FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients in steroid-free remission for >=90 daysa * p < 0.001 for Trudexa versus placebo pairwise comparisons of proportions ** p < 0.02 for Trudexa versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
Slovenian: Bolniki v remisiji brez steroidov za ≥ 90 dnia * p < 0,001 za parne primerjave deležev med Trudexo in placebom ** p < 0,02 za parne primerjave deležev med Trudexo in placebom a Od tistih, ki so izhodiščno dobivali kortikosteroide.
English: If you are unsure, please contact your doctor.
Slovenian: Če niste gotovi, se posvetujte s svojim zdravnikom.
English: 80/40 mg N = 75
Slovenian: Trudexa 80/40 mg n = 75
English: Study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had insufficient efficacy to methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexateintolerant) every week and whose methotrexate dose remained constant at 12.5 to 25 mg every week.
Slovenian: Raziskava III je ocenila 619 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih metotreksat v odmerkih od 12,5 do 25 mg (10 mg, če so bili intolerantni za metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek metotreksata ostal stalen od 12,5 do 25 mg vsak teden.
English: A
Slovenian: in
English: In patients with early rheumatoid arthritis (disease duration of less than 3 years) (Study V), elevations of ALT were more common in the combination arm (Trudexa /methotrexate) compared to the methotrexate monotherapy arm or the Trudexa monotherapy arm.
Slovenian: Pri bolnikih z zgodnjim revmatoidnim artritisom (trajanje bolezni manj kot 3 leta) (študija V) so bila zvišanja ALT pogostejša v kraku, v katerem so uporabljali kombinacijo (Trudexa/metotreksat), kot v kraku, v katerem so uporabljali monoterapijo z metotreksatom, ali v kraku, v katerem so uporabljali monoterapijo s Trudexo.
English: In controlled and open label studies with Trudexa, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated histoplasmosis, pneumocystis carinii pneumonia, aspergillosis and listeriosis).
Slovenian: 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).
English: Each pack contains 1 pre-filled syringe with needleguard for hospital administration or administration by a caregiver, with 1 alcohol pad.
Slovenian: Eno pakiranje vsebuje 1 napolnjeno injekcijsko brizgo s ščitnikom za iglo za bolnišnično uporabo oz. uporabo zdravstvenih delavcev in 1 alkoholni zloženec.
English: 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.
Slovenian: 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.
English: Uncommon chest pain, oedema, influenza like illness
Slovenian: občasni bolečina v prsih, edemi, gripi podobna bolezen
English: Hepatobiliary Disorders reactivation of hepatitis B
Slovenian: Bolezni jeter, žolčnika in žolčevodov reaktiviranje hepatitisa B
English: • upper respiratory tract infections (including cold, runny nose, sinus infection);
Slovenian: • okužbe zgornjih dihal (vključno s prehladom, izcedkom iz nosu, okužbo obnosnih votlin);
English: During Trudexa treatment:
Slovenian: Med zdravljenjem s Trudexo:
English: Use during lactation
Slovenian: Uporaba med obdobjem dojenja
English: • Arm or leg weakness.
Slovenian: • šibkost rok ali nog.
English: In patients not given concomitant methotrexate, the incidence was 13.5% (24/178 subjects), compared to 7% (14 of 198 subjects) when adalimumab was used as add-on to methotrexate.
Slovenian: Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 13,5% (24/178 bolnikov), pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 7% (14 od 198 bolnikov).
English: Impaired renal and/or hepatic function
Slovenian: Okvarjeno delovanje ledvic in/ali jeter
English: In Study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with Trudexa and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and Trudexa monotherapy at week 52 and responses were sustained at week 104 (see Table 4).
Slovenian: V študiji V pri bolnikih z zgodnjim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija s Trudexo in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom ali monoterapija s Trudexo, odzivi pa so se ohranili do 104. tedna (glejte tabelo 4).
English: Neoplasms benign and malignant (including cysts and polyps)
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
English: Injecting Trudexa
Slovenian: Injiciranje Trudexe
English: Check the expiry date on the pre-filled pen label (EXP:).
Slovenian: Preverite datum izteka roka uporabnosti na peresniku (Uporabno do).
English: A loading dose of 160 mg Trudexa on week 0 followed by 80 mg Trudexa on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/ml during the induction period.
Slovenian: 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.
English: With your index finger or your thumb, press the plum coloured button on top once you are ready to begin the injection (see below).
Slovenian: Ko ste pripravljeni na začetek injiciranja (glejte spodaj), s palcem ali kazalcem enkrat pritisnite temnomodri gumb na vrhu.
English: Trudexa 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals.
Slovenian: Trudexa 40 mg raztopina za injiciranje v viali (steklo tipa I) za enkratno uporabo, opremljeni z gumijastim zamaškom, aluminijsko obrobo in dvižno zaporko.
English: • Signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness.
Slovenian: • znaki in simptomi, ki nakazujejo bolezni krvi, npr. trdovratna zvišana telesna temperatura, modrice, krvavitve, bledica.
English: You will then hear a ‘click' as the needle is released, and you will feel a small prick as the needle advances.
Slovenian: Ko se bo igla sprožila, boste zaslišali "klik", in ob njenem vbodu boste začutili droben bodljaj.
English: The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.
Slovenian: Pomožne snovi so manitol, citronska kislina monohidrat, natrijev citrat, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, natrijev klorid, polisorbat 80, natrijev hidroksid in voda za injekcije.
English: 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.
Slovenian: Med monoterapijo lahko nekaterim bolnikom, ki se jim odziv zmanjša, koristi zvečanje odmerka adalimumaba na 40 mg vsak teden.
English: The recommended Trudexa induction dose regimen for adult patients with severe Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Slovenian: Priporočena shema odmerjanja Trudexe med indukcijo je pri odraslih bolnikih s hudo Crohnovo boleznijo 80 mg 0. teden in nato 40 mg 2. teden.
English: Antibody formation was lower when Trudexa was given together with methotrexate in comparison with use as monotherapy.
Slovenian: Če je bila Trudexa uporabljena skupaj z metotreksatom, je bilo nastajanje protiteles v primerjavi z monoterapijo manjše.
English: The rate (95% confidence interval) of non-melanoma skin cancers was 7.6 (4.7, 12.4) per 1000 patient-years among Trudexa-treated patients and 2.0 (0.5, 8.2) per 1000 patient-years among control patients.
Slovenian: Delež (95% interval zaupanja) nemelanomskih kožnih rakov je bil 7,6 (4,7, 12,4) na 1000 bolnik-let med bolniki, ki so dobivali Trudexo, in 2,0 (0,5, 8,2) na 1000 bolnik-let med kontrolnimi bolniki.
English: The Trudexa vial is a glass vial containing a solution of adalimumab.
Slovenian: Viala s Trudexo je steklena viala, ki vsebuje raztopino adalimumaba.
English: Non-serious allergic reactions associated with Trudexa were uncommon during clinical trials.
Slovenian: S Trudexo povezane alergijske reakcije, ki niso bile resne, so se v kliničnih raziskavah pojavljale občasno.
English: • If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.
Slovenian: • Če se pri vas pojavijo simptomi, ki nakazujejo okužbo, npr. zvišanje telesne temperature, trdovraten kašelj, hujšanje ali brezvoljnost, takoj poiščite zdravniško pomoč.
English: • skin disorders (such as psoriasis, eczema or infections), itchy rash, slow wound healing;
Slovenian: • bolezni kože (npr. luskavica, ekcem ali okužbe), srbeč izpuščaj, počasno celjenje ran;
English: Again, do NOT touch the needle or let it touch any surface.
Slovenian: Tudi zdaj pazite, da se igle pri tem NE DOTAKNETE ali se z njo česa ne dotaknete.
English: You are advised to avoid becoming pregnant and must use adequate contraception while using Trudexa and for at least 5 months after the last Trudexa treatment.
Slovenian: Priporočljivo je, da ne zanosite, zato morate med zdravljenjem s Trudexo in vsaj še 5 mesecev po zadnjem odmerku uporabljati ustrezno kontracepcijsko zaščito.
English: The additional adverse reactions in Table 2 have been reported from postmarketing surveillance or Phase IV clinical trials:
Slovenian: O dodatnih neželenih reakcijah (ki jih prikazuje tabela 2) so poročali v postmarketinških nadzorih ali kliničnih preskušanjih IV. faze:
English: Abbott Laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom
Slovenian: Abbott Laboratories Ltd. Queenborough Kent ME11 5EL Velika Britanija
English: • See the Trudexa package leaflet for more information.
Slovenian: • Za podrobnejše informacije glejte navodilo za uporabo Trudexe.
English: What Trudexa contains
Slovenian: Kaj vsebuje zdravilo Trudexa
English: Uncommon systemic lupus erythematosus, angioedema, drug hypersensitivity, seasonal allergy
Slovenian: Bolezni imunskega sistema občasni sistemski eritematozni lupus, angioedem, preobčutljivost na zdravila, sezonska alergija redki serumska bolezen
English: There is limited safety experience of surgical procedures in patients treated with Trudexa.
Slovenian: Izkušnje z varnostjo operacij pri bolnikih, zdravljenih s Trudexo, so omejene.
English: Slowly pull the plunger back to draw solution into the syringe.
Slovenian: Počasi izvlecite bat, da boste raztopino potegnili v brizgo.
English: Table 3: ACR Responses in Placebo-Controlled Trials
Slovenian: Tabela 3: Odziv po ACR v raziskavah, kontroliranih s placebom
English: In Study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for Trudexa/methotrexate combination therapy versus methotrexate monotherapy and Trudexa monotherapy at week 52, which was maintained through week 104.
Slovenian: V študiji V sta se indeks invalidnosti HAQ in telesna komponenta SF 36 ob kombinirani terapiji s Trudexo in metotreksatom po 52 tednih izboljšala bolj (p < 0,001) kot ob monoterapiji z metotreksatom ali ob monoterapiji s Trudexo; to se je ohranilo do 104. tedna.
English: Rare (< 1/1000)
Slovenian: Redko (≥1/10.000 do <1/1.000)
English: Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom
Slovenian: Abbott Laboratories Ltd Queenborough Kent ME11 5EL
English: Uncommon syncope, migraine, tremor, sleep disturbances
Slovenian: občasni sinkopa, migrena, tremor, motnje spanja redki multipla skleroza
English: ACR 20 Week 12 Week 24
Slovenian: ACR 20 12. teden
English: The rate (95% confidence interval) of lymphomas was 1.0 (0.2, 3.8) per 1000 patient-years among Trudexa-treated patients and 1.0 (0.1, 7.3) per 1000 patientyears among control patients.
Slovenian: Delež (95% interval zaupanja) limfomov je bil 1,0 (0,2, 3,8) na 1000 bolnik-let med bolniki, ki so dobivali Trudexo, in 1,0 (0,1, 7,3) na 1000 bolnik-let v kontrolni skupini bolnikov.
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Trudexa.
Slovenian: Med zdravljenjem s Trudexo je mogoče nadaljevati z uporabo glukokortikoidov, salicilatov, nesteroidnih protivnetnih zdravil ali analgetikov.
English: All doses/schedules of Trudexa in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to Month 6 compared to placebo and in Study III the same was seen at week 52.
Slovenian: V vseh štirih raziskavah se je indeks invalidnosti po vprašalniku HAQ od izhodišča do 6. meseca z vsemi odmerki/shemami Trudexe izboljšal statistično značilno bolj kot s placebom; v raziskavi III so isto ugotovili po 52 tednih.
English: Trudexa is contraindicated in moderate to severe heart failure (see section 4.3).
Slovenian: Pri bolnikih z zmernim do hudim srčnim popuščanjem je Trudexa kontraindicirana (glejte poglavje 4.3).
English: Common dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias)
Slovenian: Bolezni živčevja pogosti omotica (vključno z vrtoglavico), glavobol, motnje nevrološkega občutenja (vključno s parestezijami)
English: 40 mg Trudexa every other week
Slovenian: 40 mg Trudexe vsak drugi teden
English: The Trudexa pre-filled pen is a single-use grey- and plum-coloured pen which contains a glass syringe with Trudexa.
Slovenian: Napolnjeni injekcijski peresnik Trudexa je peresnik sive in temnomodre barve za enkratno uporabo, ki vsebuje stekleno brizgo z zdravilom Trudexa.
English: Placebo/MTXTRUDEXA/MTX (95% Confidence Intervalb)
Slovenian: 40 mg vsak drugi teden placebo/MTXTRUDEXA/MTX (95% interval zaupanjab)
English: 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.
Slovenian: 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.
English: • cough, sore throat;
Slovenian: • kašelj, vnetje žrela;
English: Hypokalaemia, lipids increased, appetite disorders (including anorexia), hyperuricaemia
Slovenian: Presnovne in prehranske motnje občasni hipokalemija, zvišanje lipidov, motnje apetita (vključno z anoreksijo), hiperurikemija redki hiperkalcemija
English: Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Slovenian: Pri bolnikih, ki se v tem obdobju ne odzovejo, je treba nadaljevanje zdravljenja dobro pretehtati.
English: Study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Slovenian: Raziskava I je ocenila 271 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno, pri katerih metotreksat v odmerkih od 12,5 do 25 mg (10 mg, če so bili intolerantni za metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek od 10 do 25 mg metotreksata ostal stalen vsak teden.
English: Skin and subcutaneous tissue disorders cutaneous vasculitis
Slovenian: Bolezni kože in podkožja kožni vaskulitis
English: ***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between Trudexa and placebo at Weeks 2, 12 and 24 a ASsessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Slovenian: ***,** Statistično značilno pri p < 0,001, < 0,01 za vse primerjave med Trudexo in placebom po 2, 12 in 24 tednih a Ocene pri ankilozirajočem spondilitisu (Assessments in Ankylosing Spondylitis) b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing
English: In addition very rare cases of non-melanoma skin cancer have been observed in patients taking Trudexa.
Slovenian: Poleg tega so pri bolnikih, zdravljenih s Trudexo, opazili zelo redke primere nemelanomskega kožnega raka.
English: Rare vascular occlusion, aortic stenosis, thrombophlebitis, aortic aneurysm
Slovenian: Žilne bolezni občasni hipertenzija, zardevanje, hematom redki zapora žilja, aortna stenoza, tromboflebitis, aortna anevrizma
English: If the needle is not correctly lined up with the centre of the stopper, you will feel constant resistance as it goes through the stopper and no “pop.” The needle may then enter at an angle and bend, break or prevent proper removal of the vial contents.
Slovenian: Če igla ni naravnana pravilno v sredino zamaška, boste med prodiranjem skozi zamašek čutili stalen upor in nobenega "poka".
English: o Wipe the injection site with the enclosed alcohol pad, using a circular motion.
Slovenian: • S krožnim gibom obrišite injekcijsko mesto s priloženim alkoholnim zložencem.
English: • There have been very rare cases of certain kinds of cancer in patients taking Trudexa or other TNF blockers.
Slovenian: • Med bolniki, ki so jemali Trudexo ali druge zaviralce TNF, so se pojavili zelo redki primeri določenih vrst raka.
English: Total Sharp score Erosion score 3.7 (2.7-4.7) 1.7 (1.0-2.4) 0.8 (0.4-1.2) < 0.001 0.0082 < 0.001 JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1) 0.5 (0-1.0) < 0.001 0.0037 0.151 a. p-value is from the pairwise comparison of methotrexate monotherapy and Trudexa/methotrexate combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of Trudexa monotherapy and Trudexa/methotrexate combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of Trudexa monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Slovenian: celotna Sharpova ocena ocena erozij seštevek JSN 2,0 (1,2-2,8) 1,3 (0,5-2,1) 0,5 (0-1,0) < 0,001 0,0037 0,151 a Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije s Trudexo/metotreksatom z Mann-Whitneyevim testom U b Vrednost p se nanaša na parno primerjavo monoterapije s Trudexo in kombinirane terapije s
English: • Signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,
Slovenian: • znaki in simptomi, ki nakazujejo bolezni krvi, npr. trdovratna zvišana telesna temperatura,
English: Surgery
Slovenian: OKENCE
English: Rare cardiac arrest, coronary artery insufficiency, angina pectoris, pericardial effusion
Slovenian: Srčne bolezni občasni aritmije, tahikardija, palpitacije redki zastoj srca, insuficienca koronarnih arterij, angina pektoris, perikardialna efuzija
English: Administration of Trudexa should be discontinued if a patient develops a new serious infection until infections are controlled.
Slovenian: Če se pri bolniku pojavi nova resna okužba, je treba uporabo Trudexe prekiniti, dokler okužba ni obvladana.
English: Hold the pre-filled pen with one hand with the grey cap (1) pointed down.
Slovenian: Z eno roko primite napolnjeni injekcijski peresnik tako, da bo sivi pokrovček (1) obrnjen navzdol.
English: The usual dose for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 40 mg adalimumab given every other week as a single dose.
Slovenian: Običajni odmerek za odrasle z revmatoidnim artritisom, psoriatičnim artritisom in ankilozirajočim spondilitisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku.
English: Trudexa/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 5).
Slovenian: Pri bolnikih, ki so dobivali Trudexo in metotreksat, je bilo po 6 in 12 mesecih (glejte tabelo 5) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
English: Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.4 (1.0, 5.7) per 1000 patient-years among Trudexa-treated patients and 0 per 1000 patient-years among control patients.
Slovenian: 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.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trudexa 40 mg injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Trudexa 40 mg injekcija subkutana uporaba
English: Uncommon opportunistic infections (including tuberculosis, histoplasmosis), sepsis, abscess, joint infection, wound infection, skin infection (including cellulitis and impetigo), superficial fungal infections (including skin, nail and foot)
Slovenian: Infekcijske in parazitske bolezni pogosti okužbe spodnjih dihal (vključno s pljučnico in bronhitisom), virusne okužbe (vključno z gripo in okužbami s herpesom), kandidoza, bakterijske okužbe (vključno z okužbami sečil), okužbe zgornjih dihal občasni sepsa, oportunistične okužbe (vključno s tuberkulozo in histoplazmozo), absces, okužba sklepa, okužba rane, okužba kože (vključno s celulitisom in impetigom), površinske glivične okužbe (vključno s kožo, nohti in stopali)
English: Study VII with 12-week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Slovenian: V njej so zdravili 100 bolnikov, ki se niso ustrezno odzvali na imunomodulirajočo terapijo.
English: Table 7: ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Slovenian: Tabela7: Odziv ACR v študijah psoriatičnega artritisa, kontroliranih s placebom (odstotek bolnikov)
English: • Numbness;
Slovenian: • omrtvelost;
English: • fatigue;
Slovenian: • utrujenost;
English: Carriers of HBV who require treatment with Trudexa should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Slovenian: Nosilce HBV, ki potrebujejo zdravljenje s Trudexo, je treba ves čas zdravljenja in več mesecev po koncu zdravljenja natančno spremljati glede znakov in simptomov aktivne okužbe s HBV. O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za preprečitev reaktivacije HBV ni zadostnih podatkov.
English: Do not use the Trudexa pre-filled syringe after the expiry date stated on the label/blister/carton after EXP:.
Slovenian: Zdravila Trudexa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki/pretisnem omotu/škatli za “Uporabno do:”.
English: Trudexa 40 mg solution for injection in single-use pre-filled pen for patient use.
Slovenian: Trudexa 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku za enkratno uporabo, ki ga uporabi bolnik.
English: • Put used pre-filled pen immediately into the special container as instructed by your doctor,
Slovenian: • Odrabljeni napolnjeni injekcijski peresnik takoj zavrzite v poseben vsebnik, kot vam je naročil zdravnik, medicinska sestra ali farmacevt.
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial containing 40 mg adalimumab 1 sterile injection syringe with fixed needle 2 alcohol pads
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 1 viala s 40 mg adalimumaba 1 sterilna injekcijska brizga s fiksirano iglo 2 alkoholna zloženca