FrancophonIA/ELRC3.0 huggingface dataset:
English: - Frequency not known: hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium in blood; decreased level of magnesium in blood.
Danish: Hallucinationer, forvirring (specielt hos patienter som i forvejen har haft disse symptomer); nedsat natrium;og magnesium i blodet.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Du kan finde yderligere information om PANTECTA Control på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight (not related to a diet or an exercise programme) - vomiting, particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools; which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.
Danish: Fortæl det straks til lægen før eller efter du har taget medicinen, hvis du oplever nogle af følgende symptomer, som kan være et tegn på en anden, mere alvorlig, sygdom: - uventet vægttab (som ikke er relateret til diæt eller et motionsprogram) - opkastning, især ved gentagelse - blodigt opkast, dette kan ses som mørkt kaffegrums i dit opkast - du opdager blodig afføring, som kan være sort eller tjærefarvet - synkebesvær eller smerte i forbindelse med synkning - du ser bleg ud eller føler dig sløj (blodmangel) - brystsmerter - mavesmerter - kraftig og/eller vedvarende diaré, da dette lægemiddel er forbundet med en let øget risiko for infektiøs diaré
English: Coating: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauril sulfate, polysorbate 80, triethyl citrate.
Danish: Overtræk: hypromellose, povidon K25, titandioxid (E 171), gul jernoxid (E 172), propylenglycol, methacrylsyre-ethylacrylat copolymer (1:1), natriumlaurilsulfat, polysorbat 80, triethylcitrat.
English: What you need to know before you take PANTECTA Control
Danish: Det skal du vide, før du begynder at tage PANTECTA Control
English: Printing ink: shellac, red, black and yellow iron oxide (E172) and ammonia solution, concentrated.
Danish: Blæk til prægning: Shellac; rød, sort og gul jernoxid (E 172); koncentreret ammoniakopløsning.
English: Hypromellose Povidone K25
Danish: Povidon K25
English: Do not take a double dose to make up for the forgotten dose.
Danish: Hvis du har glemt at tage PANTECTA Control Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: - warfarin and phenprocoumon (used to thin blood and prevent clots).
Danish: ketoconazol (bruges ved svampeinfektion) - warfarin og phenprocoumon (medicin som virker blodfortyndende og forebygger blodpropper).
English: - Very rare side effects (may affect up to 1 in 10,000 people): disorientation; reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets (seen in blood tests).
Danish: - Meget sjældne bivirkninger (kan påvirke færre end 1 ud af 10.000 patienter): Desorientering; nedsat antal blodplader i blodet, hvilket kan medføre at du lettere bløder eller får blå mærker; nedsat antal hvide blodlegemer, hvilket kan øge tendensen til betændelse; unormal reduktion af antallet af hvide og røde blodlegemer samt blodplader (i blodprøver).
English: Blood and lymphatic system disorders Immune system disorders
Danish: Blod og lymfesystem
English: Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
Danish: Kerne: Natriumcarbonat, vandfrit; mannitol (E 421), crospovidon, povidon K90, calciumstearat.
English: - ketoconazole (used for fungal infections).
Danish: - atazanavir (bruges til behandling af HIV-infektion).
English: What PANTECTA Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
Danish: Enterotabletterne er gule, ovale, bikonvekse filmovertrukne tabletter præget med ”P20” på den ene side.
English: PANTECTA Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.
Danish: PANTECTA Control bruges til korttidsbehandling af reflukssymptomer (f.eks. halsbrand og sure opstød) hos voksne.
English: How to take PANTECTA Control
Danish: Sådan skal du tage PANTECTA Control
English: - Uncommon side effects(may affect up to 1 in 100 people): headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; bellyache and discomfort; skin rash or hives; itching; feeling weak, exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test.
Danish: - Ikke almindelige bivirkninger ( kan påvirke mellem 1 og 100 personer): Hovedpine; svimmelhed; diaré; kvalme, opkastning; oppustethed og luftafgang fra tarmen; forstoppelse; mundtørhed; smerter og ubehag i maven; hududslæt og eksem; kløe; svaghedsfornemmelse, udmattet eller generelt utilpas; søvnforstyrrelser; forøgede leverenzymtal ved blodprøve.
English: spearmint, fatty and fried food, acidic food, spicy food, citrus fruits and fruit juices, tomatoes.
Danish: Chokolade, pebermynte, spearmint, fed og friturestegt mad, syreholdig mad, krydret mad,
English: PANTECTA Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Danish: PANTECTA Control er indiceret til korttidsbehandling af reflukssymptomer (fx halsbrand, syreregurgitation) hos voksne.
English: - if you have been treated for heartburn or indigestion continuously for 4 or more weeks - if you are over 55 years old and taking non-prescription indigestion treatment on a daily basis - if you are over 55 years old with any new or recently changed reflux symptoms - if you have previously had a gastric ulcer or stomach surgery - if you have liver problems or jaundice (yellowing of skin or eyes) - if you regularly see your doctor for serious complaints or conditions - if you are due to have an endoscopy or a breath test called a C-urea test.
Danish: - hvis du tidligere har haft et mavesår eller har fået foretaget en maveoperation - hvis du har leverproblemer eller gulsot (gulfarvning af huden og øjnene) - hvis du regelmæssigt tager til læge på grund af alvorlige sygdomme eller lidelser - hvis du skal have fortaget en endoskopi eller en udåndingstest kaldet C-urea.
English: What PANTECTA Control is and what it is used for What you need to know before you take PANTECTA Control How to take PANTECTA Control Possible side effects
Danish: Det skal du vide, før du begynder at tage PANTECTA Control Sådan skal du tage PANTECTA Control Bivirkninger
English: Other medicines and PANTECTA Control
Danish: Se brug af andet medicin sammen med PANTECTA Control.
English: PANTECTA Control 20 mg gastro-resistant tablets Pantoprazole
Danish: PANTECTA Control 20 mg enterotabletter Pantoprazol
English: Pruritus
Danish: Overtræk
English: What PANTECTA Control contains - The active substance is pantoprazole.
Danish: - Aktivt stof: Pantoprazol.
English: Co-administration with atazanavir (see section 4.5).
Danish: Samtidig behandling med atazanavir (se pkt.
English: PANTECTA Control 20 mg gastro-resistant tablets
Danish: PANTECTA Control 20 mg enterotabletter
English: Sleep disorders
Danish: Søvnforstyrrelser Depression (og
English: ‘Other medicines and PANTECTA Control'.
Danish: ”PANTECTA Control indeholder”).
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines PANTECTA Control may stop certain other medicines from working properly.
Danish: Brug af anden medicin sammen med PANTECTA Control Fortæl det til lægen eller apoteket, hvis du tager, har taget eller overvejer at tage andet medicin.
English: Pantoprazole should not be used during breast-feeding.
Danish: PANTECTA Control bør ikke anvendes under amning.
English: Fertility
Danish: Hypromellose
English: What PANTECTA Control is and what it is used for
Danish: PANTECTA Control indeholder:
English: A.
Danish: Telefon:
English: Based on the information presented to the Committee, it was not clear whether this was due to the way the study was designed, the way the results were analysed, or to the medicine itself.
Danish: Det fremgik ikke klart af de oplysninger, som udvalget havde fået fremlagt, om dette skyldtes måden, undersøgelsen var udformet på, måden resultaterne blev analyseret på eller selve lægemidlet.
English: Relapsing-remitting means that the patient has attacks (relapses) followed by periods with milder symptoms (remission).
Danish: Relapsing-remitterende betyder, at patienten får attakker (tilbagefald) efterfulgt af perioder med mildere symptomer (remission).
English: Each patient received either Biferonex or placebo for two years.
Danish: Hver patient fik enten Biferonex eller placebo i to år.
English: Questions and answers on the withdrawal of the marketing authorisation application for Biferonex interferon beta-1a
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Biferonex interferon beta-1a
English: The company had requested a re-examination of the negative opinion, but this re-examination had not yet finished when the company withdrew.
Danish: Virksomheden havde anmodet om, at den negative udtalelse blev taget op til fornyet overvejelse, men denne var endnu ikke afsluttet, da virksomheden trak ansøgningen tilbage.
English: Biferonex contains the same active substance as other medicines called Avonex and Rebif, which have been authorised in the European Union since 1997 and 1998, respectively.
Danish: Biferonex indeholder det samme aktive stof som andre lægemidler, kaldet Avonex og Rebif, som har været godkendt i EU siden henholdsvis 1997 og 1998.
English: The effects of Biferonex were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Biferonex blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: In contrast to these medicines, Biferonex is made in such a way that it does not contain the human blood protein, albumin.
Danish: I modsætning til disse lægemidler er Biferonex fremstillet på en måde, så det ikke indeholder blodproteinet humant albumin.
English: What is Biferonex?
Danish: Hvad er Biferonex?
English: Biferonex was intended for patients who had experienced two or more attacks in the previous two years.
Danish: Biferonex var beregnet til patienter, der havde haft to eller flere attakker inden for de sidste to år.
English: Biferonex is expected to work by modulating the activity of the immune system (the body's natural defences) and preventing relapses of multiple sclerosis.
Danish: Biferonex forventes at virke ved at modulere aktiviteten i immunsystemet (kroppens naturlige forsvar) og forebygge tilbagefald af dissemineret sklerose.
English: The main measure of effectiveness was the reduction in the number of attacks.
Danish: Behandlingens virkning blev hovedsagelig bedømt på reduktionen i antallet af attakker.
English: The company presented the results of one main study, in which Biferonex was compared with placebo (a dummy treatment) in 339 adults with relapsing-remitting multiple sclerosis.
Danish: Virksomheden fremlagde resultaterne af en hovedundersøgelse, hvori Biferonex blev sammenlignet med placebo (en virkningsløs behandling) hos 339 voksne med relapsing-remitterende dissemineret sklerose.
English: The company also used information relating to Avonex, and information from the published literature on other medicines containing interferon beta.
Danish: Virksomheden anvendte også oplysninger om Avonex og oplysninger fra den offentliggjorte faglitteratur om andre lægemidler indeholdende interferon beta.
English: Interferon beta-1a is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce interferon beta-1a.
Danish: Interferon beta-1a produceres ved en metode, der er kendt som "rekombinant DNA-teknologi": Det fremstilles af en celle, som har modtaget et gen (DNA), der sætter den i stand til at producere interferon beta-1a.
English: The CHMP was also of the opinion that the results of the single pivotal study of Biferonex did not show enough evidence that the medicine was effective.
Danish: CHMP var også af den opfattelse, at resultaterne af den eneste hovedundersøgelse, der var foretaget af Biferonex, ikke udgjorde tilstrækkeligt bevis for, at lægemidlet var effektivt.
English: On 28 May 2009, BioPartners GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Biferonex, for the treatment of relapsing-remitting multiple sclerosis.
Danish: Den 28. maj 2009 meddelte BioPartners GmbH officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Biferonex til behandling af relapsing-remitterende dissemineret sklerose.
English: It was to be available in prefilled syringes.
Danish: Det skulle have været leveret i fyldte injektionssprøjter.
English: What was Biferonex expected to be used for?
Danish: Hvad forventedes Biferonex anvendt til?
English: It therefore concluded that using the published studies on these interferon beta-containing medicines to support the use of Biferonex was not justified, and that studies on Biferonex itself were required.
Danish: Det konkluderede derfor, at det ikke var berettiget at anvende de offentliggjorte undersøgelser af disse lægemidler indeholdende interferon beta til støtte for anvendelsen af Biferonex, og at der krævedes undersøgelser af selve lægemidlet Biferonex.
English: Biferonex was expected to be used to treat adults with relapsing-remitting multiple sclerosis.
Danish: Biferonex forventedes anvendt til behandling af voksne med relapsing-remitterende dissemineret sklerose.
English: Multiple sclerosis is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.
Danish: Dissemineret sklerose er en nervesygdom, der ødelægger den beskyttende skede omkring nerverne som følge af en betændelseslignende tilstand.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Biferonex?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Biferonex eller i programmer for anvendelse af Biferonex med særlig udleveringstilladelse?
English: The active substance in Biferonex, interferon beta-1a, belongs to the group ‘interferons'.
Danish: Det aktive stof i Biferonex, interferon beta-1a, hører til gruppen af ‘interferoner'.
English: At the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Biferonex for the treatment of relapsing-remitting multiple sclerosis.
Danish: På tidspunktet for tilbagetrækningen af ansøgningen havde CHMP afgivet en negativ udtalelse og anbefalede at give afslag på ansøgningen om markedsføringstilladelse for Biferonex til behandling af relapsing-remitterende dissemineret sklerose.
English: The interferon beta-1a in Biferonex acts in the same way as naturally produced interferon beta.
Danish: Det interferon beta-1a, der findes i Biferonex, virker på samme måde som naturligt produceret interferon beta.
English: The company informed the CHMP that there are no clinical trials or compassionate use programmes ongoing with Biferonex.
Danish: Virksomheden har oplyst CHMP om, at der ikke er nogen igangværende kliniske undersøgelser med eller programmer for anvendelse af Biferonex med særlig udleveringstilladelse.
English: How is Biferonex expected to work?
Danish: Hvordan forventes Biferonex at virke?
English: Biferonex is a solution for injection that contains the active substance interferon beta-1a.
Danish: Biferonex er en injektionsvæske, opløsning, der indeholder det aktive stof interferon beta-1a.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Biferonex in the treatment of patients with relapsing-remitting multiple sclerosis did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Biferonex ikke opvejede risiciene til behandling af patienter med relapsing-remitterende dissemineret sklerose.
English: The Committee noted that there were differences between the active substance in Biferonex and other interferon beta-containing medicines available on the market.
Danish: Udvalget konstaterede, at det aktive stof i Biferonex adskilte sig fra det, der findes i andre lægemidler på markedet indeholdende interferon beta.
English: KIOVIG is used for
Danish: KIOVIG anvendes til
English: Date of first authorization: 19 January 2006 Date of latest renewal: 06 December 2010
Danish: Dato for første markedsføringstilladelse: 19. januar 2006 Dato for seneste fornyelse: 6. december 2010
English: Tell your doctor if you are diabetic.
Danish: Fortæl din læge, hvis du er diabetiker.
English: • Frequency not known (cannot be estimated from available data):
Danish: • Hyppig ikke kendt (kan ikke vurderes ud fra tilgængelige data):
English: Therefore, dosing should be carefully calculated for this population.
Danish: Derfor skal dosis beregnes omhyggeligt til denne population.
English: Certain adverse reactions may occur more frequently
Danish: Visse uønskede reaktioner kan optræde hyppigere
English: Therefore, your baby may be protected from certain infections.
Danish: Derfor kan dit spædbarn måske blive beskyttet mod visse infektioner.
English: It is usually prepared from pooled plasma from not fewer than 1000 donations.
Danish: Det tilberedes sædvanligvis af pooled plasma fra ikke under 1.000 bloddonationer.
English: In the case of measles, this impairment may persist for up to 1 year.
Danish: I tilfælde af mæslinger kan denne skade vare ved i op til 1 år.
English: Your doctor will choose the appropriate intravenous immunoglobulin for you.
Danish: Din læge vil vælge det passende intravenøse immunglobulin til dig.
English: The treatment can be repeated if relapse occurs.
Danish: Behandlingen kan gentages, hvis der forekommer tilbagefald.
English: Adolescents (13 to 17 years)
Danish: Unge (13 til 17 år)
English: Neutropenia/Leukopenia
Danish: Neutropeni/Leukopenia
English: Produced from the plasma of human donors.
Danish: Produceret af plasma fra humandonorer.
English: IVIg products have been shown to cross the placenta, increasingly during the third trimester.
Danish: IVIg-produkter er vist at krydse placenta, i stigende grad under tredje trimester.
English: All other patients should be observed for at least 20 minutes after administration.
Danish: Alle andre patienter bør observeres i mindst 20 minutter efter indgivelsen.
English: The median IgG half-life after administration of KIOVIG was 32.5 days.
Danish: Median IgG halveringstiden efter indgivelse af KIOVIG var 32,5 dage.
English: The safety of KIOVIG has been demonstrated in several non-clinical studies.
Danish: Sikkerheden af KIOVIG er blevet påvist i adskillige ikke-kliniske undersøgelser.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger
English: There are two alternative treatment schedules:
Danish: Der findes to forskellige behandlingsplaner:
English: Secondary immunodeficiencies (as defined in 4.1.)
Danish: Sekundære immundefekter (som beskrevet i 4.1).
English: If this happens, you should wait until the reactions have disappeared.
Danish: Hvis det sker, bør du vente, indtil bivirkningerne er gået over.
English: Pharmacokinetic parameters for KIOVIG were determined in the two clinical studies in PID patients performed in Europe and the US.
Danish: Farmakokinetiske parametre for KIOVIG er fastlagt i de to kliniske undersøgelser på PID patienter udført i Europa og USA.
English: How long monitoring is required during the infusion
Danish: Hvor lang tid det er nødvendigt med overvågning under infusionen
English: Below is a list of side effects reported with KIOVIG:
Danish: Nedenfor er en liste over bivirkninger, der er rapporteret med KIOVIG:
English: Effects on blood tests
Danish: Virkninger på blodprøver
English: Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Danish: Hyppigheden er blevet evalueret i henhold til følgende konvention: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If you experience a reaction during the infusion of KIOVIG, tell your doctor immediately.
Danish: Hvis du oplever en reaktion under infusionen af KIOVIG, fortæl det omgående til din læge.
English: • adequate hydration prior to the initiation of the infusion of IVIg
Danish: • passende hydrering forud for påbegyndelse af IVIg-infusionen
English: The treatment required depends on the nature and severity of the adverse reaction.
Danish: Hvilken behandling der kræves, afhænger af karakteren og alvoren af den uønskede reaktion.
English: In such cases, you will be closely monitored during your infusion and for an hour after your infusion has stopped.
Danish: I sådanne tilfælde vil du blive overvåget nøje under infusionen og i en time, efter at infusionen er standset.
English: IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Danish: IgG og IgG-komplekser nedbrydes i celler i det retikuloendoteliale system.
English: Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Danish: Patienterne skal overvåges nøje og observeres omhyggeligt for symptomer i hele infusionsperioden.
English: KIOVIG does not contain sucrose, maltose or glucose.
Danish: KIOVIG indeholder ikke saccharose, glucose eller maltose.
English: This may persist during the weeks following infusion of the product.
Danish: Dette kan vare ved i ugerne efter infusion af præparatet.
English: Symptoms of TRALI typically develop during or within 6 hours of a transfusion, often within 1-2 hours.
Danish: Symptomer på TRALI udvikler sig normalt i løbet af eller inden for 6 timer efter transfusion, ofte inden for 1-2 timer.
English: Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per mm
Danish: Cerebrospinalvæskeundersøgelser er ofte positive med pleocytose på op til adskillige tusinde celler pr. mm
English: All parameters were analysed separately for three age groups, children (below 12 years, n=5), adolescents (13 to 17 years, n=10), and adults (above 18 years of age, n=64).
Danish: Alle parametre blev analyseret separat for tre aldersgrupper, børn (under 12 år, n= 5), unge (13 til 17 år, n = 10) og voksne (over 18 år, n= 64).
English: KIOVIG contains a wide variety of different antibodies, some of which can affect blood tests.
Danish: KIOVIG indeholder en lang række forskellige antistoffer, hvoraf nogle kan påvirke blodprøver.
English: Antibodies help your body to fight infections.
Danish: Antistofferne hjælper kroppen til at bekæmpe infektioner.