natgillin/translations-raw huggingface dataset:
Den anslåede tid indtil første episode med emesis i den kombinerede analyse fremgår af Kaplan- Meier plottet i figur 1.
The estimated time to first emesis in the combined analysis is depicted by the Kaplan-Meier plot in Figure 1.
Figur 1 Patienter (%) som forbliver emesisfrie over tid - cyklus 1 Højemetogen kemoterapibehandling
Figure 1 Percent of Patients Receiving Highly Emetogenic Chemotherapy Who Remain Emesis Free Over Time – Cycle 1
Aprepitantregime (N=520) Aprepitant Regimen (N=520) Standardbehandling( N=523) Standard Therapy (N=424)
Aprepitant Regimen (N=520) Standard Therapy (N=523)
80% Patienter (%)
80%
Tid (timer) Time (hours)
Time (hours)
Statistisk signifikante forskelle i virkning observeredes også i hver af de to individuelle undersøgelser.
Statistically significant differences in efficacy were also observed in each of the 2 individual studies.
I de samme to kliniske undersøgelser fortsatte 851 patienter behandlingsregimet ved gentagne (op til 5) kemoterapibehandlinger.
11 In the same 2 clinical studies, 851 patients continued into the Multiple-Cycle extension for up to 5 additional cycles of chemotherapy.
Virkningen af aprepitant- behandlingsregimet blev opretholdt ved alle behandlingerne.
The efficacy of the aprepitant regimen was maintained during all cycles.
4. 2) sammenlignet med et standardbehand - lingsregime (placebo plus ondansetron 8 mg oralt (to gange på dag 1 og hver 12. time på dag 2 og 3) plus dexamethason 20 mg oralt på dag 1).
In a randomised, double-blind study in a total of 866 patients (864 females, 2 males) receiving chemotherapy that included cyclophosphamide 750-1500 mg/ m2; or cyclophosphamide 500-1500 mg/ m2 and doxorubicin (≤ 60 mg/ m2) or epirubicin (≤ 100 mg/ m2), aprepitant in combination with an ondansetron/ dexamethasone regimen (see section 4.2) was compared with standard therapy (placebo plus ondansetron 8 mg orally (twice on Day 1, and every 12 hours on Days 2 and 3) plus dexamethasone 20 mg orally on Day 1).
Tabel 2 Responderende patienter (%) pr. behandlingsgruppe og fase - cyklus 1 Moderat emetogen kemoterapibehandling
Table 2 Percent of Patients Responding by Treatment Group and Phase — Cycle 1 Moderately Emetogenic Chemotherapy
Aprepitant SAMMENSATTE
Aprepitant Regimen
MÅLINGER
(N=
%
433 )†%
%%
(N= 424)%%
Komplet respons (ingen emesis og ingen erstatningsterapi) Total (0- 120 timer) 0- 24 timer 25- 120 timer
Overall (0-120 hours) 0-24 hours 25-120 hours
(1, 6; 15, 0) (0, 7; 12, 7) (- 0, 4; 13, 0)
(1.6, 15.0) (0.7, 12.7) (-0.4, 13.0)
INDIVIDUELLE MÅLINGER
INDIVIDUAL MEASURES No Emesis (no emetic episodes regardless of use of rescue therapy)
Ingen emesis (ingen emesis uanset brug af erstatningsterapi) Total (0- 120 timer) 0- 24 timer 25- 120 timer
Overall (0-120 hours) 0-24 hours 25-120 hours
(10, 8; 23, 2) (5, 1; 15, 3) (5, 9; 17, 5)
(10.8, 23.2) (5.1, 15.3) (5.9, 17.5)
(- 1, 3; 11, 9) (- 4, 2; 6, 8) (- 2, 6; 10, 3)
(-1.3, 11.9) (-4.2, 6.8) (-2.6, 10.3)
* Konfidensintervallerne (CI) er ikke korrigeret for køn (< 55år, ≥55 år) og investigatorgruppe, som var inkluderet i den primære analyse af odds ratio og logistiske modeller. † For én patient i aprepitantregimet var der kun data for den akutte fase, og patienten blev ekskluderet fra de totale og forsinkede faseanalyser.
* The confidence intervals were calculated with no adjustment for age category (< 55 years, ≥ 55 years) and investigator group, which were included in the primary analysis of odds ratios and logistic models. † One patient in the Aprepitant Regimen only had data in the acute phase and was excluded from the overall and delayed phase analyses.
12 Den anslåede tid indtil første episode med emesis i undersøgelsen fremgår af Kaplan- Meier plottet i figur 2.
12 The estimated time to first emesis in the study is depicted by the Kaplan-Meier plot in Figure 2.
Figur 2 Patienter (%) som forbliver emesisfrie over tid - cyklus 1 Moderat emetogen kemoterapibehandling
Figure 2 Percent of Patients Receiving Moderately Emetogenic Chemotherapy Who Remain Emesis Free Over Time – Cycle 1
Aprepitantregime Standardbehandling (N=424) 90 Patienter (%)
Aprepitant Regimen (N=432) Standard Therapy (N=424) 90%
I samme kliniske undersøgelse fortsatte 744 patienter behandlingsregimet ved gentagne (op til 3) kemoterapibehandlinger.
In the same clinical study, 744 patients continued into the Multiple-Cycle extension for up to 3 additional cycles of chemotherapy.
Fosaprepitant, et aprepitant- prodrug, omdannes hurtigt til aprepitant, når det administreres intravenøst.
Fosaprepitant, a prodrug of aprepitant, when administered intravenously is rapidly converted to aprepitant.
Fosaprepitant kan ikke påvises 30 minutter efter afslutning af infusion.
Plasma concentrations of fosaprepitant are below quantifiable levels within 30 minutes of the completion of infusion.
Aprepitant efter administration af fosaprepitant Aprepitants AUC efter 115 mg fosaprepitant svarede til AUC for 125 mg peroral aprepitant, mens Cmax var 2, 5 gange højere.
Aprepitant after fosaprepitant administration The AUC of aprepitant following 115 mg of fosaprepitant was equivalent to the AUC of 125 mg of oral aprepitant, while Cmax was 2.5-fold higher.
Efter en enkelt intravenøs dosis fosaprepitant administreret som en 15- minutters infusion til raske frivillige, var aprepitants gennemsnitlige AUC0- 24t 19, 8 μg· t/ ml, og aprepitants gennemsnitlige maksimumkoncentration 3, 26 μg/ ml.
Following a single intravenous dose of fosaprepitant administered as a 15-minute infusion to healthy volunteers the mean AUC0-24hr of aprepitant was 19.8 μ g• hr/ ml and the mean maximal aprepitant concentration was 3.26 μ g/ ml.
De gennemsnitlige aprepitant- plasmakoncentrationer fra 4 timer efter dosering (inklusive koncentrationen 24 timer efter dosering) var den samme for 125 mg peroral aprepitantdosis og 115 mg intravenøs fosaprepitantdosis.
The mean aprepitant plasma concentrations from 4 hours after dosing (including the concentration at 24 hours postdose) were similar between the 125 mg oral aprepitant dose and the 115 mg intravenous fosaprepitant dose.
Distribution Aprepitant er stærkt proteinbundet, i gennemsnit 97%.
Distribution Aprepitant is highly protein bound, with a mean of 97%.
66 liter.
The geometric mean apparent volume of distribution at steady state (Vdss) is approximately 66 l in humans.
Metabolisme Fosaprepitant blev hurtigt omdannet til aprepitant i in vitro- inkubationer med leverpræparater fra mennesker.
Metabolism Fosaprepitant was rapidly converted to aprepitant in in vitro incubations with liver preparations from humans.
Desuden undergik fosaprepitant en hurtig og næsten komplet omdannelse til aprepitant i S9- præparater fra andet humant væv inklusive nyre, lunge og ileum.
Furthermore, fosaprepitant underwent rapid and nearly complete conversion to aprepitant in S9 preparations from other human tissues including kidney, lung and ileum.
Det ser således ud til, at omdannelsen af fosaprepitant til aprepitant kan foregå ekstrahepatisk.
Thus, it appears that the conversion of fosaprepitant to aprepitant can occur in multiple tissues.
I mennesker omdannedes fosaprepitantadministreret intravenøst hurtigt til aprepitant.
In humans, fosaprepitant administered intravenously was rapidly converted to aprepitant within 30 minutes following the end of infusion.
13 Aprepitant metaboliseres ekstensivt.
13 Aprepitant undergoes extensive metabolism.
19% af radioaktiviteten i plasma over 72 timer efter en enkelt intravenøst administreret 100 mg dosis af [14C] - aprepitant- prodrug, hvilket indikerer en betydende tilstedeværelse af metabolitter.
In healthy young adults, aprepitant accounts for approximately 19% of the radioactivity in plasma over 72 hours following a single intravenous administration 100 mg dose of [14C]-aprepitant prodrug, indicating a substantial presence of metabolites in the plasma.
Metabolisme af aprepitant sker hovedsageligt ved oxidation i morfolinringen og i sidekæderne, og de resulterende metabolitter var kun svagt aktive.
The metabolism of aprepitant occurs largely via oxidation at the morpholine ring and its side chains and the resultant metabolites were only weakly active.
In vitro- undersøgelsermed humane levermikrosomer indikerer, at aprepitant primært metaboliseres af CYP3A4, muligvis med mindre deltagelse af CYP1A2 og CYP2C19.
In vitro studies using human liver microsomes indicate that aprepitant is metabolised primarily by CYP3A4 and potentially with minor contribution by CYP1A2 and CYP2C19.
Alle metabolitter, der blev påvist i urin, fæces og plasma efter intravenøs dosering af 100 mg [14C] - fosaprepitant, blev også påvist efter peroral dosering af [14C] - aprepitant.
All metabolites observed in urine, faeces and plasma following an intravenous 100 mg [14C]-fosaprepitant dose were also observed following an oral dose of [14C]-aprepitant.
Ved omdannelsen af 115 mg fosaprepitant til aprepitant frigøres blev 18, 3 mg phosphat.
Upon conversion of 115 mg of fosaprepitant to aprepitant, 18.3 mg of phosphate is liberated from fosaprepitant.
Efter en enkelt intravenøst administreret 100 mg dosis af [14C] - fosaprepitant til raske forsøgspersoner blev 57% af radioaktiviteten genfundet i urinen og 45% i fæces.
Following a single intravenously administered 100 mg dose of [14C]- fosaprepitant to healthy subjects, 57% of the radioactivity was recovered in urine and 45% in faeces.
Aprepitants farmakokinetik er non- lineær i det kliniske doseringsområde.
The pharmacokinetics of aprepitant is non-linear across the clinical dose range.
9 til 13 timer efter peroral administration.
The terminal half-life of aprepitant after oral administration ranged from approximately 9 to 13 hours.
Farmakokinetik hos særlige populationer Fosaprepitants farmakokinetik er ikke vurderet hos særlige populationer.
Pharmacokinetics in special populations Fosaprepitant pharmacokinetics has not been evaluated in special populations.
Fosaprepitant er ikke undersøgt hos patienter under 18 år.
Fosaprepitant has not been evaluated in patients below 18 years of age.
Fosaprepitant metaboliseres i forskellige ekstrahepatiske væv; leverinsufficiens forventes derfor ikke at ændre omdannelsen af fosaprepitant til aprepitant.
Fosaprepitant is metabolized in various extrahepatic tissues; therefore hepatic insufficiency is not expected to alter the conversion of fosaprepitant to aprepitant.
Mild leverinsufficiens (Child- Pugh score 5- 6) har ingen klinisk relevant indflydelse på aprepitants farmakokinetik, og dosisjustering er derfor ikke nødvendig hos patienter med mild leverinsufficiens.
No dose adjustment is necessary for patients with mild hepatic insufficiency.
Der kan ikke drages konklusioner ud fra tilgængelige data vedrørende indvirkning af moderat leverinsufficiens (Child - Pugh score 7- 8) på aprepitants farmakokinetik.
Conclusions regarding the influence of moderate hepatic insufficiency (Child-Pugh score 7 to 8) on aprepitant pharmacokinetics cannot be drawn from available data.
Der er ingen kliniske eller farmakokinetiske data for patienter med svær leverinsufficiens (Child- Pugh score > 9).
There are no clinical or pharmacokinetic data in patients with severe hepatic insufficiency (Child-Pugh score > 9).
En enkelt dosis à 240 mg peroral aprepitant blev administreret til patienter med svær nyreinsufficiens (CrCl < 30 ml/ min) og til hæmodialysepatienter i det sene stadie (end stage) af nyresygdom (ESRD).
A single 240 mg dose of oral aprepitant was administered to patients with severe renal insufficiency (CrCl < 30 ml/ min) and to patients with end stage renal disease (ESRD) requiring haemodialysis.
Hos patienter med svær nyreinsufficiens faldt AUC0- ∞ for total- aprepitant (ubundet og proteinbundet) med 21% og Cmax faldt med 32% set i forhold til raske forsøgspersoner.
In patients with severe renal insufficiency, the AUC0-∞ of total aprepitant (unbound and protein bound) decreased by 21% and Cmax decreased by 32%, relative to healthy subjects.
For hæmodialysepatienter i end- stage- nyresygdom faldt AUC0- ∞ for total- aprepitant med 42% og Cmax faldt med 32%.
In patients with ESRD undergoing haemodialysis, the AUC0-∞ of total aprepitant decreased by 42% and Cmax decreased by 32%.
På grund af beskedne fald i proteinbindingen for aprepitant hos patienter med nyresygdom blev AUC for det farmakologisk aktive, ubundne aprepitant ikke signifikant påvirket hos patienter med nyreinsufficiens sammenlignet med raske forsøgspersoner.
Due to modest decreases in protein binding of aprepitant in patients with renal disease, the AUC of pharmacologically active unbound aprepitant was not significantly affected in patients with renal insufficiency compared with healthy subjects.
Hæmodialyse udført 4 eller 48 timer efter dosering havde ingen signifikant virkning på farmakokinetikken for aprepitant; mindre end 0, 2% af dosis blev genfundet i dialysatet.
Haemodialysis conducted 4 or 48 hours after dosing had no significant effect on the pharmacokinetics of aprepitant; less than 0.2% of the dose was recovered in the dialysate.
Dosisjustering er ikke nødvendig til patienter med nyreinsufficiens eller til hæmodialysepatienter i end- stage- nyresygdom.
No dose adjustment is necessary for patients with renal insufficiency or for patients with ESRD undergoing haemodialysis.
14 Forholdet mellem koncentration og effekt Fosaprepitant er et prodrug til aprepitant.
Relationship between concentration and effect Fosaprepitant is a prodrug of aprepitant.
Ved brug af en meget specifik NK1- receptortracer har PET - undersøgelser af raske unge mænd vist, at aprepitant administreret peroralt passerer blod - hjernebarrieren og binder sig til NK1- receptorer på en dosis - og plasmakoncentrationsafhængig måde.
PET imaging studies, using a highly specific NK1-receptor tracer, in healthy young men after administration of oral aprepitant have shown that aprepitant penetrates into the brain and occupies NK1 receptors in a dose-and plasma-concentration-dependent manner.
Aprepitants plasmakoncentrationer, opnået efter 3- dages behandlingsregime med peroral aprepitant, forventes at beslaglægge mere end 95% af hjernens NK1- receptorer.
Aprepitant plasma concentrations achieved with the 3-day regimen of oral aprepitant are predicted to provide greater than 95% occupancy of brain NK1 receptors.
Forholdet mellem koncentration og effekt er ikke vurderet efter administration af fosaprepitant.
The relationship between concentration and effect has not been evaluated after administration of fosaprepitant.
5. 3 Prækliniske sikkerhedsdata
14 5.3 Pre-clinical safety data
Prækliniske data, der er opnået med intravenøs administration af fosaprepitant og peroral administration af aprepitant, viser ingen særlig risiko for mennesker på basis af konventionelle undersøgelser af enkelt og gentagen dosistoksicitet, genotoksicitet (herunder in vitro tests) og reproduktionstoksicitet.
Pre-clinical data obtained with intravenous administration of fosaprepitant and oral administration of aprepitant reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity (including in vitro tests), and toxicity to reproduction.
Hos forsøgsdyr har ikke- kommercielle formuleringer af fosaprepitant forårsaget vaskulær toksicitet og hæmolyse ved koncentrationer under 1 mg/ ml og højere, afhængigt af formuleringen.
In laboratory animals, fosaprepitant in non-commercial formulations caused vascular toxicity and hemolysis at concentrations below 1 mg/ ml and higher, dependent on the formulation.
I humane vaskede blodlegemer forekom hæmolyse også med ikke- kommercielle formuleringer af fosaprepitant ved koncentrationer på 2, 3 mg/ ml og højere, selvom tests af humant blod var negative.
In human washed blood cells also evidence of hemolysis was found with non-commercial formulations at fosaprepitant concentrations of 2.3 mg/ ml and higher, although tests in human whole blood were negative.
Hæmolyse blev ikke fundet med de kommercielle formuleringer af fosaprepitant ved koncentrationer op til 1 mg/ ml i humant blod og humane vaskede erytrocytter.
No hemolysis was found with the commercial formulation up to a fosaprepitant concentration of 1 mg/ ml in human whole blood and washed human erythrocytes.
Det carcinogene potentiale hos gnavere blev kun undersøgt med peroralt administreret aprepitant.
Carcinogenic potential in rodents was only investigated with orally administered aprepitant.
Det skal imidlertid anføres, at værdien af de toksicitetsundersøgelser, der blev udført med gnavere, kaniner og aber, inklusive reproduktions- toksicitetsundersøgelserne, er begrænset, da systemisk eksponering for fosaprepitant og aprepitant kun var den samme eller lavere end eksponering hos mennesker efter terapeutiske doser.
However, it should be noted that the value of the toxicity studies carried out with rodents, rabbit and monkey, including the reproduction toxicity studies, are limited since systemic exposures to fosaprepitant and aprepitant were only similar or even lower than therapeutic exposure in humans.
I de udførte undersøgelser vedrørende sikkerhedsfarmakologi og gentagen dosistoksicitet hos hunde var fosaprepitants Cmax og aprepitants AUC henholdsvis 4- 7 gange og 60- 70 gange højere end de kliniske værdier.
In the performed safety pharmacology and repeated dose toxicity studies with dogs, fosaprepitant Cmax and aprepitant AUC values were 4-7 times and 60-70 times, respectively, higher than clinical values.
Dinatriumedetat (E386) Polysorbat 80 (E433) Lactose, vandfrit Natriumhydroxid (E524) (til justering af pH) og/ eller Saltsyre, fortyndet (E507) (til justering af pH)
Disodium edetate (E386) Polysorbate 80 (E433) Lactose anhydrous Sodium hydroxide (E524) (for pH adjustment) and/ or Hydrochloric acid diluted (E507) (for pH adjustment)
Ca2+, Mg2+) inklusive Hartmans opløsning og Ringers væske.
IVEMEND is incompatible with any solutions containing divalent cations (e. g., Ca2+, Mg2+), including Hartman’ s and Lactated Ringer’ s Solutions.
6 nævnte.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6..
Efter rekonstituering og fortynding har den kemiske og fysiske stabilitet ved anvendelse vist sig at være 24 timer ved 25°C.
After reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Hvis det ikke anvendes straks, er opbevaringstid og - forhold før anvendelse, brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2- 8°C.
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 to 8°C.
Opbevares i køleskab (2- 8°C).
Store in a refrigerator (2°C - 8°C).
Et 10 ml type I hætteglas af klart glas med gummiprop af chlorobutyl eller bromobutyl og aluminiumsforsegling med blåt plastik flip- off låg.
15 10 ml Type I clear glass vial with a chlorobutyl or bromobutyl rubber stopper and an aluminum seal with a blue plastic flip off cap.
IVEMEND findes som en pakning med 1 hætteglas à 115 mg fosaprepitant eller 10 hætteglas à 115 mg fosaprepitant.
IVEMEND will be available as a pack of 1 vial of 115 mg fosaprepitant or 10 vials of 115 mg fosaprepitant.
6. 6 Regler for destruktion og håndtering
6.6 Special precautions for disposal and other handling
Ingen specielle forholdsregler for destruktion.
No special requirements for disposal.
Sprøjt 5 ml natriumchloridopløsning 9 mg/ ml (0, 9%) ind i hætteglasset.
Inject 5 ml sodium chloride 9 mg/ ml (0.9%) solution for injection into the vial.
Vær sikker på at natriumchloridopløsningen 9 mg/ ml (0, 9%) tilsættes langs hætteglassets væg for at undgå, at det skummer.
Assure that sodium chloride 9 mg/ ml (0.9%) solution for injection is added to the vial along the vial wall in order to prevent foaming.
Undgå at ryste hætteglasset og at sprøjte natriumchloridopløsningen 9 mg/ ml (0, 9%) ind i en hård stråle.
Avoid shaking and jetting sodium chloride 9 mg/ ml (0.9%) solution for injection into the vial.
Tilbered en infusionspose med 110 ml natriumchloridopløsning 9 mg/ ml (0, 9%) (fx ved at tilsætte 10 ml natriumchloridopløsning 9 mg/ ml (0, 9%) til en 100 ml infusionspose med natriumchloridopløsning 9 mg/ ml (0, 9%).
Prepare an infusion bag filled with 110 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection (for example, by adding 10 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection to a 100 ml sodium chloride 9 mg/ ml (0.9%) solution for injection infusion bag).
Træk hele indholdet op af hætteglasset og overfør det til infusionsposen med de 110 ml natriumchloridopløsning 9 mg/ ml (0, 9%), således at det i alt giver 115 ml.
Withdraw the entire volume from the vial and transfer it into an infusion bag containing 110 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection to yield a total volume of 115 ml.
Vend forsigtig posen op og ned 2- 3 gange.
Gently invert the bag 2-3 times.
6. 2).
The medicinal product must not be reconstituted or mixed with solutions for which physical and chemical compatibility has not been established (see section 6.2).
Lægemidlet bør undersøges visuelt for partikler og misfarvning før administration.
The medicinal product should be inspected visually for particulate matter and discoloration before administration.
11. januar 2008
11 January 2008
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu
DATE OF REVISION OF THE TEXT 16 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Waarderweg 39 2031 BN Haarlem 2003 PC Haarlem Holland
Waarderweg 39 2031 BN Haarlem 2003 PC Haarlem The Netherlands
Som vedtaget i version 1. 3 af Risk Management Planen (RMP), som fremgår af Modul 1. 8. 2 i ansøgningen om markedsføringstilladelse og alle følgende opdateringer af RMP, der er vedtaget af CHMP, forpligter indehaveren af markedsføringstilladelsen sig til at udføre undersøgelser og yderligere tiltag inden for bivirkningsovervågning, sådan som det i detaljer er beskrevet i planen for bivirkningsovervågning.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
I henhold til CHMP Guideline for Risk Management for lægemidler til humant brug bør den opdaterede RMP indsendes samtidig med den førstkommende PSUR (Periodic Safety Update Report).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Desuden bør en opdateret RMP indsendes • når ny information modtages, som kan have indflydelse på den aktuelle sikkerhedsspecifikation, plan for bivirkningsovervågning eller tiltag til risikominimering • senest 60 dage efter at en vigtig milepæl (bivirkningsovervågning eller risikominimering) er nået • efter krav fra EMEA.
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached At the request of the EMEA
Fosaprepitant dimeglumin
IVEMEND 115 mg powder for solution for infusion Fosaprepitant dimeglumine
Dinatriumedetat, polysorbat 80, lactose, vandfri, NaOH og/ eller HCl, fortyndet (til justering af pH).
Disodium edetate, polysorbate 80, lactose anhydrous, NaOH and/ or HCl diluted (for pH adjustment)
1 hætteglas 10 hætteglas 1 mg/ ml
1 vial 10 vials 1 mg/ ml
Intravenøs anvendelse efter rekonstituering og opløsning.
Intravenous use after reconstitution and dilution.
Kun engangsdosis.
For single use only.
Efter rekonstituering og fortynding:
22 After reconstitution and dilution:
24 timer ved 25°C.
24 hours at 25°C.
Hertford Road, Hoddesdon Hertfordshire EN11 9BU Storbritannien
Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU Unitied Kingdom
EU/ 1/ 07/ 437/ 001 1 x 1 hætteglas EU/ 1/ 07/ 437/ 002 1 x 10 hætteglas
EU/ 1/ 07/ 437/ 001 1 x 1 vial EU/ 1/ 07/ 437/ 002 1 x 10 vials