FrancophonIA/ELRC3.0 huggingface dataset:
English: The triethylcitrate acts as a plasticizer.
Maltese: It-triethylcitrate jaħdem bħala plastifikant.
English: The application was submitted to the reference Member State Denmark and to the concerned Member States (CMS) Germany, Ireland, Italy and the United Kingdom.
Maltese: L-applikazzjoni ġiet sottomessa lill-Istat Membru ta' referenza, id-Danimarka, u lill-Istati Membri kkonċernati (CMS) il-Ġermanja, l-Irlanda, l-Italja u r-Renju Unit.
English: This effect is known as ‘dose-dumping'.
Maltese: Dan l-effett huwa magħruf bħala ‘tbattila tad-doża' (dose-dumping).
English: Having considered the overall submitted data provided by the MAH, the CHMP concluded that
Maltese: Wara li kkunsidra d-dejta sottomessa kollha pprovduta mill-MAH, is-CHMP ikkonkluda li
English: The results of the dissolution tests demonstrate that the formulation is within the limit of the Ph.Eur.
Maltese: Ir-riżultati għat-testijiet ta' dissoluzzjoni juru li l-formolazzjoni hija fil-limitu ta' Ph.Eur.
English: for conventional-release products (NLT 75% dissolved active substance within 45 minutes) and therefore experiences severe alteration, leading to an uncontrolled rapid release of the majority of the active substance.
Maltese: għal prodotti ta' rilaxx konvenzjonali (NLT 75% tas-sustanza attiva maħlula fi żmien 45 minuta) u għalhekk tesperjenza tibdil serju, li jwassal għal rilaxx malajr mhux ikkontrollat tal-maġġoranza tas-sustanza attiva.
English: Dissolution was evaluated over an 8-hour period.
Maltese: Id-dissoluzzjoni kienet evalwata matul perjodu ta' 8 sigħat.
English: The polymethacrylate preparation is miscible in water and in ethanol.
Maltese: Il-preparazzjoni ta' polymethacrylate tista' titħallat mal-ilma u mal-etanol.
English: Out of specification results were obtained after 0.25 hours in 20% alcohol, after 0.5 hour in 10% alcohol and after 2 hours in 5% alcohol.
Maltese: Inkisbu riżultati barra mill-ispeċifikazzjoni wara 0.25 siegħa f'alkoħol ta' 20%, wara 0.5 siegħa f'alkoħol ta' 10% u wara sagħtejn f'alkoħol ta' 5%.
English: Germany and the United Kingdom raised potential serious risk to public health concerns due to the dissolution profile of the modified-release product allowing the release of up to 80% of the active substance within 30 minutes, when exposed to 20% alcohol.
Maltese: Il-Ġermanja u r-Renju Unit qajmu tħassib ta' riskju serju potenzjali għas-saħħa pubblika minħabba l-profil ta' dissoluzzjoni tal-prodott b'rilaxx modifikat li jippermetti ir-rilaxx ta' sa 80% tas-sustanza attiva fi żmien 30 minuta, meta espost għal alkoħol ta' 20%.
English: • The Committee considered the procedure under Article 29(4) of Directive 2001/83/EC, as amended for Ethirfin and associated names,
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE, kif emendata għal Ethirfin u ismijiet assoċjati,
English: The prolonged release properties of this product are ensured by the film coating composed of the polymethacrylate derivative plasticized by triethylcitrate (TEC) to which talc and hydrophobic colloidal silica are added.
Maltese: Il-karatteristiċi ta' rilaxx prolungat ta' dan il-prodott huma assigurati minn rita magħmula mid-derivat ta' polymethacrylate plastiċizzat minn triethylcitrate (TEC) li għandu miżjudin miegħu terra u silica kollojdali idrofobika.
English: Triethylcitrate is water-soluble and miscible in ethanol.
Maltese: Triethylcitrate jista' jinħall fl-ilma u jitħallat mal-etanol.
English: • A pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation,
Maltese: • Tista' sseħħ interazzjoni farmakodinamika bejn prodotti tal-opjojdi u l-alkoħol irrispettivament mill-formolazzjoni,
English: Both problem drinkers as non-problem drinkers reported to use alcohol to manage pain, although in the latter group to less extent (see figure 1).
Maltese: Figure I Use of alcohol to manage pain among problem and non-problem drinkers
English: No adverse events have been reported for Ethirfin and associated names suspect to be related to the concomitant use of alcohol.
Maltese: Ma ġew irrapportati l-ebda avvenimenti aversi għal Ethirfin u ismijiet assoċjati sospetti li huma relatati mal-użu konkomitanti tal-alkoħol.
English: Notification of a referral for arbitration, under Article 29(4) of Directive 2001/83/EC as amended, to the CHMP was made by Denmark on 30 October 2009.
Maltese: Fit-30 ta' Ottubru 2009, saret notifika ta' referenza għal arbitraġġ, mid-Danimarka skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE kif emendata, lis-CHMP.
English: The polymethacrylate is a polymer that forms a continuous film when processed.
Maltese: Il-polymethacrylate huwa polimeru li meta pproċessat jifforma rita kontinwa.
English: However, a significant percentage of the patients with chronic pain who uses opioids still reports high alcohol intake (10.8%) and binge drinking at least once a month (22.3%), despite existing warnings.
Maltese: Madankollu, perċentwali sinifikanti tal-pazjenti b'uġigħ kroniku li jużaw opjojdi xorta jirrapportaw xorb ta' alkoħol għoli (10.8%) u konsum ta' ammonti kbar ta' alkoħol mill-anqas darba fix-xahar (22.3%), minkejja twissijiet eżistenti.
English: Overall summary of the scientific evaluation of Ethirfin and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Ethirfin u ismijiet assoċjati (ara Anness I)
English: • The Committee considered that the dissolution profile of Ethirfin and associated names is significantly affected in the presence of alcohol, leading to an uncontrolled rapid release of the majority of the active substance, therefore the product exhibits a significant interaction with alcohol with potentially significant clinical effects (e.g. respiratory depression and death),
Maltese: • Barra minn hekk, il-profil ta' dissoluzzjoni ta' Ethirfin huwa affettwat b'mod sinifikanti filpreżenza tal-alkoħol, u jwassal għal rilaxx malajr u mhux ikkontrollat tal-maġġoranza tassustanza attiva, u għalhekk il-prodott juri interazzjoni sinifikanti mal-alkoħol b'effetti kliniċi potenzjalment sinifikanti (eż dipressjoni respiratorja u mewt),
English: While it may be argued that patients may use less alcohol as a self-medication strategy if they are sufficiently treated with analgesics like opioids, the results of a recently published Danish Health survey (Ekholm et al. Eur J Pain 2009; 13: 606-12) reveal a different pattern of behavior.
Maltese: Eur J Pain 2009; 13: 606-12) juru tendenza ta' imġiba differenti.
English: • The Committee is also of the opinion that further risk minimisation measures would not adequately address the concern,
Maltese: • Il-Kumitat huwa wkoll tal-opinjoni li miżuri ta' minimizzazzjoni tar-riskju oħrajn ma jkunux qed jindirizzaw it-tħassib b'mod adegwat,
English: • The Committee therefore considered that patients exposed to the above mentioned products and concomitant intake of alcohol are at significantly greater risk of developing serious adverse reactions such as respiratory depression and death, and took the view that the risk-benefit balance of the product is not positive under normal conditions of use.
Maltese: • Il-Kumitat għalhekk ikkunsidra li l-pazjenti esposti għall-prodotti imsemmijin hawn fuq u b'konsum konkomitanti ta' alkoħol huma f'riskju akbar b'mod sinifikanti li jiżviluppaw reazzjonijiet avversi serji bħal dipressjoni respiratorja u mewt, u wasal għall-opinjoni li l-bilanċ benefiċċju-riskju mhuwiex pożittiv taħt kondizzjonijiet normali tal-użu.
English: In the scientific literature, drinking alcohol is referred as a coping mechanism to deal with the stress associated with pain.
Maltese: Percentage Use Alcohol to Manage Pain
English: The association between pain and drinking was evaluated by Brennan et al in a cohort of 401 elderly with different drinking behavior (Brennan, Addiction.
Maltese: L-assoċjazzjoni bejn l-uġigħ u x-xorb kienet evalwata minn Brennan et al f'koħort ta' 401 anzjan f'imġiba differenti ta' xorb (Brennan, Addiction. 2005; 100(6): 777-86).
English: In this study, subjects were interviewed about their number of alcohol consumptions of the last week and frequency of binge drinking in the last month (5292 responders).
Maltese: F'dan l-istudju, is-soġġetti ġew intervistati dwar in-numru ta' konsumi ta' alkoħol fil-ġimgħa ta' qabel u l-frekwenza ta' konsum ta' ammonti kbar ta' alkoħol fl-aħħar xahar (5292 intervistat).
English: During the assessment, major issues on safety were raised by Germany and the United Kingdom, hence the procedure was referred to CMD(h), under Article 29, paragraph 1 of Directive 2001/83/EC, as amended.
Maltese: Waqt il-valutazzjoni, tqajmu kwistjonijiet serji dwar is-sigurtà mill-Ġermanja u mir-Renju Unit, għalhekk il-proċedura ġiet riferuta lis-CMD(h), skont l-Artikolu 29, paragrafu 1 tad-Direttiva 2001/83/KE, kif emendata.
English: The CHMP considered the matter and adopted an Opinion in July 2010 recommending the renewal of the marketing authorisation subject to conditions considered essential to the safe and effective use of the product.
Maltese: Is-CHMP ikkunsidra l-kwistjoni u adotta Opinjoni f'Lulju 2010 u rrakkomanda t-tiġdid talawtorizzazzjoni għat-tqegħid fis-suq soġġetti għal kundizzjonijiet ikkunsidrati essenzjali għall-użu sigur u effettiv tal-prodott.
English: This strength is considered representative for the other (20, 60 and 120 mg) strengths as all strengths are dose proportional and manufactured with the same microgranules.
Maltese: Din il-qawwa hija kkunsidrata bħala rappreżentattiva għall-qawwiet l-oħrajn (20, 60 u 120 mg) minħabba li l-qawwiet kollha huma proporzjonali fid-doża u huma manifatturati bl-istess mikrogranuli.
English: It was shown that the dissolution rate increases with increased concentration of ethanol in the dissolution medium.
Maltese: Intwera li r-rata ta' dissoluzzjoni żdiedet maż-żieda filkonċentrazzjoni tal-etanol fil-mezz ta' dissoluzzjoni.
English: The CHMP therefore recommended the non-renewal of the marketing authorisation in line with article 24(2) of Directive 2001/83/EC as amended.
Maltese: is-CHMP, għalhekk irrakkomanda li l-awtorizzazzjoni għat-tqegħid fis-suq ma tiġġeddidx skont lArtikolu 24(2) tad-Direttiva 2001/83/KE kif emendata.
English: EMA/546649/2014 EMEA/V/C/003796
Maltese: EMEA/V/C/003796t
English: Further information on Porcilis PCV M Hyo can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Porcilis PCV M Hyo tinstab fuq is-sit elettroniku talAġenzija:ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Porcilis PCV M Hyo received a marketing authorisation valid throughout the EU for Porcilis PCV M Hyo on 7 November 2014.
Maltese: Porcilis PCV M Hyo ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Porcilis PCV M Hyo fis-7 ta' Novembru 2014.
English: Porcilis PCV M Hyo is a vaccine.
Maltese: Porcilis PCV M Hyo huwa vaċċin.
English: Porcilis PCV M Hyo (Porcine circovirus and Mycoplasma hyopneumoniae vaccine, inactivated)
Maltese: Porcilis PCV M Hyo (vaċċin taċ-ċirkovirus tal-ħnieżer u talMycoplasma hyopneumoniae, inattivat)
English: Porcilis PCV M Hyo contains porcine circovirus type 2 (PCV2) subunit antigen (a protein derived from part of the virus) and an inactivated (killed) strain of Mycoplasma hyopneumoniae bacteria.
Maltese: Porcilis PCV M Hyo fih antiġen tas-subunità taċ-ċirkovirus tal-ħnieżer tat-tip 2 (PCV2) (proteina derivata minn parti tal-virus) u razza inattivata (maqtula) ta' batterji ta' Mycoplasma hyopneumoniae.
English: • Porcine circovirus type 2 (PCV2) infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty in breathing, diarrhoea, pale skin and jaundice (yellowing of the skin).
Maltese: • L-infezzjonjiet taċ-cirkovirus tal-ħnieżer tat-tip 2 (PCV2) jistgħu jipproduċu sinjali kliniċi bħal telf fil-piż jew nuqqas ta' żvilupp, limfonodi mkabbra, diffikultà fit-teħid tan-nifs, ġilda pallida u suffejra
English: Other information about Porcilis PCV M Hyo
Maltese: Informazzjoni oħra dwar Porcilis PCV M Hyo
English: Laboratory studies in pigs showed that with two-dose vaccination the vaccine had its full effect against PCV2 by 18 days after first injection and against Mycoplasma hyopneumoniae by three weeks after the second injection, whilst with single-dose vaccination the vaccine had its full effect against PCV2 by two weeks and against Mycoplasma hyopneumoniae by four weeks.
Maltese: Studji fil-laboratorju fi ħnieżer urew li bit-tilqima ta' żewġ dożi, il-vaċċin kellu l-effett sħiħ tiegħu kontra PCV2 sa 18-il jum wara l-ewwel injezzjoni u kontra Mycoplasma hyopneumoniae sa tliet ġimgħat wara t-tieni injezzjoni, filwaqt li bit-tilqima ta' doża waħda, il-vaċċin kelllu l-effett sħiħ tiegħu kontra PCV2 sa ġimagħtejn u kontra Mycoplasma hyopneumoniae sa erba' ġimgħat.
English: Porcilis PCV M Hyo contains the adjuvants light mineral oil and aluminium hydroxide to enhance the immune response.
Maltese: Porcilis PCV M Hyo fih l-aġġuvanti żejt minerali ħafif u l-idrossidu tal-aluminju biex iżidu r-rispons immunitarju.
English: What are the risks associated with Porcilis PCV M Hyo?
Maltese: Kif jaħdem Porcilis PCV M Hyo?
English: The effectiveness of Porcilis PCV M Hyo was investigated in 10 field studies involving pig farms where signs of PCV2 and/or Mycoplasma hyopneumoniae infections had been detected.
Maltese: L-effikaċja ta' Porcilis PCV M Hyo ġiet investigata f'10 studji fuq il-post li involvew irziezet tal-ħnieżer fejn ġew identifikati sinjali ta' infezzjonijiet ta' PCV2 u/jew ta' Mycoplasma hyopneumoniae.
English: Porcilis PCV M Hyo is a veterinary vaccine used to protect pigs against two separate infections, caused by porcine circovirus and Mycoplasma hyopneumoniae.
Maltese: Porcilis PCV M Hyo huwa vaċċin veterinarju li jintuża biex jipproteġi l-ħnieżer kontra żewġ infezzjonijiet separati, ikkawżati minn ċirkovirus tal-ħnieżer u Mycoplasma hyopneumoniae.
English: Porcilis PCV M Hyo is an emulsion containing mineral oil.
Maltese: Porcilis PCV M Hyo huwa emulsjoni li fih żejt minerali.
English: With both vaccination schedules protection lasted 22 weeks after (the last) injection for PCV2 and 21 weeks after (the last) injection for Mycoplasma hyopneumoniae.
Maltese: Biż-żewġ skedi tat-tilqim, ilprotezzjoni damet 22 ġimgħa wara (l-aħħar) injezzjoni għal PCV2 u 21 ġimgħa wara (l-aħħar) injezzjoni għal Mycoplasma hyopneumoniae.
English: For both vaccination schedules protection lasts for 22 weeks after (the last) injection for PCV2 and for 21 weeks after (the last) injection for Mycoplasma hyopneumoniae.
Maltese: Għaż-żewġ skedi tat-tilqim, il-protezzjoni ddum għal 22 ġimgħa wara (l-aħħar) injezzjoni għal PCV2 u għal 21 ġimgħa wara (l-aħħar) injezzjoni għal Mycoplasma hyopneumoniae.
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: TNE [xemx] TNE [qamar] TLI [xemx] TLI [qamar] ERB [xemx] ERB [qamar] ĦAM [xemx] ĦAM [qamar] ĠIM [xemx] ĠIM [qamar] SIB [xemx] SIB [qamar] ĦAD [xemx] ĦAD [qamar]
English: Store below 25 °C.
Maltese: Aħżen f'temperatura taħt 25 °C.
English: 032266 Bucharest Romania
Maltese: 032266 Bucharest Ir-Rumanija
English: Environmental risk assessment (ERA)
Maltese: Rapport ta' Stima tar-Riskju Ambjentali (ERA)
English: Zentiva logo
Maltese: FIS-SUQ Zentiva logo
English: Frequency Preferred Term
Maltese: Frekwenza Terminu ppreferut
English: Hazard Ratio [95% CI]
Maltese: Proporzjon ta' periklu [95% CI]
English: mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin).
Maltese: mefloquine, halofantrine, pentamidine, cisapride, erythromycin minn ġol-vini).
English: st degree block (ECG prolonged PQ interval)
Maltese: Imblokk AV 1 grad (ECG prolongat fl- interval PQ)
English: OPA/Alu/PVC-Alu blisters, paper carton.
Maltese: Folji ta' OPA/Alu/PVC-Alu , kartun tal-karti.
English: Very rare
Maltese: Rari*
English: Date of first authorisation: 11/11/2016
Maltese: Data tal-ewwel awtorizzazzjoni: 11/11/2016
English: 74 received ivabradine (ratio 2:1).
Maltese: ingħataw ivabradine (proporzjon 2:1).
English: Placebo (N = 3,264) n (%)
Maltese: Plaċebo (N=3264)
English: Hypromellose Titanium dioxide Macrogol 400
Maltese: Il-kisja b'rita Hypromellose Titanium dioxide Macrogol 400
English: Combination with calcium channel blockers
Maltese: Użu flimkien ma' calcium channel blockers
English: S.C. Zentiva S.A 50 Theodor Pallady Blvd, District 3,
Maltese: Theodor Pallady Blvd, District 3,
English: Mean LVEF increased from 31.8% to 45.3% at M012 in ivabradine group versus 35.4% to 42.3% in the placebo group.
Maltese: L-LVEF medju żdied minn 31.8% għal 45.3% fil-M012 fil-grupp ta' ivabradine kontra 35.4% għal 42.3% fil-grupp tal-plaċebo.
English: Atrial fibrillation - cardiac arrhythmias
Maltese: Fibrillazzjoni tal-atriju - Arritmiji kardijaċi
English: Patients received standard care including beta-blockers (89%), ACE inhibitors and/or angiotensin II antagonists (91%), diuretics (83%), and anti-aldosterone agents (60%).
Maltese: Il-pazjenti rċevew kura standard li kienet tinkludi imblokkaturi tar-riċetturi beta (89 %), inibituri ACE u/jew antagonisti ta' angiotensin II (91 %), dijuretiċi (83 %), u sustanzi kontra l-aldosterone (60 %).
English: There was a significant improvement in NYHA class at last recorded value, 887 (28%) of patients on ivabradine improved versus 776 (24%) of patients on placebo (p = 0.001).
Maltese: Kien hemm titjib sinifikanti fil-klassi tan-NYHA fl-aħħar valur irreġistrat, 887 (28%) talpazjenti fuq ivabradine tjiebu kontra 776 (24%) tal-pazjenti li ħadu plaċebo (p=0.001).
English: QT prolonging medicinal products - Cardiovascular QT prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone).
Maltese: Prodotti mediċinali i jtawwlu l-QT - Mediċini kardjovaskulari li jtawwlu l-QT (eż. quinidine, disopyramide, bepridil, sotalol,
English: The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: 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: Ir-reazzjonijiet avversi li ġejjin ġew irrapporatati waqt provi kliniċi u huma kklassifikati blużu ta' din il-frekwenza: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1000 sa <1/100); rari (≥1/10000 sa <1/1000); rari ħafna (<1/10000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: rd degree block Sick sinus syndrome
Maltese: Sindrome tas-sick sinus
English: Ventricular extrasystoles Atrial fibrillation Uncommon Palpitations Supraventricular extrasystoles
Maltese: Żieda fl-extra sistoli ventrikulari Fibrillazzjoni atrijali
English: Lack of benefit on clinical outcomes in patients with symptomatic chronic stable angina pectoris
Maltese: Kura sintomatika ta' anġina pectoris kronika stabbli
English: Manufacturer(s)
Maltese: NUMRU(I)
English: Ivabradine Zentiva 5 mg film-coated tablets: 14, 28, 56, 84, 98, 100, 112 film-coated tablets Ivabradine Zentiva 7.5 mg: 14, 28, 56, 84, 98, 100, 112 film-coated tablets
Maltese: Ivabradine Zentiva 7.5 mg: 14, 28, 56, 84, 98, 100, 112-il pillola miksija b'rita
English: The potent CYP3A4 inhibitors ketoconazole (200 mg once daily) and josamycin (1 g twice daily) increased ivabradine mean plasma exposure by 7 to 8-fold.
Maltese: L-inibituri qawwija ta' CYP3A4 ketoconazole (200 mg darba kuljum) u josamycin (1g darbtejn kuljum) żiedu l-esponiment medju fil-plażma ta' ivabradine minn 7 għal 8 darbiet.
English: The concomitant use of potent CYP3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone is contra-indicated (see section 4.3).
Maltese: L-użu flimkien ta' inibituri qawwija ta' CYP3A4 bħal antifungali ta' tip azole (ketoconazole, itraconazole), antibijotiċi makrolidi (clarithromycin, erythtromycin per os, josamycin, telithromycin), inibituri tal-HIV protease (nelfinavir, ritonavir) u nefazodone huwa kontra-indikat (ara sezzjoni 4.3).
English: A small statistically significant increase in the PCE was observed in a pre-specified subgroup of patients with angina patients in CCS class II or higher at baseline (n = 12,049) (annual rates 3.4% versus 2.9%, relative risk ivabradine/placebo 1.18, p = 0.018), but not in the subgroup of the overall angina population in CCS class ≥ I (n = 14,286) (relative risk ivabradine/placebo 1.11, p = 0.110).
Maltese: Ġiet osservata żieda statistikament sinifikanti żgħira fil-PCE f'sottogrupp ta' pazjenti speċifikat minn qabel b'anġina fil-klassi CCS II jew ogħla fil-linja bażi (n=12,049) (rati annwali 3.4% meta mqabbel ma' 2.9%, riskju relattiv ta' ivabradine/plaċebo 1.18, p=0.018), iżda mhux fis-sottogrupp tal- popolazzjoni globali tal-anġina fil-klassi CCS ≥ I (n=14,286) (riskju relattiv ta' ivabradine/plaċebo 1.11, p=0.110).
English: nd degree.
Maltese: Torsade de pointes.
English: In pivotal phase III clinical trials the following medicinal products were routinely combined with ivabradine with no evidence of safety concerns: angiotensin converting enzyme inhibitors, angiotensin II antagonists, beta-blockers, diuretics, anti-aldosterone agents, short and long acting nitrates, HMG CoA reductase inhibitors, fibrates, proton pump inhibitors, oral antidiabetics, aspirin and other antiplatelet medicinal products.
Maltese: III tal-provi kliniċi, il-prodotti mediċinali msemmija hawn taħt ingħataw bħas-soltu flimkien ma' ivabradine mingħajr lebda evidenza ta' biża fuq is-sigurtà: inibituri angiotensin converting enżemi, antagonisti angiotensin II, imblokkaturi tar-riċetturi beta, dijuretiċi, sustanzi kontra l-aldosterone agents, nitrates li jaħdmu fil-qosor u fit-tul, inibituri HMG CoA reductase, fibrates, inibituri proton pump, antidijabetiċi orali, aspirin u prodotti mediċinali oħra anti-platelet.
English: The major active metabolite is the N-desmethylated derivative (S 18982) with an exposure about 40% of that of the parent compound.
Maltese: Is-sustanza attiva prinċipali ffurmata fil-metaboliżmu hi d- derivattiv N-desmethylated ( S18982) ma' kxif ta' madwar 40% talprodott mediċinali oriġinali.
English: Ivabradine Zentiva may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
Maltese: Ivabradine Zentiva jista' jikkaġunalek fenomeni viżivi mudwali temporanji (luminożità temporanja fil-kamp viżiv, ara “Effetti Sekondarji li jista' jkollu”).
English: The total clearance is about 400 mL/min and the renal clearance is about 70 mL/min.
Maltese: It-tneħħija totali hija ta' madwar 400 mL/min u t-tneħħija renali hija ta' madwar 70 mL/min.
English: These trials included a total of 4,111 patients with chronic stable angina pectoris, of whom 2,617 received ivabradine.
Maltese: F'dawn il- provi ħadu sehem 4111 pazjent b'angina pectoris kronika stabbli, li minnhom 2617 ħadu ivabradine.
English: A randomised, double blind, placebo controlled study was performed in 116 paediatric patients (17 aged [6 - 12] months, 36 aged [1 - 3] years and 63 aged [3 - 18] years) with CHF and dilated cardiomyopathy (DCM) on top of optimal background treatment.
Maltese: Sar studju randomizzat, double blind, ikkontrollat bi plaċebo f'116-il pazjent pedjatriku (17 li għandhom [6-12[-il xahar, 36 li għandhom [1-3[ snin u 63 li għandhom [3-18[ snin) b'CHF jew b'kardjomijopatija dilatata (DCM) flimkien ma' kura ta' sfond ottimali. 74
English: - CYP3A4 inducers: CYP3A4 inducers (e.g. rifampicin, barbiturates, phenytoin, Hypericum perforatum [St. John's Wort]) may decrease ivabradine exposure and activity.
Maltese: (eż. rifampicin, barbiturates, phenytoin, Hypericum perforatum [St. John's Wort] jistgħu jnaqqsu l- esponiment u l-attività ta' ivabradine.