FrancophonIA/ELRC3.0 huggingface dataset:
English: As required by Article 107, France informed the CHMP of its intention to suspend the marketing authorisations in France, so that the Committee could prepare an opinion on whether the marketing authorisations for products containing meprobamate should be maintained, changed, suspended or withdrawn across the EU.
Danish: I overensstemmelse med artikel 107 underrettede Frankrig CHMP om, at det havde til hensigt at suspendere markedsføringstilladelserne i Frankrig, med henblik på, at udvalget ville udarbejde en udtalelse om, hvorvidt markedsføringstilladelserne for lægemidler indeholdende meprobamat bør opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: These included restricting these medicines to patients who could not use alternative medicines and limiting treatment to a maximum of twelve weeks.
Danish: Disse bestod i, at lægemidlernes anvendelse er begrænset til patienter, der ikke kan bruge andre lægemidler, og at behandlingsperioden er indskrænket til maksimalt 12 uger.
English: Meprobamate is a sedative medicine used to treat the symptoms of anxiety and related conditions, including anxiety states, alcohol withdrawal, migraine attacks, digestive disorders, muscle tension or cramps and insomnia.
Danish: meprobamat er et beroligende lægemiddel, der anvendes til behandling af symptomer på angst og tilknyttede tilstande, herunder angsttilstande, alkoholabstinenser, migræneanfald, fordøjelsesbesvær, muskelspændinger og kramper samt søvnløshed.
English: The Committee also considered information requested from the companies that market meprobamatecontaining medicines in the EU.
Danish: Udvalget gennemgik desuden de anmodede oplysninger fra virksomheder, der markedsfører lægemidler indeholdende meprobamat i EU.
English: This included data from studies, post-marketing surveillance and the published literature, as well as from poison control centres on cases of poisoning with meprobamate.
Danish: Oplysningerne bestod af undersøgelser, overvågning efter markedsføring og publiceret litteratur samt oplysninger fra giftcentre om forgiftningstilfælde forårsaget af meprobamat.
English: Meprobamatecontaining medicines can only be obtained with a prescription.
Danish: Lægemidler indeholdende meprobamat udleveres kun efter recept.
English: • Patients should not stop their treatment without speaking to their doctor, since stopping treatment abruptly may lead to severe withdrawal symptoms.
Danish: • Patienterne bør ikke ophøre med behandlingen uden at have aftalt det med lægen, da pludseligt stop af behandlingen kan medføre svære abstinenssymptomer.
English: The Committee considered that these risks were increased by the danger of unintentional overdose due to the small difference between the treating dose and the dose that can harm patients, including elderly people.
Danish: Udvalget tog i betragtning, at denne risiko forstærkes af muligheden for utilsigtet overdosering som følge af den lille forskel mellem behandlingsdosis og skadelig dosis, navnlig hos ældre.
English: The CHMP considered the benefit-risk assessment carried out by the French medicines agency for meprobamate-containing medicines marketed in France, covering data from the period 2009 to 2011.
Danish: CHMP gennemgik den vurdering af fordele og risici, som den franske lægemiddelstyrelse havde udført for lægemidler, der indeholder meprobamat og markedsføres i Frankrig, for perioden 2009 til 2011.
English: The CHMP also noted that some patients can become addicted to the medicine, leading to serious side effects if they stop treatment abruptly after using it for a long time.
Danish: CHMP konstaterede desuden, at nogle patienter kan blive afhængige af lægemidlet, hvilket fører til alvorlige bivirkninger, hvis de stopper behandlingen brat efter at have brugt det i lang tid.
English: • Prescribers should be aware that the availability of meprobamate-containing medicines will decrease as the withdrawal from the market takes place according to national timeframes.
Danish: • De ordinerende læger bør være opmærksomme på, at lægemidler indeholdende meprobamat vil blive vanskeligere tilgængelige i takt med tilbagetrækningen fra markedet inden for de nationale tidsrammer.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of meprobamate do not outweigh its risks, and that all marketing authorisations for oral medicines containing meprobamate should be suspended throughout the European Union (EU).
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved meprobamat ikke er større end risiciene, og anbefalede, at alle markedsføringstilladelser for orale lægemidler indeholdende meprobamat suspenderes i hele Den Europæiske Union (EU).
English: • Doctors should not start new patients on meprobamate-containing medicines.
Danish: • Læger bør ikke sætte nye patienter i behandling med lægemidler indeholdende meprobamat.
English: In July 2011, the French medicines regulatory agency announced its intention to suspend the marketing authorisations for oral meprobamate-containing medicines because of serious side effects seen with these medicines.
Danish: I juli 2011 meddelte den franske lægemiddelstyrelse, at den havde til hensigt at suspendere markedsføringstilladelserne for orale lægemidler indeholdende meprobamat, da der var konstateret alvorlige bivirkninger med disse lægemidler.
English: The Committee recommended that the suspension should be implemented gradually to avoid the risk of severe withdrawal symptoms in patients stopping treatment abruptly.
Danish: Udvalget anbefalede, at suspenderingen gennemføres gradvist for at undgå risikoen for svære abstinenssymptomer hos patienter, der pludselig ophører med behandlingen.
English: The European Medicines Agency has completed a review of the safety and effectiveness of oral meprobamate-containing medicines, due to serious side effects seen with the medicine.
Danish: Det Europæiske Lægemiddelagentur har gennemgået sikkerheden og virkningen af orale lægemidler indeholdende meprobamat på grund af alvorlige bivirkninger, der er iagttaget med meprobamat.
English: The Committee acknowledged that it is important to allow for patients currently taking meprobamatecontaining medicines to be transferred gradually to alternative treatments, particularly due to the risks of severe withdrawal symptoms on stopping treatment abruptly.
Danish: Udvalget tog i betragtning, at det er vigtigt, at patienter i nuværende behandling med lægemidler indeholdende meprobamat får mulighed for gradvis overgang til andre behandlinger, navnlig på grund af risikoen for svære abstinenssymptomer ved pludseligt ophør af behandlingen.
English: The CHMP noted that there was a risk of serious and potentially fatal side effects in patients taking meprobamate-containing medicines under normal conditions of use, including coma.
Danish: CHMP konstaterede, at der er risiko for alvorlige og eventuelt dødelige bivirkninger, herunder koma, ved brug af lægemidler indeholdende meprobamat, og at disse bivirkninger optræder under normale anvendelsesbetingelser.
English: • Patients currently using meprobamate-containing medicines should speak to their doctor at their next scheduled appointment to review their treatment.
Danish: • Patienter, der på nuværende tidspunkt er i behandling med lægemidler indeholdende meprobamat, bør bede lægen tage stilling til deres behandling ved den næste planlagte konsultation.
English: • Doctors should review the treatment of patients currently taking meprobamate-containing medicines with a view to switching them to alternative treatments, in line with national recommendations for the condition being treated.
Danish: • For patienter i nuværende behandling med lægemidler indeholdende meprobamat bør lægen overveje at lade dem skifte til anden behandling i overensstemmelse med de nationale anbefalinger fra den pågældende sygdom.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of oral meprobamate-containing medicines do not outweigh their risks, and therefore recommended that all marketing authorisations for oral meprobamate-containing medicines should be suspended throughout the EU.
Danish: Efter vurdering af de nuværende oplysninger og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved orale lægemidler indeholdende meprobamat ikke er større end risiciene.
English: These included confusion and loss of consciousness, particularly in elderly people, and the risk of addiction to the medicine when used for prolonged periods, with severe withdrawal symptoms on stopping treatment abruptly.
Danish: Bivirkningerne bestod i omtågethed og bevidsthedstab, navnlig hos ældre.
English: The company requested a re-examination of the initial opinion.
Danish: Virksomheden har anmodet om en fornyet overvejelse af den oprindelige udtalelse.
English: What is Fanaptum?
Danish: Hvad er Fanaptum?
English: The company presented the results of 2 main studies of 4 and 26 weeks' duration.
Danish: Virksomheden fremlagde resultaterne af to hovedundersøgelser af fire og 26 ugers varighed.
English: It was to be available as tablets.
Danish: Det skulle have kunnet fås som tabletter.
English: The Committee considered that this risk was significant despite the measures proposed by the company to minimise it.
Danish: Udvalget fandt, at dette var en betydelig risiko på trods af de foranstaltninger, som virksomheden havde foreslået for at minimere den.
English: What was Fanaptum expected to be used for?
Danish: Hvad forventedes Fanaptum anvendt til?
English: It measured the time until the patient's symptoms came back (first relapse).
Danish: Her blev det målt, hvor lang tid der gik, før patientens symptomer vendte tilbage (første tilbagefald).
English: The company that applied for authorisation is Vanda Pharmaceuticals Ltd.
Danish: Den virksomhed, der har indgivet ansøgningen, er Vanda Pharmaceuticals Ltd.
English: By blocking these receptors, iloperidone is expected to normalise the activity of the brain and reduce the symptoms of the disease.
Danish: Ved at blokere disse receptorer forventes iloperidon at normalisere hjernens aktivitet og mindske symptomerne på sygdommen.
English: Fanaptum was expected to be used to treat schizophrenia in adults.
Danish: Fanaptum forventedes anvendt til behandling af skizofreni hos voksne.
English: The company informed the CHMP that there are no ongoing clinical studies with Fanaptum in the EU at the present time.
Danish: Virksomheden har oplyst CHMP om, at der ikke på nuværende tidspunkt er igangværende kliniske undersøgelser med Fanaptum i EU.
English: The measures included restricting use to patients whose treatment with another antipsychotic did not work or was no longer tolerated, and prohibiting use in patients who cannot effectively break down the medicine or are taking certain other medicines.
Danish: Foranstaltningerne bestod i at begrænse anvendelsen til patienter, hvis behandling med et andet antipsykotisk lægemiddel ikke virkede eller ikke længere tåltes, og forbyde anvendelse hos patienter, som ikke kan nedbryde lægemidlet, eller som tager visse andre lægemidler.
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Danish: Skizofreni er en psykisk sygdom med en række symptomer, blandt andet desorganiseret tankegang og tale, hallucinationer (at høre eller se ting, som ikke er der), mistænksomhed og vrangforestillinger.
English: Iloperidone is thought to block receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin), which play a role in schizophrenia.
Danish: Iloperidon menes at blokere receptorerne for neurotransmitterne dopamin og 5-hydroxytryptamin (også kaldet serotonin), der spiller en rolle ved skizofreni.
English: Refusal of the marketing authorisation for Fanaptum (iloperidone) EMA/729957/2017
Danish: Afslag på ansøgningen om markedsføringstilladelse for Fanaptum (iloperidon) EMA/729957/2017
English: In addition, the Committee was still concerned by the modest effectiveness of Fanaptum and its delayed onset of action.
Danish: Desuden havde udvalget fortsat betænkeligheder ved Fanaptums beskedne effektivitet og forsinkede virkning.
English: As a result, some patients may have increased blood concentrations of Fanaptum, which would increase their risk of QT prolongation.
Danish: Som følge heraf kan nogle patienter have et øget indhold af Fanaptum i blodet, hvilket ville øge deres risiko for QT-forlængelse.
English: The longterm study, involving 193 patients, compared Fanaptum with placebo.
Danish: I den langvarige undersøgelse, der omfattede 193 patienter, blev Fanaptum sammenlignet med placebo.
English: Neurotransmitters are substances that nerve cells use to communicate with neighbouring cells.
Danish: Neurotransmittere er stoffer, som nervecellerne anvender til deres indbyrdes kommunikation.
English: On 20 July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Fanaptum, intended for the treatment of schizophrenia.
Danish: Den 20. juli 2017 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Fanaptum, der er beregnet til behandling af skizofreni.
English: Refusal of the marketing authorisation for Fanaptum (iloperidone)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Fanaptum (iloperidon)
English: Fanaptum is a medicine that contains the active substance iloperidone.
Danish: Fanaptum er et lægemiddel, der indeholder det aktive stof iloperidon.
English: At the time of the initial recommendation, the CHMP considered that the effectiveness of Fanaptum in studies was modest.
Danish: Da den oprindelige anbefaling blev fremsat, vurderede CHMP, at effektiviteten af Fanaptum i undersøgelserne var beskeden.
English: The active substance in Fanaptum, iloperidone, is an antipsychotic medicine.
Danish: Det aktive stof i Fanaptum, iloperidon, er et antipsykotisk lægemiddel.
English: The CHMP also noted that the medicine starts to have its effects after 2 to 3 weeks of treatment, which is a concern when treating sudden (acute) episodes of schizophrenia.
Danish: CHMP bemærkede også, at lægemidlets virkning starter efter to til tre ugers behandling, hvilket er et problem ved behandling af pludselige (akutte) tilfælde af skizofreni.
English: During the re-examination the CHMP looked again at the data submitted by the company and the company's proposal to introduce several new measures to manage the risk of QT prolongation.
Danish: Under den fornyede overvejelse undersøgte CHMP igen de data, virksomheden havde indsendt, og virksomhedens forslag om at træffe en række nye foranstaltninger til at håndtere risikoen for QTforlængelse.
English: In terms of safety, the CHMP was concerned about the medicine's effects on the heart: Fanaptum causes QT prolongation, a change in the heart's electrical activity which can cause a life-threatening abnormality of heart rhythm.
Danish: Hvad sikkerheden angår, var CHMP betænkeligt ved lægemidlets virkninger på hjertet, idet Fanaptum forårsager QT-forlængelse, en ændring i hjertets elektriske aktivitet, som kan forårsage en livstruende abnormitet i hjerterytmen.
English: The way it works is unclear, but it is thought to attach to certain receptors (targets) for neurotransmitters on nerve cells in the brain.
Danish: Dets nøjagtige virkningsmekanisme kendes ikke, men det menes at binde sig til visse receptorer (mål) for neurotransmittere på overfladen af nervecellerne i hjernen.
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 9 November 2017.
Danish: Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en fornyet overvejelse af udtalelsen og bekræftede den 9. november 2017 afslaget på ansøgningen om markedsføringstilladelse.
English: In this study, the main measure of effectiveness was the change in the patients' symptoms after 4 weeks, assessed using a standard scale for schizophrenia.
Danish: I undersøgelsen blev virkningen hovedsagelig bedømt på ændringen i symptomerne efter fire uger, vurderet på en standardskala for skizofreni.
English: Finally, the CHMP was concerned that Fanaptum is broken down in the body by liver enzymes whose activity is reduced in certain patients and by certain other medicines.
Danish: Endelig havde CHMP betænkeligheder ved, at Fanaptum i kroppen nedbrydes af leverenzymer, hvis aktivitet bliver reduceret hos visse patienter og af visse andre lægemidler.
English: However, the CHMP was still concerned about the risk of QT prolongation and considered that the measures proposed would not appropriately address this risk in clinical practice.
Danish: CHMP havde imidlertid stadig betænkeligheder ved risikoen for QT-forlængelse og vurderede, at de foreslåede foranstaltninger ikke ville være tilstrækkelige til at afhjælpe denne risiko i klinisk praksis.
English: How does Fanaptum work?
Danish: Hvordan virker Fanaptum?
English: Therefore, the CHMP concluded that the benefits of Fanaptum did not outweigh its risks and maintained its previous recommendation that the medicine be refused marketing authorisation.
Danish: CHMP konkluderede derfor, at fordelene ved Fanaptum ikke opvejede risiciene, og udvalget fastholdt sin tidligere anbefaling om afslag på ansøgningen om markedsføringstilladelse.
English: The short-term study, involving 567 patients, compared Fanaptum with the schizophrenia medicine ziprasidone and with placebo (a dummy treatment).
Danish: I den kortvarige undersøgelse, der omfattede 567 patienter, blev Fanaptum sammenlignet med skizofrenilægemidlet ziprasidon og placebo (en uvirksom behandling).
English: A clinical response is normally seen within 3-4 days.
Danish: Et klinisk respons ses normalt i løbet af 3-4 dage.
English: Date of first authorisation: 23/02/2012
Danish: Dato for første markedsføringstilladelse: 23/02/2012
English: Please carefully follow the instructions of the veterinarian.
Danish: Følg venligst dyrlægens anvisninger.
English: All major metabolites have been shown to be pharmacologically inactive.
Danish: Alle større metabolitter har vist sig at være farmakologisk inaktive.
English: The mouth should not be opened any wider than necessary to facilitate application.
Danish: Munden skal ikke åbnes mere, end det er nødvendigt for at gøre applikationen mulig.
English: RevitaCAM is presented in:
Danish: RevitaCAM er tilgængelig som:
English: This product is for dogs and should not be used in cats as it is not suitable for use in this species.
Danish: Dette præparat er til hunde, og bør ikke anvendes til katte, da det ikke er egnet til at bruge hos denne dyreart.
English: Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Danish: Behandlingen skal seponeres senest efter 10 dage, hvis der ikke ses klinisk forbedring.
English: Each ml contains:
Danish: Hver ml indeholder
English: Approximately 97 % of meloxicam is bound to plasma proteins.
Danish: Ca. 97 % meloxicam er bundet til plasmaproteiner.
English: Interactions with other medicinal products and other forms of interaction:
Danish: Interaktioner med andre lægemidler og andre former for interaktion:
English: The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
Danish: Den behandlingsfrie periode skal imidlertid tage de farmakologiske egenskaber af de præparater, der blev anvendt tidligere, i betragtning.
English: These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Danish: Disse bivirkninger forekommer normalt i løbet af den første behandlingsuge, og er i de fleste tilfælde forbigående og forsvinder efter seponering af behandlingen, men i meget sjældne tilfælde kan de være alvorlige eller fatale.
English: Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment.
Danish: Forbehandling med antiinflammatoriske stoffer kan resultere i yderligere eller forøgede bivirkninger, og derfor skal en behandlingsfri periode med sådanne veterinærlægemidler overholdes i mindst 24 timer før behandlingen påbegyndes.
English: Particular care should be taken with regard to the accuracy of dosing.
Danish: Der skal tages særligt hensyn vedrørende nøjagtigheden af dosis.
English: Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.
Danish: Ca. 75 % af den administrerede dosis elimineres via fæces, og resten via urinen.
English: In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
Danish: In vitro- og in vivoundersøgelser viste, at meloxicam hæmmer cyklooxygenase-2 (COX-2) i større grad end cyklooxygenase-1 (COX-1).
English: RevitaCAM must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Danish: RevitaCAM må ikke administreres sammen med andre NSAID'er eller glukokortikosteroider.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Danish: Undgå brug til dehydrerede, hypovolæmiske eller hypotensive dyr, da der er en mulig risiko for forhøjet nyretoksicitet.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial.
Danish: Brug ikke dette vetrinærlægemiddel efter den udløbsdato, der står på kartonen og hætteglasset.
English: It reduces leukocyte infiltration into the inflamed tissue.
Danish: Det reducerer leukocytinfiltration i det betændte væv.
English: Remove Cap
Danish: Fjern låget
English: Meloxicam is completely absorbed following oromucosal administration and maximal plasma concentrations are obtained after approximately 4.5 hours.
Danish: Meloxicam absorberes fuldstændigt efter administration in mundhulen, og maksimale plasmakoncentrationer opnås efter ca. 4,5 timer.
English: The MAH must ensure that the system of pharmacovigilance as described in Part 1 of the marketing authorisation application, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at det lægemiddelovervågningssystem, som er beskrevet i Part I i ansøgningen om markedsføringstilladelse, er på plads og fungerer før og under markedsføringen af lægemidlet.
English: In the case of overdose symptomatic treatment should be initiated.
Danish: I tilfælde af en overdosering, skal der iværksættes symptomatisk behandling.
English: In some dogs sneezing, coughing/gagging or drooling may be observed immediately after treatment administration.
Danish: Hos nogle hunde kan der observeres nysen, hosten/gylpning eller savlen straks efter administration af behandlingen.
English: The pump should be depressed fully, ensuring no mist escapes from the mouth.
Danish: Pumpen skal trykkes helt ned, så tågen ikke lukkes ud af munden.
English: There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range.
Danish: Der er et lineært forhold mellem den administrerede dosis og de observerede plasmakoncentrationer i det terapeutiske doseringsinterval.
English: Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
Danish: Andre NSAID'er, diuretika, antikoagulantia, aminoglycosid-antibiotika og stoffer med høj proteinbinding kan konkurrere om binding og derved føre til toksiske virkninger.