FrancophonIA/ELRC3.0 huggingface dataset:
English: In the placebo-controlled (PPMS) clinical trial, IRR was the most common adverse event in patients treated with Ocrevus with an overall incidence of 40.1% compared with an incidence of 25.5% in the placebo group.
Danish: I det placebokontrollerede kliniske studie (primær progressiv multipel sclerose), var infusionsrelaterede reaktioner den hyppigste bivirkning blandt patienter behandlet med Ocrevus, med en overordnet incidens på 40,1 % sammenlignet med en incidens på 25,5 % i placebogruppen.
English: If an infusion of Ocrevus is missed, it should be administered as soon as possible; do not wait until the next planned dose.
Danish: • Hvis du springer en Ocrevus-infusion over, skal du så hurtigt som muligt aftale med lægen hvornår du kan få den. Du skal ikke vente til næste planlagte infusion.
English: · After dilution, Ocrevus is administered as an intravenous infusion through a dedicated line.
Danish: • Efter fortynding administreres Ocrevus som intravenøs infusion gennem separat anlagt intravenøs adgang.
English: Paediatrics
Danish: Pædiatrisk
English: In the active-controlled (RMS) treatment period, a decrease in neutrophils < LNN was observed in 14.7% of Ocrevus patients compared with 40.9% of patients treated with interferon beta-1a.
Danish: I den den aktivt kontrollerede behandlingsperiode (attakvis multipel sclerose) sås fald i neutrofilocytter <laveste referencegrænse hos 14,7% af de Ocrevus-behandlede patienter sammenlignet med 40,9% af de interferon-beta-1a-behandlede patienter.
English: The initial 600 mg dose is administered as two separate intravenous infusions; first as a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion (Table 1).
Danish: Den første dosis på 600 mg administreres som to, separate intravenøse infusioner; først som infusion af 300 mg efterfulgt to uger senere af endnu en infusion af 300 mg (Tabel 1).
English: Each vial contains 300 mg of ocrelizumab in 10 mL at a concentration of 30mg/mL.
Danish: Hvert hætteglas indeholder 300 mg ocrelizumab i 10 ml ved en koncentration på 30 mg/ml.
English: What Ocrevus contains
Danish: Ocrevus indeholder:
English: 21,7% and 10.1% of Ocrevus treated patients experienced mild and moderate IRRs respectively, 2.4% experienced severe IRRs and 0.1% experienced lifethreatening IRRs.
Danish: 21,7% og 10,1% af de Ocrevusbehandlede patienter oplevede hhv. milde og moderate infusionsrelaterede reaktioner; 2,4% oplevede svære infusionsrelaterede reaktioner og 0,1% oplevede livstruende infusionsrelaterede reaktioner (se pkt.
English: This is in case you have any side effects such as infusion-related reactions.
Danish: Det er for at holde øje med, om du får nogle bivirkninger, fx. infusionsrelaterede reaktioner.
English: The initial 600 mg dose is administered as two separate intravenous infusions; first as a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion.
Danish: Den første dosis på 600 mg administreres som to, separate intravenøse infusioner; først som en infusion á 300 mg efterfulgt, 2 uger senere, af endnu en infusion á 300 mg.
English: Patients receiving Ocrevus (Group A) were given 600 mg every 6 months (Dose 1 as 2 x 300 mg intravenous infusions, administered 2 weeks apart, and subsequent doses were administered as a single 600 mg intravenous infusion).
Danish: Patienter behandlet med Ocrevus (Gruppe A) fik 600 mg hver 6. måned (Dosis 1: 2 x 300 mg intravenøs infusion, administreret med to ugers mellemrum.
English: · Hypotension, as a symptom of IRR, may occur during Ocrevus infusions.
Danish: • Der kan, som symptom på infusionsrelaterede reaktioner, opstå hypotension under Ocrevusinfusioner.
English: If PML is suspected, dosing with Ocrevus must be withheld.
Danish: Hvis der er mistanke om progressiv multifokal leukoencefalopati, skal behandling med Ocrevus tilbageholdes.
English: However, the incidence was within the background rate expected for an MS population.
Danish: Forekomsten lå dog inden for hvad, der kan forventes for en multipel sclerose-population.
English: You will always be given Ocrevus as a drip (intra-venous infusion)
Danish: Du vil altid få Ocrevus som intravenøs infusion.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1231/001 1-vial pack EU/1/17/1231/002 2-vials pack
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1231/001 pakning med 1 hætteglas
English: What Ocrevus is
Danish: Hvad er Ocrevus?
English: In RMS, a decrease in lymphocyte < LLN was observed in 20.7% of Ocrevus patients compared with 32.6% of patients treated with interferon beta-1a.
Danish: I attakvis multipel sclerose blev der observeret et fald i lymfocytter < laveste referencegrænse hos 20,7% af Ocrevus-behandlede patienter sammenlignet med 32,6% af patienterne behandlet med interferon-beta-1a.
English: The percentage of patients with seroprotective titers against five influenza strains ranged from 20.0-60.0% and 16.7-43.8% pre-vaccination and at 4 weeks post vaccination from 55.6-80.0% in patients treated with ocrelizumab and 75.0-97.0% in the control group , respectively.
Danish: Den procentvise andel af patienter med serum-beskyttende titer mod fem influenzastammer varierede henholdsvis fra 20,0 - 60,0 % og fra 16,7 - 43,8 % før vaccination.
English: NEDA defined as absence of protocol defined relapses, 12-week Confirmed Disability Progression (CDP), and any MRI activity (either Gd-enhancing T1 lesions, or new or enlarging T2 lesions) during the whole 96-week treatment.
Danish: (CDP) og MRI-aktivitet (enten Gd-opladende T1-læsioner eller nye eller forstørrende T2-læsioner) i løbet af hele 96-ugers behandlingsperioden.
English: · It is supplied as a concentrate for solution for infusion.
Danish: • leveres som koncentrat til infusionsvæske, opløsning.
English: Instructions for dilution
Danish: Vejledning til fortynding
English: During the infusion
Danish: Under infusionen
English: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Whylen Germany
Danish: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Whylen Tyskland
English: In active-controlled (RMS) clinical trials, IRR was the most common adverse event in patients treated with Ocrevus with an overall incidence of 34.3% compared with an incidence of 9.9% in the interferon beta-1a treatment group (placebo infusion).
Danish: I de kontrollerede kliniske studier (attakvis multipel sclerose) med aktiv komparator, var infusionsrelaterede reaktioner den hyppigste bivirkning hos patienter behandlet med Ocrevus, med en overordnet incidens på 34,3% sammenlignet med en incidens på 9,9% i interferon-beta-1abehandlingsgruppen (samt placeboinfusion).
English: Premedication for infusion-related reactions
Danish: Præmedicinering for at reducere infusionsrelaterede reaktioner
English: Data are available on the effects of tetanus toxoid, 23-valent pneumococcal polysaccharide, keyhole limpet hemocyanin neoantigen, and seasonal influenza vaccines in patients receiving Ocrevus.
Danish: Der er tilgængelige data vedrørende effekt af vaccination hos patienter i behandling med Ocrevus for følgende vacciner: stivkrampe, 23-valent pneumokok polysakkarid (23-PPV), keyhole limpet hæmocyanin neoantigen samt sæsonbetonede influenzavacciner .
English: In particular tell your doctor if: · you have ever taken, are taking or are planning to take medicines that affect the immune system - such as chemotherapy, immunosuppressants or other medicines used to treat MS.
Danish: • du tidligere har taget, aktuelt tager eller planlægger at tage medicin der påvirker immunsystemet - fx kemoterapi, immunsupprimerende midler eller anden medicin mod multipel sclerose.
English: In PPMS, a decrease in lymphocytes <LLN was observed in 26.3% of Ocrevus treated patients vs 11.7% of placebo-treated patients.
Danish: I primær progressiv multipel sclerose blev der observeret et fald i lymfocytter < laveste referencegrænse hos 26,3% af Ocrevus-behandlede patienter versus 11,7% af de placebobehandlede patienter.
English: · Tell your doctor before being given Ocrevus if you are pregnant, think that you might be pregnant or are planning to have a baby.
Danish: • Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen eller apotekspersonalet til råds, før du får Ocrevus.
English: These reactions may present as pruritus, rash, urticaria, erythema, throat irritation, oropharyngeal pain, dyspnoea, pharyngeal or laryngeal oedema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea and tachycardia (see section 4.8).
Danish: Disse reaktioner kan vise sig som kløende hud, udslæt, nældefeber, rødme af huden, irritation eller smerter i halsen, åndenød, ødem i svælget eller strubehovedet, rødme, lavt blodtryk, feber, træthed, hovedpine, svimmelhed, kvalme og hjertebanken (se pkt.
English: The 600 mg infusions in RMS and the 2 x 300 mg infusions in PPMS demonstrated consistent PK/PD profiles.
Danish: Infusion af 600 mg i studierne med attakvis multipel sclerose og infusion af 2 x 300 mg i studierne med primær progressiv multipel sclerose viste samme farmakokinetiske/farmakodynamiske profiler.
English: Primary Progressive MS
Danish: Primær progressiv multipel sclerose
English: Percentage change in Timed 25-Foot Walk from baseline to Week 120 Relative reduction in progression rate of walking time
Danish: Procentdel ændring i ganghastighed, 25 fod målt på tid, fra baseline til Uge 120
English: Efficacy and safety of Ocrevus were also evaluated in a randomised, double-blind, placebo-controlled clinical trial in patients with primary progressive MS (Study WA25046) who were early in their disease course according to the main inclusion criteria, i.e. ages 18-55 years, inclusive; EDSS at screening from 3.0 to 6.5 points; disease duration from the onset of MS symptoms less than 10 years in patients with an EDSS at screening ≤5.0 or less than 15 years in patients with an EDSS at screening
Danish: Virkning og sikkerhed af Ocrevus er også evalueret i et randomiseret, dobbeltblændet, placebokontrolleret, klinisk studie med patienter med primær progressiv multipel sclerose (Studie WA25046) som var tidligt i deres sygdomsforløb i henhold til de vigtigste inklusionskriterier, dvs. i alderen fra 18 til og med 55 år.
English: What you need to know before you are given Ocrevus
Danish: Medicin du skal tage inden du får Ocrevus
English: If a patient experiences a mild to moderate IRR (e.g. headache), the infusion rate should be reduced to half the rate at the onset of the event.
Danish: Hvis patienten oplever en mild til moderate infusionsrelateret reaktion (fx hovedpine), infusionshastigheden reduceres til det halve af infusionshastigheden ved hændelsens indtræden.
English: Exposure in utero to ocrelizumab and vaccination of neonates and infants with live or live attenuated vaccines
Danish: Vaccination af nyfødte og spædbørn med levende eller svækkede levende vacciner efter eksponering for Ocrevus i livmoderen
English: Relative reduction in rate of brain volume loss
Danish: Relativ reduktion i progression af ganghastighed
English: Type 1 acute hypersensitivity reactions (IgE-mediated) may be clinically indistinguishable from IRR symptoms.
Danish: Det kan være umuligt klinisk at skelne mellem type 1 akutte overfølsomhedsreaktioner (IgE-medierede) og infusionsrelaterede reaktioner.
English: · To reduce the risk of infusion-related reaction, your doctor will give you other medicines before each infusion of Ocrevus (see section 3) and you will be closely monitored during the infusion and for at least one hour after the infusion has been given.
Danish: • For at mindske risikoen for infusionsrelaterede reaktioner, vil lægen muligvis give dig anden medicin før hver infusion med Ocrevus (se pkt.
English: After dilution, Ocrevus is administered as an intravenous infusion through a dedicated line.
Danish: Efter fortynding administreres Ocrevus som intravenøs infusion gennem separat anlagt intravenøs adgang.
English: If PML is confirmed, treatment must be discontinued permanently.
Danish: Hvis progressiv multifokal leukoencefalopati bekræftes, skal behandlingen seponeres permanent.
English: Solutions of Ocrevus for intravenous infusion are prepared by dilution of the medicinal product into an infusion bag containing 0.9% sodium chloride, to a final concentration of approximately 1.2 mg/mL.For instructions on dilution of the medicinal product before administration see section 6.6.
Danish: Opløsninger af Ocrevus til intravenøs infusion forberedes ved at lægemidlet fortyndes i en infusionspose med 0,9% natriumchlorid, til en endelig koncentration på ca. 1,2 mg/ml.
English: Your doctor may decide to delay your treatment with Ocrevus, or may decide you cannot receive Ocrevus if: · you have an infection.
Danish: Lægen kan beslutte at udskyde din behandling med Ocrevus eller, ikke at behandle dig med Ocrevus, hvis:
English: Clear to slightly opalescent, and colourless to pale brown solution.
Danish: Klar til let opaliserende og farveløs til lysebrun opløsning.
English: If there are signs of a life threatening or disabling IRR during an infusion, such as acute hypersensitivity or acute respiratory distress syndrome, the infusion must be stopped immediately and the patient should receive appropriate treatment.
Danish: Hvis der er tegn på livstruende eller invaliderende infusionsrelaterede reaktioner under en infusion, fx akut overfølsomhed eller akut lungesvigt, skal infusionen straks stoppes, og patienten skal modtage relevant behandling.
English: See sections 4.4 and 4.5.
Danish: 4.4 og 4.5.
English: This is because of a very rare and life-threatening brain infection, called ‘progressive multifocal leukoencephalopathy' (PML), which can cause symptoms similar to those of MS. PML can occur in patients taking medicines like Ocrevus, and other medicines used for treating MS. Tell your partner or carer about your Ocrevus treatment.
Danish: Det er vigtigt på grund af den meget sjældne og livstruende hjerneinfektion, progressiv multifokal leukoencefalopati (PML), som kan give symptomer, der minder om multipel sclerose-symptomer.
English: NAME OF THE MEDICINAL PRODUCT Ocrevus 300 mg concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Ocrevus 300 mg koncentrat til infusionsvæske, opløsning
English: 9.8% Ocrevus vs 15.2% IFN 40% (p=0.0006)7
Danish: 9,8% Ocrevus vs. 15,2% Interferon-beta-1a 40% (p=0,0006)7 43% (p=0,0139)7
English: Ocrevus will be stored by the healthcare professionals at the hospital or clinic under the following conditions: · This medicine is to be kept out of the sight and reach of children.
Danish: Ocrevus opbevares af sundhedspersonalet på hospitalet under følgende forhold:
English: Infusion instructions
Danish: Infusionsvejledning
English: B-cell depletion in utero was detected.
Danish: Der er påvist fald i Bcelle-niveauet i livmoderen.
English: Common: may affect up to 1 in 10 people sinus infection bronchitis (bronchial tube inflammation) herpes infection (cold sore or shingles).
Danish: bihulebetændelse bronkitis herpes (forkølelsessår eller helvedesild).
English: Moreover, post-hoc analyses suggested that younger patients with T1 Gd-enhancing lesions at baseline have the better treatment effect (≤ 45 years: HR 0.52 [0.27-1.00]; ≤ 46 years [median age of the
Danish: Desuden antyder post-hoc-analyser, at der er en bedre behandlingseffekt for yngre patienter med Gdopladende T1-læsioner ved baseline ≤ 45 år: (Hazard ratio 0,52 [0,27-1,00]); ≤ 46 år (medianalder i WA25046 studiet); (Hazard ratio 0,48 [0,25-0,92]); <51 år: (Hazard ratio 0,53 [0,31-0,89]).
English: Laboratory Abnormalities
Danish: Laboratorieafvigelser
English: See section 4.4 and 5.1.
Danish: 4.4 og 5.1.
English: In a randomized open-label study, RMS patients were able to mount humoral responses, although decreased, to tetanus toxoid, 23-valent pneumococcal polysaccharide with or without a booster vaccine, keyhole limpet hemocyanin neoantigen, and seasonal influenza vaccines.
Danish: Det blev undersøgt for stivkrampevaccine, 23-valent pneumokok polysakkaridvaccine (PPV-23) med eller uden en booster, keyhole limpet hæmocyanin neoantigen samt sæsonbetonede influenzavacciner.
English: Study design and baseline characteristics of the study population are summarised in Table 3.
Danish: Studiedesign og baselinekarakteristika for forsøgspopulationen opsummeres i Tabel
English: Infusion Adjustments in case of IRRs
Danish: Infusionsjusteringer i tilfælde af infusionsrelaterede reaktioner
English: Based on the limited data available (see section 5.1 and section 5.2), no posology adjustment is needed in patients over 55 years of age.
Danish: 5.2), er det ikke nødvendigt at justere dosis hos patienter over 55 år.
English: Therefore, after Dose 1 it is recommended to administer Ocrevus in a 600 mg single infusion (see section 4.2) to reduce the total number of infusions (with concurrent exposure to prophylactic methylprednisolone and an antihistamine) and the related infusion reactions).
Danish: 4.2) for at reducere det samlede antal infusioner (og tilsvarende eksponering for profylaktisk methylprednisolon og antihistamin) og de relaterede infusionsrelaterede reaktioner.
English: IRR profiles per infusion were also similar, independent of whether the 600 mg dose was administered as a single 600 mg infusion or as two 300 mg infusions separated by two weeks (see sections 4.8 and 5.2), but due to overall more infusions with the 2 x 300 mg regimen, the total number of IRRs were higher.
Danish: Profilerne for infusionsrelaterede reaktion svarede også til hinanden, uafhængigt af, om 600 mg blev administreret som enkeltdosis infusion eller som 2 x 300 mg infusioner med 2 ugers mellemrum (se pkt.
English: Across the RMS and PPMS trials, symptoms associated with IRRs included, but are not limited to: pruritus, rash, urticaria, erythema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, throat irritation, oropharyngeal pain, dyspnoea, pharyngeal or laryngeal oedema, nausea, tachycardia.
Danish: På tværs af attakvis multipel sclerose- og primær progressiv multipel sclerose-studierne omfattede symptomer i forbindelse med infusionsrelaterede reaktioner bl.a.: kløende hud, udslæt, nældefeber, rødme af huden, irritation eller smerter i halsen, åndenød, ødem i svælget eller strubehovedet, rødme, lavt blodtryk, feber, træthed, hovedpine, svimmelhed, kvalme og hjertebanken.
English: There is no experience in patients with moderate and severe renal impairment.
Danish: Der er ingen erfaring med patienter med moderat og svær nedsat nyrefunktion.
English: · You might get infections more easily with Ocrevus.
Danish: • Din risiko for at få infektioner stiger, når du får Ocrevus.
English: Proportion of patients with 24 week Confirmed Disability Progression Risk Reduction (Pooled Analysis Risk Reduction (Individual Studies2)
Danish: Risikoreduktion (poolet analyse1) Risikoreduktion (individuelle studier2)
English: Roche (Hellas) A.E. Τηλ: +30 210 61 66 100
Danish: Τηλ: +30 210 61 66 100
English: Mean/Median disease duration since diagnosis (years) Patients naive to previous DMT
Danish: Gennemsnitlig/median varighed af sygdom siden siden diagnose af primær progressiv multipel sclerose (år)
English: · Current active infection (see section 4.4) · Patients in a severely immunocompromised state (see section 4.4 ).
Danish: • Patienter i en svær immunkompromitteret tilstand (se pkt.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use For intravenous use after dilution Do not shake the vial
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
English: Due to the potential depletion of B cells in infants of mothers who have been exposed to Ocrevus during pregnancy, it is recommended that vaccination with live or live-attenuated vaccines should be delayed until B-cell levels have recovered; therefore, measuring CD19-positive B-cell levels, in neonates and infants, prior to vaccination is recommended It is recommended that all vaccinations other than live or live-attenuated should follow the local immunisation schedule and measurement of vaccine-induced response titers should be considered to check whether individuals have mounted a protective immune response because the efficacy of the vaccination may be decreased.
Danish: På grund af muligt fald i B-celleniveauet hos spædbørn, hvis mødre har fået Ocrevus under graviditeten, anbefales det, at vaccination med levende eller svækkede levende vacciner bør udskydes indtil B-celleniveauet er normaliseret.
English: Patients with a known active malignancy should not be treated with
Danish: Patienter med kendt aktiv malignitet må ikke behandles med Ocrevus (se pkt.
English: Management of IRRs before the infusion
Danish: Håndtering af infusionsrelaterede reaktioner inden infusion
English: · If you have any further questions, ask your doctor.
Danish: • Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Immunosuppressants
Danish: Immunsupprimerende midler
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof
English: Table 2 ADRs reported with Ocrevus (in RMS or PPMS)
Danish: Tabel 2 Bivirkninger indberettet for Ocrevus (til attakvis multipel sclerose og primær progressiv multipel sclerose)
English: The following infections have been seen in patients treated with Ocrevus in MS: - Very common: may affect more than 1 in 10 people upper respiratory tract infection flu.
Danish: Meget almindelig (opleves af mere end 1 ud af 10 patienter) - infektion i øvre luftveje - influenza
English: Table 1: Dose and Schedule of Ocrevus
Danish: Tabel 1: Dosis- og doseringsskema for Ocrevus Mængde Ocrevus, der skal administreres
English: Do not use diluents other than the one detailed in section 6.6 to dilute Ocrevus since its use has not been tested.
Danish: 6.6, da anvendelse heraf ikke er undersøgt.
English: Infusion 1 300 mg in 250 mL · Initiate the infusion at a rate of 30 mL/hour for 30 minutes
Danish: • Påbegynd infusionen med en hastighed på 30 ml/time i 30 minutter
English: How to store Ocrevus
Danish: Sådan skal du bruge Ocrevus
English: IV after dilution
Danish: Intravenøst efter fortynding
English: Preclinical data reveal no special hazards for humans based on studies of male and female fertility in cynomologous monkeys.
Danish: Prækliniske data fra studier af han- og hun-cynomologusabers fertilitet tyder ikke på nogen særlig risiko for mennesker.
English: There is no PK information available in patients with moderate or severe renal impairment.
Danish: Der foreligger ingen farmakokinetisk information vedrørende patienter med moderat eller svært nedsat nyrefunktion.
English: Proportion of patients with Gd enhancing T1 lesions Mean EDSS*
Danish: Andel af patienter med Gdopladende T1-læsioner
English: No increase was observed in PPMS.
Danish: Ingen stigning blev observeret ved primær progressiv multipel sclerose.
English: IFN 44 mcg (n=418)
Danish: Interferonbeta-1a 44 mikrog (n=418)
English: Mean age (years) Age range (years) at inclusion Gender distribution (% male/% female) Mean/Median disease duration since PPMS diagnosis (years) Mean EDSS
Danish: Gennemsnitlig/median varighed af sygdom siden diagnosticering (år)
English: In controlled trials there were no fatal IRRs.
Danish: Der var ingen dødelige infusionsrelaterede reaktioner i de kontrollerede kliniske studier.
English: Defined as an increase of ≥ 1.0 point from the baseline Expanded Disability Status Scale (EDSS) score for patients with baseline score of 5.5 or less, or ≥ 0.5 when the baseline score is > 5.5, Kaplan-Meier estimates at Week 96
Danish: eller derunder eller ≥0,5 hvis baseline-scoren er >5,5; Kaplan-Meier-estimater ved uge 96 4 Defineret som et fald på ≥1,0 point fra baseline EDSS-score for patienter med baseline EDSS-score ≥2
English: There is no PK information available in patients with moderate or severe hepatic impairment.
Danish: Der foreligger ingen farmakokinetisk information vedrørende patienter med moderat eller svært nedsat leverfunktion.
English: Single infusion 600 mg in 500 mL · Initiate the infusion at a rate of 40 mL/hour for 30 minutes
Danish: • Påbegynd infusionen med en hastighed på 40 ml/time i 30 minutter