FrancophonIA/ELRC3.0 huggingface dataset:
English: In the severe form of CAPS, long-term treatment improves the systemic inflammatory organ manifestations of the eye, inner ear, and CNS.
Maltese: Fil-forma severa ta' CAPS, kura fit-tul ittejjeb il-manifestazzjonijiet infjammatorji sistemiċi fl-organi tal-għajn, tal-parti ta' ġewwa tal-widna, u s-CNS.
English: The incidence of serious infection was higher in Kineret-treated patients compared to patients receiving placebo (1.8% vs. 0.7%).
Maltese: L-inċidenza ta' infezzjonijiet serji kienet ogħla f'pazjenti kkurati b'Kineret meta mqabbel ma' pazjenti li ngħataw il-plaċebo (1.8% vs. 0.7%).
English: In clinical studies and during post-marketing use, rare cases of opportunistic infections have been observed and have included fungal, mycobacterial, bacterial, and viral pathogens.
Maltese: Fi studji kliniċi u waqt użu wara t-tqegħid fis-suq, ġew osservati każijiet rari ta' infezzjonijiet opportunistiċi u dawn kienu jinkludu patoġeni fungali, mikobatterji, batterji u virali.
English: An adverse event profile similar to that seen in adult RA patients was observed in these studies.
Maltese: F'dawn l-istudji ġie osservat profil ta' avvenimenti avversi simili għal dak osservat f'pazjenti adulti b'RA.
English: In severe renal insufficiency and end stage renal disease (creatinine clearance < 30 ml/min), mean plasma clearance declined by 70% and 75%, respectively.
Maltese: F'insuffiċjenza renali severa u l-mard tal-kliewi fi stadju finali (tneħħija tal krejatinina < 30 mL/min), il-medja tat- tneħħija mill-plażma naqset b'70% u 75%, rispettivament.
English: Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still's disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids.
Maltese: (SJIA - Systemic Juvenile Idiopathic Arthritis) u l-Marda ta' Still li Toħroġ fl-Adulti (AOSD - AdultOnset Still's Disease), b'karatteristiċi sistemiċi attivi ta' attività tal-marda moderata sa għolja, jew f'pazjenti b'attività kontinwa tal-marda wara trattament b'mediċini antiinfjammatorji mhux sterojdi
English: IL-1 is found in the plasma and synovial fluid of patients with rheumatoid arthritis, and a correlation has been reported between IL-1 concentrations in the plasma and the activity of the disease.
Maltese: IL-1 jinsab fil-plażma u fil-likwidu sinovjali ta' pazjenti b'artrite rewmatojde, u nstabet korrelazzjoni bejn il-konċentrazzjonijiet ta' IL-1 fil-plażma u l-attività tal-marda.
English: After a 1-month blinded phase, 8 of 12 patients in the Kineret treated group were identified as modified ACRpedi30 responders compared to 1 of 12 in the placebo group.
Maltese: Wara fażi blinded ta' xahar, 8 minn 12-il pazjent fil-grupp ittrattat b'Kineret ġew identifikati bħala li kellhom rispons ACRpedi30 modifikat meta mqabbel ma' 1 minn 12 fil-grupp tal-plaċebo.
English: In 15 SJIA patients followed for up to 1.5 years, one patient developed a serious hepatitis in connection with a cytomegalovirus infection.
Maltese: Fi 15-il pazjent b'SJIA segwiti sa 1.5 snin, pazjent wieħed żviluppa epatite serja b'konnessjoni ma' infezzjoni b'cytomegalovirus.
English: Similar rates were obtained for the groups on the SOC level, except for eye disorders with 55 AEs (rate 0.5), whereof 35 ocular hyperemia (which could also be a symptom of CAPS) in the CIAS1 group, and 4 AEs in the non-CIAS1 group (rate 0.1).
Maltese: Rati simili inkisbu għall-gruppi fuq il-livell tal-SOC, ħlief għal disturbi fl-għajnejn b'55 avveniment avvers (rata ta' 0.5), li minnhom 35 kienu iperimja okulari (li tista wkoll tkun sintomu ta' CAPS) fil-grupp ta' CIAS1, u 4 avvenimenti avversi fil-grupp mhux ta' CIAS1 (rata ta' 0.1).
English: Elderly population (≥ 65 years)
Maltese: Persuni akbar fl-età (≥ 65 sena)
English: The safety profile in paediatric patients was similar to that seen in adult populations and no clinically relevant new adverse reactions were seen.
Maltese: Il-profil tas-sigurtà f'pazjenti pedjatriċi kien simili għal dak li deher fil-popolazzjonijiet adulti u ma dehru l-ebda reazzjonijiet avversi ġodda li kienu klinikament rilevanti.
English: In subjects with RA, maximum plasma concentrations of anakinra occurred at 3 to 7 hours after subcutaneous administration of anakinra at clinically relevant doses (1 to 2 mg/kg; n = 18).
Maltese: F'pazjenti b'RA, l-ogħla konċentrazzjonijiet filplażma seħħew minn 3 sa 7 sigħat wara l-għoti ta' anakinra taħt il-ġilda f'dożi klinikament rilevanti (1 sa 2 mg/kg; n = 18).
English: Pack sizes of 1, 7 or 28 (multipack containing 4 packs of 7 pre-filled syringes) pre-filled syringes.
Maltese: Id-daqsijiet tal-pakketti huma 1, 7 jew 28 (pakkett multiplu li fih 4 pakketti ta' 7 siringi mimlijin għal lest) siringa mimlija għal-lest.
English: In clinical trials in RA, up to 3% of adult patients tested seropositive at least once during the study for neutralizing anti-anakinra antibodies.
Maltese: Fi provi kliniċi f'RA, sa 3% tal-pazjenti adulti rriżultaw seropożittivi mill-anqas darba waqt l-istudju għall-antikorpi kontra anakinra li jinnewtralizzaw.
English: Population pharmacokinetic analysis demonstrated that the mean plasma clearance value after subcutaneous bolus administration was approximately 14% higher in men than in women and approximately 10% higher in subjects < 65 years than in subjects ≥ 65 years.
Maltese: Analiżi farmakokinetika ta' popolazzjoni wriet li l-valur medju ta' tneħħija mill-plażma wara injezzjoni taħt il-ġilda kien bejn wieħed u ieħor 14% ogħla fl-irġiel milli fin-nisa u bejn wieħed u ieħor 10% ogħla f'pazjenti ta' < 65 sena milli f'pazjenti ta' ≥ 65 sena.
English: The efficacy and safety of Kineret in patients with AST/ALT ≥ 1.5 x upper level of normal have not been evaluated.
Maltese: L-effikaċja u s-sigurtà ta' Kineret fuq pazjenti b'AST/ALT ≥ 1.5 x tal-ogħla livell tan-normal ma ġewx evalwati.
English: Excipients: anhydrous citric acid, sodium chloride, disodium edetate dihydrate, polysorbate 80, sodium hydroxide, water for injections.
Maltese: Sustanzi mhux attivi: aċidu ċitriku anidru, sodium chloride, disodium edetate dihydrate,
English: Thrombocytopenia
Maltese: Bettija tas-siringa
English: Starting dose
Maltese: MedDRA Frekwenza
English: Patients with Still's disease have an increased risk of spontaneous development of MAS.
Maltese: Pazjenti bil-Marda ta' Still għandhom riskju akbar ta' żvilupp spontanju ta' MAS.
English: None of the syringe or needle shield components are made with natural rubber latex.
Maltese: Ebda parti mill-komponenti tas-siringa jew tal-protezzjoni għal-labra ma hija magħmula minn latex tal-gomma naturali.
English: Mild thrombocytopenia has also been observed in CAPS patients.
Maltese: Ġiet osservata wkoll tromboċitopenja f'pazjenti CAPS.
English: Kineret treatment significantly decreases the manifestations of CAPS, including a reduction in frequently occurring symptoms as fever, rash, joint pain, headache, fatigue, and eye redness.
Maltese: Kura b'Kineret tnaqqas b'mod sinifikanti l-manifestazzjonijiet ta' CAPS, li jinkludu tnaqqis f'sintomi frekwenti bħal deni, raxx, uġigħ fil-ġogi, uġigħ ta' ras, għeja, u ħmura fl-għajnejn.
English: Kineret treatment should not be initiated in patients with neutropenia (ANC < 1.5 x 109/l).
Maltese: Il-kura b'Kineret m'għandhiex tinbeda f'pazjenti b'newtropenija (ANC < 1.5 x 109/L).
English: Pharmacokinetic data are lacking in older CAPS patients.
Maltese: Ma hemm l-ebda dejta farmakokinetika f'pazjenti akbar fl-età b'CAPS.
English: This is a type of cytokine (an immunosuppressive agent) that is used to treat: - Rheumatoid Arthritis (RA) - Cryopyrin-Associated Periodic Syndromes (CAPS) which includes the following autoinflammatory diseases: - Neonatal-Onset Multisystem Inflammatory Disease (NOMID), also called Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA), - Muckle-Wells Syndrome (MWS), - Familial Cold Autoinflammatory Syndrome (FCAS) - Still´s disease including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD)
Maltese: Flimkien mal-valutazzjoni tas-sintomi kliniċi u l-markaturi infjammatorji f'CAPS severi, valutazzjonijiet tal-infjammazzjoni tal-CNS, inkluż il-parti ta' ġewwa tal-widna (MRI jew CT, titqib lumbari, u awdjoloġija) u tal-għajnejn (valutazzjonijiet oftalmoloġiċi) huma rakkomandati wara l-ewwel 3 xhur ta' kura, u minn hemm 'il quddiem kull 6 xhur, sakemm ikunu ġew identifikati d-dożi effettivi ta' kura.
English: Data from mice over expressing IL-1ra and IL-1ra mutant knock-out mice, did not indicate an increased risk of tumour development.
Maltese: Dejta minn studji fuq il-ġrieden li jipproduċu aktar IL-1ra u fuq ġrieden IL-1ra mutanti knock-out, ma wriet l-ebda żieda fir-riskju ta' żvilupp ta' tumuri.
English: For a more comfortable injection, leave at room temperature for approximately 30 minutes or hold the pre-filled syringe gently in your hand for a few minutes.
Maltese: Għal injezzjoni aktar komda, ħalliha toqgħod fit-temperatura tal-kamra għal bejn wieħed u ieħor 30 minuta jew żomm is-siringa mimlija għal-lest delikatament f'idejk għal ftit minuti.
English: - CAPS: Kineret is not recommended for children younger than 8 months of age because there is no data in this age group.
Maltese: Kineret mhuwiex rakkomandat għal tfal iżgħar minn 8 xhur minħabba li ma hemm ebda dejta f'dan il-grupp ta' età.
English: There have been reports of tuberculosis in patients receiving several biological anti-inflammatory treatment regimens.
Maltese: Kien hemm rapporti ta' tuberkulosi f'pazjenti li kienu qed jirċievu diversi korsijiet ta' kura bijoloġiċi kontra l-infjammazzjoni.
English: CAPS: Adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above
Maltese: Adulti, adolexxenti, tfal u trabi ta' 8 xhur u aktar, b'piż tal-ġisem ta' aktar minn 10 kg
English: These data support that no dose adjustment is needed for patients with mild renal impairment (CLcr 50 to 80 ml/minute).
Maltese: Din id-dejta tappoġġa l-fatt li l-ebda aġġustament fid-doża ma huwa meħtieġ għal pazjenti b'indeboliment renali ħafif (CLcr 50 sa 80 mL/minuta).
English: Thus, it may be expected that for an IL-1 receptor antagonist, such as anakinra, the formation of CYP450 enzymes could be normalized during treatment.
Maltese: Għalhekk, jista' jkun mistenni li għal antagonista tar-riċettur IL-1, bħal anakinra, il-formazzjoni ta' enzimi CYP450 tista' tiġi normalizzata waqt il-kura.
English: This was not associated with any clinically significant effects on pharmacokinetics, efficacy, or safety.
Maltese: Dan ma kienx assoċjat ma' xi effetti klinikament sinifikanti fuq il-farmakokinetika, leffikaċja, jew is-sigurtà.
English: The safety and efficacy of Kineret have been demonstrated in CAPS patients with varying degrees of disease severity.
Maltese: Is-sigurtà u l-effikaċja ta' Kineret intwerew f'pazjenti b'CAPS bi gradi differenti tas-severità talmarda.
English: In RA, CAPS and in Still's disease, your body produces too much of a cytokine called interleukin-1.
Maltese: F'RA, CAPS u fil-marda ta' Still, ġismek jipproduċi ammont żejjed ta' ċitokina partikolari li jisimha interleukin-1.
English: Medicines called tumour necrosis factor (TNF-α) inhibitors, such as etanercept should not be used with Kineret because this may increase the risk of infections.
Maltese: Mediċini msejħin inibituri tal-fattur tan-nekrożi tat-tumur (TNF-α), bħal etanercept, ma għandhomx jintużaw ma' Kineret minħabba li dan jista' jżid ir-riskju ta' infezzjonijiet.
English: For a small number of patients with asthma, the incidence of serious infection was higher in Kineret-treated patients (4.5%) vs. placebo-treated patients (0%), these infections were mainly related to the respiratory tract.
Maltese: F'numru żgħir ta' pazjenti bl-ażżma, l-inċidenza ta' infezzjonijiet serji kienet ogħla f'pazjenti kkurati b'Kineret (4.5%) meta mqabbla ma' pazjenti li rċevew plaċebo (0%), dawn linfezzjonijiet kienu prinċipalment relatati mal-passaġġ respiratorju.
English: At a dose of 100 mg/day, 71% of RA patients developed an ISR compared to 28% of the placebo treated patients.
Maltese: B'doża ta' 100 mg/kuljum, 71% tal-pazjenti b'RA żviluppaw reazzjoni fil-post tal-injezzjoni meta mqabbel ma' 28% tal-pazjenti li ngħataw il-plaċebo.
English: Maintenance dose in severe CAPS (MWS and NOMID/CINCA)
Maltese: Mhux magħruf (ma tistax tittieħed stima mid data disponibbli)
English: These have shown no deleterious effect on joint cartilage.
Maltese: - Reazzjonijiet allerġiċi serji mhumiex komuni.
English: Uncommon (≥ 1/1,000 to < 1/100) Hepatic enzyme increased Not known (cannot be estimated from the available data)
Maltese: < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: No dose adjustment is needed for patients with mild renal impairment (CLcr 60 to 89 ml/min).
Maltese: Ma huwa meħtieġ l-ebda tibdil fid-doża għall-pazjenti b'indeboliment ħafif tal-kliewi (CLcr 60 sa 89 mL/min).
English: How to store Kineret
Maltese: X'fih Kineret
English: The European Medicines Agency has waived the obligation to submit the results of studies with Kineret in one or more subsets of the paediatric population in CAPS and RA (JIA) (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Kineret f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika f'CAPS u RA (JIA) (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Less than 2.5% of the administered dose of Kineret was removed by hemodialysis or continuous ambulatory peritoneal dialysis.
Maltese: Anqas minn 2.5% tad-doża mogħtija ta' Kineret tneħħiet b'emodijalisi jew dijalisi peritoneali ambulatorja kontinwa.
English: Still's disease: Children weighing less than 50 kg are dosed by body weight with a starting dose of 1-2 mg/kg/day, patients weighing 50 kg or more are dosed with 100 mg/day.
Maltese: 1-2 mg/kg/jum, pazjenti li jiżnu 50 kg jew aktar huma ddożati b'100 mg/jum.
English: Neither did anakinra increase the incidence of chromosomal abnormalities or micronuclei in bone marrow cells in mice.
Maltese: Anakinra ma żiedx l-inċidenza ta' abnormalitajiet fil-kromosomi jew fil-mikronukleji fiċ-ċelluli tal-mudullun tal-ġrieden.
English: • a sterile gauze or tissue
Maltese: • garża jew karta assorbenti sterili
English: During post-marketing use isolated case reports indicating non-infectious hepatitis have been received.
Maltese: Matul l-użu wara t-tqegħid fis-suq waslu rapporti iżolati ta' każijiet li jindikaw epatite mhux infettiva.
English: The median steady-state dose-normalized anakinra concentration in SJIA patients over 28 weeks was comparable to that observed in RA patients.
Maltese: Il-konċentrazzjoni medjana fi stat fiss (steady state) ta' doża normalizzata ta' anakinra f'pazjenti b'SJIA fuq 28 ġimgħa kienet komparabbli ma' dik osservata f'pazjenti b'RA.
English: Symptoms might be persistent high fever, shivers, cough, headache, and redness and tenderness of the skin.
Maltese: Sintomi jistgħu jkunu deni qawwi li jippersisti, tertir, sogħla, uġigħ ta' ras, u ħmura u sensittività tal-ġilda.
English: Pharmacokinetic data in children < 4 years are lacking, but clinical experience is available from 8 months of age, and when started at the recommended daily dose of 1-2 mg/kg, no safety concerns have been identified.
Maltese: Ma hemmx dejta farmakokinetika fit-tfal <4 snin, iżda l-esperjenza klinika hija disponibbli minn età ta' 8 xhur, u meta nbeda fid-doża rakkomandata ta' kuljum ta' 1-2 mg/kg, ma kien identifikat l-ebda tħassib dwar is-sigurtà.
English: Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe Anakinra
Maltese: Kineret 100 mg/0.67 mL soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest
English: The therapeutic response is primarily reflected by reduction in clinical symptoms such as fever, rash, joint pain, and headache, but also in inflammatory serum markers (CRP/SAA levels), or occurrence of flares.
Maltese: Ir-rispons terapewtiku huwa primarjament rifless permezz ta' tnaqqis fis sintomi kliniċi bħal deni, raxx, uġigħ fil-ġogi, u uġigħ ta' ras, iżda wkoll fil-markaturi infjammatorji fis-serum (livelli ta' CRP/SAA), jew l-okkorrenza ta' rikaduti.
English: - RA: Use of Kineret in children and adolescents with Rheumatoid Arthritis has not been fully investigated and therefore cannot be recommended.
Maltese: - RA: L-użu ta' Kineret fit-tfal u fl-adolexxenti bl-Artrite Rewmatojde ma kienx investigat b'mod sħiħ, u għalhekk mhuwiex rakkomandat.
English: The activated inflammasome results in proteolytic maturation and secretion of IL-1β, which has a broad range of effects including systemic inflammation.
Maltese: Ir-riżultati talinflammasome attivat iwasslu għal maturazzjoni proteolitika u s-sekrezzjoni ta' IL-1β, li għandu firxa wiesgħa ta' effetti fosthom infjammazzjoni sistemika.
English: Rheumatoid Arthritis (RA)
Maltese: Soluzzjoni għall-injezzjoni (injezzjoni).
English: The adverse event profile from these studies show no overall difference from that seen in the rheumatoid arthritis studies.
Maltese: Il-profil tal-avvenimenti avversi minn dawn l-istudji ma juri l-ebda differenza globali minn dak osservat fi studji dwar l-artrite rewmatojde.
English: Cryopyrin-Associated Periodic Syndromes (CAPS) Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of CAPS, including: - Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological,
Maltese: Kineret huwa indikat f'adulti, adolexxenti, tfal u trabi ta' età minn 8 xhur 'il fuq b'piż tal-ġisem ta' 10 kg jew aktar għat-trattament tal-marda ta' Still, inklużi Artrite Idjopatika Sistemika fil-Minorenni
English: RA: Adults
Maltese: RA:
English: The safety and efficacy of anakinra in combination with methotrexate have been demonstrated in 1,790 RA patients ≥ 18 years of age with varying degrees of disease severity.
Maltese: Effikaċja klinika u sigurtà f'RA Is-sigurtà u l-effikaċja ta' anakinra flimkien ma' methotrexate intwerew f'1,790 pazjent b'RA ≥ 18
English: 100 mg dose” section.
Maltese: Kif tipprepara doża ta' 100 mg?
English: In addition, in a clinical trial 6% of 86 paediatric patients with JIA, whereof none of the 15 SJIA subtype patients, tested seropositive at least once during the study for neutralizing anti-anakinra antibodies.
Maltese: Barra minn hekk, fi studju kliniku, 6% minn 86 pazjenti pedjatriċi b'JIA, bl-ebda wieħed mill-15-il pazjent b'sottotip ta' SJIA, irriżultaw seropożittivi għal minn tal-inqas darba waqt l-istudju għall-antikorpi kontra anakinra li jinnewtralizzaw.
English: In clinical studies transient elevations of liver enzymes have been seen.
Maltese: Fi studji kliniċi kienu osservati żidiet temporanji fl-enzimi tal-fwied.
English: Package leaflet: Information for the user Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe
Maltese: Informazzjoni għall-utent Kineret 100 mg/0.67 mL soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest
English: Each 0.67 ml graduated pre-filled syringe contains 100 mg of anakinra.
Maltese: Kull siringa gradwata mimlija għal-lest ta' 0.67 mL fiha 100 mg ta' anakinra.
English: In studies of sepsis, 1,015 patients received Kineret at doses up to 2 mg/kg/hour i.v.
Maltese: Fi studji dwar is-sepsis, 1,015-il pazjent irċevew Kineret f'dożi sa 2 mg/kg/siegħa ġol-vina (~35 darba d-doża rakkomandata f'RA) fuq perjodu ta' kura ta' 72 siegħa.
English: In general the pharmacokinetics in CAPS patients is similar to that in RA patients.
Maltese: B'mod ġenerali l-farmakokinetika f'pazjenti b'CAPS hija simili għal dik f'pazjenti b'RA.
English: The pre-filled syringe has an outer rigid plastic needle shield attached to an inner needle cover.
Maltese: F'pazjenti b'CAPS ġiet innotata linearità approssimattiva tad-doża b'tendenza żgħira ogħla miż-żieda proporzjonali.
English: - The other ingredients are anhydrous citric acid, sodium chloride, disodium edetate dihydrate, polysorbate 80 and sodium hydroxide and water for injections.
Maltese: - Is-sustanzi l-oħra huma aċidu ċitriku anidru, sodium chloride, disodium edetate dihydrate,
English: CAPS: Data in elderly patients are limited.
Maltese: Id-dejta f'pazjenti anzjani hija limitata.
English: The recommended starting dose in all CAPS subtypes is 1-2 mg/kg/day by subcutaneous injection.
Maltese: (1-2 mg/kg/kuljum).
English: There are limited amount of data from the use of anakinra in pregnant women.
Maltese: Hemm dejta limitata dwar l-użu ta' anakinra f'nisa tqal.
English: No effects on embryo-foetal development in the rabbit were observed at doses 100 times the human dose.
Maltese: Ma ġew osservati l-ebda effetti fuq l-iżvilupp embrijofetali fil-fniek b'dożi sa 100 darba tad-doża umana.
English: Most patients continued on study medicinal product after the infection resolved.
Maltese: Waqt l-istudji kliniċi ma ġewx osservati tossiċitajiet li jillimitaw id-doża.
English: Allergic reactions including anaphylactic reactions, angioedema, urticaria, rash, and pruritus have been reported uncommonly with Kineret.
Maltese: Reazzjonijiet allerġiċi, li jinkludu reazzjonijiet anafilattiċi, anġjoedema, urtikarja u ħakk.
English: If you forget to use Kineret
Maltese: Rimi ta' siringi użati u provvisti
English: It is unknown whether anakinra/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk anakinra/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: (Your doctor will have told you what dose you need to use.)
Maltese: (It-tabib tiegħek se jkun qallek liema doża għandek bżonn tuża.)
English: EU/1/06/339/003 Preotact
Maltese: EU/1/06/339/003
English: 1.61 mg (1.4 mg/ml)
Maltese: 1.61 mg (1.4 mg/ml) 2 pinen mimlijin għal-lest
English: Subcutaneous powder: dual-chamber cartridge (glass) in pre-filled pen; solvent: dual-chamber cartridge (glass) in pre-filled pen
Maltese: Trab: skartoċċ ta' żewġ kompartimenti (ħġieġ) f'pinna mimlija għal-lest; solvent: skartoċċ ta' żewġ kompartimenti (ħġieġ) f'pinna mimlija għal-lest
English: Pack size
Maltese: Preotact
English: 2 pre-filled pens
Maltese: Il-pakkett li jmiss malprodott
English: Ref.: EMEA/264573/2009 EMEA/H/C/1019
Maltese: EMEA/264573/2009 EMEA/H/C/1019
English: fluticasone furoate EPAR summary for the public
Maltese: fluticasone furoate Sommarju tal-EPAR għall-pubbliku
English: The active substance in Alisade, fluticasone furoate, is a corticosteroid.
Maltese: Is-sustanza attiva f'Alisade, fluticasone furoate hija corticosteroid.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fluticasone Furoate GSK to Glaxo Group Ltd on 6 October 2008.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Fluticasone Furoate GSK lil Glaxo Group Ltd fis-6 ta' Ottubru 2008.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni relatata mar-rakkomandazzjonijiet tas-CHMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: Previously known as Fluticasone Furoate GSK.
Maltese: Dak li qabel kien magħruf bħala Fluticasone Furoate GSK.
English: Each symptom was measured on a scale from 0 to 3, with a maximum total score of
Maltese: Kull sintomu tkejjel fuq skala minn 0 sa 3, bi skor totali massimu ta' 12.
English: In the studies of seasonal allergic rhinitis in patients aged 12 years or over, Alisade reduced symptom scores from around 9 points at the start of the study by between 3.6 and 5.4 points over two weeks, compared with a reduction of 2.3 to 3.7 points with placebo.
Maltese: Fl-istudji tar-rinite allerġika staġjonali f'pazjenti minn 12-il sena 'il fuq, Alisade naqqas liskor tas-sintomi minn madwar 9 qabel beda l-istudju għal bejn 3.6 u 5.4 punti fuq medda ta' ġimgħatejn, meta mqabbel ma' tnaqqis ta' 2.3 sa 3.7 punti bi plaċebo.