FrancophonIA/ELRC3.0 huggingface dataset:
English: In a laboratory model study lokivetmab demonstrated an onset of efficacy for pruritus by the first time point at 8 hours post administration.
Maltese: F'mudell ta' studju fil-laboratorju lokivetmab wera effett fuq il-ħakk l-ewwel darba, 8 sigħat wara l amministrazzjoni.
English: Pharmacotherapeutic group: Other dermatological preparations.
Maltese: Grupp farmako-terapewtiku:
English: PHARMACEUTICAL FORM Solution for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No adverse reactions other than those mentioned in section 4.6 were observed in laboratory overdose studies.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn Fi studji fil-laboratorju dwar dożaġġ eċċessiv ma ġew osservati l-ebda reazzjoni mhix mixtieqa minn dawk imsemmija f'sezzjoni 4.6.
English: It is not expected for this to cause any adverse effects, however, repeated self-administration may increase the risk of hypersensitivity reactions.
Maltese: Dan mhuwiex mistenni li jikkawża effetti mhux mixtieqa, madankollu, amministrazzjoni ripetittiva lilek innifsek tista' żżid ir-riskju ta' reazzjonijiet ippersensittivi.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu għal taħt il-ġilda.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Maltese: Staqsi lill-kirurgu veterinarju jew lill-ispiżjar dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: Avoid excessive shaking or foaming of the solution.
Maltese: Evita taħlit eċċessiv u li tifforma rawwa fis-soluzzjoni.
English: Primary packaging: Single dose clear glass Type I vials with chlorobutyl rubber stopper.
Maltese: Kunjetti tal-ħġieġ ċar Tip I b'tapp tar-raber chlorobutyl, ta' doża waħda.
English: In field studies up to 9 months, treatment of dogs with atopic dermatitis was demonstrated to have a favourable effect on the reduction of pruritus and on the reduction of disease severity as evaluated by Canine Atopic Dermatitis Extent and Severity Index (CADESI) 03 scores.
Maltese: Fi studji li damu sa' 9 xhur, it-trattament tal-klieb b'dermatite atopika wera effett favorevoli fuq it tnaqqis ta' ħakk u fuq it-tnaqqis fis-severità tal-marda kif imkejjel permezz tal-punteġġi 03 tal-Canine
English: In cases of atopic dermatitis, it is recommended to investigate and treat complicating factors, such as bacterial, fungal or parasitic infections/infestations (e.g. flea and mange).
Maltese: F'każ ta' dermatite atopika huwa rrakkomandat li jiġu investigati u ttrattati fatturi ta' kumplikazzjoni, bħalma huma infezzjonijiet/infestazzjonijiet batteriċi, fungali jew parasitiċi (e.g. briegħed u mange).
English: However, if the animal does not show a better response after the second dose, the veterinary surgeon should consider alternative treatments.
Maltese: Madankollu, jekk l-annimal ma jurix rispons aħjar wara t-tieni doża il-kirurgu veterinarju għandu jikkunsidra trattamenti alternattivi.
English: Each vial of 1 ml contains:
Maltese: Kull KunjettKunjetk ta' 1 ml fih:
English: CYTOPOINT 20 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
Maltese: CYTOPOINT 20 mg soluzzjoni għall-injezzjoni għall-klieb Kaxxa tal-kartun b'kunjett 1 ta' 1 ml Kaxxa tal-kartun b'2 kunjetti ta' 1 ml Kaxxa tal-kartun b'6 kunjetti ta' 1 ml
English: If the animal does not show a better response after a second dose, the veterinary surgeon should consider alternative treatments.
Maltese: Madankollu, jekk l-annimal ma jurix rispons aħjar wara t-tieni doża, il-kirurgu l-veterinarju għandu jikkunsidra trattamenti alternattivi.
English: CYTOPOINT 30 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
Maltese: CYTOPOINT 30 mg soluzzjoni għall-injezzjoni għall-klieb Kaxxa tal-kartun b'kunjett 1 ta' 1 ml Kaxxa tal-kartun b'2 kunjetti ta' 1 ml Kaxxa tal-kartun b'6 kunjetti ta' 1 ml
English: 1 vial 2 vials
Maltese: 2 kunjetti
English: CARDBOARD BOX
Maltese: KARATTERISTIĊI
English: CYTOPOINT 40 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
Maltese: CYTOPOINT 40 mg soluzzjoni għall-injezzjoni għall-klieb Kaxxa tal-kartun b'kunjett 1 ta' 1 ml Kaxxa tal-kartun b'2 kunjetti ta' 1 ml Kaxxa tal-kartun b'6 kunjetti ta' 1 ml
English: CYTOPOINT 10 mg solution for injection for dogs CYTOPOINT 20 mg solution for injection for dogs CYTOPOINT 30 mg solution for injection for dogs CYTOPOINT 40 mg solution for injection for dogs lokivetmab
Maltese: CYTOPOINT 10 mg soluzzjoni għall-injezzjoni għall-klieb CYTOPOINT 20 mg soluzzjoni għall-injezzjoni għall-klieb CYTOPOINT 30 mg soluzzjoni għall-injezzjoni għall-klieb CYTOPOINT 40 mg soluzzjoni għall-injezzjoni għall-klieb
English: INDICATION(S) Treatment of clinical manifestations of atopic dermatitis in dogs.
Maltese: Atopic Dermatitis Extent and Severity Index (CADESI).
English: CYTOPOINT 10 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
Maltese: CYTOPOINT 10 mg soluzzjoni għall-injezzjoni għall-klieb Kaxxa tal-kartun b'kunjett 1 ta' 1 ml Kaxxa tal-kartun b'2 kunjetti ta' 1 ml Kaxxa tal-kartun b'6 kunjetti ta' 1 ml
English: B. PACKAGE LEAFLET
Maltese: KONTENUT BĦALA
English: Vomiting and/or diarrhoea have been reported to occur in rare cases from spontaneous reports and may occur in connection with hypersensitivity reactions.
Maltese: Ġew rappurtati f'rapporti spontanji, każijiet rari ta' remettar u/jew dijareja li jistgħu jseħħu ma' reazzjonijiet ta' ipersensittività.
English: Linearity/Non-linearity
Maltese: Linearità/Non-linearità
English: Persistent intolerability
Maltese: Intollerabilità persistenti
English: • infection with tuberculosis, herpes, hepatitis, HIV
Maltese: • infezzjoni b'tuberkulosi, herpes, epatite, HIV
English: Ratio Roflumilast/Placebo
Maltese: Proporzjon Roflumilast/Placebo
English: Final study report by 31/03/2021.
Maltese: Rapport ta' studju finali sal-31/03/2021
English: The specific indication approved.
Maltese: L-indikazzjoni speċifika approvata.
English: (N=969) Rate (n)
Maltese: (N=969) Rata (n)
English: Placebo (N=966) Rate (n)
Maltese: Plaċebo (N=966) Rata (n)
English: EU/1/10/636/001 10 film-coated tablets EU/1/10/636/002 30 film-coated tablets EU/1/10/636/003 90 film-coated tablets EU/1/10/636/004 14 film-coated tablets EU/1/10/636/005 28 film-coated tablets EU/1/10/636/006 84 film-coated tablets EU/1/10/636/007 98 film-coated tablets
Maltese: EU/1/10/636/001 10 pilloli miksija b'rita EU/1/10/636/002 30 pillola miksija b'rita EU/1/10/636/003 90 pillola miksija b'rita EU/1/10/636/004 14 pillola miksija b'rita EU/1/10/636/005 28 pillola miksija b'rita EU/1/10/636/006 84 pillola miksija b'rita EU/1/10/636/007 98 pillola miksija b'rita
English: • multiple sclerosis or SLE
Maltese: • sklerosi multipla jew SLE
English: АстраЗенека България ЕООД Тел.
Maltese: АстраЗенека България ЕООД
English: Each pack contains 28 tablets.
Maltese: Kull pakkett fih 28 pillola.
English: PVC/PVDC aluminium blisters in packs of 28 tablets.
Maltese: Folji tal-aluminju PVC/PVDC f'pakketti ta' 28 pillola.
English: EU/1/10/636/008 28 tablets
Maltese: EU/1/10/636/008 28 pillola
English: - The other ingredients are: - Core: lactose monohydrate (see section 2 under “Daxas contains lactose”), maize starch, povidone, magnesium stearate, - Coating: hypromellose, Macrogol 4000, titanium dioxide (E171), and iron oxide yellow (E172).
Maltese: - Qalba: lactose monohydrate(ara sezzjoni 2 taħt “Daxas fih lactose”), maize starch, povidone, magnesium stearate, - Kisja: hypromellose, Macrogol 4000, titanium dioxide (E171), u iron oxide yellow (E172).
English: Each tablet contains 49.7 mg lactose (as monohydrate).
Maltese: Kull pillola fiha 49.7 mg ta' lactose (bħala monohydrate).
English: Body weight <60 kg
Maltese: Piż tal-ġisem <60 kg
English: PVC/PVDC aluminium blisters in packs of 10, 14, 28, 30, 84, 90 or 98 film-coated tablets.
Maltese: Folji tal-aluminju PVC/PVDC f'pakketti ta' 10, 14, 28, 30, 84, 90, jew 98 pillola miksija b'rita.
English: Negative binomial regression
Maltese: Rigressjoni binominali negattiva
English: Gamma-GT increased Aspartate aminotransferase (AST) increased
Maltese: Żieda fil-gamma-GT Żieda f'aspartate aminotransferase (AST)
English: Date of first authorisation: 05 July 2010 Date of latest renewal: 24 April 2015
Maltese: Data tal-aħħar tiġdid: 24 t'April 2015
English: Each pack contains 10, 14, 28, 30, 84 , 90 or 98 film-coated tablets.
Maltese: Kull pakkett fih 10, 14, 28, 30, 84, 90, jew 98 pillola miksija b'rita.
English: • severe infection
Maltese: • infezzjoni severa
English: Manufacturer Takeda GmbH Production site Oranienburg Lehnitzstraße 70-98
Maltese: Takeda GmbH Production site Oranienburg Lehnitzstraße 70-98
English: D-16515 Oranienburg Germany
Maltese: D-16515 Oranienburg Il-Ġermanja
English: Summary of COPD exacerbation endpoints in Study RO-2455-404-RD
Maltese: Sommarju ta' punti aħħarin ta' aggravamenti ta' COPD fl-Istudju RO-2455-404-RD
English: Roflumilast targets the PDE4A, 4B and 4D splicing variants with similar potency in the nanomolar range.
Maltese: Roflumilast jimmira l-varjanti splicing ta' PDE4A, 4B u 4D b'potenza simili filmedda nanomolari.
English: Blood creatine phosphokinase (CPK) increased
Maltese: Żieda fil-creatine phosphokinase (CPK) fid-demm
English: No interactions were observed with inhaled salbutamol, formoterol, budesonide and oral montelukast, digoxin, warfarin, sildenafil and midazolam.
Maltese: L-ebda interazzjonijiet ma kienu osservati ma' salbutamol, formoterol, budesonide li jinġibdu man-nifs u ma' montelukast, digoxin, warfarin, sildenafil u midazolam orali.
English: Tabulated list of adverse reactions Within the following table, adverse reactions are ranked under the MedDRA frequency classification:
Maltese: Fit-tabella li ġejja, ir-reazzjonijiet avversi huma kklassifikati taħt il-klassifikazzjoni ta' frekwenza MedDRA:
English: The design of the studies was parallel-group, double-blind and placebo-controlled.
Maltese: Id-disinn tal-istudji kienet tat-tip grupp-parallel, double-blind u kkontrollati bi plaċebo.
English: Analysis model
Maltese: Mudell ta'Analiż
English: 10 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Maltese: 10 pilloli miksija b'rita 14 pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 84 pillola miksija b'rita 90 pillola miksija b'rita 98 pillola miksija b'rita
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: Studji dwar interazzjonijiet ma' inibitur ta' CYP1A2/3A4 enoxacin 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: Daxas contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor.
Maltese: Daxas fih is sustanza attiva roflumilast, li hi mediċina kontra l infjammazzjoni msejħa inibitur ta' phosphodiesterase-4.
English: Other medicines and Daxas
Maltese: Mediċini oħra u Daxas
English: 28 tablets - 28-day starter pack.
Maltese: 28 pillola - pakkett tal-bidu ta' 28 jum.
English: Based on further in vitro results in human hepatic microsomes, therapeutic plasma concentrations of roflumilast and roflumilast N-oxide do not inhibit CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, or 4A9/11.
Maltese: Ibbażat fuq riżultati addizzjonali in vitro f'mikrosomi epatiċi umani, konċentrazzjonijiet terapewtiċi fil-plażma ta' roflumilast u roflumilast N-oxide ma jinibixxux CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, jew 4A9/11.
English: Interim Study Reports - with each PSUR.
Maltese: Rapporti ta' Studju Interim - b'kull PSUR
English: 16515 Oranienburg Germany
Maltese: 16515 Oranienburg Il-Ġermanja
English: The pharmacokinetics of roflumilast and its N-oxide metabolite are dose-proportional over a range of doses from 250 micrograms to 1,000 micrograms.
Maltese: Il-farmakokinetika ta' roflumilast u l-metabolit N-oxide tiegħu huma proporzjonali mad-doża fuq medda ta' dożi minn 250 mikrogramma sa 1,000 mikrogramma.
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-bronkodilatur żdied għall-grupp ta' roflumilast b'52 mL (95% CI: 40, 65 mL) u tnaqqas għallgrupp ta' plaċebo b'4 mL (95% CI: -16, 9 mL).
English: The absolute bioavailability of roflumilast following a 500 micrograms oral dose is approximately 80%.
Maltese: Il-bijodisponibilità assoluta ta' roflumilast wara doża orali ta' 500 mikrogramma hi ta' madwar 80%.
English: Moderate or severe hepatic impairment (Child-Pugh B or C).
Maltese: Indeboliment moderat jew sever epatiku (Child-Pugh B jew Ċ).
English: Total PDE4 inhibitory activity decreased by 9% in patients with severe renal impairment (creatinine clearance 10-30 ml/min).
Maltese: L-attività inibitorja totali ta' PDE4 naqset b'9% f'pazjenti b'indeboliment sever tal-kliewi (tneħħija ta' krejatinina ta' 10-30 ml/min).
English: Roflumilast is extensively metabolised in humans, with the formation of a major pharmacodynamically active metabolite, roflumilast N-oxide.
Maltese: Roflumilast jiġi metabolizzat b'mod estensiv fil-bnedmin, bil-formazzjoni ta' metabolit maġġuri farmakodinamikament attiv, roflumilast N-oxide.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Both roflumilast and roflumilast N-oxide have intrinsic phosphodiesterase-4 (PDE4) inhibitory activity.
Maltese: Kemm roflumilast kif ukoll roflumilast N-oxide għandhom attività intrinsika inibitorja ta' phosphodiesterase 4 (PDE4).
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: Suicidal ideation and behaviour* Depression Nervousness Panic attack
Maltese: Ħsibijiet u mġiba suwiċidali* Dipressjoni Nervożità Attakk ta' paniku
English: Roflumilast is extensively metabolised via Phase I (cytochrome P450) and Phase II (conjugation) reactions.
Maltese: Roflumilast jiġi metabolizzat b'mod estensiv permezz ta' reazzjonijiet ta' Fażi I (ċitokrom P450) u Fażi
English: Patients receiving a 500 micrograms dose once a day had a median PDE4 inhibitory activity of 1.2 (0.35, 2.03) and those receiving a 250 micrograms dose once a day had a median PDE4 inhibitory activity of 0.6 (0.20, 1.24).
Maltese: Pazjenti li kienu qed jirċievu doża ta' 500 mikrogramma darba kuljum kellhom attività inibitorja PDE4 medjana ta' 1.2 (0.35, 2.03) u dawk li kienu qed jirċievu doża ta' 250 mikrogramma darba kuljum kellhom attività inibitorja PDE4 medjana ta' 0.6 (0.20, 1.24).
English: Vomiting Gastro-esophageal reflux disease Dyspepsia
Maltese: Gastrite Rimettar Mard tar-rifluss gastroesofagali Dispepsja
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'inibituri ta' CYP3A4 erythromycin u ketoconazole urew żidiet ta' 9% fl-attività inibitorja totali ta' PDE4.
English: Daxas contains lactose
Maltese: Daxas fih lactose
English: A total of 2,690 patients were included and randomised in two supportive 1-year studies (M2-111 and M2-112).
Maltese: Total ta' 2,690 pazjent ġew inklużi u randomizzati f'żewġ studji ta' appoġġ li damu sena (M2 111 u M2 112).
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 kien bħala medja ta' 21% (p=0.0011).
English: Difference of incidence between roflumilast and placebo was quantitatively greater with concomitant LAMA for weight decreased (7.2% vs 4.2%), decreased appetite (3.7% vs 2.0%), headache (2.4% vs 1.1%) and depression (1.4% vs -0.3%).
Maltese: Id-differenza fl-inċidenza bejn roflumilast u plaċebo kienet kwantitativament akbar b'LAMA li ngħataw b'mod konkomitanti għal tnaqqis fil-piż (7.2% vs 4.2%), tnaqqis fl-aptit (3.7% vs 2.0%), uġigħ ta' ras (2.4% vs 1.1%) u depressjoni (1.4% vs -0.
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% fl-attività inibitorja totali ta' PDE4 (ara sezzjoni 4.4).
English: A major step in roflumilast metabolism is the N-oxidation of roflumilast to roflumilast N-oxide by CYP3A4 and CYP1A2.
Maltese: Pass maġġuri fil-metaboliżmu ta' roflumilast hu l-ossidazzjoni N ta' roflumilast għal roflumilast N-oxide minn CYP3A4 u CYP1A2.
English: A pre-specified sensitivity analysis using the negative binomial regression model treatment showed a statistically significant difference of -14.2% (rate ratio: 0.86; 95% CI: 0.74 to 0.99).
Maltese: Analiżi ta' sensittività speċifikata minn qabel permezz ta' trattament ta' mudell ta' rigressjoni binominali negattiva wriet differenza statistikament sinjifikanti ta' -14.2% (rata ta' proporzjon: 0.86; 95% CI: 0.74 sa 0.99).
English: You may also experience sleeplessness (common), anxiety (uncommon), nervousness (rare), panic attack (rare) or depressive mood (rare).
Maltese: Inti tista' tesperjenza wkoll nuqqas ta' rqad (komuni), ansjetà (mhux komuni), nervożità (rari), attakk ta' paniku (rari) jew burdata dipressiva (rari).
English: The tolerability of roflumilast was evaluated in a 12-week randomised, double-blind, parallel group trial (RO-2455-302-RD) in patients with severe COPD associated with chronic bronchitis.
Maltese: It-tollerabilità ta' roflumilast kienet evalwata fi prova ta' grupp parallel, double-blind, randomizzat, ta' 12-il ġimgħa (RO-2455-302-RD) f'pazjenti b'COPD sever assoċjat ma' bronkite kronika.
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-bronkodilatur wera titjib klinikament sinifikanti favur roflumilast b'56 mL meta mqabbel mal-plaċebo (95% CI: 38, 73 mL).
English: Therefore, there is a low probability of relevant interactions with substances metabolised by these P450 enzymes.
Maltese: Għalhekk, hemm probabbiltà baxxa ta' interazzjonijiet rilevanti b'sustanzi metabolizzati minn dawn l-enzimi ta' P450.
English: Experience in patients with latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster is limited.
Maltese: L-esperjenza f'pazjenti b'infezzjonijiet moħbija bħal tuberkulosi, epatite virali, infezzjoni virali bil-herpes u herpes zoster hi limitata.
English: The per-protocol Poisson regression analysis and the non-significant sensitivity to drop-out Poisson regression intention-to-treat analysis rate ratios were 0.81 (95% CI: 0.69 to 0.94) and 0.89 (95% CI: 0.77 to 1.02), respectively.
Maltese: L-analiżi ta' rigressjoni Poisson skont il-protokoll u l-analiżi tar-rati ta' proporzjon għall-intenzjoni ta' trattament ta' sensittività mhux sinifikanti għal drop-out fir-rigressjoni Poisson kienu ta' 0.81 (95% CI: 0.69 sa 0.94) u 0.89 (95% CI: 0.77 sa 1.02), rispettivament.
English: Simesa S.p.A. Tel: +39 02 9801 1
Maltese: Tel: +39 02 9801 1
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 l-użu ta' bronkodilatur) ta' FEV1 <50% tan-normali previst u storja medika ta' aggravamenti frekwenti.
English: The percentage of patients experiencing a Treatment Emergent Adverse Event (TEAE) of interest, defined as diarrhoea, nausea, headache, decreased appetite, insomnia, and abdominal pain (secondary endpoint), was nominally 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 (45.4%) compared to those receiving roflumilast 500 micrograms once a day for 12 weeks (54.2%, Odds Ratio 0.63, 95% CI [0.47, 0.83], p=0.001).
Maltese: Il-perċentwal ta' pazjenti li esperjenzaw Avveniment Avvers Emerġenti għall-Kura (TEAE) ta' interess, iddefinit bħala dijarea, nawsja, uġigħ ta' ras, nuqqas ta' aptit, insomnja u uġigħ addominali (punt aħħari sekondarju), kien nominalment u 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 (45.4%) meta mqabbla ma' dawk li rċevew doża ta' roflumilast 500 mikrogramma darba kuljum għal 12-il ġimgħa (54.2%, Proporzjon ta' Probabbiltà 0.63, 95% CI [0.47, 0.83], p=0.001).
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 insomnja, ansjetà, nervożità u dipressjoni.
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%), nawsja (2.9%), uġigħ addominali (1.9%) u uġigħ ta' ras (1.7%).
English: Plasma protein binding of roflumilast and its N-oxide metabolite is approximately 99% and 97%, respectively.
Maltese: It-twaħħil ta' roflumilast u tal-metabolit tiegħu N-oxide mal-proteini fil-plażma hu ta' madwar 99% u 97%, rispettivament.
English: The pharmacokinetics of roflumilast 250 micrograms once-daily was tested in 16 patients with mild to moderate hepatic impairment classified as Child-Pugh A and B. In these patients, the total PDE4 inhibitory activity was increased by about 20% in patients with Child-Pugh A and about 90% in patients with Child-Pugh B. Simulations suggest dose proportionality between roflumilast 250 and 500 micrograms in patients with mild and moderate hepatic impairment.
Maltese: F'dawn il-pazjenti, l-attività inibitorja totali ta' PDE4 żdiedet b'madwar 20% f'pazjenti b'ChildPugh A u b'madwar 90% f'pazjenti b'Child-Pugh B. Simulazzjonijiet jissuġġerixxu proporzjonalità tad-doża bejn roflumilast 250 u 500 mikrogramma f'pazjenti b'indeboliment ħafif u moderat tal-fwied.
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 inibitorja totali ta' PDE4 stabbilita minn porzjonijiet mhux marbuta ex 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).