natgillin/translations-raw huggingface dataset:
Over the full treatment period (120-week), ARR was 0.2 representing an 84.5% relative reduction in relapses (n=20; 95% CI [66.8, 92.8], p<0.0001), when compared to the year prior to treatment initiation.
(n = 20; 95% CI [66,8, 92,8], p < 0,0001) u odnosu na godinu prije početka liječenja.
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.
Expanded Disability Status Scale, EDSS) u rasponu od 0 do 5 uključivo, koji su doživjeli barem 1 relaps tijekom godine prije randomizacije, ili im je u 6 tjedana prije randomizacije provedena magnetska rezonancija (MR) mozga koja je pokazala barem jednu gadolinij-pozitivnu (Gd+) leziju.
Tecfidera is not expected to affect your ability to drive and use machines.
Ne očekuje se da će Tecfidera utjecati na sposobnost upravljanja vozilima i rada na strojevima.
Adverse reactions, which were more frequently reported in Tecfidera versus placebo-treated patients, are presented in the table below.
Nuspojave, koje su češće prijavljene u bolesnika koji su primali Tecfideru u odnosu na bolesnike koji su primali placebo, prikazane su u donjoj tablici.
Increase of liver enzymes and cases of drug-induced liver injury (elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN), have been reported in post marketing experience following Tecfidera administration, which resolved upon treatment discontinuation.
Povišenje jetrenih enzima i slučajevi oštećenja jetre izazvanog lijekom (povišenja transaminaza ≥3 puta GGN uz istodobna povišenja ukupnog bilirubina >2 puta GGN) prijavljeni su kod primjene Tecfidere nakon stavljanja lijeka u promet, a nestali su s prestankom liječenja.
There are no or limited amount of data from the use of dimethyl fumarate in pregnant women.
Nema podataka ili su podaci o primjeni dimetilfumarata u trudnica ograničeni.
The chronic dog study was conducted with oral administration of the dimethyl fumarate capsule.
Ispitivanje kronične toksičnosti u pasa provedeno je peroralnom primjenom kapsula dimetilfumarata.
Elevations of alanine aminotransferase and aspartate aminotransferase ≥3 times ULN, respectively, were seen in 5% and 2% of patients treated with placebo and 6% and 2% of patients treated with Tecfidera.
Povišenje razina alanin aminotransferaze i aspartat aminotransferaze ≥3 puta GGN, primijećeno je kod 5% odnosno 2% bolesnika koji su dobivali placebo te 6% i 2% bolesnika liječenih Tecfiderom.
In the MRI cohort 36% of patients entering the study had Gd+ lesions at baseline (mean number of Gd+ lesions 1.4).
U MR kohorti 36% bolesnika koji su ušli u ispitivanje imali su Gd+ lezije na početku (srednja vrijednost broja Gd+ lezija 1,4).
Two, 2-year, randomised, double-blind, placebo controlled studies [Study 1 (DEFINE) with 1234 subjects and Study 2 (CONFIRM) with 1417 subjects] of subjects with relapsing-remitting multiple sclerosis (RRMS) were performed.
Provedena su dva 2-godišnja, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja u ispitanika s relapsno-remitirajućom multiplom sklerozom (RRMS) [Ispitivanje 1 (DEFINE) s 1234 ispitanika i Ispitivanje 2 (CONFIRM) s 1417 ispitanika].
It is not known whether the active substance of Tecfidera passes into breast milk.
Nije poznato izlučuje li se djelatna tvar iz Tecfidere u majčino mlijeko.
The active substance is dimethyl fumarate.
Djelatna tvar je dimetilfumarat.
Patients subsequently entered an extension study for a further 96 weeks.
Bolesnici su potom sudjelovali u nastavku ispitivanja tijekom dodatnih
Aspartate aminotransferase increased Common Alanine aminotransferase increased Common Drug-induced liver injury1
Poremećaji jetre i žuči povišena aspartat aminotransferaza često povišena alanin aminotransferaza često oštećenje jetre izazvano lijekom1 nepoznato
How to take Tecfidera
Kako uzimati Tecfideru
In Phase 3 studies in MS patients, upon treatment with Tecfidera mean lymphocyte counts decreased on average by approximately 30% of their baseline value over the first year with a subsequent plateau.
U ispitivanjima faze 3 u bolesnika s multiplom sklerozom, nakon liječenja Tecfiderom, srednja vrijednost broja limfocita smanjivala se u prosjeku za otprilike 30% od početne vrijednosti tijekom prve godine nakon čega je uslijedio plato.
The effect of Tecfidera on the ability to drive or use machines is not known.
Učinak Tecfidere na sposobnost upravljanja vozilima i rada na strojevima nije poznat.
Dimethyl fumarate and mono-methylfumarate were negative in a battery of in vitro assays (Ames, chromosomal aberration in mammalian cells).
Dimetilfumarat i monometilfumarat bili su negativni u nizu in vitro testova za ispitivanje mutagenosti (Amesov test, kromosomska aberacija u stanicama sisavaca).
In clinical trials, 34% of Tecfidera treated patients experienced flushing.
U kliničkim ispitivanjima kod 34% bolesnika liječenih Tecfiderom pojavila se navala crvenila.
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.
Budući da esteraze metaboliziraju dimetilfumarat i monometilfumarat, bez posredovanja sustava CYP450, procjena farmakokinetike u pojedinaca s oštećenjem jetre nije provedena.
However, when reported, most patients experienced grade 2 (< 0.8 × 109/L to 0.5 × 109/L) or grade 3 (<0.5 × 109/L to 0.2 × 109/L) lymphopenia (see section 4.4).
Međutim, unutar prijavljenih slučajeva u većine bolesnika prijavljena je limfopenija 2. stupnja (< 0,8 × 109/l do 0,5 × 109/l) ili 3. stupnja (< 0,5 × 109/l do 0,2 × 109/l) (vidjeti dio 4.4).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER FOLIJA
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).
Tecfidera nije ispitivana u bolesnika s teškim oštećenjem bubrega ili jetre pa je potreban oprez pri liječenju takvih bolesnika (vidjeti dio 4.2).
In the majority of patients who experienced gastrointestinal events, it was mild or moderate in severity.
U većine bolesnika kod kojih su se javile gastrointestinalne smetnje, one su bile blage ili umjerene.
Green and white gastro-resistant hard capsules, size 0, printed with ‘BG-12 120 mg' containing microtablets.
Zelene i bijele tvrde želučanootporne kapsule, veličine 0, s otisnutom oznakom „BG-12 120 mg“, koje sadrže mikrotablete.
Small numerical differences in the response to tetanus toxoid and pneumococcal serotype 3 polysaccharide were noted in favour of non-pegylated interferon.
Zabilježen je nešto veći broj bolesnika s odgovorom na toksoid tetanusa i pneumokokni polisaharid serotipa 3 u skupini koja je primala nepegilirani interferon.
Upon treatment with Tecfidera, mean lymphocyte counts decreased over the first year with a subsequent plateau.
Nakon liječenja Tecfiderom, srednja vrijednost broja limfocita smanjivala se tijekom prve godine, nakon čega je uslijedio plato.
Caution should be used when treating patients with severe renal or severe hepatic impairment (see section 4.4).
Potreban je oprez u liječenju bolesnika s teškim oštećenjem bubrega ili teškim oštećenjem jetre (vidjeti dio 4.4).
Lymphocyte counts <0.5x109/l were observed in <1% of patients treated with placebo and 6% of patients treated with Tecfidera.
Vrijednosti broja limfocita <0,5x109/l opažene su u <1% bolesnika na placebu i u 6% bolesnika liječenih Tecfiderom.
The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class.
Nuspojave su prikazane kao preporučeni MedDRA termini prema MedDRA klasifikaciji organskih sustava.
In the MRI cohort 45% of patients entering the study had Gd+ lesions at baseline (mean number of Gd+ lesions 2.4).
U MR kohorti 45% bolesnika koji su ušli u ispitivanje imali su Gd+ lezije na početku (srednja vrijednost broja Gd+ lezija 2,4).
Regular dose 240 mg twice a day.
Redovna doza 240 mg dva puta na dan
Not known (frequency cannot be estimated from the available data)
- smanjenje broja krvnih pločica Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)
Changes in renal laboratory tests have been seen in clinical trials in subjects treated with dimethyl fumarate (see section 4.8).
U kliničkim ispitivanjima u ispitanika liječenih dimetilfumaratom primijećene su promjene u laboratorijskim testovima bubrega (vidjeti dio 4.8).
In clinical studies with psoriasis patients, dimethyl fumarate affected lymphocyte phenotypes through a down-regulation of pro-inflammatory cytokine profiles (TH1, TH17), and biased towards anti-inflammatory production (TH2).
dimetilfumarat je utjecao na fenotipove limfocita preko smanjenja profila proupalnih citokina (TH1, TH17) te je bio pristran prema protuupalnoj produkciji (TH2).
Preclinical studies indicate that dimethyl fumarate pharmacodynamic responses appear to be primarily mediated through activation of the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway.
Pretklinička ispitivanja pokazuju da dimetilfumarat izaziva farmakodinamičke odgovore prvenstveno aktivacijom signalnog puta nuklearnog transkripcijskog faktora Nrf2 [engl. nuclear factor
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.
Incidencija gastrointestinalnih smetnji (npr. proljev [14% u odnosu na 10%], mučnina [12% u odnosu na 9%], bol u gornjem dijelu trbuha [10% u odnosu na 6%], bol u trbuhu [9% u odnosu na 4%],
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
Mogu se javiti u više od 1 na 10 osoba: - crvenjenje lica ili tijela, osjećaj topline, vrućine, žarenja ili svrbeža (navala crvenila) - mekane stolice (proljev)
Effects on the immune system In preclinical and clinical studies, dimethyl fumarate demonstrated anti-inflammatory and immunomodulatory properties.
U pretkliničkim i kliničkim ispitivanjima dimetilfumarat je pokazao protuupalna i imunomodulacijska svojstva.
Green gastro-resistant hard capsules, size 0, printed with ‘BG-12 240 mg' containing microtablets.
Zelene tvrde želučanootporne kapsule, veličine 0, s otisnutom oznakom „BG-12 240 mg“, koje sadrže mikrotablete.
The majority of cases were non-serious, however, serious cases, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster oticus, herpes zoster infection neurological, herpes zoster meningoencephalitis and herpes zoster meningomyelitis have been reported.
očni herpes zoster, ušni herpes zoster, herpes zoster infekciju neurološkog sustava, meningoencefalitis uzrokovan herpes zosterom te meningomijelitis uzrokovan herpes zosterom.
Evidence from healthy volunteer studies suggests that Tecfidera-associated flushing is likely to be prostaglandin mediated.
Dokazi iz ispitivanja sa zdravim dobrovoljcima ukazuju na to da je navala crvenila povezana s Tecfiderom najvjerojatnije posredovana prostaglandinima.
PML has occurred in the setting of moderate to severe prolonged lymphopenia (see section 4.4).
PML se pojavio u uvjetima umjerene do teške i produljene limfopenije (vidjeti dio 4.4).
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.
Gastrointestinalne smetnje imaju tendenciju pojave rano u tijeku liječenja (prvenstveno u prvom mjesecu) i u bolesnika s gastrointestinalnim smetnjama, te su se smetnje ponekad isprekidano ponavljale i tijekom daljnjeg liječenja Tecfiderom.
56 gastro-resistant hard capsules 168 gastro-resistant hard capsules
56 tvrdih želučanootpornih kapsula 168 tvrdih želučanootpornih kapsula
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).
Peroralna primjena dimetilfumarata u mužjaka štakora od 75, 250 i 375 mg/kg/dan prije i za vrijeme parenja nije imala utjecaja na mušku plodnost do najviše testirane doze (najmanje 2 puta veće od preporučene doze na temelju AUC-a).
Tecfidera should not be used during breast-feeding.
Tecfideru se ne smije uzimati dok dojite.
The forestomach in rodents does not have a human counterpart.
Predželudac u glodavaca nema ekvivalenta u ljudi.
 Stop taking Tecfidera and call a doctor straight away Very common side effects
Prekinite uzimanje Tecfidere i javite se odmah liječniku.
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.
U placebom kontroliranim ispitivanjima, incidencija navale crvenila (34% u odnosu na 4%) odnosno navale vrućine (7% u odnosu na 2%) bila je povećana u bolesnika liječenih Tecfiderom u usporedbi s placebom.
Renal tubule epithelial regeneration, suggestive of injury, was observed in all species.
U svih vrsta životinja primijećena je regeneracija bubrežnog tubularnog epitela, što upućuje na pojavu ozljede.
Dimethyl fumarate was negative in the in vivo micronucleus assay in the rat.
Dimetilfumarat je bio negativan u in vivo mikronukleusnom testu u štakora.
The median number of new or newly enlarging T2 hyperintense lesions changed from 2 in the 8 week pre-treatment evaluation period to 0 in the final 8 weeks of the treatment period (median change -2, n=16).
2 u 8-tjednom razdoblju procjene prije liječenja na 0 u zadnjih 8 tjedana terapijskog razdoblja
In Study 2, patients had the following median baseline characteristics: age 37 years, disease duration 6.0 years, EDSS score 2.5.
starost 37 godina, trajanje bolesti 6,0 godina i EDSS bodova 2,5.
Tecfidera has not been studied in patients with severe active gastrointestinal disease and caution should, therefore, be used in these patients.
Tecfidera nije ispitivana u bolesnika s teškom aktivnom bolešću probavnog sustava pa je potreban oprez pri liječenju takvih bolesnika.
In Study 1, patients had the following median baseline characteristics: age 39 years, disease duration 7.0 years, EDSS score 2.0.
starost 39 godina, trajanje bolesti 7,0 godina, EDSS bodovi 2,0.
MedDRA System Organ Class Adverse reaction
MedDRA klasifikacija organskih sustava
Data from healthy volunteer studies suggest that dimethyl fumarate-associated flushing is likely to be prostaglandin mediated.
Podaci iz ispitivanja sa zdravim dobrovoljcima ukazuju na to da je navala crvenila povezana s dimetilfumaratom najvjerojatnije posredovana prostaglandinima.
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.
U kliničkim ispitivanjima (i kontroliranima i nekontroliranima), 9% bolesnika imalo je broj limfocita ≥0,5x109/l i <0,8x109/l najmanje šest mjeseci; 2% bolesnika imalo je broj limfocita <0,5x109/l najmanje šest mjeseci, a u toj je skupini broj limfocita većinom ostao na vrijednostima <0,5x109/l uz nastavak terapije.
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.
U majmuna koji su dnevne oralne doze dimetilfumarata primali 12 mjeseci, nekroza pojedinih stanica opažena je na temelju AUC-a pri dozi 2 puta većoj od preporučene.
In an ongoing long-term extension study, in which 1736 MS patients are treated with Tecfidera, approximately 5% experienced one or more events of herpes zoster, the majority of which were mild to moderate in severity.
U dugotrajnom nastavku kliničkog ispitivanja, koje je u tijeku, lijek Tecfidera primalo je 1736 bolesnika s multiplom sklerozom, od čega je u približno njih 5% jedanput ili više puta došlo do pojave herpes zostera.
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.
Potrebno je procijeniti omjer koristi i rizika u bolesnika s brojem limfocita ≥0,5x109/l i <0,8x109/l dulje od šest mjeseci.
The incidence of serious gastrointestinal events, including gastroenteritis and gastritis, was seen in 1% of patients treated with Tecfidera (see section 4.2).
Incidencija ozbiljnih gastrointestinalnih smetnji, uključujući gastroenteritis i gastritis, primijećena je u 1%
Severe active gastrointestinal disease
Teška aktivna bolest probavnog sustava
Immune system disorders
Učinci na imunološki sustav
Hypotension1
nepoznato hipotenzija1
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.
Peroralna primjena dimetilfumarata od 25, 75 i 150 mg/kg/dan gravidnim ženkama kunića tijekom organogeneze nije imala utjecaja na embriofetalni razvoj i rezultirala je smanjenjem majčine tjelesne težine pri dozi 7 puta većoj od preporučene i povećanom pobačaju kod doze 16 puta veće od preporučene na temelju AUC-a.
Limited data is available on ALC in patients with herpes zoster infection in the post-marketing setting.
Podaci o apsolutnom broju limfocita u bolesnika s herpes zoster infekcijom iz razdoblja nakon stavljanja lijeka u promet su ograničeni.
If herpes zoster occurs, appropriate treatment for herpes zoster should be administered.
U slučaju pojave herpes zostera, potrebno je primijeniti odgovarajuće liječenje.
This involves balancing the benefit of breast-feeding for your child, and the benefit of therapy for you.
To uključuje razmatranje koristi dojenja za Vaše dijete i koristi liječenja za Vas.
Concomitant administration of non-live vaccines according to national vaccination schedules may be considered during Tecfidera therapy.
Tijekom terapije Tecfiderom mogu se razmotriti istodobna cijepljenja neživim cjepivima prema nacionalnom programu cijepljenja.
It is initially metabolised by esterases, which are ubiquitous in the gastrointestinal tract, blood and tissues, before it reaches the systemic circulation.
Prije nego dođe u sistemski krvotok, dimetilfumarat se početno metabolizira esterazama koje su rasprostranjene u gastrointestinalnom traktu, krvi i tkivima.
Tecfidera 240 mg dimethyl fumarate
Tecfidera 240 mg dimetilfumarat
Gastro-resistant hard capsule
Tvrda želučanootporna kapsula
Tecfidera 120 mg dimethyl fumarate
Tecfidera 120 mg dimetilfumarat
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
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, a naročito: lijekove koji sadrže estere fumaratne kiseline (fumarate) a koriste se za liječenje psorijaze lijekove koji utječu na tjelesni imunološki sustav uključujući druge lijekove koji se koriste za liječenje MS-a, kao fingolimod, natalizumab, teriflunomid, alemtuzumab, okrelizumab ili kladribin ili neke uobičajene lijekove protiv raka (rituksimab ili mitoksantron)
Tecfidera 240 mg: Each capsule contains 240 mg of dimethyl fumarate.
Tecfidera 240 mg: Jedna kapsula sadrži 240 mg dimetilfumarata.
Monitor patients taking Tecfidera for signs and symptoms of herpes zoster especially when concurrent lymphocytopenia is reported.
Bolesnike koji uzimaju lijek Tecfidera potrebno je pratiti na pojavu znakova i simptoma herpes zostera, osobito ako je istodobno prisutna i limfocitopenija.
In case of clinical suspicion of PML, MRI should be performed immediately for diagnostic purposes.
PML, treba odmah provesti snimanje MR-om u dijagnostičke svrhe.
14 gastro-resistant hard capsules
14 tvrdih želučanootpornih kapsula
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.
U pasa koji su dnevne oralne doze dimetilfumarata primali 11 mjeseci, granica izračunata za kortikalnu atrofiju opažena je na temelju
Tecfidera 120 mg: Each capsule contains 120 mg of dimethyl fumarate.
Tecfidera 120 mg: Jedna kapsula sadrži 120 mg dimetilfumarata.
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).
Peroralna primjena dimetilfumarata na ženkama štakora od 25, 100 i 250 mg/kg/dan prije i za vrijeme parenja, i nastavkom do 7. dana gestacije, izazvala je smanjenje broja estrus faza po 14 dana, a povećala je broj životinja s duljim diestrusom pri najvišoj testiranoj dozi (11 puta veće od preporučene doze na temelju AUC-a).
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.
Liječenje dimetilfumaratom može za posljedicu imati oštećenje jetre izazvano lijekom, uključujući povišenje jetrenih enzima (≥3 puta iznad gornje granice normale (GGN)) i povišenje razina ukupnog bilirubina (≥2 GGN).
Further metabolism occurs through the tricarboxylic acid cycle, with no involvement of the cytochrome P450 (CYP) system.
Nakon toga, dimetilfumarat se metabolizira u ciklusu trikarboksilatne kiseline bez posredovanja citokrom P450 (CYP) sustava.
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).
Uzimanje Tecfidere s hranom može poboljšati podnošljivost u bolesnika koji imaju navale crvenila ili nuspojave probavnog sustava (vidjeti dijelove 4.4, 4.5 i 4.8).
PML cases have occurred with dimethyl fumarate and other medicinal products containing fumarates in the setting of moderate to severe prolonged lymphopenia.
Progresivna multifokalna leukoencefalopatija (PML) Slučajevi PML-a pojavili su se tijekom primjene dimetilfumarata i drugih lijekova koji sadrže fumarate u stanju umjerene do teške i produljene limfopenije.
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).
D smanjivale su se u bolesnika liječenih Tecfiderom u odnosu na placebo (medijan postotka smanjenja od početne vrijednosti nakon 2 godine bio je 25% odnosno 15%), a razine paratiroidnog hormona (PTH) povećale su se u bolesnika liječenih
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.
U ispitivanjima u trajanju od 3 mjeseca mjeseca ili duljim, predželudac miševa i štakora sastojao se od hiperplazija pločastog epitela i hiperkeratoza, upala te papiloma pločastih stanica i karcinoma.