FrancophonIA/ELRC3.0 huggingface dataset:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levetiracetam Actavis.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Levetiracetam Actavis.
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam Actavis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Levetiracetam Actavis.
English: • partial-onset seizures with or without generalisation in patients from one month of age;
Danish: • partielle anfald med eller uden generalisering hos patienter i alderen en måned og opefter
English: The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells.
Danish: De nøjagtige virkemåde af levetiracetam er endnu ikke klarlagt, men det ser ud til, at stoffet griber ind i funktionen af et protein kaldet det synaptiske vesikelprotein 2A, som findes i spalterne mellem nerverne, og som medvirker ved udskillelsen af kemiske signalstoffer mellem nervecellerne.
English: For more information about treatment with Levetiracetam Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Levetiracetam Actavis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The Committee recommended that Levetiracetam Actavis be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Levetiracetam Actavis.
English: Other information about Levetiracetam Actavis
Danish: Andre oplysninger om Levetiracetam Actavis
English: This means that Levetiracetam Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Danish: Det betyder, at Levetiracetam Actavis er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union, og som hedder Keppra.
English: This helps Levetiracetam Actavis to stabilise electrical activity in the brain and prevent seizures.
Danish: På denne måde stabiliserer Levetiracetam Actavis den elektriske aktivitet i hjernen og forhindrer anfald.
English: EPAR summary for the public levetiracetam
Danish: EPAR - sammendrag for offentligheden levetiracetam
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam Actavis has been shown to have comparable quality and to be bioequivalent to Keppra.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Levetiracetam Actavis er af sammenlignelig kvalitet og er bioækvivalent med Keppra.
English: What are the benefits and risks of Levetiracetam Actavis?
Danish: Hvilke fordele og risici er der forbundet med Levetiracetam Actavis?
English: Levetiracetam Actavis can also be used as an add-on to other anti-epileptic medicines to treat:
Danish: Levetiracetam Actavis kan også anvendes som en tillægsbehandling til andre antiepileptika til behandling af:
English: Levetiracetam Actavis can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Danish: Levetiracetam Actavis kan uden supplerende behandling anvendes til patienter over 16 år med nydiagnosticeret epilepsi til behandling af partielle anfald med eller uden sekundær generalisering.
English: Because Levetiracetam Actavis is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Danish: Da Levetiracetam Actavis er et generisk lægemiddel, har patientundersøgelserne været begrænset til tests for at påvise, at det er bioækvivalent med referencelægemidlet, Keppra.
English: The active substance in Levetiracetam Actavis, levetiracetam, is an anti-epileptic medicine.
Danish: Det aktive stof i Levetiracetam Actavis, levetiracetam, er et antiepileptikum.
English: Because Levetiracetam Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Levetiracetam Actavis er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Levetiracetam Actavis is a ‘generic medicine'.
Danish: Levetiracetam Actavis er et ”generisk lægemiddel”.
English: Levetiracetam Actavis tablets are swallowed with liquid.
Danish: Levetiracetam Actavis-tabletterne synkes hele med væske.
English: Levetiracetam Actavis is a medicine that contains the active substance levetiracetam.
Danish: Levetiracetam Actavis er et lægemiddel, der indeholder det aktive stof levetiracetam.
English: When Levetiracetam Actavis is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Danish: Når Levetiracetam Actavis anvendes alene, er startdosis 250 mg to gange dagligt, som efter to uger øges til 500 mg to gange dagligt.
English: When Levetiracetam Actavis is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Danish: Når Levetiracetam Actavis anvendes som tillægsbehandling til en anden behandling med antiepileptika, er startdosis til patienter over 12 år, som vejer over 50 kg, 500 mg to gange dagligt.
English: Why has Levetiracetam Actavis been approved?
Danish: Hvorfor blev Levetiracetam Actavis godkendt?
English: How has Levetiracetam Actavis been studied?
Danish: Hvordan blev Levetiracetam Actavis undersøgt?
English: What is Levetiracetam Actavis?
Danish: Hvad er Levetiracetam Actavis?
English: What is Levetiracetam Actavis used for?
Danish: Hvad anvendes Levetiracetam Actavis til?
English: How is Levetiracetam Actavis used?
Danish: Hvordan anvendes Levetiracetam Actavis?
English: How does Levetiracetam Actavis work?
Danish: Hvordan virker Levetiracetam Actavis?
English: • you are pregnant
Danish: • du er gravid
English: There might be local regulations for this.
Danish: Der kan være lokale retningslinjer for dette.
English: Annual reports to be submitted as part of the annual re-assessment.
Danish: Årlige rapporter skal indsendes som en del af den årlige revurdering.
English: Frequency not known*
Danish: Hyppighed ikke kendt*
English: Date of first authorisation: 30 July 2018
Danish: Dato for første markedsføringstilladelse: 30. juli 2018
English: • ‘U' means ‘Units'.
Danish: • "E" betyder "enheder".
English: This can help make the injections more comfortable.
Danish: Det kan være med til at gøre injektionerne mere behagelige.
English: A minimum clinical response is defined as at least:
Danish: En mindste klinisk respons defineres som mindst:
English: Not known (frequency cannot be estimated from the available data):
Danish: Ikke kendt (hyppighed kan ikke estimeres ud fra forhåndenværende data):
English: Dose increases should not be made more frequently than every 4 weeks.
Danish: Dosis bør ikke øges oftere end hver 4. uge.
English: The co-primary efficacy endpoints in this study were defined as:
Danish: De co-primære effektendepunkter i dette studie var defineret som:
English: 3) Wash your hands before preparing the medicine.
Danish: 3) Vask hænder, inden du klargør lægemidlet.
English: • controlling how hungry you feel and your energy levels
Danish: • kontrollere, hvor sulten du føler dig, og hvor meget energi du har
English: Throw it away and start again from step 1.
Danish: Smid den væk, og start forfra med trin 1.
English: You can inject this medicine into the following areas:
Danish: Du kan injicere dette lægemiddel i de følgende områder:
English: Most events occurred during the initial 1-2 months of initiation of treatment.
Danish: De fleste hændelser forekom i løbet af de første 1-2 måneder efter initiering af behandlingen.
English: This improves the ability of the body to control energy levels.
Danish: Det forbedrer kroppens evne til at kontrollere energiniveauerne.
English: The injection should be administered at the same time every day.
Danish: Injektionen skal administreres på samme tidspunkt hver dag.
English: Your doctor might need to change your treatment.
Danish: Det kan være, at din læge skal ændre din behandling.
English: It is anticipated that most children will require increasing per kg dose, especially as they reach puberty.
Danish: Det forventes, at de fleste børn vil kræve stigende doser pr. kg, især når de når puberteten.
English: You will also need 2 syringes:
Danish: Du skal også bruge 2 sprøjter:
English: You might feel dizzy or tired when using this medicine.
Danish: Du kan føle dig svimmel eller træt, mens du bruger dette lægemiddel.
English: • you have ever had problems with your blood (such as a low blood count)
Danish: • du nogensinde har haft problemer med dit blod (for eksempel lav blodprocent)
English: Your doctor will change your dose of insulin or other medicines if needed.
Danish: Din læge vil ændre din dosis af insulin eller andre lægemidler, hvis det er nødvendigt.
English: No dose recommendations can be made.
Danish: Der kan ikke gives nogen anbefalinger vedrørende dosis.
English: Contact them if you are unclear about anything or if you need more information or help.
Danish: Kontakt dem, hvis du er i tvivl om noget, eller hvis du skal bruge flere oplysninger eller hjælp.
English: It is recommended that patients should use a different injection site each day when injecting in the same region.
Danish: Det anbefales, at patienten anvender et nyt injektionssted hver dag ved injektion i den samme region.
English: No effects on the distribution of subcutaneous fat are expected.
Danish: Der forventes ingen virkning på fordelingen af subkutant fedt.
English: Therefore, an additional non-hormonal contraceptive method should be considered during treatment.
Danish: Derfor skal det overvejes at bruge en ekstra ikke-hormonel kontraceptionsmetode under behandlingen.
English: Possible side effects with this medicine:
Danish: Mulige bivirkninger med dette lægemiddel:
English: SD = standard deviation
Danish: SD = standardafvigelse
English: • feeling very thirsty or hungry
Danish: • føle sig meget tørstig eller sulten
English: Overall, the safety and tolerability of metreleptin are similar in children and adults.
Danish: Samlet set er metreleptins sikkerhed og tolerabilitet den samme for børn og voksne.
English: Step G: Throwing away used materials
Danish: Trin G: Bortskaffelse af brugte materialer
English: *Global post marketing experience
Danish: *Globale erfaringer efter markedsføring
English: A higher accumulation is observed with higher ADA levels.
Danish: Der observeres en højere akkumulering ved højere ADA-niveauer.
English: Your doctor will have prescribed the correct dose for you, based on the following:
Danish: Din læge vil ordinere den korrekte dosis for dig ud fra følgende:
English: The medicinal product was administered subcutaneously either once daily or twice daily (in two equal doses).
Danish: Lægemidlet blev administreret subkutant enten en gang dagligt eller to gange dagligt (i to lige store doser).
English: Frequencies are defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Danish: Hyppighederne defineres som meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • 0.5% HbA1c reduction and/or 25% reduction in insulin requirements and / or
Danish: • 0,5 % reduktion i HbA1c og/eller 25 % reduktion i insulinbehov og/eller
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis det sker, må du ikke føre motorkøretøj eller bruge maskiner.
English: • Then have your normal dose the next day.
Danish: • Derefter skal du tage din dosis som normalt dagen efter.
English: In one post-marketing case, an infant was exposed to a 10-fold overdose of metreleptin for 8 months.
Danish: I ét tilfælde efter markedsføring blev et spædbarn eksponeret for en 10 gange overdosis af metreleptin i 8 måneder.
English: Table 6 Dose adjustment calculation Adjust dose as follows (if necessary)
Danish: Tabel 6 Beregning af dosisjusteringer Juster dosis som følger (hvis det er nødvendigt)
English: Your doctor will monitor you for side effects.
Danish: Din læge vil overvåge dig for bivirkninger.
English: This is to prevent your blood sugar from getting too low (‘hypo-glycaemia').
Danish: Det er for at forhindre, at du får for lavt blodsukker ("hypo-glykæmi").
English: Additionally, adverse reactions from post-marketing sources are also presented.
Danish: Desuden er bivirkninger fra kilder efter markedsføringen også medtaget.
English: Natural leptin is produced by fatty tissue and has many functions in the body including:
Danish: Naturlig leptin produceres af fedtvæv og har mange funktioner i kroppen, herunder at:
English: You should not use Myalepta if you are pregnant or might become pregnant.
Danish: Du må ikke bruge Myalepta, hvis du er gravid eller måske kan blive gravid.
English: • Your doctor will decide if you should use Myalepta and will monitor you during treatment.
Danish: • Din læge vil beslutte, om du skal bruge Myalepta, og du vil blive overvåget under behandlingen.
English: Serious and severe infections
Danish: Alvorlige og svære infektioner
English: The educational programme is aimed at increasing awareness among healthcare professionals and patients/carers about the important risks contained in the Risk Management Plan.
Danish: Uddannelsesprogrammet har til formål at øge sundhedspersonalets og patienternes/omsorgspersonernes kendskab til de vigtige risici i risikostyringsplanen.
English: If you are using a medicine such as insulin or other medicines to treat diabetes, your doctor will closely monitor your blood sugar.
Danish: Hvis du bruger medicin som for eksempel insulin eller andre lægemidler til behandling af sukkersyge (diabetes), vil din læge overvåge dit blodsukker nøje.
English: • loss of interest in food
Danish: • manglende interesse for mad
English: Actual body weight at initiation of treatment should always be used when calculating the dose.
Danish: Den faktiske legemsvægt ved initiering af behandlingen skal altid bruges ved beregning af dosis.
English: Endogenous leptin is present in human milk.
Danish: Endogen leptin findes i human mælk.
English: • swelling in your hands and feet
Danish: • hævelser i hænder og fødder
English: 1) Get together all the materials you will need for your injection.
Danish: 1) Saml alle de materialer, du skal bruge til injektionen.
English: Due to the number of patients with generalised and partial LD treated in clinical trials, it is not possible to detect with certainty, events which occur at a frequency of < 1%.
Danish: På grund af antallet af patienter med generaliseret og partiel lipodystrofi behandlet i kliniske forsøg er det ikke muligt med sikkerhed at påvise hændelser, som forekommer med en hyppighed på < 1 %.
English: Use new syringes each time.
Danish: Brug nye sprøjter hver gang.
English: • Do not use the syringes more than once.
Danish: • Brug ikke sprøjterne mere end én gang.
English: Draft protocol to be submitted 3 months after notification of the European Commission decision.
Danish: Et udkast til protokollen skal indsendes 3 måneder efter meddelelse af EuropaKommissionens afgørelse.
English: Your doctor will decide if you should stop using this medicine.
Danish: Lægen vil beslutte, om du skal holde op med at bruge dette lægemiddel.
English: The final study report should be submitted by 2022.
Danish: Den endelige studierapport skal indsendes senest i 2022.
English: It can be administered any time of the day without regard to the timing of meals.
Danish: Den kan administreres på et hvilket som helst tidspunkt på dagen og er ikke afhængig af måltider.
English: • Do not use a double dose to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: This is because it is not known how metreleptin will affect your unborn baby.
Danish: Det skyldes, at det ikke vides, hvordan metreleptin vil påvirke dit ufødte barn.
English: Mean change among the 5 patients < 6 years of age was 0.2%.
Danish: Middelændringen blandt de 5 patienter < 6 år var 0,2 %.
English: Your doctor will also ask you to follow a reduced fat diet.
Danish: Din læge vil også bede dig om at følge en diæt med lavt fedtindhold.
English: It is also aimed to guide prescribers about the appropriate management of these risks.
Danish: Det skal også vejlede ordinerende læger om passende håndtering af disse risici.
English: An example is given below for the different syringe sizes.
Danish: Nedenfor vises eksempler for de forskellige sprøjtestørrelser.
English: • you have ever had a type of cancer called lymphoma
Danish: • du nogensinde har haft en form for kræft, der kaldes lymfom
English: However, you may be at higher risk of getting a lymphoma when using the medicinal product.
Danish: Du kan dog have højere risiko for at få lymfom, når du bruger lægemidlet.
English: • feeling more hungry than normal
Danish: • føle sig mere sulten end normalt
English: 1077 ZX Amsterdam The Netherlands
Danish: 1077 ZX Amsterdam Holland
English: The clearance of metreleptin appears to be delayed in the presence of ADAs.
Danish: Metreleptins clearance lader til at være forsinket ved tilstedeværelse af ADA'er.
English: • unusually heavy or long menstrual bleeding
Danish: • usædvanlig kraftig eller langvarig menstruation
English: Also some other medicines can affect the way this medicine works.
Danish: Nogle lægemidler kan også påvirke den måde, denne medicin virker på.
English: Advice will be provided on symptoms of an allergic reaction and action to be taken in the event of such a reaction.
Danish: Der skal oplyses om symptomerne på en allergisk reaktion og handlinger, der skal foretages i tilfælde af en sådan reaktion.
English: Age, Gender, Race, Body Mass Index
Danish: Alder, køn, race, kropsmasseindeks
English: When dividing doses due to volume, doses can be administered one after the other at different injection sites.
Danish: Når dosen opdeles på grund af volumen, kan doserne administreres efter hinanden på forskellige injektionssteder.
English: Some medicines need to be monitored while you are using Myalepta since the dose of these medicines might need to be changed.
Danish: Nogle lægemidler skal overvåges, mens du bruger Myalepta, da der kan være behov for at ændre dosen af disse lægemidler.
English: The patient will receive a carton containing 1 or 30 vials of Myalepta, depending on the pack size, which should be stored in a refrigerator until the day of use.
Danish: Patienten får en karton med 1 eller 30 hætteglas Myalepta, afhængigt af pakningsstørrelsen, og den skal opbevares i køleskab indtil den dag, den skal bruges.
English: While using this medicine, you or your child will be monitored by your doctor, who will decide the dose you or your child should use.
Danish: Så længe du bruger dette lægemiddel, vil din læge overvåge dig eller dit barn, og lægen vil beslutte, hvilken dosis du eller dit barn skal bruge.
English: 1077 ZX Amsterdam The Netherlands infogroup@aegerion.com
Danish: 1077 ZX Amsterdam Holland infogroup@aegerion.com
English: No interaction studies have been performed in humans.
Danish: Der er ikke udført interaktionsstudier på mennesker.
English: Name and address of the manufacturer of the biological active substance Sandoz GmbH - BP Kundl
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) Sandoz GmbH - BP Kundl
English: There are additional education training information and videos to help you understand how to use Myalepta correctly.
Danish: Der findes uddannelsesmaterialer og videoer, som kan hjælpe dig med at forstå, hvordan du skal bruge Myalepta korrekt.
English: Step A: Setting up
Danish: Trin A: Opstilling
English: Influenza, Pneumonia
Danish: Influenza, pneumoni
English: • sweating more than normal
Danish: • svede mere end normalt
English: Instructions for Use Before using Myalepta, you must first read Sections 1 - 6 of this package leaflet, and then read Section 7 Instructions for Use.
Danish: Instruktioner vedrørende anvendelsen Inden du bruger Myalepta, skal du først læse punkt 1 - 6 i denne indlægsseddel, og derefter skal du læse punkt 7 Instruktioner vedrørende anvendelsen.
English: However, no developmental abnormalities were observed and reproductive performance of the first or second generations was not affected at any dose.
Danish: Der blev dog ikke observeret nogen udviklingsmæssige abnormiteter, og første og anden generations reproduktionsevne var ikke berørt ved nogen dosis.
English: • If you forget to inject a dose, inject it as soon as you remember.
Danish: • Hvis du glemmer at injicere en dosis, skal du injicere den, så snart du kommer i tanke om det.
English: Most of these patients (13 of 16) were able to stop insulin use within the first year of metreleptin.
Danish: De fleste af disse patienter (13 ud af 16) kunne stoppe brug af insulin inden for det første år med metreleptin.
English: Autoimmune disorders are associated with an increased risk of malignancies including lymphomas.
Danish: Autoimmune sygdomme er forbundet med en øget risiko for maligniteter, herunder lymfomer.
English: This is because it is not known how this medicine will affect children under these ages.
Danish: Det skyldes, at det ikke vides, hvordan denne medicin påvirker børn i disse aldersgrupper.
English: In general, dose selection and modification for an elderly patient should be cautious, although no specific dose adjustment is recommended.
Danish: Generelt skal valg og ændring af dosis til ældre patienter foretages med forsigtighed, men der kan ikke anbefales en bestemt dosisjustering.
English: • The solution will take less than 5 minutes to become clear.
Danish: • Opløsningen bliver klar på under 5 minutter.
English: Eurofins PHAST GmbH Kardinal-Wendel-Straße 16 66424 Homburg Germany
Danish: Eurofins PHAST GmbH Kardinal Wendel Straße 16 66424 Homburg Tyskland
English: 22) Carefully choose where you want to inject Myalepta.
Danish: 22) Vælg omhyggeligt det sted, hvor du vil injicere Myalepta.
English: Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment.
Danish: Fortæl det straks til lægen, hvis du bemærker nogen af følgende alvorlige bivirkninger - du kan have brug for lægebehandling med det samme.
English: • feeling more irritable or more nervous
Danish: • føle sig mere irritabel eller mere nervøs.
English: • an increase in ‘HbA1c' in your blood, shown in tests
Danish: • øget indhold af "HbA1c" i blodet, som påvises ved blodprøver
English: Your dose of Myalepta may change over time depending on how this medicine works for you.
Danish: Din dosis af Myalepta kan ændres med tiden, afhængigt af hvordan dette lægemiddel virker for dig.
English: 28) Remove the syringe from the skin.
Danish: 28) Fjern sprøjten fra huden.
English: The final study report should be submitted by 2024.
Danish: Den endelige studierapport skal indsendes senest i 2024.
English: A causal relationship between the medicinal product treatment and the development and/or progression of lymphoma has not been established.
Danish: Der er ikke fastlagt en årsagssammenhæng mellem behandling med lægemidlet og udvikling og/eller progression af lymfom.