FrancophonIA/ELRC3.0 huggingface dataset:
English: When mutations listed as secondary integrase inhibitor associated mutations (for raltegravir/elvitegravir) are added to primary mutations (excluding at Q148) in experiments with site directed mutants, dolutegravir susceptibility remains at or near wildtype level.
Maltese: Meta jiżdiedu l-mutazzjonijiet elenkati bħala mutazzjonijiet assoċjati ma' inibitur tal-integrase sekondarju (għal raltegravir/elvitegravir) mal-mutazzjonijiet primarji (eskluż f'Q148) f'esperimenti bil-mutanti diretti lejn is-sit, is-suxxettibbiltà ta' dolutegravir tibqa' fil-livell wildtype jew viċin tiegħu.
English: abnormal dreams, depression, anxiety1, nightmare, sleep disorder
Maltese: ħolm mhux normali, dipressjoni, ansjetà1, ħolm ikrah,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE CARTON (INDIVIDUAL PACKS ONLY)
Maltese: KARTUNA TAL-FLIXKUN (PAKKETTI INDIVIDWALI
English: Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Maltese: Nukleosidi u nukleotidi jista' jkollhom impatt fuq il-funzjoni mitokondrijali sa grad varjabbli, li laktar li huwa nnotat huwa bi stavudine, didanosine u zidovudine.
English: Additionally, autoinduction of abacavir metabolism or induction of the metabolism of other medicinal products hepatically metabolised has not been observed in humans.
Maltese: Barra minn hekk, ma ġietx osservata l-awtoinduzzjoni tal-metaboliżmu ta' abacavir jew l-induzzjoni tal-metaboliżmu ta' prodotti mediċinali oħra metabolizzati fil-fwied.
English: De novo resistance was not detected to the integrase class or the NRTI class in any patients who were treated with dolutegravir + abacavir/lamivudine in the three studies mentioned.
Maltese: Ma ġietx skoperta reżistenza de novo għall-klassi integrase jew il-klassi NRTI fi kwalunkwe pazjent li kien ikkurat b'dolutegravir + abacavir/lamivudine fit-tliet studji msemmija.
English: HLA-B*5701 status must always be documented and explained to the patient prior to initiating therapy.
Maltese: HLA-B*5701 għandu dejjem jiġi dokumentat u spjegat lill-pazjent qabel tinbeda t-terapija.
English: Porcine circovirus recombinant virus (cpcv) 1-2, inactivated
Maltese: Virus rikombinanti ta' Circovirus tal-majjali (cpcv) 1-2, inattivat
English: Suvaxyn PCV is a vaccine that contains a recombinant (modified) porcine circovirus which has been inactivated (killed).
Maltese: Suvaxyn PCV huwa vaċċin li fih circovirus porċin rikombinanti (modifikat) li kien inattivat (maqtul).
English: Local tissue reactions in the form of swelling at the injection site are very common and may last for up to 26 days.
Maltese: Reazzjonijiet tat-tessut lokali fil-forma ta' nefħa fil-post tal-injezzjoni huma komuni ħafna u jistgħu jdumu sa 26 jum.
English: It has been demonstrated that the vaccine, when administered as recommended to piglets from 3 weeks of age induces active immunisation against Porcine Circovirus Type 2 (PCV2) and is able to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues caused by porcine circovirus infection, as well as to reduce clinical signs -including loss of daily weight gain- and death associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Maltese: Intwera li l-vaċċin, meta jingħata kif rakkomandat għal majjali żgħar mill-età ta' 3 ġimgħat iwassal għal immunizzazzjoni attiva kontra ċ-Circovirus Porċin tat-Tip 2 (PCV2) u huwa kapaċi li jnaqqas ittagħbija virali fid-demm u fit-tessuti limfojdi, u l-leżjonijiet fit-tessuti limfojdi kkawżati mill-infezzjoni taċ-circovirus porċin, kif ukoll fit-tnaqqis ta' sinjali kliniċi - inklużi t-tnaqqis fiż-żieda tal-piż - u l-mewt assoċjata mas-Sindromu ta' Skart Sistematiku ta' Wara l-Fatma (PMWS).
English: Suvaxyn PCV is used to vaccinate pigs over the age of 3 weeks to reduce viral load in blood and lymphoid tissues and protect the pigs against the lesions in lymphoid tissues caused by Porcine Circovirus Type 2 as well as the reduced weight gain and potentially even death that is associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Maltese: Suvaxyn PCV huwa użat sabiex jiġu vaċċinati majjali ta' ‘l fuq minn 3 ġimgħat sabiex titnaqqas ittagħbija virali fid-demm u fit-tessuti limfojde u għall-protezzjoni tal-majjali minn leżjonijiet fit-tessuti limfojde kkawżati miċ-Circovirus Porċin tat-Tip 2 kif ukoll it-tnaqqis ta' żieda fil-piż u potenzjalment anke l-mewt li hija assoċjata mas-Sindromu ta' Skart Sistematiku ta' Wara l-Fatma (PMWS).
English: Suvaxyn PCV is a vaccine.
Maltese: Suvaxyn PCV huwa vaċċin.
English: Suvaxyn PCV is a suspension for injection.
Maltese: Suvaxyn PCV huwa sospensjoni għall-injezzjoni.
English: These clinical signs normally resolve without treatment.
Maltese: Dawn is-sinjali kliniċi normalment jissolvew mingħajr kura.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suvaxyn PCV exceed the risks for the approved indications and recommended that Suvaxyn PCV be given a marketing authorisation.
Maltese: ll-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Suvaxyn PCV huma akbar mir-riskji tiegħu għall-indikazzjonijiet approvati u għaldaqstant irrakkomanda li Suvaxyn PCV jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Suvaxyn PCV on 24 July 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea, għal Suvaxyn PCV fl-24 ta' Lulju 2009.
English: Immediate mild hypersensitivity-like reactions may occur commonly after vaccination (affecting up to 1 in 10 animals) resulting in short-lived clinical signs such as vomiting.
Maltese: Reazzjonijiet immedjati simili għal sensittività eċċessiva ħafifa huma komuni wara l-vaċċinazzjoni (li jaffettwaw minn 1 sa 10 annimali) li jirriżultaw f'sinjali kliniċi temporanji bħar-remettar.
English: Other information about Suvaxyn PCV:
Maltese: Tagħrif ieħor dwar Suvaxyn PCV:
English: This protects the pigs against the disease.
Maltese: Dan jipproteġi l-majjali kontra l-marda.
English: Why has Suvaxyn PCV been approved?
Maltese: Għaliex ġie approvat Suvaxyn PCV?
English: What is Suvaxyn PCV?
Maltese: Kif jaħdem Suvaxyn PCV?
English: Suvaxyn PCV contains small amounts of a form of the pig virus that has been modified to produce a protein from the form of the virus that causes disease, but killed so that it does not cause the disease and cannot spread.
Maltese: Suvaxyn PCV fih ammonti żgħar ta' forma tal-virus talmajjal li kien modifikat biex jipproduċi proteina mill-forma tal-virus li kkawża l-marda, iżda li nqatel biex ma jikkawżax il-marda u ma jkunx jista' jinfirex .
English: How has Suvaxyn PCV been studied?
Maltese: Kif ġie studjat Suvaxyn PCV?
English: The safety of the vaccine has been addressed in both laboratory and field conditions: a temporary increase in body temperature (up to 1.7°C) is very common during the first 24 hours after vaccination.
Maltese: Is-sigurtà tal-vaċċin kien is-suġġett ta' kundizzjonijiet kemm tal-laboratorju kif ukoll fuq is-sit: żieda temporanja fit-temperatura tal-ġisem (sa 1.7°C) huwa komuni ħafna matul l-ewwel 24 siegħa wara lvaċċinazzjoni.
English: The full EPAR for MicardisPlus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about MicardisPlus
Maltese: Informazzjoni oħra dwar MicardisPlus
English: It is available as oval tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).
Maltese: Jiġi bħala pilloli ovali (40 mg jew 80 mg telmisartan u 12.5 mg idroklorotijażide; 80 mg telmisartan u 25 mg idroklorotijażide).
English: MicardisPlus has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
Maltese: MicardisPlus ġie studjat f'ħames studji ewlenin li involvew total ta' 2,985 pazjent li jbatu minn ipertensjoni minn ħafifa għal moderata.
English: This is a summary of the European public assessment report (EPAR) for MicardisPlus.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal MicardisPlus.
English: MicardisPlus contains two active substances, telmisartan and hydrochlorothiazide.
Maltese: MicardisPlus fih żewġ sustanzi attivi, it-telmisartan u l-idroklorotijażide.
English: The most common side effect with MicardisPlus (seen in between 1 and 10 patients in 100) is dizziness.
Maltese: L-effett sekondarju l-aktar komuni b'MicardisPlus (li deher f'bejn pazjent wieħed u 10 fost 100) huwa listurdament.
English: In four of these studies, MicardisPlus was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients.
Maltese: F'erbgħa fost dawn l-istudji, MicardisPlus tqabbel mal-plaċebo (kura finta) u ma' telmisartan meħud waħdu f'total ta' 2,272 pazjent.
English: Why has MicardisPlus been approved?
Maltese: Għaliex ġie approvat MicardisPlus?
English: The European Commission granted a marketing authorisation valid throughout the European Union for MicardisPlus on 19 April 2002
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal MicardisPlus valida fl-Unjoni Ewropea kollha fid-19 ta' April 2002
English: MicardisPlus is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Maltese: MicardisPlus huwa mediċina li fiha żewġ sustanzi attivi, it-telmisartan u l-idroklorotijażide.
English: A risk management plan has been developed to ensure that MicardisPlus is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li MicardisPlus jintuża bl-aktar mod sigur possibbli.
English: MicardisPlus telmisartan / hydrochlorothiazide
Maltese: Sommarju tal-EPAR għall-pubbliku telmisartan / idroklorotijażide
English: What is MicardisPlus?
Maltese: X'inhu MicardisPlus?
English: The dose of MicardisPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Maltese: Id-doża ta' MicardisPlus li għandha tintuża tiddependi mid-doża ta' telmisartan li l-pazjent kien qiegħed jieħu qabel: pazjenti li kienu qegħdin jieħdu 40 mg telmisartan għandhom jieħdu l-pilloli ta' 40/12.5 mg, u pazjenti li kienu qed jingħataw 80 mg telmisartan għandhom jieħdu l-pilloli ta' 80/12.5
English: What is the risk associated with MicardisPlus?
Maltese: X'inhu r-riskju assoċjat ma' MicardisPlus?
English: MicardisPlus must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
Maltese: MicardisPlus laqas m'għandu jintuża minn persuni li jbatu minn problemi gravi fil-fwied, fil-kliewi jew problemi biljari, persuni li jkollhom livelli wisq baxxi ta' potassju fid-demm, jew livelli wisq għoljin ta' kalċju fid-demm.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that MicardisPlus's benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' MicardisPlus huma akbar mir-riskji tiegħu fil-kura tal-ipertensjoni essenzjali f'pazjenti li l-pressjoni taddemm tagħhom mhijiex adegwatament ikkontrollata bit-telmisartan waħdu.
English: The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to MicardisPlus.
Maltese: Il-pilloli tat-80/25 mg jintużaw minn pazjenti li l-pressjoni tad-demm tagħhom mhijiex ikkontrollata permezz ta' pilloli ta' 80/12.5 mg jew li l-qagħda tagħhom ġiet stabbli permezz ta' żewġ sustanzi attivi meħuda separatament qabel ma qalbu għal MicardisPlus.
English: How has MicardisPlus been studied?
Maltese: Kif ġie studjat MicardisPlus?
English: MicardisPlus is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone.
Maltese: MicardisPlus jintuża minn pazjenti adulti li jkollhom ipertensjoni essenzjali (pressjoni tad-demm għolja), li ma tkunx ikkontrollata b'mod adegwat b'telmisartan biss. ‘Essenzjali' tfisser li l-ipertensjoni ma jkollhiex kawża evidenti
English: MicardisPlus was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo.
Maltese: MicardisPlus kien aktar effettiv fit-tnaqqis tal-pressjoni tad-demm dijastolika mit-telmisartan meħuda weħidha u mill-plaċebo.
English: Telmisartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: It-telmisartan hu tip ta' 'antagonist tar-riċetturi tal-anġjotensina
English: In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, MicardisPlus must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Maltese: F'pazjenti bid-dijabete tat-tip 2 jew f'pazjenti b'indeboliment renali moderat jew sever, MicardisPlus m'għandux jintuża wkoll flimkien ma' mediċini li fihom aliskiren (li jintużaw ukoll biex jikkuraw l-ipertensjoni essenzjali).
English: The fifth study compared the effects of remaining on the 80/12.5 mg tablet with switching to the 80/25 mg tablet in 713 patients who had not responded to the 80/12.5 mg tablet.
Maltese: Fil-pazjenti li ma kinux ikkontrollati bil-pilloli ta' 80/12.5 mg, il-fatt li qalbu għall-pilloli ta' 80/25 mg kien aktar effettiv fit-tnaqqis tal-pressjoni tad-demm dijastolika milli meta baqgħu jieħdu doża aktar baxxa.
English: For the full list of all side effects reported with MicardisPlus, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'MicardisPlus, ara l-Fuljett ta' Tagħrif.
English: • Aspirin (acetylsalicylic acid).
Maltese: • Aspirina (acetylsalicylic acid).
English: (see section 4.5)
Maltese: (ara sezzjoni 4.4)
English: 60 tablets
Maltese: Pilloli 30 pillola 60 pillola
English: The absolute bioavailability is about 75%.
Maltese: Il-bijodisponibbiltà assoluta hija madwar 75 %.
English: Hyperkalaemi a (see section 4.4 and 4.5)
Maltese: Iperkalimja (ara sezzjoni 4.4 u 4.5)
English: Nicorandil pharmacokinetics are linear from 5 mg to 40 mg.
Maltese: Il-farmakokinetika ta' nicorandil hija lineari minn 5 mg sa 40 mg.
English: Each tablet contains 20 mg nicorandil.
Maltese: Kull pillola fiha 20 mg nicorandil.
English: N-(2-hydroxyethyl)-nicotinamide is the most abundant metabolite (about 8.9% of the administered dose within 48 hours) followed by nicotinuric acid, (5.7%), nicotinamide (1.34%), N-methyl-nicotinamide (0.61%) and nicotinic acid (0.40%).
Maltese: N-(2-hydroxyethyl)-nicotinamide huwa l-metabolit li jinstab l-aktar (madwar 8.9% tad-doża mogħtija, fi żmien 48 siegħa) segwit minn nicotinuric acid, (5.7%), nicotinamide (1.34%), N-methyl-nicotinamide (0.61%) u nicotinic acid (0.40%).
English: The plasma concentration (and the area under the curve (AUC)) shows a linear proportionality to the dose.
Maltese: Il-konċentrazzjoni fil-plażma (u ż-żona taħt il kurva (AUC - area under the curve)) turi proporzjon lineari mad-doża.
English: (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1,000, <1/100), Rare (≥1/10,000, <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥1/10), Komuni (≥1/100, <1/10), Mhux komuni (≥1/1,000, <1/100), Rari (≥1/10,000, <1/1,000), Rari ħafna (<1/10,000), Mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: • Medicine for impotence such as sildenafil, tadalafil or vardenafil.
Maltese: • Mediċini għall-impotenza bħal sildenafil, tadalafil jew vardenafil.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg nicorandil.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 10 mg nicorandil.
English: Gastrointestinal ulcerations
Maltese: Ulċerazzjonijiet gastrointestinali
English: • Medicines for depression.
Maltese: • Mediċini għad-depressjoni.
English: • Acute pulmonary oedema
Maltese: • Edima akuta fil-pulmun
English: • Medicines for inflammation (corticosteroids, non-inflammatory steroidal drugs such as ibuprofen).
Maltese: • Mediċini għall-infjammazzjoni (kortikosterojdi, mediċini antiinfjammatorji li mhumiex sterojdi bħal ibuprofen).
English: • Medicines to treat pulmonary hypertension such as riociguat.
Maltese: • Mediċini għat-trattament tal-ipertensjoni pulmonarja bħal riociguat.
English: Maximum plasma concentrations (Cmax) are reached after about 30- 60 minutes.
Maltese: L-ogħla konċentrazzjonijiet filplażma (Cmax) jintlaħqu wara madwar 30 - 60 minuta.
English: Progressive dose titration may reduce the frequency of these headaches (see section 4.2).
Maltese: Titrazzjoni progressiva tad-doża tista' tnaqqas il-frekwenza ta' din l-uġigħ ta' ras (ara sezzjoni 4.2).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister strip/ 10 mg and 20 mg
Maltese: Strixxa ta' folja/ 10 mg u 20 mg
English: Impairment of Fertility
Maltese: Indeboliment tal-Fertilità
English: Pharmacotherapeutic group: Other vasodilators used in cardiac diseases, ATC code: C01DX16
Maltese: Vażodilataturi oħra li jintużaw f'mard tal-qalb, Kodiċi ATC: C01DX16 Mekkaniżmu ta' azzjoni
English: Do not take aspirin or any medicines for inflammation (corticosteroids).
Maltese: Tiħux aspirina jew xi mediċini għallinfjammazzjoni (kortikosterojdi).
English: • Nicorandil may cause injuries to your gastrointestinal tract such as ulcers.
Maltese: • Nicorandil jista' jikkawża feriti lill-passaġġ gastrointestinali tiegħek bħal ulċeri.
English: Nicorandil does not affect the pharmacodynamics of acenocoumarol.
Maltese: Nicorandil ma jaffettwax il-farmakodinamika ta' acenocoumarol.
English: • Hypersensitivity to nicorandil or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għal nicorandil jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: The IONA study was a randomised, double blind, placebo controlled study carried out in 5126 patients more than 45 years old with chronic stable angina, treated with standard antianginal therapies and at high risk of cardiovascular events defined by either: 1) previous myocardial infarction, or 2) coronary artery bypass grafting , or 3) coronary artery disease confirmed by angiography, or a positive exercise test in the previous two years, together with one of the following: left ventricular hypertrophy on the ECG, left ventricular ejection fraction ≤45%, or an end diastolic dimension of >55 mm, age
Maltese: L-istudju IONA kien studju kkontrollat bi plaċebo fejn la l-investigatur u lanqas il-parteċipanti li ntgħażlu b'mod arbitrarju ma kienu jafu liema mediċina qed tintuża, li sar f'5,126 pazjent li kellhom aktar minn 45 sena b'anġina kronika stabbli, ikkurata b'terapiji standard kontra l-anġina u b'riskju kbir ta' każijiet kardjovaskulari iddefiniti jew: 1) b'infart mijokardijaku preċedenti, jew 2) b'bajpass grafting tal-arterja koronarja, jew 3) b'mard tal-arterja koronarja kkonfermat permezz ta' anġjografija, jew riżutat pożittiv għat-test tal-eżerċizzju fis-sentejn ta' qabel, flimkien ma' waħda minn dawn li ġejjin: ipertrofija tal-ventrikulu tax-xellug fuq l-ECG, porzjon ta' tfigħ 'il barra ta' ≤45% mill ventrikulu tax-xellug jew diametru tal-ventrikulu ta' >55 mm fi tmiem id-dijastoli, età ta' ≥65,
English: • If you have glucose 6 Phosphate Deshydrogenase deficiency.
Maltese: • Jekk għandek defiċjenza ta' glucose 6 Phosphate Dehydrogenase.
English: Gastroinstestinal disorders
Maltese: Disturbi gastrointestinali
English: In plasma unchanged nicorandil accounted for 45.5% of the radioactive AUC and the alcohol metabolite, N-(2-hydroxyethyl)-nicotinamide for 40.5%.
Maltese: AUC radjuattiva u l-metabolit tal-alkoħol, N-(2-hydroxyethyl)-nicotinamide irrappreżenta 40.5%.
English: The metabolism of nicorandil is not significantly affected by cimetidine (a CYP inhibitor), or rifampicin (a CYP3A4 inducer).
Maltese: CYP), jew rifampicin (stimulatur ta' CYP3A4).
English: Gastrointestina l haemorrhage (see section
Maltese: Emorraġija gastrointestinal i (ara sezzjoni 4.4)
English: This belongs to a group of medicines called ‘potassium channel activators'.
Maltese: Din tagħmel parti minn grupp ta' mediċini li jissejħu ‘attivaturi tal-kanali tal-potassju'.
English: Additional investigative studies for testicular toxicity revealed decreased blood flow in the testis and decreased blood levels of testosterone.
Maltese: Studji investigattivi addizzjonali għal tossiċità tat-testikoli żvelaw tnaqqis fil-fluss tad-demm u tnaqqis fil-livelli tat-testosterone.
English: • if you have a build-up of fluid in the lungs (pulmonary oedema).
Maltese: • jekk għandek akkumulazzjoni ta' fluwidu fil-pulmun (edima pulmonarja).
English: Swallow the tablet (oral use).
Maltese: Ibla' l-pillola (użu orali).
English: The composite primary endpoint (coronary heart disease (CHD) death, non-fatal myocardial infarction, or unplanned hospital admission for cardiac chest pain), occurred in 337 patients (13.1%) of patients treated with nicorandil 20 mg twice daily compared with 389 patients (15.5%) of patients receiving placebo (hazard ratio 0.83; 95% confidence interval (CI) 0.72 to 0.97; p=0.014).
Maltese: infart mijokardijaku mhux fatali, jew dħul l-isptar bla mistenni minħabba uġigħ fis-sider li jkun ġej mill-qalb), seħħ fi 337 pazjent (13.1%) mill-pazjenti kkurati b'nicorandil 20 mg darbtejn kuljum imqabbla ma' 389 pazjent (15.
English: The frequencies of adverse reactions reported with nicorandil are summarised in the following table by system organ class (in MedDRA) and by frequency.
Maltese: Il-frekwenzi tar-reazzjonijiet avversi rrappurtati b'nicorandil huma mqassra fit-tabella li ġejja skont ilklassi tas-sistemi u tal-organi (f'MedDRA) u skont il-frekwenza.
English: The usual therapeutic range is 10 to 20 mg twice daily.
Maltese: Normalment, id-doża terapewtika dvarja minn 10 sa 20 mg darbtejn kuljum.
English: Study follow up for endpoint analysis was between 12 and 36 months with a mean of 1.6 years.
Maltese: segwitu tal-istudju għall-analiżi finali kienet bejn 12 u 36 xahar b'medja ta' 1.6 snin.
English: In addition, the following adverse reactions have been reported with different frequencies in the IONA (Impact of Nicorandil in Angina) study, where nicorandil has been used on top of standard therapy in patients with stable angina and at high risk of cardiovascular events (see section 5.1).
Maltese: Impatt ta' Nicorandil fl-Anġina - Impact of Nicorandil in Angina), fejn nicorandil intuża billi żdied ma' terapija standard f'pazjenti b'anġina stabbli u b'riskju kbir ta' każijiet kardjovaskulari (ara sezzjoni 5.1).
English: Liver disorders such as hepatitis, cholestasis, or jaundice
Maltese: Disturbi fil fwied bħal epatite, kolestasi, jew suffejra
English: • Hypovolaemia
Maltese: • Ipovolimja
English: At steady state, the accumulation ratio (based on AUC) is around 2 for 20 mg bid tablet and 1.7 for 10 mg bid tablet.
Maltese: Fl-istat fiss, il-proporzjon ta' akkumulu (abbażi tal-AUC) huwa ta' madwar 2 għall-pillola ta' 20 mg mogħtija bid u 1.7 għall-pillola ta' 10 mg mogħtija bid.
English: After 4-5 mg intravenous dosing (5 min infusion), the total body clearance was approximately 40-55 L/hour.
Maltese: Wara għoti ta' doża ta' 4-5 mg minn ġol-vini (infużjoni ta' 5 min), it-tneħhija totali mill-ġisem kienet ta' madwar 40-55 L/siegħa.
English: <Invented name> 10 mg [To be completed nationally] <Invented name> 20 mg [To be completed nationally]
Maltese: "Isem ivvintat" 10 mg [Biex timtela mill-pajjiż partikolari] "Isem ivvintat" 20 mg [Biex timtela mill-pajjiż partikolari]