FrancophonIA/ELRC3.0 huggingface dataset:
English: Since treatment with diuretics may be a contributory factor to the above, they should be discontinued and renal function should be monitored during the first weeks of <COVERSYL and associated names> therapy.
Slovenian: Ker lahko zdravljenje z diuretiki navedena stanja poslabša, jih morate ukiniti in spremljati delovanje ledvic v prvih tednih zdravljenja z zdravilom <COVERSYL in sorodna imena>.
English: A beneficial effect of perindopril was observed for all individual subcomponents of the primary combined endpoint, although only the risk reduction in “non-fatal MI” reached statistical significance.
Slovenian: Koristnost perindoprila so ugotovili pri vseh posameznih elementih kombiniranega primarnega kliničnega izida, čeprav je bilo zmanjšanje tveganja statistično značilno le pri »nesmrtnem MI«.
English: In addition to active perindoprilat, perindopril yields five metabolites, all inactive.
Slovenian: Poleg aktivnega perindoprilata nastane še pet presnovkov perindoprila, ki so vsi neaktivni.
English: The Applicant was also requested to justify the indication based on the results of relevant published literature on other ACE-Is in terms of patients to be included and goals of therapy.
Slovenian: Od vlagatelja je bilo nadalje zahtevano, da utemelji indikacijo, temelječo na zadevnih navedbah v literaturi o drugih ACE-I-jih, z vidika bolnikov, ki naj bi jih vključevala, ter ciljev zdravljenja.
English: Clinical trials:
Slovenian: Klinična preskušanja:
English: 2 mg on the day of dialysis * Dialysis clearance of perindoprilat is 70 ml/min.
Slovenian: 2 mg na dan dialize * Dializni očistek perindoprilata je 70 ml/min.
English: In some patients with congestive heart failure who have normal or low blood pressure, additional lowering of systemic blood pressure may occur with < COVERSYL and associated names>.
Slovenian: Pri nekaterih bolnikih s kongestivnim srčnim popuščanjem, ki imajo normalen ali nizek krvni tlak, lahko <COVERSYL in sorodna imena> dodatno zniža sistemski krvni tlak.
English: As further consistency is shown for the secondary variables, it is reasonable to extend the indication from “reduction of MI” to “reduction of cardiac events”, a term that includes patients with a history of MI and/or a history of revascularisation.
Slovenian: Glede na to, da je nadaljnja konsistentnost dokazana za sekundarne spremenljivke, je indikacijo smiselno razširiti z »zmanjševanja pojavnosti MI« na »zmanjševanje pojavnosti srčnih zapletov«, torej na termin, ki vključuje bolnike, ki so v preteklosti že imeli miokardni infarkt in/ali revaskularizacijo.
English: If an episode of unstable angina pectoris (major or not) occurs during the first month of perindopril treatment, a careful appraisal of the benefit/risk should be performed before treatment continuation.
Slovenian: V primeru epizode nestabilne angine pektoris (večje ali manjše) v prvem mesecu zdravljenja s perindoprilom je potrebno pred nadaljevanjem zdravljenja skrbno pretehtati koristi in tveganja.
English: Studies in patients with heart failure have demonstrated: decreased left and right ventricular filling pressures, reduced total peripheral vascular resistance, increased cardiac output and improved cardiac index.
Slovenian: Študije pri bolnikih s srčnim popuščanjem so pokazale: zmanjšanje polnilnega tlaka levega in desnega prekata, zmanjšanje skupnega perifernega žilnega upora, povečanje minutnega volumna srca in izboljšanje srčnega indeksa.
English: Perindopril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function.
Slovenian: Izjemno previdni morate biti pri predpisovanju perindoprila bolnikom s kolagensko žilno boleznijo, imunosupresivnim zdravljenjem, ali če jemljejo alopurinol ali prokainamid, ali imajo kombinacijo naštetih oteževalnih dejavnikov, zlasti ob že obstoječem poslabšanju ledvičnega delovanja.
English: Heart failure: Treatment of symptomatic heart failure
Slovenian: Srčno popuščanje: Zdravljenje simptomatičnega srčnega popuščanja.
English: The EUROPA study was a multicentre, international, randomised, double-blind, placebocontrolled clinical trial lasting 4 years.
Slovenian: Študija EUROPA je bila multicentrično, mednarodno, randomizirano, dvojno slepo, s placebom nadzorovano klinično preskušanje, ki je trajalo 4 leta.
English: Concomitant use of these agents may increase the hypotensive effects of perindopril.
Slovenian: Sočasno jemanje teh zdravil lahko poveča hipotenzivni učinek perindoprila.
English: Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and/or volume depletion, cardiac decompensation or severe hypertension) may experience an excessive drop in blood pressure following the initial dose.
Slovenian: Bolnikom z močno aktiviranim renin-angiotenzin-aldosteronskim sistemom (zlasti z renovaskularno hipertenzijo, izgubo soli ali hipovolemijo ali obema, dekompenzacijo srca ali hudo hipertenzijo) se lahko preveč zniža krvni tlak po prvem odmerku.
English: Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously.
Slovenian: Ves čas morate spremljati vitalne znake in koncentracijo elektrolitov ter kreatinina v serumu.
English: The main efficacy criterion was the composite of cardiovascular mortality, non fatal myocardial infarction and/or cardiac arrest with successful resuscitation.
Slovenian: Glavni kriterij učinkovitosti je bila pojavnost kardiovaskularne smrtnosti, nesmrtnega miokardnega infarkta in/ali zaustavitev srca z uspešnim oživljanjem.
English: Dosage adjustment in renal insufficiency is desirable depending on the degree of impairment (creatinine clearance).
Slovenian: Pri bolnikih z ledvičnim popuščanjem je zaželeno prilagajanje odmerka glede na stopnjo bolezni (očistek kreatinina).
English: ACE inhibitors may cause a fall in blood pressure.
Slovenian: Zaviralci angiotenzinske konvertaze lahko povzročijo padec krvnega tlaka.
English: As with other ACE inhibitors, perindopril may be less effective in lowering blood pressure in black people than in non-blacks, possibly because of a higher prevalence of low-renin states in the black hypertensive population.
Slovenian: Kot velja za preostale zaviralce angiotenzinske konvertaze, lahko perindopril manj učinkovito znižuje krvni tlak pri črncih kot bolnikom drugih etničnih skupin, verjetno zaradi večje prevalence stanj z majhno vrednostjo renina pri črnih bolnikih s hipertenzijo.
English: • The MAH has implemented the text proposed by the CHMP in the SPC:
Slovenian: • je imetnik dovoljenja za promet z zdravilom v Povzetek glavnih značilnosti vključil besedilo, ki ga je predlagal CHMP:
English: If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered.
Slovenian: Premislite tudi o zdravljenju z infuzijo angiotenzina II, intravenskimi kateholamini ali obojim, če je na voljo.
English: Few patients experienced serious adverse events: 16 (0.3%) of the 6122 perindopril patients and 12 (0.2%) of the 6107 placebo patients.
Slovenian: Doživelo jih je malo bolnikov: 16 (0,3 %) od 6122 bolnikov, ki so jemali perindopril in 12 (0,2 %) od 6107 bolnikov, ki so jemali placebo.
English: Epidemiological studies have suggested that concomitant administration of ACE inhibitors and antidiabetic medicines (insulins, oral hypoglycaemic agents) may cause an increased blood-glucose lowering effect with risk of hypoglycaemia.
Slovenian: Epidemiološke študije so pokazale, da lahko sočasno jemanje zaviralcev angiotenzinske konvertaze in antidiabetikov (insulinov, peroralnih hipoglikemikov) poveča zniževanje glukoze v krvi, s tveganjem za hipoglikemijo.
English: For patients on haemodialysis, the dose should be taken after dialysis.
Slovenian: Bolniki na hemodializi naj odmerek jemljejo po dializi.
English: Some hypertensive patients with no apparent pre-existing renal vascular disease have developed increases in blood urea and serum creatinine, usually minor and transient, especially when <COVERSYL and associated names> has been given concomitantly with a diuretic.
Slovenian: Pri nekaterih bolnikih s hipertenzijo brez očitne že obstoječe ledvične žilne bolezni so se povečale vrednosti sečnine v krvi in kreatinina v serumu, običajno blago in prehodno, zlasti ko so <COVERSYL in sorodna imena> jemali sočasno z diuretikom.
English: The converting enzyme, or kinase, is an exopeptidase that allows conversion of angiotensin I into the vasoconstrictor angiotensin II as well as causing the degradation of the vasodilator bradykinin into an inactive heptapeptide.
Slovenian: Angiotenzinska konvertaza ali kinaza je eksopeptidaza, ki omogoča pretvorbo angiotenzina I v vazokonstriktor angiotenzin II, pa tudi razgradnjo vazodilatatorja bradikinina v neaktiven heptapeptid.
English: In hypertensive patients in whom the diuretic cannot be discontinued, therapy with < COVERSYL and associated names> should be initiated with a 2 mg dose.
Slovenian: Bolnikom s hipertenzijo, pri katerih diuretika ne morete ukiniti, zdravljenje z zdravilom <COVERSYL in sorodna imena> uvedite z odmerkom po 2 mg.
English: If renovascular hypertension is also present there is an increased risk of severe hypotension and renal insufficiency.
Slovenian: Če imajo bolniki tudi renovaskularno hipertenzijo, jih spremlja povečano tveganje za hudo hipotenzijo in ledvično popuščanje.
English: Caution is therefore recommended since these patients may be volume and/or salt depleted.
Slovenian: Priporočljiva je previdnost, saj imajo lahko tovrstni bolniki izgubo volumna ali soli ali obeh.
English: Elevation of liver enzymes and serum bilirubin have been reported rarely.
Slovenian: Redko so poročali o povečanju vrednosti jetrnih encimov in bilirubina v serumu.
English: If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
Slovenian: Če se pojavi hipotenzija, ki jo najverjetneje povzroči opisani mehanizem, jo lahko odpravite s povečevanjem volumna.
English: Use of perindopril with lithium is not recommended, but if the combination proves necessary, careful monitoring of serum lithium levels should be performed (see section 4.4).
Slovenian: Jemanje perindoprila ob litiju ni priporočljivo, če je ta kombinacija vendarle potrebna, morate pozorno spremljati vrednost litija v serumu (glejte poglavje
English: Consistency was noted between the various components of the primary endpoint although significance was only reached for prevention of MI. A significant effect was noted on the occurrence of heart failure.
Slovenian: Med posameznimi elementi primarnega izida so ugotovili konsistentnost rezultatov, vendar pa so bili ti statistično značilni zgolj pri preprečevanju MI. Pomemben učinek je bil ugotovljen pri pojavljanju srčne odpovedi.
English: Inhibition of ACE results in a reduction of angiotensin II in the plasma, which leads to increased plasma renin activity (by inhibition of the negative feedback of renin release) and reduced secretion of aldosterone.
Slovenian: Zaviranje angiotenzinske konvertaze povzroči zmanjšanje vrednosti angiotenzina II v plazmi, s čimer poveča aktivnost renina v plazmi (z zaviranjem negativnega povratnega učinka sproščanja renina) in zmanjšuje izločanje aldosterona.
English: However, angiotensin converting enzyme inhibitors, as a class, have been shown to induce adverse effects on late foetal development, resulting in foetal death and congenital effects in rodents and rabbits: renal lesions and an increase in peri- and postnatal mortality have been observed.
Slovenian: Vendar so za razred zaviralcev angiotenzinske konvertaze dokazali, da povzročajo neželene učinke na poznejši razvoj plodu, ki so privedli do njegovega odmrtja ali prirojenih napak pri glodalcih in kuncih: opažali so poškodbe ledvic in povečano obporodni ter poporodni pogin.
English: In the light of the above the CHMP concludes that the proposed indication for Coversyl “Stable coronary artery disease: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation” is adequately supported by the information provided.
Slovenian: V skladu z zgoraj navedenim CHMP zaključuje, da je predlagana indikacija za zdravilo Coversyl »Stabilna koronarna arterijska bolezen: Zmanjševanje tveganja za srčne zaplete pri bolnikih, ki so v preteklosti že imeli miokardni infarkt in/ali revaskularizacijo« s predloženimi informacijami ustrezno podprta.
English: Marketing Authorisation Holder
Slovenian: Država članica Imetnik dovoljenja za promet
English: The treatment with perindopril 8 mg once daily resulted in a significant absolute reduction in the primary endpoint of 1.9% (relative risk reduction of 20%, 95%CI [9.4; 28.6] - p<0.001).
Slovenian: Zdravljenje s perindoprilom v odmerku 8 mg enkrat dnevno je privedlo do pomembnega absolutnega zmanjšanja pogostosti primarnega izida za 1,9 % (relativno zmanjšanje tveganja za 20 %, 95 % interval zaupanja [9.4; 28.6] - p<0.001).
English: Sympathomimetics: Sympathomimetics may reduce the antihypertensive effects of ACE inhibitors.
Slovenian: Simpatikomimetiki: Simpatikomimetiki lahko zmanjšajo antihipertenzivni učinek zaviralcev angiotenzinske konvertaze.
English: However, the quantity of perindoprilat formed is not reduced and therefore no dosage adjustment is required (see also sections 4.2 “Posology and method of administration” and 4.4 “Special warnings and special precautions for use”).
Slovenian: Ker se količina nastalega perindoprilata ne zmanjša, odmerka ni treba prilagajati (glejte tudi poglavji 4.2 Odmerjanje in način uporabe in 4.4 Posebna opozorila in previdnostni ukrepi).
English: Most of the patients received the study medication on top of conventional therapy including platelet inhibitors, lipid lowering agents and beta-blockers.
Slovenian: Večina bolnikov je prejemalo zdravilo v študiji poleg konvencionalnega zdravljenja, ki je vključevalo zaviralce agregacije trombocitov, zdravila za zniževanje lipidov in blokatorje beta receptorjev.
English: In patients at increased risk of symptomatic hypotension, initiation of therapy and dose adjustment should be closely monitored (see 4.2 “Posology and method of administration” and 4.8 “Undesirable effects”).
Slovenian: Pri bolnikih s povečanim tveganjem za simptomatično hipotenzijo morate uvedbo zdravljenja in prilagajanje odmerka pazljivo nadzorovati (glejte poglavji 4.2 Odmerjanje in način uporabe in 4.8 Neželeni učinki).
English: Potassium sparing diuretics (e.g. spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
Slovenian: Diuretiki, ki zadržujejo kalij (na primer spironolakton, triamteren ali amilorid), kalijevi dodatki ali nadomestki soli, ki vsebujejo kalij, lahko signifikantno povečajo vrednost kalija v serumu.
English: Eye disorders: Common: vision disturbance
Slovenian: Očesne bolezni: Pogosti: motnje vida.
English: In patients undergoing major surgery or during anaesthesia with agents that produce hypotension, <COVERSYL and associated names> may block angiotensin II formation secondary to compensatory renin release.
Slovenian: Pri bolnikih, ki prestajajo večji kirurški poseg ali so prejeli anestezijo s hipotenzivnimi zdravili, lahko <COVERSYL in sorodna imena> zavira tvorjenje angiotenzina II, sekundarno po kompenzacijskem sproščanja renina.
English: • It is proposed to add the following indication in section 4.1: “Stable coronary artery disease: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation.”
Slovenian: • Predlagano je, da se v poglavju 4.1 doda naslednja indikacija: »Stabilna koronarna arterijska bolezen: Zmanjševanje tveganja za srčne zaplete pri bolnikih, ki so v preteklosti že imeli miokardni infarkt in/ali revaskularizacijo.«
English: Reproductive system and breast disorders: Uncommon: impotence
Slovenian: Motnje reprodukcije in dojk: Občasni: impotenca.
English: Very rare: hepatitis either cytolytic or cholestatic (see section 4.4 Special warnings and special precautions for use)
Slovenian: Zelo redki: hepatitis, bodisi citolitični ali holestatični (glejte 4.4 Posebna opozorila in previdnostni ukrepi).
English: Symptomatic hypotension is seen rarely in uncomplicated hypertensive patients and is more likely to occur in patients who have been volumedepleted e.g. by diuretic therapy, dietary salt restriction, dialysis, diarrhoea or vomiting, or who have severe renin-dependent hypertension (see sections 4.5 “Interaction with other medicaments and other forms of interaction” and 4.8 “Undesirable effects”).
Slovenian: Simptomatična hipotenzija je redka pri bolnikih s hipertenzijo brez zapletov, verjetnejša pa pri tistih s hipovolemijo, na primer zaradi zdravljenja z diuretiki, omejitve soli v prehrani, dialize, driske ali bruhanja, ali pri vseh s hudo reninsko odvisno hipertenzijo (glejte poglavji 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij in 4.8 Neželeni učinki).
English: The combination of an ACE inhibitor and a thiazide also decreases the risk of hypokalaemia induced by the diuretic treatment.
Slovenian: Kombinacija zaviralca angiotenzinske konvertaze in tiazidnega diuretika tudi zmanjšuje tveganje hipokalemije kot posledice zdravljenja z diuretiki.
English: Acute renal failure, usually reversible, has been reported in this situation.
Slovenian: V takšnih primerih so poročali o akutnem ledvičnem popuščanju, običajno reverzibilnem.
English: This is most likely to occur in those patients with more severe degrees of heart failure, as reflected by the use of high doses of loop diuretics, hyponatraemia or functional renal impairment.
Slovenian: Verjetnejša je pri bolnikih, ki imajo hujše stopnje srčnega popuščanja, ki se odražajo v jemanju velikih odmerkov diuretikov zanke, ali pri onih s hiponatremijo ali s funkcijskim ledvičnim popuščanjem.
English: These reactions were avoided by temporarily withholding ACE inhibitor therapy prior to each apheresis.
Slovenian: Tovrstnim reakcijam so se izognili z začasno odtegnitvijo zaviralcev angiotenzinske konvertaze pred vsako aferezo.
English: As with other ACE inhibitors, < COVERSYL and associated names> should be given with caution to patients with mitral valve stenosis and obstruction in the outflow of the left ventricle such as aortic stenosis or hypertrophic cardiomyopathy.
Slovenian: Kot velja tudi za druge zaviralce angiotenzinske konvertaze, morate biti previdni pri predpisovanju zdravila <COVERSYL in sorodna imena> bolnikom z zožitvijo mitralne zaklopke in zaporo v iztočnem delu levega prekata, na primer z zožitvijo aorte, ali hipertrofično kardiomiopatijo.
English: MARKETING AUTHORISATION HOLDER <[See Annex I- to be completed nationally]>
Slovenian: IMETNIK DOVOLJENJA ZA PROMET <[Glejte dodatek I - izpolniti nacionalno]>
English: Potassium sparing diuretics, potassium supplements or potassium-containing salt substitutes: The combination of perindopril and potassium sparing diuretics, potassium supplements or potassiumcontaining salt substitutes is generally not recommended (see 4.5 Interaction with other medicinal products and other forms of interaction).
Slovenian: Diuretiki, ki zadržujejo kalij, dodatki kalija ali nadomestki soli, ki vsebujejo kalij: Kombinacija perindoprila in diuretikov, ki zadržujejo kalij, dodatkov kalija ali nadomestkov soli, ki vsebujejo kalij, na splošno ni priporočljiva (glejte poglavje 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij).
English: In some patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, who have been treated with ACE inhibitors, increases in blood urea and serum creatinine, usually reversible upon discontinuation of therapy, have been seen.
Slovenian: Pri nekaterih bolnikih z obojestransko zožitvijo ledvične arterije ali zožitvijo arterije v solitarno ledvico, ki so jemali zaviralce angiotenzinske konvertaze, so opazili povečanje vrednosti sečnine v krvi in kreatinina v serumu, ki je običajno izginilo po prekinitvi zdravljenja.
English: Blood pressure, renal function and serum potassium should be monitored closely, both before and during treatment with <COVERSYL and associated names> (see section 4.4 “Special warnings and special precautions for use”).
Slovenian: Pozorno morate spremljati krvni tlak, ledvično delovanje in raven kalija v serumu že pred zdravljenjem z zdravilom <COVERSYL in sorodna imena> in med njim (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
English: The dose should be individualised according to the patient profile (see 4.4 “Special warnings and special precautions for use”) and blood pressure response.
Slovenian: Odmerek prilagodite bolnikovemu profilu (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi) in odzivu krvnega tlaka.
English: 2 mg perindopril tert-butylamine salt, equivalent to 1.669 mg perindopril <[To be completed nationally]>
Slovenian: 2 mg terc-butilaminijevega perindoprilata, kar ustreza 1,669 mg perindoprila.
English: • The following description of the observed side-effects has been added in Section 4.8: Clinical trials:
Slovenian: • V poglavju 4.8 je bil dodan naslednji opis opaženih neželenih stranskih učinkov:
English: In patients with a congenital deficiency of G-6PDH, very rare cases of haemolytic anaemia have been reported (see section 4.4 Special warnings and special precautions for use).
Slovenian: Pri bolnikih s prirojenim pomanjkanjem glukoza-6-fosfatne dehidrogenaze so zelo redko poročali o hemolitični anemiji (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
English: If concomitant use of the abovementioned agents is deemed appropriate, regular monitoring of serum potassium is recommended.
Slovenian: Če menite, da je sočasno jemanje naštetih zdravil ustrezno, je priporočljivo redno merjenje ravni kalija v serumu.
English: Concomitant use of thiazide diuretics may increase the risk of lithium toxicity and enhance the already increased risk of lithium toxicity with ACE inhibitors.
Slovenian: Sočasno jemanje tiazidnih diuretikov lahko poveča tveganje za toksičnost litija in dodatno okrepi že sicer povečano tveganje za toksičnost litija ob zaviralcih angiotenzinske konvertaze.
English: In patients with symptomatic heart failure, hypotension following the initiation of therapy with ACE inhibitors may lead to some further impairment in renal function.
Slovenian: Pri bolnikih s simptomatičnim srčnim popuščanjem lahko hipotenzija po uvedbi zdravljenja z zaviralci angiotenzinske konvertaze še dodatno poslabša ledvično delovanje.
English: 4 mg perindopril tert-butylamine salt, equivalent to 3.338 mg perindopril <[To be completed nationally]>
Slovenian: 4 mg terc-butilaminijevega perindoprilata, kar ustreza 3,338 mg perindoprila.
English: Acetylsalicylic acid, thrombolytics, beta-blockers, nitrates:
Slovenian: Acetilsalicilna kislina, trombolitiki, zaviralci beta receptorjev, nitrati:
English: This dose may be increased by increments of 2 mg at intervals of no less than 2 weeks to 4 mg once daily if tolerated.
Slovenian: Začetni odmerek lahko povečujete za 2 mg v presledkih, ki ne smejo biti krajši od dveh tednov, do 4 mg enkrat na dan, če bolnik to prenaša.
English: Increases in blood urea and plasma creatinine, hyperkalaemia reversible on discontinuation may occur, especially in the presence of renal insufficiency, severe heart failure and renovascular hypertension.
Slovenian: Lahko pride do povečanja vrednosti sečnine v krvi in kreatinina v plazmi, ki je reverzibilno po prekinitvi zdravljenja, zlasti pri bolnikih z ledvičnim popuščanjem, hudim srčnim popuščanjem in renovaskularno hipertenzijo.
English: Stable coronary artery disease:
Slovenian: Stabilna koronarna arterijska bolezen:
English: In the chronic oral toxicity studies (rats and monkeys), the target organ is the kidney, with reversible damage.
Slovenian: V študijah o kronični peroralni toksičnosti pri podganah ter opicah so bile tarčni organ ledvice, kjer so opazili reverzibilne poškodbe.