FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the review of the data and the company's responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Abilify could not have been approved for the treatment of resistant major depressive episodes.
Maltese: Abbażi tal-eżami tad-dejta u t-tweġibiet tal-kumpanija għal-ista ta' mistoqsijiet tal-CHMP, fiż-żmien tal-irtirar, il-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li l-Abilify ma setax ġie approvat għattrattament ta' episodji dipressivi maġġuri reżistenti.
English: The CHMP was concerned over the patients included in the studies, as it was not clear whether they all had resistant depression, defined as failure to respond to at least two previous antidepressants.
Maltese: Il-CHMP kien ikkonċernat dwar il-pazjenti inklużi fl-istudji, billi ma kienx ċar jek kollha kellhomx depressjoni reżistenti, definita bħala n-nuqqas ta' rispons għal żewġ antidipressanti preċedenti.
English: • Adults
Maltese: • Adulti
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Maltese: • Il-Kumitat ikkunsidra r-referenza taħt l-Artikolu 30 tad-Direttiva 2001/83/KE
English: EMLA was first approved in Sweden in 1984 and is currently nationally approved in 22 countries of the European Economic Area (EEA): Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Malta, the Netherlands, Poland, Portugal, Spain, Sweden and United Kingdom and also in Iceland and Norway.
Maltese: EMLA kien approvat għall-ewwel darba fl-Isvezja fl-1984 u fil-preżent huwa approvat fil-livell nazzjonali fi 22 pajjiż taż-Żona Ekonomika Ewropea (ŻEE): l-Awstrija, il-Belġju, Ċipru, ir-Repubblika Ċeka, idDanimarka, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Irlanda, l-Italja, il-Latvja, il-Lussemburgu, Malta, il-Pajjiżi l-Baxxi, il-Polonja, il-Portugall, Spanja, l-Isvezja u r-Renju Unit u anki fl-Islanda u nNorveġja.
English: Section 4.3 - Contraindications
Maltese: Sezzjoni 4.3 - Kontraindikazzjonijiet
English: Leg ulcers
Maltese: Ulċeri fir-riġlejn
English: The MAH proposed to include the medicinal products more commonly used in paediatric practice (e.g. sulphonamides, nitrofuradantin, phenytoin, phenobarbital) which was endorsed by the CHMP.
Maltese: Il-MAH ippropona li jinkludi l-prodotti mediċinali li l-aktar jintużaw filprattika pedjatrika (eż. sulfonamidi, nitrofuradantin, phenytoin, phenobarbital) u dan kien approvat misCHMP.
English: The final agreed wording was:
Maltese: Il-kliem finali li kien hemm qbil dwaru kien:
English: 1.5-2 g/10 cm2 for 2-5 hours” was previously approved and is in line with the CSP agreed in 2012.
Maltese: Id-dożaġġ “Madwar 1.5-2 g/10 cm2 għal sagħtejn sa ħames sigħat” kien approvat minn qabel u huwa konformi mas-CSP li sar qbil dwaru fl-2012.
English: Section 5.2 - Pharmacokinetic properties
Maltese: Sezzjoni 5.2 - Tagħrif farmakokinetiku
English: Skin
Maltese: III.
English: Section 4.6 - Fertility, pregnancy and lactation
Maltese: Sezzjoni 4.6 - Fertilità, tqala u treddigħ
English: Section 5.1 - Pharmacodynamic properties
Maltese: Sezzjoni 5.1 - Proprjetajiet farmakodinamiċi
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction
Maltese: Sezzjoni 4.5 - Interazzjoni ma' prodotti mediċnali oħra u forom oħra ta' interazzjoni
English: The following text was agreed: “In studies of split-skin grafting in adults application for up to 7 hours 40 minutes to the thigh or upper arm to an area of up to 1,500 cm2 resulted in maximum plasma concentrations not exceeding 1.1 µg/mL lidocaine and 0.2 µg/mL prilocaine.”
Maltese: Kien hemm qbil dwar it-test li ġej: “Fi studji dwar ittrapjant ta' ġilda maqsuma fl-adulti l-applikazzjoni għal 7 sigħat u 40 minuta fuq il-koxxa jew in-naħa ta' fuq tad-driegħ fuq żona ta' mhux aktar minn 1,500 cm2 irriżultat f'konċentrazzjonijiet massimi fil-plażma li ma jaqbżux 1.1 µg/mL lidocaine u 0.2 µg/mL prilocaine.”
English: Section 4.9 - Overdose
Maltese: Sezzjoni 4.9 - Doża eċċessiva
English: EMLA is a fixed combination product consisting of an oil/water emulsion and eutectic mixture of lidocaine and prilocaine in equal quantities (by weight) with 2.5% of each active substance included.
Maltese: EMLA huwa prodott b'kombinazzjoni fissa li jikkonsisti f'emulsjoni ta' żejt/ilma u taħlita ewtettika ta' lidocaine u prilocaine fi kwantitajiet indaqs (skont il-piż) bi 2.5 % ta' kull sustanza attiva inkluża.
English: Section 4.2 - Posology and method of administration Adults and adolescents
Maltese: Sezzjoni 4.2 - Pożoloġija u metodu ta' kif għandu jingħata Adulti u adolexxenti
English: The MAH made a proposal in line with the wording of the latest work sharing CSP. Additionally, information on pulse oximetry and antidotes in glucose-6-phosphate dehydrogenase deficiency has been agreed.
Maltese: Barra minn hekk, kien hemm qbil dwar l-informazzjoni fuq l-ossimetrija tal-polz u l-antidoti fl-insuffiċjenza tal-glucose-6phosphate dehydrogenase.
English: A reference for section 4.4 was also added in section 4.9 as follows: “Clinically significant methaemoglobinaemia should be treated with a slow intravenous injection of methylene blue (see also section 4.4)”.
Maltese: Ġiet miżjuda wkoll referenza għas-sezzjoni 4.4 fis-sezzjoni 4.9 kif ġej: “Metaemoglobinemija klinikament sinifikanti għandha tkun ikkurata b'injezzjoni gradwali fil-vini ta' methylene blue (ara wkoll sezzjoni 4.4)”.
English: Topical anaesthesia of the genital mucosa
Maltese: Anestesija topika tal-mukoża ġenitali
English: As a result of the implementation of the outcome of the paediatric work sharing procedure SE/W/008/pdWS/001 (Article 45 of Regulation (EC) No1901/2006) several divergences between the summaries of product characteristics (SmPCs) of this product, namely in sections 4.1 and 4.2 and respective sections of the package leaflet (PL) have been identified.
Maltese: B'riżultat tal-implimentazzjoni tal-eżitu tal-proċedura ta' kondiviżjoni tal-ħidma pedjatrika SE/W/008/pdWS/001 (l-Artikolu 45 tar-Regolament (KE) Nru 1901/2006) ġew identifikati bosta diverġenzi bejn is-sommarji tal-karatteristiċi tal-prodott (SmPCs) ta' dan il-prodott, jiġifieri ssezzjonijiet 4.1 u 4.2 u s-sezzjonijiet rispettivi tal-fuljett ta' tagħrif (PL).
English: The proposal presented by the MAH reflected the latest scientific information using as basis the MAH's Core Data Sheet (CDS), the Core Safety Profile (CSP) agreed wording from the last PSUR work sharing procedure (IE/H/PSUR/0019/002) and the result of the paediatric work sharing procedure (SE/W/008/pdWS/001).
Maltese: Il-proposta ppreżentata mill-MAH kienet tirrifletti l-aħħar informazzjoni xjentifika waqt li uża bħala bażi d-Dokument ta' Dejta Ewlenija (CDS) tal-MAH, il-Profil tas-Sigurtà Ewlieni (SP) il-kliem maqbul mill-aħħar proċedura ta' kondiviżjoni talħidma tal-PSUR (IE/H/PSUR/0019/002) u r-riżultat tal-proċedura ta' kondiviżjoni tal-ħidma pedjatrika (SE/W/008/pdWS/001).
English: Finally, the age ranges were amended in line with the Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population - CPMP/ICH/2711/99 and also to reflect the degree of maturity of NADH reductase in paediatric patients.
Maltese: Fl-aħħar nett, il-meded ta' etajiet kienu emendati skont in-Nota għall-Gwida dwar l-Investigazzjoni Klinika ta' Prodotti Mediċinali fil-Popolazzjoni Pedjatrika - CPMP/ICH/2711/99 u anki sabiex jirriflettu lgrad ta' maturità ta' NADH reductase fil-pazjenti pedjatriċi.
English: “Topical anaesthesia of the genital mucosa, e.g. prior to superficial surgical procedures or infiltration anaesthesia in adults and adolescents ≥12 years.”
Maltese: “Anestesija topika tal-mukoża ġenitali, eż. qabel proċeduri kirurġiċi superfiċjali jew anestesija ta' infiltrazzjoni fl-adulti u fl-adolexxenti ta' 12-il sena jew aktar.
English: This was endorsed by the CHMP.
Maltese: Dan kien approvat mis-CHMP.
English: If the recommended dose is exceeded the patient should be monitored for system adverse reactions secondary to methaemoglobinaemia (see sections 4.2, 4.8 and 4.9).”
Maltese: Jekk tingħata doża żejda l-pazjent għandu jkun issorveljat għal reazzjonijiet avversi fis-sistema sekondarji għall-metaemoglobinemija (ara sezzjonijiet 4.2, 4.8 u 4.9).
English: The agreed dosage and application time was “2g (approx. half a 5g tube) or approx. 1.5g/10 cm2 for 1 to 5 hours”.
Maltese: Id-dożaġġ u l-ħin tal-applikazzjoni miftiehma kien “2g (madwar nofs stoċċ ta' 5 g) jew madwar 1.5 g/10 cm2 għal siegħa sa ħames sigħat”.
English: • Minor procedures, e.g. needle insertion and surgical treatment of localised lesions
Maltese: • Proċeduri żgħar, eż. titqib u kura kirurġika ta' feriti lokalizzati
English: This dosage was previously approved and supported by the clinical study program.
Maltese: Dan id-dożaġġ kien approvat qabel u appoġġjat mill-programm ta' studju kliniku.
English: • Skin of male & female genital organs - prior to injection of local anaesthetics
Maltese: • Il-ġilda tal-organi ġenitali maskili u femminili - qabel l-injezzjoni ta' anestetiċi lokali
English: There are some linguistic differences between the countries, such as “local anaesthesia”, “topical analgesia” and “topical anaesthesia”.
Maltese: Hemm xi differenzi lingwistiċi bejn il-pajjiżi, bħal pereżempju “anestesija lokali”, “analġesija topika” u “anestesija topika”.
English: An introductory paragraph describing the differences in distribution and subsequent plasma concentrations between lidocaine and prilocaine, and a description of the effect of absorption-dependent rate of metabolism and elimination have also been added.
Maltese: Ġew miżjuda wkoll paragrafu ta' introduzzjoni li jiddeskrivi d-differenzi fid-distribuzzjoni u lkonċentrazzjonijiet tal-plażma sussegwenti bejn lidocaine u prilocaine, u deskrizzjoni tal-effett tar-rata dipendenti fuq l-assorbiment tal-metaboliżmu u l-eliminazzjoni.
English: The CHMP considered “topical anaesthesia” to be the optimal description.
Maltese: Is-CHMP ikkunsidra li “anestesija topika” hija l-aħjar deskrizzjoni.
English: The contraindication proposed by the MAH and endorsed by the CHMP was “Hypersensitivity to lidocaine and/or prilocaine or local anaesthetics of the amide type or to any of the excipients listed in section 6.1.”.
Maltese: Il-kontraindikazzjoni proposta mill-MAH u approvata mis-CHMP kienet “Sensittività eċċessiva għal lidocaine u/jew prilocaine jew anestetiċi lokali tat-tip amidju jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.”. Dan il-kliem kien konformi mal-kliem tal-aħħar CSP ta' ħidma kondiviża.
English: For children aged 3 months and above, a maximum of 2 doses, separated by at least 12 hours can be given within any 24 hour period, see sections 4.4 and 4.8.”
Maltese: Fit-tfal ta' tliet xhur u aktar, jista' jingħata massimu ta' żewġ dożi, mogħtija mill-anqas 12-il siegħa bogħod minn xulxin fi żmien 24 siegħa, ara sezzjonijiet 4.4 u 4.8.”
English: The CMHP agreed with the 15 minute application time for male genital organs as the thin male genital skin enables faster absorption than other skin.
Maltese: Is-CHMP qabel mal-ħin ta' applikazzjoni ta' 15-il minuta għall-organi ġenitali maskili peress li l-ġilda rqiqa talġenitali maskili tippermetti assorbiment aktar rapidu minn ġilda oħra.
English: Interactions are likely to be similar to the adult population” is preferred.
Maltese: L-interazzjonijiet aktarx ikunu jixbħu lil dawk fil-popolazzjoni adulta” hija ppreferuta.
English: • Dermal procedures on larger areas in a hospital setting, e.g. split-skin grafting
Maltese: • Proċeduri dermali fuq partijiet akbar fi sptar, eż. trapjant ta' ġilda maqsuma
English: The harmonised information on posology and on application time was presented by the MAH per indication (i.e. skin, genital mucosa, leg ulcers) and per related procedure in a tabular format.
Maltese: L-informazzjoni armonizzata dwar il-pożoloġija u dwar iż-żmien ta' applikazzjoni kienet ippreżentata millMAH għal kull indikazzjoni (jiġifieri, għall-ġilda, għall-mukoża ġenitali, għall-ulċeri fir-riġlejn) u skont ilproċedura relatata f'forma ta' tabella.
English: There are some linguistic differences on the national texts but the CHMP considered “topical anaesthesia of the genital mucosa” to be the optimal description.
Maltese: Hemm xi differenzi lingwistiċi fit-testi nazzjonali iżda s-CHMP ikkunsidra li “anestesija topika tal-mukoża ġenitali” hija l-aħjar deskrizzjoni.
English: The following wording was agreed: “In newborn infants/infants younger than 3 months a transient, clinically insignificant increase in methaemoglobin levels is commonly observed up to 12 hours after an application of EMLA within the recommended dosing.
Maltese: Kien hemm qbil dwar dan il-kliem: “Fit-trabi tat-twelid/trabi ta' anqas minn tliet xhur, normalment tiġi osservata żieda klinikament mhux sinifikanti fil-livelli tal-metaemoglobina sa 12-il siegħa wara applikazzjoni ta' EMLA fid-dożaġġ rakkomandat.
English: EMLA provides dermal anaesthesia through the release of lidocaine and prilocaine from the cream into the epidermal and dermal layers of the skin and the vicinity of dermal pain receptors and nerve endings.
Maltese: EMLA jipprovdi anestesija għall-ġilda permezz tar-rilaxx ta' lidocaine u prilocaine mill-krema fis-saffi epidermali u dermali tal-ġilda u qrib ir-riċetturi tal-uġigħ dermali u t-truf tan-nervituri.
English: The MAH agreed that “anaphylactic reaction” should not be used for allergic reactions; however as there is no Preferred Term (PT) for “allergic reactions” in the current MedDRA coding (version 17) the PT term “hypersensitivity” will be used instead.
Maltese: Il-MAH qabel li “reazzjoni anafilattika” m'għandhiex tintuża għal reazzjonijiet allerġiċi; madankollu peress li ma hemm l-ebda Terminu Preferut (PT) għal “reazzjonijiet allerġiċi” fil-kodiċi attwali tal-MedDRA (verżjoni 17) sejjer jintuża minflok it-terminu PT “sensittività eċċessiva”.
English: Also, due to the off label use of EMLA in paediatric circumcision procedures it was agreed to introduce the statement of SE/W/008/pdWS/001 that the available paediatric data do not demonstrate adequate efficacy during circumcision procedures.
Maltese: EMLA fil-proċeduri ta' ċirkonċiżjoni pedjatrika kien hemm qbil li tkun introdotta d-dikjarazzjoni ta' SE/W/008/pdWS/001 li d-dejta pedjatrika disponibbli ma turix effikaċja adegwata waqt il-proċeduri ta' ċirkonċiżjoni.
English: Genital mucosa
Maltese: Konklużjonijiet xjentifiċi
English: Topical anaesthesia of leg ulcers
Maltese: Anestesija topika għall-ulċeri fir-riġlejn
English: Following the paediatric work sharing procedure SE/W/008/pdWS/001, the use of EMLA in “topical anaesthesia of the skin” in paediatric patients has been implemented nationally in the vast majority of the member states.
Maltese: Wara l-proċedura ta' kondiviżjoni tal-ħidma pedjatrika SE/W/008/pdWS/001, l-użu ta' EMLA f'“anestesija topika tal-ġilda” fil-pazjenti pedjatriċi ġie implimentat b'mod nazzjonali fil-parti l-kbira tal-Istati Membri.
English: • The committee reviewed the data submitted by the MAH on clinical studies, post-marketing data and published literature justifying the proposed harmonisation of the product information
Maltese: • Il-Kumitat irreveda d-dejta sottomessa mill-MAH dwar l-istudji kliniċi, id-dejta ta' wara t-tqegħid fuq is-suq u d-dokumentazzjoni ppubblikata li jiġġustifikaw il-proposta tal-armonizzazzjoni talinformazzjoni dwar il-prodott
English: The CHMP agreed to display the note on “heel lancing” in section 4.4 according to the agreed CSP from 24 September 2012.
Maltese: Is-CHMP qabel li juri n-nota dwar it-“titqib tal-għarqub” fis-sezzjoni 4.4 skont is-CSP li sar qbil dwaru mill-24 ta' Settembru 2012.
English: The SmPC harmonisation considered all relevant therapeutic and regulatory guidelines in the EU.
Maltese: L-armonizzazzjoni tal-SmPC kienet tikkunsidra l-linji gwida terapewtiċi u regolatorji kollha rilevanti fl-UE.
English: For the paediatric population the CHMP agreed to the inclusion of the paragraph describing the interaction of EMLA with vaccines.
Maltese: Għall-popolazzjoni pedjatrika s-CHMP qabel dwar l-inklużjoni tal-paragrafu li jiddeskrivi l-interazzjoni ta' EMLA mal-vaċċini.
English: Lidocaine and prilocaine stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby producing local anaesthesia.
Maltese: Lidocaine u prilocaine jistabbilizzaw ilmembrani newronali billi jinibixxu l-flussi joniċi meħtieġa għall-inizjazzjoni u l-konduzzjoni tal-impulsi, biex b'hekk jipproduċu l-anestesija lokali.
English: The proposed harmonised wording from the MAH for both procedures, i.e. “surgical treatment of localised lesions, e.g. removal of genital warts (condylomata acuminata) and prior to injection of local anaesthetics” and “prior to cervical curettage” was considered acceptable by the CHMP as it was consistent with the one in the majority of the countries.
Maltese: Il-kliem armonizzat propost mill-MAH għaż-żewġ proċeduri, jiġifieri “il-kura kirurġika ta' leżjonijiet lokalizzati, eż. it-tneħħija ta' felul ġenitali (condylomata acuminata) u qabel l-injezzjoni ta' anestetiċi lokali” u “qabel ir-raxkament ċervikali” tqis aċċettabbli mis-CHMP minħabba li kien konsistenti ma' dak użat fil-parti l-kbira tal-pajjiżi.
English: The MAH listed as rare undesirable effect “anaphylactic reaction (in the most severe cases anaphylactic shock)”.
Maltese: Il-MAH elenka bħala effett rari mhux mixtieq “reazzjoni anafilattika (fil-każijiet l-aktar severi xokk anafilattiku)”.
English: The final agreed wording for the indication “topical anaesthesia of the skin” was: “Topical anaesthesia of the skin in connection with - needle insertion, e.g. intravenous catheters or blood sampling - superficial surgical procedures in adults and in the paediatric population.”
Maltese: Il-kliem finali li kien hemm qbil dwaru għall-indikazzjoni “anestesija topika tal-ġilda” kien: “Anestesija topika tal-ġilda b'rabta ma' - titqib bil-labra, eż. kateters ġol-vini jew teħid ta' kampjuni tad-demm - proċeduri kirurġiċi superfiċjali fl-adulti u fil-popolazzjoni pedjatrika.
English: • Mechanical cleansing/debridement
Maltese: • It-tindif/il-qtugħ mekkaniku
English: In view of this, Germany (BfArM) notified the CHMP/EMA Secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised Products Information (PIs) and thus to harmonise its divergent PIs across the EU.
Maltese: Fid-dawl ta' dan, il-Ġermanja (BfArM) innotifikat lis-Segretarjat tas-CHMP/EMA dwar referenza uffiċjali taħt l-Artikolu 30 tadDirettiva 2001/83/KE sabiex jiġu solvuti d-diverġenzi fost l-Informazzjoni dwar il-Prodott awtorizzata fillivell nazzjonali (PIs) u b'hekk tarmonizza l-PIs diverġenti madwar l-UE.
English: “Consideration should be given to the fact that pulse oximeter values may overestimate the actual oxygen saturation in case of increased methaemoglobin fraction; therefore, in cases of suspected methaemoglobinaemia, it may be more helpful to monitor oxygen saturation by co-oximetry”.
Maltese: “Wieħed għandu jikkunsidra l-fatt li l-valuri tal-ossimetru tal-polz jistgħu jistmaw iżżejjed is-saturazzjoni reali tal-ossiġnu f'każ ta' frazzjoni akbar ta' metaemoglobina; għaldaqstant, f'każijiet ta' suspett ta' metaemoglobinemija, jista' jkun aktar ta' għajnuna jekk wieħed jissorvelja s-saturazzjoni tal-ossiġnu permezz tal-ko-ossimetrija”.
English: However, there were some divergences in the national SmPCs with regard to the youngest age group, and the presence of a minimum recommended dose-interval.
Maltese: Madankollu, kien hemm xi diverġenzi fl-SmPCs nazzjonali rigward l-iżgħar grupp ta' età, u l-preżenza ta' rakkomandazzjoni ta' intervall minimu bejn id-doża.
English: The dosage was previously approved and is in line with the CSP agreed in 2012.
Maltese: Id-dożaġġ kien approvat qabel u huwa konformi mas-CSP li sar qbil dwaru fl-2012.
English: There is a clinical need for the use of EMLA as a topical anaesthetic of the genital mucosa in this population.
Maltese: Hemm ħtieġa klinika għallużu ta' EMLA bħala anestesija topika tal-mukoża ġenitali f'din il-popolazzjoni.
English: The CHMP agreed that the use in adolescents is specifically supported by clinical studies which provide evidence for the similarity of the thickness of the stratum corneum (the rate-limiting barrier for percutaneous absorption) in adults and adolescents.
Maltese: Is-CHMP qabel li lużu fl-adolexxenti huwa speċifikament appoġġjat minn studji kliniċi li jipprovdu evidenza tax-xebh bejn ilħxuna tal-istratum corneum (l-ostakolu li jillimita r-rata ta' assorbiment perkutanju) fl-adulti u fladolexxenti.
English: For female genital skin a footnote was added stating that EMLA alone applied for 60 or 90 min does not provide sufficient anaesthesia for thermocautery or diathermy of genital warts.
Maltese: Fil-każ tal-ġilda ġenitali femminili żdiedet nota ta' qiegħ il-paġna li tgħid li EMLA applikat waħdu għal 60 jew 90 minuta ma jipprovdix biżżejjed anestesija għall-ħruq jew id-dijatermija ta' felul ġenitali.
English: The wording in section 5.2 is based on the MAH's CDS with some amendments.
Maltese: Il-kliem fis-sezzjoni 5.2 huwa bbażat fuq is-CDS tal-MAH b'ċerti emendi.
English: Topical anaesthesia of the skin
Maltese: Anestesija topika tal-ġilda
English: The wording in section 5.1 is based on the MAH's Core Data Sheet (CDS) with some minor rearrangements to present the text per respective indication (i.e. skin, genital mucosa, leg ulcers).
Maltese: Il-kliem fis-sezzjoni 5.1 huwa bbażat fuq id-Dokument ta' Dejta Prinċipali (CDS) tal-MAH b'xi aġġustamenti żgħar sabiex jippreżenta t-test skont l-indikazzjoni rispettiva (jiġifieri l-ġilda, il-mukoża ġenitali, l-ulċeri fir-riġlejn).
English: For the paediatric population, the MAH proposed a text stating the plasma concentrations of lidocaine and prilocaine per age group including the applied amount of cream and the application time of the cream on the skin.
Maltese: Fil-każ tal-popolazzjoni pedjatrika, il-MAH ippropona test li jiddikjara l-konċentrazzjonijiet fil-plażma ta' lidocaine u prilocaine għal kull grupp ta' età inkluż l-ammont applikat ta' krema u ż-żmien ta' applikazzjoni tal-krema fuq il-ġilda.
English: The wording proposed for other warnings and precautions (e.g. application on open wounds, atopic dermatitis, application in the vicinity of the eyes or to an impaired tympanic membrane) was considered acceptable by the CHMP.
Maltese: Il-kliem propost għal twissijiet u prekawzjonijiet oħrajn (eż. l-applikazzjoni fuq feriti miftuħa, dermatite atopika, l-applikazzjoni qrib l-għajnejn jew fuq membrana timpanika indebolita) kien ikkunsidrat aċċettabbli mis-CHMP.
English: The MAH made a proposal in line with the agreed CSP wording (IE/H/PSUR/0019/002) which in general was considered acceptable by the CHMP.
Maltese: Il-MAH ressaq proposta konformi mal-kliem tas-CSP li sar qbil dwaru (IE/H/PSUR/0019/002) li b'mod ġenerali kienet ikkunsidrata aċċettabbli mis-CHMP.
English: A similar restriction (with caveats) for children 3 months and above was also considered necessary.
Maltese: Restrizzjoni simili (bi twissijiet) għat-tfal ta' tliet xhur u aktar ukoll kienet ikkunsidrata meħtieġa.
English: Overall summary of the scientific evaluation of EMLA cream and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' EMLA krema u ismijiet assoċjati (ara Anness I)
English: The proposed text for fertility and breast-feeding was endorsed by the CHMP.
Maltese: It-test propost għall-fertilità u għat-treddigħ kien approvat mis-CHMP.
English: The CHMP noted that there are several clinical data supporting the inclusion of “topical anaesthesia of the skin in connection with needle insertion e.g. intravenous catheters or blood sampling and in superficial surgical procedures” in paediatric population.
Maltese: Is-CHMP innota li hemm bosta dejta klinika li tappoġġja l-inklużjoni ta' “anestesija topika tal-ġilda b'rabta mat-titqib bil-labra eż. kateters ġol-vini jew teħid ta' kampjuni tad-demm u fi proċeduri kirurġiċi superfiċjali” fil-popolazzjoni pedjatrika.