FrancophonIA/ELRC3.0 huggingface dataset:
English: To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zometa concentrate (5.0 ml) 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 dodatno razredčite koncentrat zdravila Zometa (5,0 ml) s 100 ml infuzijske raztopine, ki ne vsebuje kalcija ali drugih dvovalentnih kationov.
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: Additional risk minimisation measures The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil uvedbo opozorilne kartice za bolnika z opozorili glede osteonekroze čeljustnic.
English: Zometa contains the same active substance as found in Aclasta (zoledronic acid).
Slovenian: Zdravilo Zometa vsebuje isto učinkovino (zoledronsko kislino) kot zdravilo Aclasta.
English: One ampoule of solvent 5 ml Four vials 4 mg Four ampoules of solvent 5 ml
Slovenian: prašek in vehikel za raztopino za infundiranje ena viala po 4 mg ena ampula vehikla po 5 ml štiri viale po 4 mg štiri ampule vehikla po 5 ml
English: After reconstitution and dilution: From a microbiological point of view, the reconstituted and diluted solution for infusion should be used immediately.
Slovenian: Po rekonstituiranju in redčenju: z mikrobiološkega stališča je rekonstituirano in razredčeno raztopino za infundiranje najbolje uporabiti takoj.
English: The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Slovenian: Delež atrijske fibrilacije, ki so jo opredelili kot resen neželen dogodek, je bil pri bolnicah, ki so prejemale 5 mg zoledronske kisline, 1,3 % (pri 51 od 3.862 bolnic), pri bolnicah, ki so prejemale placebo, pa 0,6 % (pri 22 od 3.852 bolnic).
English: Musculoskeletal and connective tissue disorders Common:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti:
English: How Zometa is given - Zometa is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Slovenian: Kako se zdravilo Zometa daje - zdravilo Zometa dobijo bolniki v obliki infuzije v veno, ki naj traja vsaj 15 minut, in sicer kot samostojna intravenska raztopina z ločenim infuzijskim sistemom.
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) 4. dan
English: Table 2 Efficacy results (prostate cancer patients receiving hormonal therapy)
Slovenian: Preglednica 2 Rezultati učinkovitosti (bolniki z rakom prostate, ki so prejemali hormonsko zdravljenje)
English: Caution is indicated when Zometa is used with other potentially nephrotoxic medicinal products.
Slovenian: Kadar zdravilo Zometa dajemo z drugimi potencialno nefrotoksičnimi zdravili, je potrebna previdnost.
English: Zometa 4 mg/100 ml solution for infusion should be given as a single intravenous infusion in no less than 15 minutes.
Slovenian: Raztopino za infundiranje Zometa 4 mg/100 ml je treba dajati v obliki ene same intravenske infuzije, ki traja najmanj 15 minut.
English: It is given as a single 15-minute intravenous infusion in a separate infusion line.
Slovenian: Zdravilo dajemo v obliki ene same 15-minutne intravenske infuzije z ločenim infuzijskim sistemom.
English: A dental examination with appropriate preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with bisphosphonates in patients with concomitant risk factors.
Slovenian: Pri bolnikih s spremljajočimi dejavniki tveganja je pred začetkom zdravljenja z difosfonati priporočeno opraviti zobozdravniški pregled z ustreznimi preventivnimi zobozdravstvenimi ukrepi in oceniti razmerje med koristmi in tveganji pri vsakem posameznem bolniku.
English: Blood creatinine and blood urea increased, hypocalcaemia
Slovenian: zvišanje kreatinina in sečnine v krvi, hipokalciemija občasni:
English: Nasopharyngitis
Slovenian: nazofaringitis
English: This resulted in exaggerated pharmacological effects considered to be related to the compound's inhibition of skeletal calcium metabolisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
Slovenian: Prišlo je do poudarjenega farmakološkega delovanja, domnevno zaradi zaviranja mobilizacije kalcija iz kosti, ki je v obdobju okrog poroda povzročalo hipokalciemijo (kar je značilno za celotno skupino difosfonatov), distocijo in predčasno prekinitev študije.
English: Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid.
Slovenian: Poročali so o poslabšanju ledvične funkcije, napredovanju bolezni do ledvične odpovedi in dialize po začetnem odmerku ali po enkratnem odmerku 4 mg zoledronske kisline.
English: Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Slovenian: Analiza večkratnih dogodkov je pokazala za 30,7 % zmanjšano tveganje za razvoj z okostjem povezanih dogodkov (SREs) v skupini, ki je prejemala zoledronsko kislino 4 mg, v primerjavi s placebom.
English: For instructions on the dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede redčenja zdravila pred dajanjem glejte poglavje 6.6.
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, reduced Zometa doses are recommended (see also section 4.4).
Slovenian: Pri bolnikih z zasevki v kosteh, ki imajo pred začetkom zdravljenja blago do zmerno okvaro ledvic (opredeljeno za to skupino bolnikov kot CLcr 30-60 ml/min), priporočajo nižje odmerke zdravila Zometa (glejte tudi poglavje 4.4).
English: Table 3 Efficacy results (prostate cancer patients receiving hormonal therapy)
Slovenian: Preglednica 3 Rezultati učinkovitosti (bolniki z rakom prostate, ki so prejemali hormonsko zdravljenje)
English: 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.
Slovenian: 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.
English: Statistically significant differences are marked (*p<0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
Slovenian: Slika 1 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)
English: Caution is advised when Zometa 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 zdravila Zometa skupaj z antiangiogenimi zdravili je potrebna previdnost, saj so pri bolnikih, ki so sočasno prejemali navedena zdravila, opažali povečano pogostnost osteonekroze čeljustnic.
English: Zometa 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 Zometa 4 mg/5 ml 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: What Zometa looks like and contents of the pack Zometa is supplied as a powder in a vial.
Slovenian: Izgled zdravila Zometa in vsebina pakiranja Zdravilo je v obliki praška v viali.
English: Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with Zometa in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Slovenian: Pri uvajanju zdravljenja z zdravilom Zometa pri bolnikih z multiplim mielomom ali metastatičnimi kostnimi lezijami zaradi čvrstih tumorjev je treba določiti serumski kreatinin in očistek kreatinina (CLcr).
English: Zometa is supplied as a unit pack containing one bottle or as multipacks comprising 4 or 5 cartons, each containing 1 bottle.
Slovenian: Zdravilo Zometa je na voljo v posameznem pakiranju, ki vsebuje eno plastenko, ali pa v skupnem pakiranju, ki vsebuje 4 ali 5 škatel, od katerih vsaka vsebuje po 1 plastenko.
English: In the clinical studies, patients with serum creatinine > 400 µmol/l or > 4.5 mg/dl were excluded.
Slovenian: Bolnike s serumskim kreatininom > 400 µmol/l ali > 4,5 mg/dl so izključili iz kliničnih študij.
English: Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) 33.3% *p-values compared to pamidronate.
Slovenian: 55,6 % (p=0,021)* 83,3 % (p=0,010)* 86,7 % (p=0,015)*
English: One vial with 5 ml concentrate for solution for infusion Component of a multipack comprising ten packs, each containing one vial
Slovenian: koncentrat za raztopino za infundiranje ena viala po 5 ml koncentrata za raztopino za infundiranje sestavni del zavoja z več ovojninami, ki obsega deset ovojnin, od katerih vsaka vsebuje eno vialo
English: Hypocalcaemia has been reported in patients treated with Zometa.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Zometa, so poročali o hipokalciemiji.
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Slovenian: Poročali so o razvoju aritmij in nevroloških neželenih učinkih (vključno s konvulzijami, hipestezijo in tetanijo), do katerih je prišlo zaradi hude hipokalciemije.
English: Zometa must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Slovenian: - Zdravilo Zometa vam sme dati samo zdravstveni delavec, ki je usposobljen za intravensko (kar pomeni v veno) dajanje difosfonatov.
English: Use immediately after dilution.
Slovenian: Uporabite takoj po redčenju.
English: The other ingredients are mannitol, sodium citrate.
Slovenian: - Drugi sestavini zdravila sta manitol, natrijev citrat.
English: Blurred vision, scleritis and orbital inflammation
Slovenian: zamegljen vid, skleritis in orbitalno vnetje redki:
English: One vial with 5 ml concentrate for solution for infusion Four vials with 5 ml concentrate for solution for infusion
Slovenian: koncentrat za raztopino za infundiranje ena viala po 5 ml koncentrata za raztopino za infundiranje štiri viale s po 5 ml koncentrata za raztopino za infundiranje
English: Table 6 Proportion of complete responders by day in the combined TIH studies
Slovenian: Preglednica 6 Delež bolnikov s popolnim odzivom po dnevih v združenih raziskavah tumorsko povzročene hiperkalciemije (TIH) 4. dan
English: No dose adjustment is necessary in TIH patients with serum creatinine < 400 µmol/l or < 4.5 mg/dl (see section 4.4).
Slovenian: Pri bolnikih s tumorsko povzročeno hiperkalciemijo (TIH), s serumskim kreatininom < 400 µmol/l ali < 4,5 mg/dl, ni potrebno prilagajanje odmerjanja (glejte poglavje 4.4).
English: This adverse drug reaction consists of a constellation of symptoms that includes fever, myalgia, headache, extremity pain, nausea, vomiting, diarrhoea, arthralgia and arthritis with subsequent joint swelling.
Slovenian: Ta neželeni učinek zdravila zajema sklop simptomov, ki vključujejo zvišano telesno temperaturo, mialgijo, glavobol, bolečine v okončinah, navzeo, bruhanje, diarejo, artralgijo in artritis, ki povzroči otekline sklepov.
English: Zometa 4 mg/5 ml concentrate for solution for infusion
Slovenian: Zometa 4 mg/5 ml koncentrat za raztopino za infundiranje
English: FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS INTERMEDIATE PACK (WITHOUT BLUE BOX)
Slovenian: ŠKATLA ZA 1 VIALO IN 1 AMPULO KOT VMESNO PAKIRANJE (BREZ PODATKOV ZA “BLUE BOX”)
English: Prior to administration, 5.0 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution or 5% w/v glucose solution).
Slovenian: Pred uporabo je treba 5,0 ml koncentrata iz ene viale oziroma ustrezni volumen odvzetega koncentrata dodatno razredčiti s 100 ml infuzijske raztopine v kateri ni kalcija (0,9-odstotna m/v raztopina natrijevega klorida ali 5-odstotna m/v raztopina glukoze).
English: Multiple event analysis showed a 36% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Slovenian: Analiza večkratnih dogodkov je pokazala za 36 % zmanjšano tveganje za razvoj z okostjem povezanih dogodkov (SREs) v skupini, ki je prejemala zoledronsko kislino 4 mg, v primerjavi s placebom.
English: You should not be given Zometa if you are pregnant.
Slovenian: Če ste noseči, vam ne bi smeli dati zdravila Zometa.
English: After first opening: From a microbiological point of view, the solution for infusion should be used immediately.
Slovenian: Po prvem odpiranju: z mikrobiološkega stališča je raztopino za infundiranje najbolje uporabiti takoj.
English: Further dilute the Zometa reconstituted solution (5 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Slovenian: - Rekonstituirano raztopino Zometa (5 ml) dodatno razredčite s 100 ml infuzijske raztopine, ki ne vsebuje kalcija ali drugih dvovalentnih kationov.
English: Efficacy results are provided in Table 5.
Slovenian: Rezultate učinkovitosti kaže preglednica 5.
English: FOLDING BOX - INTERMEDIATE CONTAINER OF MULTIPACK (WITHOUT BLUE BOX)
Slovenian: ŠKATLA - VMESNI VSEBNIK SKUPNEGA PAKIRANJA (BREZ "BLUE BOX" PODATKOV)
English: Zometa is contraindicated in breast-feeding women (see section 4.3).
Slovenian: Pri doječih ženskah je uporaba zdravila Zometa kontraindicirana (glejte poglavje 4.3).
English: Replace with the following volume of sterile sodium chloride 9 mg/ml (0,9%) or 5% glucose solution for injection (ml)
Slovenian: Nadomestite z navedenim volumnom sterilne raztopine natrijevega klorida 9 mg/ml (0,9-odstotne) ali 5-odstotne raztopine glukoze za injiciranje (ml)
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
Slovenian: zvišana telesna temperatura, gripi podoben sindrom (z utrujenostjo, okorelostjo, splošnim slabim počutjem in zardevanjem)
English: Rare:
Slovenian: občasni:
English: Patients must be assessed prior to administration of Zometa to ensure that they are adequately hydrated.
Slovenian: Splošno Pred uporabo zdravila Zometa moramo bolnike oceniti, da zagotovimo, da so ustrezno hidrirani.
English: Table 4 Efficacy results (solid tumours other than breast or prostate cancer)
Slovenian: Preglednica 4 Rezultati učinkovitosti (čvrsti tumorji, razen raka dojke in prostate) katerikoli SRE (+TIH)
English: What Zometa contains
Slovenian: Kaj vsebuje navodilo
English: FOLDING BOX FOR 1 VIAL AS INTERMEDIATE PACK (WITHOUT BLUE BOX)
Slovenian: ŠKATLA ZA 1 VIALO KOT VMESNO PAKIRANJE (BREZ PODATKOV ZA “BLUE BOX”)
English: Table 3 Efficacy results (solid tumours other than breast or prostate cancer)
Slovenian: Preglednica 3 Rezultati učinkovitosti (čvrsti tumorji, razen raka dojke in prostate) katerikoli SRE (+TIH)
English: How to prepare and administer Zometa
Slovenian: Kako zdravilo Zometa pripravljate in dajete
English: What Zometa looks like and contents of the pack Zometa is supplied as a liquid concentrate in a vial.
Slovenian: Izgled zdravila Zometa in vsebina pakiranja Zdravilo je v obliki tekočega koncentrata v viali.
English: Powder vial:
Slovenian: Ampula z vehiklom:
English: Unit packs containing 1 or 4 vials and 1 or 4 ampoules of water for injections, respectively.
Slovenian: Posamezno pakiranje vsebuje 1 vialo in 1 ampulo z vodo za injekcije ali 4 viale in 4 ampule z vodo za injekcije.
English: Overhydration should be avoided in patients at risk of cardiac failure.
Slovenian: Bolniki, pri katerih obstaja nevarnost popuščanja srca, ne smejo biti prekomerno hidrirani.
English: Very common:
Slovenian: Preiskave zelo pogosti:
English: Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) Flu-like symptoms including arthritis and joint swelling.
Slovenian: intersticijska bolezen pljuč (vnetje tkiva okoli zračnih mešičkov v pljučih), simptomi, ki spominjajo na gripo, vključno z artritisom in oteklinami sklepov, boleča rdečina in/ali oteklina očesa.
English: Zometa 4 mg/100 ml solution for infusion
Slovenian: Zometa 4 mg/100 ml raztopina za infundiranje
English: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zometa therapy.
Slovenian: Po začetku zdravljenja z zdravilom Zometa moramo skrbno spremljati standardne presnovne parametre, povezane s hiperkalciemijo, kot so: serumske koncentracije kalcija, fosfata in magnezija.
English: Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with Zometa.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom Zometa, so poročali o znižani koncentraciji kalcija v krvi (hipokalciemiji), zaradi katere v nekaterih primerih lahko pride do mišičnih krčev, suhe kože in pekočega občutka.
English: Acute renal failure, haematuria, proteinuria
Slovenian: akutna odpoved ledvic, hematurija, proteinurija redki:
English: Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose
Slovenian: Odvzemite ustrezni volumen potrebnega koncentrata, kot sledi: - 4,4 ml za odmerek 3,5 mg
English: WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)
Slovenian: ZAVOJI Z VEČ ŠKATLAMI, ZAVITIMI V FOLIJO (VKLJUČNO S PODATKI ZA “BLUE BOX”)
English: Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Slovenian: Možne neželene učinke zoledronske kisline na plodnost generacije staršev in prve generacije potomcev so ocenjevali na podganah.
English: Remove the volume of Zometa solution indicated from the bottle and replace with an equal volume of sterile sodium chloride 9 mg/ml (0,9%) solution for injection, or 5% glucose solution for injection.
Slovenian: Navedeni volumen raztopine Zometa odvzemite iz plastenke in ga nadomestite z enakim volumnom sterilne raztopine natrijevega klorida za injiciranje 9 mg/ml (0,9-odstotne) ali 5odstotne raztopine glukoze za injiciranje.
English: Nervous system disorders Common:
Slovenian: Bolezni živčevja pogosti:
English: In clinical trials with Zometa, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.
Slovenian: Bolniki s serumskim kreatininom > 265 µmol/l ali > 3,0 mg/dl so bili iz kliničnih preskušanj z zdravilom Zometa izključeni.
English: Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov): bolečina v ustih, zobeh in/ali čeljusti, oteklost ali neceljenje ran v ustni votlini ali čeljusti, izcedek, odrevelenost ali občutek pritiska v čeljusti ali majanje zoba, kar so lahko znaki poškodbe kosti v čeljusti (osteonekroze).
English: Multipack comprising ten packs, each containing one vial.
Slovenian: zavoj z več ovojninami, ki obsega deset ovojnin, od katerih vsak vsebuje eno vialo.
English: 4.1 ml for 3.3 mg dose
Slovenian: 4,1 ml za odmerek 3,3 mg
English: Table 5 Efficacy results (breast cancer and multiple myeloma patients)
Slovenian: Preglednica 5 Rezultati učinkovitosti (bolnice/bolniki z rakom dojke in multiplim mielomom)
English: Summary of the safety profile
Slovenian: 4.8 Neželeni učinki Povzetek varnostnega profila zdravila
English: Efficacy results are provided in Table 2.
Slovenian: Rezultate učinkovitosti kaže preglednica 2.
English: - 3.8 ml for 3.0 mg dose
Slovenian: - 3,8 ml za odmerek 3,0 mg
English: - 4.1 ml for 3.3 mg dose
Slovenian: - 4,1 ml za odmerek 3,3 mg
English: Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Slovenian: pri bolnicah, ki so prejemale zoledronsko kislino zaradi postmenopavzalne osteoporoze, so opažali nepravilno bitje srca (atrijsko fibrilacijo).
English: 3.8 ml for 3.0 mg dose
Slovenian: 3,8 ml za odmerek 3,0 mg
English: Zometa 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Slovenian: Zometa 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
English: The onset time is ≤ 3 days post-Zometa infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Slovenian: Omenjeno reakcijo opisujejo tudi z izrazoma "gripi podobni simptomi" in "simptomi po odmerjanju".
English: The other ingredients are mannitol, sodium citrate, water for injections.
Slovenian: - Druge sestavine zdravila so manitol, natrijev citrat, voda za injekcije.
English: Efficacy results are provided in Table 4.
Slovenian: Rezultate učinkovitosti kaže preglednica 4.
English: Withdraw the appropriate volume of the reconstituted solution (4 mg/5 ml), as follows: 4.4 ml for 3.5 mg dose
Slovenian: Odvzemite ustrezni volumen rekonstituirane raztopine (4 mg/5 ml), kot sledi: 4,4 ml za odmerek 3,5 mg
English: Zoledronic acid 4 mg (N=86) 45.3% (p=0.104)
Slovenian: 10. dan zoledronske kisline 4 mg (N=86)
English: Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia.
Slovenian: Poročali so tudi o motnjah srčnega ritma (aritmiji), napadih krčev, posameznih krčih in trzanju (tetaniji), do katerih pride zaradi hude hipokalciemije.
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 5odstotne m/v raztopine glukoze.
English: Hypomagnesaemia, hypokalaemia
Slovenian: hipomagneziemija, hipokaliemija redki:
English: In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking Zometa.
Slovenian: Iz postmarketinških izkušenj pri bolnikih, ki so dobivali zdravilo Zometa, so poročali o hudih bolečinah v kosteh, sklepih in/ali mišicah.
English: The active substance of Zometa is zoledronic acid.
Slovenian: Kaj vsebuje zdravilo Zometa - Učinkovina zdravila Zometa je zoledronska kislina.
English: Prevention of skeletal related events in patients with advanced malignancies involving bone Adults and older people
Slovenian: Preprečevanje z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti
English: 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).
Slovenian: Potrebno količino rekonstituirane raztopine nato dodatno razredčite s 100 ml infuzijske raztopine v kateri ni kalcija (0,9-odstotna m/v raztopina natrijevega klorida ali 5-odstotna m/v raztopina glukoze).
English: From a microbiological point of view, the reconstituted and diluted solution for infusion should be used immediately.
Slovenian: - Z mikrobiološkega stališča je rekonstituirano in razredčeno raztopino za infundiranje najbolje uporabiti takoj.