FrancophonIA/ELRC3.0 huggingface dataset:
English: The applicant emphasised that these studies demonstrated efficacy in the non-prescription setting regarding the proposed indication and related posology which differs from that of the prescription product.
Danish: Ansøgeren lagde vægt på, at disse undersøgelser påviste produktets virkning i en ikke-receptpligtig sammenhæng hvad angår den foreslåede indikation og relaterede dosering, som adskiller sig fra indikationen og doseringen for det receptpligtige produkt.
English: Pan 20, Ran 300 once daily
Danish: Pan 20, Ran 300 en gang dagligt
English: Results are similar to published studies (FK3059, VMG306, FK3034 and BGSA006)
Danish: Resultaterne svarer til publicerede undersøgelser (FK3059, VMG306, FK3034 og BGSA006)
English: Out of the 17 studies submitted in support of the application, the following 11 studies did not form the basis of the applicant's request for data exclusivity:
Danish: Af de 17 undersøgelser fremsendt til støtte for ansøgningen udgjorde følgende 11 undersøgelser ikke en del af grundlaget for ansøgerens anmodning om databeskyttelse:
English: Pan 20, 40 4 weeks
Danish: Pan 20, 40 4 uger
English: With reference to Article 74a of Directive 2001/83/EC, as amended, the applicant requested one year data exclusivity for the data submitted for the change of the classification of the medicinal product
Danish: Under henvisning til artikel 74a i direktiv 2001/83/EF, med senere ændringer, anmodede ansøgeren om et års databeskyttelse for de indsendte data i forbindelse med ændringen af klassificeringen af lægemidlet til et ikke-receptpligtigt lægemiddel.
English: In this pivotal study the differences between pantoprazole 20 mg and ranitidine 150 mg results were significant; however the unpublished study conclusion for BGI022 were very similar to those of the published ranitidine 150 mg comparative study VMG306 and overall does not add significant value to the application.
Danish: I denne hovedundersøgelse var forskellene mellem resultaterne for pantoprazol 20 mg og ranitidin 150 mg signifikante, men konklusionen i den ikke-publicerede undersøgelse for BGI022 svarede i det store og hele til konklusionerne for den publicerede sammenlignende undersøgelse med ranitidin 150 mg, VMG306, og var generelt set ikke af væsentlig betydning for ansøgningen.
English: 2 weeks 521 Both PPIs were comparably effective; pantoprazole was noninferior to omeprazole, nonsignificant primary endpoint
Danish: 521 De to PPI'er var lige effektive; pantoprazol var ikke dårligere end omeprazol, ikkesignifikant primært endepunkt
English: No week 2 relief rate analysis was provided.
Danish: Der blev ikke fremlagt nogen analyse af lindringen efter uge 2.
English: Primary Objective
Danish: Primært mål
English: Study No. (CSR No.)
Danish: Undersøgelse nr. (CSR nr.)
English: The findings of this study are in line with other published studies (Study VMG305 and M3-320), which showed that the efficacy of pantoprazole is noninferior to other PPIs (such as lansoprazole and esomeprazole).
Danish: Resultaterne af denne undersøgelse er på linje med andre publicerede undersøgelser (undersøgelse VMG305 og M3-320), der viste, at virkningen af pantoprazol ikke er dårligere end andre PPI'er (som f.eks. lansoprazol og esomeprazol).
English: The CHMP reviewed the clinical data submitted, taking into account the provisions of Article 74a of Directive 2001/83/EC, as amended, in support of the classification of CONTROLOC Control 20 mg gastro-resistant tablets as ‘medicinal product not subject to medical prescription'.
Danish: CHMP gennemgik de indsendte kliniske data under hensyntagen til bestemmelserne i artikel 74a i direktiv 2001/83/EF, med senere ændringer, til støtte for klassificeringen af CONTROLOC Control 20 mg enterotabletter som et "ikke-receptpligtigt lægemiddel".
English: In the non-prescription product setting, the patient would be self-referring to their physician if no symptomatic relief was obtained by day 14, making this study of limited value in the non-prescription context.
Danish: For det ikke-receptpligtige lægemiddel skulle patienten selv søge læge, hvis symptomerne ikke var afhjulpet på dag 14, hvilket bevirkede, at denne undersøgelse havde begrænset værdi i den ikke-receptpligtige sammenhæng.
English: Similar results were shown in the published study M3-316 which compared the efficacy of 20 and 40 mg pantoprazole in the treatment of GORD symptoms.
Danish: Tilsvarende resultater blev opnået i den publicerede undersøgelse M3-316, som sammenlignede virkningen af pantoprazol 20 mg og 40 mg ved behandling af GORD-symptomer.
English: It is extensively metabolised in the liver.
Danish: Stoffet metaboliseres næsten udelukkende i leveren.
English: Similar results were shown by study FK3059, VMG306, FK3034, BGSA006, which also showed superiority of 20 mg pantoprazole compared to 300 mg ranitidine in the treatment of reflux symptoms.
Danish: Tilsvarende resultater blev opnået i undersøgelse FK3059, VMG306, FK3034, BGSA006, som også viste, at pantoprazol 20 mg er mere effektivt end 300 mg ranitidin til behandling af reflukssymptomer.
English: Pantoprazole was noninferior to lansoprazole after 4 weeks of treatment
Danish: 375 Pantoprazol var ikke ringere end lansoprazol efter 4 ugers behandling
English: The PSUR submission schedule for CONTROLOC Control 20 mg gastro-resistant tablets should follow the PSUR submission schedule of the reference medicinal product.
Danish: Indsendelsen af PSUR for CONTROLOC Control 20 mg enterotabletter skal følge indsendelsen af PSUR for referencelægemidlet.
English: Study BY1023/BGI022 was particularly emphasised.
Danish: Der blev især lagt vægt på undersøgelse BY1023/BGI022.
English: The results show that symptom relief rates are largely independent of the initial GORD stage of the patients.
Danish: Lindringsfrekvensen af syrereflukssymptomerne var stort set uafhængig af det initiale GORD-stadie.
English: Pan 10, 20, 40, Pla weeks
Danish: Pan 10, 20, 40, Pla
English: Time to first symptom relief of GORDrelated symptoms in GORD Stage 0
Danish: Tid, der går til første lindring af GORDrelaterede symptomer i GORD Fase 0
English: Relief of symptoms in GORD Stage A-D
Danish: Lindring af symptomer i GORD Fase A-D
English: Relief of typical GORD symptoms
Danish: Lindring af typiske GORD-symptomer
English: Endoscopic healing erosive esophagitis
Danish: Endoskopisk helbredelse af erosiv øsofagitis
English: Relief of leading GORD symptoms and other GI symptoms
Danish: Lindring af de vigtigste GORD-symptomer og andre gastrointestinale symptomer
English: The recommended dose is 20 mg pantoprazole (one tablet) per day.
Danish: Dosering Den anbefalede dosering er 20 mg pantoprazol (en tablet) daglig.
English: Overall treatment duration without consultation of a doctor is limited to 4 weeks; if no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor.
Danish: Hvis der ikke er opnået symptomlindring indenfor 2 ugers kontinuerlig behandling, bør patienten instrueres om at kontakte lægen.
English: Assessment of GI symptoms at day 14 and
Danish: Vurdering af gastrointestinale symptomer på dag 14 og dag 28
English: Quality of life, Time to heartburn relief
Danish: Livskvalitet, tid, der går, inden halsbrand lindres
English: Tablets are yellow, oval, biconvex, film-coated and imprinted with “P20” in brown ink on one side.
Danish: Enterotabletterne er gule, ovale, bikonvekse filmovertrukne tabletter præget med ”P20” på den ene side.
English: This study compared the efficacy of omeprazole 10 mg versus pantoprazole 20 mg after one and two weeks or treatment.
Danish: I denne undersøgelse sammenlignedes virkningen af omeprazol 10 mg med virkningen af pantoprazol 20 mg efter en og to ugers behandling.
English: Medicinal Product
Danish: FARMACEUTISKE OPLYSNINGER
English: Pan 20, 40, Niz 150 bid weeks
Danish: Pan 20, 40, Niz 150 bid
English: Additionally, in other studies efficacy of pantoprazole was compared to other PPIs (lansoprazole, esomeprazole) and it was found to be non-inferior to these PPIs in relieving symptoms of heartburn and acid regurgitation (Study VMG305 and M3-320).
Danish: Desuden var virkningen af pantoprazol blevet sammenlignet med andre PPI'er (lansoprazol, esomeprazol) i andre undersøgelser, og man fandt, at det ikke var dårligere end disse PPI'er med hensyn til at lindre symptomer på halsbrand og sure opstød (undersøgelse VMG305 og M3-320).
English: Pantoprazole was effective and well tolerated
Danish: 421 Pantoprazol var virkningsfuldtog tolereredes godt
English: Relief of symptoms in GORD Stage 0/I after 4 weeks of treatment
Danish: Lindring af symptomer i GORD Fase 0/I efter 4 ugers behandling
English: The usual starting dose for omeprazole in reflux disease is 20 mg; 10 mg omeprazole is not therapeutically equivalent to 20 mg pantoprazole.
Danish: Den sædvanlige startdosis for omeprazol ved reflukssygdom er 20 mg. 10 mg omeprazol svarer ikke behandlingsmæssigt til 20 mg pantoprazol.
English: Additionally, the usual starting dose for omeprazole in reflux disease is 20 mg; 10 mg omeprazole is not therapeutically equivalent to 20 mg pantoprazole.
Danish: Derudover er den sædvanlige startdosis for omeprazol ved reflukssygdom 20 mg. 10 mg omeprazol svarer behandlingsmæssigt ikke til 20 mg pantoprazol.
English: - Marketing authorisation number:
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
English: Pantoprazole was significantly more effective than placebo
Danish: 603 Pantoprazol var væsentlig mere virkningsfuldt end placebo
English: Clinical safety
Danish: KLINISKE OPLYSNINGER
English: Pantoprazole was significantly more effective than nizatidine
Danish: 243 Pantoprazol var væsentlig mere virkningsfuldt end nizatidin
English: This study compared the efficacy and tolerability of pantoprazole 20 mg, 40 mg, or 80 mg in healing of oesophagitis and freedom from GORD symptoms.
Danish: I denne undersøgelse sammenlignedes virkningen og tolerabiliteten af pantoprazol 20 mg, 40 mg eller 80 mg til behandling af øsofagitis og sikring af, at der ikke opstår GORD-symptomer.
English: In this study the efficacy of 20 mg pantoprazole was compared to 10 mg omeprazole at day 28 in patients with reflux oesophagitis.
Danish: I denne undersøgelse blev virkningen af pantoprazol 20 mg sammenlignet med omeprazol 10 mg på dag 28 hos patienter med refluks-øsofagitis.
English: Endoscopic healing of GORD Stage II/III after 4 and 8 weeks of treatment
Danish: Endoskopisk helbredelse af GORD Fase II/III efter 4 og 8 ugers behandling
English: Relief of GORD-related symptoms after 14 and 28 days
Danish: Lindring af GORDrelaterede symptomer efter 14 dage og 28 dage
English: Results for the relief of acid regurgitation showed similar results.
Danish: Der blev opnået tilsvarende resultater for fuldstændig lindring af syre-regurgitation som for halsbrand.
English: This study compared the efficacy of omeprazole 10 mg versus pantoprazole 20 mg at day 28 in patients without oesophagitis established by endoscopy.
Danish: I denne undersøgelse sammenlignedes virkningen af omeprazol 10 mg med virkningen af pantoprazol 20 mg på dag 28 hos patienter uden øsofagitis fastslået ved endoskopi.
English: 2.5 Pharmacovigilance
Danish: Pharmacovigilancesystemet
English: Endoscopic healing of GORD Stage I after 8 weeks, Improvement of GORD symptoms after 2 and 4 weeks
Danish: Endoskopisk helbredelse af GORD Fase I efter 8 uger, forbedring af GORDsymptomer efter 2-4 uger
English: Tablets are packed in Alu/Alu blisters without cardboard reinforcement or Alu/Alu blisters with cardboard reinforcement (blister wallet).
Danish: CONTROLOC Control findes i aluminim/aluminium-blister med eller uden kartonforstærkning.
English: “Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.”
Danish: Korttidsbehandling af reflukssymptomer (fx halsbrand, syreregurgitation) hos voksne.
English: Leading symptom relief after 2 weeks of treatment
Danish: Lindring af de vigtigste symptomer efter 2 ugers behandling
English: 344 Pantoprazole was superior to ranitidine in the relief of GORD symptoms
Danish: 344 Pantoprazol var bedre end ranitidin til at lindre GORDsymptomer
English: Pantoprazole was superior to placebo
Danish: 219 Pantoprazol var bedre end placebo
English: Endoscopic healing of GORD Stage I
Danish: Endoskopisk helbredelse af GORD Fase I
English: Pantoprazole and omeprazole were similarly effective
Danish: 327 Pantoprazol og omeprazol var lige virknings-fulde
English: This study compared the efficacy of 20 mg pantoprazole once daily with 150 mg twice daily ranitidine in healing of oesophagitis and freedom from GORD symptoms after treatment.
Danish: I denne undersøgelse sammenlignedes virkningen af pantoprazol 20 mg en gang dagligt med 150 mg ranitidin to gange dagligt til behandling af øsofagitis og sikring af, at der ikke opstår GORDsymptomer efter behandling.
English: The approved indication is:
Danish: Ud fra følgende betragtninger:
English: The absolute bioavailability of pantoprazole in healthy subjects is 77% and does not change at multiple dosing.
Danish: Den absolutte biotilgængelighed for en tablet er omkring 77%.
English: Relief of heartburn in GORD Stage 0/I at day 28
Danish: Lindring af halsbrand i GORD Fase 0/I på dag 28
English: Relief of heartburn in GORD Stage 0/I at day 14
Danish: Lindring af halsbrand i GORD Fase 0/I på dag 14
English: • Manufacture
Danish: A. ETIKETTERING
English: Both PPIs were comparably effective; pantoprazole was noninferior to esomeprazole
Danish: 529 De to PPI'er var lige virkningsfulde; pantoprazol var ikke dårligere end esomeprazol
English: There are no direct safety issues that preclude pantoprazole being available as a non-prescription medicine.
Danish: Patienterne bør ikke tage pantoprazol som et forebyggende lægemiddel.
English: Published studies showed noninferiority of pantoprazole compared to other PPIs (Study VMG305 and M3
Danish: Publicerede undersøgelser viste, at pantoprazol ikke er dårligere end andre PPI'er (undersøgelse VMG305 og M3
English: - Date of authorisation: - Marketing authorisation granted by:
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Published studies suggest noninferiority of pantoprazole compared to other PPIs (Study VMG305 and M3
Danish: Publicerede undersøgelser tyder på, at pantoprazol ikke er dårligere end andre PPI'er (undersøgelse VMG305 og M3
English: Enrolment
Danish: Enterotablet
English: 2.4 Clinical aspects
Danish: 4.8 Bivirkninger
English: CONTROLOC Control is presented in form of gastro-resistant tablets containing pantoprazole as an active substance.
Danish: CONTROLOC Control indeholder: - Aktivt stof: Pantoprazol.
English: Diarrhoea Headache Nausea / Vomiting Abdominal distension and bloating Abdominal pain and discomfort Constipation Dizziness Liver enzymes increased (transaminases, γ-GT) Rash / Exanthema / Eruption Pruritus Sleep disorders Dry mouth Asthenia, fatigue and malaise Hyperlipidaemias and lipid increases Disturbances in vision / Blurred vision Hypersensitivity (incl.
Danish: Hovedpine; svimmelhed; diaré; kvalme, opkastning; oppustethed og luftafgang fra tarmen; forstoppelse; mundtørhed; smerter og ubehag i maven; hududslæt og eksem; kløe; svaghedsfornemmelse, udmattet eller generelt utilpas; søvnforstyrrelser; forøgede leverenzymtal ved blodprøve.
English: The CHMP noted that in the majority of the studies patients were included based on endoscopic examination rather than symptoms alone.
Danish: GORDdiagnosen i disse studier er baseret på endoskopisk vurdering, med undtagelse af et enkelt studie, hvor inkluderingen af patienter alene var baseret på symptomatologi.
English: The main serum metabolite is formed by demethylation at the 4-position of the pyridine ring, followed by conjugation with sulphate.
Danish: Hovedmetabolitten i både serum og urin er desmethylpantoprazol, der er bundet til sulfat.
English: GCP
Danish: EXP
English: The most frequent adverse events (≥5%) included diarrhoea, headache, and nausea.
Danish: De mest almindeligt rapporterede bivirkninger er diaré og hovedpine, som begge forekommer hos ca. 1 % af patienterne.
English: It has been proven that the drug substance can be reproducibly manufactured.
Danish: Dyreforsøg har påvist reproduktionstoksicitet.
English: ASSESSMENT REPORT FOR CONTROLOC Control
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i CONTROLOC Control
English: Relief of GORD symptoms after 2 weeks of treatment
Danish: Lindring af GORDsymptomer efter 2 ugers behandling
English: Each gastro-resistant tablet contains 20 mg pantoprazole (equivalent of 22.6 mg of pantoprazole sodium sesquihydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver enterotablet indeholder 20 mg pantoprazol (som natriumsesquihydrat).
English: 270 Pantoprazole was superior to ranitidine
Danish: 4/8 uger 270 Pantoprazol var bedre end ranitidin
English: The application concerns the supply as non-prescription medicine.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Ikke receptpligtigt lægemiddel.
English: Clinical trials have been performed in special patient populations, such as children, the elderly and renal- or liver-impaired patients.
Danish: Dosisjustering er ikke nødvendig hos ældre patienter, eller hos patienter med nedsat nyre- eller leverfunktion.
English: Relief of heartburn in GORD Stage 0
Danish: Lindring af halsbrand i GORD Fase 0
English: The excipients used in the formulation of the finished product are well known excipients used for preparation of tablets such as sodium carbonate, mannitol, crospovidone, povidone K90, calcium stearate (present in tablet core), hypromellose, povidone K25, titanium dioxide, yellow iron oxide, methacrylic acid-ethyl acrylate copolymer (1:1), sodium laurilsulfate, polysorbate 80, triethyl citrate (present in film-coating, including enteric coating and undercoating), shellac, red iron oxide, black iron oxide, yellow iron oxide, soya lecithin, titanium dioxide and antifoam DC 1510 (present in printing ink).
Danish: Overtræk: hypromellose, povidon K25, titandioxid (E 171), gul jernoxid (E 172), propylenglycol, methacrylsyre-ethylacrylat copolymer (1:1), natriumlaurilsulfat, polysorbat 80, triethylcitrat.
English: Relief of GORD symptoms, Time to heartburn relief
Danish: Lindring af GORDsymptomer tid, der går, inden halsbrand lindres
English: Pantoprazole was superior to ranitidine in the treatment of key GORD symptoms.
Danish: Pantoprazol var bedre til behandling af de vigtigste GORDsymptomer end ranitidin.
English: Pantoprazole was significantly more effective than ranitidine
Danish: 201 Pantoprazol var væsentlig mere virkningsfuldt end ranitidin
English: Pantoprazole: Omeprazole:
Danish: Oversigt over indlægssedlen:
English: Number of patients with this adverse drug reaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: It acts by inhibiting the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells.
Danish: Pantoprazol er en substitueret benzimidazol, som hæmmer sekretionen af saltsyre i maven ved en specifik virkning på parietalcellernes protonpumper.
English: These studies showed that pantoprazole 20mg was superior to placebo and histamine2-receptor antagonist in the complete relief from heartburn and was non-inferior to other proton pump inhibitors.
Danish: Pantoprazol har konstant vist sig at være bedre end placebo og H2-receptor-antagonister og ikke mindre effektive end andre PPI'er.
English: There are potential interactions with anticoagulants and with drugs, which bioavailability is pH dependent such as atanazavir.
Danish: CONTROLOC Control kan reducere absorptionen af aktive stoffer, hvis biotilgængelighed er pHafhængig (fx. ketoconazol).
English: Symptom relief at 2 and 4 weeks of treatment
Danish: Symptomlindrin g efter 2 og 4 ugers behandling
English: There were only 2% of patients who took the study medication longer than 4 weeks.
Danish: Det forventes, at der i gennemsnit er 5 % af patienterne, som oplever bivirkninger.
English: These included diarrhoea, abdominal pain, headache, nausea, chest pain and rash.
Danish: Diaré kvalme/opkastning, udspilet abdomen og oppustethed, forstoppelse, tørhed i munden, abdominale smerter og ubehag
English: In-process controls performed during the synthesis are suitable to control the reaction progress.
Danish: For at opnå den bedste behandling skal du være omhyggelig med at følge anvisningerne for CONTROLOC Control.
English: Pharmacokinetics
Danish: FARMAKOLOGISKE EGENSKABER
English: In these studies between 57 and 78% of patients reported relief from heartburn at day 7 and 73-83% at day 14.
Danish: I disse studier var procentdelen af de patienter, som opnåede fuldstændig lindring af halsbranden efter 7 dage, mellem 54,0% og 80,6 % i gruppen som blev behandlet med pantoprazol.
English: Endoscopic healing of GORD Stage I after 8 weeks of treatment
Danish: Endoskopisk helbredelse af GORD Fase I efter 8 ugers behandling
English: The gastro-resistant coating consists of methacrylic acid - ethyl acrylate copolymer 1:1; triethyl citrate is added as a plasticizer.
Danish: Methacrylsyre-ethylacrylat copolymer (1:1) Natriumlaurilsulfat
English: • Risk and consequences of incorrect use
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG
English: Serious adverse drug reactions have therefore been rare.
Danish: - Meget sjældne bivirkninger:
English: Relief of key symptoms in GORD after 28 days
Danish: Lindring af de vigtigste GORD-symptomer efter 28 dage
English: Baseline data
Danish: INFORMATION I BRAILLE-SKRIFT
English: The co-administration with atazanavir is contra-indicated in the SPC and the Package Leaflet.
Danish: Derfor bør pantoprazol ikke gives sammen med atazanavir (se pkt.
English: Relief of heartburn in GORD Stage I after 1 and 2 weeks of treatment
Danish: Lindring af halsbrand i GORD Fase I efter 1 og 2
English: Whereas:
Danish: Det kan foreksempel være:
English: Comparator
Danish: Overtræk
English: 346 Pantoprazole and omeprazole
Danish: 4/8 uger 346 Pantoprazol og omeprazol var lige effektive
English: Endoscopic healing of GORD Stage I after 4 weeks
Danish: Endoskopisk helbredelse af GORD Fase I efter 4 uger
English: Endoscopic healing of GORD Stage I after 4 weeks of treatment
Danish: Endoskopisk helbredelse af GORD Fase I efter 4 ugers behandling
English: It inhibits basal and stimulated acid secretion in animals and man via the covalent binding H+/K+ ATP-ase, also known as the “gastric proton pump” located in the secretory membrane of the parietal cell.
Danish: Pantoprazol omdannes til dets aktive form, en cyklisk sulfonamid, i det sure miljø i parietalcellerne, hvor det hæmmer H+/K+-ATPase enzymet, dvs. det sidste stadie i produktionen af saltsyre i maven.
English: 2.7 Data exclusivity
Danish: 6.4 Særlige opbevaringsforhold
English: Typically a patient with GORD symptoms sees a pharmacist in the first instance.
Danish: Patienter med langvarige tilbagevendende symptomer på fordøjelsesbesvær eller halsbrand bør se deres læge med regelmæssige intervaller.
English: • User consultation
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
English: Pantoprazole was superior to ranitidine
Danish: 338 Pantoprazol var bedre end ranitidin
English: PP
Danish: PSUR
English: Pantozol 20 mg gastro-resistant tablets
Danish: CONTROLOC Control 20 mg enterotabletter Pantoprazol
English: The results also show an early onset of the clinical effect, with rates of complete relief of heartburn between 54.0% and 80.6% achieved after 7 days of treatment with pantoprazole 20 mg. A further improvement in the symptom relief rates was observed after 14 days and 28 days of treatment, respectively.
Danish: Efter 7 dage var procentdelen af patienter, som opnåede fuldstændig lindring af syreregurgitation mellem 61,5% og 84,4%, efter 14 dage mellem 67,7% og 90,4%, og efter 28 dage mellem 75,2% og
English: WA300
Danish: Povidon K90
English: Relief of GORD
Danish: Lever og galdeveje
English: The tablets stored in primary packaging materials as described in the dossier were in compliance with the shelf-life specifications at all tested time points.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale pakning for at beskytte mod fugt.
English: Randomisation
Danish: Amning