FrancophonIA/ELRC3.0 huggingface dataset:
English: Dizziness
Maltese: Sinożite
English: • One carton with: 56 ampoules with nebuliser solution in 7 pouches.
Maltese: • Kartuna waħda b': 56 ampulla b'soluzzjoni għan-nebulizzatur f'7 boroż.
English: Ear pain
Maltese: FEJN MA
English: Package contains 56 ampoules with nebuliser solution in 7 pouches.
Maltese: Pakkett fih 56 ampulla b'soluzzjoni għan-nebulizzatur f'7 boroż.
English: The drug delivery rate of Vantobra with the Tolero nebuliser is independent of the breathing pattern applied i.e. adult or child in contrast to the PARI LC PLUS nebuliser.
Maltese: Ir-rata ta' għoti tal-mediċina ta' Vantobra hija indipendenti mir-rata u l-mod ta' teħid tan-nifs applikati: jiġifieri adult jew tifel/tifla b'kuntrast man-nebulizzatur ġett PARI LC PLUS.
English: There was no difference in the safety profile between pediatric and adult patient population treated with
Maltese: Ma kien hemm l-ebda differenza fil-profil tas-sigurtà bejn popolazzjoni ta' pazjenti pedjatriċi u adulti kkurati
English: In the absence of conventional susceptibility breakpoints for the nebulised route of administration, caution must be exercised in defining organisms as susceptible or insusceptible to nebulised tobramycin.
Maltese: Fin-nuqqas ta' breakpoints konvenzjonali tas-suxxettibilità għar-rotta ta' għoti permezz ta' nebulizzatur, għandu jkun hemm attenzjoni fid-definizzjoni ta' organiżmi bħala suxxettibbli jew mhux suxxettibbli għal
English: Vantobra is supplied in polyethylene (PE) ampoules that are packed in sealed aluminium foil pouches (8 ampoules per pouch).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Vantobra huwa fornut f'ampulli tal-polyethylene (PE) li huma ppakkjati f'boroż issiġillati magħmula minn fojl tal-aluminju (8 ampulli f'kull borża).
English: Other inhaled medicines
Maltese: IL-PRODOTT MEDIĊINALI
English: Systemic exposure following inhalation of Vantobra is very low (see section 5.2).
Maltese: Lesponiment sistemiku wara teħid man-nifs ta' Vantobra huwa baxx ħafna (ara sezzjoni 5.2).
English: It belongs to a class of antibiotic medicines
Maltese: Jagħmel parti minn klassi ta' mediċini antibijotiċi
English: The medicine is not intended for use in children under 6 years of age.
Maltese: Il-mediċina mhux maħsuba għall-użu fi tfal b'età inqas minn 6 snin.
English: Aerosol characteristics
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: • chest tightness;
Maltese: • tagħfis fis-sider;
English: Somnolence
Maltese: Nefrotossiċità
English: Chest pain Malaise
Maltese: Jekk ikun hemm suspett ta' rispons
English: Ampoules are packed in pouches, one pouch contains 8 ampoules which correspond with 4 days of
Maltese: L-ampulli huma ppakkjati f'boroż, borża waħda fiha 8 ampulli li jikkorrispondu għal 4 ijiem ta' kura.
English: • After you have used your medicine for 28 days, you then have a 28-day break, during which you do not inhale any Vantobra.
Maltese: • Wara li tkun użajt il-mediċina tiegħek għal 28 ġurnata, għandek perijodu ta' ieqaf għal 28 ġurnata, li matulu ma tiħux Vantobra man-nifs.
English: Vantobra solution is a sterile, aqueous preparation for single use only.
Maltese: Is-soluzzjoni ta' Vantobra hija, preparazzjoni milwiema, sterili għall-użu ta' darba biss.
English: It is supplied in a carton that contains two inner cartons, one with the medicine (56 ampoules with nebuliser solution in 7 pouches), and one with the nebuliser handset.
Maltese: Huwa disponibbli f'kartuna li fiha żewġ kartuniet fuq ġewwa, waħda bil-mediċina (56 ampulla b'soluzzjoni għan-nebulizzatur f'7 boroż), u waħda bil-handset ta' nebulizzatur.
English: Headache
Maltese: Ażżma
English: UNIQUE IDENTIFIER _ HUMAN READABLE DATA
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM PC: {numru}
English: Limited data from one controlled clinical study over one treatment cycle indicate that the improvement in lung function was maintained above baseline during the 28-day off-treatment period.
Maltese: Dejta limitata minn studju kliniku kkontrollat wieħed fuq ċiklu ta' kura wieħed tindika li t-titjib fil-funzjoni tal-pulmun inżamm 'il fuq mil-linja bażi matul il-perijodu ta' 28 ġurnata mingħajr kura.
English: Based on the interaction profile for tobramycin following intravenous and aerosolised administration, concurrent and/or sequential use of Vantobra is not recommended with other medicinal products with nephrotoxic or ototoxic potential, such as:
Maltese: Ibbażat fuq il-profil ta' interazzjoni għal tobramycin wara għoti fil vini u bħala aerosol, użu fl-istess waqt u/jew sekwenzjali ta' Vantobra mhux irrakkomandat ma' prodotti mediċinali oħra b'potenzjal nefrotossiku jew ototossiku, bħal:
English: Each additional 6 months of treatment resulted in incremental increases similar in magnitude to that observed in the 6 months of controlled studies.
Maltese: Kull 6 xhur addizzjonali ta' kura wassal għal żidiet inkrementali simili fil-kobor għal dawk osservati fis-6 xhur ta'
English: Total Drug Delivered [mg±SD]
Maltese: Sodium hydroxide (għall-aġġustament tal-pH)
English: Sinusitis
Maltese: Larinġite
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000)
English: Elimination
Maltese: Distribuzzjoni
English: Vantobra should be used with great caution in patients with neuromuscular disorders such as Parkinsonism or other conditions characterized by myasthenia, including myasthenia gravis, as aminoglycosides may aggravate muscle weakness due to a potential curare-like effect on neuromuscular function.
Maltese: Vantobra għandu jintuża b'attenzjoni kbira f'pazjenti b'disturbi newromuskolari bħal Parkinsoniżmu jew kondizzjonijiet oħra kkaratterizzati minn mijastenija, inkluż mijastenija gravis, peress li aminoglycosides jistgħu jaggravaw id-dgħufija fil-muskoli minħabba effett potenzjali li jixbaħ lil curare fuq il-funzjoni
English: • Remove one ampoule of Vantobra from the aluminium foil pouch just before inhalation.
Maltese: • Neħħi ampulla waħda ta' Vantobra mill-borża tal-folj tal-aluminju eżatt qabel ma teħodha man-nifs.
English: 6.6 Special precautions for disposal and other handling The contents of one ampoule should be emptied into the medication reservoir of the Tolero nebuliser handset and administered by inhalation until no medicine is left in the reservoir.
Maltese: Il-kontenut ta' ampulla waħda għandu jitbattal fil-kontenitur tal-mediċina tal-handset ta' nebulizzatur Tolero u jingħata permezz ta' teħid man-nifs sakemm ma jkunx fadal mediċina fil-kontenitur.
English: What Vantobra looks like and contents of the pack Vantobra nebuliser solution is provided in a ready-to-use ampoule.
Maltese: Kif jidher Vantobra u l-kontenut tal-pakkett Soluzzjoni għan-nebulizzatur ta' Vantobra hija pprovduta f'ampulla lesta għall-użu.
English: ATC code: J01GB01
Maltese: Xi effetti sekondarji jistgħu jkunu serji
English: You should not take the following medicines while you are using Vantobra:
Maltese: M'għandekx tieħu l-mediċini li ġejjin waqt li tkun qed tuża Vantobra:
English: Clinical experience with tobramycin nebuliser solutions reports dysphonia and tinnitus in patients treated with tobramycin.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea
English: The systemic exposure to tobramycin after inhalation of Vantobra is expected to emerge primarily from the inhaled portion of the medicinal product as tobramycin is not absorbed to any appreciable extent when administered via the oral route.
Maltese: F'każ ta' inġestjoni aċċidentali ta' Vantobra, mhix probabbli tossiċità peress li l-assorbiment ta' tobramycin mill-apparat gastro-intestinali intatt huwa baxx.
English: In clinical studies with TOBI, most patients with P. aeruginosa isolates with tobramycin MICs < 128 µg/ml at baseline showed improved lung function following treatment with TOBI.
Maltese: Meta l-pazjenti jkunu qed jirċievu diversi prodotti mediċinali meħuda man-nifs u fiżjoterapija tas-sider, huwa rrakkomandat li Vantobra jintuża l-aħħar.
English: The most prevalent aminoglycoside resistance mechanism seen in P. aeruginosa isolated from chronically infected CF patients is impermeability, defined by a general lack of susceptibility to all aminoglycosides.
Maltese: aeruginosa iżolata minn pazjenti b'CF infettati b'mod kroniku kien impermeabilità, definita bħala nuqqas ġenerali ta' suxxettibilità għall-aminoglycosides kollha. P. aeruginosa iżolata minn pazjenti b'CF intweriet ukoll li turi reżistenza għal aminoglycoside li tadatta li hija kkaratterizzata suxxettibilità mill-ġdid meta lantibijotiku jitneħħa.
English: • if you are allergic (hypersensitive) to tobramycin, to any type of aminoglycoside antibiotics, or to any of the other ingredients of Vantobra (listed in section 6).
Maltese: antibijotiku aminoglycoside, jew għal xi sustanza oħra ta' Vantobra (elenkati fis-sezzjoni 6).
English: Frequency category Adverse Reactions Laryngitis
Maltese: GĦAMLA KWALITATTIVA
English: Nephrotoxicity
Maltese: Limfadenopatija
English: The performance parameters from in vitro aerosol characterisation studies are identical for the two controllers and are shown in section
Maltese: Il-parametri ta' eżekuzzjoni minn studji in vitro dwar karatterizzazzjoni tal-aerosol huma identiċi għaż-żewġ kontrolluri u huma murija f'sezzjoni 5.1, Tabella 2.
English: 1 connected with an eBase controller or eFlow rapid controller 2 connected with a PARI Boy SX compressor
Maltese: 1 imqabbad ma' kontrollur eBase jew eFlow rapid
English: Sputum of cystic fibrosis patients exhibits an inhibitory action on the local biological activity of nebulised aminoglycosides.
Maltese: Nefrotossiċità kienet assoċjata ma' terapija parenterali b'aminoglycoside.
English: • taste disturbances, feeling sick (nausea), mouth ulcers, being sick (vomiting), loss of appetite
Maltese: • tisgħol u ttella d-demm, tipproduċi aktar sputum miss-soltu, skumdità fis-sider, ażżma, deni • disturbi fit-togħma, tħossok imdardar (tqalligħ), ulċeri fil-ħalq, tirremetti (rimettar), telf t'aptit
English: There is no relevant use of Vantobra in children below 6 years of age.
Maltese: Vantobra fit-tfal b'età inqas minn 6 snin m'għandux użu rilevanti.
English: According to current clinical practice baseline renal function should be assessed.
Maltese: Skont il-prattika klinika kurrenti għandha tiġi evalwata l-funzjoni tal-kliewi fil-linja bażi.
English: The serum concentration of tobramycin should only be monitored using validated methods.
Maltese: Il-konċentrazzjoni fis-serum ta' tobramycin għandha tiġi mmonitorjata biss permezz ta' metodi validati.
English: Geometric Standard Deviation ±SD 1.5 ± 0.0
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis
English: Use a new Tolero nebuliser handset for each treatment cycle (28 days on-treatment) as provided with the
Maltese: Uża handset ta' nebulizzatur Tolero ġdid għal kull ċiklu ta' kura (28 ġurnata fuq il-mediċina) kif ipprovdut
English: Immediate Packaging
Maltese: 14-il kapsula
English: Benefit -risk balance
Maltese: Bilanċ benefiċċju-riskju
English: The CHMP concludes that arsenic trioxide:
Maltese: Is-CHMP ikkonkluda li arsenic trioxide:
English: Preclinical and clinical safety
Maltese: Sigurtà preklinika u klinika
English: SmPC:
Maltese: Effikaċja
English: The CHMP notes that:
Maltese: Is-CHMP innota li:
English: Alternative techniques (such as several types of local/regional anesthesics, general anesthesia, gas for inhalation) may be available.
Maltese: Tekniki alternattivi (bħal diversi tipi ta' anestesija lokali/reġjonali, anestesija ġenerali, gass għal inalazzjoni) jistgħu ikunu diponibbli.
English: The expert panel concluded that the benefit/risk of the product was negative.
Maltese: Il-panil ta' esperti kkonkluda li l-bilanċ benefiċċju/riskju tal-prodott kien wieħed negattiv.
English: In parallel, new genotoxicity assays (Ames test and in vitro micronuleus test) were conducted by the MAH with dental paste extracts of Caustinerf arsenical and the results were positive in the in vitro micronuleus test only.
Maltese: B'mod parallel, saru assaġġi ta' ġenotossiċità ġodda (test Ames u test mikronukleu in vitro) mill-MAH b'estratti tal-pejst dentali ta' Caustinerf arsenical u r-riżultati kienu pożittivi fit-test mikronukleu in vitro biss.
English: A literature review was performed by the Marketing Authorisations Holders (MAHs) (Septodont and A.T.O.
Maltese: Id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAHs) (Septodont u A.T.O.
English: • is carcinogenic in humans as stated by the IARC (Group 1),
Maltese: • huwa karċinoġeniku fil-bnedmin kif iddikjarat mill-IARC (Grupp 1),
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for Caustinerf arsenical, Yranicid arsenical and other associated names for topical use (see Annex I).
Maltese: • Is-CHMP ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati għal użu topiku (ara Anness I).
English: • point out in the relevant SmPC section that the risk of carcinogenicity cannot be excluded and that there is a risk of necrosis of periodontal tissues.
Maltese: • jiġi indikat fis-sezzjoni relevanti tal-SmPC li r-riskju ta' karċinoġeniċità ma jistax jiġi eskluż u li hemm riskju ta' nekrożi ta' tessuti periodontali.
English: • restrict the indication to the second line use;
Maltese: • l-indikazzjoni tiġi ristretta għal użu fit-tieni linja;
English: • A drug utilisation study (DUS) in order to verify the comprehension of the indication, the awareness of the safety concern, the minimisation measures in the SmPC in term of restriction of indication, the new caution related use of the product at different time (e.g. when the restricted indication is implemented/ 6 months after the implementation/ 18 months after the implementation).
Maltese: • Studju tal-utilizzazzjoni tal-mediċina (DUS) sabiex jiġi vverifikat il-fehim tal-indikazzjoni, l għarfien tat-tħassib ta' sigurtà, il-miżuri ta' minimizzazzjoni fl-SmPC f'termini ta' restrizzjonijiet tal-indikazzjoni, it-twissija ġdida relatata mal-użu tal-prodott fi żmien differenti (eż. meta l indikazzjoni ristretta tiġi implimentata/ 6 xhur wara l-implimentazzjoni/ 18-il xahar wara l implimentazzjoni).
English: • a number of ADRs have reported a lack of effect.
Maltese: • numru ta' reazzjonijiet avversi (ADRs) ġew irrappurtati b'nuqqas ta' effett.
English: The efficacy of the product is based on the above-mentioned single small prospective non-comparative study dated 1969, which estimated the efficacy in painless devitalisation of pulp to be 88% under optimal circumstances of use.
Maltese: L-effikaċja tal-prodott hija bbażata fuq l-istudju wieħed żgħir prospettiv u mhux komparattiv imsemmi hawn fuq datat 1969, li stima l-effikaċja fid-devitalizzazzjoni tal-polpa bla uġigħ bħala 88% taħt ċirkostanzi ottimi t'użu.
English: The CHMP considered that Caustinerf arsenical, Yranicid arsenical and other associated names for topical use products are associated with potential risks of carcinogenicity, tissue necrosis and show a limited efficacy in their approved indication.
Maltese: Is-CHMP ikkunsidra li Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati ta' prodotti għal użu topiku huma assoċjati ma' riskji potenzjali ta' karċinoġenità, nekrożi ta' tessuti u juru effikaċja limitata flindikazzjoni approvata tagħhom.
English: Therefore, in accordance with Article 32 of Directive 2001/83/EC, the CHMP recommends the revocation of the marketing authorisations for all medicinal products referred to in Annex I pursuant to Article 116 of Directive 2001/83/EC.
Maltese: Għalhekk, skont l-Artikolu 32 tad-Direttiva 2001/83/KE is-CHMP irrakomanda r-revokatalawtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti mediċinali kollha riferuti fl-Anness I skont l-Artikolu 116 tad-Direttiva 2001/83/KE.
English: The MAHs did not recently conduct any clinical trial with arsenic trioxide in dental paste.
Maltese: Il-MAHs ma wettqux provi kliniċi riċenti b'arsenic trioxide f'pejst dentali.
English: The risk of carcinogenicity is established by the local or systemic passage of arsenic.
Maltese: Ir-riskju ta' karċinoġenità huwa stabbilit mill-passaġġ lokali u sistemiku ta' arseniku.
English: On 24 October 2013, the CHMP started a referral procedure for Caustinerf arsenical, Yranicid arsenical and other associated names for topical use.
Maltese: Fl-24 ta' Ottubru 2013, is-CHMP beda proċedura ta' riferiment għal Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati għal użu topiku.
English: These products contain arsenous anhydride (arsenic trioxide) which is used for pulp cauterization (necrosis of the tooth pulp).
Maltese: Dawn il-prodotti fihom arsenous anhydride (arsenic trioxide) li jintuża għall-ħruq tal-polpa (nekrożi tal-polpa dentali).
English: Caustinerf arsenical, Yranicid arsenical and other associated names for topical use are indicated in the painless topical devitalisation of the dental pulp.
Maltese: Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati għal użu topiku huma indikati fiddevitalizzazzjoni topikali bla uġigħ tal-polpa dentali.
English: • is genotoxic in vitro and in vivo in rodents (clastogenicity) which would not allow a safe level of use of arsenic trioxide for achieving active concentrations,
Maltese: • huwa ġenotossiku in vitro u in vivo f'rodenti (klastoġeniċità) li ma jħallix livell sikur ta' użu ta' arsenic trioxide sabiex jintlaħqu konċentrazzjonijet attivi,
English: The risk of genotoxicity including human fertility, foetal development and carcinogenicity induced by arsenic trioxide was reviewed.
Maltese: Ir-riskju ta' ġenotossiċità, inkluż il-fertilità umana, l-iżvilupp tal-fetu u l-karċinoġeniċità kkaġunata minn arsenic trioxide ġie rivedut.
English: Having considered all available data from pre-clinical, clinical studies, published literature and postmarketing experience on Caustinerf arsenical, Yranicid arsenical and other associated names for topical use containing products provided by the MAHs in writing and during an Oral Explanation, the Committee considered that the use of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use is associated with risks of carcinogenicity and serious necrosis adverse reactions sometimes with sequelae.
Maltese: Wara li kkunsidra kull dejta disponibbli minn studji pre-kliniċi, kliniċi, letteratura ppubblikata u esperjenza ta' wara t-tqegħid fis-suq dwar Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati ta' prodotti li fihom arseniku għal użu topiku pprovduta mill-MAHs bil-miktub u waqt Spjegazzjoni Orali, il-Kumitat ikkunsidra li l-użu ta' Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati għal użu topiku huwa assoċjat mar-riskji ta' karċinoġenità u reazzjonijiet avversi serji ta' nekrożi ġieli b' sequelae.
English: The CHMP also considered the overview of cases reported submitted by the MAHs which compiles safety data from a Global Safety Database as well as published literature and data available to the Member states.
Maltese: Is-CHMP ikkunsidra wkoll l-istampa ġenerali ta' każijiet irrappurtati sottomessi mill-MAHs li tikkompila dejta ta' sigurtà minn Database ta' Sigurtà Globali kif ukoll letteratura ppublikata u dejta disponibbli, lillIstati Membri.
English: Risk minimisation measures proposed by the MAH such as amendments to the product information (restriction for use, addition of contraindications in paediatric population and during pregnancy and lactation), communication material and a PASS were considered during the discussions.
Maltese: Miżuri għall-minimizzazzjoni tar-riskju proposti mill-MAH bħal emendi għall-informazzjoni tal-prodott (restrizzjoni tal-użu, żieda ta' kontraindikazzjonijiet fil-popolazzjoni pedjatrika u waqt tqala u treddigħ), materjal komunikattiv u PASS ġew ikkunsidrati waqt id-diskussjonijiet.
English: A detailed analysis of the risks of clastogenicity or/and aneugenicity as those are recognised as a risk factor for cancer when impacting somatic cells, and teratogenicity, embryo-toxicity/spontaneous abortions and impaired male fertility, when impacting germinal cells.
Maltese: Analiżi dettaljata tar-riskji ta' klastoġeniċità jew/u anewġeniċità minħabba li dawk huma rikonoxxuti bħala fatturi ta' riskju għal kanċer meta jkollhom effett fuq ċelloli somatiċi, u teratoġeniċità, tossiċità talembriju/aborti spontanji u fertilità maskili indebolita, meta jkollhom effett fuq ċelloli ġerminali.
English: The review of the available efficacy data (including data which became available since the initial marketing authorisation), showed limited efficacy of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use in its approved indication which does not translate in evidence of a benefit for patients in particular in the current context of the therapeutic strategy where the knowledge acquired in pulp's devitalisation and analgesia techniques has considerably improved, and where safer options are available.
Maltese: Ir-reviżjoni tad-dejta tal-effikaċja disponibbli (inkluża dejta li ġiet disponibbli wara l-awtorizzazzjoni għattqegħid fis-suq inizjali), uriet effikaċja limitata ta' Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati għal użu topiku fl-indikazzjoni xierqa li ma tissarrafx f'evidenza ta' benefiċċju għall-pazjenti b'mod partikolari fil-kuntest attwali tal-istrateġija terapewtika fejn l-għarfien miksub fl-eliminazzjoni talpolpa u tekniki analġeżiċi tjiebu b'mod konsiderevoli, u fejn alternattivi iktar sikuri huma disponibbli.
English: • The CHMP considered the totality of the data available for Caustinerf arsenical, Yranicid arsenical and other associated names for topical use in relation to its genotoxicity and the risk of carcinogenicity.
Maltese: • Is-CHMP ikkunsidra t-totalità tad-dejta disponibbli għal Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati għal użu topiku fir-rigward tal-ġenotossiċità u r-riskju ta' karċinoġenità tagħhom.
English: Zizine) which revealed a potential of genotoxicity related to the use of arsenic trioxide.
Maltese: Zizine) wettqu reviżjoni tal-letteratura li żvelat potenzjal ta' ġenotossiċità relatata mal-użu ta' arsenic trioxide.
English: The French NCA therefore referred the matter to the CHMP to give an opinion under Article 31 of Directive 2001/83/EC on whether the MAs of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use products should be maintained, varied, suspended or revoked.
Maltese: Għalhekk, l-NCA Franċiża irreferiet il-kwistjoni lis-CHMP biex jagħti opinjoni skont l-Artikolu 31 tadDirettiva 2001/83/KE fuq jekk l-MAs ta' Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati oħrajn ta' prodotti għal użu topiku għandhomx jinżammu, jiġu mibdula, sospiżi jew revokati.
English: • no clinical practice guideline endorses the use of arsenic dental paste,
Maltese: • ebda linja gwida ta' prattika klinika ma tapprova l-użu ta' pejst dentali bl-arseniku,
English: Overall summary of the scientific evaluation of Caustinerf arsenical, Yranicid arsenical and other associated names for topical use (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Caustinerf arsenical, Yranicid arsenical u ismijiet assoċjati (Ara Anness I)
English: Finally the CHMP noted that the current international consensus for the recognition of ‘sufficient evidence in humans of the carcinogenicity' of arsenic trioxide along with the strict limitation of arsenic trioxide in the drinking water does no longer support the use of arsenic trioxide within the therapeutic armamentarium.
Maltese: Finalment is-CHMP innota li l-kunsens internazzjonali attwali għar-rikonoxximent ta' ‘evidenza suffiċenti tal-karċinoġenità fil-bnedmin' ta' arsenic trioxide flimkien mal-limitazzjoni stretta ta' arsenic trioxide flilma tax-xorb ma jibqax jappoġġja l-użu ta' arsenic trioxide fl-arsenal terapewtiku.