FrancophonIA/ELRC3.0 huggingface dataset:
English: 3 PHARMACEUTICAL FORM Solution for injection.
Maltese: 3 GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni.
English: Enophthalmos
Maltese: Enoftalmos
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: Risk associated with accidental intravascular injection:
Maltese: Ir-riskju assoċjat ma' injezzjoni aċċidentali intravaskulari:
English: Neuralgia (neuropathic pain) Hypoesthesia / numbness (oral and perioral) 4
Maltese: Newralġija (uġigħ newropatiku) Ipoesteżija / tirżiħ (orali u periorali)4
English: At supratherapeutic doses, articaine has cardiodepressant properties and can exert vasodilatory effects.
Maltese: F'dożi sovraterapewtiċi, articaine għandu proprjetajiet kardjodepressanti u jista' jeżerċita effetti vasodilatatorji.
English: Nervous system disorders, local injection site reaction, hypersensitivity, cardiac disorders and vascular disorders are the most frequently occurring adverse reactions.
Maltese: Disturbi fis-sistema nervuża, reazzjoni fis-sit tal-injezzjoni lokali, sensittività eċċessiva, disturbi fil-qalb u disturbi vaskulari huma r-reazzjonijiet avversi l-aktar frekwenti.
English: Angioedema (face / tongue / lip / throat / larynx / periorbital oedema) Urticaria
Maltese: Anġjoedema (edema fil-wiċċ / fl ilsien / fix-xofftejn / fil-griżmejn /
English: Toxicity of local anaesthetics is additive.
Maltese: It-tossiċità tal-anestetiċi lokali toħloq effett ta' dipendenza.
English: • hoarseness
Maltese: • urtikarja
English: • tricyclic antidepressants used to treat depression (such as amitriptyline, desipramine, imipramine,
Maltese: Antidepressanti triċikliċi (TCAs, tricyclic antidepressants) (eż., amitriptyline, desipramine,
English: Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of {(Invented) name and associated names (see Annex I)} (see Section 4.8 of SmPC).
Maltese: Sturdament (inkluż mejt, disturb fil-vista u għeja) jista' jseħħ wara l-għoti ta' {Isem (ivvintat) u ismijiet assoċjati (ara Anness I)} (ara sezzjoni 4.8 tal-SmPC).
English: o 1 ml of Y contains 40 mg of articaine hydrochloride and 10 micrograms of adrenaline (as adrenaline tartrate).
Maltese: o 1 ml ta' Y fih 40 mg ta' articaine hydrochloride u 10 mikrogrammi ta' adrenaline (bħala adrenaline tartrate).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per cartridge, i.e. it is considered as essentially “sodium free”.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) kull skartoċċ, jiġifieri huwa meqjus essenzjalment “ħieles mis-sodium”.
English: Hyperacusis Tinnitus4
Maltese: Nervi / ansjetà4
English: 4 Several adverse events, like agitation, anxiety / nervousness, tremor, speech disorder may be warning signs before CNS depression.
Maltese: Diversi avvenimenti avversi, bħal aġitazzjoni, ansjetà / nervi, rogħda, disturb fit-taħdit jistgħu jkunu sinjali ta' twissija li jseħħu qabel depressjoni ta' CNS.
English: • other local anaesthetics, medicines that cause reversible loss of sensation (including volatile anaesthetics such as halothane);
Maltese: • anestetiċi lokali oħrajn, mediċini li jikkawżaw telf riversibbli tas-sensazzjoni (inklużi anestetiċi volatili bħal halothane);
English: • lock-jaw
Maltese: • xedaq imblokkat (lock-jaw)
English: Local and loco-regional anaesthesia in dental procedures.
Maltese: Anesteżija lokali u lokoreġjonali fi proċeduri dentali.
English: Sodium chloride, disodium edetate, sodium metabisulfite (E223), sodium hydroxide, water for injections.
Maltese: Sodium chloride, disodium edetate, sodium metabisulfite (E223), sodium hydroxide, ilma għallinjezzjonijiet.
English: Neuropathy:
Maltese: Newropatija:
English: • articaine, a local anaesthetic which prevents pain, and
Maltese: • articaine, anestetiku lokali li jipprevjeni l-uġigħ, u
English: The maximum safe dose of local anaesthetics may be reduced in sedated patients due to an additive effect on central nervous system depression (see section 4.5).
Maltese: Id-doża massima sigura ta' anestetiċi lokali tista' tiġi mnaqqsa f'pazjenti li jkun ngħataw sedattiv minħabba l-effett ta' dipendenza fuq id-depressjoni tas-sistema nervuża ċentrali (ara sezzjoni 4.5).
English: • Concomitant treatment with tricyclic antidepressants, as these active substances can intensify the cardiovascular effects of adrenaline.
Maltese: • Trattament fl-istess ħin b'antidepressanti triċikliċi, billi dawn is-sustanzi attivi jistgħu jintensifikaw l-effetti kardjovaskulari tal-adrenaline.
English: • X is usually used for simple and short dental procedures
Maltese: • X normalment jintuża għal proċeduri dentali sempliċi u qosra
English: o 1 ml of X contains 40 mg of articaine hydrochloride and 5 micrograms of adrenaline (as adrenaline tartrate).
Maltese: o 1 ml ta' X fih 40 mg ta' articaine hydrochloride u 5 mikrogrammi ta' adrenaline (bħala adrenaline tartrate).
English: Uncommon side effects: may affect up to 1 in 100 people:
Maltese: Effetti sekondarji mhux komuni: jistgħu jaffettwaw sa persuna waħda minn kull 100:
English: • Sodium metabisulfite: it may rarely cause severe allergic reactions and breathing difficulties
Maltese: • Sodium metabisulfite: rarament dan jikkawża reazzjonijiet allerġiċi severi u diffikultajiet biex tieħu nifs (bronkospażmu).
English: Adverse reactions following administration of articaine / adrenaline are similar to those observed with other local amide anaesthetics / vasoconstrictors.
Maltese: Reazzjonijiet avversi wara l-għoti ta' articaine / adrenaline huma simili għal dawk osservati b'anestetiċi / vasokostritturi lokali bl-amide oħra.
English: • taking some medicines for blood pressure called beta blockers, such as propranolol.
Maltese: • tieħu xi mediċini għall-pressjoni tad-demm imsejħa imblokkaturi beta, bħal propranolol.
English: (bronchospasm).
Maltese: (anġjoedema)
English: • Hypotension
Maltese: • Ipotensjoni
English: Bronchospasm / asthma Dyspnoea2
Maltese: Bronkospażmu / ażżma
English: Posology
Maltese: Kartuna
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 tat-Titolu III tad-Direttiva 2001/83/KE.
English: MedDRA Sytem
Maltese: Twissijiet u prekawzjonijiet
English: Elevated product plasma levels may occur in patients with cholinesterase deficiency or under acetylcholinesterase inhibitors treatment since the product is inactivated at 90% by plasmatic esterases, see section 4.4 and 5.2.
Maltese: Żieda fil-livelli tal-prodott fil-plażma tista' sseħħ f'pazjenti li għandhom nuqqas ta' cholinesterase jew li qed jingħataw trattament b'inibituri ta' acetylcholinesterase billi l-prodott jiġi inattivat b'90% minn esterases tal-plażma, ara sezzjonijiet 4.4 u 5.2.
English: • COMT-inhibitors to treat Parkinson's disease (such as entacapone or tolcapone);
Maltese: • inibituri ta' COMT użati biex jittrattaw il-marda ta' Parkinson (bħal entacapone jew tolcapone);
English: • Hypersensitivity to articaine (or any local anaesthetic agent of the amide type), to adrenaline or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għal articaine (jew għal kwalunkwe aġent anestetiku lokali tal-amide), għal adrenaline jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Vascular disorders Common
Maltese: Disturbi vaskulari
English: Symptoms of overdose include severe weakness, paleness of the skin, headache, feeling agitated or restless, feeling disorientated, losing your balance, involuntary trembling or quivering, dilation of the pupil, blurred vision, problems clearly focusing an object, speech disorders, dizziness, convulsions, stupor, loss of consciousness, coma, yawning, abnormally slow or rapid breathing which could lead to temporarily stopping breathing, failure of the heart to contract effectively (called cardiac arrest).
Maltese: Sintomi ta' doża eċċessiva jinkludu debbulizza severa, ġilda pallida, uġigħ ta' ras, tħossok aġitat jew fuq ix-xwiek, tħossok diżorjentat, titlef il-bilanċ, rogħda jew ċaqliq involontarju, dilatazzjoni tal-pupilla, vista mċajpra, problemi biex tiffoka sew fuq oġġett, problemi bit-taħdit, sturdament, konvulżjonijiet, skantament, tintilef minn sensik, koma, tittewweb, nifs bil-mod jew mgħaġġel b'mod anormali li jista' jwassal li tieqaf tieħu n-nifs għal ftit ħin, il-muskoli tal-qalb ma jikkuntrattawx sew (imsejjaħ attakk tal-qalb).
English: • use other local anaesthetics, medicines that cause reversible loss of sensation (including volatile anaesthetics such as halothane);
Maltese: • tuża anestetiċi lokali oħrajn, mediċini li jikkawżaw telf riversibbli tas-sensazzjoni (inklużi anestetiċi volatili bħal halothane);
English: Psychiatric disorders Rare
Maltese: Mhux komuni Ipertensjoni Rari
English: Treatment of overdose
Maltese: TAL-PRODOTT MEDIĊINALI
English: Contradictory findings were raised from in-vitro and in-vivo genotoxicity studies with adrenaline.
Maltese: Kien hemm sejbiet kontradittorji minn studji in vitro u in vivo dwar it-tossiċità fuq il-ġeni b'adrenaline.
English: What you need to know before you are given X / Y 3.
Maltese: X'għandek tkun taf qabel ma tingħata X / Y 3.
English: • medicines used to treat irregular heartbeats (for example digitalis, quinidine);
Maltese: • mediċini użati biex jittrattaw taħbit tal-qalb irregolari (pereżempju digitalis, quinidine);
English: • Patients with cardiovascular diseases (e.g. heart failure, coronary heart disease, history of myocardial infarction, cardiac arrhythmia, hypertension)
Maltese: • Pazjenti b'mard kardjovaskulari (eż. insuffiċjenza tal-qalb, mard koronarju tal-qalb, storja ta' infart mijokardijaku, arritmija tal-qalb, ipertensjoni)
English: • facial nerve disorder (facial palsy)
Maltese: • nervi, ansjetà • disturbi fin-nervituri tal-wiċċ (paraliżi tal-wiċċ)
English: A plasma cholinesterase deficiency can be suspected when clinical signs of overdose occurs with usual dosage of anesthesia and when a vascular injection has been excluded.
Maltese: Nuqqas ta' cholinesterase fil-plażma jista' jkun suspettat meta jseħħu sinjali kliniċi ta' doża eċċessiva bid-dożaġġ normali ta' anesteżija u meta tkun ġiet eskluża injezzjoni vaskulari.
English: The maximum articaine dose of 500 mg corresponds to a healthy adult of more than 70 kg body weight.
Maltese: Id-doża massima ta' articaine ta' 500 mg tikkorrispondi għal adult f'saħħtu li għandu piż tal-ġisem ta' aktar minn 70 kg.
English: In children aged 4 years (or from 20 kg (44 lbs) of body weight) and above, the maximum dose of articaine is 7 mg/kg only with an absolute maximum dose of 385 mg articaine for a healthy child of 55 kg body weight.
Maltese: Fit-tfal minn età ta' 4 snin (jew li għandhom piż tal-ġisem minn 20 kg (44 lbs)) u ikbar, id-doża massima ta' articaine hija ta' 7 mg/kg biss b'doża massima assoluta ta' 385 mg articaine għal tifel/tifla f'saħħithom b'piż tal-ġisem ta' 55 kg.
English: Paresthesia3 (persistent hypoesthesia and gustatory loss) after mandibular or inferior alveolar nerve blocks
Maltese: (ipoesteżija u telf tassens tat-togħma persistenti) wara lużu ta' imblokk tan-nervituri mandibulari jew alveolari inferjuri
English: Ageusia
Maltese: Mijosi
English: Articaine is additionally metabolised in the liver microsomes.
Maltese: Articaine jiġi wkoll metabolizzat fil-mikrożomi tal-fwied.
English: Dysgeusia (e.g., taste metallic, taste disturbance)
Maltese: Disgewżja (eż., togħma metallika, disturb fis-sens tat togħma) Agewżja
English: • have uncontrolled diabetes;
Maltese: • għandek dijabete mhux ikkontrollata;
English: • fatigue, weakness
Maltese: • għeja, debbulizza
English: Very little articaine was detected in plasma from 12 to 24 hours following injection.
Maltese: Ftit li xejn articaine ma nstab fil-plażma minn 12 sa 24 siegħa wara l-injezzjoni.
English: Elderly patients:
Maltese: Kategorija farmakoterapewtika:
English: • involuntary eye movement
Maltese: • moviment involontarju tal-għajnejn
English: • double vision, temporary blindness
Maltese: • tara doppju, għama temporanja
English: • low blood pressure;
Maltese: • pressjoni baxxa;
English: • MAO inhibitors used to treat depressive or anxiety disorders (such as moclobemide, phenelzine,
Maltese: • inibituri ta' MAO użati biex jittrattaw disturbi depressivi jew tal-ansjetà (bħal moclobemide,
English: If there is any risk of an allergic reaction, choose a different medicine for anesthesia (see section 4.3).
Maltese: Jekk hemm ir-riskju ta' kwalunkwe reazzjoni allerġika, agħżel mediċina differenti għall-anesteżija (ara sezzjoni 4.3).
English: Animal studies with articaine 40 mg/ml + adrenaline 10 micrograms/ml, as well as with articaine alone, have not shown adverse effects on pregnancy, embryonal/foetal development, birth or postnatal development (see section 5.3).
Maltese: Studji f'annimali b'articaine 40 mg/ml + adrenaline 10 mikrogrammi/ml, kif ukoll b'articaine waħdu, ma wrewx effetti avversi fuq it-tqala, l-iżvilupp tal-embriju/fetu, it-twelid jew l-iżvilupp wara t-twelid (ara sezzjoni 5.3).
English: Single use cylindrical class I glass cartridge sealed at its base by a mobile rubber plunger and at the top by a rubber seal kept in place by an aluminium cap.
Maltese: Ossiġenazzjoni u għajnuna ventilatorja u ċirkolatorja ottimali kif ukoll it-trattament ta' aċidożi jistgħu jipprevjenu attakk tal-qalb.
English: Uncommon Burning sensation Rare
Maltese: jkollhom sensazzjoni normali.
English: Discussion with the anaesthetist before local anaesthetic administration during general anaesthesia is recommended.
Maltese: Huwa rakkomandat li dan jiġi diskuss mal-anestetista qabel ma jingħata l-anestetiku lokali matul anesteżija ġenerali.
English: There is the danger of a hypertensive crisis (very high blood pressure) or severe slowing of the pulse (see section other medicines);
Maltese: Hemm il-periklu ta' kriżi ipertensiva (pressjoni tad-demm għolja ħafna) jew tnaqqis sinifikanti tal-polz (ara s-sezzjoni mediċini oħra);
English: 1 NAME OF THE MEDICINAL PRODUCT
Maltese: 1 ISEM
English: This medicine is given by a slow injection in the oral cavity.
Maltese: Din il-mediċina tingħata permezz ta' injezzjoni bil-mod fil-kavità orali.
English: Breast-feeding can be resumed after 5 hours following anaesthesia.
Maltese: Tista' terġa tibda tredda' wara 5 sigħat wara l-anesteżija.
English: Articaine, a local amide anaesthetic, reversibly blocks nerve conduction through a well-known mechanism commonly observed with other local amide anaesthetics.
Maltese: Articaine, anestetiku lokali bl-amide, jimblokka b'mod riversibbli l-konduzzjoni tan-nervituri permezz ta' mekkaniżmu magħruf sew osservat komunement b'anestetiċi lokali oħra bl-amide.
English: For most routine dental procedures, it is preferable to use {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml.
Maltese: Għall-biċċa l-kbira tal-proċeduri dentali ta' rutina, huwa preferibbli l-użu ta' {Isem (ivvintat) u ismijiet assoċjati (ara Anness I)} 40 mg/ml + 5 mikrogrammi/ml.
English: 6.3 Shelf-life
Maltese: 6 TAGĦRIF
English: Due to articaine:
Maltese: Distribuzzjoni:
English: Pack of 4 boxes containing glass cartridges 50 x 1.7 ml.
Maltese: Pakkett ta' 4 kaxxi li fihom 50 x 1.7 ml skartoċċ tal-ħġieġ.
English: Hot flush
Maltese: Żieda fis-smigħ
English: In attendance of these signs, patients should be requested to hyperventilate and surveillance should be instituted (see Section 4.9 of SmPC).
Maltese: - Li jkollok tagħmir għar-resuxxitazzjoni disponibbli (ara sezzjoni 4.9)
English: Adrenaline is a vasoconstrictor added to articaine to slow down absorption into the systemic circulation and thus prolong maintenance of active articaine tissue concentration.The volume of distribution in plasma was about 4 l/kg.
Maltese: L-adrenaline hija vasokostrittur li tiġi miżjuda ma' articaine biex tnaqqas ir-rata ta' assorbiment fiċċirkolazzjoni sistemika u b'hekk iddewwem iż-żamma tal-konċentrazzjoni ta' articaine attiva fit tessut.
English: Reduced doses of this medicinal product should be used due to sensitization of the heart to the arrhythmogenic effects of catecholamines: risk of severe ventricular arrhythmia.
Maltese: Għandhom jintużaw dożi mnaqqsa ta' dan il-prodott mediċinali minħabba s-sensitizzazzjoni tal-qalb għall-effetti arritmoġeniċi ta' catecholamines: riskju ta' arritmija ventrikulari severa.
English: • severe heart rhythm disorders (e.g. second and third-degree AV block);
Maltese: • disturbi severi fir-ritmu tal-qalb (eż. imblokk AV tat-tieni u tat-tielet grad);
English: The use of {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection over {(Invented) name and associated names (see Annex I)} 40 mg/ ml + 10 micrograms/ml, solution for injection should be considered on account of its lower adrenaline content of 5 micrograms/ml in:
Maltese: L-użu ta' {Isem (ivvintat) u ismijiet assoċjati (ara Anness I)} 40 mg/ml + 5 mikrogrammi/ml, soluzzjoni għall-injezzjoni minflok {Isem (ivvintat) u ismijiet assoċjati (ara Anness I)} 40 mg/ml + 10 mikrogrammi/ml, soluzzjoni għall-injezzjoni għandu jiġi kkunsidrat minħabba l-kontenut aktar baxx tiegħu ta' adrenaline ta' 5 mikrogrammi/ml fi:
English: Risk associated with intraneural injection:
Maltese: Ir-riskju assoċjat ma' injezzjoni intravaskulari aċċidentali:
English: Accidental intravascular injection may cause sudden high levels of adrenaline and articaine in the systemic circulation.
Maltese: Injezzjoni aċċidentali intravaskulari tista' tikkawża livelli għoljin f'daqqa ta' adrenaline u articaine fiċċirkolazzjoni sistemika.
English: NAME OF THE MEDICINAL PRODUCT {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml, solution for injection articaine hydrochloride/adrenaline
Maltese: {Isem (Ivvintat) u ismijiet assoċjati (Ara Anness I)} 40 mg/ml + 10 mikrogrammi/ml, soluzzjoni għall-injezzjoni articaine hydrochloride/adrenaline
English: As a result of the rapid drop in serum levels and rapid elimination, clinically relevant quantities of articaine are not found in breast milk.
Maltese: Bħala riżultat tat-tnaqqis rapidu fil-livelli fis-serum u l-eliminazzjoni rapida, ma nstabux kwantitajiet klinikament sinifikanti ta' articaine fil-ħalib tas-sider.
English: The lowest dose providing effective dental anaesthesia should be used.
Maltese: Għandha tintuża l-aktar doża baxxa li tipprovdi anesteżija dentali effettiva.
English: NAME OF THE MEDICINAL PRODUCT {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection articaine hydrochloride/adrenaline
Maltese: {Isem (Ivvintat) u ismijiet assoċjati (Ara Anness I)} 40 mg/ml + 5 mikrogrammi/ml, soluzzjoni għallinjezzjoni articaine hydrochloride/adrenaline
English: Not known Local / Regional hyperaemia Vasodilatation
Maltese: Mhux magħruf Iperemija lokali / reġjonali
English: o Each cartridge of 1.7-ml of solution for injection of Y contains 68 mg of articaine hydrochloride and 17 micrograms of adrenaline (as adrenaline tartrate).
Maltese: o Kull skartoċċ ta' 1.7 ml ta' soluzzjoni għall-injezzjoni ta' Y fih 68 mg ta' articaine hydrochloride u 17-il mikrogramma ta' adrenaline (bħala adrenaline tartrate).
English: • lacking of a natural chemical substance called cholinesterase in your blood (plasma cholinesterase deficiency);
Maltese: • nuqqas ta' sustanza kimika naturali msejħa cholinesterase fid-demm tiegħek (defiċjenza ta'
English: • Patients with uncontrolled hypertension
Maltese: • Pazjenti b'ipertensjoni mhux ikkontrollata
English: At the discretion of the dentist, more cartridges may be required for more extensive procedures without exceeding the maximum recommended dose.
Maltese: Fid-diskrezzjoni tad-dentist, jistgħu jkunu meħtieġa diversi skrataċ għal proċeduri aktar estensivi mingħajr ma tinqabeż id-doża massima rakkomandata.
English: Interactions requiring precautions for use:
Maltese: Effikaċja klinika u sigurtà:
English: Allergic1, anaphylactic / anaphylactoid reactions
Maltese: Reazzjonijiet allerġiċi1, anafilattiċi /
English: Pack of 8 boxes containing glass cartridges 50 x 1.7 ml.
Maltese: Pakkett ta' 8 kaxxi li fihom 50 x 1.7 ml skartoċċ tal-ħġieġ.
English: Uncommon Neck pain Rare
Maltese: Disturbi fl-għajnejn Rari
English: X / Y is used to numb (anaesthetise) your oral cavity during dental procedures.
Maltese: X / Y jintuża biex iraqqad (janestesizza) il-kavità orali tiegħek matul proċeduri dentali.
English: Gingival / oral mucosal exfoliation (sloughing) / ulceration Not known Dysphagia Swelling of cheeks Glossodynia
Maltese: Tqaxxir (ġilda li tinqala') / ulċerazzjoni tal-mukuża tal-ħanek /
English: o Each cartridge of 1.7-ml of solution for injection of X contains 68 mg of articaine hydrochloride and 8.5 micrograms of adrenaline (as adrenaline tartrate).
Maltese: o Kull skartoċċ ta' 1.7 ml ta' soluzzjoni għall-injezzjoni ta' X fih 68 mg ta' articaine hydrochloride u 8.5 mikrogrammi ta' adrenaline (bħala adrenaline tartrate).
English: Postganglionic adrenergic blocking agents (e.g., guanadrel, guanethidine, and rauwolfia alkaloids): Reduced doses of this medicinal product should be used under strict medical supervision with careful aspiration due to possible increase response to adrenergic vasoconstrictors: risk of hypertension and other cardiovascular effects.
Maltese: Għandhom jintużaw dożi mnaqqsa ta' dan il-prodott mediċinali taħt superviżjoni medika stretta b'aspirazzjoni bir-reqqa minħabba l-possibbiltà ta' żieda fir-rispons għall-vaskostritturi adrenerġiċi: riskju ta' ipertensjoni u effetti oħra kardjovaskulari.
English: 8 MARKETING AUTHORISATION NUMBER [To be completed nationally]
Maltese: 8 NUMRU TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Maltese: 9 DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI
English: Absorption: In three published clinical studies describing the pharmacokinetic profile of the combination articaine hydrochloride 40 mg/ml with adrenaline 10 or 5 micrograms/ml, Tmax values were between 10 and 12 minutes, with Cmax values ranging from 400 to 2100 ng/ml.
Maltese: Fi tliet studji kliniċi ppubblikati li jiddeskrivu l-profil farmakokinetiku tal kombinazzjoni ta' articaine hydrochloride 40 mg/ml ma' adrenaline 10 jew 5 mikrogrammi/ml, ilvaluri
English: • neuropathic pain - pain due to nerve damage
Maltese: • uġigħ newropatiku - uġigħ minħabba ħsara fin-nervituri
English: • abnormal rapid heartbeats;
Maltese: • taħbit tal-qalb mgħaġġel anormali;
English: Adrenaline and articaine cross the placental barrier, although articaine does so to a lesser extent than other local anaesthetics.
Maltese: Adrenaline u articaine jgħaddu mill-barriera tal-plaċenta, għalkemm articaine jagħmel dan sa livell inqas minn anestetiċi lokali oħra.
English: • abnormal slow heartbeat
Maltese: • diffikultà biex tibla'
English: Reproductive toxicity studies conducted with articaine 40 mg/ml + adrenaline 10 micrograms/ml administered by the subcutaneous route at doses up to 80 mg/kg/day revealed no adverse effects on fertility, embryonal/foetal development, or pre- and postnatal development.
Maltese: 10 mikrogrammi/ml mogħtija taħt il-ġilda f'dożi sa 80 mg/kg/jum ma żvelaw l-ebda effett avvers fuq il-fertilità, l-iżvilupp tal-embriju/fetu jew l-iżvilupp ta' qabel u wara t-twelid.
English: • Cardiac impulse formation and conduction disturbances (e.g. 2nd or 3rd degree atrioventricular block,
Maltese: • Disturbi fl-impulsi u l-konduzzjoni tal-qalb (eż. imblokk atrijoventrikulari tat-tieni jew tat-tielet grad, bradikardija sinifikanti)
English: Breastfeeding
Maltese: Paresteżija
English: Local anaesthetics should be injected with caution when there is inflammation and/or infection at the site of the injection.
Maltese: L-effett tal-anestetiku lokali jista' jitnaqqas meta dan il-prodott mediċinali jiġi injettat f'parti infjammata jew infettata.