestri, če: - imate težave v ustih oziroma z zobmi, kot so slabo zdravstveno stanje zob, bolezni dlesni ali načrtovana ekstrakcija (puljenje) zoba; - nimate urejene redne oskrbe zob oziroma že dolgo niste bili na zobozdravstvenem pregledu; - ste kadilec (saj to lahko povečuje tveganje za težave z zobmi); - ste že kdaj prej prejemali katerega od difosfonatov (ki jih uporabljamo za zdravljenje ali preprečevanje bolezni kosti); - prejemate zdravila, ki jih imenujemo kortikosteroidi (kot sta prednizolon ali deksametazon); - imate raka.
English: In clinical trials in osteoporosis, approximately 0.2% of patients had notable declines of serum calcium levels (less than 1.87 mmol/l) following zoledronic acid administration.
Slovenian: V kliničnih preskušanjih pri osteoporozi je pri 0,2 % bolnikov prišlo do opaznega znižanja koncentracij kalcija v serumu (manj kot 1,87 mmol/l) po aplikaciji zoledronske kisline.
English: Figure 1: Mean changes from baseline in BPI scores.
Slovenian: Slika 1: Povprečne spremembe od izhodišča po rezultatu BPI.
English: In patients with mild to moderate renal impairment, reduced doses should be prepared as instructed below.
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic je treba pripraviti zmanjšane odmerke kot je opisano v nadaljevanju.
English: The overall percentage of patients who experienced adverse reactions were 44.7%, 16.7% and 10.2% after the first, second and third infusion, respectively.
Slovenian: Delež vseh bolnikov, pri katerih je prišlo do neželenih učinkov, je bil po prvi infuziji 44,7 %, po drugi infuziji 16,7 %, po tretji infuziji pa 10,2 %.
English: This medicine contains 16 mmol (or 360 mg) sodium per dose.
Slovenian: To zdravilo vsebuje 16 mmol (ali 360 mg) natrija na odmerek.
English: The incidence of these reactions decreased markedly with subsequent annual doses of zoledronic acid.
Slovenian: Incidenca teh učinkov je izrazito upadla pri naslednjih letnih odmerjanjih zoledronske kisline.
English: Zoledronic acid 4 mg (N=86)
Slovenian: Zoledronska kislina 4 mg (n = 86)
English: Since zoledronic acid is not metabolised in humans and the substance was found to have little or no capacity as a direct-acting and/or irreversible metabolism-dependent inhibitor of P450 enzymes, zoledronic acid is unlikely to reduce the metabolic clearance of substances which are metabolised via the cytochrome P450 enzyme systems.
Slovenian: Ker človek ne presnavlja zoledronske kisline in ker so ugotovili, da ta učinkovina v manjši meri ali pa sploh ne deluje kot neposredno delujoči in/ali ireverzibilni, od presnove odvisni, zaviralec encimov P450, ni verjetno, da bi zoledronska kislina zmanjšala presnovni očistek snovi, ki se presnavljajo prek encimskega sistema citokrom P450.
English: Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Slovenian: Zoledronske kisline ne priporočajo bolnikom, ki imajo že pred uvedbo zdravljenja hudo ledvično okvaro, ki je za to skupino bolnikov opredeljena kot CLcr < 30 ml/min.
English: The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Slovenian: Rezultati so dokazali, da je zoledronska kislina 4 mg pokazala učinkovitost za preprečevanje SRE, ki je bila primerljiva z učinkovitostjo 90 mg pamidronata.
English: Zoledronic acid has been associated with renal impairment manifested as deterioration in renal function (i.e. increased serum creatinine) and in rare cases acute renal failure.
Slovenian: Zoledronsko kislino povezujejo z okvaro ledvic ki se kaže kot poslabšanje delovanja ledvic (zvišanje vrednosti kreatinina v serumu) in v redkih primerih z akutno odpovedjo ledvic.
English: The early disposition phases (α and β, with t½ values above) presumably represent rapid uptake into bone and excretion via the kidneys.
Slovenian: Obe zgodnji obdobji prisotnosti zdravila v obtoku (α in β, z zgoraj navedenima vrednostma t½) sta po vsej verjetnosti obdobji hitrega privzema v kostnino in izločanja preko ledvic.
English: Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound medicinal products are therefore unlikely.
Slovenian: Zoledronska kislina se ne veže v veliki meri na beljakovine v plazmi (vezana je približno v 43 - 55 %) zato interakcije, ki bi bile posledica izrinjanja zdravil, pretežno vezanih na beljakovine, niso verjetne.
English: Zoledronic Acid Hospira recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Slovenian: Priporočeni odmerek zdravila Zoledronska kislina Hospira* 4,0 mg zoledronske kisline 3,5 mg* zoledronske kisline 3,3 mg* zoledronske kisline 3,0 mg* zoledronske kisline * Odmerke so izračunali s predvidenim ciljnim AUC 0,66 (mg•hr/l) (CLcr = 75 ml/min).
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: The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.
Slovenian: Pri odločitvi glede zdravljenja bolnikov z zasevki v kosteh za preprečevanje z okostjem povezanih dogodkov je treba upoštevati, da začne zdravljenje učinkovati šele po 2-3 mesecih.
English: − Severe bone, joint and/or muscle pain, occasionally incapacitating.
Slovenian: − hude bolečine kosti, sklepov in/ali mišic, občasna onesposobljenost.
English: Six patients who achieved therapeutic response 6 months after treatment with zoledronic acid and later experienced disease relapse during the extended follow-up period were re-treated with zoledronic acid after a mean time of 6.5 years from initial treatment to re-treatment.
Slovenian: Šest bolnikov, pri katerih je prišlo do terapevtskega odziva 6 mesecev po zdravljenju z zoledronsko kislino, kasneje v obdobju podaljšanega spremljanja pa do recidiva bolezni, je ponovno prejelo zoledronsko kislino, pri čemer je interval med začetnim in ponovnim zdravljenjem v povprečju znašal 6,5 let.
English: Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications.
Slovenian: Hipokalciemija predstavlja pomembno tveganje, ki ga opažajo pri uporabi zoledronske kisline za odobrene indikacije.
English: The following properties have been demonstrated in preclinical studies:
Slovenian: V predkliničnih raziskavah so dokazali sledeče lastnosti:
English: Zoledronic acid 4 mg was also studied in a double-blind, randomised, placebo-controlled trial in 228 patients with documented bone metastases from breast cancer to evaluate the effect of 4 mg zoledronic acid on the skeletal related event (SRE) rate ratio, calculated as the total number of SRE events (excluding hypercalcaemia and adjusted for prior fracture), divided by the total risk period.
Slovenian: Zoledronsko kislino 4 mg so proučevali tudi v dvojno slepem, randomiziranem, s placebom nadzorovanem preskušanju pri 228 bolnicah z dokazanimi kostnimi zasevki raka dojke, da bi ocenili učinek 4 mg zoledronske kisline na razmerje pogostnosti SRE, izračunano iz celotnega števila SRE dogodkov (brez hiperkalciemije; prilagojenega na predhodne zlome), deljenega s celotnim obdobjem tveganja.
English: Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of zoledronic acid (see section
Slovenian: Zaradi hitrega začetka delovanja zoledronske kisline na kostno premeno se utegne razviti prehodna hipokalciemija, ki je včasih simptomatska in ki je navadno najbolj izražena v prvih 10 dneh po infuziji zoledronske kisline (glejte poglavje 4.8).