FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH provided all data available for this indication namely, in vitro data, non-clinical data, pharmacokinetic data and data published by the US Centers of Disease Control and Prevention (CDC) and proposed an harmonised indication.
Maltese: Il-MAH ipprovda d-dejta kollha disponibbli għal din l-indikazzjoni, speċjalment dejta in vitro, dejta mhux klinika, dejta farmakokinetika u dejta ppubblikata miċ-Ċentri tal-Istati Uniti ta' Kontroll u Prevenzjoni tal-Mard (CDC) u ppropona indikazzjoni armonizzata.
English: Skin and Soft Tissue Infections (SSTIs)
Maltese: Infezzjonijiet fil-Ġilda u t-Tessut Artab (SSTIs)
English: The harmonised SmPC wording agreed for the prostatitis indication was: “Chronic bacterial prostatitis”.
Maltese: It-test armonizzat tal-SmPC li sar qbil dwaru għall-indikazzjoni ta' prostatite kien: “Prostatite batterjali kronika”.
English: These concentrations provide sufficient bactericidal activity on bacterial strains with sensitivity level up to 0.5-1 mg/l.
Maltese: Dawn ilkonċentrazzjonijiet jipprovdu biżżejjed attività batteriċidjali fuq razez batterjali b'livell ta' sensittività sa 0.5-1 mg/l.
English: Uncomplicated cystitis (see section 4.4)
Maltese: • Ċistite mhux ikkumplikata (ara sezzjoni 4.4)
English: In this regard, it is noted that the 500 mg dosage given once daily by oral route allow to reach a plasmatic peak concentration (Cmax) as of 5 to 6 mg/l and a Cmax/MIC ratio of 10-12 and an AUC of approximately 50 mg.h/l corresponding to an AUC/MIC ratio as of 50-100.
Maltese: F'dan ir-rigward, huwa osservat li ddożaġġ ta' 500 mg mogħti darba kuljum b'rotta orali jippermetti sabiex tintlaħaq konċentrazzjoni plasmatika massima (Cmax) ta' 5 sa 6 mg/l u proporzjon ta' Cmax/MIC ta' 10-12 u AUC ta' bejn wieħed u ieħor 50 mg.h/l li tikkorrispondi għal proporzjon ta' AUC/MIC ta' 50-100.
English: The harmonised warning on QT interval prolongation was amended in line with the updated recommendation from the CHMP' pharmacovigilance working party dated 16 April 2012 with regards fluoroquinolones and risk of QT-interval prolongation.
Maltese: It-twissija armonizzata dwar prolungament tal-intervall QT ġiet emendata b'konformità marrakkomandazzjoni aġġornata mill-grupp ta' ħidma dwar il-farmakoviġilanza tas-CHMP datata s-16 ta' April 2012 fir-rigward ta' fluorokwinoloni u r-riskju ta' prolungament tal-interval QT.
English: • PN and cUTIs (tablets and IV solution): 250 - 500 mg once daily for 7-10 days;
Maltese: • PN u cUTIs (pilloli u soluzzjoni IV): 250 - 500 mg darba kuljum għal 7-10 ijiem;
English: Based on the review of data the CHMP adopted a harmonised Module 3.
Maltese: Fuq il-bażi tal-analiżi tad-dejta, is-CHMP adotta Modulu 3 armonizzat.
English: The MAH submitted a proposal for harmonisation of the Quality module.
Maltese: Il-MAH ippreżenta proposta għal armonizzazzjoni tal-modulu dwar il-Kwalità.
English: Since the granting of this indication in the EU, twenty two additional studies have become available including 4 recent trials of levofloxacin used as a comparator versus tigecycline (2 studies), docycycline (one study) and nemonoxacin (one study).
Maltese: Sa mill-għoti ta' din l-indikazzjoni fl-UE, saru disponibbli tnejn u għoxrin studju addizzjonali, inklużi 4 provi kliniċi riċenti ta' levofloxacin użat bħala paragun versus tigecycline (2 studji), docycycline (studji wieħed) u nemonoxacin (studju wieħed).
English: • AECB (tablets only): 250 - 500 mg once daily for 7 - 10 days;
Maltese: • AECB (pilloli biss): 250 - 500 mg darba kuljum għal 7 - 10 ijiem;
English: • “Palpitation” and “ventricular tachycardia which may result in cardiac arrest” supported by data from clinical trials and post-marketing data provided by the MAH;
Maltese: • “Palpitazzjoni” u “takikardija ventrikulari li tista' tirriżulta f'arrest kardijaku” appoġġjata minn dejta minn provi kliniċi u dejta ta' wara t-tqegħid fis-suq ipprovduta mill-MAH;
English: The Core Safety Profile (CSP) approved as an outcome of the PSUR work-sharing procedure finalised on 1 April 2011 was considered.
Maltese: Ġie ikkunsidrat il-Profil tas-Sigurtà Ewlenija (CSP) approvat bħala eżitu tal-proċedura ta' qsim taxxogħol tal-PSUR iffinalizzata fl-1 ta' April 2011.
English: • Inhalation Anthrax: postexposure prophylaxis and curative treatment (see section 4.4).
Maltese: • Anthrax bin-nifs: profilassi ta' wara l-espożizzjoni u trattament kurattiv (ara sezzjoni 4.4).
English: Complicated UTIs (cUTIs) including pyelonephritis (PN), has been submitted and approved in all except one EU MS, where only the indication for acute pyelonephritis (APN) was approved.
Maltese: UTIs ikkumplikati (cUTIs) inkluża pjelonefrite (PN), ġew sottomessi u approvati fl-SM kollha tal-UE minbarra wieħed, fejn ġiet approvata biss l-indikazzjoni għal pjelonefrite akuta (APN).
English: Levofloxacin is approved in the most three common RTIs indications: acute bacterial sinusitis (ABS), acute exacerbation of chronic bronchitis (AECB) and community-acquired pneumonia (CAP).
Maltese: Levofloxacin huwa approvat fl-aktar tliet indikazzjonijiet komuni ta' RTIs: sinożite batterjali akuta (ABS), aggravazzjoni akuta ta' bronkite kronika (AECB) u pulmonite meħuda mill-komunità (CAP).
English: It is noted that fluoroquinolones, including levofloxacin are not recognised as reference treatment for staphylococci and streptococci.
Maltese: Huwa osservat li fluorokwinoloni, inkluż levofloxacin mhumiex rikonoxxuti bħala trattament ta' referenza għal stafilokokki u streptokokki.
English: Inhalation Anthrax
Maltese: Anthrax bin-nifs
English: In this harmonisation procedure the MAH claimed for RTIs indications (restricted), SSTIs, complicated and uncomplicated UTIs, chronic bacterial prostatitis and anthrax treatment.
Maltese: F'din ilproċedura ta' armonizzazzjoni, il-MAH talab indikazzjonijiet għal RTIs (ristretti), SSTIs, UTIs ikkumplikati u mhux ikkumplikati, prostatite batterjali kronika u trattament ta' anthrax.
English: • ABS (tablets only): 500 mg once daily for 10-14 days of treatment;
Maltese: • ABS (pilloli biss): 500 mg darba kuljum għal 10-14-il jum ta' trattament;
English: The CHMP noted the MAH proposal for an harmonised text for this section.
Maltese: Is-CHMP osserva l-proposta tal-MAH għal test armonizzat għal din is-sezzjoni.
English: Further amendment was agreed with regards the duration of treatment for pyelonephritis and for cUTIs to be in line with the European Association of Urology (EAU) guidelines 2010 recommendations for levofloxacin treatment duration of 7-10 days for acute uncomplicated pyelonephritis, and 7-14 days (IV followed by possible oral switch) for severe cases (EAU guidelines 2010).
Maltese: Sar qbil dwar emenda oħra fir-rigward tad-dewmien tat-trattament għal pjelonefrite u għal cUTIs sabiex ikun hemm konformità mar-rakkomandazzjonijiet fil-linji gwida tal-2010 tal-Assoċjazzjoni Ewropea tal-Uroloġija (EAU) għad-dewmien tat-trattament b'levofloxacin ta' 7-10 ijiem għal pjelonefrite akuta mhux ikkumplikata, u 7-14-il jum (IV segwita minn bidla orali possibbli) għal każijiet severi (linji gwida tal-EAU tal-2010).
English: This amendment is based on a newly submitted analysis showing that elderly are more vulnerable for tendon injury if received daily 1000 mg compared to 750 mg, epidemiologic studies, additional risk in renal impaired patients without dose adjustment and taking into account the biological plausibility of dose dependent cytotoxicity of fluoroquinolones these findings suggests that dosages of 1000 mg per day are an additional risk factor for tendon injuries.
Maltese: Din l-emenda hija bbażata fuq analiżi sottomessa riċentement li turi li l-anzjani huma aktar vulnerabbli għal feriti fittendon jekk jirċievu 1000 mg kuljum meta mqabbla ma' 750 mg, studji epidemjoloġiċi, riskju addizzjonali f'pazjenti b'indeboliment renali mingħajr aġġustament tad-doża u jekk tittieħed f'kunsiderazzjoni l-plawżibbiltà bijoloġika ta' ċitotossiċità dipendenti fuq id-doża ta' fluorokwinoloni, dawn is-sejbiet jissuġġerixxu li d-dożaġġi ta' 1000 mg kuljum huma fattur ta' riskju addizzjonali għal feriti fit-tendon.
English: • Pyelonephritis and complicated urinary tract infections (see section 4.4)
Maltese: • Pjelonefrite u infezzjonijiet ikkumplikati fl-apparat tal-awrina (ara sezzjoni 4.4)
English: Taking into account these considerations, and that the limited number of available guidelines currently recommend fluoroquinolones only in specific and complicated conditions e.g. polymicrobial infections involving Gram-negative organisms, the MAH agreed to amend the initially proposal for (“Skin and soft tissue infections when commonly recommended antibacterial agents are considered inappropriate for the treatment of this infection”) to reflect the current practice that levofloxacin should be indicated only for complicated SSTIs as an alternative (i.e. second line treatment) when recommended antibacterial agents are considered inappropriate for the treatment of this infection.
Maltese: Meta jitqiesu dawn il-kunsiderazzjonijiet, u l-fatt li n-numru limitat ta' linji gwida attwalment disponibbli jirrakkomandaw fluorokwinoloni biss f'kundizzjonijiet speċifiċi u kkumplikat, eż. infezzjonijiet polimikrobjali li jinvolvu organiżmi Gramnegattivi, l-MAH qabel li jemenda l-proposta inizjali għal (“Infezzjoni fil-ġilda u t-tessut artab meta l-sustanzi antibatterjali rrakkomandati b'mod komuni jitqiesu mhux xierqa għat-trattament ta' din l-infezzjoni”) sabiex tiġi riflessa l-prattika attwali li levofloxacin għandu jiġi indikat biss għal SSTIs ikkumplikati bħala alternattiva (jiġifieri trattament tat-tieni linja) meta sustanzi antibatterjali rakkomandati jitqiesu mhux xierqa għat-trattament ta' din l-infezzjoni.
English: The proposed harmonised lower dosage for AECB and for cSSTIs of 250 mg was further discussed in light of pharmacokinetic/pharmacodinamic profile of levofloxacin, the nature of infection and the most probable causative bacterial agent.
Maltese: Id-dożaġġ armonizzat aktar baxx li ġie propost għal AECB u għal cSSTIs ta' 250 mg ġie diskuss ulterjorment fid-dawl tal-profil farmakokinetiku/farmakodinamiku ta' levofloxacin, in-natura talinfezzjoni u l-aktar aġent batterjali probabbilment kawżattiv.
English: The harmonised warning on dysglycaemia was further amended in light of the recent reported cases of hypoglycaemic coma with fluoroquinolon agents.
Maltese: It-twissija armonizzata dwar disglikemija ġiet emendata ulterjorment fid-dawl tal-każijiet irraportati b'mod riċenti ta' koma ipoglikemika b'sustanzi ta' fluorokwinolon.
English: The European Respiratory Society guideline (ERS, 2005) proposes levofloxacin as an alternative antibiotic for both hospital and community management of AECB with no risk factors for P. aeruginosa.
Maltese: Il-linja gwida tas-Soċjetà Respiratorja Ewropea (ERS, 2005) tipproponi levofloxacin bħala antibijotiku alternattiv kemm għall-ġestjoni tal-isptar kif ukoll tal-komunità ta' AECB b'ebda fattur ta' riskju għal P. aeruginosa.
English: Tavanic is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):
Maltese: Tavanic huwa indikat f'adulti għat-trattament tal-infezzjonijiet li ġejjin (ara sezzjonijiet 4.4 u 5.1):
English: Package Leaflet (PL)
Maltese: reġistrazzjoni).
English: • Complicated skin and soft tissue infections
Maltese: • Infezzjonijiet ikkumplikati fil-ġilda u t-tessut artab
English: Namely, the inclusion of bacteroides sp. other than B. fragilis was removed due to the natural intermediate susceptibility to levofloxacin.
Maltese: Primarjament, tneħħiet l-inklużjoni ta' bacteroides sp. li mhumiex B. fragilis minħabba s-suxxettibbiltà intermedja naturali għal levofloxacin.
English: The harmonised therapeutic indications for Tavanic, film coated tablets 250 mg and 500 mg and for solution for infusion 5mg/ml which have been agreed are:
Maltese: L-indikazzjonijiet terapewtiċi armonizzati għal Tavanic, pilloli miksija b'rita 250 mg u 500 mg u għas-soluzzjoni għal infużjoni 5 mg/ml li sar qbil dwarhom huma:
English: It was further agreed that consideration should be given to the European guidelines whereby quinolones are only recommended as first line therapy if the resistance rate for E. coli (responsible for 70-80% of all UTIs caused by Gram-negative) is below 10%.
Maltese: Sar qbil ukoll li għandha tingħata kunsiderazzjoni għal-linji gwida Ewropej li skont dawn, kwinoloni huma rakkomandati biss bħala terapija tal-ewwel linja jekk ir-rata ta' reżistenza għal E. coli (responsabbli għal 70-80% tal-UTIs kollha kkawżati minn Gram-negattivi) tkun taħt l-10%.
English: Therefore, levofloxacin is active against a diverse range of common causative pathogens for sinusitis, acute exacerbation of chronic bronchitis (AECB), community-acquired pneumonia (CAP), urinary tract infections (UTIs) and skin and soft tissue infections (SSTIs).
Maltese: Għaldaqstant, levofloxacin huwa attiv kontra firxa wiesgħa ta' patoġeni kawżattivi komuni għassinużite, aggravazzjoni akuta ta' bronkite kronika (AECB), pulmonite meħuda mill-komunità (CAP), infezzjonijiet fl-apparat tal-awrina (UTIs) u infezzjonijiet fil-ġilda u fit-tessut artab (SSTIs).
English: The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) endorses the “Guideline for the management of adult lower respiratory tract infections” that establishes quinolones as second-choice treatment in case of clinically relevant pneumococcal resistance against amoxicillin and tetracyclines, or major intolerance.
Maltese: Is-Soċjetà Ewropea għall-Mikrobijoloġija Klinika u l-Mard Infettiv (ESCMID) tapprova l-“Linja gwida għall-ġestjoni ta' infezzjonijiet fl-apparat respiratorju inferjuri tal-adulti” li tistabbilixxi kwinoloni bħala trattament tat-tieni preferenza fil-każ ta' reżistenza pnewmokokkali klinikament relevanti kontra amoxicillin u tetracyclines, jew intolleranza kbira.
English: A general consideration to be taken into account is that ABS is generally a non-severe infection associated with high spontaneous cure rates (90%).
Maltese: Kunsiderazzjoni ġenerali li trid titqies hija li l-ABS hija ġeneralment infezzjoni mhux severa assoċjata ma' rati għoljin ta' kura spontanja (90%).
English: A 750 mg strength in film coated tablet and as solution for infusion 750 mg/150 ml was approved in some MS.
Maltese: F'xi SM, ġiet approvata saħħa ta' 750 mg f'pillola miksija b'rita u soluzzjoni għal infużjoni ta' 750 mg/150 ml.
English: • Community-acquired pneumonia
Maltese: • Pulmonite meħuda mill-komunità
English: Inhalation Anthrax: postexposure prophylaxis and curative treatment (see section 4.4)
Maltese: • Anthrax bin-nifs: profilassi ta' wara l-espożizzjoni u trattament kurattiv (ara sezzjoni 4.4)
English: The general text of frequencies classification, and the adverse reaction obtained from post-marketing experience were clarified, and the frequency of a number of events was revised.
Maltese: Ġew iċċarati t-test ġenerali ta' klassifikazzjoni tal-frekwenzi u r-reazzjoni avversa miksuba millesperjenza ta' wara t-tqegħid fis-suq, u ġiet reveduta l-frekwenza ta' numru ta' avvenimenti.
English: Worldwide, levofloxacin was first approved in 1993 in Japan followed by the United States in 1996.
Maltese: Madwar id-dinja, levofloxacin ġie approvat għall-ewwel darba fl-1993 fil-Ġappun segwit mill-Istati Uniti fl-1996.
English: The proposed harmonised warning on G-6-PD deficiency was supported by a review provided by the MAH on all G6PD cases and no new safety information was found.
Maltese: It-twissija armonizzata proposta dwar defiċjenza ta' G-6-PD ġiet appoġġjata minn analiżi pprovduta mill-MAH dwar il-każijiet kollha ta' G6PD u ma nstab ebda tagħrif ġdid dwar is-sigurtà.
English: • cSSTIs (tablets): 250mg once daily or 500 mg once or twice daily for 7 to 14 days;
Maltese: • cSSTIs (pilloli): 250mg darba kuljum jew 500 mg darba jew darbtejn kuljum għal 7 sa 14-il jum;
English: Antibiotic therapy is indicated and usually starts empirically, covering typical organisms with or without atypical organisms.
Maltese: It-terapija antibijotika hija indikata u ġeneralment tibda b'mod empiriku, filwaqt li tkopri organiżmi tipiċi b'organiżmi atipiċi jew mingħajrhom.
English: • CAP (tablets and IV solution): 500 mg once or twice daily for 7 - 14 days;
Maltese: • CAP (pilloli u soluzzjoni IV): 500 mg darba jew darbtejn kuljum għal 7 - 14-il jum;
English: Chronic bacterial prostatitis (or ‘prostatitis') is an approved indication for levofloxacin in all MS with exception for two MS.
Maltese: Prostatite batterjali kronika (jew ‘prostatite') hija indikazzjoni approvata għal levofloxacin fl-SM kollha minbarra tnejn.
English: The MAH voluntarily withdrew the marketing authorisation (MA) for the 750 mg film coated tablets and varied the terms of the MAs for the solution for infusion to remove the 150 ml presentation during this referral procedure.
Maltese: L-MAH irtira l-awtorizzazzjoni għat-tqegħid fis-suq (MA) b'mod volontarju għall-pilloli miksija b'rita ta' 750 mg u varja t-termini tal-MAs għas-soluzzjoni għal infużjoni sabiex titneħħa l-preżentazzjoni ta' 150 ml matul din il-proċedura ta' riferiment.
English: The SPC harmonisation considered all relevant therapeutic and regulatory guidelines in the EU.
Maltese: L-armonizzazzjoni tal-SPC qieset il-linji gwida terapewtiċi u regolatorji relevanti kollha fl-UE.
English: Betalactams, macrolides and antipneumococcal fluoroquinolones are the most commonly used antibiotics for the treatment of CAP, as monotherapy or in combination, depending on the patient risks and the severity.
Maltese: Betalactams, makrolidi u fluorokwinoloni antipnewmokokkali huma l-aktar antibijotiċi użati b'mod komuni għat-trattament ta' CAP, bħala monoterapija jew f'taħlita, skont ir-riskji tal-pazjent u s-severità.
English: In this regard a recent published epidemiologic study revealed an increased risk (OR 4.5) of fluoroquinolones for retinal detachment.
Maltese: F'dan irrigward, studju epidemjoloġiku ppubblikat b'mod riċenti wera riskju miżjud (OR 4.5) ta' fluorokwinoloni għal qlugħ retinali.
English: The discrepancies in this section regarded the use during pregnancy and in patients with glucose-6phosphate dehydrogenase (G6PD) deficiency (divergence in one MS).
Maltese: Id-diskrepanzi f'din is-sezzjoni kienu jikkonċernaw l-użu matul it-tqala u f'pazjenti b'defiċjenza ta' glucose-6-phosphate dehydrogenase (G6PD) (diverġenza f'SM wieħed).
English: The CAP indication is approved for both tablets and IV formulation of levofloxacin.
Maltese: Din l-indikazzjoni hija approvata kemm għal pilloli kif ukoll għall-formulazzjoni IV ta' levofloxacin.
English: Tavanic solution for infusion is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):
Maltese: Tavanic soluzzjoni għal infużjoni huwa indikat f'adulti għat-trattament tal-infezzjonijiet li ġejjin (ara sezzjonijiet 4.4 u 5.1):
English: In this case, “alternative” is defined as: to be used in case of hypersensitivity to a preferred drug or widespread prevalence of clinically relevant resistance in the population being treated.
Maltese: F'dan il-każ, “alternattiv” huwa definit bħala: li jintuża f'każ ta' sensittività eċċessiva għal mediċina ppreferuta jew prevalenza mifruxa ta' reżistenza klinikament relevanti fil-popolazzjoni ttrattata.
English: The pivotal study was CAPSS-101, a large registration study that showed levofloxacin to be equivalent to ciprofloxacin in well-documented chronic bacterial prostatitis, and these data have ever since been supplemented by two published studies.
Maltese: L-istudju pivotali kien CAPSS-101, studju ta' reġistrazzjoni kbir li wera li levofloxacin huwa ekwivalenti għal ciprofloxacin fi prostatite batterjali kronika dokumentata sew, u minn dak iż-żmien, din id-dejta ġiet issupplimentata b'żewġ studji ppubblikati.
English: The pivotal study was study LOFBO-UTI-060: A multicenter, double-blind, randomized study to compare the safety and efficacy of oral levofloxacin with that of Floxin (ofloxacin) in the treatment of uncomplicated urinary tract infections in women.
Maltese: Studju multiċentriku, ‘double-blind' u aleatorju biex jitqabblu s-sigurtà u l-effikaċja ta' levofloxacin orali ma' dawk ta' Floxin (ofloxacin) fit-trattament ta' infezzjonijiet mhux ikkumplikati fl-apparat tal-awrina fin-nisa.
English: The warning on exacerbation of myasthenia gravis included in the CSP was revised based on the cumulative safety review presented by the MAH during this referral procedure.
Maltese: It-twissija fuq aggravazzjoni ta' majastenija gravi inkluża fis-CSP ġiet riveduta fuq il-bażi ta' analiżi tas-sigurtà kumulattiva ppreżentata mill-MAH matul din il-proċedura ta' riferiment.
English: • Uncomplicated cystitis (tablets only): 250 mg once daily for 3 days;
Maltese: • Ċistite mhux ikkumplikata (pilloli biss): 250 mg darba kuljum għal 3 ijiem;
English: The CSP was considered when harmonising the listed adverse reactions between national SmPCs of Tavanic.
Maltese: Ġie kkunsidrat isCSP matul l-armonizzazzjoni tar-reazzjonijiet avversi elenkati bejn l-SmPCs nazzjonali ta' Tavanic.
English: Thus, the outcome of this referral procedure does not include any evaluation of levofloxacin 750 mg.
Maltese: Għalhekk, l-eżitu ta' din il-proċedura ta' riferiment ma tinkludi ebda evalwazzjoni ta' levofloxacin 750 mg.
English: Uncomplicated urinary tract infections (uUTIs)
Maltese: Infezzjonijiet mhux ikkumplikati fl-apparat tal-awrina (uUTIs)
English: Urinary tract infections (UTIs)
Maltese: Infezzjonijiet fl-apparat tal-awrina (UTIs)
English: • Benign intracranial hypertension, in line with recent labelling changes made in the US in April 2012 for levofloxacin; These cases should be kept under closely monitoring and further discussed in future PSURs.
Maltese: • Pressjoni intrakranjali għolja beninna, b'konformità mal-bidliet riċenti fit-tikkettar li saru flIstati Uniti f'April 2012 għal levofloxacin;
English: All MRP SmPCs list “Acute bacterial sinusitis” in the indication section and also specified “(adequately diagnosed according to national and/or local guidelines on the treatment of respiratory tract infections)”.
Maltese: Kull SmPC tal-MRP jelenka s-“Sinożite batterjali akuta” fis-sezzjoni ta' indikazzjoni u speċifikaw ukoll “(adegwatament djanjostikata skont il-linji gwida nazzjonali u/jew lokali dwar it-trattament ta' infezzjonijiet fl-apparat respiratorju)”.
English: In addition the warning section of the SmPC now refers to the co-resistance of the fluroquinolones including levofloxacin to MRSA.
Maltese: Barra minn hekk, is-sezzjoni tat-twissijiet tal-SmPC issa tirreferi għall-koreżistenza talfluorokwinoloni, inkluż levofloxacin, għall-MRSA.
English: Overall, levofloxacin showed to be at least as effective as other treatment recommended as first-line options, e.g. intravenous ceftriaxone and/or oral cefuroxime axetil plus macrolides and also to amoxicillin/clavulanic acid.
Maltese: B'mod ġenerali, intwera li bħala minimu, levofloxacin huwa effettiv daqs trattament ieħor rakkomandat bħala għażla tal-ewwel linja, eż. ceftriaxone ġolvina u/jew cefuroxime axetil orali ma' makrolidi u anki għal amoxicillin/aċidu klavulaniku.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product (and its associated names), the European Commission notified the CHMP/EMA Secretariat of an official referral under Article 30 of Directive 2001/83/EC as amended in order to resolve divergences amongst the nationally authorised PIs and thus to harmonise its divergent PIs across the European Union.
Maltese: Minħabba d-deċiżjonijiet nazzjonali meħuda mill-Istati Membri dwar l-awtorizzazzjoni tal-prodott imsemmi hawn fuq (u ismijiet assoċjati), il-Kummissjoni Ewropea nnotifikat lisSegretarjat tas-CHMP/EMA dwar riferiment uffiċjali skont l-Artikolu 30 tad-Direttiva 2001/83/KE kif emendata sabiex jiġu solvuti d-diverġenzi bejn il-PIs awtorizzati fil-livelli nazzjonali u għalhekk sabiex jiġu armonizzati l-PIs li jvarjaw madwar l-Unjoni Ewropea.