FrancophonIA/ELRC3.0 huggingface dataset:
English: The ACQ-5 and AQLQ(S) responder rate results in patients with elevated baseline biomarkers of type 2 inflammation in QUEST at week 52 are presented in Table 10.
Maltese: Ir-riżultati tar-rata ta' persuni li rrispondew ACQ-5 u AQLQ(S) f'pazjenti b'żieda fillivelli tal-bijomarkaturi ta' infjammazzjoni tat-tip 2 fil-linja bażi fi QUEST f'Ġimgħa 52 huma ppreżentati f'Tabella 10.
English: • 1 pre-filled syringe
Maltese: • ħakk • uġigħ fil-ġogi
English: It contains 300 mg of Dupixent for injection under the skin (subcutaneous injection).
Maltese: segwita minn 300 mg kull ġimagħtejn permezz ta' injezzjoni subkutaneja.
English: During a reproductive toxicology study conducted in monkeys, using a surrogate antibody specific to the monkey IL-4Rα, no fetal abnormalities were observed at dosages that saturate the IL-4Rα.
Maltese: Waqt studju dwar l-effett tossiku fuq is-sistema riproduttiva li twettaq fix-xadini, bl-użu ta' antikorp sostitut speċifiku għal IL-4Rα tax-xadini, ma kinux osservati anormalitajiet fil-fetu b'dożaġġi li ssaturaw IL-4Rα.
English: A significantly greater proportion of patients randomised to dupilumab achieved a rapid improvement in the pruritus NRS compared to placebo (defined as >4-point improvement as early as week 4; nominal p<0.001) and the proportion of patients responding on the pruritus NRS continued to increase through the treatment period (see Figure 5).
Maltese: 4 ġimgħa; nominali p<0.001) u l-proporzjon ta' pazjenti li rrispondew fuq l-NRS tal-pruritu komplew jiżdiedu matul il-perjodu ta' trattament (ara Figura 5).
English: 7.21b aModel estimates by logistic regression bp-value <0.0001
Maltese: 7.21b aMudelli ta' stimi permezz ta' regressjoni loġistika bvalur p <0.
English: Number of patients with baseline pruritus NRS score ≥ 4
Maltese: HADS ≥ 8 fillinja bażi
English: EN
Maltese: MT
English: With Respect to “Pregnancy”
Maltese: Fir-rigward ta' treddigħ
English: <Available pharmacodynamic/toxicological data in animals have shown excretion of {Active substance}/metabolites in milk (for details see 5.3).>
Maltese: <Dejta farmakodinamika / tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' {Sustanza attiva}/metaboliti fil-ħalib tas-sider (gћad-dettalji ara 5.3.>
English: {Invented name} is contraindicated <during pregnancy><during {trimester} of pregnancy> [this case is a strict contraindication] (see section 4.3).
Maltese: {Isem kummerċjali} m'għandux jingħata <waqt it-tqala> <waqt {trimestru} tat-tqala> [dan hu każ ta' kontra-indikazzjoni stretta] (ara 4.3).
English: [1] <{Active substance}/metabolites are excreted in human milk and effects have been shown in breastfed newborns/infants of treated women.>
Maltese: [1] <{Sustanza attiva}/metaboliti hu/ hi/ huma eliminat/a/i fil-ћalib tas-sider tal-bniedem u effetti ġew murija fit-trabi ta' twelid li qegћdin jiġu mreddgћin min-nisa li ћadu it-trattament.>
English: [5] <There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of {Active substance} in pregnant women.
Maltese: [5] <Għall-{Sustanza attiva} m'hemmx dejta jew hemm dejta limitata (inqas min 300 riżultat ta' tqala) dwar l-użu fin-nisa tqal.
English: [1]<Based on human experience [specify] {Active substance} causes <congenital malformations [specify] when administered during pregnancy.> [or] <harmful pharmacological effects during pregnancy and/or on the fetus/newborn child.>
Maltese: [1] <Skont esperjenza mill-użu fil-bniedem> [specify] <{Sustanza attiva}> tagħmel <difetti serji tat-twelid meta tingħata waqt it-tqala> [or] < effetti farmakoloġici ћżiena waqt it-tqala u / jew fuq il-fetu / tarbija tat-twelid>
English: <{Invented name} <is contraindicated during breast-feeding (see section 4.3)> [or] <should not be used during breast-feeding>.>
Maltese: <{Isem kummerċjali} <hu kontra-indikat waqt it-treddigћ (ara 4.3)> [or] < m'għandux jintuża waqt it-treddigћ.>>
English: <{Invented name}<is contraindicated during breast-feeding (see section 4.3)> [or] <should not be used during breast-feeding>.>
Maltese: <{Isem kummerċjali} <hu kontra-indikat waqt treddigħ (ara 4.3).> [or] < m'għandux jintuża waqt it-treddigћ>>
English: <Physico-chemical data suggest excretion of {Active substance}/metabolites in human milk.>
Maltese: <Dejta fiżiko-kimika tagћti ћjiel ta' eliminazzjoni ta' {Sustanza attiva}/metaboliti fil-ħalib tas-sider tal-bniedem.>
English: <{Active substance}/metabolites have not been identified in plasma of breastfed newborns/infants of treated mothers.>
Maltese: <{Sustanza attiva}/ metaboliti ma ġewx identifikati fil-plażma tat-trabi tat-twelid li qegћdin jiġu mreddgћin min-nisa li ћadu it-trattament.>
English: <{Active substance}/metabolites have been identified in breastfed newborns/infants of treated women.
Maltese: <{Sustanza attiva}/metaboliti nstabu fit-trabi ta' twelid li qegћdin jiġu mreddgћin min-nisa li ћadu it-trattament.
English: <{Active substance}/metabolites are excreted in human milk, but at therapeutic doses of {Invented name} no effects on the breastfed newborns/infants are anticipated.>
Maltese: < {Sustanza attiva}/metaboliti hu/ hi/ huma eliminat/a/i fil-ћalib tas-sider tal-bniedem bir-risultat li effetti fit-trabi ta' twelid huma mistennija.>
English: [9] <No effects during pregnancy are anticipated, since systemic exposure to {Active substance} is negligible.>
Maltese: [9] <L-ebda effett fuq il-tqala ma hu mistenni peress li l-espożizzjoni sistemika ta'{Sustanza attiva}hi baxxa.>
English: [7] <A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of {Active substance}.>
Maltese: [7] <Ammont moderat ta'dejta dwar l-użu waqt it-tqala (bejn 300 sa 1000 riżultat ta' tqala) juri li m'hemm l-ebda effett ta' formazzjoni difettuża jew effetti tossiċi fil-fetu/tarbija tat-twelid wara l-uzu ta' {Sustanza attiva}.
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma urewx effett tossiku fuq is-sistema riproduttiva (ara 5.3).
English: [4] <There are no or limited amount of data from the use of {Active substance} in pregnant women.
Maltese: [4]<M'hemmx dejta jew hemm dejta limitata dwar l-użu ta'{Sustanza attiva} f'nisa tqal.
English: [6] <A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of {Active substance}.
Maltese: [6] <Ammont moderat ta'dejta dwar l-użu waqt it-tqala (bejn 300 sa 1000 riżultat ta' tqala) juri li m'hemm l-ebda effett ta' formazzjoni difettuża jew effetti tossiċi fil-fetu/tarbija tat-twelid wara l-uzu ta' {Sustanza attiva}.
English: [2] <It is unknown whether {Active substance}/metabolites are excreted in human milk.>
Maltese: [2] < Mhux magħruf jekk {Sustanza attiva}/ metaboliti j/tiġix/jiġux eliminat/i mill-ħalib tas-sider tal-bniedem.>
English: [8] <A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no malformative nor feto/ neonatal toxicity of {Active substance}.>
Maltese: [8] <Ammont kbir ta' dejta dwar l-użu waqt il-tqala (iktar min 1000 rizultat ta'tqala) juri li m'hemm l-ebda effett ta' formazzjoni difettuża jew effetti tossiċi fil-fetu/tarbija tat-twelid wara l-uzu ta' {Sustanza attiva}.
English: As a precautionary measure, it is preferable to avoid the use of {Invented name} <during pregnancy> <during {trimester} of pregnancy>.
Maltese: Bћala prekawzjoni hu preferribli li ma j/tintuzax {Isem kummerċjali} waqt it-tqala> <waqt {trimestru} tat-tqala>>.
English: The full EPAR for Adrovance can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 04-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'04-2011.
English: Adrovance alendronic acid / colecalciferol
Maltese: Adrovance aċidu alendroniku / colecalciferol
English: The European Commission granted a marketing authorisation valid throughout the European Union for Adrovance to Merck Sharp & Dohme Ltd. on 4 January 2007.
Maltese: Il-Kummissjoni Ewropa tat l-awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Adrovance lil Merck Sharp & Dohme Ltd. fl-4 ta' Jannar 2007.
English: The most common side effects with Adrovance are headache, abdominal pain (stomach ache), dyspepsia (heartburn), constipation, diarrhoea, flatulence (gas), oesophageal (gullet) ulcers, dysphagia (difficulty swallowing), abdominal distension (swollen tummy), acid regurgitation and musculoskeletal pain (pain in the muscles, bones and joints).
Maltese: L-effetti sekondarji l-iktar komuni b'Adrovance huma uġigħ ta' ras, uġigħ addominali (taż-żaqq), dispepsija (qrusa tal-istonku), stitikezza, dijarrea, flatulenza (gass), ulċeri fl-esofagu, disfaġija (diffikultà fil-bligħ), distensjoni addominali (żaqq minfuħa), tlugħ ta' aċidu mill-istonku u wġigħ muskoloskelettriku (uġigħ fil-muskoli, fil-għadam u fil-ġogi).
English: This is a summary of the European public assessment report (EPAR) for Adrovance.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropew (EPAR) għal Adrovance.
English: Why has Adrovance been approved?
Maltese: Għaliex ġie approvat Adrovance?
English: This authorisation was based on the authorisation granted to Fosavance in 2005 (‘informed consent').
Maltese: Din l-awtorizazzjoni kienet ibbażata fuq l-awtorizzazzjoni li ngħatat lil Fosavance fl-2005 (‘kunsens infurmat').
English: It is available as white tablets (capsule-shaped: 70 mg alendronic acid and 2,800 international units [IU] colecalciferol; rectangular: 70 mg alendronic acid and 5,600 IU colecalciferol).
Maltese: Adrovance huwa mediċina li fiha żewġ sustanzi attivi: l-aċidu alendroniku u l-colecalciferol (vitamina D3). Huwa disponibbli f'pilloli bojod (f'forma ta' kapsuli: 70 mg aċidu alendroniku u 2,800 unità internazzjonali (IU) colecalciferol; rettangolari: 70 mg aċidu alendroniku u 5,600 IU colecalciferol).
English: What is Adrovance?
Maltese: X'inhu Adrovance?
English: This study was extended in 652 patients for a further 24 weeks to compare the effects on continuing with Adrovance 70 mg/2,800 IU on its own or adding another 2,800 IU vitamin D3 (equivalent to using Adrovance 70 mg/5,600 IU).
Maltese: Dan listudju ttawwal għal 24 ġimgħa oħra għal 652 pazjent biex jitqabblu l-effetti bejn it-tkomplija ta' trattament b'Adrovance 70 mg/2,800 IU waħdu jew b'żieda ta' 2,800 IU vitamina D3 (li huwa ekwivalenti għal trattament b'Adrovance 70 mg/5,600 IU).
English: Adrovance contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Maltese: Adrovance fih żewġ sustanzi attivi: l-aċidu alendroniku u l-colecalciferol (vitamina
English: In the extension study, similar numbers of patients taking Adrovance 70 mg/2,800 IU and Adrovance 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Adrovance 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.
Maltese: IU u b'Adrovance 70 mg/5,600 IU ġew osservati livelli baxxi ta' vitamina D (taħt is-6%), iżda fil-pazjenti ttrattati b'Adrovance 70 mg/5,600 IU ġew osservati żidiet ogħla fil-vitamina D fuq il-perjodu ta' 24 ġimgħa li kopra l-istudju.
English: After 15 weeks, fewer patients had low vitamin D levels when they took Adrovance 70 mg/2,800 IU (11%) than when they took alendronic acid only (32%).
Maltese: Wara 15-il ġimgħa, inqas pazjenti kellhom livelli baxxi tal-vitamina D meta ħadu Adrovance 70 mg/2,800 IU (11%) milli meta ħadu l-aċidu alendroniku waħdu (32%).
English: The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink or other medicines (including antacids, calcium supplements and vitamins).
Maltese: Il-pazjent għandu jibla' l-pillolla b'tazza ilma mimlija (iżda mhux ilma minerali), mill-anqas 30 minuta qabel kwalunkwe ikel, xorb, jew mediċina oħra (fosthom antiaċidi, supplimenti tal-kalċju u vitamini).
English: Because alendronic acid and vitamin D3 are already used separately in authorised medicines in the European Union (EU), the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets.
Maltese: Minħabba li l-aċidu alendroniku u l-vitamina D3 diġà jintużaw separatament f'mediċini awtorizzati flUnjoni Ewropea (UE), il-kumpanija ppreżentat dejta li kienet inkisbet fi studji preċedenti u middokumentazzjoni ppubblikata dwar nisa li kienu għaddew mill-menopawża u li kienu qegħdin jieħdu laċidu alendroniku u l-vitamina D bħala pilloli separati.
English: Vitamin D3, along with other forms of vitamin D, is required for calcium absorption and normal bone formation.
Maltese: Il-vitamina D3, kif ukoll il-forom l-oħra tal-vitamina D, hija neċessarja għall-assorbiment tal-kalċju u għallformazzjoni normali tal-għadam.
English: What is the risk associated with Adrovance?
Maltese: X'inhu r-riskju assoċjat ma' Adrovance?
English: The additional studies showed that including vitamin D3 in the same tablet with alendronic acid could increase vitamin D levels.
Maltese: L-istudji addizzjonali wrew li meta jkun hemm il-vitamina D3 fl-istess pillola mal-aċidu alendroniku, dan jista' jżid il-livelli ta' vitamina D.
English: To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Adrovance's ability to increase vitamin D levels.
Maltese: Bħala appoġġ għall-kombinazzjoni tal-aċidu alendroniku u l-vitamina D3 fl-istess pillola, il-kumpanija wettqet ukoll studju f'717-il pazjent li kellhom l-osteoporożi, inklużi 682 mara li kienu għaddew millmenopawża, sabiex tintwera l-kapaċità ta' Adrovance biex iżid il-livelli tal-vitamina D.
English: The CHMP decided that Adrovance's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Adrovance huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: It must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low calcium levels), or who cannot stand or sit upright for at least 30 minutes.
Maltese: Ma għandux jintuża minn pazjenti li jkollhom anomaliji fl-esofagu, li jkollhom ipokalċemija (livelli baxxi ta' kalċju), jew li ma jkunux jistgħu jqumu bilwieqfa jew ipoġġu dritti tul tal-inqas 30 minuta.
English: How does Adrovance work?
Maltese: Għal xiex jintuża Adrovance?
English: Other information about Adrovance
Maltese: Kif jaħdem Adrovance?
English: Hold the vial with the sterile water (solvent) in one hand and the syringe in the other hand.
Maltese: Dan ifisser li jiġi injettat permezz ta' labra qasira ġot-tessut xaħmi taħt il-ġilda tiegħek.
English: Figure 13a (Adults)
Maltese: Figura 13a (Adulti)
English: - The active substance is rilonacept.
Maltese: - Is-sustanza attiva hi rilonacept.
English: p< 0.0001
Maltese: NS p< 0.0001
English: Regeneron UK Limited 40 Bank Street E14 5DS London United Kingdom
Maltese: Regeneron UK Limited 40 Bank Street E14 5DS London Ir-Renju Unit
English: Part B
Maltese: Parti B
English: 45.5 to 49.0 49.1 to 52.6 52.7 to 56.3 56.4 to 59.9 60.0 to 63.5 63.6 to 67.2 67.3 to 70.8 70.9 or greater
Maltese: 49.1 sa 52.6 52.7 sa 56.3 56.4 sa 59.9 60.0 sa 63.5 63.6 sa 67.2 67.3 sa 70.8 70.9 jew aktar
English: T1/2 terminal (day)
Maltese: T1/2 terminali (ġranet)
English: Manufacturer Brecon Pharmaceuticals Ltd Wye Valley Business Park Hay-on-Wye
Maltese: Brecon Pharmaceuticals Ltd Wye Valley Business Park Hay-on-Wye
English: *p< 0.0001, comparison of rilonacept vs. placebo **p< 0.001, comparison of rilonacept vs. placebo, NS = not significant
Maltese: *p< 0.0001, paragun ta' rilonacept vs. plaċebo **p< 0.001, paragun ta' rilonacept vs. plaċebo, NS = mhux sinifikanti
English: System Organ Class
Maltese: Sistema tal-Klassi tal-Organi
English: 23.6 to 27.2 27.3 to 30.8 30.9 to 34.4 34.5 to 38.1 38.2 to 41.7 41.8 to 45.4 45.5 to 49.0 49.1 to 52.6 52.7 to 56.3 56.4 to 59.9 60.0 to 63.5 63.6 to 67.2 67.3 to 70.8 70.9 or greater
Maltese: 23.6 sa 27.2 27.3 sa 30.8 30.9 sa 34.4 34.5 sa 38.1 38.2 sa 41.7 41.8 sa 45.4 45.5 sa 49.
English: Wye Valley Business Park Brecon Road, Hay-on-Wye Hereford HR3 5PG United Kingdom
Maltese: Wye Valley Business Park Brecon Road, Hay-on-Wye Hereford HR3 5PG Ir-Renju Unit
English: Adults who entered in Part A
Maltese: Adulti li pparteċipaw f'Parti A
English: Mutation in NLRP3 gene
Maltese: Mutazzjoni fil-ġene NLRP3
English: Contains:
Maltese: NOTA:
English: With PSUR
Maltese: B'PSUR
English: Placebo (n=23)
Maltese: Plaċebo (n=23)
English: Active, severe infections (see section 4.4).
Maltese: Infezzjonijiet attivi u severi (ara sezzjoni 4.4).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/582/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/582/001
English: Patients with CAPS treated with Rilonacept Regeneron experienced mean increases from baseline for total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides of 19 mg/dl, 2 mg/dl, 10 mg/dl, and 57 mg/dl respectively after 6 weeks of open-label therapy.
Maltese: Pazjenti bilCAPS ikkurati b'Rilonacept Regeneron kellhom żidiet medji mil-linja bażi tal-kolesterol globali, kolesterol HDL, kolesterol LDL, u trigliċeridi ta' 19 mg/dl, 2 mg/dl, 10 mg/dl, u 57 mg/dl rispettivament wara 6 ġimgħat ta' terapija tat-tip open-label.
English: • an infection;
Maltese: • infezzjoni;
English: CL /F (l/day)
Maltese: CL /F (l/kuljum)
English: • 4 vials of sterile water (solvent)
Maltese: • 4 kunjetti ta' ilma sterili (solvent)
English: HR3 5PG Hereford United Kingdom
Maltese: HR3 5PG Hereford Ir-Renju Unit
English: Rilonacept Regeneron blocks the activity of substances including interleukin-1 beta (IL-1 beta).
Maltese: Rilonacept Regeneron jimblokka l-attività ta' sustanzi li jinkludu interleukin-1 beta (IL-1 beta).
English: Paediatric population (12 to 17 years old)
Maltese: Popolazzjoni pedjatrika (minn 12 sa 17-il sena)
English: • 1 vial of sterile water (solvent)
Maltese: • 1 kunjett t'ilma sterili (solvent)
English: AUC (day mg/l)
Maltese: AUC (ġranet mg/l)
English: • The identified or potential risk of immunogenicity that might lead to immune-mediated symptoms;
Maltese: • Ir-riskju potenzjali jew identifikat ta' immunoġeniċità li jista' jwassal għal sintomi medjati mill-immunità;
English: • The risk of acute injection-related reactions;
Maltese: • Ir-riskju ta' reazzjonijiet akuti marbuta mal-injezzjoni;
English: Age (26-78 years old) and body weight (50-120 kg) did not appear to have a significant effect on trough rilonacept concentrations.
Maltese: L-età (26-78 sena) u l-piż tal-ġisem (50-120 kg) ma jidhrux li kellhom effett sinifikanti fuq il-konċentrazzjonijiet minimi ta' rilonacept.
English: Do not use Rilonacept Regeneron:
Maltese: Tużax Rilonacept Regeneron:
English: Figure 12
Maltese: Figura 12
English: Rilonacept is a dimeric fusion protein consisting of the ligand-binding domains of the extracellular portions of the human type I interleukin-1 receptor (IL-1RI) and IL-1 receptor accessory protein (IL-1RAcP) linked in-line to the Fc portion of human IgG1.
Maltese: Rilonacept hu proteina ta' fużjoni dimerika li tikkonsisti f'dominji li jeħlu mal-ligand ta' porzjonijiet extra-ċellulari tar-riċettur ta' interleukin-1 ta' tip I (IL-1RI) u l-proteina aċċessorja tar-riċettur IL-1 (IL-1RAcP) marbuta in-line mal-porzjon Fc ta' IgG1 umana.
English: In the clinical program for CAPS, 8 adolescents aged 12-17 were treated for up to 18 months.
Maltese: Fil-programm kliniku għal CAPS, 8 adolexxenti li kellhom bejn 12 u 17-il sena kienu kkurati għal mhux aktar minn 18-il xahar.
English: Interleukin-1 (IL-1) blockade may interfere with immune response to infections.
Maltese: L-imblokk ta' interleukin-1 (IL-1) jista' jinterferixxi mar-rispons immuni kontra l-infezzjonijiet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 October 2009
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 t'Ottubru 2009
English: Pharmacotherapeutic group: Interleukin inhibitors, ATC code: L04AC04.
Maltese: Inibituri ta' interleukin, Kodiċi ATC:
English: • 1 gauze pad
Maltese: • 1 garża
English: Active Rilonacept Baseline Period (Weeks 13 to 15)
Maltese: Bażi ta' Rilonacept (Ġimgħat 13 sa 15)
English: Hypersensitivity common
Maltese: Sensittività eċċessiva komuni
English: Vial 2 years.
Maltese: 30 sekonda oħra.
English: - Solvent is provided in a 5 ml transparent plastic vial containing 5 ml water for injections.
Maltese: - Is-solvent hu pprovdut f'kunjett tal-plastik trasparenti (LDPE) ta' 5 ml li fih 5 ml ta' ilma għall injezzjonijiet.
English: • Dizziness
Maltese: • Meninġite
English: • Serious infections.
Maltese: • Infezzjonijiet serji.
English: A significantly higher proportion of patients in the rilonacept group compared to the placebo group experienced improvement from baseline in the composite score by at least 30% (96% vs. 29% of patients), by at least 50% (87% vs. 8%) and by at least 75% (70% vs. 0%) (p<0.0001).
Maltese: Proporzjon ogħla b'mod sinifikanti ta' pazjenti fil-grupp ta' rilonacept meta mqabbel mal-grupp talplaċebo, kellu titjib mil-linja bażi fil-punteġġ kompost b'mill-inqas 30% (96% vs. 29% tal-pazjenti), b'mill-inqas 50% (87% vs. 8%) u b'mill-inqas 75% (70% vs. 0%) (p<0.
English: • tuberculosis or you have been in close contact with someone who has had tuberculosis;
Maltese: • tuberkulosi jew jekk kont f'kuntatt mill-qrib ma' xi ħadd li kellu t-tuberkulosi;
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Maltese: Peress li din hi approvazzjoni taħt ċirkostanzi eċċezzjonali u li skont l-Artiklu 14 (8) tal-Regolament (KE) 726/2004, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jwettaq, fiżżmien stipulat, il-miżuri li ġejjin:
English: Dose volume (ml)
Maltese: Volum tad-doża (ml)
English: In placebo-controlled studies across a variety of patient populations encompassing 336 patients treated with rilonacept and 165 treated with placebo, the incidence of infections was 6.8% and 3% (0.44 per patient-exposure year and 0.19 per patient-exposure year), respectively, for rilonacept and placebo.
Maltese: Fi studji kkontrollati bil-plaċebo fuq medda ta' varjetà ta' popolazzjonijiet ta' pazjenti li kienu jinkludu 336 pazjent ikkurati b'rilonacept u 165 ikkurati bil-plaċebo, l-inċidenza ta' infezzjonijiet kienet ta' 6.8% u 3% (0.44 għal kull sena ta' espożizzjoni ta' pazjenti u 0.19 għal kull sena ta' espożizzjoni ta' pazjenti), rispettivament, għal rilonacept u l-plaċebo.
English: Weight range (kg)
Maltese: Medda ta' piż (kg)
English: Antibodies directed against the receptor domains of rilonacept were detected by an ELISA assay in 35% of patients (19 out of 55) treated for at least 6 weeks in the clinical study.
Maltese: Antikorpi diretti kontra d-dominji tar-riċetturi ta' rilonacept kienu osservati permezz ta' assaġġ ELISA fi 35% tal-pazjenti (19 minn 55) li kienu kkurati għal mill-inqas 6 ġimgħat fl-istudji kliniċi.
English: United Kingdom
Maltese: Stati Uniti tal-Amerika
English: The formation of CYP450 enzymes is suppressed by increased levels of cytokines during chronic inflammation.
Maltese: Il-formazzjoni ta' enzimi CYP450 tiġi mrażżna minn żieda fil-livelli ta' ċitokini waqt infjammazzjoni kronika.
English: • The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Rilonacept Regeneron;
Maltese: • Ir-riskju ta' infezzjonijiet serji, li jinkludu infezzjonijiet opportunistiċi batterjali, virali u fungali f'pazjenti kkurati b'Rilonacept Regeneron;
English: LDPE vials containing 5 ml water for injections Each pack contains:
Maltese: Kunjetti LDPE li fihom 5 ml ta' ilma għall-injezzjonijiet Kull pakkett fih: