FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om Zavesca på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: Other possible side effects are muscular spasms or weakness, fatigue chills and malaise, depression, difficulty sleeping, forgetfulness, and less libido.
Danish: Andre mulige bivirkninger er muskelkramper eller -svaghed, træthed, kulderystelser og utilpashed, depression, søvnbesvær, glemsomhed og nedsat lyst til sex (libido).
English: Zavesca has not been evaluated in patients with a history of significant gastrointestinal disease, including inflammatory bowel disease.
Danish: Zavesca er ikke undersøgt hos patienter med signifikant gastrointestinal sygdom, herunder inflammatorisk tarmsygdom, i anamnesen.
English: Further effects seen in animals at doses that result in exposure levels similar to or moderately higher than the clinical exposure level were: changes in lymphoid organs in all species tested, transaminase changes, vacuolation of thyroid and pancreas,
Danish: Derudover var de virkninger, der sås hos dyr ved doser, som medfører eksponeringsniveauer, som er de samme eller moderat højere end det kliniske eksponeringsniveau: Ændringer i lymfeorganer hos alle testede arter, påvirkning af aminotransferaser, vakuolisering i thyroidea og pancreas, katarakt, nefropati og myokardieændringer hos rotter.
English: Marketing Authorisation Holder:
Danish: Indehaver af markedsføringstilladelsen:
English: Muscle spasms, muscle weakness General disorders and administration site reactions Common:
Danish: Muskelspasmer, muskelsvaghed Almene symptomer og reaktioner på administrationsstedet Almindelig
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines
Danish: Fortæl altid lægen eller på apoteket, hvis De tager anden medicin eller har gjort det for nylig.
English: The most common serious adverse reaction reported with Zavesca treatment in clinical studies was peripheral neuropathy (see section 4.4).
Danish: Den hyppigst rapporterede alvorlige bivirkning i kliniske studier med Zavesca var perifer neuropati (se pkt.
English: Zavesca may make you feel dizzy.
Danish: Zavesca kan forårsage svimmelhed.
English: Until further information is available, before seeking to conceive, male patients should cease Zavesca and maintain reliable contraceptive methods for a further 3 months.
Danish: Indtil yderligere informationer er tilgængelige, bør mandlige patienter, før de søger at undfange, ophøre med Zavesca og konsekvent anvende præventive metoder i yderligere 3 måneder.
English: Cases of peripheral neuropathy have been reported in patients treated with Zavesca with or without concurrent conditions such as vitamin B12 deficiency and monoclonal gammopathy.
Danish: Der er indberettet tilfælde af perifer neuropati hos patienter behandlet med Zavesca med eller uden samtidige tilstande som cyanocobalamin-mangel og monoklonal gammopati.
English: The most common adverse reactions reported in clinical studies with Zavesca were diarrhoea, flatulence, abdominal pain, weight loss and tremor (see section 4.4).
Danish: De hyppigste bivirkninger, som blev rapporteret i kliniske studier med Zavesca, var diarré, flatulens, abdominalsmerter, vægttab og tremor (se pkt.
English: Capsule, hard White capsules with “OGT 918” printed in black on the cap and “100” printed in black on the body.
Danish: Hvide kapsler med "OGT 918" trykt i sort på overdelen og "100" trykt i sort på underdelen.
English: Capsule contents Sodium starch glycollate, Povidone (K30), Magnesium stearate.
Danish: Kapslerne indeholder Natriumstivelsesglycolat, Povidon (K30), Magnesiumstearat.
English: Nerve conduction studies abnormal
Danish: Undersøgelser af nerveimpulsoverledning unormale
English: • Zavesca is also used to treat progressive neurological symptoms in Niemann-Pick type C disease in adults and in children.
Danish: • Zavesca anvendes også til behandling af fremadskridende neurologiske symptomer ved Niemann-Picks sygdom, type C, hos voksne og børn.
English: Capsule, hard 84 capsules
Danish: 84 kapsler
English: Do not breastfeed while you are taking Zavesca.
Danish: De må ikke amme, mens De tager Zavesca.
English: The active substance is miglustat 100 mg.
Danish: Aktivt stof: miglustat 100 mg.
English: Zavesca is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
Danish: Zavesca er indiceret til oral behandling af voksne patienter med let til moderat Gauchers sygdom, type 1.
English: - If you get any side effects,talk to your doctor or pharmacist.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge eller apoteket.
English: Common effects - may affect up to 1 in 10 people Common side effects of treatment include headache, dizziness, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets).The neurological symptoms and thrombocytopenia could be due to the underlying disease.
Danish: Almindelige bivirkninger - kan forekomme hos op til 1 ud af 10 behandlede Almindelige bivirkninger af behandlingen omfatter hovedpine, svimmelhed, paræstesi (snurrende fornemmelse eller følelsesløshed), koordinationsforstyrrelser, hypoæstesi (nedsat følesans), fordøjelsesbesvær (halsbrand), kvalme (utilpashed), forstoppelse og opkastning, hævelse eller ubehag i underlivet (maven) og trombocytopeni (nedsat antal blodplader).
English: Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Danish: Zavesca må kun bruges til behandling af patienter, hvor enzymsubstitutionsterapi ikke er egnet (se pkt.
English: The usual dose of Zavesca in adult patients was 200 mg t.i.d., and was adjusted according to body surface area in paediatric patients.
Danish: Den sædvanlige Zavescadosis til voksne patienter var 200 mg 3 gange dagligt, og var justeret i forhold til legemsoverflade hos pædiatriske patienter.
English: • Zavesca is used to treat mild to moderate type 1 Gaucher disease in adults.
Danish: • Zavesca anvendes til behandling af let til moderat Gauchers sygdom, type 1, hos voksne.
English: There is limited experience with the use of Zavesca in Niemann-Pick type C disease patients under the age of 4 years.
Danish: Der er begrænset erfaring med anvendelsen af Zavesca til patienter under 4 år med Niemann-Picks sygdom, type C.
English: Zavesca 100 mg capsules
Danish: Zavesca 100 mg kapsler
English: Zavesca should not be taken during breast-feeding.
Danish: Zavesca bør ikke tages under amning.
English: Until further information is available, it is advised that before seeking to conceive, male patients should cease Zavesca and maintain reliable contraceptive methods for 3 months thereafter.
Danish: Indtil yderligere information foreligger, tilrådes det, at mandlige patienter, før konception, seponerer Zavesca og anvender sikre kontraceptionsmetoder 3 måneder herefter (se pkt.
English: Zavesca works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Danish: Zavesca virker ved at hæmme et enzym, som kaldes 'glucosylceramidsyntase', som er ansvarlig for det første trin i omdannelsen af de fleste glycosphingolipider.
English: Zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease (see sections 4.4, and 5.1).
Danish: Zavesca er indiceret til behandling af progressive neurologiske manifestationer hos voksne patienter og pædiatriske patienter med Niemann-Picks sygdom, type C (se pkt.
English: The recommended starting dose for the treatment of adult patients with type 1 Gaucher disease is 100 mg three times a day.
Danish: Den anbefalede startdosis for behandling af voksne patienter med Gauchers sygdom, type 1 er 100 mg tre gange dagligt.
English: Diarrhoea, flatulence, abdominal pain
Danish: Meget almindelig Diarré, flatulens, abdominalsmerter Almindelig
English: Male patients should maintain reliable contraceptive methods while taking Zavesca.
Danish: Mandlige patienter skal sørge for pålidelige præventionsmidler, så længe de tager Zavesca.
English: Mild reductions in platelet counts without association with bleeding were observed in patients with type 1 Gaucher disease who were switched from ERT to Zavesca.
Danish: Let nedsat trombocyttal uden forbindelse med blødning blev observeret hos patienter med Gauchers sygdom, type 1, som skiftede fra ERT til Zavesca.
English: Mild reductions in platelet counts without association to bleeding were observed in some patients with Niemann-Pick type C disease treated with Zavesca.
Danish: Der er observeret let nedsat thrombocyttal uden associeret blødning hos nogle patienter med NiemannPicks sygdom, type C, som er behandlet med Zavesca.
English: Zavesca has not been evaluated in patients with hepatic impairment.
Danish: Zavesca er ikke evalueret hos patienter med leverinsufficiens.
English: Each capsule contains 100 mg miglustat.
Danish: Hver kapsel indeholder 100 mg miglustat.
English: Growth should be monitored in paediatric and adolescent patients during treatment with Zavesca; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy.
Danish: Fordel/risiko-balancen ved fortsat behandling skal revurderes på individuel basis.
English: Male patients should maintain reliable contraceptive methods while taking Zavesca (see sections 4.4 and 5.3).
Danish: Mandlige patienter bør anvende sikre kontraceptionsmetoder, mens de tager Zavesca (se pkt.
English: How to take Zavesca
Danish: Sådan skal De tage Zavesca
English: - If you have any further questions, please ask your doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller apotekspersonalet.
English: Zavesca 100 mg capsules Miglustat
Danish: Zavesca 100 mg kapsler Miglustat
English: The recommended dose for the treatment of adolescent patients (12 years of age and above) with Niemann-Pick type C disease is 200 mg three times a day.
Danish: Den anbefalede dosis til behandling af unge patienter (på 12 år og derover) med Niemann-Picks sygdom, type C er 200 mg tre gange dagligt.
English: LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
Danish: LISTE OVER HJÆLPESTOFFER LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
English: Recommended dose 200 mg three times a day 200 mg twice a day 100 mg three times a day 100 mg twice a day 100 mg once a day
Danish: 200 mg tre gange dagligt
English: Each capsule contains 100 mg miglustat
Danish: Hver kapsel indeholder 100 mg miglustat
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Fatigue, asthenia, chills and malaise
Danish: Træthed, asteni, kuldegysninger og utilpashed
English: Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia
Danish: Kvalme, opkastning, abdominal distension/ubehag, obstipation, dyspepsi Knogler, led, muskler og bindevæv
English: Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Zavesca (see section 4).
Danish: Hvis De lider af diarré under behandlingen med Zavesca, vil Deres læge muligvis sætte Deres dosis ned, f.eks. til én kapsel (100 mg) én eller to gange dagligt (se pkt.
English: 1.Separate at perforations 2.Peel back paper at arrows 3.Push product through foil
Danish: Træk papiret tilbage ved pilene 3.
English: Sími: +46 8 544 982 50
Danish: Simi: +46 8 544 982 50
English: The benefit of treatment with Zavesca for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with Zavesca.
Danish: Fordelen ved behandling af neurologiske manifestationer med Zavesca hos patienter med NiemannPicks sygdom, type C, skal regelmæssigt evalueres f.eks. hver 6. måned.
English: The pivotal trial of Zavesca was conducted in patients unable or unwilling to receive ERT. Reasons for not receiving ERT included the burden of intravenous infusions and difficulties in venous access.
Danish: Årsagerne til ikke at modtage ERT omfattede belastningen ved intravenøse infusioner og vanskelighed ved venøs adgang.
English: Breast-feeding
Danish: Trombocytopeni
English: SN:
Danish: PC: SN: NN:
English: What Zavesca looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: What Zavesca is and what it is used for What you need to know before you take Zavesca How to take Zavesca
Danish: Det skal De vide, før De begynder at tage Zavesca Sådan skal De tage Zavesca Bivirkninger
English: Hepatic impairment
Danish: Nervesystemet
English: • or that the product (potentially modified or not) does not undergo significant dechelation and does not lead to retention of gadolinium in tissues.
Danish: • eller at lægemidlet (potentielt modificeret eller ej) ikke gennemgår væsentlig dechelatering og ikke fører til retention af gadolinium i væv.
English: • for clinically important benefits that are currently not established in an identified population or indication and which outweigh the risks related to the product.
Danish: • for klinisk vigtige fordele, der p.t. ikke er klarlagt i en identificeret population eller indikation, og som opvejer risiciene i forbindelse med lægemidlet
English: Annex IV Conditions for lifting the suspension of the marketing authorisations
Danish: Bilag IV Betingelser for ophævelse af suspenderingen af markedsføringstilladelserne
English: For the suspensions of intravenous gadodiamide, gadopentetic acid, and gadoversetamide containing medicinal products to be lifted, the Marketing Authorisation Holder(s) shall provide evidence
Danish: For at suspenderingen af lægemidler indeholdende intravenøs gadodiamid, gadopentetinsyre og gadoversetamid kan ophæves, skal indehaveren/indehaverne af markedsføringstilladelse tilvejebringe dokumentation
English: Conditions for lifting the suspension of the marketing authorisation(s)
Danish: Betingelser for ophævelse af suspenderingen af markedsføringstilladelsen/markedsføringstilladelserne
English: This summary was last updated in 02-2014.
Danish: Dette sammendrag blev sidst ajourført i 02-2014.
English: It has also been studied in 627 children aged between six and 12 years.
Danish: Det er også blevet undersøgt hos 627 børn på mellem seks og 12 år.
English: The effects were maintained after 6 months of treatment.
Danish: Virkningerne holdt sig efter 6 måneders behandling.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xolair on 25 October 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xolair den 25. oktober 2005.
English: This document is a summary of the European public assessment report (EPAR) for Xolair.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xolair.
English: All patients receiving Xolair must meet the following criteria:
Danish: Alle patienter, der får behandling med Xolair, skal opfylde følgende kriterier:
English: The full EPAR for Xolair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Xolair findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: They also reported a greater improvement in quality of life and used less fluticasone (a corticosteroid).
Danish: De angav desuden større forbedring af livskvaliteten og anvendte mindre fluticason (et kortikosteroid).
English: • they must have frequent symptoms during the day or waking up during the night;
Danish: • De skal have hyppige symptomer i dagtimerne eller natlige opvågninger.
English: The doctor will periodically re-assess the need to continue treatment with Xolair.
Danish: Lægen vil med jævne mellemrum vurdere behovet at fortsætte behandlingen med Xolair.
English: Patients with low IgE levels are less likely to benefit from the medicine.
Danish: Patienter med et lavt IgE-indhold har mindre sandsynlighed for at få gavn af lægemidlet.
English: A risk management plan has been developed to ensure that Xolair is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Xolair anvendes så sikkert som muligt.
English: Patients aged 12 years or over must also have reduced lung function (less than 80% of normal).
Danish: Patienter på 12 år eller derover skal også have nedsat lungefunktion (mindre end 80 % af det normale).
English: The usual dose range is between 75 and 600 mg in one to four injections, and the maximum recommended dose is 600 mg every two weeks.
Danish: Det normale dosisinterval ligger mellem 75 og 600 mg i en til fire injektioner, og den maksimale anbefalede dosis er 600 mg hver anden uge.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Danish: Et monoklonalt antistof er et antistof (en type protein), der er opbygget, så det genkender og binder sig til en bestemt struktur (kaldet et antigen) i kroppen.
English: For more information about treatment with Xolair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Xolair, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Each vial and syringe contains 75 or 150 mg of omalizumab.
Danish: Hvert hætteglas indeholder 75 eller 150 mg omalizumab.
English: Other information about Xolair:
Danish: Andre oplysninger om Xolair
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 Xolair.
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, hvordan Xolair skal anvendes.
English: What measures are being taken to ensure the safe and effective use of Xolair?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xolair?
English: It is used as an addon to existing treatment in patients aged 12 years or over who do not respond to treatment with antihistamines.
Danish: Det anvendes som tillægsbehandling til eksisterende behandling hos patienter på 12 år eller derover, som ikke reagerer på behandling med antihistaminer.
English: Xolair is a medicine that contains the active substance omalizumab.
Danish: Xolair er et lægemiddel, der indeholder det aktive stof omalizumab.
English: The CHMP also concluded that Xolair (300 mg) was shown to significantly improve the symptoms of chronic spontaneous urticaria when used as add-on to the patients' existing treatment, but noted that study data on long-term use beyond 6 months are limited.
Danish: CHMP konkluderede endvidere, at Xolair (300 mg) viste sig at lindre symptomerne på kronisk spontan nældefeber betydeligt, når det blev anvendt som tillægsbehandling til patientens eksisterende behandling, men bemærkede, at undersøgelsesdataene vedrørende langvarig anvendelse ud over seks måneder var begrænsede.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xolair, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Xolair, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The active substance in Xolair, omalizumab, is a monoclonal antibody.
Danish: Det aktive stof i Xolair, omalizumab, er et monoklonalt antistof.
English: It is used as an add-on to existing asthma treatment in patients aged six years or over.
Danish: Det anvendes som tillægsbehandling til en eksisterende astmabehandling hos patienter på seks år eller derover.
English: Before giving Xolair to patients with asthma, the doctor must measure the level of IgE in the patient's blood.
Danish: Før Xolair gives til patienter med astma, skal lægen måle indholdet af IgE i patientens blod.
English: The main measure of effectiveness was the change in itching severity after 12 weeks of treatment, as measured on a scale ranging from 0 (no itch) to 21 (maximum itch severity).
Danish: Virkningen blev hovedsagelig bedømt på ændringen i graden af kløe efter 12 ugers behandling målt på en skala fra 0 (ingen kløe) til 21 (sværeste grad af kløe).
English: The effects of Xolair were greater in patients with severe asthma.
Danish: Virkningerne af Xolair var større hos patienter med svær astma.
English: It usually takes 12 to 16 weeks for Xolair to show a benefit.
Danish: Det tager normalt 12 til 16 uger, før virkningen af Xolair indtræder.
English: The main measures of effectiveness were the number of exacerbations, the number of patients who had an exacerbation, quality of life (assessed using standard questionnaires), and the amount of inhaled corticosteroid that the patients needed to take to treat their asthma.
Danish: Virkningen blev hovedsagelig bedømt på antallet af forværringer, antallet af patienter, der havde en forværring, livskvaliteten (bedømt ved hjælp af standardspørgeskemaer) og den mængde inhaleret kortikosteroid, patienten skulle tage for at behandle sin astma.
English: Xolair treatment should only be considered when the asthma is caused by an antibody called immunoglobulin E (IgE).
Danish: Anvendelse af Xolair bør kun overvejes, når astmaen skyldes et antistof kaldet immunglobulin E (IgE).
English: Over the first 28 or 52 weeks of treatment in the first three studies, there were around 0.5 exacerbations per year in the Xolair group and around one per year in the placebo group.
Danish: I løbet af de første 28 eller 52 ugers behandling i de første tre undersøgelser var antallet af forværringer om året ca. 0,5 i Xolairgruppen og ca. en om året i placebogruppen.
English: Xolair has also been investigated in 3 main studies involving a total of 978 patients with chronic spontaneous urticaria who did not respond to antihistamine-based treatment.
Danish: Xolair er også blevet undersøgt i tre hovedundersøgelser, der omfattede i alt 978 patienter med kronisk spontan nældefeber, som ikke reagerede på antihistaminbaseret behandling.
English: The CHMP decided that Xolair's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Xolair opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Xolair.
English: Although the role of IgE in chronic spontaneous urticaria is less clear, reducing its availability with omalizumab has been shown to improve the symptoms of this condition.
Danish: Selv om det er mindre tydeligt, hvilken rolle IgE spiller i forbindelse med kronisk spontan nældefeber, har reduktionen af den frie IgE med omalizumab vist sig at lindre symptomerne på denne tilstand.
English: • they must have had many severe ‘exacerbations' of asthma (where asthma gets worse, requiring rescue treatment with other medicines) despite treatment with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist.
Danish: • De skal have haft mange svære forværringer af deres astma (som kræver akut behandling med andre lægemidler) trods behandling med høje doser af inhalationskortikosteroider samt en langtidsvirkende inhaleret beta2-agonist.