FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, the most common side effects (seen in more than 1 patient in 10) include nausea (feeling sick) and vomiting, particularly during the phase when the dose of Prometax is being increased.
Danish: Som helhed er de hyppigste bivirkninger (som optræder hos flere end 1 ud af 10 patienter) kvalme og opkastning, især i den fase, hvor dosis af Prometax øges.
English: Treatment should only be started if a caregiver is available who will regularly give and monitor the use of Prometax by the patient.
Danish: Behandlingen bør kun iværksættes, hvis en omsorgsgivende person regelmæssigt giver og overvåger patientens anvendelse af Prometax.
English: It is available as capsules (1.5, 3, 4.5 and 6 mg), as an oral solution (2 mg/ml), and as transdermal patches, which release either 4.6 , 9.5 or 13.3 mg rivastigmine across the skin over 24 hours.
Danish: Det fås som kapsler (1,5, 3, 4,5 og 6 mg), som oral opløsning (2 mg/ml) og som depotplastre, der afgiver enten 4,6, 9,5 eller 13,3 mg rivastigmin gennem huden i løbet af 24 timer.
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).
Danish: Hos patienter med Alzheimers sygdom eller med demens som følge af Parkinsons sygdom vil visse hjerneceller dø, hvilket medfører et for lavt indhold af neurotransmitteren acetylcholin (et stof, som bevirker, at nervecellerne kan kommunikere indbyrdes).
English: An additional study in 27 patients was used to show that Prometax capsules and oral solution produced similar levels of the active substance in the blood.
Danish: I endnu en undersøgelse hos 27 patienter blev det vist, at Prometax-kapsler og oral opløsning giver samme indhold af aktivt stof i blodet.
English: Treatment with Prometax should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Danish: Behandling med Prometax bør iværksættes og overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom og demens hos patienter med Parkinsons sygdom.
English: Prometax is a medicine containing the active substance rivastigmine.
Danish: Prometax er et lægemiddel, der indeholder det aktive stof rivastigmin.
English: Patients can be switched from the capsules or oral solution to the patches.
Danish: Patienterne kan skifte fra kapsler eller oral opløsning til plastre.
English: Prometax must not be used in people who are hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Danish: Prometax må ikke anvendes hos personer, der er overfølsomme (allergiske) over for rivastigmin, andre carbamatderivater eller andre af indholdsstofferne.
English: Therefore, the Committee decided that Prometax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget var derfor af den opfattelse, at fordelene ved Prometax opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Other information about Prometax
Danish: Andre oplysninger om Prometax:
English: The CHMP concluded that Prometax has a modest effectiveness in treating the symptoms of Alzheimer's dementia, although this does reflect an important benefit in some patients.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Prometax har en beskeden effekt ved behandling af symptomerne på Alzheimers sygdom, selv om dette udmønter sig i en betydelig gavnlig effekt hos visse patienter.
English: Prometax is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Danish: Prometax anvendes til behandling af patienter med let til middelsvær Alzheimers sygdom, en fremadskridende hjernesygdom, der gradvis angriber hukommelse, intellektuelle evner og adfærd.
English: Prometax capsules have also been studied in 541 patients with dementia due to Parkinson's disease.
Danish: Prometax-kapsler blev desuden undersøgt hos 541 patienter med demens som følge af Parkinsons sygdom.
English: Prometax must also not be used in patients who are suspected to have had in the past a severe allergic reaction called ‘allergic contact dermatitis' to Prometax patch.
Danish: Prometax må heller ikke anvendes til patienter, hvor der er mistanke om, at der tidligere er forekommet en svær allergisk reaktion kaldet ‘allergisk kontaktdermatitis' over for Prometax-depotplaster.
English: What measures are being taken to ensure the safe use of Prometax?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Prometax?
English: The highest tolerated dose should be used to get the maximum benefit, but the dose should not exceed 6 mg twice a day.
Danish: For at få størst mulig gavnlig virkning bør der anvendes den højeste dosis, som patienten tåler, dog ikke over 6 mg to gange dagligt.
English: Prometax was more effective than placebo at controlling symptoms.
Danish: Prometax var mere effektivt end placebo til at begrænse symptomerne.
English: The active substance in Prometax, rivastigmine, is an antidementia medicine.
Danish: Det aktive stof i Prometax, rivastigmin, er et middel til behandling af demens.
English: In patients who tolerate this dose, it can be increased in 1.5 mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Danish: Hos patienter, der tåler denne dosis, kan dosis øges i trin på 1,5 mg med mindst to uger mellem hvert trin, indtil en fast dosis på 3 til 6 mg to gange dagligt er nået.
English: The company that makes Prometax must ensure that all doctors who intend to prescribe Prometax transdermal patch receive an information pack containing instructions to be given to patients and caregivers on how to use the patch safely as well as a reminder card for patients and caregivers that contains key information on how to use the patch and allows them to record the application and removal of patches.
Danish: Virksomheden, der fremstiller Prometax, skal sørge for, at alle læger, som har til hensigt at ordinere Prometax depotplaster 13,3 mg/24 timer, modtager en informationspakke, som indeholder vejledning til patienter og plejepersonale i, hvordan plastret anvendes sikkert, og et huskekort til patienter og plejepersonale med vigtig information om, hvordan plastret anvendes, og hvorpå de kan notere, hvornår plastrene sættes på og tages af.
English: The Prometax transdermal patches were also more effective than placebo in preventing dementia from getting worse.
Danish: Prometax-depotplastrene var også mere effektive end placebo til at forebygge forværring af demens.
English: The capsules and oral solution can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Danish: Kapslerne og den orale opløsning kan desuden anvendes til behandling af let til middelsvær demens hos patienter med Parkinsons sygdom.
English: For the transdermal patch application site reactions are the most commonly seen side effects.
Danish: For depotplastret er den hyppigste bivirkning reaktioner på påføringsstedet.
English: In the three studies of Prometax capsules in patients with Alzheimer's dementia, patients taking doses of Prometax between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
Danish: Hos patienter med Alzheimers sygdom blev der udført tre undersøgelser med Prometax-kapsler og hos de patienter, der fik Prometax 6 til 9 mg dagligt, øgedes de kognitive symptomer gennemsnitligt med 0,2 point fra en baseline på 22,9 points ved undersøgelsens start, hvor en lavere score indicerer bedre resultater.
English: The global symptom score also improved more in the patients taking Prometax.
Danish: I den samlede score kunne der også iagttages en forbedring hos de patienter, der fik Prometax.
English: For the full list of all side effects reported with Prometax, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Prometax fremgår af indlægssedlen.
English: Prometax has been studied in mild to moderately severe Alzheimer's disease.
Danish: Prometax blev undersøgt ved let til middelsvær Alzheimers sygdom.
English: The capsules have been studied in 2,126 patients in three main studies, and the transdermal patches in one main study involving 1,195 patients.
Danish: Kapslerne blev anvendt hos 2 126 patienter i tre hovedundersøgelser.
English: All of the studies lasted six months and compared the effects of Prometax with those of placebo (a dummy treatment).
Danish: I dem alle blev virkningerne af Prometax sammenlignet med virkningerne af placebo (virkningsløs behandling).
English: The types of side effects seen with Prometax depend on the type of dementia it is being used to treat and whether the capsules, oral solution or transdermal patches are used.
Danish: Bivirkningerne ved Prometax afhænger af den form for demens, patienten har, og om patienten får kapsler, oral opløsning eller depotplastre.
English: The patients with dementia due to Parkinson's disease taking Prometax capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Danish: Hos patienter med demens som følge af Parkinsons sygdom, som fik Prometax-kapsler, kunne der iagttages en forbedring af de kognitive symptomer på 2,1 point, sammenlignet med en forværring på 0,7 point hos dem, der fik placebo, fra en baseline på ca. 24 point.
English: What is the risk associated with Prometax?
Danish: Hvilken risiko er der forbundet med Prometax?
English: Why has Prometax been approved?
Danish: Hvorfor blev Prometax godkendt?
English: The 9.5 mg/24 h patch should be used for as long as the patient benefits from it. After six months of treatment with 9.5 mg/24 hours, the doctor may increase the dose to 13.3 mg/24 hours if the patient's condition has worsened.
Danish: Efter seks måneders behandling med 9,5 mg/24 timer kan lægen øge dosis til 13,3 mg/24 timer, hvis patientens tilstand er forværret.
English: For the global score, patients taking Prometax capsules had in increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Danish: I den samlede score var der en stigning på 4,1 point hos patienter, der fik Prometax-kapsler, sammenlignet med 4,4 point hos dem, der fik placebo.
English: The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Prometax's benefits did not outweigh its risks.
Danish: Udvalget konkluderede oprindelig, at fordelene ved Prometax ikke opvejer risiciene ved behandling af demens som følge af Parkinsons sygdom.
English: What is Prometax?
Danish: Hvad er Prometax?
English: Treatment should continue as long as the medicine has a benefit, but the dose can be reduced or treatment interrupted if the patient has side effects.
Danish: Ved bivirkninger kan dosis nedsættes eller behandlingen ophøre.
English: How has Prometax been studied?
Danish: Hvordan blev Prometax undersøgt?
English: What is Prometax used for?
Danish: Hvad anvendes Prometax til?
English: See the summary of product characteristics (also part of the EPAR) for detailed information.
Danish: De nærmere oplysninger fremgår af produktresuméet, der også er en del af denne EPAR.
English: How is Prometax used?
Danish: Hvordan anvendes Prometax?
English: What benefit has Prometax shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Prometax?
English: If the transdermal patches are used, the 4.6 mg per 24 hours patch should be used first, with the dose increased to the 9.5 mg/24 h patch after at least four weeks if the lower dose is well tolerated.
Danish: Tåles denne dosis godt, kan der efter mindst fire uger skiftes til 9,5 mg pr. 24 timer.
English: This was compared with an increase of 2.6 points from 22.5 in the patients taking placebo.
Danish: Hos de patienter, der fik placebo, var der til sammenligning en stigning på 2,6 point fra baseline på 22,5.
English: How does Prometax work?
Danish: Hvordan virker Prometax?
English: By blocking these enzymes, Prometax allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia associated with Parkinson's disease.
Danish: Ved at blokere disse enzymer øger Prometax hjernens indhold af acetylcholin.
English: What is Amgevita and what is it used for?
Danish: Hvad er Amgevita, og hvad anvendes det til?
English: After the starting dose, Amgevita is most often given every two weeks, but it may be given every week in certain situations.
Danish: Efter startdosen gives Amgevita sædvanligvis hver anden uge, men kan dog i visse tilfælde gives hver uge.
English: The full EPAR for Amgevita can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Amgevita findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Amgevita.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Amgevita.
English: This means that Amgevita is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det betyder, at Amgevita svarer til et biologisk lægemiddel (også kaldet "referencelægemidlet"), der allerede er godkendt i Den Europæiske Union (EU).
English: Other information about Amgevita
Danish: Andre oplysninger om Amgevita
English: Why is Amgevita approved?
Danish: Hvorfor blev Amgevita godkendt?
English: The reference medicine for Amgevita is Humira.
Danish: Referencelægemidlet for Amgevita er Humira.
English: It is not intended to provide practical advice on how to use Amgevita.
Danish: Det er ikke en praktisk vejledning i, hvordan Amgevita bør anvendes.
English: What measures are being taken to ensure the safe and effective use of Amgevita?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Amgevita?
English: Amgevita is a medicine that acts on the immune system and is used to treat the following conditions:
Danish: Amgevita er et lægemiddel, der virker på immunsystemet, og som anvendes til følgende sygdomme:
English: After training, patients or their carers may inject Amgevita if their doctor considers it appropriate.
Danish: Efter oplæring kan patienten eller dennes omsorgsgiver selv foretage indsprøjtningen med Amgevita, hvis lægen finder det hensigtsmæssigt.
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Danish: Ved at binde sig til TNF blokerer adalimumab dets aktivitet og mindsker dermed betændelsen og de andre symptomer på sygdommen.
English: Because Amgevita is a biosimilar medicine, the studies on effectiveness and safety carried out for Humira do not all need to be repeated for Amgevita.
Danish: Da Amgevita er et biosimilært lægemiddel, behøver de undersøgelser af virkning og sikkerhed, der er udført for Humira, ikke gentages for Amgevita.
English: Doctors treating uveitis should also take advice from doctors who have experience of using Amgevita.
Danish: Læger, der behandler uveitis, bør også rådføre sig med læger, der har erfaring i brug af Amgevita.
English: The Committee recommended that Amgevita be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Amgevita.
English: Amgevita is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Danish: Amgevita bruges oftest til voksne, når deres tilstand er moderat svær eller svær, når tilstanden forværres, eller når de ikke kan få andre behandlinger.
English: In addition, studies in rheumatoid arthritis and psoriasis have shown that the effects of the medicine are equivalent to those of Humira in these conditions.
Danish: Derudover har undersøgelser vedrørende reumatoid artritis og psoriasis vist, at lægemidlets virkning svarer til Humiras virkning ved disse sygdomme.
English: Amgevita must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Danish: Amgevita må ikke anvendes til patienter med aktiv tuberkulose eller andre svære infektioner eller til patienter med moderat til svær hjerteinsufficiens (hjertets manglende evne til at pumpe tilstrækkeligt blod rundt i kroppen).
English: What are the risks associated with Amgevita?
Danish: Hvilke risici er der forbundet med Amgevita?
English: Amgevita contains the active substance adalimumab and is a ‘biosimilar medicine'.
Danish: Amgevita indeholder det aktive stof adalimumab og er et "biosimilært lægemiddel".
English: The dose depends on the condition to be treated and in children is usually calculated according to the child's weight and height.
Danish: Dosen afhænger af den sygdom, der skal behandles, og dosen til et barn skal typisk beregnes ud fra barnets vægt og højde.
English: The medicine has been shown to have similar effects to Humira in one main study involving 526 patients with moderate to severe rheumatoid arthritis that had not responded adequately to methotrexate, and in another main study in 350 patients with moderate to severe psoriasis.
Danish: Det er påvist, at lægemidlets virkning svarer til Humiras virkning, i en hovedundersøgelse med 526 patienter med moderat til svær reumatoid artritis, som ikke havde oplevet tilstrækkelig respons på metotrexat, og i en anden hovedundersøgelse med 350 patienter med moderat til svær psoriasis.
English: Patients may be given other medicines during treatment with Amgevita, such as methotrexate or corticosteroids (other anti‑inflammatory medicines).
Danish: Patienterne må gerne få andre lægemidler under behandlingen med Amgevita, f.eks. metotrexat eller binyrebarkhormoner (andre antiinflammatoriske lægemidler).
English: The medicine is available as a solution for injection under the skin in a pre-filled syringe or pen.
Danish: Lægemidlet fås som en opløsning til injektion under huden i en fyldt sprøjte eller pen.
English: Amgevita can only be obtained with a prescription and treatment should be started and supervised by specialist doctors experienced in the diagnosis and treatment of the conditions for which it is authorised.
Danish: Amgevita udleveres kun efter recept, og behandlingen bør indledes og overvåges af en speciallæge med erfaring i diagnosticering og behandling af de sygdomme, som lægemidlet er godkendt til.
English: All these data were considered sufficient to conclude that Amgevita will behave in the same way as Humira in terms of effectiveness and safety in its approved indications.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Amgevita vil have de samme egenskaber som Humira, hvad angår sikkerhed og virkning ved de godkendte anvendelser.
English: Therefore, the CHMP's view was that, as for Humira, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Humira.
English: For detailed information on the use of Amgevita in all conditions, including when it can be used in children, see the summary of product characteristics (also part of the EPAR).
Danish: Nærmere oplysninger om anvendelsen af Amgevita til alle sygdomme, herunder hvornår det kan anvendes til børn, fremgår af produktresuméet (også en del af denne EPAR).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Amgevita has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Amgevita har en struktur, renhed og biologisk aktivitet, som i høj grad minder om Humira, og at det fordeles i kroppen på samme måde.
English: The company that markets Amgevita must provide educational packs for doctors who will prescribe the medicine.
Danish: Virksomheden, der markedsfører Amgevita, skal udlevere informationspakker til læger, der skal ordinere Amgevita.
English: Extensive laboratory studies comparing Amgevita with Humira have shown that adalimumab in Amgevita is highly similar to adalimumab in Humira in terms of chemical structure, purity and biological activity.
Danish: Omfattende laboratorieundersøgelser, hvor Amgevita er blevet sammenlignet med Humira, har vist, at adalimumab i Amgevita i meget høj grad ligner adalimumab i Humira, hvad angår kemisk opbygning, renhed og biologisk aktivitet.
English: These packs will include information on the safety of the medicine and an alert card to be given to patients.
Danish: Informationspakkerne skal indeholde oplysninger om sikkerheden ved lægemidlet, og patienterne skal have udleveret et patientkort.
English: Other rare serious side effects (seen in between 1 in 10,000 and 1 in 1,000 patients) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Danish: Andre sjældne alvorlige bivirkninger (set hos mellem 1 ud af 10.000 og 1 ud af 1.000 patienter) omfatter knoglemarvens svigtende produktion af blodceller, nervelidelser, lupus og lupus-lignende sygdomme (hvor immunsystemet angriber patientens eget væv og forårsager betændelse og organskader) og Stevens-Johnsons syndrom (en alvorlig hudsygdom).
English: The active substance in Amgevita, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a chemical messenger in the body called tumour necrosis factor (TNF).
Danish: Det aktive stof i Amgevita, adalimumab, er et monoklonalt antistof (en type protein), der er opbygget, så det genkender og binder sig til et kemisk signalstof i kroppen, der kaldes tumornekrosefaktor (TNF).
English: For more information about treatment with Amgevita, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Amgevita, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints)
Danish: • polyartikulær juvenil idiopatisk artritis og aktiv enthesitis-relateret artritis (begge er sjældne sygdomme, der giver betændelse i leddene)
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections in the nose and throat, sinuses and upper respiratory tract, injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Danish: De hyppigste bivirkninger ved adalimumab (som optræder hos flere end 1 ud af 10 patienter) er infektioner i næse og hals, bihuler og de øvre luftveje, reaktioner på injektionsstedet (rødme, kløe, blødning, ømhed eller hævelse), hovedpine og knogle- og muskelsmerter.
English: This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Amgevita is used to treat.
Danish: Dette signalstof er en medvirkende årsag til betændelsestilstande og findes i høje koncentrationer hos patienter med de sygdomme, der behandles med Amgevita.
English: • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).
Danish: • non-infektiøs uveitis (betændelse af hinden under det hvide i øjeæblet).