FrancophonIA/ELRC3.0 huggingface dataset:
English: Difference of incidence between roflumilast and placebo was quantitatively greater with concomitant LAMA for weight decreased (7.2% vs 4.2%), decreased appetite (3.7% vs 2.0%), headache (2.4% vs 1.1%) and depression (1.4% vs -0.3%).
Danish: Forskellen mellem roflumilast og placebo på forekomsten var kvantitativt større for vægttab (7,2 % kontra 4,2 %), nedsat appetit (3,7 % kontra 2,0 %), hovedpine (2,4 % kontra 1,1 %) og depression (1,4 % kontra -0,3 %) ved samtidig LAMA.
English: In 1-year studies (M2-124, M2-125), a decrease of body weight occurred more frequently in patients treated with roflumilast compared to placebo-treated patients.
Danish: I 1-års-studier (M2-124, M2-125) sås hyppigere et vægttab hos patienter behandlet med roflumilast sammenlignet med placebo-behandlede patienter.
English: Both roflumilast and roflumilast N-oxide have intrinsic phosphodiesterase-4 (PDE4) inhibitory activity.
Danish: Både roflumilast og roflumilast N-oxid har intrinsic phosphodiesterase-4(PDE4)-hæmmende aktivitet.
English: Daxas contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor.
Danish: Daxas indeholder det aktive stof roflumilast, som er et anti-inflammatorisk lægemiddel, der kaldes fosfodiesterase 4-hæmmer.
English: It is not known whether roflumilast is dialysable by peritoneal dialysis.
Danish: Det er uvist, om roflumilast kan fjernes ved peritonealdialyse.
English: Patients and caregivers should be requested to report any changes in the patient`s behaviour or mood or suicidal ideation.
Danish: Patienter og plejere skal opfordres til at indberette enhver ændring i patientens adfærd, humør eller selvmordslignende tanker.
English: A slight reduction in male fertility was seen in conjunction with epididymal toxicity in rats.
Danish: En let nedsat mandlig fertilitet sås som følge af en toksisk påvirkning af bitestikler hos rotter.
English: The proportion of patients who experienced at least 1 adverse event during the double-blind treatment period were 648 (66.9%) patients and 572 (59.2%) patients in the roflumilast and placebo groups, respectively.
Danish: Andelen af patienter, der oplevede mindst 1 bivirkning i den dobbeltblinde behandlingsperiode, var henholdsvis 648 (66,9 %) i roflumilast-gruppen og 572 (59,2 %) i placebo-gruppen.
English: Rare instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression, usually within the first weeks of treatment (see section 4.8).
Danish: Sjældne tilfælde af selvmordsrelaterede tanker og adfærd, herunder selvmord, er observeret hos patienter med eller uden tidligere depression, ofte inden for de første uger af behandlingen (se pkt.
English: These adverse reactions mainly occurred within the first weeks of therapy and mostly resolved on continued treatment.
Danish: Bivirkningerne optrådte hovedsageligt inden for de første uger af behandlingen for at aftage ved fortsat behandling.
English: These findings consisted mainly of gastrointestinal findings (i.e. vomiting, increased gastric secretion, gastric erosions, intestine inflammation) and cardiac findings (i.e. focal haemorrhages, haemosiderin deposits and lympho-histiocytic cell infiltration in the right atria in dogs, and decreased blood pressure and increased heart rate in rats, guinea pigs and dogs).
Danish: Disse fund bestod hovedsageligt af gastrointestinale fund (dvs. opkastning, øget gastrisk sekretion, gastriske erosioner, tarmbetændelse) og kardielle fund (dvs. fokale blødninger, hæmosiderinaflejringer og infiltration af lymfocytter og histiocytter i højre atrium hos hund, og nedsat blodtryk og øget hjertefrekvens hos rotter, marsvin og hunde).
English: Talk to your doctor if, while taking this medicine, you observe an unintentional loss of body weight (not related to a diet or exercise programme).
Danish: Fortæl din læge, hvis du oplever et utilsigtet vægttab (som ikke er relateret til et kost- eller motionsprogram), mens du er i behandling med dette lægemiddel.
English: A major step in roflumilast metabolism is the N-oxidation of roflumilast to roflumilast N-oxide by CYP3A4 and CYP1A2.
Danish: Et væsentligt trin i metaboliseringen af roflumilast er N-oxideringen af roflumilast til roflumilast N-oxid ved hjælp af CYP3A4 og CYP1A2.
English: Rescue medicinal products Daxas is not indicated as rescue medicinal product for the relief of acute bronchospasms.
Danish: Anfaldsmedicin Daxas er ikke indiceret som anfaldsmedicin til lindring af akutte bronkospasmer.
English: In contrast to the two confirmative studies, a history of chronic bronchitis and of COPD exacerbations was not requested for patients' inclusion.
Danish: I modsætning til de to bekræftende repeterede studier var kronisk bronkitis og tidligere KOL-eksacerbationer ikke et inklusionskriterium.
English: Gamma-GT increased Aspartate aminotransferase (AST) increased
Danish: Lever og galdeveje γ-GT forøget Forøget aspartat-transaminase (ASAT)
English: You may also experience sleeplessness, anxiety, nervousness, or depressive mood.
Danish: Du kan også opleve søvnløshed, angst, nervøsitet eller føle dig nedtrykt.
English: If patients suffer from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt, it is recommended to discontinue treatment with Daxas.
Danish: Hvis patienten får nye psykiske symptomer eller de forværres, eller hvis selvmordstanker eller - forsøg opdages, anbefales det at afbryde behandling med Daxas.
English: In Phase I studies, the following symptoms were observed at an increased rate after single oral doses of 2,500 micrograms and one single dose of 5,000 micrograms (ten times the recommended dose): headache, gastrointestinal disorders, dizziness, palpitations, light-headedness, clamminess and arterial hypotension.
Danish: I fase I-studier blev følgende symptomer observeret med øget hyppighed ved oral enkeltdosis på 2.500 mikrogram og en enkeltdosis på 5.000 mikrogram (ti gange anbefalet dosis): hovedpine, mavebesvær, svimmelhed, palpitationer, uklarhed, klamsved og arteriel hypotension.
English: In clinical COPD studies, approximately 16% of patients experienced adverse reactions with roflumilast (compared to 5% in placebo).
Danish: I kliniske KOL-studier oplevede ca. 16% af patienterne bivirkninger ved behandling med roflumilast (mod 5% af placebobehandlede).
English: Interaction studies with CYP1A2/3A4 inhibitor enoxacin and the CYP1A2/2C19/3A4 inhibitors cimetidine and fluvoxamine, resulted in increases of the total PDE4 inhibitory activity of 25%, 47% and 59%, respectively.
Danish: Interaktionsstudier med CYP1A2/3A4-hæmmeren enoxacin og CYP1A2/2C19/3A4-hæmmerne cimetidin og fluvoxamin resulterede i stigninger i den samlede PDE4-hæmmende aktivitet på henholdsvis 25%, 47% og 59%.
English: In two confirmative replicate one-year studies (M2-124 and M2-125) and two supplementary six-month studies (M2-127 and M2-128), a total number of 4,768 patients were randomised and treated, of whom 2,374 were treated with roflumilast.
Danish: I to bekræftende repeterede 1-års-studier (M2-124 og M2-125) og to supplerende 6 måneders-studier (M2-127 og M2-128) blev i alt 4.768 patienter randomiseret og behandlet, heraf blev 2.374 patienter behandlet med roflumilast.
English: White to off-white, round tablet, 5 mm in diameter, embossed with “D” on one side and “250” on the other side.
Danish: Hvid til offwhite rund tablet, 5 mm i diameter, præget med ”D” på den ene side og ”250” på den anden side.
English: Psychiatric disorders
Danish: Psykiatriske forstyrrelser
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially the following: - a medicine containing theophylline (a medicine to treat respiratory diseases), or - a medicine used for treatment of immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig, specielt følgende: - medicin, der indeholder theofyllin (medicin til behandling af luftvejssygdomme), eller - medicin, der bruges til behandling af immunologiske sygdomme, som methotrexat, azathioprin,
English: Tabulated list of adverse reactions Within the following table, adverse reactions are ranked under the MedDRA frequency classification:
Danish: I den nedenstående tabel er bivirkninger rangeret efter frekvens og grupperet efter MedDRA-klassificering:
English: You may experience diarrhoea, nausea, stomach ache or headache during the first weeks of treatment with Daxas.
Danish: Du kan måske opleve diarré, kvalme, mavesmerter eller hovedpine i løbet af de første uger af behandlingen med Daxas.
English: Study RO-2455-404-RD was a one year study in COPD patients with a baseline (pre-bronchodilator) FEV1 <50% of predicted normal and a history of frequent exacerbations.
Danish: Studie RO-2455-404-RD var et 1-årigt studie med KOL-patienter med FEV1 < 50 % af forventet normalværdi ved baseline (præ-bronkodilatator) og en anamnese med hyppige eksacerbationer.
English: No dose adjustment is necessary.
Danish: Dosisjustering er ikke nødvendig.
English: Daxas is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C).
Danish: Daxas er kontraindiceret til patienter med moderat eller svær nedsat leverfunktion (Child-Pugh B eller C).
English: In the two six-month studies, pre-bronchodilator FEV1 was significantly improved by 49 ml (primary endpoint, p<0.0001) beyond the bronchodilator effect of concomitant treatment with salmeterol in Study M2-127 and by 80 ml (primary endpoint, p<0.0001) incremental to concomitant treatment with tiotropium in Study M2-128.
Danish: I de to 6 måneders-studier blev FEV1 før bronkodilatation signifikant forbedret med 49 ml (primært endepunkt, p<0,0001) udover effekten af den bronkodilaterende effekt som blev opnået ved samtidig behandling med salmeterol i studie M2-127 og med 80 ml (primært endepunkt, p<0,0001) udover effekten af samtidig behandling med tiotropium i studie M2-128.
English: If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with roflumilast.
Danish: Hvis patienten får nye psykiske symptomer, eller de forværres, eller hvis selvmordstanker/forsøg opdages, anbefales det at afbryde behandling med roflumilast.
English: • insomnia, anxiety, depression, suicidal ideation or behaviour
Danish: • Søvnløshed, angst, depression, selvmordslignende tanker eller adfærd
English: In patients with COPD, roflumilast reduced sputum neutrophils.
Danish: Hos patienter med KOL reducerede roflumilast antallet af neutrofile granolucytter i opspyt.
English: The rate of severe exacerbations was reduced in the overall patient group (rate ratio: 0.76; 95% CI: 0.60 to 0.95) with a rate of 0.24 per patient/year compared to a rate of 0.32 per patient/year in patients treated with placebo.
Danish: Hyppigheden af svære eksacerbationer blev reduceret i den samlede patientgruppe (risiko ratio: 0,76; 95% CI: 0,60-0,95) med en hyppighed på 0,24 pr. patient/år sammenlignet med en hyppighed på 0,32 pr. patient/år hos patienter, der fik placebo.
English: Patients should be advised to weigh themselves at regular intervals and record the weight in the patient card.
Danish: Patienter bør rådes til at veje sig selv med jævne mellemrum og notere vægten på patientkortet.
English: The mechanism of action is the inhibition of PDE4, a major cyclic adenosine monophosphate (cAMP)-metabolizing enzyme found in structural and inflammatory cells important to the pathogenesis of COPD.
Danish: Virkningsmekanismen er en hæmning af PDE4, som er et vigtigt cyklisk adenosinmonofosfat(cAMP)-metaboliserende enzym, fundet i de strukturelle og inflammatoriske celler, der er væsentlige for patogenesen af KOL.
English: Starting dose titration trial
Danish: Startdoserings-titrerings-studie
English: Daxas 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side.
Danish: Daxas 500 mikrogram filmovertrukne tabletter er gule, D-formede filmovertrukne tabletter, mærket med ”D” på den ene side.
English: Change
Danish: Ændring
English: The one-year studies included patients with a history of severe to very severe COPD [FEV1 (forced expiratory volume in one second) ≤50% of predicted] associated with chronic bronchitis, with at least one documented exacerbation in the previous year and with symptoms at baseline as determined by cough and sputum score.
Danish: 1-års-studierne inkluderede patienter med svær til meget svær KOL [FEV1 (forceret ekspiratorisk volumen på 1 sekund) ≤50% af forventet] associeret med kronisk bronkitis og mindst 1 dokumenteret eksacerbation i det forgangne år og med baselinesymptomer bestemt ud fra en hoste- og opspyt-score.
English: Effects were similar, independent of previous treatment with inhaled corticosteroids or underlying treatment with LABAs.
Danish: Effekten var uafhængig af tidligere behandling med inhalationskortikosteroider eller af samtidig behandling med LABA.
English: The pharmacokinetics of roflumilast 250 micrograms once-daily was tested in 16 patients with mild to moderate hepatic impairment classified as Child-Pugh A and B. In these patients, the total PDE4 inhibitory activity was increased by about 20% in patients with Child-Pugh A and about 90% in patients with Child-Pugh B. Simulations suggest dose proportionality between roflumilast 250 and 500 micrograms in patients with mild and moderate hepatic impairment.
Danish: Farmakokinetikken af roflumilast 250 mikrogram 1 gang daglig blev testet hos 16 patienter med let til moderat nedsat leverfunktion klassificeret som Child-Pugh A og B. Hos disse patienter blev den samlede PDE4-hæmmende aktivitet øget med ca. 20% hos patienter med Child-Pugh A og med ca. 90% hos patienter med Child Pugh B. Simuleringer antyder dosisproportionalitet mellem roflumilast 250 og 500 mikrogram hos patienter med let og moderat nedsat leverfunktion.
English: Clinical interaction studies with CYP3A4 inhibitors erythromycin and ketoconazole showed increases of 9% of the total PDE4 inhibitory activity.
Danish: Kliniske interaktionsstudier med CYP3A4-hæmmerne erythromycin og ketoconazol viste stigninger på 9% i den totale PDE4-hæmmende aktivitet.
English: Common side effects (may affect up to 1 in 10 people) - diarrhoea, nausea, stomach ache - weight decrease, decreased appetite - headache
Danish: Almindelige bivirkninger (forekommer hos 1 ud af 10 personer) - diarré, kvalme, mavesmerter - vægttab, nedsat appetit - hovedpine
English: Yellow, D-shaped film-coated tablet of 9 mm, embossed with “D” on one side.
Danish: Gul, D-formet filmovertrukken tablet på 9 mm, præget med ”D” på den ene side.
English: Post-bronchodilator FEV1 increased for the roflumilast group by 52 mL (95% CI: 40, 65 mL) and decreased for the placebo group by 4 mL (95% CI: -16, 9 mL).
Danish: Post-bronkodilatatorFEV1 steg i roflumilast-gruppen med 52 ml (95% CI: 40-65 ml) og faldt i placebo-gruppen med 4 ml (95% CI: -16; 9 ml).
English: Other medicines and Daxas
Danish: Brug af anden medicin sammen med Daxas
English: In an interaction study with an oral contraceptive containing gestodene and ethinyl oestradiol, the total PDE4 inhibitory activity was increased by 17%.
Danish: I et interaktionsstudie med et oralt præventionsmiddel indeholdende gestoden og ethinylestradiol, blev den samlede PDE4-hæmmende aktivitet øget med 17%.
English: Patients receiving a 500 micrograms dose once a day had a median PDE4 inhibitory activity of 1.2 (0.35, 2.03) and those receiving a 250 micrograms dose once a day had a median PDE4 inhibitory activity of 0.6 (0.20, 1.24).
Danish: Patienter, der fik en 500 mikrogram dosis én gang daglig, havde en median PDE4 inhibitor aktivitet på 1,2 (0,35, 2,03) og de som fik en 250 mikrogram dosis én gang daglig, havde en median PDE4 inhibitor aktivitet på 0,6 (0,20, 1,24).
English: Daxas 250 micrograms tablets are white to off-white, embossed with ‘D' on one side and ‘250' on the other side.
Danish: Daxas 250 mikrogram tabletter er hvide til offwhite, mærket med ”D” på den ene side og ”250” på den anden side.
English: Due to lack of relevant experience, treatment with roflumilast should not be initiated or existing treatment with roflumilast should be stopped in patients with severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy), severe acute infectious diseases, cancers (except basal cell carcinoma), or patients being treated with immunosuppressive medicinal products (i.e. methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term; except short-term systemic corticosteroids).
Danish: På grund af manglende relevant erfaring bør behandling med roflumilast ikke påbegyndes, og igangværende behandling med roflumilast bør afbrydes hos patienter med svære immunologiske sygdomme (f.eks. hiv-infektion, dissemineret sklerose, lupus erythematosus, progressiv multifokal leukoencefalopati), alvorlige akutte smitsomme sygdomme, kræftsygdomme (undtagen basalcellekarcinom), og hos patienter, der behandles med immunosuppressive lægemidler (f.eks. methotrexat, azathioprin, infliximab, etanercept eller orale kortikosteroider til langtidsbehandling; undtagen systemiske kortikosteroider til korttidsbehandling).
English: What you need to know before you take Daxas
Danish: Det skal du vide, før du begynder at tage Daxas
English: In the subgroup of patients with history of frequent exacerbations (at least 2 exacerbations during the last year), the rate of exacerbations was 1.526 with roflumilast and 1.941 with placebo corresponding to a relative risk reduction of 21.3% (95% CI: 7.5% to 33.1%).
Danish: For subgruppen af patienter med tidligere gentagne eksacerbationer (mindst 2 eksacerbationer i det forgangne år) var antallet af eksacerbationer 1,526 med roflumilast og 1,941 med placebo svarende til en relativ risikoreduktion på 21,3% (95% KI: 7,5% til 33,1%).
English: Moderate or severe hepatic impairment (Child-Pugh B or C).
Danish: Moderat eller svært nedsat leverfunktion (Child-Pugh B eller C).
English: Co-administration with theophylline resulted in an increase of 8% of the total PDE4 inhibitory activity (see section 4.4).
Danish: Samtidig administration af theofyllin resulterede i en stigning på 8% i den samlede PDE4-hæmmende aktivitet (se pkt.
English: The numbers of patients who died due to any reason were equal for those treated with placebo or roflumilast (42 deaths each group; 2.7% each group; pooled analysis).
Danish: Antallet af patienter, der døde af en vilkårlig årsag, var ens i placebo- og roflumilastgruppen (42 (2,7%) døde i hver gruppe; poolet analyse).
English: Body weight of underweight patients should be checked at each visit.
Danish: Undervægtige patienter bør have kontrolleret kropsvægten ved hver konsultation.
English: OUTER CARTON FOR BLISTER
Danish: YDRE BLISTERKARTON
English: Administration of the cytochrome P450 enzyme inducer rifampicin resulted in a reduction in total PDE4 inhibitory activity by about 60%.
Danish: Administration af CYP-induktoren rifampicin resulterede i en reduktion i den samlede PDE4-inhiberende aktivitet med omkring 60%.
English: After 28 days of treatment with the 250-micrograms starting dose, patients must be up-titrated to one tablet of 500 micrograms roflumilast, to be taken once daily.
Danish: Efter 28 dages behandling med 250 mikrogram startdosis, skal patienter titreres op til én tablet på 500 mikrogram roflumilast en gang dagligt.
English: Weight decreased Decreased appetite
Danish: Nedsat appetit
English: The per-protocol Poisson regression analysis and the non-significant sensitivity to drop-out Poisson regression intention-to-treat analysis rate ratios were 0.81 (95% CI: 0.69 to 0.94) and 0.89 (95% CI: 0.77 to 1.02), respectively.
Danish: Risiko ratioer ved den protokolmæssige Poisson-regressionsanalyse og ved Poisson-regression intention-to-treat-analysen uden signifikant følsomhed over for drop-out var henholdsvis 0,81 (95 % CI: 0,69-0,94) og 0,89 (95 % CI: 0,77-1,02).
English: Based on further in vitro results in human hepatic microsomes, therapeutic plasma concentrations of roflumilast and roflumilast N-oxide do not inhibit CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, or 4A9/11.
Danish: Baseret på yderligere in vitro-resultater i humane hepatiske mikrosomer hæmmer terapeutiske plasmakoncentrationer af roflumilast og roflumilast N-oxid ikke CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, eller 4A9/11.
English: The tolerability of roflumilast was evaluated in a 12-week randomised, double-blind, parallel group trial (RO-2455-302-RD) in patients with severe COPD associated with chronic bronchitis.
Danish: Tolerabiliteten af roflumilast blev evalueret i et 12 ugers randomiseret, dobbeltblindet, behandlingsstudie med parallelle grupper (RO-2455-302-RD) hos patienter med alvorlig KOL kombineret med kronisk bronkitis.
English: Each tablet contains 49.7 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 49,7 mg lactose (som monohydrat).
English: Since both roflumilast and roflumilast N-oxide contribute to PDE4 inhibitory activity in vivo, pharmacokinetic considerations are based on total PDE4 inhibitory activity (i.e. total exposure to roflumilast and roflumilast N-oxide).
Danish: Da både roflumilast og roflumilast N-oxid bidrager til den PDE4-hæmmende aktivitet in vivo, er de farmakokinetiske overvejelser baseret på den samlede PDE4-hæmmende aktivitet (dvs. den samlede eksponering af roflumilast og roflumilast N-oxid).
English: The incidence observed was also higher in patients less than 75 years old, treated with roflumilast when compared to those treated with placebo (3.1% vs 2.0%).
Danish: Der blev også observeret en højere forekomst hos patienter yngre end 75 år i roflumilast-armen sammenlignet med placebo-armen (3,1 % kontra 2,0 %).
English: The rate (per patient per year) of moderate exacerbations (requiring intervention with systemic glucocorticosteroids) or severe exacerbations (resulting in hospitalisation and/or leading to death) after 1 year was 1.142 with roflumilast and 1.374 with placebo corresponding to a relative risk reduction of 16.9% (95% CI: 8.2% to 24.8%) (primary endpoint, p=0.0003).
Danish: Antallet (pr. patient pr. år) af moderate eksacerbationer (krævende intervention med systemiske glukokortikosteroider) eller svære eksacerbationer (resulterende i indlæggelse og/eller førende til dødsfald) efter 1 år var 1,142 med roflumilast og 1,374 med placebo; svarende til en relativ risikoreduktion på 16,9% (95%KI: 8,2% til 24,8%) (primært endepunkt, p=0,0003).
English: In addition, in vitro studies demonstrated no induction of the CYP1A2, 2A6, 2C9, 2C19, or 3A4/5 and only a weak induction of CYP2B6 by roflumilast.
Danish: Endvidere viste in vitro-studier med roflumilast ingen induktion af CYP1A2, 2A6, 2C9, 2C19 eller 3A4/5, og kun en svag induktion af CYP2B6.
English: Elderly No dose adjustment is necessary.
Danish: Ældre Der er ikke behov for dosisjustering.
English: Experience is also limited in patients with a previous diagnosis of tuberculosis, viral hepatitis, herpes viral infection or herpes zoster.
Danish: Erfaring er også begrænset hos patienter, som tidligere er diagnosticeret med tuberkulose, viral hepatitis, viral herpesinfektion eller herpes zoster.
English: Respiratory tract infections (excluding Pneumonia)
Danish: Luftvejsinfektioner (ekskl.
English: Description of selected adverse reactions * In clinical studies and post-marketing experience, rare instances of suicidal ideation and behaviour, including suicide, were reported.
Danish: Beskrivelse af udvalgte bivirkninger *Sjældne tilfælde af selvmordstanker og -adfærd, inklusive selvmord, er rapporteret efter markedsføring og i kliniske studier.
English: Gastritis
Danish: Gastrit
English: • Summary of Product Characteristics and Patient Information Leaflet for Daxas
Danish: • Produktresumé og indlægsseddel for Daxas.