FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Sumatriptan Galpharm and Imigran, sumatriptan, works by mimicking the action of the neurotransmitter 5-hydroxytryptamine (serotonin) in the brain.
Maltese: In-newtrotrażmettituri huma kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw bejniethom.
English: During the re-examination in November 2011, the CHMP's main concerns were not resolved.
Maltese: Matul l-eżaminazzjoni mill-ġdid f'Novembru 2011, it-tħassib ewlieni tas-CHMP baqa' ma ġiex solvut.
English: The applicant requested a re-examination of the negative opinion.
Maltese: L-applikant talab li terġa' ssir eżaminazzjoni tal-opinjoni negattiva.
English: Sumatriptan will help blood vessels to return to their normal size.
Maltese: Sumatriptan jgħin il-vini jerġgħu lura għad-daqs normali tagħhom.
English: What was Sumatriptan Galpharm expected to be used for?
Maltese: Għal xiex kien mistenni jintuża Sumatriptan Galpharm?
English: How is Sumatriptan Galpharm expected to work?
Maltese: Kif mistenni jaħdem Sumatriptan Galpharm?
English: The CHMP also remained concerned about the safety of Sumatriptan Galpharm, in particular the potential for misuse and overuse as well as the risk of misdiagnosis of migraine and lack of medical follow-up when used in the non-prescription setting.
Maltese: Għaldaqstant, f'dak iż-żmien, is-CHMP kien tal-opinjoni li l-benefiċċji ta' Sumatriptan Galpharm ma kinux jisbqu r-riskji u għaldaqstant irrakkomanda li dan ma jingħatax awtorizzazzjoni għat-tqegħid fissuq.
English: Sumatriptan Galpharm was expected to be used to relieve migraine attacks in people who had been diagnosed with migraine.
Maltese: Sumatriptan Galpharm kien mistenni jintuża biex itaffi l-attakki ta' emigranja f'persuni li ġew iddijanjostikati li jbatu mill-emigranja.
English: EMA/174999/2015 EMEA/H/C/002398
Maltese: EMEA/H/C/002398
English: It is available as tablets (500 micrograms).
Maltese: Jiġi bħala pilloli (500 mikrogramma).
English: The full EPAR for Daliresp can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Daliresp jinsab fuq is-sit elettroniku tal-Aġenzija e ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 03-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'03-2015.
English: Daliresp is a medicine that contains the active substance roflumilast.
Maltese: Daliresp huwa prodott mediċinali li fih is-sustanza attiva roflumilast.
English: The active substance in Daliresp, roflumilast, belongs to a group of medicines called ‘phosphodiesterase type 4 (PDE4) inhibitors'.
Maltese: Is-sustanza attiva f'Daliresp, riflumilast, tagħmel parti minn grupp ta' mediċini li jissejjaħ ‘inibituri tattip 4 ta' fosfodjesterażi (PDE4)'.
English: This is a summary of the European public assessment report (EPAR) for Daliresp.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Daliresp.
English: Daliresp is used to treat severe chronic obstructive pulmonary disease (COPD) in adults who have chronic bronchitis (long-term inflammation of the airways), and whose COPD flares up frequently.
Maltese: Daliresp jintuża għall-kura ta' mard pulmonari ostruttiv kroniku sever (COPD - chronic obstructive pulmonary disease) f'adulti li għandhom bronkite kronika (infjammazzjoni fit-tul fil-passaġġi tal-arja), u li s-COPD tagħhom toħroġilhom spiss.
English: The most common side effects with Daliresp (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Maltese: L-effetti sekondarji l-aktar komuni b'Daliresp (li dehru f'bejn pazjent wieħed u għaxra minn kull mija) huma tnaqqis fil-piż, tnaqqis fl-aptit, insomnija (diffikultà fl-irqad), uġigħ ta' ras, dijarrea, nawżja (dardir) u wġigħ addominali (uġigħ fl-istonku).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Daliresp on 28 February 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Daliresp valida fl-Unjoni Ewropea kollha fit-28 ta' Frar 2011.
English: This authorisation was based on the authorisation granted to Daxas in 2010 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija lil Daxas fl-2010 (‘kunsens infurmat').
English: Daliresp has been compared with placebo (a dummy treatment) in two main studies involving over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year.
Maltese: Daliresp tqabbel ma' plaċebo (trattament finta) f'żewġ studji prinċipali li involvew aktar minn 3,000 adult b'COPD severa li kellhom mill-anqas attakk wieħed tal-marda tagħhom fl-aħħar sena.
English: The company is also carrying out an observational study on the long-term safety of the medicine.
Maltese: Il-kumpanija qed twettaq ukoll studju ta' osservazzjoni dwar s-sigurtà fit-tul tal-mediċina.
English: The main measure of effectiveness was the improvement in forced expiratory volumes (FEV1) and the reduction in the number of moderate or severe flare-ups of their COPD over a year of treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien it-titjib fil-volumi espiratorji furzati (FEV1) u t-tnaqqis fin-numru ta' feġġiet moderati jew severi tas-COPD tagħhom matul sena ta' kura.
English: Why has Daliresp been approved?
Maltese: Għaliex ġie approvat Daliresp?
English: Daliresp is not used on its own but as an ‘add-on' to treatment with bronchodilators (medicines that widen the airways in the lungs).
Maltese: Daliresp ma jintużax waħdu iżda bħala ‘żieda' mal-kura bi bronkodilataturi (mediċini li jwessgħu ilpassaġġi tal-arja fil-pulmun).
English: What is Daliresp?
Maltese: X'inhu Daliresp?
English: For the full list of all side effects reported with Daliresp, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Daliresp, ara lfuljett ta' tagħrif.
English: In addition, the patients who took Daliresp had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.
Maltese: Barra minn hekk, il-pazjenti li ħadu Daliresp kellhom medja ta' 1.1 attakki tal-marda moderati jew severi tal-marda tagħhom, meta mqabbla ma' 1.4 attakki fil-pazjenti li ħadu l-plaċebo.
English: In addition, the company that makes Daliresp will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine's side effects and how it should be used.
Maltese: Barra minn dan, il-kumpanija li tipproduċi Daliresp ser tiżgura li professjonisti tal-kura tas-saħħa, li jippreskrivu l-mediċina fl-Istati Membri kollha tal-Unjoni Ewropea (UE) jiġu pprovduti b'materjali edukattivi li jkun fihom informazzjoni dwar l-effetti sekondarji tal-mediċina u kif għandha tintuża.
English: The CHMP noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daliresp in patients with severe COPD.
Maltese: Is-CHMP innota li kien hemm ħtieġa ta' kuri ġodda għal COPD u li l-istudji prinċipali wrew benefiċċju modest ta' Daliresp f'pazjenti b'COPD sever.
English: How has Daliresp been studied?
Maltese: Kif ġie studjat Daliresp?
English: After considering all of the available data on the effects of the medicine, the Committee decided that Daliresp's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Wara li kkunsidra d-data kollha disponibbli dwar l-effetti tal-mediċina, ilKumitat iddeċieda li l-benefiċċji ta' Daliresp huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: After a year, the patients who took Daliresp had an average increase of 40 ml while those given placebo had an average decrease of 9 ml.
Maltese: Wara sena, il-pazjenti li ħadu Daliresp kellhom żieda medja ta' 40 ml filwaqt li dawk li ħadu l-plaċebo kellhom tnaqqis medju ta' 9 ml.
English: What is the risk associated with Daliresp?
Maltese: Għal xiex jintuża Daliresp?
English: It blocks the action of the PDE4 enzyme, which is involved in the inflammation process that leads to COPD.
Maltese: Din timblokka l-azzjoni tal-enzim PDE4, li huwa involut fil-proċess ta' infjammazzjoni li jwassal għal COPD. Billi timblokka l-azzjoni ta' PDE4, roflumilast tnaqqas linfjammazzjoni fil-pulmun, u tgħin fit-tnaqqis tas-sintomi tal-pazjent jew tipprevjeni milli dawn jiggravaw.
English: The patients could continue to receive treatment with a bronchodilator during the study.
Maltese: Id-doża rakkomandata ta' Daliresp hija ta' pillola darba kuljum.
English: A risk management plan has been developed to ensure that Daliresp is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Daliresp jintuża bl-aktar mod sigur possibbli.
English: It contains the active substance encorafenib.
Maltese: Fih is-sustanza attiva encorafenib.
English: Braftovi is available as capsules (50 mg and 75 mg).
Maltese: Braftovi huwa disponibbli bħala kapsuli (50 mg u 75 mg).
English: Further information on Braftovi 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 Braftovi
Maltese: Informazzjoni oħra dwar Braftovi
English: The most common side effects with Braftovi and binimetinib taken together at the highest recommended doses are tiredness, nausea (feeling sick), diarrhoea, vomiting, retinal detachment (an eye problem that leads to poor vision), abdominal pain, joint pain, muscle pain and high levels of an enzyme called creatine kinase, which may indicate muscle problems.
Maltese: L-effetti sekondarji l-aktar komuni bi Braftovi u binimetinib meħudin flimkien bl-ogħla dożi rrakkomandati huma għeja, nawsja (tħossok ma tiflaħx), dijarea, remettar, distakkament retinali (problema tal-għajnejn li twassal għal vista batuta), uġigħ fl-addome, uġigħ fil-ġogi, uġigħ fil-muskoli u livelli għoljin ta' enzima msejħa kinażi tal-kreatina, li tista' tindika problemi fil-muskoli.
English: In melanoma tumours with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division.
Maltese: F'tumuri tal-melanoma b'mutazzjoni BRAF V600, hija preżenti forma anomala tal-proteina BRAF, li tattiva proteina oħra msejħa MEK involuta fl-istimulazzjoni tad-diviżjoni taċ-ċelloli.
English: Up to 50% of patients with metastatic melanoma have a mutation in BRAF with the V600 mutation being the most common.
Maltese: Sa 50% tal-pazjenti b'melanoma metastatika għandhom mutazzjoni f'BRAF bil-mutazzjoni V600 tkun laktar komuni.
English: What are the risks associated with Braftovi?
Maltese: X'inhuma r-riskji assoċjati ma' Braftovi?
English: Patients normally take 450 mg (six 75 mg capsules) once a day but can have the dose reduced or treatment stopped temporarily if they experience troublesome side effects.
Maltese: Normalment il-pazjenti jieħdu 450 mg (sitt kapsuli ta' 75 mg) darba kuljum iżda jista' jkollhom id-doża mnaqqsa jew il-kura mwaqqfa temporanjament jekk jesperjenzaw effetti sekondarji problematiċi.
English: Braftovi is a medicine for treating melanoma (a skin cancer) that has spread or cannot be removed by surgery.
Maltese: Braftovi huwa mediċina għall-kura tal-melanoma (kanċer tal-ġilda) li tkun infirxet jew li ma tistax titneħħa bil-kirurġija.
English: As for all medicines, data on the use of Braftovi are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Braftovi hija ssorveljata kontinwament.
English: Braftovi is used in combination with another medicine, binimetinib (Mektovi), and is only for patients whose cancer cells have a specific mutation (change) in their genes called 'BRAF V600'.
Maltese: Braftovi jintuża flimkien ma' mediċina oħra, binimetinib (Mektovi), u huwa biss għal pazjenti li ċ-ċelloli tal-kanċer tagħhom għandhom mutazzjoni (bidla) speċifika fil-ġeni tagħhom imsejħa 'BRAF V600'.
English: The side effects seen with Braftovi are similar to those seen with other medicines in the same class and are considered manageable.
Maltese: L-effetti sekondarji esperjenzati bi Braftovi huma simili għal dawk esperjenzati b'mediċini oħrajn fl-istess klassi u huma kkunsidrati maniġġevoli.
English: The active substance in Braftovi, encorafenib, works by blocking the BRAF protein thereby stopping its activation by MEK and slowing down the growth and spread of the cancer.
Maltese: Is-sustanza attiva f'Braftovi, encorafenib, taħdem billi timblokka l-proteina BRAF, b'hekk twaqqaf l-attivazzjoni tagħha b'MEK u tnaqqas it-tkabbir u t-tifrix tal-kanċer.
English: For the full list of side effects and restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of Braftovi?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Braftovi?
English: A study of 577 patients with melanoma with the BRAF V600 mutation that had spread or could not be removed surgically showed that Braftovi with binimetinib can prolong the length of time patients lived without their disease getting worse.
Maltese: Studju ta' 577 pazjent bil-melanoma b'mutazzjoni BRAF V600 li nfirxet jew li ma tistax titneħħa bilkirurġija wera li Braftovi flimkien ma' binimetinib jista' jtawwal it-tul taż-żmien kemm idumu jgħixu lpazjenti mingħajr ma l-marda tmur għall-agħar.
English: Why is Braftovi authorised in the EU?
Maltese: Għaliex Braftovi ġie awtorizzat fl-UE?
English: Content (concentration)
Maltese: <Kontenut (konċentrazzjoni)>
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Très le Bois
Maltese: Z.I. Très le Bois
English: ATCvet code: QC09BA07.
Maltese: QC09BA07
English: Food increases the bioavailability to 80 to 90%.
Maltese: L-ikel iżid il-bijodisponibilità minn 80 sa 90%.
English: Date of first authorisation: 23/07/2012 Date of latest renewal:
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23/07/2012
English: Ceva Santé Animale 10, av. de la Ballastière 33500 Libourne France
Maltese: Ceva Santé Animale 10, av. de la Ballastière 33500 Libourne Franza
English: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne France
Maltese: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne Franza
English: Artificial beef flavour Compressible sugar Crospovidone Magnesium stearate
Maltese: Togħma artifiċjali ta' ċanga Zokkor ‘Compressible' Crospovidone Magnesium stearate
English: Vomiting has been reported very rarely in spontaneous reports.
Maltese: Ir-remettar ġie rapportat b'mod rari ħafna f'rapporti spontanji..
English: D-73614 Schorndorf Germany
Maltese: D-73614 Schorndorf Il-Ġermanja
English: EU/2/12/142/001(1 x 30 tablets, 2.5 mg/20 mg) EU/2/12/142/002 (1 x 90 tablets, 2.5 mg/20 mg) EU/2/12/142/003 (1 x 30 tablets, 5 mg/40 mg) EU/2/12/142/004 (1 x 90 tablets, 5 mg/40 mg) EU/2/12/142/005 (1 x 30 tablets, 10 mg/80 mg) EU/2/12/142/006 (1 x 90 tablets, 10 mg/80 mg)
Maltese: EU/2/12/142/001 (1 x 30 pillola, 2.5 mg/20 mg) EU/2/12/142/002 (1 x 90 pillola, 2.5 mg/20 mg) EU/2/12/142/003 (1 x 30 pillola, 5 mg/40 mg) EU/2/12/142/004 (1 x 90 pillola, 5 mg/40 mg) EU/2/12/142/005 (1 x 30 pillola, 10 mg/80 mg)
English: EU/2/12/142/001 (1 x 30 tablets 2.5 mg/20 mg) EU/2/12/142/002 (1 x 90 tablets 2.5 mg/20 mg) EU/2/12/142/003 (1 x 30 tablets 5 mg/40 mg) EU/2/12/142/004 (1 x 90 tablets 5 mg/40 mg) EU/2/12/142/005 (1 x 30 tablets 10 mg/80 mg) EU/2/12/142/006 (1 x 90 tablets 10 mg/80 mg)
Maltese: EU/2/12/142/002 (1 x 90 pillola 2.5 mg/20 mg) EU/2/12/142/003 (1 x 30 pillola 5 mg/40 mg) EU/2/12/142/004 (1 x 90 pillola 5 mg/40 mg) EU/2/12/142/005 (1 x 30 pillola 10 mg/80 mg) EU/2/12/142/006 (1 x 90 pillola 10 mg/80 mg)
English: Benazepril hydrochloride is a prodrug hydrolysed in vivo into its active metabolite, benazeprilat.
Maltese: Benazepril hydrochloride huwa prodrug idrolizzat in vivo għall-metabolit attiv tiegħu, benazeprilat.
English: In the cardiovascular system, spironolactone prevents the detrimental effects of aldosterone.
Maltese: Fis-sistema kardjovaskulari, spironolactone jimpedixxi l-effetti detrimentali t'aldosterone.
English: 30 tablets 90 tablets
Maltese: 90 pillola
English: Pack sizes of 30 or 90 tablets.
Maltese: Daqsijiet tal-pakketti ta' 30 jew 90 pillola.
English: The mean volumes of distribution of 7-α-thiomethyl-spironolactone and canrenone are approximately 153 litres and 177 litres respectively.
Maltese: Il-volumi medji ta' distribuzzjoni ta' 7-α-thiomethyl-spironolactone u canrenone huma madwar 153 litru u 177 litru rispettivament.
English: The plasma clearances of canrenone and 7-αthiomethyl-spironolactone are 1.5 l/h/kg bw and 0.9 l/h/kg bw respectively.
Maltese: It-tneħħija ta' canrenone u 7-αthiomethyl-spironolactone mill-plażma huma 1.5 l/h/kg u 0.9 l/h/kg rispettivament.
English: Bottle of 90 tablets
Maltese: Flixkun ta' 90 pillola
English: Lactose monohydrate Cellulose microcrystalline Povidone K30
Maltese: Cellulose microcrystalline
English: Manufacturers responsible for batch release: Ceva Santé Animale
Maltese: Manifatturi responsabbli għall-ħruġ tal-lott Ceva Santé Animale
English: INDICATION(S)
Maltese: TAS-SUSTANZA(I)
English: benazepril HCl 2.5 mg, spironolactone 20 mg benazepril HCl 5 mg, spironolactone 40 mg benazepril HCl 10 mg, spironolactone 80 mg
Maltese: ATTIVA(I) benazepril HCl 2.5 mg, spironolactone 20 mg benazepril HCl 5 mg, spironolactone 40 mg benazepril HCl 10 mg, spironolactone 80 mg
English: Cardboard box of 1 bottle of 90 tablets
Maltese: Kaxxa tal-kartun ta' flixkun 1 ta' 90 pillola
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s))- common (more than 1 but less than 10 animals treated in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali trattati juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali trattati f'100 annimal trattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal trattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal trattat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal trattat, inklużi rapporti iżolati).
English: Cardalis 2.5 mg/20 mg tablets
Maltese: Pilloli Cardalis 2.5 mg/20 mg
English: Tres le Bois 22600 Loudeac France
Maltese: Ceva Santé Animale Z.I. Tres le Bois 22600 Loudeac Franza
English: Lot {number}
Maltese: TA' TIŻMIM
English: The systemic bioavailability of benazepril is incomplete due to incomplete absorption and first pass metabolism.
Maltese: Il-bijodisponibilità sistemika ta' benazepril mhix kompluta minħabba assorbiment mhux kompletat u metaboliżmu first pass.
English: Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could affect the metabolism of other substances utilizing these metabolic pathways.
Maltese: Spironolactone jista' jikkaġuna kemm induzzjoni u impediment ta' enzimi ta' cytochrome P450 u jista' jaffettwa l-metaboliżmu ta' sustanzi oħra li jużaw dawn ir-rotot metaboliċi.
English: Excipients:
Maltese: Kodiċi ATCvet:
English: Spironolactone is rapidly and completely metabolised by the liver into its active metabolites, 7αthiomethyl-spironolactone and canrenone, which are the primary metabolites in the dog.
Maltese: Spironolactone huwa metabolizzat malajr u kompletament mill-fwied fil-metaboliti attivi tiegħu, 7-αthiomethyl-spironolactone u canrenone, li huma l-metaboliti prinċipali fil-kelb.
English: Do not use during pregnancy and lactation (see section "Pregnancy and lactation ").
Maltese: Tużax waqt it-tqala u treddigħ (ara sezzjoni " Tqala u treddiegħ").
English: Chewable tablet.
Maltese: Pillola li tomgħod.
English: Cardalis 5 mg/40 mg tablets
Maltese: Pilloli Cardalis 5 mg/40 mg
English: Cardalis 10 mg/80 mg tablets
Maltese: Pilloli Cardalis 10 mg/80 mg
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: After oral administration of spironolactone to dogs, it was demonstrated that the three metabolites achieved levels of 32 to 49% of the administered dose.
Maltese: Wara għoti orali ta' spironolactone lil klieb, kien osservat li t-tliet metaboliti kisbu livelli minn 32 għal 49% tad-doża mogħtija.
English: After coadministration of spironolactone (2 mg/kg bw) and benazepril hydrochloride (0.25 mg/kg bw) the terminal plasma half-lives (t½) were 7 hours and 6 hours for canrenone and 7-α-thiomethylspironolactone respectively.
Maltese: Wara l-għoti konġunt ta' spironolactone (2 mg/kg piż tal-ġisem) u benazepril hydrochloride (0.25 mg/kg piż tal-ġisem) il-half-lives terminali (t½) fil-plażma kienu ta' 7 sigħat u 6 sigħat għall canrenone u 7-α-thiomethyl-spironolactone rispettivament.
English: Dogs.
Maltese: BISS"
English: 4.11 Withdrawal period(s)
Maltese: 4.11 Perjod(u/i) ta' Tiżmin
English: At steady state, mean Cmax of 324 μg/l and 66 μg/l are achieved for the primary metabolites, 7-α-thiomethyl-spironolactone and canrenone, 2 and 4 hours post-dosing, respectively.
Maltese: Fl-istadju fiss il-medja ta' Cmax ta' 324 g/l u 66 mg/l għandhom jintlaħqu għall-metaboliti primarji, 7-α-thiomethyl-spironolactone u canrenone, sagħtejn u 4 sigħat, rispettivament wara li tkun ingħatat id-doża,.
English: Spironolactone is mainly excreted via its metabolites.
Maltese: Spironolactone huwa prinċipalment eliminat permezz tal-metaboliti tiegħu.
English: Benazepril, by preventing the formation of Angiotensin-II, inhibits the detrimental effects of vasoconstriction and stimulation of aldosterone release.
Maltese: Benazepril, peress li jxekkel l-formazzjoni t'Angiotensin-II, jimpedixxi l-effetti detrimentali ta' tidjiq talvażi u stimulazzjoni tar-rilaxx ta' aldosterone.
English: Z.I.
Maltese: L-ISEM
English: The administration of deoxycorticosterone with the product may lead to a moderate reduction of the natriuretic effects (reduction of urinary sodium excretion) of spironolactone.
Maltese: L-għoti ta' deoxycorticosterone mal-prodott jista' jwassal għal tnaqqis moderat fl-effetti natrijuretiċi (tnaqqis ta' eskrezzjoni tas-sodju fl-awrina) ta' spironolactone.
English: The association of spironolactone and benazepril is beneficial as both act on the renin-angiotensinaldosterone system (RAAS) but at different levels along the cascade.
Maltese: L-assoċjazzjoni ta' spironolactone u benazepril huwa ta' benefiċċju peress li t-tnejn jaġixxu fuq is-sistema renin-angiotensin-aldosterone (RAAS) imma fuq livelli differenti matul il-kaskata.
English: Spironolactone and its active metabolites (including 7-α-thiomethyl-spironolactone and canrenone) act as specific antagonists of aldosterone by binding competitively to mineralocorticoid receptors located in the kidneys, heart and blood vessels.
Maltese: Spironolactone u l-metaboliti attivi tiegħu (li jinkludu 7-α-thiomethyl-spironolactone u canrenone) jaġixxu bħala antagonisti speċifiċi t'aldosterone billi jintrabtu b'mod kompetittiv ma' riċetturi mineralokortikojdi li jinsabu fil-kliewi, il-qalb u l-vażi tad-demm.
English: EXP {month/year}
Maltese: DATA TA' SKADENZA EXP {xahar/sena}