natgillin/translations-raw huggingface dataset:
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. nim
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 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
Pri bolnikih s Crohnovo boleznijo doseže polnilni odmerek 80 mg Trudexe na 0. teden, ki mu sledi rav
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.
40 mg Trudexe 2. teden, med obdobjem indukcije najnižjo koncentracijo v serumu približno 5, 5 µg/ ml.
A loading dose of 160 mg Trudexa on week 0 followed by 80 mg Me
Pri bolnikih s Crohnovo Zd
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.
boleznijo, ki so dobivali vzdrževalni odmerek 40 mg Trudexe vsak drugi teden, so ugotovili najnižjo koncentracijo v stanju dinamičnega ravnovesja približno 7 µg/ ml.
The serum
Ugotovljeno je bilo, da so koncentracije prostega adalimumaba (tiste, ki ni vezan na
62 levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be lower in patients with measurable AAA.
62 protitelesa proti adalimumabu) v serumu manjše pri bolnikih, ki imajo merljivo raven teh protiteles.
ed Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
Neklinični podatki na osnovi študij toksičnosti posameznih odmerkov, toksičnosti pri ponavljajočih se
Carcinogenicity studies, and standard assessment of
me 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
au 6.
za 6.
r ge Mannitol Citric acid monohydrate Sodium citrate lon Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride Polysorbate 80 no
nja manitol citronska kislina monohidrat lje natrijev citrat natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat dihidrat vo natrijev klorid polisorbat 80 natrijev hidroksid do
Sodium hydroxide Water for injections.
voda za injekcije
6.2 Incompatibilities t uc
6. 2 Inkompatibilnosti eā
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.
6.3 Shelf life
6. 3 Rok uporabnosti av
18 months lP
18 mesecev nim
Do not freeze. na
Ne zamrzujte.
6.5 Nature and contents of container i
6. 5 Vrsta ovojnine in vsebina ilo
Trudexa 40 mg solution for injection in single-use pre-filled syringe (type I glass) with needleguard dic
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. rav
1 pre-filled syringe with needleguard (0.8 ml sterile solution) in a blister, and 1 alcohol pad.
Zd
MARKETING AUTHORISATION HOLDER 63 Abbott Laboratories Ltd.
IMETNIK DOVOLJENJA ZA PROMET 63 Abbott Laboratories Ltd.
ed 8.
t me 8.
ris 9.
pro 9.
{MM/ YYYY}
nja {MM/ LLLL}
r ge lon not uc rod lP i na dic Me
lje vo do eā av nim ilo rav Zd
ed Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
t me En 0, 8 ml napolnjen injekcijski peresnik z enim odmerkom vsebuje 40 mg adalimumaba.
au Solution for injection in pre-filled pen.
Raztopina za injiciranje v napolnjenem injekcijskem peresniku.
response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še eā
the treatment of severe, active and progressive rheumatoid arthritis in adults not previously t
Trudexo je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar av
treated with methotrexate. uc
nadaljnje zdravljenje z metotreksatom ni primerno.
Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. rod
Dokazano je, da Trudexa upočasni napredovanje rentgenografsko merjene prizadetosti sklepov in nim
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. lP
izboljša telesno funkcijo, kadar se uporablja v kombinaciji z metotreksatom.
Trudexa is indicated for the treatment of active and progressive psoriatic arthritis in adults when the na
Trudexa je indicirana za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen. ilo
Ankylosing spondylitis i dic
Ankilozirajoči spondilitis rav
65 For induction treatment, Trudexa should be given in combination with corticosteroids.
65 Za indukcijsko zdravljenje morate Trudexo uporabiti v kombinaciji s kortikosteroidi.
4.2 Posology and method of administration
t Zdravljenje s Trudexo mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in
ed Trudexa treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or Crohn’ s disease.
me zdravljenju revmatoidnega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa ali Crohnove bolezni.
ris After proper training in injection technique, patients may self-inject with Trudexa if their physician determines that it is appropriate and with medical follow-up as necessary.
pro Bolniki, ki se naučijo pravilnega postopka injiciranja, si Trudexo lahko injicirajo sami, če zdravnik presodi, da je to primerno, in je zagotovljeno ustrezno medicinsko spremljanje.
tho During treatment with Trudexa, other concomitant therapies (e. g., corticosteroids and/ or immunomodulatory agents) should be optimised.
Med zdravljenjem s Trudexo je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ ali imunomodulacijska zdravila).
au Adults
za Odrasli
r The recommended dose of Trudexa for adult patients with rheumatoid arthritis is 40 mg adalimumab
nja Priporočeni odmerek Trudexe za odrasle bolnike z revmatoidnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
ge administered every other week as a single dose via subcutaneous injection.
Med zdravljenjem s Trudexo je treba še lje naprej uporabljati metotreksat.
Methotrexate should be continued during treatment with Trudexa. lon Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Trudexa.
Med zdravljenjem s Trudexo je mogoče nadaljevati z uporabo glukokortikoidov, salicilatov, vo nesteroidnih protivnetnih zdravil ali analgetikov.
Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1. no
Za kombinirano uporabo z drugimi imunomodulirajočimi zdravili razen metotreksata glejte poglavji 4. 4 in 5. 1. do
Psoriatic arthritis and ankylosing spondylitis t uc
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. rod
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. lP
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 na
Če je potreben hitrejši odziv na zdravljenje, lahko ilo
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 i dic
Ob tem se morate zavedati, da je tveganje za rav
that the risk for adverse events is higher during induction.
neželene učinke med indukcijo večje.
Alternatively, if a patient has stopped Trudexa and signs and symptoms of disease recur, Me
Če bolnik neha uporabljati Trudexo, pa se znaki in simptomi bolezni ponovijo, je mogoče Trudexo znova Zd
66 Some patients who experience decrease in their response may benefit from an increase in dose intensity to 40 mg Trudexa every week.
Nekaterim bolnikom, ki se jim odziv zmanjša, lahko koristi povečanje odmerka Trudexe na 40 mg vsak teden.
Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12.
66 Nekaterim bolnikom, ki se ne odzovejo do 4. tedna, lahko koristi nadaljnje vzdrževalno zdravljenje do 12. tedna.
ed Elderly patients
Starejši bolniki
ris No dose adjustment is required.
t me Prilagoditev odmerka ni potrebna.
tho There is no experience in children.
pro Izkušenj pri otrocih ni.
au Trudexa has not been studied in these patient populations.
za Trudexa pri teh populacijah bolnikov še ni bila preskušena.
r ge Hypersensitivity to the active substance or to any of the excipients.
nja Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section lon 4.4).
Aktivna tuberkuloza ali druge hude okužbe, npr. sepsa, in oportunistične okužbe (glejte poglavje 4. 4). lje Zmerno do hudo srčno popuščanje (razred III/ IV po NYHA) (glejte poglavje 4. 4). vo 4. 4 Posebna opozorila in previdnostni ukrepi
Infections t
Okužbe do
Patients must be monitored closely for infections, including tuberculosis, before, during and after uc
Bolnike je treba pred, med in po zdravljenju s Trudexo natančno kontrolirati glede okužb, vključno s tuberkulozo.
Because the elimination of adalimumab may take up to five months, monitoring should be continued throughout this period. rod
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.
Zdravljenja s Trudexo se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane. av
Patients who develop a new infection while undergoing treatment with Trudexa should be monitored lP
Bolnike, pri katerih se med zdravljenjem s Trudexo pojavi nova okužba, je treba natančno nadzirati.
closely.
obvladana.
Serious infections, sepsis, tuberculosis and other opportunistic infections, including fatalities, have i
Med uporabo Trudexe so bile opisane resne okužbe, sepsa, tuberkuloza in druge oportunistične okužbe, tudi s smrtnimi primeri. ilo
Me
Resne okužbe: rav
Of particular importance are infections such as pneumonia, pyelonephritis, septic arthritis and septicaemia.
Zd
67 There have been reports of tuberculosis in patients receiving Trudexa.
Pri bolnikih, zdravljenih s Trudexo, so bili opisani primeri tuberkuloze.
Before initiation of therapy with Trudexa, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
67 Pred začetkom zdravljenja s Trudexo je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
This evaluation should include a detailed medical history with a personal history of tuberculosis or possible previous exposure to patients with active tuberculosis and
Pregled mora obsegati podrobno zdravstveno anamnezo z osebno anamnezo tuberkuloze ali morebitnih predhodnih stikov z bolniki z aktivno tuberkulozo ter predhodnega in/ ali trenutnega imunosupresivnega zdravljenja.
ed previous and/ or current immunosuppressive therapy.
t opozorilno izkaznico.
Prescribers
Zdravniki se morajo zavedati tveganja za lažno negativne izvide
ris are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
me tuberkulinskega kožnega testa, zlasti pri hudo bolnih ali imunsko oslabelih bolnikih.
tho If active tuberculosis is diagnosed, Trudexa therapy must not be initiated (see section 4.3).
Če se odkrije aktivna tuberkuloza, se zdravljenja s Trudexo ne sme začeti (glejte poglavje 4. 3).
In this situation, the
pro Če se odkrije latentna tuberkuloza, je treba pred začetkom zdravljenja s Trudexo uvesti ustrezno protituberkulozno profilakso v skladu z lokalnimi priporočili.
au benefit/ risk balance of therapy with Trudexa should be very carefully considered.
V takšnih primerih je treba zelo natančno pretehtati korist in tveganje zdravljenja s Trudexo.
Patients should be instructed to seek medical advice if signs/ symptoms (e. g., persistent cough,
za Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem s Trudexo ali po njem doživijo znake ali simptome (npr. trdovraten kašelj, hujšanje/ izgubljanje teže, nekoliko zvišano telesno temperaturo), ki nakazujejo tuberkulozno okužbo.
r wasting/ weight loss, low grade fever) suggestive of a tuberculosis infection occur during or after
nja Druge oportunistične okužbe:
Other opportunistic infections: lon There have been reports of serious and severe opportunistic infections associated with Trudexa therapy, for example pneumocystis carinii pneumonia, disseminated histoplasmosis, listeriosis and aspergillosis. no
Opisani so primeri resnih in hudih oportunističnih okužb, povezanih s terapijo s Trudexo, npr. lje pnevmocistična pljučnica, diseminirana histoplazmoza, listerioza in aspergiloza.
If a patient receiving Trudexa shows prolonged/ atypical symptoms/ signs of infections or general deterioration, prevalent opportunistic conditions must be considered.
Če se pri bolniku, ki dobiva Trudexo, pojavijo dolgotrajni oz. atipični simptomi ali znaki okužbe ali pa vo splošno poslabšanje, je treba pomisliti na prevalentne oportunistične bolezni.
Hepatitis B Reactivation t uc
Reaktivacija hepatitisa B do
Patients at risk for HBV rod
Bolnike, ki jih ogroža okužba s HBV, je treba pred začetkom zdravljenja s Trudexo oceniti glede znakov okužbe s eā
Adequate data of treating patients who are carriers of HBV with anti-viral therapy in lP
O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za av
conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
preprečitev reaktivacije HBV ni zadostnih podatkov.
In patients who develop HBV reactivation, Trudexa should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. na
Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo Trudexe prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem. nim
TNF-antagonists including Trudexa have been associated in rare cases with new onset or exacerbation i dic
Antagonisti tumorje nekrotizirajočega faktorja (TNF), s Trudexo vred, so bili v redkih primerih povezani s pojavom ali poslabšanjem kliničnih simptomov in/ ali rentgenoloških znakov demielinizirajoče bolezni.
Non-serious allergic reactions associated with Trudexa were uncommon during clinical trials.
S Trudexo povezane alergijske reakcije, ki niso bile resne, so se v kliničnih raziskavah Zd
68 reaction occurs, administration of Trudexa should be discontinued immediately and appropriate therapy initiated.
68 Pokrovček igle na brizgi vsebuje naravno gumo (lateks).
ed Immunosuppression
Imunosupresija
ris evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-and B cells and NK-cells, monocyte/ macrophages, and neutrophils.
me celic T in B, naravnih celic ubijalk, monocitov/ makrofagov ali nevtrofilcev.
tho Malignancies and lymphoproliferative disorders
Malignomi in limfoproliferativne bolezni
In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including
pro V kontroliranih delih kliničnih preizkušanj z zaviralci TNF je bilo opaženih več primerov malignomov, vključno z limfomi, tako pri bolnikih, ki so prejemali zaviralec TNF, kot pri kontrolnih bolnikih.
Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation.
Poleg tega je pri bolnikih z revmatoidnim artritisom z dolgotrajno, zelo aktivno vnetno boleznijo zvečano osnovno tveganje za limfome, kar komplicira
r development of lymphomas or other malignancies in patients treated with a TNF-antagonist cannot be
S sedanjim znanjem možnega tveganja za razvoj limfomov ali drugih malignomov pri bolnikih, zdravljenih z zaviralcem TNF, ni mogoče izključiti.
ge excluded.
Študij, ki bi vključevale bolnike z anamnezo malignoma ali v katerih bi nadaljevali zdravljenje pri
No studies have been conducted that include patients with a history of malignancy or that continue lon treatment in patients who develop malignancy while receiving Trudexa.
nja bolnikih, ki so razvili malignom med prejemanjem Trudexe, ni bilo.
Thus additional caution should be exercised in considering Trudexa treatment of these patients (see section 4.8).
Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju s Trudexo pri teh bolnikih (glejte poglavje 4. 8).
with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
lje V eksploracijskem kliničnem preskušanju infliksimaba, drugega zdravila proti TNF, pri bolnikih z zmerno do hudo kronično obstruktivno pljučno boleznijo (KOPB), so med prejemniki infliksimaba zabeležili več malignomov, večinoma pljuč ali glave in vratu, kot med primerjalnimi bolniki.
Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to t
Zato je treba pri bolnikih s KOPB in bolnikih, ki jih zaradi hudega kajenja bolj ogroža malignom, vsak antagonist TNF uporabljati previdno. do
Haematologic reactions rod
Hematološke reakcije
All patients should lP
Med uporabo Trudexe so redko poročali o neželenih učinkih na hematološki sistem, vključno eā
be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e. g. persistent fever, bruising, bleeding, pallor) while on Trudexa.
z medicinsko pomembno citopenijo (npr. trombocitopenijo, levkopenijo).
Discontinuation of Trudexa therapy should be considered in patients with confirmed significant haematologic abnormalities. na
Pri av
Vaccinations Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent i dic
bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije s Trudexo.
Patients on Trudexa may receive concurrent vaccinations, except for live vaccines.
Bolniki, ki prejemajo Trudexo, lahko sočasno dobijo cepiva, razen ilo
Me
živih cepiv. rav
Trudexa is contraindicated in moderate to severe
Pri bolnikih z blagim srčnim popuščanjem (razred I/ II po NYHA) je treba Trudexo uporabljati previdno.
69 heart failure (see section 4.3).
Pri bolnikih z zmernim ali hudim srčnim popuščanjem je Trudexa kontraindicirana (glejte poglavje 4. 3).
Treatment with Trudexa may result in the formation of autoimmune antibodies.
69 Zdravljenje s Trudexo lahko povzroči nastanek avtoimunskih protiteles.
ed term treatment with Trudexa on the development of autoimmune diseases is unknown.
Vpliv dolgoročnega zdravljenja s Trudexo na nastanek avtoimunskih bolezni ni znan.
tho Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-antagonist, etanercept, with no added clinical benefit compared to etanercept alone.
V kliničnih študijah s sočasno uporabo anakinre in etanercepta, drugega antagonista TNF, so opazili hude okužbe brez dodatnih kliničnih prednosti v primerjavi z etanerceptom samim.
Because of the nature of the adverse events seen with the combination of etanercept and anakinra therapy, similar
Glede na naravo
au toxicities may also result from the combination of anakinra and other TNF-antagonists.
pro neželenih dogodkov, opaženih pri kombiniranem zdravljenju z etanerceptom in anakinro, lahko podobne toksičnosti nastanejo tudi pri uporabi anakinre in drugih antagonistov TNF.
r ge There is limited safety experience of surgical procedures in patients treated with Trudexa.
za Izkušnje z varnostjo operacij pri bolnikih, zdravljenih s Trudexo, so omejene.
A patient who requires surgery while on Trudexa should be closely monitored for infections, and lon appropriate actions should be taken.
Bolnika, ki med zdravljenjem s Trudexo potrebuje operacijo, je treba natančno nadzirati glede okužb in ustrezno ukrepati.
There is limited safety experience in patients undergoing arthroplasty while receiving Trudexa.
Izkušnje z varnostjo
Small bowel obstruction no
nja pri bolnikih, ki so jim med zdravljenjem s Trudexo opravili artroplastiko, so omejene.
Available data suggest that Trudexa does not worsen or cause strictures. t uc
Razpoložljivi podatki kažejo, da vo Trudexa ne poslabša in ne povzroči striktur.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij do
Trudexa has been studied both in rheumatoid arthritis and psoriatic arthritis patients taking Trudexa as rod
Trudexo so raziskali tako pri bolnikih z revmatoidnim artritisom in psoriatičnim artritisom, ki so Trudexo jemali v monoterapiji, kot pri tistih, ki so jo jemali hkrati z metotreksatom.
Administration of Trudexa without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1). lP
Uporaba Trudexe brez metotreksata je zvečala nastajanje protiteles, zvečala očistek in zmanjšala učinkovitost adalimumaba (glejte poglavje 5. 1). av
4.6 Pregnancy and lactation na
4. 6 Nosečnost in dojenje
Preclinical data on postnatal toxicity and fertility effects of dic
V raziskavi razvojne toksičnosti pri opicah ni bilo znakov maternalne toksičnosti, embriotoksičnosti ali teratogenosti.
adalimumab are not available (see section 5.3).
Predkliničnih podatkov o poporodni toksičnosti adalimumaba in njegovih učinkih na plodnost ni (glejte poglavje 5. 3). ilo
Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal Me
Ker adalimumab zavira TNFα, bi njegova uporaba med nosečnostjo lahko okrnila normalne imunske odzive novorojenčka.
immune responses in the newborn.
Uporaba adalimumaba med nosečnostjo ni priporočljiva.
Administration of adalimumab is not recommended during pregnancy.
Ženske v rodni dobi morajo za preprečitev nosečnosti uporabljati ustrezno kontracepcijsko zaščito in z njo nadaljevati vsaj rav
Women of childbearing potential are strongly recommended to use adequate contraception to prevent pregnancy and continue its use for at least five months after the last Trudexa treatment.
še pet mesecev po zadnjem zdravljenju s Trudexo.