FrancophonIA/ELRC3.0 huggingface dataset:
English: HOW TO USE REBIF PRE-FILLED PEN (RebiDose)
Danish: SÅDAN BRUGES REBIF I FYLDT PEN (RebiDose)
English: These changes are generally not noticed by the patient (no symptoms), are usually reversible and mild, and most often do not require particular treatment.
Danish: Ændringerne er normalt reversible og milde, og som oftest kræver de ikke særlig behandling.
English: Rebif should be initiated with caution in patients with a history of significant liver disease, clinical evidence of active liver disease, alcohol abuse or increased serum ALT (>2.5 times ULN).
Danish: Rebif bør startes med forsigtighed hos patienter, som har haft signifikant leversygdom, patienter med kliniske tegn på aktiv leversygdom, ved alkoholmisbrug eller ved forhøjet serum-ALAT (>2,5 gange den øvre normalgrænse).
English: If you experience troubling local reactions, contact your doctor.
Danish: Hvis du oplever generende lokale reaktioner, skal du kontakte din læge.
English: Rebif should be administered with caution to patients with previous or current depressive disorders in particular to those with antecedents of suicidal ideation (see section 4.3).
Danish: Rebif skal administreres med forsigtighed til patienter med tidligere eller nuværende depressiv tilstand, specielt dem, som tidligere har haft selvmordstanker (se pkt.
English: • Injection site reactions including redness, swelling, discoloration, inflammation, pain and skin breakdown are very common.
Danish: • Injektionsstedsreaktioner herunder rødme, hævelse, misfarvning, betændelse, smerte og hudskader er meget almindelige.
English: Thyroid disorders
Danish: Thyreoidea-sygdomme
English: If you stop using Rebif
Danish: Hvis du holder op med at bruge Rebif
English: Thromboembolic events* Respiratory, thoracic and mediastinal disorders Uncommon:
Danish: Tromboemboliske hændelser* Luftveje, thorax og mediastinum Ikke almindelig:
English: Rebif (interferon beta-1a) shares the same amino acid sequence with endogenous human interferon beta.
Danish: Rebif (interferon beta-1a) har den samme aminosyresekvens som endogent, humant interferon beta.
English: • patients with relapsing multiple sclerosis.
Danish: • patienter med attakvis multipel sklerose.
English: Patients exhibiting depression should be monitored closely during therapy with Rebif and treated appropriately.
Danish: Patienter, som har tendens til at udvikle depressioner, skal følges nøje gennem deres Rebif-behandling og behandles omstændeligt.
English: Therefore, in addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, liver enzyme monitoring and complete and differential blood cell counts and platelet counts are recommended at regular intervals (1, 3 and 6 months) following introduction of Rebif therapy and then periodically thereafter in the absence of clinical symptoms.
Danish: Derfor, i tillæg til de laboratorietests, der normalt er påkrævet for at følge patienter med multipel sklerose, anbefales det at supplere med kontrol af leverenzymer og komplet tælling af blodceller, differentialtælling og blodpladetælling med regelmæssige intervaller (1, 3 og 6 måneder) efter behandlingsstart med Rebif og derefter periodevist ved mangel på kliniske symptomer.
English: Injection site pain, fatigue, rigors, fever
Danish: Smerter ved injektionsstedet, træthed, stivhed, feber
English: If you are uncertain about the benefits, please consult your doctor.
Danish: Hvis du er usikker omkring fordelene, bør du kontakte din læge.
English: When first starting treatment with Rebif, the dose should be gradually escalated in order to allow tachyphylaxis to develop thus reducing adverse reactions.
Danish: Ved opstart af Rebif-behandling skal dosis øges gradvist med henblik på udvikling at takyfylaksi, og dermed en reduktion af bivirkningerne.
English: • Full instructions for use are provided with your device.
Danish: • Der medfølger en udførlig brugsvejledning med dit apparat.
English: Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or light-headedness.
Danish: Symptomerne kan omfatte øget tendens til blå mærker, blødning, feber, ekstrem svaghed, hovedpine, svimmelhed eller uklarhed.
English: Injection site necrosis, injection site mass, injection site abscess, injection site infections*, increased sweating*
Danish: Nekrose på injektionsstedet, hævelse på injektionsstedet, absces på injektionsstedet, infektioner på injektionsstedet*, øget svedtendens*
English: • Gently pinch the skin together around the site (to lift it up a bit).
Danish: • Knib forsigtigt huden sammen omkring injektionsstedet (løft huden lidt op).
English: • Inflammation of the fatty tissue under the skin (panniculitis), which can make the skin feel hard and possibly develop painful red lumps or patches.
Danish: • Betændelse i fedtvævet under huden (panniculitis), hvilket kan få huden til at føles hård og evt.
English: Laboratory abnormalities
Danish: Unormale laboratoriedata
English: If you notice any of these side effects talk to your doctor.
Danish: Hvis du bemærker nogle af disse bivirkninger, så tal med din læge.
English: • Serious skin reactions - some with mucosal lesions
Danish: • Alvorlige hudreaktioner - nogle med slimhindelæsioner (sår på slimhinder)
English: In the absence of clinical symptoms, serum ALT levels should be monitored prior to the start of therapy, at months 1, 3 and 6 on therapy and periodically thereafter.
Danish: Ved mangel på kliniske symptomer skal serum-ALAT-niveauet monitoreres før terapistart, efter 1, 3 og 6 måneder og derefter periodevist.
English: PARTICULARS TO APPEAR ON THE LAYERS SEPARATORS FOR THE STARTER PACK
Danish: MÆRKNING DER SKAL FREMGÅ PÅ SEPARATIONSLAGET FOR OPSTARTSPAKNING
English: Clear to opalescent solution, with pH 3.5 to 4.5 and osmolarity 250 to 450 mOsm/L.
Danish: Klar til opaliserende opløsning med pH 3,5 til 4,5 og osmolaritet på 250 til 450 mOsm/l.
English: RebiDose Instructions for use
Danish: RebiDose brugsvejledning
English: For administration, the instructions provided in the package leaflet and in the instruction manual (Instructions for Use) provided with RebiSmart and RebiSlide should be followed.
Danish: Administration skal ske i henhold til indlægssedlens anvisninger og den respektive brugsvejledning, der leveres med RebiSmart og RebiSlide.
English: Injection site cellulitis*
Danish: Cellulitis på injektionsstedet*
English: This might happen several weeks to several years after starting Rebif.
Danish: Dette kan ske flere uger til flere år efter, du er startet på behandlingen med Rebif.
English: It is recommended that patients should be evaluated at least every second year in the 4-year period after initiation of treatment with Rebif and a decision for longer term treatment should then be made on an individual basis by the treating physician.
Danish: Det anbefales, at patienten bør evalueres mindst hvert andet år i de første 4 år efter påbegyndt behandling med Rebif.
English: If, immediately following Rebif administration you experience a sudden difficulty breathing, which may appear in association with swelling of face, lips, tongue or throat, nettle rash, itching all over the body, and a feeling of weakness or faintness, contact your doctor immediately or seek urgent medical attention.
Danish: Hvis du umiddelbart efter Rebif-injektionen får pludseligt åndedrætsbesvær, eventuelt i forbindelse med hævelse i ansigtet, af læberne, tungen eller i halsen, eller nældefeber, kløe over hele kroppen og en følelse af svaghed eller mathed, skal du straks kontakte læge eller skadestue.
English: (To prevent accidental freezing, avoid placing near the freezer compartment).
Danish: Må ikke nedfryses (for at undgå nedfrysning ved uheld bør Rebif-pakningen ikke placeres ved siden af fryserum i køleskab).
English: Therefore if clinical features of TMA are observed, further testing of blood platelet levels, serum LDH, blood films and renal function is recommended.
Danish: Hvis der derfor observeres kliniske symptomer på TMA, anbefales yderligere kontrol af trombocyttal, serum-LDH, blodudstrygningspræparat og nyrefunktion.
English: • Hold RebiSlide firmly and slide the release button which is on the side of the device.
Danish: • Hold RebiSlide fast og skub doseringsknappen, der sidder på siden af apparatet.
English: Acetic acid for pH adjustment Sodium hydroxide for pH adjustment Water for injections
Danish: Eddikesyre til justering af pH Natriumhydroxid til justering af pH Vand til injektionsvæsker.
English: (UPPER FLAP) 6 pre-filled pens RebiDose
Danish: (Øverste lag) 6 fyldte penne RebiDose
English: Central nervous system-related adverse events associated with the use of interferon beta (e.g. dizziness) might influence the patient's ability to drive or use machines (see section 4.8).
Danish: Centralnervesystemsrelaterede bivirkninger, der er forbundet med brugen af interferon beta (f.eks. svimmelhed) kan påvirke patientens evne til at føre motorkøretøj og betjene maskiner (se pkt.
English: It may cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Danish: Det kan give forgiftningsreaktioner og anafylaktoide reaktioner (allergiske shockreaktioner) hos spædbørn og børn op til 3 år.
English: Rebif can be used during breastfeeding.
Danish: Rebif kan anvendes under amning.
English: Laboratory findings suggestive of TMA include decreased platelet counts, increased serum lactate dehydrogenase (LDH) due to haemolysis and schistocytes (erythrocyte fragmentation) on a blood film.
Danish: Laboratoriefund, der kan tyde på TMA, inkluderer nedsat trombocyttal, forhøjet serumlaktatdehydrogenase (LDH) på grund af hæmolyse og schistocytter (erytrocytfragmentering) i et blodudstrygningspræparat.
English: The first injection(s) must be performed under the supervision of an appropriately qualified healthcare professional.
Danish: Den/de første injektion(er) skal foretages under vejledning af en kvalificeret sundhedsperson.
English: Your doctor will advise you on the possible injection sites (good sites include the upper thighs and the lower abdomen).
Danish: Din læge vil vise dig mulige injektionssteder på kroppen (gode steder er øvre del af låret og nedre del af maven).
English: 22 micrograms tiw
Danish: 22 mikrogram tiw
English: Hepatic failure* (see section 4.4), autoimmune hepatitis*
Danish: 4.4), autoimmun hepatitis*
English: Clear to opalescent solution, with pH 3.7 to 4.1 and osmolarity 250 to 450 mOsm/L.
Danish: Klar til opaliserende opløsning med pH 3,7 til 4,1 og osmolaritet på 250 til 450 mOsm/l.
English: Quincke's oedema (angio-oedema)*, erythema multiforme*, erythema multiforme-like skin reactions*, Stevens Johnson syndrome* Musculoskeletal and connective disorders Common:
Danish: Angioødem*, erytema multiforme*, erytema multiforme-lignende hudreaktion*, Stevens-Johnsons syndrom* Knogler, led, muskler og bindevæv Almindelig:
English: Laboratory abnormalities are associated with the use of interferons.
Danish: Brugen af interferoner er forbundet med abnormiteter i laboratoriedata.
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 blevet rapporteret tilfælde af nefrotisk syndrom med forskellige underliggende nefropatier, herunder collapsing fokal segmental glomerulosklerosis (FSGS), minimal change disease (MCD), membranproliferativ glomerulonefritis (MPGN) og membranøs glomerulopati (MGN) under behandling med interferon-beta-præparater.
English: * Million International Units, measured by cytopathic effect (CPE) bioassay against the in-house interferon beta-1a standard which is calibrated against the current international NIH standard (GB-23-902-531).
Danish: * Millioner Internationale Enheder målt ved cytopatisk effekt (CPE) bioassay imod den “in-house” interferon beta-1a standard som er kalibreret mod den gældende internationale NIH standard (GB-23-902-531).
English: BATCH NUMBER Batch
Danish: BATCHNUMMER Lot
English: Your doctor has prescribed you a lower dose of 22 micrograms (6 million IU) given three times per week.
Danish: Din læge har ordineret en lavere dosis på 22 mikrogram (6 millioner IE) tre gange om ugen til dig.
English: Only clear to opalescent solution without particles and without visible signs of deterioration should be used.
Danish: Kun en klar til opaliserende opløsning uden partikler og uden synlige tegn på nedbrydning må anvendes.
English: Rebif solution for subcutaneous injection in a cartridge is intended for multidose use with either the RebiSmart electronic injection device or the RebiSlide manual pen-injector device following adequate training of the patient and/or carer.
Danish: Rebif subkutan injektionsvæske, opløsning i en cylinderampul er beregnet til flergangsbrug med enten RebiSmart elektronisk injektionsapparat eller RebiSlide manuel injektionspen efter tilstrækkelig undervisning af patienten og/eller dennes plejeperson.
English: 44 micrograms tiw
Danish: 44 mikrogram tiw
English: Caution should be used, and close monitoring considered when administering interferon beta-1a to patients with severe renal and hepatic failure and to patients with severe myelosuppression.
Danish: Forsigtighed og tæt opfølgning tilrådes, når interferon beta-1a gives til patienter med alvorlig nyre- og leversvigt og til patienter med alvorlig knoglemarvssuppression.
English: Rebif solution is clear to opalescent.
Danish: Rebif er en klar til opaliserende opløsning.
English: • The initiation pack contains two identical cartridges of Rebif and you may initiate treatment with either cartridge.
Danish: • Opstartspakken indeholder to ens cylinderampuller med Rebif, og det er ligegyldigt, hvilken cylinderampul, du starter behandlingen med.
English: The patient may store Rebif at or below 25°C for a single period up to 14 days.
Danish: Patienten kan opbevare Rebif ved temperaturer på 25 °C eller derunder i en enkelt periode på op til 14 dage.
English: Single clinical event suggestive of multiple sclerosis
Danish: En enkelt klinisk hændelse, der tyder på multipel sklerose
English: Patients should be informed of the most frequent adverse reactions associated with interferon beta administration, including symptoms of the flu-like syndrome (see section 4.8).
Danish: Patienterne bør informeres om de hyppigst forekommende bivirkninger i forbindelse med interferon beta-behandling, omfattende influenzalignende symptomer (se pkt.
English: Only sparse safety and efficacy data are available from non-ambulatory patients with multiple sclerosis.
Danish: Der foreligger kun sparsomme data om sikkerhed og virkning for MS-patienter uden bevaret gangfunktion.
English: Other forms of multiple sclerosis
Danish: Andre former for multipel sklerose
English: • The active substance is interferon beta-1a.
Danish: • Aktivt stof: Interferon beta-1a.
English: OTHER (UPPER FLAP)
Danish: ANDET (Øverste lag)
English: Thyroid function testing is recommended at baseline and if abnormal, every 6-12 months following initiation of therapy.
Danish: Det anbefales at teste thyreoideafunktionen, før behandlingen påbegyndes, og hvis denne er unormal, bør den kontrolleres hver 6.-12. måned, efter at behandlingen er påbegyndt.
English: Patients with multiple sclerosis
Danish: Patienter med multipel sklerose
English: Other medicines and Rebif
Danish: Brug af anden medicin sammen med Rebif
English: • Hypersensitivity to natural or recombinant interferon beta or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for naturligt eller rekombinant interferon-beta eller over for et eller flere af hjælpestofferne anført i pkt.
English: • Store your device containing a cartridge of Rebif as instructed in section 5 “How to store
Danish: • Opbevar apparatet med en cylinderampul med Rebif som anvist i afsnit 5 “Opbevaring”.
English: • rotate the injection sites with each dose.
Danish: • skifte injektionssted ved hver dosering.
English: The recommended posology of Rebif is 44 micrograms given three times per week by subcutaneous injection.
Danish: Den anbefalede dosis af Rebif er 44 mikrogram, som gives tre gange ugentligt ved subkutan injektion.
English: • a dry cotton ball or gauze
Danish: • Et tørt stykke vat eller gazekompres
English: The posology for patients who have experienced a first demyelinating event is 44 micrograms of Rebif given three times per week by subcutaneous injection.
Danish: Doseringen for patienter, der har oplevet en første demyeliniserende hændelse, er 44 mikrogram Rebif tre gange ugentligt som subkutan injektion.
English: Pack sizes of 1, 3 or 12 pre-filled pens.
Danish: Pakningsstørrelser med 1, 3 eller 12 fyldte penne.
English: Merck Serono S.A. - Corsier-sur-Vevey Route de Fenil - Z.I.B.
Danish: Merck Serono S.A. - Corsier-sur-Vevey Route de Fenil - Z.I.B., CH-1804 Corsier-sur-Vevey Schweiz eller
English: Symptoms of the flu-like syndrome associated with interferon beta-1a therapy may prove stressful to patients with cardiac conditions.
Danish: Influenzalignende symptomer i forbindelse med injektion af interferon beta-1a kan virke stressende på patienter med hjertesygdomme.
English: Ask your pharmacist how to safely dispose of RebiDose.
Danish: Spørgapotekspersonalet, hvordan du skal bortskaffe medicinrester.
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: Rebif is available in packs of 1, 3 and 12 pre-filled pens (RebiDose).
Danish: Rebif findes i pakninger med 1, 3 og 12 fyldte penne (RebiDose).
English: Rebif should be administered with caution to patients with a history of seizures, to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with antiepileptics (see sections 4.5 and 4.8).
Danish: Rebif skal administreres med forsigtighed hos patienter, der tidligere har haft krampeanfald, og til dem, der behandles med antiepileptika, specielt hvis deres epilepsi ikke er fuldstændigt kontrolleret med antiepileptika (se pkt.
English: If you use RebiSlide • Make sure before the injection that the dose selected in the dose window of the device is:
Danish: • Sørg for inden injektionen, at den valgte dosis i apparatets doseringsvindue er:
English: RebiDose is a ready to use pre-filled pen for subcutaneous injection.
Danish: RebiDose er en fyldt pen klar til brug til subkutan injektion.
English: • Rebif is given by injection under the skin (subcutaneously) using a pre-filled pen called “RebiDose”.
Danish: • Rebif gives som injektion under huden (subkutant) med en fyldt pen kaldet ”RebiDose”.
English: Serum neutralising antibodies against interferon beta-1a may develop.
Danish: Der kan udvikles serumneutraliserende antistoffer mod interferon beta-1a.
English: 6 pre-filled syringes of Rebif 22 micrograms
Danish: 6 fyldte injektionssprøjter med Rebif 22 mikrogram
English: • Muscle and joints pain
Danish: • Smerter i muskler og led
English: • The other ingredients are mannitol, poloxamer 188, L-methionine, benzyl alcohol, sodium acetate, acetic acid, sodium hydroxide and water for injections.
Danish: • Øvrige indholdsstoffer: Mannitol, poloxamer 188, L-methionin, benzylalkohol, natriumacetat, eddikesyre, natriumhydroxid og vand til injektionsvæsker.
English: If you experience any of these symptoms, contact your doctor for advice.
Danish: Hvis du får nogle af disse symptomer, så kontakt din læge.
English: If the patient experiences any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, the patient should be advised to consult with their physician before continuing injections with Rebif.
Danish: Hvis patienten oplever irritation af huden såsom hævelse eller væskende injektionsmærker, skal patienten kontakte sin læge, før han/hun fortsætter med injektion af Rebif.
English: It has been shown to reduce the number and the severity of relapses and to slow the progression of disability.
Danish: Rebif er vist at nedsætte antallet og sværhedsgraden af attakkerne og forsinke forværringen i førlighed.
English: Pulmonary arterial hypertension has been seen at various time points during treatment,
Danish: Pulmonal arteriel hypertension er iagttaget på forskellige tidspunkter under behandlingen, også flere år efter påbegyndelse af behandlingen med Rebif
English: • Before the injection, use an alcohol wipe to clean the skin at the injection site.
Danish: • Brug en spritserviet til at rense huden på injektionsstedet inden injektionen.
English: This “Instructions for use” was last revised in
Danish: Denne brugsvejledning blev senest ændret:
English: Each pre-filled pen contains 44 micrograms,
Danish: Hver fyldt pen indeholder 44 mikrogram, svarende til
English: At licensed posology, Rebif 44 micrograms has been demonstrated to decrease the incidence (approximately 30% over 2 years) and severity of clinical relapses in patients with at least 2 exacerbations in the previous 2 years and with an EDSS of 0-5.0 at entry.
Danish: Rebif 44 mikrogram har vist sig at nedsætte hyppigheden (ca. 30% over 2 år) og sværhedsgraden af kliniske attakker hos patienter med mindst 2 attakker i de foregående to år og med en EDSS på 0-5,0 ved start.
English: Mannitol, poloxamer 188, L-methionine, benzyl alcohol, sodium acetate, acetic acid and sodium hydroxide for pH adjustment and water for injections.
Danish: Mannitol, poloxamer 188, L-methionin, benzylalkohol, natriumacetat, eddikesyre og natriumhydroxid til justering af pH samt vand til injektionsvæsker.
English: What Rebif contains
Danish: Rebif indeholder:
English: • Hold RebiSlide in place until “0” appears in the dose window, then wait 10 seconds before removing the needle from the skin.
Danish: •Hold RebiSlide på plads, indtil “0” vises i doseringsvinduet.
English: INFORMATION IN BRAILLE rebif 8.8/0.1 / 22/0.25
Danish: INFORMATION I BRAILLESKRIFT rebif 8,8/0,1 / 22/0,25
English: Events were reported at various time points during treatment and may occur after several years of treatment with interferon-beta.
Danish: Der blev rapporteret hændelser på forskellige tidspunkter i behandlingsforløbet, og de kan opstå efter flere års behandling med interferon-beta.
English: Severe renal or hepatic failure and severe myelosuppression
Danish: Alvorlig nyre- og leversvigt og alvorlig knoglemarvssuppression
English: At licensed posology, Rebif 22 micrograms has been demonstrated to decrease the incidence (approximately 30% over 2 years) and severity of clinical relapses in patients with at least 2 exacerbations in the previous 2 years and with an EDSS of 0-5.0 at entry.
Danish: Rebif 22 mikrogram har vist sig at nedsætte hyppigheden (ca. 30% over 2 år) og sværhedsgraden af kliniske attakker hos patienter med mindst 2 attakker i de foregående to år og med en EDSS på 0-5,0 ved start.
English: Rebif is administered by subcutaneous injection.
Danish: Rebif indgives som subkutan injektion.
English: For patients starting treatment with Rebif, Rebif 8.8 micrograms and Rebif 22 micrograms are available in an initiation pack.
Danish: For patienter, der starter behandling med Rebif, er Rebif 8,8 mikrogram og Rebif 22 mikrogram tilgængelig i en opstartspakning.
English: Store in a refrigerator (2°C - 8°C) away from the cooling element.
Danish: Opbevares i køleskab (2°C - 8°C) så langt fra fryserummet som muligt.
English: Patients who have experienced a single clinical event The usual dose is 44 micrograms (12 million IU) given three times per week.
Danish: Patienter, der har oplevet en enkelt klinisk hændelse Den sædvanlige dosis er 44 mikrogram (12 millioner IE) tre gange om ugen.
English: Rebif 44 micrograms is available as a package of 1, 3, 12, or 36 syringes.
Danish: Rebif 44 mikrogram forefindes som pakker af 1, 3, 12 eller 36 injektionssprøjter.
English: INFORMATION IN BRAILLE rebif 8.8 rebif 22
Danish: INFORMATION I BRAILLESKRIFT rebif 8,8 rebif 22