FrancophonIA/ELRC3.0 huggingface dataset:
English: HEXAVAC - single dose pre-filled syringe without needle - Pack of 1
Danish: HEXAVAC - endosis fyldt injektionssprøjte uden nål - pakning med 1 stk.
English: HEXAVAC - single dose pre-filled syringe with attached needle - Pack of 50
Danish: HEXAVAC - endosis fyldt injektionssprøjte med fastsiddende nål - pakning med 50 stk.
English: PHARMACEUTICAL FORM AND CONTENTS 25 single doses 0.5 ml pre-filled syringes without needle Suspension for injection in pre-filled syringe
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 25 fyldte injektionssprøjter (0,5 ml) til enkeltdosering uden nål Injektionsvæske, suspension i fyldt injektionssprøjte
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/012
Danish: NUMMER (NUMRE) I EU-REGISTRET FOR LÆGEMIDLER EU/1/00/147/012
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/011
Danish: NUMMER (NUMRE) I EU-REGISTRET FOR LÆGEMIDLER EU/1/00/147/011
English: HEXAVAC - single dose pre-filled syringe without needle - Pack of 10
Danish: HEXAVAC - endosis fyldt injektionssprøjte uden nål - pakning med 10 stk.
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/010
Danish: NUMMER (NUMRE) I EU-REGISTRET FOR LÆGEMIDLER EU/1/00/147/010
English: PHARMACEUTICAL FORM AND CONTENTS 1 single dose 0.5 ml pre-filled syringe with 2 separate needles Suspension for injection in pre-filled syringe
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 1 fyldt injektionssprøjte (0,5 ml) til enkeltdosering med 2 separate nåle Injektionsvæske, suspension i fyldt injektionssprøjte
English: HEXAVAC - single dose pre-filled syringe with 2 separate needles - Pack of 1
Danish: HEXAVAC - endosis fyldt injektionssprøjte med 2 separate nåle - pakning med 1 stk.
English: HEXAVAC - single dose pre-filled syringe with attached needle - Pack of 1
Danish: HEXAVAC - endosis fyldt injektionssprøjte med fastsiddende nål - pakning med 1 stk.
English: HEXAVAC - single dose pre-filled syringe with 2 separate needles - Pack of 10
Danish: HEXAVAC - endosis fyldt injektionssprøjte med 2 separate nåle - pakning med 10 stk.
English: HEXAVAC - single dose pre-filled syringe with attached needle - Pack of 10
Danish: HEXAVAC - endosis fyldt injektionssprøjte med fastsiddende nål - pakning med 10 stk.
English: HEXAVAC - single dose pre-filled syringe with 1 separate needle - Pack of 1
Danish: HEXAVAC - endosis fyldt injektionssprøjte med 1 separat nål - pakning med 1 stk.
English: HEXAVAC - single dose pre-filled syringe without needle - Pack of 50
Danish: HEXAVAC - endosis fyldt injektionssprøjte uden nål - pakning med 50 stk.
English: HEXAVAC - single dose pre-filled syringe with 1 separate needle - Pack of 10
Danish: HEXAVAC - endosis fyldt injektionssprøjte med 1 separat nål - pakning med 10 stk.
English: PHARMACEUTICAL FORM AND CONTENTS 1 single dose 0.5 ml pre-filled syringe with 1 separate needle Suspension for injection in pre-filled syringe
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 1 fyldt injektionssprøjte (0,5 ml) til enkeltdosering med 1 separat nål Injektionsvæske, suspension i fyldt injektionssprøjte
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/006
Danish: NUMMER (NUMRE) I EU-REGISTRET FOR LÆGEMIDLER EU/1/00/147/006
English: PHARMACEUTICAL FORM AND CONTENTS 50 single doses 0.5 ml pre-filled syringes without needle Suspension for injection in pre-filled syringe
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 50 fyldte injektionssprøjter (0,5 ml) til enkeltdosering uden nål Injektionsvæske, suspension i fyldt injektionssprøjte
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/009
Danish: NUMMER (NUMRE) I EU-REGISTRET FOR LÆGEMIDLER EU/1/00/147/009
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/005
Danish: NUMMER (NUMRE) I EU-REGISTRET FOR LÆGEMIDLER EU/1/00/147/005
English: PACKAGE LEAFLET
Danish: INDLÆGSSEDDEL
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/002
Danish: NUMMER (NUMRE) I EU-REGISTRET FOR LÆGEMIDLER EU/1/00/147/002
English: PHARMACEUTICAL FORM AND CONTENTS 10 single doses 0.5 ml pre-filled syringes without needle Suspension for injection in pre-filled syringe
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 10 fyldte injektionssprøjter (0,5 ml) til enkeltdosering uden nål Injektionsvæske, suspension i fyldt injektionssprøjte
English: The vaccine may not prevent
Danish: Vaccinen vil muligvis ikke forebygge hepatitis B i sådanne
English: PHARMACEUTICAL FORM AND CONTENTS 1 single dose 0.5 ml pre-filled syringe without needle Suspension for injection in pre-filled syringe
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 1 fyldt injektionssprøjte (0,5 ml) til enkeltdosering uden nål Injektionsvæske, suspension i fyldt injektionssprøjte
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/004
Danish: NUMMER (NUMRE) I EU-REGISTRET FOR LÆGEMIDLER EU/1/00/147/004
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/001
Danish: NUMMER (NUMRE) I EU-REGISTRET FOR LÆGEMIDLER EU/1/00/147/001
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/007
Danish: NUMMER (NUMRE) I EU-REGISTRET FOR LÆGEMIDLER EU/1/00/147/007
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/003
Danish: NUMMER (NUMRE) I EU-REGISTRET FOR LÆGEMIDLER EU/1/00/147/003
English: PHARMACEUTICAL FORM AND CONTENTS 1 single dose 0.5 ml pre-filled syringe with attached needle Suspension for injection in pre-filled syringe
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 1 fyldt injektionssprøjte (0,5 ml) til enkeltdosering med fastsiddende nål Injektionsvæske, suspension i fyldt injektionssprøjte
English: This is a summary of the European public assessment report (EPAR) for Galafold.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Galafold.
English: Regarding safety, Galafold was well-tolerated.
Danish: For så vidt angår sikkerheden, var Galafold veltolereret.
English: The recommended dose of Galafold is one capsule every other day, taken by mouth at least 2 hours before or after food.
Danish: Den anbefalede dosis af Galafold er én kapsel hver anden dag taget gennem munden mindst 2 timer før eller efter indtagelse af føde.
English: The most common side effect with Galafold (which may affect around 1 in 10 people) is headache.
Danish: Den mest almindelige bivirkning ved Galafold (som kan forekomme hos omkring 1 ud af 10 personer) er hovedpine.
English: Galafold is available as capsules (123 mg).
Danish: Galafold fås som kapsler (123 mg).
English: A risk management plan has been developed to ensure that Galafold is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Galafold anvendes så sikkert som muligt.
English: As a result, GL-3 cannot be broken down and it builds up in various cells in the body, including in the heart and kidneys.
Danish: GL-3 kan derfor ikke blive nedbrudt, og det hober sig følgelig op i forskellige celler i kroppen, herunder i hjertet og nyrerne.
English: This allows the enzyme to be transported into areas of the cell where it can break down GL-3.
Danish: Derved kan enzymet blive transporteret ind i områder af cellen, hvor det kan nedbryde GL-3.
English: The main measure of effectiveness was the change in patients' kidney function after 18 months of treatment.
Danish: Det primære mål for virkningen var ændringen i patientens nyrefunktion efter 18 måneders behandling.
English: What is Galafold and what is it used for?
Danish: Hvad er Galafold, og hvad anvendes det til?
English: Galafold has been investigated in two main studies involving a total of 127 patients with Fabry disease.
Danish: Galafold blev undersøgt i to hovedundersøgelser, som omfattede i alt 127 patienter med Fabrys sygdom.
English: The Committee noted that Galafold was studied in a limited number of patients, however the available evidence is considered sufficient for such a rare disease.
Danish: Udvalget bemærkede, at selv om Galafold kun er undersøgt hos et begrænset antal patienter, anses den tilgængelige dokumentation for at være tilstrækkelig for en så sjælden sygdom.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Galafold's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Galafold opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Because the number of patients with Fabry disease is low, the disease is considered ‘rare' and Galafold was designated an ‘orphan medicine' (a medicine used in rare diseases) on 22 May 2006.
Danish: Da antallet af patienter med Fabrys sygdom er lavt, betragtes sygdommen som "sjælden", og Galafold blev udpeget som "lægemiddel til sjældne sygdomme" den 22. maj 2006.
English: Galafold contains the active substance migalastat.
Danish: Galafold indeholder det aktive stof migalastat.
English: What measures are being taken to ensure the safe and effective use of Galafold?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Galafold?
English: Other information about Galafold
Danish: Andre oplysninger om Galafold
English: Why is Galafold approved?
Danish: Hvorfor blev Galafold godkendt?
English: The full EPAR for Galafold can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Galafold findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The CHMP also noted that Galafold is taken by mouth and this could be an advantage compared with other authorised treatments such as enzyme replacement which are given by infusion (drip) into a vein.
Danish: CHMP bemærkede også, at Galafold tages gennem munden, og at dette kan være en fordel sammenlignet med andre godkendte behandlinger som f.eks. enzymerstatning, der gives via infusion (drop) i en blodåre.
English: It is not intended to provide practical advice on how to use Galafold.
Danish: Det er ikke en praktisk vejledning i, hvordan Galafold bør anvendes.
English: Galafold can only be obtained with a prescription and treatment should only be started and supervised by a doctor who is experienced in the diagnosis and treatment of Fabry disease.
Danish: Galafold udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i diagnosticering og behandling af Fabrys sygdom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Galafold, 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 Galafold, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The second study, in 60 patients, compared Galafold with the medicines agalsidase alfa or agalsidase beta, two treatments that replace the missing enzyme.
Danish: I den anden undersøgelse, hvori 60 patienter deltog, blev Galafold sammenlignet med lægemidlerne agalsidase alfa eller agalsidase beta, der er to behandlinger til erstatning af det manglende enzym.
English: Overall, Galafold was not found to be more effective than placebo at reducing GL-3 deposits; however, additional analyses including only patients with those genetic mutations that can be treated with Galafold showed that patients responded better to Galafold than to placebo after 6 months of treatment.
Danish: Overordnet set var Galafold ikke mere effektivt end placebo til at reducere GL-3-aflejringer; yderligere analyser, som kun omfattede patienter med de genmutationer, der kan behandles med Galafold, viste imidlertid, at disse patienter reagerede bedre på Galafold end på placebo efter 6 måneders behandling.
English: Galafold is a medicine used to treat patients aged 16 years or over with Fabry disease.
Danish: Galafold er et lægemiddel, der anvendes til at behandle patienter i alderen 16 år og derover, som lider af Fabrys sygdom.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Galafold can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Galafold findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What are the risks associated with Galafold?
Danish: Hvilke risici er der forbundet med Galafold?
English: The active substance in Galafold, migalastat, attaches to certain unstable forms of alpha-galactosidase A, stabilising the enzyme.
Danish: Det aktive stof i Galafold, migalastat, binder til visse ustabile former af alfa-galaktosidase A og stabiliserer derigennem enzymet.
English: The first study, which compared Galafold with placebo (a dummy treatment) in 67 patients, looked at the proportion of patients who responded to treatment (defined as a reduction of at least 50% in GL-3 deposits in the kidneys).
Danish: Den første undersøgelse, hvori Galafold blev sammenlignet med placebo (en uvirksom behandling) hos 67 patienter, så nærmere på den andel af patienterne, der reagerede på behandlingen (defineret som et fald på mindst 50 % i GL-3-aflejringer i nyrerne).
English: In this study, Galafold was found to be as effective as enzyme replacement in stabilising patients' kidney function.
Danish: I denne undersøgelse blev det påvist, at Galafold er lige så effektivt som enzymerstatningsbehandling til at stabilisere patientens nyrefunktion.
English: Galafold is only for use in patients with certain mutations in the alpha-galactosidase A gene.
Danish: Galafold er kun til brug hos patienter med visse mutationer i alfa-galaktosidase A-genet.
English: For the full list of all side effects and restrictions with Galafold, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Galafold fremgår af indlægssedlen.
English: For more information about treatment with Galafold, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Galafold, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: How is Galafold used?
Danish: Hvordan anvendes Galafold?
English: This is a rare inherited disorder where patients have various mutations (changes) in the gene responsible for the production of an enzyme called alpha-galactosidase A, which normally breaks down a fatty substance called globotriaosylceramide (GL-3).
Danish: Fabrys sygdom er en sjælden, arvelig sygdom, hvor patienterne har forskellige mutationer (forandringer) i det gen, der danner enzymet alfa-galaktosidase A, som normalt nedbryder fedtstoffet globotriaosylceramid (GL-3).
English: In patients with Fabry disease, this enzyme does not work properly.
Danish: Dette enzym fungerer ikke normalt hos patienter med Fabrys sygdom.
English: For practical information about using Galafold, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Galafold, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Galafold have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Galafold?
English: For more information, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger fremgår af produktresuméet, der ligeledes er en del af denne EPAR.
English: How does Galafold work?
Danish: Hvordan virker Galafold?
English: Strength Pharmaceutical Form
Danish: Lægemiddelform Administration Emballage
English: CMDh agreement
Danish: CMDh-aftale
English: The PRAC also recommended that the treatment duration should be as short as possible.
Danish: PRAC anbefalede desuden, at behandlingsvarigheden er kortest mulig.
English: These amendments should be submitted within a Type IB variation.
Danish: Disse ændringer bør forelægges som en type IBændringsansøgning.
English: Hydroxyzine hydrochloride is a first generation antihistamine first authorised in the 1950s and available in 24 EEA member states.
Danish: Hydroxyzinhydrochlorid er et 1. generations antihistamin, der først blev godkendt i 1950'erne og er på markedet i 24 EØS-medlemsstater.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC;
Danish: • Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC) gennemgik proceduren i henhold til artikel 31 i direktiv 2001/83/EF,
English: The Hungarian competent authority considered it to be in the interest of the Union to refer the matter to the Pharmacovigilance Risk Assessment Committee (PRAC) under Article 31 of Directive 2001/83/EC.
Danish: De ungarske kompetente myndigheder fandt det i EU's interesse at indbringe sagen for Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC) i henhold til artikel 31 i direktiv 2001/83/EF.
English: For products with a paediatric formulation (syrup or oral solution), consideration should be given to making available an appropriate measuring device.
Danish: Produkter med en pædiatrisk formulering (sirup eller oral opløsning) skal være forsynet med passende doseringsanordning.
English: As the recommendation in children below 40 kg in weight is 2 mg/kg/day, the maximum daily dose in this population is 80 mg per day.
Danish: Da den anbefaledes dosis til børn med en legemsvægt på under 40 kg er 2 mg/kg/dag, er den maksimale dagsdosis hos denne population 80 mg.
English: The PRAC considered that the efficacy data did not raise any new concerns.
Danish: PRAC fandt, at dataene vedrørende virkning ikke gav anledning til nye betænkeligheder.
English: In the context of the review, the PRAC consulted the EMA Paediatric Committee (PDCO) and the Geriatric Expert Group (GEG).
Danish: Ved gennemgangen rådførte PRAC sig med EMA's pædiatriske udvalg og den geriatriske ekspertgruppe.
English: In addition, further changes to the product information were implemented, including a revision of the posology and a warning that use in the elderly is not recommended due to the anticholinergic effects.
Danish: Desuden blev der foretaget yderligere ændringer af produktinformationen, herunder revision af doseringen og indsættelse af en advarsel, der fraråder anvendelse hos ældre pga. de antikolinerge virkninger.
English: On 7th March 2014, the Hungarian competent authority was informed of new data on the potential risk for developing QT interval prolongation and/or Torsades de Pointes after exposure to hydroxyzine.
Danish: Den 7. marts 2014 blev de ungarske kompetente myndigheder underrettet om nye data vedrørende den potentielle risiko for forlænget QT-interval og/eller torsade de pointes efter eksponering for hydroxyzin.
English: This is in line with the concept of the repolarisation reserve, which proposes that the concomitant action of multiple factors is required for the exhaustion of the repolarisation reserve, opening the way to the occurrence of cardiac electrophysiological disturbances.
Danish: Dette er på linje med begrebet repolariseringsreserve, som indebærer, at der kræves medvirken af flere forskellige faktorer for at opbruge repolariseringsreserven, hvilket bevirker kardiale elektrofysiologiske forstyrrelser.
English: A maximum daily dose of 100 mg was found to be efficacious and well-tolerated and the PRAC therefore recommended restricting the maximum daily dose to 100 mg per day in adults, with corresponding changes in the paediatric and elderly populations, based on pharmacokinetic data.
Danish: Den maksimale dagsdosis på 100 mg blev fundet at være effektiv og veltolereret, hvorfor PRAC anbefalede at begrænse den maksimale dagsdosis for voksne til 100 mg og foretage tilsvarende ændringer for den pædiatriske population og for ældre på grundlag af farmakokinetiske data.
English: The products are nationally authorised as prescription-only medicines, for use in a number of indications including the treatment of anxiety disorders, skin conditions (such as pruritus, dermatitis or urticaria) for preoperative sedation and for the treatment of sleep disorders.
Danish: Produkterne er nationalt godkendt som receptpligtige lægemidler til en række indikationer, herunder bl.a. behandling af angstlidelser, hudlidelser (såsom pruritus, dermatitis eller urticaria), præoperativ sedation og behandling af søvnforstyrrelser.
English: • The PRAC considered that the available efficacy data did not raise any new concerns;
Danish: • PRAC fandt, at de foreliggende data vedrørende virkning ikke gav anledning til nye betænkeligheder,
English: The PRAC therefore recommended the variation to the terms of the marketing authorisation for the medicinal products referred to in Annex I and for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III of the PRAC recommendation.
Danish: anbefaler PRAC ændring af markedsføringstilladelsen for de lægemidler, der er omhandlet i bilag 1, for hvilke de relevante afsnit af produktresuméet og indlægssedlen fremgår af bilag III til PRAC's udtalelse.
English: The CMDh, having considered the PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and agrees that the marketing authorisations for hydroxyzine-containing medicinal products should be varied.
Danish: Efter gennemgang af PRAC's anbefaling tilslutter CMDh sig PRAC's overordnede videnskabelige konklusioner og er af den opfattelse, at markedsføringstilladelserne for lægemidler indeholdende hydroxyzin bør ændres.
English: Based on the available non-clinical data, the PRAC concluded that hydroxyzine has the potential to block hERG channels and other types of cardiac channels, resulting in a potential risk of QT interval prolongation and cardiac arrhythmia events.
Danish: Af de foreliggende ikke-kliniske data konkluderede PRAC, at hydroxyzin har potentiale for at blokere hERG-kanaler og andre kardiale kanaltyper, hvilket medfører potentiel risiko for forlænget QT-interval og kardiale arytmihændelser.
English: However, the CMDh considered that additional changes were necessary to the wording proposed for the Summary of Product Characteristics (SmPC) and the Package Leaflet, to provide appropriate guidance on the recommendation regarding the maximum daily dose in children and adolescents over 40 kg of body weight but below 18 years of age.
Danish: CMDh fandt det imidlertid nødvendigt med yderligere ændringer af den foreslåede ordlyd af produktresuméet og indlægssedlen med henblik på passende vejledning om anbefalingen om maksimal dagsdosis til børn og unge med legemsvægt over 40 kg og alder under 18 år.
English: The PRAC was requested to review the benefit-risk balance of hydroxyzinecontaining products, in particular giving consideration to their pro-arrhythmogenic potential in all authorised indications and target populations and to give its recommendation on whether any regulatory measures should be taken on the marketing authorisations.
Danish: PRAC blev anmodet om at gennemgå benefit/risk-forholdet for lægemidler indeholdende hydroxyzin, herunder deres arytmogene potentiale, for alle de godkendte indikationer og målpopulationer, og at fremsætte anbefalinger om, hvorvidt der bør træffes myndighedsforanstaltninger over for markedsføringstilladelserne.
English: The risk did not differ between indications and no dose effect could be observed based on postmarketing data, despite pre-clinical data suggesting that hydroxyzine has a dose-dependent hERG inhibitory effect.
Danish: Risikoen var den samme for forskellige indikationer, og der kunne ikke udledes dosisvirkning af data efter markedsføring, skønt de prækliniske data tyder på en dosisafhængig hERG-hæmmende virkning af hydroxyzin.