FrancophonIA/ELRC3.0 huggingface dataset:
English: It is best to measure your blood sugar level regularly to get the maximum benefit of insulin delivery, and to make sure the pump is working properly.
Danish: For at få størst muligt udbytte af insulinindgivelsen og for at sikre dig, at pumpen fungerer som den skal, anbefales det, at du måler dit blodsukker regelmæssigt.
English: NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps, as described in section 4.2.
Danish: NovoRapid PumpCart er kun til brug sammen med et insulininfusions-pumpesystem, som er beregnet til anvendelse sammen med denne cylinderampul, såsom Accu-Chek Insight og YpsoPump insulinpumper, som beskrevet i pkt.
English: How to store NovoRapid PumpCart Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger NovoRapid PumpCart indeholder
English: 1 cartridge contains 3 ml equivalent to 300 units.1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg).
Danish: 1 ml opløsning indeholder 100 enheder insulin aspart* (svarende til 3,5 mg).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Always keep the pen cap on your FlexPen when you are not using it in order to protect it from light.
Danish: Opbevar altid FlexPen med penhætten påsat, når den ikke er i brug, for at beskytte mod lys.
English: NovoRapid InnoLet is only suitable for injecting under the skin.
Danish: NovoRapid InnoLet er kun egnet til indsprøjtning under huden.
English: How to handle NovoRapid FlexPen
Danish: Sådan bruger du NovoRapid FlexPen
English: NovoRapid FlexPen is only suitable for injecting under the skin.
Danish: NovoRapid FlexPen er kun egnet til indsprøjtning under huden.
English: METHOD OF ADMINISTRATION FlexPen
Danish: ANVENDELSESMÅDE FlexPen
English: Administration with an insulin delivery system
Danish: Administration med injektionssystem
English: How to use NovoRapid
Danish: Sådan bruger du NovoRapid InnoLet
English: How to store NovoRapid PumpCart
Danish: Sådan skal du bruge NovoRapid PumpCart
English: NovoRapid can only be mixed with NPH (Neutral Protamine Hagedorn) insulin in a syringe for subcutaneous use.
Danish: (Neutral Protamine Hagedorn) -insulin i en sprøjte til subkutan brug.
English: Dose button
Danish: Træk penhætten af.
English: Before you set or change the basal rate, carefully read the pump manual (user guide).
Danish: Læs brugervejlidningen til pumpen omhyggeligt, inden du indstiller eller ændrer mængden af din basale insulindosis.
English: NovoRapid Penfill 100 units/ml solution for injection in cartridge Insulin aspart
Danish: NovoRapid Penfill 100 enheder/ml injektionsvæske, opløsning i cylinderampul Insulin aspart
English: NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen Insulin aspart
Danish: NovoRapid FlexTouch 100 enheder/ml injektionsvæske, opløsning i fyldt pen Insulin aspart
English: Before opening: NovoRapid PumpCart that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Danish: Før ibrugtagning: NovoRapid PumpCart, der ikke er i brug, skal opbevares i et køleskab ved 2°C til 8°C, ikke for tæt på køleelementet.
English: NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen Insulin aspart
Danish: NovoRapid FlexPen 100 enheder/ml injektionsvæske, opløsning i fyldt pen Insulin aspart
English: Do not use this medicine after the expiry date which is stated on the FlexPen label and carton, after ‘EXP'.
Danish: Tag ikke dette lægemiddel efter udløbsdatoen `EXP´, der står på FlexPen etiketten og pakningen med FlexPen.
English: Before opening: NovoRapid Penfill that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Danish: Før ibrugtagning: NovoRapid Penfill, som ikke er i brug, skal opbevares i køleskabet ved 2°C til 8°C, ikke for tæt på køleelementet.
English: Read carefully the instructions on how to use NovoRapid PumpCart included in this package leaflet.
Danish: Læs brugervejledningen til NovoRapid PumpCart i denne indlægsseddel grundigt.
English: NovoRapid FlexPen Pen cap
Danish: NovoRapid FlexPen Penhætte
English: NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION NovoRapid PumpCart 100 units/ml solution for injection Insulin aspart
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJE NovoRapid PumpCart 100 enheder/ml injektionsvæske, opløsning Insulin aspart s.c. anvendelse
English: NovoRapid 100 units/ml solution for injection in vial Insulin aspart
Danish: NovoRapid 100 enheder/ml injektionsvæske, opløsning i hætteglas Insulin aspart
English: Can be stored in a refrigerator (2˚C to 8˚C)
Danish: Kan opbevares i køleskab (2°C til 8°C) Må ikke fryses
English: NovoRapid vial
Danish: NovoRapid hætteglas
English: MARKETING AUTHORISATION NUMBERS EU/1/99/119/001 1 vial of 10 ml EU/1/99/119/008 5 vials of 10 ml
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/99/119/001 1 hætteglas med 10 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION NovoRapid FlexPen 100 units/ml solution for injection Insulin aspart
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ NovoRapid FlexPen 100 enheder/ml injektionsvæske, opløsning Insulin aspart s.c. anvendelse
English: Before opening: NovoRapid FlexPen that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Danish: Før ibrugtagning: NovoRapid FlexPen, som ikke er i brug, skal opbevares i køleskabet ved 2°C til 8°C, ikke for tæt på køleelementet.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION NovoRapid Penfill 100 units/ml solution for injection Insulin aspart
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJE NovoRapid Penfill 100 enheder/ml injektionsvæske, opløsning Insulin aspart s.c. anvendelse
English: A Pull off the pen cap.
Danish: A Træk penhætten af.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION NovoRapid FlexTouch 100 units/ml solution for injection Insulin aspart
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ NovoRapid FlexTouch 100 enheder/ml injektionsvæske, opløsning Insulin aspart s.c. anvendelse
English: NAME OF THE MEDICINAL PRODUCT NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen Insulin aspart
Danish: Indlægsseddel: Information til brugeren NovoRapid InnoLet 100 enheder/ml injektionsvæske, opløsning i fyldt pen Insulin aspart
English: ► NovoRapid FlexPen is only suitable for injecting under the skin.
Danish: ► NovoRapid FlexPen er kun egnet til indsprøjtning under huden.
English: Do not use this medicine after the expiry date which is stated on the InnoLet label and carton, after ‘EXP'.
Danish: Tag ikke dette lægemiddel efter udløbsdatoen 'EXP', der står på etiketten eller pakningen med InnoLet.
English: Before opening: NovoRapid FlexTouch that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Danish: Før ibrugtagning: NovoRapid FlexTouch, som ikke er i brug, skal opbevares i køleskabet ved 2°C til 8°C, ikke for tæt på køleelementet.
English: NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen Insulin aspart
Danish: NovoRapid InnoLet 100 enheder/ml injektionsvæske, opløsning i fyldt pen Insulin aspart
English: Always keep the pen cap on your InnoLet when you are not using it in order to protect it from light.
Danish: Opbevar altid InnoLet med penhætten påsat, når den ikke er i brug, for at beskytte mod lys.
English: Always keep the pen cap on your FlexTouch when you are not using it in order to protect it from light.
Danish: Opbevar altid FlexTouch med penhætten påsat, når den ikke er i brug, for at beskytte mod lys.
English: ► Remove and discard the needle after each injection.
Danish: ► Nålen skal fjernes og kasseres efter hver injektion.
English: Pen label Dose counter
Danish: PEN ETIKET (FYLDT PEN.
English: Treat your pen with care.
Danish: Vedligeholdelse af din NovoRapid FlexTouch pen Behandel din pen med forsigtighed.
English: people.
Danish: Øjne
English: What NovoRapid is and what it is used for What you need to know before you use NovoRapid How to use NovoRapid
Danish: Det skal du vide, før du begynder at tage NovoRapid Sådan skal du tage NovoRapid Bivirkninger
English: Before opening: NovoRapid InnoLet that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Danish: Før ibrugtagning: NovoRapid InnoLet, som ikke er i brug, skal opbevares i køleskabet ved 2°C til 8°C, ikke for tæt på køleelementet.
English: Keeping the needle upwards, press the push-button all the way in.
Danish: Hold nålen opad, og tryk dosisknappen helt i bund, hvorved dosisvælgeren nulstilles.
English: NAME OF THE MEDICINAL PRODUCT NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen Insulin aspart
Danish: Indlægsseddel: Information til brugeren NovoRapid FlexTouch 100 enheder/ml injektionsvæske, opløsning i fyldt pen Insulin aspart
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (CARTRIDGE.
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (CYLINDERAMPUL, PumpCart)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION NovoRapid 100 units/ml solution for injection Insulin aspart
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ NovoRapid InnoLet 100 enheder/ml injektionsvæske, opløsning Insulin aspart s.c. anvendelse
English: Dispose of your used FlexPen carefully without the needle attached.
Danish: Kassér omhyggeligt den brugte FlexPen uden nålen påsat.
English: NAME OF THE MEDICINAL PRODUCT NovoRapid 100 units/ml solution for injection Insulin aspart
Danish: NovoRapid 100 enheder/ml injektionsvæske, opløsning Insulin aspart
English: Invented name Strength Pharmaceutical form Route of administration Packaging Content
Danish: Særnavn Styrke Lægemiddelform
English: The company that applied for authorisation is Centauri Biotech SL.
Danish: Den virksomhed, der har indgivet ansøgningen, er Centauri Biotech SL.
English: The CVMP was also concerned about the high number of side effects reported in the field study.
Danish: CVMP var også bekymret over det store antal bivirkninger, der sås i feltstudiet.
English: Following a request from the European Commission, the CVMP revised part of its opinion concerning compliance with Good Manufacturing Practice (GMP).
Danish: På anmodning fra Europa-Kommissionen reviderede CVMP en del af sin udtalelse vedrørende overholdelse af god fremstillingspraksis (GMP).
English: It was to be available as a suspension for injection into a joint.
Danish: Det skulle markedsføres som en suspension til injektion i et led.
English: Osteoarthritis is a condition that causes swelling and pain in the joints and which is often associated with lameness.
Danish: Osteoartritis er en tilstand, der forårsager hævelse og smerter i leddene, og som ofte er forbundet med halthed.
English: The main measure of effectiveness was a reduction in 1 or more grades of lameness using a scoring system that runs from 1 to 5.
Danish: Det primære mål for virkning var en reduktion i halthed på mindst 1 i henhold til en scoringsskala fra 1 til 5.
English: The way that mesenchymal stem cells work has not been clearly established but published studies indicate that they have an anti-inflammatory action and may have an effect in regenerating tissue.
Danish: Det er ikke helt klarlagt, hvordan mesenkymale stamceller virker, men offentliggjorte studier tyder på, at de har en antiinflammatorisk virkning og kan have en effekt på regenereringen af væv.
English: What is Horse Allo 20?
Danish: Hvad er Horse Allo 20?
English: The Committee removed its previous objection that the company did not comply with GMP but all other concerns remained.
Danish: Udvalget fjernede sin oprindelige indvending om, at virksomheden ikke overholder god fremstillingspraksis, men alle de resterende betænkeligheder gælder fortsat.
English: The CVMP noted that there were problems with the way the main study was designed and carried out, and concluded that the effectiveness of the medicine had not been sufficiently demonstrated.
Danish: CVMP bemærkede, at der var problemer med hovedstudiets design og udførelse, og vurderede, at lægemidlets virkning ikke er tilstrækkeligt dokumenteret.
English: Finally, the Committee had concerns about the way the medicine was manufactured and its quality ensured.
Danish: Endelig var udvalget også bekymret over fremstillingsmetoden for lægemidlet, herunder metoden til sikring af lægemidlets kvalitet.
English: The CVMP was therefore of the opinion that the benefits of Horse Allo 20 did not outweigh its risks and recommended that it be refused marketing authorisation.
Danish: CVMP var derfor af den opfattelse, at fordelene ved Horse Allo 20 ikke opvejede risiciene, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
English: On 24 January 2019, the CVMP revised part of its opinion but confirmed its recommendation to refuse the marketing authorisation.
Danish: Den 24. januar 2019 reviderede CVMP en del af sin udtalelse, men bekræftede sin anbefaling om at give afslag på ansøgningen om markedsføringstilladelse.
English: What was Horse Allo 20 expected to be used for?
Danish: Hvad forventedes Horse Allo 20 anvendt til?
English: On 21 June 2018, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Horse Allo 20, intended for the treatment of lameness in adult horses with osteoarthritis.
Danish: Den 21. juni 2018 vedtog Udvalget for Lægemidler til Dyr (CVMP) en negativ udtalelse og anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Horse Allo 20, der er beregnet til behandling af halthed hos voksne heste med osteoartritis.
English: The applicant presented data from a field study involving horses from 2 years of age with osteoarthritis, where 37 horses were treated with Horse Allo 20 while 33 horses received a dummy treatment.
Danish: Ansøgeren fremlagte data fra et feltstudie af heste med osteoartritis i alderen fra 2 år og opefter, hvor 37 heste blev behandlet med Horse Allo 20, mens 33 heste fik placebo (ikke-aktivt stof).
English: Horse Allo 20 was developed as a novel therapy medicine containing cells that have been manipulated so that they can be used to repair, regenerate or replace tissue.
Danish: Horse Allo 20 blev udviklet som et nyt lægemiddel indeholdende celler, der er manipuleret, så de kan anvendes til at reparere, regenerere eller erstatte væv (såkaldt celleterapi).
English: This was expected to help control the inflammation and joint damage associated with osteoarthritis in horses, and so reduce lameness.
Danish: Dette skulle hjælpe med at kontrollere inflammation og ledskader hos heste med osteoartritis og dermed reducere halthed.
English: Horse Allo 20 is a veterinary medicine that contains allogeneic equine mesenchymal stem cells as active substance.
Danish: Horse Allo 20 er et veterinærlægemiddel, der indeholder allogene mesenkymale stamceller fra heste som aktivt stof.
English: Horse Allo 20 was expected to be used to treat lameness in adult horses with osteoarthritis.
Danish: Horse Allo 20 skulle anvendes til behandling af halthed hos voksne heste med osteoartritis.
English: How does Horse Allo 20 work?
Danish: Hvordan virker Horse Allo 20?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Betmiga on 20 December 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Betmiga den 20. december 2012.
English: The potential risk of hypersensitivity (allergic reactions) and effects on the heart has been adequately addressed in the product information.
Danish: Den mulige risiko for allergiske reaktioner (overfølsomhedsreaktioner) og virkningerne på hjertet er fyldestgørende omhandlet i produktinformationen.
English: The full EPAR for Betmiga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Betmiga findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Betmiga.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Betmiga.
English: A risk management plan has been developed to ensure that Betmiga is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Betmiga anvendes så sikkert som muligt.
English: Other information about Betmiga
Danish: Andre oplysninger om Betmiga
English: ‘Prolonged-release' means that mirabegron is released slowly from the tablet over a few hours.
Danish: Depottabletter indebærer, at mirabegron frigives langsomt fra tabletten i løbet af få timer.
English: The recommended dose of Betmiga is 50 mg once a day.
Danish: Den anbefalede dosis af Betmiga er 50 mg én gang dagligt.
English: Regarding its safety, most side effects are comparable to those of other medicines used for treating overactive bladder syndrome.
Danish: Vedrørende sikkerheden er de fleste bivirkninger sammenlignelige med bivirkningerne af andre lægemidler, der anvendes til behandling af overaktiv blære.
English: Betmiga has been studied in three main studies involving 4,611 patients with overactive bladder syndrome.
Danish: Betmiga er blevet undersøgt i tre hovedundersøgelser med 4 611 patienter med overaktiv blære.
English: What measures are being taken to ensure the safe and effective use of Betmiga?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Betmiga?
English: Patients received Betmiga (25 mg, 50 mg or 100 mg) or placebo (a dummy treatment) every day for 3 months.
Danish: Patienterne fik Betmiga (25 mg, 50 mg eller 100 mg) eller placebo (virkningsløs behandling) hver dag i tre måneder.
English: It is available as prolonged-release tablets (25 mg, 50 mg).
Danish: Det leveres som depottabletter (25 mg og 50 mg).
English: For more information about treatment with Betmiga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Betmiga, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Betmiga, mirabegron, is a beta-3-adrenergic-receptor agonist.
Danish: Det aktive stof i Betmiga, mirabegron, er en beta-3-adrenerg receptoragonist.
English: Serious but uncommon side effects include atrial fibrillation (cardiac rhythm disorder).
Danish: En alvorlig, men ikke almindelig bivirkning er atrieflimren (en forstyrrelse i hjerterytmen).
English: In patients who have reduced kidney or liver function the doctor may need to prescribe a lower dose or avoid the use of Betmiga, especially in patients taking certain other medicines.
Danish: Hos patienter med nedsat nyre- eller leverfunktion vil lægen muligvis finde det nødvendigt at udskrive en mindre dosis eller helt undlade at anvende Betmiga, navnlig hos patienter, der får visse andre lægemidler.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Betmiga.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Betmiga skal anvendes.
English: Betmiga is a medicine containing the active substance mirabegron.
Danish: Betmiga er et lægemiddel, der indeholder det aktive stof mirabegron.
English: The main measure of effectiveness was the change in the number of urinations and incontinence episodes per day after 3 months of treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på ændringen i antallet af vandladninger og episoder med ufrivillig vandladning pr. dag efter tre måneders behandling.
English: Betmiga must not be used in people who have hypertension (high blood pressure) that is severe and uncontrolled.
Danish: Betmiga må ikke anvendes til patienter med svær og ukontrolleret hypertension (forhøjet blodtryk).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Betmiga, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Betmiga, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: The CHMP noted that the beneficial effects seen with Betmiga were modest but comparable to the benefits of other medicines authorised for this condition.
Danish: CHMP bemærkede, at de gavnlige virkninger ved Betmiga er beskedne, men sammenlignelige med virkningen af andre lægemidler godkendt til samme anvendelse.
English: It works by attaching to and activating beta-3 receptors that are found in the muscle cells of the bladder.
Danish: Det virker ved at bindes til og aktivere beta-3-receptorer, som findes i blærens muskelceller.
English: Experimental studies have shown that, when activated, beta-3 receptors cause the bladder muscles to relax.
Danish: Forsøg har vist, at beta-3receptorerne, når de aktiveres, får blæremusklerne til at afslappes.
English: What is the risk associated with Betmiga?
Danish: Hvilken risiko er der forbundet med Betmiga?
English: For full details, see the package leaflet (also part of the EPAR).
Danish: De nærmere oplysninger fremgår af indlægssedlen (også en del af denne EPAR).
English: This is thought to lead to an increase in the capacity of the bladder and changes in the way the bladder contracts, resulting in fewer bladder contractions and thus fewer unwanted urinations.
Danish: Dette menes at resultere i en større blærekapacitet og ændre den måde, blæren trækker sig sammen på, således at der bliver færre blæresammentrækninger og dermed færre ufrivillige vandladninger.
English: Why has Betmiga been approved?
Danish: Hvorfor blev Betmiga godkendt?
English: The CHMP therefore decided that Betmiga's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede derfor, at fordelene ved Betmiga opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Betmiga.
English: The most common side effects with Betmiga are tachycardia (rapid heartbeat) seen in just over 1 person in 100, and urinary tract infection (infection of the structures that carry urine) seen in just under 3 people in 100.
Danish: De hyppigste bivirkninger ved Betmiga er takykardi (hurtig hjerterytme), som optræder hos lidt over 1 ud af 100 patienter, og urinvejsinfektion, som optræder hos lidt under tre ud af 100 patienter.
English: It is used to treat certain symptoms of the condition: urgency (sudden urge to urinate), increased urinary frequency (the need to urinate frequently) and urge incontinence (involuntary leakage of urine from the bladder when a sudden strong need to urinate is felt).
Danish: Det anvendes til behandling af visse symptomer på sygdommen, herunder pludselig vandladningstrang (imperiøs vandladning), øget vandladningshyppighed samt tvingende vandladningstrang, der medfører ufrivillig urinafgang (urgeinkontinens).
English: After 3 months of treatment, on average Betmiga 50 mg reduced the number of urinations by 1.8 per day compared with a reduction of 1.2 per day for placebo.
Danish: Efter tre måneders behandling reducerede Betmiga 50 mg det gennemsnitlige antal vandladninger med 1,8 pr. dag, sammenholdt med en reduktion på 1,2 pr. dag for placebo.