FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution is advised when bisphosphonates are administered with aminoglycosides, calcitonin or loop diuretics, since these agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required (see section 4.4).
Slovenian: Kadar difosfonate dajemo sočasno z aminoglikozidi, kalcitoninom ali diuretiki Henlejeve zanke, je priporočljiva previdnost, ker utegnejo imeti navedene učinkovine aditiven učinek, kar bi imelo za posledico nižje koncentracije serumskega kalcija za dalj časa, kot je potrebno (glejte poglavje 4.4).
English: if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zometa belongs), or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Zdravila Zometa ne smete dobiti: - če dojite, - če ste alergični na zoledronsko kislino, kak drug difosfonat (skupina snovi, ki ji pripada zdravilo Zometa) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of Zometa or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended.
Slovenian: Med dejavniki, ki lahko povečajo možnost poslabšanja delovanja ledvic, so dehidracija, predhodna ledvična okvara, večkratni ciklusi zdravljenja z zdravilom Zometa ali drugimi difosfonati, kot tudi sočasna uporaba nefrotoksičnih zdravil ali čas infundiranja, ki je krajši od priporočenega.
English: Only clear solution free from particles and discolouration should be used.
Slovenian: Za uporabo je primerna samo bistra raztopina brez delcev in nespremenjene barve.
English: Renal function impairment
Slovenian: Okvara ledvične funkcije
English: If a lower dose of Zometa is required, first withdraw the appropriate volume of the reconstituted solution (4 mg/5 ml) as indicated below and then dilute it further with 100 ml of infusion solution.
Slovenian: Če je potreben manjši odmerek zdravila Zometa, najprej odvzemite ustrezni volumen rekonstituirane raztopine (4 mg/5 ml), kot je navedeno spodaj, in ga nato dodatno razredčite s 100 ml infuzijske raztopine.
English: Caution is advised when Zometa 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 Zometa 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: Patients should have their serum creatinine levels assessed prior to each dose of Zometa.
Slovenian: Bolnikom je treba pred vsakim odmerkom zdravila Zometa določiti raven serumskega kreatinina.
English: In patients with mild to moderate renal impairment, reduced Zometa doses are recommended (see section “Posology” above and section 4.4).
Slovenian: Za bolnike z blago do zmerno okvaro ledvic so priporočeni nižji odmerki zdravila Zometa (glejte poglavje "Odmerjanje" zgoraj in poglavje 4.4).
English: In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Slovenian: V enem 3-letnem randomiziranem dvojno slepem kontroliranem preskušanju, v katerem so vrednotili učinkovitost in varnost zoledronske kisline pri zdravljenju postmenopavzalne osteoporoze (PMO), in sicer v odmerku 5 mg enkrat na leto v primerjavi s placebom, je bila skupna pojavnost atrijske fibrilacije pri bolnicah, ki so prejemale 5 mg zoledronske kisline, 2,5 % (pri 96 od 3.862 bolnic), pri bolnicah, ki so prejemale placebo, pa 1,9 % (pri 75 od 3.852 bolnic).
English: After opening the bottle, the product should be used immediately in order to avoid microbial contamination.
Slovenian: - Ko plastenko odprete, morate zdravilo porabiti takoj, da bi preprečili onesnaženje z mikroorganizmi.
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 Zometa 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 zdravilom Zometa odtehta možno nevarnost.
English: Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of a condition called osteonecrosis of the jaw.
Slovenian: Zdravnika in zobozdravnika morate obvestiti takoj, če pride do kakršnih koli težav v ustih oziroma z zobmi, na primer do majanja zoba, bolečin ali otekline, neceljenja ran ali vnetja, saj so to lahko znaki stanja, ki ga imenujemo osteonekroza čeljustnic.
English: For intravenous use only
Slovenian: Samo za intravensko uporabo.
English: The dose must be given as a single intravenous infusion over no less than 15 minutes.
Slovenian: Odmerek morate dati v obliki ene same intravenske infuzije v času, ki ne sme biti krajši od 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
Slovenian: V kliničnih preskušanjih so opredelili ledvično poslabšanje takole: - pri bolnikih z normalnim izhodiščnim serumskim kreatininom (< 1,4 mg/dl ali < 124µmol/l),
English: The administration of doses up to 48 mg of zoledronic acid in error has been reported.
Slovenian: Poročali so o dajanju odmerkov zolendronske kisline do 48 mg po pomoti.
English: The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth, except in medical emergency situations.
Slovenian: Pri bolnikih z nezaceljenimi odprtimi lezijami mehkih tkiv v ustih je treba začetek zdravljenja oziroma nov ciklus zdravljenja odložiti, razen v primeru nujnih stanj.
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of Zometa and other bisphosphonates as well as use of other nephrotoxic medicinal products.
Slovenian: Med dejavniki, ki utegnejo zvečati možnost poslabšanja ledvične funkcije so dehidracija, že obstoječa ledvična okvara, več ciklov zdravljenja z zdravilom Zometa in drugimi difosfonati, pa tudi uporaba drugih nefrotoksičnih zdravil.
English: Zoledronic acid 4 mg reduced the risk of SREs by 41% in a multiple event analysis (risk ratio=0.59, p=0.019) compared with placebo.
Slovenian: Pri analizi večkratnih dogodkov se je pokazalo, da je zoledronska kislina 4 mg zmanjšala tveganje za SRE za 41 % (razmerje tveganj = 0,59, p=0,019) v primerjavi s placebom.
English: Zometa 4 mg/100 ml solution for infusion must not be mixed with other infusion solutions and should be administered as a single intravenous solution in a separate infusion line.
Slovenian: Raztopine za infundiranje Zometa 4 mg/100 ml se ne sme mešati z drugimi infuzijskimi raztopinami in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
English: 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
Slovenian: 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
English: In the clinical studies, Zometa 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 zdravilo Zometa šele, ko se je koncentracija kreatinina vrnila na raven, ne za več kot 10 % višjo od izhodiščne vrednosti (glejte poglavje 4.4).
English: EU/1/01/176/004 1 vial EU/1/01/176/005 4 vials
Slovenian: EU/1/01/176/004 1 viala EU/1/01/176/005 4 viale
English: Table 6 Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta
Slovenian: Preglednica 6 Neželeni učinki, ki so jih opažali pri pediatričnih bolnikih s hudo obliko osteogenesis imperfecta
English: Additional information on handling of Zometa, including guidance on the preparation of reduced doses using the Zometa ready-to-use bottle, is provided in section 4.2.
Slovenian: Nadaljnje informacije o ravnanju z zdravilom Zometa, vključno z navodili za pripravo nižjih odmerkov iz plastenke z že pripravljeno raztopino zdravila Zometa, so navedene v poglavju 4.2.
English: It is especially important that you tell your doctor if you are also taking: - Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Slovenian: Posebno pomembno je, da zdravniku poveste, če jemljete tudi naslednja zdravila: - aminoglikozide (zdravila, ki jih uporabljamo za zdravljenje težkih okužb), kalcitonin (vrsta zdravila, ki ga uporabljamo za zdravljenje pri postmenopavzalni osteoporozi in hiperkalciemiji), diuretike Henlejeve zanke (vrsta zdravila za zdravljenje visokega krvnega tlaka ali otekanja) ali druga zdravila, ki znižujejo koncentracijo kalcija, ker kombinacija le-teh z difosfonati lahko preveč zniža koncentracijo kalcija v krvi, - talidomid (zdravilo, ki ga uporabljamo pri zdravljenju določenih vrst krvnega raka, ki zajemajo kosti) ali druga zdravila, ki lahko škodujejo ledvicam, - zdravilo Aclasta (zdravilo, ki prav tako vsebuje zoledronsko kislino in ga uporabljamo pri zdravljenju osteoporoze in drugih nerakavih bolezni kosti), ali kateregakoli od drugih difosfonatov, saj učinki navedenih zdravil v kombinaciji z zdravilom Zometa niso znani, - antiangiogena zdravila (uporabljamo jih pri zdravljenju raka), ker kombinacijo le-teh z zdravilom Zometa povezujejo s povečanim tveganjem za osteonekrozo čeljustnic.
English: Zometa should only be resumed when serum creatinine returns to within 10% of baseline.
Slovenian: Zdravljenje z zdravilom Zometa se sme spet začeti šele, ko se serumski kreatinin vrne na vrednost, ki ni za več kot 10 % večja od izhodiščne.
English: The powder must first be reconstituted in the vial using 5 ml water for injections from the ampoule supplied.
Slovenian: Prašek morate najprej rekonstituirati v viali s 5 ml vode za injekcije iz priložene ampule.
English: A subset had recurrence of symptoms when rechallenged with Zometa or another bisphosphonate.
Slovenian: Pri nekaterih od teh bolnikov so se simptomi ponovili ob ponovni uporabi zdravila Zometa ali drugega difosfonata.
English: In a second study including solid tumours other than breast or prostate cancer, zoledronic acid 4 mg significantly reduced the proportion of patients with an SRE, delayed the median time to first SRE by > 2 months, and reduced the skeletal morbidity rate.
Slovenian: V drugi raziskavi, v katero so bili vključeni čvrsti tumorji, razen raka dojke in prostate, je zoledronska kislina 4 mg pomembno zmanjšala delež bolnikov, ki so doživeli z okostjem povezani dogodek (SRE), podaljšala mediano časa do prvega z okostjem povezanega dogodka (SRE) za > 2 meseca in zmanjšala stopnjo obolevnosti skeleta.
English: Since no data are available on the compatibility of Zometa with other intravenously administered substances, Zometa must not be mixed with other medications/substances and should always be given through a separate infusion line.
Slovenian: - Ker o združljivosti zdravila Zometa z drugimi intravensko dajanimi snovmi ni na voljo nikakršnih podatkov, zdravila Zometa ne smete mešati z drugimi zdravili ali snovmi in jo moramo vedno dajati po ločenem infuzijskem sistemu.
English: The solution containing zoledronic acid must not be further diluted or mixed with other infusion solutions.
Slovenian: - Raztopine, ki vsebuje zoledronsko kislino, ne smete nadalje redčiti ali mešati z drugimi infuzijskimi raztopinami.
English: Table 7 Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta
Slovenian: Preglednica 7 Neželeni učinki, ki so jih opažali pri pediatričnih bolnikih s hudo obliko osteogenesis imperfecta
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 (see section 4.4).
Slovenian: Poslabšanje delovanja ledvic, napredovanje do ledvične odpovedi in dialize so opisovali pri bolnikih po začetnem oziroma enkratnem odmerku 4 mg zoledronske kisline (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 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: For storage conditions of the reconstituted solution for infusion, see section 6.3.
Slovenian: Za pogoje shranjevanja rekonstituirane raztopine za infundiranje glejte poglavje 6.3.
English: Adjusted dose (mg zoledronic acid in 100 ml)
Slovenian: Prilagojeni odmerek (mg zoledronske kisline v 100 ml)
English: The diluted Zometa infusion solution should be used immediately in order to avoid microbial contamination.
Slovenian: - Razredčeno infuzijsko raztopino zdravila Zometa morate porabiti takoj, da bi preprečili onesnaženje z mikroorganizmi.
English: Multi-packs containing 10 (10 packs of 1) vials.
Slovenian: Skupno pakiranje vsebuje 10 (10 pakiranj po 1) vial.
English: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Slovenian: astenija, periferni edemi, reakcije na mestu injiciranja (vključujoč bolečino, iritacijo, otekanje, zatrdlino), bolečina v prsih, zvečanje telesne mase, anafilaktična reakcija/šok, urtikarija redki:
English: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Slovenian: Pri zdravljenju z bisfosfonati so poročali o osteonekrozi zunanjega slušnega kanala, večinoma pri dolgoročnem zdravljenju.
English: 100 ml solution in a transparent, colourless, plastic (cycloolefinic copolymer) bottle closed with a fluorocarbon polymer coated bromobutyl rubber stopper and an aluminum cap with a flip-off component of polypropylene.
Slovenian: 100 ml raztopine v brezbarvni plastenki (iz cikloolefinskega polimera), zaprti z zamaškom iz bromobutilne gume, prevlečene s fluoropolimerom, in z aluminijasto zaporko z odmičnim delom iz polipropilena.
English: EU/1/01/176/001 1 vial and 1 ampoule EU/1/01/176/002 4 vials and 4 ampoules
Slovenian: EU/1/01/176/001 1 viala in 1 ampula EU/1/01/176/002 4 viale in 4 ampule
English: Sodium citrate
Slovenian: manitol natrijev citrat
English: For patients with normal renal function (defined as CLcr > 60 ml/min), zoledronic acid 4 mg/100 ml solution for infusion may be administered directly without any further preparation.
Slovenian: Pri bolnikih z normalnim delovanjem ledvic (opredeljenim kot CLcr > 60 ml/min) je mogoče zoledronsko kislino 4 mg/100 ml dajati neposredno, brez dodatne priprave.
English: Pain in extremities, arthralgia, musculoskeletal pain
Slovenian: bolečine v okončinah, bolečine v sklepih, mišično-skeletne bolečine
English: To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below.
Slovenian: Za pripravljanje nižjih odmerkov za bolnike z izhodiščnim očistkom kreatinina ≤ 60 ml/min glejte preglednico 1 spodaj.
English: The hydration status of patients must be assessed prior to and following administration of Zometa to assure that they are adequately hydrated.
Slovenian: Status hidracije bolnikov mora zdravnik oceniti pred in po dajanju zdravila Zometa, da se prepriča, da so ustrezno hidrirani.
English: General disorders and administration site conditions Very common:
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti:
English: Patients treated with Zometa should be given the package leaflet and the patient reminder card.
Slovenian: Bolnikom, ki prejemajo zdravilo Zometa, je treba izročiti navodilo za uporabo in opozorilno kartico za bolnika.
English: The following adverse reactions, listed in Table 1, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Slovenian: Naslednji neželeni učinki, navedeni v preglednici 1, so zbrani iz kliničnih študij in iz poročanj v obdobju po prihodu zdravila na trg, ki so sledili pretežno kroničnemu zdravljenju s 4-miligramsko zoledronsko kislino:
English: The management plan for patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ.
Slovenian: Za bolnike, pri katerih se razvije osteonekroza čeljustnic, morata načrt zdravljenja v tesnem sodelovanju pripraviti lečeči zdravnik in zobozdravnik oziroma oralni kirurg, ki ima izkušnje z zdravljenjem osteonekroze čeljustnic.
English: Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between Zometa therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Slovenian: Po pregledu podatkov kliničnih preskušanj in primerov, ki so jih opažali po prihodu zdravila na trg, je na voljo dovolj dokazov, ki povezujejo zdravljenje z zdravilom Zometa, opisane primere hipokalciemije in posledičen razvoj aritmije.
English: Clinical trial results in the prevention of skeletal related events in patients with advanced malignancies involving bone
Slovenian: Rezultati kliničnih preskušanj v preprečevanju z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajemajo kosti
English: One bottle contains 100 ml solution.
Slovenian: Ena plastenka vsebuje 100 ml raztopine.
English: Interpretation of the risk of fracture is confounded by the fact that fractures are common events in patients with severe osteogenesis imperfecta as part of the disease process.
Slovenian: Tveganje za zlom je težko pojasniti, saj na to vpliva dejstvo, da so zlomi pri bolnikih s hudo obliko osteogenesis imperfecta pogosti že zaradi osnovne bolezni.
English: The following adverse reactions, listed in Table 2, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Slovenian: Naslednji neželeni učinki, navedeni v preglednici 2, so zbrani iz kliničnih študij in iz poročanj v obdobju po prihodu zdravila na trg, ki so sledili pretežno kroničnemu zdravljenju s 4-miligramsko zoledronsko kislino:
English: From a microbiological point of view, the solution for infusion should be used immediately, after first opening.
Slovenian: Z mikrobiološkega stališča je raztopino za infundiranje najbolje uporabiti takoj po prvem odpiranju.
English: Zometa is supplied as unit packs containing 1 or 4 vials and as multi-packs containing 10 (10x1) vials.
Slovenian: Zdravilo Zometa je na voljo kot posamezno pakiranje, ki vsebuje 1 ali 4 viale in kot skupno pakiranje, ki vsebuje 10 (10x1) vial.
English: Dystocia was observed at the lowest dose (0.01 mg/kg bodyweight) tested in the rat.
Slovenian: Pri najmanjšem odmerku, preskušenem pri podganah (0,01 mg/kg telesne mase), so opažali distocijo.
English: In a third phase III randomised, double-blind trial, zoledronic acid 4 mg or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
Slovenian: V tretjem randomiziranem, dvojno slepem preskušanju faze III so pri bolnicah/bolnikih z multiplim mielomom ali rakom dojke z vsaj po eno lezijo v kosteh primerjali zoledronsko kislino 4 mg in 90 mg pamidronata vsake 3 do 4 tedne.
English: It also contains mannitol, sodium citrate and water for injections.
Slovenian: Vsebuje tudi manitol, natrijev citrat in vodo za injekcije.
English: Zometa is supplied as unit packs containing 1 or 4 vials and 1 or 4 ampoules, respectively, and as multi-packs containing 10 (10x 1+1) vials and ampoules.
Slovenian: Zdravilo Zometa je na voljo kot posamezno pakiranje, ki vsebuje 1 vialo in 1 ampulo ali 4 viale in 4 ampule in kot skupno pakiranje, ki vsebuje 10 (10x 1+1) vial in ampul.
English: An extension study was conducted in order to examine the long-term general and renal safety of once yearly or twice yearly zoledronic acid over the 12-month extension treatment period in children who had completed one year of treatment with either zoledronic acid or pamidronate in the core study.
Slovenian: Pri otrocih, ki so zaključili enoletno zdravljenje z bodisi zoledronsko kislino ali s pamidronatom v osnovni študiji, so izvedli še podaljšanje študije, da bi dolgoročno preverili splošno varnost in varnost za ledvice pri odmerjanju zoledronske kisline enkrat ali dvakrat na leto v 12-mesečnem obdobju podaljšanja.
English: The unopened vial does not require any specific storage conditions.
Slovenian: - Za shranjevanje neodprte viale niso potrebna posebna navodila.
English: To prepare an infusion solution containing 4 mg zoledronic acid, add 5 ml of water for injections from the ampoule supplied in the pack to the vial containing the Zometa powder under aseptic conditions.
Slovenian: - Infuzijsko raztopino, ki vsebuje 4 mg zoledronske kisline, pripravite tako, da aseptično dodate 5 ml vode za injekcije iz ampule, ki je priložena v škatli, viali, ki vsebuje prašek Zometa.
English: Table 1 Preparation of reduced doses of Zometa 4 mg/100 ml solution for infusion
Slovenian: Preglednica 1 Pripravljanje nižjih odmerkov iz raztopine za infundiranje Zometa 4 mg/100 ml
English: The refrigerated solution should then be equilibrated to room temperature prior to administration.
Slovenian: Ohlajeno raztopino je treba pred uporabo pustiti, da se ogreje na sobno temperaturo.
English: Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Slovenian: v primeru bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte s svojim zdravnikom.
English: In patients with normal renal function, defined as CLcr > 60 ml/min, zoledronic acid 4 mg/100 ml solution for infusion must not be further diluted.
Slovenian: Za bolnike z normalnim delovanjem ledvic, opredeljenim z očistkom kreatinina > 60 ml/min, se zoledronske kisline 4 mg/100 ml ne sme dodatno redčiti.
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, the following Zometa dose is 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 naslednji odmerek zdravila Zometa (glejte tudi poglavje 4.4):
English: One vial contains 4 mg of zoledronic acid.
Slovenian: Ena viala vsebuje 4 mg zoledronske kisline.
English: Zometa 4 mg powder and solvent for solution for infusion, reconstituted and 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 prašek in vehikel za raztopino za infundiranje, rekonstituirano in nadaljnje razredčeno v 100 ml (glejte poglavje 6.6), je treba dajati v obliki ene same intravenske infuzije, ki traja najmanj 15 minut.