natgillin/translations-raw huggingface dataset:
Coadministration of potent inducers of CYP3A4 with tofacitinib is not recommended.
Sočasna uporaba močnih induktorjev CYP3A4 in tofacitiniba ni priporočljiva.
In the entire treatment experience with tofacitinib, the overall incidence rate of infections was 60.3 events per 100 patient-years (involving 49.4% of patients; total 572 patients).
V vseh preskušanjih zdravljenja s tofacitinibom je bila celokupna stopnja incidence okužb 60,3 dogodka na 100 bolnikov-let (vključevala je 49,4 % bolnikov; skupno 572 bolnikov).
Patients treated with tofacitinib who are Japanese or Korean, or patients with long standing RA who have previously received two or more biological DMARDs, or patients with an ALC less than 1,000 cells/mm3, or patients treated with 10 mg twice daily may have an increased risk of herpes zoster (see section 4.4).
Pri bolnikih, zdravljenih s tofacitinibom, ki so Japonci ali Korejci, bolnikih z dolgotrajnim RA, ki so predhodno prejemali dva ali več bioloških DMARD, ali bolnikih z ALC, manjšim od 1.000 celic/mm in bolnikih, ki se zdravijo z odmerkom 10 mg dvakrat na dan, je tveganje za herpes zoster lahko zvečano (glejte poglavje 4.4).
Patients with latent TB, who test positive, should be treated with standard antimycobacterial therapy before administering tofacitinib.
Bolnike z latentno TB, pri katerih je test pozitiven, je treba pred začetkom uporabe tofacitiniba zdraviti s standardnimi zdravili za zdravljenje mikobakterijskih okužb.
Table 6: Adverse drug reactions
Preglednica 6: Neželeni učinki zdravila
Tofacitinib has been shown to be teratogenic in rats and rabbits, and to affect parturition and peri/postnatal development (see section 5.3).
Ugotovili so, da je tofacitinib teratogen pri podganah in kuncih ter da vpliva na kotitev in peri-/postnatalni razvoj (glejte poglavje 5.3).
Enrolled patients had failed at least 1 conventional therapy, including corticosteroids, immunomodulators, and/or a TNF inhibitor.
V preskušanja so vključili bolnike, pri katerih je bilo predhodno neučinkovito vsaj 1 običajno zdravljenje, ki je vključevalo kortikosteroide, imunomodulatorje in/ali antagonist TNF.
Other medicines and XELJANZ
Druga zdravila in zdravilo XELJANZ
All patients were required to have 1 concomitant csDMARD; 71.6% of patients received concomitant MTX, 15.7% of patients received concomitant sulfasalazine, and 8.6% of patients received concomitant leflunomide.
Vsi bolniki so morali sočasno prejemati 1 csDMARD; 71,6% bolnikov je sočasno prejemalo MTX, 15,7 % bolnikov je sočasno prejemalo sulfasalazin in 8,6 % bolnikov je sočasno prejemalo leflunomid.
The enzymatic activity of CYP enzymes is reduced in RA patients due to chronic inflammation.
Pri bolnikih z RA je encimska aktivnost encimov CYP zmanjšana zaradi kroničnega vnetja.
Pink, oval tablet of approximate average dimension of 10.8 mm × 5.5 mm × 4.4 mm (length by width by thickness) with a drilled hole at one end of the tablet band and “JKI 11” printed on one side of the tablet.
Rožnata, ovalna tableta s približnimi povprečnimi merami 10,8 mm × 5,5 mm × 4,4 mm (dolžina krat širina krat debelina), z izvrtano luknjico na enem koncu oboda tablete in natisnjeno oznako ''JKI 11'' na eni strani tablete.
Inhibition of JAK1 and JAK3 by tofacitinib attenuates signalling of interleukins (IL-2, -4, -6, -7, -9, -15, -21) and type I and type II interferons, which will result in modulation of the immune and inflammatory response.
Tofacitinib z zaviranjem kinaz JAK1 in JAK3 oslabi signaliziranje interlevkinov (IL-2, -4, -6,7, -9, -15, -21) ter interferonov tipa I in II, kar povzroči spremembo imunskega in vnetnega odziva.
All patients were required to have 1 concomitant csDMARD; 83.9% of patients received concomitant MTX, 9.5% of patients received concomitant sulfasalazine, and 5.7% of patients received concomitant leflunomide.
Vsi bolniki so morali sočasno prejemati 1 csDMARD; 83,9 % bolnikov je sočasno prejemalo MTX, 9,5 % bolnikov je sočasno prejemalo sulfasalazin in 5,7 % bolnikov je sočasno prejemalo leflunomid.
Treatment with tofacitinib was associated with an increased incidence of lymphopenia compared to placebo.
Zdravljenje s tofacitinibom je bilo povezano z zvečano incidenco limfopenije v primerjavi s placebom.
Tablet core sorbitol (E420) hydroxyethyl cellulose copovidone magnesium stearate
Jedro tablete sorbitol (E420) hidroksietilceluloza kopovidon magnezijev stearat
Efficacy may be regained by 8 weeks of 10 mg twice daily therapy (see section 5.1).
Učinkovitost lahko ponovno dosežemo z 8-tedenskim zdravljenjem z odmerkom 10 mg dvakrat na dan (glejte poglavje 5.1).
Results from population PK analysis in patients with active PsA or moderate to severe UC were consistent with those in patients with RA.
Rezultati populacijske analize farmakokinetike pri bolnikih z aktivnim PsA ali zmernim do hudim UK so bili skladni z rezultati pri bolnikih z RA.
Tofacitinib 10 mg twice daily is contraindicated in patients who have one or more of the following conditions:
Odmerek tofacitiniba 10 mg dvakrat na dan je kontraindiciran pri bolnikih z enim ali več od naslednjih stanj:
Concomitant stable doses of oral aminosalicylates and corticosteroids (prednisone or equivalent daily dose up to 25 mg) were permitted with taper of corticosteroids to discontinuation mandated within 15 weeks of entering the maintenance study.
Sočasno jemanje stabilnih odmerkov peroralnih aminosalicilatov in kortikosteroidov (dnevni odmerek prednizona ali druge enakovredne učinkovine do 25 mg) so dovolili s postopnim zmanjševanjem odmerka kortikosteroidov do prekinitve zdravljenja, do katere je moralo priti v 15 tednih od vključitve v preskušanje vzdrževalnega zdravljenja.
Tofacitinib 11 mg prolonged-release tablets must be taken whole in order to ensure the entire dose is delivered correctly.
Tofacitinib 11 mg tablete s podaljšanim sproščanjem je treba vzeti cele, da zagotovimo pravilen vnos celotnega odmerka.
Nominal p<0.0001 for active treatment versus placebo at month 3.
nominalna vrednost p < 0,0001 za aktivno zdravljenje v primerjavi s placebom po 3. mesecih.
Each pack contains 56, 112, or 182 film-coated tablets.
Eno pakiranje vsebuje 56, 112 ali 182 filmsko obloženih tablet.
Women of childbearing potential should be advised to use effective contraception during treatment with tofacitinib and for at least 4 weeks after the last dose.
Ženskam v rodni dobi je treba svetovati, da morajo med zdravljenjem s tofacitinibom in vsaj še 4 tedne po zadnjem odmerku uporabljati učinkovito metodo kontracepcije.
Since tofacitinib is metabolised by CYP3A4, interaction with medicinal products that inhibit or induce CYP3A4 is likely.
Tofacitinib se presnavlja preko CYP3A4, zato je medsebojno delovanje z zdravili, ki zavirajo ali inducirajo CYP3A4, verjetno.
- The 11 mg prolonged-release tablets are provided in blisters containing 7 prolonged-release tablets.
- 11 mg tablete s podaljšanim sproščanjem so na voljo v pretisnih omotih, ki vsebujejo 7 tablet s podaljšanim sproščanjem.
The recommended dose is one 11 mg prolonged-release tablet administered once daily.
Priporočeni odmerek je ena 11 mg tableta s podaljšanim sproščanjem enkrat na dan.
In a controlled clinical trial of patients with RA initiating tofacitinib 10 mg twice daily or placebo, the number of responders to influenza vaccine was similar in both groups: tofacitinib (57%) and placebo (62%).
V nadzorovanih kliničnih preskušanjih pri bolnikih z RA, ki so jim uvedli 10 mg tofacitiniba dvakrat na dan ali placebo, je bilo število bolnikov, ki so se odzvali na cepivo proti gripi, v obeh skupinah podobno: tofacitinib (57 %) in placebo (62 %).
Following long-term treatment (median duration of tofacitinib treatment of approximately 5 years), CD4+ and CD8+ counts showed median reductions of 28% and 27%, respectively, from baseline.
Po dolgotrajnem zdravljenju (mediano trajanje zdravljenja s tofacitinibom približno 5 let) se je mediano število celic CD4+ zmanjšalo za 28 %, število celic CD8+ pa za 27 % glede na izhodiščno vrednost.
Abbreviations: DMARD=disease-modifying antirheumatic drug; HAQ-DI=Health Assessment Questionnaire Disability Index; N=total number of patients in the statistical analysis; SC q2w=subcutaneously once every 2 weeks; TNFi=tumour necrosis factor inhibitor.
Okrajšave: DMARD = imunomodulirajoče antirevmatično zdravilo; HAQ-DI = indeks oviranosti po vprašalniku za oceno zdravstvenega stanja (Health Assessment Questionnaire Disability Index); n = skupno število bolnikov v statistični analizi; SC q2w = subkutano enkrat na 2 tedna; TNF = tumorje nekrotizirajoči faktor.
Coadministration with ketoconazole and fluconazole increased tofacitinib Cmax, while tacrolimus, ciclosporine and rifampicin decreased tofacitinib Cmax.
Sočasna uporaba ketokonazola in flukonazola je zvečala vrednost Cmax tofacitiniba, medtem ko so takrolimus, ciklosporin in rifampicin zmanjšali vrednost Cmax tofacitiniba.
• The website repository shall contain: o The educational material in digital format o The patient alert card in digital format
• Spletni repozitorij mora vsebovati: o izobraževalno gradivo v elektronski obliki; o opozorilno kartico za bolnika v elektronski obliki.
Table 9: Number (%) of subjects achieving DAS28-4(ESR) < 2.6 remission at months 3 and 6
Preglednica 9: Število (%) preskušancev, ki so dosegli remisijo DAS28-4(ESR) < 2,6 v 3. in 6. mesecu
The efficacy and safety of tofacitinib for the treatment of adult patients with moderately to severely active UC (Mayo score 6 to 12 with endoscopy subscore ≥ 2 and rectal bleeding subscore ≥ 1) were assessed in 3 multicentre, double-blind, randomised, placebo-controlled studies: 2 identical induction studies (OCTAVE Induction 1 and OCTAVE Induction 2) followed by 1 maintenance study (OCTAVE Sustain).
Učinkovitost in varnost tofacitiniba pri zdravljenju odraslih bolnikov z zmerno do močno aktivnim UK (ocena Mayo od 6 do 12 z endoskopsko podoceno ≥ 2 in podoceno rektalnih krvavitev ≥ 1) so ocenili v 3 multicentričnih, dvojno slepih, randomiziranih in s placebom nadzorovanih preskušanjih: 2 identičnih preskušanjih indukcijskega zdravljenja (OCTAVE Induction 1 in OCTAVE Induction 2), ki jima je sledilo 1 preskušanje vzdrževalnega zdravljenja (OCTAVE Sustain).
After an additional 8 weeks of tofacitinib 10 mg twice daily in OCTAVE Open, 53% (154/293) patients achieved clinical response and 14% (42/293) patients achieved remission.
Po dodatnih 8 tednih zdravljenja z 10 mg tofacitiniba dvakrat na dan v preskušanju OCTAVE Open je 53 % (154/293) bolnikov doseglo klinični odziv, 14 % (42/293) bolnikov pa remisijo.
Gastrointestinal obstruction with a non-deformable prolonged-release formulation
Obstrukcija prebavil pri jemanju zdravil z nedeformabilno formulacijo s podaljšanim sproščanjem
Treatment with tofacitinib was associated with an increased incidence of liver enzyme elevation in some patients (see section 4.8 liver enzyme tests).
Zdravljenje s tofacitinibom je bilo pri nekaterih bolnikih povezano z zvečano incidenco zvečanja vrednosti jetrnih encimov (glejte Testi jetrnih encimov v poglavju 4.8).
In a human radiolabelled study, more than 65% of the total circulating radioactivity was accounted for by unchanged active substance, with the remaining 35% attributed to 8 metabolites, each accounting for less than 8% of total radioactivity.
V študiji radioaktivno označenega zdravila pri človeku je več kot 65 % celokupne radioaktivnosti v obtoku prispevala nespremenjena učinkovina, preostalih 35 % pa 8 presnovkov, pri čemer je vsak od posameznih presnovkov prispeval manj kot 8 % celokupne radioaktivnosti.
If drug-induced liver injury is suspected, the administration of tofacitinib should be interrupted until this diagnosis has been excluded.
Ob sumu na z zdravilom povzročeno poškodbo jeter je treba dajanje tofacitiniba prekiniti, dokler ta diagnoza ni izključena.
In study OPAL BROADEN, the progression of structural joint damage was assessed radiographically utilising the van der Heijde modified Total Sharp Score (mTSS) and the proportion of patients with radiographic progression (mTSS increase from baseline greater than 0.5) was assessed at month 12.
V preskušanju OPAL BROADEN so napredovanje strukturnih poškodb sklepov ocenili radiografsko z van der Heijdejevo prirejeno Sharpovo lestvico (mTSS), po 12 mesecih pa so ocenili delež bolnikov, pri katerih je bolezen radiografsko napredovala (zvišanje mTSS za več kot 0,5 od izhodišča).
Tofacitinib 10 mg twice daily is contraindicated in patients who are at high risk for pulmonary embolism (see also section 4.3).
Odmerek tofacitiniba 10 mg dvakrat na dan je kontraindiciran pri bolnikih z velikim tveganjem za pljučno embolijo (glejte tudi poglavje 4.3).
RA and PsA patients have an increased risk for cardiovascular disorders.
Bolniki z RA in PsA imajo zvečano tveganje za nastanek srčno-žilnih bolezni.
Durability of effect was assessed by ACR20, ACR50, ACR70 response rates in studies of duration of up to two years.
V preskušanjih, ki so trajala do dve leti, so trajnost učinka ocenili s stopnjami odziva ACR20, ACR50 in ACR70.
There have been reports of patients treated with XELJANZ who have developed blood clots.
Pri bolnikih, ki so prejemali zdravilo XELJANZ, so poročali o krvnih strdkih.
• If maintaining XELJANZ 5 mg twice a day did not work for you, your doctor may decide to increase the dose to 10 mg twice a day.
• Če zdravljenje s 5 mg zdravila XELJANZ dvakrat na dan pri vas ne bo učinkovito, lahko zdravnik poveča odmerek na 10 mg na dan.
Tofacitinib was secreted in the milk of lactating rats (see section 5.3).
Tofacitinib se je izločal v mleko doječih podgan (glejte poglavje 5.3).
Prior to initiating tofacitinib, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
Pred začetkom zdravljenja s tofacitinibom je priporočljivo pri vseh bolnikih opraviti vsa cepljenja skladno z veljavnimi smernicami za cepljenje.
It is recommended that live vaccines not be given concurrently with tofacitinib.
Živih cepiv ni priporočljivo dajati sočasno s tofacitinibom.
Induction efficacy data (OCTAVE Induction 1 and OCTAVE Induction 2) The primary endpoint of OCTAVE Induction 1 and OCTAVE Induction 2 was the proportion of patients in remission at week 8, and the key secondary endpoint was the proportion of patients with improvement of endoscopic appearance of the mucosa at week 8.
Podatki o učinkovitosti indukcijskega zdravljenja (OCTAVE Induction 1 in OCTAVE Induction 2) Primarni opazovani dogodek v preskušanjih OCTAVE Induction 1 in OCTAVE Induction 2 je bil delež bolnikov v remisiji po 8 tednih, ključni sekundarni opazovani dogodek pa je bil delež bolnikov, pri katerih so po 8 tednih opazili izboljšanje endoskopskega videza sluznice.
In the induction and maintenance studies, across tofacitinib and placebo treatment groups, the most common categories of serious adverse reactions were gastrointestinal disorders and infections, and the most common serious adverse reaction was worsening of UC.
V preskušanjih indukcijskega in vzdrževalnega zdravljenja so bili najpogostejši resni neželeni učinki v skupinah, ki so jih zdravili s tofacitinibom in placebom, iz skupine bolezni prebavil in okužb, najpogostejši resni neželeni učinek pa je bil poslabšanje UK.
Study VII (O RAL Strategy)
Preskušanje VII (ORAL Strategy)
The ADRs listed in the table below are from clinical studies in patients with RA, PsA, and UC and are presented by System Organ Class (SOC) and frequency categories, defined using the following convention: 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), very rare (< 1/10,000), or not known (cannot be estimated from the available data).
Pogostnosti neželenih učinkov so opredeljene na naslednji način: 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), zelo redki (< 1/10.000) ali neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Over the course of ORAL Strategy, responses with tofacitinib 5 mg twice daily + MTX were numerically similar compared to adalimumab 40 mg + MTX and both were numerically higher than tofacitinib 5 mg twice daily.
Med preskušanjem ORAL Strategy so bili odzivi na tofacitinib 5 mg dvakrat na dan + MTX številčno podobni kot pri adalimumabu 40 mg + MTX, oboji pa so bili številčno večji kot pri tofacitinibu 5 mg dvakrat na dan.
The effect of tofacitinib on the development and course of malignancies is not known.
Učinek zdravljenja s tofacitinibom na razvoj in potek malignih bolezni ni znan.
For both studies, the primary endpoints were ACR20 response rate and change from baseline in HAQ-DI at month 3.
V obeh preskušanjih sta bila primarna opazovana dogodka stopnja odziva ACR20 in sprememba HAQ-DI od izhodišča do 3. meseca.
Events of interstitial lung disease (some of which had a fatal outcome) have been reported in patients treated with tofacitinib in RA clinical trials and in the post-marketing setting although the role of Janus kinase (JAK) inhibition in these events is not known.
Pri bolnikih, ki so tofacitinib prejemali v kliničnih preskušanjih za RA in v obdobju trženja zdravila, so poročali o primerih intersticijske pljučne bolezni (nekateri od njih s smrtnim izidom), čeprav vloga zaviranja Janusovih kinaz (JAK) pri teh primerih ni znana.
In ORAL Start, tofacitinib monotherapy resulted in significantly greater inhibition of the progression of structural damage compared to MTX at months 6 and 12 as shown in Table 10, which was also maintained at month 24.
V preskušanju ORAL Start je monoterapija s tofacitinibom v 6. in 12. mesecu pomembno bolj zavirala napredovanje strukturnih poškodb v primerjavi z MTX, kot je prikazano v preglednici 10, učinek pa je bil ohranjen še v 24. mesecu.
The proportion of patients in both tofacitinib groups who had treatment failure was lower compared to placebo at each time point as early as week 8, the first time point where treatment failure was assessed, as shown in Figure 2.
Delež bolnikov v obeh skupinah, zdravljenih s tofacitinibom, pri katerih zdravljenje ni bilo več učinkovito, je bil manjši v primerjavi s placebom na vseh časovnih točkah že od 8. tedna, prve časovne točke, na kateri so ocenili neučinkovitost zdravljenja, kot prikazuje slika 2.
In enzymatic assays, tofacitinib inhibits JAK1, JAK2, JAK3, and to a lesser extent TyK2.
Pri encimskih testih tofacitinib zavira JAK1, JAK2 in JAK3 ter v manjši meri TyK2.
ANC should be monitored at baseline and after 4 to 8 weeks of treatment and every 3 months thereafter.
ANC je treba preveriti ob izhodišču, po 4-8 tednih in nato vsake 3 mesece.
• Your doctor may decide to stop XELJANZ if XELJANZ does not work for you within 16 weeks.
• Zdravnik se lahko odloči za prekinitev zdravljenja z zdravilom XELJANZ, če zdravilo po 16 tednih pri vas ne bo učinkovito.
Tablet core microcrystalline cellulose lactose monohydrate croscarmellose sodium magnesium stearate
Jedro tablete mikrokristalna celuloza laktoza monohidrat premreženi natrijev karmelozat magnezijev stearat
Following a single dose of 10 mg, mean AUC in subjects with ESRD based on concentrations measured on a non-dialysis day was approximately 40% (90% confidence intervals: 1.5-95%) higher compared to subjects with normal renal function.
Pri preskušancih s končno ledvično odpovedjo je bila povprečna vrednost AUC na podlagi koncentracij, izmerjenih na dan brez dialize, po enem 10 mg odmerku približno za 40 % (90 % intervali zaupanja: 1,5-95 %) večja kot pri preskušancih z normalnim delovanjem ledvic.
Upon withdrawal of tofacitinib treatment, lipid levels returned to baseline.
Po prekinitvi zdravljenja s tofacitinibom so se vrednosti lipidov vrnile na izhodiščno vrednost.
RA patients have an increased risk for cardiovascular disorders.
Bolniki z RA imajo zvečano tveganje za nastanek srčno-žilnih bolezni.
Lymphocytes should be monitored at baseline and every 3 months thereafter.
Število limfocitov je treba preveriti ob izhodišču in nato vsake 3 mesece.
Common ≥1/100 to <1/10
Organski sistem Pogosti ≥ 1/100 do < 1/10
Sustained corticosteroid-free remission was defined as being in remission and not taking corticosteroids for at least 4 weeks prior to the visit at both week 24 and week 52.
Ohranjena remisija brez jemanja kortikosteroidov je pomenila, da je bil bolnik v remisiji in ni jemal kortikosteroidov vsaj 4 tedne pred obiskom po 24 tednih in obiskom po 52 tednih.
Treatment with tofacitinib has been associated with decreases in haemoglobin levels.
Zdravljenje s tofacitinibom je povezano z znižanji ravni hemoglobina.
In ORAL Scan and ORAL Start, inhibition of progression of structural joint damage was assessed radiographically and expressed as mean change from baseline in mTSS and its components, the erosion score and joint space narrowing (JSN) score, at months 6 and 12.
V preskušanjih ORAL Scan in ORAL Start so zaviranje napredovanja strukturnih poškodb sklepov ocenili radiografsko v 6. in 12. mesecu in ga izrazili kot povprečno spremembo ocene po prirejeni Sharpovi lestvici (mTSS - modified Total Sharp Score) in njenih komponentah, ocene erozije sklepov in ocene zožitve sklepne špranje (JSN - Joint Space Narrowing) glede na izhodišče.
Rheumatoid arthritis and psoriatic arthritis
Revmatoidni artritis in psoriatični artritis
The efficacy and safety of tofacitinib were assessed in 2 randomised, double-blind, placebo-controlled Phase 3 studies in adult patients with active PsA (≥ 3 swollen and ≥ 3 tender joints).
Učinkovitost in varnost tofacitiniba so ocenili v 2 randomiziranih, dvojno slepih, s placebom nadzorovanih preskušanjih 3. faze pri odraslih bolnikih z aktivnim PsA (≥ 3 otekli in ≥ 3 občutljivi sklepi).
Tofacitinib distributes equally between red blood cells and plasma.
Tofacitinib se enakomerno porazdeli med eritrocite in plazmo.
XELJANZ is not recommended for use in children or adolescents under 18 years of age.
Uporaba zdravila XELJANZ pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
Table 5: Dose adjustment for renal impairment Renal impairment category
Preglednica 5: Prilagajanje odmerka pri okvari ledvic Kategorija okvare ledvic
Tofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs.
Tofacitinib je v kombinaciji z metotreksatom (MTX - Methotrexate) indiciran za zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa (RA) pri odraslih bolnikih, ki so se nezadostno odzvali ali imajo intoleranco na enega ali več imunomodulirajočih antirevmatičnih zdravil.
• Patients treated with 10 mg twice daily.
• bolnikih, ki se zdravijo z odmerkom 10 mg dvakrat na dan.
There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other medicinal products utilising a non-deformable prolonged-release formulation.
V redkih primerih so pri bolnikih z znanimi strikturami v povezavi z zaužitjem drugih zdravil z nedeformabilno formulacijo s podaljšanim sproščanjem poročali o obstruktivnih simptomih.
The pharmacologic activity of tofacitinib is attributed to the parent molecule.
Farmakološko aktivnost tofacitiniba pripisujejo nespremenjeni molekuli.
In the RA long-term safety populations, elevations in the lipid parameters remained consistent with what was seen in the controlled clinical studies.
V populacijah z RA, pri katerih so preučevali dolgoročno varnost, so bila zvečanja vrednosti lipidnih parametrov skladna z zvečanji, ki so jih opazili v nadzorovanih kliničnih preskušanjih.
The most commonly reported adverse reactions in patients receiving tofacitinib 10 mg twice daily in the induction studies were headache, nasopharyngitis, nausea, and arthralgia.
Neželeni učinki, o katerih so najpogosteje poročali pri bolnikih, ki so v preskušanjih indukcijskega zdravljenja prejemali 10 mg tofacitiniba dvakrat na dan, so bili glavobol, nazofaringitis, navzea in artralgija.
Tofacitinib 10 mg twice daily is contraindicated in patients who are at high risk for pulmonary embolism.
Odmerek tofacitiniba 10 mg dvakrat na dan je kontraindiciran pri bolnikih z velikim tveganjem za pljučno embolijo.