FrancophonIA/ELRC3.0 huggingface dataset:
English: According to the data, this daily dose is only suitable for pathogens with a MIC90 of < 1 µg/mL, i.e. pathogens where time over MIC is > 40%.
Maltese: Skont id-dejta, din id-doża ta' kuljum hija xierqa biss għall-patoġeni b'MIC90 ta' < 1 µg/mL, jiġifieri patoġeni fejn iż-żmien fuq il-MIC huwa ta' > 40%.
English: The CHMP considered that most acute bronchitis are of viral aetiology and the systematic need for antibiotic treatment is questionable.
Maltese: Il-CHMP ikkunsidra li l-maġġoranza tal-bronkite akuta huma ta' etjoloġija virali u l-ħtieġa sistematika għal trattament antibijotiku hija dubjuża.
English: Empirical antibacterial therapy must provide broad-spectrum coverage of both aerobic and anaerobic pathogens.
Maltese: It-terapija empirika antibatterjali għandha tipprovdi kopertura ta' spettru wiesa' kemm tal-patoġeni arobiċi kif ukoll ta' dawk anerobiċi.
English: The MAH concluded that Augmentin SR demonstrates bacteriological and clinical efficacy against susceptible and resistant key respiratory pathogens when used empirically.
Maltese: Il-MAH ikkonkluda li Augmentin SR juri effikaċja batterjoloġika u klinika kontra patoġeni respiratorji ewlenin suxxettibbli u reżistenti meta użat b'mod empiriku.
English: Therefore an alternative presentation of Augmentin should be selected.”
Maltese: Għalhekk għandha tintgħażel preżentazzjoni alternattiva ta' Augmentin.”
English: Because amoxicillin is readily hydrolysed by -lactamase, Augmentin also contains the lactamase inhibitor, clavulanic acid, which protects amoxicillin from degradation and extends its antibacterial spectrum to many bacteria normally resistant to penicillins and cephalosporins.
Maltese: Minħabba li amoxicillin huwa idrolizzat malajr bi -lactamase, Augmentin fih ukoll l-inibitur -lactamase, clavulanic acid, li jipproteġi lil amoxicillin mid-degredazzjoni u jestendi l-ispettru antibatterjali tiegħu għal ħafna batterji li normalment jirreżistu lill-peniċillini u lillċefalosporini.
English: Finally, the MAH discussed the PK/PD of the 8:1 ratio, stating that the steady-state mean T>MIC values predict that this formulation given TID achieves maximum eradication against S. pneumoniae strains with amoxicillin or amoxicillin/clavulanic acid MICs of ≤2g/mL and is to have some efficacy against strains with MICs of 4g/mL.
Maltese: Fl-aħħar nett, il-MAH iddiskuta l-PK/PD tal-proporzjon 8:1, u ddikjara li l-valuri medji T>MIC ta' stat fiss jipprevedu li din il-formulazzjoni mogħtija TID tikseb il-qerda massima kontra l-ispeċi S. pneumoniae b'amoxicillin jew amoxicillin/clavulanic acid MICs ta' ≤2g/mL u għandu jkollha xi effikaċja kontra speċi b'MICs ta' 4g/mL.
English: The MAH agreed to the withdrawal of the septicaemia indication from of all the oral and parental formulations SPCs.
Maltese: Il-MAH qabel malirtirar tal-indikazzjoni ta' septikamija mill-formulazzjonijiet orali u parenterali kollha tal-SPCs.
English: The MAH responded that Augmentin SR was developed to address an unmet medical need (eradication of penicillin resistant S. pneumoniae with penicillin MICs ≥2 μg/ml in RTI) and that the clinical development programme included PK studies to assess the enhanced PD properties.
Maltese: Il-MAH wieġeb li Augmentin SR ġie żviluppat sabiex jindirizza ħtieġa medika mhux issodisfata (il-qerda ta' S. pneumoniae reżistenti għall-peniċillin b'MICs tal-peniċillina ta' ≥2 μg/ml f'RTI) u li l-programm ta' żvilupp kliniku kien jinkludi studji PK sabiex jevalwaw il-karatteristiċi mtejba tal-PD.
English: In adults, the higher dosage is recommended for severe infections, including chronic and recurrent UTIs and LRTIs.
Maltese: Fl-adulti, logħla doża hija rrakkomandata għal infezzjonijiet severi, inklużi UTIs u LRTIs kroniċi u rikorrenti.
English: The MAH listed the currently approved indications for Augmentin SR and discussed a number of indications in detail, as well as the PK/PD, stating that in vivo data supports the efficacy of Augmentin SR against infections caused by S. pneumoniae with high amoxicillin MICs (4-8g/mL).
Maltese: Il-MAH elenka l-indikazzjonijiet approvati attwalment għal Augmentin SR u ddiskuta għadd ta' indikazzjonijiet fid-dettall, kif ukoll il-PK/PD, u ddikjara li dejta in vivo tappoġġja l-effikaċja ta' Augmentin SR kontra infezzjonijiet ikkawżati minn S. pneumoniae b'MICs ta' amoxicillin għoljin (4-8g/mL).
English: The development of Augmentin ES (14:1) was based on PK/PD data as well as clinical efficacy and safety studies, providing an increased dose of amoxicillin twice daily, while retaining the same dose of clavulanic acid as in existing Augmentin 7:1 ratio.
Maltese: L-iżvilupp ta' Augmentin ES (14:1) kien ibbażat fuq dejta tal-PK/PD kif ukoll fuq studji tal-effikaċja klinika u tas-sigurtà, u jipprovdi doża miżjuda ta' amoxicillin darbtejn kuljum, filwaqt li jżomm listess doża ta' clavulanic acid bħal fil-proporzjon ta' Augmentin 7:1 attwali.
English: The MAH proposed the same indications for the 2:1, 4:1, 7:1 and 8:1 ratios and these are discussed in common.
Maltese: Il-MAH ippropona l-istess indikazzjonijiet għall-proporzjonijiet 2:1, 4:1, 7:1 u 8:1 u dawn huma diskussi b'mod komuni.
English: The CHMP considered that due to the known adverse effects of clavulanic acid and the PK/PD profile of this ß-lactamase inhibitor, a dose of 125 mg three times daily should not be exceeded.
Maltese: Il-CHMP ikkunsidra li minħabba l-effetti avversi magħrufin ta' clavulanic acid u l-profil PK/PD ta' dan l-inibitur ß-lactamase, wieħed m'għandux jaqbeż id-doża ta' 125 mg tliet darbiet kuljum.
English: A wide range of different presentations of Augmentin with an increasing ratio of amoxicillin to clavulanic acid are approved for oral (2:1, 4:1, 7:1, 8:1, 14:1 and 16:1) and parenteral (5:1 and 10:1) use in adults and children.
Maltese: Firxa wiesgħa ta' preżentazzjonijiet differenti ta' Augmentin bi proporzjon li qiegħed jiżdied ta' amoxicillin meta mqabbel ma' clavulanic acid hija approvata għall-użu orali (2:1, 4:1, 7:1, 8:1, 14:
English: The MAH discussed the pharmacokinetic data for all the existing Augmentin formulations, grouped according to their respective ratios.
Maltese: Il-MAH iddiskuta d-dejta farmakokinetika għall-formulazzjonijiet eżistenti kollha ta' Augmentin, miġbura skont il-proporzjonijiet rispettivi tagħhom.
English: THERAPEUTIC INDICATIONS FOR INTRAVENOUS AUGMENTIN 5:1 AND 10:1 RATIOS
Maltese: INDIKAZZJONIJIET TERAPEWTIĊI GĦALL-PROPORZJONIJIET TA' AUGMENTIN MINN ĠOL-VINA 5:1
English: The CHMP also differentiated between the 2:1 tablets (and dispersible tablets) and the powder for oral suspension.
Maltese: Il-CHMP għamel differenza wkoll bejn il-pilloli 2:1 (u pilloli li jixterdu) u t-trab għal soluzzjoni orali.
English: The standard dose is TID and the CHMP restricted the lower dose to SSTI and non-severe sinusitis.
Maltese: Id-doża standard hija TID u l-CHMP illimita d-doża aktar baxxa għal SSTI u sinusite ħafifa.
English: The CHMP agreed, as it should result in a standard daily dose of clavulanic acid for all formulations with 125 mg clavulanic acid per dose.
Maltese: Il-CHMP qabel, minħabba li dan jirriżulta f'doża standard ta' kuljum ta' clavulanic acid għall-formulazzjonijiet kollha b'125 mg clavulanic acid f'kull doża.
English: These two ratios allow flexibility of the amoxicillin dosage, whilst delivering an appropriate clavulanic acid unit dose.
Maltese: Dawn iż-żewġ proporzjonijiet jippermettu flessibbiltà tad-dożar ta' amoxicillin, filwaqt li jwasslu doża xierqa ta' unità ta' clavulanic acid.
English: The MAH acknowledged that Augmentin is not the first drug of choice for the treatment of acute streptococcal tonsillitis, however it is recommended as a possible alternative for the treatment of patients who have multiple recurrent episodes of streptococcal tonsillitis because Augmentin has been shown to yield high rates of eradication of streptococci from the nasopharynx.
Maltese: Il-MAH irrikonoxxa li Augmentin mhuwiex l-ewwel għażla ta' mediċina għall-kura tat-tonsillite streptokokkali akuta, madankollu huwa rrakkomandat bħala alternattiva possibbli għall-kura ta' pazjenti li jkollhom episodji rikorrenti multipli ta' tonsillite streptokokkali għax intwera li Augmentin jipproduċi proporzjonijiet għoljin ta' qerda ta' streptokokki min-nasofarinġi.
English: The MAH considered the 7:1 ratio as well established in clinical practice, and listed guidelines recommending Augmentin, concluding that the availability of the 7:1 ratio provides clinicians with a valuable broad-spectrum antibiotic suitable for the treatment of a variety of bacterial infections in adults and paediatrics.
Maltese: Il-MAH ikkunsidra l-proporzjon 7:1 ukoll li huwa stabbilit fil-prattika klinika, u elenka linji gwida li jirrakkomandaw Augmentin, u kkonkluda li d-disponibbiltà tal-proporzjon 7:1 tipprovdi antibijotiku ta' spettru wiesa' siewi lit-tobba li huwa adatt għat-trattament ta' varjetà ta' infezzjonijiet batterjali fladulti u fil-pedjatriċi.
English: • Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections,
Maltese: • Infezzjonijiet severi tal-widnejn, l-imnieħer u l-gerżuma (bħal mastoiditis, infezzjonijiet peritonsillari, epiglottite, u sinusite meta jkunu akkumpanjati minn sinjali u sintomi sistemiċi)
English: The recommendations for dosing patients with reduced renal and hepatic function have also been simplified and harmonised.
Maltese: Ir-rakkomandazzjonijiet għad-dożaġġ ta' pazjenti b'funzjoni renali jew epatika indebolita wkoll ġew issimplifikati u armonizzati.
English: Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the:
Maltese: Profilassi kontra infezzjonijiet assoċjati ma' proċeduri kirurġiċi maġġuri fl-adulti, bħal dawk li jinvolvu:
English: In adults, the higher dosage is recommended for severe infections, including chronic and recurrent urinary tract infections and lower respiratory tract infections.
Maltese: Fl-adulti, iddożaġġ l-għoli huwa rrakkomandat għal infezzjonijiet severi, inkluż infezzjonijiet tal-apparat urinarju u infezzjonijiet tal-passaġġ respiratorju t'isfel kroniċi u rikorrenti.
English: According to the data presented by the MAH, this daily dose is only suitable for pathogens with a MIC90 of < 2 µg/mL, i.e. only in these pathogens the required time over MIC is > 40%.
Maltese: Skont id-dejta ppreżentata mill-MAH, din id-doża ta' kuljum hija xierqa biss għall-patoġeni b'MIC90 ta' < 2 µg/mL, jiġifieri f'dawn il-patoġeni biss iż-żmien meħtieġ fuq il-MIC huwa > 40%.
English: The ratio was approved in the 1990s.
Maltese: Ilproporzjon ġie approvat fis-snin 90.
English: The CHMP adopted a harmonised text for this section.
Maltese: Il-CHMP adotta kliem armonizzat għal din issezzjoni.
English: • Bone and joint infections, in particular osteomyelitis
Maltese: • Infezzjonijiet tal-għadam u tal-ġogi, b'mod partikolari osteomajlite
English: The drug has been shown to be extremely useful in areas with high incidence of amoxicillin- or multidrug resistant S. pneumoniae and in selected patients (i.e. with S. pneumoniae isolates having amoxicillin+/- clavulanic acid MICs up to and including 4μg/mL).
Maltese: Il-mediċina ntweriet li hija utli ħafna f'oqsma b'inċidenza għolja ta' S. pneumoniae reżistenti għal amoxicillin jew għal ħafna mediċini u f'pazjenti magħżula (jiġifieri b'iżolati ta' S. pneumoniae li għandhom MICs ta' amoxicillin+/- clavulanic acid sa u inkluż 4μg/mL).
English: • Augmentin ES (Extra Strength) and Sustained Release (SR), developed to meet specific clinical needs related to the occurrence of resistant pathogens.
Maltese: • Augmentin ES (Qawwa Miżjuda) u Rilaxx Sostnut (Sustained Release - SR), żviluppati sabiex jissoddisfaw ħtiġijiet kliniċi speċifiċi relatati mal-okkorrenza ta' patoġeni reżistenti.
English: THERAPEUTIC INDICATIONS FOR AUGMENTIN 2:1 RATIO (ORAL)
Maltese: INDIKAZZJONIJIET TERAPEWTIĊI GĦAL PROPORZJON TA' AUGMENTIN 2:1 (ORALI)
English: In particular, data on renal impairment, crystalluria and overgrowth of fungal infections and acute generalised exanthematous pustulosis (AGEP) was reviewed and proposals for a harmonised wording were made.
Maltese: B'mod partikolari, ġiet riveduta d-dejta dwar l-indeboliment renali, ilkristallurja u t-tkabbir żejjed ta' infezzjonijiet fungali u exanthematous pustulosis ġeneralizzata akuta (AGEP) u saru proposti għal formolazzjoni ta' kliem armonizzata.
English: The unit dose of clavulanic acid (125mg) for the 2:1 and 4:1 formulations is the same as the other oral Augmentin formulations, this concentration being sufficient to inhibit the target -lactamases.
Maltese: Id-doża waħdanija ta' clavulanic acid (125mg) għall-formulazzjonijiet 2:1 u 4:1 hija l-istess bħal dik tal-formulazzjonijiet orali ta' Augmentin l-oħrajn, minħabba li din il-konċentrazzjoni hija biżżejjed biex tinibixxi l--lactamases filmira.
English: For example, the 250/125 mg tablets are not suitable for use in any EU Member State in which penicillin-insusceptible or penicillin-resistant Streptococcus pneumoniae occur commonly.
Maltese: Pereżempju, il-pilloli ta' 250/125 mg mhumiex xierqa għall-użu fi kwalunkwe Stat Membru tal-UE li fih ikun hemm okkorrenza komuni ta' pnewmonji ta' Streptococcus li mhuwiex suxxettibbli jew reżistenti għall-peneċillina.
English: The scientific basis for inclusion of a statement on the interaction with oral contraceptives was assessed and there is a lack of evidence for an interaction between Augmentin and oral contraceptives.
Maltese: Ġiet evalwata l-bażi xjentifika għallinklużjoni ta' dikjarazzjoni dwar l-interazzjoni ma' kontraċettivi orali u hemm nuqqas ta' provi ta' interazzjoni bejn Augmentin u kontraċettivi orali.
English: Although many pathogens important for urinary tract infections exhibit resistance rates of > 10% towards Augmentin, it is considered a suitable alternative, as all antimicrobial agents with this indication share the problem and the choice of the agent depends on the patient and epidemiological situation.
Maltese: Għalkemm bosta patoġeni li huma importanti għall-infezzjonijiet tal-apparat urinarju juru proporzjonijiet ta' reżistenza ta' > 10% lejn Augmentin, huwa kkunsidrat alternattiva xierqa, għax l-aġenti antimikrobjali kollha b'din lindikazzjoni jaqsmu l-istess problema u l-għażla tal-aġent tiddependi fuq il-pazjent u fuq issitwazzjoni epidemjoloġika.
English: The CHMP acknowledged the scientific rationale and the theoretical PK/PD consideration behind the development of this formulation and that it is exclusively intended to treat infections caused by PRSP.
Maltese: Il-CHMP irrikonoxxa l-loġika xjentifika u l-kunsiderazzjoni teoretika tal-PK/PD wara l-iżvilupp ta' din il-formulazzjoni u li hija esklussivament maħsuba għall-kura ta' infezzjonijiet ikkawżati minn PRSP.
English: For severe infections, and for pathogens with higher MICs, the 8:1 ratio is active for many of the intended pathogens.
Maltese: Għal infezzjonijiet severi, u għal patoġeni b'MICs ogħla, il-proporzjon 8:1 huwa attiv għal ħafna mill-patoġeni intenzjonati.
English: POSOLOGY AND METHOD OF ADMINISTRATION FOR AUGMENTIN 10:1 RATIO (INTRAVENOUS)
Maltese: POŻOLOĠIJA U METODU TA' KIF GĦANDU JINGĦATA GĦALL-PROPORZJON TA' AUGMENTIN 10:1 (MINN ĠOL-VINA)
English: This has been shown in in-vitro studies, in-vivo in numerous animal models, and has been confirmed by clinical trial data.
Maltese: Dan intwera fi studji in-vitro, in-vivo f'bosta mudelli ta' annimali, u ġie kkonfermat minn dejta ta' provi kliniċi.
English: Dosing recommendations for Augmentin SR are supported by extensive clinical safety and efficacy data.
Maltese: Ir-rakkomandazzjonijiet ta' dożar għal Augmentin SR huma appoġġjati minn dejta klinika wiesgħa ta' sigurtà u ta' effikaċja.
English: The MAH considered the indications supported by clinical, PK/PD data and publications, and thus adequate for this ratio.
Maltese: Il-MAH ikkunsidra lindikazzjonijiet appoġġati minn dejta klinika u tal-PK/PD u minn pubblikazzjonijiet, u għalhekk adegwati għal dan il-proporzjon.
English: “Bone and joint infections, in particular osteomyelitis.”
Maltese: “Infezzjonijiet tal-għadam u tal-ġogi, b'mod partikolari osteomjelite.”
English: POSOLOGY AND METHOD OF ADMINISTRATION FOR AUGMENTIN 5:1 RATIO (INTRAVENOUS)
Maltese: POŻOLOĠIJA U METODU TA' KIF GĦANDU JINGĦATA GĦALL-PROPORZJON TA' AUGMENTIN 5:1 (MINN ĠOL-VINA)
English: The studies suggested that a dose of 1.2g (1000/200 mg; 5:1 ratio) TID was generally adequate for treatment and that in many cases, IV treatment was followed by oral therapy.
Maltese: L-istudji ssuġġerew li doża ta' TID ta' 1.2g (1000/200 mg; proporzjon ta' 5:1) kienet ġeneralment adegwata għal kura u li f'bosta każijiet, il-kura minn ġol-vina kienet segwita minn kura orali.
English: The MAH stated the currently approved indications and discussed in particular the indications in genito-urinary tract, abdominal infections, respiratory tract infections and skin and soft tissue Infections (SSTIs), citing numerous clinical studies and guidelines recommending the use of the 4:1 ratio.
Maltese: Il-MAH iddikjara l-indikazzjonijiet approvati attwalment u ddiskuta b'mod partikolari l-indikazzjonijiet tal-infezzjonijiet tal-apparat ġenito-urinarju u addominali, tal-infezzjonijiet tal-apparat respiratorju u tal-infezzjonijiet tal-ġilda u tat-tessut artab (SSTIs), filwaqt li kkwota bosta studji kliniċi u linji gwida li jirrakkomandaw l-użu talproporzjon 4:1.
English: The following statements were agreed for the harmonised SPC to address this issue:
Maltese: Sar qbil dwar id-dikjarazzjonijiet li ġejjin għall-SPC armonizzat sabiex tkun indirizzata din il-kwistjoni:
English: THERAPEUTIC INDICATIONS FOR AUGMENTIN 14:1 RATIO (ORAL - ES)
Maltese: INDIKAZZJONIJIET TERAPEWTIĊI GĦALL-PROPORZJON TA' AUGMENTIN 14:1 (ORALI - ES)
English: Overall, the CHMP agreed and added a statement reflecting the regimen proposed in terms of PK/PD reasoning and prevalence of resistance across Europe.
Maltese: B'mod ġenerali, il-CHMP qabel u żied dikjarazzjoni li tirrifletti r-reġim propost f'termini ta' raġunar PK/PD u ta' prevalenza ta' reżistenza madwar lEwropa.
English: This is a particularly important section for antibacterials.
Maltese: Din hija sezzjoni partikolarment importanti għall-antibatteriċi.
English: In summary, the following harmonised wording for inclusion in the harmonised SPCs was agreed and adopted by the CHMP:
Maltese: Fil-qosor, il-kliem armonizzat li ġej għall-inklużjoni fl-SPCs armonizzati gie miftiehem u adottat mill-CHMP:
English: Amoxicillin/clavulanic acid was originally developed in response to the need for an oral broad-spectrum antibiotic that covered β-lactamase-producing pathogens.
Maltese: Amoxicillin/clavulanic acid ġie żviluppat oriġinarjament b'rispons għall-ħtieġa ta' antibijotiku orali bi spettru wiesa' li jkopri l-patoġeni li jipproduċu β-lactamase.
English: Augmentin SR is a pharmacokinetically-enhanced formulation, developed to maximise PK/PD and to provide more effective therapy against pathogens with reduced susceptibility to amoxicillin and penicillin, particularly S. pneumoniae.
Maltese: Augmentin SR huwa formulazzjoni imtejba b'mod farmakokinetiku, żviluppata sabiex timmassimizza l-PK/PD u sabiex tipprovdi kura aktar effikaċi kontra patoġeni b'suxxettibbiltà mnaqqsa għal amoxicillin u peniċillin, b'mod partikolari S. pneumoniae.
English: No clinical data are available on doses higher than 40/10 mg/kg/day in children under 2 years.
Maltese: M'hemm l-ebda dejta klinika disponibbli dwar dożi ogħla minn 40/10 mg/kg/kuljum fi tfal taħt issentejn.
English: • Bone and joint infections, in particular osteomyelitis.
Maltese: • Infezzjonijiet tal-għadam u tal-ġogi, b'mod partikolari osteomjelite.
English: POSOLOGY AND METHOD OF ADMINISTRATION FOR AUGMENTIN 14:1 RATIO (ORAL - ES)
Maltese: POŻOLOĠIJA U METODU TA' KIF GĦANDU JINGĦATA GĦALL-PROPORZJON TA' AUGMENTIN 4:1 (ORALI)
English: POSOLOGY AND METHOD OF ADMINISTRATION FOR AUGMENTIN 16:1 RATIO (ORAL - SR)
Maltese: Sezzjoni 4.7 - Effetti fuq il-ħila biex issuq u tħaddem magni
English: POSOLOGY AND METHOD OF ADMINISTRATION FOR AUGMENTIN 7:1 RATIO (ORAL)
Maltese: INDIKAZZJONIJIET TERAPEWTIĊI GĦALL-PROPORZJON TA' AUGMENTIN 7:1 (ORALI)
English: The CHMP noted the clinical trials comparing the efficacy of the different dosing regimens of amoxicillin/clavulanic acid in recurrent tonsillitis and that a number of national guidelines recommend
Maltese: Il-MAH ipprovda studji kliniċi komparattivi u mhux komparattivi li jistabbilixxu s-sigurtà u l-effikaċja u elenka l-indikazzjonijiet studjati.
English: Clear clinical signs of infection at operation will require a normal course of intravenous or oral therapy post-operatively.
Maltese: Sinjali kliniċi ċari ta' infezzjoni waqt l-intervent ikunu jeħtieġu kors normali ta' kura minn ġol-vina jew orali wara l-intervent.
English: Based on the argumentation to remove addition of amoxicillin alone for the 5:1 ratio, information was added on increasing the dose of clavulanic acid.
Maltese: Abbażi tal-argumentazzjoni li titneħħa ż-żieda ta' amoxicillin waħdu għall-proporzjon ta' 5:1, ġiet miżjuda informazzjoni dwar iż-żieda tad-doża ta' clavulanic acid.
English: The 8:1 Augmentin ratio was licensed in 1990, developed in response to concerns over the increasing prevalence of resistant S. pneumoniae strains in France, particularly amongst young children with acute otitis media.
Maltese: Il-proporzjon 8:1 ta' Augmentin ingħata liċenzja fl-1990, ġie żviluppat bħala reazzjoni għal tħassib dwar il-prevalenza dejjem tikber ta' speċi reżistenti ta' S. pneumoniae fi Franza, b'mod partikolari fost it-tfal żgħar b'otitis media akuta.
English: In recent years the MAH has developed a pro-active process for identifying safety signals, consisting of the ongoing review of important individual cases, the review of aggregate adverse event data through the use of disproportional analyses and the review of published medical literature.
Maltese: F'dawn l-aħħar snin, il-MAH żviluppa proċess pro-attiv għall-identifikazzjoni ta' sinjali ta' sigurtà, li jikkonsisti fir-reviżjoni kontinwa ta' każijiet individwali importanti, ir-reviżjoni ta dejta dwar effetti avversi aggregati permezz tal-użu ta' analiżijiet mhux proporzjonali u r-reviżjoni ta' materjal stampat ippubblikat.
English: PACKAGE LEAFLET AND USER TESTING
Maltese: Saret ukoll reviżjoni
English: Iodocasein 125mg (7.6% of iodine) and thiamine as nitrate 12.33 mg are the active substances for Antiadiposo, approved since 1955 in Italy for the treatment of obesity resulting from metabolic disorders.
Maltese: Iodocasein 125 mg (7.6% ta' jodju) u thiamine bħala nitrat 12.33 mg huma s-sustanzi attivi għal Antiadiposo, approvati sa mill-1955 fl-Italja għall-kura tal-obeżità li tirriżulta minn disturbi metaboliċi.
English: The amount of iodine released per each tablet (i.e. 9.4 mg) is noted to be 60 times higher than the daily recommended iodine dose of 150 mcg.
Maltese: L-ammont ta' jodju rilaxxat għal kull pillola (jiġifieri 9.4 mg) huwa nnutat li huwa 60 darba ogħla mid-doża ta' 150 mcg rakkomandata ta' kuljum ta' jodju.
English: Antiadiposo (iodocasein 125 mg/thiamine 12.33 mg), approved since 1955 in Italy for the treatment of obesity acts by increasing the amount of available iodine thus stimulating the thyroid gland and consequent metabolic processes.
Maltese: Antiadiposo (iodocasein 125 mg/thiamine 12.33 mg), approvat sa mill-1955 fl-Italja għall-kura talobeżità jaġixxi billi jżid l-ammont ta' jodju disponibbli u b'hekk jistimula l-glandola tat-tirojde u proċessi metaboliċi konsegwenti.
English: The CHMP discussed the matter at its September 2009 plenary meeting and the procedure in accordance with Article 107(2) of Directive 2001/83/EC, as amended was started.
Maltese: Is-CHMP ddiskuta l-każ waqt il-laqgħa plenarja tiegħu ta' Settembru 2009 u nbdiet il-proċedura skont l-Artikolu 107(2) tad-Direttiva 2001/83/KE, kif emendata.
English: This over stimulation of the metabolism is also frequently accompanied by tachycardia, palpitations and anxiety.
Maltese: Dan listimular żejjed tal-metaboliżmu spiss ikun akkumpanjat ukoll minn takikardija, palpitazzjonijiet u ansjetà.