FrancophonIA/ELRC3.0 huggingface dataset:
English: 4 - Peel back and remove the cover from the vial adapter packaging.
Danish: 4 - Fjern låget fra adapterpakningen ved at trække det bagud.
English: Renal and urinary disorders Urinary retention
Danish: Smerter i ekstremiteter Nyrer og urinveje Urinretention
English: How to use Extavia
Danish: Hvad bruges Extavia til?
English: How Extavia works
Danish: Sådan virker Extavia
English: Using Extavia with other medicines that modify the immune system response is not recommended, except anti-inflammatory medicines called corticosteroids or the adrenocorticotropic hormone (ACTH).
Danish: Med undtagelse af medicin, der modvirker betændelse (kortikosteroider eller adrenokortikotropt hormon (ACTH)), frarådes det at bruge Extavia sammen med anden medicin, der hæmmer immunsystemet.
English: 3-month multipack: 45 (3 packs of 15) vials with powder and 45 (3 packs of 15) pre-filled syringes with 1.2 ml solvent.
Danish: 3-måneders multipakning: 45 (3 pakninger med 15) hætteglas med pulver og 45 (3 pakninger med 15) fyldte injektionssprøjter med 1,2 ml solvens.
English: 3-month multipack: 42 (3 packs of 14) vials with powder and 42 (3 packs of 14) pre-filled syringes with 1.2 ml solvent.
Danish: 3-måneders multipakning: 42 (3 pakninger med 14) hætteglas med pulver og 42 (3 pakninger med 14) fyldte injektionssprøjter med 1,2 ml solvens.
English: In patients with a single clinical event suggestive of multiple sclerosis, efficacy has been demonstrated over a period of three years.
Danish: Der er en bevist effekt i en periode på 3 år hos patienter med et enkelt klinisk tilfælde, der tyder på dissemineret sklerose.
English: Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon beta products.
Danish: Der er indberettet tilfælde af nefrotisk syndrom med forskellige underliggende nefrepatier inklusive kollaberende fokal segmental glomeruloskleritis (FSGS), minimal change disease (MCD), membranproliferativ glomerulonefritis (MPGN) og membran glomerulopati (MGN) under behandling med beta-interferonprodukter.Hændelserne blev rapporteret på forskellige tidspunkter i behandlingsforløbet og kan opstå efter flere års behandling med beta-interferon.Det anbefales at udføre periodisk monitorering for tidlige symptomer, fx ødem, proteinuri og nedsat nyrefunktion, især hos patienter med øget risiko for nyresygdom.
English: Sweating *
Danish: Asteni *
English: 3-month multipack containing 45 (3x15) vials of interferon beta-1b and 45 (3x15) pre-filled syringes containing solvent.
Danish: 3-måneders multipakning indeholdende 45 (3x15) hætteglas med interferon beta-1b og 45 (3x15) fyldte sprøjter indeholdende solvens.
English: 3-month multipack containing 42 (3x14) vials of interferon beta-1b and 42 (3x14) pre-filled syringes containing solvent.
Danish: 3-måneders multipakning indeholdende 42 (3x14) hætteglas med interferon beta-1b og 42 (3x14) fyldte sprøjter indeholdende solvens.
English: Please read the instructions carefully and follow them step by step.
Danish: Læs instruktionen omhyggeligt, og følg den trin for trin. Din læge eller sygeplejersken vil instruere dig.
English: - the number of red cells in the blood may fall (anaemia), - the thyroid gland does not work properly (too little hormone is produced) (hypothyroidism), - weight increase or decrease, - confusion, - abnormally rapid heartbeat (tachycardia), - a reddish yellow pigment (bilirubin), which is produced by your liver, may rise (this will show up in blood tests),
Danish: (hypotyreoidisme) - vægtøgning eller vægttab - forvirring, - unormal hurtig hjerterytme (takykardi) - et rødgult farvestof (bilirubin), som dannes i leveren, kan forøges (viser sig i blodprøver)
English: It can cause temporary disability, such as difficulty walking.
Danish: Det kan være midlertidigt invaliderende, i form af fx gangbesvær.
English: 5 vials with powder and 5 pre-filled syringes with 1.2 ml solvent.
Danish: 5 hætteglas med pulver og 5 fyldte injektionssprøjter med 1,2 ml solvens.
English: After reconstitution, each ml contains 250 microgram (8.0 million IU) of recombinant interferon beta1b.
Danish: Efter rekonstitution indeholder 1 ml 250 mikrogram (8 mio. IE) rekombinant interferon beta-1b.
English: Each vial contains 300 microgram (9.6 million IU) interferon beta-1b per vial.
Danish: Hvert hætteglas indeholder 300 mikrogram (9,6 mio. IE) interferon beta-lb pr. hætteglas.
English: 14 vials with powder and 14 pre-filled syringes with 1.2 ml solvent.
Danish: 14 hætteglas med pulver og 14 fyldte injektionssprøjter med 1,2 ml solvens.
English: EU/1/08/454/009 3-month multipack comprising 45 vials with powder and 45 pre-filled syringes with solvent EU/1/08/454/012 3-month multipack comprising 42 vials with powder and 42 pre-filled syringes with solvent EU/1/08/454/014 3-month multipack comprising 42 vials with powder and 45 pre-filled syringes with solvent
Danish: EU/1/08/454/014 3-måneders multipakning bestående af 42 hætteglas med pulver og 45 fyldte injektionssprøjter med solvens.
English: Check with your doctor or pharmacist if you are not sure.
Danish: ► Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er noget, du er i tvivl om.
English: 3-month multipack: 42 (3 packs of 14) vials with powder and 45 (3 packs of 15) pre-filled syringes with 1.2 ml solvent.
Danish: 3-måneders multipakning: 42 (3 pakninger med 14) hætteglas med pulver og 45 (3 pakninger med 15) fyldte injektionssprøjter med 1,2 ml solvens.
English: 3 - Remove the cap from the needle by pulling and not twisting it.
Danish: 3 - Tag hætten af kanylen ved at trække i den.
English: ► Injection site reactions.
Danish: ► Reaktion ved indsprøjtningssted.
English: LABEL OF PRE-FILLED SYRINGE
Danish: ETIKET PÅ FYLDT INJEKTIONSSPRØJTE
English: 3-month multipack containing 42 (3x14) vials of interferon beta-1b and 45 (3x15) pre-filled syringes containing solvent.
Danish: 3-måneders multipakning indeholdende 42 (3x14) hætteglas med interferon beta-1b og 45 (3x15) fyldte sprøjter indeholdende solvens.
English: Patients with anaemia, thrombocytopenia or leukopenia (alone or in any combination) may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Danish: Det kan blive nødvendigt at intensivere monitoreringen af det totale blodcelletal med differential- og blodpladetal hos patienter, der lider af anæmi, thrombocytopeni og/eller leukopeni.
English: 5 vials of interferon beta-1b and 5 pre-filled syringes containing solvent.
Danish: 5 hætteglas med interferon beta-1b og 5 fyldte sprøjter indeholdende solvens.
English: If you use more Extavia than you should
Danish: Hvis du har taget for meget Extavia
English: 14 vials of interferon beta-1b and 14 pre-filled syringes containing solvent.
Danish: 14 hætteglas med interferon beta-1b og 14 fyldte sprøjter indeholdende solvens.
English: Menorrhagia
Danish: Udslæt
English: What Extavia is and what it is used for What you need to know before you use Extavia How to use Extavia
Danish: Det skal du vide, før du begynder at tage Extavia Sådan skal du tage Extavia
English: Adults and adolescents from 12-17 years of age The recommended dose of Extavia is 250 microgram (8.0 million IU), contained in 1 ml of the reconstituted solution (see section 6.6), to be injected subcutaneously every other day.
Danish: Den anbefalede dosis af Extavia er 250 mikrogram (8 millioner IE) svarende til 1 ml rekonstitueret injektionsvæske (se pkt.
English: One way to do that is to note the injection site on the enclosed medication record card.
Danish: Det kan du fx gøre ved at registrere stedet på det vedlagte skema.
English: Snap off and discard the tip of the syringe.
Danish: Knæk spidsen af den fyldte sprøjte og smid den væk.
English: 15 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
Danish: 15 hætteglas med pulver og 15 fyldte injektionssprøjter med 1,2 ml solvens.
English: Extavia can reduce the number and severity of the attacks, and slow the progression of disability.
Danish: Dermed befinder patienten sig i en situation, hvor sygdommen langsomt forværres, uanset om den blusser op eller ej. Extavia kan reducere antallet og sværhedsgraden af anfaldene og sinke sygdommens forværring.
English: 15 vials of interferon beta-1b and 15 pre-filled syringes containing solvent.
Danish: 15 hætteglas med interferon beta-1b og 15 fyldte sprøjter indeholdende solvens.
English: 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.
Danish: 1 hætteglas indeholder 300 mikrogram (9,6 mio. IE) interferon beta-1b. 1 ml indeholder 250 mikrogram (8,0 mio. IE) interferon beta-1b efter rekonstitution.
English: 14 vials of interferon beta-1b and 15 pre-filled syringes containing solvent.
Danish: 14 hætteglas med interferon beta-1b og 15 fyldte sprøjter indeholdende solvens.
English: Note: Do not shake the vial.
Danish: OBS: Hætteglasset må ikke omrystes.
English: 14 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
Danish: 14 hætteglas med pulver og 15 fyldte injektionssprøjter med 1,2 ml solvens.
English: Injection site reactions may occur less frequently if you use an auto-injector device.
Danish: Hvis du bruger en autoinjektor, kan reaktioner ved indsprøjtningsstedet forekomme mindre hyppigt.
English: BLISTER OF PRE-FILLED SYRINGE
Danish: BLISTERPAKNING MED FYLDT INJEKTIONSSPRØJTE
English: Chills
Danish: Absces
English: - Keep your syringes and syringe disposal unit out of the sight and reach of children; lock the supplies away if possible.
Danish: - Opbevar dine sprøjter og affaldsbeholder til sprøjter utilgængeligt for børn.
English: Caution should be used and close monitoring considered when administering interferon beta to patients with severe renal failure.
Danish: Når patienter med svært nedsat nyrefunktion behandles med interferon beta, bør der udvises forsigtighed og en nøje monitorering bør overvejes.
English: Migraine
Danish: Smerte
English: - 3-month multipack containing 42 (3x14) vials with powder and 42 (3x14) pre-filled syringes with solvent - 3-month multipack containing 45 (3x15) vials with powder and 45 (3x15) pre-filled syringes with solvent - 3-month multipack containing 42 (3x14) vials with powder and 45 (3x15) pre-filled syringes with solvent
Danish: - 3-måneders multipakning indeholdende 42 (3x14) hætteglas med pulver og 45 (3x15) fyldte injektionssprøjter med solvens.
English: For relapsing-remitting multiple sclerosis, efficacy has been demonstrated for therapy for the first two years.
Danish: Der er en bevist effekt ved behandling i de første 2 år af patienter med recidiverenderemitterende dissemineret sklerose.
English: This means that it has been used for many years and that there was sufficient information on its effectiveness and safety.
Danish: Det betyder, at det har været anvendt i mange år, og at der foreligger tilstrækkelige oplysninger om dets effektivitet og sikkerhed.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tepadina on 15 March 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tepadina den 15. marts 2010.
English: It must also not be used together with the vaccine against yellow fever or vaccines containing live viruses or bacteria.
Danish: Det må heller ikke bruges sammen med vaccine mod gul feber eller vacciner, der indeholder levende virus eller bakterier.
English: Because thiotepa has been used for many years in the EU, the company presented data from the published literature.
Danish: Da thiotepa har været brugt i EU i mange år, fremlagde virksomheden data fra den publicerede faglitteratur.
English: These substances are ‘cytotoxic'.
Danish: Disse stoffer er cytotoksiske.
English: A risk management plan has been developed to ensure that Tepadina is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Tepadina anvendes så sikkert som muligt.
English: In children, the daily dose ranges from 125 to 350 mg/m2 given for up to three days before transplantation.
Danish: Hos børn er den daglige dosis 125 til 350 mg/m2 i op til tre dage inden transplantationen.
English: The dose also depends on the patient's body surface area (calculated using the height and weight of the patient) or on the patient's weight.
Danish: Doseringen afhænger også af patientens kropsoverflade (beregnet ud fra patientens højde og vægt) eller af patientens vægt.
English: Tepadina treatment must be supervised by a doctor who has experience in treatments given before transplantation.
Danish: Tepadina-behandlingen skal overvåges af en læge med erfaring i behandlinger, der gives inden transplantation.
English: This is a summary of the European Public Assessment Report (EPAR) for Tepadina.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tepadina.
English: Tepadina is used in combination with chemotherapy (medicines to treat cancer) in two ways:
Danish: Tepadina bruges i kombination med kemoterapi (lægemidler til kræftbehandling) på to måder:
English: The studies looked at the number of patients with successful transplantations, how long it took for the diseases to come back and how long the patients survived.
Danish: I undersøgelserne gennemgik man, hvor mange transplantationer, der var vellykkede, hvor lang tid det tog, før sygdommene vendte tilbage, og hvor længe patienterne overlevede.
English: Thiotepa has been used to prepare patients for transplantation of blood-making cells in the European Union (EU) since the late 1980s.
Danish: Thiotepa har været brugt til at forberede patienter til transplantation af blodproducerende celler i EU siden sidst i 1980'erne.
English: This included 109 studies involving around 6,000 adults and 900 children with blood diseases or solid tumours, who were having a transplant of blood-making cells.
Danish: Den omfatter 109 undersøgelser af omkring 6 000 voksne og 900 børn med blodsygdomme eller faste svulster, der fik transplanteret blodproducerende celler.
English: What measures are being taken to ensure the safe and effective use of Tepadina?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tepadina?
English: This means that they kill cells, especially cells that multiply rapidly, such as cancer or progenitor (or ‘stem') cells (cells that can develop into different types of cell).
Danish: Det betyder, at de ødelægger celler, især celler, som formerer sig hurtigt, f.eks. kræftceller eller stamceller (celler, der kan udvikle sig til forskellige typer celle).
English: In adults, the daily dose ranges from 120 to 481 mg per square metre (m2) given for up to five days before transplantation.
Danish: Hos voksne er den daglige dosis 120 til 481 mg pr. kvadratmeter (m2) i op til fem dage inden transplantationen.
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 Tepadina.
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 anvendelsesbetingelserne for Tepadina.
English: It contains the active substance thiotepa.
Danish: Det indeholder det aktive stof thiotepa.
English: The full EPAR for Tepadina can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Tepadina findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For more information about treatment with Tepadina, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist..
Danish: Hvis du ønsker yderligere oplysninger om behandling med Tepadina, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This allows new cells to be transplanted, by creating space for the new cells and reducing the risk of rejection.
Danish: Det gør det muligt at transplantere nye celler, da det skaber plads til dem og mindsker risikoen for, at de afstødes.
English: • as a ‘conditioning' (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells).
Danish: • som "konditionerende behandling" (forberedelsesbehandling) inden transplantation af knoglemarvsceller (de celler, der producerer blodlegemer).
English: It helps to destroy the patient's existing blood-making cells, resulting in the successful transplantation of new cells, improved survival and a reduced risk of the diseases coming back.
Danish: Stoffet hjælper med at ødelægge patientens eksisterende blodproducerende celler, hvilket giver en vellykket transplantation af de nye celler, større chance for overlevelse og reduceret risiko for, at sygdommene vender tilbage.
English: The published studies showed that thiotepa used in combination with other chemotherapy medicines is beneficial to adults and children being treated for blood diseases and solid tumours.
Danish: De publicerede undersøgelser viser, at thiotepa brugt i kombination med anden kemoterapi er gavnligt for voksne og børn, der er i behandling for blodsygdomme og faste tumorer.
English: What is the risk associated with Tepadina?
Danish: Hvilken risiko er der forbundet med Tepadina?
English: The dose of Tepadina depends on the type of blood disease or solid tumour that the patient has and the type of transplantation to be carried out.
Danish: Dosis af Tepadina afhænger af den type blodsygdom eller fast svulst, patienten har, og den type transplantation, der skal udføres.
English: Tepadina must not be used in women who are pregnant or breast-feeding.
Danish: Tepadina må ikke anvendes til gravide eller ammende kvinder.
English: Because the number of patients in the European Union (EU) that undergo this type of conditioning and transplant is low, Tepadina was designated an ‘orphan medicine' (a medicine used in rare diseases) on 29 January 2007.
Danish: Antallet af patienter i EU, der gennemgår denne type forberedelsesbehandling og transplantation, er lavt, og Tepadina blev derfor udpeget som lægemiddel til sjældne sygdomme den 29. januar 2007.
English: The active substance in Tepadina, thiotepa, belongs to a group of medicines called ‘alkylating agents'.
Danish: Det aktive stof i Tepadina, thiotepa, tilhører en gruppe af lægemidler, som kaldes alkylerende midler.
English: Tepadina is used with other medicines before transplantation to destroy the abnormal cells and the patient's existing blood-making cells.
Danish: Tepadina bruges sammen med andre lægemidler inden transplantationen til at ødelægge de unormale celler og patientens eksisterende blodproducerende celler.
English: Tepadina can be used for transplantation of cells from a donor and for transplantation of cells derived from the patient's own body.
Danish: Tepadina kan bruges ved transplantation af celler fra en donor eller af celler fra patientens egen krop.
English: Why has Tepadina been approved?
Danish: Hvorfor blev Tepadina godkendt?
English: It must be given as an infusion into a large vein lasting two to four hours.
Danish: Infusionen tager to til fire timer.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tepadina, 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 Tepadina, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Tepadina can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Tepadina findes på agenturets websted underema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Other information about Tepadina
Danish: Andre oplysninger om Tepadina
English: The most common side effects seen with Tepadina when used with other medicines are infections, cytopenia (low number of cells in the blood), graft-versus-host disease (when the transplanted cells attack the body), disorders of the gut, haemorrhagic cystitis (bleeding and inflammation in the bladder) and mucosal inflammation (inflammation of the moist body surfaces).
Danish: De hyppigste bivirkninger ved Tepadina, når det anvendes sammen med andre lægemidler, er infektioner, lavt antal blodlegemer (cytopeni), at de transplanterede celler angriber kroppen (graftversus-host disease), tarmlidelser, blødning og betændelse i blæren (blødende cystitis) samt betændelse i slimhinderne (mucositis).
English: • during the treatment of solid tumours when high-dose chemotherapy followed by transplantation of haematopoietic progenitor cells is needed.
Danish: • under behandling af faste svulster, hvor det er nødvendigt med store doser kemoterapi efterfulgt af transplantation af knoglemarvsceller.
English: The Committee decided that, based on available published information, Tepadina's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget konkluderede, at fordelene ved Tepadina på baggrund af de tilgængelige publicerede oplysninger opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Tepadina.
English: Tepadina is a powder that is made up into a solution for infusion (drip into a vein).
Danish: Tepadina er et pulver, der anvendes til at fremstille en infusionsvæske, opløsning (drop i en vene).
English: The CHMP noted that the active substance in Tepadina, thiotepa, has a well established used.
Danish: CHMP noterede sig, at anvendelsen af det aktive stof i Tepadina, thiotepa, er almindeligt anerkendt.
English: For the full list of all side effects reported with Tepadina in adults and children, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Tepadina hos voksne og børn fremgår af indlægssedlen.
English: How has Tepadina been studied?
Danish: Hvordan blev Tepadina undersøgt?
English: For further information, see the summary of product characteristics (also part of the EPAR).
Danish: De yderligere oplysninger fremgår af produktresuméet, der også er en del af denne EPAR.
English: What is Tepadina?
Danish: Hvad er Tepadina?
English: What is Tepadina used for?
Danish: Hvad anvendes Tepadina til?
English: This type of transplant is used in patients who need to replace their blood-making cells because they have a blood disease such as a cancer of the blood
Danish: Denne type transplantation bruges til patienter, der har brug for nye blodproducerende celler, fordi de lider af en blodsygdom som kræft i blodet (f.eks. leukæmi) eller en sygdom, der mindsker antallet af røde blodlegemer (f.eks. thalassæmi eller seglcelleanæmi),
English: What benefit has Tepadina shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Tepadina?
English: How is Tepadina used?
Danish: Hvordan anvendes Tepadina?
English: The full EPAR for Temozolomide Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Temozolomide Sandoz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.