FrancophonIA/ELRC3.0 huggingface dataset:
English: Protein C plays a major role in prevention of excessive clot formation thus, prevent and/or treat intravascular thrombosis.
Maltese: Il-proteina Ċ għandha rwol importanti fil-prevenzjoni tal-ħolqien eċċessiv ta' emboli u b'hekk, timpedixxi u/jew tikkura trombożi intravaskulari.
English: CEPROTIN 1000 IU Powder for solution for injection Human Protein C IV
Maltese: IU Trab għal soluzzjoni għall-injezzjoni Proteina Ċ tal-Bniedem IV
English: As solvent
Maltese: TA' EĊĊIPJENTI
English: • while initiating coumarin (anticoagulant medication, blood thinner) therapy
Maltese: • waqt li tinbeda terapija b'kumarin (medikazzjoni kontra l-koagulazzjoni tad-demm, traqqiq tad-demm)
English: Additionally, CEPROTIN may be used to treat a rare complication of a blood thinner medication (anticoagulant medication named coumarin) which may result in severe skin lesion (necrosis).
Maltese: Barra minn hekk, CEPROTIN jista' jintuża biex tiġi kkurata komplikazzjoni rari ta' medikazzjoni li traqqaq id-demm (medikazzjoni kontra l-koagulazzjoni tad-demm imsejħa coumarin) li tista' tirriżulta f'leżjonijiet severi tal-ġilda (nekrożi).
English: CEPROTIN is intended for intravenous administration (infusion into a vein).
Maltese: CEPROTIN huwa maħsub sabiex jingħata ġol-vini (infużjoni ġo vina).
English: 500 IU and 1000 IU: CEPROTIN powder comes in vials of neutral glass of either hydrolytic type I (500 IU) or hydrolytic type II (1000 IU).
Maltese: IU: It-trab ta' CEPROTIN jiġi f'kunjetti magħmulin minn ħġieġ newtrali tat-tip idrolitiku I (500
English: In case of acute thrombosis CEPROTIN may be administered to you every 6 hours.
Maltese: F'każ ta' trombożi akuta CEPROTIN jista' jingħatalek kull 6 sigħat.
English: Such symptoms may constitute an allergic reaction to any of the components, to mouse protein or heparin.
Maltese: Tali sintomi jistgħu jirrappreżentaw reazzjoni allerġika għal xi wieħed mill-komponenti, għall-proteina tal-ġrieden jew l-eparina.
English: Twelve courses of short-term prophylaxis prior to surgery or invasive therapy and 7 courses of long-term prophylaxis were included in the efficacy analyses.
Maltese: Tnax-il kors ta' profilassi fuq perjodu qasir qabel il-kirurġija jew terapija invażiva u 7 korsijiet ta' profilassi fuq tul ta' żmien ġew inklużi f'analiżi tal-effikaċja.
English: Single dose toxicity testing showed that even doses of several times the recommended human dosage per kilogram body weight (10-fold) did not result in toxic effects on rodents.
Maltese: L-ittestjar tat-tossiċità b'doża waħda wera li anke dożi li huma diversi drabi aktar mid-doża rakkomandata għal bniedem, għal kull kilogramm ta' piż korporali (10 darbiet), ma rriżultax f'effetti tossiċi f'annimali li jgerrmu.
English: If you receive prophylactic administration of protein C, higher trough levels may be warranted in situations of an increased risk of thrombosis (such as infection, trauma, or surgical intervention).
Maltese: Jekk inti tirċievi amministrazzjoni profilattika ta' proteina C, jistgħu jkunu meħtieġa livelli minimi aktar għoljin f'sitwazzjonijiet ta' riskju akbar ta' trombożi (bħal infezzjoni, trawma, jew intervent kirurġiku).
English: The product reconstituted with 5 ml of Sterilised Water for Injections contains approximately 100 IU/ml human protein C.
Maltese: Il-prodott li jiġi rikostitwit b'5 ml ilma għall-injezzjoni jkun fih madwar 100 IU/ml ta' proteina Ċ.
English: - if you are allergic to Human Protein C or any of the other ingredients of this medicine (listed in section 6) including mouse protein or heparin.
Maltese: - jekk int allerġiku għall-Proteina Ċ tal-bniedem jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6) inkluż il-proteina tal-ġrieden jew l-eparina.
English: 5.3 Preclinical safety data
Maltese: Sensittività Eċċessiva
English: Take special care with CEPROTIN if symptoms of allergy occur.
Maltese: Oqgħod attent ħafna b'CEPROTIN jekk jidhru sintomi ta' allerġija.
English: Human albumin Sodium chloride Sodium citrate.
Maltese: Albumina tal-bniedem Sodium chloride Sodium citrate: 2H20
English: Treatment with CEPROTIN should be initiated under the supervision of a physician experienced in substitution therapy with coagulation factors/inhibitors where monitoring of protein C activity is feasible.
Maltese: It-trattament b'CEPROTIN għandu jinbeda taħt superviżjoni ta' tabib b'esperjenza f'terapija ta' sostituzzjoni b'fatturi/inibitturi ta' koagulazzjoni fejn sorveljanza tal-attività tal-proteina Ċ hija possibbli.
English: Hypersensitivity Rash
Maltese: L-Awstrija
English: The product reconstituted with 10 ml of Sterilised Water for Injections contains approximately 100 IU/ml human protein C.
Maltese: Il-prodott li jiġi rikostitwit b'10 ml ilma għall-injezzjoni jkun fih madwar 100 IU/ml ta' proteina Ċ.
English: Pregnancy and breast-feeding
Maltese: Proteina Ċ tal-bniedem
English: Protein C is a vitamin K-dependent anticoagulant glycoprotein which is synthesised in the liver.
Maltese: Il-proteina Ċ li tinsab f'CEPROTIN hija kostitwent normali fil-plażma tal-bniedem u taġixxi bħala proteina Ċ endoġenika.
English: If you are switched to permanent prophylaxis with oral anticoagulants, protein C replacement is to be discontinued only when stable anticoagulation is obtained (see “Important information about some of the ingredients of CEPROTIN”).
Maltese: Jekk tiġi mdawwar għal profilassi permanenti b'sustanzi orali kontra l-koagulazzjoni tad-demm, is-sostituzzjoni tal-proteina C għandha titwaqqaf biss meta tinkiseb antikoagulazzjoni stabbli (ara “Tagħrif importanti dwar xi wħud mis-sustanzi ta' CEPROTIN”).
English: Each pack also contains one transfer needle and one filter needle.
Maltese: Kull pakkett fih ukoll labra tat-trasferiment u labra tal-filtru.
English: Pruritus
Maltese: TIKKETTAR
English: General disorders and administration site conditions injection site reaction
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata reazzjoni fis-sit tal-injezzjoni
English: You should be aware of the early signs of allergic reactions such as burning and stinging at the injection site, chills, flushing, rash, hives, breathing difficulty, nausea, headache, lethargy, low blood pressure, and tightness of the chest.
Maltese: Inti għandek tkun konxju tas-sinjali bikrija ta' reazzjonijiet allerġiċi bħal ngħidu aħna ħruq u tingiż fil-post tal-injezzjoni, kesħa, fwawar, raxx, ħorriqija, diffikultà fit-teħid tan-nifs, nawsja, uġigħ ta' ras, ħedla, pressjoni baxxa tad-demm, u wġigħ tas-sider.
English: CEPROTIN will be administered to you by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections.
Maltese: CEPROTIN jingħata b'injezzjoni ġol-vini wara rikostituzzjoni tat-trab għal soluzzjoni għall-injezzjoni b'Ilma Sterilizzat għall-Injezzjonijiet.
English: What CEPROTIN looks like and contents of the pack
Maltese: Kif jidher CEPROTIN u l-kontenut tal-pakkett
English: Powder and solvent for solution for injection One transfer needle and one filter needle
Maltese: Labra waħda ta' trasferiment u labra tal-filtru waħda
English: In rare and exceptional cases, subcutaneous infusion of 250-350 IU/kg was able to produce therapeutic protein C plasma levels in patients with no intravenous access.
Maltese: Fil-bidu għandha tinkiseb attività tal-proteina Ċ ta' 100% u l-attività għandha tinżamm 'il fuq minn 25% għat-tul tal-kura.
English: VIAL LABEL
Maltese: TIKKETTA TAL-KUNJETT
English: CEPROTIN is administered by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections.
Maltese: Bħala solvent jintuża Ilma Sterilizzat għall-Injezzjonijiet.
English: The potency (IU) is determined using a chromogenic substrate method against the World Health Organisation (WHO) International standard.
Maltese: Il-qawwa (IU) tiġi stabbilita billi jintuża metodu tas-sostratt kromoġeniku li jitqabbel mal-istandard Internazzjonali tal-Organizzazzjoni Dinjija tas-Saħħa (WHO).
English: CEPROTIN proved to have no mutagenic potential in the Ames test performed.
Maltese: CEPROTIN ġie ppruvat li m'għandu ebda potenzjal mutaġeniku fit-test ta' Ames li twettaq.
English: AF recurrence was 63.5% versus 42%, respectively.
Maltese: Irrikorrenza ta' FA kienet ta' 63.5 % kontra 42 % rispettivament.
English: • Severe renal impairment (CrCl <30 ml/min)
Maltese: • Indeboliment renali sever (CrCl <30 ml/min)
English: Interactions (see section 4.5)
Maltese: Interazzjonijiet (ara sezzjoni 4.5)
English: • rifampicin - for tuberculosis.
Maltese: • rifampicin - għat-tuberkulosi.
English: • QTc Bazett interval ≥500 milliseconds
Maltese: • Intervall ta' QTc Bazett ta' ≥ 500 millisekonda
English: Pharmacotherapeutic group: cardiac therapy, antiarrhythmics class III, ATC code: C01BD07
Maltese: Kategorija farmakoterapewtika: terapija kardijaka, antiarritmiċi tal-klassi III, Kodiċi ATC: C01BD07
English: Date of first authorisation: 26 November 2009 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 26 Novembru 2009 Data tal-aħħar tiġdid:
English: • Bradycardia <50 beats per minute (bpm)
Maltese: • Bradikardija <50 taħbita fil-minuta (bpm)
English: Rare (1/10,000 to
Maltese: Rari (1/10,000 sa
English: The active substance is dronedarone.
Maltese: Is-sustanza attiva hija dronedarone.
English: Losartan and other Angiotensin II Receptor Antagonists (AIIRAs)
Maltese: Losartan u Antagonisti tar-Riċetturi Anġjotensin II (AIIRAs, Angiotensin II Receptor Antagonists) oħra
English: Interaction with metformin (OCT1 and OCT2 substrate)
Maltese: Interazzjoni ma' metformin (sustrat ta' OCT1 u OCT2)
English: Do not take MULTAQ:
Maltese: Tiħux MULTAQ jekk:
English: Dronedarone has no significant potential to inhibit CYP 1A2, CYP 2C9, CYP 2C19, CYP 2C8 and CYP 2B6.
Maltese: Dronedarone m'għandu ebda potenzjal sinifikanti biex jinibixxi CYP 1A2, CYP 2C9, CYP 2C19, CYP 2C8 u CYP 2B6.
English: Bradycardia (see sections 4.3 and
Maltese: Bradikardija (ara sezzjoni 4.3)
English: Common (1/100 to
Maltese: Komuni (1/100 sa
English: • telithromycin, erythromycin, or clarithromycin (antibiotics for infections),
Maltese: • telithromycin, erythromycin jew clarithromycin (antibijotiċi għall-infezzjonijiet),
English: • sirolimus, tacrolimus, everolimus and cyclosporine (used after a transplant),
Maltese: • sirolimus, tacrolimus, everolimus u cyclosporine (li jintużaw wara trapjant),
English: More gastrointestinal adverse events, mainly diarrhoea, were observed in the dronedarone group (12.9% versus 5.1%).
Maltese: Ġew osservati iżjed avvenimenti avversi gastrointestinali, l-iżjed dijarea, fil-grupp ta' dronedarone (12.9 % kontra 5.1 %).
English: Interaction with clopidogrel
Maltese: Interazzjoni ma' clopidogrel
English: Uncommon (1/1,000 to
Maltese: Mhux komuni (1/1,000 sa
English: Vitamin K antagonists
Maltese: Antagonisti tal-Vitamina K
English: Sanofi Winthrop Industrie 1 rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc Cedex - France
Maltese: Sanofi Winthrop Industrie 1 rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc Cedex - Franza
English: If QTc Bazett interval is ≥500 milliseconds, dronedarone should be stopped (see section 4.3).
Maltese: Jekk l-intervall QTc Bazett huwa ≥ 500 millisekondi, dronedarone għandu jitwaqqaf (ara sezzjoni 4.3).
English: EU/1/09/591/001 20 film-coated tablets EU/1/09/591/002 50 film-coated tablets EU/1/09/591/003 60 film-coated tablets EU/1/09/591/004 100x1 film-coated tablets
Maltese: EU/1/09/591/001 20 pillola miksija b'rita EU/1/09/591/002 50 pillola miksija b'rita EU/1/09/591/003 60 pillola miksija b'rita EU/1/09/591/004 100x1 pilloli miksijin b'rita
English: Interaction with theophylline (CYP 1A2 substrate)
Maltese: Interazzjoni ma' theophylline (sustrat ta' CYP 1A2)
English: Table 1: Adverse reactions
Maltese: Tabella 1:Reazzjonijiet avversi
English: Patients with permanent atrial fibrillation
Maltese: Pazjenti b'fibrillazzjoni atrijali permanenti
English: Interaction with P-gp substrates Digoxin
Maltese: Interazzjoni ma' sustrati ta' P-gp Digoxin
English: No interaction was observed between dronedarone and metformin, an OCT1 and OCT2 substrate.
Maltese: Ebda interazzjoni ma ġiet osservata bejn dronedarone u metformin, sustrat ta' OCT1 u OCT2.
English: Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès et Lagrave F-33565 Carbon Blanc Cedex France
Maltese: Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc cedex Franza
English: • nefazodone (a medicine for depression),
Maltese: • nefazodone (mediċina għad-depressjoni),
English: Dermatitis allergic Dermatitis
Maltese: Reazzjoni ta' fotosensittività Dermatite allerġika Dermatite
English: Dronedarone displays indirect antiadrenergic effects and partial antagonism to adrenergic stimulation.
Maltese: Dronedarone juri, b'mod mhux dirett, effetti antiadrinerġiċi u antagoniżmu parzjali għal stimulazzjoni adrinerġika.
English: Antidepressants
Maltese: Antidipressivi
English: Interaction with omeprazole (CYP 2C19 substrate)
Maltese: Interazzjoni ma' omeprazole (sustrat ta'CYP 2C19)
English: • terfenadine (a medicine for allergies),
Maltese: • terfenadine (mediċina għall-allerġiji),
English: The other ingredients in the tablet core are hypromellose (E464), maize starch, crospovidone (E1202), poloxamer 407, lactose monohydrate (see section 2 under ‘MULTAQ contains lactose'), colloidal anhydrous silica, magnesium stearate (E572).
Maltese: Is-sustanzi l-oħra fil-qalba tal-pillola huma hypromellose (E464), maize starch, crospovidone (E1202), poloxamer 407, lactose monohydrate (ara sezzjoni 2 taħt ‘MULTAQ fih il-lactose'), colloidal anhydrous silica, magnesium stearate (E572).
English: The mean exposure of the N-debutyl metabolite is decreased by 47% (see section 4.2).
Maltese: L-espożizzjoni medja tal-metabolit N-debutyl tonqos b'47% (ara sezzjoni 4.2).
English: Tablet coat
Maltese: Sess Maskili
English: Anaphylactic reactions including angioedema
Maltese: Reazzjonijiet anafilattiċi inkluż lanġjoedima
English: • ritonavir (a medicine for AIDS infection),
Maltese: • ritonavir (mediċina għall-infezzjoni tal-AIDS),
English: • St John's Wort - a herbal medicine for depression,
Maltese: • St John's Wort - mediċina mill-ħxejjex għad-depressjoni,
English: Each tablet also contains 41.65 mg of lactose (as monohydrate).
Maltese: Kull pillola fiha wkoll 41.65 mg ta' lactose (bħala monohydrate).
English: • some medicines for fungal infections such as ketoconazole, voriconazole, itraconazole or posaconazole,
Maltese: • xi mediċini għall-infezzjonijiet tal-fungu bħal ketoconazole, voriconazole, itraconazole jew posaconazole,
English: Patients ranged in age from 28 to 90 years, 49% were more than 65 years old.
Maltese: L-età tal-pazjenti varjat minn 28 sa 90 sena, 49 % kellhom aktar minn 65 sena.
English: There is no specific antidote available.
Maltese: M'hemmx disponibbli antidotu speċifiku.
English: Maintenance of sinus rhythm
Maltese: Il-manteniment tar-ritmu sinoatrijali
English: The other ingredients in the tablet coat are hypromellose (E464), macrogol 6000, titanium dioxide (E171), carnauba wax (E903).
Maltese: Is-sustanzi l-oħra fil-kisja tal-pillola huma hypromellose (E464),, macrogol 6000, titanium dioxide (E171), carnauba wax (E903).
English: Treatment with Class I or III antiarrhythmics (such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone) must be stopped before starting dronedarone.
Maltese: Il-kura b'antiarritmiċi ta' Klassi I jew III (bħal flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone) għandha titwaqqaf qabel ma tibda tieħu dronedarone.
English: Potent CYP3A4 inducers such as rifampicin, phenobarbital, carbamazepine, phenytoin or St John's Wort are not recommended.
Maltese: Indutturi qawwija ta' CYP3A4 bħal rifampicin, phenobarbital, carbamazepine, phenytoin jew St John's Wort mhumiex rakkomandati.
English: • some medicines for epilepsy called phenobarbital, carbamazepine or phenytoin,
Maltese: • xi mediċini għall-epilessija msejħa phenobarbital, carbamazepine jew phenytoin,,
English: Calcium antagonists
Maltese: Antagonisti tal-calcium
English: Interaction with medicinal products metabolised by CYP 2D6 Beta-blockers
Maltese: Interazzjoni ma' prodotti mediċinali mmetabolizzati minn CYP 2D6 Imblokkaturi tar-riċetturi beta
English: Beta-blockers and calcium antagonists
Maltese: Imblokkaturi tar-riċetturi beta u antagonisti tal-calcium
English: Take:
Maltese: Tel.:
English: Dronedarone is a moderate inhibitor of CYP 3A4, a mild inhibitor of CYP 2D6 and a potent inhibitor of P-glycoproteins (P-gp).
Maltese: Dronedarone huwa inibitur moderat ta' CYP 3A4, inibitur ħafif ta' CYP 2D6 u inibitur qawwi talglycoproteins-P (P-gp).
English: • Severe hepatic impairment
Maltese: • Indeboliment epatiku sever
English: Patients ranged in age from 27 to 96 years, 68% were more than 65 years old.
Maltese: L-età tal-pazjenti varjat minn 27 sa 96 sena, 68 % kellhom aktar minn 65 sena.
English: Repeated doses of diltiazem (240 mg twice daily), verapamil (240 mg once daily) and nifedipine (20 mg twice daily) resulted in an increase in dronedarone exposure of 1.7-, 1.4- and 1.2-fold, respectively.
Maltese: Dożi ripetuti ta' diltiazem (240 mg darbtejn kuljum), verapamil (240 mg darba kuljum) u nifedipine (20 mg darbtejn kuljum) irriżultaw f'żieda fl-espożizzjoni ta' dronedarone ta' 1.7-,, 1.4- u 1.2- darbiet rispettivament.
English: The in vitro plasma protein binding of dronedarone and its N-debutyl metabolite is 99.7% and 98.5% respectively and is not saturable.
Maltese: L-irbit in vitro ta' dronedarone u l-metabolit tiegħu N-debutyl mal-proteini fil-plażma hu ta' 99.7 % u 98.5 % rispettivament u mhuwiex saturabbli.
English: Erythemas (including erythema and rash erythematous) Eczema
Maltese: Eritemi(li jinkludu eritema u raxx eritematożu) Ekżema
English: The majority had hypertension (86%) and structural heart disease (60%) (including coronary artery disease: 30%; congestive heart failure (CHF): 30%; LVEF<45%: 12%).
Maltese: Il-parti l-kbira kellhom l-ipertensjoni (86 %) u mard strutturali fil-qalb (60 %) (li jinkludi mard flarterji koronarji: 30 %; insuffiċjenza konġestiva tal-qalb (CHF): 30 %; LVEF < 45 %: 12 %).
English: Dronedarone (400 mg twice daily) increased digoxin exposure by 2.5-fold by inhibiting P-gp transporter.
Maltese: Dronedarone (400 mg darbtejn kuljum) żied l-espożizzjoni ta' digoxin b'2.5 darbiet permezz talinibizzjoni tat-trasportatur P-gp.
English: Frequencies are defined as: 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); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma mfissra kif ġejjin: komuni ħafna (≥1/10), komuni (≥1/100 to <1/10); mhux komuni (≥1/1,000 to <1/100); rari (≥1/10,000 to <1/1,000); rari ħafna(<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: A potential pharmacodynamic interaction can also be expected with beta-blockers, calcium antagonists and digitalis.
Maltese: Jista' jkun hemm ukoll il-potenzjal ta' interazzjoni farmakodinamka ma' imblokkaturi tar-riċetturi beta, antagonisti tal-calcium u digitalis.
English: Dronedarone and/or its metabolites also have been shown to inhibit transport proteins of the Organic Anion Transporter (OAT), Organic Anion Transporting Polypeptide (OATP) and Organic Cation Transporter (OCT) families in vitro.
Maltese: In vitro, ġie muri wkoll li dronedarone u/jew il-metaboliti tiegħu jinibixxu l-proteini tat-trasport tal-familji tal-Organic Anion Transporter (OAT), Organic Anion Transporting Polypeptide (OATP) u l-Organic Cation Transporter (OCT).
English: Dronedarone (600 mg twice daily) increased by 1.2-fold S-warfarin with no change in R-warfarin and only a 1.07 increase in International Normalised Ratio (INR).
Maltese: Dronedarone (600 mg darbtejn kuljum) żied b'1.2 darbiet S-warfarin bla ebda tibdil f'R-warfarin u żieda biss ta' 1.07 fl-International Normalised Ratio (INR).
English: As compared to placebo, dronedarone lowered the risk of first AF/AFL recurrence during the 12-month study period by 25% (p = 0.00007).
Maltese: Meta mqabbel ma' plaċebo, dronedarone naqqas ir-riskju li terġa' sseħħ xi FA/TA waqt il-perijodu ta' studju ta' 12-il xahar b'25 % (p = 0.00007).
English: Dronedarone is primarily metabolised by CYP 3A4 (see section 5.2).
Maltese: Prinċipalment dronedarone huwa metabolizzat minn CYP 3A4 (ara sezzjoni 5.2).
English: Medicinal products inducing torsades de pointes such as phenothiazines, cisapride, bepridil, tricyclic antidepressants, certain oral macrolides (such as erythromycin), terfenadine and Class I and III antiarrhythmics are contraindicated because of the potential risk of proarrhythmia (see section 4.3).
Maltese: Prodotti mediċinali li jikkawżaw torsades de pointes bħal phenothiazines, cisapride, bepridil, antidipressivi triċikliċi, ċerti makrolidi orali (bħal erythromycin), terfenadine u antiarritmiċi ta' Klassi I u III huma kontra-indikati minħabba r-riskju potenzjali ta' proarritmija (ara sezzjoni 4.3).
English: The terminal elimination half-life of dronedarone is around 25-30 hours and that of its N-debutyl metabolite around 20-25 hours.
Maltese: Il-half-life ta' eliminazzjoni terminali hu ta' madwar 25 - 30 siegħa u dak tal-metabolit tiegħu N-debutyl ta' madwar 20-25 siegħa.
English: The DIONYSOS study compared the efficacy and safety of dronedarone (400 mg twice daily) versus amiodarone (600 mg daily for 28 days, then 200 mg daily thereafter) over 6 months.
Maltese: L-istudju DIONYSOS qabbel l-effikaċja u s-sigurtà ta' dronedarone (400 mg darbtejn kuljum) ma' amiodarone (600 mg kuljum għal 28 ġurnata, imbagħad issir 200 mg kuljum) fuq perijodu ta' 6 xhur.
English: Calcium antagonists, diltiazem and verapamil, are substrates and/or moderate inhibitors of CYP 3A4.
Maltese: L-antagonisti tal-calcium, diltiazem u verapamil, huma sustrati u/jew inibituri moderati ta' CYP 3A4.
English: The steady state mean dronedarone Cmax is 84-147 ng/ml and the exposure of the main N-debutyl metabolite is similar to that of the parent compound.
Maltese: Il-medja fl-istat fiss tas-Cmax ta'dronedarone hi ta' 84-147 ng/ml u l-espożizzjoni tal-aktar metabolit importanti N-debutyl metabolite huwa simili għas-sustanza oriġinali.
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: The N-debutyl metabolite exhibits pharmacodynamic activity but is 3 to 10-times less potent than dronedarone.
Maltese: Il-metabolit N-debutyl juri attività farmakodinamika iżda huwa 3 sa 10-darbiet inqas b'saħħtu minn dronedarone.
English: Repeated doses of 200 mg ketoconazole daily resulted in a 17-fold increase in dronedarone exposure.
Maltese: Dożi ripetuti ta' 200 mg ketoconazole kuljum irriżulta f'żieda ta' 17-il darba iżjed fl-espożizzjoni ta' dronedarone.
English: The most common co-morbidities were hypertension (56.8%) and structural heart disease (41.5%) including coronary heart disease (21.8%).
Maltese: L-aktar mard komuni li kienu preżenti fl-istess ħin kienu l-ipertensjoni (56.8 %) u mard strutturali fil-qalb (41.5 %) inkluż il-mard koronarju tal-qalb (21.8 %).
English: Since dronedarone is a weak inhibitor of CYP 2D6 in humans, it is predicted to have limited interaction on antidepressant medicinal products metabolised by CYP 2D6.
Maltese: Peress li fl-umani dronedarone huwa inibitur dgħajjef ta' CYP 2D6, huwa maħsub li l-interazzjoni ma' prodotti mediċinali antidipressivi mmetabolizzati minn CYP 2D6 ikun limitat.