natgillin/translations-raw huggingface dataset:
Do not use the Trudexa pre-filled syringe after the expiry date stated on the label/blister/carton after EXP:. 
Zdravila Trudexa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki/pretisnem omotu/škatli za “Uporabno do:”.
Trudexa 40 mg solution for injection in single-use pre-filled pen for patient use. 
Trudexa 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku za enkratno uporabo, ki ga uporabi bolnik.
• Put used pre-filled pen immediately into the special container as instructed by your doctor, 
• Odrabljeni napolnjeni injekcijski peresnik takoj zavrzite v poseben vsebnik, kot vam je naročil zdravnik, medicinska sestra ali farmacevt.
PHARMACEUTICAL FORM AND CONTENTS 1 vial containing 40 mg adalimumab 1 sterile injection syringe with fixed needle 2 alcohol pads 
FARMACEVTSKA OBLIKA IN VSEBINA 1 viala s 40 mg adalimumaba 1 sterilna injekcijska brizga s fiksirano iglo 2 alkoholna zloženca
• Cancers, other than lymphoma, have been reported in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker. 
• Pri bolnikih s posebno boleznijo pljuč, t.i. kronično obstruktivno pljučno boleznijo (KOPB), zdravljenim z nekim drugim zaviralcem TNF, so poročali o rakih, ki niso bili limfomi.
Always take the outer carton or the vial of medicine with you, even if it is empty. 
Vedno vzemite s seboj zunanjo ovojnino ali vialo zdravila, tudi če je prazna.
Rare lymphoma, solid organ tumours (including breast, ovarian, testicular), squamous cell carcinoma of the skin 
občasni redki papilom na koži limfom, tumorji parenhimskih organov (vključno z dojkami, jajčniki in testisi), ploščatocelični karcinom
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. 
Telesno delovanje, ocenjeno s HAQ in SF 36 (Short Form Health Survey), se je pri bolnikih, ki so dobivali Trudexo, od izhodišča do 24. tedna izboljšalo.
These trials included rheumatoid arthritis patients with short term and long standing disease as well as psoriatic arthritis, ankylosing spondylitis and Crohn's disease patients. 
Ta preskušanja so vključila bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), psoriatičnim artritisom, ankilozirajočim sponditisom in Crohnovo boleznijo.
ACR 50 Week 12 Week 24 
ACR 50 12. teden 24. teden np
Trudexa can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2). 
V primeru intolerance za kortikosteroide ali kadar nadaljnje zdravljenje s kortikosteroidi ni primerno, lahko Trudexo uporabite tudi v monoterapiji (glejte poglavje 4.2).
Trudexa is also available as a pre-filled syringe or a pre-filled pen. 
Trudexa je na voljo tudi kot napolnjena injekcijska brizga in napolnjen injekcijski peresnik.
Common pyrexia, fatigue (including asthenia and malaise) 
pogosti pireksija, utrujenost (vključno z astenijo in splošnim slabim počutjem)
Uncommon (≥ 1/1000 and< 1/100 patients): 
Občasno (≥1/1.000 in <1/100 bolnikov):
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 I, III, IV). 
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.
Immune system disorders anaphylaxis 
Bolezni imunskega sistema anafilaksija
Do not use the Trudexa vial after the expiry date stated on the label/blister/carton after EXP:. 
Zdravila Trudexa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki/pretisnem omotu/škatlici za “Uporabno do:”.
ASAS 50 Week 2 
BASDAIb 50 2. teden 12. teden
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Trudexa, who are chronic carriers of this virus. 
Pri bolnikih, ki so bili kronični nosilci virusa hepatitisa B in so dobivali antagonist TNF (vključno s Trudexo), so opažali reaktivacijo hepatitisa B. Nekaj primerov se je končalo s smrtjo.
Common (≥ 1/100 and < 1/10 patients): 
Pogosto (≥1/100 in <1/10 bolnikov):
2) Choosing and preparing an injection site 
2) Izbira in priprava injekcijskega mesta • Izberite mesto na stegnu ali trebuhu.
All p-values are pairwise comparisons of proportions for Trudexa versus placebo * p < 0.001 
Vse vrednosti p so za parne primerjave deležev med Trudexo in placebom.
ACR 20 Week 52 Week 104 56.0% 49.3% 69.4% 0.002 < 0.001 ACR 50 Week 52 Week 104 42.8% 36.9% 59.0% < 0.001 < 0.001 ACR 70 Week 52 Week 104 28.4% 28.1% 46.6% < 0.001 < 0.001 a. p-value is from the pairwise comparison of methotrexate monotherapy and Trudexa/methotrexate combination therapy using the Mann-Whitney U test. 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 
ACR 20 52. teden 62,6% 54,4% 72,8% 0,013 104. teden 56,0% 49,3% 69,4% 0,002 ACR 50 52. teden 45,9% 41,2% 61,6% < 0,001 < 0,001 0,317 104. teden 42,8% 36,9% 59,0% < 0,001 < 0,001 0,162 ACR 70 52. teden 27,2% 25,9% 45,5% < 0,001 < 0,001 0,656 104. teden 28,4% 28,1% 46,6% < 0,001 < 0,001 0,864
o Do not touch the area again before injecting. 
• Predela se pred injiciranjem ne dotikajte več.
Bucureşti-Ploieşti 1A Corp B, etaj 3, sector 1 013681 Bucureşti 
Bucureşti-Ploieşti 1A Corp B, etaj 3, sector 1 013681 Bucureşti Tel: + 40 21 529 30 00
Do not touch the area again before injecting. 
Tega predela se pred injiciranjem ne smete več dotakniti.
Table 7: ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients) Study VI 
Tabela 7: Odziv ACR v študijah psoriatičnega artritisa, kontroliranih s placebom (odstotek bolnikov)
No data are available on the secondary transmission of infection by live vaccines in patients receiving Trudexa. 
Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, zdravljenih s Trudexo, ni. Bolniki, ki prejemajo Trudexo, lahko sočasno dobijo cepiva, razen živih cepiv.
If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 
Če katerikoli neželen učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at week 2, can be used with the awareness that the risk for adverse events is higher during induction. 
Če je potreben hitrejši odziv na zdravljenje, lahko uporabite shemo 160 mg 0. teden (odmerek lahko aplicirate s štirimi injiciranji na en dan ali z dvema injiciranjema na dan dva dni zapored) in 80 mg 2. teden.
Doses of 20, 40 or 80 mg of Trudexa or placebo were given every other week for 24 weeks. 
Bolniki so 24 tednov vsak drugi teden dobivali odmerke 20, 40 ali 80 mg Trudexe ali placebo.
160/80 mg N=76 
Trudexa 160/80 mg n = 76
If you are a breast-feeding mother, you should stop breast-feeding during Trudexa treatment and for at least 5 months after the last Trudexa treatment. 
Če dojite, morate dojenje med zdravljenjem s Trudexo prekiniti in ne smete dojiti vsaj še 5 mesecev po zadnjem odmerku Trudexe.
Keep the syringe in the outer carton. 
Brizgo shranjujte v zunanji ovojnini.
PHARMACEUTICAL FORM Solution for injection in pre-filled syringe with needleguard. 
FARMACEVTSKA OBLIKA Raztopina za injiciranje v napolnjeni injekcijski brizgi s ščitnikom za iglo
• 1 pre-filled pen with 1 alcohol pad in a blister. 
• 1 napolnjen injekcijski peresnik z 1 alkoholnim zložencem v pretisnem omotu.
• eye inflammation; 
• mišična šibkost;
There is limited safety experience in patients undergoing arthroplasty while receiving Trudexa. 
Izkušnje z varnostjo pri bolnikih, ki so jim med zdravljenjem s Trudexo opravili artroplastiko, so omejene.
D - 65205 Wiesbaden Germany 
Max-Planck-Ring 2 D-65205 Wiesbaden Nemčija
Trudexa 40 mg solution for injection in single-use pre-filled syringe (type I glass) with needleguard for hospital and caregiver use: 
Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) za enkratno uporabo, opremljeni s ščitnikom za iglo, za zdravniško in bolnišnično uporabo.
The Trudexa pre-filled syringe is a glass syringe containing a solution of adalimumab. 
Napolnjena injekcijska brizga je steklena brizga, ki vsebuje raztopino adalimumaba.
Rare thyroid disorder (including goitre) 
Bolezni endokrinega sistema redki bolezni ščitnice (vključno z golšavostjo)
• Coughing; 
• kašelj;
• Signs of infection such as fever, malaise, wounds, dental problems, burning on urination; 
• znake okužbe, npr. zvišano telesno temperaturo, splošno slabo počutje, rane, težave z zobmi,
• abdominal symptoms (such as vomiting, indigestion, constipation), rectal bleeding; 
• trebušni simptomi (npr. bruhanje, prebavne težave, zaprtje), krvavitve v danko;
• Trouble breathing, swallowing; 
• težave pri dihanju, požiranju;
• rash, itching, hair loss; 
• izpuščaj, srbenje, izpadanje las in dlak;
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY BACKING TEXT 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Take special care with Trudexa: 
Bodite posebno pozorni pri uporabi Trudexe
Look for the needle tip inside the stopper window. 
Prepričajte se, da je konica igle vidna v okencu zamaška.
Serious allergic adverse reactions have not been reported with subcutaneous administration of Trudexa during clinical trials. 
V kliničnih raziskavah med subkutano uporabo Trudexe ni bilo opisanih resnih alergijskih neželenih reakcij.
The recommended dose of Trudexa for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. 
Priporočeni odmerek Trudexe za odrasle bolnike z revmatoidnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
Two patients out of 3441 treated with Trudexa in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome. 
V vseh študijah revmatoidnega artritisa in psoriatičnega artritisa so se klinični znaki, ki so nakazovali novonastali lupusni sindrom, pojavili pri 2 od 3441 bolnikov, zdravljenih s Trudexo.
• When the syringe is empty, remove the needle from skin, being careful to keep it at the same angle as when it was inserted 
• Ko je brizga prazna, iglo potegnite iz kože.
No dose-limiting toxicity was observed during clinical trials. 
V kliničnih raziskavah niso opazili toksičnih učinkov, ki bi omejevali odmerek.
Keep this Patient Alert Card together with the package leaflet. 
Izkaznico shranite skupaj z navodilom za uporabo.
p-valuea p-valueb p-valuec 
vrednost pa vrednost pb vrednost pc
BATCH NUMBER LOT: 
ŠTEVILKA SERIJE Serija:
Trudexa 40 mg solution for injection in single-use pre-filled syringe (type I glass) for patient use: 
Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) za enkratno bolnikovo uporabo.
Table 3: ACR Responses in Placebo-Controlled Trials (Percent of Patients) 
Tabela 3: Odziv po ACR v raziskavah, kontroliranih s placebom (odstotek bolnikov)
PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. 
FARMACEVTSKA OBLIKA Raztopina za injiciranje v napolnjeni injekcijski brizgi.
Packs of: 1 pre-filled syringe with needleguard (0.8 ml sterile solution) in a blister, and 1 alcohol pad. 
1 napolnjena injekcijska brizga s ščitnikom za iglo (0,8 ml sterilne raztopine) v pretisnem omotu in 1 alkoholni zloženec.
Abbott Laboratories S.A. 
España Abbott Laboratories, S.A.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.8 ml single dose vial contains 40 mg of adalimumab. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena 0,8 ml viala z enim odmerkom vsebuje 40 mg adalimumaba.
o Do not inject in an area where the skin is reddened, bruised, or hard. 
• Ne injicirajte v pordelo, podpluto ali zatrdelo kožo.
Trudexa should be used with caution in patients with mild heart failure (NYHA class I/II). 
Pri bolnikih z blagim srčnim popuščanjem (razred I/II po NYHA) je treba Trudexo uporabljati previdno.
Pharmacotherapeutic group: Selective immunosuppressive agents. 
Farmakoterapevtska skupina: zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA17
• Keep this container out of the reach and sight of children. 
• Ta vsebnik shranjujte nedosegljivo otrokom.
Check the appearance of the Trudexa solution through the windows on the sides of the pre-filled pen. 
Skozi okenci ob strani napolnjenega peresnika preglejte raztopino Trudexa.
Şos. 
BLAZINICA
Discontinuation of Trudexa therapy should be considered in patients with confirmed significant haematologic abnormalities. 
Pri bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije s Trudexo.
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 rheumatoid arthritis. 
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 (p < 0,001) in monoterapije s Trudexo (p < 0,001).
The recommended dose of Trudexa for patients with psoriatic arthritis and ankylosing spondylitis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. 
Priporočeni odmerek Trudexe pri bolnikih s psoriatičnim artritisom in ankilozirajočim spondilitisom je 40 mg adalimumaba, apliciran v enkratni subkutani injekciji vsak drugi teden.
Keep the pre-filled syringe in the outer carton. 
Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini.
Uncommon accidental injury, impaired healing 
Poškodbe in zastrupitve in zapleti pri posegih občasni naključne poškodbe, slabše celjenje
Week 2 Week 12 Week 24 
12. teden 4% 24. teden 6%
Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride 
6.1 Seznam pomožnih snovi manitol citronska kislina monohidrat natrijev citrat natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat dihidrat natrijev klorid polisorbat 80 natrijev hidroksid voda za injekcije
Trudexa is also available as a vial or a pre-filled pen. 
Trudexa je na voljo tudi v vialah in kot napolnjen injekcijski peresnik.
Trudexa 80/40 mg and 160/80 mg compared to placebo and was seen at weeks 26 and 56 in CHARM as well among the adalimumab treatment groups compared to the placebo group. 
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 56. teden je v skupinah, zdravljenih z adalimumabom, v primerjavi s placebom pokazala tudi študija CHARM.
PACKAGE LEAFLET: INFORMATION FOR THE USER Trudexa 40 mg solution for injection in vials 
NAVODILO ZA UPORABO Trudexa 40 mg raztopina za injiciranje v viali
Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis Studies I − V. In these trials, 11.9% of patients treated with Trudexa and 8.1% of placebo and active control − treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24. 
V teh preskušanjih so pozitivne titre protijedrnih protiteles po 24 tednih ugotovili pri 11,9% prejemnikov Trudexe in 8,1% prejemnikov placeba in kontrolne učinkovine, ki so imeli izhodiščno negativne titre teh protiteles.
• 2 pre-filled pen, each with 1 alcohol pad, in a blister. 
• 2 napolnjena injekcijska peresnika, vsak z 1 alkoholnim zložencem v pretisnem omotu.
• 4 pre-filled pen, each with 1 alcohol pad, in a blister. 
• 4 napolnjeni injekcijski peresniki, vsak z 1 alkoholnim zložencem v pretisnem omotu.
Uncommon tinnitus, ear discomfort (including pain and swelling) 
Ušesne bolezni, vključno z motnjami labirinta občasni tinitus, neprijetno občutenje v ušesu (vključno z bolečino in otekanjem)
Trudexa is also available as a vial or pre-filled syringe. 
Trudexa je na voljo tudi v vialah in napolnjenih injekcijskih brizgah.
Uncommon neutropaenia (including agranulocytosis), leucopaenia, thrombocytopaenia, anaemia, , lymphadenopathy, leucocytosis 
Bolezni krvi in limfatičnega sistema pogosti limfopenija občasni nevtropenija (vključno z agranulocitozo), levkopenija, trombocitopenija, anemija, limfadenopatija, levkocitoza redki pancitopenija, idiopatska trombocitopenična purpura
Treatment with Trudexa must be discontinued in patients who develop new or worsening symptoms of congestive heart failure. 
Pri bolnikih, ki se jim na novo pojavijo simptomi kongestivnega srčnega popuščanja ali se jim takšni simptomi poslabšajo, je treba zdravljenje s Trudexo prekiniti.
Uncommon menstrual cycle and uterine bleeding disorders 
Motnje reprodukcije in dojk občasni motnje mesečnega cikla in maternične krvavitve
• 6 pre-filled pen, each with 1 alcohol pad, in a blister. 
• 6 napolnjenih injekcijskih peresnikov, vsak z 1 alkoholnim zložencem v pretisnem omotu.
NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection Adalimumab 
IME ZDRAVILA Trudexa 40 mg raztopina za injiciranje
GAIN: Infliximab Experienced Patients 
GAIN: Bolniki, ki so že dobivali infliksimab placebo n = 74
PHARMACEUTICAL FORM Solution for injection in pre-filled pen. 
FARMACEVTSKA OBLIKA Raztopina za injiciranje v napolnjenem injekcijskem peresniku.
• ear discomfort; 
• neprijeten občutek v ušesu;
Adverse events of the haematologic system, including medically significant cytopoenia (e.g. thrombocytopaenia, leucopaenia) have been infrequently reported with Trudexa. 
Med uporabo Trudexe so redko poročali o neželenih učinkih na hematološki sistem, vključno z medicinsko pomembno citopenijo (npr. trombocitopenijo, levkopenijo).
• glaucoma; 
• glavkom;
Very Common injection site reaction (including pain, swelling, redness or pruritus) 
Splošne težave in spremembe na mestu aplikacije zelo pogosti Reakcija na mestu injiciranja (vključno z bolečino, oteklostjo, pordelostjo ali srbenjem)
• nausea, diarrhoea, abdominal pain, mouth ulcers; 
• slabost v želodcu, driska, bolečine v trebuhu, razjede v ustih;
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena 0,8 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba.
Common musculoskeletal pain 
Proteinurija, ledvične bolečine
• thyroid disorders; 
• bolezni ščitnice;
Uncommon rectal haemorrhage, gastritis, vomiting, dyspepsia, abdominal bloating, constipation, 
Bolezni prebavil pogosti diareja, bolečine v trebuhu, stomatitis in razjede v ustih, navzeja občasni rektalna krvavitev, gastritis, bruhanje, dispepsija, napenjanje v trebuhu, zaprtje intestinalna stenoza, kolitis, entreitis, ezofagitis
NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection in pre-filled syringe with needleguard Adalimumab 
Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi s ščitnikom za iglo adalimumab
STATEMENT OF ACTIVE SUBSTANCE(S) One 0.8 ml vial contains 40 mg adalimumab 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 0,8 ml viala vsebuje 40 mg adalimumaba.
NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection in pre-filled syringe with needleguard 
IME ZDRAVILA Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi s ščitnikom za iglo
MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/010 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/257/010
PHARMACEUTICAL FORM AND CONTENTS 1 pre-filled syringe containing 40 mg adalimumab 1 alcohol pad 
FARMACEVTSKA OBLIKA IN VSEBINA 1 napolnjena injekcijska brizga s 40 mg adalimumaba 1 alkoholni zloženec
Trudexa 40 mg solution for injection in vials is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution. 
Trudexa 40 mg raztopina za injiciranje v vialah je na voljo kot sterilna raztopina 40 mg adalimumaba, raztopljenega v 0,8 ml raztopine.
STATEMENT OF ACTIVE SUBSTANCE(S) One 0.8 ml pre-filled syringe with needleguard contains 40 mg adalimumab 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 0,8 ml napolnjena injekcijska brizga s ščitnikom za iglo vsebuje 40 mg adalimumaba.
PHARMACEUTICAL FORM AND CONTENTS 1 pre-filled pen, containing 40 mg adalimumab 1 alcohol pad 
FARMACEVTSKA OBLIKA IN VSEBINA 1 napolnjen injekcijski peresnik s 40 mg adalimumaba 1 alkoholni zloženec
MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/008 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/257/008
Each prefilled pen comes with 1 alcohol pad. 
Vsakemu napolnjenemu injekcijskemu peresniku je priložena 1 alkoholna blazinica.
BATCH NUMBER 
Pb vrednost
N=170 
26. teden n = 170
Mean steady-state trough levels of approximately 7 µg/ml were observed in Crohn's disease patients who received a maintenance dose of 40 mg Trudexa every other week. 
Pri bolnikih s Crohnovo boleznijo, ki so dobivali vzdrževalni odmerek 40 mg Trudexe vsak drugi teden, so ugotovili najnižjo koncentracijo v stanju dinamičnega ravnovesja približno 7 µg/ml.
Trudexa 40 mg solution for injection in pre-filled syringe with needleguard is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution. 
Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi s ščitnikom za iglo je na voljo kot sterilna raztopina 40 mg adalimumaba, raztopljenega v 0,8 ml raztopine.
Uncommon haematuria, renal impairment, bladder and urethral symptoms, 
Bolezni sečil občasni hematurija, okvara ledvične funkcije, simptomi sečnega mehurja in sečnice redki
NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection in pre-filled syringe 
IME ZDRAVILA Trudexa 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
PHARMACEUTICAL FORM AND CONTENTS 6 pre-filled syringes, each containing 40 mg adalimumab 6 alcohol pads 
FARMACEVTSKA OBLIKA IN VSEBINA 6 napolnjenih injekcijskih brizg s po 40 mg adalimumaba 6 alkoholnih zložencev
HOW TO STORE TRUDEXA 
SHRANJEVANJE ZDRAVILA TRUDEXA
PHARMACEUTICAL FORM AND CONTENTS 4 pre-filled pens, each containing 40 mg adalimumab 4 alcohol pads 
FARMACEVTSKA OBLIKA IN VSEBINA 4 napolnjeni injekcijski peresniki s po 40 mg adalimumaba 4 alkoholni zloženci
MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/006 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/257/006
PHARMACEUTICAL FORM AND CONTENTS 2 pre-filled pens, each containing 40 mg adalimumab 2 alcohol pads 
FARMACEVTSKA OBLIKA IN VSEBINA 2 napolnjeni injekcijski brizgi s po 40 mg adalimumaba 2 alkoholna zloženca
Rare reports of pancytopenia including aplastic anaemia have been reported with TNF blocking agents. 
Pri uporabi zaviralcev TNF je bila v redkih primerih opisana pancitopenija, vključno z aplastično anemijo.
There have been reports of tuberculosis in patients receiving Trudexa. 
Pri bolnikih, zdravljenih s Trudexo, so bili opisani primeri tuberkuloze.
Musculoskeletal, connective tissue and bone disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti mišičnoskeletne bolečine redki rabdomioliza
NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection in pre-filled pen 
IME ZDRAVILA Trudexa 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/001 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/257/001