natgillin/translations-raw huggingface dataset:
The frequency of severe allergic reactions cannot be estimated from the available data (not known).
Pogostnosti hudih alergijskih reakcij ni mogoče oceniti iz razpoložljivih podatkov (neznana).
Reduced white blood cells could mean your body is less able to fight an infection.
Zmanjšano število belih krvnih celic lahko pomeni, da je vaše telo manj sposobno, da se bori proti okužbam.
Otherwise the patient should wait until the next scheduled dose.
V nasprotnem primeru mora bolnik počakati do naslednjega načrtovanega odmerka.
However, these changes did not affect fertility or the number of viable fetuses produced.
Vendar pa te spremembe niso vplivale na plodnost ali število zarodkov, ki so bili sposobni preživeti.
Lymphocyte counts should be followed until recovery.
Število limfocitov je treba spremljati do okrevanja.
The Tmax of monomethyl fumarate is 2 to 2.5 hours.
Absorpcija Tmax monometil fumarata je 2 do 2,5 ure.
- medicines that affect the body's immune system including other medicines used to treat
- zdravila, ki vplivajo na imunski sistem telesa, vključno z drugimi zdravili za zdravljenje
Mean values for both parameters remained within normal range.
Povprečne vrednosti obeh parametrov so ostale znotraj normalnih vrednosti.
PML is an opportunistic infection caused by John-Cunningham virus (JCV), which may be fatal or result in severe disability.
PML je oportunistična okužba, ki jo povzroča virus John-Cunningham (JC) in ki je lahko smrtna ali pa povzroči hudo prizadetost.
Herpes zoster1
neznana herpes zoster1
This could cause inflammation of the stomach (gastritis), especially in people already prone to gastritis.
To lahko povzroči vnetje želodca (gastritis), zlasti pri osebah, ki so nagnjene h gastritisu.
Not known (frequency cannot be estimated from the available data)
- neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
then this may represent a severe allergic reaction (anaphylaxis)
potem to utegne predstavljati hudo alergijsko reakcijo (anafilaksijo).
- if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na dimetilfumarat ali katero koli sestavino tega zdravila (navedeno v poglavju
Morning Evening Mon.
zjutraj zvečer
Approximately 1,056 patients have received more than 2 years of treatment with Tecfidera.
Približno 1.056 bolnikov se je več kot 2 leti zdravilo z zdravilom Tecfidera.
MS is a long-term condition that affects the central nervous system (CNS), including the brain and the spinal cord.
MS je dolgotrajno stanje, ki vpliva na osrednji živčni sistem (OŽS), vključno z možgani in hrbtenjačo.
In two healthy volunteer studies, the occurrence and severity of flushing over the dosing period was reduced.
V dveh študijah na zdravih prostovoljcih sta se pojavljanje in resnost vročinskega oblivanja v času odmerjanja zmanjšala.
Carcinogenicity studies of dimethyl fumarate were conducted for up to 2 years in mice and rats.
Študije kancerogenosti dimetilfumarata so izvajali do 2 leti pri miših in podganah.
The safety and efficacy of Tecfidera in children and adolescents aged 10 to 18 years have not yet been established.
Varnost in učinkovitost zdravila Tecfidera pri otrocih in mladostnikih, starih 10 do 18 let, še nista bili dokazani.
Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms.
Za recidivno-remitentno MS so značilni ponavljajoči se napadi (recidivi) simptomov živčnega sistema.
The pharmacokinetics in patients aged 65 and over has not been studied.
Farmakokinetike pri bolnikih, starih 65 let ali več, niso preučili.
The clinical implications of these changes are unknown.
Klinični pomen teh sprememb ni znan.
In the event of overdose, it is recommended that symptomatic supportive treatment be initiated as clinically indicated.
V primeru prevelikega odmerjanja je priporočljivo uvesti simptomatsko podporno zdravljenje, kot je klinično indicirano.
Pharmacokinetic data were obtained in subjects with multiple sclerosis and healthy volunteers.
Farmakokinetične podatke so pridobili pri osebah z multiplo sklerozo in pri zdravih prostovoljcih.
Importantly, Fanconi syndrome can occur without elevated creatinine levels or low glomerular filtration rate.
Pomembno je vedeti, da se Fanconijev sindrom lahko pojavi tudi brez zvišanih ravni kreatinina ali nizke hitrosti glomerularne filtracije.
The Package leaflet should be updated accordingly.
Navodilo za uporabo je treba ustrezno posodobiti.
Otherwise wait until your next planned dose.
V nasprotnem primeru počakajte, da je čas za naslednji načrtovani odmerek.
As Tecfidera gastro-resistant hard capsules contain microtablets, which are protected by an enteric coating, absorption does not commence until they leave the stomach (generally less than 1 hour).
Zdravilo Tecfidera gastrorezistentne trde kapsule vsebujejo mikrotablete, ki so zaščitene z enterično oblogo, zato se absorpcija začne šele, ko zapustijo želodec (na splošno manj kot 1 uro).
Consumption of moderate amounts of alcohol did not alter exposure to dimethyl fumarate and was not associated with an increase in adverse reactions.
Uživanje zmernih količin alkohola ni spremenilo izpostavljenosti dimetilfumaratu in ni bilo povezano z zvišanjem neželenih učinkov.
Capsule contents (enteric-coated microtablets)
Vsebina kapsule (enterično obložene mikrotablete)
If a patient misses a dose, a double dose should not be taken.
Če bolnik izpusti odmerek, ne sme vzeti dvojnega odmerka.
Substances called ketones, which are naturally produced in the body, very commonly show up in urine tests while taking Tecfidera.
Snovi, imenovane ketoni, ki v telesu nastajajo naravno, se med jemanjem zdravila Tecfidera zelo pogosto pojavijo v testih urina.
If you notice you are passing more urine, are more thirsty and drinking more than normal, your muscles seem weaker, you break a bone, or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.
Če opazite, da odvajate več urina, da ste bolj žejni in pijete več kot običajno, če se vam zdi, da imate slabšo mišično moč, ste si zlomili kost ali čutite bolečine, se čim prej pogovorite z zdravnikom, ki bo ta stanja podrobneje preučil.
If your number of white blood cells decreases during treatment, your doctor may consider interrupting your treatment
Če se število vaših belih krvničk med zdravljenjem zmanjša, lahko vaš zdravnik prekine zdravljenje.
A positive immune response defined as a ≥4-fold increase in antibody titer to the three vaccines, was achieved by fewer subjects in both treatment groups.
Pozitiven imunski odziv, opredeljen kot ≥4-kratno zvečanje titra protiteles proti trem cepivom, je doseglo manj preiskovancev v obeh zdravljenih skupinah.
1171 LP Badhoevedorp The Netherlands
Prins Mauritslaan 13 1171 LP Badhoevedorp Nizozemska
Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, ATC code: L04AX07
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe in imunomodulatorji, oznaka ATC: L04AX07
Tecfidera can generally be started immediately after discontinuation of interferon or glatiramer acetate.
Z dajanjem zdravila Tecfidera je mogoče v splošnem začeti takoj po prekinitvi dajanja interferona ali glatiramer acetata.
Do not use this medicine after the expiry date which is stated on the blister and the carton after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake "EXP".
MRI imaging may be considered as part of increased vigilance in patients considered at increased risk of PML.
Slikanje z MR je mogoče šteti za del okrepljenega spremljanja pri bolnikih, pri katerih obstaja povečano tveganje za PML.
Keep the blisters in the outer carton in order to protect from light.
Pretisne omote shranjujte v zunanji škatli za zagotovitev zaščite pred svetlobo.
It should also be noted that a negative anti JCV antibody test (in the presence of normal lymphocyte counts) does not preclude the possibility of subsequent JCV infection.
Treba je tudi omeniti, da negativen test za določanje protiteles proti virusu JC (v prisotnosti normalnega števila limfocitov) ne izključuje možnosti naknadne okužbe z virusom JC.
Treatment should not be restarted (see section 4.8).
Zdravila ne smejo spet začeti jemati (glejte poglavje 4.8).
Having a low white blood cell count for a long period of time can increase your risk of infection, including a risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML).
Če imate dlje časa nizko število belih krvničk, se lahko poveča tveganje za okužbo, kar vključuje tudi redko okužbo možganov, imenovano progresivna multifokalna levkoencefalopatija
Before you start Tecfidera, your doctor will do a blood test to count the number of your white blood cells and will check that your kidneys and liver are working properly.
Preden boste začeli jemati zdravilo Tecfidera, bo zdravnik opravil krvne preiskave, da določi število belih krvničk, in preveril, ali vaše ledvice in jetra pravilno delujejo.
If you have taken too many capsules, talk to your doctor straight away.
Če ste vzeli preveč kapsul, se takoj posvetujte z zdravnikom.
Based on the results of Analysis of Variance (ANOVA), body weight is the main covariate of exposure (by Cmax and AUC) in RRMS subjects, but did not affect safety and efficacy measures evaluated in the clinical studies.
Na podlagi rezultatov analize variance (ANOVA, analysis of variance), je telesna masa glavna sospremenljivka izpostavljenosti (po Cmax in AUC) pri osebah z RRMS, vendar ni vplivala na ukrepe glede varnosti in učinkovitosti, ki so jih ovrednotili v kliničnih študijah.
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
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, še zlasti: - zdravila, ki vsebujejo estre fumarne kisline (fumarate), ki se uporabljajo za zdravljenje psoriaze
The terminal half-life of monomethyl fumarate is short (approximately 1 hour) and no circulating monomethyl fumarate is present at 24 hours in the majority of individuals.
Končni razpolovni čas monometil fumarata je kratek (približno 1 uro), pri večini posameznikov pa po 24 urah v obtoku ni prisotnega monometil fumarata.
During treatment with Tecfidera, simultaneous use of other fumaric acid derivatives (topical or systemic) should be avoided.
Med zdravljenjem z zdravilom Tecfidera se je treba sočasni uporabi z drugimi derivati fumarne kisline (lokalni ali sistemski) izogniti.
However, should flushing be accompanied by a red rash or hives and you get any of these symptoms:
Če pa rdečino spremlja rdeč izpuščaj ali koprivnica in dobite enega ali več naslednjih simptomov:
Overall, Cmax and AUC increased approximately doseproportionally in the dose range studied (120 mg to 360 mg).
Na splošno sta se Cmax in AUC v preučevanem razponu odmerka zvišala približno sorazmerno z odmerkom (120 mg do 360 mg).
Tecfidera seems to work by stopping the body's defence system from damaging your brain and spinal cord.
Zdravilo Tecfidera deluje tako, da ustavi obrambni sistem vašega telesa, da bi poškodoval vaše možgane in hrbtenjačo.
The time to onset can be directly, several weeks or longer.
Okvare jeter se lahko pojavijo takoj, po več tednih zdravljenja ali kasneje.
Exhalation of CO2 is the primary route of dimethyl fumarate elimination accounting for 60% of the dose.
Izdihovanje CO2 je glavna pot izločanja dimetilfumarata, ki predstavlja 60 % odmerka.
Mean and median lymphocyte counts remained within normal limits.
Povprečno in mediano število limfocitov je ostalo v normalnih mejah.
There are no known therapeutic interventions to enhance elimination of Tecfidera nor is there a known antidote.
Ni znanih terapevtskih ukrepov, ki bi povečali izločanje zdravila Tecfidera, niti znanega antidota.
The mechanism by which dimethyl fumarate exerts therapeutic effects in multiple sclerosis is not fully understood.
Mehanizem, s katerim dimetilfumarat povzroča terapevtske učinke pri multipli sklerozi, ni čisto razumljen.
After 7 days, the dose should be increased to the recommended maintenance dose of 240 mg twice a day (see section 4.4).
Po 7 dneh je treba odmerek zvišati na priporočeni vzdrževalni odmerek 240 mg dvakrat na dan (glejte poglavje 4.4).
Renal and faecal elimination are secondary routes of elimination, accounting for 15.5% and 0.9% of the dose respectively.
Izločanje skozi ledvice in z blatom sta sekundarni poti izločanja, pri čemer prva predstavlja 15,5 % in druga 0,9 %
Reactions generally occur after the first dose, but may also occur at any time during treatment, and may be serious and life threatening.
Te reakcije navadno nastopijo po prvem odmerku, lahko pa se pojavijo tudi kadar koli med zdravljenjem, lahko so resne in smrtno nevarne.
Moderately low to very low lymphocyte counts - Lymphocyte counts (a type of white blood cell) may be decreased for a long period of time.
Zmerno nizko do zelo nizko število limfocitov - število limfocitov (vrste belih krvničk) je lahko dlje časa zmanjšano.
Live vaccines might carry an increased risk of clinical infection and should not be given to patients treated with Tecfidera unless, in exceptional cases, this potential risk is considered to be outweighed by the risk to the individual of not vaccinating.
Živa cepiva lahko predstavljajo večje tveganje za klinične okužbe, zato jih bolnikom, ki se zdravijo z zdravilom Tecfidera, ni dovoljeno dati, razen v izjemnih primerih, ko je to možno tveganje za posameznika manjše, kot tveganje, če ne bi bil cepljen.
PML can only occur in the presence of a JCV infection.
Do PML lahko pride le ob okužbi z virusom JC.
Other medicines and Tecfidera
Druga zdravila in zdravilo Tecfidera
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).
Mediano število novih ali na novo zvečanih T2 hiperintenzivnih lezij se je spremenilo z 2 v 8-tedenskem obdobju ocenjevanja pred zdravljenjem na 0 v zadnjih 8 tednih obdobja zdravljenja (mediana sprememba -2, n=16).
The capsule or its contents should not be crushed, divided, dissolved, sucked or chewed as the enteric-coating of the microtablets prevents irritant effects on the gut.
Kapsule ali njene vsebine se ne sme drobiti, deliti, topiti, sesati ali žvečiti, saj enterična obloga mikrotablet preprečuje draženje črevesja.
In multiple sclerosis clinical studies, the concomitant treatment of relapses with a short course of intravenous corticosteroids was not associated with a clinically relevant increase of infection.
V kliničnih študijah z multiplo sklerozo sočasno zdravljenje recidivov s kratkim ciklom intravenskih kortikosteroidov ni bilo povezano s klinično pomembnim zvišanjem okužb.
In the post-marketing setting most cases of herpes zoster infection were non-serious and resolved with treatment.
V obdobju trženja zdravila v večini primerov okužba s herpesom zostrom ni bila resna in je bila odpravljena z zdravljenjem.
What you need to know before you take Tecfidera Do not take Tecfidera:
Kaj morate vedeti, preden boste vzeli zdravilo Tecfidera Ne jemljite zdravila Tecfidera:
The symptoms described in these cases were consistent with the known adverse reaction profile of Tecfidera.
Simptomi, opisani v teh primerih, so skladni z znanim profilom neželenih učinkov zdravila Tecfidera.
You may experience side effects similar to those described below in section 4.
podobne opisanim spodaj v poglavju 4.
If you forget to take Tecfidera
Če ste pozabili vzeti zdravilo Tecfidera
- 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)
Incidenca spodnjih neželenih učinkov je izražena po naslednjih kategorijah: - zelo pogosti (≥1/10) - pogosti (≥1/100 do <1/10) - občasni (≥1/1.000 do <1/100) - redki (≥1/10.000 do <1/1.000)
The experience in uncontrolled clinical trials is consistent with the experience in the placebo-controlled clinical trials.
Izkušnje iz nekontroliranih kliničnih preskušanj so v skladu z izkušnjami iz s placebom kontroliranih kliničnih preskušanj.
MS, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab or cladribine, or some commonly used cancer treatments (rituximab or mitoxantrone).
MS, kot so fingolimod, natalizumab, teriflunomid, alemtuzumab, okrelizumab ali kladribin, ali nekatera druga zdravila, ki se pogosto uporabljajo za zdravljenje raka (rituksimab ali mitoksantron)
Tecfidera is not recommended for use in children and adolescents because there is limited experience in the use of Tecfidera in this population.
Uporaba zdravila Tecfidera pri otrocih in mladostnikih ni priporočljiva, saj so izkušnje z uporabo zdravila Tecfidera pri tej populaciji omejene.
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).
Zdravilo Tecfidera je indicirano za zdravljenje odraslih bolnikov z recidivno remitentno multiplo sklerozo (glejte poglavje 5.1 za pomembne informacije o populaciji, za katere je bila učinkovitost dokazana).
Symptoms vary from patient to patient, but typically include walking difficulties, feeling off balance and visual difficulties (e.g. blurred or double vision).
Simptomi se med bolniki razlikujejo, vendar običajno vključujejo težave s hojo, občutek neravnovesja in težave z vidom (npr. zamegljen ali dvojni vid).
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.
Omejene dolgoročne izkušnje z zdravilom Tecfidera bi lahko prispevale k malo dokazom glede morebitne povezave med dimetilfumaratom in Fanconijevim sindromom pri indikaciji MS.
In clinical studies (both controlled and uncontrolled), 9% of patients had lymphocyte counts ≥0.5 x
V kliničnih študijah (kontroliranih in nekontroliranih) je imelo 9 % bolnikov število limfocitov ≥0,5 x
If you take more Tecfidera than you should
Če ste vzeli večji odmerek zdravila Tecfidera, kot bi smeli
Read the package leaflet before use Oral use
Pred uporabo preberite priloženo navodilo!
The relevance of these findings to humans is not known.
Pomen teh ugotovitev za ljudi ni znan.
This resulted in a minimal accumulation of exposure yielding an increase in the median Cmax of 12% compared to the twice daily dosing (1.72 mg/l for twice daily compared to 1.93 mg/l for three times daily) with no safety implications.
To je povzročilo minimalno kopičenje izpostavitve s povečanjem mediane Cmax za 12 % v primerjavi z odmerjanjem dvakrat na dan (1,72 mg/l za dvakrat na dan v primerjavi z 1,93 mg/l za trikrat na dan) brez vplivov na varnost.
Temporary dose reduction to 120 mg twice a day may reduce the occurrence of flushing and gastrointestinal adverse reactions.
Začasno zmanjšanje odmerka na 120 mg dvakrat na dan lahko zmanjša pojav vročinskega oblivanja in prebavnih neželenih učinkov.
On average, lymphocyte counts decreased by approximately 30% of baseline value.
Povprečno se je število limfocitov zmanjšalo za približno 30 % od izhodiščne vrednosti.
If treatment is continued despite a persistent lymphocyte count < 0.5x109/L, enhanced vigilance is recommended (see also subsection on PML).
Če se zdravljenje nadaljuje kljub temu, da število limfocitov ostaja < 0,5 x 109/l, je priporočeno okrepljeno spremljanje (glejte tudi podpoglavje o PML).
The frequencies described in the table below are based on 769 patients treated with Tecfidera 240 mg twice a day and 771 patients treated with placebo
Pogostnosti, opisane v spodnji preglednici, temeljijo na 769 bolnikih, zdravljenih z zdravilom Tecfidera 240 mg dvakrat na dan, in 771 bolnikih, zdravljenih s placebom.
Assessment of renal function (e.g. creatinine, blood urea nitrogen and urinalysis) is recommended prior to treatment initiation, after 3 and 6 months of treatment, every 6 to 12 months thereafter and as clinically indicated.
Ocena delovanja ledvic (npr. kreatinin, dušik sečnine v krvi in analiza urina) se priporoča pred začetkom zdravljenja, 3 in 6 mesecev po zdravljenju, vsakih 6 do 12 mesecev zatem, ter kot je klinično indicirano.
Tecfidera with alcohol
Zdravilo Tecfidera skupaj z alkoholom
The annualised relapse rate for glatiramer acetate and placebo was 0.286 and 0.401 respectively in Study 2, corresponding to a reduction of 29% (p=0.013), which is consistent with approved prescribing information.
Letni delež recidiva v študiji 2 je bil 0,286 za glatiramer acetat in 0,401 za placebo, kar ustreza zmanjšanju za 29 % (p = 0,013), kar je v skladu z odobrenimi informacijami za predpisovanje zdravila.
Take Tecfidera with food - it may help to reduce some of the very common side effects (listed in section 4).
Zdravilo Tecfidera vzemite s hrano - to lahko pomaga zmanjšati nekatere zelo pogoste neželene učinke (naštete v poglavju 4).
Study 2 contained a rater-blinded (i.e. study physician/ investigator assessing the response to study treatment was blinded) reference comparator of glatiramer acetate.
Študija 2 je bila slepa za ocenjevalca (tj. za zdravnika v študiji/raziskovalca, ki je ocenjeval odziv na zdravljenje v okviru študije) in je kot primerjalno zdravilo uporabila glatiramer acetat.
Patients with serious infections should not start treatment with Tecfidera until the infection(s) is resolved.
Bolniki z resnimi okužbami se ne smejo začeti zdraviti z zdravilom Tecfidera, dokler okužba(e) ne izzveni(jo).
Your doctor will help you decide whether you should stop breastfeeding, or stop using Tecfidera.
Zdravnik se vam bo pomagal odločiti, ali naj prenehate z dojenjem ali jemanjem zdravila Tecfidera.
Progression might involve symptoms such as polyuria, polydipsia and proximal muscle weakness.
Napredovanje sindroma lahko vključuje simptome, kot so poliurija, polidipsija in oslabljena moč proksimalnih mišic.
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.
Predklinične študije kažejo, da so farmakodinamični odgovori dimetilfumarata v glavnem posredovani prek aktiviranja transkripcijske poti nuklearnega faktorja Nrf2 ((erythroid-derived 2)-like 2).
Early diagnosis of Fanconi syndrome and discontinuation of dimethyl fumarate treatment are important to prevent the onset of renal impairment and osteomalacia, as the syndrome is usually reversible.
Zgodnje diagnosticiranje Fanconijevega sindroma in prekinitev zdravljenja z dimetilfumaratom sta pomembna za preprečevanje pojava ledvične okvare in osteomalacije, saj je sindrom običajno reverzibilen.
The contribution of prior immunosuppressive therapy to the development of PML in dimethyl fumarate treated patients is unknown.
Prispevek predhodnega zdravljenja z imunosupresivnimi zdravili na razvoj PML pri bolnikih, zdravljenih z dimetilfumaratom, ni znan.
Tecfidera should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the foetus.
Zdravilo Tecfidera se lahko med nosečnostjo uporablja samo, če je nujno potrebno in če možna korist opraviči možno tveganje za plod.
The lower fetal weight and delayed ossification were considered secondary to maternal toxicity (reduced body weight and food consumption).
Nižjo telesno maso zarodka in zapoznelo okostenitev so pripisali toksičnosti za mater (zmanjšanje telesne mase in uživanja hrane).