FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with unrecognised neuromuscular disorders may be at increased risk of clinically significant systemic effects, including severe dysphagia and respiratory compromise from typical doses of botulinum toxin type A. In some of these cases, dysphagia has lasted several months and required placement of a gastric feeding tube (see section 4.3).
Maltese: Pazjenti b'disturbi newromuskolari mhux rikonoxxuti jistgħu jkunu f'riskju akbar ta' effetti sistemiċi klinikament sinifikanti, inkluż bligħ anormali u problemi respiratorji severi minn dożi tipiċi tat-tossina tal-botulinju tat-tip A.
English: Table 5 - Exploratory Efficacy Endpoint - Glabellar Line Scale Score >/=2 points better at day 30 by Investigator Assessment At Rest, PP Population
Maltese: Glabellari b'titjib ta' >/=2 punti fil-jum 30 minn Valutazzjoni tal-Investigatur bil-Muskoli tal
English: Amount of solvent added (sodium chloride 9 mg/ml (0.9%) solution for injection) to a 100 Unit vial
Maltese: Ammont ta' solvent miżjud (soluzzjoni għall-injezzjoni ta' sodium chloride ta' 9 mg/ml (0.9 %)) ma' kunjett ta' 100 Unità
English: (listed in section 6); - if you have myasthenia gravis or Eaton Lambert syndrome (chronic diseases affecting the muscles);
Maltese: - jekk għandek mijastenija gravi jew is-sindrome ta' Eaton Lambert (mard kroniku li jaffettwa lmuskoli);
English: Eyelid ptosis
Maltese: Ż-ŻGĦAR EWLENIN
English: • Examination of the causes of failure, e.g. inappropriate injection technique, incorrect muscles injected, and formation of botulinum toxin-neutralising antibodies.
Maltese: injezzjoni ta' muskoli żbaljati, u l-formazzjoni ta' antikorpi li jinnewtralizzaw it-tossina talbotulinju.
English: - Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
Maltese: - Evita li tagħti l-injezzjoni qrib il-levator palpebrae superioris, b'mod partikolari f'pazjenti b'kumplessi akbar ta' dipressuri tal-ħuġbejn.
English: NUCEIVA is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.
Maltese: NUCEIVA huwa indikat għat-titjib temporanju fid-dehra ta' linji vertikali minn moderati sa severi bejn il-ħuġbejn li jidhru f'kontrazzjoni massima tal-muskoli tal-ħuġbejn (linji glabellari), meta sseverità ta' dawn il-linji fil-wiċċ għandha impatt psikoloġiku importanti fuq adulti ta' inqas minn
English: Care should be taken to ensure that NUCEIVA is not injected into a blood vessel when it is injected in the vertical lines between the eyebrows seen at maximum frown (also known as glabellar lines) (see section 4.4).
Maltese: Għandha tingħata attenzjoni biex jiġi żgurat li meta NUCEIVA jiġi injettat fil-linji vertikali bejn ilħuġbejn f'kontrazzjoni massima tal-muskoli (magħrufa wkoll bħala linji glabellari) dan ma jiġix injettat fil-vażi tad-demm (ara sezzjoni 4.4).
English: The use of botulinum toxin is not recommended in association with aminoglycoside antibiotics, spectinomycin or other medicines that interfere with nerve impulses to the muscle.
Maltese: L-użu tat-tossina tal-botulinju mhijiex rakkomandata f'assoċjazzjoni ma' antibijotiċi aminoglikosidi, ma' spektinomiċina jew mediċini oħrajn li jinterferixxu mal-impulsi tan-nervituri mal-muskoli.
English: Adverse reactions possibly related to the spread of toxin distant from the site of administration have been reported very rarely with botulinum toxin (e.g. muscle weakness, breathing difficulties, dysphagia or constipation) (see section 4.4).
Maltese: Tixrid tat-tossina Reazzjonijiet avversi possibbilment relatati mat-tixrid tat-tossina 'l bogħod mis-sit tal-għoti ġew irrapportati b'mod rari ħafna bit-tossina tal-botulinju (eż. dgħjufija fil-muskoli, diffikultà fit-teħid tannifs, disfaġja jew konstipazzjoni) (ara taqsima 4.4).
English: • Injection near the levator palpebrae superioris should be avoided, particularly in patients with larger brow depressor complexes.
Maltese: • Għandu jiġi evitat li l-injezzjoni tingħata qrib il-levator palpebrae superioris, b'mod partikolari f'pazjenti b'kumplessi akbar ta' dipressuri tal-ħuġbejn.
English: NUCEIVA is reconstituted with sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: NUCEIVA jiġi rikostitwit b'soluzzjoni għall-injezzjoni ta' sodium chloride ta' 9 mg/ml (0.9 %).
English: Intramuscular use.
Maltese: Trab abjad.
English: Procedure to follow for a safe disposal of vials, syringes and materials used:
Maltese: Proċedura li trid tiġi segwita għar-rimi sigur ta' kunjetti, ta' siringi u ta' materjali użati:
English: • Two injections should be administered in each corrugator muscle (inferior medial and superior medial aspect) and 1 injection in the procerus muscle for a total dose of 20 Units.
Maltese: • Għandhom jingħataw żewġ injezzjonijiet f'kull muskolu korrugatur (l-aspett medjali inferjuri u l-aspett medjali superjuri) u injezzjoni waħda fil-muskolu procerus għal doża totali ta' 20 Unità.
English: The most commonly reported adverse effects during treatment are headache, occurring in 9.0% of patients, followed by eyelid ptosis, occurring in 1.0% of patients.
Maltese: L-aktar effetti avversi rrapportati b'mod komuni waqt il-kura huma wġigħ ta' ras, li seħħet f'9.0 % tal-pazjenti, segwit minn ptosi tal-kappell tal-għajnejn, li seħħ f'1.0 % tal-pazjenti.
English: - Contaminated surfaces must be cleaned with an absorbent material soaked in a solution of sodium hypochlorite (Javel solution) and then dried.
Maltese: - Uċuħ kontaminati għandhom jiġu mnaddfa b'materjal assorbenti mxarrab f'soluzzjoni ta' ipoklorit tas-sodju (soluzzjoni Javel) u mbagħad jiġu xxuttati.
English: NUCEIVA injections significantly reduced the severity of glabellar lines by 1 point or greater at maximum frown for up to 139 days, as measured by the investigator assessment of glabellar line severity at maximum frown.
Maltese: L-injezzjonijiet bi NUCEIVA naqqsu b'mod sinifikanti s-severità tal-linji glabellari b'punt 1 jew aktar f'kontrazzjoni massima tal-muskoli tal-ħuġbejn sa 139 jum, kif imkejjel mill-valutazzjoni talinvestigatur tas-severità tal-linji glabellari f'kontrazzjoni massima tal-muskoli tal-ħuġbejn.
English: PC:
Maltese: Ħakk
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2° to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Maltese: il-ħinijiet tal-ħażna waqt l-użu u l-kundizzjonijiet qabel l-użu huma r-responsabbiltà tal-utent u normalment ma jkunux ta' aktar minn 24 siegħa f'temperatura ta' bejn 2˚C u 8˚C, sakemm irrikostituzzjoni/dilwizzjoni ma tkunx seħħet f'kundizzjonijiet asettiċi vvalidati u kkontrollati.
English: Dizziness, migraine, muscle tone disorder, speech disorder
Maltese: Sturdament, emigranja, disturb fissodizza tal-muskoli, disturb fit taħdit
English: Each vial contains 100 Units botulinum toxin type A After reconstitution each 0.1 mL of the solution contains 4 Units
Maltese: Kull kunjett fih 100 Unità tat-tossina tal-botulinju tat-tip A Wara r-rikostituzzjoni, kull 0.1 mL tas-soluzzjoni jkun fih 4 Unitajiet
English: It works by blocking the nerve impulses to the muscles in which it has been injected.
Maltese: Jaħdem billi jimblokka l-impulsi tan-nervituri lill-muskoli li fihom ikun ġie injettat.
English: This is followed by transfer of the toxin across the plasma membrane by receptor-mediated endocytosis.
Maltese: Dan jiġi segwit minn trasferiment tat-tossina minn ġol-membrana tal-plażma permezz ta' endoċitożi medjata mir-riċettur.
English: Application related undesirable effects that have been reported following administration of NUCEIVA are uncommon events individually, common when added together.
Maltese: L-effetti mhux mixtieqa relatati mal-applikazzjoni li ġew irrapportati wara l-għoti ta' NUCEIVA, individwalment huma avvenimenti mhux komuni, iżda komuni meta jingħaddu flimkien.
English: Adverse reactions possibly related to the spread of toxin distant from the site of administration have been reported very rarely with botulinum toxin (see section 4.8).
Maltese: Ġew irrapportati każijiet rari ħafna ta' reazzjonijiet avversi possibbilment relatati mat-tifrix tat-tossina tal-botulinju 'l bogħod mis-sit tal-għoti (ara sezzjoni 4.8).
English: No cases of systemic toxicity resulting from accidental injection of botulinum toxin type A have been observed.
Maltese: Ma ġie osservat l-ebda każ ta' tossiċità sistemika bħala riżultat ta' injezzjoni aċċidentali tat-tossina tal-botulinju tat-tip A.
English: EXP
Maltese: Massima
English: 540 patients with moderate to severe glabellar lines seen at maximum frown who felt their glabellar lines had an important psychological impact (on mood, anxiety/or depressive symptoms) have been included in the European/Canadian clinical study.
Maltese: Fl-istudju kliniku Ewropew/Kanadiż ħadu sehem 540 pazjent b'linji glabellari minn moderati sa severi osservati f'kontrazzjoni massima tal-muskoli tal-ħuġbejn li kienu jħossu li l-linji glabellari tagħhom għandhom impatt psikoloġiku importanti (fuq il-burdata, l-ansjetà/jew sintomi depressivi).
English: Number
Maltese: TIKKETTAR
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: BIJOLOĠIKA(ĊI) ATTIVA/I
English: Powder for solution for injection 1 vial
Maltese: U KONTENUT Trab għal soluzzjoni għall-injezzjoni kunjett 1
English: - Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
Maltese: - L-injezzjonijiet fil-korrugatur laterali għandhom isiru talanqas 1 cm 'il fuq mil-linja supraorbitali mgħaddma.
English: In pregnant rats, daily intramuscular injections of 0.5, 1, or 4 Units/kg during the period of organogenesis (from gestation days 6 to 16), did not induce significant test article-related toxicological effects on the dams and on embryo-fetal development.
Maltese: (mill-jum 6 sa 16 tal-ġestazzjoni), ma wasslux għal effetti tossikoloġiċi sinifikanti relatati mas-suġġetti tat-test fuq il-firien nisa u fuq l-iżvilupp embrijofetali.
English: In general, side effects occur within the first few days after injection and are temporary.
Maltese: Ġeneralment, l-effetti sekondarji jseħħu fl-ewwel ftit jiem wara l-injezzjoni u huma temporanji.
English: Admission to hospital should be considered in patients presenting with symptoms of botulinum toxin type A poisoning (generalised weakness, ptosis, diplopia, swallowing and speech disorders, or paresis of the respiratory muscles).
Maltese: Għandha titqies il-possibilità li pazjenti jiddaħħlu l-isptar jekk ikollhom sintomi ta' avvelenament bit-tossina tal-botulinju tat-tip A (debbulizza ġeneralizzata, ptosi, diplopija, disturbi fil-bligħ u fit-taħdit, jew paresi tal-muskoli respiratorji).
English: Inject the diluent slowly into the vial with a needle through the rubber stopper and gently rotate the vial avoiding bubble formation.
Maltese: Injetta d-dilwent bil-mod fil-kunjett permezz ta' labra minn ġot-tapp tal-lastiku u dawwar il-kunjett bil-mod biex tiġi evitata l-formazzjoni ta' bżieżaq.
English: Immediately after use, unused reconstituted NUCEIVA solution for injection in the vial and/or the syringe must be inactivated, prior to disposal, with 2 mL of dilute sodium hypochlorite solution at 0.5% or 1% available chlorine.
Maltese: Immedjatament wara l-użu, u qabel ir-rimi, is-soluzzjoni rikostitwita ta' NUCEIVA fil-kunjett u/jew fis-siringa li ma tkunx intużat għandha tiġi inattivata, b'2 mL ta' soluzzjoni dilwita ta' ipoklorit tas sodju ta' 0.5 % jew ta' 1 % (soluzzjoni Javel) u għandha tintrema skont kif jitolbu l-liġijiet lokali.
English: Responders for the Primary Efficacy Endpoint
Maltese: Rispondenti għall-Punt ta' Tmiem Primarju li Juri Effikaċja
English: - if you have an infection or inflammation at the proposed injection sites.
Maltese: Infezzjoni jew infjammazzjoni fis-siti tal-injezzjoni proposti.
English: Final study report by 31/03/2021
Maltese: Rapport ta' studju finali sal-31/03/2021
English: Date of first authorisation: 28 February 2011 Date of latest renewal: 24 April 2015
Maltese: Data tal-aħħar tiġdid: 24 t'April 2015.
English: Libertek 500 micrograms
Maltese: Libertek 500 mikrogramma
English: Libertek contains lactose
Maltese: Libertek fih lactose
English: - The other ingredients are: - Core: lactose monohydrate, maize starch, povidone (K90), magnesium stearate, - Coating: hypromellose, Macrogol 4000, titanium dioxide (E171), and iron oxide yellow (E172).
Maltese: - Qalba: lactose monohydrate, maize starch, povidone (K90), magnesium stearate, - Kisja: hypromellose, Macrogol 4000, titanium dioxide (E171), u iron oxide yellow (E172).
English: What Libertek contains - The active substance is roflumilast.
Maltese: X'fih Libertek - Is-sustanza attiva hi roflumilast.
English: Ratio Roflumilast/Placebo
Maltese: Proporzjon Roflumilast/Placebo Valurp ta' 2 naħat
English: Summary of COPD exacerbation endpoints in Study RO-2455-404-RD
Maltese: Sommarju ta' punti aħħarin ta' aggravar ta' COPD fi Studju RO-2455-404-RD
English: See section 4.
Maltese: Ara sezzjoni 4
English: PVC/PVDC aluminum blisters in packs of 10, 30, or 90 film-coated tablets.
Maltese: Folji tal-aluminju PVC/PVDC f'pakketti ta' 10, 30 jew 90 pilloli miksija b'rita.
English: Exacerbation Category
Maltese: Kategorija t'Aggravar
English: The rate of exacerbations (as defined in the protocols) were not significantly reduced by roflumilast in the individual studies (relative risk reduction: 13.5% in study M2-111 and 6.6% in study M2-112; p= not significant).
Maltese: Ir-rata ta' aggravamenti (kif definiti filprotokolli) ma naqsitx b'mod sinifikanti minn roflumilast fl-istudji individwali (tnaqqis tar-riskju relattiv: 13.5% fi studju M2-111 u 6.6% fi studju M2-112; p= mhux sinifikanti).
English: The most commonly reported adverse reactions were diarrhoea (5.9%), weight decreased (3.4%), nausea (2.9%), abdominal pain (1.9%) and headache (1.7%).
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod komuni kienu dijarea (5.9%), tnaqqis fil-piż (3.4%), nawseja (2.9%), uġigħ ta' żaqq (1.9%) u wġigħ ta' ras (1.7%).
English: The reduction of moderate or severe exacerbations with roflumilast and LABA compared to placebo and LABA was on average 21% (p=0.0011).
Maltese: It-tnaqqis ta' aggravamenti moderati jew severi b'roflumilast u LABA meta mqabbel mal-plaċebo u LABA kienet bħala medja ta' 21% (p=0.0011).
English: Co-administration with theophylline resulted in an increase of 8% of the total PDE4 inhibitory activity (see section 4.4).
Maltese: L-għoti flimkien ma' theophylline rriżulta f'żieda ta' 8% tal-attività inibitorja totali ta' PDE4 (ara sezzjoni 4.4).
English: Clinical interaction studies with CYP3A4 inhibitors erythromycin and ketoconazole showed increases of 9% of the total PDE4 inhibitory activity.
Maltese: Studji kliniċi ta' interazzjoni b'impedituri ta' CYP3A4 erythromycin u ketoconazole wrew żidiet ta' 9% fl-attività inibitorja totali ta' PDE4.
English: A total of 2,690 patients were included and randomized in two supportive 1-year studies (M2-111 and M2-112).
Maltese: Total ta' 2,690 pazjent ġew inklużi u magħżula b'mod każwali f'żewġ studji ta' appoġġ li damu sena (M2-111 u M2-112).
English: Libertek is to be used in addition to bronchodilators.
Maltese: Libertek għandu jintuża flimkien ma' bronkodilaturi.
English: Interim Study Reports - with each PSUR
Maltese: Rapporti ta' Studju Interim -b'kull PSUR
English: Children and adolescents Libertek should not be used by children and adolescents under 18 years of age.
Maltese: Tfal u adolexxenti Libertek m'għandux jintuża minn tfal u adolexxenti taħt l-età ta' 18-il sena.
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 mal-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: In study RO-2455-404-RD when compared with the overall population, the total PDE4 inhibitory activity determined from ex vivo unbound fractions was found to be 15% higher in patients ≥75 years of age, and 11% higher in patients with baseline body weight <60 kg (refer to section 4.4).
Maltese: Fl-istudju RO-2455-404-RD meta mqabbla mal-popolazzjoni globali, l-attività impeditorja totali ta' PDE4 stabbilita minn porzjonijiet mhux marbuta eks vivo nstabet li hi 15% ogħla f'pazjenti ≥75 sena, u 11% ogħla f'pazjenti li l-piż tal-ġisem fil-linja bażi tagħhom kien < 60 kg (irreferi għal sezzjoni 4.4).
English: Libertek 500 micrograms tablets roflumilast
Maltese: Libertek 500 mikrogramma pilloli roflumilast
English: Post-bronchodilator FEV1 increased for the roflumilast group by 52 mL (95% CI: 40, 65 mL) and decreased for the placebo group by 4 mL (95% CI: -16, 9 mL).
Maltese: L-FEV1 wara l-għoti ta' mediċina li twassa' l-bronki żdied għall-grupp ta' roflumilast b'52 mL (95% CI: 40, 65 mL) u tnaqqas għall-grupp ta' plaċebo b'4 mL (95% CI: -16, 9mL).
English: Each film-coated tablet contains 188.72 mg lactose (as monohydrate).
Maltese: 72 mg lactose (bħala monohydrate).
English: Libertek contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor.
Maltese: Libertek fih is-sustanza attiva roflumilast, li hi mediċina kontra l-infjammazzjoni msejħa inibitur ta' phosphodiesterase 4.
English: Libertek 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: Libertek 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: Study RO-2455-404-RD was a one year study in COPD patients with a baseline (pre-bronchodilator) FEV1 <50% of predicted normal and a history of frequent exacerbations.
Maltese: L-istudju RO-2455-404-RD kien studju ta' sena f'pazjenti COPD b'linja bażi (qabel il-mediċina li twassa' l-bronki) ta' FEV1 <50% tan-normali previst u storja medika ta' aggravar frekwenti.
English: Moderate or severe Moderate
Maltese: Moderat jew sever
English: Rescue medicinal products Libertek is not indicated as rescue medicinal product for the relief of acute bronchospasms.
Maltese: Prodotti mediċinali ta' salvataġġ Libertek mhuwiex indikat bħala prodott mediċinali ta' salvataġġ għas-solliev ta' bronkospażmi akuti.
English: Libertek is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C).
Maltese: Libertek hu kontraindikat f'pazjenti b'indeboliment moderat jew sever tal-fwied (Child-Pugh B jew Ċ).
English: Post-bronchodilator FEV1 showed a clinically significant improvement in favour of Roflumilast by 56 mL over placebo (95% CI: 38, 73 mL).
Maltese: L-FEV1 wara l-għoti ta' mediċina li twassa' l-bronki wera titjib klinikament sinjifikanti favur roflumilast b'56 mL fuq il-plaċebo (95% CI: 38, 73 mL).
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: 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: 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: Roflumilast is associated with an increased risk of psychiatric disorders such as insomnia, anxiety, nervousness and depression.
Maltese: Roflumilast hu assoċjat ma' żieda fir-riskju ta' disturbi psikjatriċi bħal nuqqas ta' rqad, ansjetà, nervożità u dipressjoni.
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 kien fih gestodene u ethinyl oestradiol, l-attività inibitorja totali ta' PDE4 żdiedet b'17%.
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, tumor 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: Interaction studies with CYP1A2/3A4 inhibitor enoxacin and the CYP1A2/2C19/3A4 inhibitors cimetidine and fluvoxamine, resulted in increases of the total PDE4 inhibitory activity of 25%, 47% and 59%, respectively.
Maltese: Għalhekk, wara l-għoti ta' roflumilast, l-inibizzjoni totali ta' PDE4 hi kkunsidrata li tkun l-effett kombinat kemm ta' roflumilast kif ukoll ta' roflumilast N-oxideStudji dwar interazzjonijiet ma' inibitur ta' CYP1A2/3A4 enoxacine u l-impedituri CYP1A2/2C19/3A4 cimetidine u fluvoxamine rriżultaw f'żidiet tal-attività inibitorja totali ta' PDE4 ta' 25%, 47% u 59%, rispettivament.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: 5.1 Pharmacodynamic properties
Maltese: .1 Proporjetajiet farmakodinamiċi
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 randomized 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: Each pack contains 10, 30, or 90 film-coated tablets.
Maltese: Kull pakkett fih 10, 30, jew 90 pillola miksija b'rita.