natgillin/translations-raw huggingface dataset:
No untoward clinical consequences were observed in clinical trials.
U kliničkim ispitivanjima nisu opažene nepovoljne kliničke posljedice.
If therapy is continued in the presence of moderate to severe prolonged lymphopenia, the risk of an opportunistic infection, including PML, cannot be ruled out (see section 4.4 subsection PML).
Ako se terapija nastavlja u prisutnosti umjerene do teške produljene limfopenije, ne može se isključiti rizik od oportunističke infekcije, uključujući PML (vidjeti dio 4.4,
No malformations were observed at any dose of dimethyl fumarate in rats or rabbits.
Nisu zabilježene malformacije kod bilo koje doze dimetilfumarata u štakora ili kunića.
What Tecfidera is used for Tecfidera is used to treat relapsing-remitting multiple sclerosis (MS) in adult patients.
Tecfidera se koristi za liječenje relapsno-remitirajuće multiple skleroze (MS) u odraslih bolesnika.
In rare cases hypophosphataemic osteomalacia with nonlocalised bone pain, elevated alkaline phosphatase in serum and stress fractures may occur.
U rijetkim slučajevima može se pojaviti hipofosfatemična osteomalacija s nelokaliziranim koštanim bolovima, povišenom razinom alkalne fosfataze u serumu i stres frakturama.
Tecfidera is a medicine that contains the active substance dimethyl fumarate.
Tecfidera je lijek koji sadrži djelatnu tvar dimetilfumarat.
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.
Izloženost dimetilfumaratu povećava se približno proporcionalno dozi s jednokratnim i višekratnim dozama u ispitivanom rasponu od 120 mg do 360 mg.
- Very common (≥1/10) - Common (≥1/100 to <1/10) - Uncommon (≥1/1, 000 to <1/100) - Rare (≥1/10, 000 to <1/1,000)
Incidencija nuspojava je izražena prema sljedećim kategorijama: - vrlo često (≥1/10) - često (≥1/100 i <1/10) - manje često (≥1/1000 i <1/100)
Prior to initiating treatment with Tecfidera, a current complete blood count, including lymphocytes, must be performed.
Prije početka liječenja Tecfiderom mora se provesti kompletna krvna slika, uključujući limfocite.
In rats, the incidence of renal tubular carcinoma was increased at 100 mg/kg/day, approximately 2 times higher exposure than the recommended human dose.
U štakora, incidencija bubrežnog tubularnog karcinoma bila je povećana pri 100 mg/kg/dan, pri približno 2 puta višoj izloženosti od preporučene ljudske doze.
No studies have been performed evaluating the efficacy and safety of Tecfidera when switching patients from other disease modifying therapies to Tecfidera.
Nema provedenih ispitivanja ocjene djelotvornosti i sigurnosti Tecfidere prilikom prelaska bolesnika s druge terapije koja modificira tijek bolesti na Tecfideru.
Discontinuations due to elevated hepatic transaminases were <1% and similar in patients treated with Tecfidera or placebo.
Prekid liječenja zbog povišenih razina jetrenih transaminaza bio je <1% i sličan u bolesnika liječenih Tecfiderom ili placebom.
A short course of treatment with 75 mg non-enteric coated acetylsalicylic acid may be beneficial in patients affected by intolerable flushing (see section 4.5).
Kratka kura liječenja dozom od 75 mg acetilsalicilatne kiseline bez acidorezistentne ovojnice može imati povoljan učinak u bolesnika s nepodnošljivim navalama crvenila (vidjeti dio 4.5).
Among the 10 patients with MRI data between weeks 64 and week 72 of the extension study, the median number of subjects with new or newly enlarging T2 hyperintense lesions was 0 (range 0,2).
Među 10 bolesnika s podacima o provedenom MR-u između 64. i 72. tjedna nastavka ispitivanja, medijan broja ispitanika s novim ili novoproširenim T2 hiperintenzivnim lezijama bio je 0
The findings were observed at approximately the recommended dose in rats and 3 times the recommended dose in dogs (AUC basis).
Nalazi su primijećeni kod otprilike preporučene doze u štakora i one 3 puta veće od preporučene doze kod pasa (na temelju
Renal and faecal elimination are secondary routes of elimination, accounting for 15.5% and 0.9% of the dose respectively.
Sekundarni putovi eliminacije su preko bubrega i fecesa, što čini 15,5% odnosno 0,9% doze.
Since the renal pathway is a secondary route of elimination for dimethyl fumarate accounting for less than 16% of the dose administered, evaluation of pharmacokinetics in individuals with renal impairment was not conducted.
Budući da je bubrežna eliminacija sekundarni put eliminacije dimetilfumarata, što čini manje od 16% primijenjene doze, procjena farmakokinetike u pojedinaca s oštećenjem bubrega nije provedena.
The limited long-term experience with Tecfidera could contribute to the low evidence regarding a potential association of dimethyl fumarate and Fanconi syndrome in the MS indication.
Moguće je da je ograničeno iskustvo dugotrajne primjene lijeka Tecfidera pridonosi niskoj razini dokaza potencijalne povezanosti dimetilfumarata i Fanconijeva sindroma u indikaciji multiple skleroze.
In subjects with multiple sclerosis, two 240 mg doses were administered 4 hours apart as part of a three times a day dosing regimen.
ispitivanjima s ispitanicima s multiplom sklerozom, dvije doze od 240 mg su primijenjene u razmaku od 4 sata, kao dio rasporeda doziranja od tri puta dnevno.
A rare but serious kidney disorder (Fanconi Syndrome) has been reported for a medicine containing dimethyl fumarate, in combination with other fumaric acid esters, used to treat psoriasis (a skin disease).
Rijedak ali ozbiljan poremećaj bubrega (Fanconijev sindrom) prijavljen je uz primjenu lijeka koji sadrži dimetilfumarat u kombinaciji s drugim esterima fumaratne kiseline, a koristi se za liječenje psorijaze (kožne bolesti).
These data were derived from 2 pivotal Phase 3 placebo-controlled, double-blind clinical trials with a total of 1,529 patients treated with Tecfidera and for up to 24 months with an overall exposure of 2,371 person-years (see section 5.1).
Ti su podaci dobiveni iz 2 pivotalna, placebom kontrolirana i dvostruko slijepa klinička ispitivanja faze 3, s ukupno 1529 bolesnika liječenih Tecfiderom i do 24 mjeseca uz ukupnu izloženost od 2371 bolesnik-godine (vidjeti dio 5.1).
The mechanism by which dimethyl fumarate exerts therapeutic effects in multiple sclerosis is not fully understood.
Mehanizam kojim dimetilfumarat ispoljava terapijsko djelovanje u multiploj sklerozi nije u potpunosti razjašnjen.
Compared to placebo, subjects treated with Tecfidera had a clinically meaningful and statistically significant reduction on: the primary endpoint in Study 1, proportion of subjects relapsed at 2 years; and the primary endpoint in Study 2, annualised relapse rate at 2 years.
U usporedbi s placebom, ispitanici liječeni Tecfiderom su imali klinički značajno i statistički značajno smanjenje: udjela ispitanika s relapsom unutar 2 godine (primarna mjera ishoda Ispitivanja 1) i godišnje stopa relapsa nakon 2 godine (primarna mjera ishoda Ispitivanja 2).
In a small 24-week open-label uncontrolled study in paediatric patients with RRMS aged 13 to 17 years (120 mg twice a day for 7 days followed by 240 mg twice a day for the remainder of treatment; safety population, n=22), followed by a 96 week extension study (240mg twice per day ; safety population n=20), the safety profile appeared similar to that observed in adult patients.
U malom 24-tjednom otvorenom nekontroliranom ispitivanju u pedijatrijskih bolesnika s relapsno-remitirajućom multiplom sklerozom (RRMS) u dobi od 13 do 17 godina (120 mg dvaput na dan tijekom 7 dana te potom 240 mg dvaput na dan tijekom preostalog razdoblja liječenja; populacija u kojoj se procjenjivala sigurnost, n=22), nakon kojeg je uslijedio nastavak ispitivanja u trajanju od 96 tjedana (240 mg dvaput na dan; populacija u kojoj se procjenjivala sigurnost n=20), sigurnosni profil je bio sličan onome opaženom u odraslih bolesnika.
The incidence of squamous cell papilloma and carcinoma in the nonglandular stomach (forestomach) was increased at equivalent exposure to the recommended human dose in mice and below exposure to the recommended human dose in rats (based on AUC).
Incidencija papiloma skvamoznih stanica i karcinoma nežljezdanog želuca (predželuca) bila je povećana pri ekvivalentnoj izloženosti preporučene ljudske doze u miševa i ispod izloženosti preporučene ljudske doze u štakora (na temelju AUC-a).
However, Tecfidera should be taken with food due to improved tolerability with respect to flushing or gastrointestinal adverse events (see section 4.2).
Međutim, Tecfideru treba uzeti s hranom, jer se time poboljšava podnošljivost obzirom na navalu crvenila ili gastrointestinalne štetne događaje (vidjeti dio 4.2).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS HEAT SEALED BLISTER CARD
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP TOPLINSKI ZATVORENA BLISTER KARTICA
No studies on the ability to drive and use machines have been conducted but no effects potentially influencing this ability were found to be related to dimethyl fumarate in clinical studies.
Nisu provedena ispitivanja učinka na sposobnost upravljanja vozilima i rada sa strojevima, ali u kliničkim ispitivanjima nije ustanovljeno da su učinci koji bi mogli utjecati na tu sposobnost povezani s dimetilfumaratom.
In an in vivo study, co-administration of Tecfidera with a combined oral contraceptive (norgestimate and ethinyl estradiol) did not elicit any relevant change in oral contraceptive exposure.
U jednom in vivo ispitivanju istodobna primjena Tecfidere s kombiniranim oralnim kontraceptivima (norgestimat i etinilestradiol) nije značajno promijenila izloženost oralnim kontraceptivima.
Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis.
4.2 Doziranje i način primjene Liječenje treba započeti pod nadzorom liječnika s iskustvom u liječenju multiple skleroze.
The most commonly reported adverse reactions leading to discontinuation (incidence >1%) in patients treated with Tecfidera were flushing (3%) and gastrointestinal events (4%).
Najčešće prijavljene nuspojave koje su dovele do prekida liječenja (incidencija >1%) u bolesnika liječenih Tecfiderom su navala crvenila (3%), i gastrointestinalne smetnje (4%).
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.
Tecfidera 240 mg tvrde želučanootporne kapsule su zelene boje s otisnutom oznakom „BG-12 240 mg“ i dostupne su u pakiranju od 56 ili 168 kapsula.
Gender and age did not have a clinically significant impact on the pharmacokinetics of dimethyl fumarate.
Spol i dob nisu klinički značajno utjecali na farmakokinetiku dimetilfumarata.
It is unknown whether dimethyl fumarate or its metabolites are excreted in human milk.
Nije poznato izlučuju li se dimetilfumarat ili njegovi metaboliti u majčino mlijeko.
Kidney changes were observed after repeated oral administration of dimethyl fumarate in mice, rats, dogs, and monkeys.
Primijećene su promjene na bubrezima nakon ponavljane peroralne primjene dimetilfumarata u miševa, štakora, pasa i majmuna.
The most common adverse reactions (incidence ≥10%) for patients treated with dimethyl fumarate were flushing and gastrointestinal events (i.e. diarrhoea, nausea, abdominal pain, abdominal pain upper).
Najčešće nuspojave (incidencija ≥10%) za bolesnike liječene dimetilfumaratom bile su navala crvenila i gastrointestinalne smetnje (npr. proljev, mučnina, bol u abdomenu, bol u gornjem dijelu abdomena).
Dimethyl fumarate has been shown to up regulate Nrf2-dependent antioxidant genes in patients (e.g. NAD(P)H dehydrogenase, quinone 1; [NQO1]).
Pokazalo se da dimetilfumarat potiče ekspresiju o Nrf2 ovisnih antioksidativnih gena u bolesnika (npr. NAD(P)H dehidrogenaza, kinon 1; [NQO1]).
Angioedema1
nepoznato angioedem1
Interstitial fibrosis and cortical atrophy were observed at 6 times the recommended dose based on AUC.
Intersticijska fibroza i kortikalna atrofija opažene su na temelju AUC-a pri dozi 6 puta većoj od preporučene.
Do not store above 30ºC Keep the blisters in the outer carton in order to protect from light
Ne čuvati na temperaturi iznad 30ºC Blistere čuvati u vanjskom pakiranju radi zaštite od svjetlosti
Dimethyl fumarate and monomethyl fumarate, the primary metabolite of dimethyl fumarate, significantly reduced immune cell activation and subsequent release of proinflammatory cytokines in response to inflammatory stimuli in preclinical models.
Dimetilfumarat i monometilfumarat, primarni metabolit dimetilfumarata, značajno su smanjili aktivaciju imunoloških stanica i posljedično otpuštanje proupalnih citokina kao odgovor na imunološki podražaj u pretkliničkim modelima.
In the testes, degeneration of the seminiferous epithelium was seen in rats and dogs.
Primijećena je degeneracija seminifernog epitela u testisima štakora i pasa.
In the post-marketing setting most cases of herpes zoster infection were non-serious and resolved with treatment.
U razdoblju nakon stavljanja lijeka u promet, većina slučajeva herpes zoster infekcija nije bila ozbiljna te se razriješila liječenjem.
Nonclinical studies in rodent, rabbits, and monkeys were conducted with a dimethyl fumarate suspension (dimethyl fumarate in 0.8% hydroxypropyl methylcellulose) administered by oral gavage.
Pretklinička ispitivanja provedena su u glodavaca, kunića i majmuna sa suspenzijom dimetilfumarata (dimetilfumarat u 0,8% hidroksipropilmetilcelulozi) koja je primijenjena gastričnom sondom.
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).
Nije bilo povećane incidencije ozbiljnih infekcija opaženih u bolesnika s brojem limfocita <0,8x109/l ili <0,5x109/l (vidjeti dio 4.8).
Potential drug interaction risks were not identified from in vitro CYP-inhibition and induction studies, a p-glycoprotein study, or studies of the protein binding of dimethyl fumarate and monomethyl fumarate (a primary metabolite of dimethyl fumarate).
Nisu identificirane potencijalne opasnosti od interakcija lijekova u in vitro ispitivanjima inhibicije i indukcije CYP-a, ispitivanju p-glikoproteina ili ispitivanjima vezanja dimetilfumarata i monometilfumarata (primarni metabolit dimetilfumarata) na proteine.
A decision must be made whether to discontinue breast-feeding or to discontinue Tecfidera therapy.
Potrebno je odlučiti treba li prekinuti dojenje ili terapiju
The most important signs are: proteinuria, glucosuria (with normal blood sugar levels), hyperaminoaciduria and phosphaturia (possibly concurrent with hypophosphatemia).
glikozurija (uz normalne razine šećera u krvi), hiperaminoacidurija i fosfaturija (moguće prisutna istodobno s hipofosfatemijom).
The starting dose is 120 mg twice a day.
Početna doza je 120 mg dvaput na dan.
No interaction studies have been performed with oral contraceptives containing other progestogens, however an effect of Tecfidera on their exposure is not expected.
Iako nisu provedena ispitivanja interakcija s oralnim kontraceptivima koji sadrže druge progestagene, učinak Tecfidere na izloženost tim kontraceptivima se ne očekuje.
In mice, the incidence of renal tubular carcinoma was increased at 75 mg/kg/day, at equivalent exposure (AUC) to the recommended human dose.
U miševa, incidencija bubrežnog tubularnog karcinoma bila je povećana pri 75 mg/kg/dan, pri ekvivalentnoj izloženosti (AUC) preporučene ljudske doze.
Tecfidera has no or negligible influence on the ability to drive and use machines.
Tecfidera ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Hazard ratio (95% CI) Proportion with 24 week confirmed disability progression Hazard ratio (95% CI)
Omjer hazarda (95% CI) Udio progresije onesposobljenosti potvrđeno nakon 24 tjedna
Serious effects
Ozbiljne nuspojave
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.
EDSS bodova >3,5, 32% je imalo ≥2 relapsa u prethodnoj godini, a 30% je prethodno dobilo drugo odobreno liječenje za MS.
Cases of Fanconi syndrome have been reported for a medicinal product containing dimethyl fumarate in combination with other fumaric acid esters.
Prijavljeni su slučajevi Fanconijeva sindroma povezani s primjenom lijeka koji sadrži dimetilfumarat u kombinaciji s drugim esterima fumaratne kiseline.
In humans, dimethyl fumarate is extensively metabolised by esterases before it reaches the systemic circulation and further metabolism occurs through the tricarboxylic acid cycle, with no involvement of the cytochrome P450 (CYP) system.
Kod ljudi, esteraze ekstenzivno metaboliziraju dimetilfumarat prije nego što dođe u sistemsku cirkulaciju, a daljnji metabolizam se odvija kroz ciklus trikarboksilatne kiseline, bez posredovanja sustava citokroma P450 (CYP).
In humans, dimethyl fumarate is extensively metabolised with less than 0.1% of the dose excreted as unchanged dimethyl fumarate in urine.
U ljudi, dimetilfumarat je vrlo podložan metaboliziranju, tako da se manje od 0,1% doze izlučuje u nepromijenjenom obliku u mokraći.
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.
Nakon što su ispitanici s multiplom sklerozom uzimali lijek od 240 mg dva puta dnevno s hranom, medijan vršne vrijednosti (Cmax) je bio 1,72 mg/l, a sveukupna izloženost prema površini ispod krivulje (AUC) bila je 8,02 h.mg/l.
Within 1 month, the recommended maintenance dose of 240 mg twice a day should be resumed.
Unutar mjesec dana mora se nastaviti s preporučenom dozom održavanja od 240 mg dvaput na dan.
Patients treated with Tecfidera may develop severe prolonged lymphopenia (see section 4.8).
Bolesnici liječeni Tecfiderom mogu razviti tešku produljenu limfopeniju (vidjeti dio 4.8).
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).
- Bolesnici s 2 ili više relapsa u jednoj godini i s jednom ili više Gd-pozitivnih lezija na MR mozga (n=42 u DEFINE; n=51 u CONFIRM) ili, - Bolesnici koji nisu imali odgovor na potpuno i odgovarajuće liječenje (barem godinu dana liječenja) beta-interferonom, nakon što su imali barem 1 relaps u prethodnoj godini dok su bili na terapiji, i najmanje 9 T2-hiperintenzivnih lezija u kranijalnoj MR ili barem 1 Gd-pozitivnu leziju, ili bolesnici s nepromijenjenom ili povećanom stopom relapsa u prethodnoj godini u usporedbi s prethodne 2 godine (n=177 u DEFINE; n=141 u CONFIRM).
Progressive multifocal leukoencephalopathy (PML) 1
Infekcije i infestacije gastroenteritis često progresivna multifokalna leukoencefalopatija (PML)1
Substances called ketones, which are naturally produced in the body, very commonly show up in urine tests while taking Tecfidera.
Dok uzimate Tecfideru, tvari nazvane ketoni a koje se prirodno stvaraju u tijelu, pojavljuju se vrlo često u testovima mokraće.
Overall, 3% of patients treated with Tecfidera discontinued due to flushing.
Sveukupno 3% bolesnika liječenih Tecfiderom je prekinulo liječenje zbog navale crvenila.
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.
Obzirom da su rana dijagnoza Fanconijeva sindroma i prekid primjene potencijalnog lijeka uzročnika primjerice dimetilfumarata, važni koraci za sprječavanje pojave oštećenja bubrega i osteomalacije, PRAC preporučuje uključivanje upozorenja u dio 4.4 sažetka opisa svojstava lijeka, kako bi se liječnike upozorilo na potencijalni rizik od
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)
Obavijestite svog liječnika prije uzimanja Tecfidere ako imate: - tešku bolest bubrega - tešku bolest jetre
Interruption of Tecfidera should be considered in patients with lymphocyte counts <0.5x109/L persisting for more than 6 months.
Prekid primjene Tecfidere potrebno je razmotriti u bolesnika s brojem limfocita <0,5x109/l koji traje dulje od 6 mjeseci.
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.
EDSS bodova > 3,5, 28% je imalo ≥ 2 relapsa u prethodnoj godini, a 42% je prethodno dobilo drugo odobreno liječenje za MS.
Clinical factors, evaluation of any laboratory and imaging investigations could be included as part of this reconsideration.
Kao dio ovog ponovnog razmatranja mogu se uključiti klinički čimbenici i ocjenjivanje laboratorijskih pretraga kao i pretraga oslikavanja.
Tecfidera treatment should be started gradually to reduce the occurrence of flushing and gastrointestinal adverse reactions (see section 4.2).
Početak liječenja Liječenje Tecfiderom treba započeti postupno kako bi se smanjila učestalost navale crvenila i gastrointestinalnih nuspojava (vidjeti dio 4.2).
Dimethyl fumarate has not been studied in patients with pre-existing low lymphocyte counts and caution should be exercised when treating these patients.
Dimetilfumarat nije ispitivan u bolesnika s već postojećim niskim brojem limfocita pa je potreban oprez pri liječenju takvih bolesnika.
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.
U kliničkom ispitivanju koje je uključilo 71 bolesnika s relapsno remitirajućom multiplom sklerozom, bolesnici koji su primali Tecfideru u dozi od 240 mg dvaput dnevno najmanje 6 mjeseci (n=38) ili nepegilirani interferon najmanje 3 mjeseca (n=33) razvili su usporediv imunološki odgovor (definiran kao povećanje titra poslije cijepljenja za ≥2 puta u odnosu na onaj prije cijepljenja) na toksoid tetanusa (anamnestički antigen) i polisaharidno konjugirano cjepivo protiv meningokoka skupine C (novi antigen), dok je imunološki odgovor na različite serotipove nekonjugiranog 23-valentnog polisaharidnog pneumokoknog cjepiva (antigen neovisan o T-stanicama)
A lymphocyte count <0.2x109/l was observed in 1 patient treated with Tecfidera and in no patients treated with placebo.
Broj limfocita <0,2x109/l opažen je kod 1 bolesnika liječenog Tecfiderom i kod niti jednog bolesnika na placebu.
In phase III placebo-controlled studies, the incidence of infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with Tecfidera or placebo, respectively.
U placebom kontroliranim ispitivanjima faze 3 incidencija infekcija (60% naspram 58%) i ozbiljnih infekcija (2% naspram 2%) bila je slična u bolesnika liječenih Tecfiderom ili placebom.
In the placebo-controlled studies, measurement of urinary ketones (1+ or greater) was higher in patients treated with Tecfidera (45%) compared to placebo (10%).
U placebom kontroliranim ispitivanjima mjerenje ketona u mokraći (1+ ili više) bilo je više u bolesnika liječenih Tecfiderom (45%) u usporedbi s placebom (10%).