FrancophonIA/ELRC3.0 huggingface dataset:
English: A decision must be made whether to discontinue breast feeding or to discontinue Bronchitol therapy taking into account the benefit of breast feeding for the child and the benefit of Bronchitol therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Bronchitol seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele ved Bronchitol for moderen.
English: In study 302 the most frequent adverse reaction reported during the MTT was cough in seven patients (2.1%),and in study 303 the most frequently reported adverse reaction from the MTT was also cough in eight patients (1.6%).
Danish: I studie 302 var den hyppigst rapporterede bivirkning under MTT hoste hos syv patienter (2,1 %), og i studie 303 var den hyppigst rapporterede bivirkning fra MTT også hoste hos otte patienter (1,6 %).
English: - if you have ever coughed up blood or had blood in your sputum; - if you have severe cystic fibrosis, in particular if your lung function measured by the Forced
Danish: - hvis du nogensinde har hostet blod op eller haft blod i spyttet - hvis du har alvorlig cystisk fibrose, især hvis din lungefunktion målt som forceret eksspiratorisk volumen i det første sekund, du puster ud (FEV1), normalt ligger under 30 %.
English: Mean delivered dose per capsule is 32.2 mg.
Danish: Middeldosis pr. kapsel er 32,2 mg.
English: However, if your inhaler does need cleaning, the steps to follow are: Ensure your inhaler is empty.
Danish: Hvis inhalatoren alligevel skal rengøres, skal du gøre følgende: Kontrollér, at inhalatoren er tom.
English: What Bronchitol is used for
Danish: Hvad bruges Bronchitol til
English: - You should hold the inhaler along the bottom to make sure you don't press the piercing buttons.
Danish: - Du skal holde om bunden af inhalatoren, så du ikke trykker på prikkeknapperne.
English: - Keeping the inhaler tilted downward, put the inhaler to your mouth and make sure you close your lips tightly around the mouth-piece.
Danish: - Hold inhalatoren vippet nedad, før inhalatoren hen til munden, og luk læberne helt tæt omkring mundstykket.
English: Three Phase 3, 26-week double blind, randomised, parallel arm, controlled, intervention studies (DPM-CF-301,DPM-CF-302 and DPM-CF-303) have been performed in which 324 (DPM-CF-301) and 318 (DPM-CF-302) patients aged 6 years and above were randomised in a 3:2 ratio to inhaled mannitol 400 mg twice daily or to control (inhaled mannitol 50 mg twice daily).
Danish: Der er gennemført tre 26-ugers, dobbeltblindede, randomiserede, kontrollerede parallelarm-, fase 3interventions studie (DPM-CF-301, DPM-CF-302 og DPM-CF-303), hvor 324 (DPM-CF-301) og 318 (DPM-CF-302) patienter i alderen 6 år og derover i forholdet 3:2 blev randomiseret til inhaleret mannitol 400 mg to gange dagligt eller til kontrol (inhaleret mannitol 50 mg to gange dagligt).
English: The percentage of patients receiving inhaled antibiotics was 55% in study DPM-CF-301, 56% in study DPM-CF-302 and 52% in Study DPM-CF-303.
Danish: Procentdelen af patienter, som fik inhalationsantibiotika, var 55 % i studie DPM-CF-301, 56 % i studie DPM-CF-302 og 52 % i studie DPM-CF-303..
English: Bacteria sputum identified
Danish: Almindelig Sputum med identificerede bakterier
English: These figures for study DPM-CF-302 (N=305) are as follows: 65.24 (SD:13.90) and 64.35 (SD:15.29).
Danish: De tilsvarende tal for studie DPM-CF-302 (N=305) er som følger: 65,24 (SD:13,90) og 64,35 (SD:15,29).
English: Once removed from the blister a capsule should be used immediately.
Danish: Når en kapsel er taget ud af blisteren, skal den anvendes straks.
English: How to use your medicine - Bronchitol is breathed in (inhaled) as a powder from the capsule using the inhaler supplied in the pack.
Danish: Sådan skal du bruge medicinen - Bronchitol indåndes (inhaleres) som et pulver fra kapslen med den inhalator, som medfølger i pakningen.
English: Each hard capsule contains 40 mg mannitol.
Danish: En hård kapsel indeholder 40 mg mannitol.
English: The patient's initiation dose of Bronchitol must be used under the supervision and monitoring of an experienced physician or another health care professional appropriately trained and equipped to perform spirometry, monitor oxygen saturation (SpO2), and manage acute bronchospasm (see sections 4.4 and 4.8) including appropriate use of resuscitation equipment.
Danish: Patientens initialdosis af Bronchitol skal anvendes under overvågning og monitorering af en erfaren læge eller andet sundhedspersonale, som har den relevante uddannelse og det relevante udstyr til at udføre spirometri, monitorere iltmætning (SpO2) og behandle akut bronkospasme (se pkt.
English: - If you are breast-feeding or plan to breast-feed ask your doctor for advice before using this medicine.
Danish: - Hvis du ammer eller planlægger at amme, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: Fifty five % of patients were receiving rhDNase in study DPM-CF-301 while in study DPM-CF-302 this number was 75% and for DPM-CF-303 this was 67.6%.
Danish: Femoghalvtreds procent af patienterne fik rhDNase i studie DPM-CF-301, mens i dette tal var 75 % i studie DPM-CF-302, og for DPM-CF-303 var det 67,6 %.
English: Capsules contain powder for oral inhalation using the inhaler device enclosed.
Danish: Kapslerne indeholder pulver til oral inhalation via den medfølgende inhalator.
English: Uncommon Musculoskeletal chest pain
Danish: Ikke almindelig Muskuloskeletale brystsmerter
English: Prepare for inhalation - Tilt the inhaler so that the mouth-piece faces slightly downward.
Danish: Gør dig klar til inhalation - Vip inhalatoren, så mundstykket vender lidt nedad.
English: Arvato distribution GmbH, Gottlieb-Daimler Straβe 1, 33428 Harsewinkel, North Rhine-Westphalia Germany
Danish: Arvato distribution GmbH,Gottlieb Daimlerstraβe 1, 33428 Harsewinkel, North Rhine-Westphalia, Tyskland.
English: The patient should be pre-medicated with a bronchodilator 5-15 minutes prior to the initiation dose but after the baseline FEV1 and SpO2 (Oxygen saturation in the blood) measurement.
Danish: Patienten skal præmedicineres med en bronkodilator 5-15 minutter før initialdosis, men efter måling af baseline-FEV1 (det luftvolumen, som kan udåndes i løbet af det første sekund af en forceret udånding, som forudgås af en maksimal indånding) og -SpO2 (iltmætning i blodet).
English: Mawdsleys Clinical Services, Unit 22, Quest Park, Wheatley Hall Road, Doncaster, DN2 4LT, United Kingdom.
Danish: Mawdsleys Clinical Services, Unit 22, Quest Park, Wheatley Hall Road, Doncaster, DN2 4LT, Storbritannien.
English: Bronchospasm can occur with inhalation of medicinal product and has been reported with Bronchitol in clinical studies, even in patients who were not hyperresponsive to the initiation dose of inhaled mannitol (see section 4.8).
Danish: Bronkospasme kan forekomme i forbindelse med inhalation af lægemidler og er rapporteret i kliniske studie af Bronchitol, også hos patienter, som ikke var hyperreaktive over for initialdosen af inhaleret mannitol (se pkt.
English: Step 1: Patients baseline FEV1 and SpO2 is measured prior to the initiation dose Step 2: Patient inhales 40 mg (1x40 mg capsules) and SpO2 is monitored Step 3: Patient inhales 80 mg (2x40 mg capsules) and SpO2 is monitored Step 4: Patient inhales 120 mg (3x40 mg capsules), FEV1 is measured and SpO2 is monitored
Danish: Trin 1: Patientens baseline-FEV1 og -SpO2 måles før initialdosis Trin 2: Patienten inhalerer 40 mg (1 x 40 mg kapsler), og SpO2 monitoreres Trin 3: Patienten inhalerer 80 mg (2 x 40 mg kapsler), og SpO2 monitoreres Trin 4: Patienten inhalerer 120 mg (3 x 40 mg kapsler), FEV1 måles, og SpO2 monitoreres Trin 5: Patienten inhalerer 160 mg (4 x 40 mg kapsler), FEV1 måles, og SpO2 monitoreres
English: The primary pre-specified endpoint i.e. the change from baseline in FEV1 (ml) in the modified ITT (mITT) population (n=269, 297 and 423 in studies DPM-CF-301,DPM-CF-302 and DPM-CF-303, respectively) compared to control over the 26 weeks period is provided in Table 3 alongside FEV1 presented as absolute and relative change % predicted.
Danish: Det primære forudbestemte endepunkt, dvs. ændringen i FEV1 (ml) i forhold til baseline i den modificerede ITT-population (mITT) (henholdsvis n=269, 297 og 423 i studie DPM-CF-301, DPMCF-302 og DPM-CF-303), sammenlignet med kontrolgruppen over de 26 uger er vist i tabel 3 sammen med FEV1, der er angivet som forventet absolut og relativ ændring i %.
English: In study 303 13.4% subjects in the mannitol arm and 13.6% in the control had a PDPE.
Danish: I studie 303 havde 13,4 % af forsøgspersonerne i mannitolarmen og 13,6 % i kontrolarmen en PDPE.
English: Uncommon (may affect up to 1 in 100 people) - Burning or painful sensation on the tongue - CF related diabetes - Chest and abdominal pain - Change in voice - Cold sweat - Congestion - Dehydration - Decreased appetite - Diarrhoea - Ear pain - Feeling tired - Feeling dizzy - Feeling sick (nausea) - Feeling unwell - Flu and fever - Wind - Heartburn - Hernia pain - Hyperventilation - Itching, rash, acne - Joint stiffness and pain - Morbid thoughts - Mouth ulcers - Respiratory tract infection - Runny nose - Sputum infection - Throat irritation - Trouble sleeping - Yeast infection of the mouth (thrush) - Unintentional loss of urine
Danish: Ikke almindelige (kan ramme op til 1 ud af 100 patienter) - Brænden eller smerter i tungen - CF-relateret sukkersyge - Smerter i bryst og mave - Forandret stemme - Koldsved - Tillukning - Dehydrering - Nedsat appetit - Diarré - Øresmerter - Træthed - Svimmelhed - Kvalme - Utilpashed - Influenza og feber - Luft i maven - Halsbrand - Broksmerter - Hyperventilation - Kløe, udslæt, akne - Stive led og ledsmerter - Sygelig tankegang - Sår i munden - Infektion i luftvejene - Løbende næse - Spytinfektion - Irritation i halsen - Problemer med at sove - Infektion med gærsvamp i munden (trøske) - Urininkontinens
English: - To get the best results from Bronchitol, inhale each capsule one after another.
Danish: - Du får det bedste resultat med Bronchitol, hvis du inhalerer kapslerne en for en.
English: If the inhaler does require cleaning, it must be ensured that the device is empty, then it should be washed in warm water and before re-use,the inhaler should be allowed to thoroughly air dry.
Danish: Hvis inhalatoren skal rengøres, skal det kontrolleres, at den er tom, hvorefter den skal vaskes i varmt vand.
English: The final report is expected in Q3
Danish: Den endelige rapport forventes i første kvartal af 2018.
English: The estimated effect of treatment (mean change and 95% CI from baseline over 26 weeks, mITT population) on FVC was 108.78 ml (95% CI: 49.21, 168.35) in study 301 and 71.4 ml (95% CI: 10.57, 132.13) in study 302 and 40 ml (95% CI: -12, 92) in study 303.
Danish: Den estimerede virkning af behandling (middelværdiændring og 95 % CI i forhold til baseline over 26 uger, mITT-population) på FVC var 108,78 ml (95 % CI: 49,21, 168,35) i studie 301, 71,4 ml (95 % CI: 10,57, 132,13) i studie 302 og 40 ml (95 % Cl: -12, 92) i studie 303.
English: Bronchitol is inhaled into the lungs to help with cystic fibrosis, an inherited disease that affects the glands in the lungs, gut and pancreas that secrete fluids such as mucus and digestive juices.
Danish: Bronchitol inhaleres i lungerne for at hjælpe med cystisk fibrose, som er en arvelig sygdom, der påvirker de kirtler i lungerne, tarmen og bugspytkirtlen, som udskiller slim og fordøjelsessafter.
English: One initiation dose pack of Bronchitol contains 1 blister with 10 capsules and 1 inhaler.
Danish: Pakningen med en initialdosis Bronchitol indeholder 1 blister med 10 kapsler og 1 inhalator.
English: Twenty seven (7.1%) out of 378 patients who undertook the mannitol tolerance test (MTT) in study 301, 18 (5.3%) out of 341 patientsin study 302 and 25 (5.1%) out of 486 patients in Study 303 had a positive (MTT).
Danish: 27 (7,1 %) ud af 378 patienter, som gennemførte mannitoltolerancetesten (MTT) i studie 301, 18 (5,3 %) ud af 341 patienter i studie 302 og 25 (5,1 %) ud af 486 patienter i studie 303 havde en positiv MTT.
English: Uncommon Blood alkaline phosphatase increased, Bacteria or fungus sputum test positive
Danish: Ikke almindelig Øget alkalisk fosfatase i blodet, positiv sputumtest for bakterier eller svampe
English: One 2-week treatment pack of Bronchitol contains 28 blisters with 10 capsules each (280 capsules in total) and 2 inhalers.
Danish: En pakning med 2 ugers Bronchitol-behandling indeholder 28 blistere med 10 kapsler hver (280 kapsler i alt) og 2 inhalatorer.
English: In study 302 15.2% subjects in the mannitol arm and 19% in the control had a PDPE.
Danish: I undersøgelse 302 havde 15,2 % af forsøgspersonerne i mannitolarmen og 19 % i kontrolarmen en PDPE.
English: For more advice on how to look after your inhaler, please see the end of the instructions.
Danish: Yderligere oplysninger om, hvordan du passer din inhalator, kan du se sidst i brugsanvisningen.
English: Efficacy and safety have not been established in non-CF bronchiectasis patients.
Danish: Virkning og sikkerhed er ikke klarlagt hos patienter med bronkiektasi, som ikke har CF.
English: What you need to know before you use Bronchitol
Danish: Det skal du vide, før du begynder at bruge Bronchitol
English: Adverse reactions that occurred only with initiation dose assessment (MTT) are bronchospasm, chest pain, odynophagia and retching
Danish: Bivirkninger, som kun opstod ved vurderingen af startdosen (MTT), er bronkospasmer, brystsmerter, odynofagi og kløgning.
English: In study 302 the relative change (95% CI) for rhDNase users and non-users was 3.21 (-0.61, 7.03) and 4.73 (-1.93, 11.40), respectively.
Danish: I undersøgelse 302 var den relative ændring (95 % CI) for rhDNase-brugere og ikke-brugere henholdsvis 3,21 (-0,61, 7,03) og 4,73 (-1,93, 11,40).
English: In study 303 the relative change (95% CI) for rhDNase users and non-users was 1.30 (-0.91, 3.51) and 4.45 (0.52, 8.38), respectively.
Danish: I studie 303 var den relative ændring (95 % CI) for rhDNase-brugere og ikke-brugere henholdsvis 1,30 (-0,91, 3,51) og 4,45 (0,52, 8,38).
English: The safety and efficacy of Bronchitol in children and adolescents aged 6 to 18 years has not yet been established.
Danish: Sikkerhed og virkning af Bronchitol hos børn og unge i alderen 6-18 år er endnu ikke klarlagt.
English: Uncommon Pyrexia
Danish: Ikke almindelig Pyreksi
English: AB "PharmaSwiss Tel: + 370 5 279 07 62
Danish: UAB "PharmaSwiss Tel: + 370 5 279 07 62
English: In the ITT population of an open label dose response study, DPM-CF-202, the mean (SD) percent change in FEV1 for the 400 mg dose was 8.75 (SD: 12.4) and -1.569 (SD: 9.0) for 40 mg dose (p <
Danish: I ITT-populationen i en ublindet dosisrespons studie, DPM-CF-202, var middelværdien (SD) for den procentvise ændring i FEV1 for dosen på 400 mg 8,75 (SD: 12,4) og -1,569 (SD: 9,0) for dosen på 40 mg (p < 0,0001).
English: Bronchodilator
Danish: Bronkodilator
English: Twenty seven (7.1%) out of 378 patients who undertook the mannitol tolerance test (MTT) in study 301, 18 (5.3) out of 341 patients in study 302 and 25 out of 486 patients (5.1%) in study 303 had a positive MTT defined as either 1) a fall in FEV1 >20% from baseline at midpoint (step 4) or 2) fall from baseline > 20 % at end of test that did not recover to < 20% within 15 minutes or 3) who had a fall in FEV1 > 50% from baseline at end of test (step 6) or 4) who had a fall in Sp02 to < 89% during the procedure.
Danish: 27 (7,1 %) ud af 378 patienter, som gennemførte mannitoltolerancetesten (MTT) i studie301, 18 (5,3 %) ud af 341 patienter i studie 302 og 25 ud af 486 patienter (5,1 %) i studie 303 havde en positiv MTT defineret som enten 1) et fald i FEV1 >20 % i forhold til baseline ved midtpunktet (trin 4) eller 2) et fald i forhold til baseline ved testens afslutning på > 20 %, som ikke bedredes til < 20 % inden for 15 minutter, eller 3) som havde et fald i FEV1 > 50 % i forhold til baseline ved testens afslutning (trin 6), eller 4), som havde et fald i Sp02 til < 89 % under proceduren.
English: The safety and efficacy of Bronchitol in children aged less than 6 years has not been established.
Danish: Sikkerhed og virkning af Bronchitol hos børn under 6 år er endnu ikke klarlagt.
English: - Never place a capsule directly into the mouth-piece of your inhaler.
Danish: - Skil aldrig inhalatoren ad. - Læg aldrig en kapsel direkte i inhalatorens mundstykke.
English: Bronchial hyperresponsiveness to inhaled mannitol (see section 4.4).
Danish: Bronkial hyperreaktivitet over for inhaleret mannitol (se pkt.
English: Each capsule contains 40 milligrams mannitol.
Danish: En kapsel indeholder 40 mg mannitol.
English: Dornase alfa (Pulmozyme) if this is part of your treatment routine Inhaled antibiotics if this is part of your treatment routine
Danish: Brug Bronchitol før fysioterapi, hvis det er en del af din normale daglige behandlingsrutine Dornase alfa (Pulmozyme), hvis det er en del af din behandlingsrutine Inhalationsantibiotika, hvis det er en del af din behandlingsrutine
English: Uncommon Dizziness
Danish: Ikke almindelig Svimmelhed
English: Adverse reactions that occurred only with the initiation dose assessment (MTT) are dehydration, forced expiratory volume decreased, hypoxia, diarrhoea, abdominal pain upper, aphthous stomatitis, odynophagia, chest pain and blood alkaline phosphatase increased.
Danish: Bivirkninger, der kun forekom ved vurderingen af startdosen (MTT), er dehydrering, fald i forceret eksspiratorisk volumen, hypoksi, diarré, smerter i øvre abdomen, aftøs stomatitis, odynofagi, brystsmerter og stigning i alkaliskfosfatase i blodet.
English: - Inhale the contents of the capsule using the inhaler, with one or two breaths in.
Danish: - Inhaler kapslens indhold ved hjælp af inhalatoren med en til to indåndinger.
English: In study 301, overall the most frequently reported adverse reactions during the MTT were cough in 20 (5.3%) subjects, wheezing/bronchospasm in seven (1.9%) subjects and chest discomfort in six (1.6%) subjects.
Danish: I studie 301 var de totalt set hyppigst rapporterede bivirkninger under MTT hoste hos 20 (5,3 %) forsøgspersoner, hvæsende vejrtrækning/bronkospasme hos syv (1,9 %) forsøgspersoner og ubehag i brystet hos seks (1,6 %) forsøgspersoner.
English: Detailed instructions on how to use the inhaler can be found in the patient information leaflet.
Danish: Nærmere oplysninger om anvendelsen af inhalatoren kan findes i indlægssedlen.
English: In adolescents (12-17 years) relative change in % predicted FEV1 compared to control improved by 3.31% (95% CI -2.29, 8.90, N=55) and 0.42% (95% CI -5.45, 6.29, N=94) over 26 weeks (p=0.245 and 0.888) respectively.
Danish: Hos unge (12-17 år) blev den relative ændring i % forventet FEV1 sammenlignet med kontrolgruppen forbedret med henholdsvis 3,31 % (95 % CI -2,29, 8,90, N=55) og 0,42 % (95 % CI -5,45, 6,29, N=94) over 26 uger (p=0,245 og 0,888).
English: Make a hole in the capsule - This lets the powder in the capsule be released when you breathe in.
Danish: Lav et hul i kapslen - Det frigiver pulveret i kapslen, når du trækker vejret ind. I denne indlægsseddel kalder vi det at 'prikke'.
English: Mean (SD) baseline FEV1 percent predicted in study DPM-CF-301 (safety population, N= 295) was 62.4 (SD:16.45) and 61.4 (SD:16.13) in the mannitol and control groups, respectively.
Danish: Den forventede middelværdi (SD) for baseline-FEV1-procent i studie DPM-CF-301 (sikkerhedspopulation, N= 295) var 62,4 (SD:16,45) og 61,4 (SD:16,13) i henholdsvis mannitol- og kontrolgruppen.
English: In studies DPM-CF-301 and 302 relative % predicted FEV1 compared to control in children (6-11 years) was improved by 0.44% (95% CI -5.90, 6.77, N=43) and 6.1% (95% CI -1.28, 13.54, N=59) over 26 weeks (p=0.892 and 0.104) respectively.
Danish: I studie DPM-CF-301 og 302 blev den relative % forventet FEV1 sammenlignet med kontrolgruppen hos børn (6-11 år) forbedret med henholdsvis 0,44 % (95 % CI -5,90, 6,77, N=43) og 6,1 % (95 % CI -1,28, 13,54, N=59) over 26 uger (p=0,892 og 0,104).
English: Talk to your doctor or pharmacist before using this medicine: - if you have asthma;
Danish: Advarsler og forsigtighedsregler Tal meddin læge eller apotekspersonalet, før du bruger Bronchitol: - hvis du har astma
English: The most commonly observed adverse reaction associated with the use of Bronchitol during the initiation dose assessment with the paediatric population is cough (4.8% of patients).
Danish: Den hyppigst observerede bivirkning i forbindelse med anvendelse af Bronchitol under vurdering af initialdosis hos den pædiatriske population er hoste (4,8 % af patienterne).
English: The most commonly observed adverse reaction associated with the use of Bronchitol during the initiation dose assessment is cough (2.9% of patients), (see section 4.4).
Danish: Den hyppigst observerede bivirkning i forbindelse med anvendelse af Bronchitol under vurdering af initialdosis er hoste (2,9 % af patienterne) (se pkt.
English: Bronchitol capsules can only be used with the inhaler provided in the pack.
Danish: Bronchitol-kapsler kan kun bruges med den inhalator, som medfølger i pakningen.
English: Impaired lung function
Danish: Nedsat nyre- eller leverfunktion
English: Close the inhaler - Keep the inhaler in an upright position.
Danish: Luk inhalatoren - Hold inhalatoren lodret.
English: The most important adverse reaction associated with the use of Bronchitol during the initiation dose assessment with the paediatric population is bronchospasm.
Danish: Den vigtigste bivirkning i forbindelse med anvendelse af Bronchitol under vurdering af initialdosis hos den pædiatriske population er bronkospasme.
English: Haemoptysis has been commonly reported with Bronchitol in clinical studies.
Danish: Hæmoptyse er en almindelig bivirkning, som er rapporteret i de kliniske studie af Bronchitol.
English: The most commonly observed adverse reaction associated with the use of Bronchitol is cough.
Danish: Den hyppigst observerede bivirkning i forbindelse med anvendelse af Bronchitol er hoste.
English: Chiesi Limited Tel: + 44 (0)161 488 5555
Danish: Cheisi Limited Tel: + 44 (0)161 488 5555
English: United Kingdom Chiesi Limited Tel: + 44 (0)161 488 5555
Danish: United Kingdom Cheisi Limited Tel: + 44 (0)161 488 5555
English: - The powder in the capsules must only be inhaled using the inhaler included in the pack.
Danish: - Pulveret i kapslerne må kun inhaleres med den inhalator, som medfølger i pakningen.
English: Before commencing treatment with Bronchitol all patients should be assessed for bronchial hyperresponsiveness to inhaled mannitol during administration of their initiation dose (see sections 4.4 and 5.1).
Danish: Før behandling med Bronchitol indledes, skal alle patienter vurderes med henblik på bronkial hyperreaktivitet over for inhaleret mannitol under administration af initialdosen (se pkt.
English: The 2-week carton contains 28 blisters (of 10 capsules each) and two inhaler devices.
Danish: 2-ugers-æsken indeholder 28 blistere (med 10 kapsler hver) og to inhalatorer.
English: The initiation dose carton contains 1 blister (of 10 capsules) and one inhaler device.
Danish: Æsken med initialdosis indeholder 1 blister (med 10 kapsler) og en inhalator.
English: Pharmacotherapeutic group: Cough and cold preparations, Mucolytic.
Danish: Farmakoterapeutisk klassifikation: Midler mod hoste og forkølelse, mucolytika ATC-kode: R05CB16
English: For mannitol no clinical data on fertility is available.
Danish: Der foreligger ingen kliniske data for virkningen af mannitol på human fertilitet.
English: Use your bronchodilator;
Danish: Brug din bronkieudvidende medicin
English: The powder is inhaled into the lungs using the inhaler provided in the pack.
Danish: Pulveret inhaleres i lungerne med den inhalator, som medfølger i pakningen.