FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance is pirfenidone.
Maltese: Is-sustanza attiva hi pirfenidone.
English: 21 tablets 42 tablets) 90 tablets 180 tablets
Maltese: 21 pillola 42 pillola 90 pillola 180 pillola
English: ● ciprofloxacin (a type of antibiotic)
Maltese: ● ciprofloxacin (tip ta' antibijotiku)
English: Median (25th-75th)
Maltese: Medjan (il-25 sal-75 wieħed)
English: Angioedema/Anaphylaxis
Maltese: Anġjoedima/Anafilassi
English: 270 capsules
Maltese: Kapsula iebsa 270 kapsula
English: ● rifampicin (a type of antibiotic).
Maltese: ● rifampicin (tip ta' antibijotiku).
English: Date of latest renewal: 08 September 2015
Maltese: Data tal-aħħar tiġdid: 08 ta' Settembru 2015
English: ● enoxacin (a type of antibiotic)
Maltese: ● enoxacin (tip ta' antibijotiku)
English: Roche Pharma AG Emil-Barell-Str. 1
Maltese: Roche Pharma AG Emil-Barell-Strasse 1
English: INFORMATION IN BRAILLE Esbriet
Maltese: INFORMAZZJONI BIL-BRAILLE Esbriet
English: 36 (p=0.011), and 48 (p=0.005).
Maltese: 36 (p=0.011), u fit-48 Ġimgħa (p=0.005).
English: These are rare side effects.
Maltese: Dawn huma effetti sekondarji rari.
English: The safety of Esbriet has been evaluated in clinical studies including 1,650 volunteers and patients.
Maltese: Is-sigurtà ta' Esbriet ġiet evalwata fi studji kliniċi li nkludew 1,650 voluntiera u pazjenti.
English: Myalgia; arthralgia
Maltese: Majalġja; artralġja
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Capsule content
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti
English: Brown S-1-16530 or 03A2 inks containing:
Maltese: Linka kannella S-1-16530 jew 03A2 li fiha:
English: Fluvoxamine and inhibitors of CYP1A2
Maltese: Fluvoxamine u inibituri ta' CYP1A2
English: The parent substance is predominantly metabolised to 5-carboxy-pirfenidone.
Maltese: Is-sustanza oriġinali (parent substance) hija metabolizzata b'mod predominanti għal 5-carboxy-pirfenidone.
English: ALT increased; AST increased; gamma glutamyl transferase increased
Maltese: Żieda ta' ALT; żieda ta' AST; żieda fil-gamma glutamyl transferase
English: ● History of angioedema with pirfenidone (see section 4.4).
Maltese: ● Passat ta' anġjoedima b'pirfenidone (ara sezzjoni 4.4).
English: ● fluvoxamine (used to treat depression and obsessive compulsive disorder (OCD)).
Maltese: ● fluvoxamine (użat għat-trattament tad-depressjoni u disturb ossessiv kompulsiv (OCD - obsessive compulsive disorder)).
English: Table 1 Adverse reactions by SOC and MedDRA frequency Infections and infestations
Maltese: Tabella 1 Reazzjonijiet Avversi skont SOC u l-frekwenza MedDRA Infezzjonijiet u infestazzjonijiet
English: Co-administration of Esbriet and 750 mg of ciprofloxacin (a moderate inhibitor of CYP1A2) increased the exposure to pirfenidone by 81%.
Maltese: L-għoti fl-istess waqt ta' Esbriet u 750 mg ciprofloxacin (impeditur moderat ta' CYP1A2) żied l-espożizzjoni ta' pirfenidone b'81%.
English: A statistically significant increase in uterine tumours was observed in female rats administered 1,500 mg/kg/day, 37 times the human dose of 2,403 mg/day.
Maltese: Żieda statistikament sinifikanti fit-tumuri fl-utru ġiet osservata fil-firien nisa li ngħataw 1,500 mg/kg/jum, 37 darba d-doża umana ta' 2,403 mg/jum.
English: ● Capsule shell: gelatin, titanium dioxide (E171)
Maltese: ● Il-qoxra tal-kapsula: ġelatina, titanium dioxide (E171)
English: ● Capsule filling: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate
Maltese: ● Mili tal-kapsula: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate
English: ● Concomitant use of fluvoxamine (see section 4.5).
Maltese: ● Użu konkomitanti ta' fluvoxamine (ara sezzjoni 4.5).
English: Each pack contains a total of 63 capsules.
Maltese: Kull pakkett fih total ta' 63 kapsula.
English: Pruritus; erythema; dry skin; rash erythematous; rash macular; rash pruritic Musculoskeletal and connective tissue disorders Common
Maltese: Ħakk; eritema; ġilda xotta; raxx eritematuż; raxx makulari; raxx pruritiku
English: Placebo (N = 277)
Maltese: (N = 277)
English: a p-value versus Normal = 1.00 (pair-wise comparison with Bonferroni) b p-value versus Normal = 0.009 (pair-wise comparison with Bonferroni) c p-value versus Normal < 0.0001 (pair-wise comparison with Bonferroni)
Maltese: a valur p kontra Normali = 1.00 (tqabbil f'pari ma' Bonferroni) b valur p kontra Normali = 0.009 (tqabbil f'pari ma' Bonferroni) c valur p kontra Normali < 0.0001 (tqabbil f'pari ma' Bonferroni)
English: ● Additional risk minimisation measures
Maltese: ● Miżuri addizzjonali għall-minimizzazzjoni tar-riskji
English: Agranulocytosis1
Maltese: Agranuloċitosi1
English: Dizziness; somnolence; dysgeusia; lethargy
Maltese: Sturdament; ngħas; disgewżja; letarġija
English: Pirfenidone 2,403 mg/day (N = 278)
Maltese: Pirfenidone 2,403 mg/jum (N = 278)
English: Approximately 70-80% of pirfenidone is metabolised via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6, and 2E1.
Maltese: Madwar 70-80% ta' pirfenidone jiġi metabolizzat permezz ta' CYP1A2 b'kontribuzzjoni minuri minn isoenzimi oħrajn ta' CYP li jinkludu CYP2C9, 2C19, 2D6, u 2E1.
English: ● Capsule brown printing ink: shellac, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), propylene glycol, ammonium hydroxide
Maltese: ● Linka kannella użata għall-kliem fuq il-kapsula: shellac, iron oxide iswed (E172), iron oxide aħmar (E172), iron oxide isfar (E172), propylene glycol, ammonium hydroxide
English: Pirfenidone attenuates fibroblast proliferation, production of fibrosis-associated proteins and cytokines, and the increased biosynthesis and accumulation of extracellular matrix in response to cytokine growth factors such as, transforming growth factor-beta (TGF-β) and platelet-derived growth factor (PDGF).
Maltese: Pirfenidone jattenwa l-proliferazzjoni tal-fibroblasti, il-produzzjoni ta' proteini u cytokines assoċjati mal-fibrożi u ż-żieda fil-bijosintesi u l-akkumulazzjoni ta' matriċi ekstraċellulari b'reazzjoni għal fatturi ta' tkabbir ta' cytokines bħall-fattur ta' tkabbir li jitrasforma beta (TGF-β - transforming growth factor-beta) u l-fattur ta' tkabbir derivat mill-plejtlits (PDGF - platelet-derived growth factor).
English: Treatment with pirfenidone significantly reduced mean decline in vital capacity (VC) at Week 52 (the primary endpoint) compared with placebo (-0.09±0.02 l versus -0.16±0.02 l respectively, p=0.042).
Maltese: Il-kura b'pirfenidone naqqset b'mod sinifikanti t-tnaqqis medju filkapaċità vitali (VC - vital capacity) fit-52 Ġimgħa (il-punt finali ewlieni) meta mqabbel mal-plaċebo (-0.09±0.02 l kontra -0.16±0.
English: Medicines that may increase side effects of Esbriet:
Maltese: Mediċini li jistgħu jżidu l-effetti sekondarji ta' Esbriet:
English: Cigarette smoking and inducers of CYP1A2
Maltese: Tipjip u indutturi ta' CYP1A2
English: The pharmacokinetics of pirfenidone and the 5-carboxy-pirfenidone metabolite were compared in subjects with moderate hepatic impairment (Child-Pugh Class B) and in subjects with normal hepatic function.
Maltese: Indeboliment epatiku Il-farmakokinetika ta' pirfenidone u l-metabolit 5-carboxy-pirfenidone kienu mqabbla f'suġġetti b'indeboliment epatiku moderat (Child-Pugh Klassi B) u f'suġġetti b'funzjoni epatika normali.
English: Pirfenidone 2,403 mg/day (N = 171)
Maltese: Pirfenidone 2,403 mg/jum (N = 171)
English: Three of the Phase 3 studies (PIPF-004, PIPF-006, and PIPF-016) were multinational, and one (SP3) was conducted in Japan.
Maltese: PIPF-006, u PIPF-016) kienu multinazzjonali, u wieħed (SP3) sar fil-Ġappun.
English: INFORMATION IN BRAILLE esbriet 801 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE pilloli esbriet 801 mg
English: The mean (SD) AUC0-∞ of 5carboxy-pirfenidone was significantly higher in the moderate (p = 0.009) and severe (p < 0.0001) renal impairment groups than in the group with normal renal function; 100 (26.3) mg•h/L and 168 (67.4)
Maltese: AUC0-∞ medja (SD) ta' 5-carboxy-pirfenidone kienet ogħla b'mod sinifikanti fil-gruppi b'indeboliment renali moderat (p = 0.009) u sever (p < 0.0001) milli fil-grupp b'funzjoni renali normali; 100 (26.3) mg•siegħa/L u 168 (67.4) mg•siegħa/L meta mqabbla ma' 28.7 (4.99) mg•siegħa/L rispettivament.
English: b p-value versus Normal = 0.009 (pair-wise comparison with Bonferroni)
Maltese: b valur p kontra Normali = 0.009 (tqabbil f'pari ma' Bonferroni)
English: These hepatic findings are consistent with an induction of hepatic microsomal enzymes, an effect which has not been observed in patients receiving Esbriet.
Maltese: Dawn is-sejbiet epatiċi huma konsistenti ma' induzzjoni ta' enzimi mikrosomali epatiċi, effett li ma ġiex osservat f'pazjenti li ngħataw Esbriet.
English: Pirfenidone 2,403 mg/day (N = 174)
Maltese: Pirfenidone 2,403 mg/jum (N = 174)
English: Esbriet is contraindicated in patients with concomitant use of fluvoxamine (see section 4.3).
Maltese: Esbriet huwa kontra-indikat f'pazjenti li jużaw ukoll fluvoxamine (ara sezzjoni 4.3).
English: PIPF-016 compared treatment with Esbriet 2,403 mg/day to placebo.
Maltese: PIPF-016 qabbel kura b'Esbriet 2,403 mg/jum ma' plaċebo.
English: In a total of 555 patients, the median baseline percent predicted FVC and %DLCO were 68% (range: 48-91%) and 42% (range: 27-170%), respectively.
Maltese: kienu ta' 68% (firxa: 48-91%) u 42% (firxa: 27-170%), rispettivament.
English: Adverse reactions were mild, transient, and consistent with the most frequently reported adverse reactions for pirfenidone.
Maltese: temporanji, u konsistenti mar-reazzjonijiet avversi l-aktar frekwenti rrappurtati għal pirfenidone.
English: INFORMATION IN BRAILLE esbriet 534 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE pilloli esbriet 534 mg
English: Titanium dioxide (E171)
Maltese: Qoxra tal-kapsula Titanium dioxide (E171)
English: In a pooled analysis of survival in PIPF-004 and PIPF-006 the mortality rate with Esbriet 2403 mg/day group was 7.8% compared with 9.8% with placebo (HR 0.77 [95% CI, 0.47-1.28]).
Maltese: F'analiżi komuni tas-sopravivenza f'PIPF-004 u f'PIPF-006 ir-rata ta' mortalità fil-grupp ta' Esbriet 2403 mg/jum kienet ta' 7.8% meta mqabbla ma' 9.8% bil-plaċebo (HR 0.77 [CI ta' 95%, 0.47-1.28]).
English: INFORMATION IN BRAILLE esbriet 267 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE pilloli esbriet 267 mg
English: PVC/Aclar (PCTFE) aluminium foil blister Pack sizes
Maltese: Folji magħmula minn fojl tal-PVC/Aclar (PCTFE) aluminium Daqsijiet tal-pakkett
English: a p-value versus Normal = 1.00 (pair-wise comparison with Bonferroni)
Maltese: a valur p kontra Normali = 1.00 (tqabbil f'pari ma' Bonferroni)
English: In subjects with moderate hepatic impairment (i.e. Child-Pugh Class B), pirfenidone exposure was increased by 60%.
Maltese: Child-Pugh Klassi B), l-espożizzjoni għal pirfenidone żdiedet b'60%.
English: Do not take Esbriet
Maltese: Tiħux Esbriet
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4-WEEK TREATMENT MAINTENANCE PACK CONTAINING 252 CAPSULES (14 X 18 CAPSULES CONFIGURATION)
Maltese: KARTUNA TA' BARRA - PAKKETT GĦALL-MANTENIMENT TAL-KURA TA' 4 ĠIMGĦAT LI FIH 252 KAPSULA (KONFIGURAZZJONI TA' 14 X 18-IL KAPSULA)
English: Mean apparent oral steady-state volume of distribution is approximately 70 l, indicating that pirfenidone distribution to tissues is modest.
Maltese: Il-volum ta' distribuzzjoni medju fi stat fiss orali apparenti huwa ta' madwar 70 l, li jindika li d-distribuzzjoni ta' pirfenidone għat-tessuti hija modesta.
English: The blister packs contain 21, 42, 84 or 168 film-coated tablets and the multipacks contain 63 (2-week treatment initiation pack 21+42) or 252 (continuation pack 3x84) film-coated tablets.
Maltese: Il-pakketti bil-folji fihom 21, 42, 84 jew 168 pillola miksija b'rita u l-pakketti multipli fihom 63 (pakkett ta' trattament inizjali ta' ġimagħtejn 21+42) jew 252 (pakkett ta' kontinwazzjoni 3x84) pillola miksija b'rita.
English: Other medicines and Esbriet
Maltese: Mediċini oħra u Esbriet
English: Capsule shell
Maltese: Kapsula iebsa
English: The 4-week treatment pack contains a total of 252 capsules.
Maltese: Il-pakkett tal-kura ta' 4 ġimgħat fih total ta' 252 kapsula.
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule
Maltese: Kontenut tal-kapsuli
English: 2-week treatment initiation pack (63 capsules): Week 1 - 21 capsules (7 blister strips, each with 3 capsules) Week 2 - 42 capsules (7 blister strips, each with 6 capsules)
Maltese: Ġimgħa 1 - 21 kapsula (7 strixxi tal-folja, kull waħda bi 3 kapsuli) Ġimgħa 2 - 42 kapsula (7 strixxi tal-folja, kull waħda b'6 kapsuli)
English: ● Risk Management Plan (RMP)
Maltese: ● Pjan tal-Ġestjoni tar-Riskju (RMP)
English: In vitro data indicate some pharmacologically relevant activity of the major metabolite (5-carboxy-pirfenidone) at concentrations in excess of peak plasma concentrations in IPF patients.
Maltese: Data in vitro tindika xi attività farmakoloġikament rilevanti tal-metabolit maġġuri (5-carboxy-pirfenidone) f'konċentrazzjonijiet li jaqbżu l-ogħla konċentrazzjonijiet fil-plażma f'pazjenti b'IPF.
English: Placebo (N = 174)
Maltese: (N = 174)
English: No dose adjustment is necessary in patients with mild to moderate hepatic impairment (i.e. Child-Pugh Class A and B).
Maltese: M'hemmx ħtieġa ta' aġġustament tad-doża f'pazjenti b'indeboliment epatiku ħafif sa moderat (i.e. Child-Pugh Klassi A u B).
English: IPF is a chronic fibrotic and inflammatory pulmonary disease affected by the synthesis and release of pro-inflammatory cytokines including tumour necrosis factor-alpha (TNF-α) and interleukin-1-beta
Maltese: IPF hija marda pulmonari fibrotika u infjammatorja kronika affettwata mis-sintesi u r-rilaxx ta' cytokines pro-infjammatorji inkluż fattur tan-nekrosi tat-tumur alfa (TNF-α - tumour necrosis factor alpha) u interleukin-1-beta (IL-1β) u pirfenidone intwera li jnaqqas l-akkumulazzjoni ta' ċelluli infjammatorji b'reazzjoni għal diversi stimoli.
English: The other ingredients are: microcrystalline cellulose, croscarmellose sodium, povidone K30, colloidal anhydrous silica, magnesium stearate
Maltese: Is-sustanzi mhux attivi l-oħra huma: microcrystalline cellulose, croscarmellose sodium, povidone K30, colloidal anhydrous silica, magnesium stearate
English: Discontinue Esbriet if necessary (see sections 4.2 and 4.4).
Maltese: Waqqaf Esbriet jekk meħtieġ (ara sezzjonijiet 4.2 u 4.4).
English: Placebo (N = 173)
Maltese: (N = 173)
English: Decline of less than 10% No decline (FVC change >0%)
Maltese: Tnaqqis ta' inqas minn 10% Ebda tnaqqis (Bidla fl-FVC >0%)
English: Medicines that may reduce how well Esbriet works:
Maltese: Mediċini li jistgħu jnaqqsu l-effikaċja ta' Esbriet:
English: Renal Impairment Group
Maltese: Grupp ta' Indeboliment Renali
English: ● Days 8 to 14: a dose of 534 mg administered three times a day (1602 mg/day)
Maltese: ● Jum 8 sa 14: doża ta' 534 mg mogħtija tliet darbiet kuljum (1602 mg/jum)
English: PIPF-004 and PIPF-006 compared treatment with Esbriet 2403 mg/day to placebo.
Maltese: PIPF-004 u PIPF-006 qabblu l-kura b'Esbriet 2403 mg/jum mal-plaċebo.
English: No adverse effects on fertility were observed in preclinical studies (see section 5.3).
Maltese: Ma ġewx osservati effetti avversi fuq il-fertilità fi studji prekliniċi (ara sezzjoni 5.3).
English: ● Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: ● Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Decline of ≥10% or death
Maltese: Tnaqqis ta' ≥10% jew mewt
English: EU/1/11/667/010 90 tablets
Maltese: EU/1/11/667/011 90 pillola
English: The oral clearance of pirfenidone appears modestly saturable.
Maltese: It-tneħħija orali ta' pirfenidone tidher modestament saturabbli.
English: ● Severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis (see sections 4.2 and 5.2).
Maltese: ● Indeboliment renali sever (CrCl <30 ml/min) jew mard tal-kliewi fl-aħħar stadju li jkun jeħtieġ id-dijalisi (ara sezzjonijiet 4.2 u 5.2).
English: However, existing data suggest that pirfenidone exerts both antifibrotic and anti-inflammatory properties in a variety of in vitro systems and animal models of pulmonary fibrosis (bleomycin- and transplant-induced fibrosis).
Maltese: Madankollu, id-data eżistenti tissuġġerixxi li pirfenidone jeżerċita kemm il-karatteristiċi antifibrotiċi kif ukoll anti-infjammatorji f'diversi sistemi in vitro u mudelli ta' annimali ta' fibrożi pulmonari (fibrożi indotta mill-bleomycin u t-trapjant).
English: Esbriet should be used with caution in patients with moderate (CrCl 30-50 ml/min) renal impairment.
Maltese: Esbriet għandu jintuża b'kawtela f'pazjenti b'indeboliment renali moderat (CrCl 30-50 ml/min).
English: A Phase 1 interaction study evaluated the effect of cigarette smoking (CYP1A2 inducer) on the pharmacokinetics of pirfenidone.
Maltese: Studju ta' interazzjoni ta' Fażi 1 evalwa l-effett tat-tipjip ta' sigaretti (induttur ta' CYP1A2) fuq ilfarmakokinetika ta' pirfenidone.
English: The 2-week treatment initiation pack contains a total of 63 capsules.
Maltese: Il-pakkett ta' kura inizjali ta' ġimagħtejn fih total ta' 63 kapsula.
English: 250 ml white HDPE bottle with child-resistant closure containing 270 capsules.
Maltese: Flixkun abjad tal-HDPE ta' 250 ml b'tapp reżistenti għat-tfal li fih 270 kapsula.
English: Clinically relevant pharmacodynamic activity of the metabolite in patients with moderate renal impairment cannot be excluded.
Maltese: Attività farmakodinamika klinikament rilevanti tal-metabolit f'pazjenti b'indeboliment renali moderat ma tistax tiġi eskluża.
English: Elevations in ALT and AST >3 × upper limit of normal (ULN) have been reported in patients receiving therapy with Esbriet.
Maltese: Funzjoni epatika Żidiet ta' ALT u AST >3 × il-limitu massimu tan-normal (ULN - upper limit of normal) ġew irrappurtati f'pazjenti li kienu qegħdin jirċievu terapija b'Esbriet.
English: Multiple doses of pirfenidone up to a total dose of 4,806 mg/day were administered as six 267 mg capsules three times daily to healthy adult volunteers over a 12-day dose escalation period.
Maltese: 4,806 mg/jum ingħataw bħala sitt kapsuli ta' 267 mg tliet darbiet kuljum lil voluntiera adulti f'saħħithom fuq perijodu ta' żieda gradwali ta' 12-il jum.
English: 7 x PVC/PE/PCTFE aluminium foil blister strips, each containing 3 capsules (for the Week 1 dosing), packaged together with 7 x PVC/PE/PCTFE aluminium foil blister strips, each containing 6 capsules (for the Week 2 dosing).
Maltese: 7 x strixxi ta' folji tal-fojl tal-aluminju PVC/PE/PCTFE, li kull waħda fiha 3 kapsuli (għad-dożaġġ ta' Ġimgħa 1), ippakkjati flimkien ma' 7 x strixxi ta' folji tal-fojl tal-aluminju PVC/PE/PCTFE, li kull waħda fiha 6 kapsuli (għad-dożaġġ ta' Ġimgħa 2).
English: Following oral administration of a single dose of 801 mg to healthy older adult volunteers (50-66 years of age) in the fed state, the rate of pirfenidone absorption slowed, while the AUC in the fed state was approximately 80-85% of the AUC observed in the fasted state.
Maltese: Wara l-għoti orali ta' doża waħda ta' 801 mg lil voluntiera anzjani adulti f'saħħithom (50-66 sena) wara li kielu, ir-rata tal-assorbiment ta' pirfenidone naqset, filwaqt li l-AUC fl-istat mitmugħ kienet ta' madwar 80-85% tal-AUC osservata fl-istat sajjem.
English: Clinical particulars
Maltese: KLINIKU
English: Results showed that there was a mean increase of 60% in pirfenidone exposure after a single dose of 801 mg pirfenidone (3 x 267 mg capsule) in patients with moderate hepatic impairment.
Maltese: 801 mg pirfenidone (3 x 267 mg kapsula) f'pazjenti b'indeboliment epatiku moderat.
English: Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).
Maltese: Esbriet huwa indikat f'adulti għall-kura ta' fibrożi pulmonari idjopatika (IPF - idiopathic pulmonary fibrosis) ħafifa sa moderata.
English: In study PIPF-006, treatment with Esbriet (N=171) did not reduce the decline of percent predicted FVC from Baseline at Week 72 compared with placebo (N=173; p=0.501).
Maltese: Fl-istudju PIPF-006, il-kura b'Esbriet (N=171) ma naqqsitx it-tnaqqis tal-FVC prevista f'perċentwal mil-Linja Bażi fit-72 Ġimgħa meta mqabbel mal-plaċebo (N=173; p=0.501).
English: The dose of pirfenidone may be reduced to 801 mg each day (267 mg three times a day).
Maltese: pirfenidone għandha tiġi mnaqqsa għal 801 mg kuljum (267 mg, tliet darbiet kuljum).
English: 267 mg tablet Iron oxide yellow (E172) 534 mg tablet Iron oxide yellow (E172) Iron oxide red (E172) 801 mg tablet Iron oxide red (E172) Iron oxide black (E172)
Maltese: Pillola ta' 267 mg Iron oxide isfar (E172) Pillola ta' 534 mg Iron oxide isfar (E172)
English: If ciprofloxacin at the dose of 750 mg two times a day cannot be avoided, the dose of pirfenidone should be reduced to 1602 mg daily (534 mg, three times a day).
Maltese: Jekk ciprofloxacin fid-doża ta' 750 mg darbtejn kuljum ma jistax jiġi evitat, id-doża ta' pirfenidone għandha titnaqqas għal 1602 mg kuljum (534 mg, tliet darbiet kuljum).
English: Additionally, in an ad hoc analysis, 33% of patients receiving Esbriet showed a decline of ≥50 m in 6MWT distance, compared to 47% of patients receiving placebo in PIPF-006.
Maltese: Barra minn hekk, f'analiżi ad hoc, 33% tal-pazjenti li ngħataw Esbriet urew tnaqqis ta' ≥50 m f'distanza ta' 6MWT, meta mqabbla ma' 47% tal-pazjenti li ngħataw plaċebo f'PIPF-006.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH.
Maltese: FIS-SUQ Roche Registration GmbH.
English: At Week 72, a decline from baseline in percent predicted FVC of ≥10% (a threshold indicative of the risk of mortality in IPF) was seen in 20% of patients receiving Esbriet compared to 35% receiving placebo (Table 2).
Maltese: Fit-72 Ġimgħa, tnaqqis tal-FVC prevista f'perċentwal mil-Linja Bażi ta' ≥10% (limitu indikattiv tar-riskju ta' mortalità fl-IPF) deher f'20% talpazjenti li ngħataw Esbriet meta mqabbel ma' 35% li ngħataw il-plaċebo (Tabella 2).
English: EU/1/11/667/005 EU/1/11/667/006 EU/1/11/667/007 EU/1/11/667/008 EU/1/11/667/009
Maltese: EU/1/11/667/005 EU/1/11/667/006 EU/1/11/667/007 EU/1/11/667/008 EU/1/11/667/009 EU/1/11/667/010 EU/1/11/667/011 EU/1/11/667/012 EU/1/11/667/013 EU/1/11/667/014
English: Esbriet is contraindicated in severe hepatic impairment and end stage liver disease (see sections 4.2 and 4.3).
Maltese: Esbriet huwa kontraindikat f'indeboliment epatiku sever u f'mard tal-fwied tal-aħħar stadju (ara sezzjonijiet 4.2 u 4.3).
English: Skin and subcutaneous tissue disorders Very Common Photosensitivity reaction; rash Common
Maltese: Komuni ħafna Reazzjoni ta' fotosensittività; raxx Komuni
English: ● cough
Maltese: ● sogħla
English: Pirfenidone binds to human plasma proteins, primarily to serum albumin.
Maltese: Distribuzzjoni Pirfenidone jeħel mal-proteini tal-plażma tal-bniedem, primarjament ma' albumina fis-serum.
English: The blisters pack contains 84 film-coated tablets and the multipack contains 252 (continuation pack 3x84) film-coated tablets.
Maltese: Il-pakkett bil-folji fih 84 pillola miksija b'rita u l-pakkett multiplu fih 252 (pakkett ta' kontinwazzjoni 3x84) pillola miksija b'rita.
English: Respiratory, thoracic and mediastinal disorders Common
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: The safety checklist about Esbriet should contain the following key elements related to liver function and photosensitivity:
Maltese: Il-lista ta' kontroll tas-sigurtà dwar Esbriet għandu jkun fiha l-elementi ewlenin li ġejjin relatati mal funzjoni tal-fwied u mal-fotosensittività:
English: ● Days 1 to 7: a dose of 267 mg administered three times a day (801 mg/day)
Maltese: ● Jum 1 sa 7: doża ta' 267 mg mogħtija tliet darbiet kuljum (801 mg/jum)
English: Gastroesophageal reflux disease; vomiting; abdominal distension; abdominal discomfort; abdominal pain; abdominal pain upper; stomach discomfort; gastritis; constipation; flatulence
Maltese: Marda ta' rifluss gastroesofaġali; rimettar; distensjoni addominali; skonfort addominali; uġigħ fl-addome; uġigħ fil-parti ta' fuq tal-addome; skonfort flistonku; gastrite; stitikezza; gass fl-istonku Disturbi fil-fwied u fil-marrara Komuni