FrancophonIA/ELRC3.0 huggingface dataset:
English: When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
Slovenian: Če se izkaže, da je bolnica zanosila, je treba zdravljenje z zaviralci ACE takoj prekiniti in uvesti drugo zdravljenje, če je primerno.
English: • Heartburn, constipation or dry mouth
Slovenian: • zgaga, zaprtje ali suha usta
English: The daily dose is subsequently increased by doubling the dose at intervals of one to three days up to the target maintenance dose of 5 mg twice daily.
Slovenian: Dnevni odmerek se nato povečuje s podvajanjem odmerka v presledkih od enega do treh dni, dokler ni dosežen ciljni vzdrževalni odmerek 5 mg dvakrat na dan.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: The CHMP agreed that in patients with diabetes and microalbuminuria the recommended initial dose is 1.25 mg of Tritace once daily.
Slovenian: CHMP se je strinjal, da je za bolnike s sladkorno boleznijo in mikroalbuminurijo priporočeni začetni odmerek 1,25 mg zdravila Tritace enkrat dnevno.
English: Patients at risk for development of hyperkalaemia include those with renal insufficiency, age (> 70 years), uncontrolled diabetes mellitus, or those using potassium salts, potassium retaining diuretics and other plasma potassium increasing active substances, or conditions such as dehydration, acute cardiac decompensation, metabolic acidosis.
Slovenian: Bolniki, kjer obstaja tveganje za pojav hiperkaliemije, so tisti z insuficienco ledvic, starejši bolniki (> 70 let), bolniki z neurejeno sladkorno boleznijo, uporabniki kalijevih soli, diuretikov, ki varčujejo s kalijem, in drugih zdravil, ki zvišujejo kalij v plazmi, in bolniki z motnjami, kakršne so npr. dehidracija, akutna dekompenzacija srca, metabolična acidoza.
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”.
Slovenian: CHMP je sprejel naslednje besedilo: „Kardiovaskularna preventiva: zmanjšanje kardiovaskularne umrljivosti in umrljivosti pri bolnikih z: i) izraženo aterotrombotsko boleznijo srca in ožilja (anamneza kronične bolezni srca ali infarkta ali periferne žilne bolezni) ali ii) sladkorno boleznijo z vsaj enim kardiovaskularnim dejavnikom tveganja.“
English: SANOFI-AVENTIS NETHERLANDS B.V. Kampenringweg 45 D-E (toren D en E) NL-2803 PE Gouda The Netherlands
Slovenian: Kampenringweg 45 D-E (toren D en E) NL-2803 PE Gouda Nizozemska
English: • Procainamide (for heart rhythm problems).
Slovenian: • prokainamid (proti motnjam srčnega ritma).
English: Visual disturbance including blurred vision
Slovenian: Očesne bolezni motnje vida, vključno z zamegljenim vidom konjunktivitis
English: HOW TO TAKE TRITACE
Slovenian: KAKO JEMATI ZDRAVILO TRITACE
English: - Transient or persistent heart failure post MI - Monitoring of renal function -Cough has been reported with the use of ACE inhibitors.
Slovenian: - Začasno ali trajno popuščanje srca po miokardnem infarktu - Spremljanje delovanja ledvic - Pri uporabi zaviralcev ACE so poročali o kašljanju.
English: Treatment of renal disease
Slovenian: Zdravljenje bolezni ledvic
English: The administration of ramipril to female rats during the fetal period and lactation produced irreversible renal damage (dilatation of the renal pelvis) in the offspring at daily doses of 50 mg/kg body weight or higher.
Slovenian: Uporaba ramiprila pri samicah podgan med fetalnim obdobjem in dojenjem je pri mladičih povzročila ireverzibilno okvaro ledvic (razširitev ledvičnih mehov) v dnevnih odmerkih 50 mg/telesne mase ali več.
English: • Feeling weak
Slovenian: • občutek šibkosti
English: SPECIAL PRECAUTIONS FOR STORAGE [To be completed nationally]
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE [Izpolni država članica]
English: Secondary prevention after acute myocardial infarction and with heart failure
Slovenian: Sekundarna preventiva po akutnem miokardnem infarktu in s srčnim popuščanjem
English: It is recommended that TRITACE is taken each day at the same time of the day.
Slovenian: Zdravilo TRITACE je priporočljivo jemati vsak dan ob istem dnevnem času.
English: Lithium level must be monitored.
Slovenian: Kontrolirati je treba koncentracijo litija.
English: AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A-1037 Wien
Slovenian: AstraZeneca Österreich GmbH Schwarzenbergplatz 7
English: United Kingdom AVENTIS PHARMA LTD 50 Kings Hill Avenue
Slovenian: Velika Britanija AVENTIS PHARMA LTD 50 Kings Hill Avenue
English: • As treatment following heart attack (myocardial infarction) complicated with heart failure.
Slovenian: • kot zdravljenje po srčnem infarktu (miokardnem infarktu), pri katerem se kot zaplet pojavi srčno popuščanje.
English: • Blood tests showing less sodium than usual in your blood
Slovenian: • preiskave krvi, ki kažejo manj natrija v krvi, kot po navadi.
English: The maintenance dose is divided in 2 administrations per day where possible.
Slovenian: Če je mogoče, je treba vzdrževalni odmerek razdeliti na jemanje 2-krat na dan.
English: FURTHER INFORMATION What TRITACE.contains [To be completed nationally] What TRITACE looks like and contents of the pack Tablets, hard capsules [To be completed nationally]
Slovenian: Izgled zdravila TRITACE in vsebina pakiranja Tablete, trde kapsule [Izpolni država članica]
English: Rare (affects less than 1 in 1,000 people)
Slovenian: Redki (pojavijo se pri manj kot 1 od 1.000 bolnikov)
English: Patients with increased risk of cardiovascular disease following either atherothrombotic cardiovascular disease (history of coronary heart disease, stroke or peripheral vascular disease) or diabetes mellitus with at least one additional risk factor (documented microalbuminuria, hypertension, elevated total cholesterol level, low high-density lipoprotein cholesterol level or cigarette smoking) were included in the study.
Slovenian: V študijo so bili vključeni bolniki z večjim tveganjem kardiovaskularne bolezni bodisi po aterotrombotični kardiovaskularni bolezni (anamneza koronarne bolezni, možganske kapi ali bolezni perifernih žil) bodisi s sladkorno boleznijo in vsaj še enim dodatnim dejavnikom tveganja (dokumentirana mikroalbuminurija, hipertenzija, zvišan celotni holesterol, nizek holesterol HDL ali kajenje).
English: Luxembourg:
Slovenian: Luksemburg:
English: Following oral administration ramipril is rapidly absorbed from the gastrointestinal tract: peak plasma concentrations of ramipril are reached within one hour.
Slovenian: Po peroralni uporabi se ramipril hitro absorbira iz prebavil: največja koncentracija ramiprila v plazmi je dosežena v eni uri.
English: • Blood tests showing more potassium than usual in your blood.
Slovenian: • preiskave krvi, ki kažejo več kalija v krvi, kot po navadi.
English: Belgium Aventis Pharma S.A. Boulevard de la Plaine, 9
Slovenian: Aventis Pharma S.A. Boulevard de la Plaine, 9 B-1050 Bruselj
English: Czech Republic:
Slovenian: Češka:
English: Triatec Ramipril sanofi-aventis
Slovenian: Ramipril sanofi-aventis
English: • Bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g. bleeding from the gums), purple spots blotching on the skin or getting infections more easily than usual, sore throat and fever, feeling tired, faint, dizzy or having pale skin.
Slovenian: • Večja nagnjenost k podplutbam, dolgotrajnejše krvavitve kot po navadi, kakršnekoli krvavitve (npr. krvavitev iz dlesni), vijoličaste pege na koži ali večja nagnjenost k okužbam kot po navadi, vnetje žrela in zvišana telesna temperatura, utrujenost, omedlevica, omotica ali bledica.
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).
Slovenian: - Kardiovaskularna preventiva: zmanjšanje kardiovaskularne obolevnosti in umrljivosti pri bolnikih z: o manifestno aterotrombotično kardiovaskularno boleznijo (anamnezo koronarne srčne bolezni ali možganske kapi ali z boleznijo perifernih žil), ali o sladkorno boleznijo in vsaj enim kardiovaskularnim dejavnikom tveganja (glejte poglavje 5.1).
English: PHARMACEUTICAL FORM Tablet
Slovenian: 3 FARMACEVTSKA OBLIKA Tableta
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.
Slovenian: Namenjena je bila oceni učinka zdravljenja z ramiprilom na zmanjševanje hitrosti glomerularne filtracije (GFR) pri 352 normotenzivnih ali hipertenzivnih bolnikih (starih od 18 do 70 let) z blago (tj. povprečno izločanje beljakovin v urinu > 1 in < 3 g/24 ur) ali hudo proteinurijo (≥ 3 g/24 ur) zaradi kronične nediabetične nefropatije.
English: • Blood tests showing changes in the way your liver, pancreas or kidneys are working.
Slovenian: • spremembe izvidov preiskav krvi, ki kažejo delovanje jeter, trebušne slinavke ali ledvic.
English: And finally, for patients with non diabetic nephropathy macroproteinuria ≥3gm/day, the recommended initial dose is 1.25 mg of Tritace once daily.
Slovenian: Za bolnike z nediabetično nefropatsko makroproteinurijo ≥ 3gm/dan je priporočeni začetni odmerek 1,25 mg zdravila Tritace enkrat dnevno.
English: Romania:
Slovenian: Romunija:
English: • Swollen mouth
Slovenian: • oteklost ust
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”.
Slovenian: CHMP je ob upoštevanju razpoložljivih podatkov sprejel naslednjo indikacijo: „Sekundarna preventiva po akutnem miokardnem infarktu: zmanjšanje umrljivosti zaradi akutne faze miokardnega infarkta pri bolnikih s kliničnimi znaki srčnega popuščanja, do katerih pride > 48 ur po akutnem miokardnem infarktu“.
English: • Pain in your joints
Slovenian: • bolečine v sklepih
English: Oral administration of ramipril has been found to be devoid of acute toxicity in rodents and dogs.
Slovenian: Ugotovljeno je, da peroralna uporaba ramiprila nima toksičnih učinkov pri glodavcih in psih.
English: TRITACE may be used in monotherapy or in combination with other classes of antihypertensive medicinal products.
Slovenian: TRITACE je mogoče uporabljati v monoterapiji ali v kombinaciji z drugimi skupinami antihipertenzivnih zdravil.
English: • Drinking alcohol with TRITACE may make you feel dizzy or light-headed.
Slovenian: • Pitje alkoholnih pijač hkrati z jemanjem zdravila TRITACE lahko povzroči omotico ali vrtoglavost.
English: Take special care with TRITACE
Slovenian: Bodite posebno pozorni pri jemanju zdravila TRITACE:
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).
Slovenian: - Zdravljenje bolezni ledvic: o začetne glomerularne diabetične nefropatije, opredeljene kot prisotnost mikroalbuminurije, o manifestne glomerularne diabetične nefropatije, opredeljene kot prisotnost makroproteinurije pri bolnikih z vsaj enim kardiovaskularnim dejavnikom tveganja (glejte poglavje 5.1), o manifestne glomerularne nediabetične nefropatije, opredeljene kot prisotnost makroproteinurije ≥ 3 g/dan (glejte poglavje 5.1).
English: The target daily dose is 10 mg.
Slovenian: Ciljni dnevni odmerek je 10 mg.
English: WINTHROP MEDICAMENTS 1-13 Boulevard Romain Rolland F-75159 Paris, Cedex 14 France
Slovenian: WINTHROP MEDICAMENTS 1-13 Boulevard Romain Rolland F-75159 Paris, Cedex 14 Francija
English: Norway:
Slovenian: Norveška:
English: This is so the doctor knows what you have taken.
Slovenian: S seboj vzemite ovojnino zdravila, Tako bo zdravnik lahko vedel, kaj ste vzeli.
English: Belgium:
Slovenian: Belgija:
English: • Dry tickly cough, inflammation of your sinuses (sinusitis) or bronchitis, shortness of breath
Slovenian: • suh dražeč kašelj, vnetje obnosnih votlin (sinuzitis) ali bronhitis, kratka sapa
English: Doubling the once daily dose to 2.5 mg after two weeks and then to 5 mg after a further two weeks is recommended.
Slovenian: Priporočljiva je podvojitev odmerka na 2,5 mg enkrat na dan po dveh tednih in nato na 5 mg po nadaljnjih dveh tednih.
English: Peak plasma concentrations of ramiprilat, the sole active metabolite of ramipril are reached 2-4 hours after ramipril intake.
Slovenian: Ramiprilat, ki je edini aktivni presnovek ramiprila, doseže največjo koncentracijo v plazmi od 2 do 4 ure po zaužitju ramiprila.
English: However in 6 countries the starting dose is 1.25 mg to 2.5 mg twice daily.
Slovenian: Vendar pa je v 6 državah začetni odmerek od 1,25 mg do 2,5 mg dvakrat dnevno.
English: Trading as: Sanofi-aventis One Onslow Street Guildford
Slovenian: Trguje kot: Sanofi-aventis One Onslow Street Guildford
English: Some adverse effects (e.g. symptoms of a reduction in blood pressure such as dizziness) may impair the patient's ability to concentrate and react and, therefore, constitute a risk in situations where these abilities are of particular importance (e.g. operating a vehicle or machinery).
Slovenian: Nekateri neželeni učinki (npr. nekateri simptomi znižanega krvnega tlaka, kot je omotica) lahko oslabijo zmožnost koncentracije in reagiranja.
English: Other side effects reported:
Slovenian: Med drugimi neželenimi učinki so:
English: Transient erectile impotence, libido decreased
Slovenian: Motnje reprodukcije in dojk prehodna erektilna impotenca, zmanjšanje libida ginekomastija
English: Slovak Republic SANOFI-AVENTIS SLOVAKIA s.r.o.
Slovenian: SANOFI-AVENTIS SLOVAKIA s.r.o.
English: France:
Slovenian: Francija:
English: Tritace and associated names may be used in monotherapy or in combination with other classes of antihypertensive medicinal products”.
Slovenian: Zdravilo Tritace in z njim povezana imena se lahko uporabljajo pri monoterapiji ali v kombinaciji z drugimi razredi antihipertenzivnih zdravil“.
English: There are contraindications present in one or several local SPCs.
Slovenian: V enem ali več lokalnih povzetkih glavnih značilnosti zdravila so navedene kontraindikacije.
English: Sweden:
Slovenian: Švedska:
English: Tell a doctor or go to the nearest hospital casualty department straight away.
Slovenian: Če ste vzeli večji odmerek zdravila TRITACE, kot bi smeli Takoj se posvetujte z zdravnikom ali pojdite v ambulanto za nujno pomoč najbližje bolnišnice.
English: • Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice).
Slovenian: • Zvišana telesna temperatura, mrzlica, utrujenost, izguba teka, bolečine v želodcu, siljenje na bruhanje, porumenelost kože ali očesnih beločnic (zlatenica).
English: This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
Slovenian: Ta učinkovina spada v skupino zdravil, ki jih imenujemo zaviralci ACE (zaviralci angiotenzinske konvertaze).
English: See also posology on diuretic treated patients above.
Slovenian: Glejte tudi odmerjanje za bolnike, zdravljene z diuretikom, zgoraj.
English: A single oral dose of ramipril produced an undetectable level of ramipril and its metabolite in breast milk.
Slovenian: Posamičen peroralen odmerek ramiprila je povzročil nemerljivo koncentracija ramiprila in njegovega presnovka v materinem mleku.
English: • Fingers and toes changing colour when you are cold and then tingling or feeling painful when you warm up (Raynaud's phenomenon)
Slovenian: • prsti na rokah in nogah spremenijo barvo, kadar ste na hladu, potem pa mravljinčijo ali bolijo,
English: Ireland:
Slovenian: Irska:
English: • Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or in the amount of haemoglobin.
Slovenian: • spremembe izvidov preiskav krvi, ki kažejo zmanjšanje števila eritrocitov, levkocitov ali trombocitov ali zmanjšanje količine hemoglobina.
English: Hungary:
Slovenian: Madžarska:
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally] {Name and address} {tel} {fax} {e-mail}
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - Izpolni država članica] {Ime}
English: It is recommended to double the dose after one or two weeks of treatment and - after another two to three weeks - to increase it up to the target maintenance dose of 10 mg TRITACE once daily.
Slovenian: Po enem do dveh tednih zdravljenja je odmerek priporočljivo podvojiti in ga po nadaljnjih dveh do treh tednih povečati do ciljnega vzdrževalnega odmerka 10 mg TRITACE enkrat na dan.
English: Netherlands:
Slovenian: Nizozemska:
English: Ramiprilat, the active metabolite of ramipril is poorly removed from the general circulation by haemodialysis.
Slovenian: Ramiprilat, aktivni presnovek ramiprila, se s hemodializo slabo odstrani iz krvnega obtoka.
English: PRECLINICAL SAFETY DATA
Slovenian: 5.3 Predklinični podatki o varnosti
English: • If your blood pressure is abnormally low or unstable.
Slovenian: • če imate nenormalno nizek ali nestabilen krvni tlak To mora oceniti zdravnik.
English: In summary, pregnancy and lactation should be amended in line with PhVWP recommendations on ACE-I The following should be added to the contraindication:
Slovenian: Če povzamemo, poglavje Nosečnost in dojenje je treba uskladiti v skladu s priporočili PhVWP glede ACE-I.
English: The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens are increased under ACE inhibition.
Slovenian: Med zavrtjem ACE se povečata verjetnost in izrazitost anafilaktičnih in anafilaktoidnih reakcij na strupe žuželk in druge alergene.
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).
Slovenian: V skupini z ramiprilom je kombinirano sekundarno končno točko podvojitve izhodiščne koncentracije kreatinina v serumu in/ali končne odpovedi ledvic (potreba po dializi ali presaditvi ledvice) doseglo 23,1 % bolnikov, v skupini s placebom pa 45,5 % (p = 0,02).
English: Hyperkalaemia has been observed in some patients treated with ACE inhibitors including TRITACE.
Slovenian: Pri nekaterih bolnikih, zdravljenih z zaviralci ACE, vključno s TRITACE, so zabeležili hiperkaliemijo.
English: - Transient or persistent heart failure post MI
Slovenian: - Prehodno ali trajno srčno popuščanje po miokardnem infarktu
English: The dose can be doubled at interval of two to four weeks to progressively achieve target blood pressure; the maximum permitted dose of TRITACE is 10 mg daily.
Slovenian: Odmerek se lahko podvoji v presledkih od dva do štiri tedne, tako da se postopoma doseže ciljni krvni tlak.
English: Tablets
Slovenian: Zdravila
English: Acute hepatic failure, cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional).
Slovenian: holestatska zlatenica, okvara jetrnih celic akutna odpoved jeter, holestatski ali citolitični hepatitis (zelo izjemoma so bili opisani smrtni izidi)
English: - Treatment of symptomatic heart failure.
Slovenian: - Zdravljenje simptomatskega srčnega popuščanja
English: Doubling the daily dose to 5 mg TRITACE after one or two weeks and then to 10 mg TRITACE after a further two or three weeks is recommended.
Slovenian: Priporočljiva je podvojitev dnevnega odmerka TRITACE na 5 mg po enem do dveh tednih in nato na 10 mg TRITACE po nadaljnjih dveh do treh tednih.
English: Greece: Triatec 1.25 mg δισκία, Triatec 2.5 mg δισκία, Triatec 5 mg δισκία
Slovenian: Grčija: Triatec 1.25 mg δισκία, Triatec 2.5 mg δισκία, Triatec 5 mg δισκία
English: Generally, there are no major changes in renal plasma flow and glomerular filtration rate.
Slovenian: Ledvični pretok plazme in hitrost glomerularne filtracije se praviloma ne spremenita klinično pomembno.
English: A temporary discontinuation of TRITACE should be considered prior to desensitization.
Slovenian: Pred desenzibilizacijo pride v poštev prehodno prenehanje uporabe TRITACE.
English: Steady state plasma concentrations of ramiprilat after once daily dosing with the usual doses of ramipril are reached by about the fourth day of treatment.
Slovenian: Po uporabi običajnih odmerkov in odmerjanju enkrat na dan doseže ramiprilat koncentracijo v stanju dinamičnega ravnovesja v plazmi približno četrti dan zdravljenja z ramiprilom.
English: Heart failure:
Slovenian: Srčno popuščanje:
English: SANOFI-AVENTIS DEUTSCHLAND GMBH Industriepark Hoechst D-65926 Frankfurt am Main Germany
Slovenian: SANOFI-AVENTIS DEUTSCHLAND GMBH Industriepark Hoechst D-65926 Frankfurt am Main Nemčija
English: Blood sodium decreased
Slovenian: znižanje natrija v krvi
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.
Slovenian: Pri klinično in hemodinamsko stabilnem bolniku je 48 ur po miokardnem infarktu začetni odmerek 2,5 mg dvakrat na dan tri dni.
English: Ramipril - Zentiva 2.5mg Ramipril - Zentiva 5mg Ramipril - Zentiva 10mg
Slovenian: Ramipril - Zentiva 1.25mg Ramipril - Zentiva 2.5mg Ramipril - Zentiva 5mg Ramipril - Zentiva 10mg
English: Do not crush or chew the tablets/capsules.
Slovenian: Tablet/kapsul ne smete zdrobiti ali zgristi.
English: Austria:
Slovenian: Avstrija:
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.
Slovenian: CHMP je sprejel naslednjo kontraindikacijo: - „Preobčutljivost na ramipril, na katero koli pomožno snov ali kateri koli drugi zaviralec ACE (glejte poglavje 6.1) - Anamneza dednega ali idiopatskega angioedema - Zunajtelesno zdravljenje, pri katerem gre za stik krvi z negativno nabitimi površinami (glejte poglavje 4.5) - Močna obojestranska stenoza ledvične arterije ali stenoza ledvične arterije pri samo eni delujoči ledvici - Drugo in tretje trimesečje nosečnosti (glejte poglavji 4.4 in 4.6)“
English: Cyprus: Triatec 2.5 mg δισκία, Triatec 5 mg δισκία, Triatec 10 mg δισκία
Slovenian: Ciper: Triatec 2.5 mg δισκία, Triatec 5 mg δισκία, Triatec 10 mg δισκία
English: If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja, ali ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.