FrancophonIA/ELRC3.0 huggingface dataset:
English: Dry mouth, which has been observed with medicines like Bretaris Genuair, may after using your medicine for a long time, be associated with tooth decay.
Danish: Tør mund, som er blevet set med lægemidler såsom Bretaris Genuair, kan efter langvarig brug af lægemidlet være forbundet med huller i tænderne.
English: In addition, no clinically significant effects of Bretaris Genuair on cardiac rhythm were observed on 24-hour Holter monitoring after 3 months treatment of 336 patients (of whom 164 received Bretaris Genuair 322 µg twice daily).
Danish: Endvidere blev der ikke set nogen signifikant klinisk effekt af Bretaris Genuair på hjerterytmen under 24-timers Holter-monitorering efter 3 måneders behandling af 336 patienter (hvoraf 164 fik Bretaris Genuair 322 µg to gange dagligt).
English: Nonclinical in vitro and in vivo studies showed rapid, dose-dependent and long-lasting inhibition by aclidinium of acetylcholine-induced bronchoconstriction.
Danish: Ikke-kliniske in vitro- og in vivo-undersøgelser viste hurtig, dosisafhængig og langvarig hæmning af aclidinium af acetylcholin-induceret bronkokonstriktion.
English: M3 receptors mediate contraction of airway smooth muscle.
Danish: M3-receptorerne medierer sammentrækning af luftvejenes glatte muskulatur.
English: Patients treated with Bretaris Genuair required less rescue medication than patients treated with placebo (a reduction of 0.95 puffs per day at 6 months [p=0.005]).
Danish: Patienter behandlet med Bretaris Genuair krævede mindre anfaldsmedicin end patienter behandlet med placebo (en nedgang på 0,95 pust pr. dag efter 6 måneder [p=0,005]).
English: Animal studies have shown excretion of small amounts of aclidinium bromide and/or metabolites into milk.
Danish: Dyreforsøg har påvist udskillelse af små mængder aclidiniumbromid/metabolitter i modermælk.
English: Uncommon: may affect up to 1 in 100 people - Dizziness - Dry mouth - Inflammation of the mouth (stomatitis) - Hoarseness (dysphonia) - Faster heart beat (tachycardia) - Sensation of heart beating (palpitations) - Difficulty passing urine (urinary retention) - Blurred vision - Rash - Itching of the skin
Danish: Ikke almindelig: kan påvirke op til 1 ud af 100 mennesker - Svimmelhed - Tør mund - Betændelse i munden (stomatitis) - Hæshed (dysfoni) - Hurtig puls (hurtige hjerteslag takykardi) - Følelse af hjertebanken (palpitationer) - Vandladningsbesvær (urinretention) - Sløret syn - Udslæt - Kløe på huden
English: Disease-Specific Health Status and Symptomatic Benefits Bretaris Genuair provided clinically meaningful improvements in breathlessness (assessed using the Transition Dyspnoea Index [TDI]) and disease-specific health status (assessed using the St. George's Respiratory Questionnaire [SGRQ]).
Danish: Sygdomsspecifik helbredsstatus og symptomatiske fordele Bretaris Genuair førte til klinisk meningsfulde forbedringer i kortåndethed (vurderet vha. Transition Dyspnoea Index [TDI]) og sygdomsspecifik helbredsstatus (vurderet vha. St. George's Respiratory Questionnaire [SGRQ]).
English: This corresponds to a metered dose of 400 µg aclidinium bromide equivalent to 343 µg aclidinium.
Danish: Det svarer til en afmålt dosis på 400 µg aclidiniumbromid svarende til 343 µg aclidinium.
English: Bretaris Genuair is indicated to help open the airways and relieve symptoms of COPD, a serious, longterm lung disease characterised by breathing difficulties.
Danish: Bretaris Genuair anvendes til at hjælpe med at åbne luftvejene og aflaste symptomer på KOL, en alvorlig, langsigtet lungesygdom karakteriseret ved vejrtrækningsbesvær.
English: Acute intoxication by inadvertent medicinal product ingestion of aclidinium bromide is unlikely due to its low oral bioavailability and the breath-actuated dosing mechanism of the Genuair inhaler.
Danish: Akut forgiftning ved utilsigtet lægemiddelindtagelse af aclidiniumbromid er usandsynlig pga. lægemidlets lave orale biotilgængelighed og Genuair-inhalatorens åndedrætsaktiverede doseringsmekanisme.
English: Inhaled aclidinium bromide acts locally in the lungs to antagonise M3 receptors of airway smooth muscle and induce bronchodilation.
Danish: Inhaleret aclidiniumbromid virker lokalt i lungerne ved at blokere M3-receptorer i luftvejenes glatte muskulatur og derved inducere bronkodilatation.
English: What to do if the control window is still red after pressing the button (Figure H).
Danish: Hvad skal du gøre, hvis kontrolvinduet stadigvæk er rødt efter at have trykket på knappen (Figur H)
English: Bretaris Genuair contains lactose
Danish: Bretaris Genuair indeholder lactose
English: Posology The recommended dose is one inhalation of 322 micrograms aclidinium twice daily.
Danish: Dosering Den anbefalede dosis er én inhalation af 322 mikrogram aclidinium to gange dagligt.
English: Aclidinium bromide may have minor influence on the ability to drive and use machines.
Danish: Aclidiniumbromid påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Experience in patients with cardiovascular comorbidities in clinical trials is limited (see section 5.1).
Danish: Der er begrænset erfaring med patienter med kardiovaskulære komobiditeter i kliniske studier (se pkt.
English: COPD is a long-term disease; therefore, it is recommended that Bretaris Genuair is used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.
Danish: Det anbefales derfor, at Bretaris Genuair anvendes hver dag, to gange om dagen og ikke kun, når du oplever vejrtrækningsproblemer eller andre symptomer på KOL.
English: In vitro studies have shown that aclidinium bromide at the therapeutic dose or its metabolites do not inhibit or induce any of the cytochrome P450 (CYP450) enzymes and do not inhibit esterases (carboxylesterase, acetylcholinesterase and butyrylcholinesterase).
Danish: In vitro-forsøg har vist, at aclidiniumbromid ved den terapeutiske dosis eller dets metabolitter ikke hæmmer eller inducerer cytokrom P450 (CYP450)-enzymer og ikke hæmmer esteraser (carboxylesterase, acetylcholinesterase og butyrylcholinesterase).
English: Bretaris Genuair statistically significantly reduced lung hyperinflation at rest (functional residual capacity [FRC]=0.197 L [95% CI=0.321, 0.072; p=0.002]; residual volume [RV]=0.238 L [95% CI=0.396, 0.079; p=0.004]) and also improved trough inspiratory capacity (by 0.078 L; 95% CI=0.01, 0.145; p=0.025) and reduced dyspnoea during exercise (Borg scale) (by 0.63 Borg units; 95% CI=1.11, 0.14; p=0.012).
Danish: Bretaris Genuair reducerede statistisk signifikant hyperinflation af lungerne under hvile (funktionel residualkapacitet [FRC]=0,197 l [95 % CI=0,321, 0,072; p=0,002]; residualvolumen [RV]=0,238 l [95 % CI=0,396, 0,079; p=0,004]) og forbedrede også ved den inspiratoriske kapacitet (med 0,078 l; 95 % CI=0,01, 0,145; p=0,025) og reducerede dyspnø under motion (Borg-skalaen) (med 0,63 Borgenheder; 95 % CI=1,11, 0,14; p=0,012).
English: What Bretaris Genuair looks like and contents of the pack Bretaris Genuair is a white or almost white powder.
Danish: Bretaris Genuair er et hvidt eller næsten hvidt pulver.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Bretaris Genuair 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 Bretaris Genuair i alle undergrupper af den pædiatriske population med KOL (se pkt.
English: The Bretaris Genuair Phase III clinical development programme included 269 patients treated with Bretaris Genuair 322 µg twice daily in one 6-month randomised, placebo-controlled study and 190 patients treated with Bretaris Genuair 322 µg twice daily in one 3-month randomised, placebocontrolled study.
Danish: Fase III af det kliniske udviklingsprogram for Bretaris Genuair inkluderede 269 patienter, der blev behandlet med Bretaris Genuair 322 µg to gange dagligt i et 6-måneders, randomiseret, placebokontrolleret studie, og 190 patienter, der blev behandlet med Bretaris Genuair 322 µg to gange dagligt i et 3-måneders, randomiseret, placebokontrolleret studie.
English: Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) (see section 5.1).
Danish: Bretaris Genuair er indiceret som bronkodilaterende vedligeholdelsesbehandling til lindring af symptomer hos voksne patienter med kronisk obstruktiv lungesygdom (KOL) (se pkt.
English: Bretaris Genuair is indicated for maintenance treatment and should not be used to treat a sudden attack of breathlessness or wheezing.
Danish: Bretaris Genuair anvendes som vedligeholdelsesbehandling og skal ikke anvendes til at behandle et pludseligt anfald af kortåndethed eller hvæsende vejrtrækning.
English: No significant pharmacokinetic differences were observed between subjects with normal renal function and subjects with renal impairment.
Danish: Ingen betydelige farmakokinetiske forskelle blev set mellem forsøgspersoner med normal nyrefunktion og forsøgspersoner med nedsat nyrefunktion.
English: The median time on-treatment in the Bretaris Genuair and placebo groups was 1.1 and 1 year, respectively.
Danish: Mediantiden med behandling i Bretaris Genuair-gruppen og i placebogruppen var henholdsvis 1,1 år og 1 år.
English: 1.6 Make sure the control window is now green (Figure G).
Danish: 1.6 Du skal sikre dig, at kontrolvinduet nu er grønt (Figur G).
English: Whole lung deposition of inhaled aclidinium bromide via the Genuair inhaler averaged approximately 30% of the metered dose.
Danish: Deponering i lungen af inhaleret aclidiniumbromid via Genuair-inhalatoren var i gennemsnit cirka 30 % af den afmålte dosis.
English: This leaflet was last revised in <{month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
English: 2.7 Make sure the control window is now red (Figure K).
Danish: 2.7 Du skal sikre dig, at kontrolvinduet nu er rødt (Figur K).
English: Check mouthpiece opening
Danish: Kontroller åbning i mundstykket
English: The effects of Bretaris Genuair last for 12 hours; therefore, you should try to use your Bretaris Genuair inhaler at the same time every morning and evening.
Danish: Du skal derfor forsøge at bruge Bretaris Genuairinhalatoren på samme tid hver morgen og aften.
English: Green button
Danish: Grøn knap
English: If you are not sure of how to use Bretaris Genuair, contact your doctor or pharmacist.
Danish: Er du i tvivl om, hvordan du skal bruge Bretaris Genuair, så spørg lægen eller apotekspersonalet.
English: Therefore, no dose adjustment and no additional monitoring are required for renally-impaired COPD patients.
Danish: Dosisjustering er derfor ikke nødvendig og ingen yderligere monitorering er påkrævet for KOL-patienter med nedsat nyrefunktion.
English: In vitro studies have shown that aclidinium bromide or the metabolites of aclidinium bromide are not substrates or inhibitors of P-glycoprotein.
Danish: In vitro-forsøg har vist, at aclidiniumbromid eller metabolitterne af aclidiniumbromid ikke er substrater eller hæmmere af Pglykoprotein.
English: No dose adjustments are necessary.
Danish: Det er ikke nødvendigt at justere dosen.
English: Control window Green = inhaler ready to use
Danish: Kontrolvindue Grønt = klar til brug
English: However, if it is nearly time for your next dose, skip the missed dose.
Danish: Hvis det næsten er tid til din næste dosis, skal du dog springe den manglende dosis over.
English: Additionally, no clinically relevant adverse reactions were observed following 7-day twice daily dosing of up to 800 µg aclidinium bromide in healthy subjects.
Danish: Endvidere blev der ikke set nogen relevante bivirkninger efter to daglige doseringer i 7 dage af op til 800 µg aclidiniumbromid hos raske forsøgspersoner.
English: Aclidinium bromide is a maintenance bronchodilator and should not be used for the relief of acute episodes of bronchospasm, i.e. as a rescue therapy.
Danish: Aclidiniumbromid er en bronkodilatator til vedligeholdelsesbehandling og må ikke bruges til behandling af akutte episoder med bronkospasme, dvs. som anfaldsbehandling.
English: Pooled efficacy analysis of the 6-month and 3-month placebo controlled studies demonstrated a statistically significant reduction in the rate of moderate to severe exacerbations (requiring treatment with antibiotics or corticosteroids or resulting in hospitalisations) with aclidinium 322 µg twice daily compared to placebo (rate per patient per year: 0.31 vs 0.44 respectively; p=0.0149).
Danish: Poolede effektanalyser af de placebokontrollerede studier over 6 måneder og 3 måneder påviste en statistisk signifikant reduktion i hyppigheden af moderate til svære exacerbationer (som krævede behandling med antibiotika eller kortikosteroider, eller som resulterede i hospitalsindlæggelser) med aclidinium 322 μg to gange dagligt sammenlignet med placebo (hyppighed per patient per år: hhv. 0,31 vs. 0,44; p=0,0149).
English: However, if it is nearly time for the next dose, the missed dose should be skipped.
Danish: Hvis det næsten er tid til at tage den næste dosis, skal den manglende dosis dog springes over.
English: The most frequently reported adverse reactions with Bretaris Genuair were headache (6.6%) and nasopharyngitis (5.5%).
Danish: Sammendrag af sikkerhedsprofilen Den hyppigst rapporterede bivirkning med Bretaris Genuair var hovedpine (6,6 %) og nasopharyngitis
English: Bretaris Genuair did not increase the MACE risk in patients with COPD compared to placebo when added to current background therapy (hazard ratio (HR) 0.89; 95% CI: 0.64, 1.23).
Danish: Bretaris Genuair øgede ikke MACE-risikoen for patienter med KOL sammenlignet med placebo ved tilføjelse til den igangværende baggrundsbehandling (hazard ratio (HR) 0,89; 95 % CI: 0,64, 1,23).
English: EU/1/12/781/003 3 inhalers each containing 60 doses
Danish: EU/1/12/781/003 3 inhalatorer hver med 60 doser
English: If you forget to use Bretaris Genuair
Danish: Hvis du har glemt at bruge Bretaris Genuair
English: Patients in the aclidinium bromide group had a 18% relative reduction of the risk of an exacerbation (HR 0.82; 95% CI [0.73, 0.92], p<0.001).
Danish: Patienterne i aclidiniumbromidgruppen oplevede en 18 % relativ reduktion i risikoen for en eksacerbation (HR 0,82; 95 % CI [0,73, 0,92], p<0,001).
English: The frequencies assigned to the undesirable effects listed below are based on crude incidence rates of adverse reactions (i.e. events attributed to Bretaris Genuair) observed with Bretaris Genuair 322 µg (636 patients) in the pooled analysis of one 6-month and two 3-month randomised, placebo-controlled clinical trials.
Danish: Hyppighederne tildelt bivirkningerne angivet i listen nedenfor er baseret på summariske incidensrater for bivirkninger (dvs. hændelser tilskrevet Bretaris Genuair) iagttaget med Bretaris Genuair 322 µg (636 patienter) i den poolede analyse af et 6-måneders og to 3-måneders randomiserede, placebokontrollerede kliniske studier.
English: The effect of aclidinium bromide on the occurrence of major adverse cardiovascular events (MACE) was assessed in a randomised, double-blind, placebo-controlled, parallel-group study in 3630 adult patients between 40 and 91 years of age with moderate to very severe COPD, treated for up to 36 months.
Danish: Langsigtet studie af sikkerhed og virkning op til 3 år Aclidiniumbromids virkning på forekomsten af alvorlige kardiovaskulære hændelser (MACE) blev vurderet i et randomiseret, dobbeltblindet, placebokontrolleret parallelgruppestudie med 3.630 voksne patienter mellem 40 og 91 år med moderat til meget svær KOL, der blev behandlet i op til 36 måneder.
English: Studies in animals have shown foetotoxicity only at dose levels much higher than the maximum human exposure to aclidinium bromide (see section 5.3).
Danish: Dyreforsøg har kun påvist føtotoksicitet ved dosisniveauer, som er meget højere end den maksimale eksponering af mennesker for aclidiniumbromid (se pkt.
English: AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100
Danish: AstraZeneca Pharmaceuticals (Ireland) Ltd Tel: +353 1609 7100
English: STEP 2: Inhale your medicine
Danish: PUNKT 2: Inhalér din medicin
English: After 6 months treatment, the mean improvement in morning pre-dose (trough) FEV1 compared to placebo was 128 mL (95% CI=85-170; p<0.0001).
Danish: Efter 6 måneders behandling var den gennemsnitlige forbedring i trough FEV1 om morgenen inden dosering sammenlignet med placebo 128 ml (95 % CI=85-170; p<0,0001).
English: Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium bromide (see section 5.3).
Danish: Dyreforsøg hos rotter har kun vist små reduktioner i fertiliteten ved meget højere dosisniveauer end den maksimale eksponering af mennesker for aclidiniumbromid (se pkt.
English: In a 3-week crossover, randomised, placebo-controlled clinical study Bretaris Genuair was associated with a statistically significant improvement in exercise endurance time in comparison to placebo of 58 seconds (95% CI=9-108; p=0.021; pre-treatment value: 486 seconds).
Danish: I et 3-ugers randomiseret, placebokontrolleret klinisk overkrydsningsstudie blev Bretaris Genuair forbundet med en statistisk signifikant forbedring af udholdenhedstiden ved motion på 58 sekunder sammenlignet med placebo (95 % CI=9-108; p=0,021; værdi før behandling: 486 sekunder).
English: What you need to know before you use Bretaris Genuair
Danish: Det skal du vide, før du begynder at bruge Bretaris Genuair
English: Inhaler label
Danish: Inhalatoretiket
English: GREEN
Danish: GRØNT
English: Each delivered dose contains 375 micrograms aclidinium bromide equivalent to 322 micrograms of aclidinium.
Danish: Hver leveret dosis indeholder 375 mikrogram aclidiniumbromid svarende til 322 mikrogram aclidinium.
English: In addition, Bretaris Genuair showed a statistically significant reduction of 35% in the rate of hospitalisations due to COPD exacerbations while on-treatment during the first year compared with placebo (RR 0.65; 95% CI 0.48 to 0.89; p=0.006).
Danish: Desuden viste Bretaris Genuair en statistisk signifikant reduktion på 35 % i antallet af hospitalsindlæggelser på grund af KOL-eksacerbationer under behandlingen i det første år sammenlignet med placebo (RR 0,65; 95 % CI 0,48 til 0,89; p=0,006).
English: Each delivered dose (the dose leaving the mouthpiece) contains 375 µg aclidinium bromide equivalent to 322 µg of aclidinium.
Danish: Hver leveret dosis (dosen, der kommer ud af mundstykket) indeholder 375 µg aclidiniumbromid svarende til 322 µg aclidinium.
English: Therefore, no dose adjustment is required for elderly COPD patients.
Danish: Ingen dosisjustering er derfor nødvendig for ældre patienter med KOL.
English: Elderly No dose adjustments are required for elderly patients (see section 5.2).
Danish: Ældre Det er ikke nødvendigt at justere dosis hos ældre patienter (se pkt.
English: Aclidinium bromide demonstrated kinetic linearity and a time-independent pharmacokinetic behaviour in the therapeutic range.
Danish: Linearitet/non-linearitet Aclidiniumbromid udviste lineær og tidsuafhængig farmakokinetik i det terapeutiske interval.
English: Patients treated with Bretaris Genuair showed a statistically significant reduction of 22% compared to placebo (rate ratio [RR] 0.78; 95% CI 0.68 to 0.89; p<0.001).
Danish: Patienter behandlet med Bretaris Genuair udviste en statistisk signifikant reduktion på 22 % i sammenligning med placebo (frekvensratio [RR] 0,78; 95 % CI 0,68 til 0,89; p<0,001).
English: Clinical efficacy studies showed that Bretaris Genuair provided clinically meaningful improvements in lung function (as measured by the forced expiratory volume in 1 second [FEV1]) over 12 hours following morning and evening administration, which were evident within 30 minutes of the first dose (increases from baseline of 124-133 mL).
Danish: Kliniske studier viser, at Bretaris Genuair medfører klinisk meningsfulde forbedringer i lungefunktion (målt ved forceret ekspiratorisk volumen på 1 sekund [FEV1]) over 12 timer efter administration morgen og aften.
English: The plasma protein binding of aclidinium bromide determined in vitro most likely corresponded to the protein binding of the metabolites due to the rapid hydrolysis of aclidinium bromide in plasma; plasma protein binding was 87% for the carboxylic acid metabolite and 15% for the alcohol metabolite.
Danish: Plasma-proteinbindingen af aclidiniumbromid bestemt in vitro svarer formentlig til proteinbindingen af metabolitterne pga. den hurtige hydrolyse af aclidiniumbromid i plasma.
English: It is white-coloured with an integral dose indicator and a green dosage button.
Danish: Den er hvid med en indbygget dosisindikator og en grøn doseringsknap.
English: EXP To be used within 90 days of opening the pouch.
Danish: EXP Skal anvendes inden for 90 dage efter posen åbnes.
English: EXP To be used within 90 days of opening the pouch
Danish: EXP Skal anvendes inden for 90 dage efter åbning af posen
English: To be used within 90 days of opening the pouch.
Danish: Skal anvendes inden for 90 dage efter posen åbnes.
English: The Genuair inhaler device is white coloured with an integral dose indicator and a green dosage button.
Danish: Genuair-inhalatoren er hvid med en indbygget dosisindikator og en grøn doseringsknap.
English: Bretaris Genuair 322 micrograms inhalation powder
Danish: Bretaris Genuair 322 mikrogram inhalationspulver
English: Maximal bronchodilation was achieved within 1-3 hours after dosing with mean peak improvements in FEV1 relative to baseline of 227-268 mL at steady-state.
Danish: Maksimal bronkodilatation opnåedes inden for 1-3 timer efter dosering med gennemsnitlige peak-forbedringer i FEV1 ift.
English: - if you see halos around lights or coloured images (glaucoma).
Danish: - hvis du har regnbuesyn, dvs. ser en regnbuefarvet ring omkring lys eller farvede billeder
English: Refer to the Instructions for Use for instructions on how to use the Genuair inhaler.
Danish: Se Brugsanvisning for vejledning i brug af Genuair-inhalatoren.
English: Anticholinergic activity:
Danish: Antikolinerge virkninger:
English: A placebo-controlled trial in 1791 patients with moderate to very severe COPD treated with Bretaris Genuair up to 36 months did not identify other adverse reactions.
Danish: Der blev ikke identificeret andre bivirkninger i et placebokontrolleret studie med 1.791 patienter med moderat til meget svær KOL, som blev behandlet med Bretaris Genuair i op til 36 måneder.
English: Pack sizes supplied:
Danish: Leverede pakningsstørrelser:
English: Carton containing 3 inhalers each with 60 doses.
Danish: Karton, der indeholder 3 inhalatorer hver med 60 doser.
English: Carton containing 1 inhaler with 30 doses.
Danish: Karton, der indeholder 1 inhalator med 30 doser.
English: • When a red band appears in the dose indicator, this means you are nearing your last dose
Danish: • når det røde bånd vises i dosisindikatoren.
English: EU/1/12/781/001 30 doses
Danish: EU/1/12/781/001 30 enhedsdoser
English: EU/1/12/781/002 60 doses
Danish: EU/1/12/781/002 60 enhedsdoser
English: The occurrence of headache, dizziness or blurred vision following administration of aclidinium bromide (see section 4.8) may influence the ability to drive or to use machinery.
Danish: Forekomsten af hovedpine, svimmelhed eller sløret syn efter administration af aclidiniumbromid (se pkt.
English: Hypersensitivity to aclidinium bromide or to the excipients listed in section 6.1.
Danish: Overfølsomhed over for aclidiniumbromid eller over for et eller flere af hjælpestofferne anført i punkt
English: No dose adjustment is required for hepatically-impaired COPD patients.
Danish: Ingen dosisjustering er nødvendig hos KOL-patienter med nedsat leverfunktion..
English: Carton containing 1 inhaler with 60 doses.
Danish: Karton, der indeholder 1 inhalator med 60 doser.
English: Read the package leaflet before use Inhalation use
Danish: Læs indlægssedlen inden brug.