FrancophonIA/ELRC3.0 huggingface dataset:
English: Tritace was included in the list of products for Summary of Products Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended, as the above-mentioned medicinal product does not have the same SPC across EU Member States, Iceland and Norway.
Maltese: Tritace ġie inkluż fil-lista tal-prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodott (SPC), imfassla mis-CMD(h), f'konformità mal-Artikolu 30(2) tad-Direttiva 2001/83/KE, kif emendat, minħabba li l-prodott mediċinali ma għandux l-istess SPC fl-Istati Membri tal-UE kollha, fl-Iżlanda u fin-Norveġja.
English: WINTHROP MEDICAMENTS 1-13, Boulevard Romain Roland F-75014 Paris
Maltese: WINTHROP MEDICAMENTS 1-13, Boulevard Romain Roland F-75014
English: Selective inclusion of one secondary endpoint- all cause mortality- is not recommended.
Maltese: L-inklużjoni selettiva ta' endpoint sekondarju - mortalità minn kwalunkwe kawżamhijiex rakkomandata.
English: triamterene, amiloride, potassium salts and heparin (for thinning blood)
Maltese: triamterene, amiloride, melħ ta' potassium u eparina (għat-traqqiq tad-demm)
English: Antihypertensive agents (e.g. diuretics) and other substances that may decrease blood pressure (e.g. nitrates, tricyclic antidepressants, anaesthetics, acute alcohol intake, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin): Potentiation of the risk of hypotension is to be anticipated (see section 4.2 for diuretics)
Maltese: Sustanzi antiipertensivi (eż. dijuretiċi) u sustanzi oħra li jistgħu jnaqqsu l-pressjoni tad-demm (eż. nitrati, antidipressivi triċikli, anestetiċi, teħid akkut tal-alkoħol , baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin):
English: SANOFI-AVENTIS AEBE 348, Syngrou Av. - Building A 176 74 Kallithea Greece
Maltese: SANOFI-AVENTIS AEBE 348, Syngrou Av.
English: • Loss or decrease of appetite (anorexia)
Maltese: • Telf jew nuqqas ta' aptit (anoressija)
English: France:
Maltese: Franza:
English: Vertigo, paraesthesia, ageusia, dysgeusia,
Maltese: Vertigo, parestiżja, agewżja, disgewżja tregħid, disturbi filbilanċ,
English: And finally, for patients with non diabetic nephropathy macroproteinuria ≥3gm/day, the recommended initial dose is 1.25 mg of Tritace once daily.
Maltese: U finalment, għall-pazjenti b'makroproteinurja minn nefropatija mhux dijabetika ≥3 gm/kuljum, id-doża inizjali rakkomandata hija ta' 1.25 mg Tritace darba kuljum.
English: In conclusion, the CHMP agreed the following indication: “Treatment of renal disease -Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria -Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor -Manifest glomerular non-diabetic nephropathy as defined by macroproteinuria ≥ 3g/da”
Maltese: Bħala konklużjoni, is-CHMP qabel fuq l-indikazzjoni li ġejja: “Trattament għal mard renali -Nefropatija dijabetika glomerulari tal-bidu kif iddefinita mill-preżenza ta' mikroalbuminurja - Nefropatija dijabetika glomerulari evidenti kif iddefinita minn makroproteinurja f'pazjenti b'talinqas fattur kardjovaskulari ta' riskju wieħed - Nefropatija mhux-dijabetika glomerulari evidenti kif iddefinita minn makroproteinurja ≥ 3g/kuljum”
English: Netherlands:
Maltese: L-Olanda:
English: Luxembourg:
Maltese: Il-Lussemburgu:
English: Serious adverse reactions include angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis.
Maltese: Reazzjonijiet avversi serji jinkludu anġjoedima, iperkalimja, indeboliment renali jew epatiku, pankreatite, reazzjonijiet severi fil-ġilda u newtropinja/agranuloċitosi
English: Finland:
Maltese: Il-Finlandja:
English: P.O.
Maltese: A.
English: Triatec faible 1,25 mg, gélule Triatec 2.5 mg, gélule
Maltese: Triatec faible 1,25 mg, gélule Triatec 2.5 mg, gélule Triatec 5 mg, gélule
English: SANOFI-AVENTIS DEUTSCHLAND GMBH D-65926 Frankfurt am Main Germany
Maltese: SANOFI-AVENTIS DEUTSCHLAND GMBH D-65926 Frankfurt am Main Il-Ġermanja
English: - Treatment of renal disease: o Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria, o Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1), o Manifest glomerular non diabetic nephropathy as defined by macroproteinuria ≥ 3 g/day (see section 5.1).
Maltese: ○ bidu ta' nefropatija dijabetika glomerulari ddeterminata mill-presenza ta'mikroalbuminurja ○ nefropatija dijabetika glomerulari evidenti ddeterminata minn makroproteinurja f'pazjenti b'għallinqas fattur wieħed ta' riskju kardjovaskulari (ara sezzjoni 5.1), ○ nefropatija glomerulari evidenti li mhix ikkawżata mid-dijabete ddeterminata minn makroproteinurja ≥ 3 g/ġurnata (ara sezzjoni 5.1).
English: Disturbance in attention
Maltese: Disturbi fil
English: Considering the available data the CHMP adopted the following indication: “Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started >48 hours following acute myocardial infarction”.
Maltese: Wara li kkunsidra d-dejta disponibbli, is-CHMP adotta l-indikazzjoni li ġejja: “Prevenzjoni sekondarja wara infart mijokardijaku akut: tnaqqis fil-mortalità mill-fażi akuta ta' infart mijokardijaku f'pazjenti b'sinjali kliniċi ta' insuffiċjenza kardijaka meta mibdi >48 siegħa wara infart mijokardijaku akut”.
English: The REIN study, a multicenter randomized, double-blind parallel group, placebo-controlled study aimed at assessing the effect of treatment with ramipril on the rate of decline of glomerular function rate (GFR) in 352 normotensive or hypertensive patients (18-70 years old) suffering from mild (i.e. mean urinary protein excretion > 1 and < 3 g/24 h) or severe proteinuria (≥ 3 g/24 h) due to chronic non-diabetic nephropathy.
Maltese: L-istudju REIN, studju arbitrarju, magħmul f'ħafna ċentri, ikkontrollat bil-plaċebo, b'grupp parallel double-blind, bl-għan li janalizza l-effett ta' kura b'ramipril fuq ir-rata ta' tnaqqis fil-funzjoni glomerulari (GFR) f'352 pazjent normotensiv jew ipertensiv (18-70 sena) li jbatu minn proteinurja ħafifa (jiġifieri medja ta' tneħħija ta' proteina urinarja > 1 u < 3 g/24 siegħa) jew gravi (≥ 3 g/24 siegħa) minħabba nefropatija kronika li mhix kawża taddijabete.
English: Vascular stenosis, hypoperfusion, vasculitis
Maltese: Ħmura fil-wiċċ Stenożi vaskulari, ipoperfużjoni, vaskulite
English: The CHMP adopted the following: “Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with: i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or ii) diabetes with at least one cardiovascular risk factor”.
Maltese: Is-CHMP adotta li ġej: “Prevenzjoni kardjovaskulari: tnaqqis fil-morbidità u fil-mortalità kardjovaskulari bi: i) mard kardjovaskulari aterotrombotiku evidenti (storja ta' mard koronarju tal-qalb jew puplesija, jew mard vaskulari periferiku) jew ii) dijabete b'tal-inqas fattur kardjovaskulari ta' riskju wieħed”.
English: Transient erectile impotence, libido decreased
Maltese: Impotenza erettili għal żmien qasir, tnaqqis fil-libido,
English: Triatec 1.25 mg comprimés, Triatec 2.5 mg comprimés, Triatec 5 mg comprimés, Triatec 10 mg comprimés Triateckit 2.5 mg comprimés, Triateckit 5 mg comprimés, Triateckit 10 mg comprimés Ramikit 2.5 mg comprimés, Ramikit 5 mg comprimés, Ramikit 10 mg comprimés Triatec faible 1.25 mg gélules
Maltese: Triateckit 2.5 mg comprimés, Triateckit 5 mg comprimés, Triateckit 10 mg comprimés Ramikit 2.5 mg comprimés, Ramikit 5 mg comprimés, Ramikit 10 mg comprimés Triatec faible 1.25 mg gélules
English: Estonia : Cardace 2.5 mg tabletid, Cardace 5 mg tabletid, Cardace 10 mg tabletid
Maltese: L-Estonja : Cardace 2.5 mg tabletid, Cardace 5 mg tabletid, Cardace 10 mg tabletid
English: Cardiovascular prevention/Nephroprotection;
Maltese: Prevenzjoni kardjovaskulari/protezzjoni tal-kliewi:
English: SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland F-75014 Paris
Maltese: SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland F-75014
English: The MICRO-HOPE study, a predefined substudy from HOPE, investigated the effect of the addition of ramipril 10 mg to the current medical regimen versus placebo in 3,577 patients at least ≥ 55 years old (with no upper limit of age), with a majority of type 2 diabetes (and at least another CV risk factor), normotensive or hypertensive.
Maltese: L-istudju MICRO-HOPE, sottostudju ddeterminat minn qabel minn HOPE, investiga l-effett taż-żieda ta' 10 mg ta' ramipril mal-iskeda medika kurrenti kontra plaċebo f'3,577 pazjent li kellhom għallinqas ≥ 55 sena (bla ebda limitu massimu ta' età), bil-parti l-kbira bid-dijabete tat-tip 2 (u għallinqas riskju kardjovaskulari ieħor), normotensivi jew ipertensivi.
English: Capsule, hard
Maltese: Kapsula, iebsa Użu orali
English: Greece: Triatec 1.25 mg δισκία, Triatec 2.5 mg δισκία, Triatec 5 mg δισκία
Maltese: Triatec 1.25 mg δισκία, Triatec 2.5 mg δισκία, Triatec 5 mg δισκία
English: Cyprus: Triatec 2.5 mg δισκία, Triatec 5 mg δισκία, Triatec 10 mg δισκία
Maltese: Triatec 2.5 mg δισκία, Triatec 5 mg δισκία, Triatec 10 mg δισκία
English: Hypotension, orthostatic blood pressure decreased, syncope
Maltese: Ipotensjoni, tnaqqis fil-pressjoni taddemm ortostatika, sinkope
English: Zentiva HU Kft
Maltese: Aktar tagħrif
English: The CHMP, considered that in the absence of substance specific supportive data in this post myocardial infarction (MI) 24 hour interval, agreed the following: “After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5 mg twice daily for three days.
Maltese: Is-CHMP, ikkunsidrata l-assenza ta' dejta ta' appoġġ tas-sustanza speċifika f'dan l-intervall ta' 24 siegħa ta' wara infart mijokardijaku (MI) akut, qabel fuq dan li ġej: “Wara 48 siegħa, wara infart mijokardijaku f'pazjent klinikament u emodinamikament stabbli, iddoża inizjali hija 2.5 mg darbtejn kuljum għal tlett ijiem.
English: - Transient or persistent heart failure post MI - Monitoring of renal function -Cough has been reported with the use of ACE inhibitors.
Maltese: MI ta' qasir żmien jew persistenti - Sorveljanza tal-funzjoni renali - Ġiet irrapportata sogħla bl-użu ta' inibituri ACE.
English: TRITACE can be used:
Maltese: TRITACE jista' jintuża:
English: Patients with renal impairment Daily dose in patients with renal impairment should be based on creatinine clearance (see section 5.2): - if creatinine clearance is ≥ 60 ml/min, it is not necessary to adjust the initial dose (2.5 mg/day); the maximal daily dose is 10 mg; - if creatinine clearance is between 30-60 ml/min, it is not necessary to adjust the initial dose (2.5 mg/day); the maximal daily dose is 5 mg; - if creatinine clearance is between 10-30 ml/min, the initial dose is 1.25 mg/day and the maximal daily dose is 5 mg; - in haemodialysed hypertensive patients: ramipril is slightly dialysable; the initial dose is 1.25 mg/day and the maximal daily dose is 5 mg; the medicinal product should be administered few hours after haemodialysis is performed.
Maltese: - jekk it-tneħħija tal-krejatinina hi ta' ≥ 60 ml/mim, m'hemmx bżonn ta' aġġustament fid-doża inizjali (2.5 mg/kuljum); id-doża massima ta' kuljum hi ta' 10 mg; - jekk it-tneħħija tal-krejatinina hi bejn 30-60 ml/min, m'hemmx bżonn ta' aġġustament fid-doża inizjali (2.5 mg/kuljum); id-doża massima ta' kuljum hi ta' 5 mg; - jekk it-tneħħija tal-krejatinina hi bejn 10-30 ml/min, id-doża inizjali hi ta' 1.25 mg/kuljum u ddoża massima ta' kuljum hi ta' 5 mg; - f'pazjenti ipertensivi bl-emodijaliżi: ramipril jiġi daqsxejn dijalizzat; id-doża inizjali hi ta' 1.25 mg/kuljum u d-doża massima ta' kuljum hi ta' 5 mg; il-prodott mediċinali għandu jingħata ftit sigħat wara li ssir l-emodijaliżi.
English: Regarding the therapeutic indications for heart failure, the MAH proposed the wording: “Treatment of congestive heart failure”.
Maltese: Rigward l-indikazzjonijiet terapewtiċi għall-insuffiċjenza kardijaka, il-MAH ippropona t-test: “Trattament għal insuffiċjenza kardijaka konġestiva”.
English: Usually the dose is administered once daily.
Maltese: Normalment id-doża tingħata darba kuljum.
English: • If you have collagen vascular disease such as scleroderma or systemic lupus erythematosus
Maltese: • Jekk għandek mard vaskulari ta' collagen bħal skleroderma jew lupus eritematosu sistemiku.
English: Romania:
Maltese: Ir-Rumanija:
English: • The usual dose is 10 mg daily.
Maltese: • Normalment id-doża hija 10 mg kuljum.
English: - Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin Converting Enzyme) inhibitors (see section 6.1) - History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or AIIRAs) - Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5) - Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney - 2nd and 3rd trimester of pregnancy (see sections 4.4 and 4.6) - Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.
Maltese: Is-CHMP adotta l-kontraindikazzjoni li ġejja: - “Iperensittività għal ramipril, jew għal xi sustanzi oħra jew għal xi inibituri ACE oħrajn (ara sezzjoni 6.1) - Storja ta' anġjoedema ereditarja jew idjopatika - Trattament ekstrakorporali li jwasslu għall-kuntatt tad-demm ma' wċuħ iċċarġjati negattivament (ara sezzjoni 4.5) - Stenożi bilaterali sinifikanti tal-arterja renali jew stenożi tal-arterja renali fl-unika kiljwa li taħdem -it-2 u t-3 trimestru tat-tqala (ara s-sezzjonijiet 4.4 u 4.6)”
English: The intergroup difference was thus 0.34 [0.03-0.65] per month, and around 4 ml/min/year; 23.1 % of the patients in the ramipril group reached the combined secondary endpoint of doubling of baseline serum creatinine concentration and/or end-stage renal disease (ESRD) (need for dialysis or renal transplantation) vs. 45.5 % in the placebo group (p = 0.02).
Maltese: Għalhekk iddifferenza bejn il-gruppi kien ta' 0.34 [0.03-0.65] kull xahar, u madwar 4 ml/min/sena; 23.1 % talpazjenti tal-grupp ta' ramipril laħqu l-avveniment finali sekondarju kkombinat ta' rdoppjar talkonċentrazzjoni tal-krejatinina fis-serum mill-linja bażi u/jew l-aħħar stadju tal-mard renali (ESRD) (bżonn ta' dijaliżi jew trapjant renali) vs.
English: A number of areas of disharmony in the product information for Tritace have been evaluated by the CHMP and a revised product information was adopted.
Maltese: Numru ta' oqsma ta' diskrepanza fl-informazzjoni tal-prodott għal Tritace ġew evalwati mis-CHMP u ġiet adottata informazzjoni riveduta dwar il-prodott.
English: A preventive placebo-controlled study (the HOPE-study), was carried out in which ramipril was added to standard therapy in more than 9,200 patients.
Maltese: Sar studju ta' prevenzjoni kkontrollat bil-plaċebo (l-istudju HOPE), fejn ramipril ġie miżjud ma' terapija standard f'9,200 pazjent.
English: DEUTSCHLAND GmbH 65926 Frankfurt am Main Germany
Maltese: GmbH 65926 Frankfurt am Main
English: - Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with: o manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or o diabetes with at least one cardiovascular risk factor (see section 5.1).
Maltese: - Prevenzjoni kardjovaskulari: tnaqqis fil-mortalità u morbidità kardjovaskulari f'pazjenti b': ○ mard kardjovaskulari aterotrombotiku evidenti (passat mediku ta' mard tal-qalb koronarju jew attakk ta' puplesija jew mard vaskulari periferiku) jew ○ dijabete b'għallinqas fattur wieħed ta' riskju kardjovaskulari (ara sezzjoni 5.1).
English: United Kingdom AVENTIS PHARMA LTD 50 Kings Hill Avenue
Maltese: AVENTIS PHARMA LTD 50
English: The study showed that ramipril statistically significantly decreases the incidence of myocardial infarction, death from cardiovascular causes and stroke, alone and combined (primary combined events).
Maltese: L-istudju wera li ramipril b'mod statistikament sinifikanti jnaqqas l-inċidenza ta' infart mijokardijaku, mewt minn kawżi kardjovaskulari u puplusija, waħidhom jew ikkombinati (avvenimenti primarji kkombinati).
English: 2.5mg /5mg/10mg Tablet
Maltese: 2.5mg /5mg/10mg Pillola
English: Norway:
Maltese: In-Norveġja:
English: • The usual dose is 5 mg or 10 mg once daily.
Maltese: • Normalment id-doża hija 5 mg jew 10 mg kuljum.
English: Anorexia, decreased appetite,
Maltese: Anoressija, tnaqqis fl-aptit
English: PHARMACEUTICAL FORM Tablet
Maltese: GĦAMLA FARMAĊEWTIKA Pillola
English: Delix 1.25 mg Kapseln, Delix 2.5 mg Kapseln, Delix 5 mg Kapseln, Delix 10 mg Kapseln Vesdil 1.25 mg Kapseln, Vesdil 2.5 mg Kapseln, Vesdil 5 mg Kapseln, Vesdil 1.25 mg Tabletten, Vesdil 2.5 mg Tabletten
Maltese: Delix 1.25 mg Kapseln, Delix 2.5 mg Kapseln, Delix 5 mg Kapseln, Delix 10 mg Kapseln Vesdil 1.25 mg Kapseln, Vesdil 2.5 mg Kapseln, Vesdil 5 mg Kapseln, Vesdil 1.25 mg Tabletten, Vesdil 2.5 mg Tabletten Vesdil N 2.5 mg Tabletten, Vesdil N 5 mg Tabletten Vedil 5 mg Tabletten
English: In plasma and tissue this enzyme catalyses the conversion of angiotensin I to the active vasoconstrictor substance angiotensin II, as well as the breakdown of the active vasodilator bradykinin.
Maltese: Fil-plażma u fit-tessuti, din l-enzima tikkatalizza l-konverżjoni ta' anġjotensin I fil-vasoristrettatur attiv anġjotensin II , kif ukoll tikkawża d-dekomponiment tal-vasodilatatur attiv bradykinin.
English: - Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction.
Maltese: - Prevenzjoni sekondarja wara infart mijokardijaku akut: tnaqqis fil-mortalità mill-fażi akuta ta' infart mijokardijaku f'pazjenti b'sinjali kliniċi ta' insuffiċjenza tal-qalb meta jinbeda > 48 siegħa wara infart mijokardijaku akut.
English: Triatec 1.25 mg compresse, Triatec 2.5 mg compresse, Triatec 5 mg compresse, Triatec 10 mg compresse Ramipril sanofi-aventis 2.5 mg compresse, Ramipril sanofi-aventis 5 mg compresse, Ramipril sanofi-aventis 10 mg compresse
Maltese: Ramipril sanofi-aventis 2.5 mg compresse, Ramipril sanofi-aventis 5 mg compresse, Ramipril sanofiaventis 10 mg compresse
English: • Your doctor may then decide to increase the amount you take.
Maltese: • Testijiet tad-demm li juru ammonti ta' potassju aktar mis-soltu fid-demm tiegħek.
English: Hypertension
Maltese: Ipertensjoni
English: Tritace contains ramipril, a second-generation nonsulfhydryl angiotensin converting enzyme inhibitor (ACE-I).
Maltese: Tritace fih ramipril, inibitur tal-enzima ta' konverżjoni tal-anġjotensina mhux sulfidrilika (nonsulfhydryl angiotensin converting enzyme inhibitor) (ACE-I) tat-tieni ġenerazzjoni.
English: Non-steroidal anti-inflammatory drugs and acetylsalicylic acid: Reduction of the antihypertensive effect of TRITACE is to be anticipated.
Maltese: Mediċini antiinfjammatorji li mhumiex sterojdi u acetylsalicylic acid:
English: In patients with non- diabetic nephropathy as defined by macroproteinuria ≥ 3 g/day.
Maltese: F'pazjenti b'nefropatija li mhix ikkawżata mid-dijabete, iddeterminata minn makroproteinurja ≥ 3 g/ġurnata .
English: The maximal dose is 10 mg daily.
Maltese: Id-doża massima hija 10 mg kuljum.
English: Unipril 1.25 mg compresse, Unipril 2.5 mg compresse, Unipril 5 mg compresse, Unipril 10 mg compresse Quark 1.25 mg compresse, Quark 2.5 mg compresse, Quark 5 mg compresse, Quark 10 mg compresse
Maltese: Quark 1.25 mg compresse, Quark 2.5 mg compresse, Quark 5 mg compresse, Quark 10 mg compresse
English: • The maximum dose is 10 mg daily.
Maltese: • Id-doża massima hija 10 mg kuljum.
English: • The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily.
Maltese: • Normalment id-doża tal-bidu hija 1.25 mg darba kuljum sa 2.5 mg darbtejn kuljum.
English: • Breast enlargement in men
Maltese: • Testijiet tad-demm juru ftit wisq ċelluli tad-demm fid-demm tiegħek
English: If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with TRITACE (see section 4.4).
Maltese: Jekk ikun possibbli, id-dijuretiku għandu jitwaqqaf jumejn sa tlett ijiem qabel ma tinbeda l-kura b'TRITACE (ara sezzjoni 4.4).
English: The indication for cardiovascular prevention is justified by the results of HOPE study.
Maltese: L-indikazzjoni għal prevenzjoni kardjovaskulari hija ġġustifikata mir-riżultati tal-istudju HOPE.
English: Depending on the patient's tolerability to the active substance, the dose is subsequently increased.
Maltese: Skont it-tollerabilità tal-pazjent għas-sustanza attiva, id-doża tista' sussegwentement tiżdied.
English: The study showed that after an average follow-up time of 15 months the mortality in ramipril-treated patients was 16.9 % and in the placebo treated patients was 22.6 %.
Maltese: L-istudju wera li wara medja ta' 15-il xahar għat-tieni viżta għand lispeċjalista, il-mortalità fil-pazjenti kkurati b'ramipril kienet ta' 16.9 % u f'dawk ikkurati bil-plaċebo ta' 22.6 %.
English: Tritace 2.5 mg tabletki, Tritace 5 mg tabletki, Tritace 10 mg tabletki
Maltese: Tritace 2.5 mg таблетки, Tritace 5 mg таблетки, Tritace 10 mg таблетки
English: TRITACE may be used in monotherapy or in combination with other classes of antihypertensive medicinal products.
Maltese: TRITACE jista' jintuża bħal monoterapija jew flimkien ma' klassijiet oħra ta' prodotti mediċinali antiipertensivi.
English: Lithuania: Cardace 2.5 mg tabletės, Cardace 5 mg tabletės, Cardace 10 mg tabletės
Maltese: Cardace 2.5 mg tabletės, Cardace 5 mg tabletės, Cardace 10 mg tabletės
English: Renal function and serum potassium should be monitored.
Maltese: Għandhom jiġu ċċekkjati l-funzjoni renali u l-potassju fis-serum.
English: • Drinking alcohol with TRITACE may make you feel dizzy or light-headed.
Maltese: • Ix-xorb alkoħoliku ma TRITACE jista' jagħmlek sturdut.
English: Swallow the tablets/capsules whole with liquid.
Maltese: Ibla' l-pilloli/kapsuli sħaħ ma' xi likwidu.
English: Non-productive tickling cough, bronchitis, sinusitis, dyspnoea
Maltese: Sogħla niexfa b'tagħrix filgriżmejn, bronkite, sinusite, diffikultà biex tieħu n-nifs
English: After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5 mg twice daily for three days.
Maltese: 48 siegħa wara infart mijokardijaku f'pazjent klinikament u emodinamikament stabbli, id-doża talbidu hi ta' 2.5 mg darbtejn kuljum għal tlett ijiem.
English: In all countries where the congestive heart failure indication has been approved the initial recommended dose is 0.25 mg daily and the maximum permitted dose is 10 mg daily.
Maltese: Fil-pajjiżi kollha fejn l-indikazzjoni insuffiċjenza kardijaka konġestiva ġiet approvata, id-doża inizjali rakkomandata hija 0.25 mg kuljum u d-doża massima permessa hija 10 mg kuljum.
English: Neutropenia/agranulocytosis, as well as thrombocytopenia and anaemia, have been rarely seen and bone marrow depression has also been reported.
Maltese: Newtropinja/agranuloċitosi kif ukoll tromboċitopenja u anemija dehru b'mod rari ħafna u tnaqqis flattività tal-mudullun ġie rrapportat ukoll.
English: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels Belgium
Maltese: Il-Lussemburgu NV AstraZeneca SA Egide Van Ophemstraat 110
English: • Dry tickly cough, inflammation of your sinuses (sinusitis) or bronchitis, shortness of breath
Maltese: • Sogħla vojta xotta, infjammazzjoni tas-sinus (sinożite) jew bronkite, qtugħ ta' nifs
English: Acute hepatic failure, cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional).
Maltese: Insuffiċjenza epatika akuta, epatite kolestatika jew ċitolitika (każijiet b'eżitu fatali kienu eċċeżżjonali ħafna)
English: Belgium Aventis Pharma S.A. Boulevard de la Plaine, 9
Maltese: Boulevard de la Plaine, 9 B-1050 Bruxelles