natgillin/translations-raw huggingface dataset:
For all of the above indications, available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Dosegljivi podatki za vse navedene indikacije kažejo, da se klinični odziv ponavadi pojavi v 12 tednih zdravljenja.
Puerto Rico 00617
Puerto Rico 00617 ZDA
The marketing authorisation holder should submit 6 monthly periodic safety update reports.
Imetnik dovoljenja za promet z zdravilom mora predložiti periodično poročilo o varnosti zdravila vsakih 6 mesecev.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the pharmacovigilance plan.
Imetnik dovoljenja za promet se zavezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, ki so opredeljene v farmakovigilančnem načrtu.
• You should be screened for tuberculosis.
• Opraviti morate presejalne preiskave za tuberkulozo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 1 September 2003
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET 1. september 2003
Since Trudexa is given subcutaneously, food and drink should not affect Trudexa.
Ker se Trudexa uporablja subkutano, hrana in pijača naj ne bi vplivali na Trudexo.
Do NOT remove the grey stopper or aluminium ring around the top of the vial.
NE ODSTRANITE sivega zamaška ali aluminijastega obročka na vrhu viale.
Therefore, the combination of adalimumab and anakinra is not recommended.
Zato kombinacija adalimumaba in anakinre ni priporočena.
After cleaning, do not touch the stopper with your hands.
Po očiščenju se zamaška ne dotikajte več z rokami.
Trudexa in combination with methotrexate, is indicated for:
Trudexa je v kombinaciji z metotreksatom indicirana za:
Trudexa increases the risk of getting infections.
Trudexa zvečuje tveganje za okužbe.
• sensation of heart beating rapidly, high blood pressure;
• občutek hitrega bitja srca, visok krvni pritisk;
• allergic reactions;
• alergijske reakcije;
Monoclonal antibodies are proteins that recognise and bind to other unique proteins.
Monoklonska protitelesa so beljakovine, ki prepoznajo druge specifične beljakovine in se nanje vežejo.
Patients who have a known sensitivity to latex should be advised to avoid touching the inner shield.
Bolnikom z znano občutljivostjo za lateks je treba naročiti, da se ne smejo dotikati notranjega ščitnika.
There are two caps - one is grey and labelled ‘1' and the other is plum and labelled ‘2'.
Nameščena ima dva pokrovčka - eden je siv in označen z '1', drugi pa temnomoder in označen z '2'.
Tell your doctor immediately if you notice any of the following:
Svojemu zdravniku takoj povejte, če opazite kaj od naslednjega:
Using Trudexa with food and drink
Uporaba zdravila Trudexa skupaj s hrano in pijačo
• Show this card to any doctor involved in your treatment.
• To izkaznico pokažite vsakemu zdravniku, ki vas zdravi.
Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 79% of patients continued to receive at least one of these medications.
Dovoljena je bila sočasna uporaba stabilnih odmerkov aminosalicilatov, kortikosteroidov in/ali imunomodulacijskih zdravil; 79% bolnikov je še naprej prejemalo vsaj eno od takšnih zdravil.
If you use more Trudexa than you should:
Če ste uporabili večji odmerek Trudexe, kot bi smeli
• In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding.
• Pri nekaterih bolnikih telo ne ustvari dovolj krvnih celic, ki pomagajo pri premagovanju okužbe ali ustavitvi krvavitve.
In addition, ACR response rates were maintained in the majority of patients followed in the open-label extension phase to week 104.
Poleg tega se je delež odziva po ACR ohranil pri večini bolnikov, ki so jih med odprto nadaljevalno fazo spremljali do 104. tedna.
Trudexa was studied in 5293 patients in controlled and open label trials for up to 60 months.
Trudexo so raziskali pri 5293 bolnikih v kontroliranih in odprtih preskušanjih, ki so trajala do 60 mesecev.
• Keep this card with you for 5 months after the last Trudexa dose, since side effects may occur a long time after your last dose of Trudexa.
• To izkaznico imejte pri sebi še 5 mesecev po zadnjem odmerku Trudexe, kajti neželeni učinki se lahko pojavijo še dolgo časa po zadnjem odmerku tega zdravila.
The effects of Trudexa in pregnant women are not known and so the use of Trudexa in pregnant women is not recommended.
Vplivi Trudexe pri nosečnicah niso znani, zato uporaba tega zdravila pri nosečih ženskah ni priporočljiva.
Maintenance of clinical remission was evaluated in CHARM.
Vzdrževanje klinične remisije je ocenjevala študija CHARM.
• anxiety, depression, feeling sleepy and difficulty sleeping;
• tesnobnost, depresija, zaspanost in težave s spanjem;
Hepatitis B Reactivation
Reaktivacija hepatitisa B
It is a medicine that decreases the inflammation process of these diseases.
Je zdravilo, ki ublaži vnetno dogajanje pri teh boleznih.
• If you have a severe infection, including active tuberculosis (see “Take special care with Trudexa”).
• če imate hudo okužbo, vključno z aktivno tuberkulozo (glejte "Bodite posebno pozorni pri uporabi Trudexe").
In all studies (I-VII), patients with raised ALT were asymptomatic and in most cases elevations were transient and resolved on continued treatment.
V vseh študijah (I-VII) so bili bolniki, ki so imeli zvišano ALT, asimptomatski; zvišanje je bilo večinoma prehodno in je med nadaljevanjem zdravljenja minilo.
Clinical remission results remained relatively constant irrespective of previous TNF antagonist exposure.
Rezultati glede klinične remisije so ostali razmeroma stalni, ne glede na prejšnje prejemanje antagonistov TNF.
ACR responses in Study VI were similar with and without concomitant methotrexate therapy.
Odzivi ACR v študiji VI so bili podobni ob sočasni terapiji z metotreksatom in brez nje.
• tuberculosis and other opportunistic infections (infections that occur when resistance to disease is lowered);
• tuberkuloza in druge oportunistične okužbe (okužbe, ki se pojavijo, kadar se zmanjša odpornost proti boleznim);
Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.
Nato uporabite naslednji odmerek, kot bi ga uporabili po prvotnem urniku, če ne bi pozabili odmerka.
Improvement in quality of life was measured up to week 156 (36 months) and improvement was maintained through that time.
Izboljšanje kvalitete življenja se je ocenjevalo do 156. tedna (36. meseca).
• Pull the needle completely out of the vial.
• Iglo popolnoma potegnite iz viale.
It is important to tell your doctor if you have had or have a serious heart condition (see “Take special care with Trudexa”).
Pomembno je, da zdravniku poveste, če ste imeli ali imate kakšno resno bolezen srca (glejte "Bodite posebno pozorni pri uporabi Trudexe").
Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku (2 °C - 8 °C) .
Trudexa is injected under the skin (subcutaneous use).
Trudexa se injicira pod kožo (subkutana uporaba).
Appropriate screening tests, i.e. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Pri vseh bolnikih je treba narediti ustrezne presejalne preiskave, tj. tuberkulinski kožni test in rentgensko slikanje prsnih organov (veljajo lahko lokalna priporočila).
The highest dose level evaluated has been multiple intravenous doses of 10 mg/kg.
Največji ocenjeni odmerek je obsegal večkratno intravensko aplikacijo 10 mg/kg.
Place the white end of the pre-filled pen at a right angle (90 degrees) to the skin, so that you can see the window.
Namestite beli konec napolnjenega injekcijskega peresnika pravokotno (90 stopinj) na kožo, tako da boste videli okence.
Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CLASSIC I and GAIN.
Indukcijo klinične remisije (opredeljene kot CDAI < 150) so ocenili v dveh študijah, CLASSIC I in GAIN.
Before initiation of therapy with Trudexa, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
Pred začetkom zdravljenja s Trudexo je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
• Severe rash, hives or other signs of allergic reaction;
• hud izpuščaj, koprivnico ali druge znake alergijske reakcije;
The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg subcutaneous dose was 64%.
Povprečna absolutna biološka uporabnost adalimumaba, ocenjena iz treh raziskav po enem 40 mg odmerku subkutano, je 64%.
• The Trudexa syringe should NEVER be reused.
• Brizge s Trudexo NIKDAR ne smete ponovno uporabiti.
It is not known whether adalimumab passes into breast milk.
Ni znano, ali se adalimumab izloča v materinem mleku.
If you forget to give yourself an injection, you should inject the next dose of Trudexa as soon as you remember.
Če si pozabite dati injekcijo, si morate naslednji odmerek Trudexe injicirati, čim se spomnite.
Trudexa has not been studied in these patient populations.
Trudexa pri teh populacijah bolnikov še ni bila preskušena.
Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-10 M).
Adalimumab modulira tudi biološke odzive, ki jih sproži ali uravnava TNF, vključno s spremembami koncentracije adhezijskih molekul, odgovornih za migracijo levkocitov (ELAM-1, VCAM-1 in ICAM-1 z IK50 1-2 x 10-10 M).
If you take Trudexa your risk may increase.
Če jemljete Trudexo, se ta verjetnost poveča.
This evaluation should include a detailed medical history with a personal history of tuberculosis or possible previous exposure to patients with active tuberculosis and previous and/or current immunosuppressive therapy.
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.
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).
• Feeling weak or tired;
• občutek šibkosti ali utrujenosti;
If you accidentally inject Trudexa more frequently than told to by your doctor, you should call your doctor and tell him/her that you have taken more.
Če pomotoma injicirate Trudexo pogosteje, kot vam je naročil zdravnik, se morate posvetovati z njim in mu povedati, da ste uporabili večji odmerek.
Adalimumab concentrations in the synovial fluid from several 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.
After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 ml/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase halflife was approximately two weeks.
Po odmerkih 0,5 mg/kg (~40 mg) je bil očistek od 11 do 15 ml/uro, volumen distribucije (Vss) od 5 do 6 litrov in povprečni razpolovni čas terminalne faze približno dva tedna.
NA NA 9.5% 41.5%
NP 9,5% 41,5%
Adalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.
Adalimumab se specifično veže na TNF in nevtralizira njegovo biološko delovanje, ker zavre njegovo interakcijo z receptorji p55 in p75 za TNF na površini celic.
Of those in clinical response at week 4, 48% had been previously exposed to other anti-TNF therapy.
Od tistih, ki so imeli 4. teden klinični odziv, jih je 48% predhodno dobilo drugo terapijo proti TNF.
• Use a new alcohol pad to clean the grey stopper on the vial.
• Uporabite nov alkoholni zloženec in z njim očistite sivi zamašek viale.
Similar trends (not all statistically significant) were seen in the smaller randomised, double − blind, placebo controlled study (IX) of 82 adult patients with active ankylosing spondylitis.
Podobni trendi (ki pa niso bili vsi statistično značilni) so bili opazni v manjši, randomizirani, dvojno slepi, s placebom kontrolirani študiji (IX) pri 82 odraslih bolnikih z aktivnim ankilozirajočim spondilitisom.
If your doctor determines that methotrexate is inappropriate, Trudexa can be given alone.
Če vaš zdravnik ugotovi, da metotreksat ni primeren, lahko Trudexo dobivate samo.
• Only use each pre-filled pen for one injection.
• Vsak napolnjeni injekcijski peresnik uporabite le za eno injiciranje.
The primary endpoint in Study V was the percent of patients who achieved an ACR 50 response at week 52.
Primarna končna točka študije V je bil odstotek bolnikov, ki so do 52. tedna dosegli odziv ACR 50.
• Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV. Trudexa can cause reactivation of
• Zdravniku morate povedati, če ste nosilec virusa hepatitisa B (HBV), če imate aktiven HBV ali če mislite, da bi se lahko nalezli HBV. Trudexa lahko pri nosilcih HBV povzroči reaktivacijo tega virusa.
PATIENT ALERT CARD TEXT (NOT INCLUDED IN PACK OR AS PART OF THE PACKAGE LEAFLET)
BESEDILO BOLNIKOVE OPOZORILNE IZKAZNICE (ni priložena pakiranju ali navodiliu za uporabo)
Side effects may occur at least up to 5 months after the last treatment.
Neželeni učinki se lahko pojavijo vsaj še 5 mesecev po zadnjem odmerku.
The efficacy and safety of Trudexa for the treatment of rheumatoid arthritis were assessed in five randomised, double-blind and well-controlled studies.
Učinkovitost in varnost Trudexe za zdravljenje revmatoidnega artritisa so ocenili v petih randomiziranih, dvojno slepih in dobro kontroliranih študijah.
Pull the plum safety cap (labelled ‘2') straight off to expose the plum coloured activation button at the top.
Snemite temnomodri varnostni pokrovček (označen z '2') naravnost dol, da se bo pokazal temnomodri sprožilni gumb na vrhu.
Please record the dates of the last screening for tuberculosis below: Tuberculin test: _______________ Chest X-ray:
Spodaj zabeležite datume zadnjih presejalnih preiskav za tuberkulozo: Tuberkulinski test: Rentgenogram prsnih organov: ____________
In CHARM, at week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
V študiji CHARM je imelo 4. teden klinični odziv 58% (499/854) bolnikov; ti so bili ocenjeni v primarni analizi.
If you have ankylosing spondylitis you will first be given other medicines.
Če imate ankilozirajoči spondilitis, boste najprej dobili druga zdravila.
Study VII
Študija VII
Check that the needle is below the surface of the solution.
Preverite, da je igla pod površino raztopine.
THE MARKETING AUTHORISATION HOLDER Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Depending on your response, your doctor may increase the dose to 40 mg every week.
Odvisno od vašega odziva lahko zdravnik poveča odmerek na 40 mg vsak drugi teden.
WHAT TRUDEXA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO TRUDEXA IN ZA KAJ GA UPORABLJAMO
In Study III, improvement in physical function was maintained through week 260 (60 months) of open-label treatment.
V študiji III se je izboljšanje telesne funkcije ohranilo vseskozi do 206. tedna (60. meseca) odprte faze zdravljenja.
• As cases of tuberculosis have been reported in patients treated with Trudexa, your doctor will check you for signs and symptoms of tuberculosis before starting Trudexa.
• Ker so bili pri bolnikih, zdravljenih s Trudexo, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja s Trudexo preiskal glede znakov in simptomov tuberkuloze.
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.
Table 8 - Efficacy Responses in Placebo-Controlled AS Study - Study VIII Reduction of Signs and Symptoms
Tabela 8 - Odzivi učinkovitosti v študiji AS, kontrolirani s placebom - študija VIII Zmanjšanje znakov in simptomov
If latent tuberculosis is diagnosed, appropriate anti-tuberculosis prophylaxis in accordance with local recommendations must be initiated before starting treatment with Trudexa.
Če se odkrije latentna tuberkuloza, je treba pred začetkom zdravljenja s Trudexo uvesti ustrezno protituberkulozno profilakso v skladu z lokalnimi priporočili.
• anaemia, low white blood cell counts;
• anemija, zmanjšanje števila belih krvnih celic;
• Never put the pre-filled pens that you have used into your normal household rubbish bin.
• Odrabljenih napolnjenih injekcijskih peresnikov nikdar ne zavrzite med običajne gospodinjske odpadke.
Maintenance of remission and response rates are presented in Table 10.
Vzdrževanje remisije in deleže odziva prikazuje tabela 10.
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.
This will include a thorough medical history, a chest X-ray and a tuberculin test.
To bo vključevalo natančno poizvedbo o vašem zdravju v preteklosti, rentgensko slikanje prsnih organov in tuberkulinski test.
It is not known whether adalimumab is excreted in human milk or absorbed systemically after ingestion.
Ni znano, ali se adalimumab izloča v materinem mleku in ali se po zaužitju sistemsko absorbira.
When you do this, if you accidentally push some solution back into the vial, pull slowly back in the plunger to draw the entire contents of the vial back into the syringe.
Če pri tem nazaj v vialo potisnete nekaj raztopine, bat počasi potegnite nazaj, da boste celotno vsebino viale dobili nazaj v brizgo.
The impact of longterm treatment with Trudexa on the development of autoimmune diseases is unknown.
Vpliv dolgoročnega zdravljenja s Trudexo na nastanek avtoimunskih bolezni ni znan.
NA NA 24.0% 58.9%
NP 24,0% 58,9%
Trudexa should not affect your ability to drive or use machinery.
Trudexa naj ne bi vplivala na vašo sposobnost upravljanja vozil in strojev.
For Trudexa, no clinical data on exposed pregnancies are available
Za Trudexo ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
The primary end point in Studies I, II and III and the secondary endpoint in Study IV was the percent of patients who achieved an ACR 20 response at week 24 or 26.
Primarna končna točka v raziskavah I, II in III ter sekundarna končna točka v raziskavi IV je bil odstotek bolnikov, ki so po 24 oz. 26 tednih dosegli odziv 20 po ACR.
Usually, Trudexa is used with methotrexate.
Trudexo ponavadi uporabljamo z metotreksatom.
Study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Raziskava IV je v prvi vrsti ocenila varnost pri 636 bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let.
With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
S sedanjim znanjem možnega tveganja za razvoj limfomov ali drugih malignomov pri bolnikih, zdravljenih z zaviralcem TNF, ni mogoče izključiti.
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).
Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section
Aktivna tuberkuloza ali druge hude okužbe, npr. sepsa, in oportunistične okužbe (glejte poglavje 4.4).
• urinary disturbances (such as blood in urine, increased urinary frequency);
• motnje na sečilih (npr. kri v urinu, pogostejše uriniranje);
Patients in Studies I, II and III were tested at multiple timepoints for antibodies to adalimumab during the 6 to 12 month period.
Pri bolnikih v študijah I, II in III so v obdobju od 6 do 12 mesecev ob različnih časih večkrat določali protitelesa proti adalimumabu.
Among those, 66 patients showed no progression of structural damage defined by a change in the TSS of zero or less.
Med temi bolniki jih 66 ni kazalo napredovanja strukturne prizadetosi izražene s spremembo celotne Sharpove ocene 0 ali manj.
In Study V, structural joint damage was assessed radiographically and expressed as change in modified total Sharp score (see Table 6).
V študiji V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte tabelo 6).
• Shortness of breath with exertion or upon lying down or swelling of the feet;
• težko dihanje ob naporu ali med ležanjem ali otekanje nog;
• increased menstrual bleeding;
• močnejše menstruacijske krvavitve;
Administration of Trudexa without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1).
Uporaba Trudexe brez metotreksata je zvečala nastajanje protiteles, zvečala očistek in zmanjšala učinkovitost adalimumaba (glejte poglavje 5.1).
If you forget to take Trudexa:
Če ste pozabili vzeti Trudexo
Rare hearing loss
redki izguba sluha
In patients who develop HBV reactivation, Trudexa should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo Trudexe prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
There is a window on each side of the pen through which you can see the Trudexa solution inside the syringe.
Na obeh straneh peresnika je okence; skozi okenci lahko vidite raztopino Trudexa v notranjosti brizge.
If you do not respond well enough to these medicines, you will be given Trudexa to reduce the signs and symptoms of your disease.
Če se nanje ne boste odzvali dovolj dobro, boste za zmanjšanje znakov in simptomov bolezni dobili Trudexo.
Table 5: Radiographic Mean Changes Over 12 Months in Study III
Tabela 5: Povprečne rentgenografske spremembe v 12 mesecih raziskave III
SPECIAL STORAGE CONDITIONS Store in a refrigerator.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku .
The safety and efficacy of Trudexa were assessed in over 1400 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Varnost in učinkovitost Trudexe so ocenili pri več kot 1400 bolnikih z zmerno do hudo, aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
Important information about some of the ingredients of Trudexa This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Pomembne informacije o nekaterih sestavinah zdravila Trudexa To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) v odmerku, kar pomeni, da je količina zanemarljiva.
This alert card contains important safety information that you need to be aware of before you are given Trudexa and during treatment with Trudexa.
Ta opozorilna izkaznica vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete Trudexo in med zdravljenjem z njo.
Trudexa is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
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.