FrancophonIA/ELRC3.0 huggingface dataset:
English: AstraZeneca Sverige SE-151 85 Södertälje Sweden
Slovenian: AstraZeneca Sverige SE-151 85 Södertälje Švedska
English: • Fainting, hypotension (abnormally low blood pressure), especially when you stand or sit up quickly
Slovenian: • omedlevica, nenormalno nizek krvni tlak (hipotenzija), zlasti če hitro vstanete ali sedete
English: This means an absolute mortality reduction of 5.7 % and a relative risk reduction of 27 % (95 % CI
Slovenian: To pomeni absolutno zmanjšanje umrljivosti za 5,7 % in zmanjšanje relativnega tveganja za 27 % (95 % IZ [od 11 do 40 %]).
English: You must tell your doctor if you think that you are (or might become) pregnant You should not take TRITACE in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby.
Slovenian: Zdravniku morate povedati, če se vam zdi, da ste noseči (ali bi lahko zanosili) Zdravila TRITACE ni dobro jemati v prvih 12 tednih nosečnosti, od 13. tedna naprej pa ga sploh ne smete jemati, ker lahko njegova uporaba med nosečnostjo škoduje otroku.
English: Empreendimento Lagoas Park, Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugal
Slovenian: Empreendimento Lagoas Park, Edifício 7 - 3ş Piso 2740-244 Porto Salvo Portugalska
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Slovenian: Epidemiološke ugotovitve o tveganju za teratogene učinke po izpostavljenosti zaviralcem ACE v prvem trimesečju nosečnosti niso dokončne, toda majhnega povečanja tveganja ni mogoče izključiti.
English: • Decreasing your body's production of substances that could raise your blood pressure
Slovenian: • v telesu zmanjša nastajanje snovi, ki lahko zvišajo krvni tlak
English: TRITACE can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2).
Slovenian: TRITACE je mogoče vzeti pred obroki, med njimi ali po njih, ker uživanje hrane ne vpliva na biološko uporabnost (glejte poglavje 5.2).
English: The CHMP adopted the harmonised indication: “Treatment of hypertension”.
Slovenian: CHMP je sprejel usklajeno indikacijo: „Zdravljenje hipertenzije“.
English: The subsequent dosage of TRITACE should be adjusted according to blood pressure target.
Slovenian: Nadaljnje odmerjanje TRITACE je treba prilagoditi glede na ciljni krvni tlak.
English: INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: Antihypertensive properties:
Slovenian: Antihipertenzivne lastnosti:
English: It is recommended to monitor the white blood cell count to permit detection of a possible leucopoenia.
Slovenian: Priporočljive so kontrole bele krvne slike, da bi odkrili morebitno levkopenijo.
English: • Sweating more than usual
Slovenian: • močnejše znojenje kot po navadi
English: United Kingdom HOECHST MARION ROUSSEL LTD.
Slovenian: Velika Britanija HOECHST MARION ROUSSEL LTD.
English: 81105 Bratislava
Slovenian: 81105 Bratislava Slovaška
English: • Red and swollen tongue
Slovenian: • rdeč in otekel jezik
English: This could be a sign of a severe allergic reaction to TRITACE
Slovenian: To je lahko znak hude alergijske reakcije na zdravilo TRITACE.
English: TRITACE has to be swallowed with liquid.
Slovenian: TRITACE je treba zaužiti s tekočino.
English: Titration and maintenance dose
Slovenian: Titracija in vzdrževalni odmerek
English: In conclusion, the CHMP adopted a harmonised wording according to the PhVWP recommendations.
Slovenian: Na koncu je CHMP sprejel usklajeno besedilo v skladu s priporočili skupine PhVWP.
English: TRITACE is not recommended for use in children and adolescents below 18 years of age because there is no information available in this population.
Slovenian: Zdravila TRITACE ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let, ker za to populacijo ni informacij.
English: Very rare (affects less than 1 in 10,000 people) • Being more sensitive to the sun than usual.
Slovenian: Zelo redki (pojavijo se pri manj kot 1 od 10.000 bolnikov) • večja občutljivost za sončno svetlobo, kot po navadi.
English: • Headache or feeling tired
Slovenian: • glavobol ali utrujenost
English: o Patients at particular risk of hypotension
Slovenian: o Bolniki s posebnim tveganjem za hipotenzijo
English: • Your doctor may then decide to increase the amount you take.
Slovenian: • Zdravnik se nato lahko odloči in poveča odmerek, ki ga jemljete.
English: Taking TRITACE with food and alcohol
Slovenian: Jemanje zdravila TRITRACE skupaj s hrano in alkoholom
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 %.
Slovenian: Študija je pokazala, da je bila umrljivost po povprečno 15 mesecih spremljanja med bolniki, zdravljenimi z ramiprilom 16,9 %, in med bolniki, ki so dobivali placebo 22,6 %.
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.
Slovenian: Izvedena je bila preventivna, s placebom kontrolirana študija (študija HOPE), v kateri so ramipril dodali standardnemu zdravljenju več kot 9.200 bolnikov.
English: • To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes)
Slovenian: • za zmanjšanje tveganja ali upočasnitev poslabšanja težav z ledvicami (ne glede na to, ali imate sladkorno bolezen ali ne)
English: • TRITACE may be taken with or without food.
Slovenian: • Zdravilo TRITACE lahko vzamete s hrano ali brez nje.
English: 4.1 Therapeutic Indication
Slovenian: 4.1 Terapevtske indikacije
English: • Cramps or pain in your muscles
Slovenian: • krči ali bolečine v mišicah
English: Treatment to reduce or delay the worsening of kidney problems
Slovenian: Zdravljenje za zmanjšanje ali upočasnitev slabšanja težav z ledvicami
English: Adverse reactions frequency is defined using the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
English: A starting dose of 1.25 mg is recommended in such patients and the initiation of treatment should take place under medical supervision (see section 4.4).
Slovenian: Za takšne bolnike je priporočljiv začetni odmerek 1,25 mg, uvedba zdravljenja pa mora potekati pod zdravniškim nadzorom (glejte poglavje 4.4).
English: Swallow the tablets/capsules whole with liquid.
Slovenian: Tablete/kapsule pogoltnite cele in s tekočino.
English: • If you are allergic (hypersensitive) to ramipril, any other ACE inhibitor medicine or any of the ingredients of TRITACE listed in section 6.
Slovenian: • če ste alergični (preobčutljivi) na ramipril, katerikoli drug zaviralec ACE ali katerokoli sestavino zdravila TRITACE, navedeno v poglavju 6.
English: Treatment of high blood pressure
Slovenian: Zdravljenje visokega krvnega tlaka
English: Characteristically, the cough is nonproductive, persistent and resolves after discontinuation of therapy.
Slovenian: Značilno je, da je ta kašelj neproduktiven, trdovraten in po prekinitvi zdravljenja izgine.
English: Sufficient experience is still lacking in the treatment of patients with severe (NYHA IV) heart failure immediately after myocardial infarction.
Slovenian: Še vedno ni dovolj izkušenj z zdravljenjem bolnikom s hudim srčnim popuščanjem (NYHA IV) neposredno po miokardnem infarktu.
English: In patients with diabetes and at least one cardiovascular risk
Slovenian: Bolniki s sladkorno boleznijo in vsaj enim kardiovaskularnim dejavnikom tveganja
English: • Blood tests showing too few blood cells in your blood
Slovenian: • preiskave krvi, ki kažejo premalo krvnih celic v krvi
English: EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji
English: In patients with diabetes and microalbuminuria:
Slovenian: Bolniki s sladkorno boleznijo in mikroalbuminurijo:
English: If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with TRITACE (see section 4.4).
Slovenian: Če je mogoče, je treba uporabo diuretika prekiniti 2 ali 3 dni pred začetkom zdravljenja s TRITACE (glejte poglavje 4.4).
English: If you forget to take TRITACE
Slovenian: Če ste pozabili vzeti zdravilo TRITACE
English: Alexandar Stamboliyski blvd. 103 office building Sofia Tower, fl. 8, Sofia 1303 Bulgaria
Slovenian: Alexandar Stamboliyski blvd. 103 office building Sofia Tower, fl. 8, Sofia 1303 Bolgarija
English: You may need to stop your TRITACE treatment one day beforehand; ask your doctor for advice
Slovenian: Morda boste morali en dan pred tem nehati jemati zdravilo TRITACE; posvetujte se o tem s svojim zdravnikom.
English: • An increased number of certain white blood cells (eosinophilia) found during a blood test
Slovenian: • večje število določenih belih krvnih celic (eozinofilija) na preiskavah krvi
English: The AIRE study included more than 2,000 patients with transient/persistent clinical signs of heart failure after documented myocardial infarction.
Slovenian: Študija AIRE je vključila več kot 2.000 bolnikov s prehodnimi ali trajnimi kliničnimi znaki srčnega popuščanja po dokumentiranem miokardnem infarktu.
English: • If you have collagen vascular disease such as scleroderma or systemic lupus erythematosus
Slovenian: • če imate kolagensko žilno bolezen, npr. sklerodermo ali sistemski eritematozni lupus.
English: TRITACE can be used:
Slovenian: Zdravilo TRITACE se lahko uporablja:
English: This could be a sign of pancreatitis (inflammation of the pancreas).
Slovenian: To je lahko znak pankreatitisa (vnetja trebušne slinavke).
English: Secondary endpoints Death from any cause Need for Revascularisation Hospitalisation for unstable angina
Slovenian: Sekundarne končne točke Smrt zaradi kateregakoli vzroka 10,4 Potreba po revaskularizaciji Hospitalizacija zaradi nestabilne angine pektoris
English: The ramipril treatment was started 3 to 10 days after the acute myocardial infarction.
Slovenian: Zdravljenje z ramiprilom se je začelo od 3 do 10 dni po akutnem miokardnem infarktu.
English: They can increase the chance of getting side effects if you take them with TRITACE:
Slovenian: Povečajo lahko možnost neželenih učinkov, če jih jemljete skupaj z zdravilom TRITACE:
English: Do not take TRITACE if any of the above apply to you.
Slovenian: Ne vzemite zdravila TRITACE, če kaj od naštetega velja za vas.
English: UNDESIRABLE EFFECTS
Slovenian: MOŽNI NEŽELENI UČINKI
English: • Disturbed hearing and ringing in your ears
Slovenian: • motnje sluha ali zvonjenje v ušesih
English: • Blocked nose, difficulty breathing or worsening of asthma
Slovenian: • zamašen nos, težko dihanje ali poslabšanje astme
English: Latvia sanofi-aventis Latvia SIA Kr.Valdemara 33-8 LV1010 - Riga Latvia
Slovenian: Latvija sanofi-aventis Latvia SIA Kr.Valdemara 33-8 LV1010 - Riga Latvija
English: Caution is therefore recommended since these patients may be volume and/or salt depleted.
Slovenian: Pri takšnih bolnikih je zato potrebna previdnost, ker jim lahko primanjkuje tekočine in/ali soli.
English: These patients presented with abdominal pain (with or without nausea or vomiting).
Slovenian: Bolniki so imeli bolečine v trebuhu (z navzeo in bruhanjem ali brez njiju).
English: SANOFI-AVENTIS AEBE 348, Syngrou Av. - Building A 176 74 Kallithea Greece
Slovenian: SANOFI-AVENTIS AEBE 348, Syngrou Av. - Building A 176 74 Kallithea Grčija
English: Extensive mutagenicity testing using several test systems has yielded no indication that ramipril possesses mutagenic or genotoxic properties.
Slovenian: Obsežno testiranje mutagenosti z uporabo več testnih sistemov ni pokazalo mutagenega ali genotoksičnega delovanja ramiprila.
English: • To treat high blood pressure (hypertension)
Slovenian: • za zdravljenje visokega krvnega tlaka (hipertenzije)
English: Take this medicine by mouth at the same time of the day each day.
Slovenian: Jemanje tega zdravila Zdravilo zaužijte vsak dan ob istem času.
English: Népfürdo u.22 1138 Budapest Hungary
Slovenian: Zentiva HU Kft Népfürdo u.22 1138 Budapest Madžarska
English: Studies involving chronic oral administration have been conducted in rats, dogs and monkeys.
Slovenian: Študije kronične peroralne uporabe so bile izvedene pri podganah, psih in opicah.
English: Fertility was not impaired either in male or in female rats.
Slovenian: Plodnost ni bila prizadeta ne pri podganjih samcih ne pri samicah.
English: TRITACE may increase the amount of lithium in your blood.
Slovenian: Zdravilo TRITACE lahko poveča količino litija v krvi.
English: The CHMP adopted the following wording in order to implement this section: -“ Renal Impairment: the warning should be expanded to include not just treatment in patients with renal impairment but the risk of subsequent renal impairment, risk factors and need for early discontinuation.
Slovenian: CHMP je sprejel naslednje besedilo, da bi omogočil izvajanje tega poglavja: - „Motnje v delovanju ledvic: opozorilo je treba razširiti tako, da ne vključuje le zdravljenja pri bolnikih z motnjami v delovanju ledvic, temveč tudi tveganje za kasnejše motnje v delovanju ledvic, dejavnike tveganja in potrebo po predčasnem prenehanju jemanja zdravila.
English: 4.4 Special Warnings and Precautions for Use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi
English: DK-2970 Hoersholm Denmark
Slovenian: DK-2970 Hoersholm Danska
English: • Your doctor will adjust the amount you take until your blood pressure is controlled.
Slovenian: • Zdravnik vam bo prilagajal količino zdravila, dokler vaš krvni tlak ne bo urejen.
English: Taking TRITACE with other medicines
Slovenian: Jemanje z drugimi zdravili
English: Like all medicines, TRITACE can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo TRITACE neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: What TRITACE is and what it is used for Before you take TRITACE How to take TRITACE Possible side effects
Slovenian: Kaj je zdravilo TRITACE in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo TRITACE Kako jemati zdravilo TRITACE Možni neželeni učinki
English: The CHMP, considering the previous harmonisations referrals for enalapril, perindopril and lisinopril, adopted the harmonised indication: “Treatment of symptomatic heart failure”.
Slovenian: Odbor CHMP je ob upoštevanju prejšnjih napotitev glede usklajevanja za enalapril, perindopril in lizinopril sprejel usklajeno indikacijo: „Zdravljenje simptomatskega srčnega popuščanja“.
English: Usually the dose is administered once daily.
Slovenian: Po navadi se odmerek uporabi enkrat na dan.
English: TRITACE is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Slovenian: TRITACE ni priporočljivo uporabljati pri otrocih in mladostnikih do 18. leta starosti, ker o njegovi varnosti in učinkovitosti v tej skupini ni dovolj podatkov.
English: There is a risk of impairment of renal function, particularly in patients with congestive heart failure or after a renal transplant.
Slovenian: Obstaja tveganje za okvaro delovanja ledvic, zlasti pri bolnikih s kongestivnim srčnim popuščanjem ali po presaditvi ledvice.
English: In case of angioedema, TRITACE must be discontinued.
Slovenian: V primeru angioedema je treba prenehati uporabljati zdravilo TRITACE.
English: Polifarma S.p.A. Viale Dell' Arte, 69 I - 00144 Roma Italy
Slovenian: Viale Dell' Arte, 69 I - 00144 Rim Italija
English: Abrupt discontinuation of ramipril does not produce a rapid and excessive rebound increase in blood pressure.
Slovenian: Nenadna prekinitev jemanja ramiprila ne povzroči hitrega in čezmernega preobratnega zvišanja krvnega tlaka.
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).
Slovenian: Študija je pokazala, da ramipril statistično značilno zmanjša incidenco miokardnega infarkta, smrti zaradi kardiovaskularne bolezni in možganske kapi, samih ali v kombinaciji (primarni sestavljeni dogodek).
English: Cardiovascular prevention
Slovenian: Kardiovaskularna preventiva
English: Reproduction toxicology studies in the rat, rabbit and monkey did not disclose any teratogenic properties.
Slovenian: Študije reproduktivnih toksičnih učinkov na podganah, kuncih in opicah niso pokazale teratogenih lastnosti.
English: The MAH proposed the following wording based on international guidelines: “Instead of increasing the dose above 5 mg Tritace and associated names daily, the addition of another drug, e.g. of a diuretic or a calcium-antagonist may be considered”.
Slovenian: Imetnik dovoljenja za promet z zdravilom je na podlagi mednarodnih smernic predlagal naslednje besedilo: „Namesto povečevanja odmerka nad 5 mg zdravila Tritace in z njim povezanih imen dnevno, je treba preučiti možnost dodajanja drugega zdravila, npr. diuretika ali kalcijevega antagonista“.
English: This is because TRITACE can affect the way some other medicines work.
Slovenian: Zdravilo TRITACE namreč lahko vpliva na delovanje nekaterih drugih zdravil.
English: - Treatment of hypertension.
Slovenian: - Zdravljenje hipertenzije
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).
Slovenian: TRITACE ni priporočljiv v prvem trimesečju nosečnosti (glejte poglavje 4.4) in je kontraindiciran v drugem in tretjem trimesečju nosečnosti (glejte poglavje 4.3).
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.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je preučil številna področja neskladnosti glede informacij o zdravilu Tritace in sprejel popravljene informacije o zdravilu.
English: How to store TRITACE Further information
Slovenian: Shranjevanje zdravila TRITACE Dodatne informacije
English: Because of its potent, saturable binding to ACE and slow dissociation from the enzyme, ramiprilat shows a prolonged terminal elimination phase at very low plasma concentrations.
Slovenian: Zaradi močne, saturabilne vezave na ACE in počasne disociacije z encima ima ramiprilat dolgo terminalno eliminacijsko fazo pri zelo majhni koncentraciji v plazmi.
English: Also some medicines can affect the way TRITACE works.
Slovenian: Tudi nekatera zdravila lahko vplivajo na delovanje zdravila TRITACE.
English: Should the decision be taken to treat these patients, it is recommended that therapy be started at 1.25 mg once daily and that particular caution be exercised in any dose increase.
Slovenian: Če se zdravnik odloči za zdravljenje takšnega bolnika, je priporočljivo, da se zdravljenje začne z 1,25 mg enkrat na dan in da se vsako povečanje odmerka opravi posebej previdno.
English: Do not take TRITACE:
Slovenian: Ne jemljite zdravila TRITACE:
English: If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended (see section 4.5).
Slovenian: Če presodite, da je sočasna uporaba naštetih zdravil primerna, je priporočljivo redno kontrolirati kalij v serumu (glejte poglavje 4.5).
English: Cardiovascular prevention/Nephroprotection;
Slovenian: Kardiovaskularna preventiva/zaščita ledvic:
English: NL-2803 PE Gouda The Netherlands
Slovenian: NL-2803 PE Gouda Nizozemska
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.
Slovenian: Glavna analiza bolnikov z najhujšo proteinurijo (stratum, predčasno odpravljen zaradi koristi v skupini z ramiprilom) je pokazala, da je bila povprečna hitrost zmanjševanja GFR na mesec manjša z ramiprilom kot s placebom: -0,54 (0,66) v primerjavi z -0,88 (1,03) ml/min/mesec, p = 0,038.
English: • To treat your heart when it cannot pump enough blood to the rest of your body (heart failure)
Slovenian: • za zdravljenje stanja, pri katerem srce ne more prečrpati dovolj krvi po telesu (to stanje imenujemo srčno popuščanje)
English: In conclusion, the CHMP endorsed the following: “In patients stabilised on diuretic therapy, the recommended initial dose is 1.25 mg daily Tritace and associated names should be titrated by doubling the dose every one to two weeks up to a maximum daily dose of 10 mg. Two administrations per day are preferable”.
Slovenian: Na koncu je CHMP sprejel naslednje besedilo: „Pri bolnikih, katerih stanje je stabilno zaradi zdravljenja z diuretiki, znaša priporočeni začetni odmerek 1,25 mg dnevno, zdravilo Tritace in z njim povezana imena pa se titrirajo s podvajanjem odmerka na en do dva tedna vse do največjega dnevnega odmerka 10 mg. Zaželeno je odmerjanje dvakrat dnevno“.
English: Indications of plasma electrolyte shifts and changes in blood picture have been found in the 3 species.
Slovenian: Pri 3 živalskih vrstah so odkrili spremembe elektrolitov v plazmi in spremembe krvne slike.
English: Your lithium amount will need to be closely checked by your doctor.
Slovenian: Zdravnik vam bo moral natančno kontrolirati količino litija.
English: • Feeling shaky or confused
Slovenian: • občutek tresenja ali zmedenosti
English: SANOFI-AVENTIS SPA Viale Bodio, 37/b 20158 Milano
Slovenian: SANOFI-AVENTIS SPA Viale Bodio, 37/b 20158 Milano Italija
English: o Elderly patients See section 4.2.
Slovenian: o Starejši bolniki Glejte poglavje 4.2.
English: Non-steroidal anti-inflammatory drugs and acetylsalicylic acid: Reduction of the antihypertensive effect of TRITACE is to be anticipated.
Slovenian: Nesteroidna protivnetna zdravila in acetilsalicilna kislina: Pričakovati je mogoče zmanjšanje antihipertenzivnega učinka TRITACE.
English: TRITACE may lower your blood sugar amounts.
Slovenian: Zdravilo TRITACE lahko zniža krvni sladkor.
English: Generally, it is recommended to correct dehydration, hypovolaemia or salt depletion before initiating treatment (in patients with heart failure, however, such corrective action must be carefully weighed out against the risk of volume overload).
Slovenian: Praviloma je treba pred začetkom zdravljenja odpraviti dehidracijo, hipovolemijo in pomanjkanje soli (vendar je treba pri bolnikih s srčnim popuščanjem ukrepe za odpravo teh motenj pazljivo pretehtati v primerjavi s tveganjem za volumsko preobremenitev).
English: 4.6 Pregnancy and Lactation
Slovenian: 4.6 Nosečnost in dojenje
English: The MAH proposed indication “Secondary prevention after MI in patients with heart failure” has been justified on the basis of the: Acute Infarction Ramipril Efficacy Study (AIRE).
Slovenian: Indikacija, ki jo je predlagal imetnik dovoljenja za promet z zdravilom, „Sekundarna preventiva po miokardnem infarktu pri bolnikih s srčnim popuščanjem“, je bila utemeljena na podlagi: Študije učinkovitosti ramiprila pri akutnem infarktu (AIRE).
English: Hypotension may occur following initiation of therapy with TRITACE; this is more likely in patients who are being treated concurrently with diuretics.
Slovenian: Po uvedbi zdravljenja z zdravilom TRITACE se lahko pojavi hipotenzija; verjetnejša je pri bolnikih, ki se sočasno zdravijo z diuretiki.