FrancophonIA/ELRC3.0 huggingface dataset:
English: If no or limited response is obtained within one month after initial dosing, a second dose one month later may increase effectiveness.
Danish: Hvis ingen eller kun begrænset respons observeres inden for en måned efter første dosis, kan endnu en dosis en måned senere muligvis øge effekten.
English: EXPIRY DATE EXP {month/year}
Danish: 10. UDLØBSDATO EXP {måned/år}
English: Do not mix with any other veterinary medicinal product.
Danish: Må ikke blandes med andre veterinærlægemidler.
English: Treatment should be administered as needed.
Danish: Behandling bør indgives efter behov.
English: Do not use in dogs less than 3 kg bodyweight.
Danish: Må ikke anvendes til hunde med en kropsvægt på mindre end 3 kg.
English: It is not expected for this to cause any adverse effects, however, repeated self-administration may increase the risk of hypersensitivity reactions.
Danish: Det forventes ikke, at dette vil medføre bivirkninger; gentagen selvinjicering kan dog øge risikoen for overfølsomhedsreaktioner.
English: This is likely due to the highly targeted mechanism of action of lokivetmab in the context of a complex disease and heterogeneous pathogenesis.
Danish: Dette skyldes højst sandsynligt den meget målrettede virkning af lokivetmab i forbindelse med komplekse lidelser og heterogen patogenese.
English: Do not use this veterinary medicinal product after the expiry date which stated on the label after EXP Shelf life after first opening the container: use immediately.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP. Opbevaringstid efter første åbning af beholderen: anvendes straks.
English: A small number of dogs showed a low or an absence of clinical response to lokivetmab.
Danish: Et mindre antal hunde udviste ringe eller mangel på klinisk reaktion på lokivetmab.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/205/001-012
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/17/205/001-012
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: BILAG II A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG C. ANGIVELSE AF MRL-VÆRDIER D. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: For dogs above 40 kg, the contents of more than one vial are required to administer a single dose.
Danish: Til hunde på mere end 40 kg kræves mere end indholdet af et enkelt hætteglas for at kunne indgive en enkelt dosis.
English: It is recommended to monitor dogs for bacterial infections, especially during the first weeks of treatment.
Danish: Det anbefales at holde øje med hunden med henblik på bakterieinfektioner, især i løbet de første uger af behandlingen.
English: Pharmacotherapeutic group: Other dermatological preparations.
Danish: Farmakoterapeutisk gruppe: Andre dermatologiske formuleringer.
English: The induction of such antibodies is uncommon and may have no effect (transient anti-drug antibodies) or may result in a noticeable decrease in efficacy (persistent anti-drug antibodies) in animals that responded to treatment previously.
Danish: Induktion af denne type antistoffer er dog usædvanlig og vil muligvis ikke have nogen indvirkning (transitoriske antistoffer mod lægemidlet) eller kan medføre en markant nedsat effekt (persisterende antistoffer mod lægemidlet) hos dyr, der tidligere har reageret på behandlingen.
English: When administering vaccines at the same time as this veterinary medicinal product, it is advised that each injection be given at different sites.
Danish: Hvis der vaccineres på samme tid, som injicering med dette lægemiddel til dyr, tilrådes til at give de enkelte injektioner forskellige steder.
English: The blocking of IL-31 by lokivetmab prevents IL-31 from binding to its co-receptor and thereby inhibits IL-31 mediated cell signalling, providing relief from Atopic Dermatitis-related pruritus and anti-inflammatory activity.
Danish: Når lokivetmab blokerer IL-31, hindres IL-31 i at binde sig til sin co-receptor og hæmmer således IL-31 medieret cellesignalering, hvilket giver lindring ved pruritus forårsaget af atopisk dermatitis og antiinflammatorisk aktivitet.
English: In those cases, withdraw the appropriate content from each required vial into the same syringe.
Danish: I så tilfælde udtrækkes et passende indhold fra de nødvendige hætteglas med samme sprøjte.
English: Agents for dermatitis, excluding corticosteroids.
Danish: Midler mod dermatitis, eksklusive kortikosteroider.
English: In field studies up to 9 months, treatment of dogs with atopic dermatitis was demonstrated to have a favourable effect on the reduction of pruritus and on the reduction of disease severity as evaluated by Canine Atopic Dermatitis Extent and Severity Index (CADESI) 03 scores.
Danish: I feltstudier på op til 9 måneders varighed af behandling af hunde med atopisk dermatitis viste det sig, at behandling af hunde havde en positiv indvirkning og reducerede pruritus og sygdommens sværhedsgrad efter Canine Atopic Dermatitis Extent and Severity Index (CADESI) med en score på 03.
English: MANUFACTURER'S BATCH NUMBER
Danish: FREMSTILLERENS BATCHNUMMER Lot {nummer}
English: If the animal does not show a better response after a second dose, the veterinary surgeon should consider alternative treatments.
Danish: Hvis dyret ikke udviser bedre reaktion efter en anden dosis, bør dyrlægen overveje alternative behandlinger.
English: CYTOPOINT strength (mg) to be administered
Danish: CYTOPOINT mængde (mg) til indgivelse
English: Neurological signs (seizure, convulsion or ataxia) have been rarely observed in spontaneous reports following use of the veterinary medicinal product.
Danish: Neurologiske tegn (anfald, kramper eller ataxi) er sjældent observeret i spontane rapporter efter brug af veterinærlægemidlet.
English: Accidental self-injection may result in an immune response to lokivetmab.
Danish: Utilsigtet selvinjicering kan medføre immunrespons over for lokivetmab.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No adverse reactions other than those mentioned in section 4.6 were observed in laboratory overdose studies.
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt Der blev ikke observeret andre bivirkninger end de, der er nævnt under pkt.
English: 4.11 Withdrawal period(s) Not applicable.
Danish: 4.11 Tilbageholdelsestid Ikke relevant.
English: Bodyweight (kg) of dog
Danish: Hundens kropsvægt (kg) 10
English: Secondary packaging: cardboard box.
Danish: Ydre pakning: kartonæske.
English: Dosage and treatment schedule:
Danish: Doserings- og behandlingsoversigt:
English: Shelf life after first opening the immediate packaging: use immediately
Danish: Opbevaringstid efter første åbning af den indre emballage: anvendes straks.
English: It is recommended to monitor dogs for bacterial infections associated with atopic dermatitis, especially during the first weeks of treatment.
Danish: Det anbefales at monitorere hunden med henblik på bakterieinfektioner relateret til atopisk dermatitis, især i løbet de første uger af behandlingen.
English: EU/2/17/205/009 10 mg/ml 1 vial EU/2/17/205/001 10 mg/ml 2 vials EU/2/17/205/002 10 mg/ml 6 vials EU/2/17/205/010 20 mg/ml 1 vial EU/2/17/205/003 20 mg/ml 2 vials EU/2/17/205/004 20 mg/ml 6 vials EU/2/17/205/011 30 mg/ml 1 vial EU/2/17/205/005 30 mg/ml 2 vials EU/2/17/205/006 30 mg/ml 6 vials
Danish: EU/2/17/205/009 10 mg/ml 1 hætteglas EU/2/17/205/001 10 mg/ml 2 hætteglas EU/2/17/205/002 10 mg/ml 6 hætteglas EU/2/17/205/010 20 mg/ml 1 hætteglas EU/2/17/205/003 20 mg/ml 2 hætteglas EU/2/17/205/004 20 mg/ml 6 hætteglas EU/2/17/205/011 30 mg/ml 1 hætteglas EU/2/17/205/005 30 mg/ml 2 hætteglas EU/2/17/205/006 30 mg/ml 6 hætteglas
English: 1348 Louvain-la-Neuve BELGIUM
Danish: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIEN
English: In case of adverse clinical signs after an overdose the dog should be treated symptomatically.
Danish: I tilfælde af tegn på bivirkninger efter en overdosis, bør hunden behandles symptomatisk.
English: If a vaccine(s) is to be administered at the same time as treatment with lokivetmab, the vaccine(s) should be administered at a different site to that of lokivetmab administration.
Danish: Hvis der skal gives vaccine(r) sideløbende med behandling med lokivetmab, skal vaccinen(-erne) indgives et andet sted end lokivetmab.
English: Primary packaging: Single dose clear glass Type I vials with chlorobutyl rubber stopper.
Danish: Indre emballage: Klare, enkeltdosishætteglas af type I med gummiprop af chlorbutyl.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu).
English: Administer the entire contents (1 ml) of the vial.
Danish: Indgiv alt indholdet (1 ml) i hætteglasset.
English: Avoid excessive shaking or foaming of the solution.
Danish: Undgå at ryste opløsningen voldsomt eller få den til at skumme.
English: EU/2/17/205/012 40 mg/ml 1 vial EU/2/17/205/007 40 mg/ml 2 vials EU/2/17/205/008 40 mg/ml 6 vials
Danish: EU/2/17/205/012 40 mg/ml 1 hætteglas EU/2/17/205/007 40 mg/ml 2 hætteglas EU/2/17/205/008 40 mg/ml 6 hætteglas
English: Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
English: Hypersensitivity reactions (anaphylaxis, facial oedema, urticaria) have been reported to occur in rare cases from spontaneous reports.
Danish: Overfølsomhedsreaktioner (anafylaksi, ansigtsødem, urticaria) er rapporteret at forekomme i sjældne tilfælde fra spontane rapporter.
English: No drug interactions were observed in field studies where lokivetmab was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials antiinflammatories and vaccines.
Danish: Der blev ikke observeret interaktioner med lægemidlet i feltstudier, hvor lokivetmab blev administreret samtidigt med veterinærlægemidler som f.eks. endo- og ektoparasiticider, antimikrobielle og antiinflammatoriske stoffer samt vacciner.
English: Vomiting and/or diarrhoea have been reported to occur in rare cases from spontaneous reports and may occur in connection with hypersensitivity reactions.
Danish: Opkastning og/eller diarré er rapporteret at forekomma i sjældne tilfælde fra spontane rapporter og kan forekomme i forbindelse med overfølsomhedsreaktioner.
English: ADVICE ON CORRECT ADMINISTRATION Avoid excessive shaking or foaming.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Må ikke rystes voldsomt eller skumme.
English: INDICATION(S) Treatment of clinical manifestations of atopic dermatitis in dogs.
Danish: INDIKATIONER Behandling af kliniske manifestering af atopisk eksem (dermatitis) hos hunde.
English: In cases of atopic dermatitis, it is recommended to investigate and treat complicating factors, such as bacterial, fungal or parasitic infections/infestations (e.g. flea and mange).
Danish: Det anbefales i tilfælde af atopisk dermatitis at undersøge og behandle faktorer, der kan give komplikationer, som f.eks. infektioner/infestationer med bakterier, svampe eller parasitter (f.eks. lopper og skab).
English: Hypersensitivity reactions, including anaphylaxis, could potentially occur in the case of accidental self-injection.
Danish: Der kan forekomme overfølsomhedsreaktioner, også anafylaktiske, i tilfælde af utilsigtet selvinjicering.
English: In a laboratory model study lokivetmab demonstrated an onset of efficacy for pruritus by the first time point at 8 hours post administration.
Danish: Et laboratoriemodelforsøg viste, at effekten af lokivetmab over for pruritus startede første gang 8 timer efter indgivelse.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Subcutaneous use.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: *Lokivetmab is a caninised monoclonal antibody expressed through recombinant techniques in Chinese hamster ovary (CHO) cells
Danish: *Lokivetmab er et monoklonalt antistof, der er udviklet til hunde og som er fremstillet ved rekombinant teknologi i ovariecellerne fra kinesisk hamster (CHO).
English: Each vial of 1 ml contains:
Danish: Et hætteglas på 1 ml indeholder:
English: 4.2 Indications for use, specifying the target species Treatment of clinical manifestations of atopic dermatitis in dogs.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Behandling af kliniske manifestering af atopisk dermatitis hos hunde.
English: Dose according to the dosing chart below:
Danish: Dosis i henhold til nedenstående doseringsoversigt:
English: No adverse reactions other than those mentioned in section 6 were observed in laboratory overdose studies.
Danish: Der blev ikke observeret andre bivirkninger end de, der er nævnt under pkt.
English: Dose according to the dosing chart below.
Danish: Dosis i henhold til nedenstående doseringsoversigt.
English: To allow for mixing of the solution, gently invert the syringe three or four times before administering.
Danish: Vend sprøjten rundt 3-4 gange før indgivelse, så opløsningen bliver blandet.
English: Marketing authorisation holder and Manufacturer responsible for batch release:
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse:
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: Medicines should not be disposed of via wastewater or household waste.
Danish: UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE, OM NØDVENDIGT Lægemidler må ikke bortskaffes sammen med spildevand eller husholdningsaffald.
English: PACKAGE SIZE 1 x 1 ml
Danish: PAKNINGSSTØRRELSE 1 x 1 ml
English: Lokivetmab is a caninised monoclonal antibody (mAb) specifically targeting canine interleukin-31.
Danish: Lokivetmab er et monoklonalt antistof, der er udviklet til hunde og som særligt angriber interleukin-31 hos hunde.
English: Lokivetmab may induce transient or persistent anti-drug antibodies.
Danish: Lokivetmab kan indføre forbigående (transitoriske) eller vedholdende (persistente) antistoffer mod lægemidlet (ADA).
English: Avoid excessive shaking.
Danish: Må ikke rystes voldsomt.
English: 1 vial 2 vials
Danish: 1 hætteglas 2 hætteglas
English: CYTOPOINT 10 mg solution for injection for dogs CYTOPOINT 20 mg solution for injection for dogs CYTOPOINT 30 mg solution for injection for dogs CYTOPOINT 40 mg solution for injection for dogs
Danish: CYTOPOINT 10 mg injektionsvæske, opløsning til hunde CYTOPOINT 20 mg injektionsvæske, opløsning til hunde CYTOPOINT 30 mg injektionsvæske, opløsning til hunde CYTOPOINT 40 mg injektionsvæske, opløsning til hunde
English: CYTOPOINT 10 mg solution for injection for dogs CYTOPOINT 20 mg solution for injection for dogs CYTOPOINT 30 mg solution for injection for dogs CYTOPOINT 40 mg solution for injection for dogs lokivetmab
Danish: CYTOPOINT 10 mg injektionsvæske, opløsning til hunde CYTOPOINT 20 mg injektionsvæske, opløsning til hunde CYTOPOINT 30 mg injektionsvæske, opløsning til hunde CYTOPOINT 40 mg injektionsvæske, opløsning til hunde lokivetmab
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG
English: CARDBOARD BOX
Danish: Kartonæske
English: 2 vials 1 vial
Danish: 2 hætteglas 1 hætteglas
English: Each vial of 1 ml contains 20 mg lokivetmab.
Danish: Et hætteglas på 1 ml indeholder 20 mg lokivetmab.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation; therefore its use is not recommended during pregnancy, lactation or in breeding dogs.
Danish: Anvendelse frarådes derfor under drægtighed, laktation eller til hunde, der bruges til avl.
English: Each vial of 1 ml contains 40 mg lokivetmab.
Danish: Et hætteglas på 1 ml indeholder 40 mg lokivetmab.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation; therefore its use is not recommended during pregnancy, lactation or in breeding animals.
Danish: Anvendelse frarådes derfor under drægtighed, laktation eller til dyr, der bruges til avl.
English: Each vial of 1 ml contains 30 mg lokivetmab.
Danish: Et hætteglas på 1 ml indeholder 30 mg lokivetmab.
English: Each vial of 1 ml contains 10 mg lokivetmab.
Danish: Et hætteglas på 1 ml indeholder 10 mg lokivetmab.
English: CYTOPOINT 20 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
Danish: CYTOPOINT 20 mg injektionsvæske, opløsning til hunde: Kartonæske indeholdende 1 hætteglas på 1 ml
English: CYTOPOINT 30 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
Danish: CYTOPOINT 30 mg injektionsvæske, opløsning til hunde: Kartonæske indeholdende 1 hætteglas på 1 ml
English: CYTOPOINT 40 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
Danish: CYTOPOINT 40 mg injektionsvæske, opløsning til hunde: Kartonæske indeholdende 1 hætteglas på 1 ml
English: CYTOPOINT 10 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
Danish: CYTOPOINT 10 mg injektionsvæske, opløsning til hunde: Kartonæske indeholdende 1 hætteglas på 1 ml
English: PACKAGE LEAFLET:
Danish: INDLÆGSSEDDEL:
English: Linearity/Non-linearity
Danish: Linearitet/non-linearitet
English: None of these changes were considered to be clinically meaningful.
Danish: Ingen af disse ændringer blev anset for at være klinisk relevante.
English: The specific indication approved.
Danish: Den specifikke godkendte indikation.
English: Body weight <60 kg
Danish: Kropsvægt < 60 kg
English: Daxas will not help you in this situation.
Danish: Daxas vil ikke hjælpe dig i den situation.
English: Date of first authorisation: 05 July 2010 Date of latest renewal: 24 April 2015
Danish: Dato for første markedsføringstilladelse: 5. juli 2010 Dato for seneste fornyelse: 24. april 2015
English: Symptoms you should be aware of
Danish: Symptomer, du skal være opmærksom på
English: • cancer
Danish: • Kræft
English: • severe infection
Danish: • Alvorlig infektion
English: The majority of these adverse reactions were mild or moderate.
Danish: Hovedparten af disse bivirkninger var lette eller moderate.
English: Persistent intolerability
Danish: Vedvarende intolerabilitet
English: • Educational material for the physician.
Danish: • Undervisningsmateriale til lægen.
English: Negative binomial regression
Danish: Negativ binomial regressio
English: In uncommon cases allergic reactions may occur.
Danish: I ikke almindelige tilfælde kan der opstå en allergisk reaktion.
English: Children and adolescents Daxas should not be used by children and adolescents under 18 years of age.
Danish: Børn og unge Daxas bør ikke bruges til børn og unge under 18 år.
English: Continue taking your medicine at the usual times.
Danish: Fortsæt derefter med at tage din medicin på de sædvanlige tidspunkter.
English: • multiple sclerosis or SLE
Danish: • Multipel sklerose eller SLE
English: When the activity of this protein is reduced, there is less inflammation in the lungs.
Danish: Når aktiviteten af dette protein er mindsket, er der mindre inflammation i lungerne.
English: - if you have moderate or severe liver problems.
Danish: - hvis du har moderate eller alvorlige leverproblemer.
English: The tablet can be taken with or without food.
Danish: Tabletten kan tages med eller uden føde.
English: The tablet should be swallowed with water and taken at the same time every day.
Danish: Tabletten bør sluges med vand og indtages på samme tidspunkt hver dag.
English: Moderate or severe
Danish: Moderat eller svær
English: Other diseases
Danish: Andre sygdomme
English: Summary of the safety profile
Danish: Resumé over sikkerhedsprofilen
English: Post-implantation losses were not seen in rabbits.
Danish: Post-implantative tab blev ikke observeret hos kaniner.
English: Therefore, there is a low probability of relevant interactions with substances metabolised by these P450 enzymes.
Danish: Der er derfor en lav sandsynlighed for relevante interaktioner med substanser, der metaboliseres af disse P450-enzymer.
English: You may need to take Daxas for several weeks to achieve its beneficial effect.
Danish: Det kan være nødvendigt at tage Daxas i flere uger, for at opnå den ønskede virkning.
English: There is a lack of relevant experience with Daxas under these conditions.
Danish: Der mangler relevante erfaringer med Daxasbehandling under disse omstændigheder.
English: Take the tablet at the same time every day.
Danish: Tag tabletten på samme tidspunkt hver dag.
English: Long-acting beta-agonists (LABAs) were allowed in the studies and were used in approximately 50% of the study population.
Danish: Langtidsvirkende beta-agonister (LABA) var tilladt i studierne og blev anvendt af omkring 50% af studiepopulationen.
English: It is important to continue taking Daxas for as long as prescribed by your doctor, even when you have no symptoms, in order to maintain control of your lung function.
Danish: Det er vigtigt at fortsætte med at tage Daxas så længe, som din læge har foreskrevet, selv når du ingen symptomer har, for at fastholde kontrollen over din lungefunktion.
English: Do not stop taking these medicines or reduce their dose unless advised by your doctor.
Danish: Du må ikke stoppe med at tage disse lægemidler eller tage en mindre dosis, medmindre det er anvist af din læge.
English: Other side effects include the following:
Danish: Andre bivirkninger inkluderer følgende:
English: Each pack contains 28 tablets.
Danish: Hver pakning indeholder 28 tabletter.
English: Daxas 500 micrograms has been studied in clinical trials for up to one year, and is intended for maintenance treatment.
Danish: Daxas 500 mikrogram er undersøgt i kliniske studier i op til et år, og er beregnet til vedligeholdelsesbehandling.
English: If you forget to take a tablet at the usual time, take the tablet as soon as you remember on the same day.
Danish: Hvis du glemmer at tage en tablet til sædvanlig tid, tag da tabletten, så snart du husker det den samme dag.
English: In order to relieve a sudden attack of breathlessness it is very important that your doctor provides you with another medicine to be available to you at all times that can cope with such an attack.
Danish: For at afhjælpe et pludseligt anfald af åndenød, er det meget vigtigt, at lægen forsyner dig med anden medicin, som du altid har til rådighed, og som kan klare et sådant anfald.
English: The major reasons for trial discontinuation were withdrawal of consent and reported adverse events.
Danish: De vigtigste årsager til at udgå af studiet var tilbagetrækning af samtykke og rapporterede bivirkninger.
English: At this low dose you will not get the full effect from the medicinetherefore it is important that you move on to the full dose (called a ‘maintenance dose') after 28 days.
Danish: Med denne lave dosis vil du ikke få den fulde virkning af medicinen, så derfor er det vigtigt, at du går over til den fulde dosis (vedligeholdelsesdosis) efter 28 dage.
English: If on one day you have forgotten to take a tablet of Daxas, just carry on the next day with the next tablet as usual.
Danish: Hvis du en dag har glemt at tage en tablet Daxas, fortsætter du bare den næste dag med den næste tablet som sædvanligt.