natgillin/translations-raw huggingface dataset:
I IMPACT medførte Trelegy Ellipta en statistisk signifikant reduktion i det gennemsnitlige antal natlige opvågninger som følge af KOL sammenlignet med FF/VI (-0,05; 95 % CI: -0,08; -0,01; p = 0,005) og med UMEC/VI (-0,10; 95 % CI: -0,14; -0,05; p < 0,001) i uge 49 til 52. 
In IMPACT, Trelegy Ellipta statistically significantly reduced the mean number of nighttime awakenings due to COPD compared with FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) and with UMEC/VI (-0.10; 95% CI: -0.14, -0.05; p<0.001) at weeks 49 to 52.
a) Sådan skal du klargøre en dosis 
a) Prepare a dose
Efter gentaget inhalation af umeclidinium/vilanterol blev der opnået steady-state inden for 6 dage med en akkumulering på op til 1,5 gange. 
Following repeat dosing of inhaled umeclidinium/vilanterol, steady state was achieved within 6 days with up to 1.5-fold accumulation.
Behandling med Trelegy Ellipta medførte en signifikant reduktion i den årlige frekvens af svære eksacerbationer med 34 % sammenlignet med UMEC/VI (95 % CI: 22,44; p 
Treatment with Trelegy Ellipta significantly reduced the annual rate of severe exacerbations by 34% compared with UMEC/VI (95% CI: 22, 44; p<0.001).
Ved subkutan administration var der ingen effekter ved eksponeringer, der var 62 gange højere end dem, der opnås hos mennesker ved en daglig dosis på 22 mikrogram, baseret på AUC. 
When given subcutaneously there were no effects at exposures 62-fold the human clinical exposure at a daily dose of 22 micrograms, based on AUC.
Opbevaringstid efter anbrud af bakken: 6 uger 
2 years Shelf-life after opening the tray: 6 weeks
Efter gentaget inhalation af fluticasonfuroat/vilanterol blev der opnået steady-state inden for 6 dage med en akkumulering på op til 1,6 gange. 
Following repeat dosing of inhaled fluticasone furoate /vilanterol, steady state was achieved within 6 days with up to 1.6-fold accumulation
Dyreforsøg viser ingen effekt af fluticasonfuroat, umeclidinium eller vilanterol på fertiliteten hos mennesker (se pkt. 
Animal studies indicate no effects of fluticasone furoate, umeclidinium or vilanterol on male or female fertility (see section 5.3).
Det tredje studie omfattede sikkerhedsdata fra 4.151 KOL-patienter, der fik fluticasonfuroat/umeclidinium/vilanterol 92/55/22 mikrogram én gang dagligt i op til 52 uger, med to aktive komparatorer (studie CTT116855, IMPACT). 
The third study included safety data from 4,151 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with two active comparators (study CTT116855, IMPACT).
Umeclidinium var ikke genotoksisk i en række standardstudier og ikke karcinogent ved livslang inhalationsbehandling hos mus og rotter ved eksponeringer på henholdsvis ≥ 20 og ≥ 17 gange højere end dem, der opnås hos mennesker ved en daglig dosis på 55 mikrogram umeclidinium, baseret på AUC. 
Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in mice or rats at exposures ≥ 20- or ≥ 17- fold the human clinical exposure at a daily dose of 55 micrograms umeclidinium, based on AUC respectively.
Efter intravenøs administration af fluticasonfuroat til frivillige raske forsøgspersoner var den gennemsnitlige fordelingsvolumen ved steady-state 661 liter. 
Following intravenous dosing of fluticasone furoate to healthy volunteers, the mean volume of distribution at steady state of 661 litres.
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. 
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).
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN GlaxoSmithKline Trading Services Limited. 
NAME OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Trading Services Limited GSK Logo
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). 
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).
Det skal du vide, før du begynder at bruge Trelegy Ellipta 
What you need to know before you use Trelegy Ellipta
In vitro-studier har vist, at vilanterol primært metaboliseres af cytokrom P450 3A4 (CYP3A4) og er et substrat for P-gp-transporteren. 
In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
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). 
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).
Den indeholder afmålte doser og er klar til brug med det samme. 
The Ellipta inhaler contains pre-dispensed doses and is ready to use.
Fluticasonfuroat, umeclidinium og vilanterol havde ingen bivirkninger på fertiliteten blandt hanrotter og hunrotter. 
Fluticasone furoate, umeclidinium and vilanterol did not have any adverse effects on male or female fertility in rats.
Det er ikke nødvendigt at kontrollere, om Trelegy Ellipta-inhalatoren virker korrekt, før du bruger den første gang. 
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.
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). 
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).
In vitro-studier har vist, at umeclidinium primært metaboliseres af cytokrom P450 2D6 (CYP2D6) og er et substrat for P-gp-transporteren. 
In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-gp transporter.
In vitro-studier har vist, at fluticasonfuroat primært metaboliseres af cytokrom P450 3A4 (CYP3A4) og er et substrat for P-gp-transporteren. 
In vitro studies showed that fluticasone furoate is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
For yderligere oplysning om håndtering af inhalatoren, se pkt. 
For further instructions on handling the device, see section 6.6.
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). 
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).
Brugervejledningen nedenfor kan anvendes enten til Ellipta-inhalatoren med 30 doser (30 dages forbrug) eller med 14 doser (14 dages forbrug). 
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.
Datoen "Kasseres senest" er 6 uger fra den dag, hvor 
The “Discard by” date is 6 weeks from the date you open the tray.
Trelegy Ellipta bør anvendes med forsigtighed til patienter med moderat til svært nedsat leverfunktion (se pkt. 
Trelegy Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Der bør dog udvises forsigtighed ved samtidig brug af både ikke-selektive og selektive betablokkere. 
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.
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) 
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.
Multipakning med inhalatorer med 90 (pakning med 3 x 30 doser). 
Multipack of 90 (3 packs of 30) dose inhalers.
Hvis beskyttelseshætten åbnes igen vil dosistælleren være helt rød. 
The dose counter will appear completely red if the cover is opened again.
Bakken må ikke åbnes, før du er klar til at inhalere en dosis af lægemidlet. 
Do not open the tray until you are ready to inhale a dose of your medicine.
• hurtigere hjerterytme 
• faster heart beat
LÆGEMIDLETS NAVN Trelegy Ellipta 92/55/22 µg inhalationspulver fluticasone furoate/umeclidinium/vilanterol 
NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Eksacerbationer 
Excipients
Æsken med Trelegy Ellipta-inhalatoren indeholder 
Your Trelegy Ellipta inhaler carton contains
Virkningen af fluticasonfuroat/umeclidinium/vilanterol er ikke blevet evalueret hos forsøgspersoner med nedsat nyrefunktion. 
The effect of fluticasone furoate/umeclidinium/vilanterol has not been evaluated in subjects with renal impairment.
Indlægsseddel: Information til patienten Trelegy Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt fluticasonfuroat/umeclidinium/vilanterol 
Package leaflet: Information for the patient Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
3) Inhaler lægemidlet 
3) Inhale your medicine
Du kan finde en udførlig beskrivelse i "Brugervejledning" i denne indlægsseddel. 
See ‘Step-by-step instructions' in this leaflet for full information.
Trelegy Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt 
NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
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. 
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.
Efter administration ved inhalation af fluticasonfuroat/umeclidinium/vilanterol til raske forsøgspersoner blev der opnået Cmax af fluticasonfuroat efter 15 minutter. 
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, fluticasone furoate Cmax occurred at 15 minutes.
Bakken indeholder en pose med tørremiddel for at mindske fugt. 
The tray contains a desiccant sachet, to reduce moisture.
Trelegy Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt fluticasonfuroat/umeclidinium/vilanterol 
Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Skriv dato for "Kasseres senest" i det felt, der er angivet på inhalatorens etiket og æske. 
Write the “Discard by” date on the inhaler label and the carton in the space provided.
Efter administration ved inhalation af fluticasonfuroat/umeclidinium/vilanterol til raske forsøgspersoner blev der opnået Cmax af vilanterol efter 7 minutter. 
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, vilanterol Cmax occurred at 7 minutes.
Nedsat leverfunktion 
Lung Function
Efter administration ved inhalation af fluticasonfuroat/umeclidinium/vilanterol til raske forsøgspersoner blev der opnået Cmax af umeclidinium efter 5 minutter. 
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, umeclidinium Cmax occurred at 5 minutes.
Mundstykke Luftkanaler 
Mouthpiece Air vent
Race havde ingen indvirkning på estimaterne af de farmakokinetiske parametre for umeclidinium eller vilanterol hos KOL-patienter. 
There was no effect of race on pharmacokinetic parametersof umeclidinium or vilanterol in subjects with COPD.
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. 
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).
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. 
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).
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Trelegy Ellipta 92/55/22 µg inhalationspulver fluticasone furoate/umeclidinium/vilanterol 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trelegy Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Sådan skal du bruge Trelegy Ellipta 
How to use Trelegy Ellipta
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). 
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).
Hjælpestoffer 
Symptom Relief
Hvis dosistælleren ikke tæller ned, når du hører klikket, afgiver inhalatoren ikke en dosis. 
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.
Hvis du har brugt for meget Trelegy Ellipta 
If you stop using Trelegy Ellipta
Ellipta-inhalatoren består af en lysegrå inhalator med en beige beskyttelseshætte over mundstykket og en dosistæller. 
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.
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. 
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).
Hold inhalatoren væk fra munden, og foretag den dybeste udånding, du finder behagelig. 
The inhaler should be held away from the mouth breathing out as far as is comfortable, but not breathing out into the inhaler.
Det skal du vide, før du begynder at bruge Trelegy Ellipta Sådan skal du bruge Trelegy Ellipta Bivirkninger 
What you need to know before you use Trelegy Ellipta 3.
Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter. 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
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. 
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.
Virusinfektion i luftvejene 
Viral respiratory tract infection
På inhalatorens etiket og æske er et felt, hvor datoen for "Kasseres senest" skal angives. 
The “Discard by” date should be written on the inhaler label and carton in the space provided.
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). 
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).
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. 
After inhalation, patients should rinse their mouth with water without swallowing.
Brugervejledning 
Posology
• hæshed 
Exacerbations
BLAG II 
ANNEX II
Juni 2019 
June 2019
Din læge vil foretage: 
Your doctor will perform:
• på anmodning fra Det europæiske Lægemiddelagentur 
• At the request of the European Medicines Agency;
Sørg for at du tager Iclusig hver dag, så længe den er ordineret. 
Make sure you take Iclusig daily for as long as it is prescribed.
Resistent eller intolerant 
Resistant or Intolerant
b Målt i perifert blod. 
b Measured in peripheral blood.
Andre mulige bivirkninger, som kan forekommer med følgende hyppighed, er: 
Other possible side effects that may occur with the following frequencies are:
En opdateret RMP skal fremsendes senest den 24. november 2014. 
An updated RMP shall be submitted by 24 November 2014.
Der bør anvendes en alternativ eller supplerende kontraceptionsmetode. 
An alternative or additional method of contraception should be used.
Du må ikke holde op med at tage Iclusig uden lægens tilladelse. 
Do not stop taking Iclusig without your doctor's permission.
Din læge kan ønske at træffe yderligere foranstaltninger. 
Your doctor may want to take additional precautions.
Det drejer sig om langvarig behandling. 
This is a long-term treatment.
Fortsæt Iclusig med samme dosis 
Continue Iclusig at the same dose
Forsøget er fortsat i gang. 
The trial is ongoing.
93055 Regensburg, Tyskland 
93055 Regensburg, Germany
Dette lægemiddel må ikke gives til børn under 18 år, da der ikke foreligger data om børn. 
Do not give this medicine to children under 18 years because no data are available in children.
Tal omgående med lægen, hvis det er sket. 
Talk to your doctor immediately if this occurs.
Følgende lægemidler kan påvirke eller påvirkes af Iclusig: 
The following medicines can affect or be affected by Iclusig:
Symptomer er svære smerter i maven og ryggen. 
Symptoms are severe pain in the stomach and back.
Derefter tages det hver måned eller som indiceret af lægen. 
Afterwards it is performed monthly or as indicated by the doctor.
Der foreligger ingen tilstrækkelige data vedrørende anvendelse af Iclusig til gravide kvinder. 
There are no adequate data from the use of Iclusig in pregnant women.
*Rapporteret ved hjælp af National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. 
*Reported using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Brug ikke dette lægemiddel efter den udløbsdato, som står på flaskens etiket og kartonen efter “EXP”. 
Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP.
Behandlingen skal fortsættes, så længe patienter ikke viser tegn på sygdomsprogression eller uacceptabel toksicitet. 
Treatment should be continued as long as the patient does not show evidence of disease progression or unacceptable toxicity.
• smerter i ét eller begge ben ved gang eller træning, som forsvinder efter nogle minutters hvile 
• pain in one or both legs when walking or exercising, which disappears after some minutes of rest
Tag den næste dosis på det sædvanlige tidspunkt. 
Take your next dose at your regular time.
Demografiske karakteristika ved baseline er beskrevet i tabel 5 nedenfor. 
Baseline demographic characteristics are described in Table 5 below.
Den kliniske relevans af dette fund er ukendt. 
The clinical relevance of this finding is unknown.
Første forekomst: 
First occurrence:
Myelosuppression blev hyppigt rapporteret hos alle patientpopulationer. 
Myelosuppression was commonly reported in all patient populations.
På rapporteringstidspunktet havde alle igangværende patienter en minimumopfølgning på 27 måneder. 
At the time of reporting, all ongoing patients had a minimum follow-up of 27 months.
Virkninger viste sig at være reversible efter seponering af behandling. 
The effects were shown to be reversible after withdrawal of the treatment.
Styring af toksicitet: 
Management of toxicities:
Patienter skal monitoreres for respons i henhold til normale kliniske retningslinjer. 
Patients should be monitored for response according to standard clinical guidelines.
Iclusig blokerer dette signal, hvormed dannelsen af disse blodlegemer standses. 
Iclusig blocks this signal, thereby stopping the production of these cells.
Effektresultater er opsummeret i tabel 6, tabel 7 og tabel 8. 
Efficacy results are summarized in Table 6, Table 7, and Table 8.
Foreliggende farmakodynamiske og toksikologiske data kan ikke udelukke potentiel udskillelse i human mælk. 
Available pharmacodynamic and toxicological data cannot exclude potential excretion in human milk.
Iclusig må kun anvendes under graviditeten, når det er strengt nødvendigt. 
Iclusig should be used during pregnancy only when clearly necessary.
• Vigtigheden af at vurdere risiciene inden behandling med ponatinib påbegyndes. 
• Importance of assessing the risks before starting treatment with ponatinib.
Opbevares i den originale beholder for at beskytte mod lys. 
Store in the original container in order to protect from light.
Der er dog ikke blevet udført en grundig QT-undersøgelse, så en klinisk signifikant virkning på QT kan ikke udelukkes. 
However, a thorough QT study has not been performed; therefore a clinically significant effect on QT cannot be excluded.
Opretholdt MMR 
Maintained MMR
Antal patienter 
Number of Patients
Patienter med og uden kardiovaskulære risikofaktorer, inklusive patienter på 50 år og derunder, oplevede disse hændelser. 
Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events.
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. 
Only use Iclusig during pregnancy if your doctor tells you it is absolutely necessary, as potential risks exist for the unborn child.
• feber, ofte sammen med andre tegn på betændelse på grund af nedsat antal hvide blodlegemer 
• fever, often with other signs of infection due to decreased number of white blood cells