FrancophonIA/ELRC3.0 huggingface dataset:
English: • These serious side effects include inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling, walking difficulty, feeling pins and needles, burning pain, tiredness, depression, problems with memory, sleeping, vision and hearing, and altered taste and smell.
Maltese: • Dawn l-effetti sekondarji serji jinkludu għerq infjammat jew maqsum, uġigħ jew dgħjufija filmuskoli, uġigħ jew nefħa fil-ġogi, diffikultà fil-mixi, tħoss li raqditlek parti minn ġismek, uġigħ ta' ħruq, għeja, dipressjoni, problemi bil-memorja, bl-irqad, bil-vista u bis-smigħ, u sens tat-togħma u x-xamm differenti.
English: Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided.
Maltese: Billi l-użu ta' kortikosterojde ma' fluoroquinolone jżid ukoll dan ir-riskju, l-użu kombinat ta' dawn il-mediċini għandu jiġi evitat.
English: In addition, the prescribing information for healthcare professionals and information for patients will describe the disabling and potentially permanent side effects and advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or joints and the nervous system.
Maltese: Barra minn hekk, l-informazzjoni dwar il-preskrizzjoni għall-professjonisti tal-kura tas-saħħa u l-informazzjoni għall-pazjenti se tiddeskrivi l-effetti sekondarji li jiddiżabilitaw u li huma potenzjalment permanenti u tagħti parir lill-pazjenti biex iwaqqfu l-kura bl-antibijotiku fluoroquinolone mal-ewwel sinjal ta' effett sekondarju li jinvolvi l-muskoli, l-għeruq jew il-ġogi u s-sistema nervuża.
English: Further information on Dupixent can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dupixent.
Maltese: Aktar informazzjoni dwar Dupixent tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/dupixentema.europa.eu/medicines/human/EPAR/dupixent.
English: In the first study, involving 1,902 patients, the number of severe flare-ups per year was 0.46 in patients taking 200 mg Dupixent and 0.52 in patients taking 300 mg Dupixent, compared with 0.87 or 0.97 in patients given placebo.
Maltese: Fl-ewwel studju, li kien jinvolvi 1,902 pazjenti, lgħadd ta' taħrix sever fis-sena kien 0.46 f'pazjenti li kienu qed jieħdu 200 mg ta' Dupixent u 0.52 f'pazjenti li kienu qed jieħdu 300 mg ta' Dupixent, meta mqabbla ma' 0.87 jew 0.97 f'pazjenti li ngħataw il-plaċebo.
English: Dupixent received a marketing authorisation valid throughout the EU on 27 September 2017.
Maltese: Dupixent ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-27 ta' Settembru 2017.
English: After 12 weeks of treatment, Dupixent improved patients' FEV1 (the maximum volume of air a person can breathe out in one second) by 320 ml (for 200 mg Dupixent) or 340 ml (for 300 mg Dupixent) compared with 180 ml and 210 ml for placebo.
Maltese: Wara 12-il ġimgħa ta' kura, Dupixent tejjeb il-FEV1 tal-pazjenti (il-volum massimu ta' arja li persuna tista' toħroġ f'sekonda) bi 320 ml (għal 200 mg ta' Dupixent) jew 340 ml (għal 300 mg ta' Dupixent) meta mqabbel ma' 180 ml u 210 ml għall-plaċebo.
English: A further study was carried out in 251 adolescents aged from 12 to less than 18 years with moderate to severe atopic dermatitis.
Maltese: Studju ieħor twettaq f'251 adoloxxent minn 12-il sena sa inqas minn 18-il sena b'dermatite atopika moderata sa severa.
English: The active substance in Dupixent, dupilumab, is a monoclonal antibody (a type of protein) designed to block receptors (targets) for IL-4 and IL-13.
Maltese: Is-sustanza attiva f'Dupixent, id-dupilumab, hija antikorp monoklonali (tip ta' proteina) imfassla biex timblokka r-riċetturi (miri) għal IL-4 u IL-13.
English: In adolescents weighing less than 60 kg, the 200-mg injection is used.
Maltese: Fl-adoloxxenti li jiżnu inqas minn 60 kg, tintuża l-injezzjoni ta' 200 mg.
English: Other information about Dupixent
Maltese: Informazzjoni oħra dwar Dupixent
English: What are the risks associated with Dupixent?
Maltese: X'inhuma r-riskji assoċjati ma' Dupixent?
English: In the first study, which involved 740 patients, participants were given Dupixent or placebo, both in combination with a topical corticosteroid (a medicine for inflammation applied to the skin).
Maltese: Fl-ewwel studju, li involva 740 pazjent, il-parteċipanti ngħataw Dupixent jew plaċebo, it-tnejn li huma f'kombinazzjoni ma' kortikosterojde topika (mediċina għall-infjammazzjoni applikata fuq il-ġilda).
English: The second study, involving 210 patients, showed that in 70% of patients given Dupixent their condition improved to the extent that they could reduce their dose of corticosteroids taken by mouth compared with 42% of those given placebo.
Maltese: It-tieni studju, li involva 210 pazjenti, wera li f'70 % tal-pazjenti li ngħataw Dupixent, il-kundizzjoni tagħhom tjiebet sal-punt li setgħu jnaqqsu d-doża tagħhom ta' kortikosterojdi meħuda mill-ħalq meta mqabbla ma' 42 % ta' dawk li ngħataw il-plaċebo.
English: Anaphylaxis (sudden, severe allergic reaction) has been reported very rarely.
Maltese: L-anafilassi (reazzjoni allerġika severa f'daqqa) ġiet irrappurtata b'mod rari ħafna.
English: As for all medicines, data on the use of Dupixent are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Dupixent hija ssorveljata kontinwament.
English: For atopic dermatitis, the first dose in adults and adolescents weighing 60 kg or more is two injections of 300 mg in two different sites.
Maltese: Għal dermatite atopika, l-ewwel doża fl-adulti u fl-adoloxxenti li jiżnu 60 kg jew aktar hi żewġ injezzjonijiet ta' 300 mg f'żewġ siti differenti.
English: Regarding safety, Dupixent's side effects are generally mild and manageable.
Maltese: Rigward is-sigurtà, l-effetti sekondarji ta' Dupixent ġeneralment huma ħfief u maniġġabbli.
English: Dupixent has been shown to reduce the extent and severity of atopic dermatitis in patients with moderate to severe disease, for whom available therapies are limited.
Maltese: Dupixent intwera li jnaqqas il-firxa u s-severità tad-dermatite atopika f'pazjenti b'marda moderata sa severa, li għalihom it-terapiji disponibbli huma limitati.
English: Dupixent or placebo was used on its own in the other two studies involving a total of 1,379 patients.
Maltese: Dupixent jew plaċebo ntuża waħdu fiż-żewġ studji l-oħra li involvew total ta' 1,379 pazjent.
English: After 16 weeks of treatment, 39% of patients treated with Dupixent every two weeks in the first study showed clearing or almost clearing of their atopic dermatitis compared with 12% of patients on placebo.
Maltese: Wara 16-il ġimgħa ta' kura, 39 % tal-pazjenti kkurati b'Dupixent kull ġimagħtejn fl-ewwel studju wrew li telqitilhom jew kważi telqitilhom id-dermatite atopika tagħhom meta mqabbla ma' 12 % tal-pazjenti fuq il-plaċebo.
English: Patients with atopic dermatitis and patients with asthma produce high levels of proteins called interleukin 4 and interleukin 13 (IL-4 and IL-13), which can cause inflammation of the skin and airways leading to the symptoms of these diseases.
Maltese: Il-pazjenti b'dermatite atopika u l-pazjenti li jbatu bl-ażma jipproduċu livelli għoljin ta' proteini msejħa interleukin 4 u interleukin 13 (IL-4
English: By blocking the receptors, dupilumab prevents IL-4 and IL-13 from working and relieves disease symptoms.
Maltese: Billi timblokka r-riċetturi, id-dupilumab tipprevjeni lil IL-4 u IL-13 milli jaħdmu u ttaffi s-sintomi talmarda.
English: The doctor will consider stopping treatment if the condition does not show any improvement after 16 weeks.
Maltese: It-tabib se jikkunsidra li jwaqqaf il-kura jekk il-kondizzjoni ma turix xi titjib wara 16-il ġimgħa.
English: The most common side effects with Dupixent when used in treatment of atopic dermatitis are injectionsite reactions (such as redness, swelling and itching),which may affect more than 1 in 10 people, and conjunctivitis (redness and discomfort in the eye), blepharitis (inflammation of the eyelid) and cold sores, which may affect up to 1 in 10 people.
Maltese: minn kull 10, u konġuntivite (ħmura u skumdità fl-għajn), blefaritis (infjammazzjoni tal-kappell talgħajn) u selħiet fix-xofftejn, li jistgħu jaffettwaw sa persuna 1 minn kull 10.
English: How does Dupixent work?
Maltese: Dupixent?
English: Dupixent was more effective than placebo (a dummy treatment) at reducing the extent and severity of atopic dermatitis in 3 main studies in patients with moderate to severe disease.
Maltese: Dupixent kien aktar effettiv mill-plaċebo (kura finta) biex jitnaqqsu l-firxa u s-severità tad-dermatite atopika fi 3 studji ewlenin f'pazjenti b'marda moderata sa severa.
English: In this study, after 16 weeks atopic dermatitis had cleared up or almost cleared up in around 24% of those given Dupixent every 2 weeks compared with around 2% of those given placebo.
Maltese: F'dan l-istudju, wara 16-il ġimgħa d-dermatite atopika kienet telqet jew kważi telqet f'madwar 24 % ta' dawk li ngħataw Dupixent kull ġimagħtejn meta mqabbla ma' madwar 2 % ta' dawk li ngħataw il-plaċebo.
English: Dupixent is available as pre-filled syringes containing 200 mg or 300 mg dupilumab in a solution for injection under the skin, usually in the thigh or belly.
Maltese: Dupixent jiġi bħala siringi mimlija lesti li fihom 200 mg jew 300 mg dupilumab f'soluzzjoni għallinjezzjoni taħt il-ġilda, normalment fil-koxxa jew fiż-żaqq.
English: Dupixent is a medicine used to treat patients aged 12 years or over with moderate to severe atopic dermatitis (also known as atopic eczema, when the skin is itchy, red and dry).
Maltese: Dupixent huwa mediċina li tintuża biex tikkura pazjenti minn 12-il sena jew aktar b'dermatite atopika moderata sa severa (magħrufa wkoll bħala ekżema atopika, meta jkollok ħakk fil-ġilda, il-ġilda tkun ħamra u niexfa).
English: For the full list of side effects and restrictions of Dupixent, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Dupixent, ara l-fuljett ta' tagħrif.
English: Taking the results of the other two studies together, 37% of patients treated with Dupixent every two weeks had clearing or almost clearing of their atopic dermatitis compared with 9% of patients on placebo.
Maltese: Meta jittieħdu r-riżultati taż-żewġ studji l-oħra flimkien, 37 % tal-pazjenti kkurati b'Dupixent kull ġimagħtejn urew li d-dermatite atopika tagħhom telqitilhom għal kollox jew kważi telqitilhom meta mqabbla ma' 9 % tal-pazjenti fuq il-plaċebo.
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Maltese: • Il-Kumitat ikkunsidra r-referenza skont l-Artikolu 30 tad-Direttiva 2001/83/KE
English: Amoxil is approved for marketing in Europe in 17 different formulations: two strengths of capsules (250 mg and 500 mg), two strengths of dispersible tablets (750 mg and 1 g), four strength of powder for oral suspension (125 mg/1.25 ml, 125 mg/5 ml, 250 mg/5 ml, 500 mg/5 ml), four strength of powder for oral suspension in sachets (250, 500, 1g and 3g) and four strength of 125 mg/1.25 ml powder for solution for injection or infusion via intravenous or intramuscular route (IV/IM) or both (250 mg (intravenous or intramuscular, IV/IM), 500 mg (IV/IM), 1g (IV/IM and IM) and 2g (IV)).
Maltese: Amoxil huwa approvat għas-suq fl-Ewropa f'17-il formulazzjoni differenti: żewġ qawwiet ta' kapsuli (250 mg u 500 mg), żewġ qawwiet ta' pilloli dispersabli (750 mg u 1 g), erba' qawwiet ta' trab għal sospensjoni orali (125 mg/1.25 ml, 125 mg/5 ml, 250 mg/5 ml, 500 mg/5 ml), erba' qawwiet ta' trab għal sospensjoni orali fi qratas (250, 500, 1 g u 3 g) u erba' qawwiet ta' trab 125 mg/1.25 ml għal soluzzjoni għal injezzjoni jew infużjoni ġol-vina jew ġol-muskolu (IV/IM) jew it-tnejn (250 mg (ġol-vina jew ġol-muskolu, IV/IM), 500 mg (IV/IM), 1 g (IV/IM u IM) u 2 g (IV)).
English: Gastrointestinal infections
Maltese: Infezzjonijiet gastro-intestinali
English: The breakpoint table was updated based on EUCAST (version 4) dated 01 January 2014.
Maltese: It-tabella tal-limiti ġiet aġġornata abbażi talEUCAST (verżjoni 4) datat 1 ta' Jannar 2014.
English: Several statement regarding important information about excipients present in some member states (sodium, aspartame, sodium benzoate, lactose and sorbitol) were harmonised as well.
Maltese: Diversi dikjarazzjonijiet rigward informazzjoni importanti dwar l-eċċipjenti preżenti f'xi Stati Membri (sodium, aspartame, sodium benzoate, lactose u sorbitol) ġew armonizzati wkoll.
English: The CHMP accepted the MAH proposal for a harmonised wording including information on possible gastrointestinal symptoms, crystalluria, with the addition of the potential the risk of seizures.
Maltese: Is-CHMP aċċetta l-proposta tal-MAH dwar kliem armonizzat inkluż informazzjoni dwar sintomi gastrointestinali possibbli, kristallurja, biż-żieda ta' riskju potenzjali ta' aċċessjonijiet.
English: Amoxicillin in triple therapy achieved eradication rates around 80-85% in the various studies presented.
Maltese: Amoxicillin f'terapija tripla kiseb rati ta' qerda ta' madwar 80-85% f'diversi studji ppreżentati.
English: Helicobacter pylori eradication - oral formulations
Maltese: Qerda ta' Helicobacter pylori - formulazzjonijiet orali
English: Section 1, 6.3 and 6.4 have only been partially harmonised as it is considered that these should be adapted nationally.
Maltese: Sezzjoni 1, 6.3 u 6.4 ġew armonizzati parzjalment biss minħabba li ġie kkunsidrat li għandhom jigu adattati b'mod nazzjonali.
English: Skin and soft tissues infections (SSTI)
Maltese: Infezzjonijiet fil-ġilda u fit-tessuti rotob (SSTI)
English: Acute bacterial sinusitis (ABS) - oral formulations
Maltese: Sinusite batterika akuta (ABS) - formulazzjonijiet orali
English: Whereas
Maltese: MeDRA.
English: Acute otitis media (AOM) - oral formulations
Maltese: Otite medja akuta (AOM) - formulazzjonijiet orali
English: The harmonised dossier was provided for the active substance (amoxicillin sodium and amoxicillin trihydrate) and for the different formulations of the finished product containing this substance.
Maltese: Id-dossier armonizzat għas-sustanza attiva (amoxicillin sodium u amoxicillin trihydrate) ġie pprovdut u għall-formulazzjonijiet differenti tal-prodott finali li fih din is-sustanza.
English: The use of parenteral formulation showed similar results to the oral formulation.
Maltese: L-użu ta' formulazzjoni parenterali ta riżultati simili għal dawk tal-formulazzjoni orali.
English: These included bronchitis, acute lung disease, urethritis, gonococcal infection, male genital infections, gonorrhoea, enteritis with bacteraemia and intra-abdominal infections such as peritonitis, cholecystitis and acute cholangitis, serious infections caused by haemophilus influenza.
Maltese: Dawn jinkludu bronkite, mard akut tal-pulmun, uretrite, infezzjoni gonokokkali, infezzjonijiet ġenitali fl-irġiel, gonorrea, enterite b'batteremija u infezzjonijiet intraaddominali bħal peritonite, koleċistite u kolanġite akuta, infezzjonijiet serji kkawżati minn influwenza haemophilus.
English: Acute exacerbations of chronic bronchitis (AECB) - all formulations
Maltese: Aggravar akut ta' bronkite kronika (AECB) - il-formulazzjonijiet kollha
English: The doses recommended in various national SmPCs in adults and children above 40kg range from 250mg - 1mg TID, expressed differently and are comprised in the proposed harmonised posology.
Maltese: Id-dożi rakkomandati f'diversi SmPCs nazzjonali f'adulti u tfal ‘il fuq minn 40 kg ivarjaw bejn 250 mg u 1 mg TID, espressi b'mod differenti u bħala parti mill-pożoloġija armonizzata proposta.
English: Acute streptococcal tonsillitis and pharyngitis - oral formulations
Maltese: Farinġite u tonsillite streptokokkali akuta - formulazzjonijiet orali
English: The MAH proposed to harmonise the paediatric dosing recommendations using the most commonly approved mg/kg dose (40 - 90 mg/kg/day in divided doses).
Maltese: L-MAH ippropona li jarmonizza ir-rakkomandazzjonijiet tad-dożaġġ pedjatriku permezz tad-doża mg/kg l-iktar komuni (40 - 90 mg/kg/kuljum f'dożi maqsumin).
English: Treatment with oral amoxicillin at a dose 1000mg TID or 500mg TID for 7 to 10 days produced similar results to other antibiotics with clinical response rates ranging from 86% to 90% and bacteriological response rates ranging from 82% to 92%.
Maltese: Il-kura b'amoxicillin orali f'doża ta' 1000 mg TID jew 500 mg TID għal 7 sa 10 ijiem tat riżultati simili għal antibijotiċi oħrajn b'rati ta' rispons kliniku li jvarjaw minn 86% sa 90% u rati ta' rispons batterjoloġiku li jvarjaw minn 82% sa 92%.
English: In addition the MAH presented an open study in 30 adults comparing amoxicillin (1 g amoxicillin four-times daily) to chloramphenicol (1g TID until defervesence followed by 500 mg four times a day (QID) for one week), a study comparing the efficacy of 3 g oral amoxicillin daily to 2 g oral amoxicillin given with 1 g probenecid in 8 patients and two open label, noncomparative studies in 12 and 7 patients that further supported use in this indication.
Maltese: Barra minn hekk, l-MAH ippreżenta studju miftuħ fi 30 adult li jqabbel amoxicillin (1 g ta' amoxicillin erba' darbiet kuljum) ma' chloramphenicol (1 g TID sad-defervexxenza segwit b'500 mg erba' darbiet kuljum (QID) għal ġimgħa), studju li jqabbel l-effikaċja ta' 3 g ta' amoxicillin orali kuljum ma' 2 g ta' amoxicillin orali li ngħataw ma' 1 g ta' probenecid fi 8 pazjenti u żewġ studji b'tikketta mikxufa, mhux komparattivi fi 12 u 7 pazjenti li appoġġjaw aktar l-użu f'din l-indikazzjoni.
English: Amoxil contains amoxicillin (as amoxicillin sodium or amoxicillin trihydrate), a moderate-spectrum, bacteriolytic, β-lactam antibiotic used to treat bacterial infections caused by susceptible microorganisms.
Maltese: Amoxil fih amoxicillin (bħala amoxicillin sodium jew amoxicillin trihydrate), antibijotiku β-lactam, batterjolitiku bi spectrum moderat li jintuża fil-kura ta' infezzjonijiet batteriċi kkawżati minn mikroorganiżmi suxxettibbli.
English: Infections of the female genital tract are both aetiologically and clinically diverse.
Maltese: Infezzjonijiet tal-apparat ġenitali fin-nisa huma etjoloġikament u klinikament differenti.
English: There are very few randomised trials that have evaluated the efficacy of antibiotic prophylaxis in infectious endocarditis.
Maltese: Hemm ftit provi randomizzati li evalwaw l-effikaċja ta' profilassi bl-antibijotiċi f'endokardite infettiva.
English: Several warnings were in place in all (or all but one) member states with slightly different wordings (Hypersensitivity reactions, renal impairment, crystalluria, skin reactions (including in patients with infectious mononucleosis, anticoagulant), overgrowth of non-susceptible microorganisms, prolonged therapy) and the harmonised proposal of the MAH was considered acceptable.
Maltese: Fl-Istati Membri kollha (jew kollha barra wieħed) kienu fis-seħħ diversi twissijiet bi kliem ftit differenti (Reazzjonijiet ta' sensittività eċċessiva, indeboliment renali, kristallurja, reazzjonijiet tal-ġilda (inkluż f'pazjenti b'mononukleożi infettiva, antikoagulant), tkabbir żejjed ta' mikro-organiżmi mhux suxxettibbli, terapija mtawla) u l-proposta armonizzata tal-MAH ġiet ikkunsidrata aċċettabbli.
English: As this section was not included in national SmPCs, the MAH proposal for a general wording considering the SmPC of the fixed combination amoxicillin/clavulanic SmPC (EMEA/H/A-30/979) was accepted by the CHMP with minor modifications.
Maltese: Billi din is-sezzjoni ma ġietx inkluża fl-SmPCs nazzjonali, il-proposta tal-MAH għal kliem ġenerali li jikkunsidra l-SmPC tal-kombinazzjoni fissa amoxicillin/clavulanic (EMEA/H/A-30/979) ġiet aċċettata misCHMP b'bidliet żgħar.
English: Most of the existing statements on interactions across the MSs were considered supported (probenecid, allopurinol, tetracyclines, oral anticoagulants, methotrexate) and the MAH's proposed harmonised wording was accepted by the CHMP.
Maltese: Ħafna mid-dikjarazzjonijiet eżistenti dwar l-interazzjonijiet madwar l-Istati Membri ġew ikkunsidrati bħala appoġġjati (probenecid, allopurinol, tetracyclines, antikoagulanti orali, methotrexate) u l-kliem armonizzat propost mill-MAH ġie aċċettat mis-CHMP.
English: The possible interaction with oral contraceptives through an effect on the gut flora was removed, in line with the recent Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) recommendation to remove this interaction from the PI of numerous antibiotics including amoxicillin (CMDh/326/2015, Rev.0).
Maltese: L-interazzjoni possibbli b'kontraċettivi orali permezz ta' effett fuq il-flora tal-imsaren tneħħiet, f'konformità mar-rakkomandazzjoni tal-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura deċentralizzata - Bniedem (CMDh) biex titneħħa din l-interazzjoni mill-informazzjoni dwar il-prodott ta' diversi antibijotiċi inkluż amoxicillin (CMDh/326/2015, Rev.0).
English: In line with the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) the MAH was requested to provide the dose regimen and the duration of treatment courses tabulated by indication.
Maltese: F'konformità mal-Linji Gwida dwar l-evalwazzjoni ta' prodotti mediċinali indikati għall-kura ta' infezzjonijiet batteriċi (CPMP/EWP/558/95 rev 2) l-MAH intalab jipprovdi l-iskeda ta' dożaġġ u t-tul talkorsijiet tal-kura tabulati skont l-indikazzjoni.
English: While there is a paucity of clinical studies that evaluated antibiotic therapy in late stages of Lyme disease, the MAH provided three studies investigating the efficacy of amoxicillin in treatment of stages II/III Lyme disease.
Maltese: Filwaqt li hemm nuqqas ta' provi kliniċi li evalwaw terapija antibijotika flaħħar stadji tal-marda Lyme, l-MAH ipprovda tliet studji li jinvestigaw l-effikaċja ta' amoxicillin fil-kura tal-istadji II/III tal-marda Lyme.
English: The use of varying dose regimens ranging from 40 mg/kg/day to 90 mg/kg/day showed efficacy rates of around 90% in majority of the trials.
Maltese: L-użu ta' skedi ta' dożaġġ varjati li jvarjaw bejn 40 mg/kg/jum u 90 mg/kg/jum wera rati ta' effikaċja ta' madwar 90% filmaġġoranza tal-provi.
English: In addition the MAH presented 4 clinical studies conducted between 1990 and 2005 in patients with dentoalveolar abscesses of different severity and an outcome audit to determine the influence of different antibiotic therapy on outcome treatment of acute dentoalveolar infection.
Maltese: Barra minn hekk l-MAH ippreżenta 4 studji kliniċi li twettqu bejn l-1990 u l-2005 f'pazjenti b'axxessi dentoalveolari b'severità differenti u verifika tarriżultati biex tiġi determinata l-influwenza ta' terapija antibijotika differenti fuq ir-riżultati tal-kura ta' infezzjoni dentoalveolari akuta.
English: Amoxil is indicated in both adults and children for the oral and parenteral treatment of many common infections, including bone/joint, skin/soft tissue and those of the urinary, respiratory, gastrointestinal and genital tracts.
Maltese: Amoxil huwa indikat kemm fl-adulti kif ukoll fit-tfal għall-kura orali u parenterali ta' diversi infezzjonijiet komuni, inklużi l-għadam/ġogi, ġilda/tessut artab u dawk tal-passaġġ urinarju, respiratorju, gastrointestinali u ġenitali.
English: In clinical trials amoxicillin given either at a dose of 1000mg twice a day (BID) or at a dose of 500mg BID or three times a day (TID) was found to have similar response rates to the comparators (successful clinical and microbiological outcomes in ≥81% and ≥ 85% of patients, respectively).
Maltese: Fil-provi kliniċi amoxicillin mogħti f'dożi ta' 1000 mg darbtejn kuljum (BID) jew f'doża ta' 500 mg BID jew tliet darbiet kuljum (TID) instab li għandu rati ta' rispons simili għal dawk tal-komparaturi (riżultati kliniċi u mikrobijoloġiċi tajbin f'≥81% u ≥ 85% tal-pazjenti, rispettivament).