natgillin/translations-raw huggingface dataset:
Zometa 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 Zometa 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.
Zometo so proučevali tudi v dvojno slepem, randomiziranem, s placebom kontroliranem preskušanju pri 228 bolnicah z dokazanimi kostnimi zasevki raka dojke, da bi ocenili učinek Zomete na razmerje pogostnosti z okostjem povezanih dogodkov (SRE), izračunano iz celotnega števila SRE dogodkov (brez hiperkalciemije; prilagojenega na predhodne zlome), deljenega s celotnim obdobjem tveganja.
Patients received either 4 mg Zometa or placebo every four weeks for one year.
Bolnice so v obdobju enega leta prejemale bodisi 4 mg Zomete bodisi placebo vsake štiri tedne.
Patients were evenly distributed between Zometa-treated and placebo groups.
V obe skupini, zdravljeni bodisi z Zometo bodisi s placebom, so bile bolnice razporejene enakomerno.
The SRE rate (events/ person year) was 0.628 for Zometa and 1.096 for placebo.
Pogostnost SRE (dogodki/ osebe- leta) je bila 0, 628 z Zometo in 1, 096 s placebom.
The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the Zometa-treated group versus 49.6% in the placebo group (p=0.003).
Delež bolnic z vsaj enim SRE (razen hiperkalciemije) je bil v skupini, zdravljeni z Zometo 29, 8% v primerjavi s skupino s placebom, kjer je bil 49, 6% (p=0, 003).
Median time to onset of the first SRE was not reached in the Zometa-treated arm at the end of the study and was significantly prolonged compared to placebo (p=0.007).
V skupini, zdravljeni z Zometo, mediana časa do pojava prvega SRE ob koncu študije še ni bila dosežena, bila je signifikantno podaljšana v primerjavi s placebom (p=0, 007).
Zometa 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 Zometa zmanjšala tveganje za SRE za 41% (razmerje tveganj = 0, 59, p=0, 019) v primerjavi s placebom.
In the Zometa-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).
V skupini, zdravljeni z Zometo, 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).
The pain score for Zometa was consistently below baseline and pain reduction was accompanied by a trend in reduced analgesics score.
Z Zometo so bile vrednosti na bolečinski lestvici ves čas pod izhodiščno vrednostjo, zmanjšanje bolečine je spremljal trend zmanjševanja na lestvici analgezije.
11 Figure 1.
11 Slika 1.
Placebo)
Povprečne spremembe od izhodišča na BPI lestvici, označene so statistično značilne vrednosti p (* p < 0, 05) za primerjavo med obema vrstama zdravljenja (Zometa v primerjavi s placebom) BPI: povprečne spremembe od izhodišča
Placebo ∆ Zometa BPI mean change from baseline
placebo ∆ Zometa
Clinical trial results in the treatment of TIH 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.
Rezultati kliničnih preskušanj v zdravljenju tumorsko povzročene hiperkalciemije (TIH) 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.
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.
To assess the effects of Zometa 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 Zomete v primerjavi s pamidronatom 90 mg, so v vnaprej načrtovani analizi združili rezultate dveh ključnih multicentričnih raziskav pri bolnikih s tumorsko povzročeno hiperkalciemijo (TIH).
There was faster normalisation of corrected serum calcium at day 4 for Zometa 8 mg and at day 7 for Zometa 4 mg and 8 mg.
Korigirani serumski kalcij se je hitreje normaliziral z Zometo 4. dne (8 mg) in 7. dne (4 mg in 8 mg).
Proportion of complete responders by day in the combined TIH studies
Delež bolnikov s popolnim odzivom po dnevih v združenih raziskavah tumorsko povzročene hiperkalciemije (TIH)
Zometa 4 mg (N=86) Zometa 8 mg (N=90) Pamidronate 90 mg (N=99)
Zometa 4 mg (N=86) Zometa 8 mg (N=90) pamidronat 90 mg (N=99)
*p-values compared to pamidronate.
* vrednosti p v primerjavi s pamidronatom.
Median time to relapse (re-increase of albumin-corrected serum calcium ≥ 2.9 mmol/ l) was 30 to 40 days for patients treated with Zometa versus 17 days for those treated with pamidronate 90 mg (p-values:
Mediana časa do ponovnega pojava bolezni (ponovno zvišanje za albumin korigiranega serumskega kalcija ≥ 2, 9 mmol/ l) je bila pri bolnikih, zdravljenih z Zometo, 30 do 40 dni, pri tistih, ki so bili zdravljeni s pamidronatom 90 mg, pa 17 dni (vrednosti p:
0.001 for 4 mg and 0.007 for 8 mg).
0, 001 za 4 mg in 0, 007 za 8 mg).
There were no statistically significant differences between the two Zometa doses.
Med obema odmerkoma Zomete ni bilo statistično značilnih razlik.
In clinical trials 69 patients who relapsed or were refractory to initial treatment (Zometa 4 mg, 8 mg or pamidronate 90 mg) were retreated with Zometa 8 mg.
V kliničnih preskušanjih je bilo 69 bolnikov, pri katerih se je bolezen ponovno pojavila ali so bili odporni proti začetnemu zdravljenju (Zometa 4 mg, 8 mg ali pamidronat 90 mg), ponovno zdravljenih z Zometo 8 mg.
Since those patients were retreated with the 8 mg dose only, there are no data available allowing comparison with the 4 mg dose.
12 zdravljeni samo z odmerkom 8 mg, ni na voljo podatkov, ki bi omogočali primerjavo z odmerkom 4 mg.
12 In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
V kliničnih preskušanjih, narejenih na bolnikih s tumorsko povzročeno hiperkalciemijo (TIH), je bil celotni varnostni profil v vseh treh zdravljenih skupinah (zoledronska kislina 4 in 8 mg in pamidronat 90 mg) podoben glede na vrste in izraženost.
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.
After initiating the infusion of zoledronic acid, the plasma concentrations of drug 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 drug on day 28.
Po začetku infuzije zoledronske kisline so se plazemske koncentracije zdravila 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 zdravila na 28. dan niso presegle 0, 1% maksimalne koncentracije.
Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Intravensko dana zoledronska kislina se odstranjuje iz telesa s trifaznim procesom: hitro dvofazno izginotje iz sistemskega krvnega obtoka z razpolovnima časoma t1/ 2α 0, 24 ure in t1/ 2β 1, 87 ure, ki mu sledi dolga eliminacijska faza s terminalnim eliminacijskim razpolovnim časom t1/ 2γ 146 ur.
There was no accumulation of drug in plasma after multiple doses of the drug given every 28 days.
Po več odmerkih zdravila, danih vsakih 28 dni, se zdravilo ni kopičilo v plazmi.
Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
V prvih 24 urah se izloči v urin 39 ± 16% danega odmerka, preostanek pa se predvsem veže v kostno tkivo.
The total body clearance is 5.04 ± 2.5 l/ h, independent of dose, and unaffected by gender, age, race, and body weight.
Skupni telesni očistek je 5, 04 ± 2, 5 l/ h, je neodvisen od odmerka in nanj ne vplivajo spol, starost, rasa in telesna masa.
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 renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/ min (range 22 to 143 ml/ min) in the 64 cancer patients studied.
Ledvični očistek zoledronske kisline je bil postavljen v soodnosnost z očistkom kreatinina, ledvični očistek je predstavljal 75 ± 33% očistka kreatinina, ki je pri 64 proučevanih bolnikih z rakom kazal povprečje 84 ± 29 ml/ min (razpon od 22 do 143 ml/ min).
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 (težka 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.
Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/ min).
Pri bolnikih s težko ledvično insuficienco (očistek kreatinina < 30 ml/ min) so na voljo le omejeni farmakokinetični podatki.
Zoledronic acid shows no affinity for the cellular components of blood and plasma protein binding is low (approximately 56%) and independent of the concentration of zoledronic acid.
Zoledronska kislina ne kaže nikakršne afinitete za celične sestavine krvi, vezava na plazemske beljakovine pa je majhna (okrog 56%) in neodvisna od koncentracije zoledronske kisline.
Acute toxicity The highest non-lethal single intravenous dose was 10 mg/ kg bodyweight in mice and 0.6 mg/ kg in rats.
Akutna toksičnost Največji neletalni posamezni intravenski odmerek je bil 10 mg/ kg telesne mase pri miših in 0, 6 mg/ kg pri podganah.
Subchronic and chronic toxicity Zoledronic acid was well tolerated when administered subcutaneously to rats and intravenously to dogs at doses up to 0.02 mg/ kg daily for 4 weeks.
13 Subkronična in kronična toksičnost Zoledronsko kislino, dano subkutano, so dobro prenašale podgane, intravensko dano pa psi, v odmerkih do 0, 02 mg/ kg na dan 4 tedne dolgo.
Administration of 0.001 mg/ kg/ day subcutaneously in rats and 0.005 mg/ kg intravenously once every 2– 3 days in dogs for up to 52 weeks was also well tolerated.
Podgane so dobro prenašale tudi do 52- tedensko subkutano dajanje po 0, 001 mg/ kg/ dan, psi pa enako dolgo intravensko dajanje po 0, 005 mg/ kg enkrat na 2– 3 dni.
13 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.
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, 06 – 0, 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.
Reproduction toxicity Zoledronic acid was teratogenic in the rat at subcutaneous doses ≥ 0.2 mg/ kg.
Reproduktivna toksičnost Zoledronska kislina je bila teratogena pri podganah pri subkutanih odmerkih ≥ 0, 2 mg/ kg.
Dystocia was observed at the lowest dose (0.01 mg/ kg bodyweight) tested in the rat.
Pri najmanjšem odmerku, preskušenem pri podganah (0, 01 mg/ kg telesne mase), so opažali distocijo.
Mutagenicity and carcinogenic potential Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Mutagenost in kancerogeni potencial V opravljenih testih mutagenosti zoledronska kislina ni bila mutagena, testiranje kancerogenosti pa ni dalo nikakršnih dokazov o kancerogenem potencialu.
Mannitol Sodium citrate
manitol natrijev citrat
Solvent ampoule:
Ampula z vehiklom:
To avoid potential incompatibilities, Zometa reconstituted solution is to be diluted with 0.9% w/ v sodium chloride solution or 5% w/ v glucose solution.
Da se izognete možnim nezdružljivostim, razredčite rekonstituirano raztopino Zomete z 0, 9 -% m/ v raztopino natrijevega klorida ali 5 -% m/ v raztopino glukoze.
Zometa reconstituted solution must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer’ s solution, and should be administered as a single intravenous solution in a separate infusion line.
Rekonstituirane raztopine zdravila Zometa ne smete mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata, in jo je treba aplicirati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
Studies with glass bottles, as well as several types of infusion bags and infusion lines made from polyvinylchloride, polyethylene and polypropylene (prefilled with 0.9% w/ v sodium chloride solution or 5% w/ v glucose solution), showed no incompatibility with Zometa.
Študije s steklenicami, pa tudi z več vrstami infuzijskih vrečk in infuzijskih sistemov, izdelanih iz polivinilklorida, polietilena in polipropilena (tovarniško napolnjenih z 0, 9 -% m/ v raztopino natrijevega klorida ali 5 -% m/ v raztopino glukoze), niso pokazale nezdružljivosti z Zometo.
The reconstituted solution is chemically and physically stable for 24 hours at 2°C – 8°C.
Rekonstituirana raztopina je kemijsko in fizikalno stabilna 24 ur pri 2 °C – 8 °C.
After aseptic reconstitution and dilution, it is preferable to use the reconstituted and diluted product immediately.
Najbolje je uporabiti rekonstituirano in razredčeno zdravilo takoj po aseptični rekonstituciji in razredčenju.
If not used immediately, the duration and conditions of storage prior to use are the user’ s responsibility.
Če ga ne porabite takoj, je za trajanje in pogoje shranjevanja pred uporabo odgovoren uporabnik.
The total time between reconstitution, dilution, storage in a refrigerator at 2°C – 8°C and end of administration must not exceed 24 hours.
Celotni čas od rekonstitucije in razredčenja, shranjevanja v hladilniku pri temperaturi med 2 °C – 8 °C do konca postopka dajanja zdravila ne sme preseči 24 ur.
Zometa 4 mg powder for solution for infusion is supplied as packs containing 1, 4 or 10 vials and 1, 4 or 10 ampoules of water for injections, respectively.
Zometa 4 mg prašek za raztopino za infundiranje je na voljo v ovojnini, v katerih je po 1, 4 ali 10 vial in po 1, 4 ali 10 ampul vode za injekcije.
6-ml colourless glass vial, hydrolytic glass type I (Ph.
6- mililitrska viala iz brezbarvnega stekla, hidrolitično steklo razreda I (Ph.
5-ml colourless glass ampoule.
5- mililitrska ampula iz brezbarvnega stekla.
The amount of reconstituted solution as required is then further diluted with 100 ml of calcium-free infusion solution (0.9% w/ v sodium chloride solution or 5% w/ v glucose solution).
Potrebno količino rekonstituirane raztopine nato dodatno razredčite s 100 ml infuzijske raztopine v kateri ni kalcija (0, 9 -% m/ v raztopina natrijevega klorida ali 5 -% m/ v raztopina glukoze).
If refrigerated, the solution must be allowed to reach room temperature before administration.
Če je raztopina ohlajena, moramo pred uporabo pustiti, da se segreje na sobno temperaturo.
20.03.2001 Date of first renewal:
20. 03. 2001 Datum prvega podaljšanja:
Zometa 4 mg/ 5 ml concentrate for solution for infusion
Zometa 4 mg/ 5 ml koncentrat za raztopino za infundiranje
One vial with 5 ml concentrate contains 4 mg zoledronic acid (anhydrous).
Ena viala s 5 ml koncentrata vsebuje 4 mg zoledronske kisline (brezvodne).
One ml concentrate contains zoledronic acid (as monohydrate) corresponding to 0.8 mg zoledronic acid (anhydrous).
En ml koncentrata vsebuje zoledronsko kislino (v obliki monohidrata), ki ustreza 0, 8 mg zoledronske kisline (brezvodne).
Zometa concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer’ s solution, and should be administered as a single intravenous solution in a separate infusion line.
Koncentrata zdravila Zometa se ne sme mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata, in jo je treba aplicirati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
Prevention of skeletal related events in patients with advanced malignancies involving bone Adults and elderly The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg zoledronic acid.
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti Odrasli in starejši bolniki Priporočeni odmerek za preprečevanje z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti, je 4 mg zoledronske kisline.
The concentrate must be further diluted with 100 ml sterile 0.9% w/ v sodium chloride or 5% w/ v glucose solution and given in no less than a 15- minute intravenous infusion every 3 to 4 weeks.
Koncentrat je treba dodatno razredčiti s 100 ml 0, 9 -% m/ v raztopine natrijevega klorida ali 5 -% m/ v raztopine glukoze in ga dati v obliki intravenske infuzije, ki teče vsaj 15 minut, vsake 3 do 4 tedne.
Treatment of TIH Adults and elderly The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥ 12.0 mg/ dl or 3.0 mmol/ l) is 4 mg zoledronic acid.
Zdravljenje tumorsko povzročene hiperkalciemije (TIH) Odrasli in starejši bolniki Priporočeni odmerek za hiperkalciemijo (za albumin korigirani serumski kalcij ≥ 12, 0 mg/ dl ali 3, 0 mmol/ l) je 4 mg zoledronske kisline.
The concentrate must be further diluted with 100 ml sterile 0.9% w/ v sodium chloride or 5% w/ v glucose solution and given as a single intravenous infusion in no less than 15 minutes.
Koncentrat je treba dodatno razredčiti s 100 ml sterilne 0, 9 - odstotne m/ v raztopine natrijevega klorida ali 5- odstotne m/ v raztopine glukoze in ga dati v obliki ene same intravenske infuzije, ki naj teče vsaj 15 minut.
16 Renal impairment TIH:
16 Ledvične okvare Tumorsko povzročena hiperkalciemija (TIH):
- For patients with an abnormal baseline creatinine (> 1.4 mg/ dl or > 124 µmol/ l), an increase of
- pri bolnikih s patološkim izhodiščnim kreatininom (> 1, 4 mg/ dl ali > 124µmol/ l), zvišanje za
Instructions for preparing reduced doses of Zometa Withdraw an appropriate volume of the concentrate needed, as follows:
Navodila za pripravo zmanjšanih odmerkov Zomete Odvzemite ustrezni volumen potrebnega koncentrata, kot sledi:
The withdrawn amount of concentrate must be further diluted in 100 ml of sterile 0.9% w/ v sodium chloride solution or 5% w/ v glucose solution.
Odvzeto količino koncentrata morate dodatno razredčiti v 100 ml sterilne 0, 9- odstotne m/ v raztopine natrijevega klorida ali 5- odstotne m/ v raztopine glukoze.
Zometa should not be used in that patient population until further data becomes available.
Dokler ne bo na voljo več podatkov, Zomete v tej skupini bolnikov ne smemo uporabljati.
Zometa concentrate is contraindicated in breast-feeding women and in patients with clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or any of the excipients in the formulation of Zometa.
Koncentrat Zomete je kontraindiciran pri doječih ženskah in pri bolnikih s klinično pomembno preobčutljivostjo za zoledronsko kislino, za druge difosfonate ali za katero od pomožnih snovi v sestavi Zomete.
Renal insufficiency Patients with TIH with evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with Zometa outweighs the possible risk.
Ledvična insuficienca Bolnike s tumorsko povzročeno hiperkaliemijo (TIH), ki kažejo znake poslabšanja ledvične funkcije, moramo ustrezno ovrednotiti in pri tem pretehtati, ali možna korist zdravljenja z Zometo odtehta možno nevarnost.
In patients who show evidence of renal deterioration during treatment, Zometa should be withheld.
Pri bolnikih, pri katerih se med zdravljenjem pokažejo znaki poslabšanja ledvične funkcije, je treba Zometo ukiniti.
18 Osteonecrosis of the jaw Osteonecrosis of the jaw has been reported in patients, predominantly those with cancer, receiving treatment with bisphosphonates, including Zometa.
18 Osteonekroza čeljusti Poročali so o osteonekrozi čeljusti pri bolnikih, predvsem pri tistih z rakom, ki se zdravijo z difosfonati, lahko tudi z Zometo.
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 s P450 in vitro (glejte poglavje 5. 2), niso pa bile narejene formalne klinične študije medsebojnega delovanja.
19 commonly associated with a flu-like syndrome in about 9% of patients, including bone pain (9.1%), fever (7.2%), fatigue (4.1%) and rigors (2.9%).
Intravenska uporaba je pri okrog 9% bolnikov najpogosteje povezana z gripi podobnim sindromom, ki obsega bolečine v kosteh (9, 1%), vročino (7, 2%), utrujenost (4, 1%) in okorelost (2, 9%).
Based on pooled analysis of placebo-controlled studies, severe anaemia (Hb < 8.0 g/ dl) was reported in 5.2% of patients receiving Zometa 4 mg versus 4.2% on placebo.
Na podlagi zbirne analize študij, kontroliranih s placebom, so poročali o težki anemiji (Hb < 8, 0 g/ dl) pri 5, 2% bolnikov, ki so dobivali Zometo 4 mg, proti 4, 2% tistih, ki so dobivali placebo.