FrancophonIA/ELRC3.0 huggingface dataset:
English: Owing to the presence of lactose monohydrate, patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Zdravilo vsebuje laktoza monohidrat, zato ga ne smejo jemati bolniki s prirojeno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze-galaktoze.
English: HOW TO STORE VASCACE [To be completed nationally]
Slovenian: SHRANJEVANJE ZDRAVILA VASCACE [Izpolni država članica.]
English: No rapid increase in blood pressure has been observed after abrupt withdrawal of Vascace.
Slovenian: Po nenadnem prenehanju uporabe zdravila Vascace niso opazili hitrega zvišanja krvnega tlaka.
English: Single cases of liver function disorders, such as increased values of liver function tests (transaminases, bilirubin, alkaline phosphatase, gamma GT) and cholestatic hepatitis with or without necrosis have been reported.
Slovenian: Opisani so bili posamezni primeri motenega delovanja jeter, npr. zvišanje vrednosti jetrnih funkcijskih testov (transaminaz, bilirubina, alkalne fosfataze, gama-GT) in holestatski hepatitis z nekrozo ali brez nje.
English: These conditions can co-exist, particularly in severe heart failure.
Slovenian: Te motnje so lahko prisotne hkrati, zlasti pri bolnikih s hudim srčnim popuščanjem.
English: However, in patients with impaired renal function and/or in patients taking potassium supplements (including salt substitutes) or potassiumsparing diuretics, and especially aldosterone antagonists, hyperkalemia can occur.
Slovenian: Lahko pa se hiperkaliemija pojavi pri bolnikih z okvarjenim delovanjem ledvic in/ali bolnikih, ki uživajo dodatke kalija (vključno z nadomestki soli), ali diuretike, ki varčujejo s kalijem, zlasti antagoniste aldosterona.
English: - if you have had a serious side effect called angioedema after taking other ACE inhibitor medicines, hereditary angioedema or angioedema of unknown cause.
Slovenian: - če ste kdaj po jemanju drugih zaviralcev ACE imeli resen neželen učinek, ki ga imenujemo angioedem, ali če ste dedno nagnjeni k angiodemu ali če ste imeli angioedem brez znanega vzroka.
English: United Kingdom Roche Products Ltd 6 Falcon Way, Shire Park Welwyn Garden City / AL7
Slovenian: Velika Britanija Roche Products Ltd 6 Falcon Way, Shire Park Welwyn Garden City / AL7
English: If you are not sure, talk to your doctor or pharmacist before taking Vascace.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete zdravilo Vascace.
English: “Elderly with hypertension: Treatment with Vascace should be initiated with a dose between 0.5 and 1.0 mg once daily.
Slovenian: „Starejše osebe s hipertenzijo: zdravljenje z zdravilom Vascase je treba začeti z odmerkom med 0,5 in 1,0 mg enkrat dnevno.
English: Initial dose of Vascace
Slovenian: Začetni odmerek zdravila Vascace
English: When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
Slovenian: Če pride do diagnoze nosečnosti, je treba takoj prekiniti zdravljenje z zaviralci ACE in, če je primerno, začeti z alternativnim zdravljenjem.
English: The recommended starting dose in these patients is 0.5 mg once daily.
Slovenian: Priporočeni začetni odmerek pri teh bolnikih je 0,5 mg enkrat na dan.
English: Limited data are available for overdosage in humans.
Slovenian: Podatkov o prevelikem odmerjanju pri človeku je malo.
English: HOW TO TAKE VASCACE
Slovenian: KAKO JEMATI ZDRAVILO VASCACE
English: Gold
Slovenian: Zlato
English: Anaesthetic agents with blood pressure lowering effects can cause hypotension in patients receiving ACE inhibitors.
Slovenian: Anestetiki s hipotenzivnim učinkom lahko pri bolnikih, ki prejemajo zaviralce ACE, povzročijo hipotenzijo.
English: In patients with ascites, cilazapril administration is not recommended.
Slovenian: Pri bolnikih z ascitesom uporaba cilazaprila ni priporočljiva.
English: ACE inhibitors block the action of angiotensin converting enzyme and by doing so, the production of Angiotensin II which is a potent vasoconstrictor peptide will also be decreased.
Slovenian: Zaviralci ACE zavirajo delovanje angiotenzinske konvertaze, kar vpliva tudi na znižanje ravni tvorjenja angiotenzina II, močnega vazokonstriktornega peptida.
English: For patients with impaired liver function the CHMP agreed with the following wording proposed by the MAH:
Slovenian: Pri bolnikih z okvarjenim delovanjem jeter se je CHMP strinjal z naslednjim besedilom, ki ga je predlagal imetnik dovoljenja za promet z zdravilom:
English: Excess sweating, flushing, asthenia, sleep disorder (c) Description of selected adverse events
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti utrujenost občasni čezmerno znojenje, zardevanje, astenija, motnje spanja (c) Opis izbranih neželenih dogodkov
English: Cerebral ischaemia, transient ischaemic attack, ischaemic stroke Peripheral neuropathy
Slovenian: Možganska ishemija, tranzitorna ishemična ataka, ishemična možganska kap periferna nevropatija
English: - Potassium supplements (including salt substitutes) or potassium-sparing diuretics.
Slovenian: - dodatke, ki vsebujejo kalij (vključno z nadomestki soli) ali diuretike, ki varčujejo s kalijem.
English: Maximal dose of Vascace
Slovenian: Največji odmerek zdravila Vascace
English: Low-density lipoproteins (LDL) apheresis: Patients receiving ACE inhibitors during LDL apheresis with dextran sulphate have experienced life-threatening anaphylaxis.
Slovenian: Afereza lipoproteinov majhne gostote (LDL): Pri bolnikih, ki so dobivali zaviralce ACE, se je med aferezo LDL z dekstranovim sulfatom pojavila smrtno nevarna anafilaksa.
English: At-risk patients should start treatment with cilazapril under medical supervision, with a low initial dose and careful titration.
Slovenian: Pri bolnikih s tveganjem je treba zdravljenje s cilazaprilom začeti pod zdravniškim nadzorstvom, z majhnim začetnim odmerkom in skrbnim prilagajanjem.
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with cilazapril (see section 4.4).
Slovenian: Predhodno zdravljenje z velikimi odmerki diuretikov lahko ob uvedbi zdravljenja s cilazaprilom povzroči hipovolemijo in tveganje hipotenzije (glejte poglavje 4.4).
English: As with other agents acting on the renin-angiotensin system, there is an increased risk of renal insufficiency, including acute renal failure, when patients with renal artery stenosis are treated with cilazapril.
Slovenian: Kot pri drugih zdravilih, ki delujejo na sistem renin-angiotenzin, obstaja pri bolnikih s stenozo ledvične arterije povečano tveganje za insuficienco ledvic, vključno z akutno odpovedjo ledvic.
English: No clinically significant interactions were observed when cilazapril and digoxin, nitrates, coumarin anticoagulants, and H2 receptor blockers were concomitantly administered.
Slovenian: Med sočasno uporabo cilazaprila in digoksina, nitratov, kumarinskih antikoagulantov in H2 antagonistov niso ugotovili klinično pomembnih medsebojnih delovanj.
English: Vascace is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Slovenian: Če želite dojiti, vam zdravnik lahko izbere drugo zdravilo, še posebej če je vaš otrok še novorojenček ali če je bil prezgodaj rojen.
English: Elderly with chronic heart failure: The recommended starting dose of Vascace 0.5 mg must be strictly followed.
Slovenian: Starejši bolniki s kroničnim srčnim popuščanjem: Strogo je treba upoštevati priporočeni začetni odmerek 0,5 mg zdravila Vascace.
English: Angioedema due to ACE inhibitors can present as recurrent episodes of facial swelling, which resolves on withdrawal, or as acute oropharyngeal edema and airways obstruction, which requires emergency treatment, and may be life-threatening.
Slovenian: Angioedem zaradi zaviralcev ACE se lahko kaže s ponavljajočim se otekanjem obraza, ki po prenehanju uporabe mine, ali kot akuten orofaringealen edem in obstrukcija dihal, ki zahteva nujno zdravljenje in je lahko smrtno nevarna.
English: For cirrhotic patients with ascites however, cilazapril is not recommended.
Slovenian: Pri bolnikih s cirozo, ki imajo ascites, uporaba cilazaprila ni priporočljiva.
English: The dosage schedule for patients with impaired renal function as recommended by the MAH was considered to be acceptable by the CHMP:
Slovenian: Odbor CHMP je menil, da je shema odmerjanja pri bolnikih z okvarjenim delovanjem ledvic, kakor jo je priporočil imetnik dovoljenja za promet z zdravilom, sprejemljiva.
English: Check with your doctor or pharmacist before taking Vascace - if you have a heart problem.
Slovenian: Bodite posebno pozorni pri jemanju zdravila Vascace Preden vzamete zdravilo Vascace, se posvetujte z zdravnikom ali s farmacevtom: - če imate kakšne težave s srcem.
English: There is no elimination in patients with complete renal failure, but haemodialysis reduces concentrations of both cilazapril and cilazaprilat to a limited extent.
Slovenian: Pri bolnikih s popolno odpovedjo ledvic izločanja ni, a hemodializa v majhni meri zmanjša tako koncentracijo cilazaprila kot cilazaprilata.
English: Myocardial ischaemia, angina pectoris, tachycardia, palpitations Rare
Slovenian: Srčne bolezni občasni ishemija miokarda, angina pektoris, tahikardija, palpitacije redki miokardni infarkt, motnje srčnega ritma
English: Vascace is indicated for the treatment of hypertension.
Slovenian: Zdravilo Vascace je indicirano za zdravljenje hipertenzije.
English: Excessive lowering of blood pressure may increase the chance of heart attack or stroke in certain patients - Increased heart rate - Feeling weak - Pains in the chest - Breathing problems, including shortness of breath and tightness in the chest - A runny or blocked nose and sneezing (rhinitis) - Dry or swollen mouth - Lack of appetite - Change in the way things taste - Diarrhoea and vomiting - Skin rash (which may be severe) - Muscle cramps or pain in your muscles or joints - Impotence
Slovenian: Čezmerno znižanje krvnega tlaka lahko nekaterim bolnikom poveča možnost srčnega infarkta ali možganske kapi; - hitrejše bitje srca, - občutek šibkosti, - bolečine v prsih, - težave z dihanjem, vključno s kratko sapo in tiščanjem v prsih, - izcedek iz nosu ali zamašen nos in kihanje (rinitis), - suha ali otekla usta, - pomanjkanje apetita, - spremenjeno zaznavanje okusov, - driska in bruhanje, - izpuščaj na koži (ki je lahko hud),
English: A lower starting dose of 0.5 mg once daily is recommended in such patients and the initiation of treatment should take place under medical supervision.
Slovenian: Za takšne bolnike je priporočljiv manjši začetni odmerek 0,5 mg enkrat na dan, uvedba zdravljenja pa mora potekati pod nadzorstvom zdravnika.
English: N.V. Roche S.A. Rue Dante 75
Slovenian: Roche S.A. Rue Dante 75 1070 Bruxelles Belgija
English: Hypersensitivity to cilazapril or any components of the product, or to other ACE inhibitors
Slovenian: Preobčutljivost za cilazapril, katerokoli sestavino zdravila ali druge zaviralce ACE.
English: Common (affects less than 1 in 10 people)
Slovenian: Pogosti (pojavijo se pri manj kot 1 od 10 bolnikov):
English: If indicated, cilazaprilat, the active form of cilazapril, may be removed from the general circulation by haemodialysis (see section 4.4).”
Slovenian: V primeru indikacije je mogoče cilazaprilat, aktivno obliko cilazaprila, odstraniti iz splošnega obtoka s hemodializo (glejte poglavje 4.4).“
English: In patients with renal impairment, the dosage of cilazapril should be adjusted according to creatinine clearance (see section 4.2).
Slovenian: Bolnikom z okvaro ledvic je treba odmerek cilazaprila prilagoditi glede na očistek kreatinina (glejte poglavje 4.2).
English: It also makes it easier for your heart to pump blood around your body if you have chronic heart failure.
Slovenian: Če imate kronično srčno popuščanje, srcu tudi olajša črpanje krvi po telesu.
English: “Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Slovenian: „Predklinični podatki na podlagi običajnih študij splošne farmakologije, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: “Patients with renal impairment: Reduced dosages are required for patients with renal impairment, depending on their creatinine clearance (see section 4.4).
Slovenian: „Bolniki z okvaro ledvic: zmanjšani odmerki so potrebni pri bolnikih z okvaro ledvic, pri čemer je treba upoštevati njihov očistek kreatinina (glejte poglavje 4.4).
English: Pacemaker therapy is indicated for therapy-resistant bradycardia.
Slovenian: Srčni spodbujevalnik je indiciran pri bradikardiji, ki je odporna na zdravljenje.
English: “Vascace is indicated for the treatment of hypertension.”
Slovenian: „Zdravilo Vascase je indicirano za zdravljenje hipertenzije.“
English: Therefore, there is no recommendation for administration of cilazapril to children.
Slovenian: Zato priporočil za uporabo cilazaprila pri otrocih ni.
English: Administration of ACE inhibitors to patients with diabetes may potentiate the blood glucose-lowering effect of oral hypoglycaemic agents or insulin, especially in patients with renal impairment.
Slovenian: Uporaba zaviralcev ACE pri sladkornih bolnikih lahko poveča učinek peroralnih antidiabetikov ali insulina na znižanje glukoze v krvi; to še zlasti velja za bolnike z okvaro ledvic.
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Slovenian: Zdravniku morate povedati, če dojite ali če boste v kratkem začeli dojiti.
English: - The other ingredient(s) is (are)...
Slovenian: - Pomožna snov je/pomožne snovi so ...
English: The events of cerebral ischaemia, transient ischaemic attack and ischaemic stroke reported rarely in association with ACE inhibitors may be related to hypotension in patients with underlying cerebrovascular disease.
Slovenian: Pri bolnikih z osnovno cerebrovaskularno boleznijo so primeri ishemije možganov, tranzitornih ishemičnih atak in ishemične možganske kapi, ki so bili v redkih primerih opisani med uporabo zaviralcev ACE, lahko povezani s hipotenzijo.
English: Vascace is indicated for the treatment of chronic heart failure.
Slovenian: Zdravilo Vascace je indicirano za zdravljenje kroničnega srčnega popuščanja.
English: Severe reactions:
Slovenian: Hudi neželeni učinki:
English: “Chronic heart failure: Therapy with Vascace should be initiated at a recommended starting dose of 0.5 mg once daily under close medical supervision.
Slovenian: „Kronično srčno popuščanje: zdravljenje z zdravilom Vascase je treba začeti s priporočenim začetnim odmerkom 0,5 mg enkrat dnevno pod skrbnim zdravniškim nadzorom.
English: The active substance of Vascace tablets is cilazapril.
Slovenian: Zdravilna učinkovina tablet Vascase je cilazapril.
English: Serum potassium
Slovenian: Kalij v serumu
English: No clinical trials have been carried out which prove the effect of cilazapril on morbidity and mortality in heart failure.
Slovenian: Klinična preskušanja, ki bi dokazala vpliv cilazaprila na obolevnost in smrtnost pri srčnem popuščanju, niso bila izvedena.
English: Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij splošne farmakologije, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: Cilazaprilat is eliminated unchanged by the kidneys, with an effective half-life of 9 hours after once daily dosing with Vascace.
Slovenian: Po uporabi zdravila Vascace enkrat na dan je njegov efektivni razpolovni čas 9 ur.
English: The usual starting dose of Vascace is then 0.5 mg per day.
Slovenian: Običajen začetni odmerek zdravila Vascace je v tem primeru 0,5 mg na dan.
English: Dry mouth, aphthous stomatitis, decreased appetite, diarrhoea, vomiting Rare
Slovenian: Bolezni prebavil pogosti navzea občasni suha usta, aftozni stomatitis, zmanjšanje apetita, driska, bruhanje redki glositis, pankreatitis
English: Similarly, myocardial ischaemia may be related to hypotension in patients with underlying ischaemic heart disease.
Slovenian: Podobno je lahko pri bolnikih z osnovno ishemično boleznijo srca s hipotenzijo povezana ishemija miokarda.
English: Cilazapril may be continued once the patient is volume replete, but should be given at a lower dose or discontinued if hypotension persists.
Slovenian: Zdravljenje s cilazaprilom je mogoče nadaljevati, ko je volumen nadomeščen, vendar je treba zdravilo uporabiti v manjšem odmerku.
English: The following list of adverse reactions is derived from clinical trials and post-marketing data in association with cilazapril and/or other ACE inhibitors.
Slovenian: Naslednji seznam neželenih učinkov je pridobljen iz kliničnih preskušanj in podatkov iz obdobja trženja o cilazaprilu in/ali drugih zaviralcih ACE.
English: “Vascace is indicated for the treatment of chronic heart failure.”
Slovenian: „Zdravilo Vascase je indicirano za zdravljenje kroničnega srčnega popuščanja.“
English: 0.5 mg per day and will carefully monitor your blood pressure.
Slovenian: - Če imate cirozo jeter brez ascitesa, vam bo zdravnik predpisal največ 0,5 mg na dan in bo skrbno spremljal vaš krvni tlak.
English: Uncommon (affects less than 1 in 100 people)
Slovenian: Občasni (pojavijo se pri manj kot 1 od 100 bolnikov):
English: (anemia, neutropenia, agranulocytosis and thrombocytopenia) - A type of severe allergic reaction (anaphylaxis) - Cerebral ischaemia, transient ischaemic attack, ischaemic stroke (may occur if blood pressure becomes too low) - Myocardial infarction (may occur if blood pressure becomes too low) - Irregular heartbeat - Interstitial lung disease - A disorder resembling systemic lupus erythematosus - Pins and needles or numbness in the hands or feet - Wheezing - A feeling of fullness or a throbbing pain behind the nose, cheeks and eyes (sinusitis).
Slovenian: - spremembe izvidov preiskav krvi, ki kažejo zmanjšanje števila rdečih krvnih celic, belih krvnih celic ali krvnih ploščic (anemija, nevtropenija, agranulocitoza in trombocitopenija), - vrsta hude alergijske reakcije (anafilaksa), - možganska ishemija, tranzitorna ishemična ataka, ishemična kap (do tega lahko pride, če je krvni tlak prenizek) - srčna kap (do tega lahko pride, če je krvni tlak prenizek) - nereden srčni utrip - intersticijska bolezen pljuč - motnja, podobna sistemskemu eritematoznemu lupusu, - mravljinčenje ali omrtvelost v dlaneh in stopalih, - piskajoče dihanje, - občutek polnosti in kljuvajoče bolečine za nosom, lici in očmi (sinuzitis), - vnetost jezika, - pankreatitis (vnetje trebušne slinavke).
English: Chronic heart failure - The usual starting dose is 0.5 mg per day.
Slovenian: Kronično srčno popuščanje - Običajen začetni odmerek je 0,5 mg na dan. - Zdravnik vam bo nato odmerek povečeval.
English: Chronic heart failure: Therapy with Vascace should be initiated at a recommended starting dose of 0.5 mg once daily under close medical supervision.
Slovenian: Kronično srčno popuščanje: Zdravljenje z zdravilom Vascace je treba uvesti v priporočenem začetnem odmerku 0,5 mg enkrat na dan in pod natančnim zdravniškim nadzorom.
English: Patients with renal impairment: Reduced dosages are required for patients with renal impairment, depending on their creatinine clearance (see section 4.4).
Slovenian: Bolniki z okvaro ledvic: Bolnikom z okvaro ledvic je treba odmerek zmanjšati glede na očistek kreatinina (glejte poglavje 4.4).
English: (desensitization).
Slovenian: {VRSTA/TIP}
English: treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
Slovenian: Ob potrjeni nosečnosti je treba zdravljenje z zaviralci ACE takoj prekiniti in, če je primerno, začeti alternativno zdravljenje.
English: Patients with a history of angioedema unrelated to ACE inhibitors may be at greater risk.
Slovenian: Tveganje je morda večje pri bolnikih z anamnezo angioedema, nepovezanega z zaviralci ACE.
English: The use of ACE inhibitors such as cilazapril is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Slovenian: Uporaba zaviralcev ACE, kot je cilazapril, je kontraindicirana v drugem in tretjem tromesečju nosečnosti (glejte poglavje 4.3 in 4.4).
English: The use of ACE inhibitors such as cilazapril is not recommended during the first trimester of pregnancy (see section 4.4).
Slovenian: Uporaba zaviralcev ACE, kot je cilazapril, ni priporočljiva v prvem tromesečju nosečnosti (glejte poglavje 4.4).
English: The special dosage recommendation should thus be followed in chronic heart failure patients with impaired renal function.”
Slovenian: Zato je treba pri bolnikih s kroničnim srčnim popuščanjem, ki imajo okvarjeno delovanje ledvic, upoštevati posebna priporočila glede odmerjanja.“
English: History of angioedema associated with previous ACE inhibitor therapy
Slovenian: Anamneza angioedema med predhodnim zdravljenjem z zaviralci ACE.
English: Chronic heart failure: In patients with chronic heart failure, clearance of cilazaprilat is correlated with creatinine clearance.
Slovenian: Kronično srčno popuščanje: Očistek cilazaprilata pri bolnikih s kroničnim srčnimi popuščanjem korelira z očistkom kreatinina.
English: The bioavailability of cilazaprilat from oral cilazapril approximates 60%, based on urinary recovery data.
Slovenian: Na podlagi podatkov o pojavljanju v urinu, je biološka uporabnost cilazaprilata iz peroralno uporabljenega cilazaprila približno 60 %.
English: First-dose hypotension is most likely to occur in patients whose renin-angiotensin-aldosterone system is activated, such as in renovascular hypertension or other causes of renal hypoperfusion, sodium or volume depletion, or previous treatment with other vasodilators.
Slovenian: Takšni so npr. bolniki z renovaskularno hipertenzijo ali drugimi vzroki ledvične hipoperfuzije, pomanjkanjem natrija, hipovolemijo ali predhodnim zdravljenjem z drugimi vazodilatatorji.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.
Slovenian: Med sočasno uporabo litija in zaviralcev ACE so poročali o reverzibilnih zvečanjih serumskih koncentracij litija ter njegovih toksičnih učinkov.
English: High blood pressure (hypertension) - The usual starting dose for adults is 1 mg per day.
Slovenian: Visok krvni tlak (hipertenzija) - Običajen začetni odmerek za odrasle je 1 mg na dan. - Zdravnik vam bo nato odmerek povečeval, dokler krvni tlak ne bo urejen.
English: The most frequent drug-attributable adverse events observed in patients taking ACE inhibitors are cough, skin rash and renal dysfunction.
Slovenian: Pri bolnikih, zdravljenih z zaviralci ACE, so najpogostejši neželeni učinki, ki jih je mogoče pripisati zdravilu, kašelj, izpuščaj na koži in moteno delovanje ledvic.
English: Abnormal liver function test (including transaminases, bilirubin, alkaline phosphatase, gamma GT) Cholestatic hepatitis with or without necrosis
Slovenian: Bolezni jeter, žolčnika in žolčevodov redki nenormalni testi delovanja jeter (vključno s transaminazami, bilirubinom, alkalno fosfatazo, gama-GT) holestatski hepatitis z nekrozo ali brez nje
English: “The use of ACE inhibitors such as cilazapril is not recommended during the first trimester of pregnancy (see section 4.4).
Slovenian: „Uporaba zaviralcev ACE, kot je cilazapril, v prvem tromesečju nosečnosti ni priporočljiva (glejte poglavje 4.4).
English: MedDRA System Organ Class (SOC) and Preferred Terms (PTs) are used where appropriate.
Slovenian: Kjer je ustrezno, se uporabljata organski sistem po MedDRA klasifikaciji in dogovorjena terminologija.
English: These include aspirin,
Slovenian: Mednje spadajo acetilsalicilna kislina