FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical studies involved more than 2,300 paediatric patients of all age groups and demonstrated efficacy for needle pain (venipuncture, cannulation, sc and im vaccinations, lumbar puncture), laser treatment of vascular lesions, and curettage of molluscum contagiousum.
Maltese: L-istudji kliniċi involvew aktar minn 2,300 pazjent pedjatriku tal-gruppi ta' età kollha u wrew effikaċja għall-uġigħ bil-labra (tniġġiż venali, kannullazzjoni, tilqim sc u im, titqib lumbari), kura bil-lejżer ta' leżjonijiet vaskulari, u curettage ta' contagiousum molluskum.
English: EMLA reduces the postoperative pain for up to 4 hours after debridement.
Maltese: EMLA jnaqqas l-uġigħ wara operazzjoni sa 4 sigħat wara debrajdment.
English: Plasma concentrations of lidocaine and prilocaine in paediatric age groups from 0 months to 8 years of age
Maltese: Il-konċetrazzjonijiet fil-plażma ta' lidocaine u prilocaine fil-gruppi ta' età pedjatrika minn 0 xhur sa 8 snin ta' età Età
English: In 90% of patients the anaesthesia is sufficient for the insertion of a biopsy punch (4 mm diameter) to a depth of 2 mm after 60 minutes and 3 mm after 120 minutes EMLA treatment.
Maltese: F'90% tal-pazjenti, l-anesteżija hija biżżejjed għall-inserzjoni ta' punch tal-bijopsija (dijametru ta' 4 mm) sa fond ta' 2 mm wara 60 minuta u 3 mm wara kura ta' 120 minuta b'EMLA.
English: Approx. 1-2 g/10 cm2 up to a total of 10 g to the leg ulcer(s)3) 5).
Maltese: Madwar 1-2 g/10 cm sa total ta' 10 g għal ulċeri mas-sieq/saqajn3) 5).
English: Clinically significant methaemoglobinaemia should be treated with a slow intravenous injection of methylene blue (see also section 4.4).
Maltese: Metemoglobinemija klinikament sinifikanti għandha tiġi kkurata b'injezzjoni bil-mod ġol-vina ta' methylene blue (ara wkoll sezzjoni 4.4).
English: • Medicines used to treat infections, called ‘sulphonamides' and nitrofuradantin.
Maltese: • Mediċini użati biex jikkuraw infezzjoniijet, imsejħin 'sulfonamidi' u nitrofuradantin.
English: The usual dose is 1 g of cream (1g to 2 g for female genital skin) for each area of skin that is 10 cm2 (10 square centimetres) in size.
Maltese: - Id-doża normali hija 1 g ta' krema (1g sa 2g għal ġilda ġenitali femminili) għal kull erja ta' ġilda li hija 10 cm2 (10 ċentimetri kwadri) fid-daqs.
English: Intact skin Following application to the thigh in adults (60 g cream/400 cm2 for 3 hours), the extent of absorption was approximately 5% of lidocaine and prilocaine.
Maltese: Wara applikazzjoni fuq il-koxxa fl-adulti (krema ta' 60 g/400 cm2 għal 3 sigħat), il-firxa ta' assorbiment kienet madwar 5% ta' lidocaine u prilocaine.
English: • Medicines used to treat epilepsy, called phenytoin and phenobarbital.
Maltese: • Mediċini użati biex jikkuraw l-epilessija, imsejħin phenytoin u phenobarbital.
English: A shorter application time, 15-30 minutes, may be sufficient (see section 5.1).
Maltese: Jista' jkun biżżejjed ħin ta' applikazzjoni iqsar, 15-30 minuta (ara sezzjoni 5.1).
English: 0 - 3 months
Maltese: 0 - 3 xhur
English: Approx. 1.5-2 g/10 cm2 for 2 to 5 hours1).
Maltese: Madwar 1.5-2 g/10 cm2 għal 2 sa 5 sigħat1).
English: Absorption, distribution, biotransformation and elimination The systemic absorption of lidocaine and prilocaine from EMLA is dependent upon the dose, area of application and application time.
Maltese: Assorbiment, distribuzzjoni, bijotrasformazzjoni u eliminazzjoni L-assorbiment sistemiku ta' lidocaine u prilocaine mill-EMLA huwa dipendenti fuq id-doża, iż-żona ta'
English: 2 hours
Maltese: 30 minuta.
English: Hepatic impairment A reduction of a single dose is not necessary in patients with impaired hepatic function (see section 5.2).
Maltese: Tnaqqis ta' doża waħda mhuwiex neċessarju f'pazjenti b'funzjoni epatika indebolita (ara sezzjoni 5.2).
English: Skin of female genital organs Prior to injection of local anaesthetics2)
Maltese: Qabel injezzjoni ta' anestetiċi lokali2)
English: Toddlers and children 1-5 years
Maltese: Trabi u tfal 1-5 snin
English: The usual dose for adults and adolescents over 12 years is 2 g (grams).
Maltese: - Id-doża normali għall-adulti u adolexxenti li għandhom iktar minn 12-il sena hija 2 g (grammi).
English: EMLA contains castor oil polyoxyl hydrogenated Castor oil polyoxyl hydrogenated may cause skin reactions.
Maltese: EMLA fih castor oil polyoxyl hydrogenated, li jista' jikkawża reazzjonijiet għall-ġilda.
English: EMLA produces a biphasic vascular response involving initial vasoconstriction followed by vasodilatation at the application site (see section 4.8).
Maltese: EMLA jipproduċi rispons vaskulari bifażiku li jinvolvi vażokostrizzjoni inizjali segwit minn vażodilatazzjoni fis-sit tal-applikazzjoni (ara sezzjoni 4.8).
English: This ocular reaction may have been influenced by the high pH of the formulation of the emulsion (approximately 9), but is probably also partly a result of the irritative potential of the local anaesthetics themselves.
Maltese: Din ir-reazzjoni okulari jaf kienet influwenzata mill-pH għoli talformulazzjoni tal-emulsjoni (madwar 9), iżda hija probabbilment wkoll parzjalment riżultat ta' potenzjal irritattiv tal-anestetiċi lokali nfushom.
English: Application site irritation3
Maltese: Irritazzjoni fis-sit talapplikazzjoni3
English: Their frequency of Adverse Reactions is listed by MedDRA System Organ Class (SOC) and at the preferred term level.
Maltese: Klassifika tal-Organi (SOC) ta' MedRA u fil-livell tat-terminu ppreferut.
English: Symptoms of local anaesthetic toxicity become increasingly apparent at increasing plasma concentration from 5 to 10 μg/mL of either active substance.
Maltese: Is-sintomi ta' tossiċità anestetika lokali saru dejjem aktar evidenti f'konċentrazzjonijiet fil-plażma dejjem jiżdiedu minn 5 sa 10 μg/mL ta' waħda mis-sustanzi attivi.
English: • Other local anaesthetics.
Maltese: • Anastetiki lokali oħrajn.
English: A dressing is not used.
Maltese: Ma tintużax dressing.
English: Mechanical cleansing/debridement
Maltese: Disturbi tad-demm u tassistema limfatika
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 id-doża rakkomandata tinqabeż, il-pazjent għandu jiġi sorveljat għal reazzjonijiet avversi tas-sistema sekondarji għal metemoglobinemija (ara sezzjonijiet 4.2, 4.8 u 4.9).
English: The usual dose is 1 g of cream for each area of skin that is 10 cm² (10 square centimetres) in size, applied for 1 to 5 hours under a dressing.
Maltese: Id-doża normali hija 1 g ta' krema għal kull erja ta' ġilda li hija 10 cm² (10 ċentimetri kwadri) fid-daqs, applikata għal 1 sa 5 sigħat taħt dressing.
English: With large doses of EMLA, consideration should be given to the risk of additional systemic toxicity in patients receiving other local anaesthetics or medicinal products structurally related to local anaesthetics, since the toxic effects are additive.
Maltese: Ma' dożi kbar ta' EMLA, għandha tingħata kunsiderazzjoni għar-riskju ta' tossiċità sistemika addizzjonali f'pazjenti li jkunu qed jirċievu anestetiċi lokali oħrajn jew prodotti mediċinali strutturalment relatati ma' anestetiċi lokali, minħabba li effetti tossiċi huma adittivi.
English: The cream is put on under an airtight dressing such as plastic wrap.
Maltese: - Imbagħad, il-krema tinkesa bi dressing [tgeżwira tal-plastik].
English: The usual dose depends on the child's age and is used for 30 to 60 minutes (30 minutes if the patient has atopic dermatitis).
Maltese: - Id-doża normali tiddependi mill-età tat-tifel/tifla u tintuża għal 30 sa 60 minuta (30 minuta jekk il pazjent ikollu dermatite atopika).
English: Peel the paper layer from the dressing.
Maltese: Qaxxar is-saff tal-karta minn mad-dressing.
English: After an application time of 24 hours to leg ulcers with an area of up to 50-100 cm2, the maximum plasma concentrations of lidocaine (0.19-0.71 µg/mL) and of prilocaine (0.06-0.28 µg/mL) were usually reached within 2 to 4 hours.
Maltese: Wara ħin ta' applikazzjoni ta' 24 siegħa fuq l-ulċeri tas-saqajn b'żona sa 50-100 cm2, il-konċentrazzjonijiet massimi fil-plażma ta' lidocaine (0.19-0.71 µg/mL) u ta' prilocaine (0.06-0.28 µg/mL) ġeneralment intlaħqu fi żmien sagħtejn sa 4 sigħat.
English: In studies of split-skin grafting in adults application for up to 7hours 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
Maltese: Fi studji ta' tilqim fuq ġilda maqsuma fl-adulti, l-applikazzjoni sa 7 sigħat u 40 minuta fuq il-koxxa jew fuq id-driegħ f'żona sa 1,500 cm2 irriżultat f'konċentrazzjonijiet massimi fil-plażma li ma jaqbżux 1.1 µg/mL
English: However, the rate of metabolism and elimination of the local anaesthetics after topical application of EMLA are governed by the rate of absorption.
Maltese: metaboliżmu u l-eliminazzjoni tal-anestetiċi lokali wara applikazzjoni topikali ta' EMLA hija rregolata mirrata ta' assorbiment.
English: The ratio of the embryofetal dose to the maternal serum concentration is 0.4 to
Maltese: Il-proporzjon tad-doża embrijofetali fil-konċentrazzjoni fis-serum tal-omm huwa 0.4 sa 1.3.
English: 4 hours
Maltese: 45 minuta.
English: Paediatric patients with atopic dermatitis
Maltese: Pazjenti pedjatriċi b'dermatite atopika
English: Abnormal taste.
Maltese: attività ġenotossika.
English: Following repeated application of 2-10 g EMLA to leg ulcers with an area of up to 62 cm2 for 30-60 minutes 3-7 times a week for up to 15 doses during a period of one month, there was no apparent accumulation in plasma of lidocaine and its metabolites monoglycinexylidide and 2,6-xylidine or of prilocaine and its metabolite ortho-toluidine.
Maltese: 7 darbiet fil-ġimgħa sa 15-il doża matul perjodu ta' xahar, ma kien hemm ebda akkumulu evidenti fil-plażma ta' lidocaine u l-metaboliti tiegħu monoglycinexylidide u 2,6-xylidine jew ta' prilocaine u l-metabolit tiegħu ortho-toluidine.
English: 2 g/16 cm2
Maltese: 3 - 12-il xahar 2 g/16 cm2
English: One gram of EMLA pressed out of a tube of 30 g is approximately 3.5 cm.
Maltese: Gramma ta' EMLA magħfusa minn ġewwa tubu ta' 30g hija madwar 3.5 cm.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Aluminum Tube 5 g
Maltese: Tubu tal-Aluminju 5 g
English: Up to 20 g and 200 cm2 for 1-5 hours6)
Maltese: Sa 20 g u 200 cm2 għal 1-5
English: Up to 10 g and 100 cm2 for 1-5 hours6)
Maltese: Sa 10 g u 100 cm2 għal 1-5
English: The skin thickness decreases over the course of 15 minutes air exposure.
Maltese: Il-ħxuna tal-ġilda tonqos matul esponiment ta' 15-il minuta.
English: EMLA is applied to intact skin under an occlusive dressing.
Maltese: EMLA huwa applikat fuq ġilda intatta taħt dressing okklussiv.
English: The incidences of the Adverse Drug Reactions (ADRs) associated with EMLA therapy is tabulated below.
Maltese: L-inċidenzi ta' Reazzjonijiet Avversi għall-Mediċina (ADRs) assoċjati ma' terapija b'EMLA huma mogħtija f'tabella hawn taħt.
English: EMLA contains two active substances called lidocaine and prilocaine.
Maltese: EMLA fih żewġ sustanzi attivi li huma lidocaine u prilocaine.
English: EMLA should not be used on an area of newly shaven skin larger than 600 cm² (600 square centimetres, e.g. 30 cm by 20 cm) in size.
Maltese: EMLA ma għandux jintuża fuq żona ta' ġilda li tkun għadha kif tqaxxret li tkun ikbar minn 600 cm² (600 ċentimetri kwadri, eż. 30 ċm b'20 ċm) fid-daqs.
English: Elderly No dose reduction is necessary in elderly patients (see sections 5.1 and 5.2).
Maltese: Ma huwa meħtieġ ebda aġġustament tad-doża f'pazjenti anzjani (ara sezzjonijiet 5.1 u 5.2).
English: Medicinal products that reduce the clearance of lidocaine (e.g. cimetidine or betablockers) may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period.
Maltese: Prodotti mediċinali li jnaqqsu t-tneħħja ta' lidocaine (eż. cimetidine jew betablockers) jistgħu jikkawżaw konċentrazzjonijiet tal-plażma potenzjalment tossiċi meta lidocaine jingħata f'dożi għoljin ripetuti fuq medda ta' żmien twila.
English: Leg ulcer(s)
Maltese: Ulċera(i) fis-saqajn
English: The maximum concentration does not depend on the patient´s age but is significantly (p<0.01) related to the size of the ulcer area.
Maltese: Il-konċentrazzjoni massima ma tiddependix fuq l-età tal-pazjent iżda hija b'mod sinifikanti (p <0.01) relatata mad-daqs taż-żona tal-ulċera.
English: • Topical anaesthesia of leg ulcers to facilitate mechanical cleansing/debridement in adults only
Maltese: • Anesteżija topikali ta' ulċeri mas-saqajn biex tiffaċilita tindif/tneħħija ta' ġilda mejta f'adulti biss
English: In studies on reproduction toxicity, embryotoxic or fetotoxic effects of lidocaine were detected at doses of 25 mg/kg s.c. in the rabbit and for prilocaine starting at doses of 100 mg/kg i.m.
Maltese: Fi studji dwar it-tossiċità firriproduzzjoni, inkixfu effetti fetotossiċi, jew embrijotossiċi ta' lidocaine f'dożi ta' 25 mg/kg s.c. fil-fniek u għal prilocaine li jibdew f'dożi ta' 100 mg/kg i.m. fil-firien.
English: Purpura1, Petechiae1
Maltese: Ħakk fis-sit talapplikazzjoni1
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni dwar il-prodott tista' tiġi aġġornata sussegwentament mill-awtoritajiet kompetenti talIstati Membri, b'kollaborazzjon mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċedura stabbilita fil-Kapitolu 4 tat-Titlu III tad-Direttiva 2001/83/KE.
English: The extent of systemic absorption was approximately 10% following application to the face (10 g/100 cm2 for 2 hours).
Maltese: Il-firxa ta' assorbiment sistemiku kienet madwar 10% wara l-applikazzjoni fuq il-wiċċ (10 g/100 cm2 għal sagħtejn).
English: Local tolerance studies using a 1:1 (w/w) mixture of lidocaine and prilocaine as an emulsion, cream or gel indicated that these formulations are well tolerated by intact and damaged skin and mucosal membranes.
Maltese: Studji lokali dwar it-tollerenza lokali permezz ta' taħlita 1:1 (w/w) ta' lidocaine u prilocaine bħala emulżjoni, krema jew ġel jindikaw li dawn il-formulazzjonijiet huma ttollerati sew minn ġilda u membrani mukosali intatti u danneġġjati.
English: Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsive medicinal products; circulatory signs are treated in line with recommendations for resuscitation.
Maltese: Sintomi newroloġiċi severi (konvulżjonijiet, dipressjoni CNS) għandhom jiġu kkurati b'mod sintomatiku b'appoġġ respiratorju u l-għoti ta' prodotti mediċinali antikonvulsivanti; sinjali taċ-ċirkolazzjoni huma kkurati f'konformità mar-rakkomandazzjonijiet għar-risuxxitazzjoni.
English: When lidocaine and prilocaine were combined, only additive effects were seen, with no indication of synergism or unexpected toxicity.
Maltese: Meta lidocaine u prilocaine kienu kkombinati, kienu osservati effetti addittivi biss, b'ebda indikazzjoni ta' sinergiżmu jew tossicità mhux mistennija.
English: The cream is put on under a dressing for 2 to 5 hours.
Maltese: - Il-krema titpoġġa taħt dressing għal 2 sa 5 sigħat.
English: Surgical treatment of localised lesions, e.g. removal of genital warts (condylomata acuminata) and prior to injection of local anaesthetics
Maltese: Kura kirurġika ta' leżjonijiet lokalizzati, eż. tneħħija ta' felul ġenitali (consylomata acuminata) u qabel injezzjoni ta' anestetiċi lokali
English: 6.1 List of excipients [To be completed nationally]
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti [Li għandha timtela fuq livell nazzjonali]
English: Also the loss of protective reflexes may allow corneal irritation and potential abrasion.
Maltese: Barra minn hekk, it-telf ta' riflessi protettivi jistgħu jippermettu irritazzjoni kornejali u brix potenzjali.
English: After the application of 10 g EMLA for 10 minutes to vaginal mucosa, maximum plasma concentrations of lidocaine and prilocaine (mean 0.18 µg/mL and 0.15 µg/mL respectively) were reached after 20-45 minutes.
Maltese: Wara l-applikazzjoni ta' 10 g EMLA għal 10 minuti fil-mukuża tal-vaġina, il-konċentrazzjonijiet massimi fil-plażma ta' lidocaine u prilocaine (medja ta' 0.18 µg/mL u 0.15 µg/mL rispettivament) intlaħqu wara 20
English: Blood and lymphatic system disorders
Maltese: phosphate dehydrogenase deficiency'.
English: Up to 1 g and 10 cm2 for one hour4)
Maltese: Sa 1 g u 10 cm2 għal siegħa4)
English: EMLA should not be applied to an impaired tympanic membrane.
Maltese: EMLA ma għandux jiġi applikat għal membrana timpanika indebolita.
English: Feeling light-headed or dizzy.
Maltese: - Żomm dan il-fuljett.
English: The use of EMLA prior to measles-mumps-rubella or intramuscular diphtheria-pertussis-tetanusinactivated poliovirus-Haemophilus influenzae b or Hepatitis B vaccines did not affect mean antibody titres, rate of seroconversion, or the proportion of patients achieving protective or positive antibody titres post immunization, as compared to placebo treated patients.
Maltese: L-użu ta' EMLA qabel tilqima kontra l-ħosba-gattone-rubella jew tilqim intramuskolari tad-difteritepertussis-tetnu-vajrus inattivat tal-poljo Haemophilus influenzae b jew tilqim tal-Epatite B ma jaffettwax titri ta' antikorpi medji, ir-rata ta' serokonverżjoni, jew il-proporzjon ta' pazjenti li jiksbu antikorpi protettivi jew titri ta' antikorpi pożittivi wara l-immunizzazzjoni, meta mqabbel ma' pazjenti kkurati bi plaċebo.
English: Up to 2 g and 20 cm2 for one hour5)
Maltese: Sa 2 g u 20 cm2 għal siegħa5)
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 anesteżija dermali permezz tar-rilaxx ta' lidocaine u prilocaine mill-krema fis-saff epidermali u dermiku tal-ġilda u l-viċinanza ta' riċetturi tal-uġigħ dermali u t-truf tan-nervituri.
English: Minor procedures, e.g. needle insertion and surgical treatment of localised lesions.
Maltese: Proċeduri minuri, eż., inserzjoni tal-labra u kura kirurġika ta' leżjonijiet lokali.
English: A marked irritative reaction was seen after single ocular administration of a 50 mg/g lidocaine + prilocaine 1:1 (w/w) emulsion, in an animal study.
Maltese: Ġiet osservata reazzjoni irritanti evidenti wara għoti okulari unika ta' emulsjoni ta' 50 mg/g lidocaine +
English: The usual dose is 1.5 g to 2 g of cream for each of area of skin that is 10 cm2 (10 square centimetres) in size.
Maltese: - Id-doża normali hija 1.5 g sa 2 g ta' krema għal kull erja tal-ġilda li hija 10 cm2 (10 ċentimetri kwadri)
English: EMLA should not be used in children younger than 12 months of age who are being treated at the same time with other medicines that affect blood pigment levels “methaemoglobinaemia” (e.g. sulphonamides, see also Section 2 Other medicines and EMLA).
Maltese: EMLA ma għandux jintuża fi tfal iżgħar minn 12-il xahar li jkunu qegħdin jiġu kkurati fl-istess ħin b'mediċini oħrajn li jaffettwaw il-livelli ta' pigmenti fid-demm "metaemoglobinemija" (eż. sulfonamidi, ara wkoll is-Sezzjoni 2 Mediċini oħra u EMLA).
English: Application site paraesthesia2 such as tingling
Maltese: Paraesteżija fis-sit tal appliakzzjoni2 bħal tagħrix Sħana fis-sit tal applikazzjoni1
English: • in preterm newborn infants with a gestational age less than 37 weeks as they are at risk of developing increased methaemoglobin levels.
Maltese: • fi trabi tat-twelid qabel iż-żmien b'età ta' ġestazzjoni ta' inqas minn 37 ġimgħa minħabba li huma f'riskju li jiżviluppaw livelli miżjuda ta' metaemoglobina.
English: Dermal surgical procedures on larger areas in a hospital setting, e.g. split-skin grafting.
Maltese: Proċeduri kirurġiċi dermali fuq partijiet ikbar f'ambjent ta' sptar, eż. grafting ta' ġilda maqsuma.
English: EMLA should not be applied to the genital mucosa (e.g. in the vagina) of children (below 12 years of age) owing to insufficient data on absorption of active substances.
Maltese: EMLA m'għandux jiġi aplikat fuq mukoża ġenitali (eż. fil-vaġina) ta' tfal (taħt it-12-il sena) minħabba dejta insuffiċjenti dwar l-assorbiment tas-sustanzi attivi.
English: Renal impairment A dose reduction is not necessary among patients with restricted renal function.
Maltese: Tnaqqis ta' doża waħda mhuwiex neċessarju f'pazjenti b'funzjoni renali limitata.
English: 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: Sensittività eċċessiva għal lidocaine u/jew prilocaine jew anastetiċi lokali tat-tip amidi jew għal xi eċċipjenti elenkati f'sezzjoni 6.1.
English: Animal studies have shown no impairment of male or female fertility.
Maltese: Studji fl-annimali wrew li ma hemm ebda indeboliment ta' fertilità maskili jew femminili.
English: Application site erythema1, 2, 3
Maltese: Pallidità fis-sit talapplikazzjoni1, 2, 3
English: The active substances in EMLA (lidocaine and prilocaine) are excreted into breast milk.
Maltese: Is-sustanzi attivi f'EMLA (lidocaine u prilocaine) huma eliminati mill-ħalib tas-sider.
English: 1-2 g/10 cm2 for 60 minutes
Maltese: 1 g/10 cm2 għal 15-il minuta 1-2 g/10 cm2 għal 60 minuta
English: 1 Skin
Maltese: 1 Ġilda
English: Plasma concentrations after treatment with EMLA are 20-60% lower for prilocaine than for lidocaine, because of a larger volume of distribution and more rapid clearance.
Maltese: Il-konċentrazzjonijiet fil-plażma b'EMLA huma 20-60% aktar baxxi għal prilocaine milli għal lidocaine, minħabba volum akbar ta' distribuzzjoni u tneħħija aktar rapida.
English: Maximum plasma concentrations (mean 0.16 and 0.06 µg/mL) were reached after approximately 1.5-3 hours.
Maltese: Il-konċentrazzjonijiet massimi fil-plażma (medja ta' 0.16 u 0.06 µg/mL) intlaħqu madwar wara 1.5-3 sigħat.
English: In glucose-6-phosphate dehydrogenase deficient patients the antidote methylene blue is ineffective at methaemoglobin reduction, and is capable of oxidising haemoglobin itself, and therefore methylene blue therapy cannot be given.
Maltese: F'pazjenti li huma defiċjenti f'deidroġenażi glucose-6-phosphate l-antidotu methylene blu huwa ineffettiv fit-tnaqqis ta'
English: Prilocaine in high doses may cause an increase in methaemoglobin levels, particularly in susceptible individuals (section 4.4), with too frequent dosing in newborn infants and infants below 12 months of age (section 4.2) and in conjunction with methaemoglobin-inducing medicinal products (e.g. sulphonamides, nitrofuradantin, phenytoin and phenobarbital).
Maltese: b'dożaġġ frekwenti ħafna fi trabi li jkunu għadhom kif jitwieldu u trabi li għandhom anqas minn 12-il xahar ta' età (sezzjoni 4.2) u flimkien ma' prodotti mediċinali li jinduċu metemoglobina (eż. sulfonamidi,
English: 2 g (approx. half a 5 g tube) or approx. 1.5g/10 cm2 for 1 to 5 hours1).
Maltese: 2 g (madwar nofs tubu ta' 5 g) jew madwar 1.5g/10
English: The sum of the maximum plasma concentrations of lidocaine and prilocaine is less than one-third of those associated with toxic reactions, with no apparent accumulation over 10 days.
Maltese: It-total tal-konċentrazzjonijiet massimi fil-plażma ta' lidocaine u prilocaine huwa inqas minn terz ta' dawk assoċjati ma' reazzjonijiet tossiċi, mingħajr ebda akkumulu evidenti matul 10 ijiem.
English: Transient local skin reactions (paleness, redness, swelling) in the treated area during treatment of skin, genital mucosa or leg ulcers.
Maltese: - Reazzjonijiet tal-ġilda temporanji lokali (bjudija, ħmura, nefħa) fil-parti trattata waqt il-kura tal-ġilda, mukoża ġenitali jew ulċeri mas-saqajn.
English: The active substances are: lidocaine and prilocaine [To be completed nationally]
Maltese: lidocaine / prilocaine DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Neither local anaesthetic showed a genotoxic potential in either in vitro or in vivo genotoxicity tests.
Maltese: L-ebda wieħed mill-anestetiċi ma wera potenzjal ġenotossiku fit-testijiet ta' ġenotossiċità in vitro jew in vivo.