FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Nplate in adults (seen in more than 1 patient in 10) include headache, infections of the nose and throat and allergic (hypersensitivity) reactions such as rash, itching and rapid swelling under the skin.
Danish: De hyppigste bivirkninger ved Nplate hos voksne (som optræder hos mere end 1 ud af 10 patienter) er hovedpine, infektioner i næse og hals og allergiske reaktioner (overfølsomhedsreaktioner) såsom udslæt, kløe og hurtige hævelser under huden.
English: For more information about treatment with Nplate, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Nplate, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Nplate is used in patients from 1 year of age with long-term immune thrombocytopenic purpura (ITP), a disease in which the patient's immune system destroys platelets (components in the blood that help it to clot).
Danish: Nplate anvendes til patienter fra 1 år og opefter med kronisk immun trombocytopenisk purpura (ITP), en sygdom, hvor patientens immunsystem ødelægger blodpladerne (bestanddele i blodet, som er vigtige for blodets evne til at størkne).
English: The most common side effects in children include infections of the nose and throat, runny nose, cough, fever, mouth and throat pain, abdominal (belly) pain, diarrhoea, rash and bruising.
Danish: De hyppigste bivirkninger hos børn omfatter infektioner i næse og hals, løbende næse, hoste, feber, smerter i mund og hals, mavesmerter, diarré, udslæt og blå mærker.
English: The first study involved 63 patients whose disease was not controlled despite removal of their spleen.
Danish: Det første studie omfattede 63 patienter, hvis sygdom ikke var under kontrol, selv om de havde fået fjernet milten.
English: The Agency noted that Nplate was effective in patients who had had their spleen removed, as well as in patients who had not had their spleen removed.
Danish: Agenturet bemærkede, at Nplate både var effektivt hos patienter, som havde fået fjernet milten, og hos patienter, som ikke havde fået fjernet milten.
English: Nplate can be used in patients whose spleen has been removed to control the disease and in those who still have a spleen.
Danish: Nplate kan anvendes til patienter, hvis milt er blevet fjernet, for at kontrollere sygdommen, og til patienter, som stadig har en milt.
English: Nplate is a powder that is made up into a solution for injection.
Danish: Nplate er et pulver, der anvendes til fremstilling af en injektionsvæske, opløsning.
English: For the full list of side effects reported with Nplate, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Nplate fremgår af indlægssedlen.
English: In the body, a hormone called ‘thrombopoietin' normally stimulates the production of platelets in the bone marrow.
Danish: I kroppen stimulerer et hormon kaldet "trombopoietin" normalt produktionen af blodplader i knoglemarven.
English: Therefore, in patients with intact spleens, the possibility of removing the spleen should be evaluated periodically.
Danish: Derfor bør muligheden for at fjerne milten hos de patienter, der stadig har milten i behold, evalueres jævnligt.
English: What benefits of Nplate have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Nplate?
English: The study in children involved 62 patients aged 1 to less than 18 years whose ITP had been treated previously (including some whose spleen had been removed).
Danish: Studiet hos børn omfattede 62 patienter over 1 år og under 18 år, som tidligere var blevet behandlet for ITP (herunder nogle, der havde fået milten fjernet).
English: The second study involved 62 patients whose ITP had been treated previously (but who did not have their spleen removed).
Danish: Det andet studie omfattede 62 patienter, som tidligere var blevet behandlet for ITP (men som ikke havde fået fjernet milten).
English: How does Nplate work?
Danish: Hvordan virker Nplate?
English: The active substance in Nplate, romiplostim, stimulates the production of platelets.
Danish: Det aktive stof i Nplate, romiplostim, stimulerer produktionen af blodplader.
English: For practical information about using Nplate, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Nplate, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The spleen, an organ behind the stomach, is involved in the removal of platelets from the blood.
Danish: Milten er et organ, der sidder bag mavesækken, og som medvirker til at fjerne blodplader fra blodet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nplate have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Nplate.
English: Platelet count rose above the threshold in 38% of patients who received Nplate (16 out of 42) compared with none of the 21 patients receiving placebo.
Danish: Blodpladeantallet steg til over tærsklen hos 38 % af de patienter, der fik Nplate (16 ud af 42), sammenlignet med ingen af de 21 patienter, der fik placebo.
English: How is Nplate used?
Danish: Hvordan anvendes Nplate?
English: Platelet count rose above the threshold in 61% of patients who received Nplate (25 out of 41) compared with 5% receiving placebo (1 out of 21).
Danish: Blodpladeantallet steg til over tærsklen hos 61 % af de patienter, der fik Nplate (25 ud af 41), sammenlignet med 5 % af de patienter, der fik placebo (1 ud af 21).
English: A platelet count below 30 million per millilitre puts patients at risk of bleeding while the normal count is 150 to 400 million per millilitre.
Danish: Et blodpladeantal på under 30 mio. pr. ml giver patienterne risiko for blødning.
English: Platelet count rose above the threshold in 52% of patients who received Nplate (22 out of 42) compared with 10% receiving placebo (2 out of
Danish: Blodpladeantallet steg til over tærsklen hos 52 % af de patienter, der fik Nplate (22 ud af 42), sammenlignet med 10 % af de patienter, der fik placebo (2 ud af 20).
English: By mimicking the action of thrombopoietin, romiplostim stimulates the production of platelets, thereby increasing blood platelet counts and reducing the risk of bleeding.
Danish: Ved at efterligne trombopoietins virkemåde stimulerer romiplostim produktionen af blodplader.
English: As for all medicines, data on the use of Tegsedi are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Tegsedi løbende overvåget.
English: The first injection should be given under the supervision of a qualified healthcare professional, and patients or carers can give the subsequent injections after receiving appropriate training.
Danish: Den første injektion bør gives under overvågning af en kvalificeret sundhedsperson, og patienterne selv eller deres omsorgspersoner kan give de efterfølgende injektioner efter tilstrækkelig oplæring.
English: What measures are being taken to ensure the safe and effective use of Tegsedi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tegsedi?
English: Other information about Tegsedi
Danish: Andre oplysninger om Tegsedi
English: What is Tegsedi and what is it used for?
Danish: Hvad er Tegsedi, og hvad anvendes det til?
English: The recommended dose is one injection once a week, given under the skin in the belly, upper thigh or upper arm.
Danish: Den anbefalede dosis er én injektion én gang om ugen givet under huden på maven, låret eller overarmen.
English: Further information on Tegsedi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Tegsedi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: hATTR is rare, and Tegsedi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 March 2014.
Danish: Sygdommen hATTR er sjælden, og Tegsedi blev udpeget som "lægemiddel til sjældne sygdomme" den 26. marts 2014.
English: An overview of Tegsedi and why it is authorised in the EU
Danish: En oversigt over Tegsedi, og hvorfor det er godkendt i EU
English: The European Medicines Agency therefore decided that Tegsedi's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Tegsedi opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: For more information about using Tegsedi, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Tegsedi, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Tegsedi are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Tegsedi vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: This reduces production of transthyretin, thereby reducing the formation of amyloids and relieving the symptoms of hATTR amyloidosis.
Danish: Dermed reduceres dannelsen af transthyretin, hvilket reducerer dannelsen af amyloider og lindrer symptomerne på HATTR-amyloidose.
English: The active substance in Tegsedi, inotersen, is an ‘antisense oligonucleotide', a very short piece of synthetic genetic material that has been designed to attach to and block the genetic material of the cell responsible for producing transthyretin.
Danish: Det aktive stof i Tegsedi, inotersen, er et "antisense-oligonukleotid", som er et meget kort stykke genetisk materiale, der er designet til at binde til og blokere det genetiske materiale for den celle, der danner transthyretin.
English: The main measures of effectiveness were the changes in the patients' nerve damage and quality of life, as measured using standard scales called ‘mNIS+7' and ‘Norfolk QoL-DN' respectively.
Danish: De primære mål for virkning var ændringerne i patienternes nervebeskadigelse og livskvalitet som bedømt ved anvendelse af standardskalaerne "mNIS+7" og "Norfolk QoL-DN".
English: Tegsedi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of patients with hATTR.
Danish: Tegsedi udleveres kun efter recept, og behandlingen bør påbegyndes og overvåges af en læge med erfaring i behandling af patienter med hATTR.
English: Tegsedi must not be used by patients with low platelet counts (less than 100x109/l), and by patients with severe kidney or liver problems.
Danish: Tegsedi må ikke anvendes af patienter med lavt antal blodplader (mindre end 100 x 109/l) og af patienter med alvorlige nyre- eller leverproblemer.
English: Why is Tegsedi authorised in the EU?
Danish: Hvorfor blev Tegsedi godkendt i EU?
English: In light of the unmet medical need, the safety profile of Tegsedi was considered acceptable and the risks to be manageable with specific monitoring, dose reduction and stopping rules.
Danish: I betragtning af det ikke-dækkede medicinske behov blev Tegsedis sikkerhedsprofil fundet acceptabel, og det vurderedes, at risiciene var håndterbare med specifikke regler for overvågning, dosisreduktion og ophør.
English: In patients with hATTR, a protein called transthyretin which circulates in the blood is defective and breaks easily.
Danish: Hos patienter med hATTR er proteinet transthyretin, der cirkulerer rundt i blodet, mangelfuldt og nedbrydes hurtigt.
English: The most common side effects with Tegsedi (which may affect more than 1 in 10 people) are reactions at the site of injection, nausea (feeling sick), low level of red blood cells, headache, fever, peripheral oedema (swelling, especially of the ankles and feet), chills, vomiting and low blood platelet counts which can lead to bleeding and bruising.
Danish: De hyppigste bivirkninger ved Tegsedi (som kan forekomme hos flere end 1 ud af 10 patienter) er reaktioner på injektionsstedet, kvalme, lavt antal røde blodlegemer, hovedpine, feber, perifert ødem (hævelse, især af anklerne og fødderne), kulderystelser, opkastning og lavt antal blodplader, som kan medføre blødning og blå mærker.
English: Tegsedi is a medicine used to treat nerve damage caused by hereditary transthyretin amyloidosis (hATTR), a disease in which proteins called amyloids build up in tissues around the body including around the nerves.
Danish: Tegsedi er et lægemiddel til behandling for beskadigelse af nerverne som følge af den arvelige sygdom transthyretin amyloidose (hATTR), hvor et protein kaldet amyloid ophobes i vævene rundt om i kroppen, herunder rundt om nerverne.
English: As Tegsedi can cause a reduction in the number of platelets in the blood (posing a risk of bleeding), blood platelet counts need to be monitored during treatment with Tegsedi, and the dose of the medicine and how often it is given adjusted accordingly.
Danish: Da Tegsedi kan medføre et fald i antallet af blodplader (hvilket udgør en risiko for blødning), skal blodpladetallet tjekkes under behandlingen med Tegsedi, og dosen af lægemidlet og hyppigheden, hvormed det gives, tilpasses i overensstemmelse hermed.
English: The company that markets Tegsedi will provide an alert card for patients with information about the safety of the medicine and how to manage side effects.
Danish: Den virksomhed, der markedsfører Tegsedi, skal udarbejde et patientkort med oplysninger om sikkerheden ved lægemidlet og håndtering af bivirkninger.
English: Tegsedi is used in adult patients in the first two stages of the nerve damage (stage 1, when the patient is able to walk unaided, and stage 2, when the patient can still walk but needs help).
Danish: Tegsedi anvendes hos voksne patienter, der har nervebeskadigelse af grad 1 (patienten kan gå uden hjælp) og grad 2 (patienten kan stadig gå, men har brug for hjælp).
English: In one main study involving 173 hATTR patients with stage 1 or 2 nerve damage, Tegsedi was shown to be more effective than placebo (a dummy treatment) at slowing down the nerve damage caused by the disease.
Danish: I et hovedstudie med deltagelse af 173 hATTR-patienter med grad 1- eller grad 2-nervebeskadigelse blev det påvist, at Tegsedi er mere effektivt end placebo (et ikke-aktivt stof) til at forsinke den nervebeskadigelse, som sygdommen medfører.
English: After 15 months of treatment, the mNIS+7 score, used for assessing nerve damage, worsened by a lesser extent with Tegsedi (around 11 points) than with placebo (around 25 points).
Danish: Efter 15 måneders behandling var forværringen af scoren på mNIS+7-skalaen, der anvendes til at bedømme nervebeskadigelse, mindre med Tegsedi (ca. 11 point) end med placebo (ca. 25 point).
English: Quality of life, measured by the Norfolk QoL-DN score, worsened by around 4 points in patients treated with Tegsedi, compared with around 13 points in those on placebo.
Danish: Livskvaliteten målt ved hjælp af scoren på Norfolk QoL-DN-skalaen var forværret med ca. 4 point hos patienter, der fik Tegsedi, sammenholdt med en forværring på ca. 13 point hos dem, der fik placebo.
English: What are the risks associated with Tegsedi?
Danish: Hvilke risici er der forbundet med Tegsedi?
English: The medicine is available as a solution for injection under the skin in pre-filled syringes (284 mg).
Danish: Lægemidlet fås som en injektionsvæske, opløsning, i en fyldt sprøjte (284 mg), til indgivelse under huden.
English: How is Tegsedi used?
Danish: Hvordan anvendes Tegsedi?
English: What benefits of Tegsedi have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Tegsedi?
English: For the full list of side effects of Tegsedi, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Tegsedi fremgår af indlægssedlen.
English: How does Tegsedi work?
Danish: Hvordan virker Tegsedi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tegsedi have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Tegsedi.
English: Tegsedi was shown to be effective in the treatment of stage 1 or stage 2 nerve damage in patients with hATTR; available data were not sufficient to assume a beneficial effect in stage 3 patients (those confined to a wheelchair).
Danish: Det er påvist, at Tegsedi er effektivt til behandling af nervebeskadigelse af grad 1 eller grad 2 hos patienter med hATTR.
English: It also increases the CD4 cell count in your blood.
Danish: øger også antallet af CD4-celler i dit blod.
English: Week 0 (After ≥36 Weeks on Treatment)
Danish: Uge 0 (efter ≥ 36 ugers behandling)
English: As doses below 150 mg are needed the use of an oral solution is recommended
Danish: Da der er behov for doser under 150 mg, anbefales det at anvende oral opløsning
English: Absorption differences have been observed between adult and paediatric populations (see “Special populations”).
Danish: Der er blevet observeret forskel i absorptionen mellem voksne og pædiatriske populationer (se Særlige populationer).
English: If you have taken Lamivudine Teva Pharma B.V. during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis du har taget Lamivudin Teva Pharma B.V., under din graviditet, kan din læge bede om regelmæssige blodprøver og andre diagnostiske studier for at overvåge barnets udvikling.
English: CD4 cells are a type of white blood cells, that are important in helping your body to fight infection.
Danish: CD4-celler er en type hvide blodceller, der spiller en vigtig rolle, når kroppen skal bekæmpe infektioner.
English: • high doses of co-trimoxazole, an antibiotic.
Danish: • Høje doser af co-trimoxazol, et antibiotikum
English: Date of latest renewal: 11 September 2014
Danish: Dato for første markedsføringstilladelse: 10. december 2009 Dato for seneste fornyelse: 11. september 2014
English: Following oral administration, the mean time (tmax) to maximal serum concentrations (Cmax) is about an hour.
Danish: Efter peroral indgift er gennemsnitstiden (tmax) for at opnå maksimal serumkoncentration (Cmax) omkring en time.
English: If you forget to take a dose, take it as soon as you remember.
Danish: Hvis du har glemt at tage en dosis, skal du tage den, så snart du husker det. Fortsæt derefter behandlingen som før.
English: България Актавис ЕАД
Danish: България Актавис ЕАД Teл.
English: If you notice any of these symptoms: Tell your doctor.
Danish: Hvis du bemærker et eller flere af disse symptomer: Kontakt lægen.
English: Tablet film coat Hypromellose 3cP Hypromellose 6cP Titanium dioxide Macrogol 400
Danish: Filmovertræk Hypromellose 3cP Hypromellose 6cP Titandioxid Macrogol 400
English: 2 to 12 years (N=19) PENTA 15 3 to 36 months (N=17)
Danish: 3 til 12 år (N=19) PENTA 15 3 til 36 måneder (N=17)
English: mannitol, lactitol or maltitol), if taken regularly.
Danish: xylitol, mannitol, lactitol eller maltitol), hvis de anvendes regelmæssigt
English: A rare side effect that may show up in blood tests is: • an increase in an enzyme called amylase.
Danish: Sjælden bivirkning, der kan ses i blodprøver: • en stigning i mængden af et enzym, som kaldes amylase.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumocystis jirovecii-pneumoni (ofte omtalt som PCP).
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (<4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Danish: Baseret på mere end 200 mor/barn-par behandlet for hiv er serumkoncentrationerne af lamivudin meget lave hos ammede spædbørn, hvis mødre behandles for hiv (< 4 % af moderens serumkoncentration), og falder gradvist til ikke-detekterbare niveauer, når ammede spædbørn når en alder på 24 uger.
English: The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when the main route of elimination is active renal secretion via the organic cationic transport system e.g. trimethoprim.
Danish: Muligheden for interaktioner med andre samtidigt indgivne lægemidler bør overvejes; særligt hvis udskillelsen primært sker ved aktiv renal sekretion via det organiske kationiske transportsystem, f.eks. trimethoprim.
English: The mean systemic clearance of lamivudine is approximately 0.32 l/h/kg, with predominantly renal clearance (>70%) via the organic cationic transport system.
Danish: Den gennemsnitlige systemiske clearance af lamivudin er omkring 0,32 l/time/kg; overvejende ved renal clearance (> 70 %) via det organiske kationiske transportsystem.
English: Co-administration of lamivudine with food results in a delay of tmax and a lower Cmax (decreased by 47%).
Danish: Tages lamivudin sammen med mad, resulterer det i en forsinket tmax og en lavere Cmax (nedsat med 47 %).
English: Week 0 (after 36 weeks on treatment) Any solution regimen at any time All tablet based regimen throughouts Week 96
Danish: Uge 0 (efter 36 ugers behandling) Hvilket som helst regime med opløsninger 14/26 (54) Alle regimer baseret på tabletter Uge 96
English: If you or your child has a kidney problem, your dose may be altered.
Danish: Hvis du eller dit barn har nyreproblemer, skal dosis måske justeres.
English: Uncommon side effects that may show up in blood tests are:
Danish: Ikke almindelig bivirkning, der kan ses i blodprøver:
English: A modest increase in Cmax (28%) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) is not significantly altered.
Danish: For zidovudin ses en beskeden stigning i Cmax (28 %) ved samtidig indgift af lamivudin, men den samlede eksposition (AUC) ændres ikke signifikant.
English: However, for the treatment of HIV infection only a 300 mg daily dose of lamivudine (in combination with other antiretroviral agents) has been shown to be efficacious.
Danish: Til behandling af hiv-infektion er det dog vist, at kun doser på 300 mg lamivudin (i kombination med andre antiretrovirale stoffer) dagligt, er virkningsfuldt.
English: The active moiety, intracellular lamivudine triphosphate, has a prolonged terminal half-life in the cell (16 to 19 hours) compared to the plasma lamivudine half-life (5 to 7 hours).
Danish: Den aktive del, intracellulær lamivudintriphosphat, har en forlænget terminal halveringstid i cellen (16 til 19 timer), sammenlignet med plasmalamivudinhalveringstiden (5 til 7 timer).
English: Read the information ‘Other possible side effects of combination therapy for HIV' in section 4 of this leaflet.
Danish: Læs oplysningerne under 'Andre mulige bivirkninger ved kombinationsbehandling af hiv' under punkt 4 i denne indlægsseddel.
English: • serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing
Danish: • alvorlig allergisk reaktion, der forårsager hævelse af ansigtet, tunge eller svælg, hvilket kan medføre vejrtrækningsbesvær.
English: Three subjects had undetectable viral load and one had plasmatic HIV-RNA of 900 copies/ml at Week 48.
Danish: Tre patienter havde ikke-detekterbar virusmængde og én havde hiv-RNA på 900 kopier/ml plasma ved uge 48.