FrancophonIA/ELRC3.0 huggingface dataset:
English: Conduction disorders (atrioventricular block)
Maltese: Disturbi fil-konduzzjoni (blokk atrijoventrikulari)
English: Pharmacotherapeutic group: Nervous System/Anaesthetics/Local anaesthetics/Amides/Mepivacaine ATC code: N01 BB 03
Maltese: Sistema Nervuża/Anestetiċi/Anestetiċi lokali/Amidi/Mepivacaine Kodiċi ATC:
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
Maltese: IDENTIFIKATUR UNIKU - DEJTA TINQARA MILL-BNIEDEM PC: {numru}
English: Restlessness / agitation3
Maltese: Ansjetà/Nervożità3
English: CNS toxicity occurs gradually, with symptoms and reactions of progressively increasing severity.
Maltese: It-tossiċità fis-CNS tiġri b'mod progressiv, b'sintomi u reazzjonijiet ta' severità li tiżdied progressivament.
English: Dyspnoea2
Maltese: Dispnoea2
English: For poorly controlled epileptic patients, see section 4.3.
Maltese: Għal pazjenti epilettiċi kkontrollati ħażin, ara s-sezzjoni 4.3.
English: − restlessness, agitation;
Maltese: − irrekwitezza, aġitazzjoni;
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Jippermetti monitoraġġ kontinwu tal-bilanċ tal-benefiċċju/tar-riskju tal-prodott mediċinali.
English: This medicine contains 24.67 mg sodium per 10 ml (maximum recommended dose).
Maltese: Din il-mediċina fiha 24.67 mg ta' sodju kull 10 ml (id-doża massima rakkomandata).
English: − chills;
Maltese: − ngħas;
English: Mepivacaine binds to plasmatic proteins up to around 75% and can cross placental barrier by simple diffusion.
Maltese: Il-mepivacaine jingħaqad ma' proteini plasmatiċi sa madwar 75% u jista' jaqsam il-barriera tal-plaċenta permezz ta' diffużjoni sempliċi.
English: Limited data of overdose are available.
Maltese: Huwa disponibbli dejta limitata ta' doża eċċessiva.
English: Tachypnea
Maltese: Takipnea
English: Amaurosis (blindness) Mydriasis
Maltese: Amawrosi (għama)
English: Mepivacaine is metabolised primarily by CYP1A2 enzyme.
Maltese: Inibituri CYP1A2 Il-mepivacaine huwa primarjament metabolizzat mill-enżima CYP1A2.
English: 4.2 Posology and method of administration
Maltese: .2 Pożoloġija u metodu ta' amministrazzjoni
English: Mepivacaine hydrochloride
Maltese: Kloridrat tal-mepivacaine
English: - The active substance is mepivacaine hydrochloride 30 mg/ml; Each cartridge of 1.7 ml of solution for injection contains 51 mg of mepivacaine hydrochloride.
Maltese: - Is-sustanza attiva hi kloridrat tal-mepivacaine 30 mg/ml; Kull kartriġ ta' 1.7 ml ta' taħlita likwida għall-injezzjoni fih 51 mg ta' kloridrat tal-mepivacaine.
English: Mepivacaine maximum concentrations were reported to be between 0.4 - 1.2 µg/ml at around 30 minutes post-intraoral injection with one cartridge and between 0.95-1.70 µg/ml with two cartridges.
Maltese: Il-konċentrazzjonijiet massimi ta' mepivacaine kienu rrappurtati bejn 0.4 - 1.2 μg/ml f'madwar 30 minuta wara l-injezzjoni post intraorali b'kartriġ wieħed u bejn 0.95-1.70 μg/ml b'żewġ kartriġis.
English: - Hypotension.
Maltese: - Ipotenzjoni.
English: This medicinal product contains 24.67 mg sodium per 10 ml (maximum recommended dose), equivalent to 1.23 % of the WHO recommended maximum daily intake of 2g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 24.67 mg ta' sodju kull 10 ml (id-doża massima rakkomandata), ekwivalenti għal 1.23% tal-konsum massimu ta' kuljum irrakkomandat mill-WHO ta' 2g ta' sodju għal adult.
English: The average dosage is 0.75 mg/kg = 0.025 ml of mepivacaine solution per kg body weight: ~ ¼ cartridge (15 mg of mepivacaine hydrochloride) for a 20 kg child.
Maltese: Id-doża medja hija ta' 0.75 mg/kg = 0.025 ml ta' taħlita likwida ta' mepivacainegħal kull kg ta' piż tal-ġisem: ~ ¼ ta' kartriġ (15 mg ta' kloridrat ta' mepivacaine) għal tifel/tifla ta' 20 kg.
English: 5.2 Pharmacokinetic properties
Maltese: .2 Proprjetajiet farmakokinetiċi
English: Peak plasma levels of mepivacaine 30 mg/ml solution following peri-oral injections during dental usual procedures were determined in various clinical studies.
Maltese: Assorbiment L-ogħla livelli fil-plażma ta' taħlita likwida tal-mepivacaine ta' 30 mg/ml wara injezzjonijiet periorali waqt proċeduri tas-soltu dentali kienu determinati f'diversi studji kliniċi.
English: Tabulated list of adverse reactions The reported adverse effects come from spontaneous reporting and literature.
Maltese: L-effetti avversi rrapportati jiġu minn rapportar spontanju u l-letteratura.
English: In case of relative overdose, patients generally present symptoms within 1-3 minutes.
Maltese: F'każ ta' doża eċċessiva relattiva, il-pazjenti ġeneralment ikollhom sintomi f'1-3 minuti.
English: Each cartridge of 2.2 ml of solution for injection contains 66 mg of mepivacaine hydrochloride.
Maltese: Kull kartriġ ta' 2.2 ml ta' taħlita likwida għall-injezzjoni fih 66 mg ta' kloridrat tal-mepivacaine.
English: The maximum plasma level of mepivacaine is achieved approximately after 30-60 minutes.
Maltese: Il-livell massimu fil-plażma ta' mepivacaine jinkiseb madwar wara 30-60 minuta.
English: It should be carefully swabbed either with 70% ethyl alcohol or with 90% pure isopropyl alcohol for pharmaceutical use.
Maltese: Għandha tintmesaħ bir-reqqa b'70% ta' alkoħol etiliku jew b'90% ta' alkoħol isopropil pur għal użu farmaċewtiku.
English: − loss of consciousness, fit (convulsion), coma;
Maltese: − telf tas-sensi, attakki (konvulżjoni), koma;
English: Acidosis exacerbates the toxic effects of local anaesthetics.
Maltese: L-aċidożi żżid l-effetti tossiċi tal-anestetiċi lokali.
English: Frequency “not known”: “not known (cannot be estimated from the available data)”.
Maltese: Frekwenza “mhux magħrufa”: “mhux magħrufa (ma tistax tiġi stmata mid-dejta disponibbli)”.
English: Dysesthesia (oral and perioral), including dysgeusia (e.g., taste metallic, taste distorted), ageusia Dizziness (light headedness) Tremor3
Maltese: Disestesija (orali u periorali), inkluża disgeusija (eż. togħma metallika, distorsjoni ta' togħma), agewsija Sturdament (sturdament ħafif) Rogħda3
English: Cartridges of 1.7 ml or 2.2 ml.
Maltese: Kartriġis ta' 1.7 ml jew 2.2 ml.
English: Equivalent* in cartridge numbers (2.2 ml)
Maltese: kartriġis (2.2 ml)
English: 50 x 2.2 ml cartridges
Maltese: Kartriġis ta' 50 x 2.2 ml
English: Rash (eruption)
Maltese: Raxx (eruzzjoni) Eritema
English: Serious adverse experiences are generally systemic.
Maltese: Esperjenzi avversi serji huma ġeneralment sistemiċi.
English: CLINICAL PARTICULARS
Maltese: DETTALJI KLINIĊI
English: Equivalent* in cartridge numbers (1.7 ml)
Maltese: kartiriġis (1.7 ml)
English: However, the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.
Maltese: Madankollu, in-nuqqas ta' demm fis-siringa ma jiggarantix li l-injezzjoni intravaskulari tkun ġiet evitata.
English: How to store X
Maltese: X'fih X
English: − yawning;
Maltese: − titwib;
English: As all amide-type local anaesthetics, mepivacaine is largely metabolised in the liver by microsomal enzymes (cytochrome P450 1A2 (CYP1A2)).
Maltese: Bħal l-anestetiċi lokali kollha ta' amide, il-mepivacaine huwa fil-biċċa l-kbira metabolizzat fil-fwied minn enżimi mikrosomali (ċitokromu P450 1A2 (CYP1A2)).
English: The data on this effect remains controversial (see Sections 4.4 and 5.1).
Maltese: Id-dejta dwar dan l-effett tibqa' kontroversjali (ara s-sezzjonijiet 4.4 u 5.1).
English: Visual impairment Vision blurred
Maltese: Indeboliment viżiv Vista mċajpra
English: [To be completed nationally]
Maltese: [Timtela nazzjonalment]
English: This medicine is given as an injection in the oral cavity.
Maltese: Din il-mediċina tingħata bħala injezzjoni fil-kavità orali.
English: − drowsiness;
Maltese: palpitazzjoni;
English: 1 laryngo-pharyngeal oedema may characteristically occur with hoarseness and/or dysphagia; 2 bronchospasm (bronchoconstriction) may characteristically occur with dyspnoea; 3 several adverse events, like agitation, anxiety / nervousness tremor, speech disorder may be warning signs before CNS depression.
Maltese: 2 bronkospażmu (bronkokonstrizzjoni) jista' jseħħ b'mod karatteristiku bid-dispnea; 3 bosta avvenimenti avversi, bħal aġitazzjoni, ansjetà / rogħda nervuża, disturb fid-diskors jistgħu jkunu sinjali ta' twissija qabel id-dipressjoni tas-CNS.
English: − confusion, disorientation;
Maltese: − konfużjoni, diżorjentament;
English: Hypotension (with possible circulatory collapse)
Maltese: Ipotensjoni (bil-kollass ċirkolatorju possibbli)
English: Common Headache Rare
Maltese: Rari ħafna Ipertensjoni Mhux
English: Several factors such as pH of tissue, pKa, lipid solubility, local anaesthetic concentration, diffusion in the nerve of local anaesthetic, etc., may influence the onset and the duration of the local anaesthetic.
Maltese: Diversi fatturi bħal pH tat-tessut, pKa, is-solubbiltà tal-lipidi, il-konċentrazzjoni anestetika lokali, id-diffużjoni fin-nerv ta' anestetiku lokali, eċċ. jistgħu jinfluwenzaw il-bidu u t-tul tal-anestetiku lokali.
English: Dysphonia (Hoarseness1)
Maltese: Disfonija (Ħanqa1)
English: Toxic effects are dose-dependent, comprising progressively more severe neurological manifestations, followed by vascular, respiratory and finally cardiovascular signs such as hypotension, bradycardia, arrhythmia and cardiac arrest
Maltese: L-effetti tossiċi huma dipendenti fuq id-doża, b'manifestazzjonijiet newroloġiċi progressivi, segwiti minn sinjali vaskulari, respiratorji u finalment kardjovaskulari bħall-ipotensjoni, bradikardja, arritmija u arrest kardijaku.
English: If sedative medication is administered, the maximum safe dose of mepivacaine may be reduced due to an additive effect of the combination on central nervous system depression (see section 4.5).
Maltese: Jekk tingħata mediċina sedattiva, id-doża massima sigura ta' mepivacaine tista' titnaqqas minħabba effett addittiv tat-taħlita tad-depressjoni tas-sistema nervuża ċentrali (ara s-sezzjoni 4.5).
English: It contains the active substance mepivacaine hydrochloride and belongs to the group of nervous system anaesthetics.
Maltese: Fih is-sustanza attiva kloridrat tal-mepivacaine u jappartjeni għall-grupp ta' anestetiċi tas-sistema nervuża.
English: Inhibitors of this cytochrome (e.g. ciprofloxacin, enoxacin, fluvoxamine) may decrease its metabolism, increase the risk of adverse effects and contribute to prolonged or toxic blood levels.
Maltese: iċ-ciprofloxacin, l-enoxacin, il-fluvoxamine) jistgħu jnaqqsu l-metaboliżmu tiegħu, iżidu r-riskju ta' effetti avversi u jikkontribwixxu għal-livelli ta' demm prolongati jew tossiċi.
English: This is equivalent to 1.23 % of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 1.23% tad-doża rakkomandata ta' kuljum ta' sodju għal adult.
English: Convulsion (including tonic-clonic seizure)
Maltese: Konvulżjoni (inkluża aċċessjoni tonika klonika) Presinkope, sinkope;
English: For adults, the maximum recommended dose is of 4.4 mg/kg of body weight with an absolute maximum recommended dose of 300 mg for the individuals above 70 kg of body weight corresponding to 10 ml of solution.
Maltese: Għall-adulti, id-doża massima rakkomandata hija ta' 4.4 mg/kg ta' piż tal-ġisem b'doża massima assoluta ta' 300 mg għal individwi 'l fuq minn 70 kg ta' piż tal-ġisem li jikkorrispondu għal 10 ml ta' taħlita f'likwidu.
English: Antiarrhythmic drugs
Maltese: Mediċini antiarritmiċi
English: Tell your dentist if you are taking, have recently taken or might take any other medicines, particularly: - other local anaesthetics; - medicines used to treat heartburn and ulcers of the stomach and intestines (such as cimetidine); - tranquilizing and sedative medicines; - medicines used to stabilize heartbeat (antiarrythmics); - Cytochrom P450 1A2 inhibitors; - medicines used to treat hypertension (propranolol).
Maltese: - anestetiċi lokali oħra; - mediċini użati biex jittrattaw il-ħruq ta' stonku u ulċeri tal-istonku u l-intestini (bħal cimetidine); - mediċini li jittrankwilizzaw u sedattivi; - mediċini użati biex jistabbilizzaw it-taħbit tal-qalb (antiarritmiċi); - Inibituri ċitokromu P450 1A2;
English: Each cartridge of 1.7 ml of solution for injection contains 51 mg of mepivacaine hydrochloride.
Maltese: Kull kartriġ ta' 1.7 ml ta' taħlita likwida għall-injezzjoni fih 51 mg ta' kloridrat tal-mepivacaine.
English: Given this fact, inhibitors of P450 isoenzymes may decrease its metabolism and increase the risk of adverse effects (see section 4.5.).
Maltese: jistgħu jnaqqsu l-metaboliżmu tiegħu u jżidu r-riskju ta' effetti avversi (ara s-sezzjoni 4.5).
English: Hypoxaemia and metabolic acidosis may potentiate the cardiovascular toxicity.
Maltese: L-ipossiemja u l-aċidożi metabolika jistgħu jżidu t-tossiċità kardjovaskulari.
English: Seizures may last from a few seconds to several minutes and rapidly lead to hypoxia and hypercapnia, as a result of increased muscular activity and insufficient ventilation.
Maltese: L-aċċessjonijiet jistgħu jdumu minn ftit sekondi għal diversi minuti u jwasslu malajr f'ipossija u iperkapnja, bħala riżultat ta' żieda fl-attività muskolari u ventilazzjoni insuffiċjenti.
English: The plasma elimination half-life is 2 hours for adults.
Maltese: Il-half life tal-eliminazzjoni tal-plażma hija ta' sagħtejn għall-adulti.
English: Risk associated with an accidental intravascular injection Accidental intravascular injection (e.g.: inadvertent intravenous injection into the systemic circulation, inadvertent intravenous or intra-arterial injection in the head area and neck area) may be associated with severe adverse reactions, such as convulsions, followed by central nervous system or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest, due to the sudden high level of mepivacaine in the systemic circulation.
Maltese: Injezzjoni aċċidentali intravaskulari (eż: injezzjoni intravenuża bi żball fiċ-ċirkolazzjoni sistemika, injezzjoni intravenuża jew intra-arterjali bi żball fil-żona tar-ras u żona tal-għonq) jistgħu jiġu assoċjati ma' reazzjonijiet avversi severi, bħal konvulsjonijiet, segwita minn dipressjoni tas-sistema nervuża ċentrali jew kardjorespiratorja u koma, li jwassal fl-aħħar għal waqfien respiratorju, minħabba l-livell għoli f'daqqa ta' mepivacaine fl-ċirkulazzjoni sistemika.
English: These plasmatic concentrations are well below the threshold of CNS and CVS toxicity, respectively 10 to 25 fold lower.
Maltese: Dawn il-konċentrazzjonijiet plasmatiċi huma taħt il-limitu tat-tossiċità tas-CNS u s-CVS, rispettivament 10 sa 25 darbiet aktar baxxi.
English: Risk associated with intraneural injection
Maltese: Ir-riskju assoċjat ma' injezzjoni intranewrali
English: • Children below 4 years of age (ca. 20 kg body weight),
Maltese: • Tfal taħt l-4 snin (ca. 20 kg piż tal-ġisem),
English: 4.1 Therapeutic indications {Scandonest and associated names (see Annex I) strength pharmaceutical form} is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental surgery in adults, adolescents and children above 4 years of age (c.a.
Maltese: {Scandonest u ismijiet assoċjati (ara l-Anness I) is-saħħa tal-forma farmaċewtika} huwa anestetiku lokali indikat għall-anestesija lokali u anestesija lokoreġjonali fil-kirurġija dentali f'adulti, adolexxenti u tfal ta'
English: Mepivacaine reversibly inhibits the conduction of nerve impulses by decreasing or blocking sodium (Na+) flow during propagation of the nerve action potential.
Maltese: Il-mepivacaine jinibixxi b'mod riversibbli l-konduzzjoni ta' impulsi tan-nervituri billi jnaqqas jew jimblokka l-fluss tas-sodju (Na +) waqt il-propagazzjoni tal-potenzjal ta' azzjoni tan-nervituri.
English: X contains sodium
Maltese: Jekk tingħata aktar X milli suppost
English: Accidental intraneural injection may lead the drug to move in retrograde manner along the nerve.
Maltese: Injezzjoni intranewrali tista' twassal biex il-mediċina timxi b'mod retrogressiv tul in-nerv.
English: − impaired sense of balance (disequilibrium);
Maltese: − sens imdgħajjef ta' bilanċ (skwilibriju);
English: Undesirable toxic effects may appear at plasma concentrations upper than 5 mg/l, and convulsions could appear with 10 mg/l or higher.
Maltese: Effetti tossiċi mhux mixtieqa jistgħu jseħħu b'konċentrazzjonijiet fil-plażma ikbar minn 5 mg/l, u konvulżjonijiet jistgħu jidhru b'10 mg/l jew ogħla.
English: Paediatric population {Scandonest and associated names} is contraindicated in children below 4 years of age (ca. 20 kg body weight) (see section 4.3).
Maltese: {Scandonest u ismijiet assoċjati} hija kkontraindikata fi tfal taħt l-4 snin (ca. 20 kg piż tal-ġisem) (ara s sezzjoni 4.3).
English: • Hypersensitivity to the active substance (or any local anaesthetics agent of the amide type) or to any of the excipients listed in section 6.1,
Maltese: • Sensittività eċċessiva għas-sustanza attiva (jew kwalunkwe aġent anestesiku lokali ieħor tat-tip amide) jew għal kwalunkwe eċċipjent elenkat fis-sezzjoni 6.1,
English: Anaphylatic / anaphylactoid reactions Angioedema (Face / tongue / lip / throat / larynx1 / periorbital oedema) Bronchospasm / asthma2
Maltese: Reazzjonijiet anafilattiċi/anafilattojdi Anġjoedema (Wiċċ/ilsien/xoffa/gerżuma
English: − vision blurred, problems clearly focusing an object, visual impairment;
Maltese: − vista mċajpra, problemi biex tiffuka b'mod ċar fuq oġġett, indeboliment tal-vista;
English: Not Known Ear discomfort Tinnitus
Maltese: Skumdità fil-widnejn Tinnitus
English: No relevant data reported any toxic effects on fertility in animals with mepivacaine.
Maltese: L-ebda dejta rilevanti ma rrappurtat effetti tossiċi fil-fertilità fl-annimali bil-mepivacaine.
English: Elimination can be accelerated by acidifying the urine (See section 4.9).
Maltese: L-eliminazzjoni tista' tiġi aċċellerata billi tiġi aċidifikata l-awrina (Ara s-sezzjoni 4.9).
English: − heartbeat coordination problems (conduction disorders, atrioventricular block), abnormal slow heartbeat (bradycardia), abnormal rapid heartbeat (tachycardia), palpitations;
Maltese: − problemi ta' kordinazzjoni tat-taħbit tal-qalb (disturbi tal-konduzzjoni, blokk atrioventrikulari), taħbit tal-qalb bil-mod anormali (bradikardija), taħbit tal-qalb mgħaġġel anormali (takikardija),
English: Whereas in case of absolute overdose, signs of toxicity, depending on the injection site, appear about 20-30 minutes after the injection.
Maltese: F'każ ta' doża eċċessiva assoluta, sinjali ta' tossiċità, skont is-sit tal-injezzjoni, jidhru madwar 20-30 minuta wara linjezzjoni.
English: These include inadvertent intravascular injection or abnormal rapid absorption into the systemic circulation, or delayed metabolism and elimination of the product.
Maltese: Dawn jinkludu injezzjoni intravaskulari involontarja jew assorbiment rapidu anormali fiċ-ċirkolazzjoni sistemika, jew il-metaboliżmu mdewwem u l-eliminazzjoni tal-prodott.
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted.>
Maltese: <Ġustifikazzjoni biex ma jkunx inkluż il-Braille aċċettata.>
English: Swelling face
Maltese: Ż-ŻGĦAR EWLENIN
English: Sodium chloride, sodium hydroxide (for pH-adjustment),water for injection.
Maltese: Klorur tas-sodju, idrossidu tas-sodju (għal aġġustament tal-pH), ilma għall-injezzjoni.
English: Increased serum levels of amide anaesthetics have also been reported after concomitant administration of cimetidine, which is probably due to the inhibitory effect of cimetidine on CYP1A2.
Maltese: Żieda fil-livelli tas-seru ta' anestetiċi amide kienu rrappurtati wkoll wara l-għoti fl-istess ħin tas-cimetidine, li probabbilment huwa dovut għall-effett inibitorju tas-cimetidine fuq CYP1A2.
English: 4 neural pathologies that may occur with the various symptoms of abnormal sensations (i.e., paresthesia,
Maltese: 4 patoloġiji newrali li jistgħu jseħħu bis-sintomi varji ta' sensazzjonijiet anormali (jiġifieri, parestesija,
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 mill-awtoritajiet kompetenti tal-Istati Membri, flimkien mal-Istat Membru ta' referenza, kif ikun xieraq, skont il-proċeduri stabbiliti fil-Kapitolu 4 tatTitolu III tad-Direttiva 2001/83/KE.
English: Possible side effects (frequency cannot be estimated from the available data):
Maltese: Effetti sekondarji possibbli (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli):
English: Rare side effects (may affect up to 1 in 1,000 people):
Maltese: Rari Effetti sekondarji (jista' jaffettwa sa 1 minn kull 1,000 persuna):
English: If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasopressor, and/or inotropic agents should be considered.
Maltese: Jekk isseħħ depressjoni kardjovaskulari (ipotensjoni, bradikardja), għandu jiġi kkunsidrat trattament xieraq bi fluwidi intravenużi, vasopressur, u/jew aġenti inotropiċi.
English: Caution is advised when associating the product of interest with these medications as dizziness may last longer (see section 4.7.
Maltese: Għandha tingħata attenzjoni meta tassoċja l prodott ta' interess ma' dawn il-mediċini billi l-isturdament jista' jdum iktar (ara s-sezzjoni 4.7.).
English: Reporting of side effects
Maltese: − korriment tan-nervituri Rapportar ta' effetti sekondarji
English: MedDRA Sytem Organ Class Frequency Adverse reactions Immune system disorders
Maltese: Klassi ta' Organu tas-Sistema MedDRA
English: Accommodation disorder Not known Horner's syndrome Eyelid ptosis
Maltese: Sindromu ta' Horner Ptosi tal-kappell tal-għajn Enoftalmos
English: 5 mostly in patients with underlying cardiac disease or those receiving certain drugs; 6 in predisposed patients or those with risk factors of ischemic heart disease; 7 hypoxia and hypercapnia are secondary to respiratory depression and / or to seizures and sustained muscular exertion; 8 by accidental biting or chewing of the lips or tongue while the anaesthesia persists.
Maltese: 7 ipossija u iperkapnija huma sekondarji għad-depressjoni respiratorja u / jew għal aċċessjonijiet u sforz muskolari sostnut; 8 gdim aċċidentali jew magħad tax-xufftejn jew l-ilsien waqt li tippersisti l-anestesija.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains 30 mg of mepivacaine hydrochloride.
Maltese: 1 ml taħlita likwida għall-injezzjoni fih 30 mg ta' kloridrat tal-mepivacaine.
English: Cardiovascular symptoms occur at plasma levels exceeding those inducing CNS toxicity and are therefore generally preceded by signs of CNS toxicity, unless the patient is under general anaesthesia or is heavily sedated (e.g. by a benzodiazepine or barbiturate).
Maltese: Is-sintomi kardjovaskulari jseħħu f'livelli ta' plażma ogħla minn dawk li jinduċu t-tossiċità tas-CNS u għalhekk huma ġeneralment preċeduti minn sinjali ta' tossiċità tas-CNS, sakemm il-pazjent ma jkunx taħt anestesija ġenerali jew huwa taħt sedazzjoni qawwija (eż. b'benzodiazepine jew barbiturate).
English: Elderly patients: Dosages should be reduced in elderly patients (due to lack of clinical data).
Maltese: Id-dożi għandhom jitnaqqsu f'pazjenti anzjani (minħabba nuqqas ta' dejta klinika).
English: No relevant reproductive and development toxicity study demonstrated teratogenic effects with mepivacaine.
Maltese: L-ebda studju relevanti dwar it-tossiċità għar-riproduzzjoni u l-iżvilupp ma wera effetti teratoġeniċi mill mepivacaine.
English: Not known Hypoxia7 (including cerebral) Hypercapnia7
Maltese: Ipossija 7 (inkluż ċerebrali)
English: If there is any risk of an allergic reaction, choose different medicine for anaesthesia (see Section 4.3).
Maltese: Jekk hemm xi riskju ta' reazzjoni allerġika, agħżel mediċina differenti għall-anestesija (ara t-Taqsima 4.3).
English: Balance disorder (disequilibrium) Somnolence
Maltese: Irrekwitezza/aġitazzjoni3 Disturb tal-bilanċ (skwilibriju)
English: − altered voice (hoarseness);
Maltese: − sturdament (mejt);
English: The marketed presentation is cartridges of 1.7 ml or 2.2 ml contained in box of 50 cartridges.
Maltese: Il-preżentazzjoni kkummerċjalizzata hija kartriġis ta' 1.7 ml jew 2.2 ml li jinsabu f'kaxxa ta' 50 kartriġ.
English: Posology
Maltese: KARTUN