FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Lorviqua are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Lorviqua vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Lorviqua, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Lorviqua, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: In this study Lorviqua was not compared with any other treatment or placebo (a dummy treatment).
Danish: I dette studie blev Lorviqua ikke sammenlignet med anden behandling eller placebo (et uvirksomt stof).
English: An overview of Lorviqua and why it is authorised in the EU
Danish: En oversigt over Lorviqua, og hvorfor det er godkendt i EU
English: What measures are being taken to ensure the safe and effective use of Lorviqua?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lorviqua?
English: ALK belongs to a family of enzymes called receptor tyrosine kinases, which are involved in the growth of cells and the development of new blood vessels that supply them.
Danish: ALK tilhører en familie af enzymer kaldet receptor-tyrosinkinaser, der medvirker ved cellevækst og udvikling af nye blodkar, der forsyner dem.
English: Why is Lorviqua authorised in the EU?
Danish: Hvorfor blev Lorviqua godkendt i EU?
English: Depending on which previous treatment the patients had received, around 67% and 52% of patients treated with Lorviqua had no signs of cancer in the brain or the signs of cancer had reduced.
Danish: Afhængigt af hvilken tidligere behandling patienterne havde modtaget, havde ca. 67 % og 52 % af de patienter, der blev behandlet med Lorviqua, ingen tegn på kræft i hjernen, eller tegnene på kræft var blevet reduceret.
English: What is Lorviqua and what is it used for?
Danish: Hvad er Lorviqua, og hvad anvendes det til?
English: Lorviqua contains the active substance lorlatinib.
Danish: Lorviqua indeholder det aktive stof lorlatinib.
English: Lorviqua can only be obtained with a prescription.
Danish: Lorviqua udleveres kun efter recept.
English: The most common side effects with Lorviqua (which may affect more than 1 in 5 people) are hypercholesterolaemia (high blood cholesterol levels), hypertriglyceridaemia (high blood levels of triglycerides, a type of fat), oedema (build-up of fluid), peripheral neuropathy (nerve damage in the hands and feet), problems with thinking, learning and memory, tiredness, weight gain and effects on mood.
Danish: De hyppigste bivirkninger ved Lorviqua (som optræder hos mere end 1 ud af 5 patienter) er hyperkolesterolæmi (forhøjet kolesterolniveau i blodet), hypertriglyceridæmi (forhøjet indhold af triglycerider (en type fedt) i blodet), ødem (væskeophobning), perifer neuropati (nerveskader i hænder og fødder), problemer med tænkning, indlæring og hukommelse, træthed, vægtforøgelse og ændringer i humøret.
English: Around 43% of patients who had been previously treated with alectinib or ceritinib were considered by their doctors to have had a complete or partial response to the medicine.
Danish: Ca. 43 % af de patienter, der tidligere var blevet behandlet med alectinib eller ceritinib, blev af deres læger anset for at have haft en fuldstændig eller delvis respons på lægemidlet.
English: What information is still awaited for Lorviqua?
Danish: Hvilke oplysninger afventes der stadig for Lorviqua?
English: The active substance in Lorviqua, lorlatinib, is a tyrosine kinase inhibitor.
Danish: Det aktive stof i Lorviqua, lorlatinib, er en tyrosinkinasehæmmer.
English: Lorviqua received a conditional marketing authorisation valid throughout the EU on 6 May 2019 Further information on Lorviqua can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Lorviqua.
Danish: Yderligere information om Lorviqua findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Lorviqua.
English: Lorviqua is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC), when the disease is advanced and ‘ALK-positive', which means that the cancer cells have certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).
Danish: Lorviqua er et kræftlægemiddel, der anvendes til behandling af voksne med ikke-småcellet lungekræft, når sygdommen er fremskreden, og "ALK-positiv", hvilket betyder, at kræftcellerne indeholder visse ændringer, der påvirker genet for et protein kaldet ALK (anaplastisk lymfomkinase).
English: Very few other treatments are available for patients after ALK tyrosine kinase inhibitors have failed or for those whose cancer has spread to the brain, and the side effects with Lorviqua are manageable.
Danish: Meget få andre behandlinger er tilgængelige for patienter, efter at ALK-tyrosinkinasehæmmere har slået fejl, eller for patienter, hvis kræft har spredt sig til hjernen, og bivirkningerne ved Lorviqua er håndterbare.
English: Lorviqua was also effective against cancer that had spread to the brain.
Danish: Lorviqua var også effektivt for kræft, der havde spredt sig til hjernen.
English: What are the risks associated with Lorviqua?
Danish: Hvilke risici er der forbundet med Lorviqua?
English: For the full list of side effects and restrictions with Lorviqua, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Lorviqua fremgår af indlægssedlen.
English: Since Lorviqua has been given conditional authorisation, the company that markets Lorviqua will conduct a study with the medicine in patients whose disease has worsened after treatment with alectinib or ceritinib.
Danish: Da Lorviqua har fået en betinget godkendelse, skal virksomheden, der markedsfører Lorviqua, foretage et studie med lægemidlet hos patienter, hvor sygdommen er blevet værre efter behandling med alectinib eller ceritinib.
English: Lorviqua was also effective when the cancer had spread to the brain.
Danish: Lorviqua var også effektivt, når kræften havde spredt sig til hjernen.
English: In addition, the company will provide the results of an ongoing study comparing Lorviqua with crizotinib in patients with ALK-positive NSCLC who have not been treated before.
Danish: Virksomheden vil desuden fremlægge resultaterne af et igangværende studie, hvor Lorviqua sammenlignes med crizotinib hos patienter med ALK-positiv ikke-småcellet lungekræft, som ikke tidligere er blevet behandlet.
English: Out of patients who had been previously treated with crizotinib and another ALK tyrosine kinase inhibitor, around 40% had a complete or partial response to the medicine.
Danish: Ud af de patienter, der tidligere var blevet behandlet med crizotinib og en anden ALKtyrosinkinasehæmmer, havde ca. 40 % en fuldstændig eller delvis respons på lægemidlet.
English: In patients with ‘ALK-positive' NSCLC, an abnormal form of ALK is produced that causes the cancer cells to divide and grow in an uncontrolled fashion.
Danish: Hos patienter med ALK-positiv ikke-småcellet lungekræft dannes der en unormal form af ALK, som får kræftcellerne til at dele sig og vokse ukontrolleret.
English: Genetic defects affecting ALK (‘ALK-positive' status) should be confirmed in advance.
Danish: Det bør på forhånd være fastslået, at patienten har gendefekten for ALK (er "ALK-positiv").
English: Lorviqua is used on its own when the disease has worsened despite treatment with other medicines of the same class known as ALK tyrosine kinase inhibitors (TKIs), including alectinib, ceritinib and crizotinib.
Danish: Lorviqua anvendes alene, når sygdommen er blevet værre på trods af behandling med andre lægemidler i samme klasse, kendt som ALK-tyrosinkinasehæmmere (TKI'er), herunder alectinib, ceritinib og crizotinib.
English: How is Lorviqua used?
Danish: Hvordan anvendes Lorviqua?
English: Lorviqua was effective at treating ALK-positive NSCLC in one main study which included 139 patients whose disease had worsened despite treatment with either alectinib or ceritinib or with crizotinib and another ALK tyrosine kinase inhibitor.
Danish: Lorviqua var effektivt til at behandle ALK-positiv ikke-småcellet lungekræft i ét hovedstudie, som omfattede 139 patienter, hvis sygdom var forværret trods behandling med enten alectinib eller ceritinib eller med crizotinib og en anden ALK-tyrosinkinasehæmmer.
English: Response to treatment was assessed using body scans and standardised criteria for assessing solid tumours, with complete response being when the patient had no remaining signs of the cancer.
Danish: Virkningen af behandlingen (responsen) blev vurderet ved kropsskanning og standardiserede kriterier for vurdering af solide tumorer.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lorviqua have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Lorviqua.
English: Lorviqua is effective at treating ALK-positive NSCLC that has worsened despite treatment with other ALK tyrosine kinase inhibitors.
Danish: Lorviqua er effektivt til at behandle ALK-positiv ikke-småcellet lungekræft, der er blevet værre trods behandling med andre ALK-tyrosinkinasehæmmere.
English: How does Lorviqua work?
Danish: Hvordan virker Lorviqua?
English: What benefits of Lorviqua have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Lorviqua?
English: Pack size blister (PA/Alu/PVC/Alu)
Danish: Blister (PA/Alu/PVC/Alu)
English: 224 (4 x 56) capsules
Danish: 224 (4 x kapsler
English: HDPE bottle
Danish: HDPE beholder kapsler
English: This summary was last updated in 12-2009.
Danish: Dette sammendrag blev sidst ajourført i 12-2009
English: In contrast, untreated newborns usually die within the first year of life.
Danish: I modsætning hertil dør ubehandlede nyfødte almindeligvis inden for det først leveår.
English: The marketing authorisation holder is Swedish Orphan International AB.
Danish: Indehaveren af markedsføringstilladelsen er Swedish Orphan International AB.
English: The marketing authorisation was renewed on 8 December 2004 and on 8 December 2009.
Danish: Markedsføringstilladelsen blev fornyet den 8. december 2004 og den 8. december 2009.
English: As the company had supplied the additional information requested, the ‘Exceptional Circumstances' ended on 6 July 2004.
Danish: Efter at virksomheden havde fremlagt de yderligere oplysninger, som man havde anmodet om, blev de 'særlige omstændigheder' ophævet den 6. juli 2004.
English: The survival rate was higher in patients who had developed the disease later in life.
Danish: Overlevelsesprocenten var højere hos patienter, der havde udviklet sygdommen senere i livet.
English: Other information about Ammonaps:
Danish: Andre oplysninger om Ammonaps:
English: Ammonaps was not compared with any other treatments.
Danish: Ammonaps blev ikke sammenlignet med andre behandlinger.
English: It is available as white oval tablets (500 mg) and as granules (940 mg/g).
Danish: Det leveres som hvide, ovale tabletter (500 mg) og som granulat (940 mg/g).
English: The full EPAR for Ammonaps is available here.
Danish: Den fuldstændige EPAR for Ammonaps findes her.
English: The daily dose of Ammonaps is adjusted for each patient individually and depends on the patient's diet, height and weight.
Danish: Den daglige dosis af Ammonaps tilpasses den enkelte patient og afhænger af patientens kost, højde og vægt.
English: Early diagnosis and immediate treatment are important to reduce the risk of disability.
Danish: Tidlig diagnose af sygdommen og øjeblikkelig påbegyndelse af behandlingen er vigtigt for at nedsætte risikoen for invaliditet.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ammonaps on 8 December 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ammonaps den 8. december 1999.
English: The Committee recommended that Ammonaps be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Ammonaps.
English: The tablets are for adults and children, and the granules are used in babies and in patients who cannot swallow tablets.
Danish: Tabletterne anvendes til voksne og børn, mens granulatet bruges til spædbørn og patienter, der ikke kan sluge tabletter.
English: The granules are either mixed into food or drink immediately before being taken, or dissolved in water before being given through a tube leading through the tummy or nose to the stomach.
Danish: Granulatet blandes enten i mad eller væske umiddelbart inden indtagelse eller opløses i vand, inden det tilføres gennem et rør, der er ført gennem bugvæggen eller næsen ind i maven.
English: The main measure of effectiveness was survival, but the study also looked at the number of hyperammonaemic episodes (periods of very high blood ammonia levels), cognitive development (development of the ability to think, learn and remember), growth, and blood ammonia and glutamine levels.
Danish: Det vigtigste mål for behandlingens virkning var overlevelse, men derudover undersøgtes antallet af tilfælde af hyperammoniæmi (perioder med meget højt ammoniakindhold i blodet), kognitiv udvikling (udvikling af evnen til at tænke, lære og huske), vækst samt blodets indhold af ammoniak og glutamin.
English: These patients are not able to get rid of waste nitrogen from the body because they lack some enzymes that are usually found in the liver.
Danish: Disse patienter kan ikke udskille de kvælstofholdige affaldsstoffer, fordi de mangler visse enzymer, som normalt findes i leveren.
English: Ammonaps is a long-term treatment and needs to be taken until the patient has a successful liver transplant.
Danish: Behandlingen med Ammonaps er langsigtet og skal fortsætte, indtil patienten har fået foretaget en vellykket levertransplantation.
English: Ammonaps sodium phenylbutyrate EPAR summary for the public
Danish: Ammonaps natriumphenylbutyrat EPAR - sammendrag for offentligheden
English: Ammonaps was authorised under ‘Exceptional Circumstances', because, as the disease is rare, limited information was available at the time of approval.
Danish: Ammonaps blev godkendt på "særlige omstændigheder", da der på godkendelsestidspunktet kun forelå sparsomme oplysninger som følge af sygdommens sjældenhed.
English: Ammonaps is used as an add-on to other treatments and with a special low-protein diet to reduce the intake of nitrogen.
Danish: Ammonaps anvendes som en tillægsbehandling til andre behandlinger og sammen med en særlig lavproteindiæt for at begrænse indtagelsen af kvælstof.
English: The overall survival rate was about 80% in newborn babies who received Ammonaps.
Danish: I alt overlevede ca. 80 % af nyfødte patienter, som fik Ammonaps.
English: Ammonaps is used in patients who lack one or more of the following enzymes: carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinate synthetase.
Danish: Ammonaps anvendes til patienter, der mangler et eller flere af følgende enzymer: carbamylfosfat syntetase, ornithin transcarbamylase eller argininosuccinat syntetase.
English: Therefore, despite the limited information available, the CHMP decided that Ammonaps's benefits are greater than its risks as adjunctive therapy in the chronic management of urea cycle disorders.
Danish: Selvom der kun forelå begrænsede oplysninger, besluttede CHMP derfor, at fordelene ved Ammonaps er større end risiciene til tillægsbehandling i forbindelse med kronisk kontrol af forstyrrelser i urinstofcyklus.
English: • ‘early-onset' disease in babies who show a complete lack of one or more of these enzymes within the first month of life;
Danish: • tidlig sygdomsdebut hos spædbørn, hvor et eller flere af disse enzymer mangler fuldstændigt,
English: The dose of Ammonaps should be divided into equal amounts and given with each meal.
Danish: Den daglige dosis Ammonaps skal deles i lige store mængder, der indtages med hvert måltid.
English: What is the risk associated with Ammonaps?
Danish: Hvilken risiko er der forbundet med Ammonaps?
English: Ammonaps is a medicine that contains the active substance sodium phenylbutyrate.
Danish: Ammonaps er et lægemiddel, som indeholder det aktive stof natriumphenylbutyrat.
English: Ammonaps has been studied in 82 patients with urea cycle disorders who were treated with Ammonaps and had not received other treatments for their disease before.
Danish: Ammonaps er blevet undersøgt hos 82 patienter med forstyrrelser i urinstofcyklus, som fik behandling med Ammonaps og ikke var blevet behandlet for deres sygdom tidligere.
English: For the full list of all side effects reported with Ammonaps, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Ammonaps fremgår af indlægssedlen.
English: The Committee for Medicinal Products for Human Use (CHMP) noted that urea cycle disorders are a serious disease with few treatments available, and that Ammonaps has been shown to prevent ammonia levels becoming too high.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konstaterede, at forstyrrelser i urinstofcyklus er en alvorlig sygdom med få tilgængelige behandlingsmuligheder, og at det er påvist, at Ammonaps forebygger for høje mængder ammoniak hos patienterne.
English: Ammonaps should not be used in people who may be hypersensitive (allergic) to sodium phenylbutyrate or any of the other ingredients.
Danish: Ammonaps må ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for natriumphenylbutyrat eller andre af indholdsstofferne.
English: • ‘late-onset' disease in patients who show a partial lack of an enzyme after the age of one month and have had brain damage caused by high blood ammonia levels.
Danish: • sen sygdomsdebut hos patienter, der er over en måned gamle og delvis mangler et enzym og har haft hjerneskade forårsaget af højt ammoniakindhold.
English: In the body, waste nitrogen is in the form of ammonia, which is toxic, especially for the brain.
Danish: De kvælstofholdige affaldsstoffer findes i kroppen i form af ammoniak, som er specielt giftigt for hjernen.
English: This allows the levels of nitrogen in the body to decrease, reducing the amount of ammonia produced.
Danish: Det får kvælstofindholdet i kroppen til at falde, hvorved produktionen af ammoniak nedsættes.
English: Ammonaps treatment should be supervised by a doctor who has experience in treating patients with urea cycle disorders.
Danish: Behandling med Ammonaps bør overvåges af en læge med erfaring i behandling af patienter med forstyrrelser i urinstofcyklus.
English: The active substance in Ammonaps, sodium phenylbutyrate, is converted into a substance called phenylacetate in the body.
Danish: Det aktive stof i Ammonaps, natriumphenylbutyrat, omdannes i kroppen til et andet stof kaldet phenylacetat.
English: Why has Ammonaps been approved?
Danish: Hvorfor blev Ammonaps godkendt?
English: Ammonaps is used to treat patients who have urea cycle disorders.
Danish: Ammonaps anvendes til behandling af patienter, der lider af forstyrrelser i urinstofcyklus.
English: What benefit has Ammonaps shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ammonaps?
English: The most common side effects with Ammonaps (seen in more than 1 patient in 10) are amenorrhoea (absence of periods) and irregular menstruation (irregular periods), but these only occur in fertile female patients.
Danish: De mest almindelige bivirkninger ved Ammonaps (som ses hos flere end 1 ud af 10 patienter) er udeblivende menstruation og uregelmæssig menstruation, men disse bivirkninger optræder kun hos kvinder i den fødedygtige alder. Andre almindelige bivirkninger er unormal nyrefunktion og unormal blodtælling (røde blodlegemer, hvide blodlegemer og blodplader).
English: What is Ammonaps?
Danish: Hvad er Ammonaps?
English: What is Ammonaps used for?
Danish: Hvad anvendes Ammonaps til?
English: How has Ammonaps been studied?
Danish: Hvordan blev Ammonaps undersøgt?
English: How is Ammonaps used?
Danish: Hvordan anvendes Ammonaps?
English: How does Ammonaps work?
Danish: Hvordan virker Ammonaps?
English: This is shown below.
Danish: Dette er er vist nedenfor.
English: The combination should be used with caution.
Danish: Kombinationen skal anvendes med forsigtighed
English: In patients of 12 years and older:
Danish: Patienter i alderen fra 12 år og opefter:
English: Do not use Levviax after the expiry date which is stated on the pack.
Danish: Anvend ikke Levviax efter den udløbsdato, som er angivet på pakningen.
English: If you forget to take a dose, take it as soon as possible.
Danish: Hvis De har glemt at tage en dosis, skal De tage denne hurtigst muligt.
English: Date of first renewal: 9 July 2006
Danish: Dato for første genregistrering: 9. juli 2006
English: WHAT LEVVIAX IS AND WHAT IT IS USED FOR
Danish: HVAD LEVVIAX ER, OG HVAD DET ANVENDES TIL
English: If you take more Levviax than you should
Danish: Hvis De tager mere Levviax end De bør
English: Levviax should not be used during pregnancy unless clearly necessary.
Danish: Levviax bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Vaginal Candida infection
Danish: Vaginal Candida infektion
English: - if you have liver disease.
Danish: - Hvis De har en leversygdom.
English: There are no adequate data from the use of Levviax in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af Levviax til gravide kvinder.
English: Effect on oral and faecal flora
Danish: Effekt på oral og fækal flora
English: The tablets may be taken with or without food.
Danish: Tabletterne kan tages med maden eller uden.
English: As for macrolides, H. influenzae is classified as intermediately susceptible.
Danish: Som for macrolider er H. influenzae klassificeret som intermediært følsom.
English: If you stop taking the tablets too soon, the infection may return, or your condition may get worse.
Danish: Hvis De stopper med at tage tabletterne for tidligt, kan infektionen komme tilbage, eller Deres tilstand kan forværres.
English: If you accidentally take one tablet too many, nothing is likely to happen.
Danish: Hvis De ved et uheld kommer til at tage 1- tablet for meget, sker der formentlig ingen ting.
English: Patients should be informed that these undesirable effects may occur as early as after the first dose of medication.
Danish: Patienterne bør informeres om at disse uønskede virkninger kan fremkomme allerede ved den første dosis af medicinen.
English: EU/1/01/192/001 10 tablets EU/1/01/192/002 14 tablets EU/1/01/192/003 20 tablets EU/1/01/192/004 100 tablets EU/1/01/192/005 5x2 tablets
Danish: EU/1/01/192/001 10 tabletter EU/1/01/192/002 14 tabletter EU/1/01/192/003 20 tabletter EU/1/01/192/004 100 tabletter EU/1/01/192/005 5x2 tabletter
English: Antibiotics stop the growth of bacteria which cause infections.
Danish: Antibiotika stopper væksten af bakterier, som er skyld i infektionen.
English: MARKETING AUTHORISATION NUMBERS EU/1/01/192/001-005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/192/001-005
English: Oral administration of midazolam concomitantly with Levviax should be avoided.
Danish: Oral administration af midazolam samtidig med Levviax bør undgås.
English: Like all medicines Levviax can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan Levviax forårsage bivirkninger, selvom ikke alle får bivirkninger.
English: This information provides only an approximate guidance on probabilities as to whether microorganisms will be susceptible to telithromycin.
Danish: Denne information giver kun en tilnærmet vejledning over sandsynligheden for om en mikroorganisme vil være følsom over for telithromycin
English: The holder of this marketing Authorisation will have to submit PSURs every 6 months.
Danish: • ANDRE BETINGELSER Indehaveren af denne markedsføringstilladelse skal indsende PSUR hver 6. måned.