FrancophonIA/ELRC3.0 huggingface dataset:
English: Experience with other interferons suggests a potential for impairment of male and female fertility.
Danish: Erfaringer med andre interferoner antyder, at begge køns fertilitet muligvis kan forringes.
English: To help you rotate the injection sites appropriately, we recommend that you keep a record of the date and location of your injection.
Danish: For at hjælpe dig med at skifte mellem injektionsstederne på en passende måde anbefaler vi, at du noterer dato og sted for din injektion.
English: Depression and suicidal ideation are known to occur with increased frequency in the multiple sclerosis population and in association with interferon use.
Danish: Det er kendt at depression og selvmordstanker kan opstå med øget frekvens hos patienter med dissemineret sklerose og i forbindelse med brug af interferon.
English: ► Tell your doctor immediately and stop using Betaferon:
Danish: ► Kontakt straks din læge og hold op med at bruge Betaferon:
English: Injection site necrosis has been reported in patients using Betaferon (see section 4.8).
Danish: Der er rapporteret om nekrose på injektionsstedet hos patienter, som bruger Betaferon (se afsnit 4.8).
English: The following instructions and pictures explain how to prepare Betaferon for injection and how to inject Betaferon yourself.
Danish: Denne vejledning og billederne forklarer, hvordan du klargør Betaferon, og hvordan du selv indsprøjter Betaferon.
English: 12 - Examine the solution carefully.
Danish: 12 - Undersøg nøje opløsningen.
English: Please refer to the rotation schedule at the end of this Annex to learn how to choose an injection site.
Danish: Se venligst rotationsskemaet til sidst i dette tillæg vedrørende valg af injektionssted.
English: − If you have a heart disease, the flu-like symptoms, which often occur at the start of treatment, may prove stressful to you.
Danish: - Hvis du har en hjertesygdom, kan de influenzalignende symptomer, der forekommer i starten af behandlingen, være belastende for dig.
English: However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Betaferon 8.0 million IU subcutaneously every other day is similar to that seen in adults.
Danish: Begrænsede offentliggjorte data antyder dog, at sikkerhedsprofilen hos unge i 12-16 års alderen, som behandles med 8,0 millioner IE Betaferon subkutant hver anden dag, svarer til sikkerhedsprofilen hos voksne.
English: Treatment is not recommended in patients with relapsing-remitting multiple sclerosis who have experienced less than 2 relapses in the previous 2 years or in patients with secondary-progressive multiple sclerosis who have had no active disease in the previous 2 years.
Danish: Behandlingen bør ikke anvendes til patienter med recidiverende-remitterende dissemineret sklerose, som har haft færre end 2 relapser i de forudgående 2 år eller hos patienter med sekundær progressiv dissemineret sklerose, som ikke har haft aktiv sygdom i de forudgående to år.
English: Betaferon is a sterile white to off-white powder for solution for injection.
Danish: Betaferon er et sterilt, hvidt til offwhite pulver til opløsning til injektion.
English: Withdrawal of Betaferon should be considered if the levels significantly increase or if they are associated with clinical symptoms such as jaundice.
Danish: Inddragelse af Betaferon bør overvejes, hvis koncentrationerne stiger signifikant, eller hvis der er kliniske symptomer på f.eks. gulsot.
English: Push it down firmly until you feel it snap into place on the vial.
Danish: Pres det hårdt ned, til du mærker, at det klikker på plads.
English: Boehringer Ingelheim RCV GmbH & Co KG Dr.-Boehringer-Gasse 5-11
Danish: Boehringer Ingelheim RCV GmbH & Co KG, Dr.-Boehringer-Gasse 5-11, A-1121 Wien,
English: − Betaferon contains human albumin and therefore carries a potential risk for transmission of viral diseases.
Danish: - Betaferon indeholder humant albumin, og har derved en potentiel risiko for at overføre virussygdomme.
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 his/her physician before continuing injections with Betaferon.
Danish: Hvis patienten oplever bristning af huden, som kan være forbundet med opsvulmen eller drænage af væske fra injektionsstedet, bør patienten rådgives til at søge læge, før injektionerne med Betaferon fortsættes.
English: Patients with monofocal or multifocal onset of the disease were included (i.e. patients with clinical evidence for a single or at least two lesions, respectively, of the central nervous system).
Danish: Patienter med monofokal ellers multifokal debut af sygdommen blev inkluderet (dvs. patienter med klinisk evidens for hhv. en enkelt eller mindst to læsioner i centralnervesystemet).
English: Generally, dose titration is recommended at the start of treatment.
Danish: Generelt anbefales dosistitrering ved behandlingsstart.
English: Talk to your doctor before you start using Betaferon:
Danish: Kontakt lægen, før du begynder at bruge Betaferon:
English: Table 1: Adverse events and laboratory abnormalities with incidence rates ≥ 10% and the respective percentages under placebo; significantly associated side effects < 10% based on reports from clinical trials
Danish: Tabel 1: Bivirkninger og unormale laboratorieprøveresultater med hyppigheder ≥ 10 % og de tilsvarende procenter ved placebo; signifikant associerede bivirkninger < 10 % baseret på indberetninger fra kliniske studier.
English: Patients and investigators remained blinded to the initial treatment allocation.
Danish: Blindingen blev bevaret for både patienter og investigatorer for første behandlingstildeling.
English: Patients should be started at 62.5 microgram (0.25 ml) subcutaneously every other day, and increased slowly to a dose of 250 microgram (1.0 ml) every other day (see Table A).
Danish: Patienter bør startes på 62,5 mikrogram (0,25 ml) subkutant hver anden dag og øges langsomt til en dosis på 250 mikrogram (1,0 ml) hver anden dag (se Tabel A).
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af PSUR'er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: The injection site must be changed regularly.
Danish: Skift injektionssted regelmæssigt.
English: While Betaferon does not have any known direct-acting cardiac toxicity, symptoms of the flu-like syndrome associated with beta interferons may prove stressful to patients with pre-existing significant cardiac disease.
Danish: Mens Betaferon ikke har nogen direkte kardiologisk toksicitet, kan symptomer på det influenzalignende syndrom, som forbindes med beta-interferoner, vise sig at belaste patienter med tidligere eksisterende signifikant hjertesygdom.
English: Occasionally debridement and, less often, skin grafting are required and healing may take up to 6 months.
Danish: Af og til kan debridering og mindre hyppigt hudtransplantation være nødvendig, og heling kan tage op til 6 måneder.
English: During the post-marketing period very rare reports have been received of worsening of cardiac status in patients with pre-existing significant cardiac disease temporarily associated with the initiation of Betaferon therapy.
Danish: I perioden efter markedsføringen er der modtaget meget sjældne rapporter om forværret hjertetilstand hos patienter med tidligere eksisterende signifikant hjertesygdom, som midlertidigt blev forbundet med den indledende Betaferon-behandling.
English: Your doctor may perform tests to check your kidney function.
Danish: Din læge vil muligvis tage nogle prøver for at kontrollere din nyrefunktion.
English: General disorders and administration site conditions Serious hypersensitivity reactions (rare but severe acute reactions such as bronchospasm, anaphylaxis and urticaria) may occur.
Danish: Almene symptomer og reaktioner på administrationsstedet Der kan forekomme alvorlige overfølsomhedsreaktioner (sjældne, men svære akutte reaktioner som bronkospasmer, anafylakse og urticaria).
English: The optimal dose has not been fully clarified.
Danish: Betaferons optimale dosering er ikke endeligt fastlagt.
English: Multiple sclerosis (MS) is a long-term condition that affects the central nervous system (CNS), particularly the functioning of the brain and spinal cord.
Danish: Dissemineret sklerose (DS) er en kronisk sygdom, der rammer centralnervesystemet (CNS), især funktionen af hjernen og rygmarven.
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products.
Danish: Der er indberettet tilfælde af pulmonal arteriel hypertension (PAH) med lægemidler indeholdende interferon beta.
English: The best places for injections are where the skin is loose and soft, and away from joints, nerves, or bones, for example the abdomen, arm, thigh or buttocks.
Danish: De bedste steder til injektioner er der, hvor huden er løs og blød og ikke i nærheden af led, nerver eller knogler, f.eks. på mave, arm, lår eller balder.
English: 4 Class label for interferon products, see below Pulmonary arterial hypertension.
Danish: 4.4) 4Vedrørende klassebetegnelse for interferonlægemidler: se pulmonal arteriel hypertension nedenfor.
English: This will give each injection site a chance to fully recover before receiving another injection.
Danish: Det giver hvert injektionssted mulighed for at komme sig helt før en ny injektion.
English: No benefit, attributable to immediate Betaferon treatment, in quality of life (as measured by FAMS - Functional Assessment of MS: Treatment Outcomes Index) was seen.
Danish: Der sås ingen fordele i forhold til livskvalitet (målt ved hjælp af FAMS - Functional Assessment of MS: Treatment Outcome Index), der kunne tilskrives tidlig Betaferon-behandling.
English: Due to the lack of clinical experience in multiple sclerosis patients, the use of Betaferon together with immunomodulators other than corticosteroids or ACTH is not recommended.
Danish: Grundet manglende klinisk erfaring med patienter med dissemineret sklerose bør Betaferon ikke anvendes sammen med andre immunomodulatorer end kortikosteroider eller ACTH.
English: Two controlled clinical trials with Betaferon 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) were performed.
Danish: Der blev udført to kontrollerede kliniske undersøgelser af Betaferon, som involverede i alt 1657 patienter med sekundær progressiv dissemineret sklerose (EDSS-basislinieværdier på 3 - 6,5, dvs. patienter, som var i stand til at gå).
English: 15 - Remove any air bubbles by gently tapping the syringe and pushing the plunger to the 1-ml mark, or to the volume prescribed by your doctor.
Danish: 15 - Fjern eventuelle luftbobler ved forsigtigt at banke på injektionssprøjten og skubbe stemplet ind til 1 ml-mærket eller til den mængde, din læge har ordineret.
English: In both trials secondary progressive multiple sclerosis patients receiving Betaferon showed a reduction in frequency (30%) of clinical relapses.
Danish: I begge undersøgelser viste patienter med sekundær progressiv dissemineret sklerose en reduktion i hyppighed (30 %) af kliniske relapser.
English: Interferon beta-1b has been shown to possess both antiviral and immunoregulatory activities.
Danish: Interferon beta-1b har vist sig at besidde både antivirale og immunregulerende egenskaber.
English: Separate Annex: INTRODUCTORY LEAFLET FOR TITRATION PACK
Danish: Tillæg: INTRODUKTIONSFOLDER TIL TITRERINGSPAKNINGEN
English: Blood bilirubin increased
Danish: Forhøjet blod-bilirubin
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Danish: Data fra dyreforsøg indikerer, at der er en mulig øget risiko for spontan abort (se pkt.
English: Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Betaferon (see section 4.2).
Danish: Generelt anbefales dosistitrering ved behandlingsstart for at øge tolerabiliteten over for Betaferon (se pkt.
English: No influence on the monkey oestrous cycle has been observed.
Danish: Der er ikke set påvirkning af abernes hormoncyklus.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. ml, dvs. det er i det væsentlige natrium-frit.
English: In the second trial of Betaferon in secondary progressive multiple sclerosis, no delay in the time to disability progression was observed.
Danish: I den anden undersøgelse af Betaferon hos patienter med sekundær progressiv dissemineret sklerose blev der ikke observeret forsinkelse i tid til progression af invaliditet.
English: Giving many times the dose of Betaferon recommended for the treatment of multiple sclerosis has not led to life-threatening situations.
Danish: En injektion af Betaferon i doser, der er mange gange større end den anbefalede dosis til behandling af dissemineret sklerose, har ikke ført til livstruende situationer.
English: Interferon beta-1b has been shown to change the response of the immune system and to help to reduce disease activity.
Danish: Interferon beta-1b har vist sig at ændre immunsystemets reaktion og bidrage til at hæmme sygdomsaktivitet.
English: Your doctor may find changes in your blood and the function of your kidneys.
Danish: Din læge vil måske finde ændringer i dit blod eller i din nyrefunktion.
English: This will be done before you start using Betaferon, regularly after treatment with Betaferon has been initiated and periodically whilst you are on it, even if you have no particular symptoms.
Danish: Dette vil foregå, før du begynder at bruge Betaferon, regelmæssigt efter at du er begyndt at bruge Betaferon, og periodisk under hele Betaferon-behandlingen.
English: For subcutaneous injection.
Danish: Til subkutan injektion.
English: The risk for progression to CDMS within 2 years was higher in monofocal patients with at least 9 T2-lesions or Gd-enhancement on brain MRI at baseline.
Danish: Risikoen over 2 år for progression til CDMS var højere hos monofokale patienter med mindst 9 T2-læsioner eller Gd-forstærkning ved MR-scanning af hjernen ved baseline.
English: In the pivotal study of patients with a single clinical event suggestive of multiple sclerosis an autoinjector was used in the majority of patients.
Danish: I pivotalforsøget med patienter med en enkelt klinisk hændelse, som tyder på dissemineret sklerose, blev der anvendt autoinjektor hos størstedelen af patienterne.
English: Infections and infestations Infection
Danish: Infektioner og parasitære sygdomme Infektion
English: Skin breakdown and tissue damage (necrosis) around the injection site are reported less frequently.
Danish: Hudnedbrydning og ødelagt væv (nekrose) rundt om injektionsstedet er set mindre hyppigt.
English: The administration of cytokines to patients with a pre-existing monoclonal gammopathy has been associated with the development of systemic capillary leak syndrome with shock-like symptoms and fatal outcome.
Danish: Til patienter med forud eksisterende monoklonal gammopati er administrering af cytokiner blevet forbundet med udvikling af systemisk kapillær lækage-syndrom med shocklignende symptomer og dødelig udgang.
English: ► Stop using Betaferon and tell your doctor immediately if any of these happens to you.
Danish: ► Hold op med at bruge Betaferon, og kontakt straks din læge, hvis du oplever et eller flere af disse symptomer.
English: Betaferon may also be administered with a suitable autoinjector.
Danish: Betaferon kan også indgives med en egnet autoinjektor.
English: In the different controlled clinical trials in relapsing-remitting multiple sclerosis and secondary progressive multiple sclerosis, between 23% and 41% of the patients developed serum interferon beta1b neutralising activity confirmed by at least two consecutive positive titres; of these patients, between 43% and 55% converted to a stable antibody negative status (based on two consecutive negative titres) during the subsequent observational period of the respective study.
Danish: I de forskellige, kontrollerede kliniske undersøgelser over recidiverende-remitterende dissemineret sklerose og sekundær progressiv dissemineret sklerose udviklede mellem 23 % og 41 % af patienterne neutraliserende aktivitet mod interferon beta-1b i serum, bekræftet ved mindst 2 efterfølgende positive titreringer; Af disse patienter gik mellem 43 % og 55 % over til en stabil, antistof-negativ status (baseret på to negative titreringer i træk) i løbet af det respektive studies efterfølgende observationsperiode.
English: 4 - Gently pinch the skin together around the disinfected injection site (to raise it up a little).
Danish: 4 - Klem forsigtigt huden sammen omkring injektionsstedet (for at løfte huden en smule).
English: − use a sterile (aseptic) injection technique,
Danish: − bruge en steril (aseptisk) injektionsteknik.
English: PART II: ROTATING INJECTION SITES
Danish: DEL II: VÆLG FORSKELLIGE INJEKTIONSSTEDER
English: If you are injecting less than 1 ml with the titration pack there might not be any air bubbles, however for full dose injection some air bubbles might turn up.
Danish: Hvis du skal indsprøjte mindre end 1 ml, som ved brug af titreringspakningen, er det ikke sikkert, at der kommer nogen luftbobler.
English: If reactions are severe, Betaferon should be discontinued and appropriate medical intervention instituted.
Danish: Hvis reaktionerne er svære, bør Betaferon-behandlingen seponeres, og passende medicinsk behandling indledes.
English: Dyspnoea *
Danish: Dyspnø *
English: Interferon beta-1b also enhances the suppressor activity of peripheral blood mononuclear cells.
Danish: Interferon beta-1b øger også den suppressive effekt af de mononukleære celler i det perifere blod.
English: The following side effects listing is based on reports from clinical trials with Betaferon (list 1) and from side effects reported on the marketed product (list 2).
Danish: Følgende liste over bivirkninger er baseret på kliniske undersøgelser med Betaferon (Liste 1), og rapporter efter markedsføring af præparatet (Liste 2).
English: At the beginning of treatment side effects are common but in general they become less with further treatment.
Danish: Ved starten af behandlingen er bivirkninger almindelige, men generelt aftager de med yderligere behandling.
English: It is best to use your thumb rather than your nail as it could break.
Danish: Undgå at bruge neglen, da den kan brække.
English: Transitory hyperthermia was observed, as well as a significant rise in lymphocytes and a significant decrease in thrombocytes and segmented neutrophils.
Danish: Der blev observeret forbigående hypertermi, signifikant øget lymfocyttal, signifikant fald i trombocyttal og segmenterede neutrofile granulocytter.
English: There have been no formal clinical trials undertaken in children or adolescents.
Danish: Der er ikke udført formelle kliniske studier hos børn eller unge.
English: For relapsing-remitting MS, efficacy has been demonstrated for therapy for the first two years.
Danish: For recidiverende-remitterende dissemineret sklerose er der vist effektivitet ved behandling i de første 2 år.
English: PHARMACEUTICAL FORM AND CONTENTS Titration pack comprising 4 triple packs, each containing:
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Titreringspakning indeholder 4 tredobbelte pakninger, der hver indeholder:
English: In the absence of clinical evidence for liver damage and after normalisation of liver enzymes a reintroduction of therapy could be considered with appropriate follow-up of hepatic functions.
Danish: Hvis der ikke er klinisk påvist leverbeskadigelse, og når leverenzymerne er normaliseret, kan en genoptagelse af behandlingen overvejes med en passende kontrol af leverfunktionerne.
English: Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Danish: Regelmæssig overvågning af tidlige tegn eller symptomer, f.eks. ødemer, proteinuri og nedsat nyrefunktion, anbefales, især hos patienter med høj risiko for nyresygdom.
English: Additional caution should be exercised with any co-medication which has an effect on the haematopoietic system.
Danish: Der bør udvises yderligere forsigtighed ved enhver brug af samtidig medicin, som har en virkning på det hæmatopoietiske system.
English: B) Getting ready to inject C) Reconstituting the solution, step by step D) Drawing up the injection E) Making the injection F) Quick review of the process
Danish: A) Almindelige forholdsregler b) Forberedelse af injektionen C) Trinvis tilberedning af opløsningen D) Opsugning i injektionssprøjten E) Selve injektionen F) En hurtig gennemgang af processen
English: If your depression and/or suicidal thoughts are severe, you will not be prescribed Betaferon (see also ‘Do not use Betaferon').
Danish: Hvis din depression og/eller dine selvmordstanker er alvorlige, vil du ikke få ordineret Betaferon (se også ”Brug ikke Betaferon”).
English: No primary endpoint
Danish: Intet primært endepunkt
English: When starting treatment with Betaferon, it is tolerated best by gradually increasing the dose, i.e. starting with just 0.25 ml of the medication and then increasing, after every 3rd injection, first to 0.5 ml, then to 0.75 ml and then finally to the full dose (1 ml) of Betaferon.
Danish: Du vil bedst kunne tåle Betaferon i opstarten af behandlingen, hvis dosis gradvist øges, dvs. at der indledes med en lav dosis på 0,25 ml, og efter hver tredje injektion øges dosis, først til 0,5 ml, så til 0,75 ml og endelig til den fulde dosis (1 ml) af Betaferon.
English: Pulmonary arterial hypertension4
Danish: Pulmonal arteriel hypertension4
English: No formal interaction studies have been carried out to find out whether Betaferon affects other medicines or is affected by them.
Danish: Der er ikke udført formelle undersøgelser over de indvirkninger, som én form for medicin kan have på virkningen af en anden medicin, for at finde ud af, om Betaferon indvirker på andre lægemidler eller påvirkes af disse.
English: Injection site reactions usually become less frequent over time.
Danish: Reaktionerne på injektionsstedet aftager sædvanligvis med tiden.
English: ► If you have only one sore injection site (lesion) and the tissue damage (necrosis) is not too extensive you may continue using Betaferon.
Danish: ► Hvis du kun har ét ømt injektionssted (sår) og hudbristningen (nekrosen) ikke er alt for udbredt, kan du fortsætte med at bruge Betaferon.
English: Caution should be exercised when Betaferon is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. anti-epileptics.
Danish: Der bør udvises forsigtighed, når Betaferon anvendes samtidig med medikamenter, der har et smalt terapeutisk indeks, og som hovedsagelig er afhængig af cytokrom P450-systemet til clearance.
English: Risk reduction Hazard ratio with 95% confidence interval log-rank test
Danish: Risikoreduktion Risikoforhold med 95 % konfidensinterval
English: - if you are allergic (hypersensitive) to natural or recombinant interferon beta, human albumin or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk (overfølsom) over for naturligt eller rekombinant interferon beta (rekombinant: fremstillet ved genteknik), humant albumin eller et af de øvrige indholdsstoffer i Betaferon (angivet i punkt 6).