FrancophonIA/ELRC3.0 huggingface dataset:
English: The plasma half-life of perindopril is equal to 1 hour.
Slovenian: Razpolovna doba perindoprila v plazmi znaša 1 uro.
English: Nevertheless the Applicant has tried to address the results of two studies (PEACE and HOPE) where patients with stable CAD and normal fraction ejection were included.
Slovenian: Navkljub temu je vlagatelj skušal nasloviti rezultate dveh študij (PEACE in HOPE), v kateri so bili vključeni bolniki s stabilno arterijsko koronarno boleznijo in normalnim iztisnim deležem.
English: A starting dose of 2 mg is recommended in such patients and the initiation of treatment should take place under medical supervision.
Slovenian: Zanje sta priporočena začetni odmerek 2 mg in uvedba zdravljenja pod zdravniškim nadzorom.
English: Dosage in patients with renal impairment should be based on creatinine clearance as outlined in table 1 below:
Slovenian: Odmerjanje pri bolnikih z ledvičnim popuščanjem mora temeljiti na očistku kreatinina, kot prikazuje spodnja preglednica 1.
English: Dissociation of perindoprilat bound to angiotensin converting enzyme leads to an “effective” elimination half-life of 25 hours, resulting in steady-state within 4 days.
Slovenian: Disociacija perindoprilata, vezanega na angiotenzinsko konvertazo, vodi do 'efektivne' razpolovne dobe izločanja 25 ur, ravnovesno stanje pa je doseženo v 4 dneh.
English: It improves large artery elasticity and decreases the media: lumen ratio of small arteries.
Slovenian: Izboljšuje prožnost velikih arterij in zmanjšuje razmerje med medijo in svetlino v malih arterijah.
English: NAME OF THE MEDICINAL PRODUCT <COVERSYL and associated names (see Annex I)>, <strength>, tablets <[See Annex I - to be completed nationally]>
Slovenian: IME ZDRAVILA <COVERSYL in sorodna imena (glejte dodatek I)>, <jakost>, tablete <[Glejte dodatek I - izpolniti nacionalno]>
English: Very rare: pancreatitis
Slovenian: Zelo redki: pankreatitis.
English: After oral administration, the absorption of perindopril is rapid and the peak concentration complete within 1 hour.
Slovenian: Po peroralnem jemanju se perindopril absorbira hitro in doseže največjo koncentracijo v 1 uri.
English: At the end of the MRP procedure there was a discrepancy between CMS regarding the wording of the indication that adequately reflects the EUROPA data.
Slovenian: Ob koncu postopka medsebojnega priznavanja je prišlo do razlik med zadevnimi državami članicami v zvezi z besedilom indikacije, ki ustrezno odraža podatke iz študije EUROPA.
English: Perindopril acts through its active metabolite, perindoprilat.
Slovenian: Perindopril deluje prek svojega aktivnega presnovka, perindoprilata.
English: Reproduction toxicology studies (rats, mice, rabbits and monkeys) showed no sign of embryotoxicity or teratogenicity.
Slovenian: Toksikološke študije o plodnosti pri podganah, miših, kuncih in opicah niso pokazale nikakršnih znakov embriotoksičnosti ali teratogenosti.
English: This phenomenon appeared to be more likely to occur during the first weeks of combined treatment and in patients with renal impairment.
Slovenian: Takšen pojav je verjetnejši v prvih tednih njihovega sočasnega jemanja in pri bolnikih z ledvičnim popuščanjem.
English: This benefit was statistically significant for non-fatal MI, one of the components of the combined endpoint.
Slovenian: Koristnost je bila statistično značilna za nesmrtni MI, enega od elementov kombiniranega izida.
English: Anaphylactic reactions during desensitisation:
Slovenian: Anafilaktične reakcije med desenzibilizacijo:
English: If required, diuretic therapy may be resumed.
Slovenian: Če je potrebno, ponovno uvedite zdravljenje z diuretiki.
English: Tricyclic antidepressants/Antipsychotics/Anesthetics:
Slovenian: Triciklični antidepresivi, antipsihotiki, anestetiki:
English: Psychiatric disorders: Uncommon: mood or sleep disturbances
Slovenian: Psihiatrične motnje: Občasni: motnje razpoloženja ali spanja.
English: Perindopril kinetics are modified in patients with cirrhosis : hepatic clearance of the parent molecule is reduced by half.
Slovenian: Kinetika perindoprila je spremenjena pri bolnikih s cirozo: pri njih se jetrni očistek osnovne molekule zmanjša za polovico.
English: In these patients, treatment should be started under close medical supervision with low doses and careful dose titration.
Slovenian: Tovrstnim bolnikom je treba zdravljenje uvajati pod strogim zdravniškim nadzorom z majhnimi odmerki in s pazljivim titriranjem odmerka.
English: Hypertension: < COVERSYL and associated names> may be used in monotherapy or in combination with other classes of antihypertensive therapy.
Slovenian: Hipertenzija: <COVERSYL in sorodna imena> lahko uporabljate v monoterapiji ali kombinaciji z drugimi razredi antihipertenzivnih zdravljenj.
English: In those instances where swelling was confined to the face and lips the condition generally resolved without treatment, although antihistamines have been useful in relieving symptoms.
Slovenian: Pri bolnikih, pri katerih je bilo otekanje omejeno na obraz in ustnice, so težave večinoma minile brez zdravljenja, čeprav so jim pomagali antihistaminiki pri zmanjševanju simptomov.
English: • Hereditary or idiopathic angioedema;
Slovenian: • Dedni ali idiopatični angioedem.
English: In the Final Assessment report (dated on 14.02.2005), the indication proposed by the RMS was restricted to “Reduction of risk of recurrent MI in patients with a history of MI” considering that the risk reduction was only demonstrated on the “non fatal MI” component of the primary endpoint and that the effect of perindopril was only clearly established in patients with previous MI.
Slovenian: V Končnem poročilu o oceni (z dne 14.02.2005), je bila indikacija, ki jo je predlagana referenčna država članica, omejena na »Zmanjševanje tveganja za ponavljajoči se MI pri bolnikih, ki so v preteklosti že imeli MI«, upoštevaje, da je bilo zmanjšanje tveganja dokazano zgolj pri elementu kombiniranega primarnega izida »nesmrtni MI« ter da je bila učinkovitost perindoprila nedvoumno ugotovljena le pri bolnikih, ki so v preteklosti že imeli MI.
English: The following undesirable effects have been observed during treatment with perindopril and ranked under the following frequency:
Slovenian: Med zdravljenjem s perindoprilom so opažali naslednje neželene učinke in jih razvrstili po navedenih stopnjah pogostnosti:
English: The subsequent dosage of <COVERSYL and associated names> should be adjusted according to blood pressure response.
Slovenian: Nadaljnje odmerjanje zdravila <COVERSYL in sorodna imena> prilagajajte glede na odziv krvnega tlaka.
English: The results of the HOPE and PEACE trials seem to support the beneficial effect of perindopril observed in the EUROPA study for patients with medium to high risk of cardiac events.
Slovenian: Zdi se, da rezultati PEACE in HOPE preizkušanj podpirajo ugoden učinek perindoprila za bolnike s srednjim do visokim tveganjem za srčne zaplete, ki so ga opazovali v okviru študije EUROPA.
English: The combination of lithium and perindopril is generally not recommended (see 4.5 Interaction with other medicinal products and other forms of interaction).
Slovenian: Kombinacija litija in perindoprila na splošno ni priporočljiva (glejte poglavje 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij).
English: The CHMP has recommended the granting of the variation of the Marketing Authorisations for which the Summary of Product Characteristics is set out in Annex III for Coversyl and related names (see Annex I).
Slovenian: CHMP je priporočil odobritev spremembe dovoljenj za promet z zdravilom, za katere je Povzetek glavnih značilnosti zdravila podan v Dodatku III, za zdravilo Coversyl in z njim povezana imena (glej Dodatek I).
English: 2.- The second issue addresses the question whether the beneficial effect may extend beyond a mere reduction of MI to a reduction of cardiac events.
Slovenian: 2.- Drugi predmet razprave se tiče vprašanja, ali je mogoče koristnost z zgolj zmanjševanja pogostosti MI razširiti na zmanjševanje srčnih zapletov.
English: The Applicant was also requested to justify the beneficial effect of Perindopril beyond a mere reduction of MI.
Slovenian: Od vlagatelja so nadalje zahtevali, da utemelji koristnost perindoprila, ki presega zgolj zmanjševanje pojavnosti MI.
English: Perindopril reduces peripheral vascular resistance, leading to blood pressure reduction.
Slovenian: Perindopril zmanjšuje periferni žilni upor, čemur sledi znižanje krvnega tlaka.
English: In these patients consideration should be given to using a different type of dialysis membrane or different class of antihypertensive agent.
Slovenian: Pri tovrstnih bolnikih premislite o uporabi druge vrste dializnih membran ali drugega razreda antihipertenzivov.
English: Perindoprilat is eliminated in the urine and the half-life of the unbound fraction is approximately 3 to 5 hours.
Slovenian: Perindoprilat se iz telesa izloča z urinom, razpolovna doba nevezane frakcije pa znaša približno 3 do 5 ur.
English: Dialysis clearance of perindoprilat is equal to 70 ml/min.
Slovenian: Dializni očistek perindoprilata je 70 ml/min.
English: The CHMP recommended the granting of the type II variation to extend the indication.
Slovenian: CHMP je predlagal odobritev dovoljenja za promet z zdravilom za spremembo tipa II, povezano z razširitvijo indikacije.
English: The dose should be increased only if the previous lower dose is well tolerated.
Slovenian: Odmerek naj bo povečan le, če bolnik manjši odmerek dobro prenaša.
English: Perindopril reduces left ventricular hypertrophy.
Slovenian: Perindopril zmanjšuje hipertrofijo levega prekata.
English: Discontinuation of treatment does not lead to a rebound effect.
Slovenian: Po ukinitvi zdravila ne nastopijo povratni učinki.
English: Rarely, acute renal failure may occur, especially in patients with compromised renal function such as those who are elderly or dehydrated.
Slovenian: Redko se lahko pojavi akutno ledvično popuščanje, zlasti pri bolnikih z ogroženim ledvičnim delovanjem, kot so starostniki ali dehidrirani bolniki.
English: The higher percentage of patients who had at least 70% narrowing of one or more major arteries (82.4% vs. 60.5%) would reflect serious coronary lesions in the group of patients with a history of revascularisation and with no history of MI.
Slovenian: Višji delež bolnikov z vsaj 70 % zožitvijo ene od glavnih arterij (82,4 % napram 60,5 %) v skupini bolnikov z v preteklosti izvedeno revaskularizacijo, ki pa v preteklosti niso imeli MI, bi naj odražal resne koronarne lezije.
English: Although serum potassium usually remains within normal limits, hyperkalaemia may occur in some patients treated with perindopril.
Slovenian: Čeprav vrednost kalija v serumu običajno ostaja znotraj normalnega razpona, se lahko pri nekaterih bolnikih, ki jemljejo perindopril, pojavi hiperkalemija.
English: The indication under review is based on the results of the EUROPA study, a trial designed to evaluate the ability of Perindopril to reduce the risk of the combined endpoint of cardiovascular death, non-fatal acute MI and cardiac arrest with successful resuscitation in patients with stable coronary heart disease, without evidence of heart failure.
Slovenian: Ponovno obravnavana indikacija temelji na rezultatih študije EUROPA, ki je bila načrtovana s ciljem ovrednotenja zmožnosti perindoprila, da zmanjša tveganje za kombinirani izid kamor spadajo kardiovaskularna smrt, nesmrtni akutni miokardni infarkt in zaustavitev srca z uspešnim oživljanjem, pri bolnikih s stabilno koronarno arterijsko boleznijo, brez dokazov srčne odpovedi.
English: In perindopril-treated patients, hypotension was observed in 6 patients, angioedema in 3 patients and sudden cardiac arrest in 1 patient.
Slovenian: Pri bolnikih, ki so prejemali perindopril, je bila hipotenzija opažena pri 6 bolnikih, angioedem pri 3 bolnikih in nenaden zastoj srca pri 1 bolniku.
English: Very rare: erythema multiforme
Slovenian: Zelo redki: multiformni eritem.
English: In such cases, <COVERSYL and associated names> should promptly be discontinued and appropriate monitoring should be initiated and continued until complete resolution of symptoms has occurred.
Slovenian: V teh primerih morate zdravilo <COVERSYL in sorodna imena> takoj ukiniti in bolnika ustrezno spremljati, kar nadaljujete do popolnega izginotja simptomov.
English: Concomitant use with nitroglycerin and other nitrates, or other vasodilators, may further reduce blood pressure.
Slovenian: Sočasno jemanje z nitroglicerinom in preostalimi nitrati ali vazodilatatorji lahko dodatno zniža krvni tlak.
English: 1.- The Applicant should justify the proposed indication based on the results of the EUROPA trial and relevant published literature on other ACE-Is in terms of patients to be included and goals of therapy.
Slovenian: 1.- Vlagatelj mora utemeljiti predlagano indikacijo, temelječo na rezultatih študije EUROPA in z zadevnimi navedbami v literaturi o drugih ACE-I-jih, z vidika bolnikov, ki bi jih naj vključevala, ter ciljev zdravljenja.
English: It is possible that this mechanism contributes to the blood pressure-lowering action of ACE inhibitors and is partially responsible for certain of their side effects (e.g. cough).
Slovenian: Možno je, da ta mehanizem prispeva k antihipertenzivnemu učinku zaviralcev angiotenzinske konvertaze in da je delno odgovoren za nekatere njihove neželene učinke, na primer kašelj.
English: If concomitant use is indicated because of demonstrated hypokalaemia they should be used with caution and with frequent monitoring of serum potassium.
Slovenian: Če je sočasno jemanje indicirano zaradi dokazane hipokalemije, jih morate uporabljati previdno in pogosto meriti vrednost kalija v serumu.
English: The possibility of hypotensive effects can be reduced by discontinuation of the diuretic, by increasing volume or salt intake prior to initiating therapy with low and progressive doses of perindopril.
Slovenian: Možnost hipotenzivnih učinkov lahko zmanjšate z ukinitvijo diuretika ali s povečanjem volumna ali vnosa soli še pred uvedbo zdravljenja z majhnimi in postopoma naraščajočimi odmerki perindoprila.
English: Similar considerations apply to patients with ischaemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.
Slovenian: Podobni pomisleki veljajo za bolnike z ishemično boleznijo srca ali možganskožilnimi boleznimi, pri katerih bi lahko preveliko znižanje krvnega tlaka povzročilo miokardni infarkt ali možganskožilni insult.
English: Although a statistically significant benefit was not shown for two of the three components of the composite endpoint due to the smaller number of occurrences, a positive tendency in favour of perindopril was observed.
Slovenian: Čeprav zaradi manjšega števila pojavov za dva od treh elementov kombiniranega izida statistično značilna korist ni bila dokazana, je bil pa opažen pozitiven trend v prid perindoprilu.
English: As ingestion of food decreases conversion to perindoprilat, hence bioavailability, <COVERSYL and associated names> should be administered orally in a single daily dose in the morning before a meal.
Slovenian: Ker uživanje hrane zmanjšuje pretvorbo v perindoprilat in zato tudi biološko uporabnost, morajo bolniki zdravilo <COVERSYL in sorodna imena> jemati peroralno v enem odmerku na dan, zjutraj pred obrokom.
English: The peak plasma concentration of perindoprilat is achieved within 3 to 4 hours.
Slovenian: Perindoprilat doseže največjo koncentracijo v plazmi v 3 do 4 urah.
English: Therefore the combination of perindopril with the above-mentioned drugs is not recommended (see section 4.4).
Slovenian: Kombinacija perindoprila z naštetimi zdravili torej ni priporočljiva (glejte poglavje 4.4).
English: When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible.
Slovenian: Če bolnica načrtuje nosečnost ali je že noseča, morate čimprej preiti na drugo vrsto zdravljenja.
English: In comparative studies, the first administration of 2 mg of <COVERSYL and associated names> to patients with mild to moderate heart failure was not associated with any significant reduction of blood pressure as compared to placebo.
Slovenian: V primerjalnih študijah prvi 2-mg odmerek zdravila <COVERSYL in sorodna imena> pri bolnikih z blagim do zmernim srčnim popuščanjem ni signifikantno znižal krvnega tlaka v primerjavi s placebom.
English: Pregnancy: <COVERSYL and associated names> should not be used during the first trimester of pregnancy.
Slovenian: Zdravila <COVERSYL in sorodna imena> ne smete predpisovati v prvem trimesečju nosečnosti.
English: In cases of renal impairment (creatinine clearance < 60 ml/min) the initial perindopril dosage should be adjusted according to the patient's creatinine clearance (see 4.2 “Posology and method of administration”) and then as a function of the patient's response to treatment.
Slovenian: Pri bolnikih z ledvičnim popuščanjem (očistek kreatinina < 60 ml/min) morate začetni odmerek perindoprila prilagajati glede na bolnikov očistek kreatinina (glejte poglavje 4.2 Odmerjanje in način uporabe) in nato kot funkcijo bolnikovega odziva na zdravljenje.
English: Hypertension: Treatment of hypertension
Slovenian: Hipertenzija: Zdravljenje hipertenzije.
English: At its meeting of 25-28 July 2005, the CHMP considered the data on efficacy presented by the MAHs and concluded that it had been shown that Coversyl and associated names was effective in the reduction of risk of cardiac events in patients with stable coronary artery disease with a history of myocardial infarction and/or revascularisation.
Slovenian: Na svojem sestanku v dneh od 25. do 28. julija 2005 je CHMP pretehtal podatke o učinkovitosti, ki so jih predložili imetniki dovoljenja za promet z zdravilom, ter sklenil, da je bilo dokazano, da je zdravilo Coversyl in z njim povezana imena učinkovito pri zmanjševanju tveganja za srčne zaplete pri bolnikih s stabilno koronarno arterijsko boleznijo, ki so v preteklosti že imeli miokardni infarkt in/ali revaskularizacijo.
English: Patients with a history of revascularisation would be included in these groups of patients.
Slovenian: V te skupine bolnikov bi naj bili vključeni bolniki z v preteklosti izvedeno revaskularizacijo.
English: The recommended treatment of overdosage is intravenous infusion of normal saline solution.
Slovenian: Priporočeno zdravljenje za preveliko odmerjanje zdravila je intravenska infuzija običajne fiziološke raztopine.
English: Overall, 90% of the patients had a previous myocardial infarction and/or a previous coronary revascularisation.
Slovenian: Celotno gledano je 90 % bolnikov v preteklosti že imelo miokardni infarkt in/ali koronarno revaskularizacijo.
English: The Applicant should focus in particular on the patients with a history of revascularisation but without history of MI, as this population is heterogeneous in terms of severity of lesions, revascularisation technique and concomitant treatments.
Slovenian: Vlagatelj se mora še posebej osredotočiti na bolnike z v preteklosti izvedeno revaskularizacijo, ki pa v preteklosti niso imeli MI, saj je ta populacija heterogena z vidika resnosti lezij, revaskularizacijske tehnike in sočasnega zdravljenja.
English: Table 1: dosage adjustment in renal impairment creatinine clearance (ml/min)
Slovenian: Prilagajanje odmerka pri bolnikih z ledvičnim popuščanjem Očistek kreatinina (ml/min)
English: Heart failure: <COVERSYL and associated names> reduces cardiac work by a decrease in pre-load and after-load.
Slovenian: Srčno popuščanje: <COVERSYL in sorodna imena> zmanjšuje delo srca tako, da zmanjšuje predobremenitev in poobremenitev.
English: If hypotension occurs, the patient should be placed in the supine position and, if necessary, should receive an intravenous infusion of normal saline.
Slovenian: Če se pojavi hipotenzija, bolnika polezite in mu, če je potrebno, dajte intravensko infuzijo običajne fiziološke raztopine.
English: Pregnancy and lactation: (See section 4.3 “Contraindications” and section 4.6 “Pregnancy and lactation”).
Slovenian: Nosečnost in dojenje: (Glejte poglavji 4.3 Kontraindikacije ter 4.6 Nosečnost in dojenje.)
English: Patients with stable coronary artery disease:
Slovenian: Bolniki s stabilno koronarno arterijsko boleznijo:
English: Twelve thousand two hundred and eighteen (12218) patients aged over 18 were randomised to perindopril 8 mg (n=6110) or placebo (n=6108).
Slovenian: Dvanajst tisoč dvesto osemnajst (12218) bolnikov, starejših od 18 let, je bilo naključno razdeljenih na skupini, zdravljeni s perindoprilom 8 mg (n=6110) oz. placebom (n=6108).
English: If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with < COVERSYL and associated names> (see section 4.4 “Special warnings and special precautions for use”).
Slovenian: Če je mogoče, diuretik ukinite 2 do 3 dni pred začetkom zdravljenja z zdravilom <COVERSYL in sorodna imena> (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
English: If hypotension becomes symptomatic, a reduction of dose or discontinuation of < COVERSYL and associated names> may be necessary.
Slovenian: Če hipotenzija postane simptomatična, je lahko potrebno zmanjšanje odmerka ali prekinitev zdravljenja z zdravilom <COVERSYL in sorodna imena>.
English: Concomitant use of certain anaesthetic medicinal products, tricyclic antidepressants and antipsychotics with ACE inhibitors may result in further reduction of blood pressure (see section 4.4).
Slovenian: Sočasna uporaba določenih anestetikov, tricikličnih antidepresivov in antipsihotikov z zaviralci angiotenzinske konvertaze lahko povzroči nadaljnje zniževanje krvnega tlaka (glejte poglavje 4.4).
English: Controlled studies with ACE inhibitors have not been done in humans, but in a limited number of cases with first trimester exposure there do not appear to have been any malformations consistent with human foetotoxicity as described below.
Slovenian: Pri ljudeh niso izvajali nadzorovanih študij z zaviralci angiotenzinske konvertaze, toda pri omejenem številu bolnic, ki so bile zdravilu izpostavljene v prvem trimesečju nosečnosti, niso opazili nikakršnih malformacij v smislu fetotoksičnosti pri ljudeh, ki je opisana v nadaljevanju.
English: Perindopril is currently indicated for the treatment of hypertension and symptomatic heart failure”.
Slovenian: Perindopril je trenutno indiciran za zdravljenje hipertenzije in simptomatske srčne odpovedi.
English: Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.
Slovenian: Simptomi prevelikega odmerjanja zaviralcev angiotenzinske konvertaze lahko vključujejo hipotenzijo, cirkulacijski šok, motnje elekrolitov, ledvično popuščanje, hiperventilacijo, tahikardijo, palpitacije, bradikardijo, omotico, anksioznost in kašelj.
English: Blood and the lymphatic system disorders:
Slovenian: Bolezni krvi in limfnega sistema:
English: A non-statistically significant favourable trend was observed in the other two components.
Slovenian: Pri drugih dveh elementih je bil opažen ugoden, vendar statistično neznačilen trend.
English: Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death.
Slovenian: V redkih primerih so bili zaviralci angiotenzinske konvertaze povezani s sindromom, ki se je začel s holestatično zlatenico in napredoval v fulminantno jetrno nekrozo ter (včasih) smrt.
English: If perindopril is used in such patients, periodic monitoring of white blood cell counts is advised and patients should be instructed to report any sign of infection.
Slovenian: Če tovrstnim bolnikom predpisujete perindopril, je priporočljivo redno merjenje števila levkocitov; morate jim tudi naročiti, naj poročajo o vsakem znaku okužbe.
English: The trial population had evidence of coronary artery disease with no evidence of clinical signs of heart failure.
Slovenian: V preizkušanje vključena populacija je imela dokazano koronarno arterijsko bolezen ter ni imela dokazanih kliničnih znakov srčne odpovedi.