FrancophonIA/ELRC3.0 huggingface dataset:
English: Serotonergic Drugs (e.g. SSRIs and SNRIs) There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic drugs (including SSRIs and SNRIs).
Danish: Serotoninerge lægemidler (f.eks. SSRI'er og SNRI'er) Der har været rapporter om serotonergt syndrom efter samtidig anvendelse af 5-HT3-antagonister og andre serotoninerge lægemidler (herunder SSRI'er og SNRI'er).
English: Paediatric Cancer Patientsa
Danish: Pædiatriske cancerpatientera
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
English: It is not known if Aloxi is found in breast milk.
Danish: Det er ukendt, om Aloxi udskilles i mælk.
English: A lower bound greater that -15 % demonstrates noninferiority between Aloxi oral and comparator Aloxi intravenous c
Danish: En nedre grænse større end -15 % viser noninferioritet mellem oral Aloxi og kontrollen intravenøs Aloxi.
English: However, clinical pharmacokinetic parameters are not significantly different between poor and extensive metabolisers of CYP2D6 substrates.
Danish: Kliniske farmakokinetiske parametre er imidlertid ikke signifikant forskellige ved sammenligning mellem stoffer, der er dårlige og gode til at metabolisere CYP2D6 substrater.
English: The safety and efficacy of Aloxi in children have not been established.
Danish: Aloxis sikkerhed og virkning hos børn er ikke klarlagt.
English: Non-clinical studies indicate that palonosetron, only at very high concentrations, may block ion channels involved in ventricular de- and re-polarisation and prolong action potential duration.
Danish: Prækliniske studier peger på, at palonosetron kun ved meget høje koncentrationer kan blokere ionkanaler involveret i ventrikulær de- og repolarisation og forlænge aktionspotentialets varighed.
English: The efficacy of Aloxi in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy.
Danish: Effekten af Aloxi ved forebyggelse af kvalme og opkastning fremkaldt af kemoterapi med kraftig kvalmefremkaldende virkning kan forstærkes ved at supplere med et kortikosteroid indgivet inden kemoterapien.
English: Hyperkalaemia, metabolic disorders, hypocalcaemia, hypokalaemia, anorexia, hyperglycaemia, appetite decreased
Danish: Hyperkaliæmi, stofskiftesygdomme, hypokalcæmi, hypokaliæmi, anoreksi, hyperglykæmi, nedsat appetit
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: I prækliniske studier blev der kun iagttaget virkninger af doser, der anses for at overstige den maksimale humane eksponering i væsentlig grad.
English: The non-inferiority margin was
Danish: Noninferioritets-marginen var 15 %.
English: • a medicine for feeling or being sick (nausea and vomiting) called domperidone.
Danish: • et lægemiddel mod kvalme eller opkastning kaldet domperidon.
English: In preclinical studies, palonosetron did not inhibit the antitumour activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C).
Danish: I prækliniske studier hæmmede palonosetron ikke den antineoplastiske virkning af de fem testede kemoterapeutika (cisplatin, cyclophosphamid, cytarabin, doxorubicin og mitomycin C).
English: If you stop taking Aloxi
Danish: Hvis De holder op med at tage Aloxi
English: Aloxi 500 micrograms soft capsules are plain, light beige, opaque, round to oval soft capsules, filled with a clear yellowish solution.
Danish: Aloxi 500 mikrogram bløde kapsler er ikke prægede, lys beige, uigennemsigtige, runde til ovale, bløde kapsler fyldt med en klar gullig opløsning.
English: Aloxi is used in adults, adolescents and children over one month of age to help stop you feeling or being sick (nausea and vomiting) when having cancer treatments called chemotherapy.
Danish: Aloxi anvendes til voksne, unge og børn, der er over en måned, som en hjælp til at stoppe deres kvalme eller opkastning, når de får kræftbehandlinger, som kaldes kemoterapi.
English: PK parameters expressed as Geometric Mean (CV) except for T½ which is median.
Danish: Farmakokinetiske parametre udtrykt som geometriske gennemsnit (CV) undtagen for t1/2, som er medianværdier.
English: Efficacy was based on demonstrating non-inferiority of oral palonosetron doses compared to the approved intravenous formulation.
Danish: Virkningen blev vurderet, på baggrund af hvorvidt der kunne vises noninferioritet af oral palonosetron i forhold til den godkendte intravenøse formulering.
English: Although comparative efficacy of palonosetron in multiple cycles has not been demonstrated in controlled clinical trials, 217 patients were enrolled in a multicentre, open label safety study and were treated with palonosetron capsules 750 micrograms for up to 4 cycles of chemotherapy in a total of 654 chemotherapy cycles.
Danish: Selvom den relative virkning af palonosetron ved multiple behandlingscykler ikke er blevet demonstreret i kontrollerede kliniske studier, blev der inkluderet 217 patienter i et åbent multicentersikkerhedsstudie, og de blev behandlet med palonosetron-kapsler 750 mikrogram i op til 4 yderligere cykler med kemoterapi, i alt 654 cykler med kemoterapi.
English: • muscle pain.
Danish: • Muskelsmerter.
English: No safety concerns were raised at either dose level.
Danish: Der blev ikke indberettet sikkerhedsmæssige problemer ved nogen af de to doseringsniveauer.
English: Type I glass vial with chlorobutyl siliconised rubber stopper and aluminium cap.
Danish: Type I glas hætteglas med chlorobutyl siliconeret gummiprop og aluminiumhætte.
English: Breast-feeding It is not known if Aloxi is found in breast milk.
Danish: Amning Det er ukendt, om Aloxi udskilles i mælk.
English: • ECG (electrocardiogram) abnormalities (‘QT prolongation').
Danish: • Unormalt ekg (QT-forlængelse).
English: No safety concerns were raised in either treatment group.
Danish: Der blev ikke indberettet sikkerhedsmæssige problemer i nogen af de to behandlingsgrupper.
English: Other side effects Tell your doctor if you notice any of the following side effects:
Danish: Andre bivirkninger Fortæl det til lægen, hvis De bemærker en eller flere af de følgende bivirkninger:
English: The primary efficacy endpoint was Complete Response in the acute phase of the first cycle of chemotherapy, defined as no vomiting, no retching, and no rescue medication in the first 24 hours after starting chemotherapy.
Danish: Det primære virkningsendepunkt var fuldstændigt respons (CR) i den akutte fase af den første kemoterapicyklus, defineret som ingen opkastning, ingen opkastningsfornemmelser og ingen nødmedicin i løbet af de første 24 timer efter start af kemoterapi.
English: Aloxi should not be used to prevent or treat nausea and vomiting in the days following chemotherapy if not associated with another chemotherapy administration.
Danish: Aloxi bør ikke anvendes til at forebygge og behandle kvalme og opkastning i dagene efter kemoterapi, medmindre det sker i forbindelse med anden indgift af kemoterapi.
English: If you are pregnant or think you might be pregnant, your doctor will not use Aloxi unless it is clearly necessary.
Danish: Hvis De er gravid eller har mistanke om, at De er gravid, vil Deres læge ikke behandle Dem med Aloxi, medmindre det er strengt nødvendigt.
English: Emetogenic chemotherapies administered included doxorubicin, cyclophosphamide (<1500 mg/m2), ifosfamide, cisplatin, dactinomycin, carboplatin, and daunorubicin.
Danish: De administrerede emetogene kemoterapeutika omfattede doxorubicin, cyclophosphamid (<1.500 mg/m2), ifosfamid, cisplatin, dactinomycin, carboplatin og daunorubicin.
English: Talk to your doctor or pharmacist before taking Aloxi if:
Danish: Kontakt lægen eller apotekspersonalet, før De bruger Aloxi, hvis:
English: Hepatic impairment does not significantly affect total body clearance of palonosetron compared to the healthy subjects.
Danish: Nedsat leverfunktion påvirker ikke signifikant palonosetrons totale kropsclearance sammenlignet med raske studiepersoner.
English: Currently available data are described in section 5.1 and section 5.2, but no recommendation on posology can be made.
Danish: 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: After a single intravenous bolus administration in healthy subjects the total body clearance of palonosetron was 173 ± 73 ml/min and renal clearance was 53 ± 29 ml/min.
Danish: Efter en enkelt intravenøs bolusindgift til raske studiepersoner var den totale clearance fra kroppen af palonosetron 173 ± 73 ml/min og den renale clearance var 53 ± 29 ml/min.
English: In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to Aloxi, were headache (9 %) and constipation
Danish: I kliniske studier hos voksne med en dosering på 250 mikrogram (totalt 633 patienter) var de hyppigst observerede bivirkninger, der i det mindste muligvis var relaterede til Aloxi, hovedpine (9 %) og obstipation (5 %).
English: Hypersensitivity, anaphylaxis, anaphylactic/ anaphylactoid reactions and shock
Danish: Overfølsomhed, anafylaksi, anafylaktiske/ anafylaktoide reaktioner og shock
English: Palonosetron was non-inferior versus the comparators in the acute phase of emesis both in moderately and highly emetogenic setting.
Danish: Palonosetron var ikke dårligere sammenlignet med de stoffer, det blev sammenlignet med, i den akutte fase af kvalme og opkastning både under regimer med moderat og kraftig kvalmefremkaldende behandling.
English: 500 micrograms palonosetron administered orally approximately one hour before the start of chemotherapy.
Danish: 500 mikrogram palonosetron indgivet oralt ca. én time før start af kemoterapi.
English: What Aloxi looks like and contents of the pack Aloxi solution for injection is a clear, colourless solution and is supplied in a pack of one Type I glass vial with chlorobutyl siliconised rubber stopper and aluminium cap, which contains 5 ml of the solution.
Danish: Aloxi-injektionsvæske, opløsning, er en klar og farveløs opløsning, der leveres i en pakning med ét type I-hætteglas med chlorbutyl-silikoniseret gummiprop og aluminiumshætte og med 5 ml af opløsningen.
English: Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for Aloxi overdose.
Danish: På grund af det store fordelingsvolumen er det dog usandsynligt, at dialyse vil være en effektiv behandling af Aloxi-overdosering.
English: Dermatitis allergic, pruritus, skin disorder, urticaria
Danish: Allergisk dermatitis, pruritus, hudsygdom, urticaria
English: Plain, light beige, opaque, round to oval, soft gelatine capsules, filled with a clear yellowish solution.
Danish: Ikke-prægede, lys beige, uigennemsigtige, runde til ovale, bløde gelatinekapsler fyldt med en klar gullig opløsning.
English: No pharmacokinetic data in haemodialysis patients are available.
Danish: Der findes ingen farmakokinetiske data fra hæmodialysepatienter.
English: Table 2: Pharmacokinetic Parameters in Paediatric Cancer Patients following intravenous infusion of Aloxi at 20 µg/kg over 15 min and in Adult Cancer Patients receiving 3 and 10 µg/kg palonosetron doses via intravenous bolus.
Danish: Farmakokinetiske parametre hos pædiatriske cancerpatienter efter intravenøs infusion af Aloxi 20 µg /kg i løbet af 15 min og hos voksne cancerpatienter, der fik 3 eller 10 µg/kg palonosetrondoser via intravenøs bolus.
English: 0 - 120 hours
Danish: 0 - 120 timer
English: Metoclopramide
Danish: Metoclopramid
English: Ondansetron 32 milligrams (n= 221)
Danish: Ondansetron 32 milligram (n= 221)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om Aloxi findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: In a randomised, double-blind study with a total of 667 patients receiving highly emetogenic chemotherapy that included cisplatin ≥ 60 mg/m2, cyclophosphamide > 1,500 mg/m2 and dacarbazine,
Danish: I et randomiseret, dobbeltblind studie med sammenlagt 667 patienter, der fik kraftigt kvalmefremkaldende kemoterapi omfattende cisplatin ≥ 60 mg/m2, cyclophosphamid > 1.500 mg/m2
English: In vitro metabolism studies have shown that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 isoenzymes are involved in the metabolism of palonosetron.
Danish: In vitro metabolismestudier har vist, at CYP2D6 og i mindre omfang CYP3A4 og CYP1A2 isoenzymerne er involveret i metabolismen af palonosetron.
English: High doses of palonosetron (each dose causing at least 30 times the human therapeutic exposure) applied daily for two years caused an increased rate of liver tumours, endocrine neoplasms (in thyroid, pituitary, pancreas, adrenal medulla) and skin tumours in rats but not in mice.
Danish: Høje doser af palonosetron (hver dosis medfører mindst 30 gange den humane terapeutiske eksposition) indgivet dagligt i to år medførte en forøget frekvens af levertumorer, endokrine neoplasmer (i thyreoidea, hypofyse, pancreas, binyremarv) og hudtumorer hos rotter, men ikke hos mus.
English: 250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy.
Danish: 250 mikrogram palonosetron indgivet som en enkelt intravenøs bolus ca. 30 minutter før start af kemoterapi.
English: Adults Cancer Patientsb
Danish: Voksne cancerpatienterb
English: 24 - 120 hours
Danish: 24 - 120 timer
English: Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.
Danish: Baseret på in vitro studier hæmmer eller fremmer palonosetron ikke CYP450 isoenzym i klinisk relevante koncentrationer.
English: Non-inferiority criteria were met if the lower bound of the 97.5% confidence interval for the difference in Complete Response rates of intravenous palonosetron minus intravenous ondansetron was larger than -15%.
Danish: Noninferioritetskriterierne var opfyldt, hvis den nedre grænse af 97,5 % konfidensintervallet for forskel i hyppigheden af fuldstændigt respons for intravenøs palonosetron minus intravenøs ondansetron var over -15 %.
English: Tachycardia, bradycardia, extrasystoles, myocardial ischaemia, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles
Danish: Takykardi, bradykardi, ekstrasystoler, myokardieiskæmi, sinustakykardi, sinusarytmi, supraventrikulære ekstrasystoler
English: • high levels of certain liver enzymes
Danish: • Høje niveauer af bestemte leverenzymer
English: Electrocardiogram QT prolonged conduction disorder, sinus tachycardia
Danish: QT-forlængelse i elektrokardiogram Ledningsforstyrrelse, sinustakykardi
English: Also contains mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid.
Danish: Indeholder også mannitol, dinatriumedetat, natriumcitrat, citronsyremonohydrat, vand til injektionsvæsker, natriumhydroxid og saltsyre.
English: • The active substance is palonosetron.
Danish: • Aktivt stof: palonosetron.
English: After single oral doses using buffered solution mean maximum palonosetron concentrations (Cmax) and area under the concentration-time curve (AUC0-∞) were dose proportional over the dose range of 3.0 to 80 µg/kg in healthy subjects.
Danish: Efter orale enkeltdoser med anvendelse af bufferopløsning var de gennemsnitlige højeste koncentrationer af palonosetron Cmax) og arealet under koncentrations-tids kurven (AUC0-∞) dosis-proportionale i dosisområdet fra 3,0 - 80 μg/kg hos sunde studiepersoner.
English: High doses of palonosetron (each dose causing at least 15 times the human therapeutic exposure) applied daily for two years caused an increased rate of liver tumours, endocrine neoplasms (in thyroid, pituitary, pancreas, adrenal medulla) and skin tumours in rats but not in mice.
Danish: Høje doser af palonosetron (hver dosis medfører mindst 15 gange den humane terapeutiske eksposition) indgivet dagligt i to år medførte en forøget frekvens af levertumorer, endokrine neoplasmer (i thyreoidea, hypofyse, pancreas, binyremarv) og hudtumorer hos rotter, men ikke hos mus.
English: Very rare ARs°
Danish: Meget sjældne bivirkninger°
English: In 12 cancer patients given a single oral dose of palonosetron capsules 500 micrograms one hour prior to chemotherapy, Cmax was 0.93 ± 0.34 ng/ml and Tmax was 5.1 ± 5.9 hours.
Danish: Hos 12 cancerpatienter, der fik en enkelt oral dosis palonosetron-kapsler 500 mikrogram én time før kemoterapi, var Cmax 0,93 ± 0,34 ng/ml, og Tmax var 5,1 ± 5,9 timer.
English: palonosetron 250 micrograms and 750 micrograms were compared with ondansetron 32 mg administered intravenously on Day 1.
Danish: og dacarbazine, blev palonosetron 250 mikrogram og 750 mikrogram sammenlignet med ondansetron 32 mg indgivet intravenøst på dag 1.
English: Posology Adults
Danish: Dosering Voksne
English: In non-clinical studies palonosetron possesses the ability to block ion channels involved in ventricular de- and re-polarisation and to prolong action potential duration.
Danish: I ikke-kliniske studier kunne palonosetron blokere de ionkanaler, der er involveret i den ventrikulære de- og repolarisering, og stoffet kunne forlænge varigheden af aktionspotentialet.
English: A total of 493 paediatric patients, aged 64 days to 16.9 years, receiving moderately (69.2%) or highly emetogenic chemotherapy (30.8%) were treated with palonosetron 10 µg/kg (maximum 0.75 mg), palonosetron
Danish: I alt 493 pædiatriske patienter i alderen 64 dage til 16,9 år, der fik kemoterapi med moderat (69,2 %) eller kraftig (30,8 %) kvalmefremkaldende virkning, blev behandlet med palonosetron 10 µg/kg (maks.
English: Only limited data from animal studies are available regarding the placental transfer (see section 5.3).
Danish: Der findes kun begrænsede data fra dyrestudier med vedrørende passage over placenta (se pkt.
English: In healthy subjects given palonosetron capsules 500 micrograms, the terminal elimination half-life (t½) of palonosetron was 37 ± 12 hours (mean ± SD), and in cancer patients, t½ was 48 ± 19 hours.
Danish: Hos raske studiepersoner, der fik palonosetron-kapsler 500 mikrogram, var palonosetrons terminale eliminationshalveringstid (t½) 37 ± 12 timer (gennemsnit ± SD), og hos cancerpatienter var t½ 48 ± 19 timer.
English: Palonosetron has been administered safely with analgesics, antiemetic/antinauseants, antispasmodics and anticholinergic medicinal products.
Danish: Palonosetron er indgivet sikkert sammen med analgetika, antiemetika/midler mod kvalme, spasmolytika og antikolinergika.
English: Following intravenous administration of palonosetron 0.25 mg once every other day for 3 doses in 11 testicular cancer patients, the mean (± SD) increase in plasma concentration from Day 1 to Day 5 was 42 ± 34 %.
Danish: Efter intravenøs indgift af tre doser 0,25 mg palonosetron én gang hver anden dag hos 11 patienter med testikelkræft var den gennemsnitlige stigning (± SD) i plasmakoncentration fra dag 1 til dag 5 42 ± 34 %.
English: Constipation, nausea
Danish: Obstipation, kvalme
English: Very rare (<1/10,000) adverse reactions were reported post-marketing.
Danish: Efter markedsføring er der rapporteret om meget sjældne bivirkninger (<1/10.000).
English: • feeling sleepy or trouble sleeping
Danish: • Følelse af søvnighed eller søvnbesvær
English: Since the 97.5% confidence interval (stratum adjusted MantelHaenszel test) of the difference in CR0-24h between palonosetron 20 µg/kg and ondansetron was [11.7%, 12.4%], the 20 µg/kg palonosetron dose demonstrated non-inferiority to ondansetron.
Danish: Da 97,5 % konfidensintervallet (stratum-justeret MantelHaenszel-test) for forskel i CR0-24t mellem palonosetron 20 µg/kg og ondansetron var [-11,7 %;
English: 24 - 120 hours 0 - 120 hours a Intent-to-treat cohort.
Danish: 24 - 120 timer 0 - 120 timer a Hensigt-til-at-behandle kohorte b
English: Tell your doctor if you notice any of the side effects listed above.
Danish: Fortæl det til lægen, hvis De bemærker en eller flere af bivirkningerne anført ovenfor.
English: After a single-dose of approximately 0.75 mg intravenous palonosetron, the total body clearance of palonosetron in healthy subjects was 160 ± 35 ml/h/kg (mean ± SD) and renal clearance was 66.5 ± 18.2 ml/h/kg.
Danish: Efter en enkelt dosis intravenøs palonosetron på ca. 0,75 mg var den totale clearance fra kroppen af palonosetron hos raske studiepersoner 160 ± 35 ml/t/kg (gennemsnit ± SD), og den renale clearance var 66,5 ± 18,2 ml/t/kg.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Aloxi solution for injection: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Aloxi injektionsvæske, opløsning: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Aloxi is indicated in adults for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Danish: Aloxi er hos voksne indiceret til forebyggelse af kvalme og opkastning i forbindelse med cancerkemoterapi med moderat kvalmefremkaldende virkning.
English: Ondansetron 32 milligrams (n= 185)
Danish: Ondansetron 32 milligram (n= 185)
English: The safety and efficacy of Palonosetron i.v at single doses of 1µg/kg and 3µg/kg was compared in the first clinical study in 150 patients in the following age groups, >28 days to 23 months (7 patients), 2 to 11 years (96 patients), and 12 to 16 years of age (47 patients) undergoing elective surgery.
Danish: Sikkerheden og virkningen af palonosetron indgivet intravenøst i enkeltdoser på 1 µg/kg og 3 µg/kg blev sammenlignet i det første kliniske studie med 150 patienter i aldersgrupperne > 28 dage til 23 måneder (7 patienter), 2 til 11 år (96 patienter) og 12 til 16 år (47 patienter), som fik foretaget elektiv kirurgi.
English: Age does not affect the pharmacokinetics of palonosetron.
Danish: Alder påvirker ikke palonosetrons farmakokinetik.
English: No data are available for patients with end stage renal disease undergoing haemodialysis.
Danish: Der findes ingen data vedrørende patienter med terminal nyresygdom, der er i hæmodialyse.
English: The safety and efficacy of Palonosetron i.v at single doses of 3 µg/kg and 10 µg/kg was investigated in the first clinical study in 72 patients in the following age groups, >28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy.
Danish: Sikkerheden og virkningen af palonosetron indgivet intravenøst i enkeltdoser på 3 µg/kg og 10 µg/kg blev undersøgt i det første kliniske studie med 72 patienter i følgende aldersgrupper: > 28 dage til 23 måneder (12 patienter), 2 til 11 år (31 patienter) og 12 til 17 år (29 patienter), som fik kraftigt eller moderat emetogen kemoterapi.
English: In 36 healthy male and female subjects given a single oral dose of palonosetron capsules 500 micrograms, maximum plasma palonosetron concentration (Cmax) was 0.81 ± 0.17 ng/ml (mean ± SD) and time to maximum concentration (Tmax) was 5.1 ± 1.7 hours.
Danish: Hos 36 raske mandlige og kvindelige studiepersoner, der fik en enkelt dosis palonosetron-kapsler 500 mikrogram, var den højeste plasma-palonosetronkoncentration (Cmax) 0,81 ± 0,17 ng/ml (gennemsnit ± SD) og tid til højeste koncentration (Tmax) var 5,1 ± 1,7 timer.
English: • The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid.
Danish: • Øvrige indholdsstoffer: mannitol, dinatriumedetat, natriumcitrat, citronsyremonohydrat og vand til injektionsvæsker, natriumhydroxid og saltsyre.