natgillin/translations-raw huggingface dataset:
5.2 Pharmacokinetic properties t
5. 2 Farmakokinetične lastnosti av
was slow, with peak serum concentrations being reached about 5 days after administration.
Po subkutani uporabi enega samega 40 mg odmerka sta bili absorpcija in distribucija adalimumaba počasni in največja koncentracija v serumu je bila dosežena približno 5 dni po uporabi.
The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg rod
Povprečna nim
subcutaneous dose was 64%.
absolutna biološka uporabnost adalimumaba, ocenjena iz treh raziskav po enem 40 mg odmerku subkutano, je 64%.
rheumatoid arthritis patients ranged from 31-96% of those in serum.
Koncentracije adalimumaba v sinovijski tekočini več bolnikov z revmatoidnim artritisom so bile od 31 do 96% tistih v serumu. ilo
Following subcutaneous administration of 40 mg of Trudexa every other week in rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 µg/ ml (without na
Po subkutani uporabi 40 mg Trudexe vsak drugi teden pri bolnikih z revmatoidnim artritisom (RA) so rav
concomitant methotrexate) and 8 to 9 µg/ ml (with concomitant methotrexate), respectively.
bile povprečne najmanjše koncentracije v stanju dinamičnega ravnovesja približno 5 µg/ ml (brez sočasne uporabe metotreksata) in od 8 do 9 µg/ ml (s sočasno uporabo metotreksata).
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
Zd
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.
Trudexa on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/ ml during the induction period.
Polnilni odmerek 160 mg Trudexe na 0. teden, ki mu sledi 80 mg Trudexe 2. teden, doseže med obdobjem indukcije najnižjo koncentracijo v serumu približno 12 µg/ ml.
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.
Population pharmacokinetic analyses with data from over 1300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
20 Analize populacijske farmakokinetike s podatki za več kot 1. 300 bolnikov z revmatoidnim artritisom so pokazale trend k večjemu navideznemu očistku adalimumaba z večanjem telesne teže.
The serum
Po korekciji za razlike v teži se je izkazalo, da spol in starost po vsem sodeč minimalno vplivata na očistek adalimumaba.
20 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 protitelesa proti adalimumabu) v serumu manjše pri bolnikih, ki imajo merljivo raven teh protiteles.
Trudexa has not been studied in children or in patients with hepatic or renal impairment.
t Trudexa ni raziskana pri otrocih in bolnikih z okvaro jeter ali ledvic.
5.3 Preclinical safety data
me 5. 3 Predklinični podatki o varnosti
ed Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
pro Neklinični podatki na osnovi študij toksičnosti posameznih odmerkov, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Carcinogenicity studies, and standard assessment of
Raziskava embrio- fetalne razvojne toksičnosti/ perinatalnega razvoja je bila narejena pri opicah Cynomologous z odmerki 0, 30 in 100 mg/ kg (od 9 do 17 opic na skupino) in ni pokazala znakov
tho fertility and postnatal toxicity, were not performed with adalimumab due to the lack of appropriate models for an antibody with limited cross-reactivity to rodent TNF and the development of neutralizing antibodies in rodents.
Z adalimumabom niso bile narejene raziskave kancerogenosti in standardne ocene plodnosti ter poporodne toksičnosti, in sicer zato, ker ni ustreznih modelov za protitelo z omejeno navzkrižno reaktivnostjo z glodalskim TNF, in zaradi nastanka nevtralizirajočih protiteles pri glodalcih.
au 6.
nja 6.
PHARMACEUTICAL PARTICULARS
FARMACEVTSKI PODATKI lje 6. 1 Seznam pomožnih snovi vo manitol citronska kislina monohidrat natrijev citrat do
r ge Mannitol Citric acid monohydrate Sodium citrate lon Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride Polysorbate 80 no
natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat dihidrat natrijev klorid polisorbat 80 eā
Sodium hydroxide Water for injections.
natrijev hidroksid voda za injekcije av
6.2 Incompatibilities t uc
6. 2 Inkompatibilnosti
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. rod
Zaradi pomanjkanja študij o kompatibilnosti zdravila ne smemo mešati z drugimi zdravili. nim
18 months lP
18 mesecev
6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje ilo
Do not freeze. na
Ne zamrzujte. rav
6.5 Nature and contents of container i
6. 5 Vrsta ovojnine in vsebina
Trudexa 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, dic
Trudexa 40 mg raztopina za injiciranje v viali (steklo tipa I) za enkratno uporabo, opremljeni z Zd
aluminium crimps and flip-off seals.
gumijastim zamaškom, aluminijsko obrobo in dvižno zaporko.
Me
Pakiranja:
Any unused product or waste material should be disposed of in accordance with local requirements.
6. 6 Posebni varnostni ukrepi za odstranjevanje 21 Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Abbott Laboratories Ltd.
t Abbott Laboratories Ltd.
Queenborough Kent ME11 5EL United Kingdom
me Queenborough Kent ME11 5EL Velika Britanija
ed 8.
pro 8.
tho 9.
za 9.
1 September 2003
nja 1. september 2003
au 10.
lje 10.
r {MM/ YYYY}
{MM/ LLLL} vo do eā av nim ilo rav Zd
ed Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
t me Ena 0, 8 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba.
ris Adalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells.
Adalimumab je rekombinantno humano monoklonsko protitelo, pridobljeno v celicah jajčnika
au Solution for injection in pre-filled syringe.
Raztopina za injiciranje v napolnjeni injekcijski brizgi.
4.
nja 4.
r ge 4.1 Therapeutic indications
lje 4. 1 Terapevtske indikacije
Rheumatoid arthritis lon Trudexa in combination with methotrexate, is indicated for:
Revmatoidni artritis vo Trudexa je v kombinaciji z metotreksatom indicirana za: do
the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the no
Zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, kadar odziv na imunomodulirajoča zdravila, vključno z metotreksatom, ni zadosten.
response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. t uc
Zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še eā
Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. rod
Trudexo je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljne av
Trudexa has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
izboljša telesno funkcijo, kadar se uporablja v kombinaciji z metotreksatom.
Ankylosing spondylitis i
Ankilozirajoči spondilitis rav
Trudexa is indicated for the treatment of adults with severe active ankylosing spondylitis who have dic
Zd
For induction treatment, Trudexa should be given in combination with corticosteroids.
Trudexa je indicirana za zdravljenje hude, aktivne Crohnove bolezni pri bolnikih, ki se ne odzovejo na popoln in ustrezen ciklus zdravljenja s kortikosteroidom in/ ali imunosupresivom, ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
23 4.2 Posology and method of administration
23 Za indukcijsko zdravljenje morate Trudexo uporabiti v kombinaciji s kortikosteroidi.
Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1. lon In monotherapy, some patients who experience a decrease in their response may benefit from an increase in dose intensity to 40 mg adalimumab every week.
Med monoterapijo lahko nekaterim bolnikom, ki se jim odziv na Trudexo zmanjša, koristi zvečanje odmerka adalimumaba na 40 mg vsak teden.
Psoriatic arthritis and ankylosing spondylitis no
Psoriatični artritis in ankilozirajoči spondilitis eā
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. t
Priporočeni odmerek Trudexe pri bolnikih s psoriatičnim artritisom in ankilozirajočim spondilitisom je 40 mg adalimumaba, apliciran v enkratni subkutani injekciji vsak drugi teden. av
Continued therapy should be carefully reconsidered in a patient not responding within this time period. rod
Pri bolnikih, ki se v tem obdobju ne odzovejo, je treba dobro razmisliti, ali naj nadaljujejo zdravljenje. nim
The recommended Trudexa induction dose regimen for adult patients with severe Crohn’ s disease is lP
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 ilo
80 mg at week 0 followed by 40 mg at week 2.
injiciranjema na dan dva dni zapored) in 80 mg 2. teden.
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. na
Ob tem se morate zavedati, da je tveganje za neželene učinke med indukcijo večje. rav
Trudexa may be re-administered.
Če bolnik neha uporabljati Trudexo, pa se znaki in simptomi bolezni ponovijo, je mogoče Trudexo znova uvesti.
There is little experience from re-administration after more than 8 weeks since the previous dose.
Zd
24 Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12.
24 Nekaterim bolnikom, ki se ne odzovejo do 4. tedna, lahko koristi nadaljnje vzdrževalno zdravljenje do 12. tedna.
ed No dose adjustment is required.
t Prilagoditev odmerka ni potrebna.
Children and adolescents
me Otroci in mladostniki
au 4.3 Contraindications
za 4. 3 Kontraindikacije
r Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section
nja Aktivna tuberkuloza ali druge hude okužbe, npr. sepsa, in oportunistične okužbe (glejte poglavje 4. 4).
Moderate to severe heart failure (NYHA class III/ IV) (see section 4.4). lon 4.4 Special warnings and precautions for use
lje Zmerno do hudo srčno popuščanje (razred III/ IV po NYHA) (glejte poglavje 4. 4).
Infections no
4. 4 Posebna opozorila in previdnostni ukrepi vo Okužbe do
Because the elimination of adalimumab may take up to five months, monitoring should be continued throughout this period. t uc
Ker lahko eliminacija adalimumaba traja do pet mesecev, je treba bolnike ves ta čas nadzirati. eā
Treatment with Trudexa should not be initiated in patients with active infections including chronic or localized infections until infections are controlled. rod
Zdravljenja s Trudexo se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane. av
Physicians should exercise caution when considering the use of Trudexa in patients with a history of recurring infection or with underlying conditions which may lP
Pri odločanju za uporabo Trudexe je potrebna previdnost pri bolnikih z anamnezo nim
predispose patients to infections, including the use of concomitant immunosuppressive medications.
ponavljajoče se okužbe ali z osnovnimi boleznimi, ki lahko zvečajo nagnjenost k okužbam, vključno s sočasno uporabljenimi imunosupresivnimi zdravili.
Serious infections, sepsis, tuberculosis and other opportunistic infections, including fatalities, have na
Med uporabo Trudexe so bile opisane resne okužbe, sepsa, tuberkuloza in druge oportunistične okužbe, tudi s smrtnimi primeri. ilo
Serious infections: i dic
Resne okužbe: rav
25 Before initiation of therapy with Trudexa, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
25 Pred začetkom zdravljenja s Trudexo je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
ed are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Zdravniki se morajo zavedati tveganja za lažno negativne izvide
ris If active tuberculosis is diagnosed, Trudexa therapy must not be initiated (see section 4.3).
me tuberkulinskega kožnega testa, zlasti pri hudo bolnih ali imunsko oslabelih bolnikih.
If latent tuberculosis is diagnosed, appropriate anti-tuberculosis prophylaxis in accordance with local
Če se odkrije aktivna tuberkuloza, se zdravljenja s Trudexo ne sme začeti (glejte poglavje 4. 3).
26 The needle cover of the syringe contains natural rubber (latex).
26 Pokrovček igle na brizgi vsebuje naravno gumo (lateks).
Cases of worsening congestive heart failure have also been reported in patients receiving Trudexa.
kongestivnega srčnega popuščanja so poročali pri bolnikih, ki so prejemali Trudexo.
Trudexa is contraindicated in moderate to severe heart failure (see section 4.3).
Pri bolnikih z zmernim ali hudim srčnim popuščanjem je Trudexa kontraindicirana (glejte poglavje 4. 3).
27 Autoimmune processes
27 Zdravljenje s Trudexo lahko povzroči nastanek avtoimunskih protiteles.
28 However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last Trudexa treatment.
Ker se človeški imunoglobulini izločajo v mleku, ženske ne smejo dojiti vsaj pet mesecev po zadnjem zdravljenju s Trudexo.
No studies on the effects on the ability to drive and use machines have been performed.
28 Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
tho 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 vključile bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), psoriatičnim artritisom, ankilozirajočim spondilitisom in Crohnovo boleznijo.
The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of Studies I− IX, CLASSIC I, GAIN and CHARM was 5.7% for patients taking
za delom raziskav I– IX, CLASSIC I, GAIN in CHARM, je bil 5, 7% v skupini, ki je prejemala Trudexo, in 5, 3% v kontrolni skupini.
lower respiratory infections (including pneumonia, bronchitis), viral infections
Neželena reakcija okužbe spodnjih dihal (vključno s pljučnico in bronhitisom), virusne okužbe (vključno z gripo in
(including influenza, herpes infections), candidiasis, bacterial infections (including urinary tract infections), upper respiratory infection lP
okužbami s herpesom), kandidoza, bakterijske okužbe (vključno z okužbami sečil), okužbe zgornjih dihal av
Neoplasms benign and malignant (including
Benigne, maligne in ilo
cysts and polyps)
neopredeljene novotvorbe (vključno s cistami in polipi) rav
lymphoma, solid organ tumours (including breast, ovarian, testicular), squamous cell carcinoma of the skin
limfom, tumorji parenhimskih organov (vključno
29 Blood and the lymphatic system disorders
z dojkami, jajčniki in testisi), ploščatocelični karcinom Bolezni krvi in limfatičnega sistema Zd
ris Immune system disorders
29 Bolezni imunskega sistema
au Metabolism and nutrition disorders
t me Presnovne in prehranske motnje
Hypokalaemia, lipids increased, appetite disorders (including anorexia), hyperuricaemia
hipokalemija, zvišanje lipidov, motnje apetita (vključno z anoreksijo), hiperurikemija hiperkalcemija
ge Psychiatric disorders
pro Psihiatrične motnje
dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias)
omotica (vključno z vrtoglavico), glavobol, motnje nevrološkega občutenja (vključno s
no
za parestezijami)
infection, irritation or inflammation of the eye
okužbe, draženje ali vnetje očesa lje
vision disorder, ocular sensation disorders
bolezni vida, motnje vidnega zaznavanja vo
tinnitus, ear discomfort (including pain and
tinitus, neprijetno občutenje v ušesu (vključno z
swelling)
bolečino in otekanjem)
na
eā
disorders i
Srčne bolezni
cardiac arrest, coronary artery insufficiency, angina pectoris, pericardial effusion
zastoj srca, insuficienca koronarnih arterij, angina
Vascular disorders Me
Žilne bolezni
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora ilo
30
rav
asthma, dyspnoea, dysphonia, nasal congestion
astma, dispneja, disfonija, zamašenost nosu pljučni edem, edem žrela, plevralna efuzija,
Rare
plevritis
ed Gastrointestinal disorders
Bolezni prebavil Zd
au Hepato-biliary disorders
30 Bolezni jeter, žolčnika in žolčevodov
Musculoskeletal,
pro Bolezni mišično- skeletnega sistema in vezivnega tkiva
connective tissue and bone disorders
mišičnoskeletne bolečine
Renal and urinary
za Bolezni sečil
haematuria, renal impairment, bladder and
hematurija, okvara ledvične funkcije, simptomi sečnega mehurja in sečnice
disorders
nja
Reproductive system and breast disorders lP
Motnje reprodukcije in dojk
General disorders and administration site conditions na
Splošne težave in
Very Common
zelo pogosti vo
injection site reaction (including pain, swelling, redness or pruritus)
reakcija na mestu injiciranja (vključno z bolečino,
i
oteklostjo, pordelostjo ali srbenjem)
pyrexia, fatigue (including asthenia and malaise)
pireksija, utrujenost (vključno z astenijo in
dic
eā
blood creatine phosphokinase increased, activated partial thromboplastin time
zvišanje kreatin fosfokinaze v krvi, podaljšan aktivirani parcialni tromboplastinski čas, prisotna avtoprotitelesa
Injury and poisoning
Poškodbe in zastrupitve in zapleti pri posegih nim
31 In the twelve controlled trials, 16% of patients treated with Trudexa developed injection site reactions (erythema and/ or itching, haemorrhage, pain or swelling), compared to 10% of patients receiving placebo or active control.
V dvanajstih kontroliranih preskušanjih je reakcije na mestu injiciranja (eritem in/ ali srbenje, krvavitve, bolečine ali oteklost) imelo 16% bolnikov, ki so dobivali Trudexo, in 10% bolnikov, ki so dobivali placebo ali kontrolno učinkovino.
Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Zaradi reakcij na injekcijskem mestu uporabe zdravila ilo
The infections
V dvanajstih kontroliranih preskušanjih je bil delež okužb 1, 49 na bolnik- leto med bolniki, ki so dobivali Trudexo, in 1, 42 na bolnik- leto med bolniki, ki so dobivali placebo oziroma kontrolno Zd
tho The incidence of serious infections was 0.03 per patient year in Trudexa treated patients and 0.03 per patient year in placebo and active control− treated patients.
Incidenca resnih okužb je bila 0, 03 na bolnik- leto med bolniki, ki so dobivali Trudexo, in 0, 03 na bolnik- leto med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
In controlled and open label studies with Trudexa, serious infections (including fatal infections, which
31 V kontroliranih in odprtih študijah s Trudexo so poročali o resnih okužbah (vključno s smrtno nevarnimi okužbami, ki so se pojavile redko), med katerimi so bile tuberkuloza (tudi miliarna in zunajpljučna) in invazivne oportunistične okužbe (npr. diseminirana histoplazmoza, pljučnica zaradi Pnevmocystis Carinii, aspergiloza in listerioza).
r ge latent disease.
t Malignomi in limfoproliferativne bolezni
Malignancies and lymphoproliferative disorders lon During the controlled portions of ten Trudexa trials at least 12 weeks in duration (I-IX and CHARM) in patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn’ s disease, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 5.7 (3.3, 10.1) per 1000 patient-years among no
me V kontroliranih delih desetih preskušanj Trudexe (I– IX in CHARM), ki so trajala vsaj 12 tednov, pri bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, psoriatičnim artritisom, ankilozirajočim
2887 Trudexa treated patients versus a rate of 4.1 (1.5, 10.9) 1 per 1000 patient-years among 1570 control patients (median duration of treatment was 5.7 months for Trudexa and 5.5 months for control- treated patients).
pro spondilitisom in Crohnovo boleznijo so malignome (razen limfoma in nemelanomskega kožnega raka) opažali z deležem (95% interval zaupanja) 5, 7 (3, 3, 10, 1) na 1000 bolnik- let med 2887 bolniki, ki so dobivali Trudexo, in 4, 1 (1, 5, 10. 9) na 1000 bolnik- let med 1570 kontrolnimi bolniki (pri prvih je zdravljenje mediano trajalo 5, 7 meseca in pri drugih 5, 5 meseca).
Of these skin cancers, squamous cell carcinomas occurred at rates (95% uc
za Trudexo, in 2, 0 (0, 5, 8, 2) na 1000 bolnik- let med kontrolnimi bolniki.
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.
The rate (95% confidence interval) of lymphomas was 1.0 rod
Delež (95% interval zaupanja) limfomov je bil 1, 0 (0, 2, 3, 8) na 1000 bolnik- let med bolniki, ki so dobivali
(0.2, 3.8) per 1000 patient-years among Trudexa-treated patients and 1.0 (0.1, 7.3) per 1000 patient- years among control patients.
nja Trudexo, in 1, 0 (0, 1, 7, 3) na 1000 bolnik- let v kontrolni skupini bolnikov.
The observed rate of non- melanoma skin cancers is approximately 9.0 per 1000 patient years, and the observed rate of na
Če vzamemo skupaj kontrolirane dele desetih preskušanj (I– IX in CHARM) in potekajoče lje nadaljevalne študije z medianim trajanjem približno 2 leti s 4843 bolniki in prek 13000 bolnik- leti zdravljenja, je ugotovljeni delež malignomov (razen limfoma in nemelanomskih kožnih rakov) približno 13, 6 na 1000 bolnik- let.
lymphomas is approximately 1.2 per 1000 patient years.
Ugotovljeni delež nemelanomskih kožnih rakov je približno vo 9, 0 na 1000 bolnik- let, ugotovljeni delež limfomov pa približno 1, 2 na 1000 bolnik- let.
In post-marketing experience from January 2003, predominately in patients with rheumatoid arthritis, i dic
V obdobju pomarketinške uporabe od januarja 2003, pretežno pri bolnikih z revmatoidnim artritisom, do
the reported rate of malignancies other than lymphomas and non-melanoma skin cancers is approximately 1.7 per 1000 patient years.
je bil zabeleženi delež malignomov (razen limfomov in nemelanomskih kožnih rakov) približno 1, 7 na 1000 bolnik- let.
Me
Ugotovljeni delež nemelanomskih rakov je približno 0, 2 na 1000 bolnik- let in limfomov približno 0, 4 na 1000 bolnik- let (glejte poglavje 4. 4). eā
Autoantibodies
Avtoprotitelesa av