FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH provided pharmacodynamic and pharmacokinetic data in animal models (a study in rats and another one in rabbits), children (five studies) and adults (two studies) which demonstrated a good penetration of amoxicillin in the cerebrospinal fluid (CSF).
Maltese: L-MAH ipprovda dejta farmakodinamika u farmakokinetika dwar il-mudelli tal-annimali (studju fil-firien u ieħor fil-fniek), it-tfal (ħames studji) u l-adulti (żewġ studji) li wrew penetrazzjoni tajba ta' amoxicillin fillikwidu ċerebrospinali (CSF).
English: Lyme disease- all formulations
Maltese: Marda Lyme - il-formulazzjonijiet kollha
English: The interaction with test results was moved to section 4.4 in line with the SmPC Guideline.
Maltese: L-interazzjoni mar-riżultati tat-test iċċaqalqet f'sezzjoni 4.4 f'konformità mal-Linji Gwida tal-SmPC.
English: The MAH has taken into consideration the current dataset, recommendations from recent evidence based and consensus European or national clinical prescribing guidelines in support of the use of amoxicillin in the claimed indications as well as the CHMP guidelines on the evaluation of medicinal products indicated for treatment of bacterial infections and its addendum (CPMP/EWP/558/95 rev 2 and EMA/CHMP/351889/2013).
Maltese: L-MAH ikkunsidra s-sett ta' dejta attwali, rakkomandazzjonijiet minn linji gwida Ewropej jew nazzjonali attwali li klinikament jippreskrivu bbażati fuq evidenza u b'kunsens li jappoġġjaw l-użu ta' amoxicillin fl-indikazzjonijiet mitlubin kif ukoll illinji gwida tas-CHMP dwar l-evalwazzjoni ta' prodotti mediċinali indikati għall-kura ta' infezzjonijiet batteriċi u l-addendum tiegħu (CPMP/EWP/558/95 rev 2 u EMA/CHMP/351889/2013).
English: Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms) - Parenteral formulation
Maltese: Infezzjonijiet severi tal-widna, tal-imnieħer u tal-griżmejn (bħal mastojdite, infezzjonijiet peitonsillari, epiglottite, u sinusite meta akkumpanjati minn sinjali u sintomi sistemiċi severi)
English: Treatment and prophylaxis of endocarditis- all formulations
Maltese: Kura u profilassi ta' endokardite - il-formulazzjonijiet kollha
English: The MAH has provided a number of controlled clinical trials in adults and children with amoxicillin generally in triple therapy as first (9 trials including one specifically in children and a meta-analysis of 22 studies), second (4 trials) and to a lesser extent third (1 trial) line, further supported by uncontrolled studies.
Maltese: L-MAH ipprovda numru ta' provi kliniċi kkontrollati f'adulti u tfal b'amoxicillin normalment f'terapija tripla bħala l-ewwel (9 provi inkluż waħda speċifikament fit-tfal u meta-analiżi ta' 22 studji), it-tieni (4 provi) u sa ċertu punt it-tielet (prova waħda) linja, appoġġjati iktar bi studji mhux ikkontrollati.
English: Separated dosing recommendations are provided for the oral, parenteral and intramuscular formulations for adults and children above 40kg, for children below 40kg, for patients with renal impairment including those under haemodialysis.
Maltese: Ġew ipprovduti rakkomandazzjonijiet tad-dożaġġ separati għall-formulazzjonijiet orali, parenterali u ġolmuskolu għal adulti u tfal ‘il fuq minn 40 kg, għal tfal taħt 40 kg, jew pazjenti b'indeboliment renali inkluż dawk taħt emodijalisi.
English: The risk of Jarisch-Herxheimer reaction when amoxicillin is used in treatment of Lyme disease was also included in the harmonised PI.
Maltese: Ir-riskju ta' reazzjoni Jarisch-Herxheimer meta amoxicillin jintuża fil-kura tal-marda Lyme ġie inkluż ukoll flinformazzjoni dwar il-prodott armonizzata.
English: Other sections of the SmPC have been updated in line with their respective Quality harmonised documentation provided in Module 3 and in line with the current QRD template.
Maltese: Sezzjonijiet oħrajn tal-SmPC ġew aġġornati f'konformità mad-Dokumentazzjoni dwar il-kwalità rispettiva armonizzata li ġiet ipprovduta f'Modulu 3 u f'konformità mal-mudell tal-QRD attwali.
English: This clinical data, while limited, supports the efficacy of amoxicillin in prevention of bacteraemia as well as in treatment of infectious endocarditis.
Maltese: Din id-dejta klinika, filwaqt li hija limitata, tappoġġja l-effikaċja ta' amoxicillin fil-prevenzjoni ta' batteremija kif ukoll fil-kura ta' endokartite infettiva.
English: The MAH has submitted small clinical trials conducted as part of the initial clinical development of oral and parenteral amoxicillin, numerous clinical studies conducted since then, mostly by independent research groups and individuals and studies published in the literature in peer-reviewed journals in support of the proposed harmonised PI.
Maltese: L-MAH issottometta provi kliniċi żgħar li twettqu bħala parti mill-iżvilupp kliniku inizjali ta' amoxicillin orali u parenterali, diversi studji kliniċi twettqu minn dak iż-żmien, il-maġġoranza minn gruppi ta' riċerka u individwi indipendenti u studji ppubblikati fid-dokumentazzjoni f'ġurnali analizzati bejn il-pari li jappoġġjaw l-informazzjoni dwar il-prodott armonizzata proposta.
English: Community acquired pneumonia (CAP) - all formulations
Maltese: Pnewmonja akkwistata mill-komunità (CAP) - il-formulazzjonijiet kollha
English: Bacterial meningitis - Parenteral formulation
Maltese: Meninġite batterika - Formulazzjoni parenterali
English: Recent guidelines (Public Health England guideline 2015, Infectious Diseases Society of America guidelines 2014 and Surgical Society Infections guideline 2011) recommend antibiotics other than amoxicillin for the treatment of most skin and soft tissue infections.
Maltese: Linji gwida riċenti (il-linji gwida tal-2015 tal-Public Health England, il-linji gwida tal-2014 tasSoċjetà tal-Mard Infettiv tal-Amerka u l-linji gwida tal-2011 tas-Soċjetà tal-Infezzjonijiet Kirurġiċi) jirrakkomandaw antibijotiċi oħrajn minflok amoxicillin għall-kura ta' ħafna mill-infezzjonijiet tal-ġilda u tattessuti rotob.
English: The wording on the pharmacotherapeutic group, mechanism of action and ATC code was harmonised.
Maltese: Il-kliem fil-grupp farmakoterapewtiku, il-mekkaniżmu tal-azzjoni u l-kodiċi ATC ġie armonizzat.
English: Acute cystitis, asymptomatic bacteriuria in pregnancy and acute pyelonephritis- all formulations
Maltese: Ċistite akuta, bacteriuria asintomatika fi tqala u pjelonefrite akuta - il-formulazzjonijiet kollha
English: The MAH submitted results of six randomised controlled trials comparing amoxicillin alone or in combination with probenecid 500 mg TID to other antibiotics and placebo, as well as an observational cohort study conducted in children and adults between 1989 and 2008 with amoxicillin, all in treatment of type I Lyme disease (erythema migrans).
Maltese: L-MAH issottometta r-riżultati ta' sitt provi randomizzati kkontrollati li jqabblu amoxicillin waħdu jew flimkien ma' probenecid 500 mg TID ma' antibijotiċi oħrajn u plaċebo, kif ukoll studju tal-gruppi ta' osservazzjoni li twettaq fi tfal u adulti bejn l-1989 u l-2008 b'amoxicillin, kollha fil-kura tal-marda Lyme ta' tip I (eritema migrans).
English: The CHMP requested that the warning of the potential occurrence of seizures in patients treated with high doses or with renal insufficiency or seizures history, treated epilepsy and meningeal damage present in one MS, be maintained as related adverse experiences such as myoclonic activity and seizures have been reported with beta-lactam antibiotics.
Maltese: Is-CHMP talab li t-twissija ta' okkorrenza potenzjali ta' aċċessjonijiet f'pazjenti kkurati b'dożi għoljin jew b'insuffiċenza renali jew storja ta' aċċessjonijiet, epilessija kkurata u ħsara meninġeali preżenti f'Stat Membru wieħed, tinżamm peress li ġew irrapportati esperjenzi avversi relatati bħal attività mijoklinika u aċċessjonijiet b'antibijotiċi beta-lactam.
English: Treatment with amoxicillin generally produced high clinical and bacteriological response rates (around 90%), with efficacy similar to the antibiotic comparators.
Maltese: Il-kura b'amoxicillin ġeneralment ħolqot rati ta' rispons kliniċi u batterjoloġiċi għoljin (madwar 90%), b'effikaċja simili għal komparaturi antibijotiċi.
English: The MAH presented five randomised double blind trials conducted between 1981 and 1989 comparing the efficacy of amoxicillin to other antibiotics, one open study, 9 non-comparative studies and a review in patients with various acute skin infections.
Maltese: L-MAH ippreżenta ħames provi double blind randomizzati li twettqu bejn l-1981 u l-1989 li jqabblu leffikaċja ta' amoxicillin ma' antibijotiċi oħrajn, studju wieħed miftuħ, 9 studji mhux komparattivi u reviżjoni f'pazjenti b'diversi infezzjonijiet tal-ġilda akuti.
English: The MAH presented six clinical trials conducted between 1975 and 1986 as well as a more recent review of antibiotics in postpartum infection.
Maltese: L-MAH ippreżenta sitt provi kliniċi li twettqu bejn l-1975 u l-1986 kif ukoll reviżjoni iktar riċenti ta' antibijotiċi f'infezzjonijiet wara t-twelid.
English: The MAH presented clinical studies conducted in adults and children between 1993 and 2008 as well as recommendations from various treatment guideline groups that support the use of amoxicillin in tonsillitis and pharyngitis particularly that due to group A beta-haemolytic streptococcal infections (GABHS).
Maltese: L-MAH ippreżenta studji kliniċi li twettqu f'adulti u tfal bejn l-1993 u l-2008 kif ukoll rakkomandazzjonijiet minn diversi gruppi ta' linji gwidi tal-kura li jappoġġjaw l-użu ta' amoxicillin f'tonsillite u farinġite b'mod partikolari dik ikkawżata minn infezzjonijiet streptokokkali beta-emolitiċi ta' grupp A (GABHS).
English: Upper respiratory tract infections
Maltese: Infezzjonijiet fl-apparat respiratorju ta' fuq
English: The treatment of acute skin infections was effective in about 60-90% of patients depending on the study.
Maltese: Il-kura ta' infezzjonijiet akuti tal-ġilda kienet effikaċi f'madwar 60-90% talpazjenti skont l-istudju.
English: The efficacy rates for amoxicillin were around 80%, which is comparable to the different active controls used in the studies presented.
Maltese: Ir-rati ta' effikaċja għal amoxicillin kienu madwar 80%, li huma komparabbli mal-kontrolli attivi differenti li ntużaw fl-istudji li ġew ippreżentati.
English: Although there is a paucity of clinical studies in adult AOM patients, taking into account the similarity in bacteriological aetiology and pathogenesis of adult sinusitis and AOM, it was considered that the clinical data demonstrating that amoxicillin is an effective treatment in ABS can be extrapolated to support efficacy of amoxicillin in the treatment of adult AOM.
Maltese: Għalkemm hemm nuqqas ta' studji kliniċi f'pazjenti adulti b'AOM, filwaqt li titqies is-similarità fl-etjoloġija batterjoloġika u l-patoġenesi ta' sinusite adulta u AOM, ġie kkunsidrat li d-dejta klinika li turi li amoxicillin huwa kura effikaċi f'ABS tista' tiġi estrapolata biex tappoġġja l-effikaċja ta' amoxicillin fil-kura ta' AOM f'adulti.
English: • In addition, the committee reviewed the documentation submitted by the MAH in support of the proposed harmonised Quality documentation (Module 3).
Maltese: • Barra minn hekk, il-Kumitat irreveda d-dokumentazzjoni sottomessa mill-MAH bħala appoġġ għad-Dokumentazzjoni dwar il-kwalità armonizzata proposta (Modulu 3).
English: Prosthetic joints infections (PJIs) - all formulations
Maltese: Infezzjonijiet tal-ġogi prostetiċi (PJIs) - il-formulazzjonijiet kollha
English: Considering that amoxicillin has been in use for many years and is indicated for use in a broad range of infections, in line with the Addendum to the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (EMA/CHMP/351889/2013), the CHMP was of the view that, based on the available data, the proposed indication was adequately justified..
Maltese: Meta wieħed iqis li amoxicillin intuża għal ħafna snin u huwa indikat għall-użu f'firxa wiesgħa ta' infezzjonijiet, f'konformità mal-Addendum tal-Linji Gwida dwar l-evalwazzjoni ta' prodotti mediċinali indikati għall-kura ta' infezzjonijiet batteriċi (EMA/CHMP/351889/2013), is-CHMP kien tal-fehma li, abbażi tad-dejta disponibbli, l-indikazzjoni proposta kienet ġustifikata b'mod adegwat.
English: The MAH proposed a harmonised set of indications on the different indication authorised in the MSs, however when single broad indications (e.g. infections caused by amoxicillin-sensitive organisms) were approved these were not taken into account.
Maltese: L-MAH ippropona sett ta' indikazzjonijiet armonizzati dwar l-indikazzjonijiet differenti awtorizzati fl-Istati Membri, madankollu fejn indikazzjonijiet waħdiena wesgħin (eż. infezzjonijiet ikkawżati minn organiżmi sensittivi għal amoxicillin) ġew approvati dawn ma ġewx ikkunsidrati.
English: Female genital infection - parenteral formulation
Maltese: Infezzjoni ġenitali fin-nisa - formulazzjoni parenterali
English: The manufacture and control of both the active substance and the finished product comply with CHMP and International Conference on Harmonisation (ICH) guidelines.
Maltese: Il-manifattura u l-kontroll kemm tas-sustanza attiva kif ukoll tal-prodott finali jikkonformaw mal-linji gwida tas-CHMP u tal-Konferenza Internazzjonali dwar l-Armonizzazzjoni (ICH).
English: Amoxicillin exerts its effect through inhibition of penicillin-binding transpeptidase proteins, disrupting peptidoglycan cross-linking in the cell-wall synthesis of both Gram-negative and Gram-positive organisms.
Maltese: Amoxicillin jagħmel l-effett tiegħu permezz ta' inibizzjoni ta' proteini transpeptidasi li jintrabtu mal-peniċillina, b'hekk jinterrompi l-irbit trasversali fis-sinteżi tal-ħajt taċċellola kemm ta' organiżmi Gram-negattivi kif ukoll ta' dawk Gram-pożittivi.
English: The indication “dental abscess with spreading cellulitis” for the oral formulation and “severe dental abscess with spreading cellulitis” for the parenteral formulation was therefore considered acceptable by CHMP.
Maltese: L-indikazzjonijiet “axxessi dentali b'ċellolite li qiegħda tinfirex” għall-formulazzjonijiet orali u “axxessi dentali severi b'ċellolite li qiegħda tinfirex” għall-formulazzjonijiet parenterali kienu kkunsidrati aċċettabbli mis-CHMP.
English: In addition a cross reference to section 4.2, 4.4 and 5.1 is included at the beginning of the section, in particular to highlight that “amoxicillin is not suitable for the treatment of some types of infection unless the pathogen is already documented and known to be susceptible or there is a very high likelihood that the pathogen would be suitable for treatment with amoxicillin”.
Maltese: Barra minn hekk, fil-bidu tas-sezzjoni hija inkluża referenza inkroċjata għal sezzjoni 4.2, 4.4 u 5.1, b'mod partikolari biex jiġi enfasizzat li “amoxicillin mhuwiex xieraq għall-kura ta' xi tipi ta' infezzjoni sakemm il-patoġenu mhuwiex diġa dokumentat u magħruf li huwa suxxettibbli jew hemm ċans kbir li l-patoġenu huwa xieraq għal kura b'amoxicillin”.
English: The CHMP accepted the MAH proposal when it was adequately specified by infection site as detailed below for oral and parenteral formulations.
Maltese: Is-CHMP aċċetta l-proposta tal-MAH meta ġiet speċifikata b'mod adegwat bis-siti ta' infezzjoni kif inhu ddettaljat hawn isfel għal formulazzjonijiet orali u parenterali.
English: The MAH presented 4 clinical trials, comparing the efficacy of oral amoxicillin to chloramphenicol or ampicillin in adults and children.
Maltese: L-MAH ippreżenta 4 provi kliniċi, li jqabblu l-effikaċja ta' amoxicillin orali ma' chloramphenicol jew ampicillin f'adulti u tfal.
English: The CHMP was of the view that amoxicillin remains an effective treatment for acute bacterial sinusitis.
Maltese: Is-CHMP kien tal-fehma li amoxicillin jibqa' kura effikaċi għal sinusite batterika akuta.
English: The MAH presented clinical studies in paediatrics conducted between 1986 and 2005 including comparative trials with macrolides and cephalosporins as well as recommendations from various treatment guideline groups based in the US and in the EU that support the use of amoxicillin in “acute otitis media”.
Maltese: L-MAH ippreżenta studji kliniċi f'studji pedjatriċi li twettqu bejn l-1986 u l-2005 li jinkludu provi komparattivi b'makrolidi u ċefalosporini kif ukoll rakkomandazzjonijiet minn diversi gruppi ta' linji gwida bbażati fl-Istati Uniti u fl-UE li jappoġġjaw l-użu ta' amoxicillin f'“otite medja akuta”.
English: The growing resistance to amoxicillin of H. influenzae and M. catarrhalis (through β-lactamase production) and S. pneumoniae and H. influenzae (through changes in protein binding site) increased the risk of treatment failure, therefore amoxicillin should not be used as empirical treatment in these infections.
Maltese: Ir-reżistenza għal amoxicllin li qiegħda tikber ta' H. influenzae u M. catarrhalis (permezz tal-produzzjoni ta' lattamażi-β) u S. pneumoniae u H. influenzae (permezz ta' bidliet fis-sit ta' rbit tal-proteini) żiedet irriskju li l-kura ma tirnexxiex, għalhekk amoxicillin m'għandux jintuża bħala kura empirika f'dawn linfezzjonijiet.
English: The list of organisms susceptible to amoxicillin was updated.
Maltese: Il-lista ta' organiżmi suxxettibbli għal amoxicillin ġiet aġġornata.
English: However the CHMP considered that due to the seriousness of the condition and in line with the European Society of Cardiology (ESC), American Heart Association (AHA), British Society of Antimicrobial Chemotherapy (BSAC) and British Cardiac Society (BCS) guidelines only the parenteral formulation was useful in treatment of endocarditis and requested that the indication be removed from the oral formulation.
Maltese: Madankollu s-CHMP ikkunsidra li minħabba s-serjetà tal-kundizzjoni u f'konformità mal-linji gwida tas-Soċjetà Ewropea tal-Kardjoloġija (ESC), l-Assoċċjazzjoni Amerikana talQalb (AHA), is-Soċjetà Brittanika tal-Kimoterapija Antimikrobjali (BSAC) u s-Soċjetà Kardijaka Brittanika (BCS) il-formulazzjoni parenterali biss kienet utli għall-kura ta' endokardite u talab li l-indikazzjoni titneħħa mill-formulazzjoni orali.
English: Peptidoglycan is an integral structural component of the bacterial cell wall and serves to maintain the shape and integrity of the cell.
Maltese: Peptidoglycan huwa komponent strutturali tal-ħajt taċ-ċellola batterika u jgħin sabiex iżomm il-forma u l-integrità taċ-ċellola.
English: However amoxicillin alone or in combination with metronidazole was found effective in the treatment of severe dental infections in several studies conducted between 1990 and 2005.
Maltese: Madankollu amoxicillin waħdu jew flimkien ma' metronidazole nstab li huwa effikaċi fil-kura ta' infezzjonijiet dentali severi f'diversi studji li twettqu bejn l-1990 u l-2005.
English: Only the contraindications around hypersensitivity to the active substance (or any of the penicillins and beta-lactam agents) and the excipients are harmonised.
Maltese: Ġew armonizzati biss il-kontraindikazzjonijiet dwar is-sensittività eċċessiva għas-sustanza attiva (jew għal kwalunkwe peniċillini jew aġenti beta-lactam) u l-eċċipjenti.
English: The MAH presented clinical studies in children and adults, including pregnant women, conducted between 1973 and 1993 with oral and parenteral amoxicillin as well as recommendations from various treatment guideline groups that support the use of amoxicillin in these indications.
Maltese: L-MAH ippreżenta studji kliniċi fi tfal u adulti, inklużi nisa tqal, li twettqu bejn l-1973 u l-1993 b'amoxicillin orali u parenterali kif ukoll rakkomandazzjonijiet minn diversi gruppi ta' linji gwida tal-kura li jappoġġjaw l-użu ta' amoxicillin f'dawn l-indikazzjonijiet.
English: It is currently authorised in 12 European Union (EU) Member States (MS).
Maltese: Bħalissa huwa awtorizzat fi 12-il Stat Membru (MS) tal-Unjoni Ewropea (UE).
English: There are few well-designed randomised controlled trials in patients comparing efficacy of different antibiotics.
Maltese: Hemm ftit provi kkontrollati randomizzati ddisinjati sew f'pazjenti li jqabblu l-effikaċja ta' antibijotiċi differenti.
English: The MAH also considered the SmPC Guideline and implemented the current QRD template.
Maltese: L-MAH ikkunsidra wkoll il-Linji Gwida tal-SmPC u implimenta l-mudelli tal-QRD attwali.
English: The MAH presented clinical studies in adults and paediatrics conducted between 1992 and 2008, as well as recommendations from various treatment guideline groups that support the use of amoxicillin in CAP.
Maltese: L-MAH ippreżenta studji kliniċi f'adulti u twettqu studji pedjatriċi bejn l-1992 u l-2008, kif ukoll rakkomandazzjonijiet minn diversi gruppi ta' linji gwida tal-kura li jappoġġjaw l-użu ta' amoxicillin f'CAP.
English: In line with the SmPC guideline and QRD template, the MAH has listed the ADRs derived from clinical studies and post-marketing surveillance with amoxicillin, sorted by MedDRA System Organ Class.
Maltese: F'konformità mal-linji gwida tas-SmPC u l-mudell tal-QRD, l-MAH elenka l-ADRs li nkisbu minn studji kliniċi u sorveljanza ta' wara t-tqegħid fis-suq b'amoxicillin, magħżulin skont is-Sistema tal-Klassifika talOrgani
English: Many national and European guidelines recommend amoxicillin as one of several treatment options for AECB in adults patients with increased dyspnoea, sputum volume and sputum purulence or in case of exacerbations in patients with severe chronic obstructive pulmonary disease (COPD).
Maltese: Ħafna linji gwida nazzjonali u Ewropej jirrakkomandaw amoxicillin bħala wieħed minn diversi alternattivi ta' kura għal AECB f'pazjenti adulti b'żieda fil-qtugħ tan-nifs, volum talisputum u tnixxija tal-isputum jew f'każ ta' aggravar f'pazjenti b'mard pulmonari ostruttiv kroniku (COPD).
English: The MAH presented a number of clinical studies conducted in adults and children between 1986 and 1999 comparing amoxicillin to placebo or other antibiotics as well as recommendations from guideline groups and meta-analysis that support the use of amoxicillin in adults and children with sinusitis.
Maltese: L-MAH ippreżenta numru ta' studji kliniċi li twettqu f'adulti u tfal bejn l-1986 u l-1999 li qabblu amoxicillin ma' plaċebo jew antibijotiċi oħrajn kif ukoll rakkomandazzjonijiet minn gruppi ta' linji gwida u metaanaliżijiet li jappoġġjaw l-użu ta' amoxicillin f'adulti u tfal b'sinusite.
English: The mechanism of resistance was also harmonised.
Maltese: Il-mekkaniżu tar-reżistenza ġie armonizzat ukoll.
English: However higher cure rates were observed with longer treatment duration (7-10 days) and when the causative organisms were susceptible to amoxicillin.
Maltese: Madankollu, rati ta' kura ogħla ġew osservati b'tul ta' kura itwal (7-10 ijiem) u meta l-organiżmi kawżativi kienu suxxettibbli għal amoxicillin.
English: The CHMP was therefore of the view that amoxicillin remains a valid therapeutic option in this indication.
Maltese: Is-CHMP għalhekk kien tal-fehma li amoxicillin jibqa' alternattiva terapewtika valida f'din l-indikazzjoni.
English: The MAH proposed harmonised dosing recommendations based on the doses studied in clinical trials and supported by pharmacodynamic and pharmacokinetic data and in line with international, European and national guidelines.
Maltese: L-MAH ippropona rakkomandazzjonijiet għad-dożaġġ rakkomandati abbażi tad-dożi studjati fi provi kliniċi u appoġġjati minn dejta farmakodinamika u farmakokinetika f'konformità mal-linji gwida internazzjonali, Ewropej u nazzjonali.
English: Other sections of the SmPC
Maltese: Konklużjonijiet xjentifiċi
English: The MAH provided data suggesting that the penetration of amoxicillin into bone is adequate, even when the tissue is infected and pharmacokinetic/pharmacodynamic data supporting the use of amoxicillin in these conditions however the clinical evidence is very limited.
Maltese: L-MAH ipprovda dejta li tissuġġerixxi li l-penetrazzjoni ta' amoxicillin fl-għadam hija adegwata, anki meta t-tessut huwa infettat u dejta farmakokinetika/farmakodinamika li tappoġġja lużu ta' amoxicillin f'dawn il-kundizzjonijiet madankollu l-evidenza klinika hija limitata ħafna.