FrancophonIA/ELRC3.0 huggingface dataset:
English: Values are adjusted for baseline and country.
Slovenian: Vrednosti so prilagojene glede na izhodiščne podatke in državo.
English: Limited experience is available in patients with severe renal impairment or haemodialysis.
Slovenian: Na voljo so omejene izkušnje z bolniki s hudo ledvično okvaro ali hemodializo.
English: The antihypertensive effect of Onduarp was similar irrespective of age and gender, and was similar in patients with and without diabetes.
Slovenian: Antihipertenzivni učinek zdravila Onduarp je bil podoben pri bolnikih ne glede na starost in spol ter pri bolnikih s sladkorno boleznijo in brez nje.
English: • Narrowing of the aorta (aortic stenosis).
Slovenian: • zožitev aorte (aortna stenoza),
English: You might experience low blood pressure and rapid heart beat.
Slovenian: Posledica je lahko nizek krvni tlak ali hitro bitje srca.
English: If you take more Onduarp than you should
Slovenian: Če ste vzeli večji odmerek zdravilaOnduarp, kot bi smeli
English: There are usually no symptoms of high blood pressure before damage occurs.
Slovenian: Visok krvni tlak običajno ne povzroča simptomov, dokler se ne razvijejo poškodbe.
English: Amlodipine is extensively (approximatively 90 %) metabolised by the liver to inactive metabolites.
Slovenian: Amlodipin se v jetrih obsežno (približno 90 %) presnavlja v neaktivne presnovke.
English: Telmisartan/Amlodipine
Slovenian: Telmisartan/amlodipin
English: Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Slovenian: Intravensko dajanje kalcijevega glukonata lahko ugodno deluje pri odpravi učinkov blokade kalcijevih kanalov.
English: Telmisartan works by blocking the effect of angiotensin II.
Slovenian: Telmisartan deluje tako, da zavira učinek angiotenzina II.
English: You can take Onduarp with or without food.
Slovenian: Zdravilo Onduarp lahko jemljete s hrano ali brez nje.
English: The time to reach peak plasma concentrations of amlodipine is similar in elderly and younger subjects.
Slovenian: Čas do največje koncentracije amlodipina v plazmi je pri starejših in mlajših osebah podoben.
English: • Lithium-containing medicines to treat some types of depression.
Slovenian: • zdravila z litijem, za zdravljenje nekaterih oblik depresije,
English: Data on a limited number of exposed pregnancies do not indicate that amlodipine or other calcium receptor antagonists have a harmful effect on the health of the fetus.
Slovenian: Podatki o manjšem številu primerov uporabe med nosečnostjo ne kažejo, da imajo amlodipin ali drugi antagonisti kalcijevih receptorjev škodljiv učinek na zdravje plodu.
English: Therefore, caution should be recommended when driving a car or using machines.
Slovenian: Svetovati jim je treba, da morajo biti previdni med vožnjo ali upravljanjem s stroji.
English: Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:
Slovenian: Obvestite svojega zdravnika, če imate ali ste kadarkoli v preteklosti imeli katero od naslednjih stanj ali bolezni:
English: Separate reproductive toxicity studies with the combination of telmisartan and amlodipine have not been conducted.
Slovenian: Posebnih študij o reproduktivni toksičnosti s kombinacijo telmisartana in amlodipina niso izvajali.
English: However, there may be a risk of prolonged delivery.
Slovenian: Možno pa je podaljšanje poroda.
English: Since the non-clinical toxicity profiles of telmisartan and amlodipine are not overlapping, no exacerbation of toxicity was expected for the combination.
Slovenian: Ker se neklinična profila telmisartanove in amlodipinove toksičnosti ne prekrivata, pri kombinaciji ni bilo pričakovati povečanja toksičnosti.
English: When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Slovenian: Če je glede na klinično stanje primerno, lahko presodimo o neposrednem prehodu z monoterapije na fiksno kombinacijo.
English: Sepsis (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Slovenian: Sepsa (pogosto poimenovana tudi zastrupitev krvi, je huda okužba, pri kateri pride v vsem telesu do vnetnega odziva), hitro otekanje kože in sluznice (angioedem); ti neželeni učinki so redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov), toda zelo resni, zato morajo bolniki takoj prenehati z jemanjem zdravila in nemudoma poiskati zdravniško pomoč.
English: The most common adverse reactions include dizziness and peripheral oedema.
Slovenian: Najpogostejša neželena učinka sta omotica in periferni edem.
English: Furthermore as with all calcium antagonists, amlodipine half-life is prolonged in patients with impaired liver function and dose recommendations have not been established.
Slovenian: Poleg tega je tako kot pri vseh kalcijevih antagonistih tudi razpolovna doba amlodipina daljša pri bolnikih z jetrno okvaro, vendar priporočila o odmerjanju še niso izdelana.
English: Management depends on the time since ingestion and the severity of the symptoms.
Slovenian: Ukrepi so odvisni od tega, koliko časa je preteklo od zaužitja zdravila in resnosti simptomov.
English: In case of surgery or anaesthesia, you should tell your doctor that you are taking Onduarp.
Slovenian: Če boste operirani ali boste prejeli anestezijo, morate vašemu zdravniku povedati, da jemljete zdravilo Onduarp.
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability of telmisartan up to nearly 100 %.
Slovenian: Farmakokinetične študije so pri bolnikih z jetrno okvaro pokazale skoraj 100 % povečano absolutno biološko uporabnost.
English: • Heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris).
Slovenian: • bolečino v prsnem košu, ki je povezana s srcem in se pojavlja tudi med mirovanjem ali minimalnim naporom (nestabilna angina pektoris),
English: Therefore, the dose of simvastatin in patients on amlodipine should be limited to 20 mg daily.
Slovenian: Zato je potrebno bolnikom, ki jemljejo amlodipin, omejiti odmerek simvastatina na 20 mg na dan.
English: Tendon pain (tendinitis like symptoms)
Slovenian: bolečina v kitah (tendinitisu podobni simptomi)
English: As a result, the blood vessels relax and blood pressure is lowered.
Slovenian: Žile se sprostijo in krvni tlak se zniža.
English: In two corresponding open-label long-term follow up studies performed over a further 6 months the effect of Onduarp was maintained over the trial period.
Slovenian: V dveh odprtih, dolgotrajnih, nadaljevalnih študijah, ki sta potekali nadaljnjih 6 mesecev, je bil učinek zdravila Onduarp nespremenjen ves čas preskušanja.
English: Experimental data indicate that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites.
Slovenian: Eksperimentalni podatki kažejo, da se amlodipin veže na dihidropiridinska in nedihidropiridinska vezavna mesta.
English: Onduarp has not been studied in any patient population other than hypertension.
Slovenian: Zdravila Onduarp niso preskušali pri drugih populacijah bolnikov, razen pri bolnikih s hipertenzijo.
English: There are no adequate data from the use of Onduarp in pregnant women.
Slovenian: O uporabi zdravila Onduarp pri nosečnicah ni ustreznih podatkov.
English: What Onduarp is and what it is used for What you need to know before you take Onduarp How to take Onduarp
Slovenian: Kaj je zdravilo Onduarp in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Onduarp Kako jemati zdravilo Onduarp Možni neželeni učinki
English: Overdose with amlodipine may result in excessive peripheral vasodilatation and possibly reflex tachycardia.
Slovenian: Prevelik odmerek amlodipina lahko povzroči prekomerno periferno vazodilatacijo, lahko pa tudi refleksno tahikardijo.
English: If hypotension occurs, the patient should be placed in a supine position with elevation of extremities, with salt and volume replacement given quickly.
Slovenian: Če se pojavi hipotenzija, je treba bolnika namestiti v ležeči položaj z dvignjenimi okončinami in hitro začeti nadomeščati sol in volumen.
English: Angiotensin II is a substance produced in the body which causes blood vessels to narrow, thus increasing blood pressure.
Slovenian: Angiotenzin II je snov, ki nastaja v telesu, oži žile in tako povečuje krvni tlak.
English: Differences in plasma concentrations of telmisartan were observed, with Cmax and AUC being approximately 3- and 2-fold higher, respectively, in females compared to males.
Slovenian: Telmisartanova koncentracija v plazmi je bila različna, Cmax in AUC sta bili pri ženskah približno 3-krat oziroma 2-krat večji kot pri moških.
English: In both species, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular cells were observed.
Slovenian: Pri obeh vrstah se je povečala aktivnost renina v plazmi in pojavila hipertrofija/hiperplazija ledvičnih jukstaglomerulnih celic.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim (Logo)
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Boehringer Ingelheim (logo)
English: The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Slovenian: Kombinacija obeh učinkovin ima aditivni antihipertenzivni učinek in znižuje krvni tlak učinkoviteje kot posamični učinkovini.
English: • if you have diabetes mellitus or impaired kidney function and you are treated with Rasilez.
Slovenian: • če imate sladkorno bolezen ali okvaro ledvičnega delovanja in se zdravite z zdravilom Rasilez.
English: Ten per cent of original amlodipine and 60 % of amlodipine metabolites are excreted in urine.
Slovenian: Deset odstotkov prvotnega amlodipina in 60 % amlodipinovih presnovkov se izloči s sečem.
English: If patients experience these adverse reactions, they should avoid potentially hazardous tasks such as driving or using machines.
Slovenian: Bolniki z opisanimi neželenimi učinki se morajo izogibati opravilom, pri katerih lahko pride do nesreče, na primer vožnji ali upravljanju s stroji.
English: • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (‘water tablets'), low-salt diet, diarrhoea,
Slovenian: • nizek krvni tlak (hipotenzija), ki se pojavi, če ste dehidrirani (prevelika izguba vode v telesu), ali imate pomanjkanje soli zaradi diuretičnega zdravljenja ('tablet za odvajanje vode'), dieto z majhno vsebnostjo soli, drisko ali bruhate;
English: If you have the impression that the effect of Onduarp is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če menite, da je učinek zdravila Onduarp premočan ali prešibak, se pogovorite z zdravnikom ali s farmacevtom.
English: Total plasma clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 1,500 ml/min).
Slovenian: Skupni očistek iz plazme (Cltot) je v primerjavi z jetrnim krvnim pretokom (približno 1500 ml/min) velik (približno 1000 ml/min).
English: As with any antihypertensive medicinal product, excessive reduction of blood pressure in patients with ischaemic cardiomyopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Slovenian: Enako kot pri vseh antihipertenzivnih zdravilih lahko preveliko znižanje krvnega tlaka pri bolnikih z ishemično kardiomiopatijo ali ishemično srčnožilno boleznijo povzroči miokardni infarkt ali kap.
English: After oral administration of therapeutic doses, amlodipine is well absorbed with peak blood levels between 6-12 hours post dose.
Slovenian: Po peroralnem jemanju terapevtskih odmerkov se amlodipin dobro absorbira in doseže največjo raven v krvi po 6 do 12 urah.
English: Cardiac disorders bradycardia, palpitations
Slovenian: Srčne bolezni bradikardija, palpitacije
English: This has been confirmed in a subchronic (13-week) toxicology study in rats, in which dose levels of 3.2/0.8, 10/2.5 and 40/10 mg/kg of telmisartan and amlodipine were tested.
Slovenian: To je potrdila študija o subkronični toksičnosti (13-tedenska) pri podganah, v kateri so testirali odmerke telmisartana in amlodipina po 3,2/0,8, 10/2,5 in 40/10 mg/kg.
English: Before considering the concomitant use of medicinal products that affect the renin-angiotensinaldosterone system, the benefit risk ratio should be evaluated.
Slovenian: Pred odločitvijo za sočasno zdravljenje z zdravili, ki učinkujejo na renin-angiotenzin-aldosteronski sistem, je treba oceniti razmerje med koristjo in tveganjem njihove uporabe.
English: Dual blockade of the renin-angiotensin-aldosterone system (e.g. by administering telmisartan with other blockers of the renin-angiotensin-aldosterone system) is therefore not recommended.
Slovenian: Zato dvojnega zaviranja renin-angiotenzin-aldosteronskega sistema (npr. dajanja telmisartana z drugimi zaviralci renin-angiotenzin-aldosteronskega sistema) ne priporočajo.
English: • Narrowing of the blood vessels to one or both kidneys (renal artery stenosis).
Slovenian: • zožene krvne žile, ki vodijo do ene ali obeh ledvic (stenoza ledvične arterije),
English: • if you have severe liver problems or biliary obstruction (problems with drainage of the bile from the liver and gall bladder).
Slovenian: • če imate hude težave z jetri ali zaporo žolča (težave z odtekanjem žolča iz jeter in žolčnika);
English: Concomitant administration of 240 ml of grapefruit juice with a single oral dose of 10 mg amlodipine in 20 healthy volunteers did not show a significant effect on the pharmacokinetic properties of amlodipine.
Slovenian: Sočasno dajanje 240 ml grenivkinega soka in enkratnega peroralnega odmerka amlodipina po 10 mg 20 zdravim prostovoljcem ni pomembneje vplivalo na amlodipinovo farmakokinetiko.
English: In humans, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood pressure increase.
Slovenian: Pri ljudeh odmerek telmisartana 80 mg skoraj povsem zavre povečanje krvnega tlaka, ki ga povzroča angiotenzin II.
English: With concomitant use with the CYP3A4 inhibitor erythromycin in young patients and diltiazem in elderly patients respectively, the plasma concentration of amlodipine increased by 22 % and 50 % respectively.
Slovenian: Med sočasno uporabo z zaviralcem CYP3A4 eritromicinom pri mladih bolnikih in diltiazemom pri starejših bolnikih se je koncentracija amlodipina v plazmi povečala za 22 % oziroma za 50 %.
English: Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Slovenian: Amlodipin so preskušali pri bolnikih s kronično stabilno angino pektoris, vazospastično angino pektoris in z angiografijo dokazano koronarno arterijsko boleznijo.
English: Amlodipine In patients taking amlodipine alone the following additional side effects have been reported:
Slovenian: Amlodipin Pri bolnikih, ki so jemali samo amlodipin, so poročali še o naslednjih neželenih učinkih:
English: • Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets').
Slovenian: • zdravila, ki lahko zvišajo raven kalija v krvi, na primer nadomestki soli s kalijem, diuretiki, ki zadržujejo kalij (nekatere 'tablete za odvajanje vode');
English: Patients should be advised that they may experience adverse reactions such as syncope, somnolence, dizziness, or vertigo during treatment (see section 4.8).
Slovenian: Bolnike je treba poučiti, da se lahko med zdravljenjem pojavijo neželeni učinki, kot so sinkopa, zaspanost, omotica ali vrtoglavica (glejte poglavje 4.8).
English: What you need to know before you take Onduarp
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Onduarp
English: The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle, leading to reductions in peripheral vascular resistance and in blood pressure.
Slovenian: Mehanizem amlodipinovega antihipertenzivnega delovanja temelji na neposrednem relaksantnem učinku na gladko žilno mišico, ki zniža periferni žilni upor in krvni tlak.
English: - Amlodipine belongs to a group of substances called “calcium channel blockers”.
Slovenian: - Amlodipin sodi v skupino učinkovin, ki jih imenujemo 'zaviralci kalcijevih kanalčkov'.
English: • Haemodynamically unstable heart failure after acute myocardial infarction
Slovenian: • hemodinamično nestabilno srčno popuščanje po akutnem miokardnem infarktu.
English: Interactions linked to amlodipine
Slovenian: Interakcije, ki so povezane z amlodipinom
English: If your liver is not working properly, the usual dose should not exceed one 40 mg/5 mg tablet or one 40 mg/10 mg tablet per day.
Slovenian: Če imate motnje jetrnega delovanja, običajni odmerek zdravila ne sme biti večji od ene tablete po 40 mg/5 mg ali ene tablete po 40 mg/10 mg na dan.
English: It cannot be ruled out that strong inhibitors of CYP3A4 (i.e. ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of amlodipine to a greater extent than diltiazem.
Slovenian: Ni mogoče izključiti, da bi lahko močni zaviralci CYP3A4 (ketokonazol, itrakonazol, ritonavir) močneje povečali amlodipinovo koncentracijo v plazmi kot diltiazem.
English: Date of latest renewal:
Slovenian: November 2011 Datum zadnjega podaljšanja:
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists and calcium channel blockers; ATC Code: C09DB04.
Slovenian: Farmakoterapevtska skupina: zdravila, ki vplivajo na renin-angiotenzinski sistem, antagonisti angiotenzina II in zaviralci kalcijevih kanalčkov; oznaka ATC: C09DB04
English: • if you are allergic to telmisartan or amlodipine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na telmisartan ali amlodipin ali katero koli sestavino tega zdravila (navedeno v poglavju 6) ;
English: Slow heart beat, dizziness, reduced kidney function including kidney failure, marked and prolonged low blood pressure including shock and death have also been reported.
Slovenian: Poročali so tudi o počasnem bitju srca, omotici, zmanjšanem ledvičnem delovanju, tudi ledvični odpovedi, izrazito in dolgotrajno znižanem krvnem tlaku, tudi šoku in smrti.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJE
English: Hypersensitivity, anaphylactic reaction
Slovenian: preobčutljivost, anafilaktična reakcija
English: If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate za nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 28 tablets.
Slovenian: Pretisni omoti iz aluminija (PA/Al/PVC/Al) v kartonski škatli po 28 tablet.
English: • Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis)
Slovenian: • zapora iztočnega trakta levega prekata (npr. aortna stenoza visoke stopnje),
English: Amlodipine has not been associated with any adverse metabolic effects or changes in plasma lipids and is suitable for use in patients with asthma, diabetes, and gout.
Slovenian: Amlodipina ne povezujejo z neželenimi presnovnimi učinki ali spremembami ravni lipidov v plazmi, zato je primerno zdravilo za bolnike z astmo, sladkorno boleznijo ali protinom.
English: Patients with rare hereditary problems of fructose intolerance should not take Onduarp.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo ne smejo jemati zdravilaOnduarp.
English: Both of these substances help to control your high blood pressure: - Telmisartan belongs to a group of substances called “angiotensin-II receptor antagonists”.
Slovenian: Obe učinkovini uravnavata visok krvni tlak: - Telmisartan sodi v skupino učinkovin, ki jih imenujemo 'antagonisti receptorjev za angiotenzin II'.
English: Grapefruit and grapefruit juice
Slovenian: Grenivka in grenivkin sok
English: Animal reproductive toxicity studies with Onduarp have not been performed.
Slovenian: Študij o reproduktivni toksičnosti pri živalih z zdravilom Onduarp niso izvajali.
English: Amlodipine exhibits linear pharmacokinetics.
Slovenian: Za amlodipin je značilna linearna farmakokinetika.
English: • Medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g.
Slovenian: • zdravila za zdravljenje okužbe s HIV ali AIDSa (npr. ritonavir) ali za zdravljenje glivičnih okužb (npr. ketokonazol),
English: The oedema related events (peripheral oedema, generalised oedema, and oedema) were consistently lower in patients who received Onduarp as compared to patients who received amlodipine 10 mg.
Slovenian: Z edemom povezani dogodki (periferni edem, generalizirani edem in edem) so bili dosledno manj pogosti pri bolnikih, ki so jemali zdraviloOnduarp, kot pri bolnikih, ki so jemali amlodipin v odmerkih po 10 mg.
English: Unstable angina pectoris, acute myocardial infarction There are no data to support the use of Onduarp in unstable angina pectoris and during or within one month of a myocardial infarction.
Slovenian: Nestabilna angina pektoris in akutni miokardni infarkt Ni podatkov, na podlagi katerih bi lahko zdravilo Onduarp uporabili pri nestabilni angini pektoris in med miokardnim infarktom ali v obdobju enega meseca po njem.
English: Amlodipine is relatively vessel-selective, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells.
Slovenian: Amlodipin deluje relativno selektivno na krvne žile, njegov učinek na gladke mišice krvnih žil je močnejši od učinka na srčne mišične celice.
English: The reduction in diastolic blood pressure <90 mmHg was achieved in 71.6 %, 74.8 %, 82.1 %, 85.3% of patients respectively.
Slovenian: Diastolični krvni tlak se je znižal na manj kot 90 mm Hg pri 71,6 %, 74,8 %, 82,1 % oziroma 85,3 % bolnikov.
English: Investigations hepatic enzymes increased blood uric acid increased
Slovenian: Preiskave povečana raven jetrnih encimov povečana raven sečne kisline v krvi
English: Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as oedema, may be switched to Onduarp 40 mg/5 mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.
Slovenian: Bolnikom, ki se zdravijo z 10 mg amlodipina in imajo neželene učinke, kateri omejujejo velikost odmerka, na primer edeme, ga lahko zamenjamo s tabletami Onduarp po 40 mg/5 mg enkrat na dan in tako zmanjšamo odmerek amlodipina, ne da bi se zmanjšal pričakovani odziv na antihipertenzivno zdravljenje.
English: Caution is advised when using Onduarp in such patients as amlodipine and telmisartan are not dialysable (see also section
Slovenian: Zdravilo Onduarp je treba pri teh bolnikih uporabljati previdno, ker se amlodipin in telmisartan med dializo ne odstranita (glejte tudi poglavje
English: In elderly patients, amlodipine clearance tends to decline with resulting increases in AUC and elimination half-life.
Slovenian: Pri starejših bolnikih je opaziti manjšanje amlodipinovega očistka, zaradi česar se povečata AUC in razpolovna doba izločanja.
English: The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (>70 years) - Combination with one or more other medicinal products that affect the renin-angiotensin-aldosterone system and/or potassium supplements.
Slovenian: Glavni dejavniki tveganja za pojav hiperkaliemije, ki jih je treba upoštevati, so: - sladkorna bolezen, ledvična okvara, starost (> 70 let); - kombinacija z enim ali več drugimi zdravili, ki učinkujejo na renin-angiotenzin-aldosteronski sistem, ali s kalijevimi nadomestki.
English: Onduarp is contraindicated in patients with severe hepatic impairment (see section 4.3).
Slovenian: Zdravilo Onduarp je kontraindicirano za bolnike s hudo jetrno okvaro (glejte poglavje 4.3).