FrancophonIA/ELRC3.0 huggingface dataset:
English: This solution is now referred to as the concentrated solution and contains 10,000 nanograms/mL Flolan.
Danish: Denne opløsning kaldes nu den koncentrerede opløsning og indeholder 10.000 nanogram Flolan/ml.
English: • medicines used to dissolve blood clots
Danish: • medicin som opløser blodpropper
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne:> [Se bilag I - Udfyldes nationalt]
English: INSTRUCTIONS ON USE [To be completed nationally] INFORMATION IN BRAILLE [To be completed nationally]
Danish: INFORMATION I BRAILLESKRIFT [Udfyldes nationalt]
English: To dilute the concentrated solution, draw it up into a larger syringe and then attach the sterile filter provided to the syringe.
Danish: For at fortynde den koncentrerede opløsning skal man trække den op i en større injektionssprøjte og derefter fastgøre det vedlagte filter på injektionssprøjten.
English: The infusion rate may be calculated from the formula given above for renal dialysis.
Danish: Infusionshastigheden kan beregnes ved hjælp af formlen ved hæmodialyse ovenfor.
English: The pack suitable for use in renal dialysis contains 0.5 mg freeze-dried Flolan plus 50 mL solvent.
Danish: Pakningen, som er egnet til anvendelse ved hæmodialyse, indeholder 0,5 mg frysetørret Flolan og 50 ml solvens.
English: Powder for solution for infusion: Mannitol
Danish: Pulver til infusionsvæske, opløsning: Mannitol E421
English: Severity of bleeding in those patients was improved more frequently with epoprostenol the day prior to dialysis and on dialysis day (predialysis: N=4/8; dialysis: N=6/16) than with heparin (predialysis: N=4/13; dialysis:
Danish: Hos disse patienter blev sværhedsgraden hyppigere forbedret ved brug af epoprostenol dagen før dialyse og på dialyse-dagen (præ-dialyse: N=4/8; dialyse: N=6/16) sammenlignet med heparin (præ-dialyse: N=4/13; dialyse: N=4/25).
English: The infusion rate is initiated at 2 nanograms/kg/min and increased by increments of 2 nanograms/kg/min every 15 min or longer until maximum haemodynamic benefit or dose-limiting pharmacological effects are elicited.
Danish: Der begyndes med en infusionshastighed på 2 nanogram/kg/min, og dosis øges med 2 nanogram/kg/min hvert 15. minut eller mere, indtil maksimalt hæmodynamisk respons er opnået, eller dosis-begrænsende farmakologiske virkninger ses.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Epoprostenol 0.5mg Powder for Solution for Infusion:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Epoprostenol 0,5 mg pulver og solvens til infusionsvæske, opløsning:
English: If you have any of the liquid left over, it must be thrown away.
Danish: Er der opløsningsvæske tilbage efter brug, skal det kasseres.
English: In major controlled studies, when all dialyses were combined for each treatment (heparin or epoprostenol), more heparin patients bled during the day prior to dialysis (N=13/17 vs. 8/23), dialysis day (N=25/28 vs. 16/35) and the day following dialysis (N=16/24 vs. 5/24) than epoprostenol patients during the same time periods.
Danish: Når alle dialyser med de 2 behandlinger (heparin eller epoprostenol) i de vigtigste studier blev slået sammen, blødte flere heparin-patienter i løbet af dagen før dialyse (N=13/17 vs. 8/23), på dialysedagen (N=25/28 vs. 16/35) og dagen efter dialysen (N=16/24 vs. 5/24) sammenlignet med, hvad epoprostenol-patienterne gjorde i løbet af samme tidsperioder.
English: 4.5 Interaction with other medicinal products and other forms of interaction When Flolan is administered to patients receiving concomitant anticoagulants standard anticoagulant monitoring is advisable.
Danish: Når Flolan administreres til patienter, som samtidigt får antikoagulantia, anbefales det, at standardkoagulationsparametre monitoreres.
English: Powder for solution for infusion: Clear (type 1) glass vials with synthetic butyl rubber stoppers and an aluminium collar with a snap-off top.
Danish: Hætteglas af klart (type 1)-glas med syntetisk butylgummiprop og aluminiumskrage med ”snap-off” top.
English: Very rare side effects These may affect up to 1 in 10,000 people:
Danish: Meget sjældne bivirkninger Disse kan forekomme hos op til 1 ud af 10.000 personer:
English: There are no data regarding the effect of Flolan used in renal dialysis on the ability to drive or operate machinery.
Danish: Der er ingen data om virkningen af Flolan på evnen til at føre motorkøretøj eller betjene maskiner efter administration af Flolan i forbindelse med hæmodialyse.
English: One ml of reconstituted concentrate solution contains epoprostenol (as epoprostenol sodium) 10 000 nanogram.
Danish: En ml rekonstitueret koncentreret opløsning indeholder 10.000 nanogram epoprostenol (som epoprostenolnatrium).
English: Flolan contains the active substance epoprostenol which belongs to a group of medicines called prostaglandin, which stops blood from clotting and widens the blood vessels.
Danish: Flolan indeholder det aktive stof epoprostenol, som tilhører en lægemiddelgruppe kaldet prostaglandiner.
English: 0.5 mg freeze-dried Flolan powder and shake gently until the powder has dissolved 3.
Danish: 0,5 mg frysetørret Flolan-pulver, og ryst forsigtig, indtil pulveret er opløst.
English: The infusion rate should be increased by 1 to 2 nanograms/kg/min increments at intervals sufficient to allow assessment of clinical response; these intervals should be of at least 15 min.
Danish: Infusionshastigheden skal øges med 1-2 nanogram/kg/min med intervaller, der er tilstrækkeligt lange til, at det kliniske respons kan vurderes.
English: Resultant concentration = 2,000 nanograms/mL Flolan:
Danish: Slutkoncentration = 2.000 nanogram Flolan/ml.
English: • infection at the injection site
Danish: • infektion på injektionsstedet.
English: METHOD AND ROUTE(S) OF ADMINISTRATION The powder needs to be reconstituted and diluted before infusion.
Danish: Pulveret skal rekonstitueres og fortyndes inden infusion.
English: When 0.5 mg Flolan powder is reconstituted with 50 mL of the solvent, the final injection has a pH of approximately 10.5 and a sodium ion content of approximately 56 mg.
Danish: Når 0,5 mg Flolan-pulver til intravenøs infusion rekonstitueres med 50 ml solvens, har den endelige injektionsvæske en pH på ca. 10,5 og et natriumindhold på ca. 56 mg.
English: Don't store above 25oC.
Danish: Må ikke opbevares ved temperaturer over 25 °C.
English: Your treatment may have an effect on the ability to drive or use machinery.
Danish: Din behandling kan påvirke arbejdssikkerheden og evnen til at færdes sikkert i trafikken.
English: • if you are allergic to Flolan or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Flolan: - hvis du er allergisk over for Flolan eller et af de øvrige indholdsstoffer i dette lægemiddel
English: In use shelf life reconsititued/solvent solution for infusion:
Danish: Holdbarhed efter anbrud for rekonstitueret/opløst infusionsvæske:
English: MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING LABEL for solvent vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ INDRE EMBALLAGER ETIKET til hætteglas med solvens
English: infusion is reconstituted with 50 mL of solvent, the final injection has a pH of approximately 10.5 and a sodium ion content of approximately 56 mg.
Danish: Flolan-pulver til intravenøs infusion rekonstitueres med 50 ml solvens, har den endelige injektionsvæske en pH på ca. 10,5 og et natriumindhold på ca. 56 mg.
English: • slow heart beat
Danish: • langsommere hjerterytme
English: • Flolan must not be used chronically in patients who develop pulmonary oedema during dose ranging.
Danish: • til kronisk behandling hos patienter, der udvikler lungeødem under dosistitreringen.
English: Patients on digoxin may show elevations of digoxin concentrations after initiation of therapy with Flolan, which although transient, may be clinically significant in patients prone to digoxin toxicity.
Danish: Patienter i behandling med digoxin kan få forhøjet digoxinkoncentration i blodet ved start af Flolanbehandling.
English: Concentrations commonly used in the treatment pulmonary arterial hypertension are as follows:
Danish: Følgende koncentrationer anvendes almindeligvis ved behandling af pulmonal arteriel hypertension:
English: It is possible to refrigerate Flolan reconstituted solutions, before they are used at room temperature, ranging between 2°C and 8°C and without exceeding 40 hour storage.
Danish: Det er mulig at opbevare rekonstituerede Flolan-opløsninger i køleskab (mellem 2 C - 8 C) i op til 40 timer, før de anvendes ved stuetemperatur.
English: Infusion rates for a concentration of 5,000 nanograms/mL
Danish: Eksempel på dosering ved en koncentration på 5.000 nanogram/ml
English: While you are being treated with Flolan it is important that you check the injection area.
Danish: Det er vigtigt, at du tjekker injektionsstedet, mens du får behandling med Flolan.
English: Tell your doctor or pharmacist if you are taking any of these.
Danish: Fortæl lægen eller apotekspersonalet, hvis du får nogle af ovennævnte typer af medicin.
English: • One vial containing sterile, freeze-dried Flolan equivalent to 1.5 mg Flolan, supplied with one or two 50 mL vials of solvent and a filter unit.
Danish: • Et hætteglas indeholdende sterilt, frysetørret Flolan svarende til 1,5 mg Flolan, leveret med et eller to 50 ml hætteglas med solvens samt et filter.
English: Uncommon side effects These may affect up to 1 in 100 people:
Danish: Ikke almindelige bivirkninger Disse kan forekomme hos op til 1 ud af 100 personer:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Each vial contains 0.5mg epoprostenol (as epoprostenol sodium) Each vial contains 1.5mg epoprostenol (as epoprostenol sodium)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Hvert hætteglas indeholder 0,5 mg epoprostenol (som epoprostenolnatrium)
English: Powder for solution for infusion: Mannitol, glycine, sodium chloride, sodium hydroxide( for pH adjustment)
Danish: Pulver til infusionsvæske, opløsning: mannitol E421, glycin, natriumchlorid, natriumhydroxid (til pHjustering)
English: catheter and infusion pump should be carefully considered.
Danish: Patientens evne til at acceptere og vedligeholde et permanent intravenøst kateter med infusionspumpe skal overvejes omhyggeligt.
English: • feeling agitated
Danish: • stikkende følelse
English: • redness.
Danish: • mundtørhed.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt] {Navn og adresse} <{tlf.}> <{fax}> <{e-mail}>
English: • pain at the injection site
Danish: • smerter på injektionsstedet.
English: Particular care should be taken in the preparation of the infusion and in calculating the rate of infusion.
Danish: Rekonstitution, fortynding og beregning af infusionshastighed: Særlig forsigtighed skal udvises ved tilberedning af infusionsvæske og beregning af infusionshastighed.
English: Effects on platelets have been found to disappear within 2 hours of discontinuing the infusion, and haemodynamic changes due to epoprostenol to return to baseline within 10 minutes of termination of 60 minutes infusion at 1 to 16 nanograms/kg/min.
Danish: Hæmodynamiske forandringer forårsaget af epoprostenol er normaliseret til baseline 10 minutter efter infusion af 116 nanogram/kg/min i 60 minutter.
English: Withdraw approximately 10mL of the solvent into a sterile syringe, inject it into the vial containing
Danish: Træk ca. 10 ml solvens op i en steril injektionssprøjte.
English: Nervous System Disorders Very common Headache Cardiac Disorders Common
Danish: Meget almindelig Hovedpine Hjerte
English: Only the 0.5 mg pack is suitable for use in renal dialysis.
Danish: Hæmodialyse Kun 0,5 mg pakningsstørrelsen er egnet til hæmodialyse.
English: While you are being treated with Flolan your heart rate and blood pressure will be checked.
Danish: Din puls og dit blodtryk vil blive undersøgt, mens du får Flolan.
English: Each vial contains epoprostenol sodium equivalent to 0.5 mg epoprostenol.
Danish: Hvert hætteglas indeholder epoprostenolnatrium svarende til 0,5 mg epoprostenol.
English: What Flolan is and what it is used for What you need to know before you take Flolan How to take Flolan
Danish: Det skal du vide, før du begynder at bruge Flolan Sådan skal du bruge Flolan Bivirkninger
English: • burning
Danish: • bleghed
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
English: Each vial contains epoprostenol sodium equivalent to 1.5 mg epoprostenol.
Danish: Hvert hætteglas indeholder epoprostenolnatrium svarende til 1,5 mg epoprostenol
English: There are four packs available for use in the treatment of pulmonary arterial hypertension, as follows:
Danish: Følgende fire pakningsstørrelser er tilgængelige for anvendelse til behandling af pulmonal arteriel hypertension:
English: This medicinal product contains sodium, which should be taken into consideration by patients on a controlled sodium diet.
Danish: Hvis patienten er på kontrolleret natriumdiæt, skal der tages hensyn hertil.
English: Dilution:
Danish: Fortynding:
English: How to take Flolan
Danish: Sådan skal du bruge Flolan
English: Flow rates in mL/h
Danish: Infusionshastighed i ml/time
English: The following schedule of infusion has been found effective in adults: Prior to dialysis: 4 nanograms/kg/min intravenously for 15 mins
Danish: Før dialyse: 4 nanogram/kg/min intravenøst i 15 minutter.
English: Six heparin-controlled studies and five emergency studies explored the place of epoprostenol in the general management of renal dialysis, using different techniques.
Danish: Epoprostenols placering i den generelle håndtering af hæmodialyse er undersøgt ved hjælp af forskellige teknikker i seks heparin-kontrollerede studier og 5 akutstudier.
English: • One vial containing sterile, freeze-dried Flolan equivalent to 0.5 mg Flolan supplied alone.
Danish: • Et hætteglas indeholdende sterilt, frysetørret Flolan svarende til 0,5 mg Flolan, leveret alene.
English: • 1.5 mg epoprostenol sodium.
Danish: • 1,5 mg epoprostenolnatrium
English: 10,000 nanograms/mL - Two vials containing 0.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
Danish: 10.000 nanogram/ml - To hætteglas indeholdende 0,5 mg Flolan rekonstitueret og fortyndet med solvens til et totalt volumen på 100 ml.
English: Infusion rate (mL/min) = concentration of solution (nanogram/mL)
Danish: = koncentration af opløsningen (nanogram/ml)
English: If you think any of these apply to you, don't take Flolan until you have checked with your doctor.
Danish: Brug ikke Flolan, før du har talt med lægen, hvis du tror, noget af ovennævnte gælder for dig.
English: • One vial containing sterile, freeze-dried Flolan equivalent to 1.5 mg Flolan supplied alone.
Danish: • Et hætteglas indeholdende sterilt, frysetørret Flolan svarende til 1,5 mg Flolan, leveret alene.
English: If you take more Flolan than you should
Danish: Hvis du har taget for meget Flolan
English: • blockage of the injection catheter
Danish: • tilstopning af kateter.
English: 0.5 mg vial powder for solution for infusion, 1 vial of solvent and 1 filter unit 0.5 mg vial powder for solution for infusion, 2 vials of solvent and 1 filter unit
Danish: 0,5 mg hætteglas med pulver til infusionsvæske, 1 hætteglas med solvens og 1 filter 0,5 mg hætteglas med pulver til infusionsvæske, 2 hætteglas med solvens og 1 filter
English: Dispense the concentrated solution directly into the chosen infusion solution using firm but not excessive pressure; the typical time taken for filtration of 50 mL of concentrated solution is 70 seconds.
Danish: Overfør den koncentrerede opløsning direkte til det valgte volumen af infusionsvæske ved at bruge et jævnt, ikke for kraftigt tryk.
English: Musculoskeletal and Connective Tissue Disorders Very common Jaw pain Common
Danish: Ikke almindelig Øget svedtendens Knogler, led, muskler og bindevæv Meget almindelig Kæbesmerter Almindelig
English: Flolan is contraindicated in patients: • with known hypersensitivity to the active substance(s) or to any of the excipients listed in section
Danish: • hos patienter med overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: 1.5 mg vial powder for solution for infusion, 1 vial of solvent and 1 filter unit 1.5 mg vial powder for solution for infusion, 2 vials of solvent and 1 filter unit
Danish: 1,5 mg hætteglas med pulver til infusionsvæske, 1 hætteglas med solvens og 1 filter 1,5 mg hætteglas med pulver til infusionsvæske, 2 hætteglas med solvens og 1 filter
English: • swelling
Danish: • svedtendens
English: • 15,000 nanogram/mL - One vial containing 1.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
Danish: 15.000 nanogram/ml - Et hætteglas indeholdende 1,5 mg Flolan rekonstitueret og fortyndet med solvens til et totalt volumen på 100 ml.
English: Anxiety, nervousness
Danish: • træthed, kraftesløshed
English: Erythema over the infusion site*, occlusion of the long i.v.
Danish: Meget sjælden Erythema ved injektionsstedet*, okklusion af langt i.v.-kateter*, mathed, trykken for brystet.
English: • One 1.5 mg powder vial.
Danish: • Et 1,5 mg hætteglas med pulver.
English: Pallor
Danish: Udslæt
English: Its use is forbidden in the presence of a discoloration or particles.
Danish: I tilfælde af misfarvning eller partikler skal den kasseres.
English: Reconstitution and dilution should be carried out immediately prior to use (see section 4.2, section 6.3 and Section 6.6).
Danish: Rekonstitution og fortynding skal foretages umiddelbart før anvendelse (se pkt.
English: Flolan 0.5 mg powder for solution for infusion Flolan 1.5 mg powder for solution for infusion Intravenous use
Danish: Flolan 0,5 mg pulver til infusionsvæske, opløsning Flolan 1,5 mg pulver til infusionsvæske, opløsning Intravenøs anvendelse epoprostenol
English: Flolan 0.5 mg powder and solvent for solution for infusion Flolan 1.5 mg powder and solvent for solution for infusion
Danish: Flolan 0,5 mg pulver og solvens til infusionsvæske, opløsning Flolan 1,5 mg pulver og solvens til infusionsvæske, opløsning
English: Flolan may be used either as concentrated solution or in a diluted form for the treatment of pulmonary arterial hypertension.
Danish: Ved behandling af pulmonal arteriel hypertension kan Flolan benyttes enten som koncentreret opløsning eller i fortyndet form.
English: • heart beating faster
Danish: • hurtigere hjerterytme (puls)
English: • One 0.5 mg powder vial and one or two solvent vials and a filter unit.
Danish: • Et 0,5 mg hætteglas med pulver og et eller to hætteglas med solvens samt et filter.
English: • 5,000 nanogram/mL - One vial containing 0.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
Danish: 5.000 nanogram/ml - Et hætteglas indeholdende 0,5 mg Flolan rekonstitueret og fortyndet med solvens til et totalt volumen på 100 ml.
English: Note:
Danish: F.eks:
English: Flolan 0.5 mg Powder and Solvent for Solution for Infusion Flolan 1.5 mg Powder and Solvent for Solution for Infusion
Danish: Flolan 0,5 mg pulver og solvens til infusionsvæske, opløsning Flolan 1,5 mg pulver og solvens til infusionsvæske, opløsning epoprostenol
English: • One 1.5 mg powder vial and one or two solvent vials and a filter unit.
Danish: • Et 1,5 mg hætteglas med pulver og et eller to hætteglas med solvens samt et filter.
English: • One 0.5 mg powder vial.
Danish: • Et 0,5 mg hætteglas med pulver.
English: • overactive thyroid gland
Danish: • overaktiv skjoldbruskkirtel
English: Flow rates in mL/h Infusion rates for a concentration of 15,000 nanograms/mL Example For Dosing Using a Concentration of 15,000 nanograms/mL
Danish: Eksempel på dosering ved en koncentration på 15.000 nanogram/ml
English: This medicine contains sodium: See package leaflet for further information
Danish: Se indlægssedlen for yderligere information
English: Flolan must not be administered with other parenteral solutions or medications when used for pulmonary arterial hypertension.
Danish: Ved behandling af pulmonal arteriel hypertension må Flolan ikke administreres sammen med andre infusionsvæsker eller lægemidler.
English: Each vial contains epoprostenol sodium equivalent to 1.5 mg epoprostenol One ml of reconstituted concentrate solution contains epoprostenol (as epoprostenol ) 30 000 nanogram.
Danish: En ml rekonstitueret koncentreret opløsning indeholder 30.000 nanogram epoprostenol (som epoprostenolnatrium).
English: Bradycardia associated with a considerable fall in systolic and diastolic blood pressure has followed i.v.
Danish: Bradykardi er set i forbindelse med et betydeligt fald i det systoliske og diastoliske blodtryk hos raske personer ved bevidsthed efter intravenøs administration af en dosis, der svarer til 30 nanogram/kg/min.
English: Dispense the concentrated solution directly into the solvent using firm but not excessive pressure; the typical time taken for filtration of 50 mL of concentrated solution is 70 seconds.
Danish: Overfør den koncentrerede opløsning direkte til solvensen ved et jævnt, ikke for kraftigt tryk.
English: • tenderness
Danish: • ømhed
English: The hypotensive effect of Flolan may be enhanced by the use of acetate buffer in the dialysis bath during renal dialysis.
Danish: Acetatbuffer i dialysevæsken kan muligvis øge Flolans hypotensive effekt.
English: Sweating
Danish: Amning
English: Pulmonary oedema
Danish: Mave-tarm-kanalen
English: The filter unit must be used once only and then discarded.
Danish: Derfor må et hætteglas kun bruges én gang, hvorefter det kasseres.
English: Before use, the powder needs to be dissolved in the liquid provided.
Danish: Pulveret skal opløses i opløsningsvæsken (solvens), som følger med i pakningen.
English: Methotrexate is authorised in the European Union since the 1960s.
Danish: Methotrexat har været godkendt i Den Europæiske Union siden 1960'erne.
English: T. 2018 Apr;43(4):191-248.
Danish: P T. 2018 Apr;43(4):191-248.
English: These risk minimisation measures should be reflected in a risk management plan.
Danish: Disse risikominimerende foranstaltninger bør beskrives i en risikostyringsplan.
English: It was also noted that current European guidelines do not mention the possibility of dividing the dose.
Danish: Det bemærkes også, at de gældende europæiske retningslinjer ikke nævner en mulighed for at opdele dosen.
English: Any reference to dividing the dose in the product information should therefore be deleted.
Danish: Enhver henvisning til opdeling af dosen i produktinformationen bør derfor slettes.
English: Each group of indications has a different administration schedule:
Danish: De enkelte grupper af indikationer har forskellige doseringsregimer:
English: Dispensing errors have also been reported.
Danish: Der er også rapporteret om dispenseringsfejl.
English: The PRAC adopted a recommendation on 11 July 2019 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Danish: PRAC har den 11. juli 2019 vedtaget en anbefaling, der efterfølgende er blevet vurderet af CHMP, jf. artikel 107k i direktiv 2001/83/EF.
English: Methotrexate-containing products are authorised in all EU Member States, and either oral or parenteral formulation or both pharmaceutical formulations are available.
Danish: Methotrexat-holdige lægemidler er godkendt i alle EU's medlemsstater, hvor enten en oral eller parenteral formulering eller begge dele kan fås.
English: Taking into account that such replacement may require several technical changes and not to jeopardize the availability of methotrexate formulations in some Member States, the PRAC agreed to an implementation period of up to 4 years after finalisation of this procedure.
Danish: Da en sådan udskiftning kan kræve mange tekniske ændringer, og for ikke at bringe tilgængeligheden af methotrexat-formuleringer i nogle medlemsstater i fare, har PRAC godkendt en implementeringsperiode på op til 4 år efter afslutningen af denne procedure.