FrancophonIA/ELRC3.0 huggingface dataset:
English: Following intravenous dosing of fluticasone furoate to healthy volunteers, the mean volume of distribution at steady state of 661 litres.
Danish: Efter intravenøs administration af fluticasonfuroat til frivillige raske forsøgspersoner var den gennemsnitlige fordelingsvolumen ved steady-state 661 liter.
English: FEV1=forced expiratory volume in 1 second; L=litres; LS=least squares; SE= standard error, N=number in the intent-totreat population; CI= confidence interval, a Statistically significant treatment difference for FF/UMEC/VI vs. BUD/FOR also observed at the other assessment timepoints (weeks 2, 4 and 12).
Danish: FEV1 = forceret ekspiratorisk volumen i første sekund; l = liter; LS = mindste kvadrater; SE = standardfejl; n = antal i intention to treat; CI = konfidensinterval, a Statistisk signifikant behandlingsforskel for FF/UMEC/VI ift.
English: NAME OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Trading Services Limited GSK Logo
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN GlaxoSmithKline Trading Services Limited.
English: This corresponds to a pre-dispensed dose of 100 micrograms fluticasone furoate, 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate).
Danish: Dette svarer til en afdelt dosis på 100 mikrogram fluticasonfuroat, 74,2 mikrogram umeclidiniumbromid svarende til 62,5 mikrogram umeclidinium og 25 mikrogram vilanterol (som trifenatat).
English: What you need to know before you use Trelegy Ellipta
Danish: Det skal du vide, før du begynder at bruge Trelegy Ellipta
English: In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Danish: In vitro-studier har vist, at vilanterol primært metaboliseres af cytokrom P450 3A4 (CYP3A4) og er et substrat for P-gp-transporteren.
English: The second study included safety data from 527 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol (92/55/22 micrograms) and 528 patients with COPD who received fluticasone furoate/vilanterol (92/22 micrograms) + umeclidinium (55 micrograms) once daily for up to 24 weeks (study 200812).
Danish: Det andet studie omfattede sikkerhedsdata fra 527 KOL-patienter, der fik fluticasonfuroat/umeclidinium/vilanterol (92/55/22 mikrogram) og 528 KOL-patienter, der fik fluticasonfuroat/vilanterol (92/22 mikrogram) + umeclidinium (55 mikrogram) én gang dagligt i op til 24 uger (studie 200812).
English: The Ellipta inhaler contains pre-dispensed doses and is ready to use.
Danish: Den indeholder afmålte doser og er klar til brug med det samme.
English: Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44
Danish: Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44 diam@gsk.com
English: Fluticasone furoate, umeclidinium and vilanterol did not have any adverse effects on male or female fertility in rats.
Danish: Fluticasonfuroat, umeclidinium og vilanterol havde ingen bivirkninger på fertiliteten blandt hanrotter og hunrotter.
English: The first time you use Trelegy Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Danish: Det er ikke nødvendigt at kontrollere, om Trelegy Ellipta-inhalatoren virker korrekt, før du bruger den første gang.
English: In IMPACT, the proportion of patients who were CAT responders at week 52 was significantly higher (p<0.001) for patients treated with Trelegy Ellipta (42%) compared with FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) and UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43).
Danish: I IMPACT var andelen af patienter, der var CAT-respondenter i uge 52, signifikant højere (p < 0,001) for patienter behandlet med Trelegy Ellipta (42 %) sammenlignet med FF/VI (37 %; OR 1,24; 95 % CI: 1,14; 1,36) og UMEC/VI (36 %; OR 1,28; 95 % CI: 1,15; 1,43).
English: In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-gp transporter.
Danish: In vitro-studier har vist, at umeclidinium primært metaboliseres af cytokrom P450 2D6 (CYP2D6) og er et substrat for P-gp-transporteren.
English: In vitro studies showed that fluticasone furoate is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Danish: In vitro-studier har vist, at fluticasonfuroat primært metaboliseres af cytokrom P450 3A4 (CYP3A4) og er et substrat for P-gp-transporteren.
English: For further instructions on handling the device, see section 6.6.
Danish: For yderligere oplysning om håndtering af inhalatoren, se pkt.
English: The first study included safety data from 911 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms, once daily, for up to 24 weeks, of whom 210 patients received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with an active comparator (study CTT116853, FULFIL).
Danish: Det første studie omfattede sikkerhedsdata fra 911 KOL-patienter, der har fået fluticasonfuroat/umeclidinium/vilanterol 92/55/22 mikrogram én gang dagligt i op til 24 uger, hvoraf 210 patienter fik fluticasonfuroat/umeclidinium/vilanterol 92/55/22 mikrogram én gang dagligt i op til 52 uger, med en aktiv komparator (studie CTT116853, FULFIL).
English: The step-by-step instructions for use of the inhaler provided below can be used for either the 30-dose (30 day supply) or the 14-dose (14 day supply) Ellipta inhaler.
Danish: Brugervejledningen nedenfor kan anvendes enten til Ellipta-inhalatoren med 30 doser (30 dages forbrug) eller med 14 doser (14 dages forbrug).
English: The “Discard by” date is 6 weeks from the date you open the tray.
Danish: Datoen "Kasseres senest" er 6 uger fra den dag, hvor
English: Trelegy Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Danish: Trelegy Ellipta bør anvendes med forsigtighed til patienter med moderat til svært nedsat leverfunktion (se pkt.
English: If beta-blockers are required, cardioselective beta-blockers should be considered, however, caution should be exercised during concurrent use of both non-selective and selective beta-blockers.
Danish: Der bør dog udvises forsigtighed ved samtidig brug af både ikke-selektive og selektive betablokkere.
English: FULFIL (CTT116853) was a 24-week study (N=1,810), with an extension up to 52 weeks in a subset of subjects (n=430), that compared Trelegy Ellipta (92/55/22 micrograms) with budesonide/formoterol 400/12 micrograms (BUD/FOR) administered twice-daily.
Danish: FULFIL (CTT116853) var et 24-ugers studie (n = 1.810) med forlængelse op til 52 uger i en undergruppe af forsøgspersoner (n = 430), der sammenlignede Trelegy Ellipta (92/55/22 mikrogram)
English: Multipack of 90 (3 packs of 30) dose inhalers.
Danish: Multipakning med inhalatorer med 90 (pakning med 3 x 30 doser).
English: The dose counter will appear completely red if the cover is opened again.
Danish: Hvis beskyttelseshætten åbnes igen vil dosistælleren være helt rød.
English: Do not open the tray until you are ready to inhale a dose of your medicine.
Danish: Bakken må ikke åbnes, før du er klar til at inhalere en dosis af lægemidlet.
English: • faster heart beat
Danish: • hurtigere hjerterytme
English: NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Danish: LÆGEMIDLETS NAVN Trelegy Ellipta 92/55/22 µg inhalationspulver fluticasone furoate/umeclidinium/vilanterol
English: Excipients
Danish: Eksacerbationer
English: Your Trelegy Ellipta inhaler carton contains
Danish: Æsken med Trelegy Ellipta-inhalatoren indeholder
English: The effect of fluticasone furoate/umeclidinium/vilanterol has not been evaluated in subjects with renal impairment.
Danish: Virkningen af fluticasonfuroat/umeclidinium/vilanterol er ikke blevet evalueret hos forsøgspersoner med nedsat nyrefunktion.
English: Package leaflet: Information for the patient Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Danish: Indlægsseddel: Information til patienten Trelegy Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt fluticasonfuroat/umeclidinium/vilanterol
English: 3) Inhale your medicine
Danish: 3) Inhaler lægemidlet
English: See ‘Step-by-step instructions' in this leaflet for full information.
Danish: Du kan finde en udførlig beskrivelse i "Brugervejledning" i denne indlægsseddel.
English: NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
Danish: Trelegy Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt
English: In FULFIL, based upon data up to 24 weeks, Trelegy Ellipta significantly reduced (p=0.002) the annual rate of moderate/severe exacerbations by 35% (95% CI: 14, 51) compared with BUD/FOR.
Danish: I FULFIL medførte Trelegy Ellipta en signifikant reduktion (p = 0,002) i den årlige frekvens af moderate/svære eksacerbationer på 35 % (95 % CI: 14; 51) sammenlignet med BUD/FOR, baseret på data op til 24 uger.
English: Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, fluticasone furoate Cmax occurred at 15 minutes.
Danish: Efter administration ved inhalation af fluticasonfuroat/umeclidinium/vilanterol til raske forsøgspersoner blev der opnået Cmax af fluticasonfuroat efter 15 minutter.
English: The tray contains a desiccant sachet, to reduce moisture.
Danish: Bakken indeholder en pose med tørremiddel for at mindske fugt.
English: Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Danish: Trelegy Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt fluticasonfuroat/umeclidinium/vilanterol
English: Write the “Discard by” date on the inhaler label and the carton in the space provided.
Danish: Skriv dato for "Kasseres senest" i det felt, der er angivet på inhalatorens etiket og æske.
English: Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, vilanterol Cmax occurred at 7 minutes.
Danish: Efter administration ved inhalation af fluticasonfuroat/umeclidinium/vilanterol til raske forsøgspersoner blev der opnået Cmax af vilanterol efter 7 minutter.
English: Lung Function
Danish: Nedsat leverfunktion
English: Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, umeclidinium Cmax occurred at 5 minutes.
Danish: Efter administration ved inhalation af fluticasonfuroat/umeclidinium/vilanterol til raske forsøgspersoner blev der opnået Cmax af umeclidinium efter 5 minutter.
English: Mouthpiece Air vent
Danish: Mundstykke Luftkanaler
English: There was no effect of race on pharmacokinetic parametersof umeclidinium or vilanterol in subjects with COPD.
Danish: Race havde ingen indvirkning på estimaterne af de farmakokinetiske parametre for umeclidinium eller vilanterol hos KOL-patienter.
English: In FULFIL the proportion of responders according to TDI (defined as at least 1 unit) was significantly higher (p<0.001) for Trelegy Ellipta compared with BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
Danish: I FULFIL var andelen af respondenter ifølge TDI (defineret som mindst 1 enhed) signifikant højere (p < 0,001) for Trelegy Ellipta sammenlignet med BUD/FOR (61 % ift.
English: In FULFIL, the proportion of patients who were CAT responders (defined as 2 units below baseline or lower) at week 24, was significantly higher (p<0.001) for patients treated with Trelegy Ellipta compared with BUD/FOR (53% vs. 45%; OR 1.44; 95% CI: 1.19, 1.75).
Danish: I FULFIL var andelen af patienter, der var CAT-respondenter (defineret som 2 enheder under baseline eller lavere) i uge 24, signifikant højere (p < 0,001) for patienter behandlet med Trelegy Ellipta sammenlignet med BUD/FOR (53 % ift.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trelegy Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Trelegy Ellipta 92/55/22 µg inhalationspulver fluticasone furoate/umeclidinium/vilanterol
English: How to use Trelegy Ellipta
Danish: Sådan skal du bruge Trelegy Ellipta
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to 55 micrograms umeclidinium and 22 micrograms of vilanterol (as trifenatate).
Danish: Hver enkelt inhalation leverer en afgivet dosis (den dosis, der forlader mundstykket) på 92 mikrogram fluticasonfuroat, 65 mikrogram umeclidiniumbromid svarende til 55 mikrogram umeclidinium og 22 mikrogram vilanterol (som trifenatat).
English: Symptom Relief
Danish: Hjælpestoffer
English: If the dose counter does not count down as the “click” is heard, the inhaler will not deliver a dose and should be taken back to a pharmacist for advice.
Danish: Hvis dosistælleren ikke tæller ned, når du hører klikket, afgiver inhalatoren ikke en dosis.
English: If you stop using Trelegy Ellipta
Danish: Hvis du har brugt for meget Trelegy Ellipta
English: The Ellipta inhaler consists of a light grey body, beige mouthpiece cover and a dose counter, packed into a foil laminate tray containing a desiccant sachet.
Danish: Ellipta-inhalatoren består af en lysegrå inhalator med en beige beskyttelseshætte over mundstykket og en dosistæller.
English: In IMPACT, over 52 weeks, Trelegy Ellipta significantly reduced (p<0.001) the annual rate of moderate/severe exacerbations by 15% (95% CI:10, 20) compared with FF/VI (rate; 0.91 vs 1.07 events per patient year) and by 25% (95% CI: 19, 30) compared with UMEC/VI (rate; 0.91 vs 1.21 events per patient year).
Danish: I løbet af 52 uger i IMPACT medførte Trelegy Ellipta en signifikant reduktion (p < 0,001) i den årlige frekvens af moderate/svære eksacerbationer på 15 % (95 % CI: 10; 20) sammenlignet med FF/VI (frekvens; 0,91 ift.
English: The inhaler should be held away from the mouth breathing out as far as is comfortable, but not breathing out into the inhaler.
Danish: Hold inhalatoren væk fra munden, og foretag den dybeste udånding, du finder behagelig.
English: What you need to know before you use Trelegy Ellipta 3.
Danish: Det skal du vide, før du begynder at bruge Trelegy Ellipta Sådan skal du bruge Trelegy Ellipta Bivirkninger
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Danish: Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Clinically significant drug interactions mediated by fluticasone furoate/umeclidinium/vilanterol at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
Danish: På grund af de lave plasmakoncentrationer, der opnås efter inhalation, anses det for usandsynligt, at kliniske doser af fluticasonfuroat/umeclidinium/vilanterol vil medføre klinisk signifikante lægemiddelinteraktioner.
English: Viral respiratory tract infection
Danish: Virusinfektion i luftvejene
English: The “Discard by” date should be written on the inhaler label and carton in the space provided.
Danish: På inhalatorens etiket og æske er et felt, hvor datoen for "Kasseres senest" skal angives.
English: C.
Danish: Teл.
English: Each delivered dose contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium (equivalent to 65 micrograms umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver afgivet dosis indeholder 92 mikrogram fluticasonfuroat, 55 mikrogram umeclidinium (svarende til 65 mikrogram umeclidiniumbromid) og 22 mikrogram vilanterol (som trifenatat).
English: After inhalation, patients should rinse their mouth with water without swallowing.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Efter inhalation skal patienten skylle munden med vand uden at synke det. Ellipta-inhalatoren indeholder afdelte doser og er klar til brug.
English: Posology
Danish: Brugervejledning
English: Exacerbations
Danish: • hæshed
English: ANNEX II
Danish: BLAG II
English: June 2019
Danish: Juni 2019
English: Your doctor will perform:
Danish: Din læge vil foretage:
English: • At the request of the European Medicines Agency;
Danish: • på anmodning fra Det europæiske Lægemiddelagentur
English: Make sure you take Iclusig daily for as long as it is prescribed.
Danish: Sørg for at du tager Iclusig hver dag, så længe den er ordineret.
English: Resistant or Intolerant
Danish: Resistent eller intolerant
English: b Measured in peripheral blood.
Danish: b Målt i perifert blod.
English: Other possible side effects that may occur with the following frequencies are:
Danish: Andre mulige bivirkninger, som kan forekommer med følgende hyppighed, er:
English: An updated RMP shall be submitted by 24 November 2014.
Danish: En opdateret RMP skal fremsendes senest den 24. november 2014.
English: An alternative or additional method of contraception should be used.
Danish: Der bør anvendes en alternativ eller supplerende kontraceptionsmetode.
English: Do not stop taking Iclusig without your doctor's permission.
Danish: Du må ikke holde op med at tage Iclusig uden lægens tilladelse.
English: Your doctor may want to take additional precautions.
Danish: Din læge kan ønske at træffe yderligere foranstaltninger.
English: This is a long-term treatment.
Danish: Det drejer sig om langvarig behandling.
English: Continue Iclusig at the same dose
Danish: Fortsæt Iclusig med samme dosis
English: The trial is ongoing.
Danish: Forsøget er fortsat i gang.
English: 93055 Regensburg, Germany
Danish: 93055 Regensburg, Tyskland
English: Do not give this medicine to children under 18 years because no data are available in children.
Danish: Dette lægemiddel må ikke gives til børn under 18 år, da der ikke foreligger data om børn.
English: Talk to your doctor immediately if this occurs.
Danish: Tal omgående med lægen, hvis det er sket.
English: The following medicines can affect or be affected by Iclusig:
Danish: Følgende lægemidler kan påvirke eller påvirkes af Iclusig:
English: Symptoms are severe pain in the stomach and back.
Danish: Symptomer er svære smerter i maven og ryggen.
English: Afterwards it is performed monthly or as indicated by the doctor.
Danish: Derefter tages det hver måned eller som indiceret af lægen.
English: There are no adequate data from the use of Iclusig in pregnant women.
Danish: Der foreligger ingen tilstrækkelige data vedrørende anvendelse af Iclusig til gravide kvinder.
English: *Reported using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Danish: *Rapporteret ved hjælp af National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
English: Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, som står på flaskens etiket og kartonen efter “EXP”.
English: Treatment should be continued as long as the patient does not show evidence of disease progression or unacceptable toxicity.
Danish: Behandlingen skal fortsættes, så længe patienter ikke viser tegn på sygdomsprogression eller uacceptabel toksicitet.
English: • pain in one or both legs when walking or exercising, which disappears after some minutes of rest
Danish: • smerter i ét eller begge ben ved gang eller træning, som forsvinder efter nogle minutters hvile
English: Take your next dose at your regular time.
Danish: Tag den næste dosis på det sædvanlige tidspunkt.
English: Baseline demographic characteristics are described in Table 5 below.
Danish: Demografiske karakteristika ved baseline er beskrevet i tabel 5 nedenfor.
English: The clinical relevance of this finding is unknown.
Danish: Den kliniske relevans af dette fund er ukendt.
English: First occurrence:
Danish: Første forekomst:
English: Myelosuppression was commonly reported in all patient populations.
Danish: Myelosuppression blev hyppigt rapporteret hos alle patientpopulationer.
English: At the time of reporting, all ongoing patients had a minimum follow-up of 27 months.
Danish: På rapporteringstidspunktet havde alle igangværende patienter en minimumopfølgning på 27 måneder.
English: The effects were shown to be reversible after withdrawal of the treatment.
Danish: Virkninger viste sig at være reversible efter seponering af behandling.
English: Management of toxicities:
Danish: Styring af toksicitet:
English: Patients should be monitored for response according to standard clinical guidelines.
Danish: Patienter skal monitoreres for respons i henhold til normale kliniske retningslinjer.
English: Iclusig blocks this signal, thereby stopping the production of these cells.
Danish: Iclusig blokerer dette signal, hvormed dannelsen af disse blodlegemer standses.
English: Efficacy results are summarized in Table 6, Table 7, and Table 8.
Danish: Effektresultater er opsummeret i tabel 6, tabel 7 og tabel 8.
English: Available pharmacodynamic and toxicological data cannot exclude potential excretion in human milk.
Danish: Foreliggende farmakodynamiske og toksikologiske data kan ikke udelukke potentiel udskillelse i human mælk.
English: Iclusig should be used during pregnancy only when clearly necessary.
Danish: Iclusig må kun anvendes under graviditeten, når det er strengt nødvendigt.
English: • Importance of assessing the risks before starting treatment with ponatinib.
Danish: • Vigtigheden af at vurdere risiciene inden behandling med ponatinib påbegyndes.
English: Store in the original container in order to protect from light.
Danish: Opbevares i den originale beholder for at beskytte mod lys.
English: However, a thorough QT study has not been performed; therefore a clinically significant effect on QT cannot be excluded.
Danish: Der er dog ikke blevet udført en grundig QT-undersøgelse, så en klinisk signifikant virkning på QT kan ikke udelukkes.
English: Maintained MMR
Danish: Opretholdt MMR
English: Number of Patients
Danish: Antal patienter
English: Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events.
Danish: Patienter med og uden kardiovaskulære risikofaktorer, inklusive patienter på 50 år og derunder, oplevede disse hændelser.
English: Only use Iclusig during pregnancy if your doctor tells you it is absolutely necessary, as potential risks exist for the unborn child.
Danish: Iclusig må kun anvendes under graviditet, hvis din læge fortæller dig, at det er strengt nødvendigt, da der er mulige risici for det ufødte barn.
English: • fever, often with other signs of infection due to decreased number of white blood cells
Danish: • feber, ofte sammen med andre tegn på betændelse på grund af nedsat antal hvide blodlegemer
English: Your doctor may reduce your dose or tell you to temporarily stop taking Iclusig if:
Danish: Din læge kan reducere din dosis eller fortælle dig, at du midlertidigt skal holde os med at tage Iclusig, hvis:
English: *ANC = absolute neutrophil count
Danish: *ANC = absolut neutrofiltal
English: Your doctor may evaluate your response to the treatment at regular intervals.
Danish: Din læge vil bedømme, hvordan du reagerer på behandlingen med jævne mellemrum.
English: If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Danish: Hvis det anvendes under graviditeten, bør patienten underrettes om den potentielle risiko for fostret.
English: A proportion of patients did not undergo any dose reduction, based on an individual benefit-risk assessment.
Danish: Hos en del af patienterne blev dosis ikke reduceret, baseret på en individuel benefit/risk-vurdering.
English: Dose reduction in CP-CML patients
Danish: Dosisreduktion hos CP-CML-patienter
English: Table 1 Dose modifications for myelosuppression
Danish: Tabel 1 Dosisjusteringer ved myelosuppression