FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects seen with Activyl Tick Plus (which may affect up to 1 in 10 animals) are transitory scratching, erythema (reddening of the skin) and hair loss at the application site.
Maltese: L-effetti sekondarji l-aktar komuni li dehru b'Activyl Tick Plus (li jistgħu jaffettwaw sa annimal 1 minn kull 10) huma ħakk tranżitorju, eritema (ħmura tal-ġilda) u telf ta' pil fis-sit tal-applikazzjoni.
English: Activyl Tick Plus can also be used as a repellent (a substance that deters insects from approaching and settling) against sand flies (Phlebotomus perniciosus) that is active for up to 3 weeks.
Maltese: Activyl Tick Plus jista' jintuża wkoll bħala repellent (sustanza li ma tippermettix lill-insetti milli jersqu u jissetiljaw) kontra s-sand flies (Phlebotomus perniciosus) li huwa attiv għal 3 ġimgħat.
English: The solution is supplied in pipettes filled with the appropriate amounts of indoxacarb and permethrin for dogs of various weights.
Maltese: Is-soluzzjoni hija fornuta f'pipetti mimlija bl-ammonti xierqa ta' indoxacarb u permethrin għal klieb ta' diversi piżijiet.
English: How is Activyl Tick Plus used?
Maltese: Kif jaħdem Activyl Tick Plus?
English: After application, indoxacarb and permethrin are ingested by the fleas and ticks (indoxacarb is converted in their gut into an active form).
Maltese: Wara l-applikazzjoni, l-indoksakarb u l-permetrina huma inġestiti mill-briegħed u l-qurdien (l-indoksakarb jiġi konvertit fl-imsaren f'forma attiva). Flimkien, il-forma attiva tal-indoksakarb u l-permetrina jinterferixxu mas-sistema nervuża tal-parassiti, fejn jikkawżaw paraliżi u mewt.
English: How does Activyl Tick Plus work?
Maltese: Kif jintuża Activyl Tick Plus?
English: The European Medicines Agency decided that Activyl Tick Plus's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini iddeċidiet li l-benefiċċji ta' Activyl Tick Plus huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: EMEA/V/C/047
Maltese: EMEA/V/C/047 RAPPORT TA' VALUTAZZJONI
English: The incidence is about 5-9 %.
Maltese: L-inċidenza hija ta' madwar 5.9%.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) INCURIN EPAR summary for the public
Maltese: PUBBLIKA EWROPEW (EPAR) INCURIN Sommarju ta' l-EPAR għall-pubbliku
English: Incurin is a tablet containing the natural hormone estriol as active substance.
Maltese: Incurin huwa pillola li fih l-ormon naturali estriol bħala sustanza attiva.
English: What is Incurin?
Maltese: X'inhu Incurin?
English: These effects are reversible after lowering the dose.
Maltese: L-effetti huma reversibbli wara t-tnaqqis fid-doża.
English: Incurin is used for the treatment of hormone-dependent urinary incontinence resulting from sphincter mechanism incompetence (SMI) in ovariohysterectomised bitches (i.e. in dogs having had the ovaries and uterus removed surgically).
Maltese: Incurin jintuża għat-trattament ta' inkontinenza urinarja dipendenti mill-ormon li tirriżulta minn inkompetenza fil-mekkaniżmu sphincter (SMI) fi klieb nisa li huma ovarjoisterektomizzati (jiġifieri fi klieb li jkunu tneħħewlhom l-ovarji u l-utru permezz ta' intervent kirurġiku).
English: Effects typical to oestrogens such as swollen vulva, swollen mammary glands and/or attractiveness to males and vomiting have been observed at the highest recommended dose of 2 mg per dog.
Maltese: Effetti tipiċi għall-estroġenu bħall-infjammazzjoni tal-vulva, tal-glandoli tal-ħalib u/jew kemm jiġbdu l-klieb maskili u remettar ġew osservati fl-iktar doża għolja rakkomandata ta' 2mg kull kelb.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Incurin to Intervet International B.V. on 24 March 2000 and renewed in it 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Incurin lil Intervet International B.V. fl-24 ta' Marzu tas-sena 2000 u din ġiet imġedda fl-2005.
English: Why has Incurin been approved?
Maltese: Għaliex ġie approvat Incurin?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Incurin excede the risks for the treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches, and recommended that Incurin be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veternarju (CVMP) ikkonkluda li l-benefiċċji ta' Incurin huma ikbar mir-riskji għat-trattament ta' inkontinenza urinarja dipendenti millormon dovuta għal inkompetenza tal-mekkaniżmu sphincter fil-klieb nisa li ġew ovarjoisterektomizzati u rrakkomanda li Incurin jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni fuq il-bażi tarrakkomandazzjonijiet tal-CVMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: What is the risk associated with Incurin?
Maltese: X'inhu r-riskju assoċjat ma' Incurin?
English: Other information about Incurin:
Maltese: Tagħrif ieħor dwar Incurin:
English: During the studies repeated administration of up to 2mg estriol per dog produced beneficial effects in bitches showing involuntary leakage of urine.
Maltese: Matul l-istudji, ingħataw ripetutament dożi sa 2mg ta' estriol għal kull kelb u dawn produċew effetti benefiċi fil-klieb nisa li wrew tnixxija mhux volontarja ta' l-awrina.
English: How has Incurin been studied?
Maltese: Kif ġie studjat Incurin?
English: The term urinary incontinence is used to describe the condition of involuntary leakage of urine.
Maltese: It-terminu inkontinenza urinarja huwa wżat biex jiddeskrivi l-kundizzjoni ta' tnixxija mhux volontarja ta' l-awrina.
English: For advise on dosing please see the Package Leaflet.
Maltese: F'każijiet rari ħafna ġie wkoll osservat żvilupp ta' alopekja (telf ta' xagħar).
English: Scientific findings strongly suggest a relationship between the incidence of urinary incontinence and oestrogen depletion.
Maltese: Sejbiet xjentifiċi jissuġġerixxu fermament li teżisti relazzjoni bejn l-inkontinenza urinarja u t-tnaqqis ta' l-estroġenu.
English: The results show that Incurin is efficient and safe to use against urinary incontinence due to SMI in ovariohysterectomised dogs.
Maltese: Ir-riżultati wrew li Incurin huwa effiċjenti u sigur għall-użu kontra l-inkontinenza urinarja dovuta għal SMI fi klieb li ġew ovarjoisterektomizzati.
English: Estriol contained in Incurin is a short-acting natural oestrogen which binds to the oestrogen receptor.
Maltese: Estriol li jinsab f'Incurin huwa estroġenu naturali li jaġixxi għal żmien qasir li jingħaqad marriċettur ta' l-estroġenu.
English: Case Rep. BMJ, 2014, Mar 10.
Maltese: BMJ, 2014, Mar 10.
English: A case of pseudocyanosis.
Maltese: 10 Ekanayaka RA. A case of pseudocyanosis. Case Rep.
English: 1989;63(21):66J-70J.
Maltese: Am J Cardiol. 1989;63(21):66J-70J.
English: Nicorandil was synthesised and developed by Chugai Pharmaceutical Co., Ltd in 1975 as a product producing coronary vasodilatation.
Maltese: Nicorandil kien sintetizzat u żviluppat minn Chugai Pharmaceutical Co., Ltd fl-1975 bħala prodott li jipproduċi vażodilatazzjoni koronarja.
English: 10 Ekanayaka RA.
Maltese: 4 Ulvenstam
English: One study performed by Meany and colleagues8 (1989) on 46 patients, compared nicorandil 10 mg b.i.d.
Maltese: Studju minnhom imwettaq minn Meany and colleagues8 (1989) fuq 46 pazjent, qabbel nicorandil 10 mg b.i.d. u 20 mg b.i.d. ma' plaċebo.
English: Ikorel and Dancor medicinal products are registered and marketed in the following EU Members States: Austria, Denmark, France, Ireland, the Netherlands, Portugal and United Kingdom.
Maltese: Il-prodotti mediċinali Ikorel u Dancor huma rreġistrati u kkummerċjalizzati fl-Istati Membri tal-UE li ġejjin: l-Awstrija, idDanimarka, Franza, l-Irlanda, l-Italja, il-Pajjiżi l-Baxxi, il-Portugall u r-Renju Unit.
English: Nicorandil has dual pharmacological effects; activation of ATP-sensitive inward-rectifier potassium channels and (similar to nitroglycerin) increased production of nitric oxide.
Maltese: Nicorandil għandu żewġ effetti farmokoloġiċi; l-attivazzjoni ta' kanali tal-potassju rettifikaturi 'l ġewwa sensittivi għall-ATP u (simili għan-nitrogliċerina) żiedu l-produzzjoni ta' ossidu nitriku.
English: Ulvenstam G, Diderholm E, Frithz G, et al. Antianginal and anti-ischemic efficacy of nicorandil compared with nifedipine in patients with angina pectoris and coronary heart disease: a double-blind, randomized, multicenter study.
Maltese: Antianginal and anti-ischemic efficacy of nicorandil compared with nifedipine in patients with angina pectoris and coronary heart disease: a double-blind, randomized, multicenter study.
English: • In case of beta-blocker intolerance or poor efﬁcacy attempt monotherapy with a calcium channel blocker (CCB): use long-acting nitrate, or nicorandil (Class I, level of evidence C).
Maltese: • F'każ ta' intolleranza għall-imblokkaturi tar-riċetturi beta jew monoterapija ta' tentattiv b'effikaċja ħażina b'imblokkaturi tal-kanal tal-kalċju (CCB): uża nitrat li jaħdem fit-tul, jew nicorandil (Klassi I, livell ta' evidenza C).
English: Nicorandil 20 mg was more effective in reducing resting systolic blood pressure (SBP) and increasing total exercise work load (55% vs 94%).
Maltese: Nicorandil 20 mg kien aktar effikaċi biex inaqqas il-pressjoni tad-demm sistolika (SBP) waqt isserħan u jżid it-tagħbija ta' xogħol tal-eżerċizzju totali (55% meta mqabbel ma' 94%).
English: In addition, two hemodynamic studies (SG 002 and EMD 034) studied hemodynamic effects of single oral doses of nicorandil (40 mg, 60 mg, 80 mg) in a total of 21 pharmacodynamically evaluable patients with severe heart failure (N.Y.H.A.
Maltese: Barra minn hekk, żewġ studji emodinamiċi (SG 002 u EMD 034) studjaw l-effetti emodinamiċi ta' dożi orali waħdiena ta' nicorandil (40 mg, 60 mg, 80 mg) f'total ta' 21 pazjent farmakodinamikament evalwabbli b'insuffiċjenza tal-qalb severa (N.Y.H.A klassi III u IV).
English: In addition one of the following was also in force: left ventricular hypertrophy on the ECG, left ventricular ejection fraction ≤45%, or an end diastolic dimension of >55mm, age ≥65, diabetes, hypertension, peripheral vascular disease, or cerebrovascular disease.
Maltese: Barra minn hekk kienet preżenti xi waħda minn dawn: ipertrofija ventrikulari tax-xellug fuq l-ECG, frazzjoni ta' tfigħ 'il barra tal-ventrikolu tax-xellug ≤45%, jew dimensjoni dijastolika aħħarija ta' >55 mm, ≥65 sena, dijabete, pressjoni għolja, mard vaskulari periferali, u mard ċerebrovaskulari.
English: Eur Heart J. 1993;14 Suppl B:30-4.
Maltese: Suppl B:30-4.
English: Meeter K, Kelder JC, Tijssen JG, et al. Efficacy of nicorandil versus propranolol in mild stable angina pectoris of effort: a long-term, double-blind, randomized study.
Maltese: Efficacy of nicorandil versus propranolol in mild stable angina pectoris of effort: a long-term, double-blind, randomized study.
English: Paediatric Patients
Maltese: Pazjenti Pedjatriċi
English: The objectives are to quantify the rates of ulceration in patients treated with nicorandil (including but not restricted to gastrointestinal, skin, ocular, mucosal, anal sites; alone or in multiple locations), as well as subsequent erosion, perforation, haemorrhage, abscess formation, fistulae and delayed wound healing in a real world setting; together with identification of high risk subgroups, other risk factors, and a dose and time effect assessment.
Maltese: Lobjettivi huma li jiġu kkwantifikati r-rati ta' ulċeri f'pazjenti kkurati b'nicorandil (inkluż iżda mhux limitati għal dawk gastrointestinali, tal-ġilda, tal-għajnejn, mukosali, f'siti anali; waħedhom jew f'diversi postijiet), kif ukoll erożjoni, perforazzjoni, emorraġija, formazzjoni ta' axxess, fistula u ddewmien fil-fejqan tal-feriti sussegwenti fid-dinja reali; flimkien mal-identifikazzjoni ta' gruppi ta' riskju għoli, fatturi ta' riskju oħra, u valutazzjoni tal-effett tad-doża u l-ħin.
English: Oral nicorandil to reduce cardiac death after coronary revascularization in hemodialysis patients: a randomized trial.
Maltese: Oral nicorandil to reduce cardiac death after coronary revascularization in hemodialysis patients: a randomized trial. Am J Kidney Dis. 2009 Aug;54(2):307-17
English: 6 The IONA Study group: Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in angina (IONA) randomized trial.
Maltese: Effect of nicorandil on coronary events in patients with stable angina: the Impact Of
English: The net effect is to reduce ventricular preload and afterload.
Maltese: Leffett nett huwa li jnaqqas il-preload u l-afterlood ventrikulari.
English: In summary 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 anti-anginal therapies and at high risk of cardiovascular events defined by either previous myocardial infarction, or coronary artery bypass grafting, or coronary artery disease confirmed by angiography, or a positive exercise test in the previous two years.
Maltese: Fil-qosor, l-istudju IONA kien, studju randomizzat, double blind ikkontrollat bi plaċebo li twettaq fuq 5126 pazjent li għandhom aktar minn 45 sena b'anġina kronika stabbli, ikkurati b'terapiji standard kontra l-anġina u f'riskju għoli ta' avvenimenti kardjovaskulari ddefiniti minn infart mijokardijaku preċedenti, jew bypass grafting tal-arterja koronarja, jew mard tal-arterji koronarji ikkonfermat minn anġjografija, jew test pożittiv tal-eżerċizzju fis-sentejn ta' qabel.
English: Caution is advised when nicorandil is used in combination with other medical products that may increase potassium levels (see sections 4.4 and 4.8).
Maltese: Hija rrakkomandata attenzjoni meta nicorandil jintuża flimkien ma' prodotti mediċinali oħra li jistgħu jżiedu l-livelli ta' potassju (ara sezzjonijiet 4.4 u 4.8).
English: There is a strong increase in adverse events such as GI ulceration, skin ulceration, GI haemorrhage occurring at 40 mg per day.
Maltese: Hemm żieda qawwija f'avvenimenti avversi bħal ulċeri GI, ulċeri tal-ġilda, emorraġija GI li jseħħu b'doża ta' 40 mg kuljum.
English: Section 4.1 - Therapeutic indications i. Angina pectoris
Maltese: Sezzjoni 4.1 - Indikazzjonijiet terapewtiċi i.
English: They are also available in the EU under other trade names: Adancor, Angicor and Nicorandil Zentiva.
Maltese: Huma disponibbli wkoll fl-UE taħt ismijiet kummerċjali oħrajn: Adancor, Angicor u Nicorandil Zentiva.
English: There is a lack of clinical data concerning the safety of the use of nicorandil in cardiac failure NYHA III-IV.
Maltese: Hemm nuqqas ta' dejta klinika li tikkonċerna s-sigurtà tal-użu ta' nicorandil f'insuffiċjenza kardijaka NYHA III-IV.
English: Five (5) mg nicorandil b.i.d.
Maltese: Ħames (5) mg nicorandil b.i.d. naqsu milli juru kwalunkwe tibdil oġġettiv fit-twettiq tal-eżerċizzju meta mqabbel ma' plaċebo.
English: Nicorandil may induce hyperkalaemia.
Maltese: Nicorandil jista' jinduċi iperkalemija.
English: However, the important identified risk of ulceration (gastrointestinal (GI), skin, mucosal, genital and ocular) and perforations, fistula and abscesses has been recognized and monitored since 1997.
Maltese: Madankollu, ir-riskju importanti identifikat ta' ulċeri (Gastrointestinali (GI), tal-ġilda, mukosali, ġenitali u tal-għajnejn) u perforazzjonijiet, fistula u axxess ilu li ġie rikonoxxut u ssorveljat mill1997.
English: Several clinical studies1,2,3,4 in patients with angina pectoris have shown that treatment with nicorandil 10 and 20 mg twice daily prolongs the time to onset of ischemia during exercise and the total exercise duration.
Maltese: Diversi studji kliniċi1,2,3,4 f'pazjenti b'anġina pectoris urew li kura b'nicorandil 10 u 20 mg darbtejn kuljum ittawwal il-ħin għall-bidu ta' iskemija matul l-eżerċizzju u t-tul totali tal-eżerċizzju.
English: The anti-ischemic activity of nicorandil seems to be comparable to that of diltiazem, nifedipine, nitrates and propranolol.
Maltese: L-attività kontra l-iskemija ta' nicorandil tidher li hija paragunabbli ma' dik ta' diltiazem, nifedipine, nitrati u propranolol.
English: The CHMP addressed a list of questions to the MAHs, pointing out the sections of the products SmPC where divergences existed.
Maltese: Is-CHMP indirizza lista ta' mistoqsijiet lill-MAH, fejn indika s-sezzjonijiet tal-SmPC tal-prodotti fejn jeżistu diverġenzi.
English: Thus, the endpoints were analysed for the 20 mg b.i.d.
Maltese: Għalhekk, ilpunti ta' tmiem kienu analizzati għall-pożoloġija ta' 20 mg b.i.d..
English: driven by reduction of hospitalisation with marginal significance (p=0.014).
Maltese: jitmexxa prinċipalment minn tnaqqis fir-rikoveri l-isptar b'sinifikat marġinali (p=0.014).
English: The half-life of 6 to 8 hours permits twice daily dosage, and total-daily dosages between 10 and 40 mg have been effective in patients with chronic stable angina.
Maltese: Il-half-life ta' 6 sa 8 sigħat tippermetti dożaġġ ta' darbtejn kuljum, u d-dożaġġi totali ta' kuljum bejn 10 u 40 mg kienu effikaċji f'pazjenti b'anġina kronika stabbli.
English: Overall, nicorandil shows moderate efficacy to improve exercise capacity versus placebo and seems to be comparable to other anti-anginal therapies.
Maltese: Globalment, nicorandil juri effikaċja moderata biex itejjeb il-kapaċità ta' eżerċizzju meta mqabbel ma' plaċebo u jidher li huwa paragunabbli ma' terapiji oħrajn kontra l-anġina.
English: Consequentially, 10 and 20 mg b.i.d.
Maltese: Il-biċċa l-kbira tal-istudji twettqu permezz ta' 10 mg b.i.d. u mbagħad 20 mg b.i.d..
English: The CHMP also recommended the information on the absence of pharmacodynamic interaction between nicorandil and acenocoumarol to be reflected in the SmPC with a cross reference to section 4.4 in order to refer the physician to the risk of ulcerations and associated bleeding.
Maltese: Is-CHMP irrakkomanda wkoll l-informazzjoni dwar in-nuqqas ta' interazzjoni farmakodinamika bejn nicorandil u acenocoumarol li għandha tiġi riflessa fl-SmPC b'kontroreferenza għas-sezzjoni 4.4 sabiex it-tabib issirlu referenza għar-riskju ta' ulċeri u fsada assoċjata.
English: Furthermore, nicorandil has demonstrated a spasmolytic activity in both in vitro and in vivo studies and reverses coronary spasm induced by methacholine or noradrenalin.
Maltese: Barra minn hekk, nicorandil wera attività spasmolitika kemm fi studji in vitro kif ukoll in vivo u jreġġa' lura spażmu koronarju indott minn methacholine jew noradrenaline.
English: Event counts were presented by the different daily doses in the previous Periodic Safety Update Report for nicorandil (reporting period 01-March-2010 to 28- February
Maltese: L-għadd ta' avvenimenti kienu ppreżentati skont id-dożi ta' kuljum differenti fir-Rapport Perjodiku Aġġornat dwar is-Sigurtà għal nicorandil (perjodu ta' rapportar bejn l-1 ta' Marzu 2010 u t-28 ta' Frar 2013).
English: • If CCB monotherapy or combination therapy (CCB with beta-blocker) is unsuccessful, substitute the CCB with a long-acting nitrate or nicorandil.
Maltese: • Jekk il-monoterapija CCB jew it-terapija kkombinata (CCB b'imblokkatur tar-riċetturi beta) ma tirnexxix, issostitwixxi s-CCB b'nitrat li jaħdem fit-tul jew nicorandil.
English: Package Leaflet
Maltese: Popolazzjonijiet speċjali
English: The results of the IONA study were summarised following the same wording for both groups of products.
Maltese: 6 The IONA Study group:
English: Nicorandil may also induce gastrointestinal ulceration, perforation and haemorrhage; therefore, the simultaneous administration of nicorandil with NSAIDs can increase the risk of gastrointestinal ulceration, perforation and haemorrhage due to a synergistic effect.
Maltese: Nicorandil jista' jinduċi wkoll ulċeri, perforazzjoni u emorraġija gastrointestinali; għalhekk, l-għoti fl-istess ħin ta' nicorandil ma' NSAIDs jista' jżid ir-riskju ta' ulċeri, perforazzjoni u emorraġija gastrointestinali minħabba effett sinerġistiku.
English: The reduction in preload was proportionally more important than that of the afterload.
Maltese: It-tnaqqis fil-preload kien proporzjonalment aktar importanti minn dik l-afterload.
English: This section of the SmPC has been harmonised to include the relevant available information.
Maltese: Din is-sezzjoni tal-SmPC ġiet armonizzata biex tinkludi l-informazzjoni disponibbli rilevanti.
English: No dose recommendation is proposed for prevention of CHD events and the product information was adapted accordingly.
Maltese: Mhija proposta ebda rakkomandazzjoni ta' doża għall-prevenzjoni tal-avvenimenti CHD, u linformazzjoni dwar il-prodott kienet adattata kif xieraq.
English: In patients concomitantly receiving NSAIDs including acetylsalicylic acid for both cardiovascular prevention and anti-inflammatory dosages, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and haemorrhage (see section
Maltese: F'pazjenti li jirċievu fl-istess ħin NSAIDs inkluż acetylsalicylic acid għal dożi kemm ta' prevenzjoni kardjovaskulari u anti-infjammatorji, hemm riskju akbar għal kumplikazzjonijiet severi bħal ulċeri, perforazzjoni u emorraġija gastrointestinali (ara sezzjoni 4.4).
English: Consequently, as none of the performed studies show efficacy at doses lower than 20 mg b.i.d., and as the toxicity is dose dependant and appears at 20 mg b.i.d., the indication should be restricted to second line treatment as recommended in section 4.1 for safety reasons.
Maltese: Għaldaqstant, peress li l-ebda wieħed mill-istudji mwettqa ma juri effikaċja f'dożi aktar baxxi minn 20 mg b.i.d., u peress li t-tossiċità tiddependi fuq id-doża u tidher f'20 mg b.i.d., l-indikazzjoni għandha tiġi limitata għal kura sekondarja kif irrakkomandat fissezzjoni 4.1 għal raġuni ta' sigurtà.
English: A potassium channel opening action provides arterial vasodilation, thus reducing afterload, while the nitrate component promotes venous relaxation and a reduction in preload.
Maltese: Azzjoni ta' ftuħ tal-kanal tal-potassju tipprovdi vażodilatazzjoni tal-arterji, u b'hekk tnaqqas l-afterload, filwaqt li l-komponent ta' nitrati jippromwovi rilassament tal-vini u tnaqqis fil-preload.
English: There were no major discrepancies between the existing wordings in the different SmPCs.
Maltese: Ma kien hemm ebda diskrepanzi kbar bejn il-formulazzjonijiet eżistenti fl-SmPCs differenti.
English: The information/education to gain a knowledge that allows this diagnosis is the best risk minimisation measure identified so far.
Maltese: L-informazzjoni/edukazzjoni biex jinkiseb għarfien li jippermetti din id-dijanjożi hija l-aqwa miżura ta' minimizzazzjoni tar-riskju identifikata s'issa.
English: The overall action improves blood flow to post-stenotic regions and the oxygen balance in the myocardium.
Maltese: L-azzjoni globali ttejjeb il-fluss taddemm fir-reġjuni post-stenotiċi u l-bilanċ tal-ossiġenu fil-mijokardju.
English: The proposed indication should be revised as follows: <Invented name> is indicated in adults for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or have a contraindication or intolerance to first-line anti-anginal therapies (such as beta-blockers and/or calcium antagonists).
Maltese: <Isem ivvintat> huwa indikat f'adulti għall-kura sintomatika ta' pazjenti b'anġina pectoris stabbli li ma jiġux ikkontrollati b'mod adegwat jew li għandhom kontraindikazzjoni jew intolleranza għal terapiji primarji kontra l-anġina (bħal imblokkaturi tar-riċetturi beta u/jew antagonisti tal-kalċju).
English: Efficacy in the clinical programme was based on the measurement of anginal attack rates on exercise tests.
Maltese: Tikkettar It-tikkettar ġie rrivedut matul din il-proċedura.