natgillin/translations-raw huggingface dataset:
Findings in the forestomach of mice and rats consisted of squamous epithelial hyperplasia and hyperkeratosis; inflammation; and squamous cell papilloma and carcinoma in studies of 3 months or longer in duration.
Izsledki v predželodcu miši in podgan so v 3-mesečnih in daljših študijah so bili sestavljeni iz ploščatocelične hiperplazije in hiperkeratoze epitelija in vnetje ter ploščatocelični papilom in karcinom.
A lymphocyte count <0.2x109/l was observed in 1 patient treated with Tecfidera and in no patients treated with placebo.
< 0,2 x 109/l so opazili pri 1 bolniku, zdravljenim z zdravilom Tecfidera, in pri nobenem od bolnikov, ki so prejemali placebo.
Tecfidera is not recommended during pregnancy and in women of childbearing potential not using appropriate contraception (see section 4.5).
Zdravila Tecfidera ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo ustrezne kontracepcije (glejte poglavje
Concomitant administration of non-live vaccines according to national vaccination schedules may be considered during Tecfidera therapy.
Med zdravljenjem z zdravilom Tecfidera lahko pride v poštev sočasna uporaba neživih cepiv v skladu z nacionalnimi programi cepljenja.
In dogs that received daily oral doses of dimethyl fumarate for 11 months, the margin calculated for cortical atrophy was observed at 3 times the recommended dose based on AUC.
Pri psih, ki so 11 mesecev prejemali dnevne peroralne odmerke dimetilfumarata, so opazili izračunano mejo za kortikalno atrofijo pri 3-kratniku priporočenega odmerka na osnovi AUC.
Resolution of the adverse reactions has been observed after treatment was discontinued.
Ti neželeni učinki so izzveneli po prekinitvi zdravljenja.
The effect of Tecfidera on the ability to drive or use machines is not known.
Učinek zdravila Tecfidera na sposobnost vožnje ali upravljanja strojev ni znan.
Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA
Renal tubule epithelial regeneration, suggestive of injury, was observed in all species.
Pri vseh vrstah so opazili regeneracijo epitelija ledvičnih tubulov, kar kaže na poškodbo.
Drug-induced liver injury, including liver enzyme increase (≥ 3 upper limit of normal (ULN)) and elevation of total bilirubin levels (≥ 2 ULN) can result from treatment with dimethyl fumarate.
Zaradi zdravljenja z dimetilfumaratom lahko nastanejo okvare jeter, povzročene z zdravilom, vključno z zvišanjem jetrnih encimov (≥ 3 zgornja meja normalnih vrednosti (upper limit of normal - ULN)) in zvišanjem koncentracije celotnega bilirubina (≥ 2 ULN).
The incidence of gastrointestinal events (e.g. diarrhoea [14% versus 10%], nausea [12% versus 9%], upper abdominal pain [10% versus 6%], abdominal pain [9% versus 4%], vomiting [8% versus 5%] and dyspepsia [5% versus 3%]) was increased in patients treated with Tecfidera compared to placebo, respectively.
9 %], bolečina v zgornjem delu trebuha [10 % v primerjavi s 6 %], bolečina v trebuhu [9 % v primerjavi s 4 %], bruhanje [8 % v primerjavi s 5 %] in dispepsija [5 % v primerjavi s 3 %]) je bila večja pri bolnikih, zdravljenih z zdravilom Tecfidera, kot pri bolnikih, zdravljenih s placebom.
Serious effects
Resni neželeni učinki
Tecfidera has not been studied in patients with severe active gastrointestinal disease and caution should, therefore, be used in these patients.
Zdravila Tecfidera niso preučili pri bolnikih s hudo aktivno boleznijo prebavil, zato je pri teh bolnikih potrebna previdnost.
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.
V klinični študiji, ki je zajela vsega skupaj 71 bolnikov z recidivno remitentno multiplo sklerozo, so bolniki, ki so prejemali zdravilo Tecfidera v odmerku 240 mg dvakrat na dan, vsaj 6 mesecev (n=38) ali nepegiliran interferon vsaj 3 mesece (n=33), razvili primerljiv imunski odziv (definiran kot ≥2-kratno zvečanje titra pred cepljenjem na titer po cepljenju) na tetanusni toksoid (spominski antigen) in na konjugirano meningokokno C polisaharidno cepivo
No untoward clinical consequences were observed in clinical trials.
kliničnih preskušanjih niso opazili neugodnih kliničnih posledic.
(95% CI)
Razmerje obetov (95-% IZ)
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.
V študijah, kontroliranih s placebom, se je incidenca vročinskega oblivanja (34 % v primerjavi s 4 %) in vročinskih valov (7 % v primerjavi z 2 %) zvišala pri bolnikih, zdravljenih z zdravilom Tecfidera v primerjavi z bolniki, zdravljenimi s placebom.
Aspartate aminotransferase increased Common Alanine aminotransferase increased Common Drug-induced liver injury1
Bolezni jeter, žolčnika in žolčevodov zvišana aspartat aminotransferaza pogosti zvišana alanin aminotransferaza pogosti z zdravili povzročena okvara jeter1
Laboratory abnormalities
Nenormalni laboratorijski testi
In monkeys that received daily oral doses of dimethyl fumarate for 12 months, single cell necrosis was observed at 2 times the recommended dose based on AUC.
Pri opicah, ki so 12 mesecev prejemale dnevne peroralne odmerke dimetilfumarata, so opazili nekrozo posamičnih celic pri 2-kratniku priporočenega odmerka na osnovi AUC.
Changes in renal laboratory tests have been seen in clinical trials in subjects treated with dimethyl fumarate (see section 4.8).
V kliničnih preskušanjih so pri bolnikih, zdravljenih z dimetilfumaratom, opazili spremembe ledvičnih laboratorijskih testov (glejte poglavje 4.8).
Green and white gastro-resistant hard capsules, size 0, printed with ‘BG-12 120 mg' containing microtablets.
Zelene in bele gastrorezistentne trde kapsule, velikosti 0, z napisom ‘BG-12 120 mg', ki vsebujejo mikrotablete.
Tecfidera treatment should be started gradually to reduce the occurrence of flushing and gastrointestinal adverse reactions (see section 4.2).
Zdravljenje z zdravilom Tecfidera je treba uvajati postopoma, da zmanjšamo pogostnost vročinskega oblivanja in neželenih učinkov na prebavila (glejte poglavje 4.2).
Following 240 mg twice a day administered with food, the median peak (Cmax) was 1.72 mg/l and overall area under the curve (AUC) exposure was 8.02 h.mg/l in subjects with multiple sclerosis.
Po dajanju 240 mg dvakrat na dan s hrano je bila pri osebah z multiplo sklerozo mediana najvišje koncentracije (Cmax) 1,72 mg/l in celotna površina pod krivuljo (AUC)
The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class.
Neželeni učinki so navedeni z izrazi, ki jih priporoča MedDRA, in glede na MedDRA organske sisteme.
How to take Tecfidera
Kako jemati zdravilo Tecfidera
Dimethyl fumarate was negative in the in vivo micronucleus assay in the rat.
Dimetilfumarat je bil pri podganah v preskusu mikronukleusov in vivo negativen.
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
Pojavijo se lahko pri več kot 1 od 10 bolnikov: - rdečina obraza ali telesa, občutek toplote, vročine, pekoč občutek ali občutek srbenja (vročinsko oblivanje) - redko blato (driska) - siljenje na bruhanje (navzea)
No studies have been performed evaluating the efficacy and safety of Tecfidera when switching patients from other disease modifying therapies to Tecfidera.
Predhodno zdravljenje z imunosupresivnimi ali imunomodulirajočimi zdravili Študije, ki bi ocenjevale učinkovitost in varnost zdravila Tecfidera pri prehodu zdravljenja bolnikov z drugih zdravljenj, ki spreminjajo potek bolezni, na zdravljenje z zdravilom Tecfidera, niso bile izvedene.
Green gastro-resistant hard capsules, size 0, printed with ‘BG-12 240 mg' containing microtablets.
Zelene gastrorezistentne trde kapsule, velikosti 0, z napisom ‘BG-12 240 mg', ki vsebujejo mikrotablete.
How Tecfidera works
Kako deluje zdravilo Tecfidera
Regular dose 240 mg twice a day.
Redni odmerek 240 mg dvakrat na dan.
Feeling hot
Vročinsko oblivanje
Upon treatment with Tecfidera, mean lymphocyte counts decreased over the first year with a subsequent plateau.
Po zdravljenju z zdravilom Tecfidera se je povprečno število limfocitov v prvem letu zmanjšalo, preden je doseglo konstantno raven.
A single 240 mg 14C-dimethyl fumarate dose study identified glucose as the predominant metabolite in human plasma.
dimetilfumarata so identificirali glukozo kot prevladujoči presnovek v plazmi pri človeku.
Hazard ratio (95% CI) Proportion with 24 week confirmed disability progression Hazard ratio (95% CI)
Št. oseb Letni delež recidiva Razmerje pogostnosti (95-% IZ) Delež recidiva Razmerje tveganj (95-% IZ) Delež z 12-tedenskim potrjenim napredovanjem bolezni Razmerje tveganj (95-% IZ) Delež s 24-tedenskim potrjenim napredovanjem bolezni Razmerje tveganj (95-% IZ)
In clinical trials, 3 patients out of a total of 2,560 patients treated with dimethyl fumarate experienced serious flushing symptoms that were probable hypersensitivity or anaphylactoid reactions.
V kliničnih preskušanjih so 3 bolniki od skupaj 2.560 bolnikov, zdravljenih z dimetilfumaratom,
Consider withholding Tecfidera treatment in patients with serious infections until the infection has resolved (see section 4.8).
Pri bolnikih z resnimi okužbami je treba razmisliti o začasni prekinitvi zdravljenja z zdravilom Tecfidera, dokler okužba ne izzveni (glejte poglavje 4.8).
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.
Zdravilo Tecfidera 120 mg gastrorezistentne trde kapsule so zelene in bele z natisom "BG-12 120 mg"; na voljo so v pakiranjih, ki vsebujejo po 14 kapsul.
Hypotension1
neznana hipotenzija1
Herpes zoster (shingles) may occur with Tecfidera treatment.
Pri zdravljenju z zdravilom Tecfidera se lahko pojavi herpes zoster (pasovec).
Tecfidera is for oral use
Zdravilo Tecfidera je za peroralno uporabo.
In case of unclear symptoms Fanconi syndrome should be considered and appropriate examinations should be performed.
Fanconijev sindrom in opraviti ustrezne preiskave.
However, Tecfidera should be taken with food due to improved tolerability with respect to flushing or gastrointestinal adverse events (see section 4.2).
Vendar pa je treba zdravilo Tecfidera jemati s hrano zaradi boljšega prenašanja vročinskega oblivanja ali prebavnih neželenih učinkov (glejte poglavje 4.2).
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).
Peroralno dajanje dimetilfumarata podganjim samcem v odmerkih 75, 250 in 375 mg/kg/dan pred parjenjem in med njim ni vplivalo na plodnost samcev do najvišjega testiranega odmerka (vsaj 2kratnik priporočenega odmerka na osnovi AUC).
The mechanism of dimethyl fumarate induced anaphylaxis is unknown.
Mehanizem anafilaksije, ki jo povzroča dimetilfumarat, je neznan.
Due to the design of the studies, high disease activity was defined as follows: - Patients with 2 or more relapses in one year, and with one or more Gd-enhancing lesions on brain MRI (n=42 in DEFINE; n=51 in CONFIRM) or, - Patients who have failed to respond to a full and adequate course (at least one year of treatment) of beta-interferon, having had at least 1 relapse in the previous year while on therapy, and at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gd-enhancing lesion, or patients having an unchanged or increased relapse rate in the prior year as compared to the previous 2 years (n=177 in DEFINE; n=141 in CONFIRM).
(n = 42 za DEFINE; n = 51 za CONFIRM) ali - bolniki, ki se niso odzivali na poln in ustrezen cikel (vsaj eno leto zdravljenja) z betainterferoni, ki so imeli v preteklem letu vsaj 1 recidiv, medtem ko so se zdravili, in ki so imeli vsaj 9 T2-hiperintenzivnih lezij na MRS možganov ali vsaj 1 lezijo, vidno z Gd, ali bolniki, ki so v preteklem letu imeli nespremenjeno ali večje število lezij v primerjavi s prejšnjima
Overall, 3% of patients treated with Tecfidera discontinued due to flushing.
Na splošno so se zaradi vročinskega oblivanja 3 % bolnikov, zdravljenih z zdravilom Tecfidera, prenehali zdraviti.
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).
Peroralno dajanje dimetilfumarata podganjim samicam v odmerkih 25, 100 in 250 mg/kg/dan pred parjenjem in med njim ter nadaljevanje do 7. dne brejosti je povzročilo zmanjšanje števila estrusnih stopenj na 14 dni in zvišanje števila živali s podaljšanjem diestrusa pri najvišjem testiranem odmerku (11-kratnik priporočenega odmerka na osnovi AUC).
Contents of the pack and other information
Shranjevanje zdravila Tecfidera Vsebina pakiranja in dodatne informacije
Kidney changes were observed after repeated oral administration of dimethyl fumarate in mice, rats, dogs, and monkeys.
Po ponavljajočem se peroralnem dajanju dimetilfumarata mišim, podganam, psom in opicam so opazili spremembe na ledvicah.
In the majority of patients who experienced flushing, it was mild or moderate in severity.
Pri večini bolnikov, pri katerih so se prebavni dogodki pojavljali, so bili blagi ali zmerni.
Consumption of large quantities of strong alcoholic drinks (more than 30% alcohol by volume) should be avoided within an hour of taking Tecfidera, as alcohol may lead to increased frequency of gastrointestinal adverse reactions.
se je treba eno uro pred jemanjem in eno uro po jemanju zdravila Tecfidera izogibati, ker alkohol lahko zviša pogostnost neželenih učinkov na prebavila.
The apparent volume of distribution following oral administration of 240 mg dimethyl fumarate varies between 60 L and 90 L. Human plasma protein binding of monomethyl fumarate generally ranges between 27% and 40%.
Porazdelitev Navidezni volumen porazdelitve po peroralni uporabi 240 mg dimetilfumarata je med 60 l in 90 l.
Patients should be instructed to discontinue Tecfidera and seek immediate medical care if they experience signs or symptoms of anaphylaxis.
Bolnike je treba poučiti, naj v primeru pojava znakov ali simptomov anafilaksije prenehajo jemati zdravilo Tecfidera in poiščejo takojšnjo medicinsko pomoč.
Data from preclinical studies do not suggest that dimethyl fumarate would be associated with an increased risk of reduced fertility (see section 5.3).
da bi bil dimetilfumarat povezan s povečanim tveganjem za zmanjšano plodnost (glejte poglavje 5.3).
In the testes, degeneration of the seminiferous epithelium was seen in rats and dogs.
V modih so pri podganah in psih ugotovili degeneracijo seminifernega epitelija.
The benefit/risk in patients with lymphocyte counts ≥0.5 x 109/L and <0.8 x 109/L for more than six months should be assessed.
Pri bolnikih, pri katerih je število limfocitov več kot šest mesecev ≥ 0,5 x 109/l in < 0,8 x 109/l, je treba oceniti razmerje med koristjo in tveganjem.
Tecfidera 240 mg: Each capsule contains 240 mg of dimethyl fumarate.
Tecfidera 240 mg: ena kapsula vsebuje 240 mg dimetilfumarata.
If you forget or miss a dose, do not take a double dose.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
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.
Peroralno dajanje dimetilfumarata pri odmerkih 25, 75 in 150 mg/kg/dan brejim kunčicam med organogenezo ni vplivalo na razvoj zarodka/ploda in je pri 7-kratniku priporočenega odmerka na podlagi AUC povzročilo zmanjšanje telesne mase kunčice in pri 16-kratniku priporočenega odmerka na podlagi AUC povečanje abortusov.
Levels of 1,25-dihydroxyvitamin D decreased in Tecfidera treated patients relative to placebo (median percentage decrease from baseline at 2 years of 25% versus 15%, respectively) and levels of parathyroid hormone (PTH) increased in Tecfidera treated patients relative to placebo (median percentage increase from baseline at 2 years of 29% versus 15%, respectively).
2 letih 25 % v primerjavi s 15 %), ravni paratiroidnega hormona (PTH) pa so se pri bolnikih, zdravljenih z zdravilom Tecfidera, v primerjavi z bolniki, ki so prejemali placebo, zvišale (mediana odstotka zvišanja od izhodišča pri 2 letih 29 % v primerjavi s 15 %).
Tecfidera 120 mg: Each capsule contains 120 mg of dimethyl fumarate.
Tecfidera 120 mg: ena kapsula vsebuje 120 mg dimetilfumarata.
The active substance is dimethyl fumarate.
Učinkovina je dimetilfumarat.
Consumption of more than a small quantity (more than 50 ml) of strong alcoholic drinks (more than 30% alcohol by volume, e.g. spirits) should be avoided within an hour of taking Tecfidera, as alcohol can interact with this medicine.
Zaužitju močnih alkoholnih pijač (več kot 30 vol. % alkohola, npr. žganja) v količinah, ki niso majhne
Dimethyl fumarate exposure increases in an approximately dose proportional manner with single and multiple doses in the 120 mg to 360 mg dose range studied.
Linearnost Pri preučevanih enkratnih in večkratnih odmerkih razpona odmerka 120 mg in 360 mg se izpostavljenost dimetilfumaratu veča približno sorazmerno z odmerkom.
If JCV testing is undertaken, it should be considered that the influence of lymphopenia on the accuracy of anti-JCV antibody test has not been studied in dimethyl fumarate treated patients.
zdravljenih z dimetilfumaratom, vpliv limfopenije na točnost testa za določanje protiteles proti virusu JC ni raziskan.
14 gastro-resistant hard capsules
14 gastrorezistentnih trdih kapsul
- liver inflammation and increase in levels of liver enzymes (ALT or AST in combination with bilirubin)
Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) - vnetje jeter in zvišanje ravni jetrnih encimov (ALT ali AST v kombinaciji z bilirubinom)
Cases of anaphylaxis/anaphylactoid reaction have been reported following Tecfidera administration in the post-marketing setting.
V obdobju trženja zdravila so poročali o primerih anafilaksije/anafilaktoidne reakcije po uporabi zdravila Tecfidera.
However, due to Tecfidera immunomodulatory properties (see section 5.1), if a patient develops a serious infection, suspending treatment with Tecfidera should be considered and the benefits and risks should be reassessed prior to re-initiation of therapy.
premisliti o začasni prekinitvi zdravljenja z zdravilom Tecfidera in pred ponovno uvedbo zdravljenja spet oceniti koristi in tveganja, če se pri bolniku razvije resna okužba.
There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or <0.5x109/L (see Section 4.8).
Pri bolnikih s številom limfocitov < 0,8 x 109/l ali < 0,5 x 109/l niso opazili zvišanja incidence resnih okužb (glejte poglavje 4.8).
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).
Sočasno zdravljenje z nefrotoksičnimi zdravili (kot so aminoglikozidi, diuretiki, nesteroidna protivnetna zdravila ali litij) lahko poveča možnost neželenih učinkov na ledvice (npr. proteinurija,
These may affect up to 1 in 100 people: - Allergic reactions (hypersensitivity) - reduction in blood platelets
- alergijske reakcije (preobčutljivost) - zmanjšanje števila trombocitov
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.
Vročinsko oblivanje in prebavni dogodki so se pojavili na začetku zdravljenja (v glavnem so se pojavili v prvem mesecu), pri čemer se lahko pri bolnikih, pri katerih se pojavi vročinsko oblivanje in prebavni dogodki, ti dogodki občasno pojavljajo ves čas zdravljenja z zdravilom Tecfidera.
Symptoms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or personality changes lasting for more than several days.
Simptomi lahko vključujejo novo nastalo ali poslabšano oslabelost ene strani telesa, okornost, spremembe vida,
Herpes zoster infections have been reported with Tecfidera use.
Pri uporabi zdravila Tecfidera so poročali o okužbah s herpesom zostrom.
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
aVse analize kliničnih opazovanih dogodkov so bile z namenom zdravljenja; bv analizi MRS je bila uporabljena skupina MRS *vrednost P < 0,05; **vrednost P < 0,01; ***vrednost P < 0,0001; #ni statistično značilno
Methacrylic acid - methyl methacrylate copolymer (1:1) Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30% Simeticone
mikrokristalna celuloza premrežen natrijev karmelozat smukec brezvoden koloidni silicijev dioksid magnezijev stearat trietil citrat metakrilna kislina - metil metakrilat kopolimer (1:1) metakrilna kislina - etil akrilat kopolimer (1:1) disperzija 30 % simetikon natrijev lavrilsulfat polisorbat 80
Severe active gastrointestinal disease
Huda aktivna bolezen prebavil
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
- beljakovine (albumin) v seču - zvišanje ravni jetrnih encimov (ALT, AST) v krvi
Grade 2 and 3 lymphopenia prevailed in subjects with concurrent lymphocytopenia.
Pri preiskovancih s sočasno limfocitopenijo je prevladovala limfopenija 2. in 3. stopnje.
Pharmacodynamic effects
Farmakodinamični učinki Učinki na imunski sistem
Accumulation of parent drug or monomethyl fumarate does not occur with multiple doses of dimethyl fumarate at the therapeutic regimen.
Pri več odmerkih dimetilfumarata pri terapevtskem režimu ne pride do kopičenje izhodne učinkovine ali monometil fumarata.
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.
Dajanje dimetilfumarata v peroralnih odmerkih 25, 100 in 250 mg/kg/dan brejim podganam v obdobju organogeneze je povzročilo neželene učinke za mater pri 4-kratniku priporočenega odmerka na podlagi AUC, nizko telesno maso plodov in zapoznelo okostenitev (stopalnic in prstnic zadnjih tac) pri 11-kratniku priporočenega odmerka na podlagi AUC.