natgillin/translations-raw huggingface dataset:
Rebif anvendes til behandling af patienter med recidiverende dissemineret sklerose, dvs. den type sklerose, hvor patienten får attakker (tilbagefald) ind mellem perioder uden symptomer.
This is the type of MS where the patient has attacks (relapses) within periods with no symptoms.
Der er ikke påvist nogen virkning af lægemidlet hos voksne med sekundær progressiv dissemineret sklerose (den type dissemineret sklerose, der følger efter recidiverende dissemineret sklerose), når sygdommen ikke er i en attakfase.
Its effectiveness has not been shown in patients with secondary progressive MS (the type of MS that comes after relapsing MS), when the disease is not in a relapsing phase.
Rebif bør ikke anvendes til børn under 12 år, da der ikke foreligger oplysninger om anvendelse af lægemidlet i denne gruppe.
Rebif should not be used in children aged below 12 years because of a lack of information on the use of the medicine in this group.
Behandlingen med Rebif bør indledes af en læge med erfaring i behandling af dissemineret sklerose.
Rebif treatment should be started by a doctor who has experience in the management of MS.
Dosen på 22 mikrogram anbefales til patienter, der ikke tåler den høje dosis, og til unge mellem 12 og 16 år.
The 22– microgram dose is recommended for patients who cannot tolerate the higher dose and for adolescents aged between 12 and 16 years.
Startdosen er 8, 8 mikrogram tre gange ugentligt de første to uger, efterfulgt af 22 mikrogram tre gange ugentligt de efterfølgende to uger.
When first starting treatment with Rebif, the dose should be slowly increased to avoid side effects, starting with 8.8 micrograms three times a week for the first two weeks, followed by 22 micrograms three times a week for the next two weeks.
Lægen kan råde patienten til at tage feber - og smertestillende medicin inden indsprøjtningerne og i 24 timer herefter for at reducere de influenzalignende symptomer, som kan opstå som en bivirkning ved behandlingen.
The doctor may advise the patient to take a fever-reducing painkiller before each injection and for 24 hours after injection to reduce the flu-like symptoms that may occur as a side effect of treatment.
Dissemineret sklerose er en nervesygdom, hvor betændelse ødelægger den beskyttende hinde omkring nerverne.
MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.
Det aktive stof i Rebif, interferon beta- 1a, tilhører interferon- gruppen.
The active substance in Rebif, interferon beta-1a, belongs to the group ‘ interferons’.
Det vides endnu ikke med sikkerhed, hvordan Rebif virker ved dissemineret sklerose, men det ser ud til, at interferon- beta dæmper immunsystemet og forhindrer attakker af dissemineret sklerose.
The exact way that Rebif works in MS is not yet known but interferon beta seems to calm the immune system down and prevent relapses of MS.
Interferon beta- 1a fremstilles ved en metode kaldet "rekombinant DNA- teknologi", hvor en celle får indsat et gen (dna) og dermed bliver i stand til at producere interferon beta- 1a.
Interferon beta-1a is produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce interferon beta-1a.
Det kunstigt fremstillede interferon beta- 1a virker på samme måde som naturligt produceret interferon beta.
The replacement interferon beta-1a acts in the same way as naturally produced interferon beta.
Patienterne fik enten Rebif (22 eller 44 mikrogram) eller placebo (en virkningsløs behandling) i to år.
Patients received either Rebif (22 or 44 micrograms) or placebo (a dummy treatment) for two years.
Rebif blev desuden undersøgt hos patienter med sekundær progressiv dissemineret sklerose.
Rebif has also been studied in patients with secondary progressive MS.
Undersøgelsen så nærmere på lægemidlets evne til at forhindre forværring af invaliditet over tre år.
The study looked at the effectiveness of the medicine in preventing the progression of disability over three years.
Virksomheden har ikke gennemført formelle undersøgelser af patienter under 16 år, men har fremlagt information fra offentliggjorte undersøgelser af anvendelsen af Rebif til unge mellem 12 og 18 år.
However, it presented information from published studies on the use of Rebif in children aged between 12 and 18 years.
Hvilken fordel viser undersøgelserne, at der er ved Rebif?
What benefit has Rebif shown during the studies?
Rebif var mere effektivt end placebo til at mindske antallet af attakker ved recidiverende- remitterende dissemineret sklerose.
Rebif was more effective than placebo in reducing the number of relapses in relapsing-remitting MS.
30% med både Rebif 22 og 44 mikrogram i forhold til placebo og i løbet af fire år med 22% for Rebif 22 mikrogram og 29% for Rebif 44 mikrogram.
Relapses were reduced by about 30% over two years for both Rebif 22 and 44 micrograms compared with placebo, and by 22% (Rebif 22 micrograms) and 29% (Rebif 44 micrograms) over four years.
30%.
In the study of patients with progressive MS, Rebif had no significant effect on the progression of disability, but the relapse rate was reduced by about 30%.
Kun hos de patienter, der ved undersøgelsens start havde haft attakker i de to foregående år, kunne der observeres en invaliditetsforværrende virkning.
Some effect on progression of disability could be seen only in the patients who had relapses in the two years before the start of the study.
De offentliggjorte undersøgelser viste, at patienter mellem 12 og 18 år oplevede et fald i antallet af tilbagefald.
In patients aged between 12 and 18, the published studies showed that the patients had a decrease in the rate of relapse.
Dette kan muligvis tilskrives behandlingen med Rebif.
This may be due to Rebif treatment.
De mest almindelige bivirkninger ved Rebif (der ses hos flere end 1 ud af 10 patienter) er influenzalignende symptomer, neutropeni, lymfopeni og leukopeni (lavt antal hvide blodlegemer), trombocytopeni (lavt antal blodplader), anæmi (lavt antal røde blodlegemer), hovedpine, betændelse og andre reaktioner på injektionsstedet samt forhøjede leverenzymer (transaminaser).
The most common side effects with Rebif (seen in more than 1 patient in 10) are flu-like symptoms, neutropenia, lymphopenia and leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), headache, inflammation and other reactions at the injection site, and increases in transaminases (liver enzymes).
Bivirkningerne er de samme hos børn.
The side effects are similar in children.
Den fuldstændige liste over de indberettede bivirkninger ved Rebif fremgår af indlægssedlen.
For the full list of all side effects reported with Rebif, see the Package Leaflet.
Rebif må ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for naturligt eller rekombinant interferon beta eller andre af indholdsstofferne.
Rebif should not be used in people who have a history of hypersensitivity (allergy) to natural or recombinant interferon beta, or any of the other ingredients.
Rebif må desuden heller ikke anvendes hos patienter, der lider af svær depression eller har selvmordstanker.
Rebif must also not be used in patients who are suffering from severe depression or having thoughts about suicide.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Rebif er større end risiciene ved behandling af patienter med recidiverende dissemineret sklerose.
The Committee for Medicinal Products for Human Use (CHMP) decided that Rebif’ s benefits are greater than its risks for the treatment of relapsing MS.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Rebif.
The Committee recommended that Rebif be given marketing authorisation.
2/ 3 Andre oplysninger om Rebif:
Other information about Rebif:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rebif til Serono Europe Limited den 4. maj 1998.
The European Commission granted a marketing authorisation valid throughout the European Union for Rebif to Serono Europe Limited on 4 May 1998.
Markedsføringstilladelsen blev fornyet den 4. maj 2003 og den 4. maj 2008.
The marketing authorisation was renewed on 4 May 2003 and on 4 May 2008.
Den fuldstændige EPAR for Rebif findes her.
The full EPAR for Rebif is available here.
Indgivelsesvej
Route of Administratio n
injektionsvæske, opløsning
Solution for injection
0, 5 ml (12 MIE/ ml)
0.5 ml (12 million IU/ ml)
3 fyldte injektions - sprøjter
3 pre-filled syringes
12 fyldte injektions - sprøjter
12 pre-filled syringes
0, 5 ml (24 MIE/ ml)
0.5 ml (24 million IU/ ml)
8, 8 mikrogram (2, 4 MIE) 22 mikrogram (6 MIE)
8.8 µg (2.4 m IU) + 22 µg (6 m IU)
0, 2 ml (12 MIE/ ml) 0, 5 ml (12 MIE/ ml)
0.2 ml (12 m IU/ ml) + 0.5 ml (12 m IU/ ml)
Opstartspakning:
Initiation pack:
6 fyldte injektionssprøjter med 8, 8 mikrogram og 6 fyldte injektionssprøjter med 22 mikrogram
6 pre-filled syringes of 8.8 µg + 6 pre- filled syringes of 22 µg
1, 5 ml (12 million IE/ ml)
1.5 ml (12million IU/ ml)
1, 5 ml (24 million IE/ ml)
1.5 ml (24million IU/ ml)
Injektionsvæske, opløsning
8.8 µg/ 0.1 ml Solution for 22 µg/ 0.25 ml injection
1, 5 ml (24 million IE/ ml)
1.5 ml (24 million IU/ ml)
Rebif 22 mikrogram - injektionsvæske, opløsning i en fyldt injektionssprøjte
Rebif 22 micrograms solution for injection in pre-filled syringe
Hver fyldt injektionssprøjte (0, 5 ml) indeholder 22 mikrogram (6 MIE *) interferon beta- 1a **.
Each pre-filled syringe (0.5 ml) contains 22 micrograms (6 MIU*) of interferon beta-1a**.
Produceret i kinesiske hamsteres ovarieceller (CHO- K1) ved rekombinant DNA- teknologi.
* Million International Units, measured by cytopathic effect (CPE) bioassay against the in-house IFN beta-1a standard which is calibrated against the current international NIH standard (GB-23-902-531). ** produced in Chinese hamster ovary Cells (CHO-K1) by recombinant DNA technology.
6. 1.
2.5 mg benzyl alcohol For a full list of excipients, see section 6.1.
Klar til opaliserende opløsning med pH 3, 5 til 4, 5 og en osmolaritet på 250 til 450 mOsm/ l.
Clear to opalescent solution, with pH 3.5 to 4.5 and osmolarity 250 to 450 mOsm/ l.
I kliniske studier var dette karakteriseret ved to eller flere akutte attakker i de foregående to år (se punkt 5. 1).
In clinical trials, this was characterised by two or more acute exacerbations in the previous two years (see section 5.1).
Se punkt 5. 1.
Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity (see section 5.1).
Til patienter, der skal starte med behandling af Rebif, findes der pakninger med Rebif 8, 8 mikrogram og Rebif 22 mikrogram, der svarer til patientens behov i den pågældende måned af behandlingen.
For patients initiating treatment with Rebif, Rebif 8.8 micrograms and Rebif 22 micrograms are available in a package that corresponds to the patient needs for the first month of therapy.
Den anbefalede dosis af Rebif er 44 mikrogram, som gives tre gange om ugen ved subkutane injektioner.
The recommended posology of Rebif is 44 micrograms given three times per week by subcutaneous injection.
En lavere dosis på 22 mikrogram, 3 gange ugentlig ved subkutan injektion, anbefales til patienter som ikke kan tolerere den højere dosis ifølge behandlende læge.
A lower dose of 22 micrograms, also given three times per week by subcutaneous injection, is recommended for patients who cannot tolerate the higher dose in view of the treating specialist.
Ved opstart af Rebif- behandlingen skal dosis øges gradvist med henblik på udvikling at takyfylakse, og dermed en reduktion af bivirkningerne.
When first starting treatment with Rebif, dose should be gradually escalated in order to allow tachyphylaxis to develop thus reducing adverse reactions.
Administrationsmåde Før hver injektion og yderligere 24 timer efter hver injektion anbefales det at tage et smertestillende middel med antipyretisk effekt for at mindske de influenzalignende symptomer, der forbindes med behandling med Rebif.
Method of administration Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is advised to decrease flu-like symptoms associated with Rebif administration.
På nuværende tidspunkt vides det ikke, hvor lang behandlingsperioden bør være.
2 At the present time, it is not known for how long patients should be treated.
Det anbefales, at patienten bør
Safety and efficacy with Rebif have not been demonstrated beyond 4 years of treatment.
Derefter tager den behandlende læge en individuel beslutning om langtidsbehandling.
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.
Der er ikke udført egentlige kliniske studier eller farmakokinetiske studier med børn og unge.
Paediatric use No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Begrænsede publicerede data tyder dog på, at bivirkningsprofilen hos unge fra 12 til 16 år, der behandles med Rebif 22 mikrogram subkutant tre gange om ugen, er tilsvarende den, der ses hos voksne.
However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Rebif 22 micrograms subcutaneously three times per week is similar to that seen in adults.
Der er meget begrænset information om brugen af Rebif hos børn under 12 år, hvorfor Rebif ikke bør anvendes til denne patientgruppe.
There is very limited information on the use of Rebif in children under 12 years of age and therefore Rebif should not be used in this population.
4. 4 og 4. 8)
• Initiation of treatment in pregnancy (see section 4.6). • Hypersensitivity to natural or recombinant interferon-β, or to any excipients. • Current severe depression and/ or suicidal ideation (see sections 4.4 and 4.8).
4. 8).
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).
Rebif skal administreres med forsigtighed til patienter med tidligere eller nuværende depressiv tilstand, specielt dem, som tidligere har haft selvmordstanker (se pkt. 4. 3).
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).
Forøget frekvens af depression og selvmordstanker er kendt hos multipel sklerose- patienter og i forbindelse med anvendelse af interferoner.
Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Patienter, der behandles med Rebif, skal rådgives til øjeblikkeligt at oplyse deres læge omkring enhver form for symptom på depression og/ eller selvmordstanker.
Patients treated with Rebif should be advised to immediately report any symptoms of depression and/ or suicidal ideation to their prescribing physician.
Patienter, som har tendens til at udvikle depressioner, skal følges nøje gennem deres Rebif- behandling og behandles omstændeligt.
Patients exhibiting depression should be monitored closely during therapy with Rebif and treated appropriately.
4. 3 og 4. 8).
Cessation of therapy with Rebif should be considered (see sections 4.3 and 4.8).
4. 5 og 4. 8).
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 anti-epileptics (see sections 4.5 and 4.8).
Patienter med hjertesygdomme såsom angina, kongestionshjertesvigt eller arrhytmia skal følges tæt, hvis deres kliniske tilstand bliver forværret ved behandling med interferon beta- 1a.
Patients with cardiac disease, such as angina, congestive heart failure or arrhythmia, should be closely monitored for worsening of their clinical condition during initiation of therapy with interferon beta-1a.
Influenzalignende symptomer i forbindelse med injektion af interferon beta- 1a kan virke stressende på patienter med hjertesygdomme.
Symptoms of the flu-like syndrome associated with interferon beta-1a therapy may prove stressful to patients with cardiac conditions.
For at minimere risikoen for nekrose på injektionsstedet anbefales patienter at: • bruge en aseptisk injektionsteknik • skifte injektionssted ved hver dosering
To minimise the risk of injection site necrosis patients should be advised to: • use an aseptic injection technique, • rotate the injection sites with each dose.
Proceduren m. h. t. patientens injektionsteknik bør revideres jævnligt, specielt hvis der forekommer reaktioner på injektionsstedet.
The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
Hvis patienten oplever irritation af huden såsom hævelse eller væskende injektionsmærker, skal patienten kontakte sin læge, før han/ hun fortsætter med injektion af Rebif.
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.
Hvis patienten har adskillige læsioner, skal Rebif- behandlingen ophøre, indtil der har fundet opheling sted.
If the patient has multiple lesions, Rebif should be discontinued until healing has occurred.
I kliniske forsøg med Rebif var en asymptomatisk forhøjelse af hepatisk transaminase (især ALT) almindelig, og 1- 3% af patienterne fik forhøjelser af hepatisk transaminase fem gange over den øvre normalgrænse (ULN).
3 In clinical trials with Rebif, asymptomatic elevations of hepatic transaminases (particularly alanine aminotransferase (ALT)) were common and 1-3% of patients developed elevations of hepatic transaminases above 5 times the upper limit of normal (ULN).
Ved mangel på kliniske symptomer skal serum- ALT- niveauet monitoreres før terapistart, efter 1, 3 og 6 måneder og derefter periodevist.
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.
Hvis ALT stiger til mere end fem gange den øvre normalgrænse, bør det overvejes at reducere dosis af Rebif og herefter trappe langsomt op,
Dose reduction of Rebif should be considered if ALT rises above 5 times the ULN, and gradually re-escalated when enzyme levels have normalized.
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- ALT (> 2, 5 den øvre normalgrænse).
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).
4. 8).
Treatment with Rebif should be stopped if icterus or other clinical symptoms of liver dysfunction appear (see section 4.8).
4. 8) inklusive akut hepatisk svigt.
Rebif, like other interferons beta, has a potential for causing severe liver injury (see section 4.8) including acute hepatic failure.
Mekanismen for sjældne symptomatiske hepatiske funktionsfejl er ikke kendt.
The mechanism for the rare symptomatic hepatic dysfunction is not known.
Der er forbundet abnormiteter i laboratoriedata ved brugen af interferoner.
Laboratory abnormalities are associated with the use of interferons.
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 en total og differentiel tælling og blodpladetælling i regelmæssige intervaller (1, 3 og 6 måneder) efter behandlingsstart med Rebif og derefter periodevist ved mangel på kliniske symptomer.
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.
Hos patienter, som behandles med Rebif, kan der nogle gange udvikles nye thyreoidea- anormaliteter, eller der kan ses forværring af allerede eksisterende.
Patients being treated with Rebif may occasionally develop new or worsening thyroid abnormalities.
Det anbefales at teste thyreoideafunktionen, før behandlingen påbegyndes, og hvis denne er unormal, bør den fortsat kontrolleres hver 6. - 12. måned, efter at behandlingen er påbegyndt.
Thyroid function testing is recommended at baseline and if abnormal, every 6-12 months following initiation of therapy.
4. 8).
If tests are normal at baseline, routine testing is not needed but should be performed if clinical findings of thyroid dysfunction appear (see section 4.8).
Forsigtighed og tæt opfølgning tilrådes, når interferon beta- 1a gives til patienter med alvorlig nyre - og leversvigt og til patienter med alvorlig knoglemarvssuppression.
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.
Der kan udvikles serumneutraliserende antistoffer mod interferon beta- 1a.
Serum neutralising antibodies against interferon beta-1a may develop.
24% af patienterne vedvarende serumantistoffer mod interferon beta- 1a.
Clinical data suggest that after 24 to 48 months of treatment with Rebif 22 micrograms, approximately 24% of patients develop persistent serum antibodies to interferon beta-1a.
Forekomsten af antistoffer har vist sig at svække det farmakodynamiske respons på interferon beta- 1a (Beta- 2 mikroglobulin og neopterin).
The presence of antibodies has been shown to attenuate the pharmacodynamic response to interferon beta-1a (Beta-2 microglobulin and neopterin).
Selv om den kliniske betydning af inducerede antistoffer ikke er fuldt belyst, er udvikling af neutraliserende antistoffer forbundet med reduceret effekt af kliniske og MRI- variabler.
Although the clinical significance of the induction of antibodies has not been fully elucidated, the development of neutralising antibodies is associated with reduced efficacy on clinical and MRI variables.
Hvis en patient responderer dårligt på behandling med Rebif og har neutraliserende antistoffer, bør den ansvarlige læge reevaluere ratioen for fordele/ risici ved fortsat behandling.
If a patient responds poorly to therapy with Rebif, and has neutralising antibodies, the treating physician should reassess the benefit/ risk ratio of continued Rebif therapy.
Der foreligger kun sparsomme data om sikkerhed og effekt for MS- patienter uden bevaret gangfunktion.
Only sparse safety and efficacy data are available from non-ambulatory patients with multiple sclerosis.
Rebif er endnu ikke undersøgt hos patienter med primær progressiv multipel sklerose og bør ikke anvendes til sådanne patienter.
Rebif has not yet been investigated in patients with primary progressive multiple sclerosis and should not be used in such patients.
Dette lægemiddel indeholder 2, 5 mg benzylalkohol pr. dosis, og må ikke gives til for tidligt fødte og nyfødte børn.
Must not be given to premature babies or neonates.
Kan give forgiftningsreaktioner og anafylaktoide reaktioner hos spædbørn og børn op til 3 år.
May cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Der er ikke udført interaktionsstudier med interferon beta- 1a hos mennesker.
No interaction studies have been performed with interferonbeta-1a in humans.
Der er i forbindelse med interferoner rapporteret nedsat aktivitet af hepatisk cytokrom P450- afhængige enzymer hos mennesker og dyr.
Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.