natgillin/translations-raw huggingface dataset:
For induction treatment, Trudexa should be given in combination with cortiocosteroids.
2 Za indukcijsko zdravljenje morate Trudexo uporabiti v kombinaciji s kortikosteroidi.
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 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.
t me Zdravljenje s Trudexo mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju revmatoidnega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa ali Crohnove bolezni.
ed 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.
ris 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).
tho Adults
za Odrasli
au 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.
nja Priporočeni odmerek Trudexe za odrasle bolnike z revmatoidnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
Methotrexate should be continued during treatment with Trudexa.
Med zdravljenjem s Trudexo je treba še lje naprej uporabljati metotreksat.
r Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued
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. 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 zmanjša, koristi zvečanje odmerka adalimumaba na 40 mg vsak teden.
Psoriatic arthritis and ankylosing spondylitis no
Psoriatični arthritis 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
Priporočen odmerek Trudexe pri bolnikih s psoriatičnim artritisom ali ankilozirajočim spondilitisom je 40 mg adalimumaba, apliciran v enkratni subkutani injekciji vsak drugi teden. av
within 12 weeks of treatment.
Dosegljivi podatki za vse navedene indikacije kažejo, da se klinični odziv ponavadi pojavi v 12 tednih zdravljenja.
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 nim
The recommended Trudexa induction dose regimen for adult patients with severe Crohn’ s disease is lP
Priporočena shema odmerjanja Trudexe med indukcijo je pri odraslih bolnikih s hudo Crohnovo boleznijo 80 mg 0. teden in nato 40 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 rav
Alternatively, if a patient has stopped Trudexa and signs and symptoms of disease recur, i dic
Če bolnik neha uporabljati Trudexo, pa se znaki in simptomi bolezni ponovijo, je mogoče Trudexo znova Zd
Trudexa may be re-administered.
uvesti.
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice Me
Med vzdrževalnim zdravljenjem, je mogoče kortikosteroide postopoma zmanjšati v skladu s smernicami za klinično prakso.
3 Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12.
3 Nekaterim bolnikom, ki se ne odzovejo do 4. tedna, lahko koristi nadaljnje vzdrževalno zdravljenje do 12. tedna.
ed No dose adjustment is required.
t me Prilagoditev odmerka ni potrebna.
ris There is no experience in children.
pro Izkušenj pri otrocih ni.
tho Impaired renal and/ or hepatic function
Okvarjeno delovanje ledvic in/ ali jeter
No dose recommendations can be made.
za Trudexa pri teh populacijah bolnikov še ni bila preskušena, zato priporočil za odmerjanje ni mogoče dati.
au 4.3 Contraindications
4. 3 Kontraindikacije
Hypersensitivity to the active substance or to any of the excipients.
nja Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
r Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section
lje 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
Zmerno do hudo srčno popuščanje (razred III/ IV po NYHA) (glejte poglavje 4. 4). vo 4. 4 Posebna opozorila in previdnostni ukrepi do
Infections no
Okužbe
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 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 av
Patients who develop a new infection while undergoing treatment with Trudexa should be monitored closely.
lokaliziranimi, dokler te niso obvladane.
Administration of Trudexa should be discontinued if a patient develops a new serious infection until infections are controlled.
Bolnike, pri katerih se med zdravljenjem s Trudexo pojavi nova okužba, je treba natančno nadzirati. nim
predispose patients to infections, including the use of concomitant immunosuppressive medications.
Pri odločanju za uporabo Trudexe je potrebna previdnost pri bolnikih z anamnezo 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 ilo
been reported with Trudexa.
okužbe, tudi s smrtnimi primeri. rav
Serious infections: i dic
Resne okužbe:
Of particular importance are infections such as pneumonia, pyelonephritis, septic arthritis and septicaemia.
Posebno pomembne okužbe so npr. pljučnica, Zd
Me
pielonefritis, septični artritis in septikemija.
4 Before initiation of therapy with Trudexa, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
4 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 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.
Appropriate screening tests, i. e. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
t (veljajo lahko lokalna priporočila).
Prescribers
Izvedbo teh preiskav je priporočljivo vpisati v bolnikovo
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 tuberkulinskega kožnega testa, zlasti pri hudo bolnih ali imunsko oslabelih bolnikih.
ris 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).
tho recommendations must be initiated before starting treatment with Trudexa.
pro Če se odkrije latentna tuberkuloza, je treba pred začetkom zdravljenja s Trudexo uvesti ustrezno protituberkulozno profilakso v skladu z lokalnimi priporočili.
In this situation, the 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.
au wasting/ weight loss, low grade fever) suggestive of a tuberculosis infection occur during or after therapy with Trudexa.
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 Other opportunistic infections:
nja Druge oportunistične okužbe:
ge There have been reports of serious and severe opportunistic infections associated with Trudexa therapy, for example pneumocystis carinii pneumonia, disseminated histoplasmosis, listeriosis and lon aspergillosis.
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. no
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
Reaktivacija hepatitisa B do
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.
Some cases have had fatal outcome.
Nekaj primerov se je končalo s smrtjo.
Patients at risk for HBV t uc
Bolnike, ki jih ogroža okužba s HBV, je treba pred začetkom zdravljenja s Trudexo oceniti glede znakov okužbe s eā
infection should be evaluated for prior evidence of HBV infection before initiating Trudexa therapy.
HBV v preteklosti.
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 rod
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.
Adequate data of treating patients who are carriers of HBV with anti-viral therapy in 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. lP
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 na
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.
of clinical symptoms and/ or radiographic evidence of demyelinating disease.
nedavno nastalimi demielinizirajočimi boleznimi osrednjega živčevja je potrebna previdnost. rav
Serious allergic adverse reactions have not been reported with subcutaneous administration of Trudexa Me
S Trudexo povezane alergijske reakcije, ki niso bile resne, so se v kliničnih raziskavah Zd
during clinical trials.
pojavljale občasno.
5 The needle cover of the syringe contains natural rubber (latex).
5 Pokrovček igle na brizgi vsebuje naravno gumo (lateks).
In a study of 64 patients with rheumatoid arthritis that were treated with Trudexa, there was no
V raziskavi 64 bolnikov z revmatoidnim artritisom, zdravljenih s Trudexo, niso odkrili znakov zavrtja
ed 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.
ris Malignancies and lymphoproliferative disorders
Malignomi in limfoproliferativne bolezni
tho In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
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
Poleg tega je pri bolnikih z revmatoidnim artritisom z dolgotrajno, zelo aktivno vnetno boleznijo zvečano osnovno tveganje za limfome, kar komplicira
au disease, which complicates the risk estimation.
za oceno tveganja.
r No studies have been conducted that include patients with a history of malignancy or that continue
Študij, ki bi vključevale bolnike z anamnezo malignoma ali v katerih bi nadaljevali zdravljenje pri
ge 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). lon In an exploratory clinical trial evaluating the use of another anti-TNF agent, infliximab, in patients 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.
V eksploracijskem kliničnem preskušanju infliksimaba, drugega zdravila proti TNF, pri bolnikih z lje 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.
All patients had a history of heavy smoking.
Vsi vo bolniki so imeli anamnezo hudega kajenja.
TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.
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 t uc
Hematološke reakcije
Adverse events of the haematologic system, including medically significant cytopoenia (e. g. rod
Med uporabo Trudexe so redko poročali o neželenih učinkih na hematološki sistem, vključno eā
thrombocytopaenia, leucopaenia) have been infrequently reported with Trudexa.
z medicinsko pomembno citopenijo (npr. trombocitopenijo, levkopenijo).
All patients should 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.
Pri av
Discontinuation of Trudexa therapy should be considered in patients with confirmed significant haematologic lP
bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije s Trudexo.
abnormalities.
Cepljenja nim
virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
V študiji 226 odraslih preiskovancev z revmatoidnim artritisom, ki so dobivali adalimumab ali placebo, so ugotovili podobne odzive protiteles na standardno 23- valentno pnevmokokno cepivo in trivalentno virusno cepivo proti influenci.
Patients on Trudexa may receive concurrent i dic
Bolniki, ki prejemajo Trudexo, lahko sočasno dobijo cepiva, razen ilo
vaccinations, except for live vaccines.
živih cepiv.
Congestive heart failure Me
Kongestivno srčno popuščanje rav
In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
O primerih poslabšanja Zd
Cases of worsening congestive heart failure have also been reported in patients receiving Trudexa.
kongestivnega srčnega popuščanja so poročali tudi pri bolnikih, ki so prejemali Trudexo.
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.
Trudexa is contraindicated in moderate to severe heart failure (see section 4.3).
Pri bolnikih z zmernim do hudim srčnim popuščanjem je Trudexa kontraindicirana (glejte poglavje 4. 3).
6 Autoimmune processes
6 Zdravljenje s Trudexo lahko povzroči nastanek avtoimunskih protiteles.
Treatment with Trudexa may result in the formation of autoimmune antibodies.
Vpliv dolgoročnega zdravljenja s Trudexo na nastanek avtoimunskih bolezni ni znan.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Trudexa and is positive for antibodies against double-stranded DNA, further treatment with Trudexa should not be
Če se bolniku po zdravljenju s Trudexo pojavijo simptomi, ki nakazujejo lupusu podobni sindrom, in ima pozitivna protitelesa proti dvojnoverižni DNA, zdravljenja s Trudexo ne sme nadaljevati (glejte poglavje 4. 8).
Concurrent administration of TNF-antagonists and anakinra
t me Sočasna uporaba antagonistov TNF in anakinre
ris 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
Glede na naravo
tho the nature of the adverse events seen with the combination of etanercept and anakinra therapy, similar 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.
au Surgery
Operacije
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
Če je predviden kirurški poseg, je treba upoštevati dolgi razpolovni čas adalimumaba.
r patient who requires surgery while on Trudexa should be closely monitored for infections, and
Izkušnje z varnostjo
There is limited safety experience in patients undergoing arthroplasty while receiving Trudexa. lon Small bowel obstruction
nja pri bolnikih, ki so jim med zdravljenjem s Trudexo opravili artroplastiko, so omejene.
Failure to respond to treatment for Crohn’ s disease may indicate the presence of fixed fibrotic stricture that may require surgical treatment.
Zapora tankega črevesa lje Če se bolnik ne odzove na zdravljenje Crohnove bolezni, lahko to pomeni, da ima stalno fibrotično strikturo, zaradi katere utegne biti potrebno kirurško zdravljenje.
Available data suggest that Trudexa does not worsen or cause no
Razpoložljivi podatki kažejo, da vo Trudexa ne poslabša in ne povzroči striktur.
4.5 Interaction with other medicinal products and other forms of interaction t
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 uc
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.
Antibody formation was lower when Trudexa was given together with methotrexate in comparison with use as monotherapy.
Če je bila Trudexa uporabljena skupaj z metotreksatom, je bilo nastajanje protiteles v primerjavi z monoterapijo manjše. eā
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). av
4.6 Pregnancy and lactation lP
4. 6 Nosečnost in dojenje
For Trudexa, no clinical data on exposed pregnancies are available
Za Trudexo ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu. nim
In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, na
V raziskavi razvojne toksičnosti pri opicah ni bilo znakov maternalne toksičnosti, embriotoksičnosti ali teratogenosti.
Preclinical data on postnatal toxicity and fertility effects of adalimumab are not available (see section 5.3). i dic
Predkliničnih podatkov o poporodni toksičnosti adalimumaba in njegovih učinkih na plodnost ni (glejte poglavje 5. 3). ilo
Me
še pet mesecev po zadnjem zdravljenju s Trudexo.
Use during lactation
Uporaba med obdobjem dojenja Zd
7 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.
7 Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
ris Clinical Trials
Klinična preskušanja
These
t Trudexo so raziskali pri 5293 bolnikih v kontroliranih in odprtih preskušanjih, ki so trajala do
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 vključila 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 data in Table 1 is based on the controlled Studies (I− IX, CLASSIC I, GAIN AND CHARM) (described in section 5.1) involving 3271 patients receiving Trudexa and 1809 patients receiving placebo or active comparator
pro CLASSIC I, GAIN in CHARM) (opisanih v poglavju 5. 1), ki zajemajo 3271 bolnikov, ki so med kontroliranim obdobjem dobivali Trudexo, in 1809 bolnikov, ki so med tem obdobjem dobivali placebo ali primerjalno učinkovino.
au during the controlled period.
Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje med dvojno slepim, kontroliranim
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.