FrancophonIA/ELRC3.0 huggingface dataset:
English: Potassium sparing diuretics e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium.
Croatian: Diuretici koji štede kalij, npr. spirinolakton, eplerenon, triamteren, ili amilorid, kalijevi dodaci, ili zamjenske soli koje sadrže kalij mogu dovesti do značajnog povećanja kalija u serumu.
English: Serum potassium should be monitored closely in these patients (see section 4.5).
Croatian: Potrebno je pratiti vrijednosti kalija u serumu u ovih bolesnika (vidjeti dio 4.5).
English: Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Croatian: Lijekovi ili terapijske skupine lijekova koji mogu dovesti do hiperkalijemije su zamjena za soli koje sadrže kalij, diuretici koji štede kalij, ACE inhibitori, antagonisti receptora angiotenzina II, nesteroidni protuupalni lijekovi (NSAIL-i, uključujući selektivne COX-2 inhibitore), heparin, imunosupresivi (ciklosporin ili takrolimus) i trimetoprim.
English: In elderly patients, amlodipine clearance tends to decline with resulting increases in AUC and elimination half-life.
Croatian: Kod starijih bolesnika postoji sklonost smanjenju klirensa amlodipina što uzrokuje povećanje AUC-a i poluvremena eliminacije.
English: Concomitant use to be taken into account
Croatian: Istovremena primjena koja se mora uzeti u obzir
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.
Croatian: Također su prijavljeni usporeni otkucaji srca, omaglica, smanjena bubrežna funkcija uključujući zatajenje bubrega, izraženi i produljeni niski krvni tlak uključujući šok i smrt.
English: • Haemodynamically unstable heart failure after acute myocardial infarction
Croatian: • Hemodinamički nestabilno zatajenje srca nakon akutnog infarkta miokarda
English: • Severe hypotension
Croatian: • Teška hipotenzija
English: Nervous system disorders somnolence, migraine, headache, paraesthesia syncope, peripheral neuropathy, hypoaesthesia, dysgeusia, tremor
Croatian: Poremećaji živčanog sustava omaglica somnolencija, migrena, glavobolja, parestezija sinkopa, periferna neuropatija, hipoestezija, disgeuzija, tremor
English: Activated charcoal may be useful in the treatment of overdose of both telmisartan and amlodipine.
Croatian: Aktivni ugljen može biti koristan u liječenju predoziranja, i telmisartanom i amlodipinom.
English: Tendon pain (tendinitis like symptoms)
Croatian: Bol tetiva (simptomi slični tendinitisu)
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.
Croatian: Bilo je konstatno manje edema (periferni edem, generalizirani edem i edem) kod bolesnika koji su primali Onduarp u usporedbi s bolesnicima koji su primali amlodipin 10 mg.
English: If concomitant use is indicated because of documented hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium.
Croatian: Ako je indicirana istovremena primjena zbog prijavljene hipokalijemije, oni se primjenjuju s oprezom i uz često praćenje vrijednosti kalija u serumu.
English: This is because grapefruit and grapefruit juice may lead to increased blood levels of the active ingredient amlodipine in some patients and may increase the blood pressure lowering effect of Onduarp.
Croatian: Razlog za to je što grejp i sok od grejpa mogu dovesti do povećanja koncentracije djelatne tvari amlodipina u krvi kod nekih bolesnika te mogu povećati učinak snižavanja krvnog tlaka Onduarpa.
English: In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow, without change in filtration fraction or proteinuria.
Croatian: Kod hipertenzivnih bolesnika s normalnom bubrežnom funkcijom, terapijske doze amlodipina rezultiraju smanjenjem bubrežnog vaskularnog otpora i porastom brzine glomerularne filtracije te učinkovitim protokom plazme kroz bubreg bez promjene u filtracijskom udjelu ili proteinurije.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: High blood pressure, if not treated, can damage blood vessels in several organs, which puts patients at risk of serious events such as heart attack, heart or kidney failure, stroke, or blindness.
Croatian: Visoki krvni tlak, ako se ne liječi, može oštetiti krvne žile različitim organima i time povećavati rizik od teških događaja kao što su srčani udar, zatajenja srca ili bubrega, moždani udar ili sljepilo.
English: Myocardial infarction, arrhythmia, ventricular tachycardia, atrial fibrillation
Croatian: Infarkt miokarda, aritmija, ventrikularna tahikardija, fibrilacija atrija
English: Onduarp tablets contain two active substances called telmisartan and amlodipine.
Croatian: Onduarp tablete sadrže dvije djelatne tvari koje se nazivaju telmisartan i amlodipin.
English: These changes, also a class effect of angiotensin converting enzyme inhibitors and other angiotensin II receptor antagonists, do not appear to have clinical significance.
Croatian: Ove promjene, koje su također učinak skupine svih inhibitora enzima angiotenzin-konvertaze i drugih antagonista receptora angiotenzina II, nisu klinički značajne.
English: Automated ambulatory blood pressure monitoring (ABPM) performed in a subset of 562 patients confirmed the results seen with in-clinic systolic and diastolic blood pressure reductions consistently over the entire 24-hours dosing period.
Croatian: Automatizirana ambulantna praćenja krvnog tlaka, izvedena u podskupini od 562 bolesnika, potvrdila su kliničke rezultate o dosljednom sniženju sistoličkog i dijastoličkog krvnog tlaka tijekom 24-satnog razdoblja.
English: Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Croatian: Poznato je da izloženost antagonistu receptora angiotenzina II tijekom drugog i trećeg tromjesečja trudnoće inducira fetotoksičnost u ljudi (smanjena bubrežna funkcija, oligohidramnij, usporenje osifikacije lubanje) i neonatalnu toksičnost (zatajenje bubrega, hipotenzija, hiperkalijemija) (vidjeti dio 5.3).
English: Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.
Croatian: Amlodipin je inhibitor ulaska (dotoka) kalcijevih iona dihidropiridinske skupine (blokator sporih kanala ili antagonist kalcijevih iona), i inhibira transmembranski ulaz iona kalcija u srčani mišić i glatke mišiće krvnih žila.
English: The antihypertensive efficacy of telmisartan is comparable to that of substances representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril).
Croatian: Antihipertenzivni učinak telmisartana usporediv je s antihipertenzivnim učinkom drugih skupina antihipertenziva (pokazalo se u kliničkim ispitivanjima usporedbe telmisartana s amlodipinom, atenololom, enalaprilom, hidroklorotiazidom i lizinoprilom).
English: • Biliary obstructive disorders and severe hepatic impairment
Croatian: • Bilijarna opstrukcija i teško oštećenje jetre
English: Telmisartan is metabolised by conjugation to the glucuronide of the parent compound.
Croatian: Telmisartan se metabolizira konjugacijom izvorne tvari na glukuronid.
English: • Diabetes.
Croatian: • Dijabetes.
English: The most common adverse reactions include dizziness and peripheral oedema.
Croatian: Najčešće nuspojave uključuju omaglicu i periferni edem.
English: If you forget to take Onduarp
Croatian: Ako ste zaboravili uzeti Onduarp
English: heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
Croatian: imunosupresivi (npr. ciklosporin ili takrolimus) i antibiotik trimetoprim.
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Croatian: Aortalna i mitralna stenoza zaliska, opstruktivna hipertrofična kardiomiopatija Kao i uz druge vazodilatatore, potreban je osobit oprez kod bolesnika koji pate od aortne ili mitralne stenoze, ili opstruktivne hipertrofične kardiomiopatije.
English: Amlodipine has been safely administered with digoxin, warfarin, atorvastatin, sildenafil, anti-acid medicinal products (aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, ciclosporin, antibiotics and oral hypoglycaemic medicinal products.
Croatian: Amlodipin se sigurno primjenjuje uz digoksin, varfarin, atorvastatin, sildenafil, antacidne lijekove (aluminijev hidroksid, magenzijev hidroksid, simetikon), cimetidon, ciklosporin, antibiotike i oralne hipoglikemijske lijekove.
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.
Croatian: Glavni rizični faktori za hiperkalijemiju koje je potrebno razmotriti su: - Dijabetes melitus, oštećenje bubrega, dob (>70 godina) - Kombinacija s jednim ili više drugih lijekova koji utječu na sustav renin-angiotenzin-aldosteron i/ili dodacima koji sadržavaju kalij.
English: In a subset of 1050 patients with moderate to severe hypertension (DBP ≥100 mmHg) 32.7 - 51.8 % responded sufficiently to monotherapy of either telmisartan or amlodipine.
Croatian: U podskupini od 1050 bolesnika s umjerenom do teškom hipertenzijom (DKT≥100 mmHg) 32,7-51,8% je reagiralo dostatno na monoterapiju, bilo telmisartanom ili amlodipinom.
English: Non-steroidal anti-inflammatory medicinal products NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
Croatian: NSAIL-i (tj. acetilsalicilna kiselina u protuupalnim režimima doziranja, COX-2 inhibitori i neselektivni NSAIL-i) mogu smanjiti antihipertenzivan učinak antagonista receptora angiotenzina II.
English: As a consequence of inhibiting the renin-angiotensin-aldosterone system, hypotension, syncope, hyperkalaemia and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system.
Croatian: Kao posljedica inhibicije sustava renin-angiotenzin-aldosteron, prijavljene su hipotenzija, sinkopa, hiperkalemija i promjene bubrežne funkcije (uključujući akutno bubrežno zatajenje) kod osjetljivih pojedinaca, osobito u slučaju kombinacije lijekova koji utječu na taj sustav.
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
Croatian: Kada se dijagnosticira trudnoća, liječenje antagonistima receptora angiotenzina II se mora odmah prekinuti, te ako je potrebno početi s alternativnom terapijom.
English: Furthermore it was shown that some patients not adequately controlled with Onduarp 40 mg/10 mg had additional blood pressure reduction by uptitration to Onduarp 80 mg/10 mg.
Croatian: Nadalje, pokazano je da neki bolesnici koji nisu bili odgovarajuće kontrolirani uz Onduarp 40 mg/10 mg, podizanjem doze na Onduarp 80mg/10 mg imaju dodatno sniženje krvnog tlaka.
English: Other conditions with stimulation of the renin-angiotensin-aldosterone system In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Croatian: Kod bolesnika čiji vaskularni tonus i funkcija bubrega većinom ovise o aktivnosti sustava reninangiotenzin-aldosteron (npr. bolesnici s teškim kongestivnim zatajenjem srca ili fundamentalnom bolešću bubrega, uključujući stenozu bubrežne arterije), liječenje proizvodima koji utječu na ovaj sustav povezano je s akutnom hipotenzijom, hiperazotemijom, oligurijom, ili, rijetko, akutnim zatajenjem bubrega (vidjeti dio 4.8).
English: The pharmacokinetics of amlodipine are not significantly influenced by renal impairment.
Croatian: Farmakokinetika amlodipina ne utječe značajno na oštećenje bubrega.
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the co-administration of angiotensin II receptor antagonists and medicinal products that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Croatian: Kod pojedinih bolesnika s kompromitiranom bubrežnom funkcijom (npr. dehidrirani bolesnici ili starije osobe s kompromitiranom bubrežnom funkcijom), koadministracija antagonista receptora angiotenzina II i lijekova koji inhibiraju ciklooksigenazu može rezultirati daljnjom deterioracijom bubrežne funkcije, uključujući moguće akutno zatajenje bubrega koje je obično reverzibilno.
English: Onduarp is available in a folding box containing 28 tablets in aluminium/aluminium blisters and in a folding box containing 360 (4 x 90 x 1) tablets in aluminium/aluminium perforated unit dose blisters.
Croatian: Onduarp je dostupan u kutiji koja sadrži 28 tableta u aluminij/aluminij blisterima i u kutiji koja sadrži 360 (4 x 90 x 1) tableta u aluminij/aluminij perforiranim blisterima djeljivim na jedinične doze.
English: • Heart trouble.
Croatian: • Problemi sa srcem.
English: No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an effect on the postnatal development of the offspring such as lower body weight and delayed eye opening was observed.
Croatian: Ne postoje dokazi teratogenog učinka, ali studije na životinjama pokazale su potencijalni štetni učinak toksičnih doza telmisartana na postnatalni razvoj mladunčadi, kao što su manja tjelesna težina i odgođeno otvaranje očiju.
English: Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 28 tablets or aluminium/aluminium perforated unit dose blisters (PA/Al/PVC/Al) in multipacks containing 360 (4 packs of 90 x 1) tablets.
Croatian: Aluminij/aluminij blisteri (PA/Al/PVC/Al) u kutiji koja sadrži 28 tableta ili aluminij/aluminij perforirani blisteri djeljivi na jedinične doze (PA/Al/PVC/Al) u kutiji koja sadrži višestruka pakovanja koja sadrže 360 (4 pakovanja od 90 x 1) tableta.
English: Telmisartan is highly bound to plasma protein in renal-insufficient subjects and cannot be removed by dialysis.
Croatian: Telmisartan se uveliko veže za proteine plazme kod osoba s insuficijencijom bubrega, te se ne može ukloniti dijalizom.
English: In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals.
Croatian: U pretkliničkim studijama sigurnosti, doze čije izlaganje je usporedivo s dozama unutar kliničkog terapijskog raspona izazvale su smanjene parametre crvenih zrnaca (eritrocita, hemoglobina, hematokrita) i promjene u renalnoj hemodinamici (povišeni dušik iz ureje i kreatinin u krvi ), kao i porast kalija u serumu kod normotenzivnih životinja.
English: • NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen),
Croatian: • NSAIL-i (nesteroidni protuupalni lijekovi, npr. acetilsalicilna kiselina ili ibuprofen), heparin,
English: Investigations hepatic enzymes increased blood uric acid increased
Croatian: Pretrage povišene vrijednosti jetrenih enzima povišene vrijednosti mokraćne kiseline u krvi
English: If you stop taking Onduarp
Croatian: Ako prekinete koristiti Onduarp
English: Each tablet contains 168.64 mg sorbitol (E420).
Croatian: Jedna tableta sadržava 168,64 mg sorbitola (E420).
English: - Intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis, worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extensive trauma).
Croatian: - Interkurentni događaji, osobito dehidracija, akutna dekompenzacija srca, metabolička acidoza, pogoršanje bubrežne funkcije, iznenadno pogoršanje stanja bubrega (npr. infektivne bolesti), liza stanica (npr. akutna ishemija uda, rabdomioliza, produljena trauma).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: Ime i adresa nositelja odobrenja
English: Onduarp once daily produces effective and consistent reductions in blood pressure across the 24-hour therapeutic dose range.
Croatian: Jednokratna dnevna primjena Onduarpa dovodi do učinkovitog i stalnog sniženja krvnog tlaka tijekom 24-satnog terapijskog raspona doziranja.
English: Therefore it is not expected to potentiate bradykinin-mediated adverse reactions.
Croatian: Stoga se ne očekuju nuspojave posredovane bradikininom.
English: Each tablet contains 337.28 mg sorbitol (E420).
Croatian: Jedna tableta sadržava 337,28 mg sorbitola (E420).
English: In an 8-week multicenter, randomised, double-blind, placebo-controlled, parallel group factorial study in 1461 patients with mild to severe hypertension (mean seated diastolic blood pressure ≥95 and ≤119 mmHg), treatment with each combination dose of Onduarp resulted in significantly greater diastolic and systolic blood pressure reductions and higher control rates compared to the respective monotherapy components.
Croatian: U 8-tjednoj, multicentričnoj, randomiziranoj, dvostruko-slijepoj, placebom kontroliranoj, faktorijalnoj studiji na paralelnim skupinama na 1461 bolesnika s blagom do umjerenom hipertenzijom (prosječni dijastolički krvni tlak u sjedećem položaju ≥95 i ≤119 mmHg), liječenje svakom od kombiniranih doza Onduarpa rezultiralo je značajno većim sniženjem dijastoličkog i sistoličkog krvnog tlaka te višom stopom kontrole u usporedbi s relevantnim monoterapijskim komponentama.
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.
Croatian: Uz istovremenu primjenu s CYP3A4 inhibitorom, eritromicinom kod mladih osoba te diltiazema kod starijih osoba, koncentracije amlodipina u plazmi povećale su se za 22 % i 50 %, po istom redoslijedu.
English: Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Croatian: Osim ako se produljeno liječenje antagonistima receptora angiotenzina II ne smatra neophodnom, bolesnice koje planiraju trudnoću moraju nastaviti liječenje pogodnim drugim antihipertenzivima koji imaju utvrđen profil sigurnosti za primjenu u trudnoći.
English: Japanese patients are more likely to experience these adverse reactions.
Croatian: Japanski bolesnici će vjerojatno češće imati ove nuspojave u odnosu na ostale bolesnike
English: Other medicines and Onduarp
Croatian: Uzimanje drugih lijekova uz Onduarp
English: Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance.
Croatian: Kod bolesnika s bilijarnom opstrukcijom ili insuficijencijom jetre može se očekivati smanjen klirens.
English: Angioedema (with fatal outcome), drug eruption, toxic skin eruption, urticaria
Croatian: Angioedem (s fatalnim ishodom), medikamentni osip, toksične erupcije na koži, urtikarija
English: Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening.
Croatian: Amlodipin blokira ulazak kalcija u stijenke krvnih žila, što zaustavlja stezanje krvnih žila.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE lIJEKA U PROMET
English: In patients with hypertension, once daily dosing provides clinically significant reductions of blood pressure in both the supine and standing positions throughout the 24 hour interval.
Croatian: Kod bolesnika s hipertenzijom, jedna dnevna doza osigurava klinički značajno sniženje krvnog tlaka u ležećem i uspravnom položaju, tijekom 24 satnog razdoblja.
English: How to take Onduarp
Croatian: Kako uzimati Onduarp
English: Posology The recommended dose of Onduarp is one tablet per day.
Croatian: Doziranje Preporučena doza Onduarpa je jedna tableta dnevno.
English: In another multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 947 patients with mild to severe hypertension who were not adequately controlled on amlodipine 10 mg received Onduarp (40 mg/10 mg or 80 mg/10 mg) or amlodipine alone (10 mg).
Croatian: U drugoj multicentričnoj, randomiziranoj, dvostruko-slijepoj, aktivno kontroliranoj studiji na paralelnim skupinama, ukupno 947 bolesnika s blagom do umjerenom hipertenzijom koji nisu bili odgovarajuće kontrolirani amlodipinom 10 mg primalo je Onduarp (40 mg/10 mg ili 80 mg/10 mg) ili samo amlodipin (10 mg).
English: Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension (see sections 4.3 and 4.4).
Croatian: Novorođenčad čije su majke uzimale antagoniste receptora angiotenzina II se moraju pažljivo promatrati radi moguće hipotenzije (vidjeti dijelove 4.3 i 4.4).
English: Animal reproductive toxicity studies with Onduarp have not been performed.
Croatian: Nisu provedene studije reproduktivne toksičnosti na životinjama.
English: The concomitant use of amlodipine and grapefruit or grapefruit juice is still not recommended in patients as the bioavailability of amlodipine may increase in some and may result in increased hypotensive effects.
Croatian: Istovremena primjena amlodipina i grejpa ili soka od grejpa se još uvijek ne preporučuje kod bolesnika jer se bioraspoloživost amlodipina u nekim slučajevima može povećati te može rezultirati povećanjem hipotenzivnog učinka.
English: No posology adjustment is required for patients with mild to moderate renal impairment.
Croatian: Nije potrebno prilagođavanje doze za bolesnike s blagim do umjerenim oštećenjem bubrega.
English: • Kidney disease or kidney transplant.
Croatian: • Bolest bubrega ili transplatacija bubrega.
English: Close monitoring of renal function is advisable if co-administration is considered necessary.
Croatian: Preporučuje se pažljivo praćenje bubrežne funkcije u slučaju da se istovremena primjena smatra nužnom.