natgillin/translations-raw huggingface dataset:
Virkningen (se tabellen nedenfor) og sikkerheden blev demonstreret hos patienter med scorer på den udvidede skala over invaliditetsstatus (Expanded Disability Status Scale - EDSS) på mellem 0 og 5, begge inklusive, som havde oplevet mindst 1 attak i året inden randomiseringen eller inden for 6 uger før randomiseringen fik foretaget en MR-scanning, der viste mindst en gadoliniumforstærket (Gd+) læsion.
Efficacy (see table below) and safety were demonstrated in subjects with Expanded Disability Status Scale (EDSS) scores ranging from 0 to 5 inclusive, who had experienced at least 1 relapse during the year prior to randomisation, or, in the 6 weeks before randomisation had a brain Magnetic Resonance Imaging (MRI) demonstrating at least one gadolinium-enhancing (Gd+) lesion.
I prækliniske og kliniske studier udviste dimethylfumarat antiinflammatoriske og immunmodulerende egenskaber.
Effects on the immune system In preclinical and clinical studies, dimethyl fumarate demonstrated anti-inflammatory and immunomodulatory properties.
Hyppigheden af alvorlig rødme, som kan kendetegnes ved generaliseret erytem, udslæt og/eller pruritus, blev set hos under 1% af patienterne behandlet med Tecfidera (se pkt.
The incidence of serious flushing, which may be characterised by generalised erythema, rash and/or pruritus, was seen in less than 1% of patients treated with Tecfidera (see sections 4.2, 4.4 and 4.5).
Idet dimethylfumarat og monomethylfumarat metaboliseres ved hjælp af esteraser uden involvering af CYP-systemet, blev farmakokinetikken hos individer med leverinsufficiens ikke evalueret.
As dimethyl fumarate and monomethyl fumarate are metabolised by esterases, without the involvement of the CYP450 system, evaluation of phamacokinetics in individuals with hepatic impairment was not conducted.
Herpes zoster (helvedesild) kan forekomme ved behandling med Tecfidera.
Herpes zoster (shingles) may occur with Tecfidera treatment.
Disse kan påvirke op til 1 ud af 10 personer: - tarmirritation - opkastning - dårlig fordøjelse - irritation i slimhinden i mave-tarmkanalen (mavekatar) - gener i mave og tarm - brændende fornemmelse - hedeture, varm fornemmelse - hudkløe - udslæt - lyserøde eller røde pletter på huden
These may affect up to 1 in 10 people: - inflammation of the lining of the intestines (gastroenteritis) - being sick (vomiting) - indigestion (dyspepsia) - inflammation of the lining of the stomach (gastritis) - gastrointestinal disorder - burning sensation - hot flush, feeling hot - itchy skin (pruritus) - rash - pink or red blotches on the skin (erythema)
I et klinisk studie med deltagelse af i alt 71 patienter med relapsing-remitterende multipel sklerose som fik 240 mg Tecfidera to gange dagligt i mindst 6 måneder (n=38) eller ikke-pegyleret interferon i mindst 3 måneder (n=33) sås et sammenligneligt immunrespons (defineret som en ≥ fordobling af titer fra før til efter vaccinationen) over for tetanustoksoid (recall-antigen) og en konjugeret meningokok C polysaccharid-vaccine (neoantigen).
In a clinical study involving a total of 71 patients with relapsing remitting multiple sclerosis, patients on Tecfidera 240 mg twice daily for at least 6 months (n=38) or non-pegylated interferon for at least 3 months (n=33), mounted a comparable immune response (defined as ≥2-fold increase from pre- to post-vaccination titer) to tetanus toxoid (recall antigen) and a conjugated meningococcal C polysaccharide vaccine (neoantigen), while the immune response to different serotypes of an unconjugated 23-valent pneumococcal polysaccharide vaccine (T-cell independent antigen) varied in both treatment groups.
Lymfopeni af grad 2 og 3 var udbredt hos patienter med samtidig lymfocytopeni.
Grade 2 and 3 lymphopenia prevailed in subjects with concurrent lymphocytopenia.
Dimethylfumarat var negativ i in vivo-mikronukleusanalysen hos rotter.
Dimethyl fumarate was negative in the in vivo micronucleus assay in the rat.
- medicin, der påvirker kroppens immunsystem, herunder andre lægemidler, der anvendes til behandling af MS, såsom fingolimod, natalizumab, teriflunomid, alemtuzumab, ocrelizumab eller cladribin, eller nogle hyppigt anvendte lægemidler mod kræft (rituximab eller mitoxantron)
MS, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab or cladribine, or some commonly used cancer treatments (rituximab or mitoxantrone).
Der er forekommet tilfælde af herpes zoster med Tecfidera.
Cases of herpes zoster have occurred with Tecfidera.
Startdosis er 120 mg to gange dagligt.
The starting dose is 120 mg twice a day.
Disse kan påvirke flere end 1 ud af 10 personer: - rødme i ansigtet eller på kroppen med en varm, eventuel meget varm, brændende fornemmelse eller kløe (blussen) - løs afføring (diaré) - kvalme - mavesmerter eller mavekramper
These may affect more than 1 in 10 people: - reddening of the face or body feeling warm, hot, burning or itchy (flushing) - loose stools (diarrhoea) - feeling sick (nausea) - stomach pain or stomach cramps
Hos de patienter, der måtte opleve rødme eller gastrointestinale bivirkninger, kan indtagelse af Tecfidera sammen med mad forbedre tolerancen (se pkt.
For those patients who may experience flushing or gastrointestinal adverse reactions, taking Tecfidera with food may improve tolerability (see sections 4.4, 4.5 and 4.8).
Virkning og anvendelse Hvad Tecfidera er
What Tecfidera is and what it is used for What Tecfidera is
Startdosis 120 mg to gange dagligt.
Starting dose 120 mg twice a day.
Tecfidera er ikke blevet undersøgt hos patienter med alvorlig nyre- eller leverinsufficiens, og der skal derfor udvises forsigtighed ved brug hos disse patienter (se pkt.
Tecfidera has not been studied in patients with severe renal or severe hepatic impairment and caution should, therefore, be used in these patients (see section 4.2).
MedDRA-systemorganklasse Bivirkning
MedDRA System Organ Class Adverse reaction
Mekanismen bag anafylaksi induceret af dimethylfumarat er ikke kendt.
The mechanism of dimethyl fumarate induced anaphylaxis is unknown.
Normal dosis 240 mg to gange dagligt.
Regular dose 240 mg twice a day.
Yderligere havde 16% af patienterne en EDSS-score > 3,5, 28% havde haft ≥ 2 attakker i det forudgående år, og 42% havde tidligere fået anden godkendt behandling for MS. I MRI-kohorten havde 36% af patienterne gadolinium-forstærkede (Gd+) læsioner (gennemsnitligt 1,4).
In addition, 16% of patients had an EDSS score >3.5, 28% had ≥2 relapses in the prior year and 42% had previously received other approved MS treatments.
I de placebo-kontrollerede studier var hyppigheden af rødme (34% versus 4%) og hedestigning (7% versus 2%) højere hos patienter behandlet med Tecfidera sammenlignet med placebo.
In the placebo-controlled studies, the incidence of flushing (34% versus 4%) and hot flush (7% versus 2%) was increased in patients treated with Tecfidera compared to placebo, respectively.
Grønne og hvide, hårde enterokapsler, størrelse 0, præget med ‘BG-12 120 mg', der indeholder mikrotabletter.
Green and white gastro-resistant hard capsules, size 0, printed with ‘BG-12 120 mg' containing microtablets.
Oplys især, hvis du tager følgende: - medicin, der indeholder fumarsyreestere (fumarater), som anvendes til behandling af psoriasis
Tell your doctor or pharmacist if you are taking, have recently taken or might take any medicines, in particular: - medicines that contain fumaric acid esters (fumarates) used to treat psoriasis
Yderligere havde 17% af patienterne en EDSS-score > 3,5, 32% havde haft ≥ 2 attakker i det forudgående år, og 30% havde tidligere fået anden godkendt behandling for MS. I MRI-kohorten havde 45% af patienterne gadolinium-forstærkede (Gd+) læsioner (gennemsnitligt 2,4).
In addition, 17% of patients had an EDSS score >3.5, 32% had ≥2 relapses in the prior year and 30% had previously received other approved MS treatments.
Da tidlig diagnosticering af Fanconis syndrom og seponering af det potentielle kausale lægemiddel, f.eks. dimethylfumarat, er vigtige elementer for at forhindre opståen af nyreinsufficiens og osteomalaci, anbefaler PRAC, at inkludere en advarsel i produktresuméets pkt.
Since early diagnosis of Fanconi syndrome and discontinuation of the potentially causative drug, e.g. dimethyl fumarate, are important steps to prevent the onset of renal impairment and osteomalacia, the PRAC recommends the inclusion of a warning in SmPC section 4.4 to make physicians aware of the potential risk of Fanconi syndrome including the description of corresponding symptoms.
14 hårde enterokapsler
14 gastro-resistant hard capsules
Virkninger på immunsystemet
Immune system disorders
Samtidig behandling med nefrotoksiske lægemidler (såsom aminoglykosider, diuretika, non-steroide antiinflammatoriske lægemidler eller lithium) kan øge risikoen for renale bivirkninger (f.eks. proteinuri, se pkt.
Concurrent therapy with nephrotoxic medicinal products (such as aminoglycosides, diuretics, nonsteroidal anti-inflammatory drugs or lithium) may increase the potential of renal adverse reactions (e.g. proteinuria see section 4.8) in patients taking Tecfidera (see section 4.4 Blood/laboratory tests).
Der skal udvises forsigtighed ved behandling af patienter med alvorlig nyre- eller leverinsufficiens (se pkt.
Caution should be used when treating patients with severe renal or severe hepatic impairment (see section 4.4).
I kliniske studier (både kontrollerede og ikke kontrollerede) havde 9% af patienterne lymfocyttal ≥ 0,5x109/l og < 0,8x109/l i mindst 6 måneder.
In clinical studies (both controlled and uncontrolled), 9% of patients had lymphocyte counts ≥0.5 x
2% af patienterne oplevede lymfocyttal <0,5x109/l i mindst 6 måneder, og hos denne gruppe forblev størstedelen af lymfocyttællingerne < 0,5x109/l ved fortsat behandling.
109/L and <0.8 x 109/L for at least six months; 2% of patients experienced lymphocyte counts <0.5 x 109/L for at least six months, and in this group the majority of lymphocyte counts remained <0.5 x 109/L with continued therapy.
Sådan skal du tage Tecfidera
How to take Tecfidera
Indlægsseddel: Information til patienten Tecfidera 120 mg enterokapsler, hårde Tecfidera 240 mg enterokapsler, hårde dimethylfumarat
Package leaflet: Information for the patient Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules dimethyl fumarate
Denne overvejelse vil afveje fordelen for dit barn ved at amme og fordelen for dig ved behandling.
This involves balancing the benefit of breast-feeding for your child, and the benefit of therapy for you.
(95% CI) aAlle analyser af kliniske endepunkter var intent-to-treat; bMR-kohorte anvendtt ved MR-analyser *P-værdi < 0,05; **P-værdi < 0,01; ***P-værdi < 0,0001; #ikke statistisk signifikant
No. subjects Mean (median) number of new or newly enlarging T2 lesions over 2 years Lesion mean ratio (95% CI) Mean (median) number of Gd lesions at 2 years Odds ratio (95% CI) Mean (median) number of new T1 hypointense lesions over 2 years Lesion mean ratio (95% CI) aAll analyses of clinical endpoints were intent-to-treat; bMRI analysis used MRI cohort *P-value < 0.05; **P-value < 0.01; ***P-value < 0.0001; #not statistically significant
Rødme er tilbøjelig til at starte tidligt under behandlingen (primært den første måned), og kan hos patienter, som oplever rødme, optræde med mellemrum under hele Tecfidera-behandlingen.
Flushing events tend to begin early in the course of treatment (primarily during the first month) and in patients who experience flushing, these events may continue to occur intermittently throughout treatment with Tecfidera.
Oral administration af dimethylfumarat til hanrotter i doser på 75, 250 og 375 mg/kg/dag før og under parring havde ingen virkning på hannernes fertilitet op til den højeste testede dosis (mindst 2 gange den anbefalede dosis baseret på AUC).
Oral administration of dimethyl fumarate to male rats at 75, 250, and 375 mg/kg/day prior to and during mating had no effects on male fertility up to the highest dose tested (at least 2 times the recommended dose on an AUC basis).
Grønne, hårde enterokapsler, størrelse 0, præget med ‘BG-12 240 mg', der indeholder mikrotabletter.
Green gastro-resistant hard capsules, size 0, printed with ‘BG-12 240 mg' containing microtablets.
Tirs.
Tue.
Oral administration af dimethylfumarat i doser på 25, 75 og 150 mg/kg/dag til drægtige kaniner under organogenesen havde ingen virkning på den embryo-føtale udvikling, men resulterede i reduceret maternel kropsvægt ved 7 gange den anbefalede dosis og øgede antallet af aborter ved 16 gange den anbefalede dosis - baseret på AUC.
Oral administration of dimethyl fumarate at 25, 75, and 150 mg/kg/day to pregnant rabbits during organogenesis had no effect on embryo-fetal development and resulted in reduced maternal body weight at 7 times the recommended dose and increased abortion at 16 times the recommended dose, on an AUC basis.
Kontakt omgående din læge, hvis du har taget for mange kapsler.
If you have taken too many capsules, talk to your doctor straight away.
Oral administration af dimethylfumarat til hunrotter i doser på 25, 100 og 250 mg/kg/dag før og under parring og fortsat til den 7. gestationsdag, inducerede en reduktion i antallet af østrusstadier efter 14 dage og øgede antallet af dyr med forlænget diøstrus ved den højeste testede dosis (11 gange den anbefalede dosis baseret på AUC).
Oral administration of dimethyl fumarate to female rats at 25, 100, and 250 mg/kg/day prior to and during mating, and continuing to Day 7 of gestation, induced reduction in the number of estrous stages per 14 days and increased the number of animals with prolonged diestrus at the highest dose tested (11 times the recommended dose on an AUC basis).
Gastrointestinale gener er tilbøjelige til at begynde tidligt i behandlingen (primært den første måned) og kan hos patienter, som oplever gastrointestinelle gener, optræde med mellemrum under hele behandlingen.
Gastrointestinal events tend to begin early in the course of treatment (primarily during the first month) and in patients who experience gastrointestinal events, these events may continue to occur intermittently throughout treatment with Tecfidera.
Tecfidera 240 mg: Hver enterokapsel indeholder 240 mg dimethylfumarat.
Tecfidera 240 mg: Each capsule contains 240 mg of dimethyl fumarate.
Silica, kolloid, vandfri
Silica, colloidal anhydrous
Rødme (flushing)
Hot flush
Rødme og gastrointestinale gener er tilbøjelige til at opstå tidligt i behandlingen (primært den første måned), og hos patienter, der får disse bivirkninger, kan de forekomme med mellemrum under den fortsatte behandling.
Flushing and gastrointestinal events tend to begin early in the course of treatment (primarily during the first month) and in patients who experience flushing and gastrointestinal events, these events may continue to occur intermittently throughout treatment with Tecfidera.
Tecfidera er indiceret til behandling af voksne patienter med relapsing-remitterende multipel sklerose (se pkt.
Tecfidera is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5.1 for important information on the populations for which efficacy has been established).
Middel læsionsratio
Rate ratio
Tecfidera 120 mg: Hver enterokapsel indeholder 120 mg dimethylfumarat.
Tecfidera 120 mg: Each capsule contains 120 mg of dimethyl fumarate.
Den forreste del af maven hos gnavere findes ikke tilsvarende hos mennesker.
The forestomach in rodents does not have a human counterpart.
Oral administration af dimethylfumarat ved doser på 25, 100 og 250 mg/kg/dag til rotter under drægtighed og laktation resulterede i lavere kropsvægt hos F1-afkommet og forsinket kønsmodning hos F1-hanner ved 11 gange den anbefalede dosis baseret på AUC.
Oral administration of dimethyl fumarate at 25, 100, and 250 mg/kg/day to rats during pregnancy and lactation resulted in lower body weights in the F1 offspring, and delays in sexual maturation in F1 males at 11 times the recommended dose on an AUC basis.
Oral administration af dimethylfumarat i doser på 25, 100 og 250 mg/kg/dag til drægtige rotter under organogenesen resulterede i negative virkninger hos moderdyret ved 4 gange den anbefalede dosis baseret på AUC samt lav fostervægt og forsinket ossifikation (metatarsal og posterior ekstremitet falanks) ved 11 gange den anbefalede dosis baseret på AUC.
Administration of dimethyl fumarate at oral doses of 25, 100, and 250 mg/kg/day to pregnant rats during the period of organogenesis resulted in maternal adverse effects at 4 times the recommended dose on an AUC basis, and low fetal weight and delayed ossification (metatarsals and hindlimb phalanges) at 11 times the recommended dose on an AUC basis.
Hos hovedparten af de patienter, der oplevede rødme, var sværhedsgraden let til moderat.
In the majority of patients who experienced flushing, it was mild or moderate in severity.
Det skal besluttes, om amning eller behandling med Tecfidera skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
The benefit of breast-feeding for the child and the benefit of therapy for the woman should be taken into account.
Ordinerende læger og patienter skal være opmærksomme på dette i tilfælde af svær blussen eller rødme (se pkt.
Prescribers and patients should be alert to this possibility in the event of severe flushing reactions (see sections 4.2, 4.5 and 4.8).
Hver hård enterokapsel indeholder 120 mg dimethylfumarat
Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate
Tecfidera 120 mg hårde enterokapsler er grønne og hvide og præget med ‘BG-12 120 mg'.
Tecfidera 120 mg gastro-resistant hard capsules are green and white and printed with ‘BG-12 120 mg' and are available in packs containing 14 capsules.
Hver hård enterokapsel indeholder 240 mg dimethylfumarat
Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate
Sådan virker Tecfidera
How Tecfidera works
Gastrointestinale gener
Gastrointestinal
Kliniske endepunktera
Clinical Endpointsa
Hver hårde enterokapsel indeholder 120 mg dimethylfumarat Læs indlægssedlen inden brug
Each capsule contains 120 mg dimethyl fumarate Read the package leaflet before use Keep out of the sight and reach of children
Tecfidera blev evalueret i et prospektivt, åbent, ikke kontrolleret studie med 22 pædiatriske patienter i alderen 13 til 17 år (4 patienter ≤ 14 år) med RRMS.
Tecfidera was evaluated in a prospective open-label, uncontrolled study in 22 paediatric patients with
Hvis du har taget for meget Tecfidera
If you take more Tecfidera than you should
Tecfidera 120 mg enterokapsler, hårde Hver hård enterokapsel indeholder 120 mg dimethylfumarat.
Tecfidera 120mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate.
1Bivirkninger kun fra erfaring efter markedsføring
Common White blood cell count decreased Common 1 Adverse reactions derived only during post marketing experience
- medicin, der påvirker nyrerne, herunder nogle antibiotika (til behandling af infektioner),
- medicines that affect the body's immune system including other medicines used to treat
Tors.
Thu.
Hos patienter med rødme var bivirkningen let til moderat hos flertallet.
In patients with flushing, the majority had flushing events that were mild or moderate in severity.
- en alvorlig nyresygdom - en alvorlig leversygdom - en sygdom i maven eller tarmsystemet
Talk to your doctor before taking Tecfidera if you have: - severe kidney disease - severe liver disease - a disease of the stomach or bowel - a serious infection (such as pneumonia)
Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
If you forget or miss a dose, do not take a double dose.
- protein i urinen - forhøjet niveau af leverenzymer (ALAT, ASAT) i blodet
If you have a serious infection (such as pneumonia), talk to your doctor immediately proteins (albumin) in urine increase in levels of liver enzymes (ALT, AST) in the blood
Tecfidera 240 mg hårde enterokapsler er grønne og præget med ‘BG-12 240 mg'.
Tecfidera 240 mg gastro-resistant hard capsules are green and printed with ‘BG-12 240 mg' and are available in packs containing 56 or 168 capsules.
Hård enterokapsel
Hepatic impairment
Langvarig (> 4 uger) vedvarende brug af acetylsalicylsyre er ikke blevet undersøgt (se pkt.
Potential risks associated with acetylsalicylic acid therapy should be considered prior to co-administration with Tecfidera in patients with Relapsing Remitting MS. Long term (> 4 weeks) continuous use of acetylsalicylic acid has not been studied (see sections 4.4 and 4.8).
Tecfidera 240 mg hårde enterokapsler dimethylfumarat
Tecfidera 240 mg gastro-resistant hard capsules dimethyl fumarate
Tecfidera 120 mg hårde enterokapsler dimethylfumarat
Tecfidera 120 mg gastro-resistant hard capsules dimethyl fumarate
Bivirkninger, som kan påvises i blod- eller urinprøver
Side effects which may show up in your blood or urine tests low levels of white blood cells (lymphopenia, leucopenia) in the blood.
Tecfidera 240 mg enterokapsler, hårde
Tecfidera 240mg gastro-resistant hard capsules
Gennemsnitligt antal (medianværdi) Gdlæsioner efter 2 år
Proportion with 12-week confirmed disability progression
Tecfidera 120 mg enterokapsler, hårde
Tecfidera 120mg gastro-resistant hard capsules
Tecfidera 240 mg enterokapsler, hårde Hver hård enterokapsel indeholder 240 mg dimethylfumarat.
Tecfidera 240mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate For the full list of excipients, see section 6.1.
Smerter i den øverste del af abdomen
Abdominal pain upper
Endepunkter ved MRskanningb
MRI Endpointsb
Hensigtsmæssige forholdsregler til at håndtere og minimere risici herunder behovet for tæt monitorering under og efter administration af BRINAVESS.
Appropriate measures to manage and minimize the risks, including the need for close monitoring during and after administration of BRINAVESS.
• Akut koronarsyndrom (herunder myokardieinfarkt) inden for de seneste 30 dage.
• Acute coronary syndrome (including myocardial infarction) within the last 30 days
Kriterier til udvælgelse af patienter herunder kontraindikationer, særlige advarsler og forholdsregler for anvendelse og information om patientpopulationer, hvor der er begrænset information fra kliniske undersøgelser.
Patient selection criteria, including contraindications, special warnings and precautions for use and information about patient populations with limited information from clinical trials.
Medlemslandene skal sikre, at alle betingelser eller restriktioner vedrørende sikker og effektiv anvendelse af lægemidlet som beskrevet nedenfor, bliver implementeret:
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Indehaveren af markedsføringstilladelsen skal sikre, at alle i sundhedspersonalet, der er involveret i administration af BRINAVESS, får informationspakken til læger og sundhedspersonale, som indeholder følgende:
The Marketing Authorisation Holder shall ensure that all Healthcare Professionals (HCP) involved in the administration of BRINAVESS are provided with a healthcare professional information pack containing the following:
Det antal hætteglas af BRINAVESS-koncentrat, der er nødvendigt for at tilberede den rigtige mængde opløsning til behandling af den enkelte patient, afhænger af patientens vægt og størrelsen på hætteglasset.
The number of vials of BRINAVESS concentrate required to prepare the appropriate quantity of solution for the treatment of an individual patient will depend on the patient's weight, and the vial size.
Kun en velkvalificeret læge må administrere BRINAVESS, og patienten skal monitoreres hyppigt under hele infusionsforløbet og i mindst 15 minutter efter afsluttet infusion for tegn og symptomer på pludseligt fald i blodtryk eller hjertefrekvens (se pkt.
Only a well-qualified healthcare professional should administer BRINAVESS and should frequently monitor the patient for the duration of the infusion and for at least 15 minutes after the completion of the infusion for signs and symptoms of a sudden decrease in blood pressure or heart rate (see section 4.4).