FrancophonIA/ELRC3.0 huggingface dataset:
English: In embryo-fetal development studies carried out in rats and rabbits, delafloxacin was devoid of teratogenic effects but induced foetal growth retardation and ossification delays at levels of dose producing maternal toxicity.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni L-effetti ta' prodotti mediċinali oħra fuq delafloxacin Ma hemm l-ebda data dwar effetti speċifiċi ta' prodotti mediċinali oħra fuq delafloxacin.
English: Gastritis erosive
Maltese: Artralġja Mijalġja
English: Treatment of these patients with delafloxacin should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3).
Maltese: Trattament ta' dawn ilpazjenti b'delafloxacin għandu jinbeda biss fin-nuqqas ta' għażliet alternattivi ta' trattament u wara li jkun hemm stima bir-reqqa tal-benefiċċju/riskju (ara wkoll sezzjoni 4.3).
English: No dose adjustment is necessary in patients with mild to moderate renal impairment (CrCl of ≥30 mL/min).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża ta' pazjenti b'indeboliment minn ħafif sa moderat tal kliewi (CrCl ta' ≥30 mL/min).
English: The half-life of IV delafloxacin is approximately 10 hours.
Maltese: Il-half-life ta' delafloxacin IV hija ta' madwar 10 sigħat.
English: Patients with glucose-6-phosphate dehydrogenase deficiency
Maltese: phosphate dehydrogenase.
English: Oral administration of delafloxacin with antacids containing aluminium or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as didanosine buffered tablets for oral suspension or the paediatric powder for oral solution, may substantially interfere with the absorption of delafloxacin, resulting in systemic concentrations considerably lower than desired.
Maltese: Għoti mill-ħalq ta' delafloxacin ma' antaċidi li fihom aluminum jew magnesium, ma' sucralfate, ma' katjoni tal-metall bħal iron, jew ma' multivitamini li fihom iron jew zinc, jew ma' formulazzjonijiet li fihom katjoni divalenti jew trivalenti bħall-pilloli ta' didanosine buffered għal suspensjoni mill-ħalq jew it-trab pedjatriku għal soluzzjoni mill-ħalq, jistgħu jinterferixxu b'mod sostanzjali mal-assorbiment ta' delafloxacin, li jwassal għal konċentrazzjonijiet sistemiċi b'mod konsiderevoli aktar baxxi minn dawk mixtieqa.
English: No clinically meaningful changes in delafloxacin Cmax and AUC∞ were observed, following administration of a single 300 mg intravenous dose of delafloxacin into patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B and C) compared to matched healthy control subjects.
Maltese: Ma ġew osservati l-ebda bidliet ta' sinifikat fis-Cmax u l-AUC∞, wara għoti ta' doża waħda ta' 300 mg delafloxacin minn ġol-vini lil pazjenti b'indeboliment ħafif, moderat u sever tal-fwied (Klassijiet A, B u C ta' Child-Pugh) meta mqabbel ma' individwi f'saħħithom imqabbla bħala kontroll.
English: • Swollen, red, irritated veins
Maltese: • Vini minfuħa, ħomor, irritati
English: Dosing in patients with severe renal impairment (CrCl of <30 mL/min) should be decreased to 200 mg intravenously every 12 hours; alternatively patients should receive 450 mg delafloxacin orally every 12 hours (see section 4.4 and 5.2).
Maltese: Id-dożi mogħtija f'pazjenti b'indeboliment sever tal-kliewi (CrCl ta' <30 mL/min) għandhom jitnaqqsu għal 200 mg kull 12-il siegħa minn ġol-vini; b'mod alternattiv ilpazjenti għandhom jirċievu 450 mg delafloxacin kull 12-il siegħa mill-ħalq (ara sezzjoni 4.4 u 5.2).
English: If you might become pregnant you have to use effective contraception during treatment with Quofenix.
Maltese: Jekk inti tista' toħroġ tqila inti trid tuża kontraċezzjoni effettiva matul it-trattament bi Quofenix.
English: Following a single oral dose of 14C-labeled delafloxacin, 50% of the radioactivity is excreted in the urine as unchanged delafloxacin and glucuronide metabolites and 48% is excreted unchanged in the faeces.
Maltese: Wara doża waħda ta' delafloxacin tikkettat b'14C mill-ħalq, 50% tar-radjuattività titneħħa fl-awrina bħala delafloxacin mhux mibdul u bħala metaboliti glucuronide u 48% jitneħħa mhux mibdul malippurgar.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali qabel jiingħata, ara sezzjoni 6.6.
English: Known fluoroquinolones-associated possible interactions shall be considered.
Maltese: Għandhom jitqiesu interazzjonijiet magħrufa possibbli assoċjati ma' fluoroquinolones.
English: Resistance to fluoroquinolones, including delafloxacin, can occur due to mutations in defined regions of the target bacterial enzymes topoisomerase IV and DNA gyrase referred to as Quinolone-Resistance Determining Regions (QRDRs), or through other resistance mechanisms such as efflux mechanisms.
Maltese: Reżistenza għal fluoroquinolones, inkluż għal delafloxacin, tista' sseħħ minħabba mutazzjonijiet f'reġjuni definiti tal-enzimi batteriċi topoisomerase IV u DNA gyrase fil-mira li huma magħrufa bħala
English: Infection of the bowel (Clostridioides difficile infection) is an uncommon side effect that may affect up to 1 in 100 people.
Maltese: Infezzjoni tal-musrana (infezzjoni bi Clostridioides difficile) hija effett sekondarju mhux komuni li jista' jaffettwa sa persuna 1 minn kull 100.
English: Delafloxacin pharmacokinetic is comparable in patients with ABSSSI and healthy volunteers.
Maltese: Il-farmakokinetika ta' delafloxacin hija kumparabbli f'pazjenti b'ABSSSI u voluntiera f'saħħithom.
English: Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.
Maltese: Menarini Distribution Slovakia s.r.o.
English: This medicine contains 39 mg of sodium (main component of cooking salt) in each tablet.
Maltese: Din il-mediċina fiha 39 mg ta' sodium (il-komponent prinċipali tal-melħ tat-tisjir) f'kull pillola.
English: If women of a sexually mature age are treated, effective contraception must be used during treatment (see section 4.6).
Maltese: Jekk jiġu trattati nisa sesswalment maturi fl-età, għandha tintuża kontraċezzjoni waqt it-trattament (ara sezzjoni 4.6).
English: • If you are allergic to any other fluoroquinolone or quinolone antibacterial medicine.
Maltese: • Jekk inti allerġiku għal xi mediċina antibatterika fluoroquinolone jew quinolone oħra.
English: Following single intravenous (300 mg) administration to patients with mild, moderate, or severe renal impairment or ESRD on haemodialysis with and without haemodialysis after dosing, mean total exposure (AUCt) were 1.3, 1.7, 2.1, 3.5 and 4.1-fold higher than values for matched control subjects.
Maltese: Wara għoti ta' doża waħda (300 mg) minn ġol-vini lil pazjenti b'indeboliment ħafif, moderat jew sever tal-kliewi jew b'ESRD fuq l-emodijalisi bl-emodijalisi jew mingħajrha wara l-għoti tad-doża, ilmedja tal-esponiment totali (AUCt) kienet 1.3, 1.7, 2.1, 3.5 u 4.1 drabi ogħla mill-valuri ta' individwi mqabbla bħala kontroll.
English: Prepare the required dose for intravenous infusion by withdrawing the volume of 12 ml for Quofenix 300 mg or 8 ml for Quofenix 200 mg from the reconstituted vial.
Maltese: 300 mg Quofenix jew 8 ml għal 200 mg Quofenix mill-kunjett rikostitwit.
English: Breast-feeding is contraindicated during treatment with delafloxacin.
Maltese: It-treddigħ huwa kontraindikat waqt it-trattament b'delafloxacin.
English: • Ringing or buzzing in the ears (tinnitus)
Maltese: • Tisfir jew żarżir fil widnejn (tinnitus)
English: Post-marketing serious adverse reactions, including deaths and requirement for ventilator support, have been associated with fluoroquinolone use in persons with myasthenia gravis.
Maltese: Reazzjonijiet avversi serji wara t-tqegħid fis-suq, inklużi mewt u sostenn b'ventilatur, kienu assoċjati mal-użu ta' fluoroquinolone f'persuni b'myasthenia gravis.
English: 20 ml clear type I glass vials outfitted with 20 mm type I rubber stoppers and 20 mm flip-off caps.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjetti ta' 20 ml tal-ħġieġ ċar tat-tip I mgħammra b'tappijiet ta' 20 mm tal-lastku tat-tip I u għotjien ta' 20 mm li jinqalgħu malajr.
English: Blood creatine phosphokinase increased
Maltese: Żieda fil-kreatin phosphokinase fid-demm
English: The mean systemic exposure (AUC) increased 2.2-fold, 5.3-fold, 8.5-fold and 29.8-fold for patients with moderate impairment, severe impairment and ESRD with and without haemodialysis after dosing, respectively compared to the normal control group.
Maltese: (AUC) żdiedet 2.2 drabi, 5.3 drabi, 8.5 drabi u 29.8 drabi aktar għal pazjenti b'indeboliment moderat jew sever tal-kliewi jew ESRD bl-emodijalisi jew mingħajrha wara l-għoti tad-doża, rispettivament imqabbla ma' grupp normali ta' kontroll.
English: This medicine contains 175 mg of sodium (main component of cooking salt) in each vial.
Maltese: Din il-mediċina fiha 175 mg ta' sodium (il-komponent prinċipali tal-melħ tat-tisjir) f'kull kunjett.
English: You should not take fluoroquinolone/quinolone antibacterial medicines, including Quofenix, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone.
Maltese: Inti m'għandekx tieħu mediċini antibatteriċi fluoroquinolone/quinolone, inkluż Quofenix, jekk inti kellek kwalunkwe reazzjoniji avversa serja fil-passat meta ħadt quinolone jew fluoroquinolone.
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: sensazzjonijiet mhux normali bhal tnemnim, tingiż, titrix, ħruq, titrix jew uġigħ (newropatija), depressjoni, għejja, disturbi fl-irqad, indeboliment tal-memorja, kif ukoll indeboliment fis-smigħ, fil vista, u fit-togħma u x-xamm kienu assoċjati mal-għoti tal-antibijotiċi quinolone u fluoroquinolone, f'xi każijiet irrispettivament mill-fatturi ta' riskju li jkunu jeżistu minn qabel.
English: Unit dose laminated aluminium/aluminium foil blisters.
Maltese: Folji laminati tal-fojl aluminium/aluminium b'kull doża għaliha waħedha.
English: Gastrooesophageal reflux disease Paraesthesia oral Hypoaesthesia oral Glossodynia
Maltese: Mard ta' rifluss gastroesofagali Parestesija fil-ħalq Ipoestesija fil-ħalq Glossodinja
English: Tendonitis (see section 4.4) Musculoskeletal pain (e.g. pain in extremity, back pain, neck pain), muscle weakness Muscle spasm
Maltese: għadma (ara sezzjoni 4.4) Uġigħ muskoluskeletriku (eż. uġigħ fl-idejn jew issaqajn, uġigħ fid-dahar, uġigħ fl-għonq), dgħufija fil-muskoli
English: • After reconstitution and dilution, Quofenix is to be administered via intravenous infusion, using a total infusion time of 60 minutes.
Maltese: • Wara r-rikostituzzjoni u d-dilwizzjoni, Quofenix għandu jingħata permezz ta' infużjoni filvini, bl-użu tal-ħin totali tal-infużjoni ta' 60 minuta.
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, il-fluoroquinolones għandhom jintużaw biss wara stima b'attenzjoni tal-benefiċċju u rriskju u wara li jitqiesu għażliet terapewtiċi oħra f'pazjenti bi storja pożittiva ta' mard ta' anewriżmu fil-familja, jew f'pazjenti dijanjostikati b'mard ta' anewriżmu tal-aorta u/jew dissezzjoni tal-aorta eżistenti minn qabel, jew fil-preżenza ta' fatturi oħra ta' riskju jew kondizzjonijiet li jippredisponu għal anewriżnu jew dissezzjoni tal-aorta (eż. sindrom Marfan, sindrom vaskulari Ehlers-Danlos, arterite Takayasu, arterite b'formazzjoni ta' ċelluli kbar ħafna (giant cell), marda ta' Behcet, pressjoni għolja, aterosklerożi magħrufa).
English: No dose adjustment is necessary in patients with mild to severe renal impairment (see section 4.4 and 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża ta' pazjenti b'indeboliment minn ħafif sa sever tal kliewi (ara sezzjoni 4.4 u 5.2).
English: 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
Maltese: Każijiet rari ħafna ta' reazzjonijiet avversi serji għall-mediċina, li jieħdu fit-tul (idumu għal xhur jew snin), li jinkapaċitaw u li possibilment huma irriversibbli, li jaffettwaw diversi klassijiet ta' sistemi u ta' organi u sensi, xi drabi aktar minn waħda, (inklużi reazzjonijiet bħal infjammazzjoni fl-għerq li jgħaqqad muskolu ma' għadma, tiċrit tal-għerq li jgħaqqad muskolu ma' għadma, artralġja, uġigħ fl idejn u fis-saqajn, disturb fil-mixi, newropatiji assoċjati ma' parestesija, depressjoni, għeja, indeboliment fil-memorja, disturbi tal-irqad, u indeboliment fis-smigħ, fil-vista, fit-togħma u fix xamm) ġew irrappurtati b'assoċjazzjoni ma' quinolones u fluoroquinolones f'xi każijiet irrispettivament mill-fatturi ta' riskju diġà eżistenti (ara sezzjoni 4.4).
English: Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760
Maltese: Berlin-Chemie/Menarini Polska Sp. z o.o. Tel.: +48 22 566 21 00
English: Contraception
Maltese: MEDIĊINALI
English: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving fluoroquinolone antibacterial medicinal products.
Maltese: Reazzjonijiet serji u kultant fatali ta' sensittività eċċessiva (anafilattiċi) ġew irrappurtati f'pazjenti li kienu qed jirċievu prodotti mediċinali antibatteriċi li fihom fluoroquinolone.
English: The glucuronidation of delafloxacin is mediated mainly by UGT1A1,UGT1A3 and UGT2B15.
Maltese: Il-biċċa l-kbira tal-glukuronidazzjoni ta' delafloxacin hija medjata minn UGT1A1, UGT1A3 u UGT2B15.
English: Fluoroquinolone-insusceptible microorganisms may result in superinfection with the use of delafloxacin.
Maltese: Mikroorganiżmi mhux suxxettibbli għal fluoroquinolone jistgħu jwasslu għal infezzjoni fuq oħra blużu ta' delafloxacin.
English: You should not be given fluoroquinolone/quinolone antibacterial medicines, including Quofenix, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone.
Maltese: Qabel tingħata din il-mediċina Inti m'għandekx tingħata mediċini antibatteriċi fluoroquinolone/quinolone, inkluż Quofenix, jekk inti kellek kwalunkwe reazzjoniji avversa serja fil-passat meta ħadt quinolone jew fluoroquinolone.
English: Each tablet contains 450 mg of delafloxacin (as meglumine).
Maltese: Kull pillola fiha 450 mg ta' delafloxacin (bħala meglumine).
English: As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported (see section 4.8), usually in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g., glibenclamide) or with insulin.
Maltese: Bħal ma jiġri bil-quinolones kollha, ġew irrappurtati disturbi fil-glukożju fid-demm, inklużi kemm ipogliċemija u ipergliċemija (ara sezzjoni 4.8), ġeneralment f'pazjenti dijabetiċi li jkunu qed jirċievu tarattament b'sustanza ipogliċemika mill-ħalq (eż., glibenclamide) jew insulina fl-istess waqt.
English: Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with other fluoroquinolones.
Maltese: Każijiet ta' reazzjonijiet bl-infafet fil-ġilda bħas-sindrom ta' Stevens-Johnson jew nekroliżi tossika talepidermide ġew irrappurtati bi fluoroquinolones oħra.
English: This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in 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 fl-għeruq li jgħaqqdu l-muskolu ma' għadma, fil-muskoli u filġogi tar-riġlejn u d-dirgħajn, diffikultà fil-mixi, sensazzjonijiet mhux normali bħal tnemnim, tingiż, tagħrix, titrix jew ħruq (parestesija), disturbi fis-sensi inklużi indeboliment fil-vista, fit-togħma u fixxamm, u fis-smigħ, depressjoni, indeboliment fil-memorja, għeja severa u disturbi severi fl-irqad.
English: Dermatitis allergic Urticaria
Maltese: TAL-PRODOTT MEDIĊINALI
English: • The required dose of Quofenix reconstituted solution should be aseptically transferred from the vial to a 250 mL intravenous bag.
Maltese: • Id-doża meħtieġa, ta' soluzzjoni ta' Quofenix rikostitwit għandha tiġi trasferita b'mod asettiku mill-kunjett għal borża tal-infużjoni ta' 250 mL.
English: • Muscle and musculoskeletal pain (e.g. pain in extremity, back pain, neck pain), muscle weakness
Maltese: • Uġigħ fil-muskoli u muskoluskeletriku (eż. uġigħ fid-dirgħajn u r-riġlejn, uġigħ fid-dahar,
English: How to store Quofenix
Maltese: Tiħux Quofenix:
English: Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis.
Maltese: L-irbit ta' delafloxacin mal-proteini tal-plasma ma jiġix affetwat b'mod sinifikanti mill-grad ta' indeboliment tal-kliewi.
English: The following adverse reactions have been identified in four comparative ABSSSI Phase 2 and 3 studies classified by preferred term and System Organ Class, and by frequency.
Maltese: kklassifikati skont it-terminu preferut u l-Klassi tas-Sistemi u tal-Organi, u skont il-frekwenza.
English: Tendonitis (see section 4.4) Musculoskeletal pain (e.g. pain in extremity, back pain, neck pain), muscle weakness
Maltese: għadma (ara sezzjoni 4.4) Uġigħ muskoluskeletriku (eż. uġigħ fl-idejn jew is-saqajn, uġigħ fid-dahar, uġigħ fl-għonq),
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal
English: You will be given one infusion of Quofenix, containing 300 mg of the medicine, twice a day between 5 and 14 days at the discretion of your doctor.
Maltese: Inti se tingħata infużjoni waħda ta' Quofenix, li jkun fiha 300 mg tal-mediċina, darbtejn kuljum għal bejn 5 u 14-il jum skont id-deċiżjoni tat-tabib tiegħek.
English: - Difficulty in swallowing or difficulty in breathing and cough; swelling of your lips, face, throat or tongue; dry throat or throat tightening and severe rash.
Maltese: - Uġigħ fl-addome (ta' żaqq) bil-possibiltà ta' dijarea severa; deni u dardir.
English: Chills
Maltese: Gass
English: Sinusitis
Maltese: Anzjani
English: Dysgeusia
Maltese: Disgliċemija
English: Before initiating therapy with Quofenix, careful inquiry should be made about previous hypersensitivity reactions to other quinolone or fluoroquinolone antibacterial medicinal products.
Maltese: Qabel tibda' terapija bi Quofenix, għandu jintalab tagħrif dwar reazzjonijiet preċedenti ta' sensitittività eċċessiva għal prodotti mediċinali antibatteriċi oħra ta' quinolone jew fluoroquinolone.
English: In the two major trials in ABSSSI the types of infections treated were confined to cellulitis/erysipelas, abscesses and wound infections only.
Maltese: Fiż-żewġ provi kbar f'ABSSSI it-tipi ta' infezzjonijiet trattati kienu limitati għal ċellulite/irsipli, axxess u infezzjonijiet fil-feriti biss.
English: How to take Quofenix
Maltese: Quofenix.
English: The mean peak exposure (Cmax) increased about 2-fold, 5-fold and 7-fold for patients with severe impairment and ESRD with and without haemodialysis after dosing, respectively compared to the normal control group.
Maltese: 5 darbiet u 7 darbiet aktar għal pazjenti b'indeboliment sever u ESRD bl-emodijalisi jew mingħajrha wara l-għoti tad-doża, rispettivament imqabbla mal-grupp normali ta' kontroll.
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for delafloxacin are as follows:
Maltese: stabbilita mill-Kumitat Ewropew għall-Ittestjar tas-Suxxettibbiltà Antimikrobjali (EUCASTEuropean Committee on Antimicrobial Susceptibility Testing) għal delafloxacin huma kif ġej:
English: Each vial of powder contains 300 mg of delafloxacin (as meglumine).
Maltese: Kull kunjett ta' trab fih 300 mg ta' delafloxacin (bħala meglumine).
English: Delafloxacin is excreted both unchanged and as glucuronide metabolites in urine.
Maltese: Delafloxacin jitneħħa kemm mhux mibdul kif ukoll bħala metaboliti glucuronide fl-awrina.
English: Each tablet contains 450 mg of delafloxacin (as meglumine)
Maltese: Kull pillola fiha 450 mg ta' delafloxacin (bħala meglumine)
English: Flatulence
Maltese: Ipoestesija
English: Available pharmacodynamic/toxicological data in animals have shown excretion of delafloxacin/metabolites in milk (see section 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' delafloxacin/metaboliti fil-ħalib tas-sider (ara sezzjoni 5.3). Ir-riskju gћat-trabi tat-twelid mhux eskluż.
English: The recommended dose is 450 mg oral every 12 hours for a total duration of 5 to 14 days at the discretion of your doctor.
Maltese: Id-doża rrakkomandata hija 450 mg mill-ħalq kull 12-il siegħa għal tul totali ta' żmien ta' 5 ijiem sa 14-il jum skont id-deċiżjoni tat-tabib tiegħek.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Quofenix in all subsets of the paediatric population in the treatment of local infections of skin and subcutaneous tissues (see section 4.2 for information on paediatric use).
Maltese: Quofenix f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fit-trattament ta' infezzjonijiet lokali tal-ġilda u tat-tessuti ta' taħt il-ġilda (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku). 5
English: If this happens, stop taking Quofenix and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
Maltese: Jekk dan jiġri, waqqaf Quofenix u kkuntattja lit-tabib tiegħek immedjatament sabiex tevita l iżvilupp ta' kundizzjoni possibilment irriversibbli.
English: Hepatic impairment No dosage adjustment is necessary (see section 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustment fid-doża (ara sezzjoni 5.2).
English: The reconstituted solution must be then diluted in 250mL IV bag (either 0.9% Sodium Chloride Injection or D5W) prior to administration.
Maltese: Is-soluzzjoni rikostitwita għandha mbagħad tiġi dilwita f'borża ta' 250 mL IV (ta' Injezzjoni ta' 0.9% Sodium Chloride jew inkella D5W) qabel ma tingħata.