FrancophonIA/ELRC3.0 huggingface dataset:
English: Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see section 4.4).
Maltese: Ġiet osservata amoxicillin crystalluria, li f'xi każi wasslet għal insuffiċjenza renali (ara sezzjoni 4.4).
English: Overall, the indication is well-established and the CHMP concluded that the indication should be limited to “acute otitis media”.
Maltese: B'mod ġenerali, l-indikazzjoni hija stabbilita sew u l-CHMP ikkonkluda li l-indikazzjoni għandha tiġi limitata għal “otitis media akuta”.
English: The MAH concluded that the PK/PD data supports the continued use of 2:1 oral formulation and that it continues to be active for many pathogens.
Maltese: Il-MAH ikkonkluda li d-dejta tal-PK/PD tappoġġa l-użu kontinwu tal-formulazzjoni orali 2:1 u li tkompli tkun attiva għal bosta patoġeni.
English: “Augmentin is indicated for the treatment of community-acquired pneumonia in adults and adolescents aged at least 16 years, caused or thought likely to be caused by penicillin-resistant Streptococcus pneumoniae (see section 5.1).
Maltese: “Augmentin huwa indikat għat-trattament ta' pnewmonja li tittieħed mill-komunità fl-adulti u fladoloxxenti li għandhom mill-inqas 16-il sena, ikkawżata jew maħsuba li hi x'aktarx ikkawżata minn Streptococcus pneumoniae reżistenti għall-peniċillina (ara sezzjoni 5.1).
English: Lower Respiratory Tract Infections and Acute Bronchitis According to guidelines, antibiotic treatment should be considered in patients with LRTI in the following situations: suspected or definite pneumonia, selected exacerbations of chronic obstructive pulmonary disease, patients aged > 75 years and fever, cardiac failure, diabetes mellitus and serious neurological disorder.
Maltese: Infezzjonijiet tal-Parti t'Isfel tal-Apparat Respiratorju u Bronkite Akuta Skont linji gwida, it-trattament antibijotiku għandu jiġi kkunsidrat għall-pazjenti b'LRTI (Lower Respiratory Tract Infections - Infezzjonijiet tal-Parti t'Isfel tal-Apparat Respiratorju) fissitwazzjonijiet li ġejjin: pnewmonja suspetta jew definita, taħrix speċifiku ta' mard ostruttiv kroniku tal-pulmun, pazjenti ta' età ta' > 75 u deni, kollass tal-qalb, diabetes mellitus u disturb newroloġiku serju.
English: The MAH provided extensive justifications to retain the indication acute bacterial sinusitis (ABS).
Maltese: Il-MAH ipprovda ġustifikazzjonijiet estensivi għaż-żamma tal-indikazzjoni sinużite batterjali akuta (ABS).
English: Additionally, a BID regimen of the 5:1 ratio in adults (≥40kg) would not provide the appropriate PK/PD and the pharmacokinetic parameters for a 1.2 g intravenous dose have not been determined.
Maltese: BID tal-proporzjon 5:1 fl-adulti (≥40kg) ma jipprovdix il-PK/PD xieraq u l-parametri għal doża minn ġol-vina ta' 1.2 g ma ġewx iddeterminati.
English: • Gastrointestinal tract
Maltese: • L-apparat gastro-intestinali
English: The MAH listed the currently approved indications, discussing in particular its use in SSTIs and recurrent tonsillitis, otitis media, sinusitis, LRTIs and UTIs, as well as URTIs and genito-urinary tract infections, and discussed the PK/PD, demonstrating the bacteriological equivalence of the BID and TID formulations.
Maltese: Il-MAH elenka l-indikazzjonijiet approvati attwalment, filwaqt li ddiskuta b'mod partikolari l-użu tiegħu fl-SSTIs u fit-tonsillite rikorrenti, otitis media, sinużite, LRTIs u UTIs, kif ukoll URTIs u infezzjonijiet tal-apparat ġenito-urinarju, u ddiskuta il-PK/PD, u b'hekk wera l-ekwivalenza batterjoloġika tal-formulazzjonijiet BID u TID.
English: The CHMP adopted the following indication:
Maltese: Il-CHMP adotta l-indikazzjoni li ġejja:
English: The CHMP agreed that the dose of 125 mg clavulanic acid twice daily is considered appropriate to inhibit the beta-lactamases of H. influenzae and M. catarrhalis.
Maltese: Il-CHMP qabel li d-doża ta' 125 mg ta' clavulanic acid darbtejn kuljum titqies adatta sabiex tinibixxi l-beta-lactamases ta' H. influenzae u M. catarrhalis.
English: “This presentation of amoxicillin/clavulanic acid is suitable for treatment of Streptococcus pneumoniae that are resistant to penicillin in the approved indications only (see section 4.1).”
Maltese: “Din il-preżentazzjoni ta' amoxicillin/clavulanic acid hija adatta għall-kura ta' Streptococcus pneumoniae li huma reżistenti għall-peniċillina fl-indikazzjonijiet approvati biss (ara sezzjoni 4.1).”
English: It was noted that the recommended posology for the 16:1 ratio is a daily dose of 4g amoxicillin and 250 mg clavulanic acid, resulting in serum concentrations effective even against PRSP.
Maltese: Kien innutat li l-pożoloġija rrakkomandata għall-proporzjon 16:1 hija doża ta' kuljum ta' 4g amoxicillin u 250 mg clavulanic acid, li tirriżulta f'konċentrazzjonijiet fis-serum effikaċi anki kontra PRSP.
English: The indications are supported by clinical data, T>MIC values, and publications in peer-reviewed journals.
Maltese: L-indikazzjonijiet huma appoġġati minn dejta klinika, valuri T>MIC, u pubblikazzjonijiet f'ġurnali riveduti minn esperti.
English: The CHMP noted that PK/PD principles were applied to the development of this ratio but that no true PK/PD analysis has been performed in the clinical database.
Maltese: Il-CHMP innota li l-prinċipji PK/PD ġew applikati għall-iżvilupp ta' dan il-proporzjon iżda li ma saret l-ebda analiżi reali ta' PK/PD fid-database klinika.
English: PK/PD analyses predict that the 2:1 Augmentin oral formulation (250/125mg) TID would achieve maximum eradication against S. pneumoniae strains with amoxicillin or amoxicillin/clavulanic acid MICs of ≤1 μg/mL whereas the 4:1 ratio (500/125mg) TID would be effective against strains with MICs of ≤ 2μg/mL.
Maltese: L-analiżi PK/PD jipprevedu li l formulazzjoni orali 2:1 ta' Augmentin (250/125mg) TID tista' tikseb qerda massima kontra l-ispeċi ta'S. pneumoniae b'amoxicillin jew amoxicillin/clavulanic acid MICs ta' ≤1 μg/mL filwaqt li lproporzjon 4:1 (500/125mg)
English: • Acute bacterial sinusitis (adequately diagnosed)
Maltese: • Sinużite batterjali akuta (iddijanjostikata b'mod xieraq)
English: Augmentin has the appropriate PK/PD that would predict clinical efficacy against Gram-positive and many Gramnegative pathogens including anaerobic pathogens, and penetrates well into the peritoneum.
Maltese: Augmentin għandu il-PK/PD xieraq li jista' jbassar effikaċja klinika kontra patoġeni Gram-pożittivi u kontra ħafna patoġeni Gram-negattivi inklużi l-patoġeni anerobiċi, u jippenetra sew fil-peritonju.
English: The CHMP adopted the following sentence to state that Augmentin ES (14:1) and SR (16:1) ratios can be used to treat S. pneumoniae with decreased susceptibility to penicillin in the approved indications:
Maltese: Il-CHMP adotta s-sentenza li ġejja sabiex jiddikjara li lproporzjonijiet ta' Augmentin ES (14:1) u SR (16:1) jistgħu jintużaw għall-kura ta' S. pneumoniae b'suxxettibbiltà mnaqqsa għall-peniċillina fl-indikazzjonijiet approvati:
English: The lower limit for the tablets is 40 kg bodyweight based on the minimum dose (250/125 mg TID) whereas the lower limit for the age is restricted to 6 years, based on currently approved 2:1 formulations.
Maltese: Il-limitu aktar baxx għall-pilloli huwa ta' 40 kg piż tal-ġisem ibbażat fuq id-doża minima (250/125 mg TID) filwaqt li l-limitu aktar baxx għall-età huwa limitat għal 6 snin, ibbażat fuq formulazzjonijiet approvati attwalment ta' 2:1.
English: For renal impairment, the published literature on the PK of amoxicillin and clavulanic acid, when administered to patients with renal impairment, indicates a decrease in the renal clearance of both drugs and that declining renal function has a greater influence on the clearance of amoxicillin than on that of clavulanic acid.
Maltese: Rigward l-indeboliment renali, il-materjal ippubblikat dwar il-PK ta' amoxicillin u clavulanic acid, meta jingħataw lil pazjenti b'indeboliment renali, jindika tnaqqis fl-eliminazzjoni renali taż-żewġ mediċini u li funzjoni renali mnaqqsa għandha influwenza akbar fuq it-tneħħija ta' amoxicillin milli fuq dik ta' clavulanic acid.
English: This is further supported by several Guidance documents and the CHMP adopted the indication: “Intra-abdominal infections” for the IV Augmentin formulations.
Maltese: Dan huwa appoġġat aktar minn bosta dokumenti ta' Gwida u l-CHMP adotta l-indikazzjoni: “Infezzjonijiet intra-addominali” għall-formulazzjonijiet ta' Augmentin IV.
English: • Acute exacerbations of chronic bronchitis (adequately diagnosed)
Maltese: • Taħrix akut ta' bronkite kronika (iddijanjostikat b'mod xieraq)
English: • Lower-ratio oral presentations (2:1, 4:1, and 7:1), authorised broadly for the same set of indications.
Maltese: • Preżentazzjonijiet orali ta' proporzjon iktar baxx (2:1, 4:1, u 7:1), awtorizzati b'mod wiesa' għall-istess sett ta' indikazzjonijiet.
English: The clinical studies in CAP and AECB further confirm the efficacy of Augmentin SR in treating infections due to beta-lactamase-producing H. influenzae and M. catarrhalis.
Maltese: L-istudji kliniċi f'CAP u AECB jikkonfermaw ukoll l-effikaċja ta' Augmentin SR fil-kura ta' infezzjonijiet ikkawżati minn H. influenzae u M. catarrhalis li jipproduċu beta-lactamase.
English: The verbal statement of the frequencies should be in accordance to the updated QRD-Templates and the frequencies should be listed in a table.
Maltese: Id-dikjarazzjoni verbali tal-frekwenzi għandha tkun konformi mal-Mudelli QRD aġġornati u l-frekwenzi għandhom ikunu elenkati fit-tabella.
English: For sections 4.1 and 4.2 of the SPC, the proposed text for formulations with the same amoxicillin/clavulanic acid ratio is discussed in sequence, starting with the lowest ratio 2:1, via the highest oral ratio 16:1 to the intravenous (IV) ratio 10:1.
Maltese: Għas-sezzjonijiet 4.1 u 4.2 tal-SPC, it-test propost għal formulazzjonijiet bl-istess proporzjon ta' amoxicillin/clavulanic acid huwa diskuss f'ordni ta' sekwenza, mill-proporzjon l-aktar baxx 2:1, għall-ogħla proporzjon orali 16:1 sal-proporzjon għal ġolvini (IV) 10:1.
English: • Two intravenous ratios (5:1 and 10:1), authorised for the same set of indications.
Maltese: • Żewġ proporzjonijiet għal ġol-vina (5:1 u 10:1), awtorizzati għall-istess sett ta' indikazzjonijiet.
English: • Acute otitis media • Community acquired pneumonia.
Maltese: • Otitis media akuta • Pnewmonja li tittieħed mill-komunità.
English: The PK of the clavulanic acid components are the same as the conventional Augmentin formulations.
Maltese: Il-PK tal-komponenti tal-clavulanic acid huma l-istess bħallformulazzjonijiet konvenzjonali ta' Augmentin.
English: To date the 4:1 ratio has been approved widely in Europe and the approval in 1984 of the TID dosage was supported by clinical studies in paediatric and adult patients.
Maltese: S'issa l-proporzjon 4:1 ġie approvat b'mod wiesa' fl-Ewropa u l-approvazzjoni fl-1984 tad-dożaġġ TID ġiet appoġġjata bi studji kliniċi f'pazjenti adulti u pedjatriċi.
English: Thus the 4:1 ratio is considered ineffective against penicillin-resistant S. pneumoniae.
Maltese: Għalhekk il-proporzjon 4:1 huwa kkunsidrat bħala mhux effikaċi kontra S. pneumoniae li huma reżistenti għallpeneċillina.
English: In proposing a series of harmonised indications treatable using the 2:1 and 4:1 ratios, the MAH has taken into consideration clinical data, T>MIC values, local and national guidelines, and publications in peer-reviewed journals.
Maltese: Fil-proposta ta' serje ta' indikazzjonijiet armonizzati li jistgħu jiġu ttrattati bl-użu tal-proporzjonijiet 2:1 u 4:1, il-MAH ikkunsidra d-dejta klinika, il-valuri T>MIC, il-linji gwida lokali u nazzjonali, u lpubblikazzjonijiet f'ġurnali riveduti minn esperti.
English: The CHMP generally agreed with the MAH conclusion, but further discussed the indications in LRTIs, URTIs, UTIs, gynaecological infections, SSTIs, bone and joint infections and the prophylaxis of surgical infections and agreed and adopted the following harmonised wording for inclusion in the harmonised SPCs:
Maltese: B'mod ġenerali, il-CHMP qabel mal-konklużjoni tal-MAH, iżda ddiskuta aktar l-indikazzjonijiet f'LRTIs, URTIs, UTIs, infezzjonijiet ġinekoloġiċi, SSTIs, infezzjonijiet fl-għadam u l-ġogi u lprofilassi ta' infezzjonijiet kirurġiċi u qabel fuq u adotta l-kliem armonizzat li ġej għall-inklużjoni flSPCs armonizzati:
English: The MAH discussed the dosing regimen and stated that the mechanism of inhibition of bacterial -lactamases by clavulanic acid is different from that of amoxicillin: whereas amoxicillin is a highly bactericidal agent that acts by binding to one or more of the penicillin-binding proteins (PBPs) involved in cell-wall synthesis, clavulanic acid is a competitive irreversible inhibitor of certain intracellular bacterial -lactamases, and prevents these enzymes from inactivating amoxicillin.
Maltese: Il-MAH iddiskuta r-reġim ta' dożar u ddikjara li l-mekkaniżmu ta' inibizzjoni ta' lactamases batteriċi minn clavulanic acid huwa differenti minn dak ta' amoxicillin: filwaqt li amoxicillin huwa sustanza batteriċida qawwija li taġixxi billi tingħaqad ma' proteina waħda jew aktar li tgħaqqad il-peniċillin (PBPs) involuta f'sinteżi ta' ħajt ta' ċelloli, clavulanic acid huwa inibitur irreversibbli kompetittiv ta' ċerti -lactamases batteriċi intraċellulari, u ma jħallix lil dawn l-enżimi jwaqqfu l-attività ta' amoxicillin.
English: The MAH also discussed the PK/PD of the 2:1 ratio, stating that time above minimum inhibitory concentration (T>MIC) is a determinant of efficacy for -lactam antibacterials.
Maltese: Il-MAH iddiskuta wkoll il-PK/PD tal-proporzjon 2:1, filwaqt li ddikjara li ż-żmien fuq il-konċentrazzjoni inibitorja minima (time above minimum inhibitory concentration - T>MIC) huwa determinant taleffikaċja għall-antibatterjali -lactam.
English: THERAPEUTIC INDICATIONS FOR AUGMENTIN 16:1 RATIO (ORAL - SR)
Maltese: INDIKAZZJONIJIET TERAPEWTIĊI GĦALL-PROPORZJON TA' AUGMENTIN 16:1 (ORALI - SR)
English: In particular, the contraindications referring to mononucleosis, severe hepatic impairment or hepatic insufficiency, to the presence of aspartame in the oral suspension and hypersensitivity to amoxicillin, clavulanic acid or to any excipients were discussed.
Maltese: B'mod partikolari, ġew diskussi l-kontraindikazzjonijiet li jirreferu għal mononukleożi, indeboliment epatiku sever jew indeboliment epatiku, għall-preżenza ta' aspartame fis-suspensjoni orali u ipersensittività għal amoxicillin, clavulanic acid jew għal xi sustanza mhux attiva.
English: ORAL SWITCH THERAPY
Maltese: Sezzjoni 4.1 - Indikazzjonijiet terapewtiċi
English: The CHMP agreed to the MAH proposal.
Maltese: Il-CHMP qabel mal-proposta tal-MAH.
English: The MAH concluded that the 8:1 ratio would be more appropriate than the 4:1 ratio for the treatment of certain infections and in vivo results support the PK/PD prediction that Augmentin 8:1 will be efficacious against infections caused by S. pneumoniae with high amoxicillin MICs (2-4g/mL).
Maltese: Il-MAH ikkonkluda li l-proporzjon 8:1 huwa aktar xieraq mill-proporzjon 4:1 għat-trattament ta' ċerti infezzjonijiet u riżultati in vivo jappoġġaw it-tbassir tal-PK/PD li Augmentin 8:1 ser ikun effikaċi kontra l-infezzjonijiet ikkawżati minn S. pneumoniae b'MICs ta' amoxicillin għoljin (2-4g/mL).
English: Amoxicillin, like other beta-lactam antibiotics, is largely excreted renally and is not metabolised by CYP450 enzymes; clavulanic acid is partially metabolised by the liver and mostly excreted unchanged in the urine.
Maltese: Amoxicillin, bħal antibijotiċi betalactam oħrajn, jiġi eliminat l-aktar b'mod renali u mhux metabolizzat minn enzimi CYP450; parti mill-clavulanic acid hija metabolizzata mill-fwied u l-parti kbira tiegħu titneħħa mingħajr tibdil flawrina.
English: THERAPEUTIC INDICATION FOR AUGMENTIN 8:1 RATIO (ORAL)
Maltese: INDIKAZZJONI TERAPEWTIKA GĦALL-PROPORZJON TA' AUGMENTIN 8:1 (ORALI)
English: The CHMP recommended including the following in the harmonised SPC:
Maltese: Il-CHMP irrakkomanda li jkun inkluż dan li ġej fl-SPC armonizzat:
English: The MAH provided a common discussion on the rationale for use of Augmentin 2:1 and 4:1.
Maltese: Il-MAH ipprovda diskussjoni komuni dwar il-ġustifikazzjoni għall-użu ta' Augmentin 2:1 u 4:1.
English: The interactions apply to all Augmentin ratios.
Maltese: L-effetti japplikaw għall-proporzjonijiet kollha ta' Augmentin.
English: The contraindications discussed apply to all Augmentin ratios.
Maltese: Il-kontra-indikazzjonijiet diskussi japplikaw għall-proporzjonijiet kollha ta' Augmentin.
English: The MAH considers that for treatment regimens using 7:1 and 8:1 ratios and 10:1 intravenous ratios, there are insufficient data on which to base a dosage recommendation for patients with severe renal impairment (<30 mL/min).
Maltese: Il-MAH iqis li għal reġimi ta' kura bl-użu ta' proporzjonijiet ta' 7:1 u 8:1 u proporzjonijiet minn ġol-vina ta' 10:1, m'hemmx biżżejjed dejta li wieħed jista' jibbaża fuqha rakkomandazzjoni ta' dożaġġ għal pazjenti b'indeboliment renali sever (<30 mL/min).
English: Oral formulations of Augmentin have been available worldwide since 1981 and intravenous formulation since 1984.
Maltese: Il-formulazzjonijiet orali ta' Augmentin ilhom disponibbli madwar id-dinja kollha sa mill-1981 u l-formulazzjoni għal ġol-vini ilha disponibbli mill-1984.
English: The CHMP noted that amoxicillin/clavulanic acid has been evaluated in uncomplicated skin and soft tissue infections, including conditions such as wound infection, abscess, cellulitis, furunculosis and impetigo.
Maltese: Il-CHMP innota li amoxicillin/clavulanic acid ġie evalwat f'infezzjonijiet mhux ikkumplikati tal-ġilda u tat-testtut artab, inklużi kundizzjonijiet bħal infezzjoni ta' ferita, axxessi, ċellulite, furunkulożi u impetigo.
English: Therefore the following wording was adopted for all Augmentin IV formulations by the CHMP:
Maltese: Għaldaqstant il-CHMP adotta l-kliem li ġej għall-formulazzjonijiet kollha ta' Augmentin IV:
English: History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).
Maltese: Passat ta' reazzjoni ta' sensittività eċċessiva severa immedjata (eż. anafilassi) għal sustanza betalactam oħra (eż. cephalosporin, carbapenem jew monobactam).
English: A harmonised wording was agreed by the CHMP for inclusion in the harmonised SPCs.
Maltese: Il-CHMP qabel fuq kliem armonizzat li jkun inkluż fl-SPCs armonizzati.
English: The CHMP recommended the withdrawal of the recommendation to double the 2:1 and 4:1 ratio regimens in preference for using the higher ratio of amoxicillin to clavulanic acid formulations such as the 7:1 and 8:1 ratios.
Maltese: Il-CHMP irrakkomanda l-irtirar tar-rakkomandazzjoni li r-reġimi ta' proporzjon 2:1 u 4:1 jirduppjaw filwaqt li jiffavorixxi l-użu tal-formulazzjonijiet bi proporzjon ogħla ta' amoxicillin għal clavulanic acid bħall-proporzjonijiet 7:1 u 8:1.
English: The CHMP endorsed the MAH data and rationale, especially the polymicrobial nature of intra-abdominal infections and the recent use of Augmentin in controlled trials support the use of Augmentin for both initial empirical IV treatment and continued oral treatment after switch from IV treatment.
Maltese: Il-CHMP approva d-dejta u l-ġustifikazzjoni tal-MAH, b'mod partikolari n-natura polimikrobjali talinfezzjonijiet intra-addominali u l-użu reċenti ta' Augmentin fi provi kkontrollati jappoġġaw l-użu ta' Augmentin kemm għat-trattament IV empiriku inizjali kif ukoll għat-trattament orali kontinwu wara lbidla mit-trattament IV.
English: The CHMP also considered the discussion on the indications commonly to the 2:1, 4:1, 7:1 and 8:1 ratios and the following harmonised wording for the harmonised SPCs was agreed and adopted by the CHMP:
Maltese: Il-CHMP ikkunsidra wkoll id-diskussjoni dwar l-indikazzjonijiet li huma komuni għall-proporzjonijiet 2:1, 4:1, 7:1 u 8:1 u l-kliem armonizzat li ġej għall-SPCs armonizzati ġie miftiehem u adottat millCHMP:
English: • The 8:1 ratio formulations, for general use in the renally-normal population, approved in France only, and associated with their own set of indications.
Maltese: • Il-formulazzjonijiet ta' proporzjon 8:1, għal użu ġenerali fil-popolazzjoni bi kliewi normali, li huma approvati fi Franza biss, u assoċjati mas-sett ta' indikazzjonijiet tagħhom stess.
English: The 4:1 ratio was further discussed by CHMP, noting that the maximum daily dose of amoxicillin delivered is 1500 mg.
Maltese: Il-proporzjon 4:1 ġie diskuss aktar mill-CHMP, li nnota li d-doża massima ta' kuljum ta' amoxicillin amministrata hija ta' 1500 mg.
English: POSOLOGY IN SPECIAL PATIENT POPULATIONS
Maltese: Kura ta' intossikazzjoni
English: The Augmentin 16:1 ratio was developed for, and studied in, specific indications in adults and adolescents aged 16 years and above, where higher concentrations of amoxicillin to clavulanic acid are required.
Maltese: Il-proporzjon ta' Augmentin 16:1 ġie żviluppat għal, u studjat f'indikazzjonijiet speċifiċi f'adulti u adolexxenti ta' 16-il sena u aktar, meta jkunu meħtieġa konċentrazzjonijiet ogħla ta' amoxicillin għal clavulanic acid.
English: Resistance to amoxicillin in S. pneumoniae is currently low in a number of Member States, with the majority of MICs ≤ 1 μg/mL.
Maltese: Ir-reżistenza għal amoxicillin f'S. pneumoniae attwalment hija baxxa f'għadd ta' Stati Membri, bil-maġġoranza ta' MICs ≤ 1 μg/mL.
English: Surgical prophylaxis with Augmentin IV should aim to protect the patient for the period of risk of infection.
Maltese: Profilassi kirurġika b'Augmentin IV għandha timmira li tħares lill-pazjent matul il-perijodu ta' riskju ta' infezzjoni.
English: The time above minimum inhibitory concentration (T>MIC) is one of the major determinants of efficacy for β-lactam antibacterials.
Maltese: Iż-żmien fuq il-konċentrazzjoni inibitorja minima (T>MIC) huwa wieħed mid-determinanti ewlenin tal-effikaċja għall-antibatterjali β-lactam.
English: The discussion also focused on treatment duration and the CHMP agreed to amend Section 4.2 of the SPC.
Maltese: Id-diskussjoni ffukat ukoll fuq it-tul tat-trattament u l-CHMP qabel li jemenda s-Sezzjoni 4.2 tal-SPC.
English: The MAH concluded that all available scientific evidence, clinical data, T>MIC values, guidelines and publications demonstrate that the Augmentin 2:1 and 4:1 ratios are efficacious in a wide range of indications, and provide the appropriate clinical cover against the key pathogens implicated in these infections.
Maltese: Il-MAH ikkonkluda li l-evidenza xjentifika kollha disponibbli, id-dejta klinika, il-valuri T>MIC, il-linji gwida u l-pubblikazzjonijiet juru li lproporzjonijiet ta' Augmentin 2:1 u 4:1 huma effikaċji f'medda wiesgħa ta' indikazzjonijiet, u jipprovdu l-kopertura klinika xierqa kontra l-patoġeni ewlenin li huma implikati f'dawn linfezzjonijiet.
English: Thus, efficient eradication of -lactamaseproducing organisms by amoxicillin/clavulanic acid relies on effective initial inhibition of the lactamase by clavulanic acid.
Maltese: Għalhekk, il-qerda effikaċi ta' organiżmi li jipproduċu -lactamase permezz ta' amoxicillin/clavulanic acid tiddependi fuq inibizzjoni inizjali effikaċi tal--lactamase permezz ta' clavulanic acid.
English: The IV and oral formulations facilitate switch or sequential therapy from initial intravenous therapy to subsequent oral treatment.
Maltese: Il-formulazzjonijiet IV u orali jiffaċilitaw il-bidla jew it-terapija sekwenzjali minn terapija ġol-vina inizjali għal trattament orali sussegwenti.
English: Augmentin SR plays an important role in the management of infections, particularly in countries and local areas of high levels of S. pneumoniae resistance.
Maltese: Augmentin SR għandu rwol importanti fl-immaniġġjar ta' infezzjonijiet, b'mod partikolari f'pajjiżi u f'żoni lokali b'livelli ta' reżistenza għal S. pneumoniae għoljin.
English: Finally, the paediatric posology for the 5:1 ratio was revised as IV doses of clavulanic acid greater than 5 mg/kg are not recommended and Section 4.2 already contains texts advocating the use of different strengths where higher amoxicillin doses are needed.
Maltese: Finalment, il-pożoloġija pedjatrika għall-proporzjon 5:1 ġiet riveduta minħabba li dożi IV ta' clavulanic acid akbar minn 5 mg/kg mhumiex irrakkomandati u s-Sezzjoni 4.2 diġà fiha kliem favur l-użu ta' qawwiet differenti meta jkunu meħtieġa dożi akbar ta' amoxicillin.