natgillin/translations-raw huggingface dataset:
In controlled Phase 3 clinical studies, the rates of infections over 0-3 months in the 5 mg twice daily (total 616 patients) and 10 mg twice daily (total 642 patients) tofacitinib monotherapy groups were 16.2% (100 patients) and 17.9% (115 patients), respectively, compared to 18.9% (23 patients) in the placebo group (total 122 patients).
U kontroliranim kliničkim ispitivanjima faze 3, stope infekcija kroz 0-3 mjeseci u skupinama koje su primale tofacitinib u monoterapiji bile su 16,2% (100 bolesnika) uz dozu od 5 mg dvaput dnevno (ukupno 616 bolesnika), odnosno 17,9% (115 bolesnika) uz dozu od 10 mg dvaput dnevno (ukupno 642 bolesnika) u usporedbi s 18,9% (23 bolesnika) u skupini koja je primala placebo (ukupno 122 bolesnika).
The between-subject variability (percentage coefficient of variation) in AUC of tofacitinib is estimated to be approximately 27%.
u AUC-u tofacitiniba približno 27%.
System Organ Class
Klasifikacij a organskih sustava
Lymphoma and other cancers (such as lung, breast, melanoma, prostate and pancreatic) have been reported in patients treated with XELJANZ.
Limfomi i drugi oblici raka (poput raka pluća, dojke, kože (melanoma), prostate i gušterače)
How to store XELJANZ
Moguće nuspojave Kako čuvati XELJANZ
This medicine is provided to you and supervised by a specialised doctor who knows how to treat your condition.
Kako uzimati XELJANZ Liječnik specijalist koji zna kako liječiti Vaše stanje će Vam propisivati ovaj lijek i pratiti Vaše liječenje.
Possible side effects
Moguće ozbiljne nuspojave
Pulmonary embolism (PE) has been observed in patients taking tofacitinib in clinical trials and post marketing reports.
U bolesnika koji su uzimali tofacitinib u kliničkim ispitivanjima i postmarketinškim izvješćima zabilježena je plućna embolija (PE).
• The Guide for healthcare professionals shall contain the following key elements: o Relevant information of the safety concerns addressed by the aRMM (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) o Details of the population at higher risk for the safety concern addressed by the aRMM (i.e. contraindications, risk factors, increased risk by interactions with certain medicine) o Details on how to minimise the safety concern addressed by the aRMM through appropriate monitoring and management (i.e. what to do, what not do, and who is most likely be impacted according to different scenarios, like when to limit or stop prescribing/ingestion, how to administer the medicine, when to increase/decrease the dosage according to laboratory measurements, signs and symptoms) o Key message to convey in patients counselling o Instructions on how to handle possible adverse events o Information about the BSRBR, ARTIS, RABBIT and BIODABASER and UC registries and the importance of contributing to these
o Detalje o tome kako miminizirati sigurnosna pitanja adresirana u dodatnim mjerama minimizacije rizika kroz odgovarajuće praćenje i upravljanje (tj. što uraditi, što ne uraditi i tko će najvjerojatnije biti pogođen sukladno različitom tijeku događanja, npr. kada treba ograničiti ili prekinuti propisivanje/ingestiju, kako uzimati lijek, kako povisiti/sniziti dozu prema laboratorijskim parametrima, znakovima i simptomima)
NA ORAL Scan: MTX Inadequate Responders
ORAL Scan: Bolesnici s neodgovarajućim odgovorom na MTX
The most common serious infections included pneumonia, herpes zoster, urinary tract infection, cellulitis, gastroenteritis and diverticulitis.
herpes zoster, infekciju urinarnog trakta, celulitis, gastroenteritis i divertikulitis.
It is not recommended to initiate tofacitinib treatment in patients with an ANC less than 1,000 cells/mm3.
Ne preporučuje se započeti liječenje tofacitinibom u bolesnika čiji je ABN manji od 1000 stanica/mm3.
Remission was defined as clinical remission (a total Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0.
Remisija je bila definirana kao klinička remisija (ukupni Mayo rezultat ≤ 2 bez pojedinačnog podrezultata > 1) i podrezultat rektalnog krvarenja koji iznosi 0.
4 weeks prior to the visit at both week 24 and week 52. f. N=59 for placebo, N=65 for tofacitinib 5 mg twice daily, N=55 for tofacitinib 10 mg twice daily.
f. N = 59 za placebo, N = 65 za 5 mg tofacitiniba dva puta dnevno, N = 55 za 10 mg tofacitiniba dva puta dnevno.
QOW=every other week, N=number of subjects analysed, ACR20/50/70=American College of Rheumatology ≥20, 50, 70%
N=broj analiziranih ispitanika, ACR20/50/70= ACR odgovor ≥ 20, 50, 70% poboljšanja, NP=nije primjenjivo,
Tofacitinib 5 mg Twice Daily + DMARD(s)
Tofacitinib 5 mg dva puta dnevno + DMARD(ovi)
OCTAVE Induction 1 OCTAVE Induction 2 OCTAVE Sustain
Ispitivanje uvodnog liječenja OCTAVE Induction 2
MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS BLISTER FOR 10 MG TABLETS
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI ZA TABLETE OD 10 MG
a SD = Standard Deviation b Difference between least squares means tofacitinib minus placebo (95% CI = 95% confidence interval) c Month 6 and month 12 data are mean change from baseline d Difference between least squares means tofacitinib minus MTX (95% CI = 95% confidence interval)
6. mjesec 12. mjesec a SD = standardna devijacija b Razlika tofacitinib minus placebo dobivena metodom najmanjih kvadrata (95% CI = 95%-tni interval pouzdanosti)
TNFi Inadequate Responders b
TNFi Bolesnici s neadekvatnim odgovoromb
Induction 2) baseline Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or rectal bleeding subscore of 0 or 1.
Mayo rezultata u ispitivanju uvodnog liječenja (OCTAVE Induction 1, OCTAVE Induction 2) za ≥ 3 boda i ≥ 30% uz popratno smanjenje podrezultata rektalnog krvarenja za ≥ 1 bod ili podrezultat rektalnog krvarenja 0 ili 1.
XELJANZ is a medicine that contains the active substance tofacitinib.
Što je XELJANZ i za što se koristi XELJANZ je lijek koji sadrži djelatnu tvar tofacitinib.
Tofacitinib 10 mg Twice Daily Placebo
Tofacitinib 10 mg dva puta dnevno Placebo
ACR20 Month 3 Month 6 Month 12
ACR20 3. mjesec 6. mjesec 12. mjesec
ACR70 Month 3
ACR70 3. mjesec 6. mjesec
In the subgroup of patients with prior TNF inhibitor failure, the observed treatment difference from placebo was numerically greater for tofacitinib 10 mg twice daily than tofacitinib 5 mg twice daily by 9.7 to 16.7 percentage points across the primary and key secondary endpoints.
Razlika u liječenju u odnosu na placebo, opažena u podskupini bolesnika s prethodno neuspješnim liječenjem inhibitorom TNF-a, bila je brojčano veća za 10 mg tofacitiniba primijenjenog dva puta dnevno od one za 5 mg tofacitiniba primijenjenog dva puta dnevno za 9,7 do
≥1/10,000 to
Rijetko ≥ 1/10 000 i
Patients receiving tofacitinib 5 mg twice daily demonstrated a greater improvement in arthritis pain (as measured on a 0-100 visual analogue scale) from baseline at week 2 (first post-baseline assessment) through month 3 compared to placebo in studies OPAL BROADEN and OPAL BEYOND (nominal p≤ 0.05).
U ispitivanjima OPAL BROADEN i OPAL BEYOND, u bolesnika koji su primali 5 mg tofacitiniba dva puta dnevno uočeno je veće poboljšanje u odnosu na početne vrijednosti s obzirom na bol uzrokovanu artritisom (izmjereno vizualno-analognom ljestvicom od 0 do 100) u 2. tjednu (prva procjena nakon početka terapije) te do 3. mjeseca, nego u bolesnika koji su primali placebo (nominalni p ≤ 0,05).
A controlled study was conducted in patients with RA on background MTX immunised with a live attenuated virus vaccine (Zostavax®) 2 to 3 weeks before initiating a 12-week treatment with tofacitinib 5 mg twice daily or placebo.
Kontrolirano ispitivanje provedeno je u bolesnika s RA uz osnovno liječenje MTX-om, cijepljenih živim atenuiranim virusnim cjepivom (Zostavax®) 2 do 3 tjedna prije početka 12-tjednog liječenja s
Table 14: Phase 3 Clinical Studies of Tofacitinib 5 and 10 mg Twice Daily Doses in Patients with UC
Tablica 14: Klinička ispitivanja faze 3 tofacitiniba u dozi od 5 mg i 10 mg dva puta dnevno u bolesnika s ulceroznim kolitisom Ispitivanje uvodnog liječenja OCTAVE
Time to Treatment Failure in Maintenance Study OCTAVE Sustain (Kaplan-Meier Curves)
Slika 2. Vrijeme do neuspjeha liječenja u ispitivanju terapije održavanja OCTAVE Sustain
Maintenance (OCTAVE Sustain)
OCTAVE Sustain.
Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in physical functioning compared to placebo at month 3 (studies ORAL Solo, ORAL Sync, ORAL Standard, and ORAL Step) and month 6 (studies ORAL Sync and ORAL Standard).
U bolesnika koji su primali tofacitinib u dozi od 5 mg ili 10 mg dva puta dnevno, poboljšanje fizičkih funkcija u 3. mjesecu u odnosu na početne vrijednosti bilo je značajno veće u usporedbi s onim u bolesnika koji su primali placebo (ispitivanja ORAL Solo, ORAL Sync, ORAL Standard i ORAL Step) i u 6. mjesecu (ispitivanja ORAL Sync i ORAL
ACR50 Month 3 Month 6
ACR50 3. mjesec 6. mjesec
croscarmellose sodium, magnesium stearate, hypromellose 6cP (E464), titanium dioxide
Drugi sastojci su mikrokristalična celuloza, laktoza hidrat (pogledajte dio 2.), umrežena karmelozanatrij, magnezijev stearat, hipromeloza 6cP (E464), titanijev dioksid (E171),
ORAL Strategy: MTX Inadequate Responders
ORAL Strategy: Bolesnici s neodgovarajućim odgovorom na MTX
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.
MTX bili su brojčano slični odgovorima na primjenu adalimumaba u dozi od 40 mg + MTX i u oba navedena slučaja brojčano veći od odgovora na primjenu tofacitiniba u dozi od 5 mg dva puta dnevno.
1.3% of patients and for ALC between 500 and 750 cells/mm3 in 8.4% of patients for the 5 mg twice daily and 10 mg twice daily doses combined.
0,3% bolesnika, odnosno ALC između 500 i 750 stanica/mm3 u 1,9% bolesnika, sveukupno za bolesnike liječene s 5 mg dva puta dnevno i 10 mg dva puta dnevno.
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.
Solo, ORAL Sync, ORAL Standard, ORAL Scan, ORAL Step, ORAL Start i ORAL Strategy ispitivanjima prikazani su u Tablici 8.
AUC Cmax
Cmax
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.
8 tjedana uzimanja 10 mg tofacitiniba dva puta dnevno u ispitivanju OCTAVE Open, 53% (154/293)
Tofacitinib 5 or 10 mg twice daily-treated patients demonstrated significantly greater improvement in physical functioning compared to placebo as early as week 2 in ORAL Solo and ORAL Sync.
Bolesnici liječeni tofacitinibom 5 mg ili 10 mg dva puta dnevno pokazali su značajno veće poboljšanje fizičkih funkcija u usporedbi s onima koji su primali placebo već u 2. tjednu u ispitivanjima ORAL Solo i ORAL Sync.
Don't take XELJANZ 10 mg twice daily if you have any of the following conditions: - Are taking combined hormonal contraceptives or hormone replacement therapy - Have heart failure (when the heart does not work as well as it should) - Have had blood clots in the veins - Have cancer - Will have or have recently had major surgery
Uzimate kombinirane hormonske kontraceptive ili hormonsku nadomjesnu terapiju Imate zatajenje srca (kada srce ne radi kako treba)
Tofacitinib 10 mg Twice Daily N=368 Mean (SD)a
Tofacitinib 10 mg dva puta dnevno N=368 Srednja vrijednost (SD)a
Tofacitinib 10 mg Twice Daily N=476
Tofacitinib 10 mg dva puta dnevno N = 476
The proportion of patients who discontinued treatment due to adverse reactions during first 3 months of the double-blind, placebo or MTX controlled studies was 3.8% for patients taking tofacitinib.
placebom ili MTX-om kontroliranog ispitivanja, iznosio je 3,8% u bolesnika koji su uzimali tofacitinib.
XELJANZ is not recommended for use with medicines that depress the immune system, including so-called targeted biologic (antibody) therapies, such as those that inhibit tumour necrosis factor, interleukin-17, interleukin-12/interleukin-23, anti-integrins, and strong chemical immunosuppressants including azathioprine, mercaptopurine, ciclosporine, and tacrolimus.
interleukin 17, interleukin 12/interleukin 23, anti-integrine i snažne kemijske imunosupresivne lijekove, uključujući azatioprin, merkaptopurin, ciklosporin i takrolimus.
Tofacitinib 5 mg Twice Daily N=384
Tofacitinib 5 mg dva puta dnevno N=384
In controlled Phase 3 clinical studies with background DMARDs, the rates of infections over 0-3 months in the 5 mg twice daily (total 973 patients) and 10 mg twice daily (total 969 patients) tofacitinib plus DMARD group were 21.3% (207 patients) and 21.8% (211 patients), respectively, compared to 18.4% (103 patients) in the placebo plus DMARD group (total 559 patients).
U kontroliranim ispitivanjima faze 3 s osnovnim liječenjem DMARD-ovima, stope infekcija kroz 0-3 mjeseci bile su 21,3% (207 bolesnika) u skupini koja je primala 5 mg dva puta dnevno (ukupno 973 bolesnika) i 21,8% (211 bolesnika) u skupini koja je primala 10 mg dva puta dnevno (ukupno 969 bolesnika) tofacitiniba i DMARD, u usporedbi s 18,4% (103 bolesnika) u skupini koja je primala placebo i DMARD (ukupno 559 bolesnika).
NAME OF THE MEDICINAL PRODUCT XELJANZ 10 mg tablets tofacitinib
NAZIV LIJEKA XELJANZ 10 mg tablete tofacitinib
Tofacitinib 5 mg Twice Daily + MTX N=277 Mean (SD)a
Tofacitinib 5 mg dva puta dnevno + MTX N=277 Srednja vrijednost (SD)a
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.
Nakon dugotrajnog liječenja (medijan trajanja liječenja tofacitinibom od približno 5 godina), CD4+ i
Tofacitinib was shown to be teratogenic in rats and rabbits, and have effects in rats on female fertility (decreased pregnancy rate; decreases in the numbers of corpora lutea, implantation sites, and viable foetuses; and an increase in early resorptions), parturition, and peri/postnatal development.
(smanjena stopa gravidnosti; smanjenje broja žutih tijela, mjesta implantacije i živućih fetusa; i porast u ranoj resorpciji), okot i peri-/postnatalni razvoj.
Tofacitinib 5 mg Twice Daily N=344 Mean (SD)a
Tofacitinib 5 mg dva puta dnevno N=344 Srednja vrijednost (SD)a
ACR20 Month 3 Month 6
ACR20 3. mjesec 6. mjesec
In the controlled portion of the RA Phase 3 studies on background DMARDs (0-3 months) (studies II-V, see section 5.1), ALT elevations greater than 3x ULN were observed in 0.9%, 1.24% and 1.14% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
U kontroliranom dijelu ispitivanja RA-a faze 3 uz osnovno liječenje DMARD-ovima (0 - 3 mjeseca) (ispitivanja II-V, vidjeti dio 5.1), porast ALT-a veći od 3 x GGN zabilježen je u 0,9%, 1,24% odnosno 1,14% bolesnika koji su primali placebo, 5 mg tofacitiniba, odnosno 10 mg tofacitiniba dva puta dnevno.
a. ≤3 weekly doses (MTX-naïve).
≤ 3 doze tjedno (MTX-naivni, tj. koji prethodno nisu liječeni metotreksatom).
Tofacitinib 10 mg Twice Daily N=197
Tofacitinib 10 mg dva puta dnevno N = 197
Tofacitinib 5 mg Twice Daily N=198
Tofacitinib 5 mg dva puta dnevno N = 198
Tofacitinib 10 mg twice daily demonstrated greater improvement from baseline compared to placebo in physical component summary (PCS) and mental component summary (MCS) scores, and in all 8 domains of the SF-36 in the induction studies (OCTAVE Induction 1, OCTAVE Induction 2).
Primjena 10 mg tofacitiniba dva puta dnevno dovela je do većeg poboljšanja rezultata profila fizičkog zdravlja (engl. physical component summary, PCS) i profila duševnog zdravlja (engl. mental component summary, MCS) u odnosu na početne vrijednosti u usporedbi s placebom te u pogledu svih
Tofacitinib 10 mg Twice Daily + DMARD(s) N=315
Tofacitinib 10 mg dva puta dnevno + DMARD(ovi) N=315
Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in both scales compared to placebo in ORAL Sync, ORAL Standard and ORAL Scan.
U bolesnika koji su primali tofacitinib 5 mg ili 10 mg dva puta dnevno nađeno je značajno poboljšanje u odnosu na početne vrijednosti u obje ljestvice u usporedbi s bolesnicima koji su primali placebo u ispitivanjima ORAL Sync, ORAL Standard i ORAL Scan.
NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg tablets tofacitinib
NAZIV LIJEKA XELJANZ 5 mg tablete tofacitinib
In the long-term safety all exposure population, the overall rates of serious infections were 2.4 and 3.0 patients with events per 100 patient-years for 5 mg and 10 mg twice daily tofacitinib groups, respectively.
U ispitivanjima dugoročne sigurnosti za cjelokupnu izloženost populacije, ukupne stope ozbiljnih infekcija bile su 2,4 i 3,0 bolesnika s događajem na 100 bolesnik-godina za skupine koje su primale
Prophylactic zoster vaccination should be considered in accordance with vaccination guidelines.
Potrebno je uzeti u obzir profilaktičko cijepljenje protiv herpesa zostera, sukladno smjernicama za cijepljenje.
Tofacitinib 10 mg Twice Daily + MTX N=290 Mean (SD)a
Tofacitinib 10 mg dva puta dnevno + MTX N=290 Srednja vrijednost (SD)a
In the RA Phase 3 monotherapy study (0-24 months) (study VI, see section 5.1), ALT elevations greater than 3x ULN were observed in 7.1%, 3.0%, and 3.0% of patients receiving MTX, tofacitinib 5 mg and 10 mg twice daily, respectively.
U ispitivanju RA-a faze 3 uz monoterapiju (0 - 24 mjeseci) (ispitivanje VI, vidjeti dio 5.1), porast ALT-a veći od 3 x GGN zabilježen je u 7,1%, 3,0% odnosno 3,0% bolesnika koji su primali MTX, 5 mg tofacitiniba, odnosno 10 mg tofacitiniba dva puta dnevno.
Exposure in monkeys at the no observed adverse effect level (NOAEL) for the lymphomas was approximately 1 or 0.5 times the clinical exposure level of 5 mg or 10 mg twice daily.
(NOAEL) za limfome u majmuna bila je približno 1 ili 0,5 puta veća od razine izloženosti uz dozu od 5 mg ili 10 mg dva puta dnevno u kliničkoj primjeni.
Tofacitinib 10 mg Twice Daily N=429
Tofacitinib 10 mg dva puta dnevno N = 429
• The patient alert card shall contain the following key messages: o A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using XELJANZ o That treatment with XELJANZ may increase the risk of infections and non melanoma skin cancer o That patients should inform health professionals if they are planning to receive any vaccine or become pregnant o Signs or symptoms of the following safety concern and when to seek attention from a HCP: infections, herpes zoster reactivation, non-melanoma skin cancer, transaminase elevation and potential for drug-induced liver injury, gastrointestinal perforation, interstitial lung disease, increased immunosuppression when used in combination with biologics and immunosuppressants including B lymphocyte depleting agents, increased risk of adverse events when XELJANZ is administered in combination with MTX, increased exposure to XELJANZ when co-administered with CYP3A4 and CYP2C19
uključujući hitna stanja, da bolesnik uzima XELJANZ o Da liječenje lijekom XELJANZ može povećati rizik od infekcije i nemelanomskog raka kože o Da bolesnici trebaju obavijestiti zdravstvene radnike ako planiraju primiti bilo koje cjepivo ili trudnoću o Znakove ili simptome sljedećih problema s obzirom na sigurnost primjene te kad potražiti pomoć zdravstvenog radnika: infekcije, reaktivacija herpes zostera, nemelanomski rak kože, porast transaminaza i potencijal za lijekom uzrokovano oštećenje jetre,
5 mg twice daily demonstrated greater improvement (p≤ 0.05) from baseline in physical functioning compared to placebo at month 3 (see Table 13).
U 3. mjesecu u bolesnika koji su primali 5 mg tofacitiniba dva puta dnevno poboljšanje fizičkih funkcija (p ≤ 0,05) u odnosu na početne vrijednosti bilo je veće nego u bolesnika koji su primali placebo (vidjeti Tablicu 13).
Tofacitinib Twice Daily + MTX
Tofacitinib dva puta dnevno + MTX
Table 3: Low Haemoglobin Value Low Haemoglobin Value (Section 4.4)
Niska razina hemoglobina (dio 4.4)
ORAL Standard: MTX Inadequate Responders
ORAL Standard: Bolesnici s neodgovarajućim odgovorom na MTX
ANNEX III LABELLING AND PACKAGE LEAFLET
Tablica 6: Nuspojave Klasifikacij a organskih sustava
The incidence rates and types of serious infections in the UC clinical studies were generally similar to those reported in RA clinical studies with tofacitinib monotherapy treatment groups.
Ulcerozni kolitis U skupinama liječenim tofacitinibom u monoterapiji, stope incidencije i vrste ozbiljnih infekcija u kliničkim ispitivanjima ulceroznog kolitisa uglavnom su bile slične onima prijavljenim u kliničkim ispitivanjima RA.
Placebo Tofacitinib 5 mg Twice Daily
Placebo Tofacitinib 5 mg dva puta dnevno
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/003 56 film-coated tablets EU/1/17/1178/004 182 film-coated tablets EU/1/17/1178/014 112 film-coated tablets
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1178/003 56 filmom obloženih tableta EU/1/17/1178/004 182 filmom obložene tablete EU/1/17/1178/014 112 filmom obloženih tableta
Treatment with tofacitinib resulted in significant improvements in some signs and symptoms of PsA, as assessed by the ACR20 response criteria compared to placebo at month 3.
PsA-a procijenjenih na temelju odgovora prema kriteriju ACR20, u usporedbi sa skupinom koja je primala placebo.
Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in fatigue compared to placebo in all 5 studies.
U bolesnika koji su primali tofacitinib 5 mg ili 10 mg dva puta dnevno nađeno je značajno smanjenje umora u odnosu na početne vrijednosti u usporedbi s bolesnicima koji su primali placebo u svih 5 ispitivanja.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dobroćudne, zloćudne i nespecificira ne novotvorine
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.
lipoproteini niske gustoće (LDL) i lipoproteini visoke gustoće (HDL).
Tofacitinib 10 mg Twice Daily + MTX Mean Difference from Placebob
Tofacitinib 10 mg dva puta dnevno + MTX Srednja vrijednost razlike od placebab
4.1 Therapeutic indication
4.1 Terapijske indikacije Reumatoidni artritis
In the controlled portion of the RA Phase 3 monotherapy study (0-3 months) (study I, see section 5.1), ALT elevations greater than 3x ULN were observed in 1.65%, 0.41%, and 0% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
U kontroliranom dijelu ispitivanja RA-a faze 3 uz monoterapiju (0 - 3 mjeseca) (ispitivanje I, vidjeti dio 5.1), porast ALT-a veći od 3 x GGN zabilježen je u 1,65%, 0,41% odnosno 0% bolesnika koji su primali placebo, 5 mg tofacitiniba, odnosno 10 mg tofacitiniba dva puta dnevno.
Tofacitinib 5 mg Twice Daily + MTX N=376
Tofacitinib 5 mg dva puta dnevno + MTX N=376
In the controlled RA clinical studies, confirmed decreases in ALC below 500 cells/mm3 occurred in 0.3% of patients and for ALC between 500 and 750 cells/mm3 in 1.9% of patients for the 5 mg twice daily and 10 mg twice daily doses combined.
U populaciji s RA-om u ispitivanju dugoročne sigurnosti potvrđeno je smanjenje ALC-a ispod 500 stanica/mm3 u 1,3% bolesnika, odnosno ALC između 500 i 750 stanica/mm3 u 8,4% bolesnika, sveukupno za bolesnike liječene s 5 mg dva puta dnevno i 10 mg dva puta dnevno.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/007 56 film-coated tablets EU/1/17/1178/008 112 film-coated tablets EU/1/17/1178/009 182 film-coated tablets
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1178/007 56 filmom obloženih tableta EU/1/17/1178/008 112 filmom obloženih tableta EU/1/17/1178/009 182 filmom obložene tablete 13.
Tofacitinib 10 mg Twice Daily + MTX
Tofacitinib 10 mg dva puta dnevno + MTX
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 5 MG BLISTER PACK
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTER PAKIRANJA S TABLETAMA OD 5 MG