FrancophonIA/ELRC3.0 huggingface dataset:
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: While the risk is reduced with a dose of 4 mg zoledronic acid administered over 15 minutes, deterioration in renal function may still occur.
Slovenian: Čeprav se nevarnost zmanjša, če 4-miligramski odmerek zoledronske kisline dajemo 15 minut, lahko kljub temu nastopi poslabšanje ledvične funkcije.
English: 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.
Slovenian: 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.
English: The pain score for zoledronic acid was consistently below baseline and pain reduction was accompanied by a trend in reduced analgesics score.
Slovenian: Z zoledronsko kislino so bile vrednosti na bolečinski lestvici ves čas pod izhodiščno vrednostjo, zmanjšanje bolečine je spremljal trend zmanjševanja na lestvici analgezije.
English: Low level of calcium in the blood.
Slovenian: nizka koncentracija fosfata v krvi.
English: Episcleritis
Slovenian: episkleritis
English: Your doctor may recommend a dental examination before you start treatment with Zometa.
Slovenian: Zdravnik vam bo morda svetoval, da pred začetkom zdravljenja z zdravilom Zometa opravite zobozdravstveni pregled.
English: Multipack (4x1 bottle)
Slovenian: skupno pakiranje (4x1 steklenica)
English: Solvent ampoule: 5-ml colourless glass ampoule.
Slovenian: Ampula z vehiklom: 5-mililitrska ampula iz brezbarvnega stekla.
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: Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with Zometa.
Slovenian: - Študije z več vrstami infuzijskih sistemov, izdelanih iz polivinilklorida, polietilena in polipropilena, niso pokazale nezdružljivosti z zdravilom Zometa.
English: Instructions for preparing reduced doses of Zometa
Slovenian: Navodila za pripravo zmanjšanih odmerkov zdravila Zometa
English: 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).
Slovenian: 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).
English: The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.
Slovenian: Pri odločanju glede zdravljenja bolnikov z zasevki v kosteh za preprečevanje z okostjem povezanih dogodkov moramo upoštevati, da nastopi učinek zdravljenja čez 2-3 mesece.
English: The solvent ampoule contains water for injections.
Slovenian: Ampula z vehiklom vsebuje vodo za injekcije.
English: Zoledronic acid is not metabolised and is excreted unchanged via the kidney.
Slovenian: Zoledronska kislina se ne presnavlja in se izloča nespremenjena skozi ledvice.
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 Zometa 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 zdravila Zometa pri bolnikih s težko ledvično okvaro ne priporočamo.
English: From the bone tissue it is released very slowly back into the systemic circulation and eliminated via the kidney.
Slovenian: Iz kostnega tkiva se zelo počasi sprošča nazaj v sistemski krvni obtok in se odstranjuje iz telesa skozi ledvice.
English: 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.
Slovenian: 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.
English: Angioneurotic oedema
Slovenian: angionevrotični edem
English: 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).
Slovenian: 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).
English: The primary endpoint of the study was the percent change from baseline in lumbar spine bone mineral density (BMD) after 12 months of treatment.
Slovenian: Primarni cilj opazovanja v študiji je bila odstotna sprememba mineralne gostote kosti ledvenega dela hrbtenice po 12 mesecih zdravljenja.
English: Musculoskeletal pain
Slovenian: Mišično-skeletne bolečine
English: Nausea, vomiting, decreased appetite
Slovenian: navzea, bruhanje, zmanjšan apetit občasni:
English: Zoledronic acid 4 mg was also studied in a double-blind, randomised, placebo-controlled trial in 228 patients with documented bone metastases from breast cancer to evaluate the effect of 4 mg zoledronic acid on the skeletal related event (SRE) rate ratio, calculated as the total number of SRE events (excluding hypercalcaemia and adjusted for prior fracture), divided by the total risk period.
Slovenian: Zoledronsko kislino 4 mg so proučevali tudi v dvojno slepem, randomiziranem, s placebom 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.
English: Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
Slovenian: konvulzije, hipestezija in tetanija (zaradi hipokalciemije)
English: Unit packs containing 1 or 4 vials.
Slovenian: Posamezno pakiranje vsebuje 1 ali 4 viale.
English: Zometa has been associated with reports of renal dysfunction.
Slovenian: Zdravilo Zometa povezujejo s poročili o disfunkciji ledvic.
English: 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.
Slovenian: 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.
English: Each pack contains the vial with powder, together with an ampoule of 5 ml water for injections, which is used to dissolve the powder.
Slovenian: Vsaka škatla vsebuje vialo s praškom, skupaj z ampulo s 5 ml vode za injekcije, ki se uporablja za raztapljanje praška.
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: 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.
Slovenian: 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.
English: In patients who show evidence of renal deterioration during treatment, Zometa should be withheld.
Slovenian: Bolnikom, pri katerih se med zdravljenjem pokažejo znaki poslabšanja ledvične funkcije, je treba zdravilo Zometa ukiniti.
English: Zometa must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Slovenian: Zdravilo Zometa smejo predpisovati in dajati bolnikom samo zdravstveni delavci, ki imajo izkušnje z uporabo intravenskih difosfonatov.
English: 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).
Slovenian: 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).
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 then 24 hours at 2°C - 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 bilo redčenje izvedeno pod kontroliranimi in validiranimi aseptičnimi pogoji.
English: 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.
Slovenian: 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.
English: Multi-packs containing 10 (10 packs of 1+1) vials and ampoules of water for injections.
Slovenian: Skupno pakiranje vsebuje 10 (10 pakiranj po 1+1) vial in ampul z vodo za injekcije.
English: Upon initiation of treatment in patients with bone metastases with mild to moderate renal impairment, lower doses of zoledronic acid are recommended.
Slovenian: Po uvedbi zdravljenja pri bolnikih z zasevki v kosteh in blago do zmerno ledvično okvaro priporočajo manjše odmerke zoledronske kisline.
English: Very rare:
Slovenian: uveitis zelo redki:
English: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Slovenian: vrtoglavost, parestezija, disgevzija, hipestezija, hiperestezija, tremor, somnolenca zelo redki:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Bolniki, ki prejemajo zdravilo Zometa, ne smejo sočasno prejemati še zdravila Aclasta ali kateregakoli od drugih difosfonatov, saj učinki kombinacije navedenih učinkovin niso znani.
English: For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Slovenian: Pri bolnikih, pri katerih se med difosfonatnim zdravljenjem razvije osteonekroza čeljustnic, utegne stomatološka operacija stanje poslabšati.
English: 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.
Slovenian: Korigirani serumski kalcij se je hitreje normaliziral 4. dne (8 mg zoledronske kisline) in 7. dne (4 mg in 8 mg zoledronske kisline).
English: Interstitial lung disease
Slovenian: intersticijska bolezen pljuč
English: One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
Slovenian: En ml koncentrata vsebuje 0,8 mg zoledronske kisline (v obliki monohidrata).
English: The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Slovenian: Rezultati so dokazali, da je zoledronska kislina 4 mg pokazala učinkovitost za preprečevanje z okostjem povezanih dogodkov (SREs), ki je bila primerljiva z učinkovitostjo 90 mg pamidronata.
English: Adjusted dose (mg zoledronic acid in 100 ml) *
Slovenian: Prilagojeni odmerek (mg zoledronske kisline v 100 ml) *
English: In a pooled analysis of safety data from Zometa 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 Zometa (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 zdravila Zometa 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 zdravilom Zometa, (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: Dyspnoea, cough, bronchoconstriction
Slovenian: dispneja, kašelj, bronhokonstrikcija redki:
English: It also contains mannitol and sodium citrate.
Slovenian: Vsebuje tudi manitol in natrijev citrat.
English: Increases in serum creatinine also occur in some patients with chronic administration of Zometa at recommended doses for prevention of skeletal related events, although less frequently.
Slovenian: Čeprav redkeje, se zvišanje serumskega kreatinina pojavlja tudi pri nekaterih bolnikih, ki kronično prejemajo zdravilo Zometa v priporočenih odmerkih za preprečevanje z okostjem povezanih dogodkov.
English: Fewer zoledronic acid 4 mg patients suffered pathological fractures.
Slovenian: Manj bolnikov, ki so prejemali zoledronsko kislino 4 mg, je imelo patološke zlome.
English: The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Slovenian: V prvi randomizirani, dvojno slepi raziskavi, kontrolirani s placebom, so primerjali zoledronsko kislino 4 mg s placebom za preprečevanje z okostjem povezanih dogodkov (SREs) pri bolnikih z rakom prostate.
English: You will be given adequate calcium and vitamin D supplements.
Slovenian: Prejeli boste dodaten kalcij in vitamin D v ustreznem odmerku.
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: Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
Slovenian: Posvetujte se z zdravnikom, če občutite bolečine, šibkost ali nelagodje v stegnu, kolku ali dimljah, saj so to lahko zgodnji znaki možnega zloma stegnenice.
English: No pharmacokinetic data for zoledronic acid are available in patients with hypercalcaemia or in patients with hepatic insufficiency.
Slovenian: O zoledronski kislini pri bolnikih s hiperkalciemijo ali pri bolnikih z insuficienco jeter ni farmakokinetičnih podatkov.
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to zoledronic acid administration.
Slovenian: Med zdravljenjem je potrebna previdnost pri izvajanju invazivnih zobozdravstvenih posegov, povsem pa se jim je treba izogibati v času blizu termina odmerjanja zoledronske kisline.
English: Remove the following amount of Zometa solution for infusion (ml)
Slovenian: Odvzemite navedeni volumen raztopine za infundiranje Zometa (ml)
English: Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Slovenian: Pri bolnikih s težko ledvično insuficienco (očistek kreatinina < 30 ml/min) so na voljo le omejeni farmakokinetični podatki.
English: In patients with mild to moderate renal impairment, reduced doses should be prepared as instructed below.
Slovenian: Za bolnike z blago do zmerno okvaro ledvic je treba po spodnjih navodilih pripraviti nižje odmerke.
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Zometa.
Slovenian: Vsem bolnikom je treba naročiti, naj v času zdravljenja z zdravilom Zometa skrbijo za dobro ustno higieno in redno hodijo na preglede k zobozdravniku, v primeru simptomov v ustni votlini, kot so majavost zob, bolečine, otekline ali neceljenje ran ali vnetje, pa naj takoj obvestijo zdravnika.
English: Blood and lymphatic system disorders Common:
Slovenian: Bolezni krvi in limfatičnega sistema pogosti:
English: Pam 90 mg zoledronic acid 4 mg
Slovenian: Pam 90 mg zoledronska kislina 4 mg
English: To assess the effects of 4 mg zoledronic acid versus pamidronate 90 mg, the results of two pivotal multicentre studies in patients with TIH were combined in a pre-planned analysis.
Slovenian: Za oceno učinkov 4 mg zolendronske kisline v primerjavi s pamidronatom 90 mg so v vnaprej načrtovani analizi združili rezultate dveh ključnih multicentričnih raziskav pri bolnikih s tumorsko povzročeno hiperkalciemijo (TIH).
English: Patients should be adequately supplemented with calcium and vitamin D.
Slovenian: Bolniki morajo prejemati zadostno količino kalcija in vitamina D.
English: Shake the vial gently to dissolve the powder.
Slovenian: Vialo rahlo stresate, da se prašek raztopi.
English: Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
Slovenian: driska, zapeka, bolečine v trebuhu, dispepsija, stomatitis, suha usta
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Slovenian: osteonekroza zunanjega slušnega kanala (neželeni učinek skupine bisfosfonatov) in osteonekroza na drugih anatomskih lokacijah, vključno s stegnenico in kolkom
English: Risk reduction of suffering from multiple events** (%)
Slovenian: vrednost p stopnja obolevnosti skeleta vrednost p zmanjšanje tveganja za pojav večkratnih dogodkov ** (%)
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: 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.
Slovenian: Zoledronsko kislino, dano subkutano, so dobro prenašale podgane, intravensko dano pa psi, v odmerkih do 0,02 mg/kg na dan 4 tedne dolgo.
English: Zometa 4 mg/100 ml solution for infusion contains 4 mg zoledronic acid in 100 ml of infusion solution for immediate use in patients with normal renal function.
Slovenian: Zometa 4 mg/100 ml raztopina za infundiranje vsebuje 4 mg zoledronske kisline v 100 ml infuzijske raztopine, ki je že pripravljena za uporabo pri bolnikih z normalno ledvično funkcijo.
English: In clinical trials 69 patients who relapsed or were refractory to initial treatment (zoledronic acid 4 mg, 8 mg or pamidronate 90 mg) were retreated with 8 mg zoledronic acid.
Slovenian: V kliničnih preskušanjih je bilo 69 bolnikov, pri katerih se je bolezen ponovno pojavila ali so bili odporni proti začetnemu zdravljenju (zoledronska kislina 4 mg, 8 mg ali pamidronat 90 mg), ponovno zdravljenih z 8 mg zoledronske kisline.
English: The following are the important identified risks with Zometa in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Slovenian: Pri uporabi zdravila Zometa za odobrene indikacije so ugotovili naslednja pomembna tveganja: moteno delovanje ledvic, osteonekrozo čeljustnic, reakcijo akutne faze, hipokalciemijo, atrijsko fibrilacijo, anafilaksijo, intersticijsko bolezen pljuč.
English: Vial: 5-ml plastic vial made of clear, colourless cycloolefine copolymer with fluoropolymer-coated bromobutyl rubber stopper and aluminium cap with plastic flip-off component.
Slovenian: Viala: 5-mililitrska plastična viala, izdelana iz prozornega, brezbarvnega cikloolefinskega kopolimera, z zamaškom iz bromobutilne gume, prevlečene s fluoropolimerom, in aluminijasto zaporko s plastičnim zaščitnim pokrovčkom.
English: Proportion of patients with SREs (%) p-value
Slovenian: N delež bolnikov s SREs (%) vrednost p mediana časa do SRE (dnevi)
English: During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphopsphonate 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).