natgillin/translations-raw huggingface dataset:
In patients with Crohn's disease, the loading dose of 80 mg Trudexa on week 0 followed by 40 mg Trudexa on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 µg/ml during the induction period.
Pri bolnikih s Crohnovo boleznijo doseže polnilni odmerek 80 mg Trudexe na 0.teden, ki mu sledi 40 mg Trudexe 2. teden, med obdobjem indukcije najnižjo koncentracijo v serumu približno 5,5 µg/ml.
• cough, sore throat;
• kašelj, vnetje žrela;
Hypokalaemia, lipids increased, appetite disorders (including anorexia), hyperuricaemia
Presnovne in prehranske motnje občasni hipokalemija, zvišanje lipidov, motnje apetita (vključno z anoreksijo), hiperurikemija redki hiperkalcemija
Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Pri bolnikih, ki se v tem obdobju ne odzovejo, je treba nadaljevanje zdravljenja dobro pretehtati.
Study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Raziskava I je ocenila 271 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno, pri katerih metotreksat v odmerkih od 12,5 do 25 mg (10 mg, če so bili intolerantni za metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek od 10 do 25 mg metotreksata ostal stalen vsak teden.
Skin and subcutaneous tissue disorders cutaneous vasculitis
Bolezni kože in podkožja kožni vaskulitis
***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between Trudexa and placebo at Weeks 2, 12 and 24 a ASsessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
***,** Statistično značilno pri p < 0,001, < 0,01 za vse primerjave med Trudexo in placebom po 2, 12 in 24 tednih a Ocene pri ankilozirajočem spondilitisu (Assessments in Ankylosing Spondylitis) b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing
In addition very rare cases of non-melanoma skin cancer have been observed in patients taking Trudexa.
Poleg tega so pri bolnikih, zdravljenih s Trudexo, opazili zelo redke primere nemelanomskega kožnega raka.
Rare vascular occlusion, aortic stenosis, thrombophlebitis, aortic aneurysm
Žilne bolezni občasni hipertenzija, zardevanje, hematom redki zapora žilja, aortna stenoza, tromboflebitis, aortna anevrizma
If the needle is not correctly lined up with the centre of the stopper, you will feel constant resistance as it goes through the stopper and no “pop.” The needle may then enter at an angle and bend, break or prevent proper removal of the vial contents.
Če igla ni naravnana pravilno v sredino zamaška, boste med prodiranjem skozi zamašek čutili stalen upor in nobenega "poka".
o Wipe the injection site with the enclosed alcohol pad, using a circular motion.
• S krožnim gibom obrišite injekcijsko mesto s priloženim alkoholnim zložencem.
• There have been very rare cases of certain kinds of cancer in patients taking Trudexa or other TNF blockers.
• Med bolniki, ki so jemali Trudexo ali druge zaviralce TNF, so se pojavili zelo redki primeri določenih vrst raka.
Total Sharp score Erosion score 3.7 (2.7-4.7) 1.7 (1.0-2.4) 0.8 (0.4-1.2) < 0.001 0.0082 < 0.001 JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1) 0.5 (0-1.0) < 0.001 0.0037 0.151 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
celotna Sharpova ocena ocena erozij seštevek JSN 2,0 (1,2-2,8) 1,3 (0,5-2,1) 0,5 (0-1,0) < 0,001 0,0037 0,151 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
• Signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,
• znaki in simptomi, ki nakazujejo bolezni krvi, npr. trdovratna zvišana telesna temperatura,
Surgery
OKENCE
Rare cardiac arrest, coronary artery insufficiency, angina pectoris, pericardial effusion
Srčne bolezni občasni aritmije, tahikardija, palpitacije redki zastoj srca, insuficienca koronarnih arterij, angina pektoris, perikardialna efuzija
Administration of Trudexa should be discontinued if a patient develops a new serious infection until infections are controlled.
Če se pri bolniku pojavi nova resna okužba, je treba uporabo Trudexe prekiniti, dokler okužba ni obvladana.
Hold the pre-filled pen with one hand with the grey cap (1) pointed down.
Z eno roko primite napolnjeni injekcijski peresnik tako, da bo sivi pokrovček (1) obrnjen navzdol.
The usual dose for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 40 mg adalimumab given every other week as a single dose.
Običajni odmerek za odrasle z revmatoidnim artritisom, psoriatičnim artritisom in ankilozirajočim spondilitisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku.
Trudexa/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 5).
Pri bolnikih, ki so dobivali Trudexo in metotreksat, je bilo po 6 in 12 mesecih (glejte tabelo 5) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.4 (1.0, 5.7) per 1000 patient-years among Trudexa-treated patients and 0 per 1000 patient-years among control patients.
Med temi kožnimi raki je bil delež (95% interval zaupanja) skvamocelularnega karcinoma 2,4 (1,0, 5,7) na 1000 bolnik-let med bolniki, ki so dobivali Trudexo, in 0 na 1000 bolnik-let v kontrolni skupini bolnikov.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trudexa 40 mg injection
IME ZDRAVILA IN POT(I) UPORABE Trudexa 40 mg injekcija subkutana uporaba
Uncommon opportunistic infections (including tuberculosis, histoplasmosis), sepsis, abscess, joint infection, wound infection, skin infection (including cellulitis and impetigo), superficial fungal infections (including skin, nail and foot)
Infekcijske in parazitske bolezni pogosti okužbe spodnjih dihal (vključno s pljučnico in bronhitisom), virusne okužbe (vključno z gripo in okužbami s herpesom), kandidoza, bakterijske okužbe (vključno z okužbami sečil), okužbe zgornjih dihal občasni sepsa, oportunistične okužbe (vključno s tuberkulozo in histoplazmozo), absces, okužba sklepa, okužba rane, okužba kože (vključno s celulitisom in impetigom), površinske glivične okužbe (vključno s kožo, nohti in stopali)
Study VII with 12-week duration, treated 100 patients who had an inadequate response to DMARD therapy.
V njej so zdravili 100 bolnikov, ki se niso ustrezno odzvali na imunomodulirajočo terapijo.
Table 7: ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Tabela7: Odziv ACR v študijah psoriatičnega artritisa, kontroliranih s placebom (odstotek bolnikov)
• Numbness;
• omrtvelost;
• fatigue;
• utrujenost;
Carriers of HBV who require treatment with Trudexa should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Nosilce HBV, ki potrebujejo zdravljenje s Trudexo, je treba ves čas zdravljenja in več mesecev po koncu zdravljenja natančno spremljati glede znakov in simptomov aktivne okužbe s HBV. O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za preprečitev reaktivacije HBV ni zadostnih podatkov.
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