FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/99/126/019 2 pre-filled pens EU/1/99/126/020 4 pre-filled pens EU/1/99/126/021 12 pre-filled pens
Maltese: EU/1/99/126/019 2 pinen mimlijin għal-lest EU/1/99/126/020 4 pinen mimlijin għal-lest EU/1/99/126/021 12-il pinna mimlijin għal-lest
English: • Not known (frequency cannot be estimated from the available data): Merkel cell carcinoma (a type of skin cancer); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash).
Maltese: • Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli): karċinoma taċ-ċelluli Merkel (tip ta' kanċer tal-ġilda); attivazzjoni eċċessiva ta' ċelluli bojod tad-demm assoċjati ma' infjammazzjoni (sindrome ta' l-attivazzjoni tal-makrofagu); rikorrenza tal-epatite B (infezzjoni tal-fwied); aggravar ta' kundizzjoni msejħa dermatomijosite (infjammazzjoni u dgħjufija talmuskoli b'raxx tal-ġilda li jiġi magħha).
English: Each vial contains 25 mg of etanercept.
Maltese: Kull kunjett fih 25 mg ta' etanercept.
English: Leave the white needle cap in place and wait approximately 15-30 minutes to allow the Enbrel solution in the pen to reach room temperature.
Maltese: Wara li tistenna madwar 15-30 minuta għas-soluzzjoni fil-pinna biex tisħon sat-temperatura talkamra, aħsel idejk bl-ilma u bis-sapun.
English: (It may be helpful to keep notes on the location of the previous injections.)
Maltese: (Jista' jkun utli jekk iżżomm nota tal-postijiet fejn ikunu ngħataw l-injezzjonijiet ta' qabel.)
English: Enbrel 50 mg solution for injection in pre-filled pen EU/1/99/126/019
Maltese: Enbrel 50 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest EU/1/99/126/019
English: PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH) Tηλ: +357 22 817690
Maltese: Pfizer Croatia d.o.o. Tel: +385 1 3908 777
English: EXP
Maltese: HAQ
English: Doses of 10 mg or 25 mg Enbrel were administered subcutaneously (SC) twice a week for up to 24 months.
Maltese: Dożi ta' 10 mg u 25 mg ingħataw taħt il-ġilda (SC) darbtejn f'ġimgħa sa 24 xahar.
English: Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling).
Maltese: Infezzjonijiet (li jinkludu rjiħat, sinusite, bronkite, infezzjonijiet ta' l-apparat urinarju u infezzjonijiet tal-ġilda); reazzjonijiet fis-sit ta' l-injezzjoni (li jinkludu ħruġ ta' demm, tbenġil, ħmura, ħakk, uġigħ u nefħa).
English: The long-term safety and effectiveness of Enbrel 0.8 mg/kg (up to 50 mg) once weekly was assessed in an open-label extension study of 181 paediatric subjects with plaque psoriasis for up to 2 years beyond the 48 week study discussed above.
Maltese: Is-sikurezza u l-effikaċja fit-tul ta' Enbrel 0.8 mg/kg (sa 50 mg) darba fil-ġimgħa ġew ivvalutati fi studju ta' estensjoni b'tikketta mikxufa ta' 181 suġġett pedjatriku bi psorjasi tal-plakka għal massimu ta' sentejn apparti l-istudju ta' 48 ġimgħa diskuss hawn fuq.
English: Enbrel 10 mg powder and solvent for solution for injection for paediatric use is supplied as a white powder with solvent for solution for injection (powder for injection).
Maltese: Enbrel 10 mg u solvent għal soluzzjoni għall-injezzjonijiet għal użu pedjatriku jiġi bħala trab abjad u solvent għal soluzzjoni għall-injezzjoni (trab għall-injezzjoni).
English: Each pre-filled syringe contains 0.5 ml of solution, providing 25 mg of etanercept.
Maltese: Kull siringa mimlija għal-lest fiha 0.5 ml ta' soluzzjoni, li tipprovdi 25 mg ta' etanercept.
English: Cartons contain 4 vials of Enbrel, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs.
Maltese: Il-kaxxi tal-kartun fihom 4 kunjetti ta' Enbrel b'4 siringi mimlija għal-lest bl-ilma għall-injezzjonijiet, 4 labar, 4 adapters tal-kunjetti u 8 swabs bl-alkoħol.
English: ACR 20 Month 3
Maltese: ACR 20
English: • You will also need the following items: A sterile syringe and needle(s) of 25 gauge x 16 mm or similar A vial or ampoule of water for injections 2 alcohol swabs
Maltese: Siringa sterili u labra (labar) ta' 25 gauge x 16 mm jew simili Kunjett jew ampulla ta' ilma għall-injezzjonijiet 2 swabs bl-alkoħol
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR SYRINGE LABEL - EU/1/99/126/022 (For paediatric use)
Maltese: KITBA FUQ IT-TIKKETTA TAS-SIRINGA - EU/1/99/126/022 (Għal użu pedjatriku)
English: Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common); abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems).
Maltese: • Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100): infezzjonijiet serji (li jinkludu pnewmonja, infezzjonijiet profondi tal-ġilda, infezzjonijiet talġogi, infezzjoni tad-demm, u infezzjonijiet f'siti differenti); iggravar ta' insuffiċjenza konġestiva tal-qalb, għadd baxx taċ-ċelluli bojod tad-demm, għadd baxx ta' newtrofili (tip ta' ċelluli bojod tad-demm); għadd baxx ta' plejtlits fid-demm; kanċer tal-ġilda (ħlief ilmelanoma); nefħa lokalizzata tal-ġilda (anġjoedema); ħorriqija (irqajja' elevati ta' ġilda ħamra jew pallida li ħafna drabi iqabbduk il-ħakk); infjammazzjoni tal-għajnejn; psorjasi (ġdida jew li tmur għall-agħar); infjammazzjoni tal-vini/arterji tad-demm li taffettwa bosta organi; żieda flenżimi tal-fwied fid-demm (f'pazjenti li jkunu qed jirċievu kura b'methotrexate, il-frekwenza taż-żieda fl-enżimi tal-fwied fid-demm hija komuni); bugħawwiġ u uġigħ fl-addome, dijarea, telf fil-piż jew demm fl-ippurgar (sinjali ta' problemi tal-musrana).
English: a. p < 0.0001 compared with placebo.
Maltese: *p 0.0001 meta mqabbel mal-plaċebo a.
English: Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with Enbrel.
Maltese: Avvenimenti avversi serji kienu wkoll irrapurtati b'Enbrel.
English: This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy.
Maltese: Din l-evalwazzjoni għandha tinkludi storja medika dettaljata bi storja medika personali ta' tuberkulosi jew kuntatt possibbli fil-passat mat-tuberkulosi, u terapija immunosoppressiva fil-passat u/jew fil-preżent.
English: The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever.
Maltese: L-aktar avvenimenti avversi rrapurtati b'mod komuni huma reazzjonijiet fis-sit fejn tingħata linjezzjoni (bħal uġigħ, nefħa, ħakk, ħmura u ħruġ ta' demm minn parti li kienet mtaqqba), infezzjonijiet (bħal infezzjonijiet fis-sistema respiratorja ta' fuq, bronkite, infezzjonijiet fil-bużżieqa ta' l-awrina ċistite, infezzjonijiet tal-ġilda), reazzjonijiet allerġiċi, formazzjoni ta' awtoantikorpi, ħakk, u deni.
English: Pruritus, rash Angioedema, psoriasis (including new onset or worsening and pustular, primarily palms and soles), urticaria, psoriasiform rash
Maltese: Prurite, raxx Anġjoedema, psorjasi (li tinkludi bidu mill-ġdid jew aggravament ta' psorjasi, u psorjasi bil-ponot, primarjament filkeffa tal-id u filqiegħ tas-saqajn), urtikarja, raxx psorjasiformi
English: In part 2, 6 of 25 (24%) patients remaining on Enbrel experienced a disease flare compared to 20 of 26 (77%) patients receiving placebo (p=0.007).
Maltese: Fit-tieni parti, 6 minn 25 (24%) tal-pazjenti li baqgħu fuq Enbrel kellhom żieda qawwija fl-intensità tal-marda meta mqabbla ma' 20 minn 26 (77%) pazjent li rċivew il-plaċebo (p=0.007).
English: The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive.
Maltese: Etanercept jista' wkoll jimmodula r-risponsi bijoloġiċi kkontrollati b'molekuli addizzjonali downstream (eż. cytokines, molekuli ta' l-adeżjoni jew proteinases) li huma kkaġunati jew irregolati mit-TNF.
English: These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection,
Maltese: Dawn kienu jinkludu axxess (f'partijiet differenti), batteremija, bronkite, bursite, ċellulite, koleċistite, dijarea, divertikulite, endokardite (issuspettata), gastroenterite, epatite B, herpes zoster, ulċera fir-riġlejn, infezzjoni fil-ħalq, osteomajelite, otitis, peritonite, pnewmonja, pajelonefrite, sepsis, artrite settika, sinusite, infezzjoni tal-ġilda, ulċera talġilda, infezzjoni fl-apparat ta' l-awrina, vaskulite, u infezzjoni fil-feriti.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for etanercept (except for biosimilars), the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal etanercept (apparti bijoanalogi), il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Adult patients treated with Enbrel and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either Enbrel or anakinra alone (historical data).
Maltese: Kien osservat li pazjenti adulti kkurati b'Enbrel u b'anakinra kellhom rata ogħla ta' infezzjonijiet serji meta mqabbla ma' pazjenti kkurati jew b'Enbrel jew b'anakinra waħidhom (informazzjoni storika).
English: Cartons contain 4, 8, 12 or 24 pre-filled syringes of Enbrel and 4, 8, 12 or 24 alcohol swabs.
Maltese: Il-kaxxi tal-kartun fihom 4, 8, 12 jew 24 siringa mimlija għal-lest ta' Enbrel u 4, 8,12 jew 24 swab bl-alkoħol.
English: Pfizer Luxembourg SARL filialas Lietuvoje Tel. +3705 2514000
Maltese: Pfizer Luxembourg SARL, organizačná zložka Tel: +421 2 3355 5500
English: Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA) There have been reports of IBD and uveitis in JIA patients being treated with Enbrel (see section 4.8).
Maltese: Wara li Enbrel ħareġ fuq is-suq, kien hemm rapporti ta' panċitopenja u anemija aplastika, li x'uħud minnhom spiċċaw biex kienu fatali (ara sezzjoni 4.4).
English: Psoriatic Arthritis Response n = 104
Maltese: % ta' Pazjenti Plaċebo n = 104
English: In controlled trials in patients with plaque psoriasis, approximately 13.6% of patients treated with Enbrel developed injection site reactions compared with 3.4% of placebo-treated patients during the first 12 weeks of treatment.
Maltese: Fi provi kkontrollati f'pazjenti bi psorjasi tal-plakka, bejn wieħed u ieħor 13.6% tal-pazjenti kkurati b'Enbrel żviluppaw reazzjonijiet fis-siti tal-injezzjoni meta mqabbla ma' 3.4% tal-pazjenti kkurati bilplaċebo waqt l-ewwel 12-il ġimgħa tal-kura.
English: Cartons contain 4 vials of Enbrel with 8 alcohol swabs.
Maltese: Kull pakkett fih 4 kunjetti ta' doża waħda u 8 swabs bl-alkoħol.
English: Significant improvement was also observed for the ASAS partial remission and BASDAI 50.
Maltese: Titjib sinifikanti kien osservat ukoll għar-remissjoni parzjali tal-ASAS u BASDAI 50.
English: Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/l vs. 2.6 mg/l, Cmin of 1.2 mg/l vs. 1.4 mg/l, and partial AUC of 297 mgh/l vs. 316 mgh/l for 50 mg Enbrel once weekly (n=21) vs. 25 mg Enbrel twice weekly (n=16), respectively.
Maltese: L-effikaċja ta' Enbrel kienet evalwata fi studju randomised, double-blind, u kkontrollat bil-plaċebo li sar fuq 211-il pazjent pedjatriku bejn l-4 u 17-il sena, li kellhom psorjasi tal-plakka minn moderata sa severa (kif definita minn punteġġ sPGA ta' ≥ 3, li tinvolvi ≥ 10% tal-BSA, u PASI ta' ≥ 12).
English: Merkel cell carcinoma (see section 4.4)
Maltese: Karċinoma taċċelluli Merkel (ara sezzjoni
English: -0.23†,φ
Maltese: Ġimagħtejn 3 xhur 6 xhur
English: 48 alcohol swabs
Maltese: 48 swab ta' l-alkoħol
English: At week 12, there was a statistically significant improvement in the SPARCC (Spondyloarthritis Research Consortium of Canada) score for the sacroiliac joint (SIJ) as measured by MRI for patients receiving Enbrel.
Maltese: Fil-ġimgħa 12, kien hemm titjib statistikament sinifikanti fil-punteġġ tal-SPARCC (Konsorzju talKanada għar-Riċerka dwar l-Ispondiloartrite) għall-ġog sakroiljaku (SIJ) kif imkejjel mill-MRI għal pazjenti li kienu qed jirċievu Enbrel.
English: 24 pre-filled syringes 24 alcohol swabs
Maltese: 24 siringa mimlija għal-lest 24 swab ta' l-alkoħol
English: In long-term (up to 34 months) open-label studies where Enbrel was given without interruption, clinical responses were sustained and safety was comparable to shorter-term studies.
Maltese: Fi studji open-label fit-tul (li damu sa 34 xahar) fejn Enbrel ingħata mingħajr interruzzjoni, ir-risponsi kliniċi kienu sostnuti u s-sigurtà kienet komparabbli ma' dik fi studji li damu inqas żmien.
English: EU/1/99/126/023 4 pre-filled pens EU/1/99/126/024 8 pre-filled pens EU/1/99/126/025 24 pre-filled pens
Maltese: EU/1/99/126/023 4 pinen mimlijin għal-lest EU/1/99/126/024 8 pinen mimlijin għal-lest EU/1/99/126/025 12-il pinna mimlija għal-lest
English: Each vial of Enbrel 10 mg powder and solvent for solution for injection for paediatric use contains 10 mg of etanercept.
Maltese: Kull kunjett ta' Enbrel 10 mg trab u solvent għal soluzzjoni għall-injezzjonijiet għal użu pedjatriku fih 10 mg ta' etanercept.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED PEN - EU/1/99/126/019-021 (50 mg Pre-filled Pen)
Maltese: KITBA GĦALL-PINNA MIMLIJA GĦAL-LEST- EU/1/99/126/019-021 (Pinna Mimlija għalLest 50 mg)
English: Enbrel 25 mg powder and solvent for solution for injection etanercept
Maltese: Enbrel 25 mg trab u solvent għal soluzzjoni għall-injezzjoni etanercept
English: After taking a pre-filled pen from the refrigerator, wait approximately 15-30 minutes to allow the Enbrel solution in the pen to reach room temperature.
Maltese: Ħalli l-għatu abjad tal-labra f'postu u stenna madwar 15-30 minuta biex tippermetti lissoluzzjoni ta' Enbrel fil-pinna biex tilħaq it-temperatura tal-kamra.
English: This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in adults with psoriatic arthritis, one study in adults with ankylosing spondylitis, one study in adults with non-radiographic axial spondyloarthritis, four studies in adults with plaque psoriasis, three studies in juvenile idiopathic arthritis and one study in paediatric patients with plaque psoriasis.
Maltese: Din is-sezzjoni fiha tagħrif meħud minn erba' studji randomised u kkontrollati f'adulti b'artrite rewmatojde, studju wieħed f'adulti b'artrite psorjatika, studju wieħed f'adulti b'ankylosing spondylitis, studju wieħed f'adulti bi spondiloartrite assjali mhux radjografika, erba' studji f'adulti b'artrite psorjatika, tliet studji dwar artrite idjopatika taż-żgħażagħ u studju wieħed fuq pazjenti pedjatriċi bi psorjasi tal-plakka.
English: Chemical and physical in-use stability has been demonstrated for 6 hours at temperatures of up to 25°C after reconstitution.
Maltese: L-istabbilità kimika jew fiżika waqt l-użu ntweriet għal 6 sigħat f'temperaturi ta' massimu ta' 25C wara r-rikostituzzjoni.
English: In adults (aged 18 and over), Enbrel can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis including ankylosing spondylitis, and moderate or severe psoriasis - in each case usually when other widely used treatments have not worked well enough or are not suitable for you.
Maltese: Fl-adulti (ta' 18-il sena jew aktar), Enbrel jista' jintuża għal artrite rewmatojde, artrite psorjatika minn moderata sa severa, spondiloartrite assjali severa li tinkludi ankylosing spondylitis, u psorjasi moderata jew severa - f'kull każ fejn ġeneralment kuri użati komunament ma jkunux ħadmu tajjeb biżżejjed jew m'humiex adattati għalik.
English: 12 pre-filled syringes 12 alcohol swabs
Maltese: 12-il siringa mimlija għal-lest 12-il swab tal-alkoħol
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED PEN - EU/1/99/126/023-025 (25 mg Pre-filled Pen)
Maltese: KITBA GĦALL-PINNA MIMLIJA GĦAL-LEST- EU/1/99/126/023-025 (Pinna Mimlija għalLest 25 mg)
English: The syringe inside the pen is made from clear type 1 glass with a stainless steel 27 gauge needle, rubber needle cover, and plastic plunger.
Maltese: Is-siringa ġolpinna hi magħmula minn ħġieġ ċar ta' tip 1 b'labra ta' azzar li ma jsaddadx ta' 27 gauge, għatu tallabra magħmul mil-lastku, u planġer tal-plastik.
English: The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose), given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses or 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly.
Maltese: Id-doża rakkomandata hi ta' 0.4 mg/kg (sa massimu ta' 25 mg għal kull doża), mogħti darbtejn f'ġimgħa bħala injezzjoni taħt il-ġilda b'intervall ta' 3-4 ijiem bejn id-dożi jew 0.8 mg/kg (sa massimu ta' 50 mg kull doża) mogħtija darba fil-ġimgħa.
English: Τηλ.
Maltese: HBsAg.
English: Compared to placebo, patients with rheumatic diseases treated with Enbrel had a significantly higher incidence of injection site reactions (36% vs. 9%).
Maltese: Imqabbla mal-plaċebo, pazjenti b'mard rewmatiku kkurati b'Enbrel kellhom inċidenza b'mod sinifikanti aktar għolja ta' reazzjonijiet fis-siti ta' l-injezzjoni (36% vs. 9%).
English: Patients should be evaluated for infections before, during, and after treatment with Enbrel, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
Maltese: Il-pazjenti għandhom ikunu evalwati għal infezzjonijiet qabel, matul, u wara l-kura b'Enbrel, u trid tkun ikkunsidrata li l-medja tal-half-life ta' l-eliminazzjoni ta' etanercept hi ta' madwar 70 siegħa (medda ta' 7 sa 300 siegħa).
English: Diagram 1 The MYCLIC pre-filled pen
Maltese: Pass 1: Kif tipprepara għall-injezzjoni
English: Each pre-filled syringe contains 1.0 ml of solution, providing 50 mg of etanercept.
Maltese: Kull siringa mimlija għal-lest fiha 1.0 ml ta' soluzzjoni, li tipprovdi 50 mg ta' etanercept.
English: Responses of Patients with Psoriatic Arthritis in a PlaceboControlled Trial Percent of Patients Placebo
Maltese: Risponsi ta' Pazjenti b'Artrite Psorjatika fi Prova Kkontrollata bil-Plaċebo
English: Step 1: Preparing for an Enbrel injection Step 2: Choosing an injection site Step 3: Injecting the Enbrel solution Step 4: Disposing of the used MYCLIC pen
Maltese: Pass 1: Kif tipprepara għall-injezzjoni ta' Enbrel Pass 2: Kif tagħżel is-sit tal-injezzjoni Pass 3: Kif tinjetta s-soluzzjoni ta' Enbrel Pass 4: Kif tarmi l-pinna użata MYCLIC
English: Enbrel 25 mg is supplied as a white powder and solvent for solution for injection (powder for injection).
Maltese: Enbrel 25 mg jiġi bħala trab abjad u solvent għal soluzzjoni għall-injezzjoni (trab għall-injezzjoni).
English: Purple needle safety shield
Maltese: Protezzjoni tas-sigurtà tallabra vjola
English: However, the solution may be used for up to 6 hours when stored at a temperature up to 25°C.
Maltese: Madankollu, issoluzzjoni tista' tintuża sa 6 sigħat meta maħżun f'temperatura ta' mhux aktar minn 25C.
English: Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system.
Maltese: It-tabib tiegħek ser jistabbilixxi jekk kura preventiva għall-ġidri r-riħ hix adattata.
English: • Uncommon (may affect up to 1 in 100 people):
Maltese: • Komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10):
English: In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving Enbrel during 3 months of the study (part 1, open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of open-label extension therapy.
Maltese: Fi studju fi tfal b'artrite idjopatika taż-żgħażagħ li għandhom minn 4 sa 17-il sena, 43 mid-69 (62%) tat-tfal li kienu fuq il-kura b'Enbrel kellhom infezzjoni matul it-3 xhur ta' l-istudju (l-ewwel parti open-label), u l-frekwenza u s-severità ta' l-infezzjoni kienet simili fi 58 pazjent li spiċċaw it-12il xahar ta' terapija open-label ta' estensjoni.
English: Non-radiographic axial spondyloarthritis
Maltese: Spondiloartrite assjali mhux radjografika
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR VIAL LABEL - EU/1/99/126/022 (For paediatric use)
Maltese: KITBA FUQ IT-TIKKETTA TAL-KUNJETT - EU/1/99/126/022 (Għal użu pedjatriku)
English: • Remove the needle cover by firmly pulling it straight off the syringe taking care not to touch the needle or allow the needle to touch any surfaces (see Diagram 15).
Maltese: • jekk it-tifel/tifla li qed tieħu ħsieb ikun/tkun allerġiku/ka għal etanercept jew sustanzi oħra ta' Enbrel (elenkati fis-sezzjoni 6).
English: Method of administration Enbrel is administered by subcutaneous injection (see section 6.6).
Maltese: Kif jingħata Enbrel jingħata permezz ta' injezzjoni taħt il-ġilda (ara sezzjoni 6.6).
English: Enbrel 50 mg solution for injection in pre-filled syringe etanercept
Maltese: Enbrel 50 mg injezzjoni etanercept
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TEXT FOR TRAY BACKING - EU/1/99/126/002
Maltese: KITBA FUQ IT-TIKKETTA TAL-KUNJETT - EU/1/99/126/002
English: The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose) given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses or 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly.
Maltese: Id-doża rakkomandata hi ta' 0.4 mg/kg (sa massimu ta' 25 mg għal kull doża) mogħti darbtejn f'ġimgħa bħala injezzjoni taħt il-ġilda b'intervall ta' 3-4 ijiem bejn id-dożi jew 0.8 mg/kg (sa massimu ta' 50 mg kull doża) mogħtija darba fil-ġimgħa.
English: Re-introduction of treatment with Enbrel after discontinuation of up to 24 months resulted in the same magnitudes of responses as patients who received Enbrel without interruption of therapy based on results of open-label studies.
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: If any of the above warnings and precautions apply to you (or you are not sure), talk to your healthcare worker before receiving Ervebo.
Maltese: Dan ifisser li għad trid tingħata aktar evidenza dwar dan il-prodott mediċinali.
English: PC SN NN
Maltese: PC SN
English: Immunocompromised individuals
Maltese: Individwi immunokompromessi
English: Protocol 009
Maltese: Protokoll 009§
English: 30 Oct 2020
Maltese: 30 ta' Ottubru 2020
English: See sections 4.4 and 6.6 for further information.
Maltese: Ara sezzjonijiet 4.4 u 6.6 għal aktar informazzjoni.
English: Protocol 011
Maltese: Protokoll 011§
English: See section 5.3.
Maltese: Ara sezzjoni 5.3.
English: • Respiratory hygiene
Maltese: • Iġjene respiratorja
English: A total of 1,197 healthy subjects 18 to 65 years of age were enrolled in the US, Canada, and Spain.
Maltese: Total ta' 1,197 individwu f'saħħtu b'età minn 18 sa 65 sena kienu rreġistrati fl-Istati Uniti, ilKanada u Spanja.