FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients, average peak plasma concentrations of vernakalant were 3.9 μg/ml following a single 10-minute infusion of 3 mg/kg vernakalant hydrochloride, and 4.3 μg/ml following a second infusion of 2 mg/kg with a 15-minute interval between doses.
Maltese: Fil-pazjenti, il-konċentrazzjonijiet massimi medji ta' vernakalant fil-plażma kienu ta' 3.9 μg/ml wara infużjoni waħda ta' 3 mg/kg fuq 10 minuti ta' vernakalant hydrochloride, u 4.3 μg/ml wara t-tieni infużjoni ta' 2 mg/kg b'intervall ta' 15-il minuta bejn id-dożi.
English: 25 mL: 500 mg/25 mL
Maltese: 500 mg/25 ml
English: The company will start to include the pre-infusion check list in packs packed at the packaging site as soon as possible but at the latest on 15 November 2012.
Maltese: Il-kumpanija se tibda tinkludi l-lista ta' kontroll għal qabel l-infużjoni fil-pakketti ppakkjati fil-post fejn isir l-ippakkjar mill-aktar fis possibbli iżda mhux aktar tard mill-15 ta' Novembru 2012.
English: Acute vernakalant pharmacokinetics is not significantly influenced by gender, history of congestive heart failure, renal impairment, or concomitant administration of beta blockers and other medications, including warfarin, metoprolol, furosemide and digoxin.
Maltese: Vernakalant farmakokinetiku akut mhuwiex influwenzat b'mod sinifikanti mis-sess tal-persuna, listorja ta' insuffiċjenza konġestiva tal-qalb, l-indeboliment tal-kliewi, l-indeboliment tal-fwied, jew lgħoti simultanju ta' imblokkaturi beta u medikazzjonijiet oħra, fosthom warfarin, metoprolol, furosemide u digoxin.
English: BRINAVESS 20 mg/ml sterile concentrate vernakalant hydrochloride IV
Maltese: BRINAVESS 20 mg/ml konċentrat għal soluzzjoni għall-infużjoni vernakalant hydrochloride
English: For atrial fibrillation lasting less than 48 hours, immediate cardioversion was allowed.
Maltese: Għal fibrillazzjoni atrijali ta' inqas minn 48 siegħa, kienet permessa kardjoverżjoni immedjata.
English: • Patients with severe aortic stenosis, patients with systolic blood pressure < 100 mm Hg, and patients with heart failure class NYHA III and NYHA IV.
Maltese: • Pazjenti bi stenożi severa tal-aorta, pazjenti bi pressjoni tad-demm sistolika ta' <100 mm Hg u pazjenti b'insuffiċjenza tal-qalb klassi NYHA III u NYHA IV.
English: This risk is higher in patients who use Class I antiarrhythmics (see section 4.8).
Maltese: Dan ir-riskju huwa ogħla f'pazjenti li jużaw anti-arritmiċi ta' Klassi I (ara sezzjoni 4.8).
English: • irritation, itching at the infusion site
Maltese: • irritazzjoni, ħakk fis-sit tal-infużjoni
English: Treatment success (responder) was defined as conversion of atrial fibrillation to sinus rhythm within 90 minutes.
Maltese: Is-suċċess tat-trattament (pazjenti li rrispondew għall-kura) kien definit bħala qlib tal-fibrillazzjoni atrijali għal ritmu sinusali fi żmien 90 minuta.
English: • Patients with severe aortic stenosis, patients with systolic blood pressure < 100 mm Hg, and patients with heart failure class NYHA III and NYHA IV. - Alert HCP about BRINAVESS special warnings and precautions in patients with, clinically meaningful valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis, previously documented LVEF ≤ 35 %, advanced hepatic impairment.
Maltese: - Wissi lill-HCP dwar twissijiet u prekawżjonijiet speċjali ta' BRINAVESS f'pazjenti bi stenożi valvulari klinikament importanti, kardjomijopatija ostruttiva ipertrofika, kardjomijopatija restrittiva, jew perikardite kostrittiva, LVEF iddokumentata preċedentament ≤ 35 %, indeboliment avvanzat tal-fwied.
English: 25 mL:1 vial 500 mg/25 ml
Maltese: 1 kunjett 500 mg/25 ml
English: The recommended initial dose is 3 mg/kg, with a maximum calculated dose based upon 113 kg.
Maltese: Id-doża tal-bidu rakkomandata hija 3 mg/kg b'doża massima kkalkulata bażata fuq 113 kg.
English: In embryo-foetal development studies with oral administration of vernakalant two times a day resulting in exposure levels (AUC) generally higher than those achieved in humans after a single intravenous dose of vernakalant malformations (misshapen/absent/fused skull bones including cleft palates, bent radius, bent/misshapen scapula, constricted trachea, absent thyroid, undescendent testes) occurred in rats and increased embryo-foetal lethality, increased number of foetuses with fused and/or additional sternebrae were seen in rabbits at the highest doses tested.
Maltese: Fi studji fuq l-iżvilupp embrijofetali b'amministrazzjoni orali ta' vernakalant darbtejn kuljum f'livelli ta' espożizzjoni (AUC) ġeneralment ogħla minn dawk miksubin fl-umani wara doża waħdanija ta' vernakalant ġol-vini, seħħew malformazzjonijiet (għadam tal-kranju deformati/nieqsa/mwaħħlin ma' xulxin inkluż qsim tas-saqaf tal-ħalq, radjus mgħawweġ, skapula mgħawwġa/deformata, trakea ristretta, tirojde nieqsa, testikoli li ma jinżlux) f'firien u żieda fl-imwiet embrijofetali, żieda fin-numru ta' feti bi sternebrae magħqudin u/jew bi sternebrae addizzjonali ġew osservati fi fniek meta ttestjati bl-ogħla dożi.
English: • The other ingredients are citric acid, sodium chloride, sodium hydroxide (E524) and water for injections.
Maltese: • Is-sustanzi mhux attivi l-oħra huma citric acid, sodium chloride, sodium hydroxide (E524) u ilma għall-injezzjonijiet.
English: BRINAVESS may be available in different vial sizes (available vial sizes to be inserted locally).
Maltese: Brinavess jista' jkun disponibbli f'kunjetti ta' daqsijiet differenti (daqsijiet tal-kunjetti disponibbli għandhom jiddaħħlu lokalment).
English: Does the patient have prolonged QT interval at baseline (uncorrected > 440 msec)?
Maltese: Il-pazjent għandu intervall QT imtawwal fil-linja bażi (mhux irregolat > 440 msek)?
English: In post-marketing experience rare cases of atrial flutter with 1:1 atrioventricular conduction are observed.
Maltese: Fil esperjenza postmarketing każijiet rari ta palpitazzjoni atrijali ma 'konduzzjoni atrijuventrikulari 1:1 huma osservati.
English: Atrial fibrillation patients receiving vernakalant have a higher incidence of converting to atrial flutter within the first 2 hours post-dose (1.2 % versus 0 % in placebo).
Maltese: Pazjenti b'fibrillazzjoni atrijali li jirċievu vernakalant għandhom inċidenza akbar li jaqilbu għal palpitazzjonijiet atrijali sal-ewwel sagħtejn wara d-doża (1.2 % kontra 0 % fi plaċebo).
English: ACT I and ACT III studied the effect of vernakalant in the treatment of patients with sustained atrial fibrillation > 3 hours but not more than 45 days in duration.
Maltese: ACT I u ACT III studjaw l-effett ta' vernakalant fit-trattament ta' pazjenti b'fibrillazzjoni atrijali sostnuta ta' > 3 sigħat iżda li ma damitx aktar minn 45 ġurnata.
English: The diluted sterile concentrate is chemically and physically stable for 12 hours at or below 25 °C.
Maltese: Il-konċentrat sterili dilwit huwa kimikament u fiżikament stabbli għal 12-il siegħa f'temperatura ta' 25 °C jew inqas.
English: Efficacy from Post-Marketing Observational Study In the post-approval safety study SPECTRUM that included 1,778 patients with 2,009 BRINAVESS treatment episodes, effectiveness was assessed as the proportion of patients who converted to sinus rhythm for at least one (1) minute within 90 minutes from the start of BRINAVESS infusion, excluding patients who received electrical cardioversion or intravenous Class I/III antiarrhythmics for cardioversion within the 90-minute window.
Maltese: Effikaċja minn Studju ta' Osservazzjoni ta' Wara t-Tqegħid fis-Suq Fl-istudju ta' sikurezza ta' wara l-approvazzjoni SPECTRUM li kien jinkludi 1,778 pazjent bi 2,009 episodji ta' trattament bi BRINAVESS, l-effettività ġiet assessjata bħala l-proporzjon ta' pazjenti li kkonvertew għal ritmu sinusali għal mill-inqas minuta (1) fi żmien 90 minuta mill-bidu tal-infużjoni ta' BRINAVESS, li kien jeskludi pazjenti li rċevew kardjoverżjoni elettrika jew antiarritmiċi ta' Klassi 1/III għal kardjoverżjoni ġol-vina fiż-żmien tat-tieqa ta' 90 minuta.
English: There was no meaningful difference when stratifying the analysis by therapeutic indication (i.e. non-surgery and post-cardiac surgery patients).
Maltese: Ma kienx hemm differenza notevoli meta ġiet stratifikata l-analiżi skont l-indikazzjoni terapewtika (i.e pazjenti mingħajr kirurġija u pazjenti kirurġiċi wara operazzjoni tal-qalb).
English: Recommended diluents are sodium chloride 9 mg/ml (0.9 %) solution for injection, Lactated Ringers solution for injection, or 5 % glucose for solution for injection.
Maltese: Dilwenti rakkomandati huma soluzzjoni ta' 0.9% sodium chloride għall-injezzjoni, soluzzjoni ta' Lactated Ringers għall-injezzjoni, jew soluzzjoni ta' 5% glucose għall-Injezzjoni.
English: Uncommon: Dyspnoea; throat irritation; oropharyngeal pain; nasal congestion; suffocation feeling; choking sensation; rhinorrhoea Gastrointestinal disorders Common: Nausea; paraesthesia oral; vomiting Uncommon: Dry mouth; diarrhoea; hypoaesthesia oral; defecation urgency
Maltese: Komuni: Sogħla; skumdità fl-imnieħer Mhux komuni: Qtugħ ta' nifs; irritazzjoni fil-gerżuma; uġigħ orofarinġeali; konġestjoni nasali; sensazzjoni ta' suffokazzjoni; sensazzjoni ta' li wieħed jifga;; rinoreja Disturbi gastro-intestinali
English: BRINAVESS is available in pack of 1 vial containing 200 mg or 500 mg of vernakalant hydrochloride.
Maltese: BRINAVESS jiġi f'pakkett ta' kunjett wieħed li fih jew 200 mg jew 500 mg ta' vernakalant hydrochloride.
English: Use of AADs (antiarrhythmic drugs) prior to or after vernakalant Vernakalant cannot be recommended in patients previously administered intravenous AADs (class I and III) 4-24 hours prior to vernakalant due to lack of data.
Maltese: Użu ta' AADs (antiarrhythmic drugs, mediċini antiarrittmiċi) qabel jew wara vernakalant Vernakalant ma jistax jiġi rrakkomandat f'pazjenti li qabel kienu ngħataw AADs (klassi I u III) ġolvini 4-24 siegħa qabel vernakalant minħabba nuqqas ta' dejta.
English: BRINAVESS 20 mg/ml concentrate for solution for infusion
Maltese: BRINAVESS 20 mg/ml, konċentrat għal soluzzjoni għall-infużjoni
English: In addition, acute exposure of vernakalant in poor metabolisers of CYP2D6 is only minimally different when compared to that of extensive metabolisers.
Maltese: Barra minn hekk, l-esponiment akut ta' vernakalant f'metabolizzaturi ħżiena ta' CYP2D6 huwa biss minimament differenti meta mqabbel ma' dak ta' metabolizzaturi estensivi.
English: Vernakalant is mainly eliminated by CYP2D6 mediated O-demethylation in CYP2D6 extensive metabolisers.
Maltese: Vernakalant jitneħħa prinċipalment permezz ta' demitilizzazzjoni-O medjata minn CYP2D6 f'metabolizzaturi estensivi ta' CYP2D6.
English: EXP
Maltese: P†
English: As a precautionary measure, it is preferable to avoid the use of BRINAVESS during pregnancy.
Maltese: Bħala prekawzjoni, huwa preferibbli li ma jintużax BRINAVESS waqt it-tqala.
English: Across the Phase 3 population, vernakalant treated patients had an increase in heart rate-corrected QT (using Fridericia's correction, QTcF) compared to placebo (22.1 msec and 18.8 msec placebo-subtracted peaks after first and second infusions, respectively).
Maltese: Tul il-popolazzjoni ta' Fażi 3, il-pazjenti kkurati b'vernakalant kellhom żieda fil-QT korrett tar-rata tal-qalb (bl-użu tal-korrezzjoni ta' Fridericia, QTcF) meta pparagunat mal-plaċebo (22.1 msec u 18.8 msec qċaċet imnaqqsa mill-plaċebo wara l-ewwel u t-tieni infużjonijiet).
English: Important Instructions when using BRINAVESS
Maltese: Istruzzjonijiet importanti għal meta tuża BRINAVESS
English: These arrhythmias typically presented as asymptomatic, monomorphic, non-sustained (average 3-4 beats) ventricular tachycardias.
Maltese: Dawn l-arritmiji ġeneralment dehru bħala takikardiji ventrikolari asintomatiċi, monomorfiċi, mhux sostnuti (medja 3-4 taħbitiet).
English: Each vial contains 500 mg vernakalant hydrochloride equivalent to 452.5 mg vernakalant.
Maltese: Kull kunjett ta' 500 mg vernakalant hydrochloride huwa ekwivalenti għal 452.5 mg vernakalant.
English: Vernakalant was not found to be effective in converting typical primary atrial flutter to sinus rhythm.
Maltese: Vernakalant ma nstabx li kien effettiv biex jaqleb palpitazzjoni atrijali primarja tipika għal ritmu sinusali.
English: • BRINAVESS cannot be recommended in patients previously administered intravenous AADs (class I and III) 4-24 hours prior to vernakalant, due to lack of data.
Maltese: • BRINAVESS ma jistax jiġi rrakkomandat f'pazjenti li qabel kienu ngħataw AADs (klassi I u III) 4-24 siegħa qabel vernakalant minħabba nuqqas ta' dejta.
English: Of the patients who did not convert to sinus rhythm, the incidence of bradycardia events in the first 2 hours post-dose was similar in placebo and vernakalant treated groups (4.0% and 3.8%, respectively).
Maltese: Fost il-pazjenti li ma qalbux għal ritmu sinusali, l-inċidenza tal-episodji ta' bradikardija fl-ewwel sagħtejn wara d-doża kienet simili fil-gruppi kkurati bi plaċebo u dawk ikkurati b'vernakalant (4.0% u 3.8%, rispettivament).
English: Although vernakalant is a substrate of CYP2D6, population pharmacokinetic (PK) analyses demonstrated that no substantial differences in the acute exposure of vernakalant (Cmax and AUC0-90min) were observed when weak or potent CYP2D6 inhibitors were administered within 1 day prior to vernakalant infusion compared to patients that were not on concomitant therapy with CYP2D6 inhibitors.
Maltese: Għalkemm vernakalant huwa substrat ta' CYP2D6, analiżi farmakokinetika (PK) tal-popolazzjoni uriet li ma kinux osservati differenzi sostanzjali fl-esponiment akut ta' vernakalant (Cmax u AUC0-90min) meta ngħataw inibituri dgħajfa jew b'saħħithom ta' CYP2D6 sa ġurnata qabel l-infużjoni ta' vernakalant meta pparagunat ma' pazjenti li ma kinux fuq terapija konkomitanti b'inibituri ta' CYP2D6.
English: Vernakalant should be used with caution in patients on oral AADs (class I and III), due to limited experience.
Maltese: Vernakalant għandu jintuża b'kawtela f'pazjenti fuq AADs orali (klassi I u III), minħabba esperjenza limitata.
English: AVRO studied the effect of vernakalant versus intravenous amiodarone in patients with recent onset atrial fibrillation (3 hrs to 48 hrs).
Maltese: AVRO studja leffett ta' vernakalant kontra amiodarone mogħti fil-vini f'pazjenti b'fibrillazzjoni atrijali li ma tkunx ilha li bdiet (3 sigħat sa 48 siegħa).
English: Very common: Dysgeusia
Maltese: Komuni ħafna: Għatis
English: Vernakalant is an antiarrhythmic medicine that acts preferentially in the atria to prolong atrial refractoriness and to rate-dependently slow impulse conduction.
Maltese: Vernakalant huwa mediċina antiarritmika li taġixxi b'mod preferenzjali fl-atriji sabiex ittawwal irrefrattorjetà atrijali u biex tittardja l-konduzzjoni tal-impulsi b'mod dipendenti fuq ir-rata.
English: How to store BRINAVESS
Maltese: X'fih BRINAVESS
English: Elderly (≥ 65 years): No dose adjustment necessary.
Maltese: Anzjani (≥ 65 sena): M'hemmx bżonn ta' aġġustament fid-doża.
English: During atrial fibrillation, the frequency- and voltage-dependent block of sodium channels further focuses the action of the medicine toward rapidly activating and partially depolarized atrial tissue rather than toward the normally polarized ventricle beating at lower heart rates.
Maltese: Waqt fibrillazzjoni atrijali, l-imblokk tal-kanali tas-sodium dipendenti fuq il-frekwenza u fuq il-vultaġġ, jiffoka ulterjorment lazzjoni tal-mediċina fuq it-tessut atrijali li jattiva malajr u tessut atrijali parzjalment depolarizzat pjuttost milli fuq il-ventrikolu polarizzat b'mod normali li jħabbat b'rati tal-qalb iżjed baxxi.
English: The mean elimination half-life of vernakalant in patients was approximately 3 hours in CYP2D6 extensive metabolisers and approximately 5.5 hours in poor metabolisers.
Maltese: Il-half-life medja taleliminazzjoni ta' vernakalant fil-pazjenti kienet ta' madwar 3 sigħat f'metabolizzaturi estensivi ta' CYP2D6 u madwar 5.5 sigħat f'metabolizzaturi ħżiena.
English: Correvio Tlf: +41 848 00 79 70
Maltese: Tlf: +41 848 00 79 70
English: After dilution the concentration of the solution is 4 mg/ml vernakalant hydrochloride.
Maltese: Wara dilwizzjoni, il-konċentrazzjoni tas-soluzzjoni hija ta' 4 mg/ml ta' vernakalant hydrochloride
English: • ECG changes (such as a clinically meaningful sinus pause, complete heart block, new bundle branch block, significant prolongation of the QRS or QT interval, changes consistent with ischaemia or infarction and ventricular arrhythmia)
Maltese: • Bidliet fl-ECG (bħal pawsa klinikament sinifikanti fis-sinus, imblokk komplet tal-qalb, imblokk ġdid ta' bundle branch, titwil sinifikanti fl-intervall QRS jew QT, bidliet konsistenti ma'
English: If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10-minute infusion of 2 mg/kg may be administered (maximum second infusion of 226 mg (56.5 ml of 4 mg/ml solution)).
Maltese: Jekk ma sseħħx bidla għar-rittmu sinusali sa 15-il minuta wara t-tmiem tal-ewwel infużjoni, tista' tingħata infużjoni oħra ta' 2 mg/kg għal 10 minuti (it-tieni infużjoni massima ta' 226 mg (56.5 ml ta' soluzzjoni ta' 4 mg/ml)).
English: Very common: Sneezing
Maltese: Komuni ħafna: Diżgewżja
English: Each vial contains 200 mg vernakalant hydrochloride equivalent to 181 mg vernakalant.
Maltese: Kull kunjett ta' 200 mg vernakalant hydrochloride huwa ekwivalenti għal 181 mg vernakalant.
English: Within the clinical development program, oral maintenance antiarrhythmic therapy was halted for a minimum of 2 hours after vernakalant administration.
Maltese: Fil-programm tal-iżvilupp kliniku, it-terapija antiarritmika orali ta' manteniment twaqqfet għal minimu ta' sagħtejn wara l-għoti ta' vernakalant.
English: There is limited experience with the use of vernakalant in patients with previously documented LVEF ≤ 35 %.
Maltese: NYHA I sa II. Ftit hemm esperjenza dwar l-użu ta' vernakalant f'pazjenti b'LVEF ≤ 35% dokumentata qabel.
English: Each 25 ml vial contains 500 mg of vernakalant hydrochloride equivalent to 452.5 mg of vernakalant.
Maltese: Kull kunjett ta' 25 ml fih 500 mg ta' vernakalant hydrochloride ekwivalenti għal 452.5 mg ta' vernakalant.
English: • coughing, sore nose
Maltese: • sogħla, uġigħ fl-imnieħer
English: Patients with hepatic impairment: No dose adjustment necessary (see sections 4.4 and 5.2).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża (ara sezzjonijiet 4.4 u 5.2).
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq id-dilwazzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati f'sezzjoni 6.1
English: - Alert HCP for use of antiarrhythmic drugs (AADs) prior to or after BRINAVESS.
Maltese: - Wissi lill-HCP dwar l-użu ta' mediċini kontra l-arritmiji (antiarrhythmic drugs, AAD) qabel jew wara BRINAVESS.
English: Efficacy in patients with sustained atrial fibrillation, (ACT I and ACT III) Primary efficacy endpoint was the proportion of subjects with short duration atrial fibrillation (3 hours to 7 days) who had a treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of one minute within 90 minutes of first exposure to study drug.
Maltese: L-effikaċja f'pazjenti b'fibrillazzjoni atrijali sostnuta (ACT I u ACT III) Il-punt ta' tmiem primarju tal-effikaċja kien il-proporzjon ta' pazjenti b'fibrillazzjoni atrijali li ma damitx ħafna (3 sigħat sa 7 ijiem) li kellhom qlib indottt mit-trattament tal-fibrillazzjoni atrijali għal ritmu sinusali għal perjodu minimu ta' minuta fi żmien 90 minuta mill-ewwel esponiment għallmediċina tal-istudju.
English: The initial infusion is administered as a 3 mg/kg dose over 10 minutes.
Maltese: L-ewwel infużjoni tingħata bħala doża ta' 3 mg/kg fuq perjodu ta'10 minuti.
English: If atrial flutter is observed as secondary to treatment, continuation of infusion should be considered (see section 4.2).
Maltese: Jekk il-palpitazzjoni atrijali tkun osservata bħala sekondarja għattrattament, għandha tiġi kkunsidrata t-tkomplija tal-infużjoni (ara sezzjoni 4.2).
English: The safety of vernakalant has been evaluated in clinical studies involving 1,148 subjects (patients and healthy volunteers) who received treatment with it. Based on data from 1,018 patients in eight phase 2 and phase 3 trials, the most commonly reported adverse reactions (> 5 %) seen in the first 24 hours after receiving vernakalant were dysgeusia (taste disturbance) (17.9 %), sneezing (12.5 %), and paraesthesia (6.9 %).
Maltese: Fuq il-bażi ta' informazzjoni minn 1018-il pazjent fi tmien provi ta' fażi 2 u fażi 3, l-iżjed reazzjonijiet avversi relatati rrappurtati b'mod komuni (> 5%) li dehru fl-ewwel 24 siegħa wara l-għoti ta' vernakalant kienu diżgewżja (disturb fit-togħma) (7.9 %), għatis (12.5 %) u parasteżija (6.9 %).
English: The recommended initial infusion is 3 mg/kg to be infused over a 10-minute period with a maximum initial dose of 339 mg (84.7 ml of 4 mg/ml solution).
Maltese: L-infużjoni tal-bidu rakkomandata hija 3 mg/kg li għandha tiġi infuża fuq perjodu ta' 10 minuti b'doża massima inizjali ta' 339 mg (84.7 ml ta' soluzzjoni ta' 4 mg/ml).
English: For atrial fibrillation lasting longer than 48 hours, anticoagulation was required as per treatment guidelines.
Maltese: Għal fibrillazzjoni atrijali ta' aktar minn 48 siegħa, kienet meħtieġa antikoagulazzjoni skont il-linji gwida tat-trattament.
English: Each ml of concentrate contains 20 mg vernakalant hydrochloride equivalent to 18.1 mg vernakalant.
Maltese: Kull ml ta' konċentrat fih 20 mg vernakalant hydrochloride li huwa ekwivalenti għal 18.1 mg vernakalant.
English: Common: Infusion site pain; feeling hot; infusion site paraesthesia Uncommon: Fatigue; infusion site irritation; infusion site hypersensitivity; infusion site pruritus; malaise
Maltese: Mhux komuni: Għeja; irritazzjoni fis-sit tal-infużjoni; sensittività eċċessiva fis-sit tal-infużjoni; ħakk fis-sit tal-infużjoni; telqa;
English: Risk of atrial flutter may be increased in patients receiving class I AADs (see above).
Maltese: Ir-riskju ta' palpitazzjoni atrijali jista' jiżdied f'pazjenti li jirċievu AADs ta' klassi I (ara fuq).
English: • urgency to have a bowel movement, diarrhoea
Maltese: • urġenza li jkollok moviment fl-imsaren, dijarrea
English: Atrial
Maltese: Atrijali
English: Hypotension can occur in a small number of patients (vernakalant 5.7 %, placebo 5.5 % in the first 2 hours post-dose).
Maltese: Tista' tirriżulta pressjoni baxxa f'numru żgħir ta' pazjenti (vernakalant 5.7 %, plaċebo 5.5 % fl-ewel sagħtejn wara d-doża).
English: In patients with uncorrected hypokalaemia (serum potassium of less than 3.5 mmol/l), potassium levels should be corrected prior to use of vernakalant.
Maltese: F'pazjenti b'ipokalimja mhux regolata (potassium fis-serum inqas minn 3.5 mmol/l), il-livelli tal-potassium għandhom jiġu regolati qabel lużu ta' vernakalant.
English: However, blockade of cationic currents, including hERG channels and cardiac voltage-dependent sodium channels, which are present in the ventricles has been documented.
Maltese: Madankollu, ġie ddokumentat imblokk tal-kurrenti katjoniċi, inkluż il-kanali hERG u l-kanali kardijaċi tas-sodium dipendenti fuq il-vultaġġ, li huma preżenti fil-ventrikuli.
English: No significant differences in safety or effectiveness were observed based on age, gender, use of rate control medications, use of antiarrhythmic medications, use of warfarin, history of ischaemic heart disease, renal impairment or expression of the cytochrome P450 2D6 enzyme.
Maltese: Ma kinux osservati differenzi sinifikanti fis-sigurtà u l-effikaċja fuq il-bażi tal-età, is-sess tal-persuna, l-użu ta' medikazzjonijiet għall-kontroll tar-rata tat-taħbit tal-qalb, l-użu ta' medikazzjonijiet antiarritmiċi, l-użu tal-warfarina, storja ta' mard tal-qalb iskemiku, indeboliment tal-kliewi jew lespressjoni tal-enzima taċ-ċitokromu P450 2D6.