FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking into account that fenspiride is indicated to treat benign symptoms and the seriousness of the risk of unpredictable QT prolongation leading to proarrhythmic potential in human, the ANSM concluded that the benefit-risk balance of fenspiride-containing medicinal products was no longer favourable in the treatment of symptoms related to bronchopulmonary diseases, and suspended the marketing authorisations of these products.
Maltese: Filwaqt li jitqies li fenspiride huwa indikat biex jikkura sintomi beninni u l-gravità tar-riskju ta' titwil mhux prevedibbli tal-QT li jwassal għal potenzjal proarritmiku fil-bniedem, l-ANSM ikkonkludiet li l-bilanċ bejn il-benefiċċju u r-riskju ta' prodotti mediċinali li fihom fenspiride m'għadux favorevoli filkura ta' sintomi relatati ma' mard bronkopulmonari, u ssospendiet l-awtorizzazzjonijiet għat-tqegħid fis-suq ta' dawn il-prodotti.
English: Newly available results of two non-clinical studies showed that fenspiride can induce an inhibition of hERG tail current in vitro, and increase the corrected QT (QTc) intervals in isolated and perfused guinea pig heart.
Maltese: Ir-riżultati disponibbli ġodda ta' żewġ studji mhux kliniċi wrew li fenspiride jista' jinduċi inibizzjoni ta' kurrent fid-denb ta' hERG in vitro, u jżid l-intervalli ta' QT (QTc) ikkorreġuti fil-qalb tal-fenek tal-Indi iżolata u perfuża.
English: The French Competent Authority (ANSM) considered that these results taken together with pharmacovigilance data support the risk of prolongation of the QTc interval in these patients.
Maltese: L-Awtorità Kompetenti Franċiża (ANSM) qieset li dawn irriżultati flimkien mad-dejta tal-farmakoviġilanza jappoġġaw ir-riskju ta' titwil tal-intervall QTc f'dawn ilpazjenti.
English: The PRAC considered all data submitted by the MAHs, received from stakeholders and provided by EMA.
Maltese: Il-PRAC ikkunsidra d-dejta kollha ppreżentata mill-MAHs, irċevuta mill-partijiet ikkonċernati u pprovduta mill-EMA.
English: Regarding clinical data, analysis of post-marketing cases reported since the marketing authorisation showed evidence to support a causal association between occurrence of QT prolongation/TdP in patients, mostly with risk factors for these events, and the treatment with fenspiride-containing medicinal products.
Maltese: Rigward id-dejta klinika, l-analiżi ta' każijiet ta' wara t-tqegħid fis-suq irrappurtati wara lawtorizzazzjoni għat-tqegħid fis-suq uriet evidenza biex tappoġġja assoċjazzjoni kawżali bejn lokkorrenza ta' titwil tal-QT/TdP fil-pazjenti, l-aktar b'fatturi ta' riskju għal dawn l-avvenimenti, u l-kura bi prodotti mediċinali li fihom fenspiride.
English: Therefore, the PRAC concluded that the risk of QT prolongation, the proarrhythmic potential and associated risk of TdP outweighs the benefits of fenspiride in its authorised indication(s).
Maltese: Għalhekk, il-PRAC ikkonkluda li r-riskju ta' titwil tal-QT, il-potenzjal proarritmiku u r-riskju assoċjat ta' TdP huma akbar mill-benefiċċji ta' fenospiride fl-indikazzjoni(jiet) awtorizzata(i) tiegħu.
English: Therefore, pursuant to Article 116 of Directive 2001/83/EC, the CMDh recommends the revocation of the marketing authorisations for fenspiride-containing medicinal products.
Maltese: Għalhekk, skont l-Artikolu 116 tad-Direttiva 2001/83/KE, il-Kumitat jirrakkomanda r-revoka talawtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti mediċinali li fihom fenspiride.
English: Calculated safety margins between the hERG inhibition concentration and the effective therapeutic plasma concentration were below the lowest acceptable margin proposed in the literature for administration in humans.
Maltese: Il-marġini tas-sigurtà kkalkulati bejn il-konċentrazzjoni ta' inibizzjoni hERG u lkonċentrazzjoni fil-plażma terapewtika effettiva kienu inqas mill-marġini aċċettabbli l-aktar baxx propost fil-letteratura għal għoti fil-bnedmin.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TWINRIX ADULT EPAR summary for the public
Maltese: RAPPORT TAL-VALUTAZZJONI PUBBLIKA EWROPEA (EPAR) TWINRIX ADULT Sommarju ta' l-EPAR għall-pubbliku
English: This summary was last updated in 02-2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'02-2008.
English: Twinrix Adult has been studied in three main studies involving 843 healthy people aged between 18 and 60 years, most of whom were under 40 years of age.
Maltese: Twinrix Adult ġie studjat fi tliet studji ewlenin li involvew 843 nies f'saħħithom ta' etajiet bejn 18 u 60 sena, il-parti l-kbira minnhom kienu taħt l-età ta' 40 sena.
English: For hepatitis B, antibodies were detected in 71% of adults after the first dose, 97% after the second dose and 99.7% after the third dose.
Maltese: Għall-epatite B, antikorpi kienu osservati f'71% wara l-ewwel doża, 97% wara t-tieni doża u 99.7% wara t-tielet doża.
English: Each person received Twinrix Adult doses at months 0, 1 and 6.
Maltese: Kull persuna rċiviet dożi ta' Twinrix Adult f'xhur 0, 1 u 6.
English: The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Maltese: metodu magħruf bħala ‘teknoloġija rekombinanti tad-DNA': huma jsiru minn ħmira li tkun irċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l-proteini.
English: This document is a summary of the European Public Assessment Report (EPAR).
Maltese: Dan id-dokument huwa sommarju tar-Rapport tal-Valutazzjoni Pubblika Ewropea (EPAR).
English: The studies showed that for hepatitis A, antibodies were detected in 94% of adults after the first dose, 99.5% after the second dose and 100% after the third dose.
Maltese: L-istudji wrew li għall-epatite A, antikorpi kienu osservati f'94% ta' adulti wara l-ewwel doża, 99.5% wara t-tieni doża u 100% wara t-tielet.
English: The marketing authorisation was renewed on 20 September 2001 and on 20 September 2006.
Maltese: Lawtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fl-20 ta' Settembru 2001 u fl-20 ta' Settembru
English: The European Commission granted a marketing authorisation valid throughout the EU to GlaxoSmithKline Biologicals s.a. for Twinrix Adult on 20 September 1996.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq għal Twinrix Adult valida flUnjoni Ewropea kollha lil GlaxoSmithKline Biologicals s.a. fl-20 ta' Settembru 1996.
English: Twinrix Adult is a vaccine, which is available as a suspension for injection.
Maltese: Twinrix Adult huwa vaċċin, li jiġi bħala sospensjoni għal injezzjoni.
English: Twinrix Adult contains small amounts of inactivated hepatitis A viruses and the ‘surface antigen' (proteins from the surface) of the hepatitis B virus.
Maltese: Twinrix Adult fih ammonti żgħar ta' virusis ta' l-epatite A inattivati u l-‘antiġen tal-wiċċ' (proteini mill-wiċċ) tal-virus ta' l-epatite B.
English: It contains inactivated (killed) hepatitis A viruses and parts of the hepatitis B virus as active substances.
Maltese: Bħala sustanzi attivi huwa fih virusis inattivati (maqtulin) ta' l-epatite A u partijiet mill-virus ta' l-epatite B.
English: Twinrix Adult is used to protect against hepatitis A and hepatitis B infection (diseases that affect the liver).
Maltese: Twinrix Adult jintuża biex jipproteġi kontra infezzjoni b'epatite A u b'epatite B (mard li jaffettwa lfwied).
English: Twinrix Adult is a vaccine.
Maltese: Twinrix Adult huwa vaċċin.
English: The three-week vaccination schedule also led to the production of antibodies in around 83% of patients, rising to around 89% after the booster dose at month 12.
Maltese: L-iskeda ta' tilqim ta' tliet ġimgħat wasslet ukoll għall-produzzjoni ta' antikorpi f'madwar 83% ta' pazjenti, li telgħu għal madwar 89% wara d-doża booster f'xahar 12.
English: What is Twinrix Adult?
Maltese: X'inhu Twinrix Adult?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Adult's benefits are greater than its risks for use in non-immune adults and adolescents of 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.
Maltese: Huwa jintuża f'adulti u f'adolexxenti ta' etajiet minn 16-il sena li mhumiex diġà immuni għal dawn iż-żewġ mardiet u li huma f'riskju li jieħduhom it-tnejn li huma.
English: Further studies looked at the persistence of antibodies after vaccination in adults and adolescents, and at the schedule for vaccinating adults over three weeks when rapid protection is required.
Maltese: Aktar studji ħarsu lejn il-persistenza ta' livelli ta' antikorpi wara t-tilqim f'adulti u adolexxenti, u lejn l-iskeda ta' tilqim ta' l-adulti fuq tliet ġimgħat meta tkun meħtieġa protezzjoni ta' malajr.
English: For the full list of all side effects reported with Twinrix Adult, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji kollha rrapportati bi Twinrix Adult, ara l-Fuljett ta' Tagħrif.
English: Why has Twinrix Adult been approved?
Maltese: Għalfejn ġiex approvat Twinrix Adult?
English: Other information about Twinrix Adult:
Maltese: Tagħrif ieħor dwar Twinrix Adult:
English: It is available in a 1 ml vial and in a 1 ml prefilled syringe.
Maltese: Huwa jinsab f'kunjett ta' 1 ml u f'siringa mimlija għal-lest ta' 1 ml.
English: Twinrix Adult should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic).
Maltese: Twinrix Adult m'għandux jintuża f'nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal kwalunkwe sustanza attiva, għal kwalunkwe sustanza oħra jew għal neomycin (antibijotiku).
English: The most common side effects with Twinrix Adult (seen in more than 1 in 10 doses of the vaccine) are headache, pain and redness at the injection site, and fatigue (tiredness).
Maltese: L-aktar effetti sekondarji komuni bi Twinrix Adult (dehru f'aktar minn doża 1 minn kull 10 tal-vaċċin) huma uġigħ ta' ras, uġigħ u ħmura fis-sit ta' l-injezzjoni u għeja kbira.
English: What is the risk associated with Twinrix Adult?
Maltese: X'inhu r-riskju assoċjat ma' Twinrix Adult?
English: How has Twinrix Adult been studied?
Maltese: Kif ġie studjat Twinrix Adult?
English: It should never be injected into a vein.
Maltese: Huwa qatt m'għandu jiġi injettat ġol-vina.
English: The active substances in Twinrix Adult have been available in the European Union (EU) for a number of years in separate vaccines: Havrix Adult for protection against hepatitis A and Engerix-B for protection against hepatitis B.
Maltese: Adult għal protezzjoni kontra l-epatite A u Engerix-B għal protezzjoni kontra l-epatite B.
English: Canazole clotrimazole cream was authorised in Ireland on 8 December 2000 under Article 4.8 (a) (iii) of Directive 65/65/EEC.
Maltese: L-ingwent Canazole clotrimazole kien awtorizzat fl-Irlanda fit-8 ta' Diċembru 2000 skont lArtikolu 4.8 (a) (iii) tad-Direttiva 65/65/KEE.
English: Canazole Clotrimazole Cream 1% w/w is an anti-fungal agent indicated for the treatment of superficial fungal skin and mucous membrane infections, such as candidiasis, dermatophytoses and commensal yeast infections.
Maltese: L-Ingwent Canazole Clotrimazole 1% w/w huwa aġent anti-fungali indikat għall-kura ta' infezzjonijiet fungali fuq is-superfiċje tal-ġilda u tal-membrani mukożi, bħal kandidjasi, dermatofitożi u infezzjonijiet kommensali tal-ħmira.
English: Comparative in vitro microbial tests to investigate the antimicrobial nature of the drug product were not provided.
Maltese: It-testijiet mikrobjali komparattivi in vitro li jinvestigaw innatura anti-mikrobjali tal-prodott mediċinali ma ġewx ipprovduti.
English: At the time of the initial authorisation, the need for therapeutic equivalence studies was waived based on quality data demonstrating that the proposed formulation was similar to the reference product with respect to formulation (except the benzyl alcohol concentration), pH and viscosity of the cream, globule size of the dispersed oil phase and size of the active substance present as particles.
Maltese: Waqt il-ħin tal-awtorizzazzjoni inizjali, ġie eliminat ilbżonn ta' studji ta' ekwivalenza terapewtika fuq il-bażi ta' dejta dwar il-kwalità li kienet turi li lformulazzjoni proposta kienet simili għall-prodott ta' referenza fir-rigward tal-formulazzjoni (minbarra l-konċentrazzjoni ta' benzyl alcohol), il-pH u l-viskożità tal-ingwent, id-daqs tal-qatra mifruxa fil-fażi taż-żejt u d-daqs tas-sustanza attiva preżenti bħala partikoli.
English: In addition, the CHMP considered that the preservative efficacy test lacked the methodological details which would allow a correct interpretation.
Maltese: Barra minn hekk, is-CHMP ikkunsidra li t-test għall-effikaċja tal-preservattivi kien nieqes mid-dettalji metodoloġiċi li kienu jippermettu interpretazzjoni korretta.
English: It is therefore considered that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Maltese: Għalhekk huwa kkunsidrat li d-dettalji sottomessi b'appoġġ tal-applikazzjoni ma jikkonformawx mal-Artikolu 10 tad-Direttiva 2001/83/KE kif emendata.
English: The CHMP considered the comparative quality data and a preservative efficacy test (in vitro) to demonstrate comparable anti-fungal activity provided.
Maltese: Is-CHMP ikkunsidra d-dejta komparattiva dwar il-kwalità u t-test għall-effikaċja tal-preservattivi (in vitro) biex jiddetermina l-attività anti-fungali komparabbli pprovduta.
English: The CHMP noted that inconsistent data were provided regarding the state of the drug substance in the drug product and critical quality attributes were not satisfactorily addressed.
Maltese: Is-CHMP innota li d-dejta pprovduta ma kinitx konsistenti mal-istat tas-sustanza mediċinali fil-prodott mediċinali u l-attributi kritiċi dwar il-kwalità ma kinux indirizzati b'mod sodisfaċenti.
English: The totality of data submitted does not support the conclusion that the product is therapeutically equivalent.
Maltese: It-totalità tad-dejta sottomessa ma tappoġġax il-konklużjoni li l-prodott huwa terapewtikament ekwivalenti.
English: Differences in droplets size and their possible effect in tissue penetration were not explained.
Maltese: Id-differenzi fid-daqs tal-qtar u l-effett possibbli tagħhom fuq il-penetrazzjoni tattessut ma ġewx spjegati.
English: An appropriate skin permeation or similar in vitro studies should have been performed to investigate this matter.
Maltese: Kellhom isiru studji dwar il-permeazzjoni tal-ġilda jew studji simili xierqa in vitro biex din il-kwistjoni tiġi investigata.
English: 08019 Barcelona Spain
Maltese: 08019 Barcelona Spanja
English: Placebo relative risk (95% confidence interval)
Maltese: Plaċebo riskju relattiv (95% intervall ta'
English: Hearing impaired, tinnitus
Maltese: Diffikultà fissmigħ, tinnitus
English: United Kingdom HOECHST MARION ROUSSEL LTD.
Maltese: HOECHST MARION ROUSSEL LTD.
English: NO-1325 Lysaker Norway
Maltese: NO-1325 Lysaker In-Norveġja
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110
Maltese: NV AstraZeneca SA Egide Van Ophemstraat 110
English: All patients n=4,645
Maltese: Pazjenti kollha n=4,645
English: Alexandar Stamboliyski blvd. 103 office building Sofia Tower, fl. 8, Sofia 1303 Bulgaria
Maltese: Alexandar Stamboliyski blvd. 103 office building Sofia Tower, fl. 8, Sofia 1303 Il-Bulgarija
English: A. Juozapavičiaus g. 6/2 LT-09310 Vilnius Lithuania
Maltese: Juozapavičiaus g. 6/2 LT-09310 Vilnius Il-Litwanja
English: AstraZeneca Sverige SE-151 85 Södertälje Sweden
Maltese: AstraZeneca Sverige SE-151 85 Södertälje
English: Raynaud's phenomenon
Maltese: Fenomenu ta' Raynaud,
English: Confusional state
Maltese: Stat konfużjonarju
English: SANOFI-AVENTIS NETHERLANDS B.V. Kampenringweg 45 D-E (toren D en E) NL-2803 PE Gouda The Netherlands
Maltese: SANOFI-AVENTIS NETHERLANDS B.V. Kampenringweg 45 D-E (toren D en E) NL-2803 PE Gouda L-Olanda
English: There are differences, however, in the results obtained from various trials (HOPE, EUROPA, PEACE, and PART 2).
Maltese: Madankollu, hemm differenzi fir-riżultati miksubin minn diversi provi (HOPE, EUROPA, PEACE, u PART 2).
English: NL-2803 PE Gouda The Netherlands
Maltese: NL-2803 PE Gouda L-Olanda
English: SANOFI-AVENTIS ESTONIA OÜ Pärnu mnt. 139 E/2 11317 Tallinn Estonia
Maltese: Pärnu mnt. 139 E/2 11317 Tallinn L-Estonja
English: Polifarma S.p.A. Viale Dell' Arte, 69 I - 00144 Roma Italy
Maltese: Viale Dell' Arte, 69 I - 00144
English: SANOFI-AVENTIS SPA Viale Bodio, 37/b 20158 Milano
Maltese: SANOFI-AVENTIS SPA Viale Bodio, 37/b 20158 Milano L-Italja
English: Ireland sanofi-aventis Ireland Ltd. Citywest Business Campus Dublin 24
Maltese: L-Irlanda sanofi-aventis Ireland Ltd. Citywest Business Campus Dublin 24
English: Glossitis
Maltese: Glossite
English: Népfürdo u.22 1138 Budapest Hungary
Maltese: 22 1138 Budapest L-Ungerija
English: Zenra 2.5 Zenra 5
Maltese: Zenra 2.5
English: The CHMP adopted the harmonised indication: “Treatment of hypertension”.
Maltese: Is-CHMP adotta lindikazzjoni armonizzata: “Trattament tal-ipertensjoni”.
English: Antihypertensive properties:
Maltese: Karatteristiċi antiipertensivi:
English: Tritace 1.25 Tritace 2.5 Tritace 5
Maltese: Tritace 1.25 Tritace 2.5
English: Czech Republic AVENTIS PHARMA DEUTSCHLAND GMBH Industriepark Höchst
Maltese: Ir-Repubblika Ċeka AVENTIS PHARMA DEUTSCHLAND GMBH Industriepark Höchst
English: Iceland Ireland sanofi-aventis Ireland Ltd. Citywest Business Campus, Dublin 24, Ireland
Maltese: L-Irlanda sanofi-aventis Ireland Ltd. Citywest Business Campus, Dublin 24, LIrlanda
English: Belgium SANOFI-AVENTIS BELGIUM Culliganlaan 1C
Maltese: Il-Lussemburgu SANOFI-AVENTIS BELGIUM Culliganlaan 1C
English: Pharmacokinetics and Metabolism Absorption
Maltese: Farmakokinetika u Metaboliżmu
English: Do not take TRITACE:
Maltese: Tieħux TRITACE :
English: The main areas for harmonisation were: the sections 4.1, 4.2, 4.3, 4.4 and 4.6 of the summary of product information (SPC).
Maltese: L-oqsma prinċipali għall-armonizzazzjoni kienu: is-sezzjonijiet 4.1, 4.2, 4.3, 4.4 u 4.6 tas-sommarju tal-karatteristiċi tal-prodott (SPC).
English: Triatec Ramipril sanofi-aventis
Maltese: Ramipril sanofi-aventis
English: AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A-1037 Wien
Maltese: AstraZeneca Österreich GmbH Schwarzenbergplatz 7
English: Muscle spasms, myalgia
Maltese: Spażmi fil-muskoli, mijalġja
English: Kings Hill
Maltese: Kings Hill Avenue Kings Hill
English: • Procainamide (for heart rhythm problems).
Maltese: • Procainamide (għal problemi fir-ritmu tal-qalb).
English: Toxic epidermal necrolysis, StevensJohnson syndrome, erythema multiforme, pemphigus, psoriasis aggravated, dermatitis psoriasiform, pemphigoid or lichenoid exanthema or enanthema, alopecia
Maltese: Nekroliżi epidermali tossika, sindrome Stevens-Johnson, eritema multiforme, pemfigus, psorjasi li tmur għall-agħar, dermatite psorjasiforme, pemfigojd jew eksantema liċenojde jew enantema, alopeċja
English: Secondary prevention after acute myocardial infarction
Maltese: Prevenzjoni sekondarja wara infart mijokardijaku akut
English: WINTHROP MEDICAMENTS 1-13 Boulevard Romain Rolland F-75159 Paris, Cedex 14 France
Maltese: WINTHROP MEDICAMENTS 1-13 Boulevard Romain Rolland F-75159 Paris, Cedex 14
English: Latvia sanofi-aventis Latvia SIA Kr.Valdemara 33-8 LV1010 - Riga Latvia
Maltese: Il-Latvja sanofi-aventis Latvia SIA Kr.Valdemara 33-8
English: This means an absolute mortality reduction of 5.7 % and a relative risk reduction of 27 % (95 % CI
Maltese: Dan ifisser tnaqqis assolut fil-mortalità ta' 5.7 % u tnaqqis relattiv fir-riskju ta' 27 % (95 % Cl [11-40 %]).
English: Pharmacotherapeutic group: ACE Inhibitors, plain, ATC code C09AA05.
Maltese: Inibituri ACE, sempliċi, Kodiċi ATC: C09AA05
English: Primary combined events Myocardial infarction Death from cardiovascular causes 6.1 Stroke
Maltese: Avvenimenti primarji kkombinati Infart mijokardijaku Mewt minn kawżi kardjovaskulari 6.1 Attakk ta' puplesija
English: Spain:
Maltese: Spanja:
English: Patients with hepatic impairment (see section 4.2)
Maltese: Pazjenti b'indeboliment epatiku (ara sezzjoni 5.2)
English: Slovak Republic SANOFI-AVENTIS SLOVAKIA s.r.o.
Maltese: SANOFI-AVENTIS SLOVAKIA s.r.o.
English: The primary analysis showed that 117 (6.5 %) participants on ramipril and 149 (8.4 %) on placebo developed overt nephropathy, which corresponds to a RRR 24 %; 95 % CI [3-40], p = 0.027.
Maltese: L-analiżi primarja wriet li 117 -il partiċipant (6.5%) fuq ramipril u 149 partiċipant (8.4 %) fuq plaċebo żviluppaw nefropatija evidenti li tikkorispondi għal RRR ta' 24 % Cl [3-40], p = 0.027.
English: Tritace 2.5 Tritace 5
Maltese: Tritace 2.5
English: Symptomatic Heart failure
Maltese: Insuffiċjenza kardijaka sintomatika
English: AVENTIS PHARMA
Maltese: AVENTIS PHARMA DEUTSCHLAND
English: The HOPE study: Main results Ramipril
Maltese: L-istudju HOPE : Ir-riżultati l-aktar importanti Ramipril
English: This could be a sign of pancreatitis (inflammation of the pancreas).
Maltese: Dan jista' jkun sinjal ta' pankreatite (infjammazzjoni tal-pankreas).
English: Lithium level must be monitored.
Maltese: Għandu jkun hemm monitoraġġ tal-livelli ta' lithium.
English: Ireland:
Maltese: L-Irlanda:
English: SANOFI-AVENTIS DEUTSCHLAND GMBH Industriepark Hoechst D-65926 Frankfurt am Main Germany
Maltese: SANOFI-AVENTIS DEUTSCHLAND GMBH Industriepark Hoechst D-65926 Frankfurt am Main Il-Ġermanja
English: Bone marrow failure, pancytopenia, haemolytic anaemia
Maltese: Insuffiċjenza filfunzjoni talmudullun, panċitopenja, anemija emolitika
English: The AIRE study included more than 2,000 patients with transient/persistent clinical signs of heart failure after documented myocardial infarction.
Maltese: L-istudju AIRE kien jinkludi iżjed minn 2,000 pazjent b'sinjali kliniċi momentanji/persistenti ta' insuffiċjenza tal-qalb wara infart mijokardijaku dokumentat.
English: Symptoms associated with overdosage of ACE inhibitors may include excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.
Maltese: Sintomi assoċjati ma' doża eċċessiva ta' inibituri ACE jistgħu jinkludu vasodilatazzjoni periferali eċċessiva (b'ipotensjoni kbira, xokk), bradikardija, disturbi fl-elettroliti u insuffiċjenza renali.
English: Diuretic-Treated patients
Maltese: TAL-PRODOTT MEDIĊINALI
English: The CHMP, considering the previous harmonisations referrals for enalapril, perindopril and lisinopril, adopted the harmonised indication: “Treatment of symptomatic heart failure”.
Maltese: Is-CHMP, wara li kkunsidra r-referenzi talarmonizzazzjonijiet preċedenti għal enalapril, perindopril u lisinopril, adotta l-indikazzjoni armonizzata “Trattament għal insuffiċjenza kardijaka sintomatika”.
English: SANOFI-AVENTIS PRIVATE CO LTD
Maltese: SANOFI-AVENTIS PRIVATE CO
English: Ramipril - Zentiva 2.5mg Ramipril - Zentiva 5mg Ramipril - Zentiva 10mg
Maltese: Ramipril - Zentiva 1.25mg Ramipril - Zentiva 2.5mg Ramipril - Zentiva 5mg Ramipril - Zentiva 10mg
English: The main analysis of patients with the most severe proteinuria (stratum prematurely disrupted due to benefit in ramipril group) showed that the mean rate of GFR decline per month was lower with ramipril than with placebo; -0.54 (0.66) vs. -0.88 (1.03) ml/min/month, p = 0.038.
Maltese: L-aktar analiżi importanti tal-pazjenti bl-aktar proteinurja gravi (saff li twaqqaf ħesrem qabel it-tmiem minħabba benefiċċju fil-grupp ta' ramipril) uriet li r=rata medja ta' tnaqqis fil-GFR kull xahar kien inqas b'ramipril milli bil-plaċebo; -0.54 (0.66) vs. -0.88 (1.03) ml/min/xahar, p = 0.038.
English: TRITACE is not recommended during the first trimester of pregnancy (see section 4.4) and contraindicated during the second and third trimesters of pregnancy (see section 4.3).
Maltese: TRITACE mhux rakkomandat waqt l-ewwel trimestru ta' tqala (ara sezzjoni 4.4) u kontra-indikat waqt it-tieni u t-tielet trimestru ta' tqala (ara sezzjoni 4.3).
English: Intestinal angioedema has been reported in patients treated with ACE inhibitors including TRITACE (see section 4.8).
Maltese: Ġiet irrapportata anġjoedima intestinali f'pazjenti kkurati b'inibituri ACE inkluż TRITACE (ara sezzjoni 4.8).
English: Not known
Maltese: Isem inventat