natgillin/translations-raw huggingface dataset:
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.
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.
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).
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.
If concomitant use is indicated because of demonstrated hypokalaemia they should be used with caution and with frequent monitoring of serum potassium.
Če je sočasno jemanje indicirano zaradi dokazane hipokalemije, jih morate uporabljati previdno in pogosto meriti vrednost kalija v serumu.
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.
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.
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.
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.
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.
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.
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.
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.
The peak plasma concentration of perindoprilat is achieved within 3 to 4 hours.
Perindoprilat doseže največjo koncentracijo v plazmi v 3 do 4 urah.
Therefore the combination of perindopril with the above-mentioned drugs is not recommended (see section 4.4).
Kombinacija perindoprila z naštetimi zdravili torej ni priporočljiva (glejte poglavje 4.4).
When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible.
Če bolnica načrtuje nosečnost ali je že noseča, morate čimprej preiti na drugo vrsto zdravljenja.
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.
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.
Pregnancy: <COVERSYL and associated names> should not be used during the first trimester of pregnancy.
Zdravila <COVERSYL in sorodna imena> ne smete predpisovati v prvem trimesečju nosečnosti.
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.
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.
Hypertension: Treatment of hypertension
Hipertenzija: Zdravljenje hipertenzije.
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.
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.
Patients with a history of revascularisation would be included in these groups of patients.
V te skupine bolnikov bi naj bili vključeni bolniki z v preteklosti izvedeno revaskularizacijo.
The recommended treatment of overdosage is intravenous infusion of normal saline solution.
Priporočeno zdravljenje za preveliko odmerjanje zdravila je intravenska infuzija običajne fiziološke raztopine.
Overall, 90% of the patients had a previous myocardial infarction and/or a previous coronary revascularisation.
Celotno gledano je 90 % bolnikov v preteklosti že imelo miokardni infarkt in/ali koronarno revaskularizacijo.
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.
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.
Table 1: dosage adjustment in renal impairment creatinine clearance (ml/min)
Prilagajanje odmerka pri bolnikih z ledvičnim popuščanjem Očistek kreatinina (ml/min)
Heart failure: <COVERSYL and associated names> reduces cardiac work by a decrease in pre-load and after-load.
Srčno popuščanje: <COVERSYL in sorodna imena> zmanjšuje delo srca tako, da zmanjšuje predobremenitev in poobremenitev.
If hypotension occurs, the patient should be placed in the supine position and, if necessary, should receive an intravenous infusion of normal saline.
Če se pojavi hipotenzija, bolnika polezite in mu, če je potrebno, dajte intravensko infuzijo običajne fiziološke raztopine.
Pregnancy and lactation: (See section 4.3 “Contraindications” and section 4.6 “Pregnancy and lactation”).
Nosečnost in dojenje: (Glejte poglavji 4.3 Kontraindikacije ter 4.6 Nosečnost in dojenje.)
Patients with stable coronary artery disease:
Bolniki s stabilno koronarno arterijsko boleznijo:
Twelve thousand two hundred and eighteen (12218) patients aged over 18 were randomised to perindopril 8 mg (n=6110) or placebo (n=6108).
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).
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”).
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).
If hypotension becomes symptomatic, a reduction of dose or discontinuation of < COVERSYL and associated names> may be necessary.
Če hipotenzija postane simptomatična, je lahko potrebno zmanjšanje odmerka ali prekinitev zdravljenja z zdravilom <COVERSYL in sorodna imena>.
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).
Sočasna uporaba določenih anestetikov, tricikličnih antidepresivov in antipsihotikov z zaviralci angiotenzinske konvertaze lahko povzroči nadaljnje zniževanje krvnega tlaka (glejte poglavje 4.4).
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.
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.
Perindopril is currently indicated for the treatment of hypertension and symptomatic heart failure”.
Perindopril je trenutno indiciran za zdravljenje hipertenzije in simptomatske srčne odpovedi.
Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.
Simptomi prevelikega odmerjanja zaviralcev angiotenzinske konvertaze lahko vključujejo hipotenzijo, cirkulacijski šok, motnje elekrolitov, ledvično popuščanje, hiperventilacijo, tahikardijo, palpitacije, bradikardijo, omotico, anksioznost in kašelj.
Blood and the lymphatic system disorders:
Bolezni krvi in limfnega sistema:
A non-statistically significant favourable trend was observed in the other two components.
Pri drugih dveh elementih je bil opažen ugoden, vendar statistično neznačilen trend.
Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death.
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.
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.
Če tovrstnim bolnikom predpisujete perindopril, je priporočljivo redno merjenje števila levkocitov; morate jim tudi naročiti, naj poročajo o vsakem znaku okužbe.
The trial population had evidence of coronary artery disease with no evidence of clinical signs of heart failure.
V preizkušanje vključena populacija je imela dokazano koronarno arterijsko bolezen ter ni imela dokazanih kliničnih znakov srčne odpovedi.
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.
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>.
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.
Koristnost perindoprila so ugotovili pri vseh posameznih elementih kombiniranega primarnega kliničnega izida, čeprav je bilo zmanjšanje tveganja statistično značilno le pri »nesmrtnem MI«.
In addition to active perindoprilat, perindopril yields five metabolites, all inactive.
Poleg aktivnega perindoprilata nastane še pet presnovkov perindoprila, ki so vsi neaktivni.
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.
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.
Clinical trials:
Klinična preskušanja:
2 mg on the day of dialysis * Dialysis clearance of perindoprilat is 70 ml/min.
2 mg na dan dialize * Dializni očistek perindoprilata je 70 ml/min.
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>.
Pri nekaterih bolnikih s kongestivnim srčnim popuščanjem, ki imajo normalen ali nizek krvni tlak, lahko <COVERSYL in sorodna imena> dodatno zniža sistemski krvni tlak.
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.
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.
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.
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.
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.
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.
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.
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.
Heart failure: Treatment of symptomatic heart failure
Srčno popuščanje: Zdravljenje simptomatičnega srčnega popuščanja.
The EUROPA study was a multicentre, international, randomised, double-blind, placebocontrolled clinical trial lasting 4 years.
Študija EUROPA je bila multicentrično, mednarodno, randomizirano, dvojno slepo, s placebom nadzorovano klinično preskušanje, ki je trajalo 4 leta.
Concomitant use of these agents may increase the hypotensive effects of perindopril.
Sočasno jemanje teh zdravil lahko poveča hipotenzivni učinek perindoprila.
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.
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.
Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously.
Ves čas morate spremljati vitalne znake in koncentracijo elektrolitov ter kreatinina v serumu.
The main efficacy criterion was the composite of cardiovascular mortality, non fatal myocardial infarction and/or cardiac arrest with successful resuscitation.
Glavni kriterij učinkovitosti je bila pojavnost kardiovaskularne smrtnosti, nesmrtnega miokardnega infarkta in/ali zaustavitev srca z uspešnim oživljanjem.
Dosage adjustment in renal insufficiency is desirable depending on the degree of impairment (creatinine clearance).
Pri bolnikih z ledvičnim popuščanjem je zaželeno prilagajanje odmerka glede na stopnjo bolezni (očistek kreatinina).
ACE inhibitors may cause a fall in blood pressure.
Zaviralci angiotenzinske konvertaze lahko povzročijo padec krvnega tlaka.
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.
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.
• The MAH has implemented the text proposed by the CHMP in the SPC:
• je imetnik dovoljenja za promet z zdravilom v Povzetek glavnih značilnosti vključil besedilo, ki ga je predlagal CHMP:
If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered.
Premislite tudi o zdravljenju z infuzijo angiotenzina II, intravenskimi kateholamini ali obojim, če je na voljo.
Few patients experienced serious adverse events: 16 (0.3%) of the 6122 perindopril patients and 12 (0.2%) of the 6107 placebo patients.
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.
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.
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.
For patients on haemodialysis, the dose should be taken after dialysis.
Bolniki na hemodializi naj odmerek jemljejo po dializi.
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.
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.
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.
Angiotenzinska konvertaza ali kinaza je eksopeptidaza, ki omogoča pretvorbo angiotenzina I v vazokonstriktor angiotenzin II, pa tudi razgradnjo vazodilatatorja bradikinina v neaktiven heptapeptid.
In hypertensive patients in whom the diuretic cannot be discontinued, therapy with < COVERSYL and associated names> should be initiated with a 2 mg dose.
Bolnikom s hipertenzijo, pri katerih diuretika ne morete ukiniti, zdravljenje z zdravilom <COVERSYL in sorodna imena> uvedite z odmerkom po 2 mg.
If renovascular hypertension is also present there is an increased risk of severe hypotension and renal insufficiency.
Če imajo bolniki tudi renovaskularno hipertenzijo, jih spremlja povečano tveganje za hudo hipotenzijo in ledvično popuščanje.
Caution is therefore recommended since these patients may be volume and/or salt depleted.
Priporočljiva je previdnost, saj imajo lahko tovrstni bolniki izgubo volumna ali soli ali obeh.
Elevation of liver enzymes and serum bilirubin have been reported rarely.
Redko so poročali o povečanju vrednosti jetrnih encimov in bilirubina v serumu.
If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
Če se pojavi hipotenzija, ki jo najverjetneje povzroči opisani mehanizem, jo lahko odpravite s povečevanjem volumna.
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).
Jemanje perindoprila ob litiju ni priporočljivo, če je ta kombinacija vendarle potrebna, morate pozorno spremljati vrednost litija v serumu (glejte poglavje
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.
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.
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.
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.
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.
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.
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.
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.
Marketing Authorisation Holder
Država članica Imetnik dovoljenja za promet
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).
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).
Sympathomimetics: Sympathomimetics may reduce the antihypertensive effects of ACE inhibitors.
Simpatikomimetiki: Simpatikomimetiki lahko zmanjšajo antihipertenzivni učinek zaviralcev angiotenzinske konvertaze.
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”).
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).
Most of the patients received the study medication on top of conventional therapy including platelet inhibitors, lipid lowering agents and beta-blockers.
Večina bolnikov je prejemalo zdravilo v študiji poleg konvencionalnega zdravljenja, ki je vključevalo zaviralce agregacije trombocitov, zdravila za zniževanje lipidov in blokatorje beta receptorjev.