FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/19/1393/002 10 x 1 tablets EU/1/19/1393/003 20 x 1 tablets EU/1/19/1393/004 30 x 1 tablets EU/1/19/1393/005 50 x 1 tablets EU/1/19/1393/006 60 x 1 tablets EU/1/19/1393/007 100 x 1 tablets
Maltese: EU/1/19/1393/002 10 pilloli x 1 EU/1/19/1393/003 20 pillola x 1 EU/1/19/1393/004 30 pillola x 1 EU/1/19/1393/005 50 pillola x 1 EU/1/19/1393/006 60 pillola x 1 EU/1/19/1393/007 100 pillola x 1
English: Arthritis reactive
Maltese: Artrite reattiva
English: Via Sette Santi 3, 50131 Florence, Italy
Maltese: Via Sette Santi 3, 50131 Florence, L-Italja
English: SX Via Morolense 5 03013 Ferentino (FR) Italy or
Maltese: SX Via Morolense 5 03013 Ferentino (FR) L-Italja jew
English: Resistant (R >)
Maltese: Reżistenti (R >)
English: Pack-size: 10 vials.
Maltese: Daqs tal-pakkett: 10 kunjetti.
English: There is limited experience in patients aged > 75 years.
Maltese: Hemm esperjenza limitata f'pazjenti b'età ta' > 75 sena.
English: Patheon Italia S.p.A. 2° Trav.
Maltese: Patheon Italia S.p.A.
English: Staphylococcus aureus Streptococcus pyogenes Streptococcus dysgalactiae Streptococcus agalactiae Streptococcus anginosus group Escherichia coli
Maltese: Staphylococcus aureus Streptococcus pyogenes Streptococcus dysgalactiae Streptococcus agalactiae Grupp Streptococcus anginosus Escherichia coli
English: AlfaSigma 1 Via Enrico Fermi 65020 Alanno (PE) Italy
Maltese: AlfaSigma 1 Via Enrico Fermi 65020
English: Pack sizes of 10 x1, 20 x1, 30 x1, 50 x1, 60 x1 or 100 x1 tablets.
Maltese: Daqsijiet tal-pakkett ta' 10 x1, 20 x1, 30 x1, 50 x1, 60 x1 jew 100 x1 pillola.
English: A. Menarini Portugal - Farmacêutica, S.A. Tel: +351 210 935 500
Maltese: Menarini Portugal - Farmacêutica, S.A. Tel: +351 210 935 500
English: Gram-negative micro-organisms:
Maltese: Mikroorganiżmi negattivi għal gram:
English: Millmount Healthcare Block-7, City North Business Campus, Stamullen, Co. Meath Ireland or
Maltese: MillMount Healthcare Block-7, City North Business Campus, Stamullen, Co. Meath L-Irlanda jew
English: • Staphylococcus aureus (including methicillin-resistant [MRSA])
Maltese: • Staphylococcus aureus (inkluż dak reżistenti għal methicillin [MRSA])
English: • Insomnia
Maltese: • Ansjetà • Insomnja
English: Exacerbation of myasthenia gravis
Maltese: myasthenia gravis.
English: • Streptococcus mitis group (including Streptococcus cristatus, Streptococcus gordonii,
Maltese: • Streptococcus mitis group (inklużi Streptococcus cristatus, Streptococcus gordonii,
English: Each vial contains 175 mg of sodium.
Maltese: Kull kunjett fih 175 mg ta' sodium.
English: Fluoroquinolones form chelates with alkaline earth and transition metal cations.
Maltese: Fluoroquinolones jiffurmaw kelati ma' katjoni alkaline earth u transition metal.
English: Streptococcus oralis, Streptococcus mitis, and Streptococcus sanguinis)
Maltese: Streptococcus oralis, Streptococcus mitis, u Streptococcus sanguinis)
English: - The active substance is delafloxacin.
Maltese: - Is-sustanza attiva hija delafloxacin.
English: Sinus tachycardia Palpitations Bradycardia
Maltese: Takikardija tas-sinus Palpitazzjonijiet Bradikardija
English: Quofenix contains cyclodextrin
Maltese: Quofenix fih cyclodextrin
English: • If you are a child or growing adolescent below 18 years of age.
Maltese: • Jekk inti tifel jew tifla jew adolexxent li għadu qed jikber taħt l-età ta' 18-il sena.
English: 10x1 tablets 20x1 tablets 30x1 tablets 50x1 tablets 60x1 tablets 100x1 tablets
Maltese: 10 pilloli x 1 20 pillola x1 30 pillola x1 50 pillola x1 60 pillola x1 100 pillola x1
English: Frequencies are defined as: 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).
Maltese: (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000).
English: Meglumine, sulfobutylbetadex sodium, disodium edetate, sodium hydroxide, hydrochloric acid, concentrated.
Maltese: Meglumine, sulfobutylbetadex sodium, disodium edetate, sodium hydroxide, hydrochloric acid,
English: Clostridioides difficile infection (see section 4.4)
Maltese: Infezzjoni bi Clostridioides difficile (ara sezzjoni 4.4)
English: MIC breakpoints (mg/L) Susceptible (S ≤)
Maltese: Breakpoints tal-MIC (mg/L) Suxxettibbli (S ≤)
English: Musculoskeletal and connective tissue disorders*
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi*
English: Fluoroquinolones have been associated with an increased risk of central nervous system (CNS) reactions, including: convulsions and increased intracranial pressure (including pseudotumor cerebri) and toxic psychosis.
Maltese: Fluoroquinolones ġew assoċjati ma' żiedet fir-riskju ta' reazzjonijiet fis-sistema nervuża ċentrali (CNS, central nervous system), inklużi: konvulżjonijiet u żieda fil-pressjoni ta' ġol-kranju (inkluża pseudotumor cerebri) u psikożi tossika.
English: Quofenix must be reconstituted under aseptic conditions, using 10.5 mL of dextrose 50 mg/ml (5%) solution for injection (D5W) or sodium chloride 9 mg/ml (0.9%) solution for injection for each 300 mg vial.
Maltese: mL ta' soluzzjoni għall injezzjoni ta' dextrose 50 mg/ml (5%) (D5W) jew sodium chloride 9 mg/ml (0.9%) għal kull kunjett ta' 300 mg.
English: • an antacid, multivitamin, or other product that has magnesium, aluminium, iron, or zinc
Maltese: • antaċidu, multivitamina, jew prodott ieħor li fih magnesium, aluminum, iron, jew zinc
English: • Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus)
Maltese: • Grupp Streptococcus anginosus (inklużi Streptococcus anginosus, Streptococcus intermedius,
English: The plasma protein binding of delafloxacin, is approximately 84%; it primarily binds to albumin.
Maltese: L-irbit ta' delafloxacin mal-proteini tal-plasma huwa madwar 84%; huwa jintrabat laktar mal-albumina.
English: Sulfobutylbetadex sodium
Maltese: Sulfobutylbetadex sodium Disodium edetate
English: - The other ingredients are cellulose microcrystalline, povidone, crospovidone, sodium hydrogen carbonate, sodium dihydrogen phosphate monohydrate, citric acid, magnesium stearate.
Maltese: - Is-sustanzi l-oħra huma cellulose microcrystalline, povidone, crospovidone, sodium hydrogen carbonate, sodium dihydrogen phosphate monohydrate, citric acid, magnesium stearate.
English: Susceptibility testing breakpoints
Maltese: Ittestjar tal-breakpoints ta' suxxettibilità
English: Pharmacokinetic parameters are not altered in obese patients (BMI ≥ 30 kg/m2).
Maltese: Il-parametri farmakokinetiċi ma jinbidlux f'pazjenti b'ħafna piż żejjed (BMI ≥ 30 kg/m2).
English: Organism
Maltese: Organiżmu
English: Delafloxacin does not induce CYP1A2, CYP2B6, CYP2C9, CYP2C8, CYP2C19 or CYP3A4/5.
Maltese: Delafloxacin ma jinduċix CYP1A2, CYP2B6, CYP2C9, CYP2C8, CYP2C19 jew CYP3A4/5.
English: • didanosine buffered tablets for oral suspension or the paediatric powder for oral solution
Maltese: • pilloli ta' didanosine buffered għal suspensjoni orali jew it-trab pedjatriku għal soluzzjoni orali Tqala u treddigħ
English: It is available in perforated unit dose blister pack which contains blisters of 10x1 tablets into pack size of 10,20,30,50, 60 or 100 tablets per carton.
Maltese: Huwa disponibbli f'pakkett b'folja b'sarbut toqob biex tinqata' doża waħda li fih folji ta' 10x1 pilloli f'daqsijiet ta' pakketti ta' 10, 20, 30, 50, 60 jew 100 pillola f'kull kaxxa tal-kartun.
English: A. Menarini Farmaceutica Internazionale S.R.L.
Maltese: Menarini Farmaceutica Internazionale S.R.L.
English: Likewise at clinically relevant concentrations delafloxacin does not inhibit the transporters MDR1, BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2K and BSEP.
Maltese: MDR1, BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2K u BSEP.
English: • You have kidney problems.
Maltese: • Inti għandek problemi fil-kliewi.
English: Quofenix contains sodium
Maltese: Quofenix fih sodium
English: Obese patients (≥30 kg/m2 BMI)
Maltese: Pazjenti b'ħafna piż żejjed (BMI ≥ 30 kg/m2)
English: Each vial contains 2480 mg of sulfobutylbetadex sodium.
Maltese: Kull kunjett fih 2,480 mg ta' sulfobutylbetadex sodium.
English: Insomnia
Maltese: Ansjetà Insomnja
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 20 to 25ºC or at 2 to 8°C.
Maltese: L-istabilità kimika u fiżika waqt l-użu intweriet li hija 24 siegħa f'temperatura ta' 20 sa 25ºC jew f'temperatura ta' 2 sa 8°C.
English: The most common adverse drug reactions reported in ABSSSI Phase 2 and 3 studies involving 868 patients exposed to delafloxacin, intravenous or oral formulation, were diarrhoea and nausea (6.91% and 7.83%, respectively) which were mild to moderate in intensity.
Maltese: L-aktar reazzjonijiet avversi komuni għall-mediċina rrappurtati fi studji ta' Fażi 2 u 3 ta' ABSSSI li kienu jinvolvu 868 pazjent esposti għal delafloxacin, bil-formulazzjoni mill-vini jew mill-ħalq, kienu dijarea u dardir (6.91% u 7.83%, rispettivament) li kienu minn ħfief sa moderati fil-qawwa tagħhom.
English: Hypoglycaemia (see section 4.4) Hyperglycaemia (see section 4.4) Decreased appetite
Maltese: Ipogliċemija (ara sezzjoni 4.4) Ipergliċemija (ara sezzjoni 4.4)
English: Gram-positive micro-organisms:
Maltese: Mikroorganiżmi pożittivi għal gram:
English: • Dizziness or loss of balance (vertigo)
Maltese: • Sturdament jew telf ta' bilanċ (vertigo)
English: Dry mouth
Maltese: Sess tal-persuna
English: A. Menarini - Industrie Farmaceutiche Riunite - s.r.l.
Maltese: Menarini - Industrie Farmaceutiche Riunite - s.r.l.
English: Each tablet contains delafloxacin meglumine equivalent to 450 mg delafloxacin.
Maltese: Kull pillola fiha delafloxacin meglumine ekwivalenti għal 450 mg delafloxacin.
English: The total duration of treatment is 5 to 14 days.
Maltese: It-tul ta' żmien totali ta' trattament huwa minn 5 ijiem sa 14-il jum.
English: Paediatric population Quofenix is contraindicated in children and adolescents (see section 4.3).
Maltese: Popolazzjoni pedjatrika Quofenix huwa kontraindikat fit-tfal u l-adolexxenti (ara sezzjoni 4.3).
English: Effect of other medicinal products on delafloxacin Chelation active substance: antacids, sucralfate, metal cations, multivitamins
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni L-effetti ta' prodotti mediċinali oħra fuq delafloxacin Sustanza attiva ta' kelazzjoni: antaċidi, sucralfate, katjoni tal-metall, multivitamini
English: Psychiatric disorders*
Maltese: Disturbi psikjatriċi*
English: This medicinal product contains sulfobutylbetadex sodium.
Maltese: Dan il-prodott mediċinali fih sulfobutylbetadex sodium.
English: Quofenix 450 mg tablets
Maltese: Quofenix 450 mg pilloli
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM/ALUMINIUM BLISTER (TABLETS)
Maltese: FOLJA ALUMINIUM/ALUMINIUM (PILLOLI)
English: This is equivalent to 8.8% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 8.8% tas-sodium massimu rrakkomandat li għandu jittieħed kuljum mid-dieta minn adult.
English: - The other excipients are meglumine, sulfobutylbetadex sodium,disodium edetate, sodium hydroxide (for pH-adjustment), hydrochloric acid, concentrated (for pH-adjustment).
Maltese: - Is-sustanzi l-oħra huma meglumine, sulfobutylbetadex sodium, disodium edetate, sodium hydroxide (għal aġġustament tal-pH), hydrochloric acid, ikkonċentrat (għal aġġustament tal pH).
English: Presyncope
Maltese: Presinkope
English: Unchanged parent drug is the predominant component in plasma.
Maltese: Il-mediċina oriġinali mhux mibdula hija l-komponent prinċipali fil-plasma.
English: Nervous system disorders*
Maltese: Disturbi fis sistema nervuża*
English: Each tablet contains 39 mg of sodium.
Maltese: Kull pillola fiha 39 mg ta' sodium.
English: • You or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase.
Maltese: • Inti jew membru tal-familja tiegħek huwa magħruf li għandkom defiċjenza ta' glucose-6
English: In vitro data indicate that delafloxacin at clinically relevant concentrations does not inhibit cytochrome P450 CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4/5 nor UDP glucuronosyl transferases isoforms UGT1A1 and UGT2B7.
Maltese: Data in vitro tindika li delafloxacin f'konċentrazzjonijiet rilevanti b'mod kliniku ma jinibixxix iċ ċitokroma P450 CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 u CYP3A4/5 u lanqas l-isoformi tal-glucuronosyl transferases UDP UGT1A1 u UGT2B7.
English: Glucuronidation of delafloxacin is the primary metabolic pathway with oxidative metabolism representing <1% of an administered dose.
Maltese: Glukuronidazzjoni ta' delafloxacin hija r-rotta metabolika prinċipali b'metaboliżmu ossidattiv jirrapreżenta <1% tad-doża mogħtija.
English: Quofenix is an antibiotic that contains the active substance delafloxacin.
Maltese: Quofenix huwa antibijotiku li fih is-sustanza attiva delafloxacin.
English: Beige to mottled beige, oblong biconvex tablets of approximately 10 mm width x 21 mm length, with RX3341 debossed on one side.
Maltese: Pilloli beige jew beige b'tikek b'kuluri differenti, oblongi, konvessi fuq iż-żewġ naħat b'wisa' ta' madwar 10 mm x tul ta' madwar 21 mm, b'RX3341 imnaqqxa fuq naħa waħda.
English: This medicinal product contains 175 mg sodium per vial, equivalent to 8.8% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 175 mg sodium f'kull kunjett, li huwa ekwivalenti għal 8.8% tat-teħid massimu ta' 2 g sodium kuljum għal adult rrakkomandat mill-WHO.
English: Each vial contains delafloxacin meglumine equivalent to 300 mg delafloxacin.
Maltese: Kull kunjett fih delafloxacin meglumine ekwivalenti għal 300 mg delafloxacin.
English: • You have experienced a previous episode of aortic dissection (a tear in the aorta wall).
Maltese: • Inti esperjenzajt episodju preċedenti ta' dissezzjoni aortika (tiċrita fil-ħajt tal-aorta).
English: Central Nervous System Effects
Maltese: Effetti fuq is-Sistema Nervuża Ċentrali
English: Quofenix is a beige to mottled beige, oblong biconvex tablets, with RX3341 debossed on one side.
Maltese: Quofenix huma pilloli beige sa beige bit-tikek ikkuluriti, oblongi, konvessi miż-żewġ naħat, b'RX3341 imnaqqxa fuq naħa waħda.
English: The 300-mg IV formulation and 450 mg tablet are bioequivalent with regard to total exposure (AUC).
Maltese: Il-formulazzjoni ta' 300 mg IV u l-pillola ta' 450 mg huma bijoekwivalenti f'dak li huwa esponiment totali (AUC).
English: Hypersensitivity (see section 4.4) Seasonal allergy
Maltese: Sensittività eċċessiva (ara sezzjoni 4.4) Allerġija tal-istaġun
English: Hypersensitivity to any fluoroquinolone or quinolone antibacterial medicinal product.
Maltese: Sensittività eċċessiva għal kwalunkwe prodott mediċinali antibatteriku fluoroquinolone jew quinolone.
English: Delafloxacin is a probable substrate of BCRP.
Maltese: Jista' jkun li delafloxacin huwa sustrat ta' BCRP.
English: This medicinal product contains 39 mg sodium per tablet, equivalent to 2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 39 mg sodium f'kull pillola, li huwa ekwivalenti għal 2% tat-teħid massimu ta' 2 g sodium kuljum rrakkomandat mill-WHO għal adult.
English: Other medicines and Quofenix
Maltese: Mediċini oħra u Quofenix
English: • Low haemoglobin level (anaemia)
Maltese: • Livell baxx ta' emoglobina (anemija)
English: Quofenix 450mg tablets delafloxacin
Maltese: Quofenix 450mg pilloli delafloxacin
English: The recommended dose is 300 mg delafloxacin every 12 hours administered over 60 minutes by intravenous infusion.
Maltese: Id-doża rrakkomandata hija 300 mg delafloxacin kull 12-il siegħa mogħtija fuq perjodu ta' 60 minuta permezz ta' infużjoni fil-vini.
English: The fAUC24/MIC ratio, as for other quinolone antibiotics, resulted in the pharmacokinetic/ pharmacodynamic parameter most closely associated with the efficacy of delafloxacin.
Maltese: Il-proporzjon fAUC24/MIC, bħal dak għal antibijotiċi quinolone oħra, wassal għall-parametru farmakokinetiku/farmakodinamiku assoċjat l-aktar mill-qrib mal-effikaċja ta' delafloxacin.
English: A. Menarini -Industrie Farmaceutiche Riunites.r.l.
Maltese: Menarini -Industrie Farmaceutiche Riunites.r.l.
English: Delafloxacin inhibits bacterial topoisomerase IV and DNA gyrase (topoisomerase II), enzymes required for bacterial DNA replication, transcription, repair, and recombination.
Maltese: Delafloxacin jinibixxi topoisomerase IV u DNA gyrase (topoisomerase II) tal-batterji, li huma enzimi meħtieġa għar-replikazzjoni, transkrizzjoni, tiswija u rikommbinazzjoni tad-DNA tal-batterju.
English: The 450-mg tablet and 300-mg IV formulations are bioequivalent with regard to total exposure (AUC).
Maltese: Il-formulazzjonijiet tal-pillola ta' 450 mg u IV ta' 300 mg huma bijoekwivalenti f'dak li huwa esponiment totali (AUC).
English: Quofenix is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4.4 and 5.1).
Maltese: Quofenix huwa indikat għat-trattament ta' infezzjonijiet akuti bil-batterji fil-ġilda u tal-istruttura talġilda (ABSSSI, acute bacterial skin and skin structure infections) fl-adulti meta jkun meqjus li ma jkunx xieraq li tuża sustanzi antibatteriċi oħra li jkunu rrakkomandati b'mod komuni għat-trattment inizjali ta' dawn l-infezzjonijiet (ara sezzjonijiet 4.4 u 5.1).
English: In patients with moderate to severe renal impairment, accumulation of cyclodextrins occurs.
Maltese: F'pazjenti b'indeboliment moderat sa sever tal-kliewi, jseħħ akkumulu ta' cyclodextrins.
English: Quofenix 450 mg tablets delafloxacin
Maltese: Quofenix 450 mg pilloli delafloxacin
English: The use of delafloxacin 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' delafloxacin għandu jiġi evitat f'pazjenti li kellhom reazzjonijiet avversi serji fil-passat meta użaw prodotti li kien fihom quinolone jew fluoroquinolone (ara sezzjoni 4.8).
English: A. Menarini - Industrie Farmaceutiche Riunites.r.l.
Maltese: Menarini - Industrie Farmaceutiche Riunites.r.l.
English: Peripheral neuropathy (including paraesthesia and hypoaesthesia) (see section 4.4) Dizziness
Maltese: Newropatija periferali (inkl. parestesija u ipoestesija) (ara sezzjoni 4.4) Sturdament
English: Fluoroquinolones may also cause CNS reactions of nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or acts.
Maltese: Il-fluoroquinolones jistgħu jikkawżaw ukoll reazzjonijiet fisCNS ta' nervi, aġitazzjoni, insomnja, ansjetà, ħmar il-lejl, paranojja, sturdament, konfużjoni, rogħda, alluċinazzjonijiet, depressjoni, u ħsibijiet jew atti ta' suwiċidju.
English: You and your doctor will decide on continuing the treatment considering also an antibiotic from another class.
Maltese: Inti u t-tabib tiegħek se tiddeċiedu fuq it tkomplija tat-trattament filwaqt li jitqies ukoll antibijotiku minn klassi oħra.
English: Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones, ATC code: J01MA23 Mechanism of action
Maltese: Antibatteriċi għal użu sistemiku, fluoroquinolones, Kodiċi ATC:
English: Children or growing adolescents below 18 years of age (see section 4.2).
Maltese: Tfal jew adolexxenti li għadhom qed jikbru b'età taħt it-18-il sena (ara sezzjoni 4.2).
English: • 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 Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).
Maltese: • Inti għandek storja fil-familja ta' anewriżmu aortiku jew dissezzjoni aortika jew fatturi ta' riskju oħrajn jew kundizzjonijiet ta' predispożizzjoni (eż. disturbi tat-tessut konnettiv bħas sindromu ta' Marfan, jew is-sindromu ta' Ehlers-Danlos vaskulari, jew disturbi vaskulari bħal arterite Takayasu, arterite b'ċellola ġganteska, il-marda ta' Behcet, pressjoni għolja, jew aterosklerożi magħrufa).
English: Quofenix is not recommended in patients with End Stage Renal Disease (ESRD).
Maltese: Stadju (ESRD, End Stage Renal Disease).
English: Clostridioides difficile-associated disease
Maltese: Mard assoċjat ma' Clostridioides difficile
English: • Itchiness, red rash
Maltese: • Ħakk, raxx aħmar
English: Quofenix will be given to you by a nurse or doctor via an infusion (drip) into a vein.
Maltese: Quofenix se jingħatalek minn infermier jew tabib permezz ta' infuzjoni (dripp) fil-vina.
English: Ear and labyrinth disorders*
Maltese: Disturbi filwidnejn u fissistema labirintika*
English: In vitro data indicate that delafloxacin at clinically relevant concentrations does not inhibit cytochrome P450 CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4/5 nor UDP glucuronosyltransferases isoforms UGT1A1 and UGT2B7.
Maltese: Data in vitro tindika li delafloxacin f'konċentrazzjonijiet rilevanti b'mod kliniku ma jinibixxix iċċitokroma P450 CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 u
English: • Seasonal allergy
Maltese: • Reazzjoni allerġika
English: Muscle spasm
Maltese: Spażmu fil-muskoli
English: This medicine contains 2480 mg of sulfobutylbetadex sodiumin each vial.
Maltese: Din il-mediċina fiha 2,480 mg ta' sulfobutylbetadex sodium f'kull kunjett.
English: How to store Quofenix 6.
Maltese: Kif taħżen Quofenix 6.
English: Fungal infection
Maltese: Infezzjonijiet u infestazzjonijiet
English: After single intravenous dose of 14C-labeled delafloxacin, 65% of the radioactivity is excreted in the urine and 28% is excreted in the faeces.
Maltese: Wara doża waħda ta' delafloxacin tikkettat b'14C minn ġol-vini, 65% tar-radjuattività titneħħa flawrina u 28% titneħħa mal-ippurgar.
English: Patients with toxic shock, neutropenia (neutrophil counts <500 cells/mm3) or severely immunocompromised patients were not included in the studies.
Maltese: Pazjenti b'xokk tossiku, newtropenija (għadd tan-newtrofili < 500 ċellula/mm3) jew pazjenti immunokompromessi b'mod sever ma ġewx inklużi fl-istudji.
English: Sodium hydroxide (for pH-adjustment) Hydrochloric acid, concentrated (for pH-adjustment)
Maltese: Sodium hydroxide (għal aġġustament tal-pH)
English: Medicinal products inhibiting the peristalsis are contraindicated if Clostridioides difficile-associated disease is suspected.
Maltese: Prodotti mediċinali li jinibixxu l-peristalsi huma kontraindikati jekk ikun hemm suspett ta' mard assoċjat ma' Clostridioides difficile.
English: In addition increases in serum ALT and ALP, and reduced total protein and globulin values were recorded at the end of the treatment period in the pivotal 4-week IV dog study at the high dose (75 mg/kg) in individual dogs.
Maltese: Barra minn hekk ġew irreġistrati żidiet fl-ALT u fl-ALP fis-serum, u tnaqqis fil-valuri totali tal-proteina u l-globulina fit-tmiem tal-perjodu ta' trattament fl-istudju l-aktar importanti ta' 4 ġimgħat fil-klieb bid-doża IV għolja (75 mg/kg) fi klieb individwali.
English: This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 2% tas-sodium massimu rrakkomandat li għandu jittieħed kuljum mid-dieta minn adult.
English: • You have had tendon problems during previous treatment with a fluoroquinolone or quinolone antibiotic.
Maltese: • Inti kellek problemi fl-għerq li jgħaqqad muskolu ma' għadma waqt trattament preċedenti b'antibijotiku fluoroquinolone jew quinolone.
English: Wound complication
Maltese: Disturbi vaskulari
English: Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o.
Maltese: Menarini Distribution Ljubljana d.o.o.
English: Hepatic impairment
Maltese: Dermetite allerġika