natgillin/translations-raw huggingface dataset:
ge using the Mann-Whitney U test
Po 52. tednih je klinično remisijo (DAS28 < 2, 6) doseglo 42, 9% bolnikov, ki so dobivali kombinirano terapijo s Trudexo/ metotreksatom, 20, 6% bolnikov, ki so dobivali metotreksat v monoterapiji, in
At week 52, 42.9% of patients who received Trudexa/ methotrexate combination therapy achieved lon clinical remission (DAS28 < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Trudexa monotherapy.
za 23, 4% bolnikov, ki so dobivali Trudexo v monoterapiji.
Trudexa/ methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and Trudexa monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe no
Za doseganje nizkega stanja bolezni pri bolnikih z nedavno diagnosticiranim zmernim do hudim revmatoidnim artritisom je bila kombinirana terapija s Trudexo in metotreksatom klinično in statistično boljša od monoterapije z metotreksatom
rheumatoid arthritis.
nja (p < 0, 001) in monoterapije s Trudexo (p < 0, 001).
Radiographic response t
Rentgenografski odziv
In Study III, where Trudexa treated patients had a mean duration of rheumatoid arthritis of uc
Bolniki, ki so v raziskavi III dobivali Trudexo, so imeli revmatoidni artritis v povprečju približno 11 vo let.
approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified total Sharp score and its components, the erosion score and joint space narrowing score.
V raziskavi so strukturno prizadetost sklepov ocenjevali rentgenografsko.
Trudexa/ methotrexate patients demonstrated significantly less radiographic progression than rod
Okvaro so izrazili kot spremembo modificirane celotne Sharpove ocene in njenih komponent, ocene erozij in ocene zožitve sklepne špranje.
patients receiving methotrexate alone at 6 and 12 months (see Table 5).
tabelo 5) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
Data from the open-label extension phase indicate that the reduction in rate of progression of structural damage is maintained for 60 months in a subset of patients.
Podatki iz odprte podaljšane faze kažejo, da se upočasnitev napredovanja strukturne prizadetosti sklepov ohrani vseh vseh 60 mesecev v tej podskupini bolnikov.
113/ 207 of patients originally treated with 40 mg Humira every other week were evaluated radiographically at 5 years.
113 od 207 bolnikov, ki so bili zdravljeni s 40 mg Trudexe vsak drugi teden, so rentgenografsko ocenili po eā
progression of structural damage defined by a change in the TSS of zero or less.
Med temi bolniki jih 66 ni kazalo napredovanja strukturne prizadetosi izražene s spremembo celotne Sharpove ocene 0 ali manj. av
Radiographic Mean Changes Over 12 Months in Study III na
Povprečne rentgenografske spremembe v 12 mesecih raziskave III
i
X
MTXa
TRUDEXA/ MTX
40 mg every
40 mg vsak drugi teden
TRUDEXA/ MTX
(95% interval zaupanjab)
dic
< 0, 001c
other week
Celotna Sharpova ocena
(95% Confidence
0, 1
Intervalb) Me
2, 6 (1, 4, 3, 8)
Total Sharp score Erosion score
Ocena erozij d ilo
JSNd score
Ocena ZSŠ
methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and Trudexa. c Based on rank analysis d Joint Space Narrowing
metotreksat b 95% intervali zaupanja za razlike v spremembi ocen med metotreksatom in Trudexo rav
78 In Study V, structural joint damage was assessed radiographically and expressed as change in modified total Sharp score (see Table 6).
modificirani celotni Sharpovi oceni (glejte tabelo 6).
ed
Trudexa
p-valueb
78
(95% confidence (95% confidence
(95% interval
interval) interval)
(95% interval
(95% confidence
zaupanja)
ris interval)
zaupanja)
Total Sharp score
zaupanja)
5.7 (4.2-7.3)
celotna
tho Erosion score JSN score
Sharpova ocena
1.7 (1.0-2.4) 1.3 (0.5-2.1)
0, 8 (0, 4- 1, 2)
0.8 (0.4-1.2) 0.5 (0-1.0)
2, 0 (1, 2- 2, 8) 1, 3 (0, 5- 2, 1)
0.0082 0.0037
< 0, 001
< 0.001 0.151
0, 0037
a. p-value is from the pairwise comparison of methotrexate monotherapy and Trudexa/ methotrexate combination therapy using the Mann-Whitney U test.
0, 151
au b. p-value is from the pairwise comparison of Trudexa monotherapy and Trudexa/ methotrexate combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of Trudexa monotherapy and methotrexate monotherapy using the Mann-Whitney U test
me a Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije s Trudexo/ metotreksatom z Mann- Whitneyevim testom U b Vrednost p se nanaša na parno primerjavo monoterapije s Trudexo in kombinirane terapije s
r ge Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified total Sharp score ≤ 0.5) was significantly higher with lon Trudexa/ methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and Trudexa monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
pro Trudexo/ metotreksatom z Mann- Whitneyevim testom U c Vrednost p se nanaša na parno primerjavo monoterapije s Trudexo in monoterapije z metotreksatom z Mann- Whitneyevim testom U.
Quality of life and physical function no
104 tednih zdravljenja je bil v skupini s kombinirano terapijo s Trudexo in metotreksatom
Health-related quality of life and physical function was assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at week 52 in Study III.
61, 2%) kot v skupinah, ki sta prejemali monoterapijo z metotreksatom (37, 4% in 33, 5%, p < 0, 001) ali monoterapijo s Trudexo (50, 7%, p < 0, 002, oz.
All doses/ schedules of Trudexa t
44, 5%, p < 0, 001).
in all four studies showed statistically significantly greater improvement in the disability index of the uc
nja Kakovost življenja in telesna funkcija
HAQ from baseline to Month 6 compared to placebo and in Study III the same was seen at week 52.
V vseh štirih raziskavah se je indeks invalidnosti po vprašalniku HAQ od izhodišča do 6. meseca z vsemi vo odmerki/ shemami Trudexe izboljšal statistično značilno bolj kot s placebom; v raziskavi III so isto ugotovili po 52 tednih.
Results from the Short Form Health Survey (SF 36) for all doses/ schedules of Trudexa in all four rod
Te izsledke podpirajo rezultati SF 36 (Short Form Health Survey) za vse odmerke/ sheme Trudexe v vseh štirih raziskavah, s statistično značilnim seštevkom PCS (Physical do
studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
Component Summary) in statistično značilnima seštevkoma za področje bolečin in vitalnosti za odmerek 40 mg vsak drugi teden.
A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (Studies lP
V vseh treh raziskavah (raziskave I, III in IV), v katerih so ocenjevali utrujenost s funkcijsko oceno terapije kronične bolezni (functional assessment of chronic illness therapy (FACIT)), so ugotovili statistično značilno zmanjšanje utrujenosti. eā
Improvement in quality of life was measured up to week 156 (36 months) and na
V tem času se av
In Study V, the improvement in the HAQ disability index and the physical component of the SF 36 i dic
V študiji V sta se indeks invalidnosti HAQ in telesna komponenta SF 36 ob kombinirani terapiji s nim
Me
Trudexo in metotreksatom po 52 tednih izboljšala bolj (p < 0, 001) kot ob monoterapiji z metotreksatom ali ob monoterapiji s Trudexo; to se je ohranilo do 104. tedna.
Trudexa, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, Studies VI and VII.
Študija VI je trajala 24 tednov.
Study VI with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50% were taking methotrexate.
V njej so zdravili 313 odraslih, ki se niso ustrezno odzvali na terapijo z rav
79 There is insufficient evidence of the efficacy of Trudexa in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied (see Table 7).
Zaradi majhnega števila bolnikov ni dovolj dokazov o učinkovitosti Trudexe pri bolnikih s psoriatično Zd
Placebo
79 Odziv ACR 20
Trudexa Placebo
Placebo N = 162
ris Response
Placebo N = 49
58%
58% *** 57% ***
***
t me
36%
36% *** 39% ***
r *** p < 0.001 for all comparisons between Trudexa and placebo
*** p < 0, 001 za vse primerjave med Trudexo in placebom * p < 0, 05 za vse primerjave med Trudexo in placebom np ne pride v poštev
p < 0.05 for all comparisons between Trudexa and placebo
za Odzivi ACR v študiji VI so bili podobni ob sočasni terapiji z metotreksatom in brez nje.
Trudexa treated patients demonstrated improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36), from base-line to week 24. no
Telesno delovanje, ocenjeno s HAQ in SF 36 (Short Form Health Survey), se je pri bolnikih, ki so
Trudexa 40 mg every other week was assessed in 393 patients in two randomised, 24 week double− blind, placebo− controlled studies in patients with active ankylosing spondylitis (mean t
nja dobivali Trudexo, od izhodišča do 24. tedna izboljšalo.
baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] uc
Ankilozirajoči spondilitis lje Trudexo 40 mg vsak drugi teden so ocenili v dveh randomiziranih 24- tedenskih dvojno slepih, s placebom kontroliranih študijah pri 393 bolnikih z aktivnim ankilozirajočim spondilitisom (povprečna izhodiščna ocena aktivnosti bolezni [indeks BASDAI (Bathov indeks bolezenske aktivnosti vo ankilozirajočega spondilitisa – Bath Ankylosing Spondylitis Disease Activity Index)] je bil v vseh skupinah 6, 3), ki se niso odzvali ustrezno na konvencionalno terapijo.
Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti − rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Devetinsedemdeset (20, 1%) bolnikov je sočasno dobivalo imunomodulacijska antirevmatična zdravila, 37 (9, 4%) bolnikov pa do
Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at Weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses. lP
Preiskovanci (n = 215, 54, 7%), ki 12. ali 16. ali 20. teden niso dosegli ASAS 20, so začeli v predčasni odprti fazi dobivati 40 mg adalimumaba vsak drugi teden subkutano, v poznejših statističnih analizah dvojno slepe faza pa eā
In the larger study (VIII) with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Trudexa compared to placebo. na
Rezultati obsežnejše študije (VIII) pri 315 bolnikih so pri bolnikih, ki so dobivali Trudexo, pokazali av
Significant response was first observed at Week 2 and maintained through 24 weeks (Table 8).
Značilen odziv so najprej opazili po 2 tednih in se je ohranil do 24. tedna (tabela 8). nim
Table 8 - Efficacy Responses in Placebo-Controlled AS Study – Study VIII i dic
Tabela 8 - Odzivi učinkovitosti v študiji AS, kontrolirani s placebom - študija VIII Zmanjšanje znakov in simptomov
Me
Odziv
Response
placebo n = 107
Placebo N=107
Trudexa n = 208
Trudexa N=208
ilo
ASAS 50
ASAS 50 Zd
Week 2 Week 12
2. teden
Week 24
12. teden 24. teden
***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between Trudexa and placebo at Weeks 2, 12 and 24
***, ** Statistično značilno pri p < 0, 001, < 0, 01 za vse primerjave med Trudexo in placebom po 2, 12 in 24 tednih
tho a ASsessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
t me a Ocene pri ankilozirajočem spondilitisu (Assessments in Ankylosing Spondylitis) b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index)
Trudexa treated patients had significantly greater improvement at Week 12 which was maintained
pro Bolniki, ki so dobivali Trudexo, so imeli po 12 tednih značilno večje izboljšanje (ki se je ohranilo do 24. tedna) SF36 in ASQoL (Vprašalnik o kakovosti življenja pri ankilozirajočem spondilitisu – Ankylosing Spondylitis Quality of Life Questionnaire).
au through Week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Podobni trendi (ki pa niso bili vsi statistično značilni) so bili opazni v manjši, randomizirani, dvojno
Similar trends (not all statistically significant) were seen in the smaller randomised, double− blind,
za slepi, s placebom kontrolirani študiji (IX) pri 82 odraslih bolnikih z aktivnim ankilozirajočim spondilitisom.
r placebo controlled study (IX) of 82 adult patients with active ankylosing spondylitis.
nja Crohnova bolezen
ge Crohn’ s Disease lon The safety and efficacy of Trudexa were assessed in over 1400 patients with moderately to severely active Crohn’ s disease (Crohn’ s Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Varnost in učinkovitost Trudexe so ocenili pri več kot 1400 bolnikih z zmerno do hudo, aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450) v randomiziranih, lje dvojno slepih, s placebom kontroliranih študijah.
478 of the enrolled patients (32%) were defined as having a severe disease (CDAI score > 300 and concomitant corticosteroid and/ or immunosuppressants) no
Pri 478 zajetih bolnikih (32%) je bila bolezen opredeljena kot huda (seštevek CDAI > 300 ter sočasno zdravljenje s kortikosteroidom in/ ali imunosupresivom), kar ustreza populaciji, opredeljeni pri indikacijah (glejte poglavje 4. 1).
Concomitant stable doses of aminosalicylates, corticosteroids, and/ or immunomodulatory agents were permitted and 79% of patients continued to receive at least one of these medications. t
Dovoljena vo je bila sočasna uporaba stabilnih odmerkov aminosalicilatov, kortikosteroidov in/ ali imunomodulacijskih zdravil; 79% bolnikov je še naprej prejemalo vsaj eno od takšnih zdravil. do
Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CLASSIC I and uc
Indukcijo klinične remisije (opredeljene kot CDAI < 150) so ocenili v dveh študijah, CLASSIC I in GAIN.
In GAIN, 325 patients who had lost rod
V študiji CLASSIC I so 299 bolnikov, ki pred tem še niso dobivali antagonistov TNF, randomizirali v eno od štirih skupin: placebo 0. in 2. teden, 160 mg Trudexe 0. teden in 80 mg eā
The primary non-responders were excluded from the studies and therefore these patients were not further evaluated. lP
Študija ni vključila primarno neodzivnih bolnikov in ti tako niso bili dodatno ocenjeni. av
Patients in clinical na
Na 4. teden so bolnike randomizirali na 40 mg nim
Corticosteroid taper was permitted after week 8. i
Po 8. tednu je bilo dovoljeno postopno zmanjševanje kortikosteroida.
CLASSIC I and GAIN induction of remission and response rates are presented in Table 9. dic Me
Indukcijo remisije in deleže odziva v študijah CLASSIC I in GAIN prikazuje tabela 9. ilo rav Zd
81 Table 9:
81 Tabela 9:
In CLASSIC I and GAIN, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to
Študiji CLASSIC I in GAIN sta pokazali statistično značilno izboljšanje celotnega seštevka po vprašalniku IBDQ (vprašalnik, specifičen za vnetno bolezen črevesa) do 4. tedna pri bolnikih, randomiziranih na shemi s Trudexo 80/ 40 mg in 160/ 80 mg, v primerjavi s placebom; razliko 26. in 82 56. teden je v skupinah, zdravljenih z adalimumabom, v primerjavi s placebom pokazala tudi študija CHARM.
The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg every other week and every week subcutaneous dosing. i dic
sorazmerno odmerku po 20, 40 in 80 mg vsak drugi teden in vsak teden subkutano. rav
83 levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be lower in patients with measurable AAA.
Ugotovljeno je bilo, da so koncentracije prostega adalimumaba (tiste, ki ni vezan na 83 protitelesa proti adalimumabu) v serumu manjše pri bolnikih, ki imajo merljivo raven teh protiteles.
Trudexa 40 mg solution for injection in single-use pre-filled pen for patient use. dic
Trudexa 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku za enkratno uporabo, ki ga uporabi bolnik. rav
Packs of: • 1 pre-filled pen with 1 alcohol pad in a blister.
Pakiranja: • 1 napolnjen injekcijski peresnik z 1 alkoholnim zložencem v pretisnem omotu. • 2 napolnjena injekcijska peresnika, vsak z 1 alkoholnim zložencem v pretisnem omotu.
• 2 pre-filled pen, each with 1 alcohol pad, in a blister. • 4 pre-filled pen, each with 1 alcohol pad, in a blister. • 6 pre-filled pen, each with 1 alcohol pad, in a blister.
• 4 napolnjeni injekcijski peresniki, vsak z 1 alkoholnim zložencem v pretisnem omotu. • 6 napolnjenih injekcijskih peresnikov, vsak z 1 alkoholnim zložencem v pretisnem omotu.
84 Any unused product or waste material should be disposed of in accordance with local requirements.
84 Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
ed Queenborough Kent ME11 5EL United Kingdom
me Queenborough Kent ME11 5EL Velika Britanija
ris 8.
pro 8.
tho EU/ 1/ 03/ 257/ 007 EU/ 1/ 03/ 257/ 008 EU/ 1/ 03/ 257/ 009
EU/ 1/ 03/ 257/ 007
au EU/ 1/ 03/ 257/ 010
za EU/ 1/ 03/ 257/ 008 EU/ 1/ 03/ 257/ 009 EU/ 1/ 03/ 257/ 010
9.
nja 9.
r ge 1 September 2003 10.
lje 1. september 2003 vo 10.
{MM/ YYYY}
{MM/ LLLL} do eā av nim ilo rav Zd
85 ed ris tho r au ge lon ANNEX II
85 t me pro za nja lje DODATEK II vo A.
MANUFACTURER(S) OF THE OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR no
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, do
BATCH RELEASE
ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
MANUFACTURER(S) OF THE OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
86 A IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
ed Abbott Bioresearch Center 100 Research Drive Worcester
t Abbott Bioresearch Center
ris MA 01605 USA
me 100 Research Drive Worcester MA 01605
tho and
pro ZDA
Road No.
za Road No.
au Barceloneta Puerto Rico 00617
59. 2 Barceloneta Puerto Rico 00617 ZDA
ge Abbott Biotechnology Deutschland GmbH Max-Planck-Ring 2 lon D-65205 Wiesbaden Germany
nja Ime in naslov izdelovalca, odgovornega za sproščanje serije lje Abbott Biotechnology Deutschland GmbH Max- Planck- Ring 2 D- 65205 Wiesbaden vo Nemčija
CONDITIONS OF THE MARKETING AUTHORISATION no
B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM do
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER t uc
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM eā
Summary of Product Characteristics, section 4.2). rod
Povzetek glavnih značilnosti zdravila, poglavje 4. 2). av
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA nim
• OTHER CONDITIONS na
• DRUGI POGOJI
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the pharmacovigilance plan. i
Imetnik dovoljenja za promet se zavezuje, da bo izvedel študije in dodatne farmakovigilančne ilo
An updated risk management plan should be provided as per the CHMP guideline on the risk dic
aktivnosti, ki so opredeljene v farmakovigilančnem načrtu.
management systems for medicinal products for human use.
odbora CHMP “ Guideline on the risk management systems for medicinal products for human use ”.
87 ed ris tho r au ge lon ANNEX III
87 t me pro za nja lje DODATEK III vo OZNAČEVANJE IN NAVODILO ZA UPORABO do eā av nim ilo rav Zd
88 Me dic ina lP rod uc t
88 Zd rav ilo nim av eā
89 no A.
89 do A.
LABELLING lon ge PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OZNAČEVANJE vo lje nja za pro me t PODATKI NA ZUNANJI OVOJNINI
ed Trudexa 40 mg solution for injection Adalimumab
Trudexa 40 mg raztopina za injiciranje adalimumab
Excipients: mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate
nja Pomožne snovi: manitol, citronska kislina monohidrat, natrijev citrat, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, natrijev klorid, polisorbat 80, natrijev hidroksid in voda za injekcije.
See leaflet for further information. lon 4.
Za nadaljne informacije glejte navodilo za uporabo. lje 4.
1 vial containing 40 mg adalimumab 1 sterile injection syringe with fixed needle no
1 viala s 40 mg adalimumaba do
2 alcohol pads
1 sterilna injekcijska brizga s fiksirano iglo 2 alkoholna zloženca eā
METHOD AND ROUTE(S) OF ADMINISTRATION t uc
POSTOPEK IN POT( I) UPORABE ZDRAVILA
Subcutaneous use.
Subkutana uporaba av
Read the package leaflet before use. rod
Pred uporabo preberite navodilo. nim
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN lP
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
Keep out of the reach and sight of children. na
Zdravilo shranjujte nedosegljivo otrokom! ilo
OTHER SPECIAL WARNING(S), IF NECESSARY i dic
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA rav
ed Abbott Laboratories Ltd Queenborough
t me Abbott Laboratories Ltd Queenborough Kent ME11 5EL Velika Britanija
tho 12.
pro 12.
au EU/ 1/ 03/ 257/ 001
EU/ 1/ 03/ 257/ 001
13.
za 13.
r ge LOT: lon 14.
nja Serija:
Medicinal product subject to medical prescription. no
Izdaja zdravila je le na recept. vo do
INSTRUCTIONS ON USE t
NAVODILA ZA UPORABO
INFORMATION IN BRAILLE uc
PODATKI V BRAILLOVI PISAVI eā
Trudexa 40 mg rod lP i na dic Me
Trudexa 40 mg av nim ilo rav Zd
ris Store in a refrigerator.
pro Shranjujte v hladilniku.
au Abbott Laboratories Ltd.
za Abbott Laboratories Ltd.
r ge EXP {MM/ YYYY} 4.
{MM/ LLLL} 4.
LOT:
Serija: do
OTHER t uc rod lP Me
DRUGI PODATKI eā av nim ilo rav Zd
ed Trudexa 40 mg injection Subcutaneous use
pro subkutana uporaba
LOT: ge lon 5.
Serija: vo
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT do
40 mg/ 0.8 ml no
40 mg/ 0, 8 ml eā
OTHER t uc rod lP i na dic Me
DRUGI PODATKI av nim ilo rav Zd
ed Trudexa 40 mg solution for injection in pre-filled syringe Adalimumab
Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi adalimumab
1 pre-filled syringe containing 40 mg adalimumab 1 alcohol pad no
1 napolnjena injekcijska brizga s 40 mg adalimumaba do
METHOD AND ROUTE(S) OF ADMINISTRATION t
POSTOPEK IN POT( I) UPORABE ZDRAVILA eā
Subcutaneous use uc
Subkutana uporaba av
Read the package leaflet before use. rod
Pred uporabo preberite navodilo.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN lP
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN nim
EXP {MM/ YYYY} Me
{MM/ LLLL} Zd
2 pre-filled syringes, each containing 40 mg adalimumab 2 alcohol pads no
2 napolnjeni injekcijski brizgi s po 40 mg adalimumaba do
97 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
97 PODATKI NA ZUNANJI OVOJNINI
4 pre-filled syringes, each containing 40 mg adalimumab 4 alcohol pads no
4 napolnjene injekcijske brizge s po 40 mg adalimumaba do
au EU/ 1/ 03/ 257/ 004
EU/ 1/ 03/ 257/ 004
6 pre-filled syringes, each containing 40 mg adalimumab 6 alcohol pads no
6 napolnjenih injekcijskih brizg s po 40 mg adalimumaba do
100 10.
100 10.
101 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
101 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU