natgillin/translations-raw huggingface dataset:
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.
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.
Additional information on handling of Zometa, including guidance on preparation of reduced doses, is provided in section 4.2.
Nadaljnje informacije o ravnanju z zdravilom Zometa, vključno z navodili za pripravo nižjih odmerkov, so navedene v poglavju 4.2.
1 bottle
1 plastenka
Do not use Zometa after the expiry date stated on the pack.
- Zdravilo Zometa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.
Bolniki morajo prejeti tudi peroralni dodatek 500 mg kalcija in 400 i.e. vitamina D na dan.
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.
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.
The frequencies for each of these identified risks are shown in Table 2.
Pogostnosti vsakega od navedenih ugotovljenih tveganj so prikazane v preglednici 2.
• To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
• preprečevanje zapletov na kosteh, na primer zlomov, pri odraslih bolnikih z metastazami v kosteh (z razširitvijo raka s prvotnega mesta na kosti),
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.
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.
This condition is known as tumour-induced hypercalcaemia (TIH).
To stanje imenujemo tumorsko povzročena hiperkalciemija (TIH).
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.
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.
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).
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).
Powder vial: 6 ml colourless glass vial, hydrolytic glass type I (Ph.
Viala s praškom: 6-mililitrska viala iz brezbarvnega stekla, hidrolitično steklo razreda I (Ph.
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.
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.
- 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.
- 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.
Your doctor will carry out blood tests before you start treatment with Zometa and will check your response to treatment at regular intervals.
Preden začnete zdravljenje z zdravilom Zometa, vam bo zdravnik opravil preiskave krvi in v rednih presledkih preverjal vaš odziv na zdravljenje.
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).
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).
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).
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).
There were no statistically significant differences between the two zoledronic acid doses.
Med obema odmerkoma zoledronske kisline ni bilo statistično značilnih razlik.
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.
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.
The interpatient variability in pharmacokinetic parameters for zoledronic acid was high, as seen with other bisphosphonates.
Variabilnost farmakokinetičnih parametrov zoledronske kisline med posameznimi bolniki je bila velika, podobno kot pri drugih difosfonatih.
The active substance in Zometa is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Zdravilna učinkovina v zdravilu Zometa je zoledronska kislina, ki sodi v skupino snovi, ki se imenujejo difosfonati.
Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Razmisliti je treba o začasni prekinitvi zdravljenja z zoledronsko kislino, dokler se stanje ne razreši in dokler se ne zmanjša vpliv vpletenih dejavnikov tveganja, če je to mogoče doseči.
Thus these results precluded determining a definitive effect of zoledronic acid on fertility in humans.
Na podlagi teh rezultatov ni mogoče določiti dejanskega vpliva zoledronske kisline na plodnost pri ljudeh.
Zoledronic acid was teratogenic in the rat at subcutaneous doses  0.2 mg/kg.
Zoledronska kislina je bila teratogena pri podganah pri subkutanih odmerkih  0,2 mg/kg.
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.
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.
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).
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).
Multipack (5x1 bottle)
skupno pakiranje (5x1 steklenica)
Zometa treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
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.
Zoledronic acid belongs to the class of bisphosphonates and acts primarily on bone.
Zoledronska kislina pripada skupini difosfonatov in deluje primarno na kost.
Solvent for Zometa Water for injections 5 ml
vehikel za Zometo voda za injekcije 5 ml
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.
Zoledronska kislina 4 mg je značilno (signifikantno) zmanjšala delež bolnikov, ki so doživeli vsaj po en z okostjem povezan dogodek (SRE), odložila mediano časa nastopa prvega z okostjem povezanega dogodka (SRE) za > 5 mesecev in zmanjšala letno incidenco dogodkov na bolnika - stopnjo obolevnosti skeleta.
While the risk is reduced with a dose of 4 mg zoledronic acid administered over 15 minutes, deterioration in renal function may still occur.
Čeprav se nevarnost zmanjša, če 4-miligramski odmerek zoledronske kisline dajemo 15 minut, lahko kljub temu nastopi poslabšanje ledvične funkcije.
Longer-term repeat administration at doses bracketing the highest intended human therapeutic dose of zoledronic acid produced toxicological effects in other organs, including the gastrointestinal tract, liver, spleen and lungs, and at intravenous injection sites.
Dolgoročnejše večkratno dajanje v odmerkih okrog največjega nameravanega humanega terapevtskega odmerka zoledronske kisline je povzročilo toksične učinke v drugih organih z gastrointestinalnim traktom, jetri, vranico in pljuči vred, in na mestih intravenskega injiciranja.
The pain score for zoledronic acid was consistently below baseline and pain reduction was accompanied by a trend in reduced analgesics score.
Z zoledronsko kislino so bile vrednosti na bolečinski lestvici ves čas pod izhodiščno vrednostjo, zmanjšanje bolečine je spremljal trend zmanjševanja na lestvici analgezije.
Low level of calcium in the blood.
nizka koncentracija fosfata v krvi.
Your doctor may recommend a dental examination before you start treatment with Zometa.
Zdravnik vam bo morda svetoval, da pred začetkom zdravljenja z zdravilom Zometa opravite zobozdravstveni pregled.
Multipack (4x1 bottle)
skupno pakiranje (4x1 steklenica)
Solvent ampoule: 5-ml colourless glass ampoule.
Ampula z vehiklom: 5-mililitrska ampula iz brezbarvnega stekla.
The recommended dose in hypercalcaemia (albumin-corrected serum calcium  12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
Priporočeni odmerek za hiperkalciemijo (za albumin korigirani serumski kalcij  12,0 mg/dl ali 3,0 mmol/l) je enkratni odmerek 4 mg zoledronske kisline.
Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with Zometa.
- Študije z več vrstami infuzijskih sistemov, izdelanih iz polivinilklorida, polietilena in polipropilena, niso pokazale nezdružljivosti z zdravilom Zometa.
Instructions for preparing reduced doses of Zometa
Navodila za pripravo zmanjšanih odmerkov zdravila Zometa
The following conventional classification is used: 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).
Kategorije pogostnosti so opredeljene z naslednjim dogovorom: 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).
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.
Pri odločanju glede zdravljenja bolnikov z zasevki v kosteh za preprečevanje z okostjem povezanih dogodkov moramo upoštevati, da nastopi učinek zdravljenja čez 2-3 mesece.
The solvent ampoule contains water for injections.
Ampula z vehiklom vsebuje vodo za injekcije.
Zoledronic acid is not metabolised and is excreted unchanged via the kidney.
Zoledronska kislina se ne presnavlja in se izloča nespremenjena skozi ledvice.
In view of the potential impact of zoledronic acid on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum creatinine ≥ 400 µmol/l or ≥ 4.5 mg/dl for patients with TIH and ≥ 265 µmol/l or ≥ 3.0 mg/dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/min), the use of Zometa is not recommended in patients with severe renal impairment.
Glede na možni vpliv zoledronske kisline na delovanje ledvic ob pomanjkanju kliničnih podatkov o varnosti pri bolnikih s težko izhodiščno okvaro ledvic (v kliničnih preskušanjih opredeljeno s serumskim kreatininom ≥ 400 µmol/l ali ≥ 4,5 mg/dl za bolnike s tumorsko povzročeno hiperkalciemijo - TIH - oziroma s serumskim kreatininom ≥ 265 µmol/l ali ≥ 3,0 mg/dl za bolnike z rakom in zasevki v kosteh) in glede na samo omejene farmakokinetične podatke pri bolnikih s težko izhodiščno ledvično okvaro (očistek kreatinina < 30 ml/min), uporabe zdravila Zometa pri bolnikih s težko ledvično okvaro ne priporočamo.
From the bone tissue it is released very slowly back into the systemic circulation and eliminated via the kidney.
Iz kostnega tkiva se zelo počasi sprošča nazaj v sistemski krvni obtok in se odstranjuje iz telesa skozi ledvice.
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.
Angioneurotic oedema
angionevrotični edem
Zometa 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).
Priporočeni odmerek zdravila Zometa* 4,0 mg zoledronske kisline 3,5 mg* zoledronske kisline 3,3 mg* zoledronske kisline 3,0 mg* zoledronske kisline * Odmerke so izračunali tako, da so predpostavili tarčno AUC 0,66 (mg•hr/l) (CLcr=75 ml/min).
The primary endpoint of the study was the percent change from baseline in lumbar spine bone mineral density (BMD) after 12 months of treatment.
Primarni cilj opazovanja v študiji je bila odstotna sprememba mineralne gostote kosti ledvenega dela hrbtenice po 12 mesecih zdravljenja.
Musculoskeletal pain
Mišično-skeletne bolečine
Nausea, vomiting, decreased appetite
navzea, bruhanje, zmanjšan apetit občasni:
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.
Zoledronsko kislino 4 mg so proučevali tudi v dvojno slepem, randomiziranem, s placebom kontroliranem preskušanju pri 228 bolnicah z dokazanimi kostnimi zasevki raka dojke, da bi ocenili učinek 4 mg zoledronske kisline 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.
Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
konvulzije, hipestezija in tetanija (zaradi hipokalciemije)
Unit packs containing 1 or 4 vials.
Posamezno pakiranje vsebuje 1 ali 4 viale.
Zometa has been associated with reports of renal dysfunction.
Zdravilo Zometa povezujejo s poročili o disfunkciji ledvic.
The multiple event analysis revealed a significant risk reduction of 16% in patients treated with zoledronic acid 4 mg in comparison with patients receiving pamidronate.
Analiza večkratnih dogodkov je pokazala pomembno zmanjšanje tveganja za 16 % pri bolnikih, zdravljenih z zoledronsko kislino 4 mg, v primerjavi z bolniki, ki so prejemali pamidronat.
Each pack contains the vial with powder, together with an ampoule of 5 ml water for injections, which is used to dissolve the powder.
Vsaka škatla vsebuje vialo s praškom, skupaj z ampulo s 5 ml vode za injekcije, ki se uporablja za raztapljanje praška.
Median time to relapse (re-increase of albumin-corrected serum calcium  2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
Mediana časa do ponovnega pojava bolezni (ponovno zvišanje za albumin korigiranega serumskega kalcija  2,9 mmol/l) je bila pri bolnikih, zdravljenih z zoledronsko kislino, 30 do 40 dni, pri tistih, ki so bili zdravljeni s pamidronatom 90 mg, pa 17 dni (vrednosti p: 0,001 za 4 mg in 0,007 za 8 mg zoledronske kisline).
During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Bolnikom je treba svetovati, naj v času zdravljenja z difosfonati sporočijo kakršnekoli bolečine v stegnu, kolku ali dimljah, vsakega bolnika z navedenimi simptomi pa je treba pregledati glede nepopolnega zloma stegnenice.
In patients who show evidence of renal deterioration during treatment, Zometa should be withheld.
Bolnikom, pri katerih se med zdravljenjem pokažejo znaki poslabšanja ledvične funkcije, je treba zdravilo Zometa ukiniti.
Zometa must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Zdravilo Zometa smejo predpisovati in dajati bolnikom samo zdravstveni delavci, ki imajo izkušnje z uporabo intravenskih difosfonatov.
Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as Zometa (see section 4.4).
O osteonekrozi čeljustnic so poročali predvsem pri bolnikih z rakom, zdravljenih z zdravili, ki zavirajo resorpcijo kosti, kot je zdravilo Zometa (glejte poglavje 4.4).
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer then 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Če zdravstveni delavec raztopine ne uporabi takoj, je sam odgovoren za trajanje in pogoje shranjevanja pred uporabo, kar ponavadi ne traja dalj kot 24 ur pri temperaturi 2ºC 8ºC, razen če je bilo redčenje izvedeno pod kontroliranimi in validiranimi aseptičnimi pogoji.
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 pri 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.
Multi-packs containing 10 (10 packs of 1+1) vials and ampoules of water for injections.
Skupno pakiranje vsebuje 10 (10 pakiranj po 1+1) vial in ampul z vodo za injekcije.
Upon initiation of treatment in patients with bone metastases with mild to moderate renal impairment, lower doses of zoledronic acid are recommended.
Po uvedbi zdravljenja pri bolnikih z zasevki v kosteh in blago do zmerno ledvično okvaro priporočajo manjše odmerke zoledronske kisline.
Very rare:
uveitis zelo redki:
Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
vrtoglavost, parestezija, disgevzija, hipestezija, hiperestezija, tremor, somnolenca zelo redki:
Zometa 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.
Zdravila Zometa ne priporočajo bolnikom, ki imajo že pred uvedbo zdravljenja težko ledvično okvaro, ki je za to skupino bolnikov opredeljena kot CLcr < 30 ml/min.
Patients being treated with Zometa should not be treated with Aclasta or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Bolniki, ki prejemajo zdravilo Zometa, ne smejo sočasno prejemati še zdravila Aclasta ali kateregakoli od drugih difosfonatov, saj učinki kombinacije navedenih učinkovin niso znani.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Pri bolnikih, pri katerih se med difosfonatnim zdravljenjem razvije osteonekroza čeljustnic, utegne stomatološka operacija stanje poslabšati.
There was faster normalisation of corrected serum calcium at day 4 for 8 mg zoledronic acid and at day 7 for 4 mg and 8 mg zoledronic acid.
Korigirani serumski kalcij se je hitreje normaliziral 4. dne (8 mg zoledronske kisline) in 7. dne (4 mg in 8 mg zoledronske kisline).
Interstitial lung disease
intersticijska bolezen pljuč
One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
En ml koncentrata vsebuje 0,8 mg zoledronske kisline (v obliki monohidrata).
The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Rezultati so dokazali, da je zoledronska kislina 4 mg pokazala učinkovitost za preprečevanje z okostjem povezanih dogodkov (SREs), ki je bila primerljiva z učinkovitostjo 90 mg pamidronata.
Adjusted dose (mg zoledronic acid in 100 ml) *
Prilagojeni odmerek (mg zoledronske kisline v 100 ml) *