FrancophonIA/ELRC3.0 huggingface dataset:
English: However, dose adjustments were not employed in clinical studies of Quinsair which allowed for the inclusion of patients with mild to moderate renal impairment (estimated creatinine clearance ≥ 20 ml/min using the Cockcroft-Gault formula in adult patients and ≥ 20 ml/min/1.73 m2 using the Bedside Schwartz formula in patients < 18 years old).
Maltese: Madankollu, ma ntużawx aġġustamenti fid-doża fl-istudji kliniċi ta' Quinsair, u dan ippermetta l-inklużjoni ta' pazjenti b'indeboliment ħafif sa moderat tal-kliewi (tneħħija stmata tal-kreatinina ta' ≥ 20 ml/min bl-użu tal-formula ta' Cockroft-Gault f'pazjenti adulti u ta' ≥ 20 ml/min/1.73 m2 bl-użu tal-formula ta' Bedside Schwartz f'pazjenti li kellhom < 18-il sena).
English: Study 209 (Core Phase) was a randomised, open-label, parallel group, active-controlled, non-inferiority study comparing Quinsair to tobramycin inhalation solution (TIS) over 3 treatment cycles.
Maltese: Studju 209 (Fażi Ewlenija) kien studju li fih l-individwi ntgħażlu b'mod każwali, open-label, grupp parallel, ikkontrollat b'mod attiv, ta' noninferjorità, li qabbel Quinsair ma' soluzzjoni ta' tobramycin biex tinġibed man-nifs (TIS) fuq 3 ċikli ta' kura.
English: You should not take fluoroquinolone/quinolone antibacterial medicines, including Quinsair, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone.
Maltese: M'għandekx tieħu mediċini antibatteriċi fluoroquinolones/quinolones, inkluż Quinsair, jekk qatt kellek xi reazzjoni avversa serja fil-passat meta ħadt quinolone jew fluoroquinolone.
English: Rare (≥ 1/10,000 to
Maltese: Rari (≥ 1/10,000 sa < 1/1,000)
English: 2) Squeeze all of the contents of one ampoule into the medicine reservoir of the Zirela Nebuliser Handset (Figure 1).
Maltese: 2) Agħfas il-kontenut kollu ta' ampulla waħda ġol-kontenitur tal-mediċina tas-Sett tal-Idejn tan-Nebulizzatur Zirela (Figura 1).
English: The development of fluoroquinolone-resistant P. aeruginosa and superinfection with fluoroquinolone-insusceptible microorganisms represent potential risks associated with the use of Quinsair.
Maltese: L-iżvilupp ta' P. aeruginosa reżistenti għal fluoroquinolone u superinfezzjoni b'mikroorganiżmi li mhumiex suxxettibbli għal fluoroquinolone, jirrappreżenta riskji potenzjali assoċjati mal-użu ta' Quinsair.
English: Urticaria*, Pruritus*
Maltese: Urtikarja*, Ħakk*
English: A total of 189 patients were randomised to Quinsair 240 mg twice daily (≥ 18 years, n = 170; ≥ 12 to < 18 years old, n = 19) and 93 were randomised to TIS (≥ 18 years, n = 84; ≥ 12 to < 18 years old, n = 9).
Maltese: Total ta' 189 pazjent intgħażlu b'mod każwali biex jieħdu Quinsair 240 mg darbtejn kuljum (≥ 18-il sena, n = 170; ≥ 12 sa < 18-il sena, n = 19) u 93 pazjent intgħażlu b'mod każwali biex jieħdu TIS (≥ 18-il sena, n = 84; ≥ 12 sa < 18-il sena, n = 9).
English: The apparent clearance (CL/F) of levofloxacin following inhalation of Quinsair 240 mg twice daily is 31.8 +/- 22.4 L/hour.
Maltese: It-tneħħija apparenti (CL/F) ta' levofloxacin wara l-ġbid man-nifs ta' Quinsair 240 mg darbtejn kuljum hi ta' 31.8 +/- 22.4
English: On the front of the ampoule tail Quinsair 240 mg
Maltese: Fuq in-naħa ta' quddiem tad-denb tal-ampulla Quinsair 240 mg
English: In Studies 204, 207 and 209, the relative change in FEV1 percent predicted from baseline to the end of treatment in Cycle 1 was of similar magnitude in the 51 adolescents with CF (≥ 12 to < 18 years old and weighing ≥ 30 kg) receiving Quinsair 240 mg twice daily to that in adults.
Maltese: Fi Studji 204, 207 u 209, il-bidla relattiva fil-perċentwali mbassra ta' FEV1 mil-linja bażi sat-tmiem tal-kura f'Ċiklu 1 kienet simili fil-kobor fil-51 adolexxent b'CF (≥ 12 sa < 18-il sena u jiżnu ≥ 30 kg) li kienu qed jirċievu Quinsair 240 mg darbtejn kuljum milli dik fl-adulti.
English: For the subgroup of patients who received TIS during the Core Phase and switched to Quinsair in the Extension Phase, the improvement in FEV1 percent predicted was more marked on Quinsair than on TIS (LS Mean change in FEV1 percent predicted on TIS ranged between 0.97% to 3.60% across Cycles 1 to 3 and between 4.00% to 6.91% across Cycles 4 to 6 on Quinsair).
Maltese: Għas-sottogrupp ta' pazjenti li rċivew TIS matul il-Fażi Ewlenija u qalbu għal Quinsair fil-Fażi ta' Estensjoni, it-titjib fil-perċentwali mbassra ta' FEV1 kien aktar notevoli fuq Quinsair milli fuq TIS (bidla fil-Medja ta' LS fil-perċentwali mbassra f'FEV1 fuq TIS varjat bejn 0.97% sa 3.60% f'Ċikli 1 sa 3 u bejn 4.00% sa 6.91% f'Ċikli 4 sa 6 fuq Quinsair).
English: Elimination is primarily by the renal route (> 85% of the dose following oral or intravenous administration).
Maltese: L-eliminazzjoni sseħħ primarjament permezz tar-rotta renali (> 85% tad-doża wara l-għoti orali jew ġol-vini).
English: Alanine aminotransferase increased, Aspartate aminotransferase increased, Pulmonary function test decreased*, Blood glucose increased and decreased*, Blood creatinine increased* Breath sounds abnormal*
Maltese: Żieda f'alanine aminotransferase, Żieda f'aspartate aminotransferase, Tnaqqis fit-test talfunzjoni pulmonari*, Żieda u tnaqqis talglucose fid-demm*, Żieda fil-kreatinina taddemm*,
English: Psychotic reactions (e.g. hallucination, paranoia), Agitation, Abnormal dreams, Nightmares
Maltese: Reazzjonijiet psikotiċi (eż. alluċinazzjoni, paranojja), Aġitazzjoni,
English: Following systemic administration, levofloxacin obeys linear pharmacokinetics over a range of 50 to 1000 mg.
Maltese: Wara l-għoti sistemiku, levofloxacin jobdi farmakokinetika lineari fuq medda ta' 50 sa 1000 mg.
English: CI = Confidence interval; FEV1 = forced expiratory volume in 1 second; ITT = intent to treat (all patients randomised); P = P value; SD = standard deviation; SE = standard error; ANCOVA = analysis of covariance.
Maltese: ITT = intenzjoni li tikkura (il-pazjenti kollha magħżula b'mod każwali); P = valur P; SD = devjazzjoni standard; SE = żball standard; ANCOVA = analiżi ta' kovarjanza.
English: Via Martin Luther King, 13 20060 Pessano con Bornago (MI) Italy
Maltese: Pessano con Bornago (MI) L-Italja
English: Other medicines and Quinsair
Maltese: Mediċini oħra u Quinsair
English: It belongs to the group of antibiotics called fluoroquinolones.
Maltese: Jappartjeni għall-grupp ta' antibijotiċi msejħa fluoroquinolones.
English: However, at the tested doses in the study, the statistically significant kinetic differences are unlikely to be of clinical relevance.
Maltese: Madankollu, fid-dożi ttestjati fl-istudju, id-differenzi kinetiċi statistikament sinifikanti mhumiex probabbli li jkunu ta' rilevanza klinika.
English: Inhale the contents of one ampoule (240 mg) twice a day using the Zirela Nebuliser System.
Maltese: Iġbed man-nifs il-kontenut ta' ampulla waħda (240 mg) darbtejn kuljum billi tuża s-Sistema tan-Nebulizzatur Zirela.
English: PHARMACEUTICAL FORM AND CONTENTS Nebuliser solution
Maltese: U KONTENUT Soluzzjoni tan-nebulizzatur
English: Peripheral sensory neuropathy, Peripheral sensory motor neuropathy, Dyskinesia, Extrapyramidal disorder,
Maltese: Newropatija sensorjali periferali tal-moviment, Diskinesija,
English: Higher sputum concentrations were observed in adults compared to paediatric patients in Study 207; similar sputum concentrations were observed in adult and paediatric patients in Study 209.
Maltese: Konċentrazzjonijiet ogħla fl-isputum ġew osservati fl-adulti meta mqabbla ma' pazjenti pedjatriċi fi Studju 207; konċentrazzjonijiet simili fl-isputum ġew osservati fl-adulti u f'pazjenti pedjatriċi fi Studju 209.
English: Quinsair should only be used with the Zirela Nebuliser Handset (including a Zirela Aerosol Head) provided in the pack connected to an eBase Controller or an eFlow rapid Control Unit (see section 6.6).
Maltese: Quinsair għandu jintuża biss mal-Sett tal-Idejn tan-Nebulizzatur Zirela (li jinkludi Zirela Aerosol Head) ipprovdut fil-pakkett ikkonnettjat ma' eBase Controller jew eFlow rapid Control Unit (ara sezzjoni 6.6).
English: Table 3: Comparison of mean (SD) multiple dose levofloxacin pharmacokinetic parameters following Quinsair administration by inhalation to patients with CF and following oral and intravenous administration of levofloxacin to healthy adult volunteers
Maltese: Tabella 3: Paragun tal-medja (SD) tal-parametri farmakokinetiċi ta' dożi multipli ta' levofloxacin wara l-għoti ta' Quinsair permezz tal-ġbid man-nifs lil pazjenti b'CF u wara għoti orali u ġol-vini ta' levofloxacin lil voluntiera adulti b'saħħithom
English: Each ampoule contains 240 mg of levofloxacin,
Maltese: Kull ampulla fiha 240 mg ta' levofloxacin,
English: The mean apparent total body clearance of levofloxacin following systemic administration of a 500 mg single dose was 175 +/- 29.2 ml/min.
Maltese: Il-medja tat-tneħħija totali apparenti mill-ġisem ta' levofloxacin wara l-għoti sistemiku ta' doża waħda ta' 500 mg kienet ta' 175 +/- 29.2 ml/min.
English: Tendinitis and tendon rupture
Maltese: Tendinite u tiċrit tat-tendins
English: Clostridium difficile-associated disease
Maltese: Mard assoċjat ma' clostridium difficile
English: - Glucose-6-phosphate dehydrogensae deficiency Quinolone antibiotics, such as Quinsair, can cause patients with glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease) to be prone to blood complications leading to a sudden rise in body temperature, yellowing of the skin and mucous membranes, dark coloured urine, paleness, tiredness, heavy, fast breathing and a weak, rapid pulse.
Maltese: - Defiċjenza ta' glucose-6-phosphate dehydrogenase Antibijotiċi li fihom quinolone, bħal Quinsair, jistgħu jikkawżaw pazjenti b'defiċjenza ta' glucose-6-phosphate dehydrogenase (marda ereditarja rari) li jkunu suxxettibbli għal komplikazzjonijiet tad-demm, u dan iwassal għal żieda f'daqqa fit-temperatura tal-ġisem, sfurija tal-ġilda u tal-membrani mukużi, awrina skura, sfura, għeja, nifs tqil u mgħaġġel, u polz dgħajjef u mgħaġġel.
English: • Congenital long QT syndrome.
Maltese: • Sindrome konġenitali ta' QT twil.
English: The safety of the recommended dose of Quinsair was evaluated in 472 patients with CF from two double-blind, single-cycle, placebo-controlled trials and from an active-comparator study with an optional uncontrolled extension.
Maltese: Is-sigurtà tad-doża rakkomandata ta' Quinsair ġiet evalwata f'472 pazjent b'CF minn żewġ provi double-blind, b'ċiklu wieħed, ikkontrollati bi plaċebo, u minn studju b'komparatur attiv b'estensjoni mhux ikkontrollata mhux obbligatorja.
English: Cross-resistance between levofloxacin and other fluoroquinolones is observed.
Maltese: Ġiet osservata reżistenza inkroċjata bejn levofloxacin u fluoroquinolones oħrajn.
English: Each ampoule contains 240 mg of levofloxacin.
Maltese: Kull ampulla fiha 240 mg ta' levofloxacin.
English: You and your doctor will decide on continuing the treatment considering also an antibiotic from another class.
Maltese: Int u t-tabib tiegħek se tiddeċiedu jekk tkomplix it-trattament b'konsiderazzjoni wkoll ta' antibijotiku minn klassi oħra.
English: Levofloxacin caused no impairment of fertility or reproductive performance in rats (see section 5.3).
Maltese: Levofloxacin ma kkawża l-ebda indeboliment tal-fertilità jew tal-prestazzjoni riproduttiva fil-firien (ara sezzjoni 5.3).
English: The safety and efficacy of Quinsair in children aged ˂ 18 years old have not yet been established (see section 4.2).
Maltese: Is-sigurta u l-effikaċja ta' Quinsair fit-tfal ta' età ta' ˂ 18-il sena ma ġewx determinati s'issa (ara sezzjoni 4.2).
English: Anaemia*, Neutropenia*
Maltese: Anemija*, Newtropenija
English: Transient vision loss
Maltese: Telf temporanju tal-vista
English: 1 Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see section 4.4).
Maltese: 1 Każijiet rari ħafna ta' reazzjonijiet serji tal-mediċina li jdumu fit-tul (sa xhur jew snin), li jinkapaċitaw u potenzjalment irriversibbli, li jaffettwaw diversi klassijiet tas-sistema tal-organi u sensi, kultant multipli, (inklużi reazzjonijiet bħal tendinite, ksur ta' tendins, artralġja, uġigħ fl-estremitajiet, disturb fil-mixi, newropatiji assoċjati ma' parasteżija, depressjoni, għeja, indeboliment fil-memorja, disturbi fl-irqad u indeboliment fissmigħ, vista, togħma u xamm) ġew irrappurtati f'assoċjazzjoni mal-użu ta' quinolones u fluoroquinolones, f'xi każijiet irrispettivament minn fatturi ta' riskju eżistenti minn qabel (ara sezzjoni 4.4).
English: Quinsair is taken in alternating cycles of 28 days on treatment followed by 28 days off treatment.
Maltese: Quinsair jittieħed f'ċikli alternanti ta' 28 jum fuq it-terapija segwiti minn 28 jum mingħajr terapija.
English: - Nerve damage
Maltese: - Ħsara fin-nervaturi
English: Each treatment cycle included 28 days of treatment with Quinsair 240 mg twice daily or TIS 300 mg twice daily followed by 28 days without inhaled antibiotics.
Maltese: Kull ċiklu ta' kura kien jinkludi 28 jum ta' kura bi Quinsair 240 mg darbtejn kuljum jew TIS 300 mg darbtejn kuljum segwiti minn 28 jum mingħajr antibijotiċi li jinġibdu man-nifs.
English: Levofloxacin is primarily excreted unchanged in the urine and metabolism is minimal (see section 5.2).
Maltese: Levofloxacin jitneħħa primarjament mhux mibdul fl-awrina u l-metaboliżmu hu minimu (ara sezzjoni 5.2).
English: Levofloxacin can cause serious, potentially fatal hypersensitivity reactions (e.g. including angioedema and anaphylactic shock).
Maltese: Levofloxacin jista' jikkawża reazzjonijiet ta' sensittività eċċessiva serji u potenzjalment fatali (eż. li jinkludu anġjoedema u xokk anafilattiku).
English: Furthermore, clinical data do not suggest interaction with P-glycoprotein (P-gp) substrates such as digoxin.
Maltese: Barra minn hekk, dejta klinika ma tissuġġerixxix interazzjoni ma' substrati ta' P-glikoproteina (P-gp) bħal digoxin.
English: a Treatment difference for Quinsair minus TIS, or Hazard ratio for Quinsair/TIS.
Maltese: a Differenza fil-kura għal Quinsair nieqes TIS, jew Proporzjon ta' periklu għal Quinsair/TIS.
English: Multiple dose administration of Quinsair 240 mg twice daily by inhalation results in levofloxacin systemic exposure approximately 50% lower than that observed following systemic administration of comparable doses (see Table 3).
Maltese: L-għoti ta' dożi multipli ta' Quinsair 240 mg darbtejn kuljum permezz tal-ġbid man-nifs jirriżulta fi tnaqqis tal-esponiment sistemiku għal levofloxacin ta' madwar 50% milli dak osservat wara l-għoti sistemiku ta' dożi komparabbli (ara Tabella 3).
English: In addition, 14 children with CF (≥ 6 to < 12 years old) and 13 adolescents with CF (≥ 12 to < 17 years old) received Quinsair 180 mg or 240 mg once daily for 14 days.
Maltese: Barra minn hekk, 14-il tifel/tifla b'CF (≥ 6 sa < 12-il sena) u 13-il adolexxent b'CF (≥ 12 sa < 17-il sena) irċivew Quinsair 180 mg jew 240 mg darba kuljum għal 14-il jum.
English: The adverse reactions with at least a reasonable possibility of a causal relationship with levofloxacin are presented according to the MedDRA System Organ Classification.
Maltese: Ir-reazzjonijiet avversi b'mill-inqas possibbiltà raġonevoli ta' relazzjoni kawżali ma' levofloxacin huma ppreżentati skont is-Sistema tal-Klassifika tal-Organi MedDRA.
English: - Ciclosporin (used after organ transplants) or medicines that affect your heart beat (such as antiarrhythmics, tricyclic antidepressants, macrolide antibiotics or antipsychotics).
Maltese: - Ciclosporin (jintuża wara trapjanti tal-organi) jew mediċini li jaffettwaw it-taħbit tal-qalb tiegħek (bħal mediċini antiarritimiċi, antidepressanti triċikliċi, antibijotiċi macrolide jew antipsikotiċi).
English: Women who take these types of medicines may be more likely to be affected.
Maltese: In-nisa li jieħdu dawn it-tipi ta' mediċini jistgħu jkunu aktar probabbli li jiġu affettwati.
English: - Theophylline (used to treat breathing problems) or non-steroidal anti-inflammatory medicines (NSAIDs) such as fenbufen, acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting) or ibuprofen.
Maltese: - Theophylline (jintuża biex jikkura problemi tan-nifs) jew mediċini mhux sterojdi kontra l-infjammazzjoni (non-steroidal anti-inflammatory medicines, NSAIDs) bħal fenbufen, acetylsalicylic acid (sustanza preżenti f'ħafna mediċini li jintużaw biex itaffu l-uġigħ u jbaxxu d-deni, kif ukoll biex jipprevjenu t-tagħqid tad-demm) jew ibuprofen.
English: Quinolone antibiotics, including Quinsair, may cause seizures or convulsions (fits).
Maltese: Antibijotiċi li fihom quinolone, li jinkludu Quinsair, jistgħu jikkawżaw aċċessjonijiet jew konvulżjonijiet (puplesiji).
English: Patients who completed Study 209 (Core Phase) could continue in an optional Extension Phase for 3 additional cycles (i.e. 28 days of treatment with Quinsair 240 mg twice daily followed by 28 days off treatment).
Maltese: Il-pazjenti li temmew Studju 209 (Fażi Ewlenija) setgħu jkomplu f'Fażi ta' Estensjoni mhux obbligatorja għal 3 ċikli addizzjonali (i.e. 28 jum ta' kura bi Quinsair 240 mg darbtejn kuljum segwiti minn 28 jum mingħajr kura).
English: Haemodialysis, including peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD), are not effective in removing levofloxacin from the body.
Maltese: Emodijalisi, li tinkludi dijalisi peritoneali u dijalisi peritoneali ambulatorja kontinwa (continuous ambulatory peritoneal dialysis, CAPD), mhumiex effettivi fit-tneħħija ta' levofloxacin mill-ġisem.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON BOX CONTAINING 56 (14 SACHETS OF 4) AMPOULES
Maltese: U KONTENUT Soluzzjoni tan-nebulizzatur 56 (14-il qartas ta' 4) ampulla
English: Animal studies with levofloxacin do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali b'levofloxacin ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: if you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular EhlersDanlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).
Maltese: jekk għandek storja fil-familja ta' anewriżmu aortiku jew dissezzjoni aortika jew fatturi ta' riskju oħrajn jew kundizzjonijiet li jippredisponu (eż. disturbi tat-tessut konnettiv bħas-sindromu ta' Marfan, jew is-sindromu ta' Ehlers-Danlos vaskulari, jew disturbi vaskulari bħal arterite Takayasu, arterite taċċellula ġganteska, il-marda ta' Behcet, pressjoni għolja, jew aterosklerożi magħrufa).
English: FEV1 Relative change from Baseline to Day 28 of Cycle 3
Maltese: FEV1 Bidla relattiva minn Linja bażi sa Jum 28 ta' Ċiklu 3
English: Levofloxacin did not show any genotoxic potential in a photomutagenicity assay.
Maltese: Levofloxacin ma wera l-ebda potenzjal ġenotossiku f'assaġġ tal-fotomutaġeniċità.
English: FEV1 Relative change from Baseline to Day 28 of Cycle 2
Maltese: FEV1 Bidla relattiva minn Linja bażi sa Jum 28 ta' Ċiklu 2
English: Median time to administration of anti-pseudomonal antimicrobials
Maltese: Żmien medjan sal-għoti ta' antimikrobjali antipsewdomonali
English: - Diarrhoea
Maltese: - Dijarea
English: Pneumonitis allergic
Maltese: Pnewmonite allerġika
English: FEV1 Relative change from Baseline to Day 28 of Cycle 1
Maltese: FEV1 Bidla relattiva minn Linja bażi sa Jum 28 ta' Ċiklu 1
English: Sputum PK exposure in children aged 7 to 16 years old was approximately one-third of adult exposure.
Maltese: L-esponiment PK fis-serum fi tfal li kellhom minn 7 sa 16-il sena kien ta' madwar terz tal-esponiment fl-adulti.
English: The weight-based dosing scheme resulted in consistent serum and sputum PK exposure across the range of ages (7 to 16 years old) and weights (22 to 61 kg) observed in the study.
Maltese: Liskema bbażata fuq il-piż irriżultat f'esponiment PK konsistenti fis-serum u fl-isputum PK fil-meded kollha ta' etajiet (7 sa 16-il sena) u piżijiet (22 sa 61 kg) osservati fl-istudju.
English: The use of levofloxacin should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8).
Maltese: L-użu ta' levofloxacin għandu jiġi evitat f'pazjenti li kellhom reazzjonijiet avversi serji fil-passat meta użaw prodotti li fihom quinolone jew fluoroquinolone (ara sezzjoni 4.8).
English: Table 1: FEV1 Percent predicted relative change from baseline to Day 28 in placebo-controlled efficacy and safety studies of Quinsair in patients with CF
Maltese: Tabella 1: Bidla relattiva mil-linja bażi fil-perċentwali mbassra ta' FEV1 sa Jum 28 fi studji kkontrllati bi plaċebo dwar l-effikaċja u s-sigurtà ta' Quinsair f'pazjenti b'CF
English: Coagulation tests, therefore, should be monitored in patients treated with vitamin K antagonists (see section 4.4).
Maltese: Għalhekk, it-testijiet tal-koagulazzjoni għandhom jiġu mmonitorjati f'pazjenti kkurati b'antagonisti ta' vitamina K (ara sezzjoni 4.4).
English: In vitro studies using the Zirela Nebuliser System with Quinsair have demonstrated the following drug delivery characteristics: mass median aerodynamic diameter (droplet size distribution):
Maltese: Studji in vitro li użaw is-Sistema tan-Nebulizzatur Zirela ma' Quinsair urew il-karatteristiċi li ġejjin tal-forniment tal-mediċina: piż medjan tad-dijametru aerodinamiku (distribuzzjoni tad-daqs tal-qtar): 3.56 mikrometri (1.51 devjazzjoni standard ġeometrika); rata ta' forniment tal-mediċina:
English: Bronchospasm is a complication associated with inhaled therapies including Quinsair (see section 4.8).
Maltese: Il-bronkospażmu hi komplikazzjoni assoċjata ma' terapiji ta' ġbid man-nifs li jinkludu Quinsair (ara sezzjoni 4.8).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON BOX CONTAINING INNER CARTON BOX CONTAINING 56 (14 SACHETS OF 4) AMPOULES PLUS ONE “ZIRELA” NEBULISER HANDSET
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KAXXA TAL-KARTUN LI FIHA KAXXA TAL-KARTUN TA' ĠEWWA LI FIHA 56 (14-IL QARTAS TA' 4) AMPULLA
English: In addition, the pharmacokinetics of weight-based doses of levofloxacin administered by inhalation once daily for 14 days in paediatric patients with CF (≥ 6 to < 12 years old, n = 14 and ≥ 12 to < 17 years old, n = 13) were evaluated in Study 206.
Maltese: Barra minn hekk, il-farmakokinetika ta' dożi ta' levofloxacin ibbażati fuq il-piż mogħtija permezz ta' ġbid man-nifs darba kuljum għal 14-il jum f'pazjenti pedjatriċi b'CF (≥ 6 sa < 12-il sena, n = 14 u ≥ 12 sa < 17-il sena, n = 13) ġew evalwati fi Studju 206.
English: Figure 1 3) Close the medicine reservoir by aligning the tabs of the medicine cap with the slots of the reservoir (a).
Maltese: Figura 1 3) Agħlaq il-kontenitur tal-mediċina billi tallinja t-tabs tal-għatu tal-mediċina mas-slotts tal-kontenitur (a).
English: 3) After a few seconds, an aerosol mist will begin to flow into the aerosol chamber of the Zirela Nebuliser Handset.
Maltese: 3) Wara ftit sekondi, ċpar tal-aerosol se jibda jnixxi ġol-kompartiment tal-aerosol tal-Sett tal-Idejn tan-Nebulizzatur Zirela.
English: These two placebo-controlled studies showed that 28 days of treatment with Quinsair 240 mg twice daily resulted in significant improvement in relative change from baseline in FEV1 percent predicted compared to placebo (see Table 1).
Maltese: Dawn iż-żewġ studji kkontrollati bi plaċebo wrew li 28 jum tal-kura bi Quinsair 240 mg darbtejn kuljum irriżultaw f'titjib sinifikanti fil-bidla relattiva mil-linja bażi fil-perċentwali mbassra ta' FEV1 meta mqabbel mal-plaċebo (ara Tabella 1).