FrancophonIA/ELRC3.0 huggingface dataset:
English: NA NA 4.5% 23.2% a Study I at 24 weeks, Study II at 26 weeks , and Study III at 24 and 52 weeks b 40 mg Trudexa administered every other week c MTX = methotrexate
Maltese: NA NA 4.5% 23.2% a Studju I fir-24 ġimgħa, Studju II fis-26 ġimgħa , u Studju III fir-24 u t-52 ġimgħa b 40 mg Trudexa mgħotija ġimgħa iva u ġimgħa le c MTX = methotrexate **p < 0.01, Trudexa kontra l-plaċebo
English: Dates of Trudexa treatment:
Maltese: Dati tal-kura b'Trudexa:
English: Trudexa 40 mg every other week was assessed in 393 patients in two randomised, 24 week double − blind, placebo − controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Maltese: It-teħid ta' 40 mg Trudexa ġimgħa iva u ġimgħa le kien stimat fi 393 pazjent f'żewġ studji doubleblind, kontrollati bil-plaċebo li ħadu 24 ġimgħa u li saru b'ordni addoċċ fuq pazjenti li jbatu minn infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis) (il-punt medju tal-linja bażi ta' l-attività tal-mard [l-Indiċi ta' l-Attività tal-Mard Ankylosing Spondylitis (BASDAI)] kien 6.3 fil-gruppi kollha) li ma kellhomx rispons adegwata għat-terapija konvenzjonali.
English: In Study V, structural joint damage was assessed radiographically and expressed as change in modified total Sharp score (see Table 6).
Maltese: Fi Studju V, il-ħsara strutturali fil-ġogi ġiet stimata radjografikament u ġiet espressa bħala bidla filpunteġġ totali Sharp (ara Tabella 6).
English: the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Maltese: • kura ta' artrite rewmatika attiva u progressiva severa f'adulti li ma jkunux ingħataw kura b'methotrexate qabel.
English: Trudexa was evaluated in over 3000 patients in all rheumatoid arthritis clinical trials.
Maltese: Trudexa ġie evalwat fuq aktar minn 3000 pazjent fil-provi kliniċi kollha ta' l-artrite rewmatika.
English: If a patient receiving Trudexa shows prolonged/atypical symptoms/signs of infections or general deterioration, prevalent opportunistic conditions must be considered.
Maltese: Jekk pazjent li jircievi Trudexa juri sintomi/sinjali ta' infezzjoni jew deterjorament ġenerali fittul/atipiċi, għandhom jiġu kkunsdrati kundizzjonijiet opportunistiċi prevalenti.
English: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Maltese: • kura ta' artrite rewmatika attiva minn moderata sa severa f'pazjenti adulti, meta r-rispons tagħhom għal mediċini anti-rewmatiċi li jaffetwaw il-proċess tal-mard, inkluż methotrexate, ma kienx adegwat.
English: 1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe in pouch and 2 alcohol pads, all in a blister.
Maltese: Kunjett wieħed (0.8 ml soluzzjoni sterili), siringa waħda għall-injezzjoni vojta b'basket għaliha u 2 kuxxinetti bl-alkoħol, kollha ġo folja.
English: 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 given (see section 4.8).
Maltese: Jekk pazjent jiżviluppa sintomi li jindikaw sindromu li jixbaħ lis-sindromu tal-lupus wara li tkun ingħatat kura b'Trudexa, u jkun pożittiv għall-anti-korpi kontra DNA li hi double stranded, m'għandhiex tingħata aktar kura b'Trudexa (ara sezzjoni 4.8).
English: • You might get infections more easily while you are receiving Trudexa treatment including serious infections, tuberculosis, opportunistic infections and sepsis that may, in rare cases, be life-threatening.
Maltese: • Jista' jkun li waqt li tkun qiegħed tirċievi l-kura b'Trudexa, jaqbduk infezzjonijiet aktar faċilment, inkluż infezzjonijiet serji, tuberkulosi, infezzjonijiet opportunistiċi u sepsis li, f'każi rari, jistgħu ipoġġu l-ħajja fil-periklu.
English: Common musculoskeletal pain
Maltese: Komuni uġigħ muskoskeletrali
English: This alert card contains important safety information that you need to be aware of before you are given Trudexa and during treatment with Trudexa.
Maltese: Din il-kartuna ta' twissija fiha informazzjoni importanti dwar is-sigurtà, li inti għandek tkun taf biha qabel ma tingħata u waqt il-kura b'Trudexa.
English: 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.
Maltese: M'hawnx informazzjoni adegwata fuq il-kura ta' pazjenti li jġorru l-HBV permezz ta' terapija anti-virali flimkien ma' terapija b'antagonist ta' TNF biex tiġi evitata r-riattivazzjoni ta' l-HBV.
English: In GAIN, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg Trudexa at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
Maltese: F'GAIN, 325 pazjent li ma kinux baqgħu juru rispons għall-kura jew li ma kinux jittolleraw infliximab kienu mqassma bl-addoċċ biex jirċievu jew 160 mg Trudexa f'ġimgħa 0 u 80 mg f'ġimgħa 2 jew plaċebo f'ġimgħat 0 u 2.
English: Deutschland Abbott GmbH & Co. KG Max-Planck-Ring 2
Maltese: Deutschland Abbott GmbH & Co.
English: LOT:
Maltese: IV:
English: Trudexa increases the risk of getting infections.
Maltese: Trudexa jżid ir-riskju illi inti tieħu infezzjonijiet.
English: In the twelve controlled trials, 16% of patients treated with Trudexa developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 10% of patients receiving placebo or active control.
Maltese: Fit-tnax -il studji kontrollati li saru, 16% tal-pazjenti kkurati b'Trudexa żviluppaw reazzjonijiet filpost ta' l-injezzjoni (eritema u/jew ħakk, emorraġija, uġigħ jew nefħa), ipparagunati ma' 10% talpazjenti li kienu qegħdin jirċievu l-plaċebo jew sustanza attiva użata bħala kontroll.
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Maltese: DATA META JISKADI JIS {XX/SSSS}
English: • serious infections (such as sepsis [blood poisoning]), joint infection, fungal infections;
Maltese: • infezzjonijiet serji (bħal fil-pene [avvelenament tad-demm]), infezzjoni fil-ġogi, infezzjonijiet tal-fungu;
English: A. MANUFACTURER(S) OF THE OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: Injecting Trudexa
Maltese: Biex tinjetta Trudexa
English: The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.4 per 1000 patient years, respectively (see section 4.4).
Maltese: Ir-rati rrappurtati ta' kanċer tal-ġilda li m'humiex melanoma u limfomi, huma ta' bejn wieħed u ieħor 0.2 u 0.4 kull 1000 sena ta' pazjent, rispettivament (ara sezzjoni 4.4).
English: In clinical trials an increased risk of serious infections in patients receiving Trudexa has been shown, and reports from the post-marketing setting support this finding.
Maltese: Fi provi kliniċi, irriżulta riskju akbar ta' infezzjonijiet serji f'pazjenti li jirċievu Trudexa, u rapporti li saru wara li l-prodott tpoġġa fis-suq jikkonfermaw dan.
English: The infections consisted primarily of upper respiratory tract infections, bronchitis and urinary tract infections.
Maltese: L-infezzjonijiet kienu jikkonsistu primarjament f'infezzjonijiet fin-naħa ta' fuq tas-sistema respiratorja, bronkite u infezzjonijiet fis-sistema urinarja.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Trudexa, who are chronic carriers of this virus.
Maltese: Seħħet riattivazzjoni ta' epatite B f'pazjenti li jġorru dan il-virus b'mod kroniku u li jirċievu xi antagonist ta' TNF, inkluż Trudexa.
English: Common lymphopaenia
Maltese: GĦAMLA FARMAĊEWTIKA
English: 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.
Maltese: Adalimumab jeħel speċifikament mat-TNF u jinnewtralizza il-funzjoni bijoloġika tat-TNF billi jimblokka l-interazzjoni tiegħu ma'riċetturi TNF p55 u p75 fuq il-wiċċ taċ-ċellola.
English: • Remove the plastic cap from the Trudexa vial.
Maltese: • Neħħi l-għatu tal-plastik mill-kunjett ta' Trudexa.
English: Uncommon systemic lupus erythematosus, angioedema, drug hypersensitivity, seasonal allergy
Maltese: Rari systemic lupus erythematosus, anġjoedema, sensittività eċċessiva għall-mediċina, allerġija assoċjata ma' l-istaġuni marda tas-serum
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.
Maltese: Id-dożaġġ irrakkomandat biex tinbeda l-kura b'Trudexa fuq pazjenti adulti li jbatu mill-marda Crohn (Crohn's disease) severa huwa ta' 80 mg f'ġimgħa 0 segwiti b'40 mg f'ġimgħa 2.
English: CLASSIC I: Infliximab Naive Patients
Maltese: Pazjenti li kienu diġà ħadu infliximab qabel
English: 1 st injection: _______________________ Following injections:
Maltese: L-ewwel injezzjoni: _______________________
English: Ankylosing spondylitis
Maltese: Tfal u adoloxxenti
English: Common rash, dermatitis and eczema, pruritus, hair loss
Maltese: Komuni raxx, dermatite u ekżema, ħakk, taqa' x-xagħar
English: • thyroid disorders;
Maltese: • distrubi fit-tirojde;
English: Trudexa treated patients demonstrated improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36), from base-line to week 24.
Maltese: Pazjenti kkurati b'Trudexa urew titjib fil-funzjoni fiżika kif stimat bl-HAQ u l-istudju tas-saħħa filforma il-qasira (SF 36), mil-linja bażi sa ġimgħa 24.
English: little bleeding may occur.
Maltese: TAGĦTIHIEX lil persuni oħra.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika attiva
English: Psoriatic arthritis is an inflammation of the joints associated with psoriasis.
Maltese: L-artrite psorjatika hija infjammazzjoni tal-ġogi assoċjata mal-psorajiżi.
English: THE MARKETING AUTHORISATION HOLDER Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (Ara Anness I : Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: • If you have multiple sclerosis, your doctor will decide if you should receive Trudexa.
Maltese: • Jekk inti tbati minn sklerosi multipla, it-tabib tiegħek għandu jiddeċiedi jekk inti għandekx tirċievi Trudexa.
English: Table 3: ACR Responses in Placebo-Controlled Trials (Percent of Patients)
Maltese: Tabella 3: Risponsi għall-ACR fi Provi kontrollati bil-Plaċebo (Persentaġġ ta' Pazjenti)
English: paleness.
Maltese: Trudexa
English: Week 12
Maltese: Tabella 10:
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
Maltese: * p < 0.001 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal Trudexa kontra l-plaċebo ** p < 0.02 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal Trudexa kontra l-plaċebo a Minn dawk li jirċievu l-corticosteroids fil-linja bażi
English: Other side effects that have been observed in patients taking Trudexa: tuberculosis and other opportunistic infections (infections that occur when resistance to disease is lowered); lung disease.
Maltese: Effetti sekondarji oħra li ġew osservati f'pazjenti li jieħdu Trudexa: tuberkulosi u infezzjonijiet opportunistiċi oħra (infezzjonijiet li jiġu kkawżati meta r-reżistenza għallmard tiddgħajjef); mard tal-pulmun.
English: Do not use the Trudexa pre-filled pen after the expiry date stated on the label/blister/carton after EXP:.
Maltese: Tużax il-kunjett ta' Trudexa wara d-data ta' skadenza li tidher fuq it-tikketta/il-folja/il-pakkett wara
English: • 2 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
Maltese: • 2 siringi mimlijin għal-lest (0.8 ml soluzzjoni sterili), b'kuxxinett wieħed bl-alkoħol f'folja kull wieħed.
English: NAME OF THE MEDICINAL PRODUCT Trudexa 40 mg solution for injection in pre-filled syringe
Maltese: Trudexa 40 mg soluzzjoni għall-injezzjoni
English: Appropriate screening tests, i.e. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Maltese: Testijiet xierqa għall-iċċekjar, jiġifieri test tal-ġilda għat-tuberkolina u X-ray tassider, għandhom isiru fuq il-pazjenti kollha (rakkomandazzjonijiet lokali jistgħu japplikaw).
English: 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 during the controlled period.
Maltese: L-informazzjoni f'Tabella 1 hija bbażata fuq l-Istudji konrollati (I-IX, CLASSIC I, GAIN u CHARM) (deskritti f'sezzjoni 5.1) li nvolvew 3271 pazjent li kienu qegħdin jirċievu Trudexa u 1809 pazjent li kienu qegħdin jirċievu l-plaċebo jew sustanza attiva li l-effetti tagħħa tista' titqabbel ma' Trudexa, matul il-perijodu kontrollat.
English: Of those in clinical response at week 4, 48% had been previously exposed to other anti-TNF therapy.
Maltese: Minn dawk li kellhom rispons kliniku f'ġimgħa 4, 48% kienu ġew esponuti għal kura oħra għal kontra TNF fil-passat.
English: Psoriatic arthritis and ankylosing spondylitis
Maltese: Artrite Psorjatika u infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis)
English: Instructions for preparing and giving an injection of Trudexa:
Maltese: Istruzzjonijiet għall-preparamenti u l-għotja ta' l-injezzjoni ta' Trudexa:
English: Each pack contains 1 vial with an empty sterile syringe and 2 alcohol pads.
Maltese: Kull pakkett fih kunjett wieħed b'siringa sterili vojta u 2 kuxxinetti bl-alkoħol.
English: Response
Maltese: Rispons
English: • abdominal symptoms (such as vomiting, indigestion, constipation), rectal bleeding;
Maltese: • sintomi addominali (bħal rimettar, indiġestjoni, stitikezza), ħruġ ta' demm mir-rektum;
English: The efficacy and safety of Trudexa for the treatment of rheumatoid arthritis were assessed in five randomised, double-blind and well-controlled studies.
Maltese: L-effikaċja u s-sigurtà ta' Trudexa għall-kura ta' l-artrite rewmatika ġew studjati f'ħames studji randomized,u double-blind u kontrollati ħafna.
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Trudexa.
Maltese: Mediċini glukokortikojdi, saliċilati u mediċini anti-infjammatorji mhux sterojdi, jew mediċini analġeżiċi jistgħu jitkomplew waqt il-kura b'Trudexa.
English: This study evaluated the efficacy of Trudexa 40 mg every other week/methotrexate combination therapy, Trudexa 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
Maltese: Dan l-istudju evalwa l-effikaċja ta' 40 mg Trudexa ġimgħa iva u ġimgħa le/ terapija kombinata b'methotrexate, 40 mg Trudexa mgħoti waħdu ġimgħa ive u ġimgħa le u methotrexate mgħoti waħdu, li jnaqqas is-sinjali u s-sintomi u r-rata ta' avanz tal-ħsara fil-ġogi fl-artrite rewmatika għal 104 ġimgħat.
English: Very common (≥ 1/10 patients):
Maltese: Komuni ħafna (≥ 1/10 pazjent):
English: In Studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg/dl) values) improved at 24 or 26 weeks compared to placebo.
Maltese: Fl-Istudji minn I-IV, il-komponenti kollha tal-kriterji tar-rispons għall-ACR (numru ta' ġogi bl-uġigħ u minfuħa, l-istima ta' l-attività tal-mard u ta' l-uġigħ magħmula mit-tabib u mill-pazjent, il-punti ta' l-indiċi ta' diżabilità (HAQ) u valuri tas-CRP (mg/dl)) marru għall-aħjar fir-24 u fis-26 ġimgħa meta pparagunati mal-plaċebo.
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.
Maltese: Fil-porzjonijiet kontrollati tal-provi kliniċi ta' antagonisti ta' TNF, ġew osservati aktar każi ta' tumuri malinni, inkluż limfoma, f'pazjenti li jirċievu xi anagonist ta' TNF, meta ipparagunati ma' pazjenti kontrollati.
English: After single intravenous doses ranging from 0.25 to 10 mg/kg, concentrations were dose proportional.
Maltese: Wara dożi waħdenin meħuda ġol-vini li jvarjaw minn 0.25 sa 10 mg/kg, il-konċentrazzjoni kienet proporzjonali għad-doża.
English: • 4 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
Maltese: • 4 siringi mimlijin għal-lest (0.8 ml soluzzjoni sterili), b'kuxxinett wieħed bl-alkoħol f'folja kull wieħed.
English: Uncommon rectal haemorrhage, gastritis, vomiting, dyspepsia, abdominal bloating, constipation,
Maltese: Mhux Komuni emorraġija fir-rektum, gastrite, rimettar, dispepsja, nefħa addominali, stitikezza stenosi ta' l-intestini, kolite, enterite, esofaġite
English: Administration of Trudexa without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1).
Maltese: L-għoti ta' Trudexa mingħajr methotrexate rriżulta f'żieda fil-formazzjoni ta'anti-korpi, żieda fittneħħija u tnaqqis fl-effikaċja ta' adalimumab (ara sezzjoni 5.1).
English: Trudexa can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs.
Maltese: Trudexa jista' jittieħed flimkien ma' methotrexate jew ċerti tipi ta' aġenti anti-rewmatiċi li jaffetwaw il-proċess tal-mard (sulfasalazine, hydroxychloroquine, leflunomide u preparazzjonijiet tad-deheb li jingħata b' injezzjoni), sterojdi jew medikazzjonijiet għall-uġigħ, li jinkludu mediċini antiinfjammatorji mhux sterojdi.
English: It is recommended that the conduct of these tests should be recorded in the patient alert card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Maltese: Min jagħti l-mediċina huwa mfakkar fir-riskju ta' testijiet negattivi tal-ġilda għat-tuberkolina foloz, speċjalment f'pazjenti li huma morda serjament jew li għandhom immunita kompromessa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One 0.8 ml pre-filled pen contains 40 mg adalimumab
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Pinna waħda ta' 0.8 ml mimlija għal-lest fiha 40 mg adalimumab
English: Patients in clinical response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
Maltese: Pazjenti li kellhom rispons kliniku (tnaqqis f' CDAI ≥ 70) f'ġimgħa 4 ġew isseparati minn ma' l-oħrajn u ġew analizzati separatement minn dawk li ma kellhomx rispons kliniku f'ġimgħa 4.
English: PHARMACEUTICAL FORM AND CONTENTS 6 pre-filled syringes, each containing 40 mg adalimumab 6 alcohol pads
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 6 siringi mimlijin għal-lest, li fihom 40 mg adalimumab kull waħda 6 kuxxinetti bl-alkoħol
English: 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.
Maltese: Il-livelli minimali fissi fis-serum ta' adalimumab żdiedu bejn wieħed u ieħor proporzjonalment mad-doża wara t-teħid ta' 20, 40 u 80 mg ġimgħa iva u ġimgħa le u dożaġġ ta' injezzjoni taħt il-ġilda kull ġimgħa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/009
Maltese: FIS-SUQ EU/1/03/257/009
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/008
Maltese: FIS-SUQ EU/1/03/257/008
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/006
Maltese: FIS-SUQ EU/1/03/257/006
English: Do not use Trudexa:
Maltese: X'fih Trudexa:
English: Trudexa 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.
Maltese: Trudexa 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest hija fornuta bħala soluzzjoni sterili ta' 40 mg adalimumab imdewba f'soluzzjoni ta' 0.8 ml.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/257/010
Maltese: FIS-SUQ EU/1/03/257/010
English: PHARMACEUTICAL FORM AND CONTENTS 6 pre-filled pens, each containing 40 mg adalimumab 6 alcohol pads
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 6 pinen mimlijin għal-lest, li fiha 40 mg adalimumab kull waħda 6 kuxxinetti bl-alkoħol
English: Trudexa treated patients had significantly greater improvement at Week 12 which was maintained through Week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Maltese: It-titjib fil-kwalità ta' ħajja ġie mkejjel sa ġimgħa 156 (36 xahar) u dan it-titjib ġie mantenut matul dan il-perjodu.
English: 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.
Maltese: L-iskop primarju fi Studji I, II u III u l-iskop sekondarju fi Studju IV kien il-persentaġġ ta' pazjenti li laħqu rispons għall-ACR 20 f'ġimgħa 24 jew 26.
English: Uncommon haematuria, renal impairment, bladder and urethral symptoms
Maltese: Rari sinkope, migranja, tregħid, disturbi fl-irqad sklerosi multipla
English: In Study IV, the ACR 20 response of patients treated with Trudexa plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
Maltese: Fi Studju IV, ir-rispons għall-ACR 20 ta' pazjenti kkurati b'Trudexa flimkien ma' stàndard ta' kura, kienu statistikament aħjar b'mod sinifikanti f'dawn il-pazjenti, milli kienu f'pazjenti kkurati bilplaċebo flimkien ma' stàndard ta' kura (p < 0.001).
English: Rheumatoid arthritis clinical trials: in controlled rheumatoid arthritis clinical trials (Studies I − IV), elevations of ALT were similar in patients receiving adalimumab or placebo.
Maltese: I-IV), żieda fil-livelli ta' l-ALT kienu simili f'pazjenti li jirċievu adalimumab jew il-plaċebo.
English: • Signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,
Maltese: Jekk jitfaċċaw sintomi tat-tuberkulosi (sogħla persistenti, tnaqqis fil-piż,
English: PHARMACEUTICAL FORM AND CONTENTS 4 pre-filled pens, each containing 40 mg adalimumab 4 alcohol pads
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 4 pinen mimlijin għal-lest, li fiha 40 mg adalimumab kull waħda 4 kuxxinetti bl-alkoħol
English: • 6 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
Maltese: • 6 siringi mimlijin għal-lest (0.8 ml soluzzjoni sterili), b'kuxxinett wieħed bl-alkoħol f'folja kull wieħed.
English: Clinical remission results remained relatively constant irrespective of previous TNF antagonist exposure.
Maltese: Irriżultati tat-titjib kliniku baqgħu relattivament kostanti, irrispettivament mill-esponimenti għal antagonist ta' TNF li kien hemm fil-passat.
English: Rare cardiac arrest, coronary artery insufficiency, angina pectoris, pericardial effusion
Maltese: Rari tħabbit irregolari tal-qalb, takikardija, palpitazzjonijiet attakk tal-qalb, insuffiċjenza ta' l-arterja koronarja, anġina pectoris, effużjoni talperikardju
English: Trudexa 40 mg solution for injection in pre-filled syringe with needleguard is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.
Maltese: Trudexa 40 mg soluzzjoni għall-injezzjoni fil-kunjetti hija fornuta bħala soluzzjoni sterili ta' 40 mg adalimumab imdewba f'soluzzjoni ta' 0.8 ml.
English: • cough, sore throat;
Maltese: • ażżma, qtugħ ta' nifs;