natgillin/translations-raw huggingface dataset:
EU/1/15/1029/001 10 tabletter EU/1/15/1029/002 14 tabletter EU/1/15/1029/003 16 tabletter EU/1/15/1029/004 28 tabletter EU/1/15/1029/005 30 tabletter EU/1/15/1029/006 35 tabletter EU/1/15/1029/007 56 tabletter EU/1/15/1029/008 70 tabletter EU/1/15/1029/009 14 x 1 tabletter EU/1/15/1029/010 28 x 1 tabletter EU/1/15/1029/011 49 x 1 tabletter EU/1/15/1029/012 56 x 1 tabletter EU/1/15/1029/013 98 x 1 tabletter 
EU/1/15/1029/001 10 tablets EU/1/15/1029/002 14 tablets EU/1/15/1029/003 16 tablets EU/1/15/1029/004 28 tablets EU/1/15/1029/005 30 tablets EU/1/15/1029/006 35 tablets EU/1/15/1029/007 56 tablets EU/1/15/1029/008 70 tablets EU/1/15/1029/009 14 x 1 tablets EU/1/15/1029/010 28 x 1 tablets EU/1/15/1029/011 49 x 1 tablets EU/1/15/1029/012 56 x 1 tablets EU/1/15/1029/013 98 x 1 tablets
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1029/028 
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/028
LÆGEMIDLETS NAVN Aripiprazole Sandoz 5 mg tabletter aripiprazol 
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 5 mg tablets aripiprazole
INFORMATION I BRAILLESKRIFT Ydre karton: Aripiprazole Sandoz 10 mg 
INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 10 mg
INFORMATION I BRAILLESKRIFT Ydre karton: Aripiprazole Sandoz 15 mg 
INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 15 mg
LÆGEMIDLETS NAVN Aripiprazole Sandoz 15 mg tabletter aripiprazol 
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 15 mg tablets aripiprazole
LÆGEMIDLETS NAVN Aripiprazole Sandoz 10 mg tabletter aripiprazol 
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 10 mg tablets aripiprazole
EU/1/15/1029/029 10 tabletter EU/1/15/1029/030 14 tabletter EU/1/15/1029/031 16 tabletter EU/1/15/1029/032 28 tabletter EU/1/15/1029/033 30 tabletter EU/1/15/1029/034 35 tabletter EU/1/15/1029/035 56 tabletter EU/1/15/1029/036 70 tabletter EU/1/15/1029/037 14 x 1 tabletter EU/1/15/1029/038 28 x 1 tabletter EU/1/15/1029/039 49 x 1 tabletter EU/1/15/1029/040 56 x 1 tabletter EU/1/15/1029/041 98 x 1 tabletter 
EU/1/15/1029/029 10 tablets EU/1/15/1029/030 14 tablets EU/1/15/1029/031 16 tablets EU/1/15/1029/032 28 tablets EU/1/15/1029/033 30 tablets EU/1/15/1029/034 35 tablets EU/1/15/1029/035 56 tablets EU/1/15/1029/036 70 tablets EU/1/15/1029/037 14 x 1 tablets EU/1/15/1029/038 28 x 1 tablets EU/1/15/1029/039 49 x 1 tablets EU/1/15/1029/040 56 x 1 tablets EU/1/15/1029/041 98 x 1 tablets
Aripiprazole Sandoz 5 mg tabletter Lactosemonohydrat Majsstivelse 
Aripiprazole Sandoz 5 mg tabletsLactose monohydrate Maize starch
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1029/014 
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/014
EU/1/15/1029/048 10 tabletter EU/1/15/1029/049 14 tabletter EU/1/15/1029/050 16 tabletter EU/1/15/1029/051 28 tabletter EU/1/15/1029/052 30 tabletter EU/1/15/1029/053 35 tabletter EU/1/15/1029/054 56 tabletter EU/1/15/1029/055 70 tabletter EU/1/15/1029/056 14 x 1 tabletter EU/1/15/1029/057 28 x 1 tabletter EU/1/15/1029/058 49 x 1 tabletter EU/1/15/1029/059 56 x 1 tabletter EU/1/15/1029/060 98 x 1 tabletter 
EU/1/15/1029/048 10 tablets EU/1/15/1029/049 14 tablets EU/1/15/1029/050 16 tablets EU/1/15/1029/051 28 tablets EU/1/15/1029/052 30 tablets EU/1/15/1029/053 35 tablets EU/1/15/1029/054 56 tablets EU/1/15/1029/055 70 tablets EU/1/15/1029/056 14 x 1 tablets EU/1/15/1029/057 28 x 1 tablets EU/1/15/1029/058 49 x 1 tablets EU/1/15/1029/059 56 x 1 tablets EU/1/15/1029/060 98 x 1 tablets
17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE 
UNIQUE IDENTIFIER - 2D BARCODE [Only Carton for bottle:]
Kontakt lægen eller apoteket, hvis du mener, virkningen af Aripiprazole Sandoz er for kraftig eller for svag. 
If you have the impression that the effect of Aripiprazole Sandozis too strong or too weak, talk to your doctor or pharmacist.
EU/1/15/1029/019 (30 tabletter) EU/1/15/1029/020 (35 tabletter) EU/1/15/1029/021 (56 tabletter) EU/1/15/1029/022 (70 tabletter) EU/1/15/1029/023 (14 x 1 tabletter) EU/1/15/1029/024 (28 x 1 tabletter) EU/1/15/1029/025 (49 x 1 tabletter) EU/1/15/1029/026 (56 x 1 tabletter) EU/1/15/1029/027 (98 x 1 tabletter) EU/1/15/1029/028 (100 tabletter) 
Aripiprazole Sandoz 10 mg tablets EU/1/15/1029/015 (10 tablets) EU/1/15/1029/016 (14 tablets) EU/1/15/1029/017 (16 tablets) EU/1/15/1029/018 (28 tablets) EU/1/15/1029/019 (30 tablets) EU/1/15/1029/020 (35 tablets) EU/1/15/1029/021 (56 tablets) EU/1/15/1029/022 (70 tablets) EU/1/15/1029/023 (14 x 1 tablets) EU/1/15/1029/024 (28 x 1 tablets) EU/1/15/1029/025 (49 x 1 tablets) EU/1/15/1029/026 (56 x 1 tablets) EU/1/15/1029/027 (98 x 1 tablets) EU/1/15/1029/028 (100 tablets)
hydroxypropylcellulose, magnesiumstearat, rød jernoxid (E172). 
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172).
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for PegIntron den 25. maj 2000. 
The European Commission granted a marketing authorisation valid throughout the EU for PegIntron on 25 May 2000.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for PegIntron. 
This document is a summary of the European Public Assessment Report (EPAR) for PegIntron.
Den fuldstændige EPAR for PegIntron findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for PegIntron can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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 anvendelsesbetingelserne for PegIntron. 
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 PegIntron.
Hos voksne er de hyppigst forekommende bivirkninger ved PegIntron (set hos flere end 1 ud af 10 patienter) virusinfektion, faryngitis (ondt i halsen), anæmi (lavt antal røde blodlegemer), neutropeni (lavt antal neutrofiler, som er en type hvide blodlegemer), appetitløshed, depression, angst, emotionel labilitet (humørsvingninger), nedsat koncentrationsevne, insomni (søvnbesvær), hovedpine, svimmelhed, dyspnø (vejrtrækningsbesvær), hoste, opkastning, kvalme, mavesmerter, diarré, mundtørhed, alopeci (hårtab), kløe, tør hud, udslæt, muskelsmerter, ledsmerter, smerter i muskler og knogler, reaktioner på injektionsstedet, betændelse på injektionsstedet, træthed, asteni (svaghed), irritabilitet, kulderystelser, pyreksi (feber), influenzalignende sygdom og vægttab. 
In adults, the most common side effects with PegIntron (seen in more than 1 patient in 10) are viral infection, pharyngitis (sore throat), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), loss of appetite, depression, anxiety, emotional lability (mood swings), impaired concentration, insomnia (difficulty sleeping), headache, dizziness, dyspnoea (difficulty breathing), cough, vomiting, nausea (feeling sick), abdominal pain (stomach ache), diarrhoea, dry mouth, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection, inflammation at the site of the injection, fatigue (tiredness), asthenia (weakness), irritability, chills, pyrexia (fever), influenza (flu)-like illness and weight loss.
Da PegIntron sættes i forbindelse med bivirkninger som depression, skal patienterne overvåges nøje under behandlingen. 
Because PegIntron is linked to side effects such as depression, patients must be closely monitored during treatment.
PegIntron sættes ligeledes i forbindelse med vægttab og nedsat vækst hos børn og unge. 
PegIntron is also linked to weight loss and reduced growth in children and adolescents.
CHMP besluttede, at fordelene ved PegIntron er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for PegIntron. 
The CHMP decided that PegIntron's benefits are greater than its risks and recommended that it be given marketing authorisation.
Hvis du ønsker yderligere oplysninger om behandling med PegIntron, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with PegIntron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Andre oplysninger om PegIntron 
Other information about PegIntron:
Behandlingen med PegIntron bør indledes og overvåges af en læge med erfaring i behandling af patienter med hepatitis C. PegIntron gives en gang om ugen som indsprøjtning under huden. 
Treatment with PegIntron should be started and supervised by a doctor who has experience in the management of patients with hepatitis C. PegIntron is given once a week as an injection under the skin.
Hos voksne (fra 18. år) kan PegIntron anvendes til ikke tidligere behandlede patienter eller hvor en tidligere behandling har slået fejl. 
In adults (aged 18 years and older), PegIntron can be used in patients who have not been treated before or whose previous treatment failed.
Hos voksne gives det i kombinationsbehandling sammen med ribavirin i en dosis på 1,5 mikrogram pr. kg legemsvægt, eller det anvendes alene i en dosis på 0,5 eller 1,0 mikrogram/kg legemsvægt. 
In adults, it is used in combination treatments at a dose of 1.5 micrograms per kilogram body weight, or on its own at 0.5 or 1.0 micrograms/kg.
Kombinationen af PegIntron og ribavirin blev også undersøgt i en undersøgelse, der omfattede 1 354 voksne, hvis tidligere behandling var slået fejl, og i en undersøgelse, der omfattede 107 børn og unge mellem tre og 17 år, som ikke var blevet behandlet før. 
The combination of PegIntron and ribavirin has also been studied in one study involving 1,354 adults whose previous treatment had failed and in one study involving 107 children and adolescents aged between three and 17 years who had not been treated before.
Hvilken risiko er der forbundet med PegIntron? 
What is the risk associated with PegIntron?
PegIntron må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for nogen interferoner eller andre af indholdsstofferne. 
PegIntron must not be used in people who are hypersensitive (allergic) to any interferon or any of the other ingredients.
Omkring en fjerdedel af de voksne, hvis tidligere behandling var slået fejl, og omkring to tredjedele af børnene og de unge responderede på behandling med PegIntron og ribavirin. 
Around a quarter of the adults whose previous treatment had failed and around two-thirds of the children and adolescents responded to treatment with PegIntron and ribavirin.
Den tredobbelte behandling resulterede i en stigning på cirka 30 % i antallet af tidligere ubehandlede patienter, der reagerede hurtigt på behandlingen og blev helbredt. 
Triple therapy led to an increase of about 30% in the number of previously untreated early responders who were cured.
PegIntron må ikke anvendes hos patienter med en alvorlig sygdomstilstand, alvorlige leverproblemer, ukontrollerede skjoldbruskkirtelsygdomme, epilepsi eller andre problemer med centralnervesystemet. 
PegIntron must not be used in patients with a severe medical condition, severe liver problems, thyroid disease that is not controlled, epilepsy or other central nervous system problems.
Interferon alfa-2b i PegIntron fremstilles ved hjælp af en metode, der kaldes "rekombinant DNA-teknologi": Det fremstilles af en bakterie, der har fået indsat et gen (DNA), som sætter den i stand til at producere interferon alfa-2b. 
The interferon alfa-2b in PegIntron is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b.
Kombinationen af PegIntron og ribavirin var effektiv hos patienter med cirrose og hos hiv-smittede patienter. 
The combination of PegIntron with ribavirin was effective in patients with cirrhosis and in patients infected with HIV.
Hvorfor blev PegIntron godkendt? 
Why has PegIntron been approved?
Hos andre voksne med hepatitis C-virus i blodet, herunder patienter, der desuden er smittet med humant immundefektvirus (hiv), gives PegIntron enten sammen med ribavirin (dobbeltbehandling) eller alene, hvis patienterne ikke må få ribavirin. 
In other adults with hepatitis C virus in their blood, including patients also infected with human immunodeficiency virus (HIV), PegIntron is given either with ribavirin (dual therapy) or on its own if they cannot take ribavirin.
PegIntron kan gives i en tredobbelt kombinationsbehandling sammen med ribavirin og boceprevir til voksne med hepatitis C type 1, hvis lever er beskadiget, men stadig virker normalt (kompenseret leversygdom). 
PegIntron can be given in a triple therapy combination with ribavirin and boceprevir to adults with type 1 hepatitis C whose liver is damaged but still able to work normally (compensated liver disease).
Den fuldstændige liste over alle de indberettede bivirkninger ved PegIntron fremgår af indlægssedlen. 
For the full list of all side effects reported with PegIntron, see the package leaflet.
PegIntron blev - henholdsvis med og uden ribavirin - sammenlignet med interferon alfa-2b i fem hovedundersøgelser, der i alt omfattede over 6 000 ikke tidligere behandlede voksne med hepatitis C, herunder 328 patienter med cirrose og 507 patienter, der også var smittet med hiv. 
PegIntron, with or without ribavirin, has been compared with interferon alfa-2b in five main studies involving a total of over 6,000 adults with hepatitis C who had not been treated before, including 328 patients with cirrhosis and 507 patients also infected with HIV.
PegIntron er et lægemiddel, der indeholder det aktive stof peginterferon alfa-2b. 
PegIntron is a medicine that contains the active substance peginterferon alfa-2b.
Hos voksne var PegIntron mere effektivt end interferon alfa-2b til ikke tidligere behandlede patienter, idet ca. en fjerdedel af patienterne responderede på PegIntron alene, og ca. halvdelen responderede på kombinationen af PegIntron og ribavirin. 
In adults, PegIntron was more effective than interferon alfa-2b in patients who had not been treated before, with around a quarter of the patients responding to PegIntron alone and around a half responding to the combination of PegIntron and ribavirin.
Det aktive stof i PegIntron, peginterferon alfa-2b, tilhører gruppen af "interferoner". 
The active substance in PegIntron, peginterferon alfa-2b, belongs to the group ‘interferons'.
Hvad er PegIntron? 
What is PegIntron?
I PegIntron er interferon alfa-2b blevet "pegyleret" (dvs. bundet til det kemiske stof polyethylenglycol). 
In PegIntron, the interferon alfa-2b has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Der var desuden en markant stigning i helbredelsesprocenten hos patienter med kronisk hepatitis C type 1, når de fik den tredobbelte behandling bestående af PegIntron i kombination med ribavirin og boceprevir. 
There is also a marked increase in cure rates in patients with long-term type 1 hepatitis C when given the triple therapy of PegIntron in combination with ribavirin and boceprevir.
I undersøgelserne med tredobbelt kombinationsbehandling ved hepatitis C type 1 og kompenseret leversygdom var PegIntron i kombination med ribavirin og boceprevir mere effektivt end den dobbelte kombination af PegIntron og ribavirin alene. 
In the studies on triple therapy in patients with type 1 hepatitis C and compensated liver disease, PegIntron in combination with ribavirin and boceprevir was shown to be more effective than the dual combination of PegIntron with ribavirin alone.
Afhængigt af graden af bivirkningerne kan det være nødvendigt helt at standse behandlingen (herunder boceprevir). 
Depending on the severity of the side effects treatment may have to be stopped altogether (including boceprevir).Patients can inject themselves once they have been trained appropriately.
Hvad anvendes PegIntron til? 
What is PegIntron used for?
PegIntron anvendes til behandling af patienter i alderen 3 år og opad med langvarig hepatitis C (leverbetændelse forårsaget af hepatitis C-virus). 
PegIntron is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Hvordan blev PegIntron undersøgt? 
How has PegIntron been studied?
Hos børn og unge, der fik PegIntron i kombination med ribavirin, var bivirkningerne de samme som hos voksne. 
In children and adolescents receiving PegIntron in combination with ribavirin, side effects were similar to adults, although reduced growth was also seen in more than 1 patient in 10.
Hvilken fordel viser undersøgelserne, at der er ved PegIntron? 
What benefit has PegIntron shown during the studies?
I tilfælde af bivirkninger kan det være nødvendigt at justere dosis af ribavirin og PegIntron. 
The doses of ribavirin and PegIntron may need to be adjusted for patients who experience side effects.
Hvordan anvendes PegIntron? 
How is PegIntron used?
Hvordan virker PegIntron? 
How does PegIntron work?
Undersøgelserne vedrørte virkningen af PegIntron i en tredobbelt kombinationsbehandling med ribavirin og boceprevir, som blev sammenlignet med PegIntron og ribavirin alene. 
Two main studies involving 1,503 adult patients with type 1 hepatitis C and compensated liver disease investigated the effect of PegIntron in a triple therapy combination with ribavirin and boceprevir compared with PegIntron and ribavirin alone.
Medlemsstaterne skal sikre, at alle betingelserne eller begrænsingerne vedrørende sikker og effektiv anvendelse af lægemidlet, som beskrives nedenfor, implementeres. 
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented.
Medlemsstaterne skal sikre at indehaveren af markedsføringstilladelsen leverer et Direct Healthcare Professional Communication (DHPC)-brev til alle læger, som forventes at ordinere eller anvende Tamiflu. 
The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Tamiflu a Direct Healthcare Professional Communication (DHPC) letter, the text of which is appended to the CHMP assessment report.
Medlemsstaterne skal aftale en kommunikationsplan for DHPC-brevet med indehaveren af markedsføringstilladelsen. 
The Member States shall agree with the MAH the communication plan for the DHPC letter.
BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES I MEDLEMSSTATERNE 
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
BILAG BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES I MEDLEMSSTATERNE 
ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Sikkerhedsprofilen vurderes overordnet set til at være acceptabel. 
Overall, the safety profile was considered acceptable.
Lægen kan træffe beslutning om, at patienter eller deres plejere selv må indsprøjte lægemidlet efter at have fået tilstrækkelig oplæring. 
The doctor may decide that patients or their caregivers can inject the medicine themselves after they have been properly trained.
Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/medicines/human/orphan-designations/eu3151551 
Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3151551
Som for alle lægemidler bliver data vedrørende brug af Takhzyro løbende overvåget. 
As for all medicines, data on the use of Takhzyro are continuously monitored.
Andre oplysninger om Takhzyro 
Other information about Takhzyro
Yderligere information om Takhzyro findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Takhzyro. 
Further information on Takhzyro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Takhzyro.
Den anbefalede startdosis er 300 mg hver 2. uge. 
The recommended starting dose of Takhzyro is 300 mg every 2 weeks.
Hvis patienten forbliver anfaldsfri under behandlingen med dosis hver 2. uge, kan lægen ændre hyppigheden til en gang hver 4. uge. 
If the patient remains free of attacks with the two-weekly dose, the doctor can reduce the frequency to once every 4 weeks.
For mere information om brug af Takhzyro, se indlægssedlen eller kontakt lægen eller apotekspersonalet. 
For more information about using Takhzyro, see the package leaflet or contact your doctor or pharmacist.
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Takhzyro opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency therefore decided that Takhzyro's benefits are greater than its risks and it can be authorised for use in the EU.
Bivirkninger rapporteret for Takhzyro vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Takhzyro are carefully evaluated and any necessary action taken to protect patients.
Hereditært angioødem er sjældent, og Takhzyro blev udpeget som "lægemiddel til sjældne sygdomme" den 9. oktober 2015. 
Hereditary angioedema is rare, and Takhzyro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 October 2015.
Takhzyro indeholder det aktive stof lanadelumab. 
Takhzyro contains the active substance lanadelumab.
Patienterne oplevede i gennemsnit 0,3 anfald i måneden ved indsprøjtninger med Takhzyro hver 2. uge og 0,5 anfald ved indsprøjtninger hver 4. uge. 
Patients experienced on average 0.3 attacks per month when given Takhzyro injections every 2 weeks and 0.5 attacks when given injections every 4 weeks.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Takhzyro? 
What measures are being taken to ensure the safe and effective use of Takhzyro?
Anfald af hereditært angioødem kan være livstruende, når hævelsen omkring halsen trykker imod luftvejen. 
Attacks of hereditary angioedema can be life threatening when the swelling around the throat presses against the airway.
En oversigt over Takhzyro, og hvorfor det er godkendt i EU 
An overview of Takhzyro and why it is authorised in the EU
Takhzyro var effektivt til at reducere antallet af angioødemanfald i et hovedstudie, der omfattede 126 voksne og børn på over 12 år med hereditært angioødem. 
Takhzyro was found to be effective in reducing the number of angioedema attacks in a main study in 126 adults and children above 12 years of age with hereditary angioedema.
Takhzyro udleveres kun efter recept og bør iværksættes under opsyn af en læge med erfaring i håndtering af hereditært angioødem. 
Takhzyro can only be obtained with a prescription and should be started under supervision of a doctor experienced in managing hereditary angioedema.
Patienter med angioødem får hurtig hævelse under huden i bl.a. ansigtet, halsen, armene og benene. 
Patients with angioedema have rapid swelling under the skin in areas such as the face, throat, arms and legs.
Hvorfor blev Takhzyro godkendt i EU? 
Why is Takhzyro authorised in the EU?
Takhzyro er effektivt til at forebygge angioødemanfald, og det blev betragtet som en fordel i forhold til eksisterende behandlinger, at det kun skal gives hver 2. eller hver 4. uge. 
Takhzyro is effective in preventing angioedema attacks and the fact that it only needs to be given every 2 or 4 weeks was considered an advantage over existing treatments.
Det aktive stof i Takhzyro, lanadelumab, virker ved at binde sig til og blokere et enzym i blodet kaldet "kallikrein", som har flere funktioner og bl.a. øger niveauet af bradykinin. 
The active substance in Takhzyro, lanadelumab, works by attaching to and blocking an enzyme in the blood called 'kallikrein', which has several functions, including increasing levels of bradykinin.