FrancophonIA/ELRC3.0 huggingface dataset:
English: More patients in the roflumilast group (27.6%) than placebo (19.8%) withdrew study medication due to any reason (risk ratio: 1.40; 95% CI: 1.19 to 1.65).
Maltese: Aktar pazjenti fil-grupp ta' roflumilast (27.6%) milli fil-grupp tal-plaċebo (19.8%) irtiraw waqt listudju tal-mediċina minħabba kwalunkwe raġuni (rata ta' proporzjon: 1.40; 95% CI: 1.19 sa 1.65).
English: In an interaction study with an oral contraceptive containing gestodene and ethinyl oestradiol, the total PDE4 inhibitory activity was increased by 17%.
Maltese: Fi studju dwar l-interazzjonijiet ma' kontraċettiv orali li fih gestodene u ethinyl oestradiol, l-attività inibitorja totali ta' PDE4 żdiedet bi 17%.
English: The other ingredients are lactose monohydrate (see section 2 under “Daxas contains lactose”), maize starch, povidone, magnesium stearate.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate (ara sezzjoni 2 taħt “Daxas fih lactose”), lamtu tal-qamħirrum, povidone, magnesium stearate.
English: What Daxas contains The active substance is roflumilast.
Maltese: X'fih Daxas Is-sustanza attiva hi roflumilast.
English: Daxas is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C).
Maltese: Daxas hu kontraindikat f'pazjenti b'indeboliment moderat jew sever tal-fwied (Child-Pugh B jew Ċ).
English: A risk to the breastfed infant cannot be excluded.
Maltese: Ir-riskju gћat-tarbija li tkun qed terda' mhux eskluż.
English: Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
Maltese: Daxas hu indikat għal kura ta' manteniment ta' mard pulmonari ostruttiv kroniku (COPD) sever (FEV1 wara l-użu ta' bronkodilatur, inqas minn 50% ta' dak imbassar) assoċjat ma' bronkite kronika f'pazjenti adulti bi storja ta' aggravamenti frekwenti flimkien ma' kura bi bronkodilatur.
English: • Educational material for the physician.
Maltese: • Materjal edukattiv għat-tabib.
English: In the subgroup of patients with history of frequent exacerbations (at least 2 exacerbations during the last year), the rate of exacerbations was 1.526 with roflumilast and 1.941 with placebo corresponding to a relative risk reduction of 21.3% (95% CI: 7.5% to 33.1%).
Maltese: Fis sottogrupp ta' pazjenti bi storja medika ta' aggravamenti frekwenti (mill inqas 2 aggravamenti matul l aħħar sena), ir rata ta' aggravamenti kienet ta' 1.526 b'roflumilast u 1.941 bi plaċebo li tikkorrispondi għal tnaqqis fir riskju relattiv ta' 21.3% (95% CI: 7.5% sa 33.1%).
English: Upon in vitro stimulation of human neutrophils, monocytes, macrophages or lymphocytes, roflumilast and roflumilast N-oxide suppress the release of inflammatory mediators e.g. leukotriene B4, reactive oxygen species, tumour necrosis factor α, interferon γ and granzyme B.
Maltese: Meta saret stimulazzjoni in vitro ta' newtrofili, monoċiti, makrofaġi jew limfoċiti umani, roflumilast u roflumilast N-oxide rażżnu l-ħruġ ta' medjaturi infjammatorji, eż. leukotriene B4, speċi ta' ossiġnu reattiv, fattur tan-nekrosi tat-tumur α, interferon γ u granzyme B.
English: However, Cmax and tmax of roflumilast N-oxide are unaffected.
Maltese: Madankollu, is-Cmax u t-tmax ta' roflumilast N-oxide ma jiġux affettwati.
English: Volume of distribution for single dose of 500 micrograms roflumilast is about 2.9 l/kg.
Maltese: Il-volum tad-distribuzzjoni għal doża waħda ta' 500 mikrogramma ta' roflumilast hu ta' madwar 2.9 l/kg.
English: Haematochezia Constipation
Maltese: Tqala u treddigħ
English: A total of 1323 patients were randomised to receive roflumilast 500 micrograms once a day for 12 weeks (n=443), roflumilast 500 micrograms every other day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (n=439), or roflumilast 250 micrograms once a day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (n=441).
Maltese: Total ta' 1323 pazjent kienu randomizzati biex jirċievu doża ta' roflumilast 500 mikrogramma darba kuljum għal 12-il ġimgħa (n=443), doża ta' roflumilast 500 mikrogramma kull jumejn għal 4 ġimgħat, segwita minn doża ta' roflumilast 500 mikrogramma darba kuljum għal 8 ġimgħat (n=439), jew doża ta' roflumilast 250 mikrogramma darba kuljum għal 4 ġimgħat segwita minn doża ta' roflumilast 500 mikrogramma darba kuljum għal 8 ġimgħat (n=441).
English: The respective reduction in exacerbations seen in patients without concomitant LABAs was on average 15% (p=0.0387).
Maltese: It-tnaqqis rispettiv fl-aggravamenti li kien osservat f'pazjenti mingħajr użu fl-istess ħin ta' LABAs kien bħala medja ta' 15% (p=0.0387).
English: Daxas 500 micrograms has been studied in clinical trials for up to one year, and is intended for maintenance treatment.
Maltese: Daxas 500 mikrogramma ġie studjat fi studji kliniċi għal sa perjodu ta' sena, u hu maħsub bħala kura ta' manteniment.
English: CALENDAR BLISTERS
Maltese: STRIXXA BIL-KALENDARJU
English: The observed adverse reactions for roflumilast in Study RO-2455404-RD were in line with those already included in section 4.8.
Maltese: Ir-reazzjonijiet avversi osservati għal roflumilast fl-Istudju RO-2455-404-RD kienu f'konformità ma' dawk li diġà ġew inklużi f'sezzjoni 4.8.
English: Children and adolescents Daxas should not be used by children and adolescents under 18 years of age.
Maltese: Tfal u adolexxenti Daxas m'għandux jintuża minn tfal u adolexxenti taħt l-età ta' 18-il sena.
English: Rescue medicinal products Daxas is not indicated as rescue medicinal product for the relief of acute bronchospasms.
Maltese: Prodotti mediċinali ta' salvataġġ Daxas mhuwiex indikat bħala prodott mediċinali ta' salvataġġ għas-solliev ta' bronkospażmi akuti.
English: In the two six-month studies, pre-bronchodilator FEV1 was significantly improved by 49 ml (primary endpoint, p<0.0001) beyond the bronchodilator effect of concomitant treatment with salmeterol in Study M2-127 and by 80 ml (primary endpoint, p<0.0001) incremental to concomitant treatment with tiotropium in Study M2-128.
Maltese: Fiż-żewġ studji li damu sitt xhur, FEV1 qabel l-użu ta' bronkodilatur ittejjeb b'mod sinifikanti b'49 ml (punt aħħari primarju, p<0.0001) lil hemm mill-effett tal-bronkodilatur tal-kura fl-istess ħin b'salmeterol fi studju M2-127 u bi 80 ml (punt aħħari primarju, p<0.0001) inkrementali għal kura fl-istess ħin b'tiotropium fi studju M2-128.
English: Daxas is to be used in addition to bronchodilators.
Maltese: Daxas għandu jintuża flimkien ma' bronkodilaturi.
English: Concomitant treatment with long acting muscarinic antagonists (LAMA) A higher incidence of weight decrease, decreased appetite, headache and depression was observed during Study RO-2455-404-RD in patients receiving concomitant roflumilast and long-acting muscarinic antagonists (LAMA) plus concomitant inhaled corticosteroids (ICS) and long acting B2 agonists (LABA) compared to those treated only with concomitant roflumilast, ICS and LABA.
Maltese: Inċidenza ogħla ta' tnaqqis fil-piż, tnaqqis fl-aptit, uġigħ ta' ras u depressjoni ġew osservati waqt Studju RO-2455-404-%D f'pazjenti li rċevew roflumilast flimkien ma' riċettaturi muskariniċi li jaġixxu għal żmien twil (LAMA) flimkien ma' kortikosterojdi li ttieħdu man-nifs (inhaled corticosteroids, ICS) u agonisti B2 li jaġixxu għal żmien twil (long acting B2 agonists, LABA), meta mqabbla ma' dawk trattati biss b'roflumilast, ICS u LABA fl-istess waqt.
English: • After 28 days - the recommended maintenance dose is one 500 micrograms tablet once daily.
Maltese: • Wara 28 jum - id-doża ta' manteniment rakkomandata hija pillola waħda ta' 500 mikrogramma darba kuljum.
English: Since both roflumilast and roflumilast N-oxide contribute to PDE4 inhibitory activity in vivo, pharmacokinetic considerations are based on total PDE4 inhibitory activity (i.e. total exposure to roflumilast and roflumilast N-oxide).
Maltese: Billi kemm roflumilast kif ukoll roflumilast N-oxide jikkontribwixxu għal attività inibitorja ta' PDE4 in vivo, il-konsiderazzjonijiet farmakokinetiċi huma bbażati fuq l-attività inibitorja totali ta' PDE4 (i.e. l-espożizzjoni totali għal roflumilast u roflumilast N-oxide).
English: A total of 1935 patients were randomised to doubleblind medication and approximately 70% were also using a long-acting muscarinic antagonist (LAMA) through the course of the trial.
Maltese: Total ta' 1935 pazjent ġew randomizzati għal mediċina double-blind u madwar 70% kienu qed jużaw antagonista muskariniku li jaġixxi għal żmien twil (LAMA) matul il-kors tal-prova.
English: Roflumilast 500 micrograms once daily significantly improved lung function compared to placebo, on average by 51 ml (pre-bronchodilator FEV1, p<0.0001), and by 53 ml (post-bronchodilator FEV1, p<0.0001).
Maltese: Roflumilast 500 mikrogramma darba kuljum tejjeb b'mod sinifikanti l-funzjoni tal-pulmun meta mqabbel ma' plaċebo, bħala medja b'51 ml (qabel l-użu ta' bronkodilatur FEV1, p<0.0001), u b'53 ml (wara l-użu ta' bronkodilatur FEV1, p<0.0001).
English: Inhibition of PDE4 leads to elevated intracellular cAMP levels and mitigates COPD-related malfunctions of leukocytes, airway and pulmonary vascular smooth muscle cells, endothelial and airway epithelial cells and fibroblasts in experimental models.
Maltese: L-inibizzjoni ta' PDE4 twassal għal livelli intraċellulari għolja ta' cAMP u ttaffi l-funzjonament ħażin marbut ma' COPD ta' lewkoċiti, taċ-ċelluli vaskulari tal-passaġġ tan-nifs u pulmonari tal-muskoli lixxi, taċ-ċelluli endoteljali u epiteljali tal-passaġġ tan-nifs, u fibroblasts f'mudelli sperimentali.
English: Nervous system disorders Headache
Maltese: Disturbi fis-sistema nervuża
English: - a medicine containing fluvoxamine (a medicine to treat anxiety disorders and depression), enoxacin (a medicine to treat bacterial infections) or cimetidine (a medicine to treat stomach ulcers or heartburn).
Maltese: - mediċina li jkun fiha fluvoxamine (mediċina għall-kura ta' disturbi ta' ansjetà u dipressjoni), enoxacin (mediċina għall-kura ta' infezzjonijiet batteriċi) jew cimetidine (mediċini għall-kura ta' ulċeri tal-istonku jew ħruq tal-istonku).
English: A similar reduction was achieved in the subgroup of patients concomitantly treated with LAMA (rate ratio: 0.77; 95% CI: 0.60 to 0.99) and in the subgroup not treated with LAMA (rate ratio: 0.71; 95% CI: 0.42 to 1.20).
Maltese: Tnaqqis simili kien miksub fis-sottogrupp ta' pazjenti li ġew trattati fl-istess waqt b'LAMA (rata ta' proporzjon 0.77; 95% CI 0.60 sa 0.99) u fis-sottogrupp mhux trattat b'LAMA (rata ta' proporzjon: 0.71; 95% CI 0.42 sa 1.20).
English: Due to lack of relevant experience, treatment with roflumilast should not be initiated or existing treatment with roflumilast should be stopped in patients with severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy), severe acute infectious diseases, cancers (except basal cell carcinoma), or patients being treated with immunosuppressive medicinal products (i.e. methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term; except short-term systemic corticosteroids).
Maltese: Minħabba nuqqas ta' esperjenza rilevanti, il-kura b'roflumilast m'għandhiex tinbeda, jew kura eżistenti b'roflumilast għandha titwaqqaf f'pazjenti b'mard immunoloġiku sever (eż. infezzjoni bl-HIV, sklerosi multipla, lupus erythematosus, lewkoenċefalopatija multifokali progressiva), mard sever akut u infettiv, kanċers (ħlief karċinoma taċ-ċelluli bażali), jew pazjenti li jkunu qed jiġu kkurati bi prodotti mediċinali immunosoppressivi (i.e. methotrexate, azathioprine, infliximab, etanercept, jew kortikosterojdi orali li għandhom jittieħdu għal żmien twil; ħlief kortikosterojdi sistemiċi għal żmien qasir).
English: The rate (per patient per year) of moderate exacerbations (requiring intervention with systemic glucocorticosteroids) or severe exacerbations (resulting in hospitalisation and/or leading to death) after 1 year was 1.142 with roflumilast and 1.374 with placebo corresponding to a relative risk reduction of 16.9% (95% CI: 8.2% to 24.8%) (primary endpoint, p=0.0003).
Maltese: Ir-rata (kull pazjent kull sena) ta' aggravamenti moderati (li kienu jeħtieġu intervent bi glukokortikosterojdi sistemiċi) jew aggravamenti severi (li rriżultaw f'li l-pazjenti kellhom jiddaħħlu l-isptar u/jew li wasslu għal mewt) wara sena kienet ta' 1.142 b'roflumilast u 1.374 bil-plaċebo, li tikkorrispondi għal tnaqqis relattiv fir-riskju ta' 16.9% (95%CI: 8.2% sa 24.8%) (punt aħħari primarju, p=0.0003).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Furthermore, roflumilast attenuated influx of neutrophils and eosinophils into the airways of endotoxin challenged healthy volunteers.
Maltese: Flimkien ma' dan, roflumilast naqqas l-influss ta' newtrofili u eosinofili ġol-passaġġi tan-nifs ta' voluntiera b'saħħithom li kienu endotoxin challenged.
English: Reductions were achieved in the subgroup of patients concomitantly treated with LAMA (rate ratio: 0.88; 95% CI: 0.75 to 1.04) and in the subgroup not treated with LAMA (rate ratio: 0.83; 95% CI: 0.62 to 1.12).
Maltese: (rata ta' proporzjon: 0.88; 95% CI: 0.75 sa 1.04) u fis-sottogrupp mhux trattat b'LAMA (rata ta' proporzjon: 0.83; 95% CI: 0.62 sa 1.12).
English: Adverse reactions with roflumilast in clinical COPD studies and post-marketing experience
Maltese: Reazzjonijiet avversi b'roflumilast fi studji kliniċi dwar COPD
English: The affinity to the PDE4C splicing variants is 5 to 10-fold lower.
Maltese: L-affinità għall-varjanti splicing ta' PDE4C hi minn 5 sa 10 darbiet iktar baxxa.
English: Roflumilast reduces the activity of phosphodiesterase-4, a protein occurring naturally in body cells.
Maltese: Roflumilast inaqqas l attività ta' phosphodiesterase-4, proteina li tinsab b'mod naturali fiċ ċelluli tal ġisem.
English: Child-Pugh A patients (see section 4.2).
Maltese: Il-kawtela hi meħtieġa f'pazjenti li qegħdin f'Child-Pugh A (ara sezzjoni 4.2).
English: Over the entire study period of 12 weeks, the percentage of patients discontinuing treatment due to any reason was statistically significantly lower in patients initially receiving roflumilast 250 micrograms once a day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (18.4%) compared to those receiving roflumilast 500 micrograms once a day for 12 weeks (24.6%; Odds Ratio 0.66, 95% CI [0.47, 0.93], p=0.017).
Maltese: Matul il-perjodu kollu ta' studju ta' 12-il ġimgħa, il-perċentwal ta' pazjenti li waqfu l-kura minħabba kwalunkwe raġuni kien statistikament aktar baxx b'mod sinifikanti f'pazjenti li fil-bidu bdew jirċievu doża ta' roflumilast 250 mikrogramma darba kuljum għal 4 ġimgħat segwita minn doża ta' roflumilast 500 mikrogramma darba kuljum għal 8 ġimgħat (18.4%) meta mqabbla ma' dawk li rċevew roflumilast 500 mikrogramma darba kuljum għal 12-il ġimgħa (24.6%; Proporzjon ta' Probabbiltà 0.66, 95% CI [0.47, 0.93], p=0.017).
English: Gastrointestinal disorders Diarrhoea Nausea
Maltese: Disturbi gastro-intestinali
English: Tremor Vertigo Dizziness
Maltese: Rogħda Vertigo Sturdament
English: In a pooled analysis of the one-year studies M2-124 and M2-125, roflumilast 500 micrograms once daily significantly improved lung function compared to placebo, on average by 48 ml (pre-bronchodilator FEV1, primary endpoint, p<0.0001), and by 55 ml (post-bronchodilator FEV1, p<0.0001).
Maltese: M2-124 u M2-125 li damu sena, roflumilast 500 mikrogramma darba kuljum tejjeb b'mod sinifikanti l-funzjoni tal-pulmun meta mqabbel mal-plaċebo, b'medja ta' 48 ml (qabel l-użu ta' bronkodilatur FEV1, punt aħħari primarju, p<0.0001), u b'55 ml (wara l-użu ta' bronkodilatur FEV1, p<0.0001).
English: A higher incidence of sleep disorders (mainly insomnia) in patients ≥75 years or older was observed in Study RO-2455-404-RD for patients treated with roflumilast when compared to those treated with placebo (3.9% vs 2.3%).
Maltese: Inċidenza ogħla ta' disturbi fl-irqad (prinċipalment insomnja) f'pazjenti ta' ≥ 75 sena ġiet osservata fi Studju RO-2455-404-RD għal pazjenti trattati b'roflumilast meta mqabbla ma' dawk trattati bi plaċebo (3.9% vs 2.3%).
English: Experience is also limited in patients with a previous diagnosis of tuberculosis, viral hepatitis, herpes viral infection or herpes zoster.
Maltese: L-esperjenza hi limitata wkoll f'pazjenti b'dijanjosi fil-passat ta' tuberkulosi, epatite virali, infezzjoni virali bil-herpes jew herpes zoster.
English: The rate of severe exacerbations was reduced in the overall patient group (rate ratio: 0.76; 95% CI: 0.60 to 0.95) with a rate of 0.24 per patient/year compared to a rate of 0.32 per patient/year in patients treated with placebo.
Maltese: Ir-rata ta' aggravamenti severi tnaqqset fil-grupp ta' pazjenti globali (rata ta' proporzjon: 0.76; 95% CI: 0.60 sa 0.95) b'rata ta' 0.24 kull pazjent/sena meta mqabbel ma' rata ta' 0.
English: An early distribution phase with marked penetration into tissues is followed by a marked elimination phase out of fatty tissue most probably due to pronounced break-down of parent compound to roflumilast N-oxide.
Maltese: Fażi bikrija ta' distribuzzjoni b'penetrazzjoni notevoli fit-tessut tiġi segwita minn fażi notevoli ta' eliminazzjoni 'l barra minn tessut xaħmi, probabbilment l-aktar minħabba tkissir prominenti tal-kompost prinċipali għal roflumilast N-oxide.
English: You may also experience sleeplessness, anxiety, nervousness, or depressive mood.
Maltese: Jista' jkollok ukoll nuqqas ta' rqad, ansjetà, nervożità, jew burdata dipressiva.
English: When the activity of this protein is reduced, there is less inflammation in the lungs.
Maltese: Meta l-attività ta' din proteina titnaqqas, ikun hemm inqas infjammazzjoni fil-pulmun.
English: Starting dose titration trial
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Rescue medicinal products (salbutamol or albuterol) were allowed on an as-needed basis.
Maltese: Prodotti mediċinali ta' salvataġġ (salbutamol jew albuterol) kienu permessi skont il-ħtieġa.
English: Roflumilast or placebo treatment was added to continuous treatment with a long-acting bronchodilator, in particular salmeterol in Study M2-127 or tiotropium in Study M2-128.
Maltese: Il-kura b'roflumilast jew bi plaċebo żdiedet ma' kura kontinwa bi bronkodilatur li jaġixxi għal żmien twil, b'mod partikulari salmeterol fi studju M2-127 jew tiotropium fi studju M2-128.
English: In clinical COPD studies, approximately 16% of patients experienced adverse reactions with roflumilast (compared to 5% in placebo).
Maltese: Fi studji kliniċi dwar COPD, madwar 16% tal-pazjenti ġarrbu reazzjonijiet avversi b'roflumilast (meta mqabbla ma' 5% ta' dawk li kienu qed jieħdu plaċebo).
English: A higher incidence of sleep disorders (mainly insomnia) in patients with a baseline body weight <60 kg was observed in Study RO-2455-404-RD for patients treated with roflumilast when compared to those treated with placebo (6.0% vs 1.7%).
Maltese: Inċidenza ogħla ta' disturbi fl-irqad (prinċipalment insomnja) f'pazjenti b'piż tal-ġisem fil-linja bażi ta' <60 kg ġiet osservata fi Studju RO-2455-404-RD għal pazjenti trattati b'roflumilast meta mqabbla ma' dawk trattati bi plaċebo (6.0% vs 1.7%).
English: Inhaled corticosteroids were used in 809 (61%) of the roflumilast treated patients, whereas the use of LABAs and theophylline was prohibited.
Maltese: Kortikosterojdi li jinġibdu man-nifs intużaw fi 809 (61%) tal-pazjenti kkurati b'roflumilast, filwaqt li l-użu ta' LABAs u theophylline kien ipprojbit.
English: Daxas 250 micrograms tablets are white to off-white, embossed with ‘D' on one side and ‘250' on the other side.
Maltese: Il-pilloli ta' Daxas 250 mikrogramma huma bojod għal offwajt, intaljati b'“D” fuq naħa waħda u “250” fuq in-naħa l-oħra.
English: Uncommon side effects (may affect up to 1 in 100 people) - trembling, sensation of spinning head (vertigo), dizziness - sensation of rapid or irregular heartbeat (palpitations) - gastritis, vomiting - reflux of stomach acid to the gullet (acid regurgitations), indigestion - rash - muscle pain, muscle weakness or cramps - back pain - feeling of weakness or tiredness, feeling unwell.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 f'100) - rogħda, tħoss rasek iddur bik (vertigo), sturdament - tħoss taħbit mgħaġġel jew irregolari tal-qalb (palpitazzjonijiet) - gastrite, rimettar - rifluss tal-aċidu tal-istonku għal ġol-gerżuma (rigurġitazzjonijiet tal-aċidu), indiġestjoni - raxx - uġigħ, dgħjufija muskolari jew bugħawwieġ fil-muskoli - uġigħ fid-dahar - sensazzjoni ta' dgħjufija jew għeja, ma tħossokx tajjeb.
English: AstraZeneca d.o.o.
Maltese: AstraZeneca A.E.
English: In two confirmative replicate one-year studies (M2-124 and M2-125) and two supplementary six-month studies (M2-127 and M2-128), a total number of 4,768 patients were randomised and treated of whom 2,374 were treated with roflumilast.
Maltese: F'żewġ studji konfermattivi u duplikati li damu sena (M2-124 u M2-125) u żewġ studji supplimentari li damu sitt xhur (M2-127 u M2-128), numru totali ta' 4,768 pazjent intgħażlu b'mod każwali u ġew ikkurati, li minnhom, 2,374 ġew ikkurati b'roflumilast.
English: The N-oxide metabolite is the major metabolite observed in the plasma of humans.
Maltese: Il-metabolit N-oxide hu l-metabolit maġġuri osservat fil-plażma tal-bnedmin.
English: Daxas 500 micrograms tablets roflumilast
Maltese: Daxas 500 mikrogramma pilloli roflumilast
English: Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. phenobarbital, carbamazepine, phenytoin) may reduce the therapeutic efficacy of roflumilast.
Maltese: Għalhekk, l-użu ta' indutturi qawwija ta' enzimi ta' ċitokrom P450 (eż. phenobarbital, carbamazepine, phenytoin) jista' jnaqqas l-effikaċja terapewtika ta' roflumilast.
English: Each tablet contains 500 micrograms roflumilast.
Maltese: Kull pillola fiha 500 mikrogramma ta' roflumilast.
English: Following an oral dose, the median plasma effective half-life of roflumilast and its N-oxide metabolite are approximately 17 and 30 hours, respectively.
Maltese: Wara doża orali, il-medjan tal-half-life effettiva ta' roflumilast u tal-metabolit tiegħu N-oxide fil-plażma huma ta' madwar 17 u 30 siegħa, rispettivament.
English: In patients with COPD, roflumilast reduced sputum neutrophils.
Maltese: F'pazjenti b'COPD, roflumilast naqqas in-newtrofili fl-isputum.
English: In uncommon cases allergic reactions may occur.
Maltese: F'każijiet mhux komuni kien hemm reazzjonijiet allerġiċi.
English: In vitro studies and clinical interaction studies suggest that the metabolism of roflumilast to its N-oxide metabolite is mediated by CYP1A2 and 3A4.
Maltese: Studji in vitro u studji dwar interazzjonijiet kliniċi jissuġġerixxu li l-metaboliżmu ta' roflumilast għal metabolit tiegħu N-oxide hu medjat minn CYP1A2 u 3A4.
English: Administration of the cytochrome P450 enzyme inducer rifampicin resulted in a reduction in total PDE4 inhibitory activity by about 60%.
Maltese: L-għoti tal-inducer tal-enzimi ta' ċitokrom P450 rifampicin irriżulta fi tnaqqis fl-attività inibitorja totali ta' PDE4 b'madwar 60%.
English: That increased exposure might occur in certain populations and increase the risk of persistent intolerability: o Special populations who have increased PDE4 inhibition such as black non smoking females; o Patients concomitantly treated with CYP1A2/2C19/3A4 inhibitors (such as fluvoxamine and cimetidine) or CYP1A2/3A4 inhibitors (such as enoxacin).
Maltese: o Popolazzjonijiet speċjali li għandhom żieda fl-inibizzjoni għal PDE4 bħal nisa suwed li ma jpejpux; oPazjenti kkurati fl-istess ħin b'inibituri ta' CYP1A2/2C19/3A4 (bħal fluvoxamine u cimetidine) jew b'inibituri ta' CYP1A2/3A4 (bħal enoxacin).