FrancophonIA/ELRC3.0 huggingface dataset:
English: the CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxastad 4 mg prolonged release tablets and associated names (see Annex I).
Danish: anbefaler CPMP, at der udstedes markedsføringstilladelse(r) for Doxastad 4 mg depottabletter og de tilknyttede navne (se bilag I).
English: - Benign prostatic hyperplasia and concomitant urinary outflow obstruction, chronic urinary tract infections or bladder stones - Overflow bladder, anuria or progressive renal insufficiency
Danish: Benign prostatahyperplasi og samtidig obstruction af urinafløb, kroniske urinvejsinfektioner eller blæresten.
English: Respiratory, thoracic and mediastinal disorders: Dyspnoea, cough, bronchial spasms, epistaxis.
Danish: Sygdomme i åndedrætsorganer, brysthule og mediastinum: Dyspnøe, hoste, bronchiespasmer, epistaxis.
English: Doxastad 4 mg prolonged release tablets and associated names [See Annex I] Doxazosin
Danish: Doxastad 4 mg depottabletter og dermed forbundne navne [se Bilag I] Doxazosin
English: The active ingredient in your tablets, doxazosin, belongs to a group of medicines known as alpha-1 antagonists.
Danish: Hvis blodtrykket ikke bliver kontrolleret, kan det øge risikoen for hjertesygdomme eller hjerneblødning Det aktive stof i Deres tabletter, doxazosin, hører til den gruppe lægemidler, der kaldes alfa-1 antagonister.
English: • if you suffer from liver disease
Danish: • hvis De har en leverlidelse
English: General disorders and administration site conditions: Chest pain, agitation, facial flushing.
Danish: Almene lidelser og reaktioner på indgivelsesstedet: Brystsmerter, agitation, ansigtsrødmen.
English: Tablet coat:
Danish: Tabletkerne:
English: If you forget to take use Doxastad 4 mg prolonged release tablets and associated names If you miss a dose, do not worry.
Danish: Hvis De glemmer at tage Doxastad 4 mg depottabletter og dermed forbundne navne Hvis De glemmer at tage en dosis, er der ingen grund til bekymring, Tag bare den næste dags tablet, når det er tid til den.
English: Doxastad 4 mg prolonged release tablets and associated names can cause drowsiness.
Danish: Doxastad 4 mg depottabletter og dermed forbundne navne kan medføre døsighed.
English: Interruption of breast-feed should be considered in cases of required continuation of doxazosin.
Danish: I de tilfælde, hvor det er påkrævet at fortsætte med doxazosin, bør det overvejes at afbryde amningen.
English: Vascular disorders Common Dizziness, postural dizziness.
Danish: Svimmelhed, postural svimmelhed.
English: What Doxastad 4 mg prolonged release tablets and associated names is and what it is used for 2.
Danish: Hvad Doxastad 4 mg depottabletter og dermed forbundne navne er, og hvad de anvendes til.
English: Gastrointestinal disorders: Anorexia, obstipation, increased appetite.
Danish: Gastrointestinale sygdomme: Anorexi, obstipation, øget appetit Sygdomme i lever og galdeveje: Ikterus, forhøjede lever transaminaser.
English: Liver impairment:
Danish: Nedsat nyrefunktion:
English: DOXAZOSINA NEO STADA 4 mg comprimidos de
Danish: DOXAZOSINA NEO STADA 4 mg comprimidos de liberación prolongada EEG
English: General disorders Common
Danish: Gastrointestinale sygdomme Almindelig
English: Your doctor may have prescribed Doxastad 4 mg prolonged release tablets and associated names because your blood pressure is high, which if left uncontrolled can increase the risk of heart disease or stroke.
Danish: En grund til at Deres læge har ordineret Doxastad 4 mg depottabletter og dermed forbundne navne til Dem kan være, at De har for højt blodtryk.
English: What Doxastad 4 mg prolonged release tablets and associated names looks like and contents of the pack
Danish: Hvordan Doxastad 4 mg depottabletter og dermed forbundne navne ser ud og pakningsstørrelsen
English: You must keep taking your Doxastad 4 mg prolonged release tablets and associated names as instructed by your doctor.
Danish: Doxastad 4 mg depottabletter og dermed forbundne navne bør altid tages i nøje overensstemmelse med Deres læges instruktioner.
English: 1 WHAT DOXASTAD 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES IS AND WHAT IT IS USED FOR
Danish: HVAD DOXASTAD 4 MG DEPOTTABLETTER OG DERMED FORBUNDNE NAVNE NAVNE ER, OG HVAD DE ANVENDES TIL
English: Respiratory, thoracic and mediastinal disorders Common Rhinitis.
Danish: Sygdomme i åndedrætsorganer, brysthule og mediastinum Almindelig
English: The generic name for the active substance in Doxastad 4 mg prolonged release tablets and associated names is doxazosin, which is a quinazoline derivative.
Danish: Farmakoterapeutisk klassifikation: Alfa-adrenoreceptorantagonister, ATC-kode: C02CA04 Det generiske navn for det active indholdsstof i Doxastad 4 mg depottabletter og dermed forbundne navne er doxazosin, der er et quinazolinderivat.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Doxastad 4 mg prolonged release tablets and associated names [See Annex I] (Doxazosin)
Danish: INDLÆGSSEDDEL Doxastad 4 mg depottabletter og dermed forbundne navne [se Bilag I] (Doxazosin)
English: Taking Doxastad 4 mg prolonged release tablets and associated names with food and drink Doxastad 4 mg prolonged release tablets and associated names can be taken with or after food.
Danish: Doxastad 4 mg depottabletter og dermed forbundne navne kan tages sammen med eller efter maden.
English: 5 HOW TO STORE DOXASTAD 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES :
Danish: HVORDAN DE OPBEVARER DOXASTAD 4 MG DEPOTTABLETTER OG DERMED FORBUNDNE NAVNE:
English: Take special care with Doxastad 4 mg prolonged release tablets and associated names
Danish: Vær særlig forsigtig med at anvende Doxastad 4 mg depottabletter og dermed forbundne navne
English: Do not take Doxastad 4 mg prolonged release tablets and associated names
Danish: De bør ikke tage Doxastad 4 mg depottabletter og dermed forbundne navne
English: How to take Doxastad 4 mg prolonged release tablets and associated names 4.
Danish: Hvordan De tager Doxastad 4 mg depottabletter og dermed forbundne navne.
English: Gastrointestinal disorders Common Diarrhoea, nausea, vomiting, gastritis.
Danish: Diaré, kvalme, opkastning, gastrit.
English: 8 MARKETING AUTHORISATION NUMBER [To be completed nationally]
Danish: 8 MARKEDSFØRINGSTILLADELSESNUMMER
English: Applicant
Danish: PRODUKTRESUME
English: 2 BEFORE YOU TAKE DOXASTAD 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES
Danish: HVAD DE SKAL GØRE, FØR DE BEGYNDER AT TAGE DOXASTAD 4 MG DEPOTTABLETTER OG DERMED FORBUNDNE NAVNE
English: 3 HOW TO TAKE DOXASTAD 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES
Danish: HVORDAN DE TAGER DOXASTAD 4 MG DEPOTTABLETTER OG DERMED FORBUNDNE NAVNE
English: 7 MARKETING AUTHORISATION HOLDER [To be completed nationally]
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt]
English: Before you take Doxastad 4 mg prolonged release tablets and associated names 3.
Danish: Hvad De skal gøre, før De begynder at tage Doxastad 4 mg depottabletter og dermed forbundne navne.
English: 25 January 2010
Danish: 25. januar 2010
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was the United Kingdom and the Concerned Member States were Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Spain, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, the Netherlands, Poland, Portugal, Romania, Slovakia and Slovenia.
Danish: Ansøgningen blev indgivet i henhold til artikel 32 i direktiv 2001/82/EF, med senere ændringer, hvor referencemedlemsstaten var Det Forenede Kongerige, og de berørte medlemsstater var Belgien, Bulgarien, Den Tjekkiske Republik, Danmark, Estland, Spanien, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Nederlandene, Polen, Portugal, Rumænien, Slovakiet og Slovenien.
English: The final opinion was converted into a Decision by the European Commission on 25 January 2010.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 25. januar
English: 1 Article 33 (4) of Directive 2001/82/EC.
Danish: 1 Artikel 33, stk. 4, i direktiv 2001/82/EF.
English: The Mutual Recognition Procedure UK/V/0335/001/MR started on 29 January 2009.
Danish: Den gensidige anerkendelsesprocedure UK/V/0335/001/MR blev indledt den 29. januar
English: The Rapporteur and Co-Rapporteur appointed were Dr. F. Descamps (Belgium) and Dr. A.-M. Brady (the United Kingdom) respectively.
Danish: Den udpegede rapportør og medrapportør var henholdsvis dr. F. Descamps (Belgien) og dr. A.-M. Brady (Det Forenede Kongerige).
English: The referral procedure started on 14 July 2009.
Danish: Indbringelsesproceduren blev indledt den 14. juli 2009.
English: Opinion following an Article 33 (4)
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 33, stk. 4
English: Written explanations were provided by the Marketing Authorisation Holder on 17 August 2009.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 17. august 2009.
English: On 13 July 2009 the United Kingdom, referred the matter to the Agency under Article 33 (4) of Directive 2001/82/EC due to concerns raised by Belgium regarding an unfavourable benefit and risk balance of the vaccine.
Danish: Den 13. juli 2009 indbragte Det Forenede Kongerige sagen for EMEA i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF som følge af de betænkeligheder, Belgien havde givet udtryk for med hensyn til vaccinens negative risk/benefit-forhold.
English: The Marketing Authorisation Holder (Fort Dodge Animal Health Ltd) submitted an application for Mutual Recognition Procedure of Poulvac Bursa Plus (lyophilisate for suspension in drinking water, 102.2-103.4 EID50/dose), indicated for chickens from 10 days of age for oral administration via the drinking water.
Danish: Indehaveren af markedsføringstilladelsen (Fort Dodge Animal Health Ltd) indgav en ansøgning om en gensidig anerkendelsesprocedure for Poulvac Bursa Plus (lyofilisat til suspension i drikkevand, 102.2103.4 EID50/dosis), indiceret til kyllinger, som er over 10 dage gamle, til oral indgivelse gennem drikkevandet.
English: During its 13-15 October 2009 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by a majority of 25 out of 27 votes an opinion concluding that objections raised by Belgium should not prevent the granting of a Marketing Authorisation.
Danish: På baggrund af alle de fremsendte oplysninger og den faglige drøftelse i udvalget vedtog CVMP med et flertal på 25 ud af 27 stemmer på mødet den 13.-15. oktober 2009 en udtalelse, hvor det blev konkluderet, at Belgiens indsigelser ikke bør forhindre udstedelsen af en markedsføringstilladelse.
English: On the basis of the grounds for referral, the points considered by the CVMP were whether the studies carried out by the Marketing Authorisation Holder were sufficient to address the risks associated with immunosuppression in a comprehensive way and whether the benefit/risk balance was favourable for the vaccine Poulvac Bursa Plus.
Danish: På baggrund af begrundelserne for indbringelsen drøftede CVMP, hvorvidt de undersøgelser, som indehaveren af markedsføringstilladelsen havde foretaget, var tilstrækkelige til at behandle risiciene i forbindelse med immunosuppression på en omfattende måde, og hvorvidt risk/benefit-forholdet var positivt for vaccinen Poulvac Bursa Plus.
English: Opinion following an Article 33 (4)F F referral for Poulvac Bursa Plus and associated names
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 33, stk. 4F F, om Poulvac Bursa Plus og tilknyttede navne
English: Bursa Plus and associated names
Danish: 1, om Poulvac Bursa Plus og tilknyttede navne
English: Given its residual pathogenicity, the vaccine strain, V877, is classified as “intermediate plus” and also known as a “hot” strain.
Danish: På grund af vaccinestammen V877's residuale patogenicitet klassificeres den som en "intermediær plus"-type og er også kendt som en "varm" stamme.
English: Date of first authorisation: 08 January 2018
Danish: Dato for første markedsføringstilladelse: 08. januar 2018
English: (pre- and postoperative)
Danish: (præ- og postoperative)
English: This is particularly important if you are having major surgery.
Danish: Det er særlig vigtigt, hvis du skal gennemgå en større operation.
English: Uncommon (PTPs)*
Danish: Ikke almindelig (PTPs)*
English: Incremental recovery was comparable with both products.
Danish: Trinvis bedring var sammenlignelig for begge produkter.
English: • Administer as soon as possible, but no later than 3 hours after reconstitution.
Danish: • Administrer opløsningen hurtigst muligt og senest 3 timer efter rekonstitution.
English: The vacuolations did not recover after 2 weeks.
Danish: Vakuoliseringerne var ikke bedret efter 2 uger.
English: You must contact your doctor immediately if you have any of the following early symptoms of allergic reactions:
Danish: Du skal straks kontakte lægen, hvis du får nogen af de følgende tidlige symptomer på allergiske reaktioner:
English: Results for the full-analysis population were similar to those for the per-protocol population.
Danish: Resultaterne for den fulde analysepopulation var de samme som for per protokol-populationen.
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Danish: Bemærk, at ABR ikke er sammenlignelig mellem forskellige faktorkoncentrater og mellem forskellige kliniske studier.
English: Frequency of doses (hours)/duration of therapy (days)
Danish: Dosisfrekvens (timer)/behandlingens varighed (dage)
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis det ikke anvendes omgående, er opbevaringstid og -forhold efter ibrugtagning brugerens ansvar.
English: You or someone else might also administer ADYNOVI as an injection, but only after receiving adequate training.
Danish: Du eller en anden person kan også give ADYNOVI som injektion, men kun efter at have fået tilstrækkelig oplæring.
English: At the end of this period the product shall not be put back in the refrigerator, but shall be used or discarded.
Danish: Ved udgangen af denne periode må produktet ikke lægges i køleskabet igen, men skal bruges eller kasseres.
English: (See section 4 “Possible side effects”).
Danish: (Se punkt 4 "Bivirkninger").
English: Do not inject a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: If this happens your medicine may stop working properly and you may experience persistent bleeding.
Danish: Hvis dette sker, kan din medicin stoppe med at virke korrekt, og du kan opleve vedvarende blødning.
English: Use the product within 3 hours once the powder is completely dissolved.
Danish: Brug produktet inden for 3 timer efter, at pulveret er helt opløst.
English: After reconstitution, the solution has a pH of 6.7 to 7.3.
Danish: Efter rekonstitution har opløsningen en pH-værdi på 6,7 til 7,3.
English: Proceed with the next injection as scheduled and continue as advised by your doctor.
Danish: Fortsæt med den næste injektion som planlagt, og fortsæt derefter som anvist af lægen.
English: Unopened vial 2 years.
Danish: Uåbnet hætteglas 2 år.
English: The frequency of administration will depend on how well ADYNOVI is working for you.
Danish: Hyppigheden af behandlingen afhænger af, hvor godt ADYNOVI virker for dig.
English: Usually, the replacement therapy with ADYNOVI is a life-long treatment.
Danish: Som regel er substitutionsbehandling med ADYNOVI en livslang behandling.
English: The product is for single use only.
Danish: Produktet er kun til engangsbrug.
English: Including tooth extraction.
Danish: Inklusive tandudtrækning.
English: See 4.2 for information on paediatric use.
Danish: 4.2 for oplysninger om pædiatrisk anvendelse.
English: Paediatric population < 12 years of age
Danish: Pædiatrisk population <12 år
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Danish: i sådanne tilfælde anbefales det at kontakte et specialiseret hæmofilicenter.
English: Rarely, inhibitors may develop after the first 100 exposure days.
Danish: i sjældne tilfælde kan der udvikles inhibitorer efter de første 100 eksponeringsdage.
English: An increase in AUC and a decrease in clearance as compared to the parent molecule, octocog alfa, were also observed.
Danish: En stigning i AUC og et fald i clearance sammenlignet med modermolekylet, octocog alfa, blev også observeret.
English: ADYNOVI can be used only in adolescents and adults (12 years and above).
Danish: ADYNOVI kan kun anvendes hos unge og voksne (i alderen 12 år og derover).
English: Table 2: Adverse reactions reported for ADYNOVI
Danish: Tabel 2: Bivirkninger rapporteret for ADYNOVI
English: Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighed er vurderet i henhold til følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Verify that the solvent transfer is complete.
Danish: Kontrollér, at solvensen er helt overført.
English: The table presented below is according to the MedDRA system organ classification (System Organ Class and Preferred Term Level).
Danish: Tabellen nedenfor er klassificeret efter MedDRA-systemorganklasser (systemorganklasse- og foretrukken term-niveau).
English: This date should never exceed the one initially mentioned on the outer carton.
Danish: Datoen må aldrig være en senere dato end den, der oprindeligt er nævnt på den ydre emballage.
English: The medicinal product is provided in one of the following configurations:
Danish: Dette lægemiddel leveres i en af følgende sammensætninger:
English: Required international units (IU) = body weight (kg) x desired factor VIII rise (%) x 0.5
Danish: Nødvendige internationale enheder (IE) = legemsvægt (kg) x ønsket faktor VIII-stigning (%) x 0,5
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Danish: Hvis sådanne inhibitorer forekommer, vil tilstanden vise sig ved utilstrækkelig klinisk respons.
English: The human coagulation factor VIII has been modified to prolong its duration of action.
Danish: Human koagulationsfaktor VIII er modificeret for at forlænge dets virkningsvarighed.
English: A total of 518 bleeding episodes were treated with ADYNOVI in the per-protocol population.
Danish: I alt 518 blødningsepisoder blev behandlet med ADYNOVI i per protokol-populationen.
English: Discard any unused solution appropriately.
Danish: Bortskaf al ubrugt opløsning på en passende måde.
English: The osmolality is ≥ 380 mOsmol/kg.
Danish: Osmolaliteten er ≥380 m osmol/kg.
English: The medicinal product contains traces of mouse and hamster proteins.
Danish: Lægemidlet indeholder spor af muse- og hamsterproteiner.
English: Be sure that the powder is completely dissolved, otherwise not all reconstituted solution will pass through the device filter.
Danish: Kontroller, at pulveret er helt opløst, ellers vil ikke al rekonstitueret opløsning passere gennem udstyrets filter.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Danish: Den mængde, der skal administreres, og administrationshyppigheden skal altid indrettes efter den kliniske effekt i det enkelte tilfælde.
English: A total of 21 major surgical procedures and 5 additional minor surgeries were performed and assessed in 21 unique subjects in the surgery study.
Danish: I alt 21 større kirurgiske procedurer og 5 yderligere mindre kirurgiske indgreb blev foretaget og bedømt hos 21 unikke forsøgspersoner i det kirurgiske studie.
English: Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor VIII levels.
Danish: Din læge tager relevante laboratorieprøver for at sikre, at dit faktor VIII-niveau er tilstrækkelig højt.
English: ADYNOVI must not be mixed with other medicinal products or solvents.
Danish: ADYNOVI må ikke blandes med andre lægemidler eller solvenser.
English: The clearance value of 12.18 ml/(kg·h) for subject 122001 in age group 12 to < 18 years was not included in the analysis of clearance.
Danish: Clearance-værdien på 12,18 ml/(kg·t) for forsøgsperson 122001 i aldersgruppen 12 til < 18 år var ikke inkluderet i analysen af clearance.
English: If you suffer from cardiac disease, please inform your doctor, as there is an increased risk of blood clotting (coagulation) complications.
Danish: Hvis du lider af en hjertesygdom, bedes du fortælle det til lægen, da der er en øget risiko for komplikationer med koagulation (størkning af blod).
English: The long-term safety of ADYNOVI in children below 12 years has not yet been established.
Danish: ADYNOVIs langtidssikkerhed hos børn under 12 år er endnu ikke klarlagt.
English: The human relevance of kidney vacuolation observed in the preclinical study is unknown.
Danish: Relevansen for mennesker af den nyrevakuolisering, der blev observeret i det prækliniske studie, er ikke kendt.
English: Common * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients.
Danish: Almindelig * Hyppigheden er baseret på studier med alle FVIII-produkter, som omfattede patienter med svær hæmofili A. PTPs = tidligere behandlede patienter.
English: The mean clearance (based on body weight) of ADYNOVI was higher and the mean half-life was lower in children less than 12 years of age than adults.
Danish: Den gennemsnitlige clearance (baseret på legemsvægt) for ADYNOVI var højere, og den gennemsnitlige halveringstid var lavere hos børn under 12 år end hos voksne.
English: Repeat injections every 12 to 24 hours.
Danish: Injektion gentages hver 12. til 24. time.
English: If severe, sudden allergic reactions (anaphylactic) occur, the injection must be stopped immediately.
Danish: Hvis der opstår svære, pludselige allergiske reaktioner (anafylaksi), skal injektionen straks stoppes.
English: Turn the package over.
Danish: Vend pakningen om.
English: Allergic type hypersensitivity reactions are possible with ADYNOVI.
Danish: Allergiske overfølsomhedsreaktioner er mulige med ADYNOVI.
English: Abbreviations: Cmax: maximum observed activity; AUC: area under the curve; MRT: mean residence time; CL: clearance; Vss: body weight adjusted volume of distribution at steady-state,
Danish: Forkortelser: Cmax: maksimal observeret aktivitet; AUC: arealet under kurven; MRT: gennemsnitlig opholdstid; CL: clearance; Vss: distributionsvolumen justeret efter legemsvægt ved steady state,
English: Every 24 hours at least 1 day, until healing is achieved.
Danish: Hver 24. time mindst 1 dag, indtil opheling er opnået.
English: Animal reproduction studies have not been conducted with factor VIII.
Danish: Der er ikke udført reproduktionsstudier med faktor VIII hos dyr.
English: No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.
Danish: Der er ikke rapporteret om interaktioner mellem human koagulationsfaktor VIII (rDNA)-produkter og andre lægemidler.
English: The powder must not be mixed with other medicinal products or solvents or used with other reconstitution devices.
Danish: Pulveret må ikke blandes med andre lægemidler eller solvenser eller anvendes med andet rekonstitutionsudstyr.
English: There is a rare risk that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ADYNOVI.
Danish: Der er en lille risiko for, at du kan få en anafylaktisk reaktion (en alvorlig, pludselig allergisk reaktion) på ADYNOVI.