natgillin/translations-raw huggingface dataset:
This may occur at any time during therapy.
Pojavi se lahko kadarkoli med zdravljenjem.
The decrease in blood pressure occurs rapidly.
Znižanje krvnega tlaka nastopi hitro.
Results in this population are less convincing and further differentiation of risk may be needed before this patient group can be included in the wording of the indication.
Rezultati pri tej populaciji so manj prepričljivi in pred vključitvijo te skupine bolnikov v besedilo indikacije utegne biti potrebna nadaljnja diferenciacija tveganja.
Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, <1/1000); very rare (<1/10000), including isolated reports.
zelo pogosti (> 1/10), pogosti (> 1/100, < 1/10), občasni (> 1/1.000, < 1/100), redki (> 1/10.000, < 1/1.000), zelo redki (< 1/10.000), vključno s posameznimi primeri.
PHARMACEUTICAL FORM Tablets.
FARMACEVTSKA OBLIKA Tableta.
ATC code: C09A A04
Oznaka ATC: C09AA04.
• the CHMP considered the referral made under article 6.12 of Commission Regulation (EC) No 1084/2003, for Coversyl and associated names (see Annex I),
• je CHMP preučil napotitev v skladu s členom 6.12 Uredbe Komisije (ES) št. 1084/2003 za zdravilo Coversyl in z njim povezana imena (glej Dodatek I),
This wording would be in line with the general CHMP policy regarding products using composite endpoints for evaluation of efficacy.
To besedilo bi se skladalo s splošno politiko CHMP v zvezi z izdelki, ki za ovrednotenje učinkovitosti uporabljajo kombinirani izid.
<[To be completed nationally]>
<[Izpolniti nacionalno]>
The applicant subsequently sent on 23.02.2005 a Position Paper to all MS stating that the indication proposed by the RMS was not acceptable, and that a broader indication reflecting the study population should be approved, namely:
Zatem je vlagatelj 23.02.2005 poslal vsem državam članicam dokument o stališču, v katerem trdi, da indikacija, ki jo je predlagala referenčna država članica, ni sprejemljiva, ter da bi bilo potrebno odobriti širšo indikacijo, ki se je odražala v raziskovani populaciji, in sicer:
Overall conclusion on benefit/risk
Celostni sklep glede razmerja med koristmi in tveganji
The Company has provided data showing that this population is not so heterogeneous but quite similar to the whole population included in EUROPE study, at least in terms of revascularisation techniques and concomitant treatments.
Podjetje je predložilo podatke, ki kažejo, da ta populacija ni tako heterogena, temveč precej podobna celotni populaciji, vključeni v študijo EUROPA, in sicer vsaj z vidika revaskularizacijskih tehnik in sočasnega zdravljenja.
Evaluation of Clinical Efficacy
Ocena klinične učinkovitosti
The volume of distribution is approximately 0.2 l/kg for unbound perindoprilat.
Volumen porazdelitve je pri nevezanem perindoprilatu približno 0,2 l/kg.
An official referral for arbitration was notified by the Netherlands to the CHMP on 17.03.2005.
17.03.2005 je Nizozemska CHMP prijavila uradno napotitev na arbitražo.
• the CHMP, as a consequence, considered the benefit/risk balance for the above-mentioned extension of indication to be favourable,
• je CHMP posledično menil, da je razmerje med tveganji in koristmi za zgoraj omenjeno razširitev indikacije ugodno.
The following LoQ was adopted by the CHMP in April 2005:
CHMP je aprila 2005 sprejel naslednji seznam vprašanj:
• Section 5.1 has been updated to include the results of the EUROPA trial as follows: Patients with stable coronary artery disease:
• Poglavje 5.1 je bilo posodobljeno tako, da vključuje rezultate študije EUROPA kot sledi: Bolniki s stabilno koronarno arterijsko boleznijo:
Difficulties in making comparisons among the different trials are recognised as they include a different population and use different endpoints.
Težave pri oblikovanju primerjav med različnimi preizkušanji, glede na to, da vključujejo različne populacije in uporabljajo različne izide, so priznane.
Renal blood flow increases as a rule, while the glomerular filtration rate (GFR) is usually unchanged.
Ledvični krvni pretok se praviloma poveča, medtem ko stopnja glomerulne filtracije (GFR) običajno ostaja nespremenjena.
Some of these patients developed serious infections, which in a few instances did not respond to intensive antibiotic therapy.
Pri nekaterih od njih so se pojavile resne okužbe, ki se v nekaj primerih niso odzivale na intenzivno zdravljenje z antibiotiki.
The results showed that treatment with perindopril once daily resulted in a significant absolute reduction in the primary endpoint.
Rezultati so pokazali, da je zdravljenje s perindoprilom enkrat dnevno privedlo do pomembnega zmanjšanja pogostosti primarnega izida.
Perindopril is contraindicated during the second and third trimesters of pregnancy.
Perindopril je kontraindiciran v drugem in tretjem trimesečju nosečnosti.
Therefore, use in children is not recommended.
Zato uporaba zanje ni priporočljiva.
During the randomised period of the EUROPA study, only serious adverse events were collected.
Med randomiziranim obdobjem študije EUROPA so zbirali le poročila o hudih neželenih učinkih.
When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur.
Pri vožnji ali upravljanju s stroji morate upoštevati, da se včasih lahko pojavljata omotica ali utrujenost.
In responding patients, normalisation is achieved within a month and persists without the occurrence of tachyphylaxis.
Bolniki, ki se odzivajo, dosežejo normalizacijo v enem mesecu in jo ohranjajo brez pojava tahifilaksije.
Coversyl and associated names contain perindopril, a well-known, potent angiotensin converting enzyme inhibitor (ACE-I), marketed in France as Coversyl 2 and 4 mg since 1988, the entire European Union, and world-wide in more than 10 countries including USA and Japan.
Zdravilo Coversyl in z njim povezana imena vsebujejo perindopril, dobro znan, učinkovit zaviralec angiotenzinske konvertaze (ACE-I), ki ga tržijo v Franciji kot Coversyl 2 in 4 mg od leta 1988, v celotni Evropski uniji ter po vsem svetu v več kot 10 državah, vključno z ZDA in Japonsko.
• A warning has been introduced in Section 4.4:
• V poglavju 4.4 je bilo dodano opozorilo:
Non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin ≥ 3 g/day:
Nesteroidni antirevmatiki, vključno z Aspirinom ≥ 3 g na dan:
About 20 % of the total quantity of perindopril absorbed is converted into perindoprilat, the active metabolite.
Približno 20 % skupne absorbirane količine perindoprila se pretvori v aktivni presnovek perindoprilat.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENI S STRANI EMEA
A transient hypotensive response is not a contraindication to further doses, which can be given usually without difficulty once the blood pressure has increased after volume expansion.
Prehoden hipotenzivni odziv ni kontraindikacija za nadaljnje odmerjanje, ki običajno poteka brez težav, potem ko se krvni tlak poveča po povečanju volumna.
In patients with normal renal function and no other complicating factors, neutropenia occurs rarely.
Pri bolnikih z normalnim ledvičnim delovanjem in brez drugih oteževalnih dejavnikov se nevtropenija pojavlja le redko.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF COVERSYL AND ASSOCIATED NAMES (see Annex I)
SPLOŠEN POVZETEK ZNANSTVENE OCENE ZDRAVILA COVERSYL IN Z NJIM POVEZANIH IMEN (glej Dodatek I)
The CHMP believes that the lack of a statistically significant difference for two of the three components of the composite endpoint in the EUROPA study is not a reason to restrict the indication to a single component, given that a positive and fully consistent trend for these two components is observed.
CHMP meni, da odsotnost statistično pomembne razlike pri dveh od treh elementov kombiniranega izida pri študiji EUROPA ni zadosten razlog za omejitev indikacije na en sam element, upoštevaje dejstvo, da je bil za preostala dva elementa opažen pozitiven in docela konsistenten trend.
Consistency for secondary variables was also observed and even a significant effect was shown on the occurrence of heart failure in the overall population.
Opažena je bila tudi konsistentnost sekundarnih spremenljivk, dokazan pa je bila celo pomemben vpliv na pojavljanje srčne odpovedi pri celotni populaciji.
It is recommended that <COVERSYL and associated names> is taken once daily in the morning before a meal.
<COVERSYL in sorodna imena> je priporočljivo jemati enkrat na dan zjutraj pred obrokom.
The antihypertensive activity is maximal between 4 and 6 hours after a single dose and is sustained for at least 24 hours: trough effects are about 87-100 % of peak effects.
Antihipertenzivni učinek je največji 4 do 6 ur po enkratnem odmerku in traja najmanj 24 ur: najmanjši učinek znaša približno 87 do 100 % največjega učinka.
As a consequence, peripheral blood flow increases, with no effect on heart rate.
Posledično se poveča periferni krvni pretok, ne da bi to vplivalo na srčno frekvenco.
• The posology in Section 4.2 has been updated as follows:
• Odmerjanje v poglavju 4.2 je bilo posodobljeno kot sledi:
If hypotension occurs, the patient should be placed in the shock position.
Če se pojavi hipotenzija, bolnika namestite v položaj za šok.
Characteristically, the cough is nonproductive, persistent and resolves after discontinuation of therapy.
Zanj je značilno, da je neproduktiven, trdovraten in izgine po prekinitvi zdravljenja.
No carcinogenicity has been observed in long term studies in rats and mice.
V dolgoročnih študijah pri podganah in miših niso opažali nikakršne kancerogenosti.
Protein binding is slight (binding of perindoprilat to angiotensin converting enzyme is less than 30 %), but is concentration-dependent.
Vezava na beljakovine je majhna (vezava perindoprilata na angiotenzinsko konvertazo je manjša od 30 %), a odvisna od koncentracije.
Limited data are available for overdosage in humans.
O prevelikem odmerjanju pri ljudeh so na voljo le omejeni podatki.
United Kingdom Les Laboratoires Servier
Velika Britanija Les Laboratoires Servier
The patient should be under close medical supervision until complete and sustained resolution of symptoms has occurred.
Bolnik mora ostati pod strogim zdravniškim nadzorom do popolnega in trajnega izginotja simptomov.
The recommended starting dose is 4 mg given once daily in the morning.
Priporočeni začetni odmerek je po 4 mg enkrat na dan, in sicer zjutraj.
• Second and third trimesters of pregnancy (see 4.6 “Pregnancy and lactation”).
• Drugo in tretje trimesečje nosečnosti (glejte poglavje 4.6 Nosečnost in dojenje).
In the initial type II variation dossier submitted by MRP (FR/H/246/01-02/001), the applicant claimed the following indication: “Stable coronary artery disease: Reduction of risk of cardiovascular events in patients with stable coronary artery disease”.
V prvotni dokumentaciji spremembe tipa II, predloženi po postopku medsebojnega priznavanja (FR/H/246/01-02/001), je vlagatelj predložil zahtevo za naslednjo indikacijo: »Stabilna koronarna arterijska bolezen: Zmanjševanje tveganja kardiovaskularnih dogodkov pri bolnikih s stabilno koronarno arterijsko boleznijo«.
Routine monitoring of potassium and creatinine are part of normal medical practice for these patients (see 4.8 “Undesirable effects”).
Rutinsko spremljanje ravni kalija in kreatinina je del običajne medicinske prakse pri tovrstnih bolnikih (glejte poglavje 4.8 Neželeni učinki).
As it was expected that the subgroup of patients with a history of revascularisation but with no history of MI was heterogeneous in terms of severity of lesions, revascularisation technique and concomitant treatments, the Applicant was asked to address this issue in order to justify the inclusion of this specific group of patients in the proposed indication.
Glede na pričakovanje, da je podskupina bolnikov z v preteklosti izvedeno revaskularizacijo, ki pa v preteklosti niso imeli MI, heterogena z vidika resnosti lezij, revaskularizacijske tehnike in sočasnega zdravljenja, je bilo od vlagatelja zahtevano, da posebej obravnava to vprašanje, da bi tako utemeljil vključitev te specifične skupine bolnikov v predlagano indikacijo.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINA UPORABE, IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
The plasma half-life of perindopril is equal to 1 hour.
Razpolovna doba perindoprila v plazmi znaša 1 uro.
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.
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.
A starting dose of 2 mg is recommended in such patients and the initiation of treatment should take place under medical supervision.
Zanje sta priporočena začetni odmerek 2 mg in uvedba zdravljenja pod zdravniškim nadzorom.
Dosage in patients with renal impairment should be based on creatinine clearance as outlined in table 1 below:
Odmerjanje pri bolnikih z ledvičnim popuščanjem mora temeljiti na očistku kreatinina, kot prikazuje spodnja preglednica 1.
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.
Disociacija perindoprilata, vezanega na angiotenzinsko konvertazo, vodi do 'efektivne' razpolovne dobe izločanja 25 ur, ravnovesno stanje pa je doseženo v 4 dneh.
It improves large artery elasticity and decreases the media: lumen ratio of small arteries.
Izboljšuje prožnost velikih arterij in zmanjšuje razmerje med medijo in svetlino v malih arterijah.
NAME OF THE MEDICINAL PRODUCT <COVERSYL and associated names (see Annex I)>, <strength>, tablets <[See Annex I - to be completed nationally]>
IME ZDRAVILA <COVERSYL in sorodna imena (glejte dodatek I)>, <jakost>, tablete <[Glejte dodatek I - izpolniti nacionalno]>
Very rare: pancreatitis
Zelo redki: pankreatitis.
After oral administration, the absorption of perindopril is rapid and the peak concentration complete within 1 hour.
Po peroralnem jemanju se perindopril absorbira hitro in doseže največjo koncentracijo v 1 uri.
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.
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.
Perindopril acts through its active metabolite, perindoprilat.
Perindopril deluje prek svojega aktivnega presnovka, perindoprilata.
Reproduction toxicology studies (rats, mice, rabbits and monkeys) showed no sign of embryotoxicity or teratogenicity.
Toksikološke študije o plodnosti pri podganah, miših, kuncih in opicah niso pokazale nikakršnih znakov embriotoksičnosti ali teratogenosti.
This phenomenon appeared to be more likely to occur during the first weeks of combined treatment and in patients with renal impairment.
Takšen pojav je verjetnejši v prvih tednih njihovega sočasnega jemanja in pri bolnikih z ledvičnim popuščanjem.
This benefit was statistically significant for non-fatal MI, one of the components of the combined endpoint.
Koristnost je bila statistično značilna za nesmrtni MI, enega od elementov kombiniranega izida.
Anaphylactic reactions during desensitisation:
Anafilaktične reakcije med desenzibilizacijo:
If required, diuretic therapy may be resumed.
Če je potrebno, ponovno uvedite zdravljenje z diuretiki.
Tricyclic antidepressants/Antipsychotics/Anesthetics:
Triciklični antidepresivi, antipsihotiki, anestetiki:
Psychiatric disorders: Uncommon: mood or sleep disturbances
Psihiatrične motnje: Občasni: motnje razpoloženja ali spanja.
Perindopril kinetics are modified in patients with cirrhosis : hepatic clearance of the parent molecule is reduced by half.
Kinetika perindoprila je spremenjena pri bolnikih s cirozo: pri njih se jetrni očistek osnovne molekule zmanjša za polovico.
In these patients, treatment should be started under close medical supervision with low doses and careful dose titration.
Tovrstnim bolnikom je treba zdravljenje uvajati pod strogim zdravniškim nadzorom z majhnimi odmerki in s pazljivim titriranjem odmerka.
Hypertension: < COVERSYL and associated names> may be used in monotherapy or in combination with other classes of antihypertensive therapy.
Hipertenzija: <COVERSYL in sorodna imena> lahko uporabljate v monoterapiji ali kombinaciji z drugimi razredi antihipertenzivnih zdravljenj.
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.
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.
• Hereditary or idiopathic angioedema;
• Dedni ali idiopatični angioedem.
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.
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.
The following undesirable effects have been observed during treatment with perindopril and ranked under the following frequency:
Med zdravljenjem s perindoprilom so opažali naslednje neželene učinke in jih razvrstili po navedenih stopnjah pogostnosti:
The subsequent dosage of <COVERSYL and associated names> should be adjusted according to blood pressure response.
Nadaljnje odmerjanje zdravila <COVERSYL in sorodna imena> prilagajajte glede na odziv krvnega tlaka.
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.
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.
The combination of lithium and perindopril is generally not recommended (see 4.5 Interaction with other medicinal products and other forms of interaction).
Kombinacija litija in perindoprila na splošno ni priporočljiva (glejte poglavje 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij).
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).
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).
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.
2.- Drugi predmet razprave se tiče vprašanja, ali je mogoče koristnost z zgolj zmanjševanja pogostosti MI razširiti na zmanjševanje srčnih zapletov.
The Applicant was also requested to justify the beneficial effect of Perindopril beyond a mere reduction of MI.
Od vlagatelja so nadalje zahtevali, da utemelji koristnost perindoprila, ki presega zgolj zmanjševanje pojavnosti MI.
Perindopril reduces peripheral vascular resistance, leading to blood pressure reduction.
Perindopril zmanjšuje periferni žilni upor, čemur sledi znižanje krvnega tlaka.
In these patients consideration should be given to using a different type of dialysis membrane or different class of antihypertensive agent.
Pri tovrstnih bolnikih premislite o uporabi druge vrste dializnih membran ali drugega razreda antihipertenzivov.
Perindoprilat is eliminated in the urine and the half-life of the unbound fraction is approximately 3 to 5 hours.
Perindoprilat se iz telesa izloča z urinom, razpolovna doba nevezane frakcije pa znaša približno 3 do 5 ur.
Dialysis clearance of perindoprilat is equal to 70 ml/min.
Dializni očistek perindoprilata je 70 ml/min.
The CHMP recommended the granting of the type II variation to extend the indication.
CHMP je predlagal odobritev dovoljenja za promet z zdravilom za spremembo tipa II, povezano z razširitvijo indikacije.
The dose should be increased only if the previous lower dose is well tolerated.
Odmerek naj bo povečan le, če bolnik manjši odmerek dobro prenaša.
Perindopril reduces left ventricular hypertrophy.
Perindopril zmanjšuje hipertrofijo levega prekata.
Discontinuation of treatment does not lead to a rebound effect.
Po ukinitvi zdravila ne nastopijo povratni učinki.
Rarely, acute renal failure may occur, especially in patients with compromised renal function such as those who are elderly or dehydrated.
Redko se lahko pojavi akutno ledvično popuščanje, zlasti pri bolnikih z ogroženim ledvičnim delovanjem, kot so starostniki ali dehidrirani bolniki.
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.
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.
Although serum potassium usually remains within normal limits, hyperkalaemia may occur in some patients treated with perindopril.
Čeprav vrednost kalija v serumu običajno ostaja znotraj normalnega razpona, se lahko pri nekaterih bolnikih, ki jemljejo perindopril, pojavi hiperkalemija.
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.
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.
In perindopril-treated patients, hypotension was observed in 6 patients, angioedema in 3 patients and sudden cardiac arrest in 1 patient.
Pri bolnikih, ki so prejemali perindopril, je bila hipotenzija opažena pri 6 bolnikih, angioedem pri 3 bolnikih in nenaden zastoj srca pri 1 bolniku.
Very rare: erythema multiforme
Zelo redki: multiformni eritem.
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.
V teh primerih morate zdravilo <COVERSYL in sorodna imena> takoj ukiniti in bolnika ustrezno spremljati, kar nadaljujete do popolnega izginotja simptomov.
Concomitant use with nitroglycerin and other nitrates, or other vasodilators, may further reduce blood pressure.
Sočasno jemanje z nitroglicerinom in preostalimi nitrati ali vazodilatatorji lahko dodatno zniža krvni tlak.