FrancophonIA/ELRC3.0 huggingface dataset:
English: One ampoule contains levofloxacin hemihydrate equivalent to 240 mg of levofloxacin.
Maltese: Ampulla waħda fiha levofloxacin hemihydrate ekwivalenti għal 240 mg ta' levofloxacin.
English: Quinsair is not recommended for use in patients with severe renal impairment (creatinine clearance ˂ 20 ml/min).
Maltese: Quinsair mhuwiex rakkomandat għall-użu f'pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-kreatinina ta' ˂ 20 ml/min).
English: Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment.
Maltese: Tendinite u tiċrit tat-tendins (speċjalment iżda mhux limitat għal tendin ta' Achilles), kultant bilaterali, jistgħu jseħħu sa fi żmien 48 siegħa mill-bidu tal-kura bi quinolones u fluoroquinolones, u ġew irrappurtati li jseħħu sa diversi xhur wara t-twaqqif tal-kura.
English: Caution should be taken when using fluoroquinolones, including levofloxacin, in patients with known risk factors for prolongation of the QT interval (see sections 4.5, 4.8 and 4.9) such as, for example:
Maltese: Għandu jkunu hemm kawtela meta tuża fluoroquinolones, li jinkludu levofloxacin, f'pazjenti b'fatturi ta' riskju magħrufa għat-titwil tal-intervall tal-QT (ara sezzjonijiet 4.5, 4.8 u 4.9) bħal, pereżempju:
English: Ear and labyrinth disorders1
Maltese: Disturbi fil-widnejn u fis-sistema labirintika1
English: 240 mg Inhalation BID
Maltese: 240 mg Ġbid man-nifs BID
English: Hepatitis*, Hyperbilirubinaemia*
Maltese: Epatite*, Iperbilirubinemija*
English: Nebuliser Solution Levofloxacin
Maltese: L-effett ta' prodotti mediċinali oħrajn fuq levofloxacin
English: Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and, therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis.
Maltese: Levofloxacin jista' jinibixxi t-tkabbir ta' Mycobacterium tuberculosis u, għalhekk, jista' jagħti riżultati foloz negittivi fid-dijanjosi batterjoloġika ta' tuberkulożi.
English: The recommended dosage is 240 mg (one ampoule) administered by inhalation twice daily (see section 5.2).
Maltese: Id-dożaġġ rakkomandat hu ta' 240 mg (ampulla waħda) mogħti billi jinġibed man-nifs darbtejn kuljum (ara sezzjoni 5.2).
English: It is recommended that patients should not expose themselves unnecessarily to strong sunlight or to artificial UV rays (e.g. sunray lamp, solarium) during treatment and for 48 hours following treatment discontinuation in order to prevent photosensitisation.
Maltese: UV artifiċjali (eż. bozza tax-xemx, solarium) matul l-kura u għal 48 siegħa wara t-twaqqif tal-kura sabiex jipprevjenu l-fotosensitizzazzjoni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of nebuliser solution contains levofloxacin hemihydrate equivalent to 100 mg of levofloxacin.
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni għan-nebulizzatur fiha levofloxacin hemihydrate ekwivalenti għal 100 mg ta' levofloxacin.
English: - Medicines such as probenecid (used to prevent gout) or cimetidine (used to treat ulcers).
Maltese: - Mediċini bħal probenecid (jintuża biex jipprevjeni l-gotta) jew cimetidine (jintuża biex jikkura lulċeri).
English: The pharmacokinetics of levofloxacin following inhalation of Quinsair 240 mg twice daily were investigated in paediatric patients with CF aged 12 years and older and weighing ≥ 30 kg. A population PK model based on sparse sampling determined that levofloxacin serum concentrations were comparable between paediatric and adult patients following 28 days of treatment.
Maltese: Mudell PK tal-popolazzjoni bbażat fuq ammont żgħir ta' kampjuni stabbillixxa li l-konċentrazzjonijiet ta' levofloxacin fis-serum kienu komparabbli bejn pazjenti pedjatriċi u adulti wara 28 jum ta' kura.
English: Inner box
Maltese: Tab Slot
English: In the “crimped area” on either side of the ampoule tail LOT
Maltese: Fiż-“żona crimped” fuq iż-żewġ naħat tad-denb tal-ampulla LOT
English: Resistance to levofloxacin, other antibacterial agents and treatment-emergent microorganisms
Maltese: Reżistenza għal levofloxacin, mediċini antibijotiċi oħrajn u mikroorganiżmi li jiżviluppaw minħabba l-kura
English: Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.
Maltese: Każijiet rari ħafna ta' reazzjonijiet avversi tal-medicina li jieħdu fit-tul (sa xhur jew snin) jew permanenti, bħal infjammazzjonijiet tat-tendins, tiċrit tat-tendins, uġigħ fil-ġogi, uġigħ fir-riġlejn u/jew dirgħajn, diffikultà fil-mixi, sensazzjonijiet mhux normali bħal tingiż, titrix, ħruq, tnemnim jew uġigħ (newropatija), depressjoni, għeja, disturbi fl-irqad, indeboliment fil-memorja, kif ukoll indeboliment fis-smigħ, vista, u togħma u xamm ġew assoċjati mal-għoti ta' antibijotiċi quinolones u fluoroquinolones, f'xi każijiet irrispettivament minn fatturi ta' riskju eżistenti minn qabel.
English: Studies using systemic administration of levofloxacin show that the pharmacokinetics of levofloxacin are affected by renal impairment; with decreasing renal function (estimated creatinine clearance < 50 ml/min), renal elimination and clearance are decreased, and elimination half-life increased.
Maltese: Studji li użaw l-għoti sistemiku ta' levofloxacin juru li l-farmakokinetika ta' levofloxacin tiġi affettwata minn indeboliment tal-kliewi; bi tnaqqis fil-funzjoni tal-kliewi (tneħħija stmata talkreatinina ta' < 50 ml/min), l-eliminazzjoni mill-kliewi u t-tneħħija jonqsu, u l-half-life taleliminazzjoni tiżdied.
English: Inhale this medicine at least 15 minutes or up to 4 hours before your next dose of Quinsair.
Maltese: Iġbed man-nifs din il-mediċina mill-inqas 15 minuta jew għal sa 4 sigħat qabel id-doża tiegħek li jkun imiss ta' Quinsair.
English: Tell your doctor before using Quinsair if you have or have ever had any of the following: - Prolonged, disabling and potentially irreversible serious side effects Fluoroquinolone/quinolone antibacterial medicines, including Quinsair, have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible.
Maltese: - Effetti sekondarji serji li jieħdu fit-tul, li jinkapaċitaw u potenzjalment irriversibbli Mediċini antibatteriċi fluoroquinolones/quinolones, inkluż Quinsair, ġew assoċjati ma' effetti sekondarji rari ħafna iżda serji, li xi wħud minnhom damu għal tul ta' żmien (komplew sa xhur jew snin), jinkapaċitaw jew potenzjalment irriversibbli.
English: Quinsair is supplied as a 28-day pack.
Maltese: Quinsair hu fornut bħala pakkett ta' 28 jum.
English: However, Quinsair is not recommended for use in patients with severe renal impairment (creatinine clearance ˂ 20 ml/min, see section 4.2).
Maltese: Madankollu, Quinsair mhuwiex rakkomandat għall-użu f'pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-kreatinina ta' ˂ 20 ml/min, ara sezzjoni 4.2).
English: Each 28-day pack of Quinsair contains one box of 56 (14 sachets of 4) ampoules and one box holding a Zirela Nebuliser Handset with the Manufacturer's Instructions for Use.
Maltese: Kull pakkett ta' 28 jum ta' Quinsair fih kaxxa waħda ta' 56 (14-il qartas ta' 4) ampulla u kaxxa waħda li jkun fiha Sett tal-Idejn tan-Nebulizzatur Zirela flimkien mal-Istruzzjonijiet tal-Użu tal-Manifattur.
English: The adverse reactions with at least a reasonable possibility of a causal relationship with Quinsair are presented according to the MedDRA System Organ Classification.
Maltese: Ir-reazzjonijiet avversi b'mill-inqas possibbiltà raġonevoli ta' relazzjoni kawżali ma' Quinsair huma ppreżentati skont is-Sistema tal-Klassifika tal-Organi
English: These metabolites account for ˂ 5% of the dose following systemic administration and are excreted in urine.
Maltese: Dawn il-metaboliti jammontaw għal ˂ 5% tad-doża wara l-għoti sistemiku, u jitneħħew fl-awrina.
English: In common with other fluoroquinolones, levofloxacin showed effects on cartilage (blistering and cavities) in rats and dogs.
Maltese: Kif inhu komuni bi fluoroquinolones oħrajn, levofloxacin wera effetti fuq il-kartilaġni (infafet u kavitajiet) fil-firien u fi-klieb.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Quinsair in one or more subsets of the paediatric population in cystic fibrosis patients with P. aeruginosa pulmonary infection/colonisation (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji bi Quinsair f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika f'pazjenti b'fibrożi ċistika b'infezzjoni/kolonizzazzjoni pulmonari b'P. aeruginosa {ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku}.
English: Based on these limited data, there does not appear to be any clinically relevant difference in the safety profile of Quinsair in these subsets of the paediatric population compared to adults.
Maltese: Ibbażat fuq din id-dejta limitata, ma jidhirx li hemm kwalunkwe differenza klinikament rilevanti fil-profil tas-sigurtà ta' Quinsair f'dawn issottosetti tal-popolazzjoni pedjatriku meta mqabbla mal-adulti.
English: ECG monitoring should be undertaken because of the possibility of QT interval prolongation.
Maltese: Għandu jsir monitoraġġ permezz ta' ECG minħabba l-possibbiltà ta' titwil fl-intervall tal-QT.
English: High levofloxacin concentrations were observed in sputum following Quinsair 240 mg twice daily dosing in patients with CF.
Maltese: Adolexxent wieħed li ntgħażel b'mod każwali biex jieħu Quinsair 240 mg darbtejn kuljum ma rċeviex il-mediċina tal-istudju.
English: A total of 88 patients received at least 1 dose of Quinsair in Study 209 (Extension Phase), 32 of these had received TIS and 56 of these had received Quinsair in the Core Phase.
Maltese: Total ta' 88 pazjent irċivew mill-inqas 1 doża ta' Quinsair fi Studju 209 (Fażi ta' Estensjoni), 32 minnhom kienu rċivew TIS u 56 minnhom kienu rċivew Quinsair fil-Fażi Ewlenija.
English: Fatigue/asthenia, Exercise tolerance decreased
Maltese: Għeja/astenja, Tnaqqis fittolleranza għalleżerċizzju
English: if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
Maltese: jekk esperjenzajt episodju preċedenti ta' dissezzjoni aortika (tiċrita fil-ħajt tal-aorta).
English: Dyspnoea,
Maltese: Dardir,
English: The mean apparent volume of distribution of levofloxacin in serum is approximately 250 L following inhalation of Quinsair 240 mg twice daily.
Maltese: Il-medja tal-volum apparenti tad-distribuzzjoni ta' levofloxacin fis-serum hu ta' madwar 250 L wara l-ġbid man-nifs ta' Quinsair 240 mg darbtejn kuljum.
English: These medicines may interfere with the effects of Quinsair.
Maltese: Dawn il-mediċini jistgħu jinterferixxu mal-effetti ta' Quinsair.
English: Active substances known to prolong the QT interval Levofloxacin should be used with caution in patients receiving active substances known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
Maltese: Sustanzi attivi magħrufa li jtawlu l-intervall tal-QT Levofloxacin, għandu jintuża b'kawtela f'pazjenti li jkunu qed jirċievu sustanzi attivi magħrufa li jtawlu l-intervall tal-QT (eż. mediċini antiarritimiċi ta' Klassi
English: The safety and efficacy of Quinsair in children aged ˂ 18 years old have not yet been established.
Maltese: Is-sigurta u l-effikaċja ta' Quinsair fit-tfal minn età ta' ˂ 18 snin ma ġewx determinati s'issa.
English: Sealed foil laminate sachet containing 4 ampoules.
Maltese: Laminat issiġillat tal-fojl qartas li fih 4 ampulli.
English: Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis.
Maltese: Fluoroquinolones, li jinkludu levofloxacin, għandhom attività ta' imblokk newromuskolari, u jistgħu jaggravaw dgħufija fil-muskoli f'pazjenti b'mijastenija gravis.
English: 2nd Dornase alfa 3rd Airway clearance techniques 4th Quinsair
Maltese: Kif għandek tuża Quinsair
English: Hazard ratio [95% CI] d: P = 0.040 e
Maltese: Proporzjon ta' periklu [95% CI] d: P = 0.
English: As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g. glibenclamide) or with insulin.
Maltese: Bħal fil-każ tal-quinolones kollha, ġew irrappurtati disturbi fil-glucose tad-demm, li jinkludu kemm ipogliċemija kif ukoll ipergliċemija, normalment f'pazjenti dijabetiċi li jirċievu kura fl-istess ħin b'mediċina ipoglikemika orali (eż. glibenclamide) jew b'insulina.
English: Quinsair can interfere with the effects of these medicines.
Maltese: Quinsair jista' jinterferixxi mal-effetti ta' dawn il-mediċini.
English: Not known: frequency cannot be estimated from the available data - Low numbers of all types of cells in the blood - Diabetic coma - Severe mental problems (which in very rare cases may lead to self-harm) - Pain, burning, tingling, numbness and/or weakness in the limbs (neuropathy) - Involuntary muscle movements, twitching or spasms - Fainting - Severe throbbing headaches with loss of eyesight - Temporary loss of vision - Rapid or abnormal heart beat - Inflammation of the lung - Severe skin reactions such as painful blistering or lesions possibly in the mouth, nose or vagina - Increased sensitivity of the skin to sunlight or UV light (sunbeds or other UV lamps) - Inflammation of the blood vessels - Inflammation of the mouth or lips - Rapid breakdown of muscles - Inflammation of a tendon or a broken tendon - Pain including pain in the back, chest, arms and legs and arms
Maltese: Mhux magħruf: ma tistax tittieħed stima mid-data disponibbli - Numri baxxi ta' kull tip ta' ċelluli fid-demm - Koma dijabetika - Problemi mentali severi (li f'każijiet rari ħafna jistgħu jwasslu għal ħsara li ssir minn dak li jkun fuqu nnifsu) - Uġigħ, ħruq, tnemnim, tmewwit u/jew debbulizza fir-riġlejn jew fid-dirgħajn (newropatija) - Movimenti involontarji tal-muskoli, kontrazzjonijiet jew spażmi tal-muskoli - Ħass ħażin - Uġigħ ta' ras qawwi ħafna b'telf tal-vista - Telf temporanju tal-vista - Taħbit tal-qalb mgħaġġel jew mhux normali
English: Uncommon: may affect up to 1 in 100 people - Feeling confused or nervous - Shaking - Sensation of dizziness, spinning or falling over (vertigo) - Excessive sweating
Maltese: Mhux komuni: jistgħu jaffettwaw sa 1 minn kull 100 persuna - Tħossok konfuż jew nervuż - Roghda - Sensazzjoni ta' sturdament, mejt jew li tkun qed taqa' (vertigo) - Għaraq eċċessiv
English: Cases of hepatic necrosis up to fatal hepatic failure have been reported with systemically administered levofloxacin, primarily in patients with severe underlying diseases (e.g. sepsis, see section 4.8).
Maltese: Każijiet ta' nekrożi tal-fwied sa insuffiċjenza fatali tal-fwied ġew irrappurtati b'levofloxacin mogħti sistematikament, l-aktar f'pazjenti b'mard sottostanti sever (eż. sepsis, ara sezzjoni 4.8).
English: - False test results
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Sachet
Maltese: Mejt
English: Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin.
Maltese: Reazzjonijiet psikotiċi ġew irrappurtati f'pazjenti li jkunu qed jirċievu quinolones, li jinkludu levofloxacin.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LOW DENSITY POLYETHYLENE AMPOULE
Maltese: Ż-ŻGĦAR EWLENIN AMPULLA TA' POLYETHYLENE TA' DENSITÀ
English: LIST OF EXCIPIENTS magnesium chloride hexahydrate and water for injections.
Maltese: TA' EĊĊIPJENTI Magnesium chloride hexahydrate u ilma għal injezzjonijiet.
English: Ampoule
Maltese: Manifattur
English: Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, known atherosclerosis).
Maltese: Għalhekk, fluoroquinolones għandhom jintużaw biss wara valutazzjoni bir-reqqa tal-benefiċċju-riskju u wara kunsiderazzjoni ta' għażliet terapewtiċi oħrajn f'pazjenti bi storja pożittiva tal-familja ta' marda ta' anewriżmu, jew f'pazjenti dijanjostikati b'anewriżma aortika li kienet hemm qabel u/jew dissezzjoni aortika, jew fil-preżenza ta' fatturi ta' riskju oħrajn jew ta' kundizzjonijiet li jippredisponu għal anewriżmu aortiku u dissezzjoni (eż. is-sindromu ta' Marfan, is-sindromu ta' Ehlers-Danlos vaskulari, arterite Takayasu, arterite b'ċellula ġganteska, il-marda ta' Behcet, pressjoni għolja, aterosklerożi magħrufa).
English: Jaundice and severe liver injury, including cases with fatal acute liver failure
Maltese: Suffejra u feriti serji filfwied, li jinkludu każijiet ta' insuffiċjenza akuta tal-fwied fatali
English: How do I use the Zirela Nebuliser System?
Maltese: Kif nuża s-Sistema tan-Nebulizzatur Zirela?
English: Efficacy was not evaluated in the 14 children with CF (≥ 6 to < 12 years old) and 13 adolescents with CF (≥ 12 to < 17 years old) who participated in Study 206.
Maltese: L-effikaċja ma' ġietx evalwata fl-14-il tifel u tifla b'CF (≥ 6 sa < 12-il sena) u 13-il adolexxent b'CF (≥ 12 sa < 17-il sena) li pparteċipaw fi Studju 206.
English: Levofloxacin caused no impairment of fertility or reproductive performance in rats and its only effect on foetuses was delayed maturation as a result of maternal toxicity.
Maltese: Levofloxacin ma kkawża l-ebda indeboliment fil-fertilità jew fil-prestazzjoni riproduttiva fil-firien, u l-uniku effett tiegħu fuq il-feti kienet il-maturazzjoni ttardjata b'riżultat ta' tossiċità materna.
English: - The other ingredients are magnesium chloride hexahydrate and water for injections.
Maltese: - Is-sustanzi l-oħra huma magnesium chloride hexahydrate u ilma għall-injezzjonijiet.
English: Clinical efficacy was demonstrated in two placebo-controlled studies and one active-comparator study in 448 patients randomised to receive Quinsair 240 mg twice daily.
Maltese: L-effikaċja klinika ntweriet f'żewġ studji kkontrollati bi plaċebo, u studju wieħed b'komparatur attiv, li saru fuq 448 pazjent li ntgħażlu b'mod każwali biex jirċievu Quinsair 240 mg darbtejn kuljum.
English: Table 2: Results for the primary and key secondary endpoints in the active-controlled efficacy and safety study of Quinsair in patients with CF
Maltese: Tabella 2: Riżultati għall-punti aħħarin ewlenin primarji u sekondarji fl-istudju dwar is-sigurtà u l-effikaċja, ikkontrollat b'mod attiv, ta' Quinsair f'pazjenti b'CF
English: Rare: may affect up to 1 in 1,000 people - Hallucinations and/or feeling paranoid - Feeling agitated - Unusual dreams or nightmares - Convulsions (fits) - Tingling sensation (pins and needles) and/or numbness - Palpitations - Low blood pressure - Muscle weakness
Maltese: Rari: jistgħu jaffettwaw sa 1 minn kull 1,000 persuna - Alluċinazzjonijiet u/jew tħossok paranojde - Tħossok aġitat - Ħolm mhux tas-soltu jew ħmar il-lejl - Konvulżjonijiet (puplesiji) - Sensazzjoni ta' tnemnim (qisu xi ħadd qed iniggżek bil-labar) u/jew tmewwit - Palpitazzjonijiet - Pressjoni baxxa - Dgħufija fil-muskoli
English: Leukocytoclastic vasculitis,
Maltese: Vaskulite lewkoċitoklastika, Stomatite
English: Levofloxacin did not induce gene mutations in bacterial or mammalian cells but did induce chromosome aberrations in Chinese hamster lung cells in vitro.
Maltese: Levofloxacin ma induċiex mutazzjonijiet fil-ġeni f'ċelluli batteriċi jew tal-mammiferi, iżda induċa aberrazzjonijiet tal-kromosomi fiċ-ċelluli tal-pulmun tal-ħamster Ċiniż in vitro.
English: Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents.
Maltese: Pazjenti b'difetti moħbija jew attwali fl-attività ta' glucose-6-phosphate dehydrogenase jistgħu jkunu suxxettibbli għal reazzjonijiet emolitiċi meta jiġu kkurati b'mediċini antibatteriċi li jkun fihom quinolone.
English: You will hear one ‘beep' and the status light will turn green.
Maltese: Se tisma ‘beep' waħda, u d-dawl li juri l-istat isir aħdar.
English: This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders.
Maltese: Dan jinkludi uġigħ fit-tendins, muskoli u ġogi tad-dirgħajn u r-riġlejn, diffikultà fil-mixi, sensazzjonijiet mhux normali bħal tingiż, titrix, tnemnim jew ħruq (parasteżija), disturbi fis-sensi inkluż indeboliment fil-vista, togħma u xamm, u smigħ, depressjoni, indeboliment fil-memorja, għeja kbira u disturbi severi fl-irqad.
English: In the absence of human data and findings in non-clinical studies suggesting a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, use of Quinsair is contraindicated in breast-feeding women (see sections 4.3 and 5.3).
Maltese: Madankollu, fl-assenza ta' dejta mill-bnedmin u r-riżultati tal-istudji kliniċi li jissuġġerixxu riskju ta' ħsara minn fluoroquinolones lill-kartilaġni li jġorr il-piż fl-organiżmu li jkun qed jikber, l-użu ta' Quinsair hu kontraindikat waqt it-tqala (ara sezzjonijiet 4.3 u 5.3).
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; TIS = tobramycin inhalation solution.
Maltese: ITT = intenzjoni li tikkura (il-pazjenti kollha magħżula b'mod każwali); P = valur P; SD = devjazzjoni standard; SE = żball standard;
English: Quinsair should be taken by inhalation using a Zirela Nebuliser Handset (including a Zirela Aerosol Head).
Maltese: Quinsair għandu jittieħed permezz tal-ġbid man-nifs billi tuża Sett tal-Idejn tan-Nebulizzatur Zirela (li jinkludi Zirela Aerosol Head).
English: Syncope,
Maltese: Rimettar,
English: Hypoglycaemic coma
Maltese: Kaxxa ta' ġewwa
English: Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have been reported in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin).
Maltese: Żieda fit-testijiet tal-koagulazzjoni (PT/INR) u/jew tal-ħruġ ta' demm, li jista' jkun sever, ġew irrappurtati f'pazjenti kkurati b'levofloxacin flimkien ma' antagonist ta' vitamina K (eż. warfarin).
English: - Resistance to antibiotics
Maltese: - Reżistenza għall-antibijotiċi
English: The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, patients receiving daily doses of 1000 mg levofloxacin, and those treated concurrently with corticosteroids.
Maltese: Ir-riskju ta' tendinite u tiċrit tat-tendins jiżdied f'pazjenti anzjani, pazjenti b'indeboliment tal-kliewi, pazjenti bi trapjant ta' organi solidi, pazjenti li jirċievu dożi ta' kuljum ta' 1000 mg levofloxacin u dawk ittrattati b'kortikosterojdi fl-istess ħin.
English: Quinsair is used to treat lung infections caused by Pseudomonas aeruginosa in adults with cystic fibrosis.
Maltese: Quinsair jintuża biex jikkura infezzjonijiet tal-pulmun ikkawżati minn Pseudomonas aeruginosa f'adulti b'fibrożi ċistika.
English: - Heart rhythm abnormalities
Maltese: - Reazzjonijiet severi tal-ġilda