FrancophonIA/ELRC3.0 huggingface dataset:
English: However, no evidence of any drug interactions with aztreonam were identified from clinical studies in which Cayston was taken concomitantly with bronchodilators, dornase alfa, pancreatic enzymes, azithromycin, tobramycin, oral steroids (less than 10 mg daily/20 mg every other day) and inhaled steroids.
Maltese: Madankollu, l-ebda evidenza ta' kwalunkwe interazzjonijiet tal-mediċina ma' aztreonam ma kienu identifikati minn studji kliniċi fejn Cayston ittieħed fl-istess ħin ma' bronkodilaturi, dornase alfa, enzimi pankreatiċi, azithromycin, tobramycin, sterojdi orali (inqas minn 10 mg kuljum/20 mg kull jumejn) u sterojdi li jinġibdu man-nifs.
English: The following rare and severe adverse reactions have been reported after parenteral use of other aztreonam containing products: toxic epidermal necrolysis, anaphylaxis, purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae, pruritus, diaphoresis.
Maltese: Ir-reazzjonijiet avversi rari u severi li ġejjin kienu rrappurtati wara l-użu parenterali ta' prodotti oħrajn li fihom aztreonam: nekrolisi epidermali tossika, anafilassi, purpura, eritema multiforme, dermatite bil-qxur, urtikarja, tbenġil, ħakk, dijaforesi.
English: CP-AI-007 enrolled 164 adult (predominantly) and paediatric patients randomised in a 1:1 ratio comparing Cayston 75 mg (80 patients) or placebo (84 patients) administered 3 times a day for 28 days (one course).
Maltese: CP-AI-007 irreġistra 164 persuna adulta (fil-biċċa l-kbira tagħhom) u pazjenti pedjatriċi li ntgħażlu b'mod każwali fi proporzjon ta' 1:1 li qabbel Cayston 75 mg(80 pazjent) jew plaċebo (84 pazjent), mogħti 3 darbiet kuljum għal 28 jum (kors wieħed).
English: Cross-reactivity may occur in patients with a history of allergy to beta-lactam antibiotics, such as penicillins, cephalosporins, and/or carbapenems.
Maltese: Tista' sseħħ reattività inkroċjata fil-pazjenti b'storja medika ta' allerġija għal antibijotiċi beta-lactam, bħal penicillins, cephalosporins, u/jew carbapenems.
English: Method of administration
Maltese: Mekkaniżmi tar-reżistenza
English: Bronchospasm (an acute reduction of ≥ 15% in FEV1) is a complication associated with nebulised therapies.
Maltese: Il-bronkospażmu (tnaqqis akut ta' ≥ 15% fl-FEV1) hu komplikazzjoni assoċjata ma' terapiji li jingħataw bin-nebulizzatur.
English: EU/1/09/543/001: 28-day pack of Cayston EU/1/09/543/002: 28-day pack of Cayston plus one Altera Nebuliser Handset
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/543/001: pakkett ta' 28 jum ta' Cayston EU/1/09/543/002: pakkett ta' 28 jum ta' Cayston flimkien ma' Altera Nebuliser Handset wieħed
English: Nebulised therapies, including Cayston, may be associated with bronchospasm (an acute reduction of ≥ 15% in FEV1).
Maltese: Terapiji li jingħataw bin-nebulizzatur, li jinkludu Cayston, jistgħu jiġu assoċjati ma' bronkospażmu (tnaqqis akut ta' ≥ 15% fl-FEV1).
English: Date of first authorisation: 21 September 2009 Date of latest renewal: 26 May 2016
Maltese: Data tal-aħħar tiġdid: 26 ta' Mejju, 2016
English: Entry criteria included CF, baseline FEV1 between 25% and 75% predicted, and chronic P. aeruginosa lung infection.
Maltese: Il-kriterji tal-parteċipazzjoni kienu jinkludu CF, FEV1 fillinja bażi bejn 25% u 75% imbassra, u infezzjoni kronika fil-pulmun b'P. aeruginosa.
English: Lung function test decreased has been reported with use of Cayston, but was not associated with a sustained decrease in FEV1 (see section 5.1).
Maltese: Tnaqqis fir-riżultat tat-test tal-funzjoni pulmonari ġie rrappurtat bl-użu ta' Cayston, iżda ma kienx assoċjat ma' tnaqqis sostnut f'FEV1 (ara sezzjoni 5.1).
English: Pharmacokinetic properties for aztreonam for injection
Maltese: Proprjetajiet farmakokinetiċi għal aztreonam għall-injezzjoni
English: Powder vial and solvent ampoule:
Maltese: Kunjett bit-trab u ampulla bis-solvent:
English: Uncommon side effects (affects 1 to 10 users in 1000) - Joint swelling
Maltese: Effetti sekondarji komuni (jaffettwaw minn 1 sa 10 utenti minn kull 100)
English: Mean peak plasma levels at Days 0, 14, and 28 of a course with 75 mg inhaled aztreonam 3 times a day were 0.55 µg/ml, 0.67 µg/ml, and 0.65 µg/ml, respectively, indicating no systemic accumulation of aztreonam following 3 times a day dosing.
Maltese: Il-medja tal-livelli massimi fil-plażma f'Jiem 0, 14, u 28 ta' kors b'75 mg aztreonam miġbud man-nifs 3 darbiet kuljum kienet ta' 0.55 µg/ml, 0.67 µg/ml, u 0.65 µg/ml, rispettivament, li ma tindika l-ebda akkumulazzjoni sistemika ta' aztreonam wara dożaġġ li jingħata 3 darbiet kuljum.
English: A total of 137 paediatric patients aged 6 to 17 years with chronic P. aeruginosa infection and FEV1 ≤ 75% predicted have received Cayston in Phase 2 and Phase 3 clinical studies (6-12 years, n = 35; 13-17 years, n = 102).
Maltese: Total ta' 137 pazjent pedjatriku li kellhom minn 6 sa 17-il sena b'infezzjoni kronika b'P. aeruginosa u FEV1 ≤ 75% imbassra rċivew Cayston fi studji kliniċi ta' Fażi 2 u Fażi 3 (6-12-il sena, n = 35; 13-17-il sena, n = 102).
English: - Joint pain - Lower lung function test results
Maltese: Tnaqqis fir-riżultat tat-test tal-funzjoni pulmonari
English: CP-AI-006 was an open-label follow-on study to CP-AI-005 and CP-AI-007 evaluating the safety of repeated exposure to aztreonamand the effect on disease-related endpoints over multiple 28-day courses.
Maltese: CP-AI-006 kien studju open-label follow-on għal CP-AI-005 u CP-AI-007 li evalwa s-sigurtà ta' espożizzjoni ripetuta għal aztreonam u l-effett fuq l-endpoints marbuta mal-marda fuq aktar minn kors wieħed ta' 28 jum.
English: Aztreonam-treated patients also demonstrated larger mean improvements in CFQ-R respiratory symptoms scores compared to TNS-treated patients across 3 treatment courses (6.30 versus 2.17, p = 0.019).
Maltese: Pazjenti kkurati b'aztreonam urew ukoll medja akbar ta' titjib fil-punteġġi tas-sintomi respiratorji CFQ-R meta mqabbla ma' pazjenti kkurati b'TNS fit-3 korsijiet ta' kura (6.30 versus 2.17, p = 0.019).
English: The adverse reactions considered at least possibly related to treatment from clinical study and postmarketing experience are listed below by body system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi li huma kkunsidrati tal-anqas possibbilment relatati mal-kura mill-istudju kliniku u esperjenza wara t-tqegħid fis-suq, huma elenkati hawn taħt skond il-klassi tal-organi tassistema tal-ġisem u l-frekwenza.
English: The following pack sizes are available:
Maltese: Id-daqsijiet tal-pakketti li ġejjin huma disponibbli:
English: The recommended dose for adults is 75 mg three times per 24 hours for 28 days.
Maltese: Id-doża rakkomandata għall-adulti hi ta' 75 mg tliet darbiet kull 24 siegħa għal 28 jum.
English: Bronchospasm has been reported after Cayston administration (see section 4.8).
Maltese: Bronkospażmu kien irrappurtat wara l-għoti ta' Cayston (ara sezzjoni 4.8).
English: For the combined Phase 3 placebo-controlled studies, ten minutes following a single dose of 75 mg inhaled aztreonamon Days 0, 14, and 28, the mean sputum concentrations in 195 patients with CF were 726 µg/g, 711 µg/g, and 715 µg/g, respectively, indicating no increased accumulation of aztreonam following repeated dosing.
Maltese: Għall-istudji kombinati ta' Fażi 3, ikkontrollati bil-plaċebo, għaxar minuti wara doża singola ta' 75 mg aztreonam miġbud man-nifs f'Jiem 0, 14, u 28, il-medja tal-konċentrazzjonijiet fl-isputum f'195 pazjent bis-CF kienet ta' 726 µg/g, 711 µg/g, u 715 µg/g, rispettivament, li ma tindika l-ebda żieda fl-akkumulazzjoni ta' aztreonam wara dożaġġ ripetut.
English: Cayston is administered by inhalation over a 2 to 3 minute period, using a Cayston specific Altera Nebuliser Handset and Altera Aerosol Head connected to an eBase Controller or an eFlow rapid Control Unit.
Maltese: Cayston jingħata permezz tal-ġbid man-nifs fuq perjodu ta' minn 2 sa 3 minuti, bl-użu ta' Altera Nebuliser Handset speċifiku għal Cayston u Altera Aerosol Head ikkonnettjata ma' eBase Controller jew eFlow rapid Control Unit.
English: In a 24-week active-controlled clinical study of Cayston therapy, increases were observed in the MIC90 for all P. aeruginosa isolates as well as in the percentages of patients with P. aeruginosa resistant (MIC above the parenteral breakpoint) to aztreonam, to at least 1 beta-lactam antibiotic, and to all 6 beta-lactam antibiotics tested (see section 5.1).
Maltese: Fi studju kliniku kkontrollat attivament li dam 24 ġimgħa dwar it-terapija b'Cayston, ġew osservati żidiet fil-MIC90 għall-iżolati kollha ta' P. aeruginosa kif ukoll filperċentwali ta' pazjenti b'iżolati ta' P. aeruginosa reżistenti (MIC ogħla mill-breakpoint parenterali) għal aztreonam, għal mill-inqas antibijotiku beta-lactam 1, u għas-6 antibijotiċi beta-lactam kollha ttestjati (ara sezzjoni 5.1).
English: The serum half-life of aztreonam averaged 1.7 hours in subjects with normal renal function, independent of the dose and route.
Maltese: Il-half-life ta' aztreonam fis-serum kien ta' medja ta' 1.7 sigħat f'persuni b'funzjoni renali normali, indipendentement mid-doża u l-mod kif jingħata.
English: Each 28-day pack of Cayston contains 84 vials of lyophilised Cayston and 88 solvent ampoules.
Maltese: Kull pakkett ta' 28 jum ta' Cayston fih 84 kunjett ta' Cayston lajofilizzat u 88 ampulla bis-solvent.
English: An increased prevalence of methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive S. aureus (MSSA), Aspergillus and Candida species was observed over time in patients treated with several Cayston treatment courses.
Maltese: Żieda fil-prevalenza Staphylococcus aureus reżistenti għal methicillin (MRSA - methicillin-resistant Staphylococcus aureus), S. aureus sensittiva għal methicillin (MSSA - methicillin-sensitive Staphylococcus aureus) speċi t'Aspergillus u Candida kienet osservata maż-żmien f'pazjenti kkurati b'diversi korsijiet ta' kura b'Cayston.
English: In a 24-week active-controlled study of Cayston therapy, no increases in P. aeruginosa MIC50 (± 2 dilution change) were observed, whereas MIC90 increased to 4 times the initial MIC. At the end of the study, the percentage of patients with aztreonam MIC for P. aeruginosa above the parenteral breakpoint (> 8 µg/ml) increased from 34% at baseline to 49%, the percentage of patients with P. aeruginosa resistant to at least 1 betalactam antibiotic increased from 56% at baseline to 67%, and the percentage of patients with P. aeruginosa resistant to all 6 beta-lactam antibiotics tested increased from 13% at baseline to 18%.
Maltese: Fit-tmiem tal-istudju, ilperċentwali ta' pazjenti b'MIC għal aztreonam għal P. aeruginosa fuq il-breakpoint parenterali (> 8 µg/ml) żdied minn 34% fil-linja bażi għal 49%, il-perċentwal ta' pazjenti b'P. aeruginosa reżistenti għal mill-inqas antibijotiku beta-lactam 1 żdied minn 56% fil-linja bażi għal 67%, u lperċentwal ta' pazjenti b'P. aeruginosa reżistenti għas-6 antibijotiċi beta-lactam kollha ttestjati żdied minn 13% fil-linja bażi għal 18%.
English: Each vial contains aztreonam lysine equivalent to 75 mg aztreonam.
Maltese: Kull kunjett fih aztreonam lysine ekwivalenti għal 75 mgta aztreonam.
English: Plasma concentrations
Maltese: Konċentrazzjonijiet fil-plażma
English: In the two Phase 3 placebo-controlled clinical studies where patients received Cayston for 28 days, the most frequently occurring adverse reactions to Cayston were cough (58%), nasal congestion (18%), wheezing (15%), pharyngolaryngeal pain (13.0%), pyrexia (12%) and dyspnoea (10%).
Maltese: Fiż-żewġ studji kliniċi ta' Fażi 3 kkontrollati bil-plaċebo fejn il-pazjenti rċivew Cayston għal 28 jum, l-iktar reazzjonijiet avversi għal Cayston li seħħew b'mod frekwenti kienu sogħla (58%), konġestjoni nażali (18%), tħarħir (15%), uġigħ faringolarinġeali (13.0%), deni (12%) u qtugħ ta' nifs (10%).
English: Preparing the Altera Nebuliser to take your Cayston 1.
Maltese: 2 Kif tipprepara l-Altera Nebuliser biex tieħu Cayston 1.
English: Known mechanisms of resistance to aztreonam mediated by mutation of chromosomal genes include: hyperexpression of the Class C beta-lactamase AmpC and up-regulation of the efflux pump MexAB-OprM.
Maltese: Il-mekkaniżmi magħrufa tar-reżistenza għal aztreonam medjati mill-mutazzjoni ta' ġeni kromosomali jinkludu: iperespressjoni tal-beta-lactamase ta' Klassi Ċ AmpC u up-regulation tal-pompa tal-effluss MexAB-OprM.
English: Gilead Sciences Ireland UC Teл.
Maltese: Gilead Sciences Ireland UC
English: The 1 ml solvent is contained in a plastic ampoule.
Maltese: Il-1 ml ta' solvent tkun fl-ampulla tal-plastik.
English: bronchospasm1, chest discomfort, rhinorrhoea, haemoptysis1 Skin and subcutaneous tissue disorders: Common:
Maltese: bronkospażmu1, skonfort fis-sider, ħruġ ta' likwidu mill-imnieħer, emoptisi1 Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda:
English: Powder vial also contains L-Lysine Solvent ampoule contains sodium chloride, water for injections
Maltese: Il-kunjett bit-trab fih ukoll L-Lysine L-ampulla bis-solvent fiha sodium chloride, ilma għall-injezzjonijiet
English: Safely dispose of the metal seal.
Maltese: Armi s-siġill tal-metall b'mod sigur.
English: Cayston was compared to TNS over three 28-day courses of treatment in a randomised, activecontrolled, multicenter study (GS-US-205-0110).
Maltese: Cayston ġie mqabbel ma' TNS fuq tliet korsijiet ta' kura li damu 28 jum, fi studju li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat b'mod attiv u multiċentriku (Studju GS-US-205-0110).
English: Respiratory, thoracic and mediastinal disorders: Very common:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali:
English: administration.
Maltese: Handset.
English: - The powder vial contains 75 mg aztreonam (as lysine).
Maltese: - Il-kunjett bit-trab fih 75 mg ta' aztreonam (bħala lysine).
English: Pharmacotherapeutic group: Antibacterials for systemic use, other beta-lactam antibacterials, ATC code: J01DF01
Maltese: Antibatterjali għall-użu sistemiċi, antibatterjali beta-lactam oħrajn, Kodiċi ATC:
English: Patients were randomised in a 2:2:1:1 ratio to be treated with aztreonam 75 mg 2 or 3 times a day or volume-matched placebo 2 or 3 times a day for 28 days immediately following the 28-day lead-in course of open-label TNS.
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 2:2:1:1 biex ikunu kkurati b'aztreonam 75 mg darbtejn jew 3 darbiet kuljum, jew plaċebo volume-matched darbtejn jew 3 darbiet kuljum għal 28 jum immedjatament wara l-kors lead-in ta' t-28 jum ta' open-label TNS.
English: Gilead Sciences s.r.o.
Maltese: Česká republika Gilead Sciences s.r.o.
English: Cayston 75 mg powder and solvent for nebuliser solution aztreonam
Maltese: Cayston 75 mg trab u solvent għal soluzzjoni għan-nebulizzatur Aztreonam
English: Efficacy has not been established in patients with FEV1 > 75% predicted.
Maltese: L-effikaċja ma ġietx determinata f'pazjenti b'FEV1 mbassra ta' > 75%.
English: • Pack containing one 28-day pack of Cayston plus one Altera Nebuliser Handset
Maltese: • pakkett li fih pakkett wieħed ta' 28 jum ta' Cayston flimkien ma' Altera Nebuliser Handset wieħed
English: Aztreonamtherapy resulted in significant improvements in pulmonary function and respiratory symptoms at Day 28 in the 66 patients treated with one course Cayston 75 mg 3 times a day.
Maltese: It-terapija b'aztreonam irriżultat f'titjib sinifikanti fil-funzjoni pulmonari u sintomi respiratorji f'Jum 28 fis-66 pazjent ikkurati b'kors wieħed b'Cayston 75 mg 3 darbiet kuljum.
English: bronchodilator mucolytics (a medicine that helps to dissolve the thick mucous produced in the lungs) and finally:
Maltese: bronkodilatur mukolitiċi (mediċina li tgħin biex tħoll il-mukus oħxon magħmul fil-pulmun) u finalment:
English: The principal metabolite (SQ26,992) is inactive and is formed by opening of the beta-lactam ring due to hydrolysis.
Maltese: Il-metabolit ewlieni (SQ26,992) hu inattiv u jiġi ffurmat mill-ftuħ taċ-ċirku tal-beta-lactam minħabba idroliżi.
English: Haemoptysis
Maltese: Emoptisi
English: For storage conditions of the reconstitued medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Solvent for Cayston Sodium Chloride 0.17% Inhalation use only 1 ml
Maltese: Solvent għal Cayston Sodium Chloride 0.17% Għal biex jinġibed man-nifs biss
English: lung function test decreased1 1 See section Description of selected adverse reactions
Maltese: tnaqqis fir-riżultat tat-test tal-funzjoni pulmonari1 1 Ara sezzjoni Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: - Take Cayston 3 times a day in repeated cycles of 28 days on therapy followed by 28 days off Cayston therapy.
Maltese: - Ħu Cayston 3 darbiet kuljum f'ċikli ripetuti ta' 28 jum fuq terapija segwita minn 28 jum bla terapija b'Cayston.
English: Rash has been reported with the use of Cayston and may be indicative of an allergic reaction to aztreonam (see section 4.4).
Maltese: Ir-raxx ġie rrappurtat bl-użu ta' Cayston u jista' jindika reazzjoni allerġika għal aztreonam (ara sezzjoni 4.4).
English: Each 28-day pack of Cayston contains 84 vials of lyophilised aztreonam and 88 solvent ampoules.
Maltese: Kull pakkett ta' 28 jum ta' Cayston fih 84 kunjett ta' aztreonam lajofilizzat u 88 ampulla bis-solvent.
English: Of the 101 patients, all having a positive cultures for P. aeruginosa within 30 days of study enrolment, of whom 56 (55.4%) were free of P. aeruginosa at baseline who completed a 28-day treatment course 89.1% (n = 90) were free of P. aeruginosa at the end of treatment (Day 28) and 75.2% (n = 76) were free of P. aeruginosa 1 month after the end of treatment (Day 56).
Maltese: Mill-101 pazjenti, li kollha kellhom kolturi pożittivi għal P. aeruginosa fi żmien 30 jum minn meta ddaħħlu fl-istudju, li minnhom 56 (55.4%) kienu ħielsa minn P. aeruginosa fil-linja bażi li komplew kors ta' kura ta' 28 jum 89.1% (n = 90) kienu ħielsa minn P. aeruginosa fl-aħħar tal-kura (Jum 28) u 75.2% (n = 76) kienu ħielsa minn P. aeruginosa xahar wara l-aħħar tal-kura (Jum 56).
English: Do not put other medicinal products in the Altera Nebuliser Handset.
Maltese: Tpoġġix prodotti mediċinali oħrajn fl-Altera Nebuliser Handset.
English: Put the prepared Cayston solution in the Altera Nebuliser Handset (see below).
Maltese: Poġġi s-soluzzjoni ppreparata ta' Cayston fl-Altera Nebuliser Handset (ara hawn taħt).
English: EU/1/09/543/002: 28-day pack of Cayston plus one Altera Nebuliser Handset
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/543/002: pakkett ta' 28 jum ta' Cayston flimkien ma' Altera Nebuliser Handset wieħed
English: Cayston should only be used with the Altera Nebuliser Handset and Altera Aerosol Head connected to an eBase Controller or an eFlow rapid Control Unit.
Maltese: Cayston għandu jintuża biss ma' Altera Nebuliser Handset u Altera Aerosol Head ikkonnettjata ma' eBase Controller jew eFlow rapid Control Unit.
English: Use the prepared solution within 8 hours.
Maltese: Uża s-soluzzjoni ppreparata fi żmien 8 sigħat.
English: The development of antibiotic-resistant P. aeruginosa and superinfection with other pathogens represent potential risks associated with antibiotic therapy.
Maltese: L-iżvilupp ta' P. aeruginosa reżistenti għall-antibijotiċi u superinfezzjoni b'patoġeni oħra, tirrappreżenta riskji potenzjali assoċjati ma' terapija antibijotika.
English: Short acting bronchodilators can be taken between 15 minutes and 4 hours and long acting bronchodilators can be taken between 30 minutes and 12 hours prior to each dose of Cayston.
Maltese: Bronkodilaturi li jaħdmu għal ftit ħin jistgħu jittieħdu bejn 15-il minuta u 4 sigħat u bronkodilaturi li jaħdmu għal ħin twil jistgħu jittieħdu bejn 30 minuta u 12-il siegħa qabel kull doża ta' Cayston.
English: Cayston may be taken in repeated cycles of 28 days on therapy followed by 28 days off Cayston therapy.
Maltese: Cayston jista' jittieħed f'ċikli ripetuti ta' 28 jum fuq terapija segwiti minn 28 jum mingħajr terapija b'Cayston.
English: Aztreonam
Maltese: Anzjani
English: Musculoskeletal and connective tissue disorders: Common:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi:
English: Resistance to aztreonam, other antibiotics and treatment-emergent microorganisms
Maltese: Reżistenza għal aztreonam, antibijotiċi oħrajn u mikroorganiżmi li joħorġu mill-kura
English: How to store Cayston
Maltese: Solvent for Cayston
English: A total of 79 patients who completed a 28-day treatment course and who did not receive an additional antipseudomonal antibiotic during the treatment period were evaluable 6 months after the end of treatment; of these, 58.2% (n = 46) remained free of P. aeruginosa throughout this time period.
Maltese: Total ta' 79 pazjent li komplew kors ta' kura ta' 28 jum u li ma rċivewx antibijotiku antipsewdomonali addizzjonali matul il-perjodu ta' kura setgħu jiġu evalwati 6 xhur wara t-tmiem tal-kura; minn dawn, 58.2% (n = 46) baqgħu ħielsa minn P. aeruginosa matul dan il-perjodu ta' żmien kollu.
English: After reconstitution, each ml of the nebuliser solution contains 75 mg aztreonam (as lysine).
Maltese: Wara r-rikostituzzjoni, kull ml tas-soluzzjoni għan-nebulizzatur ikun fiha 75 mg ta' aztreonam (bħala lysine).
English: In studies of up to nine 28-day courses of Cayston therapy, no increases of clinical significance were observed in the treatment-emergent isolation of other gram-negative bacterial respiratory pathogens (Burkholderia species, Stenotrophomonas maltophilia and Alcaligenes species).
Maltese: Fi studji li saru fuq sa disa' korsijiet ta' 28 jum bit-terapija ta' Cayston, l-ebda żidiet ta' rilevanza klinika ma ġew osservati fl-iżolament li joħroġ mill-kura ta' patoġeni respiratorji batterjali gramnegattivi (speċi Burkholderia, Stenotrophomonas maltophilia u l-ispeċi Alcaligenes).
English: - The solvent ampoule contains water for injections and sodium chloride.
Maltese: - L-ampulla bis-solvent fiha ilma għall-injezzjonijiet u sodium chloride.
English: In contrast, the serum concentration of aztreonam following administration of aztreonam for injection (500 mg) is approximately 54 µg/ml.
Maltese: B'kuntrast ma' dan, il-konċentrazzjoni fis-serum ta' aztreonam wara l-għoti ta' aztreonam għallinjezzjoni (500 mg) hi ta' madwar 54 µg/ml.
English: - Do not put other medicines in the Altera Nebuliser Handset.
Maltese: - Tpoġġix mediċini oħra fl-Altera Nebuliser Handset.
English: Pour all of the prepared Cayston from the vial into the Altera Nebuliser Handset medicine reservoir (Figure 3a).
Maltese: 3. Ferra' l-Cayston kollu ppreparat minn ġol-kunjett għal ġol-kontenitur tal-mediċina tal-Altera Nebuliser Handset (Figura 3a).
English: Patients participating in these studies could subsequently receive multiple courses of Cayston in an open-label follow-on study (CP-AI-006).
Maltese: Il-pazjenti li kienu qed jipparteċipaw f'dawn l-istudji setgħu sussegwentement jirċievu aktar minn kors wieħed ta' Cayston fi studju open-label follow-on (CP-AI-006).
English: The occurrence of rash may be indicative of an allergic reaction to aztreonam.
Maltese: L-okkorrenza ta' raxx tista' tindika reazzjoni allerġika għal aztreonam.
English: There is a risk that P. aeruginosa isolates may develop resistance to aztreonam or other beta-lactam antibiotics in patients treated with Cayston.
Maltese: Hemm riskju li iżolati ta' P. aeruginosa jistgħu jiżviluppaw reżistenza għal aztreonam jew antibijotiċi beta-lactam oħrajn f'pazjenti kkurati b'Cayston.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (Outer carton containing one 28-day pack of Cayston and one Altera Nebuliser Handset with a Blue Box)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA (Kartuna ta' barra li fiha pakkett wieħed ta' 28 jum ta' Cayston u Altera Nebuliser Handset wieħed b' Blue Box)
English: The Kaplan-Meier estimates for this event rate at week 24 were 36% in aztreonamtreated patients and 54% in TNS-treated patients.
Maltese: L-istimi Kaplan-Meier għal din ir-rata ta' avvenimenti f'ġimgħa 24 kienu 36% f'pazjenti kkurati b'aztreonam u 54% f'pazjenti kkurati b'TNS.