FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <[To be completed nationally]>
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET <[Izpolniti nacionalno]>
English: Cough:
Slovenian: Kašelj:
English: Patients at risk for the development of hyperkalaemia include those with renal insufficiency, uncontrolled diabetes mellitus, or those using concomitant potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes; or those patients taking other drugs associated with increases in serum potassium (e.g. heparin).
Slovenian: Tveganje za nastanek hiperkalemije spremlja na primer bolnike z ledvičnim popuščanjem, neurejeno sladkorno boleznijo ali tiste, ki sočasno jemljejo diuretike, ki zadržujejo kalij, dodatke kalija ali nadomestke soli, ki vsebujejo kalij, pa tudi bolnike, ki jemljejo druga zdravila, povezana s povečanjem vrednosti kalija v serumu (na primer heparin).
English: Hypersensitivity/Angioedema:
Slovenian: Preobčutljivost in angioedem:
English: Since ACE inactivates bradykinin, inhibition of ACE also results in an increased activity of circulating and local kallikreinkinin systems (and thus also activation of the prostaglandin system).
Slovenian: Ker angiotenzinska konvertaza inaktivira bradikinin, njeno zaviranje privede tudi do povečane aktivnosti kalikreinsko kininskega sistema v krvnem obtoku in lokalno (in s tem tudi do aktivacije prostaglandinskega sistema).
English: Hyperkalaemia:
Slovenian: Hiperkalemija:
English: 15 < ClCR < 30
Slovenian: 15 < očistek kreatinina < 30
English: No mutagenicity has been observed in in vitro or in vivo studies.
Slovenian: V študijah in vivo ter in vitro niso opazili mutagenosti.
English: “Stable coronary artery disease: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation”.
Slovenian: »Stabilna koronarna arterijska bolezen: Zmanjševanje tveganja za srčne zaplete pri bolnikih, ki so v preteklosti že imeli miokardni infarkt in/ali revaskularizacijo«.
English: Antidiabetic agents:
Slovenian: Antidiabetiki:
English: Surgery/Anaesthesia:
Slovenian: Kirurški posegi in anestezija:
English: Elderly patients should receive 2 mg once daily for one week, then 4 mg once daily the next week, before increasing the dose up to 8 mg once daily depending on renal function (see Table 1 “Dosage adjustment in renal impairment”).
Slovenian: Starejši bolniki naj dobivajo 2 mg enkrat dnevno v obdobju enega tedna, nato 4 mg enkrat dnevno naslednji teden, preden se odmerek poveča na 8 mg enkrat dnevno, v odvisnosti od ledvične funkcije (glej tabelo 1 »Prilagajanje odmerka v primeru prizadetosti ledvic«).
English: Therefore the use of <COVERSYL and associated names> is not recommended in women who are breast-feeding.
Slovenian: Zato predpisovanje zdravila <COVERSYL in sorodna imena> doječim materam ni priporočljivo.
English: Perindopril may be used concomitantly with acetylsalicylic acid (when used as a thrombolytic), thrombolytics, beta-blockers and/or nitrates.
Slovenian: Perindopril lahko uporabljate sočasno z acetilsalicilno kislino (kot trombolitikom), trombolitiki, blokatorji beta receptorjev, nitrati ali vsemi.
English: Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (see 4.3 Contraindications).
Slovenian: Bolnike z angiodemom v anamnezi, ki ni bil povezan z zdravljenjem z zaviralci angiotenzinske konvertaze, lahko spremlja povečano tveganje za angioedem ob jemanju zaviralca angiotenzinske konvertaze (glejte poglavje 4.3 Kontraindikacije).
English: Aortic and mitral valve stenosis/hypertrophic cardiomyopathy:
Slovenian: Bolniki z zožitvijo aorte in mitralne zaklopke ter hipertrofično kardiomiopatijo:
English: Elimination of perindoprilat is decreased in the elderly, and also in patients with heart or renal failure.
Slovenian: Izločanje perindoprilata iz telesa je počasnejše pri starejših in bolnikih s srčnim ali ledvičnim popuščanjem.
English: Paediatric use:
Slovenian: Uporaba v pediatriji:
English: Hypotension:
Slovenian: Hipotenzija:
English: Patients at high risk of symptomatic hypotension e.g. patients with salt depletion with or without hyponatraemia, patients with hypovolaemia or patients who have been receiving vigorous diuretic therapy should have these conditions corrected, if possible, prior to therapy with <COVERSYL and associated names>.
Slovenian: Bolnikom, ki jih spremlja veliko tveganje za simptomatično hipotenzijo (z izgubo soli s hiponatremijo ali brez nje), hipovolemija ali intenzivno jemljejo diuretike, morate tovrstna stanja odpraviti pred uvedbo zdravila <COVERSYL in sorodna imena>, če je mogoče.
English: This is especially likely in patients with renal insufficiency.
Slovenian: Ta učinek je zlasti verjeten pri bolnikih z ledvičnim popuščanjem.
English: Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up (see 4.8 Undesirable effects).
Slovenian: Če se pri bolnikih, ki jemljejo zaviralce angiotenzinske konvertaze, pojavi zlatenica ali izrazito povečanje vrednosti jetrnih encimov, jim morate ukiniti zaviralec angiotenzinske konvertaze in jih ustrezno zdravniško spremljati (glejte poglavje 4.8 Neželeni učinki).
English: Common: hypotension and effects related to hypotension Very rare: arrhythmia, angina pectoris, myocardial infarction and stroke, possibly secondary to excessive hypotension in high-risk patients (see 4.4 Special warnings and special precautions for use).
Slovenian: Zelo redki: aritmije, angina pektoris, miokardni infarkt in možganska kap, verjetno sekundarno kot posledica prevelike hipotenzije pri bolnikih z velikim tveganjem (glejte 4.4 Posebna opozorila in previdnostni ukrepi).
English: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation.
Slovenian: Zmanjševanje tveganja za srčnožilne dogodke pri bolnikih z miokardnim infarktom ali revaskularizacijo ali obema v anamnezi.
English: In the same patients, these reactions have been avoided when the ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge.
Slovenian: Pri njih so tovrstne reakcije preprečili z začasno odtegnitvijo zaviralcev angiotenzinske konvertaze, vendar so se pri nehoteni ponovni izpostavljenosti spet pojavile.
English: Uncommon: angioedema of face, extremities, lips, mucous membranes, tongue, glottis and/or larynx, urticaria (see 4.4 Special warnings and special precautions for use).
Slovenian: Občasni: angioedem obraza, okončin, ustnic, sluznic, jezika ter glotisa ali grla ali obeh, koprivnica (glejte 4.4 Posebna opozorila in previdnostni ukrepi).
English: MARKETING AUTHORISATION NUMBER(S) <[To be completed nationally]>
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET <[Izpolniti nacionalno]>
English: In severe heart failure and in other patients considered to be at high risk (patients with impaired renal function and a tendency to have electrolyte disturbances, patients receiving simultaneous treatment with diuretics and/or treatment with vasodilating agents), treatment should be initiated under careful supervision (see 4.4 “Special warnings and special precautions for use”).
Slovenian: Pri bolnikih s hudim srčnim popuščanjem in pri drugih zelo rizičnih skupinah (ledvično popuščanje in nagnjenost k motnjam ravnovesja elektrolitov; sočasno jemanje diuretikov, vazodilatatorjev ali obojih) mora uvedba zdravljenja potekati pod strogim zdravniškim nadzorom (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
English: The dose may be increased to 8 mg once daily after one month of treatment.
Slovenian: Po enem mesecu zdravljenja lahko odmerek povečate na 8 mg enkrat na dan.
English: More patients withdrew for cough, hypotension or other intolerance on perindopril than on placebo, 6.0% (n=366) versus 2.1% (n=129) respectively.
Slovenian: Ob perindoprilu je v primerjavi s placebom več bolnikov prekinilo zdravljenje zaradi kašlja, hipotenzije ali drugačnega neprenašanja: 6,0 % (n = 366) proti 2,1 % (n = 129).
English: In elderly patients treatment should be initiated at a dose of 2 mg which may be progressively increased to 4 mg after one month then to 8 mg if necessary depending on renal function (see table below).
Slovenian: Starejšim bolnikom uvedite zdravljenje z odmerkom 2 mg, ki ga lahko postopoma povečujete na 4 mg po enem mesecu in nato na 8 mg, če je potrebno, odvisno od ledvičnega delovanja (glejte spodnjo preglednico).
English: 30 < ClCR < 60
Slovenian: 30 < očistek kreatinina < 60
English: Additionally, NSAIDs and ACE inhibitors exert an additive effect on the increase in serum potassium and may result in a deterioration of renal function.
Slovenian: Poleg tega se učinki nesteroidnih antirevmatikov in zaviralcev angiotenzinske konvertaze na povečanje vrednosti kalija v serumu seštevajo, kar lahko povzroči poslabšanje ledvičnega delovanja.
English: Prolonged ACE inhibitor exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Slovenian: Znano je, da podaljšana izpostavljenost zaviralcem angiotenzinske konvertaze v drugem in tretjem trimesečju pri ljudeh povzroča fetotoksičnost (zmanjšano delovanje ledvic, oligohidramnij, upočasnjeno osifikacijo lobanje) in toksičnost pri novorojenčkih (ledvično popuščanje, hipotenzijo, hiperkalemijo) (glejte poglavje 5.3 Predklinični podatki o varnosti).
English: No dosage adjustment is necessary in patients with hepatic impairment (see sections 4.4 “Special warnings and special precautions for use” and 5.2 “Pharmacokinetic properties”)
Slovenian: Bolnikom z jetrnim popuščanjem ni potrebno prilagajati odmerka (glejte poglavji 4.4 Posebna opozorila in previdnostni ukrepi in 5.2 Farmakokinetične lastnosti).
English: Stable coronary artery disease: <COVERSYL and associated names> should be introduced at a dose of 4 mg once daily for two weeks, then increased to 8 mg once daily, depending on renal function and provided that the 4 mg dose is well tolerated.
Slovenian: Bolnikom s stabilno koronarno arterijsko boleznijo uvedite zdravilo <COVERSYL in sorodna imena> po 4 mg enkrat na dan za dva tedna, nato odmerek povečajte na 8 mg enkrat na dan, odvisno od delovanja ledvic in če bolniki odmerek po 4 mg dobro prenašajo.
English: Decreases in haemoglobin and haematocrit, thrombocytopenia, leucopenia/neutropenia, and cases of agranulocytosis or pancytopenia, have been reported very rarely.
Slovenian: Zelo redko so opažali zmanjšanje hemoglobina in hematokrita, trombocitopenijo, levkopenijo in nevtropenijo ter primere agranulocitoze ali pancitopenije.
English: 4 mg per day
Slovenian: 4 mg
English: This wording was based on a significant relative risk reduction (RRR) of 20% (95% CI [9.4; 28.6] p=0.0003) in the primary combined endpoint of cardiovascular mortality, non-fatal myocardial infarction (MI) or cardiac arrest with successful resuscitation observed in the EUROPA study.
Slovenian: Besedilo je temeljilo na pomembnem relativnem zmanjšanju tveganja (RRR) za kombiniran primarni klinični izid, kamor spadajo kardiovaskularna smrt, nesmrtni miokardni infarkt (MI) ali zaustavitev srca z uspešnim oživljanjem, in sicer za 20 % (95% interval zaupanja [9.4; 28.6] p=0.0003), kot so ugotovili v okviru študije EUROPA.
English: In patients with a history of myocardial infarction and/or revascularisation, an absolute reduction of 2.2% corresponding to a RRR of 22.4% (95%CI [12.0; 31.6] - p<0.001) in the primary endpoint was observed by comparison to placebo.
Slovenian: Pri bolnikih, ki so v preteklosti že imeli miokardni infarkt in/ali revaskularizacijo, je bilo opaženo absolutno zmanjšanje pogostosti primarnega izida za 2,2 %, ki ustreza relativnemu zmanjšanju tveganja za 22,4 % (95 % interval zaupanja [12.0; 31.6] - p<0.001), v primerjavi s placebom.
English: This is more likely to occur in patients with pre-existing renal impairment.
Slovenian: Ta vpliv je verjetnejši pri bolnikih, ki že imajo ledvično popuščanje.
English: Uncommon: renal insufficiency Very rare: acute renal failure
Slovenian: Zelo redki: akutno ledvično popuščanje.
English: COVERSYL should be introduced at a dose of 4 mg once daily for two weeks, then increased to 8 mg once daily, depending on renal function and provided that the 4 mg dose is well tolerated.
Slovenian: COVERSYL naj bo vpeljan v odmerku 4 mg enkrat dnevno za obdobje dveh tednov, nato pa naj se odmerek poveča na 8 mg enkrat dnevno, v odvisnosti od ledvične funkcije in pod pogojem, da bolnik odmerek 4 mg dobro prenaša.
English: Dosage reduction and/or discontinuation of the diuretic and/or <COVERSYL and associated names> may be required.
Slovenian: Včasih je treba zmanjšati odmerek ali ukiniti diuretik ali <COVERSYL in sorodna imena> ali oba.
English: The administration of a non-steroidal anti-inflammatory drugs may reduce the antihypertensive effect of ACE inhibitors.
Slovenian: Jemanje nesteroidnih antirevmatikov lahko zmanjša antihipertenzivni učinek zaviralcev angiotenzinske konvertaze.
English: • Hypersensitivity to perindopril, to any of the excipients or to any other ACE inhibitor;
Slovenian: • Preobčutljivost za perindopril, katero od pomožnih snovi ali katerikoli drug zaviralec angiotenzinske konvertaze.
English: The other metabolites show no inhibition of ACE activity in vitro.
Slovenian: Drugi presnovki perindoprila ne zavirajo aktivnosti angiotenzinske konvertaze in vitro.
English: Angiotensin converting enzyme inhibitors cause a higher rate of angioedema in black patients than in non-black patients.
Slovenian: Zaviralci angiotenzinske konvertaze pogosteje povzročajo angioedem pri črncih kot pri bolnikih iz drugih etničnih skupin.
English: Ear and labyrinth disorders: Common: tinnitus
Slovenian: Ušesne bolezni, vključno z motnjami labirinta: Pogosti: tinitus.
English: Background information on the type II variation through the MRP
Slovenian: Osnovne informacije v zvezi s spremembo tipa II v okviru postopka medsebojnega priznavanja (MRP)
English: 2 mg per day
Slovenian: 2 mg
English: Potassium sparing diuretics, potassium supplements or potassium-containing salt substitutes:
Slovenian: Diuretiki, ki zadržujejo kalij, kalijevi dodatki ali nadomestki soli, ki vsebujejo kalij:
English: An adjunctive therapy with a thiazide diuretic produces an additive-type of synergy.
Slovenian: Pri dodatnem zdravljenju s tiazidnim diuretikom se učinka zdravil sinergistično seštevata.
English: Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (Angiotensin Converting Enzyme ACE).
Slovenian: Perindopril je zaviralec angiotenzinske konvertaze (ACE), encima, ki pretvarja angiotenzin I v angiotenzin II.
English: The EUROPA study was a multicentre, international, randomised, double-blind, placebo-controlled clinical trial lasting 4 years.
Slovenian: Bolniki s stabilno koronarno arterijsko boleznijo Študija EUROPA je bila multicentrično, mednarodno, randomizirano, dvojno slepo, s placebom nadzorovano klinično preskušanje, ki je trajalo 4 leta.
English: • History of angioedema associated with previous ACE inhibitor therapy;
Slovenian: • Angioedem v anamnezi, povezan s predhodnim zdravljenjem z zaviralci angiotenzinske konvertaze.
English: Diuretics:
Slovenian: Dojenje:
English: Haemodialysed patients * ClCR < 15
Slovenian: 2 mg vsak drug dan bolniki na hemodializi* očistek kreatinina < 15
English: 2 mg every other day
Slovenian: 2 mg na dan
English: Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, emergency therapy should be administered promptly.
Slovenian: Kadar zajame jezik, glotis ali grlo in grozi zapora dihalnih poti, je potrebno takojšnje urgentno zdravljenje, ki obsega dajanje adrenalina, ohranjanje odprtih dihalnih poti ali oboje.
English: Common: nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhoea, constipation Uncommon: dry mouth
Slovenian: Pogosti: slabost, bruhanje, trebušne bolečine, disgevzija, dispepsija, driska, zaprtje.
English: Renal function and serum potassium should be monitored.
Slovenian: Spremljati morate delovanje ledvic in raven kalija v serumu.
English: Haemodialysis patients:
Slovenian: Bolniki na hemodializi:
English: Antihypertensive agents and vasodilators:
Slovenian: Antihipertenzivi in vazodilatatorji:
English: After repeated administration, no accumulation of perindopril is observed.
Slovenian: Pri večkratnemu jemanju se perindopril ne kopiči v telesu.
English: Rarely, patients receiving ACE inhibitors during low-density lipoprotein (LDL) apheresis with dextran sulphate have experienced life-threatening anaphylactoid reactions.
Slovenian: Anafilaktoidne reakcije med aferezo lipoproteinov majhne gostote (LDL): Bolniki, ki so jemali zaviralce angiotenzinske konvertaze med aferezo lipoproteinov majhne gostote z dekstranovim sulfatom, so v redkih primerih doživeli smrtno nevarne anafilaktoidne reakcije.
English: Angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and/or larynx has been reported rarely in patients treated with ACE inhibitors, including <COVERSYL and associated names> (see 4.8 Undesirable effects).
Slovenian: Pri bolnikih, ki so jemali zaviralce angiotenzinske konvertaze, vključno z zdravilom <COVERSYL in sorodna imena>, so redko poročali o angioedemu obraza, okončin, ustnic, sluznic, jezika ter glotisa ali grla ali obeh (glejte poglavje 4.8 Neželeni učinki).
English: Patients on diuretics, and especially those who are volume and/or salt depleted, may experience excessive reduction in blood pressure after initiation of therapy with an ACE inhibitor.
Slovenian: Bolnikom, ki jemljejo diuretike, ali imajo hipovolemijo, pomanjkanje soli ali oboje, se lahko preveč zniža krvni tlak po uvedbi zaviralca angiotenzinske konvertaze.
English: Musculoskeletal, connective tissue and bone disorders: Common: muscle cramps
Slovenian: Bolezni kosti, sklepov, mišic in vezivnega tkiva: Pogosti: mišični krči.
English: It is recommended that <COVERSYL and associated names>, generally associated with a nonpotassium-sparing diuretic and/or digoxin and/or a beta blocker, be introduced under close medical supervision with a recommended starting dose of 2 mg taken in the morning.
Slovenian: Simptomatično srčno popuščanje: <COVERSYL in sorodna imena> je priporočljivo uvajati pod strogim zdravniškim nadzorom in v priporočenem začetnem odmerku 2 mg zjutraj, in sicer običajno ob diuretikih, ki ne zadržujejo kalija, digoksinu, blokatorjih beta receptorjev ali vseh.
English: Angioedema associated with laryngeal oedema may be fatal.
Slovenian: Angioedem lahko ob sočasnem edemu grla povzroči smrten izid.
English: Kidney transplantation:
Slovenian: Bolniki s presaditvijo ledvic:
English: Lithium:
Slovenian: Litij:
English: Patients receiving ACE inhibitors during desensitisation treatment (e.g. hymenoptera venom) have experienced anaphylactoid reactions.
Slovenian: Bolniki, ki so jemali zaviralce angiotenzinske konvertaze med desenzibilizacijskim zdravljenjem (na primer s strupom kožokrilcev), so imeli anafilaktoidne reakcije.
English: Anaphylactoid reactions have been reported in patients dialysed with high flux membranes, and treated concomitantly with an ACE inhibitor.
Slovenian: Pri bolnikih, ki so prestajali dializo z visokopretočnimi membranami in sočasno jemali zaviralce angiotenzinske konvertaze, so poročali o anafilaktoidnih reakcijah.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.
Slovenian: Med sočasnim jemanjem litija in zaviralcev angiotenzinske konvertaze so poročali o reverzibilnem povečanju koncentracije litija v serumu ter toksičnosti.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients <[To be completed nationally]> 6.2 Incompatibilities <[To be completed nationally]>
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi <[Izpolniti nacionalno]>
English: Respiratory, thoracic and mediastinal disorders: Common: cough, dyspnoea Uncommon: bronchospasm Very rare: eosinophilic pneumonia, rhinitis
Slovenian: Zelo redki: eozinofilna pljučnica, rinitis.
English: (See 5.3 “Preclinical safety data”) Should exposure to perindopril have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Slovenian: Če je bolnica v drugem trimesečju nosečnosti ali pozneje izpostavljena perindoprilu, je priporočljiv ultrazvočni pregled ledvičnega delovanja in lobanje.
English: Dosage adjustment in hepatic impairment:
Slovenian: Prilagajanje odmerka pri bolnikih z jetrnim popuščanjem:
English: Perindopril is active in all grades of hypertension : mild, moderate, severe ; a reduction in systolic and diastolic blood pressures in both supine and standing positions is observed.
Slovenian: Perindopril učinkuje na vse stopnje hipertenzije: blago, zmerno in hudo.
English: Diabetic patients:
Slovenian: Bolniki s sladkorno boleznijo:
English: 6.4 Special precautions for storage <[To be completed nationally]> 6.6 Nature and contents of container <[To be completed nationally]> 6.6 Instructions for use and handling < and disposal> <[To be completed nationally]>
Slovenian: 6.4 Posebna navodila za shranjevanje <[Izpolniti nacionalno]>
English: In diabetic patients treated with oral antidiabetic agents or insulin, glycaemic control should be closely monitored during the first month of treatment with an ACE inhibitor.
Slovenian: Pri bolnikih s sladkorno boleznijo, ki jemljejo peroralne antidiabetike ali insulin, morate pazljivo spremljati urejenost glukoze v krvi v prvem mesecu zdravljenja z zaviralci angiotenzinske konvertaze (glejte poglavje 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij, Antidiabetiki).
English: Investigations:
Slovenian: Laboratorijske preiskave:
English: In man, perindopril has been confirmed to demonstrate vasodilatory properties.
Slovenian: Dokazali so, da perindopril pri človeku deluje vazodilatacijsko.
English: There is no experience regarding the administration of < COVERSYL and associated names> in patients with a recent kidney transplantation.
Slovenian: Pri bolnikih z nedavno presaditvijo ledvic ni izkušenj z uporabo zdravila <COVERSYL in sorodna imena>.
English: In patients with symptomatic heart failure, with or without associated renal insufficiency, symptomatic hypotension has been observed.
Slovenian: Opažali so jo pri bolnikih s simptomatičnim srčnim popuščanjem s sočasnim ledvičnim popuščanjem ali brez njega.
English: Common: headache, dizziness, vertigo, paresthaesia Very rare: confusion
Slovenian: Pogosti: glavobol, omotica, vrtoglavost, parestezija.
English: 6.3 Shelf life <[To be completed nationally]> 6.4 Special precautions for storage <[To be completed nationally]> 6.5 Nature and contents of container <[To be completed nationally]> 6.6 Instructions for use and handling < and disposal> <[To be completed nationally]>
Slovenian: 6.5 Posebna navodila za shranjevanje <[Izpolniti nacionalno]>
English: ClCR ≥ 60
Slovenian: Priporočeni odmerek očistek kreatinina ≥ 60
English: Dosage adjustment in renal impairment:
Slovenian: Prilagajanje odmerka pri bolnikih z ledvičnim popuščanjem:
English: Pacemaker therapy is indicated for therapy-resistant bradycardia.
Slovenian: Srčni spodbujevalnik je indiciran pri bolnikih z bradikardijo, ki se ne odziva na zdravljenje.
English: Neutropenia/Agranulocytosis/Thrombocytopenia/Anaemia:
Slovenian: Nevtropenija, agranulocitoza, trombocitopenija, anemija:
English: <COVERSYL and associated names> 4 mg: 4 mg perindopril tert-butylamine salt, equivalent to 3.338 mg perindopril
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA <COVERSYL in sorodna imena> 4 mg:
English: Symptomatic hypotension may occur following initiation of therapy with < COVERSYL and associated names>; this is more likely in patients who are being treated concurrently with diuretics.
Slovenian: Ob uvedbi zdravljenja z zdravilom <COVERSYL in sorodna imena> se lahko pojavi simptomatična hipotenzija.
English: Symptomatic heart failure:
Slovenian: Srčnožilne bolezni: