FrancophonIA/ELRC3.0 huggingface dataset:
English: With regards to pregnancy and lactation, although data is limited there is no evidence of teratogenic or embryotoxic effects of metamizole when used during the 1st trimester.
Maltese: Fir-rigward tat-tqala u t-treddigħ, għalkemm id-data hija limitata, m'hemm l-ebda evidenza ta' effetti teratoġeniċi jew embrijotossiċi ta' metamizole meta jintuża waqt l-1 trimestru.
English: Whilst metamizolecontaining medicinal products were withdrawn in several European countries and also in the USA due to the risk of agranulocytosis, in other countries such as Spain, Poland and Germany, metamizole is frequently used.
Maltese: Filwaqt li l-prodotti mediċinali li fihom metamizole ġew irtirati f'diversi pajjiżi Ewropej u wkoll fl-Istati Uniti tal-Amerika minħabba r-riskju ta' agranuloċitożi, f'pajjiżi oħra bħal Spanja, il-Polonja u l-Ġermanja, metamizole jintuża ta' spiss.
English: The recommended oral single dose in adults and adolescents aged 15 years or over is also 500 to 1,000 mg. A single dose can be taken up to 4 times daily at intervals of 6-8 hours leading to a maximum daily dose of 4,000 mg.
Maltese: Id-doża waħda orali rakkomandata f'adulti u adolexxenti li għandhom 15-il sena jew aktar hija wkoll 500 sa 1 000 mg.
English: Poland considered that it is in the interests of the Union to harmonise the information regarding maximum daily dose and contraindications in pregnancy and breastfeeding in the product information of all metamizole-containing medicinal products in the EU.
Maltese: Il-Polonja kkunsidrat li huwa fl-interessi tal-Unjoni li tarmonizza l-informazzjoni dwar id-doża massima ta' kuljum u l-kontraindikazzjonijiet fit-tqala u t-treddigħ fl-informazzjoni dwar il-prodott tal-prodotti kollha li fihom metamizole fl-UE.
English: Article 31 of Directive 2001/83/EC for metamizole-containing medicinal products
Maltese: • Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għall-prodotti mediċinali li fihom metamizole.
English: Current indications for metamizole (as single ingredient) include acute severe pain after trauma or surgery, painful colic, tumour pain, other acute or chronic pain, if other therapeutic measures are contraindicated, and high fever, not responding to other measures.
Maltese: Indikazzjonijiet attwali għal metamizole (bħala ingredjent uniku) jinkludu uġigħ sever akut wara trawma jew kirurġija, kolika bl-uġigħ, uġigħ tat-tumur, uġigħ akut jew kroniku ieħor, jekk jiġu kontraindikati miżuri terapewtiċi oħra, u deni għoli, li ma jirrispondux għal miżuri oħra.
English: • The Committee considered the identified divergences in the product information of metamizole containing medicinal products, relating to the maximum daily dose and the use of metamizole in pregnancy and breastfeeding.
Maltese: • Il-Kumitat ikkunsidra d-diverġenzi identifikati fl-informazzjoni dwar il-prodott tal-prodotti mediċinali li fihom metamizole, fir-rigward tad-doża massima ta' kuljum u l-użu ta' metamizole fit-tqala u t-treddigħ.
English: • The Committee concluded that the posology recommendations for metamizole-containing medicinal products should be harmonised.
Maltese: • Il-Kumitat ikkonkluda li r-rakkomandazzjonijiet dwar pożoloġija għall-prodotti mediċinali li fihom metamizole għandhom jiġu armonizzati.
English: Metamizole has been associated with agranulocytosis and anaphylactic shock.
Maltese: Metamizole ġie assoċjat ma' agranuloċitożi u xokk anafilattiku.
English: This single dose can be taken up to 4 times daily at intervals of 6-8 hours.
Maltese: Din id-doża waħda tista' tittieħed sa 4 darbiet kuljum f'intervalli ta' 68 sigħat.
English: It is available as monocomponent but also available in several combination products.
Maltese: Dan jiġi bħala monokomponent iżda huwa jiġi wkoll f'diversi prodotti ta' kombinazzjoni.
English: Age appropriate formulations (oral drops, solution for injection) are available.
Maltese: Hemm disponibbli formulazzjonijiet xierqa għall-età (taqtir orali, soluzzjoni għall-injezzjoni).
English: Via Palermo, 26/A 43122 Parma
Maltese: Via Palermo, 26/A 43122 Parma L-Italja
English: (See sections 4.2 and 5.3.)
Maltese: (Ara sezzjonijiet 4.2 u 5.3.)
English: c Tested using alpha of 0.05.
Maltese: c Ittestjat bl-użu ta' alpha ta' 0.05.
English: • Epilepsy.
Maltese: • Epilessija.
English: Anorexia*
Maltese: Anoreksja*
English: Secondary endpoints:
Maltese: Punti aħħarin sekondarji:
English: b LS Mean (SE).
Maltese: b Medja ta' LS (SE).
English: Anxiety*, Depression*
Maltese: Ansjetà*, Depressjoni*
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26/03/2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 26/03/2015
English: - Depression or mental health problems.
Maltese: - Depressjoni jew problemi ta' saħħa mentali.
English: 500 mg Oral QD*
Maltese: 500 mg Orali QD*
English: Convulsion, Paraesthesia
Maltese: Konvulżjoni, Parasteżija
English: P = 0.0026 c
Maltese: P = 0.0026 ċ
English: Pharmacokinetic parameter
Maltese: Parametru farmakokinetiku
English: and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
Maltese: IA u III, antidepressanti triċikliċi, makrolidi, mediċini antipsikotiċi).
English: Bronchodilators;
Maltese: Bronkodilaturi;
English: LS mean [95% CI]: 1.86 [-0.66, 4.39] c
Maltese: Medja ta' LS [95% CI]: 1.86 [-0.66, 4.39] ċ
English: Treatment Difference a
Maltese: Differenza fil-Kura a
English: Patients with glucose-6-phosphate dehydrogenase deficiency
Maltese: Pazjenti b'defiċjenza ta' glucose-6-phosphate dehydrogenase
English: Vitamin K antagonists
Maltese: Antagonisti ta' vitamina K
English: Oral fungal infection
Maltese: Infezzjoni fungali orali
English: INFORMATION IN BRAILLE Quinsair
Maltese: INFORMAZZJONI BIL-BRAILLE Quinsair
English: Visual disturbance*
Maltese: Disturbi tal-vista*
English: LS mean [95% CI]:
Maltese: Medja ta' LS [95% CI]:
English: Confusional state, Nervousness
Maltese: Stat ta' konfużjoni, Nervożità
English: Prevention of photosensitisation
Maltese: Prevenzjoni ta' fotosensitizzazzjoni
English: Levofloxacin is an antibacterial agent of the fluoroquinolone class and is the S (-) enantiomer of the racemic active substance ofloxacin.
Maltese: Levofloxacin hu mediċina antibatterika tal-klassi fluoroquinolone u hu l-S(-)enantiomer tas-sustanza attiva raċemika ofloxacin.
English: Respiratory domain of Cystic Fibrosis Questionnaire - Revised (CFQ-R)
Maltese: Dominju respiratorju talKwestjonarju dwar il-Fibrożi Ċistika - Rivedut (CFQ-RCystic Fibrosis QuestionnaireRevised)
English: Photosensitisation has been reported with levofloxacin (see section 4.8).
Maltese: Fotosensitizzazzjoni ġiet irrappurtata b'levofloxacin (ara sezzjoni 4.8).
English: Arthralgia, Myalgia*
Maltese: Artralġja, Mijalġja*
English: Ventricular tachycardia, Ventricular arrhythmia and torsade de pointes
Maltese: Takikardja ventrikulari, Arritmija ventrikulari u torsade de pointes
English: The renal clearance of levofloxacin was reduced by cimetidine (24%) and probenecid (34%).
Maltese: It-tneħħija mill-kliewi ta' levofloxacin tnaqqset minn cimetidine (24%) u probenecid (34%).
English: Stevens-Johnson syndrome,
Maltese: Nekrolisi epidermali tossika, Sindrome ta' StevensJohnson,
English: Other relevant information
Maltese: Informazzjoni rilevanti oħra
English: Exacerbation of myasthenia gravis
Maltese: Aggravament ta' mijastenija gravis
English: Tabulated list of adverse reactions reported with Quinsair
Maltese: Lista tabulata ta' reazzjonijiet avversi rrappurtati bi Quinsair
English: Final study report - by Q2 2022.
Maltese: Q2 2022.
English: The frequency categories are defined using the following convention: 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); and not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma definiti bl-użu tal-konvenzjoni li ġejja: 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: Currently available data are described in sections 4.8, 5.1, 5.2 and 5.3 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 4.8, 5.1, 5.2 u 5.3 imma l-ebda rakkomandazzjoni dwar ilpożoloġija ma tista' tingħata.
English: Elderly patients (≥ 65 years old)
Maltese: Pazjenti anzjani (≥ 65 sena)
English: Pivotal Study - Study 209 (Core Phase; ITT)
Maltese: Studju Importanti Ħafna - Studju 209 (Fażi Ewlenija; ITT)
English: Rhabdomyolysis, Tendon rupture, Ligament rupture, Muscle rupture, Arthritis
Maltese: Rabdomijolosi, Tiċrit tat-tendins, Tiċrit tal-ligamenti, Tiċrit tal-muskoli, Artrite
English: N = 93 90.5 days
Maltese: N = 93 90.5 jum
English: In vitro studies demonstrated that inhibition of the key transporters associated with drug disposition in the kidney (organic anion-transporting polypeptide-1B1 (OATP1B1), OATP1B3, organic anion transporter-1 (OAT1), OAT3 and organic cationic transporter-2 (OCT2)) at exposures following inhalation of 240 mg levofloxacin twice daily is low.
Maltese: Interazzjonijiet medjati mill-effetti fuq it-trasportaturi Studji in vitro wrew li l-inibizzjoni tat-trasportaturi ewlenin assoċjati mad-dispożizzjoni tal-mediċina fil-kliewi (organic anion-transporting polypeptide-1B1 (OATP1B1), OATP1B3, organic anion transporter-1 (OAT1), OAT3 u organic cationic transporter-2 (OCT2)) f'esponimenti wara l-ġbid man-nifs ta' 240 mg ta' levofloxacin darbtejn kuljum hi baxxa.
English: Pancytopenia*, Agranulocytosis*, Haemolytic anaemia*
Maltese: Panċitopenija*, Agranuloċitożi*, Anemija emolitika*
English: Tachycardia*
Maltese: Takikardija*
English: - Vision problems
Maltese: - Problemi tal-vista
English: Study 207 (ITT)
Maltese: Studji ta' appoġġ Studju 207 (ITT)
English: Musculoskeletal and connective tissue disorders1
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi1
English: LS Mean (SE) Treatment Difference at Day 28 [95% CI] b
Maltese: Differenza fil-Kura f'Jum 28 [95% CI] b
English: * See paragraph below for further details.
Maltese: * Ara l-paragrafu t'hawn taħt għal dettalji addizzjonali.
English: Quinsair contains an antibiotic medicine called levofloxacin.
Maltese: Quinsair fih mediċina antibijotika msejħa levofloxacin.
English: 3.56 micrometres (1.51 geometric standard deviation); drug delivery rate: 24.86 mg/minute (4.05 standard deviation, SD) and total drug delivered: 236.1 mg (7.1 SD).
Maltese: 24.86 mg/minuta (4.05 devjazzjoni standard, SD) u total ta' mediċina fornuta: 236.1 mg (7.1 SD).
English: 56 (14 sachets of 4) ampoules.
Maltese: 56 (14-il qartas ta' 4) ampulla.
English: Approximately 30 to 40% of levofloxacin is bound to serum protein.
Maltese: Madwar 30 sa 40% ta' levofloxacin jeħel mal-proteini tas-serum.
English: Median time to pulmonary exacerbation
Maltese: Żmien medjan sa aggravament pulmonari
English: • Cardiac disease (e.g. heart failure, myocardial infarction, bradycardia).
Maltese: • Mard kardijaku (eż. insuffiċjenza tal-qalb, infart mijokardjali, bradikardja).
English: LS mean [95% CI]: P = 0.046 e
Maltese: Medja ta' LS [95% CI]: P=0.046 e
English: Vulvovaginal mycotic infection
Maltese: Infezzjoni mikotika vulvovaġinali
English: Psychiatric disorders1
Maltese: Disturbi psikjatriċi1
English: ≥ 12 to < 18 years, n (%) ≥ 18 years, n (%) FEV1 Percent predicted Baseline mean (SD) Primary endpoint:
Maltese: ≥ 12 sa < 18-il sena, n (%) ≥ 18-il sena, n (%) Perċentwali mbassra ta' FEV1 Medja fil-linja bażi (SD) Punt aħħari primarju:
English: 3 ml, Low density polyethylene ampoule.
Maltese: Ampulla ta' 3 ml ta' polyethylene b'densità baxxa.
English: Nervous system disorders1
Maltese: Disturbi fis-sistema nervuża1
English: Bronchodilators
Maltese: Bronkodilaturi
English: The parameters associated with the antibacterial effects of levofloxacin are the Cmax/MIC and AUC/MIC ratios (Cmax = maximum concentration at the site of infection, AUC = area under the curve and MIC = minimal inhibitory concentration).
Maltese: Il-parametri assoċjati mal-effetti antibatteriċi ta' levofloxacin huma l-proporzjonijiet tas-Cmax/MIC u AUC/MICs (Cmax = konċentrazzjoni massima fis-sit tal-infezzjoni, AUC = erja taħt il-kurva u MIC = konċentrazzjoni inibitorja minima).
English: N = 93 110 days
Maltese: N = 93 110 jum
English: - A severe allergic reaction.
Maltese: - Reazzjoni allerġika severa.
English: This should be connected to either an eBase Controller or an eFlow rapid Control Unit.
Maltese: Dan għandu jiġi kkonnettjat jew ma' eBase Controller jew ma' eFlow rapid Control Unit.
English: Clinical pharmacology studies have shown that the pharmacokinetics of levofloxacin were not affected to any clinically relevant extent when levofloxacin was administered together with the following active substances: calcium carbonate, digoxin, glibenclamide and ranitidine.
Maltese: Studji farmakoloġiċi kliniċi wrew li l-farmakokinetika ta' levofloxacin ma ġietx affettwata bi kwalunkwe mod klinikament rilevanti meta levofloxacin ingħata flimkien mas-sustanzi attivi li ġejjin: calcium carbonate, digoxin, glibenclamide u ranitidine.
English: Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis (CF, see section 5.1).
Maltese: Quinsair hu indikat għall-immaniġġjar ta' infezzjonijiet pulmonari kroniċi minħabba Pseudomonas aeruginosa f'pazjenti adulti b'fibrożi ċistika (cystic fibrosis, CF, ara sezzjoni 5.1).
English: Following oral and intravenous administration, levofloxacin is eliminated relatively slowly from the plasma (t1/2: 6 to 8 hours).
Maltese: Wara l-għoti orali u ġol-vini, levofloxacin jiġi eliminat relattivament bil-mod mill-plażma (t1/2: 6 sa 8 sigħat).
English: • Uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia).
Maltese: • Żbilanċ mhux ikkoreġut tal-elettroliti (eż. ipokalemija, ipomanjesemija).
English: Ciclosporin The half-life of ciclosporin was increased by 33% when coadministered with levofloxacin.
Maltese: Ciclosporin Il-half-life ta' ciclosporin żdiedet bi 33% meta ngħata flimkien ma' levofloxacin.
English: - Superinfections
Maltese: - Superinfezzjonijiet
English: Pharmacotherapeutic group: antibacterials for systemic use, fluoroquinolones ATC code: J01MA12
Maltese: Kategorija farmakoterapewtika: antibatteriċi għal użu sistemiku, fluoroquinolones Kodiċi ATC:
English: Baseline to Day 28 of Cycle 1
Maltese: Linja bażi sa Jum 28 ta' Ċiklu 1
English: Hazard ratio [95% CI] d: P = 0.154 e
Maltese: Proporzjon ta' periklu [95% CI] d: P = 0.154 e
English: 56 (14 sachets of 4) ampoules
Maltese: 56 (14-il qartas ta' 4) ampulla
English: An in vitro study indicated a low potential for interaction between levofloxacin and CYP2C9 substrates.
Maltese: Substrati ta' CYP2C9 Studju in vitro indika potenzjal baxx għal interazzjoni bejn levofloxacin u substrati ta' CYP2C9.
English: N = 189 141 days
Maltese: N = 189 141 jum
English: Cumulative intermediate analyses - annually.
Maltese: Analiżijiet intermedji kumulattivi - kull sena.
English: Levofloxacin is metabolised to a very small extent, the metabolites being desmethyl-levofloxacin and levofloxacin N-oxide.
Maltese: Levofloxacin jiġi metabolizzat f'ammont żgħir ħafna, bil-metaboliti li huma desmethyl-levofloxacin u levofloxacin N-oxide.
English: Benign intracranial hypertension
Maltese: Magnesium chloride hexahydrate
English: During the Extension Phase, the LS Mean change for FEV1 percent predicted ranged between 4.83% to 1.46% across the 3 additional treatment cycles.
Maltese: Matul il-Fażi ta' Estensjoni, il-bidla fil-Medja ta' LS għal perċentwali mbassra ta' FEV1 varjat bejn 4.83% sa 1.46% fit-3 ċikli addizzjonali ta' kura.
English: FEV1 percent predicted
Maltese: Perċentwali mbassra ta' FEV1
English: Adult and adolescent (≥ 12 to < 18 years old and weighing ≥ 30 kg) patients who had a FEV1 percent predicted between 25% and 85% were enrolled.
Maltese: Pazjenti adulti u adolexxenti (≥ 12 sa < 18-il sena u li jiżnu ≥ 30 kg) li kellhom perċentwali mbassra ta' FEV1 bejn 25% u 85% ġew irreġistrati.
English: Tendinitis, Costochondritis, Joint stiffness
Maltese: Tendinite, Kostokondrite, Ebusija fil-ġogi
English: What Quinsair contains - The active substance is levofloxacin.
Maltese: X'fih Quinsair - Is-sustanza attiva hi levofloxacin.
English: The most frequently reported adverse reactions were cough/productive cough (54%), dysgeusia (30%) and fatigue/asthenia (25%).
Maltese: L-iktar reazzjonijiet avversi li ġew irrappurtati b'mod frekwenti kienu sogħla/sogħla produttiva (54%), indeboliment fis-sens tat-togħma (30%) u għeja/astenja (25%).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/973/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/973/001
English: Retching, Dyspepsia*, Flatulence*
Maltese: Dardir, Dispepsija*, Gass*
English: Patients weighing 22 to 30 kg received 180 mg levofloxacin/day and patients weighing ˃ 30 kg received 240 mg levofloxacin/day.
Maltese: Pazjenti li kienu jiżnu 22 sa 30 kg irċivew 180 mg ta' levofloxacin/jum u pazjenti li kienu jiżnu > 30 kg irċivew 240 mg ta' levofloxacin/jum.
English: • Hypersensitivity to the active substance, other quinolones or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva, quinolones oħrajn jew għal kwalunkwe wieћed mill eċċipjenti elenkati fis-sezzjoni 6.1.
English: a ANCOVA with terms for treatment, region, age (16 to 18 years, > 18 years), and baseline FEV1 percent predicted as quartiles.
Maltese: a ANCOVA b'termini għall-kura, reġjun, età (16 sa 18-il sena, > 18-il sena), u perċentwali mbassra fil-linja bażi ta' FEV1 bħala quartiles.
English: ≥ 12 to < 18 years, n (%) ≥ 18 years, n (%) Baseline mean (SD) Relative change from Baseline to Day 28
Maltese: ≥ 12 sa < 18-il sena, n (%) ≥ 18-il sena, n (%) Medja fil-linja bażi (SD) Bidla relattiva mil-linja bażi sa Jum 28
English: Quinsair is administered by inhalation over a 5 minute period using a Quinsair specific Zirela Nebuliser Handset and Zirela Aerosol Head connected to an eBase Controller or an eFlow rapid Control Unit (see section 4.2).
Maltese: Quinsair jingħata permezz ta' ġbid man-nifs fuq perjodu ta' 5 minuti bl-użu ta' Sett tal-Idejn tanNebulizzatur Zirela speċifiku u Zirela Aerosol Head ikkonnettjata ma' eBase Controller jew eFlow rapid Control Unit (ara sezzjoni 4.2).
English: Cases of severe bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with systemic administration of levofloxacin (see section 4.8).
Maltese: Każijiet ta' reazzjonijiet severi bullużi tal-ġilda bħas-sindrome ta' Stevens-Johnson jew nekrolisi epidermali tossika ġew irrappurtati bl-għoti sistemiku ta' levofloxacin (ara sezzjoni 4.8).
English: The mean post-dose sputum concentrations were approximately 500-1900 µg/ml and were approximately 400-1700 times higher than those observed in serum.
Maltese: Il-medja tal-konċentrazzjonijiet fl-isputum wara d-doża kienu madwar 500-1900 µg/ml u kienu madwar 400-1700 darba ogħla minn dawk osservati fis-serum.
English: IV = intravenous; QD = quaque die (once a day); BID = bis in die (twice a day) * Predicted value from population PK analysis in CF patients ** Healthy males 18-53 years old
Maltese: QD = quaque die (darba kuljum); BID = bis in die (darbtejn kuljum) * Valur imbassar minn analiżi PK tal-popolazzjoni f'pazjenti b'CF ** Irġiel b'saħħithom li kellhom 18-53 sena
English: N = 189 131 days
Maltese: N = 189 131 jum
English: In a pharmacokinetic interaction study, levofloxacin did not affect the pharmacokinetics of theophylline (which is a probe substrate for CYP1A2) indicating that levofloxacin is not a CYP1A2 inhibitor.
Maltese: Fi studju dwar interazzjonijiet farmakokinetiċi, levofloxacin ma affettwax il-farmakokinetika ta' theophylline (li hu substat sonda għal CYP1A2), u dan jindika li levofloxacin mhuwiex inibitur ta' CYP1A2.
English: What if I am using several different inhalers and other therapies for cystic fibrosis?
Maltese: X'jiġri jekk inkun qed nuża diversi inalaturi differenti u terapiji oħrajn għal fibrożi ċistika?
English: The proportion of patients who received Quinsair throughout Study 209 Core and Extension Phases (with a highest levofloxacin MIC P. aeruginosa isolate exceeding 1 µg/ml) was similar at the end of treatment during Cycles 1 and 3 in the Core Phase (76.6% to 83.3%) and at the end of treatment during Cycles 4 to 6 in the Extension Phase (77.8% to 87.5%).
Maltese: MIC P. aeruginosa li kien jaqbeż 1 µg/ml kien simili fit-tmiem tal-kura matul Ċikli 1 u 3 fil-Fażi Ewlenija (76.6% sa 83.3%) u fit-tmien tal-kura matul Ċikli 4 sa 6 fil-Fażi ta' Estensjoni (77.8% sa 87.5%).
English: The mechanism of action of levofloxacin and other fluoroquinolone antimicrobials involves inhibition of bacterial DNA gyrase and topoisomerase IV enzymes.
Maltese: Il-mekkaniżmu ta' azzjoni ta' levofloxacin u antimikrobjali fluoroquinolone oħrajn jinvolvi l-inibizzjoni ta' enzimi batteriċi DNA gyrase u topoisomerase IV.
English: N = 93 0.38 (1.262) b
Maltese: N = 93 0.38 (1.262)
English: A total of 259 patients were randomised to Quinsair 240 mg twice daily for 28 days (≥ 18 years, n = 226; ≥ 12 to < 18 years old, n = 33) and 147 were randomised to placebo (≥ 18 years, n = 127; ≥ 12 to < 18 years old, n = 20).
Maltese: Total ta' 259 pazjent intgħażlu b'mod każwali għal Quinsair 240 mg darbtejn kuljum għal 28 jum (≥ 18-il sena, n = 226; ≥ 12 sa < 18-il sena, n = 33) u 147 intgħażlu b'mod każwali għal plaċebo (≥ 18-il sena, n = 127; ≥ 12 sa < 18-il sena, n = 20).
English: In clinical trials, 51 adolescents with CF (≥ 12 to < 18 years old) received Quinsair 240 mg twice daily and 6 adolescents with CF received Quinsair 120 mg (n = 3) or 240 mg (n = 3) once daily.
Maltese: Fil-provi kliniċi, 51 adolexxent b'CF (≥ 12 sa < 18-il sena) irċivew Quinsair 240 mg darbtejn kuljum, u 6 adolexxenti b'CF irċivew Quinsair 120 mg (n = 3) jew 240 mg (n = 3) darba kuljum.
English: Bronchospasm**, Bronchial hyper-reactivity, Obstructive airways disorder
Maltese: Bronkospażmu**, Reattività eċċessiva tal-bronki, Disturb ta' ostruzzjoni talpassaġġ tan-nifs
English: Systemic levofloxacin
Maltese: Levofloxacin sistemiku
English: Tinnitus*
Maltese: Stitikezza*
English: Two randomised, double-blind, single-cycle, placebo-controlled clinical trials (Studies 204 and 207) in patients with CF chronically infected with P. aeruginosa were conducted.
Maltese: Twettqu żewġ provi kliniċi li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, b'ċiklu wieħed, ikkontrollati bi plaċebo (Studji 204 u 207) f'pazjenti b'CF infettati b'mod kroniku b'P. aeruginosa.
English: (Note: In Study 204, an additional 38 patients were randomised to Quinsair 120 mg once daily (≥ 18 years, n = 35; ≥ 16 to < 18 years old, n = 3) and an additional 37patients were randomised to Quinsair 240 mg once daily (≥ 18 years, n = 34; ≥ 16 to < 18 years old, n = 3).)
Maltese: (Nota: Fi Studju 204, 38 pazjent addizzjonali ntgħażlu b'mod każwali biex jieħdu Quinsair 120 mg darba kuljum (≥ 18-il sena, n = 35; ≥ 16 sa < 18-il sena, n = 3) u 37 pazjent addizzjonali ntgħażlu b'mod każwali biex jieħdu Quinsair 240 mg darba kuljum (≥ 18-il sena, n = 34; ≥ 16 sa < 18-il sena, n = 3).)
English: Tendinitis was reported in patients with CF receiving Quinsair as an uncommon adverse reaction during clinical trials (see section 4.8).
Maltese: Tendinite ġiet irrappurtata f'pazjenti b'CF li kien qed jirċievu Quinsair bħala reazzjoni avversa mhux komuni matul il-provi kliniċi (ara sezzjoni 4.8).
English: Levofloxacin is systemically absorbed following inhalation of Quinsair and eliminated similarly to levofloxacin following systemic administration.
Maltese: Levofloxacin jiġi assorbit sistematikament wara l-ġbid man-nifs ta' Quinsair, u jiġi eliminat b'mod simili bħal levofloxacin wara l-għoti sistemiku.
English: - Kidney problems.
Maltese: - Problemi tal-kliewi.