FrancophonIA/ELRC3.0 huggingface dataset:
English: - the number of platelets (which help the blood to clot) may fall (thrombocytopenia), - a certain type of blood fats (triglycerides) may increase (will show up in blood tests), see section 2 “Warnings and precautions”, - suicide attempts, - mood swings, - convulsion, - a specific liver enzyme (gamma GT) which is produced by your liver, may rise (this will show up in blood tests), - inflammation of the liver (hepatitis), - skin discolouration.
Danish: - antallet af blodplader (medvirker til, at blodet størkner) kan falde (trombocytopeni), - en bestemt type fedtstoffer i blodet (triglycerider) kan stige (vil vise sig i blodprøver), se afsnit 2 ”Advarsler og sikkerhedsregler) - selvmordsforsøg - humørsvingninger - krampeanfald - et specielt leverenzym (gamma-GT), som dannes i leveren, kan øges (viser sig i blodprøver) - leverbetændelse (hepatitis) - misfarvning af huden
English: Adverse events related to the central nervous system associated with the use of Extavia might influence the ability to drive and use machines in susceptible patients.
Danish: Hos modtagelige patienter kan brugen af Extavia påvirke centralnervesystemet og nedsætte evnen til at føre bil eller betjene maskiner.
English: - If you experience symptoms such as itching all over your body, swelling of your face and/or your tongue or sudden shortness of breath.
Danish: - Hvis du får symptomer som kløe over hele kroppen, hvis dit ansigt og/eller din tunge svulmer op, eller hvis du pludselig får åndenød.
English: 8 - Holding the vial and adapter securely, screw the syringe fully onto the vial adapter.
Danish: 8 - Hold fast på hætteglas og adapter og skru sprøjten helt på adapteren.
English: However, there are some data available in adolescents aged from 12 to 17 years which suggest that the safety of Extavia in this group is the same as in adults.
Danish: De begrænsede, offentliggjorte data antyder dog, at Extavia har samme grad af sikkerhed hos børn og teenagere mellem 12 og 17 år som hos voksne.
English: if you experience loss of appetite, tiredness, feeling sick (nausea), repeated vomiting, especially if you notice widespread itching, yellowing of the skin, or of the whites of the eyes or easy bruising.
Danish: Hvis du mister appetitten, føler træthed, får kvalme, har gentagne opkastninger, især hvis du også bemærker udbredt kløe, gulfarvning af huden eller af det hvide i øjnene og får tendens til blå mærker.
English: Class label for interferon beta products (see section 4.4).
Danish: Klasserelateret bivirkning ved interferon-beta-præparater (se pkt.
English: As for other beta interferons, cases of severe hepatic injury, including hepatic failure, have been reported in patients treated with Extavia.
Danish: Som ved andre beta-interferoner er der indberettet tilfælde af alvorlige leverskader, herunder leversvigt, hos patienter i behandling med Extavia.
English: if you notice pain in your belly which is radiating to your back , and/or you feel sick or have a fever.
Danish: Hvis du bemærker mavesmerter med udstråling til ryggen, og/eller du får kvalme eller feber.
English: Hypersensitivity to natural or recombinant interferon beta, human albumin or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for naturligt eller rekombinant interferon beta, humant albumin eller over for et eller flere af hjælpestofferne anført i pkt.
English: - If you notice any unusual bruising, excessive bleeding after injury or if you seem to be catching a lot of infections.
Danish: - Hvis du bemærker usædvanlige blå mærker, hvis du bløder voldsomt efter at være kommet til skade, eller hvis du mener, at du får mange infektioner.
English: - swollen and usually itchy patches of skin or mucous membranes (urticaria), - itching (pruritus), - loss of scalp hair (alopecia), - menstrual disorders (menorrhagia).
Danish: - hævede og sædvanligvis kløende områder i hud eller slimhinder (nældefeber) - kløe (pruritus) - tab af hår på hovedet (alopecia) - menstruationsforstyrrelser (menoragi)
English: Secondary progressive multiple sclerosis (SP-MS) Two controlled clinical trials were performed with Extavia involving a total of 1,657 patients with secondary progressive multiple sclerosis (baseline EDSS 3 to 6.5, i.e. patients were able to walk).
Danish: Forsøgene involverede i alt 1657 patienter med sekundær progressiv dissemineret sklerose (EDSS-baselineværdier på 3-6,5, dvs. patienter, som var i stand til at gå).
English: Do not use any area where you can feel lumps, bumps, firm knots, pain or an area that is discoloured, indented, scabbed, or where the skin is broken.
Danish: Undlad at sprøjte dig på steder, hvor du har infiltrationer, knuder, faste knuder, smerte, eller hvor huden er misfarvet, indsunken, skorpet eller revnet.
English: Nervous system disorders Headache 
Danish: Nervesystemet Hovedpine
English: The solvent for Extavia is provided in a 2.25 ml pre-filled syringe and contains 1.2 ml sodium chloride 5.4 mg/ml (0.54% w/v) solution for injection.
Danish: Solvens til Extavia leveres i en fyldt 2,25 ml sprøjte og indeholder 1,2 ml natriumchloridinjektionsvæske 5,4 mg/ml (0,54 % vægt/vol).
English: ► Flu-like symptoms such as fever, chills, painful joints, malaise, sweating, headache, or muscular pain.
Danish: ► Influenzalignende symptomer som feber, kuldegysninger, ledsmerter, alment ubehag, svedudbrud, hovedpine eller muskelsmerter.
English: Note: Be careful not to touch the exposed end of the syringe.
Danish: OBS: Undgå at røre ved sprøjtens spids.
English: 16 - Take the needle out of its wrapping and screw it firmly onto the top of the syringe.
Danish: 16 - Pak kanylen ud af emballagen og skru den fast på sprøjtespidsen.
English: Neutralising antibodies are not produced in all patients.
Danish: Det er ikke alle patienter, der producerer neutraliserende antistoffer, og det er p.t. ikke muligt at forudsige, hvilke patienter, der producerer dem.
English: If you experience any break in the skin, associated with swelling or fluid leaking out from the injection site:
Danish: Hvis huden brister i forbindelse med hævelse, eller hvis det væsker fra indsprøjtningsstedet:
English: Symptoms include redness, swelling, change in skin colour, inflammation, pain, and hypersensitivity.
Danish: Symptomerne omfatter rødme, hævelse, ændring i hudfarve, betændelse, smerte og overfølsomhed.
English: For details on storage conditions see section 5 of the leaflet, “How to store Extavia”.
Danish: Detaljer om opbevaringsbetingelser findes under afsnit 5 ”Opbevaring” på indlægssedlen.
English: There are sparse and inconclusive data on patients who have developed neutralising activity and have completed Extavia therapy.
Danish: Data fra patienter, som har udviklet neutraliserende aktivitet og har afsluttet behandlingen med Extavia, er sparsomme og utilstrækkelige.
English: Extavia should be used with caution with: - medicines which need a certain liver enzyme system (known as cytochrome P450 system) for their removal from the body, for example medicines used to treat epilepsy (such as phenytoin).
Danish: Medicin, der nedbrydes via et specielt enzymsystem i leveren (CYP-enzymsystem), fx lægemidler til behandling af epilepsi (såsom phenytoin).
English: Skin breakdown and tissue damage (necrosis) around the injection site are reported less frequently.
Danish: Der er set tilfælde af nedbrudt hud og ødelagt væv (nekrose) rundt om indsprøjtningsstedet.
English: 7 - Discard the syringe in the disposal unit.
Danish: 7 - Kassér sprøjten i affaldsbeholderen.
English: Leave the swab on top of the vial.
Danish: Lad spritservietten ligge oven på hætteglasset.
English: As for other beta interferons, severe liver damage, including cases of liver failure, have been reported rarely in patients taking Extavia.
Danish: Som ved andre beta-interferoner er der i sjældne tilfælde indberettet alvorlige leverskader, herunder tilfælde af leversvigt, hos patienter, der blev behandlet med Extavia.
English: - Blood clots in the small blood vessels may occur during your treatment.
Danish: - Under behandlingen kan der opstå blodpropper i de små blodårer.
English: Transfer all the solvent to the vial.
Danish: Overfør al væsken til hætteglasset.
English: Injection site necrosis has been reported in patients using Extavia (see section 4.8).
Danish: Der er rapporteret om nekrose på injektionsstedet hos patienter, som bruger Extavia (se pkt.
English: To reconstitute the powder, the pre-filled syringe with solvent should be used with a needle or a vial adapter to inject the 1.2 ml of the solvent (sodium chloride 5.4 mg/ml (0.54%) solution for injection) into the Extavia vial.
Danish: For at rekonstituere pulveret før injektion anvendes den fyldte injektionssprøjte med solvens og en kanyle eller en adapter til hætteglas til injektion af 1,2 ml af denne solvens (5,4 mg/ml (0,54 % vægt/vol.)
English: Note: Do not shake the vial as this may cause excessive foaming.
Danish: OBS: Omryst ikke glasset, da der vil dannes meget skum.
English: 5 - Holding the syringe like a pencil or a dart, push the needle straight into the skin at a 90˚ angle with a quick, firm motion.
Danish: Stik kanylen direkte ind i huden (i en vinkel på 90˚) med en hurtig, bestemt bevægelse.
English: - Always place the used syringes in the proper disposal unit.
Danish: - Smid altid brugte sprøjter i den dertil indrettede affaldsbeholder.
English: Secondary progressive multiple sclerosis: In some cases people with relapsing-remitting MS find that their symptoms increase and they progress to another form of MS called secondary progressive MS. With this, people find themselves becoming increasingly impaired, whether or not they have relapses.
Danish: Sekundær progressiv dissemineret sklerose: I nogle tilfælde har patienter med recidiverende/remitterende dissemineret sklerose erfaret at deres symptomer forstærkes, og at de udvikler en anden form for dissemineret sklerose, der kaldes progressiv dissemineret sklerose.
English: 17 - Leave the needle cap on. You are now ready to manually inject yourself or to use the ExtaviPro 30G auto-injector for the administration of Extavia.
Danish: Du er nu klar til at foretage indsprøjtningen manuelt selv eller til at bruge ExtaviPro 30G-autoinjektoren til indsprøjtning af Extavia.
English: Preparing the injection
Danish: B) Forberedelse af indsprøjtning
English: Stopping Extavia is not known to cause acute withdrawal symptoms.
Danish: Ophør med Extaviabehandling giver, så vidt det vides, ikke akutte abstinenssymptomer.
English: - kidney problems including scarring (glomerulosclerosis) that may reduce your kidney function, (uncommon).
Danish: ardannelse (glomerulosklerose), som kan nedsætte din nyrefunktion (ikke almindelig).
English: Therefore, the tip cap may contain natural rubber latex.
Danish: Beskyttelseshætten kan derfor indeholde naturgummi-latex.
English: * The titration period may be adjusted if any significant adverse reaction occurs.
Danish: 1,0 ml * Titreringsperioden kan justeres, hvis der forekommer signifikante bivirkninger.
English: In order to obtain adequate efficacy, a dose of 250 microgram (1.0 ml) every other day should be reached.
Danish: En dosis på 250 mikrogram (1,0 ml) hver anden dag bør tilstræbes for at opnå tilstrækkelig effekt.
English: One controlled clinical trial was performed with Extavia in patients with relapsing-remitting multiple sclerosis and able to walk unaided (baseline EDSS 0 to 5.5).
Danish: Recidiverende-remitterende dissemineret sklerose (RR-DS) Der blev udført én kontrolleret klinisk undersøgelse af Extavia til patienter med recidiverenderemitterende dissemineret sklerose, som var i stand til at gå uden hjælp (EDSS-baselineværdier på 0-5,5).
English: Patients exhibiting depression should be monitored closely during therapy with Extavia and treated appropriately.
Danish: Patienter, der udviser tegn på depression, bør monitoreres nøje under behandlingen med Extavia og behandles hensigtmæssigt, og seponering af Extavia bør overvejes (se også pkt.
English: However, if you are not able to do so, it will remain usable for a period of 3 hours, if kept in a refrigerator (2°C - 8°C).
Danish: Efter klargøring af opløsningen, skal du straks anvende den. Er du ikke i stand til straks at anvende den, vil den dog kunne bruges i 3 timer, hvis den opbevares i et køleskab ved 2 °C - 8 °C.
English: Extavia 250 microgram/ml powder and solvent for solution for injection interferon beta-1b
Danish: Extavia 250 mikrogram/ml, pulver og solvens til injektionsvæske, opløsning interferon beta-1b
English: Solvent for Extavia For subcutaneous use after reconstitution.
Danish: Til subkutan brug efter rekonstitution.
English: 3 - Clean the top of the vial with an alcohol swab, moving the swab in one direction only.
Danish: 3 - Aftør toppen af hætteglasset med en spritserviet.
English: A) General advice
Danish: A) Almindelige forholdsregler
English: This equals 250 microgram (8.0 million IU) interferon beta-1b.
Danish: Dette svarer til 250 mikrogram (8,0 mio. IE) interferon beta-1b.
English: 1.2 ml sodium chloride solution 5.4 mg/ml
Danish: 1,2 ml natriumchlorid injektionsvæske 5,4 mg/ml
English: Uncommon (1/1,000 to
Danish: Ikke almindelig (1/1.000 til
English: There is no evidence for benefit in terms of confirmed disability progression in the majority of patients receiving “immediate” treatment.
Danish: Hos størstedelen af patienterne var en øjeblikkelig behandling ikke en beviselig fordel med hensyn til bekræftet invaliditetsudvikling.
English: Patients with decompensated liver disease (see sections 4.4, 4.5 and 4.8).
Danish: 4.4, 4.5 og 4.8).
English: Although no natural rubber latex is detected in the cap, the safe use of Extavia pre-filled syringe in latex-sensitive individuals has not been studied and there is therefore a potential risk for hypersensitivity reactions which cannot be completely ruled out.
Danish: Selvom der ikke kan måles naturgummi-latex i hætten, er sikkerheden ved brugen af fyldte injektionssprøjter ikke undersøgt hos personer, som er overfølsomme overfor latex.
English: The removable tip cap of the Extavia pre-filled syringe contains a derivative of natural rubber latex.
Danish: Beskyttelseshætten på Extavias fyldte injektionssprøjter indeholder et derivat af naturgummi-latex.
English: if you experience symptoms like irregular heart beat, swelling such as of the ankles or legs, or shortness of breath.
Danish: Hvis du får symptomer såsom uregelmæssig hjerterytme (puls), hævede ankler eller ben eller åndenød.
English: Extavia is injected under the skin so any food or drink you consume is not thought to have any effect on Extavia.
Danish: Det forventes derfor ikke, at indtagelsen af mad og drikke vil have nogen indflydelse på Extavia.
English: Extavia contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial*.
Danish: Extavia indeholder 300 mikrogram (9,6 mio. IE) rekombinant interferon beta-1b pr. hætteglas*.
English: What Extavia looks like and contents of the pack Extavia is a powder and solvent for solution for injection.
Danish: Udseende og pakningsstørrelser Extavia er et pulver og en solvens (opløsningsvæske) til injektionsvæske, opløsning.
English: • Alcohol swabs
Danish: • Spritservietter
English: C) Reconstituting and drawing up the solution for injection, step by step D) Making the injection manually (to make an injection with the ExtaviPro 30G auto injector, refer to the instructions for use provided with the auto-injector)
Danish: C) Tilberedning og opsugning af opløsningen (til injektion), trin for trin D) Indsprøjtningen manuelt (hvis du skal lave en indsprøjtning med ExtaviPro 30G
English: Talk to your doctor if you stop or wish to stop treatment.
Danish: Hvis du stopper eller ønsker at stoppe behandlingen, skal du kontakte din læge.
English: Injection site reactions
Danish: Reaktion ved indsprøjtningssted
English: What Extavia contains The active substance is interferon beta-1b.
Danish: Extavia indeholder: Aktivt stof: interferon beta-lb.
English: Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Danish: - Patienter med aktuel, alvorlig depression og/eller selvmordstanker (se pkt.
English: 9 - Hold the syringe-vial assembly at a slight angle.
Danish: 9 - Hold det samlede sprøjte-hætteglas let på skrå.
English: ► Common (may affect up to 1 in 10 people):
Danish: ► Almindelige (kan forekomme hos op til 1 ud af 10 personer):
English: Maximum serum levels of about 40 IU/ml were found 1-8 hours after subcutaneous injection of 500 microgram (16.0 million IU) interferon beta-1b.
Danish: Maksimumværdier i serum var ca. 40 IE/ml 1-8 timer efter subkutan injektion af 500 mikrogram (16,0 millioner IE) interferon beta-1b. På baggrund af data fra adskillige studier er den gennemsnitlige clearance estimeret til 30 ml·min
English: Extavia 250 microgram/ml powder for solution for injection interferon beta-1b
Danish: Extavia 250 mikrogram/ml, pulver til injektionsvæske, opløsning interferon beta-1b
English: If you are allergic to latex, talk to your doctor before using Extavia.
Danish: Rådfør dig med din læge, før du bruger Extavia, hvis du er overfølsom overfor latex.
English: Cardiomyopathy*
Danish: Kardiomyopati*
English: From various studies mean clearance rates and half-lives of disposition phases from serum were estimated to be at most 30 ml·min
Danish: , og den gennemsnitlige halveringstid for fordelingsfasen i serum var 5 timer.
English: - If you experience loss of appetite, tiredness, feeling sick (nausea), repeated vomiting, and especially if you notice widespread itching, yellowing of the skin or of the whites of the eyes, or easy bruising.
Danish: - Hvis du mister appetitten, føler dig træt, får kvalme, kaster op flere gange, og især hvis du bemærker kløe over hele kroppen, huden eller at det hvide i øjnene bliver gulligt, samt hvis du får tendens til blå mærker.
English: ► Uncommon (may affect up to 1 in 100 people):
Danish: ► Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer):
English: Extavia 250 microgram (Placebo) n=124 (n=123)
Danish: Extavia 250 mikrogram (Placebo) n=124 (n=123)
English: Extavia 250 microgram (Placebo) n=292 (n=176)
Danish: Extavia 250 mikrogram (Placebo) n=292 (n=176)
English: - painful periods (dysmenorrhoea), menstrual disorder, heavy uterine bleeding (metrorrhagia) especially between menstrual periods, impotence - injection site reaction (including redness, swelling, discolouration, inflammation, pain, allergic reaction, see section 2 “Warnings and precautions”), skin breakdown and tissue damage (necrosis) at injection site (see section 2 “Warnings and precautions”) - flu-like symptoms, fever, pain, chest pain, accumulation of fluid in arm, leg or face (peripheral oedema), lack/loss of strength (asthenia), chills, sweating, general feeling of being unwell.
Danish: allergisk reaktion, se afsnit 2 ”Advarsler og forsigtighedsregler”), nedbrydning af huden og ødelagt væv (nekrose) ved indsprøjtningsstedet (se afsnit 2 ”Advarsler og forsigtighedsregler”), - influenzalignende symptomer, feber, smerte, smerter i brystet, væskeansamlinger i arme, ben eller ansigt (perifert ødem), tab af/eller mangel på styrke (asteni), kuldegysninger, svedudbrud,
English: Weight increased, Weight decreased
Danish: Vægtøgning, vægttab
English: Annex: SELF-INJECTION PROCEDURE
Danish: Bilag: FREMGANGSMÅDE, NÅR DU SELV SKAL INDSPRØJTE LÆGEMIDLET
English: 7 - Take out the pre-filled solvent syringe from its package.
Danish: 7 - Pak den fyldte sprøjte med væske ud af emballagen.
English: A number of these products have been measured in the serum and cellular fractions of blood collected from patients treated with interferon beta-1b.
Danish: En del af disse genetiske produkter er blevet målt i serum og i cellulære fraktioner fra blod fra patienter, der er blevet behandlet med interferon beta-1b. Interferon beta-1b nedsætter bindingsaffiniteten og øger internaliseringen og nedbrydningen af inteferon-gamma receptorerne.
English: The tip cap of the pre-filled syringe contains a derivative of natural rubber latex.
Danish: Beskyttelseshætten på den fyldte injektionssprøjte indeholder et derivat af naturgummi-latex.
English: 2 - Remove the flip off cap from the Extavia vial.
Danish: 2 - Fjern beskyttelseshætten fra Extavia hætteglasset.
English: Table 2 Adverse drug reactions (ADRs) identified during post-marketing surveillance (frequencies - where known - calculated based on pooled clinical trial data N = 1,093)
Danish: Tabel 2 Bivirkninger set efter markedsføringen (hyppighed - hvis kendt - beregnet på data fra de samlede kliniske forsøg.
English: Extavia 250 microgram (Placebo) n=317 (n=308)
Danish: Extavia 250 mikrogram (Placebo) n=317 (n=308)
English: Extavia 250 microgram (Placebo) n=360 (n=358)
Danish: Extavia 250 mikrogram (Placebo) n=360 (n=358)
English: After reconstitution, each millilitre contains 250 microgram (8.0 million IU) interferon beta-1b.
Danish: Efter rekonstitution indeholder hver mililiter 250 mikrogram (8,0 mio. IE) interferon beta-lb.
English: - If you experience symptoms such as irregular heartbeat, swelling such as of the ankles or legs, or shortness of breath.
Danish: - Hvis du får symptomer som fx uregelmæssig hjerterytme (puls), hævede ankler eller ben eller får åndenød.
English: Skin and subcutaneous tissue disorders Skin disorder
Danish: Hud og subkutane væv Hudlidelse
English: Please refer to section 3 of the leaflet, “How to use Extavia”, for further details on how to use Extavia.
Danish: Yderligere oplysninger om brugen af Extavia findes under afsnit 3 ”Sådan skal du tage Extavia” på indlægssedlen.
English: Urinary urgency
Danish: Urininkontinens
English: The damage to the CNS can occur within an MS attack (relapse).
Danish: Beskadigelse på centralnervesystemet kan ske ved et dissemineret skleroseanfald (attak).
English: Hypothyroidism
Danish: Hypotyroidism e
English: 5 - Remove the swab from the top of the vial.
Danish: 5 - Fjern spritservietten fra hætteglasset.
English: The other ingredients are in the powder: mannitol and human albumin.
Danish: Øvrige indholdsstoffer: i pulveret: mannitol og humant albumin i solvensen: natriumchlorid, vand til injektionsvæsker.
English: How to store Extavia
Danish: Sådan skal du tage Extavia
English: As rodents do not react to human interferon beta, repeated dose studies were carried out with rhesus monkeys.
Danish: Der er udført flerdosisstudier på rhesusaber, idet humant interferon beta ikke har effekt på gnavere.
English: Adverse Event and Laboratory Abnormalities
Danish: Bivirkninger og uregelmæssigheder i laboratorieresultater
English: - infection, abscess - reduced number of white blood cells, swollen lymph glands (lymphadenopathy) - decrease in the amount of sugar in the blood (hypoglycaemia) - depression, anxiety - headache, dizziness, sleeplessness, migraine, numbness or tingling feeling (paraesthesia) - eye inflammation (conjunctivitis), abnormal vision - ear pain - irregular, rapid beating or pulsation of the heart (palpitation) - redness and/or facial flushing due to widening of blood vessels(vasodilation), increased blood pressure (hypertension) - runny nose, cough, hoarseness due to infection of the upper respiratory tract, sinusitis, cough increased, shortness of breath (dyspnoea) - diarrhoea, constipation, nausea, vomiting, abdominal pain - rises in the blood levels of liver enzymes (will show up in blood tests) - skin disorder, rash - muscle stiffness (hypertonia), painful muscles (myalgia), muscular debility (myasthenia), back pain, pain in extremities such as fingers and toes - holding urine (urinary retention), protein in the urine (will show up in urine tests), urinary frequency, inability to hold back urination (urinary incontinence), urinary urgency
Danish: (sinusitis), tiltagende hoste, åndenød (dyspnø) - diarré, forstoppelse, kvalme, opkastning, mavesmerter - stigning i blodtælling af leverenzymer (vil vise sig i blodprøverne) - hudlidelser, udslæt - muskelstivhed (hypertoni), muskelsmerter (myalgi), muskelsvækkelse (myasteni), rygsmerter,
English: You need to choose a new site for each injection to allow the area time to recover and help prevent infection.
Danish: For at give området tid til at komme sig og for at forebygge infektion skal du vælge et nyt sted til hver indsprøjtning.
English: Dysmenorrhoea Menstrual disorder * Metrorrhagia Impotence
Danish: Metrorrhagia Impotens