natgillin/translations-raw huggingface dataset:
- hovedpine og andre influenzalignende symptomer (f. eks. myalgi, natlige svedeture)
- headaches and other flu-like symptoms (e. g. muscle pain, night sweats)
- protein i urinen
- protein in your urine
- træthed
- tiredness
- blodforgiftning *
- blood poisoning*
- åndedrætsbesvær
- breathing problems
- forstoppelse eller muligvis diarré
- constipation, or possibly diarrhoea
- formindskelse af koncentrationen af visse bestanddele i blodet
- reductions in levels of certain blood components
- nerveskader
- nerve damage
Følgende bivirkninger er rapporteret som ikke almindelige:
The following side effect has been observed uncommonly:
- nyreforgiftning der resulterer i midlertidig funktionelle forandringer
- kidney toxicity resulting in temporary functional changes
* Da kun få patienter har anvendt BEROMUN er det vanskeligt at beregne hyppigheden for disse bivirkninger.
*Due to the low patient number having used BEROMUN it is difficult for these side effects to calculate the frequency.
Det er dog antaget at de forekommer som almindelige.
However, they are assumed to occur commonly.
Det er endvidere vigtigt at forstå, at BEROMUN og melfalan- behandlingen kan medføre at ovennævnte bivirkninger optræder alvorligere end beskrevet ovenfor.
In addition, it is important to realise that BEROMUN and melphalan treatment can result in the above general side-effects becoming more severe and serious.
Risikoen herfor er størst ved systemisk lækage (en højere dosis end 10% af den administrerede dosis af BEROMUN og melfalan løber ud i kroppen).
This is more likely to occur when there is a higher level (greater than 10% of the administered dose) of BEROMUN and melphalan systemic leakage.
Her kan lægen bedre overvåge Dem og ordinere passende behandling for enhver alvorlig opstået bivirkning.
If your doctor notices that you are suffering from, or are likely to suffer from, any of these severe side- effects described above, you will be immediately transferred to an intensive care unit (ICU) within the hospital, where your doctor can more closely monitor you and prescribe suitable treatment to deal with any dangerous side-effects which have developed.
Hvis De synes, at nogle af de ovennævnte bivirkninger er alvorlige og at lægen ikke har været opmærksom herpå, så fortæl det straks til ham/ hende.
If you feel any of the above side-effects are severe, but have not been noticed by your doctor, please inform him or her immediately.
HVORDAN OPBEVARES BEROMUN
STORING BEROMUN
BEROMUN skal opbevares uåbnet og uopløst i køleskab (2°C- 8°C).
BEROMUN should be stored unopened and undissolved in a refrigerator (2°C - 8°C).
Deres læge anbefales at bruge BEROMUN hurtigst muligt efter blanding med den tilhørende opløsning af natriumklorid (saltvand).
Your doctor has been recommended to use BEROMUN as soon as possible after reconstitution in the supplied solution of sodium chloride (saline).
Deres læge vil være opmærksom på udløbsdato på pakningen.
Your doctor will note the expiry date on the pack.
BEROMUN må ikke bruges efter denne dato.
BEROMUN will not be used after this date.
BEROMUN er til éngangsbrug og evt. ubrugt opløsning vil blive destrueret efter gældende regler af Deres læge.
BEROMUN is for single use only and any unused solution will be carefully disposed of by your doctor.
EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR)
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) BETAFERON EPAR summary for the public
Hvis du ønsker yderligere oplysninger om grundlaget for CHMPs anbefalinger, kan du læse den faglige drøftelse (også en del af denne EPAR).
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Betaferon er et pulver og en solvens, som omdannes til en opløsning til injektion.
Betaferon is a powder and solvent, which is made into a solution for injection.
IE) pr. ml af det aktive stof interferon beta - 1b.
It contains 250 micrograms (8 million international units - MIU) per ml of the active substance interferon beta-1b.
Det anvendes til patienter: • som for første gang har oplevet symptomer på dissemineret sklerose, og hos hvem disse symptomer er så svære, at det berettiger til behandling med injektion af cortikosteroider (anti - inflammatoriske lægemidler).
It is used in patients: • who have experienced the signs of MS for the first time, and these are severe enough to justify treatment with injected corticosteroids (anti-inflammatory medicines).
Det anvendes til patienter, der anses for at have høj risiko for at udvikle dissemineret sklerose.
It is used when the patient is considered to be at high risk of developing MS.
Før det anvendes, skal lægen have udelukket, at der er andre årsager til symptomerne. • som har dissemineret sklerose af den form, der kaldes recidiverende- remitterende dissemineret sklerose, hvor patienten får attakker (recidiver) ind mellem de symptomfrie perioder (remissioner), og hvor patienten har haft mindst to attakker inden for de seneste to år. • som har sekundær progressiv dissemineret sklerose (den form for dissemineret sklerose, der følger efter attakvis dissemineret sklerose), når sygdommen er aktiv.
Before using it, doctors need to exclude other causes for the symptoms. • who have MS of the type known as relapsing remitting, when the patient has attacks (relapses) within periods with no symptoms (remissions), in patients with at least 2 relapses within the last two years. • who have secondary progressive MS (the type of MS that comes after relapsing remitting MS), when their disease is active.
IE) hver anden dag.
The treatment should start with 62.5 micrograms (a quarter of the dose) every other day, increasing progressively over 2 and a half weeks to reach the recommended dose of 250 micrograms (8 MIU) given every other day.
Betaferon indgives ved subkutan injektion (under huden).
Betaferon is given by a subcutaneous (under the skin) injection.
(demyelinisation).
MS is a disease of the nerves, where inflammation destroys the protective sheath around the nerves (demyelination).
Det aktive stof i Betaferon, interferon beta- 1b, tilhører interferon- gruppen.
The active substance in Betaferon, interferon beta-1b, belongs to the group of the interferons.
Interferoner er naturlige stoffer, der produceres af kroppen som 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged forsvar mod f. eks. virusinfektioner.
The exact way that Betaferon works in MS is not yet known but beta-interferon seems to calm the immune system and prevents the relapses of MS.
Interferon beta- 1b fremstilles ved "rekombinant DNA- teknologi":
Interferon beta-1b is produced by a method known as ‘ recombinant DNA technology’.
Interferon beta- 1b produceres af en celle, der har fået indsat et gen (dna), som gør den i stand til at producere stoffet.
The interferon beta-1b is made by a bacterium that has received a gene (DNA), which makes it able to produce it.
Det kunstigt fremstillede interferon beta- 1b virker på samme måde som naturligt produceret interferon beta.
The replacement interferon beta-1b acts in the same way as naturally produced interferon beta.
Hvordan blev Betaferon undersøgt?
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Betaferon er blevet undersøgt gennem to år hos 338 patienter, som havde attakvis dissemineret sklerose og kunne gå.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Betaferon been studied?
Betaferon blev her sammenlignet med placebo (virkningsløs behandling).
Betaferon was studied over 2 years in 338 patients with relapsing remitting MS and able to walk unaided, where its effectiveness was compared to that of a placebo (dummy treatment.
Hovedmålet for behandlingens virkning var reduktionen i antallet af attakker.
The main measure of effectiveness was the reduction in the number of relapses.
Betaferon blev her sammenlignet med placebo.
Betaferon has also been studied in 1,657 patients in two studies of secondary progressive MS patients who were able to walk, where it was compared with a placebo.
Undersøgelsen af Betaferon hos patienter med en enkelt demyeliniserende hændelse omfattede 487 patienter, som fik enten Betaferon eller placebo i to år.
The study of Betaferon in patients with a single demyelinating event involved 487 patients, who received either Betaferon or a placebo for two years.
De patienter, der fik lægemidlet, havde i gennemsnit 0, 84 attakker pr. år, mens de patienter, der fik placebo, havde 1, 27 attakker pr. år.
In patients with relapsing remitting MS, Betaferon was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27.
I den ene af de to undersøgelser hos patienter med sekundær progressiv dissemineret sklerose sås en væsentlig forlængelse af den tid, der gik, til invaliditeten forværredes (31% lavere risiko med Betaferon), og af den tid, der gik, til patienten måtte bruge rullestol (39%).
One of the two studies in patients with secondary progressive MS showed a significant delay in the time to disability progression (31% risk reduction due to Betaferon) and in the time to becoming wheelchair bound (39%).
I begge undersøgelser medførte Betaferon et fald (30%) i antallet af kliniske attakker.
In both trials, Betaferon showed a reduction in the number (30%) of clinical relapses.
I undersøgelsen af patienter med en enkelt demyeliniserende hændelse blev det vist, at Betaferon mindsker risikoen for at udvikle klinisk påviselig dissemineret sklerose:
In the study of patients with a single demyelinating event, Betaferon was shown to reduce the risk of developing clinically defined MS:
28% af de patienter, der fik Betaferon, udviklede dissemineret sklerose, mod 45% hos dem, der fik placebo.
28% of the patients who received Betaferon developed MS, against 45% of those who received placebo.
Meget almindelige bivirkninger er influenzalignende symptomer (feber, forkølelse, ledsmerter, utilpashed, hovedpine og muskelsmerter) samt reaktioner på injektionsstedet.
Very common side effects are flu-like symptoms (fever, chills, arthralgia [joint pain, malaise [feeling ill], headache or myalgia [muscle pain]) and injection site reactions.
Den fuldstændige liste over de indberettede bivirkninger ved Betaferon fremgår af indlægssedlen.
For the full list of all side effects reported with Betaferon, see the Package Leaflet.
Betaferon bør ikke anvendes til patienter, som tidligere har vist overfølsomhed (allergi) over for naturligt eller rekombinant interferon beta, humant albumin eller andre af indholdsstofferne.
Betaferon should not be used in people who have a history of hypersensitivity (allergy) to natural or recombinant interferon beta, human albumin or any of the other ingredients.
Behandling med Betaferon bør ikke indledes under graviditet.
Betaferon treatment should not be started during pregnancy.
Betaferon bør ikke anvendes til patienter, der aktuelt har en svær depression eller har selvmordstanker.
Betaferon should not be used in patients who are currently suffering from severe depression and/ or have thoughts of suicide.
Betaferon bør ikke anvendes hos patienter med dekompenseret leversygdom (dvs. en tilstand, hvor leveren ikke fungerer normalt).
Betaferon should not be used in patients who have decompensated liver disease (when the liver does not function normally).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Betaferon opvejer risiciene til behandling af patienter med attakvis dissemineret sklerose og patienter med sekundær progressiv dissemineret sklerose samt patienter med en enkelt demyeliniserende hændelse af en sværhedsgrad, der berettiger behandling med injektion af cortikosteroider.
The Committee for Medicinal products for Human Use (CHMP) decided that Betaferon’ s benefits are greater than its risks for the treatment of patients with relapsing remitting multiple sclerosis, secondary progressive multiple sclerosis, and in patients with a single episode of demyelination, severe enough to justify treatment with injected corticosteroids.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Betaferon.
They recommended that Betaferon be given marketing authorisation.
Betaferon blev oprindeligt godkendt under "særlige omstændigheder", da der på godkendelsestidspunktet af faglige årsager kun forelå begrænsede oplysninger.
Betaferon was originally authorised under "Exceptional Circumstances", because, for scientific reasons, limited information was available at the time of approval.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Betaferon til Schering Aktiengesellschaft den 30. november 1995.
The European Commission granted a marketing authorisation valid throughout the European Union, for Betaferon to Schering Aktiengesellschaft on 30 November 1995.
Denne tilladelse blev fornyet den 30. november 2000 og den 30. november 2005.
This was renewed on 30 November 2000 and 30 November 2005.
Den europæiske offentlige vurderingsrapport (EPAR) for Betaferon kan ses i sin helhed her.
The full EPAR for Betaferon is available here.
Dette sammendrag blev sidst ajourført i 09- 2006.
©EMEA 2006
EU- nummer EU/ 1/ 95/ 003/ 003
EU/ 1/ 95/ 003/ 003
Særnavn Betaferon
Betaferon
Styrke 0, 25 mg/ ml
0.25 mg/ ml
Lægemiddelform Pulver og opløsning til injektion
Powder and solvent for solution for injection
Emballage Pulver: hætteglas (glas); Opløsning: fyldt sprøjte (glas)
Powder: vial (glass); solvent: pre-filled syringe (glass)
Indhold opløsning:
solvent:
Paknings- størrelse 15 hætteglas + 15 fyldte sprøjter
15 vials + 15 pre-filled syringes
opløsning:
solvent:
15 x (1 hætteglas + 1 fyldt sprøjte + 1 adapter til hætteglas med kanyle + 2 spritservietter)
15 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
5 x (1 hætteglas + 1 fyldt sprøjte + 1 adapter til hætteglas med kanyle + 2 spritservietter)
5 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
3 x 15 x (1 hætteglas + 1 fyldt sprøjte + 1 adapter til hætteglas med kanyle + 2 spritservietter)
3 x 15 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
3 x 14 x (1 hætteglas + 1 fyldt sprøjte + 1 adapter til hætteglas med kanyle + 2 spritservietter)
3 x 14 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
Betaferon 250 mikrogram/ ml, pulver og solvens til injektionsvæske, opløsning.
Betaferon 250 microgram/ ml, powder and solvent for solution for injection.
IE) per 1 ml.
Recombinant interferon beta-1b * 250 microgram (8.0 million IU) per ml when reconstituted.
IE) rekombinant interferon beta- 1b pr. hætteglas.
Betaferon contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial.
Alle hjælpestoffer er anført under sektion 6. 1.
For a full list of excipients, see section 6.1.
Sterilt hvidt til off- white pulver.
Sterile white to off-white powder.
- patienter med recidiverende- remitterende dissemineret sklerose, som har haft to eller flere relapser
Betaferon is indicated for the treatment of • patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1). • patients with relapsing remitting multiple sclerosis and two or more relapses within the last two years, • patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Betaferon- behandling skal påbegyndes under opsyn af en læge med erfaring i behandling af sygdommen.
The treatment with Betaferon should be initiated under the supervision of a physician experienced in the treatment of the disease.
Den anbefalede dosis af Betaferon til patienter er 250 mikrogram (8 millioner IE) indeholdt i 1 ml genopløst injektionspræparat (se sektion 6. 6) injiceret subkutant hver anden dag.
The recommended dose of Betaferon 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.
Begrænsede offentliggjorte data antyder dog, at sikkerhedsprofilen hos unge i 12- 16 års alderen, som behandles med 8 millioner IE Betaferon subkutant hver anden dag, svarer til sikkerhedsprofilen hos voksne.
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.
Der findes ingen oplysninger om brugen af Betaferon hos børn under 12 år, og Betaferon bør derfor ikke anvendes hos denne population.
There is no information on the use of Betaferon in children under 12 years of age and therefore Betaferon should not be used in this population.
* Produceret ved genteknologi fra Escherichia coli stammen.
* produced by genetic engineering from strain of Escherichia coli.
2 der forekommer nogen tegn på bivirkninger.
The titration period may be adjusted, if any significant adverse reaction occurs.
For at opnå tilstrækkelig effekt bør der nås en dosis på 250 mikrogram (1, 0 ml) hver anden dag.
In order to obtain adequate efficacy, a dose of 250 microgram (1.0 ml) every other day should be reached.
Tabel A:
Table A:
Skema til dosistitrering *
Schedule for dose titration*
dosis
dose
62, 5 mikrogram
62.5 microgram
187, 5 mikrogram 250 mikrogram
187.5 microgram 250 microgram
* Titreringsperioden kan justeres, hvis der forekommer signifikante bivirkninger.
* The titration period may be adjusted, if any significant adverse reaction occurs.
Der foreligger opfølgninger fra kontrollerede kliniske undersøgelser for patienter med recidiverende- remitterende dissemineret sklerose i op til 5 år og for patienter med sekundær progressiv dissemineret sklerose i op til 3 år.
For relapsing-remitting MS, efficacy has been demonstrated for therapy for the first two years.
For recidiverende- remitterende dissemineret sklerose er der vist effektivitet ved behandling i de første 2 år.
The available data for the additional three years are consistent with sustained treatment efficacy of Betaferon over the whole time period.
De tilgængelige data for de følgende tre år er i overensstemmelse med at Betaferon har en vedvarende behandlingseffekt over hele perioden.
In patients with a single clinical event suggestive of multiple sclerosis, efficacy has been demonstrated over a period of three years.
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.
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.
Hvis patienten ikke reagerer på behandlingen, f. eks. hvis der sker en stadig progression af EDSS i 6 måneder, eller der inden for 1 år har været behov for mindst 3 supplerende behandling med ACTH eller kortikosteroider til trods for behandling med Betaferon, bør Betaferon- behandlingen seponeres.
If the patient fails to respond, for example a steady progression in EDSS for 6 months occurs or treatment with at least 3 courses of ACTH or corticosteroids during a one year period is required despite Betaferon therapy, treatment with Betaferon should be stopped.
(se sektion 4. 4, 4. 5, 4. 8.).
− Initiation of treatment in pregnancy (see section 4.6 Pregnancy and lactation). − Patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin or to any excipients. − Patients with current severe depression and/ or suicidal ideation (see section 4.4 Special warnings and special precautions for use and 4.8 Undesirable effects). − Patients with decompensated liver disease (see sections 4.4, 4.5, 4.8).
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.
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.
Sygdomme i nervesystemet Betaferon skal administreres med forsigtighed til patienter med tidligere eller nuværende depressive symptomer især hos de patienter, som forudgående har haft selvmordstanker (se sektion 4. 3).
Betaferon 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).
Det er kendt at depression og selvmordstanker kan opstå med øget frekvens hos patienter med dissemineret sklerose og i forbindelse med brug af interferon.
Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Patienter der
Patients treated with Betaferon should be advised to immediately report any symptoms of depression and/ or suicidal ideation to their prescribing physician.
3 udviser depression bør monitoreres nøje under behandling med Betaferon, og behandles hensigtsmæssigt.
Patients exhibiting depression should be monitored closely during therapy with Betaferon and treated appropriately.
Seponering af Betaferon bør overvejes (se også sektion 4. 3 og sektion 4. 8).
Cessation of therapy with Betaferon should be considered (see also section 4.3 and section 4.8).
Betaferon bør administreres med forsigtighed til patienter med krampeanfald i anamnesen samt til patienter, der er i behandling med antiepileptika, især hvis deres epilepsi ikke er tilstrækkeligt kontrolleret med antiepileptika (se sektion 4. 5 og sektion 4. 8).
Betaferon 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 anti- epileptics (see section 4.5 and section 4.8).
Risiko for overførsel af Creutzfeld- Jacob sygdom kan ikke udelukkes.
A risk for transmission of Creutzfeld-Jacob disease (CJD) cannot be excluded.
Ud over de laboratorietests, som normalt er nødvendige til monitorering af patienter med dissemineret sklerose, anbefales fuldstændig blodtælling og differentialtælling af hvide blodceller og blodpladetal samt blodkemi, herunder leverfunktionstests (f. eks.
In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests (e. g.
AST (SGOT), ALT (SGPT) og γ- GT) før behandlingen indledes og med regelmæssige intervaller efter starten af Betaferon- behandlingen og med mellemrum derefter, hvis der ikke foreligger nogen kliniske symptomer.
AST (SGOT), ALT (SGPT) and γ -GT), are recommended prior to initiation and at regular intervals following introduction of Betaferon therapy, and then periodically thereafter in the absence of clinical symptoms.
Patienter med anæmi, thrombocytopeni, leukopeni (alene eller i kombination) kan kræve mere intensiv monitorering af det totale blodcelletal med differential - og blodpladetal.
Patients with anemia, thrombocytopenia, leukopenia (alone or in any combination) may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.