FrancophonIA/ELRC3.0 huggingface dataset:
English: Septodont SAS 58, rue du Pont de Créteil
Slovenian: Specialites Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-des-Fossés France
English: Septanest 1/200 000 68 mg/1.7 ml + 0.015 mg/1.7 ml
Slovenian: Septanest N 40 mg/ml + 0.005 mg/ml
English: Adrenaline 0.01 mg/ml adrénaline (tartrate d'): non précisé
Slovenian: Adrenalinée au 1/100 000, solution injectable à usage dentaire lokalno ali regionalno injiciranje, intraoralno submukozna uporaba artikainijev klorid 40 mg/ml adrenalin 0,01 mg/ml adrenalin (tartrat): nedoločen
English: Septocaine
Slovenian: Septodont SAS
English: Dental use Infiltration and perineural use in the oral cavity
Slovenian: Септанест с Адреналин dentalna uporaba submukozna uporaba
English: Not Known (cannot be estimated from the available data)
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 March 2017
Slovenian: Datum prve odobritve: 22. marec 2017
English: Treatment groups (Randomisation ratio)
Slovenian: Skupine zdravljenja (razmerje randomizacije)
English: b.Antimalarials were allowed.
Slovenian: Antimalariki so bili dovoljeni.
English: Signs of allergic reactions (rare) include
Slovenian: Znaki alergijskih reakcij (redki) vključujejo:
English: c OPAL BEYOND had a duration of 6 months.
Slovenian: Preskušanje OPAL BEYOND je trajalo 6 mesecev.
English: Possible serious side effects In rare cases, infection may be life-threatening
Slovenian: Možni resni neželeni učinki V redkih primerih so okužbe lahko življenjsko ogrožajoče.
English: (E171), macrogol 3350, and triacetin (E1518).
Slovenian: (E171), makrogol 3350 in triacetin (E1518).
English: Greater than 2 g/dL decrease or less than 8.0 g/dL (confirmed by repeat testing)
Slovenian: zmanjšanje za več kot 2 g/dl ali vrednost manjša od 8,0 g/dl (potrjeno s ponovnim testiranjem)
English: • antibiotics such as clarithromycin and rifampicin, used to treat bacterial infections
Slovenian: • antibiotiki, kot sta klaritromicin in rifampicin, ki se uporabljata za zdravljenje bakterijskih okužb,
English: Your doctor may also perform other tests, for example to check your blood cholesterol levels or monitor the health of your liver.
Slovenian: Zdravnik bo morda opravil tudi druge preiskave, na primer za preverjanje ravni holesterola v krvi ali spremljanje delovanja jeter.
English: f For patients with Baseline score > 0.
Slovenian: f Za bolnike z izhodiščno oceno > 0.
English: After intravenous administration, the volume of distribution is 87 L. Approximately 40% of circulating tofacitinib is bound to plasma proteins.
Slovenian: Po intravenski uporabi je volumen porazdelitve 87 l. Približno 40 % cirkulirajočega tofacitiniba je vezanega na beljakovine v plazmi.
English: Patients screened positive for hepatitis B or C were excluded from clinical trials.
Slovenian: Bolniki, pri katerih je bil presejalni test za hepatitis B ali C pozitiven, so bili izključeni iz kliničnih preskušanj.
English: Health-related quality of life was assessed by the Short Form Health Survey (SF-36).
Slovenian: Z zdravjem povezano kakovost življenja so ocenili s kratkim vprašalnikom o zdravju (SF-36 - Short Form Health Survey).
English: If the history of chickenpox is considered doubtful or unreliable it is recommended to test for antibodies against VZV.
Slovenian: Če je anamneza noric dvomljiva ali nezanesljiva, je priporočljivo izvesti test na protitelesa proti VZV.
English: Tofacitinib binds predominantly to albumin and does not appear to bind to α1-acid glycoprotein.
Slovenian: Tofacitinib se veže predvsem na albumin in ni videti, da bi se vezal na α1-kisli glikoprotein.
English: • Physician educational material
Slovenian: • izobraževalno gradivo za zdravnika;
English: - The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2),
Slovenian: - Druge sestavine zdravila so mikrokristalna celuloza, laktoza monohidrat (glejte poglavje 2),
English: The safety and efficacy of tofacitinib in children aged 0 to less than 18 years have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost tofacitiniba pri otrocih, starih od 0 do manj kot 18 let, nista bili dokazani.
English: Less than or equal to 2 g/dL decrease and greater than or equal to 9.0 g/dL
Slovenian: Priporočilo zmanjšanje za 2 g/dl ali manj in vrednost večja od ali enaka 9,0 g/dl
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA holder logo)
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Pfizer Europe MA EEIG (kot logo imetnika dovoljenja za promet)
English: Your doctor may also stop treatment temporarily or permanently if blood tests show low white blood cell or red blood cell counts.
Slovenian: Zdravnik vam lahko zdravljenje začasno ali trajno prekine, če rezultati krvnih preiskav kažejo na majhno število belih ali rdečih krvnih celic.
English: OTHER Mon., Tue., Wed., Thu., Fri., Sat., Sun.
Slovenian: DRUGI PODATKI pon., tor., sre., čet., pet., sob., ned.
English: Each film-coated tablet contains 118.88 mg of lactose.
Slovenian: Ena filmsko obložena tableta vsebuje 118,88 mg laktoze.
English: There was no clear relationship between neutropenia and the occurrence of serious infections.
Slovenian: Povezava med nevtropenijo in pojavom resnih okužb ni jasna.
English: Table 8: Proportion (%) of Patients with an ACR Response ORAL Solo: DMARD Inadequate Responders
Slovenian: Preglednica 8: Delež (%) bolnikov z odzivom ACR ORAL Solo: bolniki z nezadostnim odzivom na DMARD
English: Study VII (ORAL Strategy)
Slovenian: Preskušanje VII (ORAL Strategy)
English: • Patients with an ALC less than 1,000 cells/mm3 (see section 4.2).
Slovenian: • bolnikih z ALC, manjšim od 1.000 celic/mm3 (glejte poglavje 4.2),
English: Month 6: mTSS ACR70
Slovenian: 6. mesec: mTSS ACR70
English: Population PK analysis in RA patients indicated that systemic exposure (AUC) of tofacitinib in the extremes of body weight (40 kg, 140 kg) were similar (within 5%) to that of a 70 kg patient.
Slovenian: Populacijska analiza farmakokinetike pri bolnikih z RA je pokazala, da je sistemska izpostavljenost (AUC) tofacitinibu pri bolnikih z ekstremno telesno maso (40 kg, 140 kg) podobna (znotraj 5 %) kot pri bolniku s telesno maso 70 kg.
English: Rheumatoid arthritis patients taking corticosteroids may be predisposed to infection.
Slovenian: Bolniki z revmatoidnim artritisom, ki jemljejo kortikosteroide, so lahko dovzetni za okužbe.
English: The MAH shall ensure that in each Member State where XELJANZ is marketed, all healthcare professionals and patients/carers who are expected to prescribe or use XELJANZ have access to/are provided with the following educational package:
Slovenian: Imetnik DzP mora v vsaki državi članici, v kateri se zdravilo XELJANZ trži, vsem zdravstvenim delavcem in bolnikom/skrbnikom, za katere je pričakovati, da bodo predpisovali oziroma uporabljali zdravilo XELJANZ, zagotoviti dostop do naslednjega izobraževalnega gradiva:
English: The percentages of tofacitinib-treated patients achieving ACR20, ACR50 and ACR70 responses in studies ORAL Solo, ORAL Sync, ORAL Standard, ORAL Scan, ORAL Step, ORAL Start, and ORAL Strategy are shown in Table 8.
Slovenian: Odstotki bolnikov, zdravljenih s tofacitinibom, ki so dosegli odziv ACR20, ACR50 in ACR70 v preskušanjih ORAL Solo, ORAL Sync, ORAL Standard, ORAL Scan, ORAL Step, ORAL Start in Oral Strategy, so prikazani v preglednici 8.
English: Caution is also recommended in patients with a history of chronic lung disease as they may be more prone to infections.
Slovenian: Previdnost je priporočljiva tudi pri bolnikih s kroničnimi pljučnimi boleznimi v anamnezi, saj so lahko bolj dovzetni za okužbe.
English: Prior to launch of XELJANZ in each Member State, the MAH must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora pred pričetkom trženja zdravila XELJANZ v vsaki državi članici s pristojnim organom v tej državi dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s komunikacijskimi sredstvi, načinom distribucije in vsemi drugimi vidiki programa.
English: For persistent (2 sequential values in this range on routine testing) decreases in this range, dosing should be reduced or interrupted until ANC is greater than 1,000.
Slovenian: Pri vztrajnem (2 zaporedni vrednosti v tem razponu pri rutinskem merjenju) zmanjšanju v tem razponu je treba odmerjanje zmanjšati ali prekiniti, dokler ni ANC večje od 1.000.
English: Each film-coated tablet contains 59.44 mg of lactose.
Slovenian: Ena filmsko obložena tableta vsebuje 59,44 mg laktoze.
English: For persistent (2 sequential values in this range on routine testing) decrease in this range, dosing should be reduced or interrupted until ALC is greater than 750.
Slovenian: Pri vztrajnem (2 zaporedni vrednosti v tem razponu pri rutinskem merjenju) zmanjšanju v tem razponu je treba odmerjanje zmanjšati ali prekiniti, dokler ni ALC večje od 750.
English: In a human radiolabeled 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.
Slovenian: V študiji radioaktivno označenega zdravila pri človeku je več kot 65 % celokupne cirkulirajoče radioaktivnosti prispevala nespremenjena učinkovina, preostalih 35 % pa 8 presnovkov, pri čemer je vsak od posameznih presnovkov prispeval manj kot 8 % celokupne radioaktivnosti.
English: - if you are at high risk of developing skin cancer, your doctor may recommend that you have regular skin examinations while taking XELJANZ.
Slovenian: - če imate veliko tveganje za pojav kožnega raka, vam bo zdravnik morda svetoval, da vam med jemanjem zdravila XELJANZ opravljajo redne preglede kože.
English: • fluconazole, ketoconazole, clotrimazole, itraconazole, and voriconazole, used to treat fungal infections
Slovenian: • flukonazol, ketokonazol, klotrimazol, itrakonazol in vorikonazol, ki se uporabljajo za zdravljenje glivičnih okužb.
English: HDPE bottles with silica gel desiccant and child-resistant caps containing 60 or 180 film-coated tablets.
Slovenian: Plastenke iz HDPE s silikagelom kot sušilnim sredstvom in za otroke varno zaporko, ki vsebujejo 60 ali 180 filmsko obloženih tablet.
English: Confirmed ALC less than 750 cells/mm3 were associated with an increased incidence of serious infections (see section 4.4).
Slovenian: Potrjeno ALC, manjše od 750 celic/mm3, je bilo povezano z zvečano incidenco resnih okužb (glejte poglavje 4.4).
English: Patients in the Phase 3 studies had a mean Disease Activity Score (DAS28-4[ESR]) of 6.1-6.7 at baseline.
Slovenian: Pri bolnikih v preskušanjih 3. faze je bila povprečna ocena aktivnosti bolezni (DAS28-4[ESR]) ob izhodišču 6,1-6,7.
English: Your doctor should perform blood tests before you start taking XELJANZ, and after 4 to 8 weeks of treatment and then every 3 months, to determine if you have a low white blood cell (neutrophil or lymphocyte) count, or a low red blood cell count (anaemia).
Slovenian: Zdravnik mora pred začetkom jemanja zdravila XELJANZ in po 4 do 8 tednih zdravljenja ter nato vsake 3 mesece opraviti krvne preiskave, da preveri, če imate zmanjšano število belih krvnih celic (nevtrofilcev ali limfocitov) ali rdečih krvnih celic (anemijo).
English: Your doctor should test your cholesterol levels 8 weeks after you start receiving XELJANZ.
Slovenian: Zdravnik mora ravni holesterola preveriti 8 tednov po začetku jemanja zdravila XELJANZ.
English: Aluminium foil/PVC backed aluminium foil blisters containing 14 film-coated tablets.
Slovenian: Pretisni omoti iz aluminijaste folije/aluminijaste folije s podlago iz PVC, ki vsebujejo 14 filmsko obloženih tablet.
English: Time to Treatment Failure in Maintenance Study OCTAVE Sustain (Kaplan-Meier Curves)
Slovenian: Čas do prenehanja učinkovitosti zdravljenja v preskušanju vzdrževalnega zdravljenja OCTAVE Sustain (Kaplan-Meierjeve krivulje)
English: Study I (ORAL Solo)
Slovenian: Preskušanja Preskušanje I (ORAL Solo)
English: Study IV (ORAL Scan)
Slovenian: Preskušanje IV (ORAL Scan)
English: The available data have also shown that there are no major differences in tofacitinib AUC between White, Black and Asian patients.
Slovenian: Razpoložljivi podatki so pokazali tudi, da med belopoltimi, temnopoltimi in bolniki azijske rase ni večjih razlik v vrednosti AUC tofacitiniba.
English: Antituberculosis therapy should also be considered prior to administration of tofacitinib in patients who test negative for TB but who have a past history of latent or active TB and where an adequate course of treatment cannot be confirmed; or those who test negative but who have risk factors for TB infection.
Slovenian: Pred uporabo tofacitiniba je treba pretehtati tudi možnost zdravljenja tuberkuloze pri bolnikih z negativnim testom na TB, ki imajo latentno ali aktivno TB v anamnezi in pri katerih ni mogoče potrditi ustreznega poteka zdravljenja; ali pri katerih je bil test negativen, vendar imajo dejavnike tveganja za okužbo s TB.
English: Study II (ORAL Sync)
Slovenian: Preskušanje II (ORAL Sync)
English: Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of gastrointestinal perforation.
Slovenian: Bolnike, pri katerih se na novo pojavijo trebušni znaki in simptomi, je treba takoj pregledati za zgodnje odkrivanje perforacij prebavil.
English: Treatment with tofacitinib was associated with increases in lipid parameters such as total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol.
Slovenian: Zdravljenje s tofacitinibom je bilo povezano z zvečanjem vrednosti lipidnih parametrov, kot so celokupni holesterol, holesterol lipoproteinov nizke gostote (LDL) in holesterol lipoproteinov visoke gostote (HDL).
English: Taking XELJANZ with these medicines may increase your risk of side effects including infection.
Slovenian: Jemanje zdravila XELJANZ skupaj s temi zdravili lahko zveča tveganje za pojav neželenih učinkov, vključno z okužbo.
English: croscarmellose sodium, magnesium stearate, hypromellose 6cP (E464), titanium dioxide
Slovenian: premreženi natrijev karmelozat, magnezijev stearat, hipromeloza 6 cP (E464), titanov dioksid
English: Lymphocyte counts less than 750 cells/mm3 were associated with an increased incidence of serious infections.
Slovenian: Število limfocitov, manjše od 750 celic/mm3, je bilo povezano z zvečano incidenco resnih okužb.
English: Study V (ORAL Step)
Slovenian: Preskušanje V (ORAL Step)
English: The main objective of the programme is to increase awareness about the risks of the product, specifically in regards to serious infections, herpes zoster, tuberculosis (TB) and other opportunistic infections, malignancy, gastrointestinal perforations, interstitial lung disease, and laboratory abnormalities.
Slovenian: Glavni cilj programa je povečanje ozaveščenosti glede tveganj zdravila, še zlasti v povezavi z resnimi okužbami, herpes zostrom, tuberkulozo (TB) in drugimi oportunističnimi okužbami, malignimi boleznimi, perforacijami prebavil, intersticijsko pljučno boleznijo in nenormalnostmi laboratorijskih preiskav.
English: Events of gastrointestinal perforation have been reported in clinical trials although the role of JAK inhibition in these events is not known.
Slovenian: V kliničnih preskušanjih so poročali o primerih perforacij prebavil, čeprav vloga zaviranja JAK v teh primerih ni znana.
English: Treatment with tofacitinib was associated with an increased incidence of neutropenia (less than 2,000 cells/mm3) compared to placebo.
Slovenian: Zdravljenje s tofacitinibom je bilo povezano z zvečano incidenco nevtropenije (manj kot 2.000 celic/mm3) v primerjavi s placebom.
English: Periodic skin examination is recommended for patients who are at increased risk for skin cancer (see Table 6 in section 4.8).
Slovenian: Pri bolnikih z zvečanim tveganjem za kožnega raka so priporočljivi redni pregledi kože (glejte preglednico 6 v poglavju 4.8).
English: Enrolled patients had failed at least 1 conventional therapy, including corticosteroids, immunomodulators, and/or a TNF inhibitor.
Slovenian: V preskušanja so vključili bolnike, pri katerih je bilo predhodno neučinkovito vsaj 1 običajno zdravljenje, ki je vključevalo kortikosteroide, imunomodulatorje in/ali zaviralec TNF.
English: Table 6: Adverse Drug Reactions
Slovenian: Preglednica 6: Neželeni učinki zdravila
English: XELJANZ may be used in combination with methotrexate or sometimes alone when used to treat rheumatoid arthritis.
Slovenian: Zdravilo XELJANZ se lahko uporablja v kombinaciji z metotreksatom, včasih pa tudi samostojno, kadar ga uporabljamo za zdravljenje revmatoidnega artritisa.
English: • The centralised website shall contain: o The educational material in digital format o The patient alert card in digital format
Slovenian: • Osrednja spletna stran mora vsebovati: o izobraževalno gradivo v elektronski obliki; o opozorilno kartico za bolnika v elektronski obliki.
English: Tofacitinib is not an inhibitor or inducer of CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) and is not an inhibitor of UGTs (UGT1A1, UGT1A4, UGT1A6, UGT1A9, and UGT2B7).
Slovenian: Tofacitinib ni niti inhibitor niti induktor CYP (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP3A4), prav tako pa ni inhibitor UGT (UGT1A1, UGT1A4, UGT1A6, UGT1A9 in UGT2B7).
English: 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).
Slovenian: 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/mm3, in bolnikih, ki se zdravijo z odmerkom 10 mg dvakrat na dan, je tveganje za herpes zoster lahko zvečano (glejte poglavje 4.4).
English: Signs of stomach problems (uncommon: ulcers or holes in your stomach or intestines) include • fever
Slovenian: Znaki želodčnih težav (občasni: razjede ali predrtje v želodcu in črevesju) vključujejo:
English: In vitro, tofacitinib is a substrate for MDR1, but not for breast cancer resistance protein (BCRP), OATP1B1/1B3, or OCT1/2, and is not an inhibitor of MDR1, OATP1B1/1B3, OCT2, OAT1/3, or MRP at clinically meaningful concentrations.
Slovenian: Tofacitinib je in vitro substrat za MDR1, ne pa tudi za beljakovino odpornosti pri raku dojke (BCRP - Breast Cancer Resistance Protein), OATP1B1/1B3 ali OCT1/2, in v klinično pomembnih koncentracijah ni zaviralec MDR1, OATP1B1/1B3, OCT2, OAT1/3 ali MRP.
English: 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%).
Slovenian: 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 odzivali na cepivo proti gripi, v obeh skupinah podobno: tofacitinib (57 %) in placebo (62 %).
English: Nominal p<0.0001 for active treatment versus placebo at month 3.
Slovenian: nominalna vrednost p < 0,0001 za aktivno zdravljenje v primerjavi s placebom po 3 mesecih.
English: Table 12: Proportion (%) of PsA Patients Who Achieved Clinical Response and Mean Change from Baseline in OPAL BROADEN and OPAL BEYOND Studies Conventional Synthetic DMARD Inadequate Responders a
Slovenian: Preglednica 12: Delež (%) bolnikov s PsA, ki so dosegli klinični odziv, in povprečna sprememba od izhodišča v preskušanjih OPAL BROADEN in OPAL BEYOND Običajno sintetično DMARD bolniki z nezadostnim odzivom a
English: Study III (ORAL Standard)
Slovenian: Preskušanje III (ORAL Standard)
English: 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.
Slovenian: Po dolgotrajnem zdravljenju (mediano trajanje zdravljenja s tofacitinibom približno 5 let) se je mediano število celic CD4+ zmanjšalo za 28 %, celic CD8+ pa za 27 % glede na izhodiščno vrednost.
English: ≥1/10,000 to
Slovenian: Redki ≥ 1/10.000 do
English: Treatment with tofacitinib has been associated with decreases in haemoglobin levels.
Slovenian: Zdravljenje s tofacitinibom so povezali z znižanji ravni hemoglobina.
English: Пфайзер Люксембург САРЛ, Клон България Pfizer S.A.
Slovenian: Пфайзер Люксембург САРЛ, Клон България Тел.
English: 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.
Slovenian: 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) in njenih komponentah, ocene erozije sklepov in ocene zožitve sklepne špranje (JSN - Joint Space Narrowing) glede na izhodišče.
English: Table 9: Number (%) of Subjects Achieving DAS28-4(ESR) < 2.6 Remission at Months 3 and 6 Time Point
Slovenian: Preglednica 9: Število (%) preskušancev, ki so dosegli remisijo DAS28-4(ESR) < 2,6 v 3. in 6. mesecu
English: MTX-IR MTX-IR TNFi-IR MTX-naïvea MTX-IR
Slovenian: DMARD-IR DMARD-IR MTX-IR MTX-IR antagonist TNF-IR
English: • hives (itching or skin rash)
Slovenian: • koprivnica (srbenje ali kožni izpuščaj).
English: • The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals o Prescriber checklist o Patient alert card o A reference to the website with the educational material and patient alert card
Slovenian: • Izobraževalno gradivo za zdravnika mora vsebovati: o povzetek glavnih značilnosti zdravila; o brošuro za predpisovalce; o kontrolni seznam za predpisovalce; o opozorilno kartico za bolnika; o napotilo na spletno stran z izobraževalnim gradivom in opozorilno kartico za bolnika.
English: Placebo Placebo Placebo Placebo Placebo MTX
Slovenian: Kontrolna skupina placebo placebo placebo placebo placebo
English: - The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2), croscarmellose sodium, magnesium stearate, hypromellose 6cP (E464), titanium dioxide (E171), macrogol 3350, triacetin (E1518), FD&C Blue #2/Indigo Carmine Aluminum Lake (E132), and FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).
Slovenian: - Druge sestavine zdravila so mikrokristalna celuloza, laktoza monohidrat (glejte poglavje 2), premreženi natrijev karmelozat, magnezijev stearat, hipromeloza 6 cP (E464), titanov dioksid (E171), makrogol 3350, triacetin (E1518), indigotin (E132) in briljantno modro FCF (E133).
English: g. N=101 for placebo, N=101 for tofacitinib 5 mg twice daily, N=87 for tofacitinib 10 mg twice daily.
Slovenian: n = 101 za placebo, n = 101 za 5 mg odmerek tofacitiniba dvakrat na dan, n = 87 za 10 mg odmerek tofacitiniba dvakrat na dan.
English: P Ratio and 90% CI
Slovenian: Razmerje in 90 % IZ Priporočilo
English: • The patient information pack should contain: o Patient information leaflet o The patient alert card
Slovenian: • Paket informacij za bolnika mora vsebovati: o navodilo za uporabo; o opozorilno kartico za bolnika.
English: Changes in circulating T-lymphocyte counts and T-lymphocyte subsets (CD3+, CD4+ and CD8+) were small and inconsistent.
Slovenian: Zdravljenje s tofacitinibom je bilo povezano z od odmerka odvisnim zvečanjem števila celic B. Spremembe v številu cirkulirajočih limfocitov T in podskupinah limfocitov T (CD3+, CD4+ ter CD8+) so bile majhne in nedosledne.