FrancophonIA/ELRC3.0 huggingface dataset:
English: • Because almitrine has been shown to carry a risk of damage to the nerves in the hands and feet as well as weight loss, and because a number of alternative treatments are now available, it will be withdrawn across the EU.
Danish: • Da det er påvist, at almitrin medfører risiko for beskadigelse af nerverne i hænder og fødder samt vægttab, og da der i dag findes en række andre behandlingsmuligheder, vil det blive trukket tilbage i hele EU.
English: • Prescribers and pharmacists will be sent a letter giving them further information on the withdrawal of oral almitrine.
Danish: • Ordinerende læger og apoteker vil få tilsendt et brev med yderligere information om tilbagetrækningen af oralt almitrin.
English: • The PRAC noted that cases of weight loss and peripheral neuropathy have continued to be reported, despite the introduction of a number of risk minimisation measures, including sequential administration (two months treatment followed by a one-month break), dose reduction and appropriate warnings in the product information.
Danish: • PRAC bemærkede, at der fortsat er blevet indberettet tilfælde af vægttab og perifer neuropati trods indførelsen af en række risikominimeringsforanstaltninger, herunder sekventiel administration (to måneders behandling efterfulgt af en måneds pause), dosisreduktion og passende advarsler i produktinformationen.
English: Additional results from clinical studies suggested that neuropathy was most common after three months or more of treatment.
Danish: Yderligere resultater fra kliniske undersøgelser tydede på, at neuropati oftest forekommer efter en behandlingsvarighed på tre måneder eller længere.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Danish: CMDh er et organ, der repræsenterer EEA's medlemsstater og har ansvar for at sikre harmoniserede sikkerhedsnormer i hele EU for lægemidler, der godkendes ved nationale procedurer.
English: As almitrine-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Danish: Da lægemidler indeholdende almitrin alle er godkendt nationalt, blev anbefalingerne fra PRAC overgivet til koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - human (CMDh), som vedtog et endeligt standpunkt.
English: Patients who have any questions should speak to their doctor or pharmacist.
Danish: Patienter, der ønsker yderligere oplysninger, bør kontakte lægen eller apotekspersonalet.
English: Almitrine is a stimulant of the part of the brain responsible for the breathing reflex.
Danish: Almitrin er en stimulans af den del af hjernen, der er ansvarlig for vejrtrækningsrefleksen.
English: • The understanding of COPD and the therapeutic options for its management have changed considerably since the original authorisation of oral almitrine.
Danish: • Indsigten i KOL og dens behandlingsmuligheder har ændret sig betydeligt siden den oprindelige godkendelse af oralt almitrin.
English: The company marketing almitrine identified 795 spontaneously reported cases of weight loss and 2,304 cases of peripheral neuropathy over the 30-year period that the medicine has been marketed (representing several million patient months of treatment).
Danish: Den virksomhed, der markedsfører almitrin, konstaterede 795 spontant indberettede tilfælde af vægttab og 2 304 tilfælde af perifer neuropati i løbet af den 30-årige periode, hvor lægemidlet er blevet markedsført (svarende til flere millioner patientmåneders behandling).
English: • Patients being treated with oral almitrine should have their treatment reviewed at the next scheduled appointment, and appropriate alternative treatments should be considered.
Danish: • Patienter i behandling med oralt almitrin bør få behandlingen gennemgået ved næste planlagte konsultation hos lægen, og der bør overvejes andre egnede behandlingsmuligheder.
English: In view of the potentially serious adverse effects and the lack of an established role in the current management of hypoxaemic pulmonary disease, the benefit-risk of oral almitrine is no longer considered favourable.
Danish: På baggrund af almitrins potentielt alvorlige bivirkninger og manglende etablerede rolle i den nuværende behandling af hypoksæmisk lungesygdom anses benefit/risk-forholdet for oralt almitrin ikke længere for positivt.
English: These conditions pose a particular problem in patients with lung conditions known as chronic obstructive pulmonary disease (COPD), where the airways and air sacs inside the lungs become damaged or blocked.
Danish: Disse tilstande er navnlig et problem hos patienter med kronisk obstruktiv lungesygdom (KOL), hvor luftveje og lungeblæresække bliver beskadiget eller blokeret.
English: The PRAC concluded that there is a clear association between oral almitrine treatment and potentially serious and long-lasting peripheral neuropathy (damage to the nerves in the hands and feet) and significant weight loss that further weakens patients.
Danish: PRAC konkluderede, at der er klar sammenhæng mellem oral behandling med almitrin og potentielt alvorlig og langvarig perifer neuropati (beskadigelse af nerverne i hænder og fødder) og vægttab af betydeligt omfang, som yderligere svækker patienterne.
English: • Oral almitrine-containing products should no longer be prescribed or dispensed to patients.
Danish: • Produkter indeholdende oralt almitrin bør ikke længere ordineres eller udleveres.
English: Almitrine is a respiratory stimulant, a medicine that stimulates the part of the brain responsible for the breathing reflex.
Danish: Almitrin er en respiratorisk stimulans, dvs. et lægemiddel, der stimulerer den del af hjernen, der er ansvarlig for vejrtrækningsrefleksen.
English: • The safety review confirmed a clear association of oral almitrine therapy with significant weight loss and peripheral neuropathy (which can be long-lasting and possibly irreversible).
Danish: • Sikkerhedsgennemgangen bekræftede en klar sammenhæng mellem behandling med oralt almitrin og betydeligt vægttab og perifer neuropati (som kan være langvarig og eventuelt irreversibel).
English: • If you are taking an almitrine-containing medicine, you should make a non-urgent appointment with your doctor to review your treatment.
Danish: • Hvis du bruger et lægemiddel indeholdende almitrin, skal du få en ikke-akut tid hos lægen for at få gennemgået din behandling.
English: Almitrine is not one of the treatments currently recommended in international guidelines for COPD management (GOLD), and the available evidence does not support a clinical benefit for long-term oral treatment with the medicine.
Danish: Almitrin hører ikke til de behandlinger, der i dag anbefales i internationale retningslinjer (GOLD) for behandling af KOL, og den foreliggende evidens underbygger ikke en klinisk fordel af oral langtidsbehandling med lægemidlet.
English: In line with the PRAC recommendation, the marketing authorisations for oral almitrine-containing medicines will be revoked in the affected Member States, which means that permission for the medicines to be marketed has been withdrawn.
Danish: Efter anbefalingerne fra PRAC vil markedsføringstilladelserne for orale lægemidler indeholdende almitrin blive tilbagekaldt i de berørte medlemsstater, dvs. markedsføringsgodkendelsen af lægemidlerne skal inddrages.
English: Furthermore, oral almitrine is no longer included as a recommended therapy in international treatment guidelines for the management of COPD.
Danish: Desuden anbefales oralt almitrin ikke længere i internationale behandlingsvejledninger for KOL.
English: As the PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented directly by the Member States where oral almitrine is authorised, according to an agreed timetable which should be completed by 25 July 2013.
Danish: Eftersom PRAC's anbefaling blev vedtaget enstemmigt af CMDh, vil den nu blive gennemført direkte af alle de medlemsstater, hvor oralt almitrin er godkendt, hvilket i henhold til den aftalte tidsplan skal have fundet sted pr. 25. juli 2013.
English: • Almitrine, a medicine that was authorised several years ago to be taken by mouth to help breathing, is not one of the currently recommended treatments for lung diseases.
Danish: • Almitrin er et lægemiddel, der for en del år siden blev godkendt til at lette vejrtrækningen ved oral indtagelse, men er i dag ikke blandt de anbefalede midler mod lungesygdomme.
English: As the CMDh position was adopted by consensus, it will be directly implemented by the Member States where oral almitrine-containing medicines are authorised.
Danish: Da CMDh's standpunkt blev vedtaget enstemmigt, vil det blive direkte gennemført i de medlemsstater, hvor orale lægemidler indeholdende almitrin er godkendt.
English: In the EU, it is authorised in France, Poland and Portugal as 50-mg tablets (Vectarion, Armanor) for the treatment of chronic respiratory failure (inability of the lungs to take in oxygen and get rid of carbon dioxide properly), which is associated with hypoxaemia (lower than normal levels of oxygen in the blood).
Danish: I EU er det godkendt i Frankrig, Polen og Portugal som 50 mg tabletter (Vectarion, Armanor) til behandling af kronisk respirationssvigt (utilstrækkelig kapacitet af lungerne til at optage ilt og afgive kuldioxid), som er forbundet med hypoksæmi (unormalt lavt iltindhold i blodet).
English: The safety review of oral almitrine was requested by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), because of concerns about side effects and a view that the available evidence did not support the use of the medicine in the current management of COPD.
Danish: Sikkerhedsgennemgangen af oralt almitrin fandt sted på anmodning af den franske lægemiddelstyrelse ANSM (Agence nationale de sécurité du médicament et des produits de santé), som havde betænkeligheder ved bivirkningerne og fandt, at lægemidlets anvendelse ved KOL ikke underbygges af den nuværende evidens.
English: In three of the latter cases, patients were rechallenged with almitrine and this led to a recurrence of neuropathic symptoms, including sequelae in two.
Danish: I tre af sidstnævnte tilfælde forekom der recidiv af de neuropatiske symptomer ved reeksponering af patienterne for almitrin, hvilket i to tilfælde medførte sequelae.
English: In the EU, it is authorised in France, Poland and Portugal to be taken orally for the treatment of chronic respiratory failure (inability of the lungs to take in oxygen and get rid of carbon dioxide properly), which is associated with hypoxaemia (lower than normal levels of oxygen in the blood).
Danish: I EU er det godkendt i Frankrig, Polen og Portugal til oral indgift til behandling af kronisk respirationssvigt (utilstrækkelig kapacitet af lungerne til at optage ilt og afgive kuldioxid), som er forbundet med hypoksæmi (unormalt lavt iltindhold i blodet).
English: PRAC recommendation will be directly implemented following CMDh consensus
Danish: Efter den enstemmige afgørelse i CMDh vil PRAC's anbefaling blive gennemført direkte
English: • Pharmacists should refer patients presenting a new or repeat prescription to their treating physician.
Danish: • Patienter, der på apoteket fremviser en ny eller fornyet recept, bør henvises til lægen.
English: The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), a medicines regulatory body representing the EU Member States, has endorsed the recommendation by the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), that permission to market oral medicines containing almitrine should be withdrawn across the European Union (EU).
Danish: Markedsføringstilladelsen for orale lægemidler indeholdende almitrin skal inddrages i hele Den Europæiske Union (EU), efter at koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - human (CMDh) (en lægemiddelmyndighed, der repræsenterer EU's medlemsstater), har vedtaget anbefalingen herom fra PRAC (Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering).
English: These measures will help protect the environment.
Danish: Disse foranstaltninger vil bidrage til at beskytte miljøet..
English: However, a risk cannot be completely excluded.
Danish: En risiko kan dog ikke udelukkes helt.
English: Do not pass it on to others.
Danish: Lad derfor være med at give det videre til andre.
English: This will depend on your individual situation.
Danish: Det vil afhænge af din situation.
English: These patients should also be carefully observed.
Danish: Desuden skal disse patienter observeres omhyggeligt.
English: Children aged 2 to 18 years
Danish: Børn 2-18 år
English: Do this by:
Danish: Gør dette ved at:
English: Influenza vaccination may be of value.
Danish: Vaccination mod influenza kan være af værdi.
English: Your doctor will have to advise you on what vaccines you can have.
Danish: Din læge vil rådgive dig om, hvilke vacciner du må få.
English: In many of these cases, no adverse events were reported.
Danish: I adskillige af disse tilfælde blev der ikke rapporteret uønskede hændelser.
English: As a result, there is an increased risk of skin cancer.
Danish: Af denne grund er der en øget risiko for hudkræft.
English: The following areas should be covered in these guides:
Danish: Følgende emner skal være dækket i disse vejledninger;
English: Prescribers should refer to national guidelines for influenza vaccination.
Danish: Receptudstedere bør henvise til nationale retningslinier for influenzavaccination.
English: The usual doses are shown below.
Danish: De sædvanlige doser er vist nedenfor.
English: • using a sunscreen with a high protection factor.
Danish: • anvende solcreme med høj beskyttelsesfaktor.
English: Talk to your doctor about the most suitable contraception for you.
Danish: Tal med din læge om den bedst egnede prævention for dig.
English: • You plan to become pregnant.
Danish: • du planlægger at blive gravid
English: • Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger
English: Do not take this medicine if any of the above applies to you.
Danish: Tag ikke dette lægemiddel, hvis noget af ovenstående gælder for dig.
English: Usual problems
Danish: Sædvanlige problemer
English: Paediatric population < 2 years
Danish: Pædiatrisk population < 2 år
English: The following malformations were most frequently reported:
Danish: Følgende misdannelser blev hyppigst rapporteret:
English: The educational materials should be implemented within four months after completion of this procedure and shall contain the following key elements:
Danish: Uddannelsesmaterialet skal implementeres indenfor 4 måneder efter afslutning af denne procedure og skal indeholde følgende hovedemner:
English: Read the information carefully and follow the instructions.
Danish: Læs informationen grundigt og følg vejledningen.
English: Effects of hepatic disease on this process probably depend on the particular disease.
Danish: Virkningen af hepatisk sygdom på denne proces afhænger sandsynligvis af den enkelte sygdom.
English: • If this happens, wash the area thoroughly with soap and water.
Danish: • Hvis dette sker, skal du vaske området grundigt med vand og sæbe.
English: You may get general side effects affecting your body as a whole.
Danish: Du kan få generelle bivirkninger, som kan påvirke hele din krop.
English: MPA's disposition depends on several transporters.
Danish: MPAs fordeling afhænger af adskillige transportører.
English: Precautions to be taken before handling or administering the medicinal product.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet.
English: • wearing protective clothing which also covers your head, neck, arms and legs
Danish: • iklæde dig beskyttende beklædning, som også dækker hoved, hals, arme og ben
English: This means you may catch more infections than usual.
Danish: Dette betyder, at du kan være modtagelig for flere infektioner end normalt.
English: It is not known whether this substance is excreted in human milk.
Danish: Det vides ikke, om dette stof udskilles i human mælk.
English: 300 hard capsules
Danish: 300 hårde kapsler
English: Talk to a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Tal med en læge med det samme, hvis du bemærker nogen af nedenstående alvorlige bivirkninger - du kan have brug for øjeblikkelig lægehjælp:
English: Limit the amount of sunlight and UV light you get.
Danish: Begræns mængden af sollys og UV-lys, som du udsættes for.
English: Results of all pregnancy tests should be discussed with the patient.
Danish: Resultaterne af alle graviditetstests skal diskuteres med patienten.
English: In addition there have been isolated reports of the following malformations:
Danish: Derudover har der været enkelte rapporter om følgende misdannelser:
English: Your doctor will do regular blood tests to check for any changes in
Danish: Lægen vil tage blodprøver regelmæssigt for at tjekke for ændringer i:
English: Children may be more likely than adults to have some side effects.
Danish: Børn kan have en større risiko end voksne for at få visse bivirkninger.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage medicinen, da den indeholder vigtige oplysninger for dig.
English: The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.
Danish: Risikoen synes snarere at være relateret til intensiteten og varigheden af immunsuppression end til brugen af et bestemt middel.
English: Hepatic transplant patients were followed for at least 1 year, but less than 3 years.
Danish: Levertransplanterede patienter fulgtes i mindst 1 år, men i mindre end 3 år.
English: • This belongs to a group of medicines called “immunosuppressants”.
Danish: • Det tilhører en gruppe lægemidler, som kaldes immunsuppressiva.
English: This is because small amounts of the medicine can pass into the mother's milk.
Danish: Dette skyldes, at små mængder af medicinen kan passere over i mælken.
English: Do not throw away any medicines via wastewater or household waste.
Danish: Smid ikke nogen form for medicin ud via spildevand eller husholdningsaffald.
English: If you are planning to have a child, talk to your doctor about the potential risks.
Danish: Hvis du planlægger at få et barn, skal du tale med din læge om potentielle risici.
English: Two complementary forms of contraception simultaneously are preferred.
Danish: Samtidig brug af to komplementære former for prævention er foretrukket.
English: These changes are not associated with impaired neutrophil function.
Danish: Ændringerne er ikke associerede med en svækket neutrofil funktion.
English: However, MPA Cmax was decreased by 40 % in the presence of food.
Danish: MPA Cmax var dog nedsat med 40 % i nærvær af føde.
English: MPA is a powerful teratogen.
Danish: MPA er et stærkt teratogen.
English: • Your doctor will decide the most appropriate dose based on your child's height and weight
Danish: • Lægen vil beregne den mest hensigtsmæssige dosis ud fra barnets højde og vægt
English: • You are post-menopausal, i.e. at least 50 years old and your last period was more than a year ago (if your periods have stopped because you have had treatment for cancer, then there is still a chance you could become pregnant)
Danish: • Du har passeret overgangsalderen, dvs. er mindst 50 år, og din sidste menstruation var for mere end et år siden (hvis din menstruation er stoppet, fordi du er blevet behandlet for kræft, er der stadigvæk mulighed for, at du kan blive gravid)
English: Your doctor may request more than one test to ensure you are not pregnant before starting treatment.
Danish: Lægen kan kræve mere end én test for at sikre, at du ikke er gravid, før du påbegynder behandlingen.
English: Also do this if someone else accidentally takes your medicine.
Danish: Det skal du også gøre, hvis en anden ved et uheld har indtaget din medicin.
English: Guides should also mention that patients should not to give this drug to any other person.
Danish: Vejledningen skal også nævne, at patienten ikke må give lægemidlet til andre personer.
English: The pharmacodynamic profile and the reported adverse reactions indicate that an effect is unlikely.
Danish: Den farmakodynamiske profil og de rapporterede uønskede reaktioner peger på, at en påvirkning er usandsynlig.
English: SPECIAL STORAGE CONDITIONS Store below 30 °C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ved temperaturer under 30 °C.
English: It is not known if MPA is present in semen.
Danish: Det vides ikke, om MPA findes i sæd.
English: The need for subsequent pregnancy tests during treatment will also be explained.
Danish: Nødvendigheden af efterfølgende graviditetstests under behandlingen skal også forklares.
English: (body surface area - measured as square metres or ‘m2').
Danish: (legemsoverfladeareal - målt som kvadratmeter eller ”m2”).
English: If neutropenia develops (absolute neutrophil count < 1.3 x 10
Danish: Hvis der optræder neutropeni (det absolutte neutrofillocyttal < 1,3 x 10
English: • the number of your blood cells
Danish: • antallet af blodceller
English: Calculations based on animal data show that the maximum amount of MPA that could potentially be transferred to woman is so low that it would be unlikely to have an effect.
Danish: Beregninger baseret på dyremodeller viser, at den maksimale mængde af MPA, der potentielt kunne overføres til kvinden, er så lav, at det sandsynligvis ikke vil have effekt.
English: The proportion of patients with CMV viraemia/syndrome was 13.5 %.
Danish: Andelen af patienter med CMV-viræmi/syndrom var 13,5 %.
English: Myclausen reduces your body's defences.
Danish: Myclausen nedsætter kroppens forsvar.
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester du ikke længere bruger.
English: Talk to your doctor if you develop a persistent cough or breathlessness
Danish: Tal med din læge, hvis du udvikler vedvarende hoste eller kortåndethed
English: You are a woman who is not capable of becoming pregnant if any of the following applies to you:
Danish: Hvis du er kvinde, kan du ikke blive gravid, hvis et af følgende gælder for dig:
English: However, hepatic disease with predominantly biliary damage, such as primary biliary cirrhosis, may show a different effect.
Danish: Imidlertid kan hepatisk sygdom med overvejende biliær skade som f.eks. primær biliær cirrhose vise en anden virkning.
English: • rifampicin (an antibiotic used to prevent and treat infections such as tuberculosis)
Danish: • rifampicin (et antibiotikum, som bruges til forebyggelse og behandling af infektioner såsom tuberkulose (TB))
English: The amount you take depends on the type of transplant you have had.
Danish: Dosis afhænger af, hvilken transplantation du har fået udført.
English: The need to plan a pregnancy will be highlighted.
Danish: Nødvendigheden af graviditetsplanlægning skal fremhæves.
English: Multidrug resistance protein 1 (MDR1) is also able to transport MPA, but its contribution seems to be confined to the absorption process.
Danish: Multidrug resistance protein 1 (MRP1) er ligeledes i stand til at transportere MPA, men synes at være begrænset til absorptionsprocessen.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE BETINGELSER OG KRAV FOR MARKEDSFØRINGSTILLADELSEN
English: Additional amendments have been made regarding use of contraception in women and pregnancy testing, to clarify the requirements.
Danish: Der er foretaget yderligere ændringer vedrørende brug af prævention hos kvinder og graviditetstest, for at præcisere kravene.
English: PHARMACEUTICAL FORM Capsule, hard.
Danish: LÆGEMIDDELFORM Kapsel, hård.