FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the severity of the side effect, your doctor may slow or temporarily interrupt the infusion and/ or give you additional medicines to reduce the effects of a severe allergic reaction (e.g. antihistamines and/or corticosteroids) or to reduce fever (antipyretics).
Danish: Alt efter hvor alvorlig bivirkningen er, kan lægen give infusionen langsommere eller midlertidigt afbryde infusionen og/eller give dig ekstra medicin for at mindske virkningen af en svær allergisk reaktion (f.eks. antihistaminer og/eller kortikosteroider) eller for at reducere feberen (antipyretika).
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på æsken og hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Patients received elosulfase alfa 2 mg/kg every week (n=58) or 2 mg/kg every other week (n=59), or placebo (n=59) for a total of 24 weeks.
Danish: Patienterne fik elosulfase alfa 2 mg/kg hver uge (n= 58) eller 2 mg/kg hver anden uge (n= 59) eller placebo (n= 59) i i alt 24 uger.
English: Other medicines and Vimizim Please tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Vimizim Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: The diluted solution is to be mixed gently prior to infusion.
Danish: Den fortyndede opløsning skal blandes forsigtigt før infusion.
English: Enzyme uptake by cells into lysosomes is mediated by cation independent mannose-6-phosphate receptors leading to restored GALNS activity and clearance of KS and C6S.
Danish: Enzymoptag af celler i lysosomer formidles af kation-uafhængige mannose-6phosphat-receptorer, hvilket fører til genoprettet GALNS-aktivitet og clearance af KS og C6S.
English: This medicine contains 8 mg sodium (main component of cooking/table salt) in each 5 ml vial.
Danish: Dette lægemiddel indeholder 8 mg natrium (hovedkomponent af madlavnings-/bordsalt) pr. hætteglas på 5 ml.
English: The recommended dose of elosulfase alfa is 2 mg/kg of body weight administered once a week.
Danish: Den anbefalede dosis elosulfase alfa er 2 mg/kg legemsvægt, som administreres én gang ugentligt.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes.
Danish: Pharmakoterapeutisk klassifikation: Andre mave-tarm-kanal og fordøjelsesprodukter, enzymer.
English: It is not known whether Vimizim is excreted in breast milk.
Danish: Det vides ikke, om Vimizim udskilles i modermælk.
English: CL, ml/minute/kg‡ t1/2, minute§
Danish: AUC0-t, minut • µg/ml* Cmax, µg/ml† CL, ml/minut/kg‡ t1/2, minut§
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (Sterile concentrate).
Danish: LÆGEMIDDELFORM Koncentrat til infusionsvæske, opløsning (sterilt koncentrat).
English: Infusion reactions (IRs) were the most commonly observed adverse reactions in clinical studies.
Danish: Infusionsreaktioner var de hyppigst observerede bivirkninger i kliniske studier.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg elosulfase alfa*.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml opløsning indeholder 1 mg elosulfase alfa*.
English: If severe IRs occur, immediately stop the infusion and initiate appropriate treatment.
Danish: Hvis der forekommer svære infusionsreaktioner, skal infusionen straks standses, og passende behandling indledes.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 5 ml VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER 5 ml HÆTTEGLAS
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 mg/5 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 5 mg/5 ml
English: This medicinal product contains 8 mg sodium per vial, equivalent to 0.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult, and is administered in sodium chloride 9 mg/ml (0.9%) solution for infusion (see section 6.6).
Danish: Dette lægemiddel indeholder 8 mg natrium pr. hætteglas svarende til 0,4 % af WHO's anbefalede maksimale daglige indtag på 2 g natrium for en voksen og administreres i en 9 mg/ml (0,9 %) natriumchloridinfusionsvæske (se pkt.
English: The assessment of adverse reactions is based on the exposure of 176 patients with MPS IVA, ages 5 to 57 years old to 2 mg/kg elosulfase alfa once a week (n=58), 2 mg/kg elosulfase alfa once every other week (n=59), or placebo (n=59) in a randomised, double-blind, placebo-controlled study.
Danish: Vurderingen af bivirkninger er baseret på eksponering af 176 patienter med MPS IVA i alderen 5 til 57 år for 2 mg/kg elosulfase alfa en gang om ugen (n= 58), 2 mg/kg elosulfase alfa en gang hver anden uge (n= 59) eller placebo (n= 59) i et randomiseret, dobbelt-blindet, placebo-kontrolleret studie.
English: Dizziness was reported in some patients during the Vimizim infusion.
Danish: Svimmelhed blev rapporteret hos nogle patienter i løbet af insusionen med Vimizim.
English: The diluted solution is to be visually inspected for particulate matter prior to use.
Danish: Den fortyndede opløsning skal inspiceres visuelt for partikler før brug.
English: Vimizim contains sodium and sorbitol (E 420)
Danish: Vimizim indeholder natrium og sorbitol (E420)
English: Diluted Vimizim solution is to be administered to patients using an infusion set.
Danish: Fortyndet Vimizimopløsning skal administreres til patienterne med et infusionssæt.
English: o all patients should receive antihistamines with or without antipyretics 30-60 minutes prior to the start of infusion o appropriate medical support should be readily available when VIMIZIM® is administered o the need to immediately stop the infusion and initiate appropriate medical treatment if these reactions occurred
Danish: • risikoen for anafylakse og svære allergiske reaktioner og de nødvendige foranstaltninger for at mindske dette: o alle patienter skal gives antihistamin med eller uden antipyretika 30-60 minutter o inden infusionen startes o passende medicinsk hjælp skal være let tilgængeligt, når VIMIZIM® indgives o behovet for at stoppe infusionen øjeblikkeligt og påbegynde relevant medicinsk o behandling, hvis disse reaktioner opstår
English: Preparation of the Vimizim infusion
Danish: Forberedelse af Vimiziminfusion
English: Do not heat or microwave vials.
Danish: Hætteglas må ikke opvarmes eller sættes i mikrobølgeovn.
English: Vimizim is slowly added to the infusion bag using care to avoid agitation.
Danish: Vimizim tilføjes langsomt til infusionsposen med forsigtighed for at undgå omrystning.
English: Elosulfase alfa is intended to provide the exogenous enzyme N-acetylgalactosamine-6-sulfatase that will be taken up into the lysosomes and increase the catabolism of the GAGs KS and C6S.
Danish: Elosulfase alfa er beregnet til at tilvejebringe den eksogene enzym N-acetylgalaktosamin-6-sulfatase, som vil blive optaget i lysosomerne og øge katabolismen af GAG'er, KS og C6S.
English: * Infusion rate may be increased as tolerated by patient.
Danish: * infusionshastigheden kan øges alt efter, hvordan det tåles af patienten.
English: How to store Vimizim 6.
Danish: Sådan skal du tage Vimizim 4.
English: Serious IRs were observed in clinical studies and included anaphylaxis, hypersensitivity and vomiting.
Danish: Svære infusionsreaktioner blev observeret i kliniske studier og omfattede anafylaksi, overfølsomhed og opkastning.
English: What you need to know before you are given Vimizim
Danish: Det skal du vide, før du begynder at tage Vimizim
English: The recommended dose regimen is 2 mg/kg body weight administered once every week through a drip into a vein (by intravenous infusion).
Danish: Det anbefalede doseringsregime er 2 mg/kg kropsvægt, som administreres én gang ugentligt gennem et drop i en vene (ved intravenøs infusion).
English: Sodium acetate trihydrate Sodium dihydrogen phosphate monohydrate Arginine hydrochloride Sorbitol (E 420)
Danish: Natriumacetattrihydrat Natriumdihydrogenphosphatmonohydrat Argininhydrochlorid Sorbitol (E420)
English: Other very common adverse reactions were diarrhoea, mouth and throat pain, dizziness and trouble breathing.
Danish: Andre meget almindelige bivirkninger er diarré, smerter i mund og hals, svimmelhed og åndedrætsbesvær.
English: March 2025
Danish: Indsendelse af endelig forsøgsrapport: Marts 2025
English: The active substance is elosulfase alfa.
Danish: Aktivt stof/aktive stoffer: elosulfase alfa.
English: The recommended dose regimen for adults and children is 2 mg/kg body weight given once every week through a drip into a vein (intravenous infusion).
Danish: Det anbefalede doseringsregime for voskne og børn er 2 mg/kg kropsvægt, som givet én gang ugentligt gennem et drop i en vene (intravenøs infusion).
English: An infusion set equipped with an in-line 0.2 µm filter can be used.
Danish: Et infusionssæt udstyret med et in-line filter på 0,2 µm kan anvendes.
English: • Patient dose (mg) divided by 1 (mg/ml concentrate of Vimizim) = Total number of ml of
Danish: • Patientens dosis (mg) divideret med 1 (mg/ml koncentrat Vimizim) = samlet antal ml af
English: The modelled treatment effect for the percent change in urine KS, compared to placebo, was -40.7 % (CI95, -49.0, -32.4; p<0.0001) for the 2 mg/kg per week regimen.
Danish: Den modellerede behandlingseffekt for den procentvise ændring i KS i urinen sammenlignet med placebo var -40,7 % (CI95, -49,0, -32,4; P<0,0001) for regimet med 2 mg/kg per uge.
English: * One patient in the Vimizim group dropped out after 1 infusion ‡ Model-based mean of Vimizim versus placebo, adjusted for baseline
Danish: ‡ Model-baseret middel af Vimizim versus placebo, justeret for baseline
English: Babies and young children (below 2 years of age) may not yet be diagnosed with hereditary fructose intolerance (HFI).
Danish: Babyer og småbørn (under 2 år) kan have hereditær fructoseintolerans (HFI) uden at være diagnosticeret for det. Lægemidler indeholdende sorbitol/fructose givet intravenøst kan være livstruende.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vimizim 1 mg/ml sterile concentrate elosulfase alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Vimizim 1 mg/ml sterilt koncentrat elosulfase alfa
English: Each vial contains 5 mg elosulfase alfa in 5 ml of solution (1 mg/ml).
Danish: Hvert hætteglas indeholder 5 mg elosulfase alfa i en 5 ml opløsning (1 mg/ml).
English: Before withdrawing Vimizim from the vial, each vial is visually inspected for particulate matter and discoloration.
Danish: Inden Vimizim trækkes op af hætteglasset, skal hvert hætteglas inspiceres visuelt for partikler og misfarvning.
English: The clear to slightly opalescent and colourless to pale yellow concentrate must be free of visible particles.
Danish: Det klare til let opaliserende og farveløse til svagt gule koncentrat skal være frit for synlige partikler.
English: This medicinal product contains 100 mg sorbitol in each vial which is equivalent to 40 mg/kg.
Danish: Dette lægemiddel indeholder 100 mg sorbitol pr. hætteglas, hvilket svarer til 40 mg/kg.
English: The diluted solution is administered to patients using an infusion set.
Danish: Den fortyndede opløsning administreres til patienterne med et infusionssæt.
English: The Vimizim solution should be clear to slightly opalescent and colourless to pale yellow.
Danish: Vimizimopløsningen skal være klar til let opaliserende og farveløs til svagt gul.
English: Vimizim 1 mg/ml concentrate for solution for infusion elosulfase alfa
Danish: Vimizim 1 mg/ml koncentrat til infusionsvæske, opløsning elosulfase alfa
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: An infusion set equipped with an in-line 0.2 μm filter can be used.
Danish: Et infusionssæt, der er udstyret med et 0,2 μm in-line-filter, kan anvendes.
English: For single use only Read the package leaflet before use.
Danish: Kun til engangsbrug Læs indlægssedlen inden brug Til intravenøst brug efter fortynding
English: At Week 104 mean (±SD) normalised standing height z-score was -3.1 (±
Danish: I uge 104 var den gennemsnitlige (±SD) normaliserede ståhøjdes z-score -3,1 (±1,13).
English: The clear to slightly opalescent and colourless to pale yellow solution must be free of visible particles.
Danish: Den klare til let opaliserende og farveløse til svagt gule opløsning skal være fri for synlige partikler.
English: A volume of the sodium chloride 9 mg/ml (0.9 %) solution for infusion is to be withdrawn and discarded from a 100 ml or 250 ml infusion bag equal to the total volume of Vimizim to be added.
Danish: En mængde natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning trækkes ud og kasseres fra en 100 ml eller 250 ml infusionspose svarende til den samlede mængde Vimizim, der skal tilføjes.
English: Infusion rate may be increased as tolerated by patient.
Danish: Infusionshastigheden kan forøges alt efter, hvordan det tåles af patienten.
English: No impairment of fertility has been observed in nonclinical studies (see section 5.3) with elosulfase alfa.
Danish: Der er ikke observeret nogen forringelse af fertiliteten i ikke-kliniske studier (se pkt.
English: The modelled treatment effect in stairs climbed per minute, compared to placebo, was 1.1 stairs/minute (CI95, -2.1, 4.4; p=0.4935) for the 2 mg/kg per week regimen.
Danish: Den modellerede behandlingseffekt på trappetrin besteget pr. minut sammenlignet med placebo var 1,1 trapper/minut (CI95, -2,1 og 4,4; P= 0,4935) for regimet med 2 mg/kg per uge.
English: Sodium dihydrogen phosphate monohydrate; Arginine hydrochloride;
Danish: Natriumdihydrogenphosphatmonohydrat; Argininhydrochlorid;
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Anafylaksi og svære allergiske reaktioner
English: This medicine contains 100 mg sorbitol in each 5 ml vial which is equivalent to 40 mg/kg.
Danish: Dette lægemiddel indeholder 100 mg sorbitol pr. hætteglas på 5 ml, svarende til 40 mg/kg.
English: For management of adverse reactions, see sections 4.4 and 4.8.
Danish: 4.4 og 4.8 for håndtering af utilsigtede reaktioner.
English: The modelled treatment effect in the distance walked in 6 minutes, compared to placebo, was 22.5 m (CI95, 4.0, 40.9; p=0.0174) for the 2 mg/kg per week regimen.
Danish: Den modellerede behandlingseffekt i tilbagelagt afstand på 6 minutter sammenlignet med placebo var 22,5 m (CI95, 4,0 40,9; P= 0,0174) for regimet med 2 mg/kg per uge.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse
English: NAME OF THE MEDICINAL PRODUCT Vimizim 1 mg/ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Vimizim 1 mg/ml koncentrat til infusionsvæske, opløsning
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and should normally not be longer than 24 hours at 2C - 8C followed by up to 24 hours at 23C - 27C during administration.
Danish: Hvis det ikke anvendes med det samme, er ibrug-opbevaringstider og forhold brugerens ansvar og bør normalt ikke være længere end 24 timer ved 2 C - 8 C efterfulgt af op til 24 timer ved 23 C - 27 C under administration.
English: Do not use if the solution is discoloured or if there is particulate matter in the solution 10.
Danish: Opløsningen må ikke bruges, hvis den er misfarvet, eller hvis der er partikler i opløsningen 10.
English: When diluted in 250 ml, the initial infusion rate should be 6 ml/hr.
Danish: Når lægemidlet fortyndes i 250 ml, bør den indledende infusionshastighed være 6 ml/time.
English: Spinal/Cervical cord compression
Danish: Kompression af medulla spinalis cervicalis
English: Respiratory, thoracic, and mediastinal disorders
Danish: Luftveje, thorax og mediastinum Dyspnø
English: Pack sizes: 1 vial of 5 ml
Danish: Pakningsstørrelser: 1 hætteglas på 5 ml
English: Before dilution, each vial is to be inspected for particulate matter and discolouration.
Danish: Før fortynding skal hvert hætteglas efterses for partikler og misfarvning.
English: Dizziness was reported during Vimizim infusions; if dizziness occurs after the infusion, the ability to drive and use machines may be affected.
Danish: Hvis svimmelhed forekommer efter infusionen, kan evnen til at føre motorkøretøj og betjene maskiner være påvirket.
English: People with MPS IVA disease either lack completely or do not have enough N-acetylgalactosamine-6sulfatase, an enzyme which breaks down specific substances in the body such as keratan sulphate, which are found in many tissues of the body, including cartilage and bone.
Danish: N-acetylglaktosamin-6-sulfatase er et enzym, som nedbryder specifikke stoffer i kroppen som f.eks. keratansulfat, som findes i mange af kroppens væv inklusive brusk og knogler.
English: BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork Ireland
Danish: BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork Irland
English: Each ml of concentrate contains 1 mg elosulfase alfa.
Danish: Hver ml koncentreret Vimizim indeholder 1 mg elosulfase alfa.
English: IV use after dilution
Danish: I.v.brug efter fortynding
English: When diluted in 100 ml, the initial infusion rate should be 3 ml/hr.
Danish: Når lægemidlet fortyndes i 100 ml, bør den indledende infusionshastighed være 3 ml/time.
English: The volume of Vimizim is to be slowly added to the sodium chloride 9 mg/ml (0.9 %) solution for infusion.
Danish: Mængden af Vimizim skal langsomt tilføjes til natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning.
English: 2D barcode carrying the unique identifier included
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator 18.
English: Pack sizes: 1 vial
Danish: Pakningsstørrelser: 1 hætteglas.
English: A volume of the sodium chloride 9 mg/ml (0.9 %) solution for infusion is to be withdrawn and discarded from the infusion bag, equal to the volume of Vimizim concentrate to be added.
Danish: En mængde 9 mg/ml (0,9 %) natriumchloridinfusionsvæske skal trækkes ud og kasseres fra infusionsposen, svarende til den mængde Vimizimkoncentrat, der skal tilføjes.
English: When diluted with 250 ml sodium chloride 9 mg/ml (0.9 %) solution for infusion; the initial rate will be 6 ml/hr.
Danish: Når lægemidlet fortyndes med 250 ml 9 mg/ml (0,9 %) natriumchlorid infusionsvæske, opløsning: Den indledende hastighed vil være 6 ml/t.
English: How Vimizim works
Danish: Sådan virker Vimizim
English: Each vial of 5 ml contains 5 mg elosulfase alfa.
Danish: Hvert hætteglas på 5 ml indeholder 5 mg elosulfase alfa.
English: Vimizim has to be diluted with sodium chloride 9 mg/ml (0.9 %) solution for infusion using aseptic technique.
Danish: Vimizim skal fortyndes med natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning ved brug af aseptisk teknik.
English: A clear to slightly opalescent and colourless to pale yellow solution.
Danish: En klar til let opaliserende og farveløs til svagt gul opløsning.
English: What Vimizim looks like and contents of the pack Vimizim is supplied as a concentrate for solution for infusion (sterile concentrate).
Danish: Vimizim leveres som et koncentrat til infusionsvæske, opløsning (sterilt koncentrat).
English: • Total amount (ml) Vimizim divided by 5 ml per vial = Total number of vials 2.
Danish: • Samlet mængde (ml) Vimizim divideret med 5 ml pr. hætteglas = samlet antal hætteglas 2.
English: When diluted with 100 ml sodium chloride 9 mg/ml (0.9 %) solution for infusion; the initial rate will be 3 ml/hr.
Danish: Når lægemidlet fortyndes med 100 ml 9 mg/ml (0,9 %) natriumchlorid infusionsvæske, opløsning: Den indledende hastighed vil være 3 ml/t.
English: • Total amount (ml) Vimizim divided by 5 ml per vial = Total number of vials
Danish: • Samlet mængde (ml) Vimizim divideret med 5 ml pr. hætteglas = samlet antal hætteglas
English: Patients weighing less than 25 kg should receive a total volume of 100 ml.
Danish: Patienter, der vejer mindre end 25 kg, skal modtage et samlet volumen på 100 ml.
English: Do not use if the solution is discoloured or if there is particulate matter in the solution.
Danish: Opløsningen må ikke bruges, hvis den er misfarvet, eller hvis der er partikler i opløsningen.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN BioMarin International Limited
English: • Patients weighing less than 25 kg should receive a total volume of 100 ml.
Danish: • Patienter, der vejer mindre end 25 kg, skal have et samlet volumen på 100 ml.
English: Patients weighing 25 kg or more should receive a total volume of 250 ml.
Danish: Patienter, der vejer 25 kg eller derover, skal modtage et samlet volumen på 250 ml.
English: How to store Vimizim
Danish: Sådan skal du tage Vimizim
English: Cmax, µg/ml†
Danish: Tmax, minut¶
English: • Patients weighing 25 kg or more should receive a total volume of 250 ml.
Danish: • Patienter, der vejer mere end 25 kg, skal have et samlet volumen på 250 ml.
English: Dizziness
Danish: Kuldegysninger
English: Step 5 minutes (ml/hr)
Danish: Trin 5 minutt er (ml/t)
English: Step 7 minutes (ml/hr)
Danish: Trin 7 minutt er (ml/t)
English: N 58 6-Minute walk test (meters) Mean SD
Danish: N 6-minutters gangtest (m) Middel ± SD
English: An infusion bag containing sodium chloride 9 mg/ml (0.9 %) solution for infusion is obtained suitable for intravenous administration.
Danish: En infusionspose, som er velegnet til intravenøs administration, og som indeholder natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning, fremskaffes.
English: 3-Minute stair climb test (stairs/minute)
Danish: 3-minutters trappetest (trin/minut) Middel ± SD
English: concentrate for solution for infusion 1 vial
Danish: koncentrat til infusionsvæske, opløsning 1 hætteglas
English: The infusion rate will be increased every 15 minutes as follows: first increase the rate to 12 ml/hr, then increase the rate every 15 minutes by 12 ml/hr increments until a maximum rate of 72 ml/hr is reached.
Danish: Infusionshastigheden vil blive øget hvert 15. minut, som følger: Øg først hastigheden til 12 ml/t, øg derefter hastigheden hvert 15. minut i trin på 12 ml/t, indtil der opnås en maksimal hastighed på 72 ml/t.
English: Step 2 minutes (ml/hr)
Danish: Trin 2 minutt er (ml/t)
English: The infusion rate will be increased every 15 minutes as follows: first increase the rate to 6 ml/hr, then increase the rate every 15 minutes by 6 ml/hr increments until a maximum rate of 36 ml/hr is reached.
Danish: Infusionshastigheden vil blive øget hvert 15. minut på følgende måde: Øg først hastigheden til 6 ml/t, øg derefter hastigheden hvert 15. minut i trin på 6 ml/t, indtil der opnås en maksimal hastighed på 36 ml/t.
English: Step 4 minutes (ml/hr)
Danish: Trin 4 minutt er (ml/t)
English: Step 6 minutes (ml/hr)
Danish: Trin 6 minutt er (ml/t)
English: The infusion rate may be increased as tolerated, every 15 minutes as follows: first increase the rate to 12 ml/hr, then increase the rate every 15 minutes by 12 ml/hr increments until a maximum rate of 72 ml/hr is reached.
Danish: Infusionshastigheden kanalt efter hvordan det tåles - øges hver 15. minut, som følger: øg først hastigheden til 12 ml/time, øg derefter hastigheden hver 15. minut i trin på 12 ml/time, indtil der nås en maksimal hastighed på 72 ml/time.
English: Step 3 minutes (ml/hr)
Danish: Trin 3 minutt er (ml/t)
English: The infusion rate may be increased as tolerated, every 15 minutes as follows: first increase the rate to 6 ml/hr, then increase the rate every 15 minutes by 6 ml/hr increments until a maximum rate of 36 ml/hr is reached.
Danish: Infusionshastigheden kanalt efter hvordan det tåles - øges hver 15 minutter på følgende måde: øg først hastigheden til 6 ml/time, øg derefter hastigheden hver 15. minut i trin på 6 ml/time, indtil der opnås en maksimal hastighed på 36 ml/time.
English: Do not shake vials.
Danish: Hætteglas må ikke rystes.
English: EU/1/13/847/001 MACI
Danish: EU/1/13/847/001