FrancophonIA/ELRC3.0 huggingface dataset:
English: When daunorubicin and cytarabine are administered as components of Vyxeos liposomal, the liposomes appear to govern their tissue distribution and rates of elimination; therefore, while the nonliposomal medicinal products have markedly different clearance (CL), volume of distribution (V), and terminal half-life (t1/2) Vyxeos liposomal causes these pharmacokinetic parameters to converge.
Danish: Selvom de ikke-liposomale lægemidler har betydeligt forskellig clearance (CL), distributionsvolumen (V) og terminal halveringstid (t1/2), får Vyxeos liposomal derfor disse farmakokinetiske parametre til at konvergere.
English: Pregnancy warning/women of childbearing potential Patients should be advised to avoid becoming pregnant while receiving Vyxeos liposomal.
Danish: Advarsel vedrørende graviditet/kvinder i den fertile alder Patienterne skal tilrådes at undgå graviditet under behandling med Vyxeos liposomal.
English: Serious or fatal haemorrhagic events, including fatal central nervous system (CNS) haemorrhages, associated with severe thrombocytopenia were seen in patients treated with Vyxeos liposomal (see section 4.4).
Danish: Der er observeret tilfælde af alvorlige eller letale blødningshændelser, herunder letale blødninger i centralnervesystemet (CNS), forbundet med alvorlig trombocytopeni, hos patienter, der blev behandlet med Vyxeos liposomal (se pkt.
English: Visual impairment (10.4)
Danish: Synsforringelse (10,4)
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 2°C to 8°C when kept in an upright position.
Danish: Stabilitet af den rekonstituerede suspension i hætteglasset Den kemiske og fysiske stabilitet efter åbning er påvist i 4 timer ved 2 °C til 8 °C ved opbevaring i opret position.
English: • After reconstitution, the vials should be stored in a refrigerator (2°C to 8°C) for up to 4 hours in an upright position.
Danish: • Efter rekonstituering skal hætteglassene opbevares i køleskab (2 °C til 8 °C) i op til 4 timer i opret position.
English: • If the diluted infusion solution is not used immediately, store in a refrigerator (2°C to 8°C) for up to 4 hours.
Danish: • Hvis den fortyndede infusionsvæske ikke bruges straks, skal den opbevares i køleskab (2 °C til 8 °C) i op til 4 timer.
English: Second induction daunorubicin 44 mg/m and cytarabine 100 mg/m on days 1 and 3
Danish: Anden induktion daunorubicin 44 mg/m og cytarabin 100 mg/m på dag 1 og 3
English: Treatment with Vyxeos liposomal should be discontinued in patients with impaired cardiac function unless the benefit of initiating or continuing treatment outweighs the risk (see sections 4.5 and 4.8).
Danish: Behandling med Vyxeos liposomal skal seponeres hos patienter med svækket hjertefunktion, medmindre fordelen ved initiering eller fortsættelse af behandlingen opvejer risiciene (se pkt.
English: Based on a population pharmacokinetic analysis using data from clinical studies in patients, no significant difference in clearance of daunorubicin or cytarabine was observed in patients with pre-existing mild to moderate renal impairment (60 mL/min ≥ to ≤ 89 mL/min creatinine clearance [CrCL] for mild, and 30 mL/min ≥ to ≤ 59 mL/min creatinine clearance [CrCL] for moderate) compared to patients with baseline normal renal function (CrCL ≥ 90 mL/min).
Danish: Baseret på en farmakokinetisk populationsanalyse med anvendelse af data fra kliniske studier med patienter blev der ikke observeret nogen signifikant forskel i clearancen af daunorubicin eller cytarabin hos patienter med eksisterende let til moderat nedsat nyrefunktion (60 ml/min.
English: your doctor will also check you for infections during treatment.
Danish: Din læge vil kontrollere dig under behandlingen.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Meget almindelig
English: • Gently invert the bag to mix the solution.
Danish: • Vend forsigtigt posen om, så væsken blandes.
English: Hypersensitivity (including rash)
Danish: Overfølsomhed (inkl.
English: Dizziness (0.8)
Danish: Svimmelhed (0,8)
English: • After dilution, the solution in infusion bags should be stored in a refrigerator (2°C to 8°C) for up to 4 hours.
Danish: • Efter fortynding skal infusionsvæsken i infusionsposer opbevares i køleskab (2 °C til 8 °C) i op til 4 timer.
English: Renal insufficiency (10.4)
Danish: Nyreinsufficiens (10,4)
English: Dosing schedule
Danish: Doseringsskema
English: • bleeding
Danish: • blødning
English: Patients should be monitored until symptoms resolve (see sections 4.2 and 4.8).
Danish: Patienten skal monitoreres, indtil symptomerne svinder (se pkt.
English: ADRs reported in clinical studies in patients treated with Vyxeos liposomal
Danish: Tabel 2: Bivirkninger, der er indberettet i kliniske studier hos patienter, der er behandlet med Vyxeos liposomal (n=375)
English: • After reconstitution the solution contains 2.2 mg/mL daunorubicin and 5 mg/mL cytarabine encapsulated in liposomes.
Danish: • Efter rekonstituering indeholder opløsningen 2,2 mg/ml daunorubicin og 5 mg/ml cytarabin indkapslet i liposomer
English: Tumour lysis syndrome (7.5)
Danish: Tumorlysesyndrom (7,5)
English: How you are given Vyxeos liposomal
Danish: Sådan får du Vyxeos liposomal
English: • increased sweating
Danish: • øget svedproduktion
English: Vyxeos liposomal should only be used in patients with a history of Wilson's disease or other copperrelated disorder if the benefits outweigh the risks (see section 6.1).
Danish: Vyxeos liposomal må kun bruges til patienter med Wilsons sygdom eller anden kobberrelateret lidelse i anamnesen, hvis fordelene opvejer risiciene (se pkt.
English: Chest pain (1.9)
Danish: Brystsmerter (1,9)
English: After reconstitution the solution contains 2.2 mg/mL daunorubicin and 5 mg/mL cytarabine encapsulated in liposomes
Danish: Efter rekonstituering indeholder opløsningen 2,2 mg/ml daunorubicin og 5 mg/ml cytarabin indkapslet i liposomer
English: Musculoskeletal pain (44.5)
Danish: Smerter i bevægeapparat (44,5)
English: Tumour lysis syndrome (2.7)
Danish: Tumorlysesyndrom (2,7)
English: • Do not throw away any medicines via wastewater.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet.
English: Dose adjustment is not required for patients with mild (creatinine clearance [CrCL] 60 mL/min to 89 mL/min by Cockcroft Gault equation [C-G]) or moderate (CrCL 30 mL/min to 59 mL/min) renal impairment.
Danish: ≥ til ≤ 89 ml/min kreatininclearance [CrCL] for let og 30 ml/min ≥ til ≤ 59 ml/min kreatininclearance [CrCL] for moderat) sammenlignet med patienter med normal nyrefunktion ved baseline (CrCL ≥ 90 ml/min.).
English: Similar to non-liposomal daunorubicin and cytarabine, subsequent to release from Vyxeos liposomal liposomes, both daunorubicin and cytarabine are extensively metabolised in the body.
Danish: Svarende til ikke-liposomal daunorubicin og cytarabin metaboliseres både daunorubicin og cytarabin omfattende i kroppen efter frigivelse fra Vyxeos liposomal-liposomerne.
English: Cardiotoxic agents
Danish: Kardiotoksiske midler
English: Infections and infestations Very Common
Danish: Infektioner og parasitære sygdomme
English: The incidence of haemorrhage events is 69.1%; the incidence of non-serious events of haemorrhage was 67.2 %; the incidence of serious events of haemorrhage is 5.6%; the incidence of haemorrhage which led to discontinuation is 0.
Danish: Forekomsten af blødningshændelser var 69,1%; forekomsten af ikke-alvorlige blødningshændelser var 67,2%; forekomsten af alvorlige blødningshændelser var 5,6%; forekomsten af blødningshændelser, der førte til seponering, var 0.
English: Purple, lyophilised cake.
Danish: Violet lyofilisat.
English: Carcinogenicity, mutagenicity, and reproductive toxicity studies have not been conducted with Vyxeos liposomal.
Danish: Der er ikke udført studier med Vyxeos liposomal af karcinogeniciteten, mutageniciteten eller reproduktionstoksiciteten.
English: Intravenous use after dilution
Danish: IVanvendelse efter fortynding
English: There is no experience with Vyxeos liposomal in patients with severe renal impairment (CrCL 15 mL/min to 29 mL/min) or end-stage renal disease.
Danish: Der er ingen erfaring med anvendelse af Vyxeos liposomal til patienter med svært nedsat nyrefunktion (CrCL 15 ml/min.
English: Therapy
Danish: Dosering
English: Vyxeos liposomal should only be used in patients with severe hepatic and/or renal impairment if the benefits outweigh the risks (see section 4.2).
Danish: Vyxeos liposomal bør kun bruges til patienter med svært nedsat lever- og/eller nyrefunktion, hvis fordelene opvejer risiciene (se pkt.
English: What Vyxeos liposomal is and what it is used for What Vyxeos liposomal is
Danish: Virkning og anvendelse Hvad er Vyxeos liposomal?
English: Palmar-plantar erythrodysaesthesia syndrome
Danish: Palmoplantar erytrodysæstesi-syndrom) (0,8)
English: Musculoskeletal pain (5.1)
Danish: Smerter i bevægeapparat (5,1)
English: Vyxeos liposomal should only be used in patients with severe hepatic impairment if the benefits outweigh the risks (see section 4.4).
Danish: Vyxeos liposomal bør kun anvendes til patienter med svært nedsat leverfunktion, hvis fordelene opvejer risiciene (se pkt.
English: What Vyxeos liposomal is used for
Danish: Hvad bruges Vyxeos liposomal til?
English: ADRs/Frequency (%)
Danish: Overlevelse (%)
English: Hepatotoxic agents
Danish: Hepatotoksiske midler
English: Haemorrhage (13.1)
Danish: udslæt) (9,1)
English: Due to the neutropenia experienced with Vyxeos liposomal, infections of various types were very common ADRs.
Danish: Forskellige typer infektioner var meget almindelige bivirkninger på grund af den neutropeni, der opstod med Vyxeos liposomal.
English: Dizziness (23.2)
Danish: Hovedpine (32,3) Svimmelhed (23,2)
English: • stomach cramps or excessive gas
Danish: • mavepine eller meget luft i maven
English: Due to the thrombocytopenia experienced with Vyxeos liposomal a variety of haemorrhagic events were seen in clinical studies.
Danish: I kliniske studier blev der observeret flere forskellige blødningshændelser som følge af den trombocytopeni, der opstod efter behandling med Vyxeos liposomal.
English: What you need to know before you are given Vyxeos liposomal 3.
Danish: Virkning og anvendelse Det skal du vide, før du får Vyxeos liposomal Sådan får du Vyxeos liposomal Bivirkninger
English: Whereas:
Danish: Eftersom:
English: Greater safety in a substantial portion of the target population
Danish: Større sikkerhed hos en væsentlig andel af målgruppen
English: The Decentralised procedure LT/H/0112/001/DC started on 24 September 2014.
Danish: Den decentrale procedure LT/H/0112/001/DC blev indledt den 24. september 2014.
English: The application was submitted to the reference Member State (RMS): Lithuania, and the concerned Member States (CMS): Bulgaria, Estonia, Hungary, Latvia, Poland and Romania.
Danish: Ansøgningen blev indgivet til referencemedlemsstaten: Litauen, og de berørte medlemsstater: Bulgarien, Estland, Ungarn, Letland, Polen og Rumænien.
English: Overall summary of the scientific evaluation of Tobramycin VVB and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Tobramycin VVB og relaterede navne (jf. bilag I)
English: The CMDh 60 day procedure was initiated on 03 August 2015.
Danish: CMDh's 60-dages procedure blev indledt den 3. august 2015.
English: The EAGER study
Danish: EAGER-undersøgelsen
English: These observations were replicated in post-hoc analyses of different age groups.
Danish: Disse iagttagelser blev gentaget ved post hoc-analyser hos forskellige aldersgrupper.
English: Tobramycin is an aminoglycoside antibiotic.
Danish: Tobramycin er et antibiotikum af aminoglykosidtypen.
English: Although fewer children receiving TIP discontinued the treatment, the overall number of children in EAGER study was small, and thus no definite conclusion about this subpopulation can be drawn.
Danish: Færre børn behandlet med TIP ophørte med behandlingen, men da det samlede antal børn i EAGER-undersøgelsen var lille, kan der ikke drages en endelig konklusion om denne undergruppe.
English: When taken together, these elements allow to estimate that at least 10% of the target population may not be able to use TOBI Podhaler due to intolerance.
Danish: Tilsammen gør disse elementer det muligt at skønne, at mindst 10 % af målpopulationen muligvis ikke kan bruge TOBI Podhaler pga. intolerans.
English: This is in line with fact that cough is described as a ‘very common' adverse reaction in association with TOBI Podhaler, which means that it occurs with a frequency of at least 10%.
Danish: Dette er i overensstemmelse med det forhold, at hoste er beskrevet som en "meget almindelig" bivirkning i forbindelse med TOBI Podhaler, hvilket betyder, at den optræder med en hyppighed på mindst 10 %.
English: For these patients, the nebuliser solution is a safer alternative (in terms of tolerability) and 10% is considered by CHMP to be a substantial portion of the target population.
Danish: For disse patienter er inhalationsvæske et sikrere alternativ (i form af tolerabilitet), og 10 % anses af CHMP for at være en væsentlig del af målpopulationen.
English: The overall discontinuation rates for TIP were 3.6% in the children (≥6 to <13 years), 18.2% in the adolescents (≥13 to <20 years), and 32.7% in the adults (≥ 20 years), while the discontinuation rates with TIS were 16.7% in the children and adolescents, and 18.9% in the adults.
Danish: Den samlede frafaldsrate med TIP var 3,6 % hos børn (≥6 til <13 år), 18,2 % hos unge (≥13 til <20 år), og 32,7 % hos voksne (≥ 20 år), mens frafaldsraten med TIS var 16,7 % hos børn og unge, og 18,9 % hos voksne.
English: It is therefore established that there is a portion of the target population who cannot use powder inhalator due to the development of intolerance.
Danish: Det er derfor fastlagt, at en del af målpopulationen ikke kan anvende pulverinhalator pga. udvikling af intolerans.
English: According to the European Cystic Fibrosis Society Patient Registry, 48.0% of cystic fibrosis patients in the 20 European countries presenting data are over 18 years of age3.
Danish: I henhold til patientregisteret hos European Cystic Fibrosis Society er 48 % af patienter med cystisk fibrose over 18 år i de 20 europæiske lande, hvorfra der foreligger data3.
English: Local respiratory intolerability to the dry powder inhalation can manifest itself through symptoms such as cough, and result in discontinuation of treatment.
Danish: Lokal respiratorisk intolerans over for inhalation af det tørre pulver kan vise sig som symptomer såsom hoste og medfører ophør af behandlingen.
English: • The Committee considered the notification of the referral initiated by the Reference Member State Lithuania under Article 29(4) of Directive 2001/83/EC where the Concerned Member State Poland raised objections to the granting of the marketing authorisation;
Danish: • udvalget behandlede anmeldelsen af indbringelsen, der var indledt af referencemedlemsstaten Litauen i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF, og hvor den berørte medlemsstat Polen fremsatte indvendinger mod udstedelsen af markedsføringstilladelsen,
English: With regards to the claim of clinical superiority on the ground of greater safety in a substantial portion of the target population, the applicant was requested by CHMP during the procedure:
Danish: Hvad angår påberåbelsen af klinisk overlegenhed pga. større sikkerhed hos en væsentlig del af målpopulationen, blev ansøgeren under proceduren af CHMP anmodet om:
English: Post hoc subgroup analyses of EAGER data compared the safety profiles of TIP and TIS in children, adolescents, and adults.
Danish: I post hoc-undergruppeanalyser af EAGER-data sammenlignedes sikkerhedsprofilen af TIP og TIS hos børn, unge og voksne.
English: Day 60 of the CMDh procedure was on 01 October 2015 and since the Member States failed to reach an agreement, the procedure was referred to the CHMP in accordance with Article 29(4) of Directive 2001/83/EC.
Danish: Dag 60 i CMDh's procedure var den 1. oktober 2015, og da medlemsstaterne ikke var i stand til at nå til enighed, blev proceduren forelagt CHMP i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF.
English: A Marketing Authorisation for Tobramycin VVB can therefore only be granted with the currently proposed indication if at least one of the derogation grounds set out in Article 8(3) of Regulation (EC) No 141/2000 is fulfilled.
Danish: Markedsføringstilladelse for Tobramycin VVB kan derfor kun udstedes til den anførte indikation, hvis mindst én af grundene til fravigelse som fastlagt i artikel 8, stk. 3, i forordning (EF) nr. 141/2000 er opfyldt.
English: For these patients, tobramycin nebuliser solution is an alternative.
Danish: Til disse patienter er tobramycin inhalationsvæske en mulighed.
English: Considering the data from EAGER study and its post-hoc analyses, the difference in overall discontinuations is nearly 9% and difference in discontinuations due AEs is ~5% in favour of Tobramycin nebuliser solution.
Danish: Når data fra EAGER-undersøgelsen og de tilhørende post hoc-analyser tages i betragtning, er forskellen i samlet frafald næsten 9 %, og forskellen i bivirkningsbetinget ophør er ~5 % til fordel for Tobramycin inhalationsvæske.
English: On day 210, major issues on safety and efficacy were raised which remained unsolved; hence the procedure was referred to the CMDh, under Article 29, paragraph 1 of Directive 2001/83/EC by Lithuania on 24 July 2015.
Danish: På dag 210 blev der rejst problemer vedrørende sikkerhed og virkning, som forblev uafklarede; proceduren blev derfor af Litauen den 24. juli 2015 forelagt CMDh i henhold til artikel 29, stk. 1, i direktiv 2001/83/EF.
English: During the discussion, CHMP also noted the differences in terms of inhalation time between Tobramycin VVB and Tobi Podhaler.
Danish: Under drøftelserne bemærkede CHMP også forskellen i inhalationstid mellem Tobramycin VVB og Tobi Podhaler.
English: Post hoc analysis of AEs profile in different age groups confirmed the results that were originally observed in EAGER study, i.e., any AE and cough, dysphonia and dysgeusia were more frequent among TIP-treated patients across all age groups.
Danish: Post hoc-analyse af bivirkningsprofilen hos forskellige aldersgrupper bekræftede de resultater, der oprindelig blev iagttaget i EAGER-undersøgelsen, dvs. at alle bivirkninger, herunder hoste, dysfoni og dysgeusi, var hyppigere blandt patienter behandlet med TIP i alle aldersgrupper.
English: The frequency of severe cough events was also higher in TIP group (2.6% versus 1.9%).
Danish: Hyppigheden af svære hosteepisoder var ligeledes højere i TIP-gruppen (2,6 % mod 1,9 %).
English: In the EAGER trial, the overall discontinuation rate was higher with TIP (26.9%) than TIS (18.2%).
Danish: I EAGER-undersøgelsen var den totale frafaldsrate højere med TIP (26,9 %) end med TIS (18,2 %).
English: In addition, 3.9% (12/308) of TIP-treated patients discontinued due to cough vs 1% (2/209) of TIS-treated patients.
Danish: Desuden udgik 3,9 % (12/308) af patienter behandlet med TIP pga. hoste, mod 1 % (2/209) af dem, der blev behandlet med TIS.
English: The proposed medicinal product contains the same qualitative and quantitative composition and the same pharmaceutical form as TOBI 300mg/5 ml nebuliser solution, therefore clinical studies for demonstrating therapeutic equivalence can be waived in accordance with the scientific guidelines (EMEA/CHMP/QWP/49313/2005 Corr. and CPMP/EWP/4151/00 Rev.1).
Danish: Det ansøgte lægemiddel har samme kvalitative og kvantitative sammensætning og samme farmaceutiske form som TOBI, inhalationsvæske, 300 mg/5 ml, hvorfor kravet om kliniske undersøgelser til påvisning af terapeutisk ækvivalens kan fraviges i overensstemmelse med de videnskabelige retningslinjer (EMEA/CHMP/QWP/49313/2005 Corr. og CPMP/EWP/4151/00 Rev.1).
English: Cough (not including productive cough) was the most frequently reported AE throughout the entire study period (TIP: 48.4%; TIS: 31.1%) despite being present in the same proportion of patients (42%) in both groups as a baseline symptom.
Danish: Hoste (som ikke omfattede produktiv hoste) var den hyppigst beskrevne bivirkning i hele undersøgelsesperioden (TIP: 48,4 %; TIS: 31.1 %), skønt den som baseline-symptom fandtes hos samme andel af patienterne (42 %) i begge grupper.
English: This study evaluated the safety, efficacy and convenience of TIP vs TIS in CF patients aged 6 years and above with chronic P. aeruginosa infection.
Danish: Undersøgelsen vurderede sikkerhed, virkning og bekvemmelighed af TIP i forhold til TIS hos patienter med cystisk fibrose i alderen over 6 år med kronisk infektion med P. aeruginosa.
English: Other treatment-related AEs more commonly reported in the TIP group were dysphonia (13.6% vs 3.8%) and dysgeusia (3.9% vs 0.5%).
Danish: Andre behandlingsrelaterede bivirkninger, der blev beskrevet hyppigere i TIP-gruppen, var dysfoni (13,6 % mod 3,8 %) og dysgeusi (3,9 % mod 0,5 %).
English: Difference in the incidence of adverse events
Danish: Forskel i bivirkningshyppigheden
English: The difference is even more pronounced in the adult cystic fibrosis patient population (14% difference in overall discontinuations and 8% - in discontinuations due to AEs).
Danish: Forskellen er endnu mere udtalt hos voksne patienter med cystisk fibrose (14 procents forskel i totalt ophør og 8 % i ophør pga. bivirkninger).
English: During the assessment of the marketing authorisation application for Tobramycin VVB and in the context of the abovementioned Article, a similarity assessment was performed concluding that Tobramycin VVB was similar to Tobi Podhaler.
Danish: Under vurderingen af ansøgningen om markedsføringstilladelse og i forbindelse med ovennævnte artikel blev der foretaget en lighedsvurdering, der konkluderede, at Tobramycin VVB svarede til Tobi Podhaler.
English: Having established that there is a portion of the target population who cannot use powder inhalator due to the development of intolerance and that for these patients the tobramycin nebuliser solution is a safer alternative, in order for a conclusion on clinical superiority to be drawn CHMP needed to assess whether these patients correspond to a substantial portion of the target population.
Danish: Efter at have fastslået, er en del af målgruppen ikke kan anvende pulverinhalatoren pga. udvikling af intolerans, og at tobramycin inhalationsvæske er et sikrere alternativ for disse patienter, behøvede CHMP at vurdere, om disse patienter svarer til en væsentlig andel af målpopulationen, for at drage en konklusion om klinisk overlegenhed.
English: • The Committee reviewed the responses submitted by the applicant to address the issues raised with regard to the claim for clinical superiority of Tobramycin VVB vs. TOBI Podhaler;
Danish: • udvalget gennemgik ansøgerens besvarelse af de rejste spørgsmål vedrørende påberåbelse af klinisk overlegenhed af Tobramycin VVB over TOBI Podhaler,
English: A higher percentage of TIP- than TIS-treated patients reported AEs (90.3% versus 84.2%, p<0.05).
Danish: En større procentdel af patienter behandlet med TIP end med TIS meldte om bivirkninger (90,3 % mod 84,2 %, p<0,05).
English: This is particularly illustrated by the differences in the discontinuation rates due to AEs (13% for the inhalation powder vs. 8% for the nebuliser solution), development of cough as an adverse drug related event (25% for the inhalation powder vs. 4% for the nebuliser solution) and dysphonia rates (13% for the inhalation powder vs. 4% for the nebuliser solution).
Danish: Dette illustreres navnlig af forskellene i frafaldsrate som følge af bivirkninger (13 % for inhalationspulver mod 8 % for inhalationsvæsken), i udvikling af hoste som en lægemiddelrelateret uønsket hændelse (25 % for inhalationspulveret mod 4 % for inhalationsvæsken) og i forekomsten af dysfoni (13 % for inhalationspulveret mod 4 % for inhalationsvæsken).
English: The smallest difference was observed in the adult population (45% powder inhalation vs 34% nebuliser solution).
Danish: Den mindste forskel var hos den voksne population (45 % med inhalationspulver, mod 34 % med inhalationsvæske).