FrancophonIA/ELRC3.0 huggingface dataset:
English: Combined hormonal contraceptives (CHCs) containing medicinal products The following CHMP Member supports the divergent position appended to the PRAC recommendation on combined hormonal contraceptives containing medicinal products dated 10 October 2013, as stated CHMP members expressing a divergent position:
Maltese: Għalhekk, fl-informazzjoni dwar il-prodott talprodotti, ġie rrakkomandat li qabel ma jiġu preskritti prodotti mediċinali CHC, għandha tiġi ċċekkjata listorja personali u familjari ta' VTE.
English: • The PRAC is of the opinion that the benefits of combined hormonal contraceptive containing medicinal products continue to outweigh the risks in the indication of contraception.
Maltese: • Il-PRAC huwa tal-fehma li l-benefiċċji ta' prodotti mediċinali li fihom kontraċettivi ormonali kkombinati jkomplu jegħlbu r-riskji fl-indikazzjoni ta' kontraċezzjoni.
English: • The PRAC considered that further data are required for the combined hormonal contraceptives containing chlormadinone and imposed the conduct of a post authorisation safety study (PASS) to evaluate the relative risk of thromboembolic events due to these products compared to the
Maltese: • Il-PRAC ikkunsidra li hemm il-ħtieġa ta' aktar tagħrif għall-kontraċettivi ormonali kkombinati li fihom chlormadinone u impona li jsir studju dwar is-sigurtà wara l-awtorizzazzjoni (PASS) biex jivvaluta r-riskju relattiv ta' avvenimenti tromboembolitiċi minħabba dawn il-prodotti meta mqabbla ma' dawk li fihom levonorgestrel.
English: Furthermore, proactive information to communicate the outcome of the present review and to highlight the risk of the thromboembolic events through a direct healthcare professional communication (DHPC) was recommended.
Maltese: Barra minn hekk, kien irrakkomandat li jkun hemm informazzjoni proattiva li tikkomunika r-riżultat tar-reviżjoni attwali u li tenfasizza r-riskju talavvenimenti tromboemboliċi permezz ta' komunikazzjoni diretta lill-professjonisti tal-kura tas-saħħa
English: EMEA/301122/2007-EN
Maltese: EMEA/301122/2007-MT
English: London, 24 July 2007 EMEA/301122/2007
Maltese: Londra, 24 ta' Lulju 2007 EMEA/301122/2007
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: The rapporteur was Dr. J. Schefferlie and the co-rapporteur was Prof. R. Kroker.
Maltese: Schefferlie u l-ko-rapporteur kien il-Prof. R. Kroker.
English: The Marketing Authorisation Holder (MAH) provided written explanations on 16 January 2006.
Maltese: Id-Detentur ta' lAwtorizzazzjoni għat-Tqegħid fis-Suq (MAH) ta spjegazzjonijiet bil-miktub fis-16 ta' Jannar 2006.
English: OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR Suramox 15 % LA and its associated name Stabox 15 % LA International Non-Proprietary Name (INN): Amoxicillin
Maltese: OPINJONI WARA RIFERIMENT TAĦT L-ARTIKOLU 351 GĦAL Suramox 15 % LA u l-isem assoċjat tiegħu Stabox 15 % LA Denominazzjoni Komuni Internazzjonali (DKI): Amoxicillin
English: The product is used in the treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica in cattle and for the treatment of respiratory infections due to Pasteurella multocida in pigs.
Maltese: Il-prodott jintuża għall-kura ta' infezzjonijiet respiratorji kkawżati minn Pasteurella multocida u Mannheimia haemolytica fil-frat u għall-kura ta' infezzjonijiet respiratorji dovuti għal Pasteurella multocida fil-majjali.
English: In both species the product is administered intramuscularly at a dose rate of 15 mg amoxicillin/kg bw (equivalent to 1 ml of Suramox 15% LA / 10 kg bw) twice at 48 hours interval.
Maltese: Fiż-żewġ speċi, il-prodott jingħata ġo muskolu b'rata ta' doża ta' 15 mg amoxicillin/kg piż korporali (ekwivalenti għal 1 ml ta' Suramox 15% LA/10 kg piż korporali) darbtejn f'intervall ta' 48 siegħa.
English: The arbitration procedure started on 8 September 2005 with the adoption of list of questions.
Maltese: Il-proċedura ta' arbitraġġ inbdiet fit-8 ta' Settembru 2005 bl-adozzjoni ta' lista ta' mistoqsijiet.
English: The Reference Member State was France and the Concerned Member States were Belgium, the Czech Republic, Germany, Italy, Spain, and the United Kingdom.
Maltese: L-Istat Membru ta' Referenza kien Franza u l-Istati Membri Konċernati kienu l-Belġju, ir-Repubblika Ċeka, il-Ġermanja, l-Italja, Spanja u r-Renju Unit.
English: A Marketing Authorisation for Suramox 15% LA was previously granted to Virbac S.A. in France on 6 July 2004 based on an abridged application having Duphamox LA as reference medicinal product, with a withdrawal period of 58 days in cattle for meat and offal and 35 days in pigs for meat and offal.
Maltese: Awtorizzazzjoni għat-Tqegħid fis-Suq għal Suramox 15% LA kienet ingħatat preċedentament lil Virbac S.A. fi Franza fis-6 ta' Lulju 2004 abbażi ta' applikazzjoni imqassra għal Duphamox LA, bħala prodott mediċinali ta' referenza, b'perjodu ta' irtirar ta' 58 jum fil-frat għall-laħam u l-intern u 35 jum f'majjali għall-laħam u l-intern.
English: Suramox 15% LA is an injectable suspension containing amoxicillin, which is a beta-lactam antibiotic, belonging to the group of penicillins.
Maltese: Suramox 15% LA huwa sospensjoni li tiġi injettata li fiha amoxicillin, li huwa antibijotiku betalactam, li jappartieni għall-grupp ta' peniċillini.
English: Belgium referred the reason for disagreement to the EMEA on 28 July 2005.
Maltese: Il-Belġju rrefera r-raġuni għan-nuqqas ta' ftehim lill-EMEA fit-28 ta' Lulju 2005.
English: A mutual recognition procedure was started on 28 April 2005.
Maltese: Fit-28 ta' April 2005 inbdiet proċedura ta' rikonoxximent reċiproku.
English: During their June 2006 meeting, the CVMP appointed Dr. R. Breathnach as rapporteur for the assessment of the grounds for the request for re-examination of the opinion.
Maltese: Matul il-laqgħa tiegħu ta' Ġunju 2006, il-CVMP ħatar lil Dr. R. Breathnach bħala rapporteur għall-valutazzjoni tar-raġunijiet għat-talba ta' eżami mill-ġdid ta' l-opinjoni.
English: On 13 September 2006 the CVMP, considered the detailed grounds the re-examination of the opinion and confirmed its previous opinion concluding that the marketing authorisations for Suramox 15% LA should be suspended.
Maltese: Fit-13 ta' Settembru 2006, il-CVMP ikkunsidra r-raġunijiet dettaljati ta' l-eżami mill-ġdid ta' lopinjoni u kkonferma l-opinjoni preċedenti tiegħu li tgħid li l-awtorizzazzjoni għat-tqegħid fis-suq għal Suramox 15% LA għandha tiġi sospiża.
English: The oral explanations were presented on 17 May 2006 by the MAH to the Committee.
Maltese: L-ispjegazzjonijiet bil-fomm ġew ippreżentati fis-17 ta' Mejju 2006 mid-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq lill-Kumitat.
English: Therefore the Committee adopted by consensus a revised opinion confirming its previous recommendation for the suspension of the marketing authorizations for Suramox 15% LA and the associated invented name, Stabox 15% LA.
Maltese: Għalhekk, il-Kumitat adotta b'konsensus opinjoni riveduta li tikkonferma r-rakkomandazzjoni preċedenti għas-sospensjoni ta' lawtorizzazzjonijiet għat-tqegħid fis-suq għal Suramox 15 % LA u l-isem ivvintat assoċjat, Stabox 15% LA.
English: The withdrawal period for milk was 2.5 days.
Maltese: Il-perjodu ta' irtirar għall-ħalib kien ta' jumejn u nofs (2.5 jiem).
English: On 1 June 2006, the representative of the MAH notified the EMEA on his intention to request the reexamination of the CVMP opinion in accordance with Article 36(4)2.
Maltese: Fl-1 ta' Ġunju 2006, ir-rappreżentant tad-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq innotifika lill-EMEA bl-intenzjoni tiegħu li jitlob l-eżami mill-ġdid ta' l-opinjoni tal-CVMP skond lArtikolu 36(4)2.
English: The Marketing Authorisation Holder submitted the new residue studies to the CVMP on 9 January 2007 and provided oral explanations to the Committee on 13 March 2007 including presentation of a new residue study in pigs and a new calculation and proposal for the withdrawal period for pigs.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq issottometta l-istudji l-ġodda dwar ir-residwi lill-CVMP fid-9 ta' Jannar u fit-13 ta' Marzu 2007 ta spjegazzjonijiet bil-fomm lill-Kumitat inkluż preżentazzjoni ta' studju ġdid dwar ir-residwi fil-majjali u kalkolazzjoni u proposta ġdida għal perjodu ta' rtirar għal majjali.
English: On 14 November 2006 the European Commission suspended the written procedure and on 16 November 2006, requested the CVMP, to consider the new residue studies in the assessment of the referral and to revise as appropriate the opinion of 13 September 2006.
Maltese: Fl-14 ta' Novembru 2006, il-Kummissjoni Ewropea ssospendiet il-proċedura bil-miktub u fis-16 ta' Novembru 2006, talbet lill-CVMP, sabiex jikkunsidra l-istudji ġodda dwar ir-residwi fil-valutazzjoni tar-riferiment u sabiex jirrevedi bix-xieraq l-opinjoni tat-13 ta' Settembru 2006.
English: During its March 2007 meeting, the CVMP, considered the new residue studies submitted with regard to Suramox 15% LA and concluded that the new data did not allow establishment of withdrawal periods for edible tissues in cattle and pigs.
Maltese: Matul il-laqgħa tiegħu ta' Marzu 2007, il-CVMP, ikkunsidra l-istudji ġodda dwar ir-residwi ppreżentati fir-rigward ta' Suramox 15% LA u kkonkluda li t-tagħrif ġdid ma ppermettix li jiġu iffissati perjodi ta' rtirar għal tessuti li jittieklu fil-frat u fil-majjali.
English: Bronchospasm, including paradoxical
Maltese: Bronkospażmu, inkluż paradossali
English: Additional information:
Maltese: Informazzjoni addizzjonali:
English: The plasma protein binding of formoterol is 61% to 64% (34% primarily to albumin).
Maltese: It-twaħħil tal-proteina fil-plażma ta' formoterol huwa 61% sa 64% (34% primarjament għal albumin).
English: Dose indicator moves slowly from 60 to 0: 60, 50, 40, 30, 20, 10, 0.
Maltese: L-indikatur tad-doża jiċċaqlaq bilmod minn 60 għal 0: 60, 50, 40, 30,
English: EU/1/14/963/001 1 inhaler with 60 doses EU/1/14/963/002 3 inhalers each with 60 doses EU/1/14/963/003 1 inhaler with 30 doses
Maltese: EU/1/14/963/001 1 inalatur b'60 doża EU/1/14/963/002 3 inalaturi kull wieħed b'60 doża EU/1/14/963/001 1 inalatur bi 30 doża
English: Brimica Genuair contains lactose
Maltese: Brimica Genuair fih lactose
English: Cytochrome P450 isoenzymes CYP2D6, CYP2C19, CYP2C9 and CYP2A6 are involved in the O-demethylation of formoterol.
Maltese: Isoenzimi ta' ċitokromu P450 CYP2D6, CYP2C19, CYP2C9 u CYP2A6 huma involuti f'demetilizzazzjoni-O ta' formoterol.
English: Formoterol is a potent selective β2-adrenoceptor agonist.
Maltese: Formoterol huwa agonist β2-adrenoċettur selettiv.
English: Formoterol is eliminated primarily by metabolism.
Maltese: Formoterol huwa eliminat primarjament mill-metaboliżmu.
English: The Genuair inhaler is a multicomponent device made of plastic (polycarbonate, acrylonitrilebutadiene-styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene) and stainless steel.
Maltese: L-inalatur Genuair huwa strument b'diversi komponenti magħmul minn plastik (polycarbonate, acrylonitrile-butadiene-styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene) u stainless steel.
English: Orange button
Maltese: Buttuna oranġjo
English: Up to 65% of the dose was eliminated as metabolites in the urine and up to 33% as metabolites in the faeces.
Maltese: Sa 65% tad-doża ġiet eliminata bħala metaboliti fl-awrina u sa 33% bħala metaboliti fl-ippurgar.
English: - If you have heart problems.
Maltese: - Jekk għandek problemi bil-qalb.
English: How to store Brimica Genuair 6.
Maltese: Kif taħżen Brimica Genuair 6.
English: Clinical Efficacy and Safety
Maltese: Effikaċja klinika u sigurtà
English: Aclidinium is rapidly and extensively hydrolysed to its pharmacologically inactive alcohol- and carboxylic acid-derivatives.
Maltese: Aclidinium huwa idrolizzat malajr u b'mod estensiv għad-derivati farmakoloġikament inattivi tiegħu tal-alkoħol u tal-carboxylic acid.
English: A total of 1222 patients were treated with Brimica Genuair 340 micrograms /12 micrograms.
Maltese: Total ta' 1222 pazjent ikkurati b'Brimica Genuair 340 mikrogramma/12-il mikrogramma.
English: The most frequently reported adverse reactions with Brimica Genuair were nasopharyngitis (7.9%) and headache (6.8%).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni b'Brimica Genuair kienu nażofarinġite (7.9%) u wġigħ ta' ras (6.8%).
English: Supportive and symptomatic treatment is indicated.
Maltese: Huwa indikat trattament ta' appoġġ u sintomatiku.
English: Aclidinium is a competitive, selective muscarinic receptor antagonist, with a longer residence time at the M3 receptors than the M2 receptors.
Maltese: Aclidinium huwa antagonista tar-riċettur muskariniku kompetittiv u selettiv, bi żmien ta' residenza akbar fir-riċetturi M3 mir-riċetturi M2.
English: Formoterol does not inhibit the CYP450 enzymes at therapeutically relevant concentrations (see section 5.2).
Maltese: Formoterol ma jinibixxix l-enzimi CYP450 f'konċentrazzjonijiet terapewtikament rilevanti (ara sezzjoni 5.2).
English: Nasopharyngitis Urinary tract infection Sinusitis
Maltese: Infezzjoni fl-apparat urinarju Sinusite
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża ċentrali
English: For instructions for use, see section 6.6.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Brimica Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: Brimica Genuair huwa indikat bħala trattament ta' manteniment bi bronkodilatatur sabiex itaffi s-sintomi fil-pazjenti adulti b'mard pulmonari ostruttiv kroniku (COPD).
English: 1.5 Release the orange button (Figure F).
Maltese: Itlaq il-buttuna l-oranġjo (Figura F).
English: Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.
Maltese: Slovenská republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.
English: The onset of action of Brimica Genuair was comparable to the effect of the fast-acting β2-agonist formoterol 12 micrograms.
Maltese: Il-bidu ta' azzjoni ta' Brimica Genuair kien komparabbli mal-effett tal-agonist β2 b'azzjoni rapida formoterol 12-il mikrogramma.
English: In vitro studies have shown that aclidinium or its metabolites at the therapeutic dose are not expected to cause interactions with P-glycoprotein (P-gp) substrate drugs or drugs metabolised by cytochrome P450 (CYP450) enzymes and esterases.
Maltese: Studji in vitro wrew li aclidinium jew il-metaboliti tiegħu fid-doża terapewtika mhumiex mistennija li jikkawżaw interazzjonijiet ma' mediċini substrati ta' P-glikoproteina (P-gp) jew ma' mediċini metabolizzati minn enzimi taċ-ċitokrom P450 (CYP450) u esterases.
English: Maximal bronchodilator effects (peak FEV1) relative to baseline were evident from day one (304 ml) and were maintained over the 6-month treatment period (326 ml).
Maltese: L-effetti bronkodilatatorji massimi (l-ogħla FEV1) relattivi għal-linja bażi kienu evidenti mill-ewwel jum (304 ml) u nżammu fuq perjodu ta' kura ta' 6 xhur (326 ml).
English: Respiratory, Thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: Following repeated inhalations of Brimica Genuair 340/12 micrograms, the systemic exposure of aclidinium and formoterol, as measured by AUC, is similar in Japanese and Caucasian patients.
Maltese: Wara inalazzjonijiet ripetuti ta' Brimica Genuair 340/12-il mikrogramma, l-esponiment sistemiku ta' aclidinium u formoterol, kif imkejjel mill-AUC, huwa simili f'pazjenti Ġappuniżi u Kawkasi.
English: Brimica Genuair is not indicated for the treatment of acute episodes of bronchospasm.
Maltese: Brimica Genuair mhuwiex indikat għat-trattament ta' episodji akuti ta' bronkospażmu.
English: Brimica Genuair contains two bronchodilators: aclidinium is a long-acting muscarinic antagonist (also known as an anticholinergic) and formoterol is a long-acting β2-adrenergic agonist.
Maltese: Brimica Genuair fih żewġ bronkodilaturi: aclidinium huwa antagonist muskariniku b'azzjoni fit-tul (magħruf ukoll bħala antikolinerġiku) u formoterol huwa agonist adrenerġiku β2 li jaġixxi fit-tul.
English: After inhalation, 6% to 9% of the delivered dose of formoterol is excreted in the urine unchanged or as direct conjugates of formoterol.
Maltese: Wara inalazzjoni, 6% sa 9% tad-doża mogħtija ta' formoterol tiġi eliminata fl-awrina mhux mibdula jew bħala konjugati diretti ta' formoterol.
English: There is limited evidence on the management of overdose with Brimica Genuair.
Maltese: Hemm evidenza limitata fuq il-ġestjoni ta' doża eċċessiva b'Brimica Genuair.
English: Angioedema Anaphylactic reaction
Maltese: Anġjoedema Reazzjoni anafilattika
English: Hypokalaemic treatment
Maltese: Trattament ipokalimiku
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' lactase totali jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Myalgia Muscle spasms
Maltese: Majalġja Spażmi fil-muskoli
English: Date of first authorisation: 19 November 2014 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 19 Novembru 2014
English: Other medicines and Brimica Genuair
Maltese: Mediċini oħra u Brimica Genuair
English: Following inhalation of a single dose of Brimica Genuair 340/12 micrograms, aclidinium and formoterol were rapidly absorbed into plasma, reaching peak plasma concentrations within 5 minutes of inhalation in healthy subjects and within 24 minutes of inhalation in patients with COPD.
Maltese: Wara inalazzjoni ta' doża unika ta' Brimica Genuair 340/12 -il mikrogramma, aclidinium u formoterol ġew assorbiti b'mod rapidu fil-plażma, u laħqu l-ogħla konċentrazzjonijiet fil-plażma fi żmien 5 minuti mill-inalazzjoni fl-individwi b'saħħithom u fi żmien 24 minuta mill-inalazzjoni f'pazjenti b'COPD.
English: Show the packaging of Brimica Genuair.
Maltese: Uri l-pakkett ta' Brimica Genuair.
English: Although no formal in vivo drug interaction studies have been performed with Brimica Genuair, it has been used concomitantly with other COPD medicinal products including short-acting β2-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Maltese: Għad li ma sar l-ebda studju formali in vivo tal-interazzjoni tal-mediċina b'Brimica Genuair, intuża b'mod konkomitanti ma' prodotti mediċinali tas-COPD oħrajn inklużi bronkodilataturi adrenerġiċi β2 b'azzjoni fuq żmien qasir, methylxanthines, u sterojdi orali u li jittieħdu man-nifs mingħajr prova klinika ta' interazzjonijiet tal-mediċina.
English: Infectious and infestations
Maltese: Infezzjonijiet u infestazzjonijiet
English: In addition, a higher percentage of patients receiving Brimica Genuair responded with a clinically meaningful improvement in SGRQ total score compared to aclidinium and formoterol (56.6% compared to 53.9% and 52.2%, respectively; p=0.603 and p=0.270, respectively).
Maltese: Barra minn hekk, perċentwal ogħla ta' pazjenti li ngħataw Brimica Genuair irrispondew b'titjib klinikament sinifikanti fil-punteġġ totali ta' SGRQ meta mqabbel ma' aclidinium u formoterol (56.6% meta mqabbel ma' 53.9% u 52.2%, rispettivament; p=0.603 and p=0.270, rispettivament).
English: After 4 weeks of treatment, Brimica Genuair improved the number of steps per day compared to placebo (731 steps/day; 95% CI=279, 1181; p=0.0016) and reduced the percentage of inactive patients (<6000 steps per day) [40.8% compared to 54.5%; p<0.0001].
Maltese: Wara 4 ġimgħat ta' kura, Brimica Genuair tejjeb in-numru ta' passi kuljum meta mqabbel mal-plaċebo (731 pass/jum; 95% CI=279, 1181; p=0.0016) u naqqas il-perċentwali ta' pazjenti mhux attivi (<6000 pass kuljum) [40.8% meta mqabbel ma' 54.5%; p<0.0001].
English: Brimica Genuair 340 mcg/12 mcg inhalation powder aclidinium/formoterol fumarate dihydrate
Maltese: Brimica Genuair 340 mcg/12 mcg trab li jittieħed man-nifs aclidinium/formoterol fumarate dihydrate
English: Common (may affect up to 1 in 10 people) - Combination of sore throat and runny nose - these may be signs of nasopharyngitis - Headache - Painful and/or frequent urination - these may be signs of a urinary tract infection - Cough - Diarrhoea - A blocked, runny or stuffy nose and/or pain or a feeling of pressure in the cheeks or forehead these may be symptoms of sinusitis - Dizziness - Muscle cramps - Nausea (feeling sick) - Difficulty sleeping - Dry mouth - Muscle pain - Abscess (infection) in the tissues at the base of a tooth - Increased blood levels of a protein found in muscle called creatine phosphokinase - Shaking/tremor - Anxiety
Maltese: nażofarinġite - Uġigħ ta' ras - Uġigħ biex tagħmel l-awrina jew tkun tagħmel l-awrina b'mod frekwenti - dawn jistgħu jkunu sinjali ta' infezzjoni fl-apparat urinarju - Sogħla - Dijarea - Imnieħer imblokkat, inixxi jew misdud u/jew uġigħ jew sensazzjoni ta' pressjoni fil-ħaddejn jew fuq il-moħħ - dawn jistgħu jkunu sintomi ta' sinusite - Sturdament - Bugħawwieġ fil-muskoli - Nawseja (tħossok imdardar) - Diffikultà biex torqod - Ħalq xott - Uġigħ fil-muskoliAxxesi (infezzjoni) fit-tessuti fil-bażi ta' sinna - Żieda fil-livelli fid-demm ta' proteina misjuba f'muskolu msejħa creatine phosphokinase - Rogħda/tertir - Ansjetà
English: In study AUGMENT, Brimica Genuair showed improvements in FEV1 at 1 hour post-dose relative to placebo and aclidinium of 284 ml and 108 ml (both p<0.0001), respectively, and improvements in trough FEV1 relative to placebo and formoterol of 130 ml (p<0.0001) and 45 ml (p=0.01), respectively.
Maltese: Fl-istudju AUGMENT, Brimica Genuair wera titjib f'FEV1 f'siegħa wara d-doża meta mqabbel ma' plaċebo u aclidinium ta' 284 ml u 108 ml (it-tnejn p<0.0001), rispettivament u titjib fl-FEV1 l-aktar baxx meta mqabbel ma' plaċebo u formoterol ta' 130 ml (p<0.0001) u 45 ml (p=0.01), rispettivament.
English: Formoterol does not inhibit CYP450 enzymes at therapeutically relevant concentrations.
Maltese: Formoterol ma jinibixxix l-enzimi CYP450 f'konċentrazzjonijiet terapewtikament rilevanti.
English: FEV1 at 1 hour post-dose and trough FEV1 (compared to aclidinium 400 micrograms and formoterol 12 micrograms, respectively) were defined as co-primary endpoints in both 6-month pivotal Phase III studies to demonstrate the bronchodilator contributions of formoterol and aclidinium in Brimica Genuair, respectively.
Maltese: FEV1 f'siegħa wara d-doża u permezz ta' FEV1 (meta mqabbel ma' aclidinium 400 mikrogramma u formoterol 12 -il mikrogramma, rispettivament) kienu definiti bħala punti ta' tmiem koprimarji fiż-żewġ studji importanti ħafna ta' 6 xhur ta' Fażi
English: In the pooled analysis of these two studies, Brimica Genuair showed greater improvements in SGRQ total score compared to formoterol (-1.7 units; p=0.018) or aclidinium (-0.79 units, p=0.273).
Maltese: Fl-analiżi miġbura ta' dawn iż-żewġ studji, Brimica Genuair wera titjib akbar fil-punteġġ totali ta' SGRQ meta mqabbel ma' formoterol (-1.7 unità; p=0.018) jew aclidinium (-0.79 unità, p=0.273).
English: Brimica Genuair showed improvements compared to placebo in lung volumes at 2-3h post dose (FRC=-0.366 L [95% CI=0.515, -0.216; p<0.0001]; residual volume [RV]=-0.465 L [95% CI=-0.648, -0.281; p<0.0001] and inspiratory capacity [IC]=0.293 L [95% CI=0.208, 0.378; p<0.0001]).
Maltese: 465 L [95% CI=0.648, -0.281; p<0.0001] u fil-kapaċità ispiratorja [IC]= 0.293 L [95% CI=0.208, 0.378; p<0.