FrancophonIA/ELRC3.0 huggingface dataset:
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2008 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2008 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EASOTIC EPAR summary for the public
Maltese: PUBBLIKA EWROPEW (EPAR) EASOTIC Sommarju tal-EPAR għall-pubbliku
English: It is available in a 10 ml bottle.
Maltese: Huwa disponibbli fi flixkun ta' 10 ml.
English: Easotic contains three active substances: hydrocortisone aceponate, miconazole nitrate and gentamicin sulphate.
Maltese: Easotic fih tliet sustanzi attivi: aċeponat idrokortiżon, mikonażol nitrat u ġentamiċina sulfat.
English: It acts by preventing bacteria making proteins.
Maltese: Dan jaġixxi billi jipprevjeni lbatterji jiffurmaw proteini.
English: Equal numbers of dogs were assigned to each group, of different breeds, ages, sex and weight.
Maltese: Ġie assenjat listess numru ta' klieb għal kull grupp ta' razza, età, sess u piż differenti.
English: Gentamicin sulphate is an antibiotic that belongs to the group aminoglycosides.
Maltese: Isġentamiċina sulfat huwa antibijotiku li jappartjeni għall-grupp .
English: What is Easotic?
Maltese: X'inhu Easotic?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Easotic exceed the risks for the treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole in particular Malassezia pachydermatis, and recommended that Easotic be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Easotic huma akbar mir-riskji tiegħu għat-trattament ta' otite esterna akuta u taħrix akut ta' otite esterna rikorrenti fil-klieb assoċjati ma' batterji suxxettibbli għal ġentamiċina u fungi suxxettibbli għal mikonażol b'mod partikolari l-Malassezia pachydermatis u rrakkomanda li Easotic jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What is the risk associated with Easotic?
Maltese: X'inhu r-riskju assoċjat ma' Easotic?
English: Why has Easotic been approved?
Maltese: Għaliex ġie approvat Easotic?
English: Mild reddening of the ear has been seen in around 2% of dogs.
Maltese: Dehret daqxejn ħmura tal-widna f'madwar 2% tal-klieb.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Easotic to Virbac S.A. on 20/11/2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Easotic lil Virbac S.A. fit-20/11/08.
English: This is usually temporary and happens primarily in older dogs.
Maltese: Dan huwa normalment temporanju u jiġri primarjament fi klieb aktar anzjani.
English: When used at the recommended dose for five days, Easotic was as effective as the comparator medicine in improving the symptoms of ear infection (redness, swelling, ear discharge and discomfort).
Maltese: Meta wżat f'doża rakkomandata fuq ħamest ijiem, Easotic kien effettiv bħal mediċina ta' paragun fit-titjib tas-sintomi ta' infezzjonijiet tal-widnejn (ħmura, nefħa, tisfija tal-widna u skomdu).
English: Miconazole nitrate is an antifungal that works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Maltese: In-mikonażol nitrat huwa sustanza kontra l-fungi li jaħdem billi jipprevjeni il-formazzjoni ta' ergosterol li huwa parti importanti mill-ħitan taċċelloli tal-fungi.
English: This summary was last updated in November 2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: Novembru 2008.
English: How has Easotic been studied?
Maltese: Kif ġie studjat Easotic?
English: The medicine was well tolerated.
Maltese: Il-mediċina ġiet tollerata b'mod tajjeb.
English: The dose is 1 ml, which is given directly into the ear by one activation of the pump supplied with the bottle.
Maltese: Id-doża hija ta' 1 ml, li tingħata direttament fil-widna b'attivazzjoni waħda tal-pompa fornuta flimkien mal-flixkun.
English: Other information about Easotic:
Maltese: Tagħrif ieħor dwar Easotic:
English: List of the name, pharmaceutical form, strength of the medicinal product, route of administration, marketing authorisation holder in the Member States
Maltese: Lista ta` ismijiet, għamliet farmaċewtiċi, qawwa tal-prodott mediċinali, mnejn jingħata, id-detentur ta` l-awtorizzazzjoni għat-tqegħid fis-suq flistati membri
English: Austria implant, pre-filled syringe subcutaneous use
Maltese: L-Awstrija impjant, siringa mimlija għal-lest
English: EMA/783550/2013 EMEA/V/C/002729
Maltese: EMEA/783550/2013 EMEA/V/C/002729
English: NexGard (afoxolaner) EMA/783550/2013
Maltese: NexGard (afossolaner)EMA/783550/2013
English: Further information on NexGard can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/NexGard.
Maltese: Aktar informazzjoni dwar NexGard tista' tinstab fuq is-sit web talAġenzija:ema.europa.eu/medicines/veterinary/EPAR/NexGard.
English: NexGard (afoxolaner)
Maltese: NexGard (afossolaner)
English: Other information about NexGard
Maltese: Informazzjoni oħra dwar NexGard
English: NexGard reduced the number of live mites by 97% 56 days after starting treatment and by 98% 84 days after starting treatment.
Maltese: NexGard naqqas l-għadd ta' dud ħaj b'97 % 56 jum wara l-bidu tal-kura u bi 98 % 84 jum wara l-bidu tal-kura.
English: NexGard contains the active substance afoxolaner.
Maltese: NexGard fih is-sustanza attiva afossolaner.
English: NexGard received a marketing authorisation valid throughout the EU on 11 February 2014.
Maltese: NexGard ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-11 ta' Frar 2014.
English: NexGard reduced the number of fleas and ticks by at least 98% and was at least as effective as a spoton medicine containing pyriprole (another medicine against fleas and ticks).
Maltese: NexGard naqqas l-għadd ta' briegħed u qurdien b'mill-inqas 98 % u kien tal-inqas effettiv daqs mediċina għall-użu lokalizzat li fiha l-piriprol (mediċina oħra kontra l-briegħed u l-qurdien).
English: The active substance in NexGard, afoxolaner, acts as an ‘ectoparasiticide'.
Maltese: Is-sustanza attiva f'NexGard, l-afossolaner, taġixxi bħala ‘ektoparassitiċida'.
English: NexGard reduced the number of live mites by 96% 28 days after starting treatment and by 100% 56 days after starting treatment.
Maltese: NexGard naqqas l-għadd ta' dud ħaj b'96 % 28 jum wara l-bidu tal-kura u b'100% 56 jum wara l-bidu tal-kura.
English: What are the risks associated with NexGard?
Maltese: X'inhuma r-riskji assoċjati ma' NexGard?
English: NexGard is a medicine used to treat infestations with fleas and ticks, as well as demodectic and sarcoptic mange (skin infestations caused by two different types of mites) in dogs.
Maltese: Nexgard huwa mediċina li tintuża biex tikkura infestazzjonijiet bil-briegħed u bil-qurdien, kif ukoll ġarab demodektiku u sarkoptiku (infestazzjonijiet fil-ġilda kkawżati minn żewġ tipi differenti ta' dud) fil-klieb.
English: It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA), a substance which conveys messages between nerves (neurotransmitter).
Maltese: Din timblokka l-moviment normali tal-partikoli ċċarġjati tal-klorur (joni) ġewwa u barra ċ-ċelloli tannervituri, speċjalment dawk assoċjati ma' aċidu gamma-aminobutirriku (GABA) sustanza li tgħaddi l
English: In an EU field study involving 146 dogs with flea and/or tick infestations, a single treatment with NexGard was effective in treating flea and tick infestations in dogs for up to 30 days after treatment.
Maltese: Fi studju tal-UE fuq il-post li kien jinvolvi 146 kelb b'infestazzjonijiet tal-briegħed u/jew tal-qurdien, trattament wieħed b'NexGard kien effettiv fil-kura tal-infestazzjonijiet tal-briegħed u tal-qurdien filklieb sa 30 jum wara l-kura.
English: Why is NexGard authorised in the EU?
Maltese: Għaliex NexGard huwa awtorizzat fl-UE?
English: Afoxolaner kills parasites by causing an over-stimulation of their nervous system.
Maltese: L-afossolaner toqtol il-parassiti billi tikkawża stimulazzjoni eċċessiva tas-sistema nervuża tagħhom.
English: A second EU field study involved 31 dogs with demodectic mange which were treated monthly on 3 occasions with NexGard.
Maltese: It-tieni studju tal-UE fuq il-post involva 31 kelb b'ġarab demodektiku li ġew ikkurati kull xahar fi tliet okkażjonijiet b'NexGard.
English: How does NexGard work?
Maltese: X'inhu NexGard u għal xiex jintuża?
English: The effectiveness of NexGard was investigated in both laboratory and field studies.
Maltese: L-effikaċja ta' NexGard ġiet investigata kemm fi studji tal-laboratorju kif ukoll fuq il-post.
English: Treatment should be repeated at monthly intervals during the flea or tick seasons, monthly for demodectic mange until the mange is successfully treated (as confirmed by two negative skin scrapings one month apart) and monthly for two months for sarcoptic mange, or longer if treatment is unsuccessful as indicated by clinical signs and skin scrapings.
Maltese: Il-kura għandha tiġi ripetuta f'intervalli ta' kull xahar matul l-istaġuni tal-briegħed jew talqurdien, kull xahar għall-ġarab demodektiku sakemm il-ġarab ikun ikkurat b'suċċess (kif ikkonfermat minn żewġ biċċiet ta' ġilda negattivi kull xahar bejn kura u oħra) u kull xahar għal xahrejn għall-ġarab sarkoptiku, jew għal aktar jekk il-kura ma tirnexxix kif indikat mis-sinjali kliniċi u mill-biċċiet tal-ġilda.
English: NexGard is available as chewable tablets in four different strengths for use in dogs of different weights.
Maltese: Nexgard jiġ bħala pilloli li jintmagħdu f'erba' qawwiet differenti għall-użu fi klieb ta' piżijiet differenti.
English: NexGard kills fleas within 8 hours and ticks within 48 hours.
Maltese: NexGard joqtol il-briegħed fi żmien 8 sigħat u l-qurdien fi żmien 48-il siegħa.
English: A third EU field study involved 38 dogs with sarcoptic mange which were treated monthly for two months with NexGard.
Maltese: It-tielet studju tal-UE fuq il-post involva 38 kelb b'ġarab sarkoptiku li ġew ikkurati kull xahar għal xahrejn b'NexGard.
English: (See section 4.8.)
Maltese: (Ara s-sezzjoni 4.8.)
English: • Bradycardia
Maltese: • Bradikardija
English: Efficacy versus amiodarone (AVRO)
Maltese: Effikaċja kontra amiodarone (AVRO):
English: Luxembourg/Luxemburg
Maltese: Luxembourg/Luxemburg Correvio
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Correvio
English: 15 rue du Bicentenaire 92800 Puteaux France
Maltese: 15 rue du Bicentenaire 92800 Puteaux Franza
English: Fibrillation
Maltese: Fibrillazzjoni
English: • The active substance is vernakalant hydrochloride.
Maltese: • Is-sustanza attiva hi vernakalant hydrochloride.
English: Table 1: Adverse reactions with BRINAVESS *
Maltese: Tabella 1: Reazzjonijiet avversi bi BRINAVESS*
English: Pharmacodynamics effects
Maltese: Effetti farmakodinamiċi
English: EU/1/10/645/001 EU/1/10/645/002
Maltese: EU/1/10/645/002
English: Overall, BRINAVESS was effective in 70.2% (1,359/1,936) of these patients.
Maltese: Globalment, BRINAVESS kien effettiv f'70.2 % (1,359/1,936) ta' dawn il-pazjenti.
English: By 90 minutes after the start of infusion, this difference was reduced to 8.1 msec.
Maltese: Sa 90 minuta wara l-bidu tal-infużjoni, din id-differenza tnaqqset għal 8.1 msec.
English: ACT III BRINAVESS Placebo P-Value† BRINAVESS Placebo P-Value†
Maltese: BRINAVESS Plaċebo Valur P†
English: Correvio Tel: +39 02 600 63037
Maltese: Tel: +39 02 600 63037
English: Treatment with vernakalant effectively converted atrial fibrillation to sinus rhythm (47.0 % vernakalant, 14.0 % placebo; P value = 0.0001).
Maltese: It-trattament b'vernakalant qaleb b'mod effettiv il-fibrillazzjoni atrijali għal ritmu sinusali (47.0 % vernakalant, 14.0 % plaċebo; valur P = 0.0001).
English: The osmolality of the medicinal product is controlled between the following range: 270-320 mOsmol/kg
Maltese: L-osmolalità tal-prodott mediċinali hija kkontrollata fil-medda li ġejja: 270-320 mOsmol/kg
English: The Cmax and AUC were dose proportional between 0.5 mg/kg and 5 mg/kg.
Maltese: Is-Cmax u l-AUC kienu proporzjonali mad-doża bejn 0.5 mg/kg u 5 mg/kg.
English: Vernakalant is a moderate, competitive inhibitor of CYP2D6.
Maltese: Vernakalant huwa inibitur moderat, kompetittiv ta' CYP2D6.
English: Suomi/Finland
Maltese: Suomi/Finland Correvio
English: †Cochran-Mantel-Haenszel test
Maltese: > 3 sigħat sa ≤ 7 ijiem †Test ta' Cochran-Mantel-Haenszel
English: Correvio Tel: +49 69 33 29 62 76
Maltese: Tel: +49 69 33 29 62 76
English: Correvio Tlf: +45 8082 6022
Maltese: Tlf: +45 8082 6022
English: The free fraction of vernakalant in human serum is 53-63 % at concentration range of 1-5 μg/ml.
Maltese: Il-frazzjoni libera ta' vernakalant fis-serum uman hija 53-63% f'medda ta' konċentrazzjoni ta' 1-5 μg/ml.
English: Contains citric acid, sodium chloride, water for injections, sodium hydroxide (E524).
Maltese: TA' EĊĊIPJENTI Fih citric acid, sodium chloride, ilma għall-injezzjonijiet, sodium hydroxide (E524).
English: BRINAVESS contains the active substance vernakalant hydrochloride.
Maltese: BRINAVESS fih is-sustanza attiva vernakalant hydrochloride.
English: The initial dose is 339 mg (84.7 ml of 4 mg/ml solution).
Maltese: Id-doża inizjali hi ta' 339 kg (84.7 ml ta' soluzzjoni ta' 4 mg/ml).
English: Correvio Tel: +46 8 408 38440
Maltese: Tel: +46 8 408 38440
English: BRINAVESS contains sodium
Maltese: BRINAVESS fih sodium
English: Step 2: Dilution of concentrate
Maltese: Pass 2: Dilwizzjoni tal-konċentrat
English: Correvio Tél: +33 1 77 68 89 17
Maltese: Tél: +33 1 77 68 89 17
English: Correvio Tel: +44 203 002 8114
Maltese: Tel: +44 203 002 8114
English: Date of first authorisation: 01 September 2010 Date of latest renewal: 06 September 2015
Maltese: Data tal-aħħar tiġdid: 1 ta' Settembru 2015
English: Pharmacotherapeutic group: Cardiac therapy, other antiarrhythmics class I and III; ATC code: C01BG11.
Maltese: Terapija kardijaka, anti-arritmiċi oħrajn klassi I u III; Kodiċi ATC:
English: Does the patient have a systolic blood pressure < 100 mm Hg?
Maltese: Il-pazjent għandu pressjoni sistolika ta' < 100 mm Hg?
English: Studies in animal have shown malformations after repeated oral exposure (see section 5.3).
Maltese: Studji f'annimali wrew malformazzjonijiet wara esponiment orali ripetut (ara sezzjoni 5.3).
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100).
English: Table 2: Conversion of Atrial Fibrillation to Sinus Rhythm in ACT I and ACT III Duration of
Maltese: Tabella 2: Qalba ta' Fibrillazzjoni Atrijali għal Ritmu Sinusali f'ACT I u ACT III Tul ta' Żmien tal
English: • Risk management plan (RMP)
Maltese: • Pjan tal ġestjoni tar-riskju (RMP)
English: • taste disturbances
Maltese: Disturbi vaskulari
English: 10 mL: EU/1/10/645/001
Maltese: EU/1/10/645/001
English: Vernakalant was studied in 116 pts with atrial fibrillation (3 hrs to 48 hrs) including patients with hypertension (74.1 %), IHD (19 %), valvular heart disease (3.4 %) and CHF (17.2 %).
Maltese: Vernakalant ġie studjat f'116-il pazjent b'fibrillazzjoni atrijali (3 sigħat sa 48 siegħa) fosthom pazjenti bi pressjoni għolja (74.1 %), IHD (19 %), mard valvulari tal-qalb (3.4 %) u CHF (17.2 %).
English: Patients with body weight > 113 kg:
Maltese: Pazjenti b'piż tal-ġisem > 113 kg:
English: Sodium hydroxide (E524) (for pH-adjustment)
Maltese: Sodium hydroxide (E524) (għall-aġġustament tal-pH) 6.2 Inkompatibbiltajiet
English: Correvio Tel: +31 20 808 32 06
Maltese: Tel: +31 20 808 32 06
English: Each ml of the diluted solution contains approximately 3.5 mg of sodium (sodium chloride 9 mg/ml (0.9 %) solution for injection), 0.64 mg sodium (5 % glucose solution for injection) or 3.2 mg sodium (Lactated Ringers solution for injection).
Maltese: Kull ml tas-soluzzjoni dilwita fih madwar 3.5 mg ta' sodium (sodium chloride 9 mg/ml (0.9%) soluzzjoni għal injezzjoni), 0.64 mg sodium (soluzzjoni għall-injezzjoni ta' 5 % glucose) jew 3.2 mg sodium (soluzzjoni għall-injezzjoni ta' Lactated Ringers).
English: By 24 hours there appears to be insignificant levels of vernakalant.
Maltese: Sa 24 siegħa jidher li jkun hemm livelli insinifikanti tal-mediċina ta' vernakalant.
English: • Acute coronary syndrome (including myocardial infarction) within the last 30 days.
Maltese: • Sindrome koronarju akut (inkluż infart mijokardijaku) fl-aħħar 30 jum.
English: - Alert HCP on BRINAVESS contraindications:
Maltese: - Wissi lill-HCP dwar kontraindikazzjonijiet ta' BRINAVESS:
English: Patients > 100 kg: 30 ml of BRINAVESS 20 mg/ml is added to 120 ml of diluent.
Maltese: Pazjenti > 100 kg: 30 ml ta' BRINAVESS 20 mg/ml huma miżjudin ma' 120 ml ta' dilwent.
English: The higher cardioversion rate in SPECTRUM as compared to clinical phase 3 studies (70.2% vs 47% to 51%) is correlated with a shorter duration of the duration of the index atrial fibrillation period (median duration of 11.1 hours in SPECTRUM vs 17.7 to 28.2 hours in clinical studies).
Maltese: 47 % għal 51 %) hija korelatata mad-dewmien iqsar tat-tul tal-perijodu ta' fibrillazzjoni atrijali (tul medjan ta' 11.1 sigħat fi SPECTRUM kontra 17.7 sa 28.2 sigħat fl-istudji kliniċi).
English: • choking sensation
Maltese: • sensazzjoni ta' faga
English: Conversion of atrial fibrillation in patients with longer-duration atrial fibrillation (> 7 days and ≤ 45 days) assessed as a secondary efficacy endpoint in a total of 185 patients did not show statistically significant differences between vernakalant and placebo.
Maltese: Il-qlib tal-fibrillazzjoni atrijali f'pazjenti li kellhom fibrillazzjoni atrijali li damet aktar fit-tul (> 7 ijiem u ≤ 45 jum) ivvalutat bħala punt ta' tmiem sekondarju tal-effikaċja f'total ta' 185 pazjent ma weriex differenzi statistikament sinifikanti bejn vernakalant u plaċebo.
English: Clinical Trial Design: The clinical effect of vernakalant in the treatment of patients with atrial fibrillation has been evaluated in three, randomised, double-blind, placebo-controlled studies, (ACT I, ACT II and ACT III) and in an active comparator trial versus intravenous amiodarone (AVRO).
Maltese: Disinn tal-Provi Kliniċi: L-effett kliniku ta' vernakalant fit-trattament ta' pazjenti b'fibrillazzjoni atrijali ġie evalwat fi tliet studji randomizzati, double-blind, ikkontrollati bi plaċebo, (ACT I, ACT II u ACT III) u fi prova ta' komparatur attiv kontra amiodarone fil-vini (AVRO).
English: • the electrical activity of your heart (uncommon)
Maltese: • l-attività elettrika ta' qalbek (mhux komuni).
English: Each vial of 200 mg contains approximately 1.4 mmol (32 mg) sodium.
Maltese: Kull kunjett ta' 200 mg fih madwar 1.4 mmol (32 mg) sodium.
English: Efficacy was studied in a total of 390 haemodynamically stable adult patients with short duration atrial fibrillation including patients with hypertension (40.5 %), ischaemic heart disease (12.8 %), valvular heart disease (9.2 %) and CHF (10.8 %).
Maltese: L-effikaċja ġiet studjata f'total ta' 390 pazjent adult emodinamikament stabbli b'fibrillazzjoni atrijali li ma tantx damet fosthom pazjenti bi pressjoni għolja (40.5%), mard tal-qalb iskemiku (12.8%), mard valvulari tal-qalb (9.2%) u CHF (10.8%).
English: Common: Paraesthesia; dizziness
Maltese: Komuni: Parasteżija; sturdament
English: Treatment with vernakalant, converted 51.7 % of patients to SR at 90 minutes versus 5.2 % with amiodarone resulting in a significantly faster conversion rate from AF to SR within the first 90 minutes compared to amiodarone (log-rank P-value < 0.0001).
Maltese: It-trattament b'vernakalant qaleb 51.7 % tal-pazjenti għal SR wara 90 minuta kontra 5.2 % b'amiodarone u dan jirriżulta f'rata ta' konverżjoni konsiderevolment aktar mgħaġġla minn AF għal SR fl-ewwel 90 minuta meta mqabbel ma' amiodarone (valur P log-rank <0.
English: If patients who received electrical cardioversion, intravenous antiarrhythmics or oral propafenone/flecainide within 90 minutes from the start of BRINAVESS infusion are regarded as treatment failures in addition to patients who did not convert for one minute within 90 minutes, the conversion rate among the 2,009 patients who received BRINAVESS was 67.3 % (1,352/2,009).
Maltese: Jekk pazjenti li rċevew kardjoverżjoni elettrika, antiarritmiċi intravenużi jew propafenone orali /flecainide fi żmien 90 minuta mill-bidu tal-infużjoni ta' BRINAVESS huma meqjusa bħala trattamenti falluti flimkien ma' pazjenti li ma kkonvertewx għal minuta waħda fi żmien 90 minuta, ir-rata ta' konverżjoni fost 2,009 pazjenti li rċevew BRINAVESS kienet ta' 67.3% (1,352/2,009).
English: Resumption or initiation of oral maintenance antiarrhythmic therapy after this time period can be considered (see sections 4.3 and 4.4).
Maltese: Wara dan il-perjodu ta' ħin jistgħu jiġu kkunsidrati ttkomplija jew il-bidu ta' terapija antiarritmika orali ta' manteniment (ara sezzjonijiet 4.3 u 4.4).
English: Each vial of 500 mg contains approximately 3.5 mmol (80 mg) of sodium.
Maltese: Kull kunjett ta' 500 mg fih madwar 3.5 mmol (80 mg) sodium.
English: Common: Bradycardia**; atrial flutter** Uncommon: Sinus arrest; ventricular tachycardia; palpitations; bundle branch block left; ventricular extrasystoles; AV block first degree; AV block complete; bundle branch block right; sinus bradycardia; ECG QRS complex prolonged; cardiogenic shock
Maltese: Komuni: Bradikardija**; palpitazzjonijiet atrijali** Mhux komuni: Waqfa sinusali; takikardija ventrikulari; palpitazzjonijiet; imblokk fil-bundle branch tax-xellug; extrasistoli ventrikulari; imblokk AV tal-ewwel grad; imblokk AV komplet; imblokk fil-bundle branch tal-lemin; bradikardija sinusali; titwil filkumpless tal-ECG QRS; xokk kardjoġeniku
English: Efficacy in patients who developed atrial fibrillation post cardiac surgery (ACT II) Efficacy was studied in patients with atrial fibrillation after cardiac surgery in ACT II, a phase 3, double-blind, placebo-controlled, parallel group study (ACT II) in 150 patients with sustained atrial fibrillation (3 hours to 72 hours duration) that occurred between 24 hours and 7 days post coronary artery bypass graft and/or valvular surgery.
Maltese: L-effikaċja f'pazjenti li żviluppaw fibrillazzjoni atrijali wara operazzjoni tal-qalb (ACT II) L-effikaċja ġiet studjata f'pazjenti li kellhom fibrillazzjoni atrijali wara operazzjoni tal-qalb f'ACT II, studju ta' grupp parallel, double-blind, ikkontrollat bil-plaċebo, ta' fażi 3 (ACT II) f'150 pazjent b'fibrillazzjoni atrijali sostnuta (li damet minn 3 sigħat sa 72 siegħa) li seħħet bejn 24 siegħa u 7 ijiem wara coronary artery bypass graft u/jew operazzjoni valvulari.
English: How to store BRINAVESS Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Vernakalant given by infusion is not expected to perpetrate meaningful drug drug interactions due to the rapid distribution and transient exposure, low protein binding, lack of inhibition of other CYP P450 enzymes tested (CYP3A4, 1A2, 2C9, 2C19 or 2E1) and lack of P-glycoprotein inhibition in a digoxin transport assay.
Maltese: Vernakalant mogħti b'infużjoni, mhuwiex mistenni li jqanqal interazzjonijiet sinifikanti talmediċina minħabba d-distribuzzjoni rapida u l-espożizzjoni temporanja, twaħħil baxx mal-proteina, nuqqas ta' inibizzjoni ta' enzimi ta' CYP P450 oħrajn ittestjati (CYP3A4, 1A2, 2C9, 2C19 jew 2E1) u nuqqas ta' inibizzjoni ta' P-glycoproteina f'assaġġ ta' trasport ta' digossina.