FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Committee considered that a number of neurological and psychiatric adverse events, which can be serious and potentially fatal, have been reported with the use of meprobamate, including under normal conditions of use.
Danish: • udvalget tog i betragtning, at der er indberettet en række neurologiske og psykiatriske bivirkninger af meprobamat, som kan være alvorlige og potentielt dødelige, også under normale anvendelsesbetingelser,
English: In conclusion, the CHMP was of the opinion that no risk minimisations measures could be identified that would adequately reduce the identified risks associated with the use of meprobamate to a clinically acceptable level within normal conditions of use.
Danish: Som konklusion var det CHMP's opfattelse, at der ikke kunne udpeges risikominimeringsforanstaltninger, der ville mindske de konstaterede risici ved brugen af meprobamat til et klinisk acceptabelt niveau under normale anvendelsesbetingelser.
English: With regard to risk minimisation measures, the CHMP reviewed the pharmacovigilance analyses of the impact of the risk minimisation measures for meprobamate and meprobamate/aceprometazine implemented in France and the limited additional risk minimisation measures proposed by the MAHs.
Danish: Hvad angår risikominimeringsforanstaltninger gennemgik CHMP de lægemiddelovervågningsanalyser af virkningen af de risikominimeringsforanstaltninger for meprobamat og meprobamat/aceprometazin, der var indført i Frankrig, og de begrænsede yderligere risikominimeringsforanstaltninger, der var foreslået af indehaverne af markedsføringstilladelserne.
English: • The CHMP considered, based on the assessment of the impact of the risk minimisation measures implemented in France and of the limited additional risk minimisation measures proposed by the MAHs, that no risk minimisations measures could be identified that would adequately reduce the identified risks associated with the use of meprobamate to a clinically acceptable level.
Danish: • på grundlag af vurderingen af virkningen af de i Frankrig gennemførte foranstaltninger til risikominimering og de begrænsede yderligere risikominimeringsforanstaltninger, der var foreslået af indehaverne af markedsføringstilladelserne, fandt CHMP, at der ikke kan udpeges risikominimeringsforanstaltninger, som vil reducere de konstaterede risici ved anvendelsen af meprobamat til et klinisk acceptabelt niveau,
English: The CHMP considered that the data identified a risk of pharmacodependence, based on utilization data issued from a claims database showing prolonged use of meprobamate.
Danish: CHMP fandt, at der var risiko for lægemiddelafhængighed på grundlag af data vedrørende anvendelsen fra en database over sygeforsikringskrav, som viste langvarig brug af meprobamat.
English: • The Committee noted that meprobamate has a relatively narrow therapeutic index and therefore considered that accidental overdoses, which are often serious and can be fatal, are a serious risk with meprobamate.
Danish: • udvalget konstaterede, at meprobamat har et relativt smalt terapeutisk indeks, og anså derfor accidentel overdosering, der ofte er alvorlig og kan være dødelig, for at udgøre en alvorlig risiko ved anvendelsen af meprobamat,
English: The CHMP reviewed the MAH proposals but considered them insufficient to reduce the identified risk of meprobamate.
Danish: CHMP gennemgik forslagene fra indehaverne af markedsføringstilladelserne, man fandt dem utilstrækkelige til at nedsætte den udpegede risiko ved meprobamat.
English: With regards to safety, the CHMP considered that a number of serious neurological (coma, loss of consciousness) and psychiatric (pharmacodependence and withdrawal symptoms) adverse events, which can be serious and potentially fatal, have been reported with the use of meprobamate, including under normal conditions of use.
Danish: Vedrørende sikkerheden tog CHMP i betragtning, at der er indberettet en række alvorlige bivirkninger af meprobamat, dels neurologiske (koma, bevidsthedstab), dels psykiatriske (lægemiddelafhængighed og abstinenssymptomer), som kan være alvorlige og potentielt dødelige, også under normale anvendelsesbetingelser.
English: System Organ Classes (SOCs) nervous system disorders (29%) and procedure-related lesions/intoxications and complications (12%).
Danish: I undersøgelsesperioden var de vigtigste rapporterede bivirkninger hovedsagelig i systemorganklasserne (SOC) nervesystemet (29 %) og procedurebetingede skader/forgiftninger og komplikationer (12 %).
English: In addition, while the efficacy remains largely unchanged since the granting of the initial marketing authorisation, the CHMP was of the opinion that the available data showed only very limited clinical efficacy of meprobamate in its approved indications.
Danish: Uanset at virkningen stort set er uændret siden udstedelsen af den oprindelige markedsføringstilladelse, fandt CHMP, at de foreliggende data kun dokumenterer meget begrænset klinisk virkning af meprobamat til de godkendte indikationer.
English: • The CHMP considered that meprobamate has a potential for pharmacodependence under normal conditions of use and that as a consequence, meprobamate is also associated with a risk of serious withdrawal symptoms.
Danish: • CHMP tog i betragtning, at meprobamat har potentiale for lægemiddelafhængighed under normale anvendelsesbetingelser og derfor er forbundet med risiko for alvorlige abstinenssymptomer,
English: This analysis assessed the impact of the implementation of risk minimisation measures (restriction of the indication and the posology as well as a reduction of the pack size) on its risk profile.
Danish: Denne analyse vurderede virkningen på produktets risikoprofil af gennemførelsen af risikominimeringsforanstaltningerne (indskrænkning af indikationer og dosis samt begrænsning af pakningsstørrelsen).
English: The CHMP noted that meprobamate has a relatively narrow therapeutic index, with a steep dose-response curve, as supported by the available data which identified a number of accidental overdoses which were often serious, including fatalities.
Danish: CHMP bemærkede, at meprobamat har et forholdsvis smalt terapeutisk indeks med en stejl dosis-responskurve, hvilket ses af de foreliggende data, der viser en række tilfælde er accidentel overdosering, som ofte er alvorlige og for nogles vedkommende dødelige.
English: • The CHMP is of the opinion that patients treated for alcohol withdrawal are at risk of potential serious adverse reactions due to impaired liver function.
Danish: • CHMP var af den opfattelse, at patienter, der behandles for at alkoholabstinenser, risikerer potentielle alvorlige bivirkninger som følge af nedsat leverfunktion,
English: Finally, the CHMP was of the opinion that patients treated for alcohol withdrawal are at risk of potential serious adverse reactions due to impaired liver function.
Danish: Endelig var det CHMP's opfattelse, at patienter i behandling for alkoholabstinenser risikerer alvorlige bivirkninger som følge af nedsat leverfunktion.
English: Noting that meprobamate has a relatively narrow therapeutic index, with a steep dose-response curve, the CHMP therefore concluded that accidental overdoses are a serious risk with meprobamate.
Danish: CHMP konstaterede, at meprobamat har et forholdsvis smalt terapeutisk indeks med en stejl dosis-responskurve, hvorfor udvalget konkluderede, at accidentel overdosering er en alvorlig risiko ved meprobamat.
English: In conclusion, while the efficacy remains largely unchanged since the granting of the initial marketing authorisation, the CHMP was of the opinion that the available data showed only very limited clinical efficacy of meprobamate in its approved indications.
Danish: Virkningen er i det store hele uændret siden udstedelsen af den oprindelige markedsføringstilladelse, men CHMP konkluderede, at den foreliggende dokumentation kun viser en meget begrænset klinisk virkning af meprobamat til de godkendte indikationer.
English: In conclusion, taking into account the serious neurological and psychiatric adverse events associated with the use of meprobamate, including under normal conditions of use, the risk of accidental overdoses and of pharmacodependence associated with withdrawal symptoms, the very limited clinical evidence of meprobamate and the lack of effectiveness of the implemented and proposed risk minimisation measures, the CHMP was of the opinion that the risk-benefit balance of meprobamatecontaining medicinal products for oral use is not positive under normal conditions of use.
Danish: Som konklusion var det CHMP's opfattelse, at benefit/risk-forholdet for lægemidler indeholdende meprobamat til oral indgift ikke er positivt under normale anvendelsesbetingelser i betragtning af de alvorlige neurologiske og psykiatriske bivirkninger, der er forbundet med brug af meprobamat under normale anvendelsesbetingelser, risikoen for accidentel overdosering og for lægemiddelafhængighed og dermed forbundne abstinenssymptomer, den meget begrænsede kliniske dokumentation for meprobamat og den manglende effektivitet af de gennemførte og foreslåede risikominimeringsforanstaltninger.
English: The CHMP also considered that meprobamate has a potential for pharmacodependence after prolonged use, leading to a risk of withdrawal symptoms which are serious and can be fatal.
Danish: CHMP tog desuden i betragtning, at meprobamat har potentiale for lægemiddelafhængighed efter langvarig brug, hvilket medfører risiko for alvorlige abstinenssymptomer, som kan være dødelige.
English: The CHMP therefore concluded that meprobamate has a potential for pharmacodependence after prolonged use, leading to a risk of withdrawal symptoms which are serious and can be fatal.
Danish: CHMP konkluderede på dette grundlag, at meprobamat efter langvarig brug har potentiale for lægemiddelafhængighed med risiko for abstinenssymptomer, som er alvorlige og kan have dødelig udgang.
English: The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products cannot be fully excluded.
Danish: Enzymet, der er ansvarlig for metaboliseringen af desloratadin, er endnu ikke blevet identificeret , og nogle interaktioner med andre lægemidler kan derfor ikke fuldstændigt udelukkes.
English: Treatment with Azomyr also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Danish: Behandling med Azomyr reducerede også signifikant påvirkningen af søvn og daglig funktionsevne, målt ved en fire-points skala, der anvendtes for at vurdere disse parametre.
English: Use caution when taking Azomyr with alcohol.
Danish: Du skal udvise forsigtighed, hvis du tager Azomyr sammen med alkohol.
English: There are no known interactions of Azomyr with other medicines.
Danish: Der er ingen kendte interaktioner mellem Azomyr og andre lægemidler.
English: Azomyr effectively controlled symptoms for 24 hours.
Danish: Azomyr regulerede effektivt symptomerne i 24 timer.
English: However, the safety of desloratadine syrup formulation, which contains the same concentration of desloratadine as Azomyr oral solution, was demonstrated in three paediatric trials.
Danish: Sikkerheden af desloratadin syrup-formuleringen, som indeholder samme koncentration af desloratadin som Azomyr oral opløsning, blev imidlertid påvist i tre pædiatriske studier.
English: What Azomyr is Azomyr contains desloratadine which is an antihistamine.
Danish: Hvad Azomyr er Azomyr indeholder desloratadin, som er et antihistamin.
English: As Azomyr oral solution contains the same concentration of desloratadine, no bioequivalence study was required and it is expected to be equivalent to the syrup and tablet.
Danish: Da Azomyr oral opløsning indeholder samme koncentration af desloratadin, var et bioækvivalensstudie ikke nødvendigt, og den orale opløsning forventes at være ækvivalent med syruppen og tabletten.
English: In clinical trials in a paediatric population, the desloratadine syrup formulation was administered to a total of 246 children aged 6 months through 11 years.
Danish: I kliniske studier i en pædiatrisk population blev desloratadin syrup anvendt til ialt 246 børn i alderen 6 måneder til 11 år.
English: When Azomyr should be used
Danish: Hvornår Azomyr skal bruges
English: In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Azomyr was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
Danish: I to placebokontrollerede seks-ugers studier hos patienter med kronisk idiopatisk urticaria var Azomyr effektivt til at lindre kløe og mindske størrelsen og antallet af kløende udslæt ved slutningen af det første doseringsinterval.
English: Therefore, the efficacy of Azomyr orodispersible tablet is expected to be the same as with the Azomyr tablet formulation.
Danish: Virkningen af Azomyr smeltetablet forventes derfor at være den samme som med Azomyr tabletformuleringen.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Azomyr therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Hvorvidt amningen skal fortsættes eller om behandlingen med Azomyr skal seponeres/undlades skal vurderes ud fra afvejning af barnets fordele ved amning og kvindens fordele ved behandling.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Azomyr findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: If you forget to take Azomyr
Danish: Hvis du har glemt at tage Azomyr
English: Water had no effect on the bioavailability of Azomyr orodispersible tablets.
Danish: Vand har ingen indflydelse på biotilgængeligheden for Azomyr smeltetabletter.
English: Talk to your doctor, pharmacist or nurse before taking Azomyr: - if you have poor kidney function.
Danish: Kontakt lægen, apoteket eller sundhedspersonalet, før du tager Azomyr: - hvis du har dårlig nyrefunktion.
English: A. MANUFACTURIERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Efficacy of Azomyr syrup has not been investigated in paediatric trials in children less than 12 years of age.
Danish: Virkningen af Azomyr syrup er ikke undersøgt i pædiatriske studier med børn under 12 år.
English: Clinical efficacy and safety In a multiple dose trial, Azomyr orodispersible tablets were well tolerated.
Danish: Klinisk virkning og sikkerhed I et flerdosisstudie var Azomyr smeltetabletter veltolereret.
English: As a precautionary measure, it is preferable to avoid the use of Azomyr during pregnancy.
Danish: For en sikkerheds skyld bør Azomyr undgås under graviditet.
English: In clinical studies with Azomyr, the following side effects were reported as:
Danish: I kliniske studier med Azomyr er følgende bivirkninger blevet rapporteret som:
English: Taking Azomyr is not recommended if you are pregnant or nursing a baby.
Danish: Det frarådes, at du tager Azomyr, hvis du er gravid, eller hvis du ammer dit spædbarn.
English: Adverse reactions seen with Azomyr
Danish: Bivirkninger set med Azomyr
English: During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Danish: Under markedsføringen af Azomyr er tilfælde af alvorlige allergiske reaktioner (vejrtrækningsbesvær, hiven efter vejret, kløe, kløende udslæt og hævelse) blevet rapporteret meget sjældent.
English: The efficacy of Azomyr tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Danish: Virkningen af Azomyr-tabletter er ikke blevet tydeligt vist i studier med unge patienter mellem 12 og 17 år.
English: If you forget to take Azomyr orodispersible tablet If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule.
Danish: Hvis du har glemt at tage Azomyr smeltetabletter Hvis du glemmer at tage din medicin til tiden, så tag den snarest muligt og vend derefter tilbage til din sædvanlige medicineringsplan.
English: Azomyr tablets effectively controlled symptoms for 24 hours.
Danish: Azomyr-tabletter regulerede effektivt symptomerne i 24 timer.
English: Do not use this medicine if you notice any change in the appearance of Azomyr orodispersible tablet.
Danish: Tag ikke lægemidlet, hvis du bemærker ændringer i udseendet af Azomyr smeltetabletter.
English: Adults During the marketing of Azomyr, the following side effects were reported as:
Danish: Voksne Efter markedsføring af Azomyr er følgende bivirkninger blevet rapporteret:
English: At the recommended dose, Azomyr 5 mg orodispersible tablet was found to be bioequivalent to the Azomyr 5 mg conventional tablet formulation of desloratadine.
Danish: Ved den anbefalede dosis blev Azomyr 5 mg smeltetablet fundet værende bioækvivalent med den konventionelle Azomyr 5 mg tabletformulering af desloratadin.
English: Additionally, Azomyr orodispersible tablet may be taken with or without a meal.
Danish: Herudover kan Azomyr smeltetabletter tages med eller uden mad.
English: Azomyr was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Danish: Azomyr var effektivt til at lindre generne ved sæsonbetinget allergisk rhinitis, vist ved den totale score i rhino-konjunktivitis livskvalitetsspørgeskemaet.
English: Azomyr oral solution, is supplied in 30, 50, 60, 100, 120, 150, 225 and 300 ml size Type III amber glass bottles closed with a plastic child resistant (C/R) screw closure having a multi-ply polyethylenefaced liner.
Danish: Azomyr oral opløsning leveres i flasker med 30, 50, 60, 100, 120, 150, 225 og 300 ml i type III ravgule glasflasker lukket med et børnesikkert polypropylenskruelåg med en indsats af multi-ply polyethylen.
English: Azomyr tablets contain lactose.
Danish: Azomyr-tabletter indeholder lactose.
English: Azomyr 2.5 mg orodispersible tablet is light red, speckled, and round with “K” branded on one side.
Danish: Azomyr 2,5 mg smeltetabletter er lys rød, plettet og rund med ”K” trykt på den ene side.
English: Azomyr oral solution contains sorbitol.
Danish: Azomyr oral opløsning indeholder sorbitol.
English: In single-dose crossover studies of Azomyr 5 mg orodispersible tablets with Azomyr 5 mg conventional tablets, the formulations were bioequivalent.
Danish: I enkeltdosis overkrydsningsstudier af Azomyr 5 mg smeltetablet over for konventionelle Azomyr 5 mg tabletter var formuleringerne bioækvivalente.
English: Azomyr orodispersible tablet with food, drink and alcohol Azomyr orodispersible tablet does not need to be taken with water or liquid.
Danish: Brug af Azomyr smeltetabletter sammen med mad, drikke og alkohol Azomyr smeltetabletter behøver ikke at blive taget med vand eller væske.
English: Azomyr is supplied in blisters comprised of laminate blister film with foil lidding.
Danish: Azomyr leveres i blistre af formstøbt blisterfilm med folielåg.
English: In a clinical pharmacology trial, Azomyr tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Danish: I et klinisk farmakologisk studie forstærkede Azomyr-tabletter indtaget sammen med alkohol ikke alkohols præstationshæmmende virkninger (se pkt.
English: Azomyr 5 mg orodispersible tablet is light red, speckled, and round with “A” branded on one side.
Danish: Azomyr 5 mg smeltetabletter er lys rød, plettet og rund med ”A” trykt på den ene side.
English: During the marketing of Azomyr, the following side effects were reported as:
Danish: Efter markedsføring af Azomyr er følgende bivirkninger blevet rapporteret:
English: This product contains 1.4 mg of phenylalanine per 2.5 mg dose of Azomyr orodispersible tablet.
Danish: Dette lægemiddel indeholder 1,4 mg phenylalanin per 2,5 mg Azomyr smeltetablet.
English: Azomyr contains lactose
Danish: Azomyr indeholder lactose
English: Children 1 through 5 years of age: 2.5 ml (1.25 mg) Azomyr oral solution once a day.
Danish: Børn i alderen 1 til 5 år: 2,5 ml (1,25 mg) Azomyr oral opløsning en gang daglig.
English: Azomyr tablets were effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Danish: Azomyr-tabletter lindrede effektivt generne ved sæsonbetonet allergisk rhinitis, vist ved den totale score i rhino-konjunktivitis livskvalitetsspørgeskemaet.
English: If you take more Azomyr oral solution than you should Take Azomyr oral solution only as it is prescribed for you.
Danish: Hvis du har taget for meget Azomyr oral opløsning Tag udelukkende Azomyr oral opløsning således, som det er ordineret til dig.
English: In clinical studies in most children and adults, side effects with Azomyr were about the same as with a dummy solution or tablet.
Danish: Hos de fleste børn og voksne var bivirkningerne i kliniske studier med Azomyr nogenlunde de samme som ved en placeboopløsning eller placebotablet.
English: Efficacy of Azomyr oral solution has not been investigated in separate paediatric trials.
Danish: Virkningen af Azomyr oral opløsning er ikke vurderet i særlige studier hos børn.
English: Azomyr oral solution contains sorbitol
Danish: Azomyr oral opløsning indeholder sorbitol
English: This product contains 2.9 mg of phenylalanine per 5 mg dose of Azomyr orodispersible tablet.
Danish: Dette lægemiddel indeholder 2,9 mg phenylalanin per 5 mg Azomyr smeltetablet.
English: Adults and adolescents (12 years of age and over) The recommended dose of Azomyr is one tablet once a day.
Danish: Voksne og unge (i alderen 12 år og derover) Den anbefalede dosis Azomyr er en tablet en gang dagligt.
English: Azomyr 5 mg film-coated tablets are packed in blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50 or 100 tablets.
Danish: Azomyr 5 mg filmovertrukne tabletter er pakket i blisterpakninger med 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50 eller 100 tabletter.
English: Azomyr is an antiallergy medicine that does not make you drowsy.
Danish: Azomyr er et lægemiddel mod allergi, som ikke gør dig døsig.
English: Children 6 to 11 years of age: the recommended dose of Azomyr is one 2.5 mg orodispersible tablet placed in mouth once a day.
Danish: Børn i alderen 6 til 11 år: den anbefalede dosis Azomyr er en 2,5 mg smeltetablet lagt i munden en gang dagligt.
English: Other medicines and Azomyr
Danish: Brug af anden medicin sammen med Azomyr
English: Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Azomyr.
Danish: Med hensyn til varigheden af behandlingen, vil din læge bestemme hvilken type allergisk snue, du lider af, og vil fastsætte, hvor længe du skal tage Azomyr.
English: Azomyr orodispersible tablets are supplied in unit dose blisters comprised of laminate blister film with foil lidding.
Danish: Azomyr smeltetabletter leveres i enkeltdosisblistre af formstøbt blisterfilm med folielåg.
English: Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Azomyr oral solution.
Danish: Med hensyn til varigheden af behandlingen, vil din læge bestemme hvilken type allergisk snue, du lider af, og vil fastsætte, hvor længe du skal tage Azomyr oral opløsning.
English: Azomyr oral solution with food, drink and alcohol Azomyr may be taken with or without a meal.
Danish: Brug af Azomyr oral opløsning sammen med mad, drikke og alkohol Azomyr kan tages med eller uden mad.
English: Children 6 through 11 years of age: 5 ml (2.5 mg) Azomyr oral solution once a day.
Danish: Børn i alderen 6 til 11 år: 5 ml (2,5 mg) Azomyr oral opløsning en gang daglig.
English: Azomyr with food, drink and alcohol Azomyr may be taken with or without a meal.
Danish: Brug af Azomyr sammen med mad, drikke og alkohol Azomyr kan tages med eller uden mad.
English: Azomyr 0.5 mg/ml oral solution
Danish: Azomyr 0,5 mg/ml oral opløsning