natgillin/translations-raw huggingface dataset:
These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Ti prečni ali kratki poševni zlomi se lahko pojavljajo kjerkoli na stegnenici, od mesta tik pod malim trohanterjem do tik nad suprakondilarno grčo.
A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
okvara v delovanju ledvic, imenovana Fanconijev sindrom (običajno jo ugotovi zdravnik s pomočjo določenih preiskav urina).
* Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR Not Reached
* zajema vertebralne in nevertebralne zlome; ** velja za vse skeletne dogodke, tako za njihovo celotno število kot za trajanje vsakega dogodka med preskušanjem;
Tumours can accelerate normal bone change in such a way that the release of calcium from bone is increased.
Tumorji lahko pospešijo normalno spreminjanje kosti, tako da se poveča sproščanje kalcija iz kosti.
Tell your doctor about any of the following serious side effects straight away:
Takoj povejte zdravniku, če imate katerega od naslednjih resnih neželenih učinkov:
Although no teratogenicity or foetotoxicity was observed in the rabbit, maternal toxicity was found.
Čeprav pri kuncu niso opazili teratogenosti ali fetotoksičnosti, je bila ugotovljena toksičnost za mater.
In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several antitumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
Poleg tega, da je zoledronska kislina močan inhibitor resorpcije kosti, ima tudi več protitumorskih lastnosti, ki bi lahko prispevale k njeni celotni učinkovitosti v zdravljenju metastatične bolezni kosti.
In long-term animal studies, zoledronic acid inhibits bone resorption without adversely affecting the formation, mineralisation or mechanical properties of bone.
V dolgoročnih raziskavah na živalih zoledronska kislina zavira resorpcijo kosti, ne da bi neugodno vplivala na oblikovanje, mineralizacijo ali mehanske lastnosti kosti.
For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Glede bolnikov, pri katerih so potrebni zobozdravstveni postopki, ni na voljo nikakršnih podatkov, ki bi kazali na to, ali prekinitev difosfonatnega zdravljenja zmanjša tveganje za osteonekrozo čeljustnic.
How much Zometa 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.
Koliko zdravila Zometa 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.
The most frequent finding in repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound's pharmacological antiresorptive activity.
Najpogostejša ugotovitev v študijah večkratnih odmerkov je bilo zvečanje primarne spongiozne kostne substance v metafizah dolgih kosti pri rastočih živalih pri skoraj vseh odmerkih; ta ugotovitev odseva farmakološki antiresorpcijski učinek zdravila.
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.
The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone, but the precise molecular mechanism leading to the inhibition of osteoclastic activity is still unclear.
Selektivno delovanje difosfonatov na kost temelji na njihovi veliki afiniteti do mineralizirane kosti, vendar je natančen molekularni mehanizem, ki privede do inhibicije osteoklastne aktivnosti, še nejasen.
Clinical experience with acute overdose of Zometa is limited.
Klinične izkušnje z akutnim prevelikim odmerjanjem zdravila Zometa so omejene.
Date of first authorisation: 20.03.2001 Date of latest renewal: 20.03.2006
Datum prve odobritve: 20. marec 2001 Datum zadnjega podaljšanja: 20. marec 2006
Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Med možne dejavnike tveganja za osteonekrozo zunanjega slušnega kanala spadajo uporaba steroidov in kemoterapija in/ali lokalni dejavniki tveganja, kot sta okužba in poškodba.
How often Zometa is given - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zometa every three to four weeks.
Kako pogosto se daje zdravilo Zometa - Če prejemate zdravilo za preprečevanje zapletov na kosteh zaradi kostnih metastaz, boste prejeli eno infuzijo zdravila Zometa vsake tri do štiri tedne.
*Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
*Odmerki so preračunani s predpostavko, da je ciljna AUC 0,66 (mg•h/l) (za CLcr=75 ml/min).
Cases of severe hypocalcaemia requiring hospitalisation have been reported.
Poročali so tudi o primerih hude hipokalciemije, zaradi katere je bilo treba bolnika hospitalizirati.
The SRE rate (events/person year) was 0.628 for zoledronic acid and 1.096 for placebo.
Pogostnost SRE (dogodki/osebe-leta) je bila 0,628 z zoledronsko kislino in 1,096 s placebom.
• Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1.
• Preobčutljivost na učinkovino, na druge difosfonate ali katero koli pomožno snov, navedeno v poglavju 6.1.
If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Če nastopi hipokalciemija, hipofosfatemija ali hipomagneziemija, moramo uvesti kratkoročno dopolnilno zdravljenje.
Patients received either 4 mg zoledronic acid or placebo every four weeks for one year.
Bolnice so v obdobju enega leta prejemale bodisi 4 mg zoledronske kisline bodisi placebo vsake štiri tedne.
Date of first authorisation: 24.03.2003 Date of latest renewal: 20.03.2006
Datum prve odobritve: 24. marec 2003 Datum zadnjega podaljšanja: 20. marec 2006
It is not known whether zoledronic acid is excreted into human milk.
Ni znano, ali se zoledronska kislina izloča v materino mleko.
Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
V opravljenih testih mutagenosti zoledronska kislina ni bila mutagena, testiranje kancerogenosti pa ni dalo nikakršnih dokazov o kancerogenem potencialu.
Children and adolescents Zometa is not recommended for use in adolescents and children below the age of 18 years.
Otroci in mladostniki Pri otrocih in mladostnikih, ki so stari manj kot 18 let, uporaba zdravila Zometa ni priporočena.
Healthcare professionals are advised not to dispose of unused Zometa via the domestic sewage system.
Zdravstvenim delavcem svetujemo, da neporabljenega zdravila Zometa ne izlijejo v gospodinjske odplake.
Use immediately after reconstitution and dilution.
Uporabite takoj po rekonstituciji in redčenju.
• Breast-feeding (see section 4.6).
• Dojenje (glejte poglavje 4.6).
Zometa should not be used during pregnancy.
Zdravila Zometa ne smete uporabljati med nosečnostjo.
Following initiation of therapy, serum creatinine should be measured prior to each dose of Zometa and treatment should be withheld if renal function has deteriorated.
Po uvedbi terapije je treba izmeriti serumski kreatinin pred vsakim odmerkom zdravila Zometa, terapijo pa je treba prekiniti, če se je ledvična funkcija poslabšala.
Limited pharmacokinetic data in children with severe osteogenesis imperfecta suggest that zoledronic acid pharmacokinetics in children aged 3 to 17 years are similar to those in adults at a similar mg/kg dose level.
Majhno število podatkov o farmakokinetiki pri bolnikih s hudo obliko osteogenesis imperfecta kaže, da so farmakokinetične lastnosti zoledronske kisline pri otrocih v starosti od 3 do 17 let podobne tistim pri odraslih pri enakovredni ravni odmerjanja v mg/kg.
While being treated with Zometa, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
V času zdravljenja z zdravilom Zometa morate skrbeti za dobro ustno higieno (kar vključuje redno čiščenje zob) in redno hoditi na rutinske preglede k zobozdravniku.
The type of adverse reactions observed in this population were similar to those previously seen in adults with advanced malignancies involving the bone (see section 4.8).
Vrste neželenih dogodkov, ki so jih opažali v tej populaciji, so bile večinoma podobne tistim, ki so jih prej opažali pri odraslih z napredovalimi malignimi boleznimi, ki zajamejo kosti (glejte poglavje 4.8).
Clinical trial results in the treatment of severe osteogenesis imperfecta in paediatric patients aged 1 to 17 years
Rezultati kliničnih preskušanj zdravljenja hude oblike osteogenesis imperfecta pri pediatričnih bolnikih, starih od 1 leta do 17 let
Adverse reactions, such as dizziness and somnolence, may have influence on the ability to drive or use machines, therefore caution should be exercised with the use of Zometa along with driving and operating of machinery.
Neželeni učinki, kot na primer vrtoglavost in somnolenca, lahko vplivajo na sposobnost vožnje in upravljanja strojev, zato je ob uporabi zdravila Zometa potrebna previdnost pri vožnji in upravljanju strojev.
The highest non-lethal single intravenous dose was 10 mg/kg bodyweight in mice and 0.6 mg/kg in rats.
Največji neletalni posamezni intravenski odmerek je bil 10 mg/kg telesne mase pri miših in 0,6 mg/kg pri podganah.
- Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
- Zdravljenje odraslih bolnikov s tumorsko povzročeno hiperkalciemijo (TIH).
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).
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.
Možnost osteonekroze zunanjega slušnega kanala je treba upoštevati pri bolnikih, ki prejemajo bisfosfonate in pri katerih se pojavljajo simptomi bolezni ušesa, vključno s kroničnimi vnetji ušesa.
Confusion
zmedenost
How Zometa is used
Kako se zdravilo Zometa uporablja
Untreated hypercalcaemia patients generally have some degree of renal function impairment, therefore careful renal function monitoring should be considered.
Bolniki z nezdravljeno hiperkalciemijo imajo na splošno bolj ali manj izraženo okvaro delovanja ledvic, zato moramo razmisliti o skrbnem spremljanju ledvične funkcije.
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).
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).
Zometa treatment should be resumed at the same dose as that given prior to treatment interruption.
Zdravljenje z zdravilom Zometa je treba spet začeti z enakim odmerkom kot ga je bolnik prejemal pred prekinitvijo zdravljenja.
Anxiety, sleep disturbance
anksioznost, motnje spanja redki:
Women of child-bearing potential should be advised to avoid becoming pregnant.
Ženskam v rodni dobi je treba naročiti, naj pazijo, da ne bodo zanosile.
The frequencies for each of these identified risks are shown in Table 1.
Pogostnosti vsakega od navedenih ugotovljenih tveganj so prikazane v preglednici 1.
- 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.
- 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.
Patients whose blood calcium levels are not too high will also be prescribed calcium and vitamin D supplements to be taken each day.
Bolnikom, ki nimajo previsoke koncentracije kalcija v krvi, bo zdravnik predpisal nadomestke kalcija in vitamina D, ki jih bodo jemali vsak dan.
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.
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.
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.
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.
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.
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.
Hyperkalaemia, hypernatraemia
hiperkaliemija, hipernatriemija
In the event of hypocalcaemia, calcium gluconate infusions should be administered as clinically indicated.
V primeru hipokalciemije je treba dati infuzijo kalcijevega glukonata v skladu s klinično indikacijo.
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.
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.
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)
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).
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.
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.
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.
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.
In clinical studies, Zometa has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
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.
If your level of calcium falls too low, you may have to be given supplemental calcium by infusion.
Če se vam koncentracija kalcija preveč zniža, vam bodo morda morali nadomeščati kalcij z infuzijo.
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.
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.
Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
hipertenzija, hipotenzija, atrijska fibrilacija, hipotenzija, ki povzroči sinkopo ali cirkulacijski kolaps redki:
Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change.
Zoledronska kislina deluje tako, da se pripne na kost in upočasni hitrost spreminjanja kosti.
Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
huda alergijska reakcija: zadihanost, otekanje zlasti v obraz in žrelo oziroma grlo.
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.
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).
Estimated treatment effects on BMD were similar, but the trial design was not sufficiently robust to establish non-inferior efficacy for zoledronic acid.
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.
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.
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.
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.
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.
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.
What Zometa is and what it is used for What you need to know before you are given Zometa How Zometa is used
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
Multi-packs containing 4 (4x 1) or 5 (5x 1) bottles.
Skupno pakiranje vsebuje 4 (4x 1) ali 5 (5x 1) plastenk.
Hypocalcaemia is an important identified risk with Zometa in the approved indications.
Hipokalciemija predstavlja pomembno tveganje, ki ga opažajo pri uporabi zdravila Zometa za odobrene indikacije.
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.
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.
VIAL LABEL
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- Carefully follow all the other instructions given to you by your doctor, pharmacist or nurse.
- Skrbno se ravnajte tudi po vseh drugih navodilih, ki jih dobite od svojega zdravnika, farmacevta ali medicinske sestre.
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.
Instructions for preparing reduced doses of Zometa:
Navodila za pripravo zmanjšanih odmerkov zdravila Zometa:
Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Študije razmnoževanja na živalih z zoledronsko kislino so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
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.
- 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.
In multiple myeloma patients, the risk of renal dysfunction may be increased when Zometa is used in combination with thalidomide.
Pri bolnikih z multiplim mielomom se utegne zvečati tveganje za disfunkcijo ledvic, kadar zdravilo Zometa uporabljamo v kombinaciji s talidomidom.
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.
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.
1 bottle, 100 ml
1 plastenka, 100 ml
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zometa.
Če imate hipokalciemijo, jo je treba odpraviti preden prejmete prvi odmerek zdravila Zometa.