FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Votrient (seen in more than 1 patient in 10) include reduced appetite, dysgeusia (taste disturbances), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), vomiting, pain, hair colour change, fatigue (tiredness), skin hypopigmentation (discolouration of the skin), exfoliative (flaky) rash, headache, stomatitis (inflammation of the lining of the mouth), decreased weight and increased blood levels of certain liver enzymes.
Danish: De hyppigste bivirkninger ved Votrient (som optræder hos flere end 1 ud af 10 patienter) omfatter nedsat appetit, dysgeusi (smagsforstyrrelser), hypertension (forhøjet blodtryk), diarré, kvalme, opkastning, smerter, hårfarveændringer, udmattelse (træthed), hypopigmentering af huden (affarvning af huden), skællende udslæt, hovedpine, stomatitis (betændelse i mundslimhinden), vægttab samt øget indhold af visse enzymer i blodet.
English: These enzymes can be found in some receptors on the surface of cells that are involved in the growth and spread of cancer cells, such as ‘VEGFR', ‘PDGFR' and ‘KIT'.
Danish: Disse enzymer findes i visse receptorer på overfladen af celler, der er med til at danne og sprede kræftceller, såsom "VEGFR", "PDGFR" og "KIT".
English: Treatment with Votrient should only be started by a doctor who has experience in giving anticancer medicines.
Danish: Behandlingen med Votrient bør kun indledes af en læge med erfaring i anvendelse af lægemidler mod kræft.
English: Therefore, the Committee decided that Votrient's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget besluttede derfor, at fordelene ved Votrient opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: It is used in patients who have been previously treated with chemotherapy (medicines to treat cancer) because their cancer had spread, or in patients whose cancer has progressed within 12 months after receiving adjuvant or neoadjuvant therapy (treatment received after or before their main treatment).
Danish: Det anvendes til patienter, der tidligere er blevet behandlet med kemoterapi (lægemidler til behandling af kræft), fordi deres kræft havde spredt sig, eller til patienter, hvis kræft har udviklet sig inden for 12 måneder efter at have fået adjuvant eller neoadjuvant terapi (behandling modtaget efter eller før den egentlige behandling).
English: Votrient must not be used in people who are hypersensitive (allergic) to pazopanib or any of the other ingredients.
Danish: Votrient må ikke anvendes til personer, som er overfølsomme (allergiske) over for pazopanib eller andre af indholdsstofferne.
English: What is the risk associated with Votrient?
Danish: Hvilken risiko er der forbundet med Votrient?
English: • certain forms of soft-tissue sarcoma, a type of cancer that develops from the soft, supporting tissues of the body.
Danish: • visse former for blødtvævssarcom, en kræftform, der udvikles fra kroppens bløde støttevæv.
English: It is used in patients who have not received any previous treatment or in patients who have already been treated for their advanced disease with anticancer medicines called ‘cytokines'.
Danish: Det anvendes til patienter, der ikke tidligere har modtaget behandling, eller til patienter, der allerede er blevet behandlet for deres fremskredne sygdom med kræftmidler kaldet "cytokiner".
English: The active substance in Votrient, pazopanib, is a protein kinase inhibitor.
Danish: Det aktive stof i Votrient, pazopanib, er en proteinkinasehæmmer.
English: On average, the patients who took Votrient lived for 20 weeks without their disease getting worse, compared with seven weeks for the patients who took placebo.
Danish: Patienterne, som fik Votrient, levede i gennemsnit 20 uger, uden at deres sygdom blev forværret, sammenlignet med syv uger for de patienter, der fik placebo.
English: Votrient is a medicine that contains the active substance pazopanib.
Danish: Votrient er et lægemiddel, der indeholder det aktive stof pazopanib.
English: On average, the patients who took Votrient lived for 9.2 months without their disease getting worse, compared with 4.2 months for the patients who took placebo.
Danish: Patienterne, som fik Votrient, levede i gennemsnit 9,2 måneder, inden sygdommen forværredes, sammenlignet med 4,2 måneder for de patienter, der fik placebo.
English: For the full list of all side effects reported with Votrient, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Votrient fremgår af indlægssedlen.
English: The CHMP considered that Votrient has been shown to be an effective medicine for patients with advanced renal cell carcinoma and soft-tissue sarcoma, with a clinically relevant improvement in progression-free survival.
Danish: CHMP vurderede det som påvist, at Votrient er et effektivt lægemiddel til patienter med fremskredent renalcellecarcinom og blødtvævssarcom med en klinisk relevant forbedring i progressionsfri overlevelsestid.
English: Votrient was originally given ‘conditional approval' because there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma.
Danish: Votrient blev oprindeligt godkendt under "særlige omstændigheder", eftersom der afventedes yderligere dokumentation om lægemidlet, navnlig vedrørende behandlingen af renalcellecarcinom.
English: • advanced renal cell carcinoma, a type of kidney cancer.
Danish: • fremskredent renalcellecarcinom, en form for nyrekræft.
English: Why has Votrient been approved?
Danish: Hvorfor blev Votrient godkendt?
English: Votrient has also been compared with placebo in a main study involving 369 patients with soft-tissue sarcoma whose disease had progressed during or following previous chemotherapy.
Danish: Votrient er desuden blevet sammenlignet med placebo i en hovedundersøgelse af 369 patienter med blødtvævssarcom, hvis sygdom havde udviklet sig under eller efter tidligere kemoterapi.
English: Votrient has been compared with placebo (a dummy treatment) in one main study involving 435 patients with advanced renal cell carcinoma, some of whom had previously been treated with cytokines.
Danish: Votrient er blevet sammenlignet med placebo (en virkningsløs behandling) i en hovedundersøgelse af 435 patienter med fremskredent renalcellecarcinom, hvoraf nogle tidligere var blevet behandlet med cytokiner.
English: Votrient was more effective than placebo at treating advanced renal cell carcinoma.
Danish: Votrient var mere effektivt end placebo til behandling af fremskredent renalcellecarcinom.
English: Votrient was also more effective than placebo at treating soft-tissue sarcoma.
Danish: Votrient var også mere effektivt end placebo til behandling af blødtvævssarcom.
English: What is Votrient?
Danish: Hvad er Votrient?
English: What benefit has Votrient shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Votrient?
English: What is Votrient used for?
Danish: Hvad anvendes Votrient til?
English: How has Votrient been studied?
Danish: Hvordan blev Votrient undersøgt?
English: How is Votrient used?
Danish: Hvordan anvendes Votrient?
English: How does Votrient work?
Danish: Hvordan virker Votrient?
English: The full EPAR for Levetiracetam Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Levetiracetam Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Epilepsy is caused by excessive electrical activity in the brain.
Danish: Epilepsi skyldes overdreven elektrisk aktivitet i hjernen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Accord on3 October 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Levetiracetam Accord den 3. oktober 2011.
English: It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg).
Danish: Det fås som tabletter (250 mg, 500 mg, 750 mg og 1 000 mg).
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam Accord.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Levetiracetam Accord.
English: This is a type of epilepsy where excessive electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
Danish: Det en form for epilepsi, hvor for stærk elektrisk aktivitet i en side af hjernen giver symptomer som pludselige, sætvise bevægelser af en del af kroppen, forvrænget hørelse, lugt- eller synshallucinationer, følelsesløshed eller pludselig angst.
English: For patients weighing less than 50 kg, the dose depends on body weight.
Danish: Hos børn, der vejer under 50 kg, afhænger dosis af legemsvægten.
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 Accord.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Levetiracetam Accord skal anvendes.
English: This helps Levetiracetam Accord to stabilise electrical activity in the brain and prevent seizures.
Danish: Det er med til at bevirke, at Levetiracetam Accord kan stabilisere den elektriske aktivitet i hjernen og forhindre anfald.
English: Patients who cannot take tablets should be given a solution containing levetiracetam.
Danish: Patienter, der ikke kan synke tabletter, skal have en opløsning, der indeholder levetiracetam.
English: For more information about treatment with Levetiracetam Accord, 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 Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: • partial-onset seizures with or without generalisation in patients from 1 month of age;
Danish: • partielle anfald med eller uden generalisering hos patienter i alderen en måned og opefter
English: This means that Levetiracetam Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Danish: Det betyder, at Levetiracetam Accord er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Keppra.
English: The exact way in which levetiracetam works is unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells.
Danish: Det vides ikke nøjagtigt, hvordan levetiracetam virker, men det bindes til proteinet synaptisk vesikelprotein 2A, som medvirker ved udskillelsen af kemiske signalstoffer fra nervecellerne.
English: Levetiracetam Accord 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 Accord kan anvendes alene til patienter fra 16 år og opefter med nydiagnosticeret epilepsi til at behandle partielle anfald med eller uden sekundær generalisering.
English: What measures are being taken to ensure the safe and effective use of Levetiracetam Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Levetiracetam Accord?
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam Accord 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 Accord er af sammenlignelig kvalitet og er bioækvivalent med Keppra.
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
Danish: • myoklone anfald (kortvarige, rykvise trækninger i en muskel eller muskelgruppe) hos patienter fra 12-års alderen med juvenil myoklon epilepsi
English: Levetiracetam Accord can also be used as an add-on to other epilepsy medicines to treat:
Danish: Levetiracetam Accord kan også anvendes som tillægsbehandling til andre antiepileptika til at behandle:
English: • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to be inherited).
Danish: • primære generaliserede tonisk-kloniske anfald (alvorlige krampeanfald, herunder med bevidsthedstab) hos patienter fra 12-års alderen med idiopatisk generaliseret epilepsi (en form for epilepsi, som menes at have en genetisk årsag).
English: Lower doses are used in patients who have problems with their kidneys (such as older patients).
Danish: Til patienter med nyreproblemer (såsom ældre patienter) anvendes lavere doser.
English: Levetiracetam Accord is a ‘generic medicine'.
Danish: Levetiracetam Accord er et "generisk lægemiddel".
English: Other information about Levetiracetam Accord
Danish: Andre oplysninger om Levetiracetam Accord
English: The Committee recommended that Levetiracetam Accord be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Levetiracetam Accord.
English: What are the benefits and risks of Levetiracetam Accord?
Danish: Hvilken fordel og risiko er der forbundet med Levetiracetam Accord?
English: Levetiracetam Accord tablets are swallowed with liquid.
Danish: Levetiracetam Accord-tabletter synkes med væske.
English: The active substance in Levetiracetam Accord, levetiracetam, is an epilepsy medicine.
Danish: Det aktive stof i Levetiracetam Accord, levetiracetam, er et antiepileptikum.
English: Levetiracetam Accord is a medicine that contains the active substance levetiracetam.
Danish: Levetiracetam Accord er et lægemiddel, der indeholder det aktive stof levetiracetam.
English: Because Levetiracetam Accord 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 Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: When Levetiracetam Accord is added to another epilepsy treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Danish: Når Levetiracetam Accord 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: Because Levetiracetam Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Danish: Da Levetiracetam Accord er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Keppra.
English: When Levetiracetam Accord 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 Accord anvendes alene, er startdosis 250 mg to gange dagligt, som efter to uger øges til 500 mg to gange dagligt.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Levetiracetam Accord have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der angivet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Levetiracetam Accord.
English: The dose can be further increased at two-week intervals according to the patient's response, to a maximum dose of 1,500 mg twice a day.
Danish: Afhængigt af patientens reaktion på behandlingen kan dosis med to ugers mellemrum øges yderligere til en maksimal dosis på 1 500 mg to gange dagligt.
English: How has Levetiracetam Accord been studied?
Danish: Hvordan blev Levetiracetam Accord undersøgt?
English: Why has Levetiracetam Accord been approved?
Danish: Hvorfor blev Levetiracetam Accord godkendt?
English: What is Levetiracetam Accord used for?
Danish: Hvad anvendes Levetiracetam Accord til?
English: How is Levetiracetam Accord used?
Danish: Hvordan anvendes Levetiracetam Accord?
English: What is Levetiracetam Accord?
Danish: Hvad er Levetiracetam Accord?
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1269/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1269/001
English: Your doctor may have to adjust your dose.
Danish: Lægen kan være nødt til at justere dosen.
English: This is because Alpivab may prevent these vaccines from working well enough.
Danish: Det skyldes, at Alpivab kan forhindre disse vacciner i at virke ordentligt.
English: Uncomplicated influenza in adults
Danish: Ukompliceret influenza hos voksne
English: These medicines prevent the influenza virus from spreading inside the body.
Danish: Disse lægemidler forhindrer influenzavirusset i at sprede sig i kroppen.
English: *Absolute GFR not adjusted for body surface area
Danish: * Absolut GFR ikke justeret for legemsoverflade
English: Not known, frequency cannot be estimated from the available data
Danish: Ikke kendt (frekvensen kan ikke estimeres ud fra forhåndenværende data):
English: Tel: +353 1223 3541
Danish: Tlf.: +353 1223 3541
English: Other side effects occur with the following frequencies:
Danish: Andre bivirkninger kan optræde med følgende hyppigheder:
English: Key efficacy results are presented in Table 4.
Danish: De væsentligste effektresultater er anført i tabel 4.
English: • Patients with reduced kidney function may require a reduced dose.
Danish: • Patienter med nedsat nyrefunktion kan have behov for en nedsat dosis.
English: Treatment of an overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Danish: Behandling af en overdosis bør bestå af generelle understøttende foranstaltninger, herunder overvågning af vitale tegn og af patientens kliniske status.
English: In-vitro activity
Danish: In vitro-aktivitet
English: In-vitro binding of peramivir to human plasma proteins is less than 30 %.
Danish: In vitro-binding af peramivir til humane plasmaproteiner er mindre end 30 %.
English: Chemical and physical in-use stability has been demonstrated for 72 hours at 5 ºC and 25 ºC.
Danish: Kemisk og fysisk brugsstabilitet er påvist i 72 timer ved temperaturer på 5-25 ºC.
English: There are no or limited amount of data (less than 300 pregnancies outcomes) from the use of peramivir in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 graviditetsudfald) fra anvendelse af peramivir til gravide kvinder.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).
Danish: Hyppigheden 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) og meget sjælden (< 1/10 000).
English: Based on a population pharmacokinetic analysis, the central volume of distribution was 12.56 L.
Danish: På grundlag af en farmakokinetisk populationsanalyse var det centrale fordelingsvolumen 12,56 l.
English: Adults and adolescents (13 years and older)
Danish: Voksne og unge (13 år og opefter)
English: Symptoms may include confusion, difficulty thinking or hallucinations.
Danish: Symptomerne kan omfatte forvirring, problemer med at tænke eller hallucinationer.
English: There is no specific antidote to treat an overdose of this medicine.
Danish: Der findes ingen specifik modgift mod en overdosis af dette lægemiddel.
English: Peramivir has not been shown to prevent such complications.
Danish: Det er ikke påvist, at peramivir kan forebygge sådanne komplikationer.
English: Available data do not support a conclusion that peramivir is effective in patients with influenza B or in patients with complicated influenza.
Danish: De tilgængelige data understøtter ikke en konklusion om, at peramivir er effektivt hos patienter med influenza B eller hos patienter med kompliceret influenza.
English: Recommended single dose
Danish: Anbefalet enkeltdosis
English: The teratological importance of these findings is unclear.
Danish: Den teratologiske betydning af disse fund er ikke klarlagt.
English: • if you are allergic to peramivir or any of the other ingredients of this medicine (listed in section
Danish: • hvis du er allergisk over for peramivir eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i pkt.
English: This is equivalent to 10.6 % of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Det svarer til 10,6 % af det anbefalede maksimale daglige indtag af natrium for en voksen.
English: Resistance to peramivir
Danish: Resistens over for peramivir
English: As a precautionary measure, it is preferable to avoid the use of peramivir during pregnancy.
Danish: Som forsigtighedsforanstaltning bør peramivir undgås under graviditet.
English: It must be colourless and without particulate matter.
Danish: Det skal være farveløst og uden synlige partikler.
English: Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza.
Danish: Alvorlige bakterieinfektioner kan begynde med influenza-lignende symptomer eller kan forekomme samtidig med eller opstå som komplikationer til influenza-sygdom.
English: Patients with influenza should be closely monitored for signs of abnormal behaviour.
Danish: Patienter med influenza bør overvåges tæt for tegn på unormal adfærd.
English: Contact your doctor immediately if any of the following side effects occur:
Danish: Kontakt lægen øjeblikkeligt, hvis du oplever en eller flere af følgende bivirkninger:
English: 4.7 Effects on ability to drive and use machines Peramivir has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Peramivir påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Serum creatinine measurements were used to calculate creatinine clearance (Cockcroft-Gault equation).
Danish: Serumkreatinin blev målt for at beregne kreatinin-clearance (Cockcroft-Gault).
English: Pharmacokinetic sampling in this study was limited to approximately 3 hours after administration of peramivir.
Danish: Den farmakokinetiske prøvetagning i denne undersøgelse var begrænset til ca. 3 timer efter administration af peramivir.
English: Peramivir is not significantly metabolised in humans.
Danish: Peramivir metaboliseres ikke i væsentlig grad hos mennesker.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i appendiks V. Ved at indberette bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Subjects participating in the trial were required to self-assess their influenza symptoms as “none', ‘mild', ‘moderate' or ‘severe' twice daily.
Danish: Forsøgspersonerne i undersøgelsen blev bedt om at selvvurdere deres influenza-symptomer som 'ingen', 'milde', 'moderate' eller 'svære' to gange dagligt.