FrancophonIA/ELRC3.0 huggingface dataset:
English: The diluted Zoledronic Acid Accord infusion solution should be used immediately in order to avoid microbial contamination.
Slovenian: Razredčeno infuzijsko raztopino zdravila Zoledronska kislina Accord morate porabiti takoj, da bi preprečili onesnaženje z mikroorganizmi.
English: The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients.
Slovenian: Neravnovesja, ki so ga opažali v tem preskušanju, niso opažali v drugih preskušanjih z zoledronsko kislino, vključno s preskušanji z zoledronsko kislino v odmerku 4 mg vsake 3-4 tedne pri onkoloških bolnikih.
English: 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 than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: 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 redčenje potekalo pod kontroliranimi in validiranimi aseptičnimi pogoji.
English: Zoledronic Acid Accord treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Slovenian: Zdravljenje z zdravilom Zoledronska kislina Accord pri bolnikih s TIH, ki imajo tudi težko ledvično okvaro, lahko pride v poštev šele po oceni nevarnosti in koristnih učinkov zdravljenja.
English: Zoledronic Acid Accord 4 mg concentrate for solution for infusion, 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 Accord 4 mg koncentrat za raztopino za infundiranje, nadaljnje razredčeno v 100 ml (glejte poglavje 6.6), je treba dajati v obliki ene same intravenske infuzije, ki traja najmanj 15 minut.
English: In the clinical trials, renal deterioration was defined as follows: For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 µmol/l), an increase of 0.5 mg/dl or 44 µmol/l; For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 µmol/l), an increase of 1.0 mg/dl or 88 µmol/l.
Slovenian: V kliničnih preskušanjih so opredelili ledvično poslabšanje takole: pri bolnikih z normalnim izhodiščnim serumskim kreatininom (< 1,4 mg/dl ali < 124µmol/l), zvišanje za 0,5 mg/dl ali 44 µmol/l; pri bolnikih s patološkim izhodiščnim kreatininom (> 1,4 mg/dl ali > 124 µmol/l), zvišanje za 1,0 mg/dl ali 88 µmol/l.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni "brez natrija".
English: From a microbiological point of view, the diluted solution for infusion should be used immediately.
Slovenian: Z mikrobiološkega stališča je razredčeno raztopino za infundiranje najbolje uporabiti takoj.
English: This medicinal product does not require any special storage condition.
Slovenian: Za shranjevanje zdravila niso potrebna posebna navodila.
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: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI MEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: In-vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer drugs, anti-adhesion/invasion activity.
Slovenian: In vitro: Inhibicijo proliferacije osteoblastov, neposredno citostatično in pro-apoptotično aktivnost pri tumorskih celicah, sinergističen citostatični učinek z drugimi zdravili proti raku, anti-adhezijsko in anti-invazijsko aktivnost.
English: Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Slovenian: Zdravljenje odraslih bolnikov s tumorsko povzročeno hiperkalciemijo (TIH).
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 t1/2 0,24 ure in t1/2 1,87 ure, ki mu sledi dolga eliminacijska faza s terminalnim eliminacijskim razpolovnim časom t1/2 146 ur.
English: • Carefully follow all the other instructions given to you by your doctor, pharmacist or nurse.
Slovenian: - Skrbno se ravnajte tudi po vseh drugih navodilih, ki jih dobite od svojega zdravnika, farmacevta ali medicinske sestre.
English: 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 than 24 hours at 2°C-8°C.
Slovenian: 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.
English: • The other ingredients are: mannitol, sodium citrate, water for injections.
Slovenian: Druge sestavine so: manitol, natrijev citrat, voda za injekcije.
English: Very rare (may affect up to 1 in 10,000 people):
Slovenian: Zelo redki (lahko se pojavijo pri 1 od 10.000 ljudi):
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic Acid Accord.
Slovenian: Če imate hipokalciemijo, jo je treba odpraviti preden prejmete prvi odmerek zdravila Zoledronska kislina Accord.
English: Zoledronic Acid Accord is supplied as packs containing 1, 4 or 10 vials.
Slovenian: Zdravilo Zoledronska kislina Accord je na voljo v ovojnini, ki vsebuje 1 vialo, 4 viale ali 10 vial.
English: • The unopened vial does not require any specific storage conditions.
Slovenian: Za shranjevanje neodprte viale niso potrebna posebna navodila.
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 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.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/834/001- 1vial pack EU/1/13/834/002- 4 vial pack EU/1/13/834/003- 10 vial pack
Slovenian: EU/1/13/834/001-1 viala EU/1/13/834/002- 4 viale EU/1/13/834/003-10 vial
English: 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.
Slovenian: 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.
English: Excipients: mannitol (E421), sodium citrate and water for injections.
Slovenian: Pomožne snovi: manitol (E421), natrijev citrat in voda za injekcije.
English: Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Accord and will check your response to treatment at regular intervals.
Slovenian: Preden začnete zdravljenje z zdravilom Zoledronska kislina Accord, vam bo zdravnik opravil preiskave krvi in v rednih presledkih preverjal vaš odziv na zdravljenje.
English: In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Slovenian: V kliničnih študijah so nadaljevali z zdravljenjem z zoledronsko kislino šele, ko se je koncentracija kreatinina vrnila na raven, ne za več kot 10 % višjo od izhodiščne vrednosti (glejte poglavje 4.4).
English: Table 5: Proportion of complete responders by day in the combined TIH studies
Slovenian: Preglednica 5: Delež bolnikov s popolnim odzivom po dnevih v združenih raziskavah tumorsko povzročene hiperkalciemije (TIH)
English: 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).
Slovenian: 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).
English: 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 zoledronic acid is not recommended in patients with severe renal impairment.
Slovenian: 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 zoledronske kisline pri bolnikih s težko ledvično okvaro ne priporočamo.
English: • Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Slovenian: Osteonekrozo so zelo redko opažali tudi na drugih kosteh in ne le na čeljustnici, še posebej na kolku in stegnu.
English: N Proportion of patients with SREs p-value Median time to SRE (days)
Slovenian: N delež bolnikov s SREs (%) vrednost p mediana časa do SRE (dnevi)
English: Musculoskeletal pain
Slovenian: Mišično- skeletne bolečine
English: 5-ml plastic vial made of clear, cycloolefine copolymer with chlorobutyl rubber stopper and aluminium cap with flip-off component.
Slovenian: 5-mililitrska plastična viala iz brezbarvnega cikloolefinskega kopolimera z zamaškom iz klorobutilne gume in aluminijasto zaporko z zaščitnim pokrovčkom.
English: In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
Slovenian: V združeni analizi podatkov o varnosti zdravila iz registracijskih preskušanj zoledronske kisline pri preprečevanju z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajemajo kosti, so bile pogostnosti neželenih dogodkov, ki so vključevali okvaro ledvic in pri katerih je obstajal sum, da so povezani z zoledronsko kislino, (torej neželenih učinkov), naslednje: multipli mielom (3,2 %), rak prostate (3,1 %), rak dojke (4,3 %), tumor na pljučih in drugi čvrsti tumorji (3,2 %).
English: In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Slovenian: Za bolnike z blago do zmerno okvaro ledvic so priporočeni nižji odmerki zoledronske kisline (glejte poglavje "Odmerjanje" zgoraj in poglavje 4.4).
English: • Since no data are available on the compatibility of Zoledronic Acid Accord with other intravenously administered substances, Zoledronic Acid Accord must not be mixed with other medications/substances and should always be given through a separate infusion line.
Slovenian: Ker o združljivosti zdravila Zoledronska kislina Accord z drugimi intravensko dajanimi snovmi ni na voljo nikakršnih podatkov, zdravila Zoledronska kislina Accord ne smete mešati z drugimi zdravili ali snovmi in jo morate vedno dajati po ločenem infuzijskem sistemu.
English: Patients with TIH and evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with zoledronic acid outweighs the possible risk.
Slovenian: Bolnike s tumorsko povzročeno hiperkalciemijo (TIH) in z znaki poslabšanja ledvične funkcije, moramo ustrezno ovrednotiti in pri tem pretehtati, ali možna korist zdravljenja z zoledronsko kislino odtehta možno nevarnost.
English: Patients being treated with Zoledronic Acid Accord should not be treated with Aclasta or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Slovenian: Bolniki, ki prejemajo zdravilo Zoledronska kislina Accord, ne smejo sočasno prejemati še zdravila Aclasta ali kateregakoli od drugih difosfonatov, saj učinki kombinacije navedenih učinkovin niso znani.
English: EU/1/13/834/003
Slovenian: EU/1/13/834/001 EU/1/13/834/002 EU/1/13/834/003
English: During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).
Slovenian: Med izkušnjami v obdobju trženja so poročali o naslednjih neželenih učinkih (pogostnost je redka): atipični subtrohanterni zlomi stegnenice in zlomi diafize stegnenice (za difosfonate značilen neželeni učinek).
English: • Do not use Zoledronic Acid Accord after the expiry date stated on the pack.
Slovenian: Zdravilo Zoledronska kislina Accord ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: 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.
Slovenian: 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).
English: The hydration status of patients must be assessed prior to and following administration of Zoledronic Acid Accord to ensure that they are adequately hydrated.
Slovenian: Status hidracije bolnikov mora zdravnik oceniti pred in po dajanju zdravila Zoledronska kislina Accord, da se prepriča, da so ustrezno hidrirani.
English: The active substance in Zoledronic Acid Accord is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Slovenian: Zdravilna učinkovina v zdravilu Zoledronska kislina Accord je zoledronska kislina, ki sodi v skupino snovi, ki se imenujejo difosfonati.
English: • The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Slovenian: Raztopino, ki vsebuje zoledronsko kislino, dajemo v obliki ene same 15-minutne intravenske infuzije z ločenim infuzijskim sistemom.
English: The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Slovenian: Pri uporabi zoledronske kisline za odobrene indikacije so ugotovili naslednja pomembna tveganja: moteno delovanje ledvic, osteonekrozo čeljustnic, reakcijo akutne faze, hipokalciemijo, atrijsko fibrilacijo, anafilaksijo, intersticijsko bolezen pljuč.
English: Caution is advised when Zolendronc Acid Accord is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Slovenian: Pri dajanju zdravila Zoledronska kislina Accord skupaj z zdravili, za katera je znano, da povzročajo hipokalciemijo, je potrebna previdnost, saj lahko delujejo sinergistično in povzročijo hudo hipokalciemijo (glejte poglavje 4.5).
English: The plasma protein binding is low, with the unbound fraction ranging from 60% at 2 ng/ml to 77% at 2000 ng/ml of zoledronic acid
Slovenian: Vezava na beljakovine v plazmi je majhna, tako da nevezana frakcija predstavlja od 60 % pri koncentraciji zoledronske kisline 2 ng/ml do 77 % pri koncentraciji 2.000 ng/ml.
English: 319, Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom
Slovenian: North Harrow, Middlesex HA1 4HF Velika Britanija
English: Baseline creatinine clearance (ml/min) Zoledronic acid 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 zoledronske kisline * 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).
English: Mannitol (E421) Sodium citrate Water for injections
Slovenian: 6.1 Seznam pomožnih snovi manitol (E421) natrijev citrat voda za injekcije
English: Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia)
Slovenian: bradikardija, aritmija (zaradi hipokalciemije)
English: What you need to know before you are given Zoledronic Acid Accord
Slovenian: Kaj morate vedeti, preden vam bodo dali zdravilo Zoledronska kislina Accord
English: What you need to know before you are given Zoledronic Acid Accord 3.
Slovenian: Kaj morate vedeti, preden vam bodo dali zdravilo Zoledronska kislina Accord 3.
English: Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Possible Side Effects
Slovenian: Možni neželeni učinki
English: Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline.
Slovenian: Zdravljenje z zoledronsko kislino se sme spet začeti šele, ko se serumski kreatinin vrne na vrednost, ki ni za več kot 10 % večja od izhodiščne.
English: Risk reduction of suffering from multiple events** (%)
Slovenian: vrednost p stopnja obolevnosti skeleta vrednost p zmanjšanje tveganja za pojav večkratnih dogodkov** (%)
English: How Zoledronic Acid Accord is used 4.
Slovenian: Kako se zdravilo Zoledronska kislina Accord uporablja 4.
English: What Zoledronic Acid Accord looks like and contents of the pack Zoledronic Acid Accord is supplied as a liquid concentrate in a vial.
Slovenian: Izgled zdravila Zoledronska kislina Accord in vsebina pakiranja Zdravilo Zoledronska kislina Accord je v obliki tekočega koncentrata v viali.
English: Zoledronic acid is contraindicated in breast-feeding women (see section 4.3).
Slovenian: Pri doječih ženskah je uporaba zoledronske kisline kontraindicirana (glejte poglavje 4.3).
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Slovenian: Preglednica 3: Rezultati učinkovitosti (čvrsti tumorji, razen raka dojke in prostate)
English: Patients must be assessed prior to administration of zoledronic acid to ensure that they are adequately hydrated.
Slovenian: Pred uporabo zoledronske kisline moramo bolnike oceniti, da zagotovimo, da so ustrezno hidrirani.
English: Do not mix Zoledronic Acid Accord concentrate with calcium-containing or other divalent cation-containing solutions such as lactated Ringer's solution.
Slovenian: Ne mešajte koncentrata zdravila Zoledronska kislina Accord z raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata.
English: • if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zoledronic Acid Accord belongs), or any of the other ingredients of this medicine
Slovenian: Zdravila Zoledronska kislina Accord ne smete dobiti: - če dojite, - če ste alergični na zoledronsko kislino, kak drug difosfonat (skupina snovi, ki ji pripada zdravilo Zoledronska kislina Accord) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: What Zoledronic Acid Accord is and what it is used for 2.
Slovenian: Kaj je zdravilo Zoledronska kislina Accord in za kaj ga uporabljamo 2.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted 17.
Slovenian: Sprejeta je utemeljitev, da Braillova pisava ni potrebna
English: Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Slovenian: Številni izmed njih so imeli znake lokalne okužbe, med katere sodi tudi osteomielitis.
English: • As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Slovenian: zaradi nizke vrednosti kalcija: napadi krčev, otrplost in tetanija (zaradi hipokalciemije).
English: Caution is advised when zoledronic acid is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Slovenian: Pri uporabi zoledronske kisline skupaj z antiangiogenimi zdravili je potrebna previdnost, saj so pri bolnikih, ki so sočasno prejemali navedena zdravila, opažali povečano pogostnost osteonekroze čeljustnic.
English: • To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Accord concentrate (5ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Slovenian: Infuzijsko raztopino, ki vsebuje 4 mg zoledronske kisline, pripravite tako, da koncentrat zdravila Zoledronska kislina Accord (5 ml) razredčite s 100 ml infuzijske raztopine, ki ne vsebuje kalcija ali drugih dvovalentnih kationov.
English: Zoledronic Acid Accord contains the same active substance as found in Aclasta (zoledronic acid).
Slovenian: Zdravilo Zoledronska kislina Accord vsebuje isto učinkovino (zoledronsko kislino) kot zdravilo Aclasta.
English: Intravenous use.
Slovenian: Intravenska uporaba po redčenju.
English: The following properties have been demonstrated in preclinical studies: In-vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
Slovenian: 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: Zoledronic Acid Accord is not recommended for use in adolescents and children below the age of 18 years.
Slovenian: Pri otrocih in mladostnikih, ki so stari manj kot 18 let, uporaba zdravila Zoledronska kislina Accord ni priporočena.
English: 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.
Slovenian: 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.
English: Statistically significant differences are marked (*p< 0.05) for between treatment comparisons (4 mg zoledronic acid vs.
Slovenian: Povprečne spremembe od izhodišča na BPI lestvici, označene so statistično značilne vrednosti p (*p<0,05) za primerjavo med obema vrstama zdravljenja (4 mg zoledronska kislina v primerjavi s placebom)