FrancophonIA/ELRC3.0 huggingface dataset:
English: the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Tritace and associated names (see Annex I).
Slovenian: je CHMP priporočil dopolnitev dovoljenj(a) za promet z zdravilom, za katera so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo določeni v Dodatku III za zdravilo Tritace in z njim povezana imena (glejte Dodatek I).
English: • Nail problem (e.g. loosening or separation of a nail from its bed)
Slovenian: • težave z nohti (npr. zrahljanje ali odstopanje nohtov z nohtne posteljice)
English: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels Belgium
Slovenian: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Bruselj Belgija
English: If you become pregnant while on TRITACE, tell your doctor immediately.
Slovenian: Če med zdravljenjem z zdravilom TRITACE zanosite, morate to takoj povedati zdravniku.
English: In patients with non- diabetic nephropathy as defined by macroproteinuria ≥ 3 g/day.
Slovenian: Bolniki z nediabetično nefropatijo, opredeljeno kot prisotnost makroproteinurije ≥ 3 g/dan.
English: If the dose cannot be increased to 2.5 mg twice a day the treatment should be withdraw” (See SPC for Titration and maintenance dose)
Slovenian: Če odmerka ni mogoče povečati na 2,5 mg dvakrat dnevno, je treba zdravljenje prekiniti.“ (Glejte povzetek glavnih značilnosti zdravila glede titracije in vzdrževalnega odmerka)
English: In addition to conventional therapy with diuretics and optional cardiac glycosides, ramipril has been shown to be effective in patients with functional classes II-IV of the New-York Heart Association.
Slovenian: Ramipril je poleg konvencionalnega zdravljenja z diuretiki in, fakultativno, srčnimi glikozidi dokazano učinkovit pri bolnikih v funkcijskih razredih od II do IV po NYHA.
English: As an expression of the pharmacodynamic activity of ramipril, pronounced enlargement of the juxtaglomerular apparatus has been noted in the dog and monkey from daily doses of 250 mg/kg/d.
Slovenian: Kot izraz farmakodinamskega delovanja ramiprila so pri psih in opicah ugotovili izrazito povečanje jukstaglomerularnega aparata pri dnevnih odmerkih od 250 mg/kg/dan.
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.
Slovenian: V vseh državah, v katerih je bila odobrena indikacija srčnega popuščanja, znaša začetni priporočeni odmerek 0,25 mg dnevno, največji dovoljeni odmerek pa je 10 mg dnevno.
English: Blood glucose monitoring is recommended.
Slovenian: Priporočljivo je kontrolirati glukozo v krvi.
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.
Slovenian: Študija MICRO-HOPE, vnaprej opredeljena podštudija študije HOPE, je raziskala učinek dodatka 10 mg ramiprila trenutni shemi farmakoterapije v primerjavi s placebom pri 3.577 bolnikih, starih vsaj ≥ 55 let (brez zgornje starostne meje), z večinoma sladkorno boleznijo tipa 2 (in vsaj še enim kardiovaskularnim dejavnikom tveganja), ki so bili normotenzivni ali hipertenzivni.
English: Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including, administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration.
Slovenian: Med priporočljivimi ukrepi so primarna detoksifikacija (izpiranje želodca, uporaba adsorbensov) in ukrepi za obnovitev hemodinamske stabilnosti, vključno z uporabo adrenergičnih agonistov alfa 1 ali angiotenzina II (angiotenzinamid).
English: Renal function and serum potassium should be monitored.
Slovenian: Kontrolirati je treba delovanje ledvic in kalija v serumu.
English: Pharmacokinetics and Metabolism Absorption
Slovenian: Farmakokinetika in presnova Absorpcija
English: The safety profile of ramipril includes persistent dry cough and reactions due to hypotension.
Slovenian: Med varnostnimi značilnostmi ramiprila sta dolgotrajen suh kašelj in reakcije zaradi hipotenzije.
English: The average response to ACE inhibitor monotherapy was lower in black (AfroCaribbean) hypertensive patients (usually a low-renin hypertensive population) than in non-black patients.
Slovenian: Povprečni odziv na monoterapijo z zaviralci ACE je manjši pri črnih (osebah afro-karibskega porekla) hipertenzivnih bolnikih (ki so po navadi nizkoreninska hipertenzivna populacija) kot pri bolnikih nečrncih.
English: The drug had beneficial effects on cardiac haemodynamics (decreased left and right ventricular filling pressures, reduced total peripheral vascular resistance, increased cardiac output and improved cardiac index).
Slovenian: Zdravilo ugodno vpliva na srčno hemodinamiko (zmanjšanje polnilnega tlaka levega in desnega prekata, zmanjšanje celotnega perifernega žilnega upora, povečanje minutnega volumna srca in izboljšanje srčnega indeksa).
English: This is more likely to happen when you start taking TRITACE or start taking a higher dose.
Slovenian: Verjetnost tega je večja, ko začnete jemati zdravilo TRITACE ali začnete jemati večji odmerek.
English: Depending on the patient's tolerability to the active substance, the dose is subsequently increased.
Slovenian: Odvisno od bolnikovega prenašanja zdravilne učinkovine se odmerek nato povečuje.
English: As with other ACE inhibitors, ramipril may be less effective in lowering blood pressure in black people than in non black patients, possibly because of a higher prevalence of hypertension with low renin level in the black hypertensive population.
Slovenian: Tako kot drugi zaviralci ACE lahko tudi ramipril manj učinkovito zniža krvni tlak pri bolnikih-črncih kot nečrncih, verjetno zaradi večje prevalence hipertenzije z majhno koncentracijo renina pri črni hipertenzivni populaciji.
English: PREGNANCY AND LACTATION
Slovenian: Nosečnost in dojenje
English: • Diuretics (water tablets) such as furosemide
Slovenian: • diuretiki (tablete za odvajanje vode, npr. furosemid).
English: SANOFI-AVENTIS CYPRUS LTD 14 Charalambou Mouskou street 2015 - Nicosia
Slovenian: 14 Charalambou Mouskou street 2015 - Nicosia
English: Ramipril must not be used in patients in patients with hypotensive or haemodynamically unstable states
Slovenian: Ramiprila ni dovoljeno uporabljati pri bolnikih s hipotenzivnimi ali hemodinamično nestabilnimi stanji.
English: Lithium salts: Excretion of lithium may be reduced by ACE inhibitors and therefore lithium toxicity may be increased.
Slovenian: Soli litija: Zaviralci ACE lahko zmanjšajo izločanje litija in toksični učinki litija se zato lahko povečajo.
English: In hypertensive patients in whom the diuretic is not discontinued, therapy with TRITACE should be initiated with a 1.25 mg dose.
Slovenian: Pri hipertenzivnih bolnikih, ki jim diuretika ni mogoče ukiniti, je treba zdravljenja s TRITACE začeti z odmerkom 1,25 mg.
English: WHAT TRITACE IS AND WHAT IT IS USED FOR TRITACE contains a medicine called ramipril.
Slovenian: KAJ JE ZDRAVILO TRITACE IN ZA KAJ GA UPORABLJAMO Zdravilo TRITACE vsebuje zdravilno učinkovino ramipril.
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.
Slovenian: Primarna analiza je pokazala, da se je razvita nefropatija pojavila pri 117 (6,5 %) sodelujočih, ki so dobivali ramipril, in pri 149 (8,4 %) tistih, ki so dobivali placebo, kar ustreza zmanjšanju relativnega tveganja za 24 %; 95 % IZ [3-40], p = 0,027.
English: Symptoms associated with overdosage of ACE inhibitors may include excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.
Slovenian: Med simptomi prevelikega odmerjanja zaviralcev ACE so lahko čezmerna periferna vazodilatacija (z izrazito hipotenzijo, šokom), bradikardija, elektrolitske motnje in odpoved ledvic.
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.
Slovenian: Ta encim v plazmi in tkivih katalizira pretvorbo angiotenzina I v aktivno vazokonstrikcijsko snov angiotenzin II ter razgradnjo vazodilatatorja bradikinina.
English: • Shortness of breath or a cough.
Slovenian: • Težko dihanje ali kašelj.
English: • Feeling depressed, anxious, more nervous than usual or restless
Slovenian: • potrtost, tesnobnost, izrazitejša živčnost kot po navadi ali nemir
English: - Patients with strongly activated renin-angiotensin-aldosterone system Patients with strongly activated renin-angiotensin-aldosterone system are at risk of an acute pronounced fall in blood pressure and deterioration of renal function due to ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is given for the first time or at first dose increase.
Slovenian: - Bolniki z močno aktiviranim sistemom renin-angiotenzin-aldosteron Pri bolnikih z močno aktiviranim sistemom renin-angiotenzin-aldosteron obstaja možnost akutnega, izrazitega padca krvnega tlaka in poslabšanja delovanja ledvic zaradi zavrtja ACE, zlasti če je zaviralec ACE ali sočasni diuretik uporabljen prvič ali prvič v večjem odmerku.
English: Evropská 2590/33c
Slovenian: Evropská 2590/33c 16000 Praga 6
English: Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count: Increased likelihood of haematological reactions (see section 4.4).
Slovenian: Alopurinol, imunosupresivi, kortikosteroidi, prokainamid, citostatiki in druge snovi, ki lahko spremenijo število krvnih celic: Večja verjetnost hematoloških reakcij (glejte poglavje 4.4).
English: • Your doctor will adjust the amount you are taking.
Slovenian: • Zdravnik vam bo prilagodil odmerek, ki ga jemljete.
English: The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing
Slovenian: Med njenimi znaki so srbenje, koprivnica (urtikarija), rdeče spremembe na rokah, stopalih in žrelu, oteklost žrela in jezika, oteklost okrog oči in ustnic, težko dihanje in težko požiranje.
English: More frequent monitoring is advised in the initial phase of treatment and in patients with impaired renal function, those with concomitant collagen disease (e.g. lupus erythematosus or scleroderma), and all those treated with other medicinal products that can cause changes in the blood picture (see sections 4.5 and 4.8).
Slovenian: Pogostejše kontrole so priporočljive v uvodnem obdobju zdravljenja, pa tudi pri bolnikih z okvarjenim delovanjem ledvic, sočasno kolagensko boleznijo (npr. eritematoznim lupusom ali sklerodermo) ter med zdravljenjem z vsemi zdravili, ki lahko spremenijo krvno sliko (glejte poglavji 4.5 in 4.8).
English: Uncommon Rare
Slovenian: Občasni redki
English: Ireland sanofi-aventis Ireland Ltd. Citywest Business Campus Dublin 24
Slovenian: Irska sanofi-aventis Ireland Ltd. Citywest Business Campus Dublin 24
English: Vasopressor sympathomimetics and other substances (e.g. isoproterenol, dobutamine, dopamine, epinephrine) that may reduce the antihypertensive effect of TRITACE: Blood pressure monitoring is recommended.
Slovenian: Vazopresorski simpatikomimetiki in druge snovi (npr. izoproterenol, dobutamin, dopamin, adrenalin), ki lahko zmanjšajo antihipertenzivni učinek TRITACE: Priporočljivo je nadziranje krvnega tlaka.
English: Trading as: Aventis Pharma 50 Kings Hill Avenue Kings Hill
Slovenian: Trguje kot: Aventis Pharma 50 Kings Hill Avenue Kings Hill
English: Iceland Ireland sanofi-aventis Ireland Ltd. Citywest Business Campus, Dublin 24, Ireland
Slovenian: Irska sanofi-aventis Ireland Ltd. Citywest Business Campus, Dublin 24, Ireland
English: Regarding the therapeutic indications for heart failure, the MAH proposed the wording: “Treatment of congestive heart failure”.
Slovenian: Glede terapevtskih indikacij za srčno popuščanje je imetnik dovoljenja za promet z zdravilom predlagal naslednje besedilo: „Zdravljenje kongestivnega srčnega popuščanja“.
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.
Slovenian: - če je očistek kreatinina ≥ 60 ml/min, začetnega odmerka (2,5 mg/dan) ni treba prilagoditi; največji dnevni odmerek je 10 mg. - če je očistek kreatinina med 30 in 60 ml/min, začetnega odmerka ni treba prilagoditi (2,5 mg/dan); največji dnevni odmerek je 5 mg. - če je očistek kreatinina med 10 in 30 ml/min, je začetni odmerek 1,25 mg/dan; največji dnevni odmerek je 5 mg. - hipertenzivni bolniki na hemodializi: ramipril se rahlo dializira; začetni odmerek je 1,25 mg/dan in največji dnevni odmerek je 5 mg.
English: Depressed mood, anxiety, nervousness, restlessness, sleep disorder including somnolence
Slovenian: Psihiatrične motnje depresivno razpoloženje, anksioznost, živčnost, nemir, motnje spanja, vključno z zaspanostjo stanje zmedenosti motena pozornost
English: • Loss or decrease of appetite (anorexia)
Slovenian: • izguba ali zmanjšanje teka (neješčnost)
English: The CHMP agreed the following: “The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Slovenian: CHMP je soglašal z naslednjim besedilom: „Odmerek se prilagaja vsakemu bolniku posebej glede na profil bolnik (glejte poglavje 4.4) in uravnavanjem krvnega tlaka.
English: - Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney -2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6)”
Slovenian: - Pomembna obojestranska stenoza ledvičnih arterij ali stenoza ledvične arterije edine delujoče ledvice - 2. in 3. trimesečje nosečnosti (glejte poglavji 4.4 in 4.6).
English: Serious adverse reactions include angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis.
Slovenian: Med resnimi neželenimi učinki so angioedem, hiperkaliemija, okvara ledvic ali jeter, pankreatitis, hude kožne reakcije in nevtropenija/agranulocitoza.
English: • If you are already taking diuretics (water tablets), your doctor may stop or reduce the amount of the diuretic you take before beginning treatment with TRITACE.
Slovenian: • Če že jemljete diuretike (tablete za odvajanje vode), vam bo zdravnik pred začetkom zdravljenja z zdravilom TRITACE morda naročil, da diuretike nehate jemati, ali vam bo odmerek diuretika zmanjšal .
English: Reduced angiotensin II formation and inhibition of bradykinin breakdown lead to vasodilatation.
Slovenian: Manjše nastajanje angiotenzina II in zavrtje razgradnje bradikinina povzročita vazodilatacijo.
English: This leaflet was last approved in {MM/YYYY} [To be completed nationally]
Slovenian: Navodilo je bilo odobreno {MM/LLLL} [Izpolni država članica]
English: • Faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in your chest or more serious problems including heart attack and stroke
Slovenian: • Hitrejše bitje srca, neenakomerno ali močno bitje srca (palpitacije), bolečine v prsih, tiščanje v prsih ali resnejše težave, vključno srčnim infarktom in možgansko kapjo.
English: • If you have kidney problems where the blood supply to your kidney is reduced (renal artery stenosis)
Slovenian: • če imate težave z ledvicami, pri katerih je prekrvitev ledvic zmanjšana (zožitev ledvične arterije).
English: If the dose cannot be increased to 2.5 mg twice a day the treatment should be withdrawn.
Slovenian: Če odmerka ni mogoče povečati na 2,5 mg dvakrat na dan, je treba zdravljenje prekiniti.
English: In patients with diabetes and at least one cardiovascular risk the initial dose shold be 2.5 mg once a day.
Slovenian: Pri bolnikih s sladkorno boleznijo in vsaj enim kardiovaskularnim dejavnikom tveganja znaša začetni odmerek 2,5 mg enkrat dnevno.
English: Patients with a strongly activated renin-angiotensin-aldosterone system may experience an excessive drop in blood pressure following the initial dose.
Slovenian: Bolnikom z močno aktiviranim sistemom renin-angiotenzin-aldosteron se lahko krvni tlak po prvem odmerku čezmerno zniža.
English: ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough”.
Slovenian: Kašelj, ki nastane zaradi uporabe zaviralcev ACE, je treba obravnavati kot del diferencialne diagnoze kašlja“.
English: Primary combined events Myocardial infarction Death from cardiovascular causes 6.1 Stroke
Slovenian: Primarni kombinirani dogodki Miokardni infarkt Smrt zaradi kardiovaskularnih vzrokov
English: The MAH calls on a high level of evidence for ACE-Is administered in the first 24 hours following acute myocardial infarction (MI) in international recommendations, to justify initiating therapy with 24 hours of MI at the lowest dose of 1.25 mg daily (that used as first dose in the heart failure indication), provided that stable haemodynamic conditions are met and the regulatory precedent with lisinopril wording.
Slovenian: Imetnik dovoljenja za promet z zdravilom se sklicuje na trdne dokaze v mednarodnih priporočilih za angiotenzinske konvertaze, ki so bili odmerjene v prvih 24 urah po akutnem miokardnem infarktu, da bi utemeljil začetek zdravljenja v 24 urah po miokardnem infarktu pri najnižjem odmerku 1,25 mg dnevno (ki se uporablja kot prvi odmerek pri indikaciji srčnega popuščanja), če so izpolnjeni stabilni hemodinamični pogoji in na podlagi precedensa z besedilom, ki velja za lizinopril.
English: Toxic epidermal necrolysis, StevensJohnson syndrome, erythema multiforme, pemphigus, psoriasis aggravated, dermatitis psoriasiform, pemphigoid or lichenoid exanthema or enanthema, alopecia
Slovenian: fotosenzibilnostna reakcija toksična epidermalna nekroliza, StevensJohnsonov sindrom, multiformni eritem, pemfigus, poslabšanje psoriaze, psoriaziformni dermatitis, pemfigoiden ali lihenoiden eksantem ali enantem, alopecija
English: A reduced initial dose of 1.25 mg ramipril should be considered.
Slovenian: V poštev pride manjši začetni odmerek 1,25 mg ramiprila.
English: Secondary prevention after acute myocardial infarction In all countries where the post myocardial infarction indication has been approved the initial recommended dose is 2.5 mg twice daily.
Slovenian: Sekundarna preventiva po akutnem miokardnem infarktu V vseh državah, v katerih je bila odobrena indikacija po miokardnem infarktu, znaša priporočeni začetni odmerek 2,5 mg dvakrat dnevno.
English: Should exposure to ACE inhibitor have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Slovenian: Če od drugega trimesečja nosečnosti naprej pride do izpostavljenosti zaviralcu ACE, je priporočljivo z ultrazvokom preveriti delovanje ledvic in lobanjo.
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.
Slovenian: CHMP se je ob upoštevanju dejstva, da ni na voljo podpornih podatkov za to snov v tem 24-urnem intervalu po miokardnem infarktu (MI), strinjal z naslednjim besedilom: „48 ur po miokardnem infarktu pri klinično in hemodinamično stabilnem bolniku je začetni odmerek 2,5 mg dvakrat dnevno v obdobju treh dni.
English: Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I (synonyms: angiotensin-converting enzyme; kininase II).
Slovenian: Aktivni presnovek ramiprila, ramiprilat, zavira encim dipeptidilkarboksipeptidazo I (sinonima: angiotenzinska konvertaza, kininaza II).
English: Secondary prevention after acute myocardial infarction
Slovenian: Sekundarna preventiva po akutnem miokardnem infarktu
English: Renal impairment including renal failure acute, urine output increased, worsening of a pre-existing proteinuria, blood urea increased, blood creatinine increased
Slovenian: Bolezni sečil okvara ledvic, vključno z akutno odpovedjo ledvic, večje izločanje urina, poslabšanje obstoječe proteinurije, zvišanje sečnine v krvi, zvišanje kreatinina v krvi
English: ACE inhibitors cause higher rate of angioedema in black patients than in non black patients.
Slovenian: Zaviralci ACE pogosteje povzročijo angioedem pri bolnikih-črncih kot nečrncih.
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”
Slovenian: Na koncu je CHMP sprejel naslednjo indikacijo: „Zdravljenje bolezni ledvic - Začetna glomerulna diabetična nefropatija, kot je opredeljena s prisotnostjo mikroalbuminurije - Izražena glomerulna diabetična nefropatija, kot je opredeljena s prisotnostjo makroalbuminurije pri bolnikih z vsaj enim kardiovaskularnim dejavnikom tveganja - Izražena glomerulna nediabetična nefropatija, kot je opredeljena z makroproteinurijo ≥ 3g/da“.
English: In patients with impaired liver function, the metabolism of ramipril to ramiprilat was delayed, due to diminished activity of hepatic esterases, and plasma ramipril levels in these patients were increased.
Slovenian: Pri bolnikih z okvarjenim delovanjem jeter je presnova ramiprila v ramiprilat upočasnjena zaradi manjše aktivnosti jetrnih esteraz in koncentracija ramiprila v plazmi teh bolnikov je povečana.
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)
Slovenian: Antihipertenzivna zdravila (npr. diuretiki) in druge snovi, ki lahko znižajo krvni tlak (npr. nitrati, triciklični antidepresivi, anestetiki, akutno pitje alkohola, baklofen, alfuzosin, doksazosin, prazosin, tamsulosin, terazosin): Pričakovati je treba večje tveganje hipotenzije (glejte poglavje 4.2 za diuretike).
English: The CHMP recommended a contraindication only for the second and third trimester of pregnancy in line with PhVWP wording on use of AEC-I in pregnancy.
Slovenian: 4.6 Nosečnost in dojenje CHMP je priporočil kontraindikacijo le za drugo in tretje trimesečje nosečnosti v skladu z besedilom skupine PhVWP o uporabi ACE-I med nosečnostjo.
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.
Slovenian: - Sekundarna preventiva po akutnem miokardnem infarktu: zmanjšanje umrljivosti v akutni fazi miokardnega infarkta pri bolnikih s kliničnimi znaki srčnega popuščanja z začetkom > 48 ur po akutnem miokardnem infarktu.