FrancophonIA/ELRC3.0 huggingface dataset:
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from Pharmacovigilance data, for fusafungine-containing products for oromucosal and nasal use (see Annex I).
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE bħala riżultat taddata ta' Farmakoviġilanza, għal prodotti li fihom fusafungine għall-użu oromukosali u nażali (ara Anness I).
English: The distribution of ADRs as follows:
Maltese: Id-distribuzzjoni tal-ADRs hija kif ġejja:
English: The MAH submitted studies regarding rhinopharyngitis, rhinosinusitis, pharyngitis, laryngitis, status after tonsillectomy and URTI in general.
Maltese: Il-MAH ippreżenta studji rigward ir-rinofariniġite, rinosinużite, farinġite, larinġite, l-istat wara ttonsillekotmija u URTI b'mod ġenerali.
English: The MAH provided: - 5 clinical studies in adults including 3 pivotal studies in acute rhinopharyngitis (Chabolle, 19991, Eccles 20002 and Bouter, 20023) and 2 supportive randomized, double-blind, placebo controlled studies in rhinosinusitis (Cuénant 19884, Mösges 2002) and, - one study in children (a double-blind, placebo-controlled, randomized, in 515 children, aged 8-12 years, with acute rhinopharyngitis, Januszewicz 2002).
Maltese: - 5 studji kliniċi fl-adulti inkludew 3 studji pivotali dwar ir-rinofarinġite akuta u (Chabolle, 19991, Eccles 20002 and Bouter, 20023) u 2 studji ta' appoġġ randomizzati, double-blind, ikkontrollati millplaċebo dwar ir-rinosinużite (Cuénant 19884, Mösges 2002) u,
English: The PRAC considered also the views expressed by experts such as the CHMP Scientific Advisory Group (SAG) in Anti-Infectives and the Paediatric Committee (PDCO).
Maltese: Il-PRAC ikkunsidra wkoll l-opinjonijiet espressi minn esperti bħallGrupp ta' Konsulenza Xjentifika (SAG) tas-CHMP dwar l-Anti-Infettivi u l-Kumitat Pedjatriku (PDCO).
English: The PDCO questioned the place of this product in the treatment armamentarium of viral upper respiratory illnesses and concluded that information on limited beneficial effect in the literature, did not point towards a different clinical interest of fusafungine across the various paediatric age sub-groups.
Maltese: Il-PDCO wera d-dubju tiegħu dwar il-post ta' dan il-prodott fl-armamentarju tal-kura ta' mard virali respiratorju fil-parti ta' fuq u kkonkluda li l-informazzjoni dwar l-effett ta' benefiċċju limitat fil-letteratura, ma ppuntax lejn interess kliniku differenti ta' fusafungine fis-sottogruppi varji tal-età pedjatrika.
English: Fusafungine was shown to be superior to placebo in the acute rhinopharyngitis indication regarding evolution of nasal symptom score after 4 days of treatment in adults in three pivotal studies Chabolle, 19995, Eccles 20006 and Bouter, 20027) and the pooled analysis of them (Grouin 20038).
Maltese: Fusafungine intwera li kien superjuri fuq il-plaċebo fl-indikazzjoni dwar ir-rinofarinġite akuta firrigward tal-evoluzzjoni tal-punteġġ tas-sintomu nażali wara 4 ijiem ta' kura fl-adulti fi tliet studji pivitali Chabolle, 19995, Eccles 20006 u Bouter, 20027) u l-analiżi miġbura tagħhom (Grouin 20038).
English: In addition, the mechanism of action of fusafungine is unclear, and while the MAH argues that it is predominantly related to an anti-inflammatory activity, the compound has bacteriostatic activity and has been classified as an antibiotic compound (e.g. in the SmPC, the Pharmacotherapeutic group is listed as Respiratory System, Throat preparations/ Antibiotics, ATC code: R02A B03).
Maltese: Barra minn hekk, il-mekkaniżmu tal-azzjoni ta' fusafungine mhuwiex ċar, u waqt li l-MAH isostni li huwa relatat b'mod predominanti ma' attività antiinfjammatorja, il-kompost għandu attività batterjostatika u kien ikklassifikat bħala kompost antibijotiku (eż. fl-SmPC, il-grupp Farmakoterapewtiku huwa elenkat bħala Sistema Respiratorja, preparazzjonijiet talGriżmejn/Antibijotiċi, kodiċi ATC:
English: Its bacteriostatic properties were presented as an additional activity by the MAH.
Maltese: Ilkaratteristiċi batterjostatiċi tiegħu kienu ppreżentati bħala attività addizzjonali mill-MAH.
English: The current risk minimisations measures (restriction of the indication to acute rhinopharyngitis and additional contra-indication) are considered insufficient to mitigate the risk of serious hypersensitivity reactions.
Maltese: Il-miżuri għat-tnaqqis tar-riskji attwali (restrizzjoni tal-indikazzjoni għal rinofarinġite akura u kontroindikazzjoni addizzjonali) huma meqjusin insuffiċjenti sabiex inaqqsu r-riskju ta' reazzjonijiet serji ta' sensittività eċċessiva.
English: In addition to the data from clinical trials, the PRAC reviewed data from spontaneous reports provided by the MAH.
Maltese: Minbarra d-data minn provi kliniċi, il-PRAC irreveda d-data minn rapporti spontanji pprovduti millMAH.
English: • The PRAC considered that the risk minimisations measures discussed during the assessment, including further restriction of the indication and additional contra-indications, limitation of treatment duration, addition of special warning and precautions for use, limitation of excipients, Direct Health Care Professional communication and restriction to prescription only, would not sufficiently reduce the risk of serious hypersensitivity (including allergic) reactions.
Maltese: • Il-PRAC ikkunsidra li l-miżuri għall-minimizzazzjoni tar-riskji diskussi waqt il-valutazzjoni, inkluż aktar restrizzjoni tal-indikazzjoni u kontro-indikazzjonijiet addizzjonali, limitazzjoni fit-tul tażżmien tal-kura, żieda ta' twissija speċjali u prekawzjonijiet għall-użu, limitazzjoni tal-eċċipjenti, komunikazzjoni diretta tal-Professjonisti tal-Kura tas-Saħħa u restrizzjoni għar-riċetta tat-tabib biss, mhumiex biżżejjed sabiex inaqqsu r-riskju ta' reazzjonijiet (inkluż allerġiċi) ta' sensittività eċċessiva serja.
English: With regards to the antimicrobial activity, the MAH submitted several studies presenting the Minimum Inhibitory Concentration (MIC) data for fusafungine for a wide range of clinical isolates (bacterial species and fungi), claiming that there was no significant change in the observed MICs after fusafungine exposure.
Maltese: Fir-rigward tal-attività antimikrobjali, il-MAH ippreżenta diversi studji li jippreżentaw id-data talKonċentrazzjoni Inibitorja Minima (MIC) ta' fusafungine għal firxa wiesgħa ta' iżolati kliniċi (speċijiet batterjali u fungi), fejn sostna li ma kienx hemm bidla sinifikanti fl-MICs osservati wara lesponiment ta' fusafungine.
English: • The PRAC reviewed the totality of the data submitted in support of the safety and efficacy of fusafungine-containing products for oromucosal and nasal use including submissions from the marketing authorisation holders and views expressed by experts such as the CHMP Scientific Advisory Group (SAG) in Anti-Infectives and the Paediatric Committee (PDCO).
Maltese: • Il-PRAC irreveda t-totalità tad-data ppreżentata f'appoġġ tas-sigurtà u l-effikaċja ta' prodotti li fihom fusafungine għall-użu oromukosali u nażali inkluż sottomissjonijiet mid-detenturi talawtorizzazzjoni għat-tqegħid fis-suq u opinjonijiet espressi minn esperti bħall-Grupp ta' Konsulenza Xjentifika (SAG) tas-CHMP dwar l-Anti-Infettivi u l-Kumitat Pedjatriku (PDCO).
English: The PRAC adopted a recommendation on 22 February 2016 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Maltese: Il-PRAC adotta rakkomandazzjoni, fit-22 ta' Frar 2016 li dak iż-żmien kienet ikkunsidrata misCMDh, skont l-Artikolu 107k tad-Direttiva 2001/83/KE.
English: a. the medicinal product is harmful, and,
Maltese: a. il-prodott mediċinali huwa ta' periklu, u,
English: In the clinical studies (Chabolles, Eccles and Bouter) conducted in adults, non-consistent figures were provided regarding frequency of hypersensitivity reactions, none of the events were serious.
Maltese: Fl-istudji kliniċi (Chabolles, Eccles and Bouter) mwettqa fl-adulti, figuri mhux konsistenti kienu pprovduti rigward il-frekwenza ta' reazzjonijiet ta' sensittività eċċessiva, l-ebda avveniment ma kien serju.
English: Hypersensitivity including anaphylactic reactions with short time to onset can be considered as a risk related to the use of fusafungine.
Maltese: Is-sensittività eċċessiva inkluż reazzjonijiet anafilattiċi li jfeġġu ft ftit żmien tista' titqies bħala riskju relatat mal-użu ta' fusafungine.
English: The PRAC therefore concluded that revocation, rather than suspension, was justified.
Maltese: Għaldaqstant, il-PRAC ikkonkluda li revoka, aktar milli sospensjoni, kienet iġġustifikata.
English: The PRAC reviewed all the available data submitted with regards to the clinical safety of fusafunginecontaining products.
Maltese: Il-PRAC irreveda d-data disponibbli kollha ppreżentata fir-rigward tas-sigurtà klinika ta' prodotti li fihom fusafungine.
English: In the majority of cases (62.8%), the time interval from exposure to onset of first signs and symptoms of allergic episodes showed the likelihood of the causality of fusafungine in the hypersensitivity reaction (i.e. within 24 hours).
Maltese: Fil-maġġoranza tal-każijiet (62.8%), l-intervall taż-żmien mill-esponiment sal-bidu tal-ewwel sinjali u sintomi ta' episodji allerġiċi wera l-probabilità tal-kawżalità ta' fusafungine fir-reazzjoni ta' sensittività eċċessiva (jiġifieri fi żmien 24 siegħa).
English: Fusafungine is currently indicated in the local antibacterial and anti-inflammatory treatment of diseases in the upper respiratory airways (sinusitis, rhinitis, rhinopharyngitis, angina, laryngitis), inhaled in usual doses of 500 micrograms every 4 hours into each nostril or via the mouth.
Maltese: Fusafungine huwa attwalment indikat fil-kura lokali antibatterjali u anti-infjammatorja ta' mard filpassaġġi tal-arja respiratorji ta' fuq (sinużite, rinite, rinofarinġite, anġina, larinġite), jittieħed mannifs fid-dożi tas-soltu ta' 500 mikrogramma kull 4 sigħat f'kull minħar jew permezz tal-ħalq.
English: • The PRAC is of the view, after having reviewed the available data that fusafungine, in the context of a mild disease of self-limited nature, is associated with an increased risk of serious hypersensitivity (including allergic) adverse reactions including anaphylactic reactions which can be life threatening and fatal.
Maltese: • Il-PRAC huwa tal-opinjoni li, wara li rreveda d-data disponibbli li fusafungine, fil-kuntest ta' marda ħafifa ta' natura limitata fiha nnifisha, huwa assoċjat ma' żieda fir-riskju ta' reazzjonijiet avversi (inkluż allerġiċi) ta' sensittività eċċessiva serja inkluż reazzjonijiet anafilattiċi li jistgħu jkunu ta' theddida għall-ħajja u fatali.
English: These 717 cases represent 65.1% of all reports for fusafungine found in MAH's safety database.
Maltese: Dawn is-717-il każ jirrappreżentaw 65.1% tar-rapporti kollha għal fusafungine li jinsabu fil-bażi tad-data tas-sigurtà tal-MAH.
English: In order to minimize the risk of allergic reactions, the MAH proposed the several risk minimisation measures (RMMs) within the above mentioned variation including an extension of the existing contraindication in children (by restricting the age limit from less than 30 months to less than 12 years of age) and the introduction of a contraindication regarding the use in patients with allergic tendencies and bronchospasm.
Maltese: Sabiex jiġi minimizzat ir-riskju ta' reazzjonijiet allerġiċi, il-MAH ippropona diversi miżuri għattnaqqis tar-riskju (RMMs) fi ħdan il-varjazzjoni msemmija hawn fuq inkluż estensjoni talkontroindikazzjoni eżistenti fit-tfal (permezz ta' restrizzjoni tal-limitu tal-età minn inqas mill-età ta' 30 xahar għal inqas minn 12-il sena) u l-introduzzjoni ta' kontroindikazzjoni rigward l-użu f'pazjenti b'tendenzi allerġiċi u bronkospażmu.
English: The PRAC, having due regard to the therapeutic effect of the above medicinal products, concluded that the benefit-risk balance of fusafungine for oromucosal and nasal use is not favourable as pursuant to Article 116 of Directive 2001/83/EC due to safety concerns in relation to serious, potentially fatal, hypersensitivity reactions, in the context of limited clinical efficacy for a self-limiting condition.
Maltese: Il-PRAC, wara li kkunsuidra l-effett terapewtiku tal-prodotti mediċinali t'hawn fuq, ikkonkluda li lbilanċ bejn il-benefiċċju u r-riskju ta' fusafungine għall-użu oromukosali u nażali mhuwiex favorevoli skont l-Artikolu 116 tad-Direttiva 2001/83/KE minħabba t-tħassib dwar is-sigurtà firrigward ta' reazzjonijiet ta' sensittività eċċessiva serji, potenzjalment fatali, fil-kuntest tal-effikaċja klinika limitata għal kundizzjoni limitata fiha nnifisha.
English: Later in the procedure, the MAH re-defined fusafungine as a primarily anti-inflammatory medicine for symptomatic relief of acute (and predominantly viral) rhinopharyngitis.
Maltese: Aktar tard fil-proċedura, il-MAH reġa' ddefinixxa fusafungine bħala mediċina anti-infjammatorja b'mod primarju għal serħan mis-sintomi għal rinofarinġite akuta (u virali b'mod predominanti).
English: To include all possibly relevant cases, the MAH used the combined search of “Identified Risk Events Anaphylactic reaction hypersensitivity” for its data collection and analysis.
Maltese: Sabiex jinkludi l-każijiet kollha possibbli ta' referenza, il-MAH uża t-tfittxija kkombinata ta' "Avvenimenti ta' Riskju Identifikati Sensittività eċċessiva għal reazzjoni anafilattika" għall-ġbir taddata u l-analiżi tagħha.
English: • The PRAC noted that serious, life-threatening hypersensitivity (including allergic) reactions have been reported with fusafungine for oromucosal and nasal use, including fatal cases, with short time to onset (even at first dose).
Maltese: • Il-PRAC innota li reazzjonijiet (inkluż allerġiċi) ta' sensittività eċċessiva serja, ta' theddida għallħajja ġew irrapportati b'fusafungine għall-użu oromukosali u nażali, inkluż każijiet fatali, li jfeġġu fi ftit żmien (anke fl-ewwel doża).
English: The PRAC noted that there have been 6 fatal cases reported post-marketing since the first MA of fusafungine.
Maltese: Il-PRAC innota li kien hemm 6 każijiet fatali rrapportati wara t-tqegħid fis-suq sa mill-ewwel MA ta' fusafungine.
English: In the context of signal detection activities, the Marketing Authorization Holder (MAH) of fusafunginecontaining medicinal products for oromucosal and nasal use noted an increased reporting rate of all adverse drug reactions (ADRs) including allergic reactions.
Maltese: Fil-kuntest ta' attivitajiet tad-detezzjoni tas-sinjali, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) ta' prodotti mediċinali li fihom fusafungine għall-użu għal membrana mukuża talħalq u nażali nnota żieda fir-rata ta' rapportar tar-reazzjonijiet avversi tal-mediċina (ADRs) inkluż reazzjonijiet allerġiċi.
English: Overall, the number of serious allergic reactions including the fatal cases is not acceptable to the PRAC in the context a mild disease of self-limited nature, usually of a viral aetiology.
Maltese: B'mod ġenerali, in-numru ta' reazzjonijiet allerġiċi serji inkluż il-każijiet fatali mhuwiex aċċettabbli għall-PRAC fil-kuntest ta' marda ħafifa ta' natura limitata fiha nnifisha, ġeneralment ta' etjoloġija virali.
English: 7 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.
Maltese: Rapport ta' studju, 2000 [NP07760] 7 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.
English: Further risk minimisation measures, as proposed by the MAH, such as additional amendments to the product information (further restriction of the indication and additional contra-indications, limitation of treatment duration, addition of the wording ‘do not inhale' in special warning and precautions for use, limitation of excipients), communication material (Direct Health Care Professional communication) and restriction to prescription only were also considered during the discussions.
Maltese: Aktar miżuri għat-tnaqqis tar-riskju bħal emendi addizzjonali għallinformazzjoni tal-prodott (aktar restrizzjoni tal-indikazzjoni u kontroindikazzjonijiet, limitazzjoni tat-tul taż-żmien tal-kura, żieda tal-kliem 'tiħux nifs' fi twissija speċjali u prekawzjonijiet għall-użu, limitazzjoni tal-eċċipjenti), materjal ta' komunikazzjoni (Komunikazzjoni diretta tal-Professjonisti tal-Kura tas-Saħħa) u restrizzjoni għar-riċetta tat-tabib biss kienu għaldaqstant ukoll ikkunsidrati waqt id-diskussjonijiet.
English: Fusafungine , used in the form of a spray, is indicated in the local antibacterial and anti-inflammatory treatment of diseases in the upper respiratory airways (sinusitis, rhinitis, rhinopharyngitis, angina, laryngitis), inhaled in usual doses of 500 micrograms every 4 hours into each nostril or via the mouth.
Maltese: Fusafungine, użat fil-forma ta' sprej, huwa indikat fil-kura lokali antibatterjali u anti-infjammatorja ta' mard fil-passaġġi tal-arja respiratorji ta' fuq (sinużite, rinite, rinofarinġite, anġina, larinġite), jittieħed man-nifs fid-dożi tas-soltu ta' 500 mikrogramma kull 4 sigħat f'kull minħar jew permezz tal-ħalq.
English: In line with the PDCO position, the PRAC concluded that the efficacy data of fusafungine-containing medicinal products for oromucosal and nasal use in the paediatric population is limited.
Maltese: Skont il-pożizzjoni tal-PDCO, il-PRAC ikkonkluda li d-data dwar l-effikaċja ta' prodotti mediċinali li fihom fusafungine għall-użu oromukosali u nażali fil-popolazzjoni pedjatrika hija limitata.
English: While the anti-bacterial effect of fusafungine is presented by the MAH as beneficial to the antiinflammatory effect, the PRAC is of the view that anti-bacterial effect can be regarded as a potential risk because it cannot be excluded that the medicine might induce antimicrobial resistance and interfere with the throat microbiota.
Maltese: Filwaqt li l-effett antibatterjali ta' fusafungine huwa ppreżentat mill-MAH bħala ta' benefiċċju għalleffett anti-infjammatorju, il-PRAC huwa tal-opinjoni li l-effett antibatterjali jista' jitqies bħala riskju potenzjali minħabba li ma jistax ikun eskluż li l-mediċina tista' tinduċi reżistenza antimikrobjali u tinterferixxi mal-mikrobijota tal-griżmejn.
English: This was based on a recent Cochrane review (Reveiz, et al, 2015) which concluded that the outcomes achieved by fusafungine was not relevant in clinical practice, and that antibiotics appeared to have no benefits in the treatments of acute laryngitis in adults that may not outweigh the risk of adverse effects and negative consequences for antibiotic resistance patterns.
Maltese: Dan kien ibbażat fuq reviżjoni ta' Cochrane riċenti (Reveiz, et al, 2015) li kkonkludiet li r-riżultati miksuba minn fusafungine ma kinux rilevanti fil-prattika klinika, u li lantibijotiċi dehru li ma kellhomx benefiċċji fil-kura ta' larinġite akuta fl-adulti li jistgħu ma jkunux ogħla mir-riskju ta' avvenimenti avversi u konsegwenzi negattivi għal mudelli ta' reżistenza għallantibijotiċi.
English: 2002, Study report [NP08516] 4 Cuénant G. Intérêt de Locabiotal Pressurisé dans les rhinosinusites.
Maltese: Rapport ta' studju, 2002 [NP08516] 4 Cuénant G.
English: The PRAC considered that the use of fusafungine-containing medicinal products for oromucosal and nasal use is associated with serious hypersensitivity (including allergic) reactions including fatal cases, with short time to onset.
Maltese: Il-PRAC ikkunsidra li l-użu ta' prodotti mediċinali li fihom fusafungine għall-użu għal membrana oromukosali u nażali huwa assoċjat ma' reazzjonijiet (inkluż allerġiċi) ta' sensittività eċċessiva serja inkluż każijiet fatali, li jfeġġu fi ftit żmien.
English: Overall, based on the above and the views expressed by the experts of the CHMP SAG in AntiInfectives, the PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, showed only limited efficacy of local fusafungine in its approved indications which does not translate into evidence of a benefit for patients in the current context of the therapeutic strategy and knowledge acquired in diseases in the upper respiratory airways.
Maltese: B'mod ġenerali, abbażi ta' dak t'hawn fuq u l-opinjonijiet espressi mill-esperti tas-CHMP SAG dwar l-Anti-Effettivi, il-PRAC ikkunsidra li data dwar l-effikaċja disponibbli, inkluż id-data li saret disponibbli sa mill-awtorizzazzjoni għat-tqegħid fis-suq inizjali, uriet biss effikaċja limitata ta' fusafungine lokali fl-indikazzjonijiet approvati tiegħu li ma jsarrfux f'evidenza ta' benefiċċju għal pazjenti fil-kuntest attwali tal-istrateġija terapewtika u għarfien miksub dwar mard fil-passaġġi talarja respiratorji ta' fuq.
English: Valid Marketing Authorisations of fusafungine-containing medicinal products for oral use for oromucosal and nasal use currently available in 19 Member States (see Annex I).
Maltese: Awtorizzazzjonijiet għat-Tqegħid fis-Suq validi ta' prodotti mediċinali li fihom fusafungine għall-użu orali, għall-użu għal membrana mukuża tal-ħalq u nażali attwalment disponibbli fi 19-il Stat Membru (ara Anness I).
English: During the assessment, the PRAC also noted that the MAH stated that available data no longer support tonsillitis and laryngitis indications; the MAH also confirmed that all the available data have been provided and that they will not be able to provide any further data to demonstrate the clinical safety and benefit of fusafungine in the management of diseases of the upper respiratory airways.
Maltese: Waqt il-valutazzjoni, il-PRAC innota wkoll li l-MAH stqarr li d-data disponibbli ma tappoġġjax aktar l-indikazzjonijiet tat-tonsillite u l-larinġite; il-MAH ikkonferma wkoll li d-data disponibbli kollha ġiet ipprovduta u li ma jkunux kapaċi jipprovdu aktar data sabiex juru l-effikaċja klinika u l-benefiċċju ta' fusafungine fil-ġestjoni ta' mard fil-passaġġi tal-arja respiratorji ta' fuq.
English: With regards to the allergic reactions, a total of 717 non-serious and serious cases have been spontaneously reported in patients exposed to fusafungine since the launch of the product (from 1963 up to 31 August 2015).
Maltese: Fir-rigward tar-reazzjonijiet allerġiċi, ġie rrapportat total ta' 717-il każ mhux serju u serju b'mod spontanju f'pazjenti esposti għal fusafungine sa mit-tnedija tal-prodott (mill-1963 sal31 ta' Awwissu 2015).
English: The PRAC reviewed all the available data submitted with regards to the clinical efficacy and safety of fusafungine-containing products.
Maltese: Il-PRAC irreveda d-data disponibbli kollha ppreżentata fir-rigward tal-effikaċja klinika u sigurtà ta' prodotti li fihom fusafungine.
English: In addition, in the Cochrane review by Reveiz et al. (2015), fusafungine or fusafungine plus clarithromycin in acute laryngitis in adults were more effective than no treatment only at day five, but no differences were found at days 8 and 28.
Maltese: (2015), fusafungine jew fusafungine flimkien ma' clarithromycin f'larinġite akuta fl-adulti kienu aktar effettivi minn l-ebda kura biss filħames jum, iżda ma nstabux differenzi fil-jiem 8 u 28.
English: The PRAC is of the opinion that when treating upper respiratory tract infections, the aetiology of which is mainly viral, with antibiotics the risk for selecting antimicrobial resistance cannot be excluded.
Maltese: Il-PRAC huwa tal-opinjoni li meta jiġu kkurati linfezzjonijiet fin-naħa ta' fuq tal-apparat respiratorju, fejn l-etjoloġija tagħhom hija primarjament virali, bl-antibijotiċi, ir-riskju tal-għażla tar-reżistenza antimikrobjali ma jistax jiġi eskluż.
English: Based on the safety data from post marketing data, the PRAC is of the view that the risk minimisation measures proposed by the MAH would not be able to adequately reduce the risks of serious adverse reactions considering that the severity of hypersensitivity reactions cannot be predicted.
Maltese: Il-PRAC kien tal-opinjoni li l-miżuri għat-tnaqqis tar-riskju proposti millMAH mhumiex sejrin inaqqsu r-riskji ta' reazzjonijiet avversi serji b'mod suffiċjenti.