FrancophonIA/ELRC3.0 huggingface dataset:
English: Nadir Platelet Count (cells/µl)
Danish: Nadir trombocyttal (celler/µl)
English: • liver function tests abnormal
Danish: • unormale leverfunktionsprøver
English: Content of the pack and other information What Myocet liposomal contains
Danish: Pakningsstørrelser og yderligere oplysninger Myocet liposomal indeholder:
English: A meta-analysis showed a statistically significant lower rate of grade 4 neutropenia (RR = 0.82, p=0.005) in patients treated with Myocet liposomal versus conventional doxorubicin.
Danish: En metaanalyse viste en statistisk signifikant lavere hyppighed af grad 4 neutropeni (RR = 0,82; p = 0,005) hos patienter, som blev behandlet med Myocet liposomal, sammenlignet med konventionelt doxorubicin.
English: A meta-analysis showed a statistically significant lower rate of nausea/vomiting grade ≥ 3 (RR = 0.65, p=0.04) and diarrhoea grade ≥ 3(RR = 0.33, p=0.03) in patients treated with Myocet liposomal versus conventional doxorubicin.
Danish: En metaanalyse viste en statistisk signifikant lavere hyppighed af kvalme/opkastning grad ≥ 3 (RR = 0,65; p = 0,04) og diarré grad ≥ 3 (RR = 0,33; p = 0,03) hos patienter, der blev behandlet med Myocet liposomal, sammenlignet med konventionelt doxorubicin.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BUFFER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER BUFFER
English: DISPOSAL
Danish: BORTSKAFFELSE
English: Plasma levels of doxorubicin and its metabolite, doxorubicinol, may be increased when doxorubicin is administered with cyclosporin, verapamil, paclitaxel or other agents that inhibit Pglycoprotein (P-Gp).
Danish: når doxorubicin indgives sammen med ciclosporin, verapamil, paclitaxel eller andre stoffer, der hæmmer P-glykoprotein (P-gp).
English: Wait one week and if symptoms improve redose at 25% dose reduction
Danish: Vent en uge, og hvis symptomerne bedres ny dosering med 25 % dosisreduktion.
English: • difficulty breathing, chest pains
Danish: • åndedrætsbesvær, smerter i brystet
English: - From a microbiological point of view, the product should be used immediately.
Danish: - Mikrobiologisk set skal produktet anvendes øjeblikkeligt.
English: • feeling thirsty, pain or swelling of your food pipe
Danish: • følelse af tørst, smerter i spiserøret eller opsvulmet spiserør
English: Carton contents:
Danish: Æsken indeholder:
English: • Remove the carton of constituents from the refrigerator.
Danish: • Tag æsken med indholdsstofferne ud af køleskabet.
English: Myocet liposomal doxorubicin HCl IV use
Danish: Myocet liposomal doxorubicin HCl i.v.
English: Glass vials sealed with siliconised grey stopper and blue aluminium flip-off seals, containing not less than 3 ml of buffer.
Danish: Hætteglas af glas, lukket med grå silikonerede propper og blå aluminiumforseglinger, der kan vippes af, indeholdende mindst 3 ml buffer.
English: Wait one week and if symptoms improve redose at 50% dose reduction
Danish: Vent en uge, og hvis symptomerne bedres ny dosering med 50 % dosisreduktion.
English: Asthenia/Fatigue
Danish: Asteni/træthed
English: PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
Danish: KLARGØRING TIL INTRAVENØS INDGIVELSE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (1 set of 3 constituents)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre æske (1 sæt af 3 bestanddele)
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (2 sets of 3 constituents)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre æske (2 sæt af 3 bestanddele)
English: Reconstitute doxorubicin HCl
Danish: Opbland doxorubicin HCl
English: For precautions regarding the use of Myocet liposomal with other medicinal products, see section 4.5.
Danish: 4.5 vedrørende forsigtighedsregler for brugen af Myocet liposomal sammen med andre lægemidler.
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter)
English: Package leaflet: Information for the user Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion
Danish: Indlægsseddel: Information til brugeren Myocet liposomal 50 mg pulver, dispersion og solvens til koncentrat til infusionsvæske, dispersion
English: • if you are allergic to doxorubicin or any of the other ingredients of this medicine (listed in section Do not have Myocet liposomal if this applies to you.
Danish: • hvis du er allergisk over for doxorubicin eller et af de øvrige indholdsstoffer i Myocet liposomal
English: Liposome-encapsulated doxorubicin-citrate complex corresponding to 50 mg doxorubicin hydrochloride (HCl).
Danish: Liposom-indkapslet doxorubicin-citratkompleks svarende til 50 mg doxorubicinhydrochlorid (HCl).
English: Antitumour efficacy summary for combination and single-agent studies
Danish: Tabel 3 Oversigt over antitumor-effekt for kombinations- og monoterapistudier
English: Myocet liposomal is available in cartons containing 1 set or 2 sets of the three constituents.
Danish: Myocet liposomal findes i æsker indeholdende 1 sæt eller 2 sæt á de tre bestanddele.
English: 1 vial doxorubicin HCl 1 vial liposomes 1 vial buffer
Danish: 1 hætteglas doxorubicin HCl 1 hætteglas liposomer 1 hætteglas buffer
English: The resulting reconstituted preparation of Myocet liposomal contains 50 mg of doxorubicin HCl/25 ml of liposomal dispersion (2 mg/ml).
Danish: Det fremkomne, rekonstituerede Myocet liposomal-præparat indeholder 50 mg doxorubicin HCl/25 ml liposom-dispersion (2 mg/ml).
English: Modification more and/or platelets 100,000 or more then redose at 25% dose reduction
Danish: Modifikation mere, derefter ny dosering med 25 % dosisreduktion.
English: Add Ph-adjusted liposomes to doxorubicin
Danish: Tilsæt pH-justerede liposomer til doxorubicin
English: In a phase III study comparing single-agent Myocet liposomal (75 mg/m2) versus single-agent doxorubicin (75 mg/m2), 12% versus 27% of patients, respectively developed a significant decrease in LVEF.
Danish: I et fase III-studie, der sammenligner Myocet liposomal (75 mg/m2) som monoterapi med doxorubicin (75 mg/m2) som monoterapi, udviklede henholdsvis 12 % og 27 % af patienterne betydeligt reduceret LVEF.
English: Folliculitis
Danish: Follikulit
English: Myocet liposomal consists of a powder, dispersion and solvent for concentrate for dispersion for infusion.
Danish: Myocet liposomal består af et pulver, dispersion og solvens til koncentrat til infusionsvæske, dispersion.
English: The resulting reconstituted preparation of Myocet liposomal contains 50 mg of doxorubicin HCl/25 ml of concentrate for liposomal dispersion for infusion (2 mg/ml).
Danish: Det fremkomne, rekonstituerede Myocet liposomal-præparat indeholder 50 mg doxorubicin HCl/25 ml koncentrat til liposom-dispersion til infusionsvæske (2 mg/ml).
English: phenobarbital, phenytoin and warfarin.
Danish: Interaktioner med doxorubicin er også rapporteret for streptozocin, phenobarbital, phenytoin og warfarin.
English: Adjust Ph of liposomes
Danish: Justér liposomernes pH
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LIPOSOMES
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER LIPOSOMER
English: Liposome-encapsulated doxorubicin corresponding to 50 mg doxorubicin hydrochloride
Danish: Liposom-indkapslet doxorubicin svarende til 50 mg doxorubicinhydrochlorid
English: For dose reduction of Myocet liposomal due to liver function impairment, see section 4.2.
Danish: 4.2 angående dosisreduktion af Myocet liposomal på grund af nedsat leverfunktion.
English: Tests
Danish: Undersøgelser
English: Myocet liposomal must be reconstituted and further diluted prior to administration.
Danish: Myocet liposomal skal rekonstitueres og yderligere fortyndes forud for indgivelse (se pkt.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: • skin rash and nail problems.
Danish: • udslæt og problemer med neglene.
English: • nose bleeds, hot flushes
Danish: • næseblod, hedeture
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: Powder, dispersion and solvent for concentrate for dispersion for infusion
Danish: Pulver, dispersion og solvens til koncentrat til infusionsvæske, dispersion
English: Other medicines and Myocet liposomal
Danish: Brug af anden medicin sammen med Myocet liposomal
English: Myocet liposomal 50 mg concentrate for dispersion for infusion Liposomal doxorubicin HCl
Danish: Myocet liposomal 50 mg koncentrat til dispersion til infusionsvæske Liposom doxorubicinHCl i.v.
English: 3.1 Preparation of Myocet liposomal
Danish: 3.1 KLARGØRING AF MYOCET LIPOSOMAL
English: Vial 1 - doxorubicin HCl
Danish: Hætteglas 1 - doxorubicin HCl
English: In addition to these three components, 0.9% (w/v) sodium chloride solution for injection will also be required for the reconstitution of the doxorubicin HCl.
Danish: Foruden disse tre komponenter vil der også være behov for 0,9 % (vægt/vol.)
English: What Myocet liposomal is and what it is used for What you need to know before you are given Myocet liposomal How Myocet liposomal is given Possible side effects
Danish: Det skal du vide, før du begynder at få Myocet liposomal Sådan gives Myocet liposomal Bivirkninger
English: Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion.
Danish: Myocet liposomal, 50 mg pulver, dispersion og solvens til koncentrat til infusionsvæske, dispersion.
English: Inject into the buffer vial to adjust the Ph of liposomes.
Danish: • Træk 1,9 ml liposomer op. Injicér det i bufferhætteglasset for at justere liposomernes pH.
English: • difficulty sleeping
Danish: • søvnløshed
English: After reconstitution the finished product must be further diluted in 0.9% (w/v) sodium chloride solution for injection, or 5% (w/v) glucose solution for injection to a final volume of 40 ml to 120 ml per 50 mg reconstituted Myocet liposomal so that a final concentration of 0.4 mg/ml to 1.2 mg/ml doxorubicin is obtained.
Danish: glucoseopløsning til injektion, til en slutvolumen på 40 ml til 120 ml pr. 50 mg rekonstitueret Myocet liposomal, så der opnås en slutkoncentration på 0,4 mg/ml til1,2 mg/ml doxorubicin.
English: Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion Liposomal doxorubicin hydrochloride
Danish: Myocet liposomal 50 mg pulver, dispersion og solvens til koncentrat til infusionsvæske, dispersion Liposom doxorubicinhydrochlorid
English: Myocet liposomal/CP A
Danish: Myocet liposomal/C PA
English: Vial 1 - doxorubicin HCl lactose
Danish: Hætteglas 1 - doxorubicin HCl lactose
English: After reconstitution the finished product must be further diluted in 0.9% (w/v) sodium chloride for injection, or 5% (w/v) glucose solution for injection to a final volume of 40 ml to 120 ml so that a final concentration of 0.4 mg/ml to 1.2 mg/ml doxorubicin is obtained.
Danish: glucoseopløsning til injektion til en slutvolumen på 40 ml til 120 ml, så der opnås en slutkoncentration på 0,4 mg/ml -1,2 mg/ml doxorubicin.
English: Haemorrhagic cystitis
Danish: Hæmoragisk cystit
English: • muscle aches, back pain, headache
Danish: • muskelsmerter, rygsmerter, hovedpine
English: Myocet liposomal is available in cartons containing 1 set or 2 sets of the three constituent vials.
Danish: Myocet liposomal fås i æsker med 1 sæt eller 2 sæt af tre hætteglas med bestanddele.
English: Vial 1 - doxorubicin HCl • lactose
Danish: Hætteglas 1 - doxorubicin HCl • Lactose
English: Myocet liposomal has been reported to cause dizziness.
Danish: Myocet liposomal har vist sig at medføre svimmelhed.
English: How to store Myocet liposomal
Danish: Sådan gives Myocet liposomal
English: Preparation of Myocet liposomal
Danish: Klargøring af Myocet liposomal
English: - Do not use this medicine after the expiry date stated on the label and carton.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og æsken - Opbevares i køleskab (2º C til 8º C).
English: Abnormal gait
Danish: Unormal gang
English: Grade
Danish: Vægttab
English: • constipation, weight loss
Danish: • forstoppelse, vægttab
English: Increased hepatic transaminases
Danish: Forhøjede leveraminotransferaser
English: • coughing up blood
Danish: • ophostning af blod
English: Vial 1 - doxorubicin HCl is a red lyophilised powder.
Danish: Myocet liposomal leveres som et system i tre hætteglas, på følgende måde: Hætteglas 1 - doxorubicin HCl er et rødt frysetørret pulver.
English: Check with your doctor or nurse before having your medicine if:
Danish: Tal med lægen eller sundhedspersonalet, før du får Myocet liposomal, hvis:
English: Arrhythmia
Danish: Hæmoptyse
English: Radiation therapy
Danish: Strålebehandling
English: Tumour response rate 43% 43% 46% 39% 26% 26% Relative Risk (95% C.I.)
Danish: Tumor-responsrate Relativ risiko (95 % C.I.)
English: Constipation
Danish: Neglelidelse
English: Posology
Danish: Opsætning
English: if you are allergic to umeclidinium or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for umeclidinium, eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Incruse Ellipta should be administered at the same time of the day each day to maintain bronchodilation.
Danish: Incruse Ellipta skal administreres på samme tidspunkt hver dag for at opretholde bronkodilatation.
English: • Increase of the measured eye pressure
Danish: • stigning i det målte øjentryk
English: Instructions for use: a) Prepare a dose
Danish: Brugervejledning: a) Klargøring af en dosis
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: På lægemidlets trykte indlægsseddel skal der anføres navn og adressse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch.
English: Umeclidinium bromide should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
Danish: Umeclidiniumbromid bør kun anvendes under graviditet, hvis den forventede fordel for moderen opvejer den potentielle risiko for fostret.
English: Don't use this medicine if you are pregnant unless your doctor tells you so.
Danish: Brug ikke dette lægemiddel, hvis du er gravid, medmindre din læge siger, at du kan bruge det.
English: Date of latest renewal: 11 January 2019
Danish: Dato for første markedsføringstilladelse: 28. april 2014 Dato for seneste fornyelse: 11 januar 2019
English: It is very important that you use Incruse Ellipta every day, as instructed by your doctor.
Danish: Det er meget vigtigt, at du tager Incruse Ellipta hver dag nøjagtigt efter lægens anvisning.
English: There is no relevant use of Incruse Ellipta in the paediatric population (under 18 years of age) in the indication for COPD.
Danish: Der er ikke relevant at anvende Incruse Ellipta i den pædiatriske population (i alderen under 18 år) til indikationen KOL.
English: If you have any of the following symptoms after taking Incruse Ellipta, stop using this medicine and tell your doctor immediately:
Danish: Hvis du oplever nogle af de følgende symptomer efter at have taget Incruse Ellipta, skal du stoppe med at tage medicinen og straks kontakte din læge:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: The other ingredients are lactose monohydrate (see section 2 under ‘Incruse Ellipta contains lactose') and magnesium stearate.
Danish: Øvrige indholdsstoffer: lactosemonohydrat (se punkt 2 under ”Incruse Ellipta indeholder lactose”) og magnesiumstearat.
English: No dose adjustment is required in patients over 65 years (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter over 65 år (se pkt.
English: The primary endpoint was annual rate of ontreatment moderate and severe exacerbations in subjects treated with FF/UMC/VI compared with FF/VI.
Danish: Det primære endepunkt var den årlige hyppighed af moderate og svære eksacerbationer under behandling hos forsøgspersoner behandlet med FF/UMEC/VI sammenlignet med FF/VI.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Incruse Ellipta therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre, eller behandling med Incruse Ellipta skal seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Submission of the final clinical study report on a Post-Authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Incruse Ellipta compared with tiotropium (study 201038), according to a protocol agreed by the PRAC.
Danish: Indsendelse af den endelige rapport for det kliniske observationssikkerhedsstudie (kohorte) efter godkendelsen (PAS - Post-Authorisation Safety), der skal kvantificere incidensen og sammenlignende sikkerhed for udvalgte kardiovaskulære og cerebrovaskulære bivirkninger hos KOL-patienter forbundet med Incruse Ellipta i sammenligning med tiotropium (studie 201038), i henhold til den protokol, der er aftalt med PRAC.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Danish: (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: There was no evidence for tachyphylaxis in the effect of Incruse Ellipta over time.
Danish: Der var ingen tegn på takyfylaksi for effekten af Incruse Ellipta over tid.
English: Table 1: Trough FEV1 (ml) at Week 12 and Week 24 (primary endpoint) Treatment with Incruse Ellipta 55 mcg
Danish: Tabel 1: Trough-FEV1 (ml) ved uge 12 og uge 24 (primært endepunkt) Behandling med Incruse Ellipta 55 mikrogram
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Incruse Ellipta inhaler:
Danish: Hvis du får trykken for brystet, hoste, hvæsende vejrtrækning eller åndenød, umiddelbart efter at du har brugt din Incruse Ellipta inhalator:
English: The probability of having an exacerbation in patients receiving Incruse Ellipta at week 24 was 8.9% compared with 13.7% for placebo.
Danish: Sandsynligheden for at få en eksacerbation hos patienter, der fik Incruse Ellipta ved uge 24, var 8,9 % sammenlignet med 13,7 % for placebo.
English: Incruse Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Danish: Incruse Ellipta er indiceret som bronkodilaterende vedligeholdelsesbehandling til symptomlindring hos voksne patienter med kronisk obstruktiv lungesygdom (KOL).
English: Driving and using machines It is unlikely that this medicine will affect your ability to drive or use machines.
Danish: Det er ikke sandsynligt, at denne medicin vil påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Incruse Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Danish: Incruse Ellipta må ikke anvendes til lindring af pludselige anfald af åndenød eller hvæsende vejrtrækning.
English: The effect of umeclidinium 500 micrograms (pre-dispensed) on the QT interval was evaluated in a placebo- and moxifloxacin-controlled QT trial of 103 healthy volunteers.
Danish: Effekten af umeclidinium 500 mikrogram (afdelt) på QT-intervallet blev vurderet i et placebo- og moxifloxacin-kontrolleret QT-studie hos 103 raske personer.
English: Patients receiving Incruse Ellipta had a higher percentage of days when no rescue medication was needed (on average 31.1%) compared with placebo (on average 21.7%).
Danish: Patienter, der fik Incruse Ellipta, havde en højere procentdel af dage uden behov for anfaldsmedicin (gennemsnitligt 31,1 %) sammenlignet med placebo (gennemsnitligt 21,7 %).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Incruse Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Incruse Ellipta i alle undergrupper af den pædiatriske population ved indikationen KOL (se pkt.
English: Use Incruse Ellipta regularly
Danish: Tag Incruse Ellipta regelmæssigt
English: The short duration of these two studies and limited number of exacerbation events, preclude any conclusion regarding additional effect of Incruse Ellipta on COPD exacerbation rate.
Danish: Grundet det korte forløb af disse to studier og det begrænsede antal eksacerbationer var det ikke muligt at konkludere, om Incruse Ellipta havde en additiv effekt på hyppigheden af KOL-eksacerbationer.
English: Eye problems during treatment with Incruse Ellipta If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with Incruse Ellipta:
Danish: Hvis du under behandling med Incruse Ellipta får øjensmerter eller -ubehag, midlertidig sløring af synet, visuelle ringe eller farvet syn i forbindelse med røde øjne:
English: The bronchodilatory effects with Incruse Ellipta compared with placebo were evident after the first day of treatment in both studies and were maintained over the 12-week and 24-week treatment periods.
Danish: I begge studier var de bronkodilaterende effekter af Incruse Ellipta sammenlignet med placebo evidente efter den første dag med behandling og blev opretholdt over behandlingsperioderne på 12 uger og 24 uger.
English: Not known Not known Rare Not known
Danish: Ikke kendt Ikke kendt Sjælden Ikke kendt
English: To use Incruse Ellipta, you breathe it into your lungs through your mouth using the Ellipta inhaler.
Danish: Incruse Ellipta tages ved at indånde medicinen ned i dine lunger gennem munden ved hjælp af Ellipta-inhalatoren.
English: It is not known whether the ingredients of Incruse Ellipta can pass into breast milk.
Danish: Det vides ikke, om indholdsstofferne i Incruse Ellipta går over i modermælken.
English: What you need to know before you use Incruse Ellipta 3.
Danish: Det skal du vide, før du begynder at tage Incruse Ellipta 3.
English: Each delivered dose contains approximately 12.5 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver afgivet dosis indeholder ca. 12,5 mg lactose (som monohydrat).