natgillin/translations-raw huggingface dataset:
Ud over at være en potent hæmmer af knogleresorption, har zolendronsyre også adskillige anti- tumor egenskaber der kan bidrage til den samlede effekt i behandling af metastaserende knoglesygdom.
In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several anti- tumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
Hæmning af osteoklastisk knogleresorption, hvilket ændrer knoglemarvens mikromiljø
Inhibition of osteoclastic bone resorption, which alters the bone marrow
og mindsker bidraget til tumorcellevæksten, den anti- angiogenetiske aktivitet og anti- smerte aktiviteten.
microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
- In vivo:
- In vitro:
Hæmning af osteoblastdannelse, direkte cytostatisk og pro- apoptotisk aktivitet på
Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on
tumorceller, synergistisk cytostatisk effekt med andre anti- cancermidler, anti- adhæsion - / invasionsaktivitet.
tumour cells, synergistic cytostatic effect with other anti-cancer drugs, anti-adhesion/ invasion activity.
8 Resultater fra kliniske studier vedrørende forebyggelse af skeletrelaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser Det første randomiserede, dobbeltblinde placebo- kontrollerede studie sammenlignede Zometa med placebo med henblik på forebyggelse af skeletrelaterede hændelser (SRE’ er) hos patienter med prostatacancer.
8 Clinical trial results in the prevention of skeletal related events in patients with advanced malignancies involving bone The first randomised, double-blind, placebo-controlled study compared Zometa to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Zometa 4 mg reducerede signifikant andelen af patienter, der oplevede mindst én skeletrelateret hændelse (SRE), forsinkede den gennemsnitlige tid til første SRE med > 5 måneder og reducerede den årlige incidens af hændelser per patient - skeletal morbiditet.
Zometa 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.
Analyser af gentagne hændelser viste risikoreduktion på 36% i udviklingen af skeletrelaterede hændelser i Zometa- gruppen sammenlignet med placebo.
Multiple event analysis showed a 36% risk reduction in developing SREs in the Zometa group compared with placebo.
Patienter, der fik Zometa, indberettede mindre stigning i smerter end patienter, der fik placebo, og forskellen nåede signfikansniveauet ved måned 3, 9, 21 og 24.
Patients receiving Zometa reported less increase in pain than those receiving placebo, and the difference reached significance at months 3, 9, 21 and 24.
Færre Zometa- patienter oplevede patologiske frakturer.
Fewer Zometa patients suffered pathological fractures.
I et andet studie inkluderende andre solide tumorer end bryst - eller prostatacancer, reducerede Zometa 4 mg signifikant andelen af patienter med SRE’ er, forsinkede gennemsnitstiden til første SRE med > 2 måneder og reducerede den skeletale morbiditets rate.
In a second study including solid tumours other than breast or prostate cancer, Zometa 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.
Analyser af gentagne hændelser viste risikoreduktion på 30, 7% i udviklingen af skeletrelaterede hændelser i Zometa- gruppen sammenlignet med placebo.
Multiple event analysis showed 30.7% risk reduction in developing SREs in the Zometa group compared with placebo.
Effektresultater (patienter med prostatacancer i hormonbehandling)
Efficacy results (prostate cancer patients receiving hormonal therapy)
Frakturer *
Fractures*
N Andel af patienter med SRE’ er (%)
N Proportion of patients with SREs (%)
Reduktion i risiko for gentagne hændelser ** (%)
Risk reduction of suffering from multiple events** (%)
NR Ikke nået (Not Reached) NA Ikke relevant (Not Applicable)
* Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR Not Reached NA Not Applicable
Effektresultater (solide tumorer udover bryst - og prostatacancer)
Efficacy results (solid tumours other than breast or prostate cancer)
I et tredje fase III randomiseret, dobbeltblindt studie blev Zometa 4 mg eller pamidronat 90 mg administreret hver 3. til 4. uge sammenlignet hos patienter med multiple myelomer eller brystkræft og mindst én knoglelæsion.
In a third phase III randomised, double-blind trial, 4 mg Zometa 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.
Resultaterne viste, at Zometa 4 mg havde sammenlignelig effekt med 90 mg pamidronat til forebyggelse af skeletrelaterede hændelser (SRE).
The results demonstrated that Zometa 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Analysen vedrørende gentagne hændelser afslørede en signifikant risikoreduktion på 16% hos patienter behandlet med Zometa 4 mg sammenlignet med patienter behandlet med pamidronat.
The multiple event analysis revealed a significant risk reduction of 16% in patients treated with Zometa 4 mg in comparison with patients receiving pamidronate.
10 Tabel 4:
10 Table 4:
Effektresultater (patienter med brystcancer eller multiple myelomer)
Efficacy results (breast cancer and multiple myeloma patients)
Pam Zometa Pam Zom
Pam 90 mg Zometa Pam Zome
Zometa Pam Zometa Pam Zometa
Zometa Pam 90 mg Zometa Pam Zometa
90 mg 4 mg 90 mg 4 mg
90 mg
555 561 555 561 52 37 39 19
555 561 52 37
Skeletal morbiditet p- værdi
Skeletal morbidity rate
Zometa blev også undersøgt i et dobbeltblindt, randomiseret, placebokontrolleret studie i 228 patienter med dokumenterede knoglemetastaser fra brystkræft, for at evaluere effekten af Zometa på skeletrelaterede hændelser (SRE) forekomsts- ratio beregnet som det totale antal af SRE hændelser (eksklusiv hypercalcæmi og justeret for tidligere frakturer) delt med den totale risikoperiode.
Zometa 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 Zometa 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.
Patienterne fik enten 4 mg Zometa eller placebo hver fjerde uge i et år.
Patients received either 4 mg Zometa or placebo every four weeks for one year.
Patienterne var lige fordelt mellem den Zometa behandlede og placebo grupperne.
Patients were evenly distributed between Zometa-treated and placebo groups.
SRE forekomsten (hændelser/ person- år) var 0, 628 for Zometa og 1, 096 for placebo.
The SRE rate (events/ person year) was 0.628 for Zometa and 1.096 for placebo.
Andelen af patienter med mindst én SRE (eksklusiv hypercalcæmi) var 29, 8% i den Zometa behandlede gruppe sammenlignet med 49, 6% i placebo gruppen (p=0, 003).
The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the Zometa-treated group versus 49.6% in the placebo group (p=0.003).
Median tiden for fremkomst af den første SRE blev ikke nået i den Zometa behandlede studiearm ved slutningen af studiet og var signifikant forlænget sammenlignet med placebo (p=0, 007).
Median time to onset of the first SRE was not reached in the Zometa-treated arm at the end of the study and was significantly prolonged compared to placebo (p=0.007).
Zometa reducerede risikoen for SRE med 41% i en analyse med multiple hændelser (risikoforhold=0, 59, p=0, 019) sammenlignet med placebo.
Zometa reduced the risk of SREs by 41% in a multiple event analysis (risk ratio=0.59, p=0.019) compared with placebo.
I den Zometa behandlede gruppe blev statistisk signifikante forbedringer i smerte- scoringer (ved brug af Brief Pain Inventory, BPI) set ved 4 uger og ved hver efterfølgende tidsmåling i løbet af studiet, når sammenlignet med placebo (Figur 1).
In the Zometa-treated group, statistically significant improvement in pain scores (using the Brief Pain Inventory, BPI) was seen at 4 weeks and at every subsequent time point during the study, when compared to placebo (Figure 1).
Smerte scoringen for Zometa var konsekvent under baseline og smertereduktionen var ledsaget af en tendens til nedsat smertestillende score.
The pain score for Zometa was consistently below baseline and pain reduction was accompanied by a trend in reduced analgesics score.
11 Figur 1.
11 Figure 1.
Gennemsnitlige ændringer fra baseline i BPI scoringer.
Mean changes from baseline in BPI scores.
Statistisk signifikante forskelle er markeret (* < 0, 05) for sammenligning mellem behandlinger (Zometa vs.
Statistically significant differences are marked (*p < 0.05) for between treatment comparisons (Zometa vs.
Placebo) BPI gennemsnitlig ændring fra baseline
Placebo)
Resultater fra kliniske undersøgelser vedrørende behandling af TIH Kliniske studier af tumorinduceret hypercalcæmi (TIH) viser, at effekten af zoledronsyre er karakteriseret ved fald i serumcalcium og urinudskillelse af calcium.
Clinical trial results in the treatment of TIH Clinical studies in tumour-induced hypercalcaemia (TIH) demonstrated that the effect of zoledronic acid is characterised by decreases in serum calcium and urinary calcium excretion.
I fase I doseringsundersøgelser i patienter med mild til moderat tumorindiceret hypercalcæmi (TIH), var den afprøvede effektive dosis cirka 1, 2– 2, 5 mg.
In Phase I dose finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2– 2.5 mg.
For at vurdere virkningerne af Zometa i forhold til 90 mg pamidronat blev resultaterne af to pivotale multicenterundersøgelser af patienter med TIH kombineret i en forud planlagt analyse.
To assess the effects of Zometa versus pamidronate 90 mg, the results of two pivotal multicentre studies in patients with TIH were combined in a pre-planned analysis.
Der optrådte hurtigere normalisering af korrigeret serumcalcium på 4. dag for Zometa 8 mg og på 7. dag for Zometa 4 mg og 8 mg.
There was faster normalisation of corrected serum calcium at day 4 for Zometa 8 mg and at day 7 for Zometa 4 mg and 8 mg.
Andel af patienter med fuldt respons pr. dag i de kombinerede TIH- studier
Proportion of complete responders by day in the combined TIH studies
Zometa 4 mg (N = 86) Zometa 8 mg (N = 90)
Zometa 4 mg (N=86) Zometa 8 mg (N=90) Pamidronate 90 mg (N=99)
45, 3% (p = 0, 104) 55, 6% (p = 0, 021) *
45.3% (p=0.104) 55.6% (p=0.021)* 33.3%
82, 6% (p = 0, 005) * 83, 3% (p = 0, 010) *
82.6% (p=0.005)* 83.3% (p=0.010)* 63.6%
88, 4% (p = 0, 002) * 86, 7% (p = 0, 015) *
88.4% (p=0.002)* 86.7% (p=0.015)* 69.7%
* p- værdier sammenlignet med pamidronat.
*p-values compared to pamidronate.
Mediantid til recidiv (fornyet stigning af albuminkorrigeret serumcalcium ≥2, 9 mmol/ l) var 30– 40 dage for patienter i behandling med Zometa i forhold til 17 dage for patienter i behandling med 90 mg pamidronat (p- værdier:
Median time to relapse (re-increase of albumin-corrected serum calcium ≥ 2.9 mmol/ l) was 30 to 40 days for patients treated with Zometa versus 17 days for those treated with pamidronate 90 mg (p-values:
0, 001 for 4 mg og 0, 007 for 8 mg).
0.001 for 4 mg and 0.007 for 8 mg).
Der var ingen statistisk signifikante forskelle mellem de to doser af Zometa.
There were no statistically significant differences between the two Zometa doses.
I kliniske undersøgelser blev 69 patienter, som fik recidiv eller som var uimodtagelig for den indledende behandling (Zometa 4 mg, 8 mg eller pamidronat 90 mg), efterbehandlet med Zometa 8 mg.
In clinical trials 69 patients who relapsed or were refractory to initial treatment (Zometa 4 mg, 8 mg or pamidronate 90 mg) were retreated with Zometa 8 mg.
Idet disse patienter kun blev efterbehandlet med en dosis på 8 mg, er der ingen tilgængelige data som sammenligner med 4 mg dosen.
Since those patients were retreated with the 8 mg dose only, there are no data available allowing comparison with the 4 mg dose.
12 I kliniske undersøgelser udført i patienter med tumorinduceret hypercalcæmi (TIH), var den overordnede sikkerhedsprofil mellem de tre behandlingsgrupper (zoledronsyre 4 og 8 mg og pamidronat 90 mg) lignende i art og alvorlighed.
12 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.
Efter påbegyndelse af infusion med zoledronsyre, øges plasmakoncentrationen af stoffet hurtigt, og maksimal koncentration nås ved slutningen af infusionsperioden, efterfulgt af et hurtigt fald til < 10% af maksimalkoncentrationen efter 4 timer og < 1% af maksimalkoncentrationen efter 24 timer, med en efterfølgende forlænget periode med meget lave koncentrationer der ikke overstiger 0, 1% af den maksimale koncentration inden den 2. infusion af lægemidlet på dag 28.
After initiating the infusion of zoledronic acid, the plasma concentrations of drug rapidly increased, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak prior to the second infusion of drug on day 28.
Intravenøst indgivet zoledronsyre elimineres i en trifasisk proces: hurtig bifasisk elimination fra det systemiske kredsløb med halveringstider på t ½α 0, 24 og t ½α 1, 87 timer efterfulgt af en lang elimineringsfase med en terminal eliminationshalveringstid på t ½α 146 timer.
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.
Der sås ingen akkumulering af lægemidlet i plasma efter gentagne doser administreret hver 28. dag.
There was no accumulation of drug in plasma after multiple doses of the drug given every 28 days.
Total legemsclearance er 5, 04±2, 5 l/ h uafhængigt af dosis og uanset køn, alder, race og legemsvægt.
The total body clearance is 5.04 ± 2.5 l/ h, independent of dose, and unaffected by gender, age, race, and body weight.
Zoledronsyre inhiberer ikke humane P450- enzymer in vitro og udviser ingen biotransformation, og i dyreforsøg blev < 3% af den indgivne dosis fundet i fæces, hvilket antyder, at leverfunktionen ikke spiller en væsentlig rolle for zoledronsyres farmakokinetiske egenskaber.
Zoledronic acid does not inhibit human P450 enzymes in vitro, shows no biotransformation and in animal studies < 3% of the administered dose was recovered in the faeces, suggesting no relevant role of liver function in the pharmacokinetics of zoledronic acid.
Den renale clearance af zoledronsyre korrelerer tydeligt med kreatininclearance, idet den renale clearance er ansvarlig for 75±33% af kreatininclearance, hvilket viser en median på 84±29 ml/ min (varierende fra 22 til 143 ml/ min) hos de 64 undersøgte cancerpatienter.
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.
Populationsanalyser viste, at for en patient med en kreatinineclearance på 20 ml/ min (svær nyreinsufficiens) eller på 50 ml/ min (moderat insufficiens), skulle den tilsvarende beregnede clearance af zoledronsyre være henholdsvis 37% eller 72% af clearance hos en patient med en kreatinineclearance på 84 ml/ min.
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.
Der er kun begrænsede farmakokinetiske data vedrørende patienter med svær nyreinsufficiens (kreatinineclearance < 30 ml/ min).
Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/ min).
56%) og uafhængig af zoledronsyrekoncentrationen.
Zoledronic acid shows no affinity for the cellular components of blood and plasma protein binding is low (approximately 56%) and independent of the concentration of zoledronic acid.
Akut toksicitet Den højeste ikke- letale intravenøse enkeltdosis var 10 mg/ kg legemsvægt hos mus og 0, 6 mg/ kg hos rotter.
Acute toxicity The highest non-lethal single intravenous dose was 10 mg/ kg bodyweight in mice and 0.6 mg/ kg in rats.
13 Subkronisk og kronisk toksicitet Zoledronsyre blev fint tolereret, når den blev indgivet subkutant til rotter og intravenøst til hunde i doser indtil 0, 02 mg/ kg dagligt i 4 uger.
Subchronic and chronic toxicity 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.
Subkutan indgift af 0, 001 mg/ kg/ dag til rotter og 0, 005 mg/ kg intravenøst en gang hver 2– 3 dag til hunde i indtil 52 uger blev også fint tolereret.
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.
Dette resultat afspejler stoffets farmakologiske antiresorptive aktivitet.
13 The most frequent finding in repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound’ s pharmacological antiresorptive activity.
Sikkerhedsmargenerne i forbindelse med renal påvirkning var smalle i langvarige dyrestudier med gentaget parenteral indgift, men det kumulativ niveau af ingen uønskede hændelser (NOAELs) ved studier med enkeltdoser (1, 6 mg/ kg) og flere doser på op til en måned (0, 06– 0, 6 mg/ kg/ dag) tydede ikke på renal påvirkning ved doser svarende til eller højere end den højeste dosis beregnet til human terapi.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/ kg) and multiple dose studies of up to one month (0.06– 0.6 mg/ kg/ day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Reproduktionstoksicitet Zoledronsyre var teratogen hos rotter i subkutane doser på ≥0, 2 mg/ kg.
Reproduction toxicity Zoledronic acid was teratogenic in the rat at subcutaneous doses ≥ 0.2 mg/ kg.
Dystoci blev observeret ved den laveste dosis (0, 01 mg/ kg kropsvægt) testet i rotter.
Dystocia was observed at the lowest dose (0.01 mg/ kg bodyweight) tested in the rat.
Mutagenicitet og cancerogent potentiale Zoledronsyre var ikke mutagen i de udførte mutagenicitetsprøver, og undersøgelse af cancerogenicitet kunne ikke påvise cancerogent potentiale.
Mutagenicity and carcinogenic potential Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Ampul med solvens:
Solvent ampoule:
For at forhindre eventuelle uforligeligheder skal den rekonstituerede Zometa opløsning fortyndes med 0, 9% w/ v natriumklorid - eller 5% w/ v glukoseopløsning.
To avoid potential incompatibilities, Zometa reconstituted solution is to be diluted with 0.9% w/ v sodium chloride solution or 5% w/ v glucose solution.
Den rekonstituerede Zometa opløsning må ikke blandes med infusionsopløsninger opløsninger indeholdende calcium eller andre divalente kationer så som lakteret Ringer’ s væske, og bør administreres som en enkelt intravenøs infusion i en separat infusionsslange.
Zometa reconstituted solution must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer’ s solution, and should be administered as a single intravenous solution in a separate infusion line.
Studier med glasflasker og forskellige typer af infusionsposer og infusionslinjer fremstillet af polyvinylklorid, polyethylen og polypropylen (med 0, 9% w/ v natriumkloridopløsning eller 5% w/ v glukoseopløsning) viste ingen uforligelighed med Zometa.
Studies with glass bottles, as well as several types of infusion bags and infusion lines made from polyvinylchloride, polyethylene and polypropylene (prefilled with 0.9% w/ v sodium chloride solution or 5% w/ v glucose solution), showed no incompatibility with Zometa.
Den rekonstituerede opløsning er kemisk og fysisk stabil i 24 timer ved 2°C – 8°C.
The reconstituted solution is chemically and physically stable for 24 hours at 2°C – 8°C.
14 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
Efter aseptisk opblanding og fortynding bør det opblandede og fortyndede præparat anvendes straks.
After aseptic reconstitution and dilution, it is preferable to use the reconstituted and diluted product immediately.
Hvis det ikke anvendes straks, er brugeren ansvarligt for holdbarhedstid og opbevaringsbetingelser før anvendelsen.
If not used immediately, the duration and conditions of storage prior to use are the user’ s responsibility.
Den samlede tid mellemopblanding, fortynding, opbevaring i køleskab ved 2°C – 8°C og indgiftens afslutning må ikke overskride 24 timer.
The total time between reconstitution, dilution, storage in a refrigerator at 2°C – 8°C and end of administration must not exceed 24 hours.
Zometa 4 mg pulver til infusionsvæske, opløsning, leveres i pakninger med henholdsvis 1, 4 eller 10 hætteglas og 1, 4 eller 10 ampuller med vand til injektionsvæsker.
Zometa 4 mg powder for solution for infusion is supplied as packs containing 1, 4 or 10 vials and 1, 4 or 10 ampoules of water for injections, respectively.
6 ml farveløst hætteglas af glas, hydrolytisk type I glas (Ph. Eur.)
Eur.).
Opløsningsmiddel ampul:
Solvent ampoule:
5 ml farveløs ampul af glas
5-ml colourless glass ampoule.
Den mængde af rekonstituerede opløsning, som påkræves, fortyndes herefter yderligere med 100 ml calciumfri infusionsvæske (0, 9% w/ v natriumklorid - eller 5% w/ v glukoseopløsning).
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).
Hvis opløsningen afkøles, skal den have stuetemperatur, før den indgives.
If refrigerated, the solution must be allowed to reach room temperature before administration.
20. 03. 2001 Dato for første fornyelse:
20.03.2001 Date of first renewal:
Zometa 4 mg/ 5 ml koncentrat til infusionsvæske, opløsning
Zometa 4 mg/ 5 ml concentrate for solution for infusion
Et hætteglas med 5 ml koncentrat indeholder 4 mg zoledronsyre (vandfri).
One vial with 5 ml concentrate contains 4 mg zoledronic acid (anhydrous).
En ml koncentrat indeholder zoledronsyre (som monohydrat) svarende til 0, 8 mg zoledronsyre (vandfri).
One ml concentrate contains zoledronic acid (as monohydrate) corresponding to 0.8 mg zoledronic acid (anhydrous).
Den rekonstituerede opløsning af Zometa må ikke blandes med calcium eller andre infusionsopløsninger som indeholder divalente kationer, som lakteret Ringer’ s væske, og bør administreres som en enkelt intravenøs infusion i en separat infusionsslange.
Zometa concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer’ s solution, and should be administered as a single intravenous solution in a separate infusion line.