natgillin/translations-raw huggingface dataset:
At week 16 of treatment, 13/175 (7.4%) of patients were noted to have lymphocyte levels <0.7x 10
V 16. tednu zdravljenja je bilo 13/175 (7,4 %) bolnikov obveščenih, da imajo ravni limfocitov < 0,7 x 10
Reproduction toxicity No fertility or pre- and post-natal development studies have been conducted with Skilarence.
Reproduktivna toksičnost Študij plodnosti ali predporodnega in poporodnega razvoja z zdravilom Skilarence niso izvedli.
Despite the high inter-subject variability, the exposure measured as AUC and Cmax was generally dose-proportional after single dose administration of 4 x 30 mg dimethyl fumarate tablets (total dose of 120 mg) and 2 x 120 mg dimethyl fumarate tablets (total dose of 240 mg).
Kljub veliki variabilnosti med preiskovanci je bila izpostavljenost, merjena kot AUC in Cmax na splošno sorazmerna z odmerkom po dajanju enkratnega odmerka 4 tablete po 30 mg dimetilfumarata (skupni odmerek 120 mg) in 2 tableti po 120 mg dimetilfumarata (skupni odmerek 240 mg).
A part of the total dimethyl fumarate is hydrolysed by esterases and the alkaline milieu of the small intestine, while the remainder enters the portal vein blood.
Del celokupnega dimetilfumarata se hidrolizira s pomočjo esteraz in alkalnega okolja v tankem črevesju, medtem ko preostanek vstopi v kri v portalni veni.
If you get severe or prolonged diarrhoea with Skilarence, other medicines may not work as well as they should.
Če se med jemanjem zdravila Skilarence pri vas pojavi huda ali dalj časa trajajoča driska, druga zdravila morda ne bodo delovala tako učinkovito, kot bi morala.
However, if you become flushed and get any of the following signs: - wheezing, difficulty breathing or shortness of breath, - swelling of the face, lips, mouth or tongue stop taking Skilarence and call a doctor straight away.
Če zardevate ali opazite katerega od naslednjih znakov: - sopenje, težave z dihanjem ali zasoplost, - otekanje obraza, ustnic, ust ali jezika prenehajte jemati zdravilo Skilarence in takoj pokličite zdravnika.
Animal studies have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale toksičen vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
The most common adverse reactions observed with Skilarence in the Phase III clinical study (1102) in psoriasis patients were gastrointestinal events (62.7%), flushing (20.8%) and lymphopenia (10.0%).
Najpogostejši neželeni učinki, ki so jih opazili pri zdravilu Skilarence v III. fazi klinične študije (1102) s psoriatičnimi bolniki, so bili neželeni učinki na prebavila (62,7 %), vročinsko oblivanje (20,8 %) in limfopenija (10,0 %).
40 gastro-resistant tablets 70 gastro-resistant tablets 90 gastro-resistant tablets 100 gastro-resistant tablets 120 gastro-resistant tablets 180 gastro-resistant tablets 200 gastro-resistant tablets 240 gastro-resistant tablets 300 gastro-resistant tablets 360 gastro-resistant tablets 400 gastro-resistant tablets
40 gastrorezistentnih tablet 70 gastrorezistentnih tablet 90 gastrorezistentnih tablet 100 gastrorezistentnih tablet 120 gastrorezistentnih tablet 180 gastrorezistentnih tablet 200 gastrorezistentnih tablet 240 gastrorezistentnih tablet 300 gastrorezistentnih tablet 360 gastrorezistentnih tablet 400 gastrorezistentnih tablet
There is no evidence for Skilarence interaction with cytochrome P450 and the most common efflux and uptake transporters, thus no interactions are expected with medicinal products metabolised or transported by these systems (see section 5.2).
Ni dokazov o medsebojnem delovanju zdravila Skilarence s citokromom P450 in z najpogostejšimi efluksnimi transporterji in transporterji privzema, zato ne pričakujemo medsebojnega delovanja z zdravili, ki se presnavljajo ali prenašajo prek teh sistemov (glejte poglavje 5.2).
The plasma protein binding of monomethyl fumarate is around 50%.
Vezava monometilfumarata na človeške plazemske beljakovine je približno 50 %.
The biotransformation of dimethyl fumarate does not involve cytochrome P450 isoenzymes.
Biotransformacija dimetilfumarata ne vključuje izoencimov citokroma P450.
Other haematological disorders
Druge hematološke motnje
Prior and concomitant treatment with immunosuppressive or immunomodulating therapies Limited data are available on the efficacy and safety of Skilarence in patients who have been previously treated with other immunosuppressive or immunomodulating therapies.
Predhodno in sočasno zdravljenje z imunosupresivnimi ali imunomodulirajočimi zdravili O učinkovitosti in varnosti zdravila Skilarence pri bolnikih, ki so bili predhodno zdravljeni z imunosupresivnimi ali imunomodulirajočimi zdravili, je na voljo malo podatkov.
In vitro studies have shown that dimethyl fumarate at a therapeutic dose does not inhibit CYP3A4/5 and BCRP and is a weak P-glycoprotein inhibitor.
Študije in vitro so pokazale, da dimetilfumarat v terapevtskem odmerku ne zavira CYP3A4/5 in BCRP in je šibek zaviralec P-glikoproteina.
If you have severe side effects after an increase in dose, your doctor may recommend that you temporarily go back to the last dose.
Če se bodo po povečanju odmerka pri vas pojavili hudi neželeni učinki, vam bo zdravnik morda priporočil začasno vrnitev na zadnji odmerek.
In the event of a clinically relevant change in hepatic parameters, particularly in the absence of alternative explanations, consideration should be given to dose reduction or treatment discontinuation.
V primeru klinično pomembne spremembe jetrnih parametrov, zlasti, če ni alternativne razlage, je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja.
40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets in PVC/PVDC-aluminium blister packs.
40, 70, 90, 100, 120, 180, 200, 240, 300, 360 in 400 gastrorezistentnih tablet v pretisnih omotih PVC/PVDC-aluminij.
Hepatic enzymes increased Serum creatinine increased*
Preiskave povišane vrednosti jetrnih encimov povišane vrednosti kreatinina v serumu*
Opportunistic infections/progressive multifocal leukoencephalopathy (PML) Cases of opportunistic infections, particularly of progressive multifocal leukoencephalopathy (PML) have been reported with other dimethyl fumarate-containing products (see section 4.8).
Oportunistične okužbe/progresivna multifokalna levkoencefalopatija (PML) Pri uporabi drugih zdravil, ki so vsebovala dimetilfumarat, so poročali o primerih oportunističnih okužb, še zlasti o progresivni multifokalni levkoencefalopatiji (PML) (glejte poglavje 4.8).
No data are available on the efficacy and safety of Skilarence when taken concomitantly with other immunosuppressive or immunomodulating therapies (see section 4.5).
Podatkov o učinkovitosti in varnosti zdravila Skilarence ob sočasnem jemanju drugih imunosupresivnih ali imunomodulirajočih zdravil ni na voljo (glejte poglavje 4.5).
Do not crush, break, dissolve or chew your tablets, as they have a special coating to help prevent irritation of your stomach.
Tablet ne drobite, ne razpolavljajte, ne raztapljajte in ne žvečite, saj imajo posebno oblogo, ki preprečuje draženje črevesja.
Skilarence with alcohol
Zdravilo Skilarence skupaj z alkoholom
However, Skilarence has not been studied in patients with severe renal impairment, and some cases of renal toxicity have been reported during post-marketing surveillance with fumaric acid esters.
Vendar pa zdravila Skilarence niso preučevali pri bolnikih s hudo okvaro delovanja ledvic, v obdobju trženja zdravila pa so poročali o nekaj primerih ledvične toksičnosti z estri fumarne kisline.
Fanconi syndrome is a rare but serious kidney disorder which may occur with Skilarence.
Fanconijev sindrom je redka, a resna bolezen ledvic, ki se lahko pojavi ob zdravljenju z zdravilom Skilarence.
In rare cases hypophosphataemic osteomalacia with non-localised bone pain, elevated alkaline phosphatase in serum and stress fractures may occur.
V redkih primerih lahko pride do hipofosfatemične osteomalacije z nelokalizirano bolečino v kosteh, zvišanjem alkalne fosfataze v serumu in stresnimi zlomi.
During treatment
Med zdravljenjem
In the event of a clinically relevant change in renal function, particularly in the absence of alternative explanations, consideration should be given to dosage reduction or treatment discontinuation.
V primeru klinično pomembne spremembe v delovanju ledvic, zlasti, če ni alternativne razlage, je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja.
If a particular dose increase is not tolerated, it may be temporarily reduced to the last tolerated dose.
Če bolnik ne prenaša posameznega povečanja odmerka, je odmerek mogoče začasno znižati na zadnji odmerek, ki ga je bolnik še prenašal.
It has not been studied in patients with pre-existing low leukocyte or lymphocyte counts.
Zdravila Skilarence niso preučili pri bolniki z obstoječim nizkim številom levkocitov ali limfocitov.
In vitro studies have shown that monomethyl fumarate at the therapeutic dose does not inhibit or induce any of the cytochrome P450 enzymes, it is not a substrate or inhibitor of P-glycoprotein and is not an inhibitor of the most common efflux and uptake transporters.
Študije in vitro so pokazale, da monometilfumarat v terapevtskem odmerku ne zavira ali inducira nobenega encima citokroma P450, da ni substrat ali zaviralec P-glikoproteina in da ni zaviralec najpogostejših efluksnih transporterjev in transporterjev privzema.
Skilarence 30 mg 42, 70 and 210 gastro-resistant tablets in PVC/PVDC-aluminium blister packs.
Skilarence 30 mg 42, 70 in 210 gastrorezistentnih tablet v pretisnih omotih PVC/PVDC-aluminij.
Skilarence is not recommended in women of child-bearing potential not using appropriate contraception.
Zdravila Skilarence ne uporabljajte pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
Taking these medicines with Skilarence could increase the risk of side effects on your immune system.
Jemanje teh zdravil skupaj z zdravilom Skilarence bi lahko povečalo tveganje za pojav stranskih učinkov na vaš imunski sistem.
Carcinogenicity
Karcinogeneza
Caution should be exercised when prescribing medicinal products with a narrow therapeutic index that require absorption in the intestinal tract.
Previdnost je potrebna pri predpisovanju zdravil z ozkim terapevtskim indeksom, ki se presnavljajo v prebavilih.
Skilarence tablets are used to treat moderate to severe plaque psoriasis in adults.
Tablete zdravila Skilarence se uporabljajo za zdravljenje zmerne do hude psoriaze v plakih pri odraslih.
Superiority testing vs placebo PASI 75, n (%) p-value a a
Testiranje superiornosti v primerjavi s placebom PASI 75, n (%) p-vrednost
What Skilarence is and what it is used for
Kaj je zdravilo Skilarence in za kaj ga uporabljamo
Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
Zdravilo Skilarence je indicirano za zdravljenje zmerne do hude psoriaze v plakih pri odraslih, ki potrebujejo zdravljenje s sistemskim zdravilom.
- Severe hepatic or renal impairment.
− Huda okvara jeter ali ledvic.
42 gastro-resistant tablets 70 gastro-resistant tablets 210 gastro-resistant tablets
42 gastrorezistentnih tablet 70 gastrorezistentnih tablet 210 gastrorezistentnih tablet
*Additional adverse reactions reported with Fumaderm, a related medicinal product containing dimethyl fumarate along with other fumaric acid esters.
*Dodatni neželeni učinki, o katerih so poročali pri zdravljenju z zdravilom Fumaderm, ki je podobno zdravilo, ki vsebuje dimetilfumarat, skupaj z drugimi estri fumarne kisline.
Data from the Phase III clinical study as well as from the literature show that changes in haematological parameters are most likely to occur during the first 3 months after starting treatment with dimethyl fumarate.
Podatki iz klinične študije III. faze in podatki iz literature kažejo, da se spremembe hematoloških parametrov najverjetneje pojavijo v prvih 3 mesecih po začetku zdravljenja z dimetilfumaratom.
Each gastro-resistant tablet contains 136.8 mg lactose (as monohydrate).
Ena gastrorezistentna tableta vsebuje 136,8 mg laktoze (v obliki monohidrata).
The portion of dimethyl fumarate that reacts with glutathione, forming a glutathione-adduct, is metabolised further to its mercapturic acid, which is excreted in the urine.
Del dimetilfumarata, ki reagira z glutationom in tvori adukt glutationa, se nadalje presnavlja v njegovo merkapturno kislino, ki se izloča z urinom.
A transient increase in mean values of eosinophils was noted as early as week 3, reached a maximum at week 5 and 8, and had returned to baseline values at week 16.
Že v tretjem tednu so opazili prehodno povečanje povprečnih vrednosti eozinofilcev, ki je doseglo največjo vrednost v 5. in 8. tednu, vrednosti pa so se vrnile na izhodiščne v 16. tednu.
Blue, film-coated, round, biconvex tablet with a diameter of approximately 11.6 mm.
Modra, filmsko obložena, okrogla, bikonveksna tableta s premerom približno 11,6 mm.
The NOAEL for maternal and embryo-foetal toxicity was 40 mg/kg/day, corresponding to 0.2-fold and 2.0-fold the human systemic exposure at the highest recommended dose (720 mg/day), as AUC and Cmax values, respectively.
NOAEL za maternalno in embriofetalno toksičnost je bil 40 mg/kg/dan, kar ustreza 0,2-kratni in 2,0- kratni sistemski izpostavljenosti pri človeku pri najvišjem priporočenem odmerku (720 mg/dan), kot vrednosti AUC in Cmax.
White, film-coated, round, biconvex tablet with a diameter of approximately 6.8 mm. Skilarence 120 mg
Bela, filmsko obložena, okrogla, bikonveksna tableta s premerom približno 6,8 mm. Skilarence 120 mg
In patients experiencing diarrhoea during Skilarence treatment, the effect of oral contraceptives may be reduced and additional barrier methods of contraception may be necessary (see section 4.5).
Pri bolnicah, pri katerih se med zdravljenjem z zdravilom Skilarence pojavi diareja, se lahko učinek peroralnih kontracepcijskih sredstev zmanjša, zato bo morda treba uporabiti alternativne pregradne kontracepcijske metode (glejte poglavje 4.5).
Skilarence contains lactose.
Zdravilo Skilarence vsebuje laktozo.
Skilarence may decrease leukocyte and lymphocyte counts (see section 4.8).
Zdravilo Skilarence lahko zmanjša število levkocitov in limfocitov (glejte poglavje 4.8).
Most patients had moderate psoriasis based on Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA) scores at baseline: the mean PASI score at baseline was 16.35 and 60% of patients scored as moderate on the PGA.
Večina bolnikov je imela ob izhodišču zmerno psoriazo na podlagi ocene indeksa PASI [indeks jakosti psoriaze in telesne površine, prizadete s psoriazo] in ocene PGA [celostna ocena, ki jo poda zdravnik]: povprečna ocena PASI je v izhodišču znašala 16,35 in 60 % bolnikov je dobilo oceno PGA »zmerno«.
It is not known how commonly they occur.
Njuna pogostnost ni znana.
However, because renal elimination plays a minor role in the total clearance from plasma, it is unlikely that renal impairment may affect the pharmacokinetic characteristics of Skilarence (see section 4.2).
Ker pa izločanje skozi ledvice igra manjšo vlogo pri celokupnem očistku iz plazme, ni preveč verjetno, da bi okvara ledvic lahko vplivala na farmakokinetične lastnosti zdravila Skilarence (glejte poglavje 4.2).
Placebo with a difference of 22.2% for PASI 75 and 20.0% for PGA score clear or almost clear, superiority of Fumaderm vs Placebo with a difference of 25.0% for PASI 75 and 24.4% for PGA score clear or almost clear; b Non-inferiority of Skilarence vs. Fumaderm with a difference of -2.8% for PASI 75 and -4.4% for PGA score clear or almost clear.
Zdravilo Fumaderm = aktivna primerjava, kombinirano zdravilo z enako količino dimetilfumarata in s 3 monometilnimi fumaratnimi solmi; n = število bolnikov z razpoložljivimi podatki; N = število bolnikov v populaciji; PASI = Psoriasis Area Severity Index; PGA = Physician's Global Assessment; a Večja učinkovitost zdravila Skilarence v primerjavi s placebom z razliko 22,2 % za PASI 75 in 20,0 % za oceno PGA brez znakov ali skoraj brez znakov, superiornost zdravila Fumaderm v primerjavi s placebom z razliko 25,0 % za PASI 75 in 24,4 % za oceno PGA brez znakov ali skoraj brez znakov; b Neinferiornost zdravila Skilarence v primerjavi z zdravilom Fumaderm z razliko -2,8 % za PASI 75 in -4,4 % za oceno PGA brez znakov ali skoraj brez znakov.
The no-observed adverse-effect-level (NOAEL) after 3 months of treatment was 30 mg/kg/day, which corresponds to 2.9-fold and 9.5-fold the human systemic exposure at the highest recommended dose (720 mg/day), as AUC and Cmax values, respectively.
Raven brez vidnih neželenih učinkov (NOAEL) je bila po treh mesecih zdravljenja 30 mg/kg/dan, kar ustreza 2,9-kratni in 9,5-kratni sistemski izpostavljenosti pri človeku pri najvišjem priporočenem odmerku (720 mg/dan), kot vrednosti AUC in Cmax.
9/L were observed in 1/29 (3.5%) patient at 6 months and 0/28 (0%) at 12 months after stopping treatment.
Med spremljanjem brez zdravljenja so opazili ravni limfocitov < 0,7 x 109/l pri 1/29 (3,5 %) bolniku v 6. mesecu in 0/28 (0 %) v 12. mesecu po prenehanju zdravljenja.
Marketing Authorisation Holder Almirall, S.A.
Imetnik dovoljenja za promet z zdravilom Almirall, S.A.
Based on observations in the Phase III clinical study as well as on literature data, flushing is most likely to occur during the early weeks of treatment and tends to lessen with time.
Na podlagi opažanj iz klinične študije III. faze in podatkov iz literature se vročinsko oblivanje najverjetneje pojavi v zgodnjih tednih zdravljenja in se običajno sčasoma zmanjša.
- Other medicines used to treat psoriasis, such as methotrexate, retinoids, psoralens, ciclosporin, or other immunosuppressants or cytostatics (medicines that affect the immune system).
- druga zdravila za zdravljenje psoriaze, kot so metotreksat, retinoidi, psoraleni, ciklosporin ali drugi imunosupresivi ali citostatiki (zdravila, ki vplivajo na imunski sistem).
Warnings and precautions Talk to your doctor or pharmacist before taking Skilarence.
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Skilarence se posvetujte z zdravnikom ali farmacevtom.
Progressive multifocal leukoencephalopathy*
Bolezni živčevja glavobol parestezija omotica* progresivna multifokalna levkoencefalopatija*
After oral administration, dimethyl fumarate is not detected in plasma because it is rapidly hydrolysed by esterases to its active metabolite monomethyl fumarate.
Po peroralnem dajanju dimetilfumarata v plazmi ni mogoče določiti, saj se hitro hidrolizira z esterazami v svoj aktivni presnovek monometilfumarat.
No carcinogenicity studies have been performed for Skilarence.
Z zdravilom Skilarence niso opravili študij karcinogenosti.
- Other medicines that can affect your kidney function, such as methotrexate or ciclosporin (used to treat psoriasis), aminoglycosides (used to treat infections), diuretics (which increase urine), nonsteroidal anti-inflammatory drugs (used to treat pain) or lithium (used for bipolar disease and depression).
- druga zdravila, ki lahko vplivajo na delovanje vaših ledvic, kot so metotreksat ali ciklosporin (ki ju uporabljamo za zdravljenje psoriaze), aminoglikozidi (ki jih uporabljamo za zdravljenje okužb), diuretiki (ki povečajo izločanje urina), nesteroidna protivnetna zdravila (ki jih uporabljamo za zdravljenje bolečin) ali litij (ki ga uporabljamo za zdravljenje bipolarne bolezni in depresije).
At 12 months after stopping treatment 3/28 (10.7%) of patients had lymphocyte values below 1.0x10
V 12. mesecu po prenehanju zdravljenja so imeli 3/28 (10,7 %) bolniki vrednosti limfocitov pod 1,0 x 10
Data from the Phase III clinical study as well as from the literature show that gastrointestinal disorders with dimethyl fumarate-containing products are most likely to occur during the first 2 to 3 months after starting treatment.
Podatki iz klinične študije III. faze in podatki iz literature kažejo, da se gastrointestinalne motnje pri zdravilih, ki vsebujejo dimetilfumarat, najpogosteje pojavijo v prvih dveh do treh mesecih po začetku zdravljenja.
If you notice new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking or memory; confusion; or personality changes lasting several days, stop taking Skilarence and talk to your doctor straight away.
Če opazite šibkost ene strani telesa oz. poslabšanje obstoječe šibkosti, nespretnost, spremembe vida, razmišljanja ali spomina, zmedenost ali spremembe osebnosti, ki trajajo več dni, prenehajte jemati zdravilo Skilarence in se takoj posvetujte z zdravnikom.
Skilarence should be used cautiously in combination with other systemic antipsoriatic therapy (e.g. methotrexate, retinoids, psoralens, ciclosporin, immunosuppressants or cytostatics) (see section 4.4).
Zdravilo Skilarence je treba v kombinaciji z drugimi sistemskimi zdravili za zdravljenje psoriaze (kot so metotreksat, retinoidi, psoraleni, ciklosporin, imunosupresivi ali citostatiki) uporabljati previdno (glejte poglavje 4.4).
Skilarence may have a minor influence on the ability to drive and use machines.
Zdravilo Skilarence ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Treatment should not be initiated if leukopenia below 3.0x10
Zdravljenja se ne sme uvesti, če je pri bolniku ugotovljena levkopenija s številom levkocitov pod 3,0 x 10
Since renal elimination plays a minor role in the clearance of Skilarence from plasma, it is unlikely that renal impairment would affect the pharmacokinetic characteristics, and so a need for dose adjustment in patients with mild to moderate renal impairment is not expected (see sections 4.2 and
Ker izločanje skozi ledvice igra manjšo vlogo pri očistku zdravila Skilarence iz plazme, je malo verjetno, da bi okvarjeno delovanje ledvic vplivalo na farmakokinetične lastnosti, zato ni pričakovati potrebe po prilagajanju odmerka pri bolnikih z blago do zmerno okvaro delovanja ledvic (glejte poglavji 4.2 in 5.2).
After oral administration of a single Skilarence 120 mg tablet in healthy subjects, monomethyl fumarate reached plasma peak concentrations of around 1325 ng/mL and 1311 ng/mL under fasted or fed conditions, respectively.
Po peroralnem dajanju ene tablete zdravila Skilarence 120 mg zdravim preiskovancem je monometilfumarat dosegel najvišje koncentracije v plazmi približno 1.325 ng/ml na tešče in 1.311 ng/ml na poln želodec.
However, as dimethyl fumarate is metabolised by esterases and the alkaline milieu of the small intestine without the involvement of cytochrome P450, hepatic impairment is not expected to influence exposure (see section 4.2).
Ker pa se dimetilfumarat presnavlja s pomočjo esteraz in alkalnega okolja v tankem črevesju brez udeležbe citokroma P450, ni pričakovati vpliva okvare jeter na izpostavljenost zdravilu (glejte poglavje 4.2).
Uncommon side effects (may affect up to 1 in 100 people): - dizziness - excess protein in the urine (proteinuria) - increase in serum creatinine (a substance in the blood used for measuring how well your kidneys are working)
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): - omotica - odvečne beljakovine v urinu (proteinurija) - porast vrednosti kreatinina v serumu (snov v krvi, katere vrednost merimo za ugotavljanje delovanja vaših ledvic)
Symptomatic treatment is indicated in the case of an overdose.
V primeru prevelikega odmerjanja je indicirano simptomatsko zdravljenje.
For monitoring recommendations and clinical management of haematological adverse reactions, see section 4.4.
Za priporočila glede spremljanja in klinične obravnave hematoloških neželenih učinkov glejte poglavje 4.4.
What Skilarence 30 mg looks like and contents of the pack Skilarence 30 mg is a white, round tablet with a diameter of approximately 6.8 mm.
Izgled zdravila Skilarence 30 mg in vsebina pakiranja Zdravilo Skilarence 30 mg je bela, okrogla tableta s premerom približno 6,8 mm.
The following is a list of adverse reactions experienced by patients treated with Skilarence during the clinical study and with Fumaderm, a related medicinal product containing dimethyl fumarate along with other fumaric acid esters.
Naslednji seznam neželenih učinkov zajema neželene učinke, ki so se pojavili pri bolnikih, zdravljenih z zdravilom Skilarence v klinični študiji in z zdravilom Fumaderm, ki vsebuje dimetilfumarat, skupaj z drugimi estri fumarne kisline.