FrancophonIA/ELRC3.0 huggingface dataset:
English: In PAH, Stayveer added to patient's current therapy was more effective than placebo (a dummy treatment) in improving the distance patients could walk in 6 minutes (a way of measuring exercise capacity) after 16 weeks of treatment.
Maltese: Fil-PAH, iż-żieda ta' Stayveer mat-terapija attwali tal-pazjent kienet iktar effikaċi minn plaċebo (kura finta) sabiex titjieb id-distanza li l-pazjenti setgħu jimxu f'6 minuti (mezz biex titkejjel il-kapaċità tależerċizzju) wara 16-il ġimgħa ta' kura.
English: Stayveer is given to reduce the number of new digital ulcers.
Maltese: Stayveer huwa maħsub sabiex inaqqas in-numru ta' ulċeri ġodda fis-swaba'.
English: Stayveer must not be used in patients who have certain liver problems, who are pregnant or could become pregnant and who are not using reliable contraceptive methods or who are taking ciclosporin (a medicine that acts on the immune system).
Maltese: Stayveer m'għandux jintuża f'pazjenti li għandhom ċerti problemi tal-fwied, f'nisa li huma tqal jew li jistgħu joħorġu tqal u li ma jużawx metodi ta' kontraċezzjoni affidabbli jew li qed jieħdu ciclosporin (mediċina li taħdem fuq is-sistema immunitarja).
English: In patients with systemic sclerosis and digital ulcer disease, there is narrowing of the blood vessels of the fingers and toes leading to ulcers.
Maltese: F'pazjenti bi sklerożi sistemika u b'marda tal-ulċeri fis-swaba', hemm djuq fil-vażi tas-swaba' tal-idejn u tas-saqajn li jwassal għall-ulċeri.
English: The company that makes Stayveer will provide a patient alert card to remind patients of the need for regular blood tests for liver function and to use effective contraception to avoid pregnancy.
Maltese: Il-kumpanija li tipproduċi Stayveer se tipprovdi kard tat-twissija tal-pazjent biex tfakkar lill-pazjenti dwar il-bżonn li jagħmlu testijiet tad-demm regolari għall-funzjoni tal-fwied u biex jużaw kontraċezzjoni effettiva biex jevitaw tqala.
English: Treatment of systemic sclerosis with digital ulcers
Maltese: Il-kura ta' sklerożi sistemika b'ulċeri fis-swaba'
English: For the full list of side effects of Stayveer, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Stayveer, ara l-fuljett ta' tagħrif.
English: Stayveer can also be used in adults with systemic sclerosis in whom poor blood circulation caused by the disease has led to the development of digital ulcers (sores on the fingers and toes).
Maltese: Stayveer jista' jintuża wkoll f'adulti bi sklerożi sistemika, li fihom iċ-ċirkolazzjoni tad-demm dgħajfa kkawżata mill-marda wasslet għall-iżvilupp ta' ulċeri fis-swaba' (feriti fis-swaba' tal-idejn u tas-saqajn).
English: What measures are being taken to ensure the safe and effective use of Stayveer?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Stayveer?
English: How does Stayveer work?
Maltese: Kif jaħdem Stayveer?
English: Similar results were seen in the second study after 24 weeks.
Maltese: Fit-tieni studju li sar 24 ġimgħa wara, intwerew riżultati simili.
English: <Fertility:>
Maltese: <Fertilità:>
English: <Official control authority batch release is required for this product.> [only for those immunological veterinary medicinal products which are listed for HYPERLINK "https://www.edqm.eu/en/Veterinary-OCABR-Guidelines-1531.html" \l "PSG"Official Control Authority Batch Release (OCABR) in accordance with Article 82 of Directive 2001/82/EC as amended.]
Maltese: <Hemm bżonn ta' ħrug tal-lott minn awtorità ta' kontroll uffiċjali għal dan il-prodott.> [only for those immunological veterinary medicinal products which are listed for HYPERLINK "https://www.edqm.eu/en/Veterinary-OCABR-Guidelines-1531.html" \l "PSG"Official Control Authority Batch Release (OCABR) in accordance with Article 82 of Directive 2001/82/EC as amended.]
English: <6 months.><…><1 year.><18 months.><2 years.><30 months.><3 years.><use immediately.>
Maltese: <6 xhur.> <...> <Sena.> <18il xahar.> <Sentejn.> <30 xahar.> <3 snin.> <uża immedjatament.>
English: <PHARMACOLOGICAL><IMMUNOLOGICAL> PROPERTIES
Maltese: KWALITAJIET <FARMAKOLOĠIĊI> <IMMUNOLOĠIĊI>
English: Pharmacotherapeutic group: {group}.
Maltese: Grupp farmako-terapewtiku:
English: <5.1 Pharmacodynamic properties>
Maltese: <5.1 Kwalitajiet farmakodinamiċi >
English: <5.2 Pharmacokinetic particulars>
Maltese: <5.2 Tagħrif farmakokinetiku >
English: <Onset of immunity: {x weeks}>
Maltese: <Perjodu tal-immunità: {x snin}>
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ( HYPERLINK "http://www.ema.europa.eu/" http://www.ema.europa.eu/).
Maltese: dwar il-Mediċini HYPERLINK "http://www.ema.europa.eu" http://www.ema.europa.eu/.
English: <Laying birds:>
Maltese: <Tjur tal-bajd:>
English: <Store and transport refrigerated (2 (C - 8 (C).>*
Maltese: <Aħżen fil-friġġ (2(C - 8(C).>
English: DescriptionDue date>>
Maltese: DeskrizzjoniData mistennija>>
English: <Store and transport frozen.>**
Maltese: <Aħżen u ttrasporta ffriżat.>**
English: Pharmaco-logically active substanceMarker residueAnimal speciesMRLsTarget tissuesOther provisionsTherapeutic classification
Maltese: Sustanza farmakoloġikament attivaResidwu li jimmarkaSpeċe tal-annimalMRLTessuti mmiratiDispożizzjonijiet oħrajnKlassifikazzjoni terapewtika
English: <Store in a freezer.>
Maltese: <Aħżen fil-friża.>
English: <Store in a refrigerator (2 (C - 8 (C).>
Maltese: <Aħżen u ttrasporta fil-friġġ (2(C - 8(C).
English: <Use only accordingly to the benefit-risk assessment by the responsible veterinarian.>
Maltese: <Uża biss skont il-valutazzjoni tal-benefiċċju u r-riskju mill-veterinarju responsabbli.>
English: The active substance
 in {name of the product} <is><are> <an> allowed substance
 as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza(i) attiva(i) f'(isem tal-prodott) <hija> <huma> sustanza(i) ammissibbli kif deskritt fit-tabella numru 1 fl-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010:
English: ATC vet code: {lowest available level (e.g. subgroup for chemical substance)}.
Maltese: Kodiċi ATC veterinarja {l-inqas livell disponibbli (e.ż. sottogrupp għas-sustanza kimika)}.
English: <Store and transport frozen {temperature range}.>**
Maltese: <Aħżen u ttrasporta ffriżat {firxa ta' temperatura}.>**
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (HYPERLINK "http://www.ema.europa.eu/"http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini HYPERLINK "http://www.ema.europa.eu" http://www.ema.europa.eu/.
English: The active substance being a principle of biological origin intended to <produce> <active><passive><diagnose a state of> immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bijoloġika maħsuba sabiex <tipproduċi> <issir djanjosi ta' stat ta'> immunità <attiva> <passiva> ma taqax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: <According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: <Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista', skont il-liġijiet nazzjonal tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, il-pussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: <For use by veterinary surgeons only.>
Maltese: <Għall-użu minn kirurgi veterinarji biss.>
English: <Name and address of the manufacturer
 of the biological active substance

Maltese: <Isem u indirizz tal-manufattur<i> tas-sustanza<i> bijoloġika<ċi> attiva<i>
English: <Specific pharmacovigilance requirements:>
Maltese: <Ħtiġijiet ta' farmakoviġilanza:>
English: A. <MANUFACTURER<S> OF THE BIOLOGICAL ACTIVE SUBSTANCE<S> AND> MANUFACTURER<S> RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I) U> MANIFATTUR(I) RESPONSABBLI GĦALL-ĦRUĠ TAL-LOTT>
English: <In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.>
Maltese: <Fin-nuqqas ta' studji dwar kompatibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma' prodotti mediċinali veterinarji oħra.>
English: <Date of first authorisation:> <{DD/MM/YYYY}><{DD month YYYY}.>
Maltese: <Data tal-ewwel awtorizzazzjoni:> <{JJ/XX/SSSS}><{JJ xahar SSSS}>
English: <This being an approval under exceptional circumstances and pursuant to Article 39(7) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Maltese: <Peress li din hi approvazzjoni taħt ċirkustanzi eċċezzjonali u skont l-Artiklu 39(7) tar-Regolament (KE) 726/2004, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jagħmel, fiż-żmien stipulat, il-miżuri li ġejjin:
English: DescriptionDue date>
Maltese: DeskrizzjoniData mistennija>
English: <<Accidental administration> <Contact with the mucosa> is dangerous.>
Maltese: <Użu aċċidentali> <Kuntatt mal-mukuża> huwa perikoluż.>
English: <Disposal: read package leaflet.>
Maltese: <Armi materjal ta' skart skont ir-rekwiżiti lokali.>
English: <Excipient
:>
Maltese: <Ingredjent(<i>) ieħor/oħra:>
English: The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of {name of the active substance(s)} in {name of the product} in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 37/2010 as follows:
Maltese: Il-Kumitat għal Prodotti Mediċinali Veterinarji rrakkomanda l-inkluzjoni ta' (isem tas-sustanza(i) attiva(i)) f'(isem tal-prodott) f'tabella numru 1 (Sustanzi ammissibbli) fl-Anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 kif ġej:
English: <The excipients (including adjuvants) listed in section 6.1 of the SPC are <either> <allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required> <or> <considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product>.>
Maltese: <L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tal-Karatteristiċi tal-Prodott filQosor huma <jew> <sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010> <jew> <huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju>.>
English: <<Meat and offal><Eggs><Milk> <Honey>: {X} <days><hours>.>
Maltese: <Laħam u ġewwieni tal-annimali > <Bajd> <Ħalib> <Għasel> : {X} <ġranet> <sigħat>.
English: <Store in a freezer {temperature range}.>
Maltese: <Aħżen fil-friża {firxa ta' temperatura}.>
English: <The <vaccine><immunological veterinary medicinal product> can be pathogenic for humans.
Maltese: <Il-<vaċċin> <prodott mediċinali veterinarju immunoloġiku> jista' jkun patoġeniku għall-bnedmin.
English: <Date of last renewal:> <{DD/MM/YYYY}> <{DD month YYYY}.>
Maltese: <Data tal-aħħar tiġdid:> <(JJ/XX/SSSS)> <(JJ xahar SSSS).>
English: · <SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES>
Maltese: [Only applicable, if justified after authorisation.]
English: <Laboratory studies in {species} have shown evidence of <teratogenic>, <foetotoxic>, <maternotoxic> effects.>
Maltese: <Studji fil-laboratorju fil-{speċi} ma pprovdewx evidenza ta' <ħsara fit-tqala>, <ħsara lill-fetu>, <ħsara lill-omm>.>
English: - common (more than 1 but less than 10 animals in 100 animals treated )
Maltese: - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal)
English: <The excipients, listed in section 6.1 of the SPC are <either> <allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required> <or> <considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product>.>
Maltese: <L-addittivi elenkati f'sezzjoni 6.1 tal-Karatteristiċi tal-Prodott filQosor huma <jew> <sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010> <jew> <huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju>.>
English: B. PACKAGE LEAFLET
Maltese: 4. DAQS TAL-PAKKETT
English: <Immunocompromised persons are advised to avoid contact with the <vaccine><immunological veterinary medicinal product> and vaccinated animals during {period}.>
Maltese: <Persuni immunokompromessi huma avżati sabiex jevitaw il-kuntatt mal-<vaċċin> <prodott mediċinali veterinarju immunoloġiku> u l-annimali vaċċinati matul {il-perjodu}.>
English: <In case of accidental <self-administration><self-injection><ingestion><spillage onto skin>, seek medical advice immediately and show the package leaflet or the label to the physician.>
Maltese: <Hemm informazzjoni dwar <is-sigurtà> <u> <l-effikaċja> li turi li dan il-<vaċċin> <prodott mediċinali veterinarju immunoloġiku> jista' jiġi amministrat tal-anqas {X } <ġranet> <ġimgħat> <qabel> <wara> l-amministrazzjoni ta' {deskrizzjoni tal-prodott(i) ittestjat(i).}>
English: <Shelf life after <dilution><reconstitution> according to directions: ….>
Maltese: <Iż-żmien kemm idum tajjeb wara li jiġi <dilwit><imħallat> skont kif rakkomandat: ....>
English: <Safety> <and> <efficacy> data are available which demonstrate that this <vaccine><immunological veterinary medicinal product> can be administered at least {X} <days><weeks> <before><after> the administration of {description of tested product(s).
Maltese: <Hemm informazzjoni dwar <is-sigurtà> <u> <l-effikaċja> li turi li dan il-<vaċċin> <prodott mediċinali veterinarju immunoloġiku> jista' jitħallat u jiġi amministrat ma' {deskrizzjoni tal-prodott(i) ittestjat(i).}>
English: <Safety <and> <efficacy> data are available which demonstrate that this <vaccine><immunological veterinary medicinal product> can be mixed and administered with {description of tested product(s).
Maltese: <M'hemmx informazzjoni dwar is-sigurtà u l-effikaċja ta' dan il-<vaċċin> <prodott mediċinali veterinarju immunoloġiku> jekk jintuża flimkien ma' kwalunkwe prodott mediċinali veterinarju ieħor.
English: 4.7 Use during pregnancy, lactation or lay
Maltese: 4.7 Użu fit-tqala, fit-treddigħ u fi żmien il-bidien
English: · CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD L-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: - very common (more than 1 in 10 animals treated displaying adverse reaction(s))
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda)
English: Then place the dressing carefully over the mound of cream.
Maltese: TAL-PRODOTT,
English: Methaemoglobinaemia1
Maltese: Metaemoglobinemija1
English: months1) 2) 3)
Maltese: xahrejn1) 2) 3)
English: The maximum dose is 60 g.
Maltese: Id-doża massima hija 60 g.
English: Interactions are likely to be similar to the adult population.
Maltese: Interazzjonijiet huma probabbilment simili filpopolazzjoni adulta.
English: lidocaine and 0.2 µg/mL prilocaine.
Maltese: lidocaine u 0.2 µg/mL prilocaine.
English: Application time: 30 minutes
Maltese: Ħin tal-applikazzjoni: 30 minuta
English: Application time: 30-60 minutes.
Maltese: 30-60 minuta.
English: See table 4.
Maltese: Ara tabella 4.
English: Peel the ‘centre cut-out' from the dressing.
Maltese: Qaxxar il-"cut-out taċ-ċentru" mid-dressing.
English: Pharmacotherapeutic group: anesthetics, local; amides; ATC code: N01B B20
Maltese: Kategorija farmakoterapewtika: anestetiċi, lokali; amidi; Kodiċi ATC:
English: Adults and adolescents
Maltese: Adulti u Adolexxenti
English: 10 g of cream should be administered in the lateral vaginal fornices for 10 minutes.
Maltese: 10 g ta' krema għandhom jiġu amministrati filforniċi vaġinali laterali għal 10 minuti.
English: Then leave it in place for at least 60 minutes.
Maltese: Imbagħad ħalliha f'postha għal mill inqas 60 minuta.
English: 6 - 8 years
Maltese: 6 - 8 snin
English: Table 2 Paediatric patients 0-11 years of age
Maltese: Popolazzjoni pedjatrika Tabella 2 Pazjenti pedjatriċi 0-11-il sena Grupp ta' età
English: The usual dose is 5 g to 10 g of cream for 10 minutes.
Maltese: - Id-doża normali hija 5 g sa 10 g ta' krema għal 10 minuti.
English: EMLA Cream is indicated for:
Maltese: EMLA Krema huwa indikat għal:
English: Approx. 5-10 g of cream for 5-10 minutes1) 3) 4).
Maltese: Madwar 5-10 g ta' krema għal 5-10 minuti1) 3) 4).
English: 2 Genital mucosa 3 Leg ulcer
Maltese: 2 Mukoża ġenitali 3 Ulċeri fis-saqajn
English: The maximum observed plasma concentrations for prilocaine and ortho-toluidine were 0.08 µg/mL and 0.01 µg/mL respectively.
Maltese: Il-konċentrazzjonijiet massimi osservati fil-plażma għal prilocaine u ortho-toluidine kienu 0.08 µg/mL u 0.01 µg/mL rispettivament.
English: Hypersensitivity1, 2, 3
Maltese: Sensittività eċċessiva1, 2, 3
English: An application time of 60 minutes may improve the anaesthesia further.
Maltese: Ħin ta' applikazzjoni ta' 60 minuta jista' jtejjeb l-anesteżija ulterjorment.
English: A metabolite of lidocaine, 2,6-dimethylaniline, and a metabolite of prilocaine, σ-toluidine, showed evidence of genotoxic activity.
Maltese: Metabolit ta' lidocaine, 2,6-dimethylaniline, u metabolit ta' prilocaine, σ-toluidine, wera evidenza ta'
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Maltese: Fi ħdan kull Sistema ta' Klassifika tal-Organi, ir-reazzjonijiet avversi huma elenkati skont il-kategoriji tal frekwenzi ta': komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000).
English: Infants 3-11 months2)
Maltese: Trabi 3-11-il xahar2)
English: There is also a risk of ‘acute methaemoglobinaemia' (a problem with blood pigment levels).
Maltese: - Hemm ukoll riskju ta' ‘metemoglobinemija akuta' (problema bil-livelli ta' pigment tad-demm.
English: • Cimetidine or beta-blockers, which may cause an increase in the blood levels of lidocaine.
Maltese: • Cimetidine jew beta-blockers, li jistgħu jikkawżaw żieda fil-livelli tad-demm ta' lidocaine.
English: Local anaesthetic toxicity is manifested by symptoms of nervous system excitation and, in severe cases, central nervous and cardiovascular depression.
Maltese: It-tossiċità lokali tal-anestetiċi hija manifestata minn sintomi ta' eċċitazzjoni tas-sistema nervuża u, f'każijiet severi, depressjoni kardjovaskulari u nervuża ċentrali.
English: 2) On female genital skin, EMLA alone applied for 60 or 90 minutes does not provide sufficient anaesthesia for thermocautery or diathermy of genital warts.
Maltese: 2) Fuq ġilda ġenitali femminili, EMLA waħdu applikat għal 60 jew 90 minuta ma jipprovdix anesteżija suffiċenti għal thermocautery jew diathermy ta' felul ġenitali.
English: • Topical anaesthesia of the genital mucosa, e.g. prior to superficial surgical procedures or infiltration anaesthesia; in adults and adolescents ≥12 years
Maltese: • Anesteżija topikali tal-mukoża ġenitali, eż. qabel proċeduri kirurġiċi superfiċjali jew anesteżija ta' infiltrazzjoni; f'adulti u adolexxenti ≥12-il sena
English: Prilocaine in high doses may cause an increase in methaemoglobin levels particularly in conjunction with methaemoglobin-inducing medicinal products (e.g. sulphonamides, nitrofuradantin, phenytoin, phenobarbital).This list is not exhaustive.
Maltese: prodotti mediċinali li jinduċu metaemoglobina (eż. sulphonamides, nitrofuradantin, phenytoin, phenobarbital).
English: Maximum recommended dose: 60 g. Maximum recommended treated area; 600 cm2 for a minimum of 1 hour, maximum 5 hours1).
Maltese: Doża massima rakkomandata: 60 g. Erja massima rakkomandata ta' kura; 600 cm2 għal mill-inqas siegħa, massimu ta' 5 sigħat1).
English: Other medicines and EMLA
Maltese: Mediċini oħra u EMLA
English: In patients with atopic dermatitis, a similar but shorter vascular reaction is seen, with erythema occurring after 30-60 minutes, indicating more rapid absorption through the skin (see section 4.4).
Maltese: F'pazjenti b'dermatite atopika, hija osservata reazzjoni vaskulari simili iżda iqsar bl-okkorrenza ta' eritema wara 30-60 minuta, li tindika assorbiment aktar rapidu mill-ġilda (ara sezzjoni 4.4).
English: Applied amount of cream
Maltese: Ammont applikat ta' krema
English: Lidocaine crosses the placental barrier by means of simple diffusion.
Maltese: Lidocaine jaqsam il-barriera tal-plaċenta permezz ta' diffużjoni sempliċi.
English: Half a 5 g tube corresponds to about 2 g EMLA.
Maltese: Nofs tubu ta' 5 g jikkorrespondi għal madwar 2 g EMLA.
English: Lidocaine and prilocaine have bacteriocidal and antiviral properties in concentrations above 0.5-2%.
Maltese: Lidocaine u prilocaine għandhom karatteristiċi batteriċidali u antivirali f'konċentrazzjonijiet ogħla minn 0.52%.
English: Tabulated list of adverse reactions
Maltese: Tabella 3 Reazzjonijiet avversi
English: This is the same concentration of local anaesthetics and a similar formulation as for EMLA.
Maltese: Din hija l-istess konċentrazzjoni ta' anestetiċi lokali u formulazzjoni simili għal EMLA.
English: 5) No clinically significant increase in methaemoglobin levels has been observed after an application time of up to 4 hours on 16 cm2.
Maltese: 5) Ebda żieda klinikament sinifikanti fil-livelli ta' metaemoglobina ma ġiet osservata wara żmien ta' applikazzjoni ta' sa 4 sigħat fuq 16 cm2.
English: A line of cream of about 3.5 cm from the 30 g tube is equal to 1 g of cream.
Maltese: Linja ta' krema ta' madwar 3.5 cm mit-tubu ta' 30 g hija ugwali għal 1 g ta' krema.
English: In the back passage (anus).
Maltese: - Fil-passaġġ ta' wara (anus).
English: Table 1 Adults and adolescents 12 years of age and above Indication/Procedure
Maltese: Tabella 1 Adulti u adolexxenti minn 12-il sena ‘il fuq
English: • Minor skin operations.
Maltese: • Operazzjonijiet minuri tal-ġilda.
English: In clinical studies of EMLA on intact skin, no differences in safety or efficacy (including anaesthetic onset time) were observed between geriatric patients (aged 65 to 96 years) and younger patients.
Maltese: Fi studji kliniċi ta' EMLA fuq ġilda intatta, ma ġiet osservata l-ebda differenza fis-sigurtà jew l-effikaċja (inkluż ħin ta' bidu anestetiku) bejn pazjenti ġerjatriċi (li għandhom bejn 65-96 sena) u pazjenti iżgħar.
English: Specific interaction studies with lidocaine/prilocaine and anti-arrhythmics class III (e.g. amiodarone) have not been performed, but caution is advised (see also section 4.4).
Maltese: Ma sarux studji speċifiċi ta' interazzjoni b'lidocaine/prilocaine u anti-arritmiċi ta' klassi III (eż. amiodarone), iżda hija rrakkomandata attenzjoni kbira (ara wkoll sezzjoni 4.4).
English: Analgesic efficacy increased from 15 to 90 minutes application on normal skin but on vascular lesions 90 minutes provided no benefit over 60 min.
Maltese: L-effikaċja analġesika żdiedet minn applikazzjoni ta' 15 sa 90 minuta fuq ġilda normali iżda fuq leżjonijiet vaskulari 90 minuta ma pprovdew ebda benefiċċju ieħor meta mqabbel ma' 60 minuta.
English: Corneal irritation1
Maltese: Irritazzjoni tal-kornea1
English: Lidocaine and prilocaine are amide-type local anaesthetics.
Maltese: Lidocaine u prilocaine huma anestetiċi lokali tat-tip amidju.