FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose and duration of the substitution therapy depends on the severity of the factor IX deficiency, on the location and extent of the bleeding, and on the patient's clinical condition, age and pharmacokinetic parameters of factor IX, such as incremental recovery and half-life.
Maltese: Id-doża u t-tul tat-terapija ta' sostituzzjoni jiddependu fuq is-severità tad-defiċjenza ta' fattur IX, fuq il-post u l-firxa tal-ħruġ ta' demm, u fuq il-kundizzjoni klinika u l-età tal-pazjent u l-parametri farmakokinetiċi ta' fattur IX, bħal irkuprar inkrementali u l-halflife.
English: Catheter-related complications
Maltese: Kumplikazzjonijiet relatati tal-kateter
English: Clinical studies with RIXUBIS included 99 subjects with at least one exposure to RIXUBIS reporting in total 5 adverse reactions.
Maltese: Studji kliniċi b'RIXUBIS kienu jinkludu 99 individwu li kellhom mill-inqas esponiment wieħed għal RIXUBIS u b'kollox irrappurtaw total ta' 5 reazzjonijiet avversi.
English: Solvent Sterilised water for injections
Maltese: Ilma sterilizzat għall-injezzjonijiet.
English: 1 vial: 3000 IU nonacog gamma, approx. 600 IU/ml after reconstitution with 5 ml solvent.
Maltese: 3000 IU nonacog gamma, madwar 600
English: Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton.
Maltese: RIXUBIS fih il-fattur IX tal-koagulazzjoni tad-demm rikombinanti (nonacog gamma). Fattur IX hu glikoproteina ta' katina waħda b'massa molekulari ta' madwar 68,000 Dalton.
English: RIXUBIS 500 IU powder and solvent for solution for injection One vial contains nominally 500 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 100 IU/ml after reconstitution with 5 ml solvent.
Maltese: IU ta' nonacog gamma, fattur IX tal-koagulazzjoni umana rikombinanti (rDNA), li jikkorrispondu għal konċentrazzjoni ta' 100 IU/ml wara r-rikostituzzjoni b'5 ml ta' solvent.
English: After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.8 to 7.2.
Maltese: Wara r-rikostituzzjoni, is-soluzzjoni tkun ċara, bla kulur, bla frak u jkollha pH ta' 6.8 sa 7.2.
English: All subjects had severe (factor IX level <1%) or moderately severe (factor IX level ≤2%) haemophilia B. Fifty-nine PTPs received RIXUBIS for prophylaxis.
Maltese: L-individwi kollha kellhom emofilija B (livell ta' fattur IX ta' <1%) jew moderatament severa (livell ta' fattur IX ta' ≤2%).
English: Pharmacokinetic parameters for evaluable subjects (per-protocol analysis) are presented in the table below.
Maltese: Il-parametri farmakokinetiċi għal individwi li setgħu jiġu evalwati (analiżi skont il-protokoll) huma ppreżentati fit-tabella hawn taħt.
English: See tables below.
Maltese: Ara t-tabelli ta' hawn taħt.
English: RIXUBIS 2000 IU powder and solvent for solution for injection One vial contains nominally 2000 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 400 IU/ml after reconstitution with 5 ml solvent.
Maltese: IU ta' nonacog gamma, fattur IX tal-koagulazzjoni umana rikombinanti (rDNA), li jikkorrispondu għal konċentrazzjoni ta' 400 IU/ml wara r-rikostituzzjoni b'5 ml ta' solvent.
English: RIXUBIS 3000 IU powder and solvent for solution for injection nonacog gamma (recombinant human coagulation factor IX)
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni nonacog gamma (fattur IX tal-koagulazzjoni umana rikombinanti)
English: RIXUBIS is used for the treatment and prevention of bleeding in patients with haemophilia B of all age groups.
Maltese: RIXUBIS jintuża għall-kura u l-prevenzjoni ta' ħruġ ta' demm f'pazjenti b'emofilija B tal-gruppi kollha ta' età.
English: A randomised, blinded, controlled, crossover pharmacokinetic study of RIXUBIS and a comparator was conducted in non-bleeding male subjects (≥15 years of age) as part of the combined phase 1/3 pivotal study.
Maltese: Studju li fih il-parteċipanti ntgħażlu b'mod każwali, blinded, ikkontrollat, tat-tip crossover, dwar RIXUBIS u komparatur twettaq f'individwi rġiel bla ħruġ ta' demm (li kellhom ≥15-il sena) bħala parti minn studju kombinat importanti ħafna ta' fażi 1/3.
English: • one vial of 5 ml sterilised water for injections in a glass vial with a rubber stopper
Maltese: • kunjett wieħed ta' 5 ml ilma sterilizzat għall-injezzjonijiet f'kunjett tal-ħġieġ b'tapp tal-lastku
English: The calculation of the required dose of factor IX is based on the empirical finding that 1 International Unit factor IX per kg body weight raises the plasma factor IX activity by 0.7 IU/dL (range from 0.31 to 1.0 IU/dL) or 0.7% of normal activity in patients less than 12 years of age (further information see section 5.2).
Maltese: IU/dL) jew 0.7% tal-attività normali f'pazjenti li jkollhom inqas minn 12-il sena (għal aktar informazzjoni ara sezzjoni 5.2).
English: Date of first authorisation: 19 December 2014 Date of latest renewal: DD month YYYY
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19 Diċembru 2014
English: Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor IX in plasma).
Maltese: L-attività ta' Fattur IX fil-plażma hi espressa jew bħala perċentwali (imqabbla mal-plażma umana normali) jew f'Unitajiet Internazzjonali (imqabbla mal-Istandard Internazzjonali għal fattur IX fil-plażma).
English: Elderly
Maltese: Solvent
English: RIXUBIS was administered by bolus infusions.
Maltese: RIXUBIS ingħata permezz ta' infużjonijiet bolus.
English: Hypersensitivity Allergic type reactions have been manifested by dyspnoea, pruritus, generalised urticaria and rash.
Maltese: Sensittività eċċessiva Reazzjonijiet tat-tip allerġiku dehru bħala qtugħ ta' nifs, ħakk, urtikarja ġeneralizzata u raxx.
English: RIXUBIS 500 IU powder for injection nonacog gamma
Maltese: IU trab għal soluzzjoni għall-injezzjoni nonacog gamma
English: RIXUBIS 250 IU powder and solvent for solution for injection One vial contains nominally 250 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 50 IU/ml after reconstitution with 5 ml solvent.
Maltese: IU ta' nonacog gamma, fattur IX tal-koagulazzjoni umana rikombinanti (rDNA), li jikkorrispondu għal konċentrazzjoni ta' 200 IU/ml wara r-rikostituzzjoni b'5 ml ta' solvent.
English: No investigations on carcinogenicity, fertility impairment, and fetal development have been conducted.
Maltese: Ma twettqu l-ebda investigazzjonijiet dwar il-karċinoġeniċità, indeboliment fil-fertilità, u l-iżvilupp fetali.
English: It is a vitamin K-dependent coagulation factor and it is synthesised in the liver.
Maltese: L-effetti ta' dożi ogħla mid-dożi rakkomandati ta' RIXUBIS ma ġewx ikkaratterizzati.
English: Nine subjects (39.1%) experienced zero bleeds.
Maltese: Disa' individwi (39.1%) ma kellhom l-ebda ħruġ ta' demm.
English: Haemostatic efficacy at resolution of a bleed was rated excellent or good in 96.2% of all treated bleeding episodes.
Maltese: L-effikaċja emostatika fil-fejqan tal-ħruġ ta' demm ġiet ikklassifikata bħala eċċellenti jew tajba f'96.2% tal-episodji kollha kkurati ta' ħruġ ta' demm.
English: The calculation of the required dose of factor IX is based on the empirical finding that 1 International Unit (IU) factor IX per kg body weight raises the plasma factor IX activity by 0.7 IU/dL (range from 0.31 to 1.0 IU/dL) or 0.7% of normal activity in patients less than 12 years of age (further information see section 5.2).
Maltese: Il-kalkolu tad-doża meħtieġa ta' fattur IX hu bbażat fuq is-sejba empirika li Unità Internazzjonali (IU) waħda ta' fattur IX għal kull kg ta' piż tal-ġisem, iżżid l-attività ta' fattur IX fil-plażma 0.7 IU/dL (medda minn 0.31 sa 1.0
English: Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries.
Maltese: Pazjenti individwali jistgħu jvarjaw fir-rispons tagħhom għal fattur IX, u juru half-lives u rkupri differenti.
English: The product contains traces of hamster proteins.
Maltese: Il-prodott fih traċċi ta' proteini tal-ħamster.
English: • epilepsy;
Maltese: • epilessija;
English: Frequency Adverse Reactions
Maltese: Frekwenza Reazzjonijiet Avversi
English: (see section 4.5)
Maltese: (ara sezzjoni 4.5)
English: SN: {number} <NN: {number} >
Maltese: {numru} SN:
English: Adults and adolescents (12 to 18 years of age)
Maltese: Adulti u adolexxenti (età minn 12 sa 18-il sena)
English: Adrenaline exhibits sympathomimetic effects.
Maltese: L-adrenaline turi effetti simpatomimetiċi.
English: • absolute overdose,
Maltese: • doża eċċessiva assoluta,
English: 4.8 Undesirable effects a) Summary of the safety profile
Maltese: .8 Effetti mhux mixtieqa a) Sommarju tal-profil tas-sigurtà
English: (tricyclic antidepressants).
Maltese: (antidepressanti triċikliċi).
English: Ptosis
Maltese: Ptosi
English: Bradycardia Tachycardia
Maltese: Bradikardija Takikardija
English: Dose of adrenaline (mg)
Maltese: adrenaline (mg)
English: X / Y contains sodium and sodium metabisulfite.
Maltese: X / Y fih is-sodium u sodium metabisulfite.
English: Maximum dose of articaine hydrochloride (mg)
Maltese: Doża massima ta' articaine hydrochloride (mg)
English: • muscle twitch, involuntary muscle contraction
Maltese: • tiġbid tal-muskoli, kontrazzjoni involontarja tal-muskoli
English: The frequencies classification follows the convention: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), and very rare (<1/10,000)
Maltese: 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), u rari ħafna (<1/10,000)
English: The safety profile was similar in children and adolescents from 4 to 18 years old compared to adults.
Maltese: Il-profil tas-sigurtà kien simili fit-tfal u fl-adolexxenti f'età minn 4 sa 18-il sena meta mqabbla mal adulti.
English: Diplopia (paralysis of oculomotor muscles)4
Maltese: Viżjoni doppja (paraliżi tal-muskoli okulomotorji)4
English: (7.0 cartridges)
Maltese: (7.0 skrataċ)
English: Serious adverse reactions are generally systemic.
Maltese: Reazzjonijiet avversi serji ġeneralment ikunu sistemiċi.
English: There is a risk of adrenergic toxicity.
Maltese: Hemm ir-risku ta' tossiċità adrenerġika.
English: The reported adverse reactions come from spontaneous reporting, clinical studies and literature.
Maltese: Ir-reazzjonijiet avversi rrapportati jiġu minn rapportar spontanju, studji kliniċi u letteratura.
English: d) Paediatric population
Maltese: d) Popolazzjoni pedjatrika
English: b) Tabulated list of adverse reactions
Maltese: b) Lista f'tabella ta' reazzjonijiet avversi
English: Sedatives (central nervous system depressants e.g. benzodiazepine, opioids):
Maltese: Sedattivi (depressanti tas-sistema nervuża ċentrali eż. benzodiazepine, opjojdi):
English: Visual impairment (temporary blindness)4
Maltese: Indeboliment tal-vista (għama temporanja)4
English: Ergot-type oxytocic drugs (e.g., methysergide, ergotamine, ergonovine):
Maltese: Mediċini ossitoċiki bl-ergot (eż., methysergide, ergotamine, ergonovine):
English: Pharmacotherapeutic group: Nervous System / Local Anaesthetics / Anaesthetics, local / Amides / Articaine, combinations
Maltese: Sistema Nervuża / Anestetiċi Lokali / Anestetiċi, lokali / Amides /
English: Halogenated volatile anaesthetics (e.g., halothane):
Maltese: Anestetiċi volatili aloġenati (eż., halothane):
English: nortriptyline, maprotiline and protriptyline);
Maltese: imipramine, nortriptyline, maprotiline u protriptyline);
English: (5.2 cartridges)
Maltese: (5.2 skrataċ)
English: • worsening of the neuromuscular symptoms in Kearns-Sayre syndrome
Maltese: • aggravar tas-sintomi newromuskulari fis-sindrome ta' Kearns-Sayre
English: ● Children (4 to 11 years of age)
Maltese: ● Tfal (età minn 4 sa 11-il sena)
English: Distribution: High protein binding of articaine was observed with human serum albumin (68.5-80.8%), and ∝/β-globulins (62.5-73.4%).
Maltese: (68.5-80.8%), u ∝/β-globulins (62.5-73.4%).
English: • sympathomimetic vasopressors (such as cocaine, amphetamines, phenylephrine, pseudoephedrine,
Maltese: • vasopressuri simpatomimetiċi (bħal kokaina, amfetamini, phenylephrine, pseudoephedrine,
English: Binding to γ-globulin (8.6-23.7%) was much lower.
Maltese: L-irbit ma' γ-globulin (8.6-23.7%) kien ferm aktar baxx.
English: Other medicines and X / Y
Maltese: Mediċini oħra u X / Y
English: Non-selective beta-adrenergic blockers (e.g., propranolol, nadolol):
Maltese: Imblokkaturi beta-adrenerġiċi mhux selettivi (eż., propranolol, nadolol):
English: The pKa of articaine has been estimated at 7.8.
Maltese: Il-pKa ta' articaine kienet stmata għal 7.8.
English: {(Invented) name and associated names (see Annex I)} contains 0.804 mg sodium per 1 ml of solution i.e. 1.44 mg/1.7 ml.
Maltese: {Isem (Ivvintat) u ismijiet assoċjati (ara Anness I)} fih 0.804 mg sodium kull 1 ml ta' soluzzjoni, jiġifieri 1.44 mg/1.7 ml.
English: What X / Y contains - The active substances are articaine hydrochloride and adrenaline tartrate.
Maltese: X'fih X / Y - Is-sustanzi attivi huma articaine hydrochloride u adrenaline tartrate.
English: • Patients with recent (3 months) coronary artery bypass surgery
Maltese: • Pazjenti li reċentement (3 xhur) kellhom kirurġija ta' bypass tal-arterji koronarji
English: Children (4 to 11 years of age)
Maltese: Tfal (età minn 4 sa 11-il sena)
English: • Patients taking non-cardioselective beta-blockers (e.g. propranolol) (risk of hypertensive crisis or severe bradycardia), (see section 4.5)
Maltese: • Pazjenti li qed jieħdu imblokkaturi beta mhux kardjoselettivi (eż. propranolol) (riskju ta' kriżi ipertensiva jew bradikardija severa), (ara sezzjoni 4.5)
English: Interactions with adrenaline
Maltese: Interazzjonijiet ma' adrenaline
English: (6.2 cartridges)
Maltese: (6.2 skrataċ)
English: • heart and blood pressure medicines (such as guanadrel, guanethidine, propranolol, nadolol,)
Maltese: • mediċini tal-qalb u tal-pressjoni (bħal guanadrel, guanethidine, propranolol, nadolol,)
English: The anaesthetic duration of articaine 40 mg/mL with adrenaline 1: 200 000 is of 45 to 60 minutes for pulpal anaesthesia and 120 to 300 minutes for soft tissue anaesthesia.
Maltese: Id-dewmien anestitiku ta' articaine 40 mg/mL b'adrenaline 1: 200 000 huwa ta' 45 sa 60 minuta għal anesteżija pulpali u 120 sa 300 minuta għal anesteżija fit-tessuti rotob.
English: (4.1 cartridges)
Maltese: (4.1 skrataċ)
English: The anaesthetic duration of articaine 40 mg/mL with adrenaline 1: 100 000 is of 60 to 75 minutes for pulpal anaesthesia and 180 to 360 minutes for soft tissue anaesthesia.
Maltese: Id-dewmien anestetiku ta' 40 mg/mL b'adrenaline 1: 100 000 huwa ta' 60 sa 75 minuta għall anesteżija pulpali u 180 sa 360 minuta għal anesteżija fit-tessuti rotob.
English: • are more than 70 years old.
Maltese: • għandek aktar minn 70 sena.
English: Total volume (ml) and equivalent in number of cartridges (1.7 ml)
Maltese: Volum totali (ml) u l ekwivalenti f'għadd ta' skrataċ (1.7 ml)
English: Adrenaline, as vasoconstrictor, acts directly on both α- and β-adrenergic receptors; β-adrenergic effects predominate.
Maltese: Adrenaline, bħala vaskostrittur, taġixxi direttament fuq ir-riċetturi α- u β-adrenerġiċi; l-effetti β adrenerġiċi jiddominaw.
English: Acidosis exacerbates the toxic effects of local anaesthetics.
Maltese: L-aċidożi taggrava l-effetti tossiċi tal-anestetiċi lokali.
English: In clinical trials performed in children, Cmax was 1382 ng/ml and Tmax 7.78 min following infiltration of a dose of 2 mg/kg body weight.
Maltese: Fi provi kliniċi li twettqu fit-tfal, is-Cmax kienet ta' 1382 ng/ml u Tmax ta' 7.78 min wara infiltrazzjoni ta' doża ta' 2 mg/kg ta' piż tal-ġisem.
English: Animal studies with articaine 40 mg/ml + adrenaline 10 micrograms/ml have not shown effects on fertility (see section 5.3).
Maltese: Studji f'annimali b'articaine 40 mg/ml + adrenaline 10 mikrogrammi/ml ma wrewx effetti fuq il fertilità (ara sezzjoni 5.3).
English: 50 x 1.7 ml cartridges 50 x 1.7 ml cartridges, selfaspirating 4 (50 x 1.7 ml) cartridges 8 (50 x 1.7 ml) cartridges
Maltese: 4 (50 x 1.7 ml) skartoċċ 8 (50 x 1.7 ml) skartoċċ
English: 5 PHARMACOLOGICAL PROPERTIES
Maltese: 5 PROPRJETAJIET FARMAKOLOĠIĊI 5
English: Rare side effects: may affect up to 1 in 1,000 people:
Maltese: Effetti sekondarji rari: jistgħu jaffettwaw sa persuna waħda minn kull 1,000:
English: The rate of injection should be very slow (1 ml/min).
Maltese: Ir-rata ta' injezzjoni għandha tkun bil-mod ħafna (1 ml/min).
English: The average effective dose of articaine is 2 mg/kg and 4 mg/kg for simple and complex procedures, respectively.
Maltese: Id-doża medja effettiva ta' articaine hija ta' 2 mg/kg u 4 mg/kg għal proċeduri sempliċi u kumplessi, rispettivament.
English: Within 24 hours, approximately 57% (68 mg) and 53% (204 mg) of the dose was eliminated in the urine.
Maltese: Fi żmien 24 siegħa, madwar 57% (68 mg) u 53% (204 mg)
English: The symptoms are dose-dependent and have progressive severity in the realm of neurological manifestations (presyncope, syncope, headache, restlessness, agitation, confusional state, disorientation, dizziness (lightheadedness), tremor, stupor, deep CNS depression, loss of consciousness, coma, convulsion (including tonic-clonic seizure), speech disorder (e.g., dysarthria, logorrhea), vertigo, balance disorder (disequilibrium)), eyes manifestations (mydriasis, vision blurred, accommodation disorder) followed by vascular (pallor (local, regional, general)), respiratory (apnoea (respiratory arrest), bradypnoea, tachypnoea, yawning, respiratory depression) and finally cardiac (cardiac arrest, myocardial depression) toxicity.
Maltese: Is-sintomi jiddependu mid-doża u għandhom severità progressiva fil-qasam tal-manifestazzjonijiet newroloġiċi (presinkope, sinkope, uġigħ ta' ras, irrekwitezza, aġitazzjoni, stat konfużjonali, sturdament (tħossok se tistordi), rogħda, skantament, depressjoni qawwija ta' CNS, telf tas-sensi, koma, konvulżjoni (inkluż puplesija tonika-klonika), disturb fit-taħdit (eż., disartrija, logorrea), mejt, disturbi fil-bilanċ (żbilanċ)), manifestazzjonijiet fl-għajnejn (midrijasi, vista mċajpra, disturbi filfokus) segwiti minn tossiċità vaskulari (sfurija (lokali, reġjonali, ġenerali)), respiratorja (apnea
English: Allodynia
Maltese: Allodinija
English: Hyperesthesia
Maltese: Termoiperesteżija
English: 3 These neural pathologies may occur with various symptoms of abnormal sensations.
Maltese: 3 Dawn il-patoloġiji newtrali jistgħu jseħħu b'diversi sintomi ta' sensazzjonijiet anormali.
English: • problems with your kidneys;
Maltese: • problemi bil-kliewi;
English: Not known Conduction disorders (atrioventricular block)
Maltese: Mhux magħruf Disturbi fil-konduzzjoni (imblokk atrijoventrikulari)
English: • headache
Maltese: • sirdat
English: Excipients with known effect: sodium metabisulfite (E223), sodium chloride, disodium edetate, sodium hydroxide.
Maltese: Eċċipjenti b'effett magħruf: sodium metabisulfite (E223), sodium chloride, disodium edetate, sodium hydroxide.
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 jiggarantixxix li l-injezzjoni intravaskulari tkun ġiet evitata.
English: Swelling of tongue, lip, gums Uncommon Stomatitis, glossitis Nausea, vomiting, diarrhoea
Maltese: Mhux komuni Stomatite, glossite Nawsja, rimettar, dijarea
English: This medicinal product contains sodium metabisulfite, a sulfite that may rarely cause hypersensitivity reactions and bronchospasm.
Maltese: Dan il-prodott mediċinali fih sodium metabisulfite, sulfit li rarament jista' jikkawża reazzjonijiet ta' sensittività eċċessiva u bronkospażmu.
English: • wheezing (bronchospasm), asthma
Maltese: • tħarħir (bronkospażmu), ażżma
English: X / Y with food
Maltese: X / Y ma' ikel
English: • neuroleptic drugs (for example phenothiazines).
Maltese: • mediċini newrolettiċi (pereżempju phenothiazines).
English: • medicines used for migraine attacks (such as methysergide or ergotamine);
Maltese: • mediċini użati għall-attakki tal-emigranja (bħal methysergide jew ergotamine);
English: • heartbeat coordination problems (conduction disorders, atrioventricular block)
Maltese: • problemi bil-koordinazzjoni tat-taħbit tal-qalb (disturbi fil-konduzzjoni, imblokk atrijoventrikolari)
English: Not known Dysphonia (Hoarseness)1
Maltese: Mhux magħruf Disfonija (Ħanqa)1
English: Uncommon Rash (eruption) Pruritus
Maltese: Mhux komuni Raxx (eruzzjoni)
English: More than 50% of the dose was eliminated in the urine, 95% as articainic acid, within 8 hours of administration.
Maltese: Aktar minn 50% tad-doża kienet eliminata fl-awrina, 95% bħala articainic acid, fi żmien 8 sigħat mill-għoti.
English: • allergy to other local anaesthetics;
Maltese: • allerġija għal anestetiċi lokali oħrajn;
English: Renal elimination of unchanged articaine accounted for only about 2% of total elimination.
Maltese: L-eliminazzjoni mill-kliewi ta' articaine mhux mibdul kienet tammonta biss għal madwar 2% tal-eliminazzjoni totali.
English: Other local anaesthetics
Maltese: Anestetiċi lokali oħra
English: The symptoms are dose-dependent and have progressive severity in the realm of neurological manifestations (restlessness, agitation, presyncope, syncope) followed by vascular (pallor (local, regional, general)), respiratory (apnoea (respiratory arrest), bradypnoea, tachypnoea, respiratory depression) and finally cardiac (cardiac arrest, myocardial depression) toxicity.
Maltese: Is-sintomi jiddependu mid-doża u għandhom severità progressiva fil-qasam tal-manifestazzjonijiet newroloġiċi (irrekwitezza, aġitazzjoni, presinkope, sinkope) segwiti minn tossiċità vaskulari (sfurija (lokali, reġjonali, ġenerali)), respiratorja (apnea (waqfien tan-nifs), bradipnea, takipnea, depressjoni respiratorja) u fl-aħħar nett tal-qalb (attakk ta' qalb, depressjoni mijokardijaka).
English: Muscle twitching4
Maltese: Moviment involontarju tal-muskoli4
English: • Sodium: less than 23 mg sodium per cartridge, meaning it is essentially "sodium free".
Maltese: • Sodium: inqas minn 23 mg sodju kull skartoċċ, li jfisser li huwa essenzjalment “ħieles mis sodium”.
English: Phenothiazines (and other neuroleptics):
Maltese: Phenothiazines (u mediċini newrolettiċi oħra):
English: In adults and adolescents, the maximum articaine dose is 7 mg/kg with an absolute maximum articaine dose of 500 mg.
Maltese: Fl-adulti u l-adolexxenti, id-doża massima ta' articaine hija ta' 7 mg/kg b'doża massima assoluta ta' articaine ta' 500 mg.
English: Not known Aggravation of the neuromuscular manifestations in Kearns-Sayre syndrome Trismus
Maltese: Mhux magħruf Aggravar tal-manifestazzjonijiet newromuskolari fis-sindrome ta' Kearns-Sayre
English: MAO inhibitors (both A-selective (e.g. moclobemide) and non-selective (e.g. phenelzine, tranylcypromine, linezolide) :
Maltese: Inibituri ta' MAO (kemm A-selective (eż. moclobemide) kif ukoll mhux selettivi (eż. phenelzine,
English: No difference was observed in pharmacodynamic properties between the adult and the paediatric population.
Maltese: Ma kienet osservata l-ebda differenza fil-proprjetajiet farmakodinamiċi bejn il-popolazzjoni tal-adulti u dik pedjatrika.
English: Infiltration and perineural use in oral cavity.
Maltese: Użu għall-infiltrazzjoni u għal madwar in-nervituri fil-kavità orali.
English: Subcutaneous injections of articaine combined with adrenaline induced adverse effects from 50 mg/kg/day in rats and 80 mg/kg/day in dogs after 4 weeks daily repeated administrations.
Maltese: Injezzjonijiet taħt il-ġilda ta' articaine kombinati ma' adrenaline ħolqu effetti avversi minn 50 mg/kg/jum fil-firien u 80 mg/kg/jum fil-klieb wara għoti ripetut kuljum fuq 4 ġimgħat.
English: • tumour called pheochromocytoma;
Maltese: • Pazjenti b'feokromoċitoma:
English: Articainic acid is the major product of cytochrome P450-induced metabolism of articaine, further metabolised to form articainic acid glucuronide.
Maltese: articaine, li jiġi metabolizzat aktar biex jifforma articainic acid glucuronide.
English: Interactions with articaine
Maltese: Articaine, kombinazzjonijiet