FrancophonIA/ELRC3.0 huggingface dataset:
English: In study PIPF-016, the decline of percent predicted FVC from Baseline at Week 52 of treatment was significantly reduced in patients receiving Esbriet (N=278) compared with patients receiving placebo (N=277; p<0.000001, rank ANCOVA).
Maltese: Fi studju PIPF-016, it-tnaqqis f'FVC imbassra f'perċentwali mil-Linja Bażi f'Ġimgħa 52 tal-kura kien imnaqqas b'mod sinifikanti f'pazjenti li jirċievu Esbriet (N=278) meta mqabbel ma' pazjenti li jirċievu plaċebo (N=277; p<0.000001, grad ANCOVA).
English: Upper respiratory tract infection; urinary tract infection Blood and lymphatic system disorders Rare
Maltese: Infezzjoni fl-apparat respiratorju ta' fuq; infezzjoni fl-apparat urinarju Disturbi tad-demm u tas-sistema limfatika Rari
English: Table 1 shows the adverse reactions reported at a frequency of ≥2% in 623 patients receiving Esbriet at the recommended dose of 2,403 mg/day in three pooled pivotal Phase 3 studies.
Maltese: Tabella 1 turi r-reazzjonijiet avversi rrappurtati bi frekwenza ta' ≥2% f'623 pazjent li kienu qegħdin jingħataw Esbriet fid-doża rakkomandata ta' 2,403 mg/jum fi tliet studji importanti miġbura f'daqqa ta' Fażi 3. Reazzjonijiet avversi minn esperjenza ta' wara t-tqegħid fis-suq huma elenkati wkoll f'tabella 1.
English: EU/1/11/667/005 21 tablets EU/1/11/667/006 42 tablets (2 x 21) EU/1/11/667/020 42 tablets EU/1/11/667/007 90 tablets EU/1/11/667/008 180 tablets (2 x 90) EU/1/11/667/021 180 tablets
Maltese: EU/1/11/667/020 42 pillola EU/1/11/667/007 90 pillola EU/1/11/667/008 180 pillola (2 x 90)
English: 14 x PVC/PE/PCTFE aluminium foil blister strips each containing 18 capsules (2-day supply).
Maltese: 14 x strixxi ta' folji tal-fojl tal-aluminju PVC/PE/PCTFE, li kull waħda fiha 18-il kapsula (provvista ta' jumejn).
English: In the fed state, the 801 mg tablet met bioequivalence criteria based on the AUC measurements compared to the capsules, while the 90% confidence intervals for Cmax (108.26% - 125.60%) slightly exceeded the upper bound of standard bioequivalence limit (90% CI: 80.00% - 125.00%).
Maltese: Fi stat mitmugħ, il-pillola ta' 801 mg laħqet kriterji ta' bijoekwivalenza abbażi ta' kejl tal-AUC meta mqabbla mal-kapsuli, filwaqt li l-intervalli ta' kunfidenza ta' 90% għal Cmax (108.
English: 3 years for bottles.
Maltese: 3 darbiet kuljum.
English: 60 (p<0.001).
Maltese: (p<0.001), 48 (p<0.001), u s-60 Ġimgħa (p<0.001).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Film-coated Tablets in Blisters Multi Pack 63 - (INCLUDING BLUE BOX)
Maltese: KARTUNA Pilloli Miksija b'Rita f'Folji Pakkett Multiplu ta' 63 - (INKLUŻA KAXXA BLU)
English: In the case of moderate inducers of CYP1A2 (e.g. omeprazole), concomitant use may theoretically result in a lowering of pirfenidone plasma levels.
Maltese: Fil-każ ta' indutturi moderati ta' CYP1A2 (eż. omeprazole), l-użu konkomitanti jista' teoretikament jirriżulta fit-tnaqqis tal-livelli ta' pirfenidone fil-plażma.
English: Fluvoxamine should be discontinued prior to the initiation of Esbriet therapy and avoided during Esbriet therapy due to the reduced clearance of pirfenidone.
Maltese: Fluvoxamine għandu jitwaqqaf qabel tibda t-terapija b'Esbriet u evitat waqt it-terapija b'Esbriet minħabba t-tneħħija mnaqqsa ta' pirfenidone.
English: The most frequently reported adverse reactions during clinical study experience with Esbriet at a dose of 2,403 mg/day compared to placebo, respectively, were nausea (32.4% versus 12.2%), rash (26.2% versus 7.7%), diarrhoea (18.8% versus 14.4%), fatigue (18.5% versus 10.4%), dyspepsia (16.1% versus 5.0%), anorexia (11.4% versus 3.5%), headache (10.1% versus 7.7%), and photosensitivity reaction (9.3% versus 1.1%).
Maltese: 12.2%), raxx (26.2% kontra 7.7%), dijarea (18.8% kontra 14.4%), għeja (18.5% kontra 10.
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg hard capsules
Maltese: Esbriet 267 mg kapsuli iebsin
English: Phototoxicity and irritation were noted in guinea pigs after oral administration of pirfenidone and with exposure to UVA/UVB light.
Maltese: Fototossiċità u irritazzjoni kienu nnutati fil-fniek tal-Indi wara li ngħataw pirfenidone oralment u b'espożizzjoni għad-dawl UVA/UVB.
English: Other therapies that are inhibitors of both CYP1A2 and one or more other CYP isoenzymes involved in the metabolism of pirfenidone (e.g. CYP2C9, 2C19, and 2D6) should be avoided during pirfenidone treatment.
Maltese: Terapiji oħrajn li huma inibituri kemm ta' CYP1A2 kif ukoll ta' isoenzima oħra jew aktar ta' CYP involuti fil-metaboliżmu ta' pirfenidone (eż. CYP2C9, 2C19, u 2D6) għandhom ikunu evitati waqt il-kura b'pirfenidone.
English: Exposure to 5-carboxy-pirfenidone increases 3.5 fold or more in patients with moderate renal impairment.
Maltese: L-espożizzjoni għal 5-carboxy-pirfenidone tiżdied bi 3.5 darbiet jew aktar f'pazjenti b'indeboliment renali moderat.
English: The bottle pack contains one bottle containing 90 tablets.
Maltese: Il-pakketti bi flixkun fihom flixkun wieħed li fih 90 pillola.
English: Mon. Tue. Wed. Thu. Fri. Sat. Sun.
Maltese: (tlugħ ix-xemx; doża ta' filgħodu)
English: 534 mg tablet
Maltese: Pillola ta' 534 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/016 63 tablets (21 + 42)
Maltese: EU/1/11/667/016 63 pillola (21 + 42)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH
Maltese: Roche Registration GmbH
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg hard capsules Pirfenidone
Maltese: Esbriet 267 mg kapsuli iebsin Pirfenidone
English: ● Day 15 onward: a dose of 801 mg administered three times a day (2403 mg/day) The recommended maintenance daily dose of Esbriet is 801 mg three times a day with food for a total of 2403 mg/day.
Maltese: ● Minn jum 15 'il quddiem: tliet kapsuli, tliet darbiet kuljum (2403 mg/jum) Id-doża ta' manteniment ta' kuljum rakkomandata ta' Esbriet hija tliet kapsuli ta' 267 mg tliet darbiet kuljum ma' xi ħaġa tal-ikel għal total ta' 2403 mg/jum.
English: In a pre-specified pooled analysis of studies PIPF-016, PIPF-004, and PIPF-006 at Month 12, all-cause mortality was significantly lower in Esbriet 2403 mg/day group (3.5%, 22 of 623 patients) compared with placebo (6.7%, 42 of 624 patients), resulting in a 48% reduction in the risk of all-cause mortality within the first 12 months (HR 0.52 [95% CI, 0.31-0.87], p=0.0107, log-rank test).
Maltese: F'analiżi miġbura speċifikata minn qabel ta' studji PIPF-016, PIPF-004, u PIPF-006 f'Xahar 12, ilmewt minn kull kawża kienet anqas b'mod sinifikanti fil-grupp ta' Esbriet 2403 mg/jum (3.5%, 22 minn 623 pazjent) meta mqabbel ma' plaċebo (6.7%, 42 minn 624 pazjent), li wassal għal tnaqqis ta'
English: Although there was no difference between patients receiving Esbriet compared to placebo in change from Baseline to Week 72 of distance walked during a six minute walk test (6MWT) by the prespecified rank ANCOVA, in an ad hoc analysis, 37% of patients receiving Esbriet showed a decline of ≥50 m in 6MWT distance, compared to 47% of patients receiving placebo in PIPF-004.
Maltese: Għalkemm ma kienx hemm differenza bejn il-pazjenti li ngħataw Esbriet meta mqabbel mal-plaċebo fil-bidla mil-Linja Bażi sat-72 Ġimgħa fid-distanza koperta waqt test ta' mixja ta' sitt minuti (6MWTsix minute walk test) permezz tal-grad ANCOVA speċifikat minn qabel, f'analiżi ad hoc, 37% tal pazjenti li ngħataw Esbriet urew tnaqqis ta' ≥50 m f'distanza ta' 6MWT, meta mqabbla ma' 47% talpazjenti li ngħataw il-plaċebo f'PIPF-004.
English: Doses above 2403 mg/day are not recommended for any patient (see section 4.9).
Maltese: Dożi ogħla minn 2403 mg/jum mhumiex rakkomandati għall-ebda pazjent (ara sezzjoni 4.9).
English: Two percent of patients had percent predicted FVC below 50% and 21% of patients had a percent predicted DLCO below 35% at Baseline.
Maltese: Tnejn fil-mija tal-pazjenti kellhom FVC imbassra f'perċentwali taħt 50% u 21% tal-pazjenti kellhom DLCO imbassar f'perċentwali anqas minn 35% fil-Linja Bażi.
English: ● from day 15 onwards (maintenance), take a dose of 801 mg (3 yellow tablets or 1 brown tablet), 3 times a day with food (a total of 2,403 mg/day).
Maltese: ● mill-15-il jum 'il quddiem (manteniment), ħu doża ta' 801 mg (3 pilloli sofor jew pillola kannella waħda), 3 darbiet kuljum mal-ikel (total ta' 2,403 mg/jum).
English: ● tiredness
Maltese: ● sturdamenti
English: Esbriet 534 mg film-coated tablets are orange, oval, approximately 1.6 x 0.8 cm biconvex film-coated tablets, debossed with “PFD”.
Maltese: Esbriet 534 mg pilloli miksija b'rita huma pilloli miksija b'rita, oranġjo, ovali, madwar 1.6 x 0.8 ċm, ibbuzzati fuq iż-żewġ naħat, imnaqqxa b'“PFD”.
English: Treatment with Esbriet also significantly reduced the decline of percent predicted FVC from Baseline at Weeks 13 (p<0.000001), 26 (p<0.000001), and 39 (p=0.000002).
Maltese: 000001), 26 (p<0.000001), u 39 (p=0.000002).
English: PARTICULARS TO APPEAR ON THE OUTERPACKAGING LABEL - INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
Maltese: TIKKATTA - KARTUNA INTERMEDJA TA' PAKKETTI MULTIPLI (MINGĦAJR KAXXA
English: At Week 72, a decline in FVC of ≥10% was seen in 23% of patients receiving Esbriet and 27% receiving placebo (Table 3).
Maltese: Fit-72 Ġimgħa, tnaqqis fl-FVC ta' ≥10% deher fi 23% talpazjenti li kienu qegħdin jingħataw Esbriet u f'27% li kienu qegħdin jingħataw plaċebo (Tabella 3).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Film-coated Tablets in Blisters Multi Pack 252 - (INCLUDING BLUE BOX)
Maltese: KARTUNA Pilloli Miksija b'Rita f'Folji Pakkett Multiplu ta' 252 - (INKLUŻA KAXXA BLU)
English: ● from day 8 to 14 take a dose of 534 mg (2 yellow tablets or 1 orange tablet), 3 times a day with food (a total of 1,602 mg/day)
Maltese: ● mit-8 jum sal-14-il jum, ħu doża ta' 534 mg (2 pilloli sofor jew pillola oranġjo waħda), 3 darbiet kuljum mal-ikel (total ta' 1,602 mg/jum)
English: 2 bottles each containing 21 film-coated tablets (42 film-coated tablets in total) 1 bottle containing 42 film-coated tablets 1 bottle containing 90 film-coated tablets 2 bottles each containing 90 film-coated tablets (180 film-coated tablets in total) 1 bottle containing 180 film-coated tablets
Maltese: Il-pakketti bi fliexken fihom flixkun wieħed li fih 21 pillola, żewġ fliexken li kull wieħed fih 21 pillola (42 pillola b'kollox), flixkun wieħed li fih 42 pillola, flixkun wieħed li fih 90 pillola, żewġ fliexken li kull wieħed fih 90 pillola (180 pillola b'kollox) jew flixkun wieħed li fih 180 pillola.
English: 267 mg tablet
Maltese: Pillola ta' 267 mg
English: Continuation pack: multipack containing 252 (3 packs each containing 4 blisters of 21) film-coated tablets
Maltese: Pakkett ta' kontinwazzjoni: pakkett multiplu li fih 252 (3 pakketti li kull wieħed fih 4 folji ta' 21)
English: Metabolism and nutrition disorders Very Common Anorexia Common
Maltese: Komuni ħafna Anoressija
English: Children and adolescents Do not give Esbriet to children and adolescents under the age of 18.
Maltese: Tagħtix Esbriet lil tfal u adolexxenti taħt it-18-il sena.
English: ; 100 (26.3) mg•h/L and 168 (67.4)
Maltese: 100b (26.3)
English: Photosensitivity reaction and rash
Maltese: Reazzjoni ta' fotosensittività u raxx
English: No decline (FVC change >0%)
Maltese: Tnaqqis ta' inqas minn 10% L-ebda tnaqqis (bidla fl-FVC >0%)
English: Esbriet 534 mg film-coated tablets are orange, oval, biconvex film-coated tablets, debossed with “PFD”.
Maltese: Esbriet 534 mg pilloli miksija b'rita huma oranġjo, ovali, ibbuzzati fuq iż-żewġ naħat, imnaqqxa b'“PFD”.
English: Compared to the fasted state, administration of either formulation with food reduced pirfenidone Cmax, with Esbriet tablet reducing the Cmax slightly less (by 40%) than Esbriet capsules (by 50%).
Maltese: Meta mqabbel mal-istat sajjem, l-għoti ta' xi waħda mill-formulazzjonijiet mal-ikel naqqas Cmax ta' pirfenidone, bil-pillola Esbriet tnaqqas Cmax kemmxejn inqas (b'40%) mill-kapsuli Esbriet (b'50%).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: ● Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Each capsule contains 267 mg of pirfenidone.
Maltese: Kull kapsula fiha 267 mg pirfenidone.
English: There is limited clinical experience with overdose.
Maltese: Hemm esperjenza klinika limitata dwar dożi eċċessivi.
English: 801 mg tablet
Maltese: Pillola ta' 801 mg
English: The study (SP3) in Japanese patients compared pirfenidone 1800 mg/day (comparable to 2403 mg/day in the US and European populations of PIPF-004/006 on a weight-normalised basis) with placebo (N=110, N=109, respectively).
Maltese: L-istudju (SP3) f'pazjenti Ġappuniżi qabbel pirfenidone 1800 mg/jum (komparabbli ma' 2403 mg/jum fil-popolazzjonijiet Amerikani u Ewropej ta' PIPF-004/006 fuq bażi ta' piż normalizzat) ma' plaċebo
English: This may become clinically relevant in patients with moderate renal impairment where plasma exposure to 5-carboxy-pirfenidone is increased
Maltese: Dan jista' jsir klinikament rilevanti f'pazjenti b'indeboliment renali moderat fejn l-espożizzjoni tal-plażma għal 5-carboxy-pirfenidone tiżdied.
English: Ammonium hydroxide
Maltese: Tfal u adolexxenti
English: In vitro and in vivo extrapolations indicate that strong and selective inhibitors of CYP1A2 (e.g. enoxacin) have the potential to increase the exposure to pirfenidone by approximately 2 to 4-fold.
Maltese: Ekstrapolazzjonijiet in vitro u in vivo jindikaw li impedituri qawwija u selettivi ta' CYP1A2 (eż. enoxacin) jistgħu jżidu l-espożizzjoni ta' pirfenidone b'madwar darbtejn sa 4 darbiet.
English: Be careful if you have to take part in activities where you have to be alert and co-ordinated.
Maltese: Oqgħod attent jekk tkun ser tieħu sehem f'xi attività fejn trid tkun attent u kkoordinat.
English: There are 14 x 18 capsules in PVC/PE/PCTFE aluminium foil perforated blister strips for a total of 252 capsules per pack.
Maltese: PVC/PE/PCTFE għal total ta' 252 kapsula f'kull pakkett.
English: What Esbriet looks like and contents of the pack Esbriet hard capsules (capsules) have a white to off-white opaque body and a white to off-white opaque cap with ‘PFD 267 mg' printed in brown ink.
Maltese: Esbriet kapsuli iebsin (kapsuli) għandhom parti ta' taħt ta' lewn abjad sa abjad maħmuġ opak u kappa ta' lewn abjad sa abjad maħmuġ opak stampata b'“PFD 267 mg” b'linka kannella.
English: ● loss of appetite
Maltese: ● telf ta' aptit
English: In a multiple-dose, dose-ranging study in healthy older adults administered doses ranging from 267 mg to 1,335 mg three times a day, the mean clearance decreased by approximately 25% above a dose of 801 mg three times a day.
Maltese: Fi studju ta' dożi multipli u ta' firxa ta' dożi f'adulti anzjani f'saħħithom li ngħataw dożi li kienu jvarjaw minn 267 mg sa 1,335 mg tliet darbiet kuljum, it-tneħħija medja naqset b'madwar 25% f'dożi ogħla minn 801 mg tliet darbiet kuljum.
English: No clinically relevant differences in the pharmacokinetics of pirfenidone were observed in subjects with mild to severe renal impairment compared with subjects with normal renal function.
Maltese: Ma ġewx osservati differenzi klinikament rilevanti fil-farmakokinetika ta' pirfenidone f'suġġetti b'indeboliment renali ħafif sa sever meta mqabbla ma' suġġetti b'funzjoni renali normali.
English: If concomitant use of Esbriet with a strong and selective inhibitor of CYP1A2 cannot be avoided, the dose of pirfenidone should be reduced to 801 mg daily (one capsule, three times a day).
Maltese: Jekk l-użu fl-istess waqt ta' Esbriet u impeditur qawwi u silettiv ta' CYP1A2 ma jistax jiġi evitat, id-doża ta' pirfenidone għandha tiġi mnaqqsa għal 801 mg kuljum (kapsula waħda, tliet darbiet kuljum).
English: Esbriet is for oral use.
Maltese: Esbriet huwa għall-użu orali.
English: At Week 52, a decline from Baseline in percent predicted FVC of ≥10% or death was seen in 17% of patients receiving Esbriet compared to 32% receiving placebo (Table 4).
Maltese: F'Ġimgħa 52, tnaqqis mil-Linja Bażi f'FVC imbassra f'perċentwali ta' ≥10% jew mewt kien osservat fi 17% tal-pazjenti li kienu qed jirċievu Esbriet meta mqabbel ma' 32% li kienu qed jirċievu plaċebo (Tabella 4).
English: Table 2 Categorical assessment of change from Baseline to Week 72 in percent predicted FVC in study PIPF-004
Maltese: Tabella 2 Valutazzjoni kategorika tal-bidla mil-Linja Bażi sat-72 Ġimgħa fl-FVC imbassra f'perċentwali fl-istudju PIPF-004
English: Table 3 Categorical assessment of change from Baseline to Week 72 in percent predicted FVC in study PIPF-006
Maltese: Tabella 3 Valutazzjoni kategorika tal-bidla mil-Linja Bażi sat-72 Ġimgħa fl-FVC imbassra f'perċentwali fl-istudju PIPF-006
English: Each film-coated tablet contains 534 mg pirfenidone.
Maltese: Kull pillola fiha 534 mg pirfenidone.
English: In a Phase 1 study, the co-administration of Esbriet and fluvoxamine (a strong inhibitor of CYP1A2 with inhibitory effects on other CYP isoenzymes [CYP2C9, 2C19, and 2D6]) resulted in a 4-fold increase in exposure to pirfenidone in non-smokers.
Maltese: Fi studju ta' Fażi 1, l-għoti ta' Esbriet flimkien ma' fluvoxamine (inibitur qawwi ta' CYP1A2 b'effetti ta' inibizzjoni fuq isoenzimi ta' CYP oħrajn [CYP2C9, 2C19, u 2D6]) irriżulta f'żieda ta' erba' darbiet fl-espożizzjoni għal pirfenidone f'persuni li ma jpejpux.
English: There are 14 x 2-day blister strips each containing 18 capsules (3 capsules per pocket).
Maltese: Hemm 14-il strixxa tal-folja ta' jumejn li kull waħda fiha 18-il kapsula (3 kapsuli f'kull vojt).
English: Hepatic function
Maltese: Funzjoni epatika:
English: Film-coated tablet Multipack containing 252 (3 packs each containing 4 blisters of 21) film-coated Tablets
Maltese: Pakkett multiplu li fih 252 (3 pakketti li kull wieħed fih 4 folji ta' 21) pillola miksija b'rita
English: The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172) and iron oxide black (E172)
Maltese: Il-kisja b'rita tikkonsisti minn: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide aħmar (E172) u iron oxide iswed (E172)
English: 267 mg tablet and 801 mg tablet 3 years for blisters.
Maltese: Pillola ta' 267 mg u pillola ta' 801 mg
English: As a precautionary measure, it is preferable to avoid the use of Esbriet if you are pregnant, planning to become pregnant or think you might be pregnant as the potential risks to the unborn child are unknown.
Maltese: Bħala miżura ta' prekawzjoni, huwa preferibbli li jiġi evitat l-użu ta' Esbriet jekk inti tqila, qed tippjana li jkollok tarbija jew jekk taħseb li tista' tkun tqila għax ir-riskji potenzjali għat-tarbija fil-ġuf mhumiex magħrufa.
English: At high doses (≥450 mg/kg/day) rats exhibited a prolongation of oestrous cycle and a high incidence of irregular cycles.
Maltese: F'dożi għoljin (≥450 mg/kg/jum) il-firien urew titwil taċ-ċiklu tal-oestrus u inċidenza għolja ta' ċikli irregolari.
English: Esbriet 801 mg film-coated tablets are brown, oval, approximately 2 x 0.9 cm biconvex film-coated tablets, debossed with “PFD”.
Maltese: Esbriet 801 mg pilloli miksija b'rita huma pilloli miksija b'rita, kannella, ovali, madwar 2 x 0.9 ċm,
English: In study PIPF-004, the decline of percent predicted FVC from Baseline at Week 72 of treatment was significantly reduced in patients receiving Esbriet (N=174) compared with patients receiving placebo (N=174; p=0.001, rank ANCOVA).
Maltese: Fl-istudju PIPF-004 it-tnaqqis fil-FVC prevista f'perċentwal mil-Linja Bażi fit-72 Ġimgħa tal-kura naqas b'mod sinifikanti f'pazjenti li ngħataw Esbriet (N=174) meta mqabbel ma' pazjenti li ngħataw il-plaċebo (N=174; p=0.001, grad ANCOVA).
English: Each film-coated tablet contains 801 mg pirfenidone.
Maltese: Kull pillola fiha 801 mg pirfenidone.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/017 252 tablets (3 x 84)
Maltese: EU/1/11/667/017 252 pillola (3 x 84)
English: Severe photosensitivity reactions are uncommon.
Maltese: Reazzjonijiet ta' fotosensittività severi mhumiex komuni.
English: Bioequivalence was demonstrated in the fasted state when comparing the 801 mg tablet to three 267 mg capsules.
Maltese: Bijoekwivalenza ntweriet fi stat sajjem meta tqabblet il-pillola ta' 801 mg ma' tliet kapsuli ta' 267 mg.
English: ● from day 8 to 14 take 2 capsules, 3 times a day with food (a total of 1,602 mg/day)
Maltese: ● mit-8 jum sal-14-il jum, ħu żewġ kapsuli, 3 darbiet kuljum mal-ikel (total ta' 1,602 mg/jum)
English: Propylene glycol
Maltese: F'dożi għoljin
English: The bottle pack contains 270 capsules.
Maltese: Il-pakkett tal-flixkun fih 270 kapsuli.
English: If a patient exhibits an aminotransferase elevation to >3 to ≤5 x ULN after starting Esbriet therapy, confounding medicinal products should be discontinued, other causes excluded, and the patient monitored closely.
Maltese: Jekk pazjent juri żieda ta' aminotransferase minn >3 sa ≤5 x ULN wara li jibda t-terapija b'Esbriet, għandhom jitwaqqfu l-prodotti mediċinali li jfixklu lil xulxin, jiġu esklużi kawżi oħrajn, u l-pazjent għandu jkun sorveljat sew.
English: Table 4 Categorical assessment of change from Baseline to Week 52 in percent predicted FVC in study PIPF-016
Maltese: Ġimgħa 52 fl-FVC imbassra f'perċentwali fi studju PIPF-016
English: The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172)
Maltese: Il-kisja b'rita tikkonsisti minn: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide isfar (E172)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/018 84 tablets (4x21)
Maltese: EU/1/11/667/018 84 pillola (4 x 21)
English: Cigarette smoking can reduce the effect of Esbriet.
Maltese: It-tipjip tas-sigaretti jista' jnaqqas l-effett ta' Esbriet.
English: Immune system disorders Uncommon
Maltese: Disturbi fis-sistema immuni Mhux komuni
English: EU/1/11/667/012 21 tablets EU/1/11/667/013 42 tablets (2 x 21) EU/1/11/667/014 84 tablets (4 x 21) EU/1/11/667/015 168 tablets (8 x 21)
Maltese: EU/1/11/667/012 21 pillola EU/1/11/667/013 42 pillola (2 x 21)
English: (sunrise; morning dose)
Maltese: (xemx; doża ta'
English: There are 7 blister strips with 3 capsules per strip (1 capsule per pocket for Week 1) and 7 blister strips with 6 capsules per strip (2 capsules per pocket for Week 2).
Maltese: Hemm 7 strixxi tal-folja bi 3 kapsuli f'kull strixxa (kapsula waħda f'kull vojt għall-Ġimgħa 1) u 7 strixxi tal-folja b'6 kapsuli f'kull strixxa (2 kapsuli f'kull vojt għal Ġimgħa 2).
English: ● You should not take other medicines, such as tetracycline antibiotics (such as doxycycline),
Maltese: ● M'għandekx tieħu mediċini oħrajn, bħal antibijotiċi tetracycline (bħal doxycycline), li jistgħu jagħmluk aktar sensittiv għad-dawl tax-xemx.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/019 252 tablets (3 x 84)
Maltese: EU/1/11/667/019 252 pillola (3 x 84)
English: ● Patient information (PIL)
Maltese: ● Tagħrif għall-pazjenti (PIL)
English: Each film-coated tablet contains 267 mg pirfenidone.
Maltese: Kull pillola fiha 267 mg pirfenidone.
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 (two capsules, 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 (żewġ kapsuli, tliet darbiet kuljum).
English: Esbriet 267 mg film-coated tablets are yellow, oval, biconvex film-coated tablets, debossed with “PFD”.
Maltese: Esbriet 267 mg pilloli miksija b'rita huma sofor, ovali, ibbuzzati fuq iż-żewġ naħat, imnaqqxa b'“PFD”.
English: NAME OF THE MEDICINAL PRODUCT Esbriet 801 mg film-coated tablets Pirfenidone
Maltese: Esbriet 801 mg pilloli miksija b'rita Pirfenidone