FrancophonIA/ELRC3.0 huggingface dataset:
English: Cmax and to a lesser extent AUC increase disproportionately at doses above 40 mg.
Croatian: Cmax i, u manjoj mjeri, AUC se disproporcionatno povećavaju pri dozama iznad 40 mg.
English: If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Croatian: Ako ste slučajno uzeli previše tableta, odmah se obratite liječniku, ljekarniku, ili u hitnu službu najbliže bolnice.
English: Concomitant use not recommended
Croatian: Istovremena primjena se ne preporučuje
English: The safety and efficacy of Onduarp in children aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost Onduarpa u primjeni kod djece ispod 18 godina starosti nisu utvrđene.
English: No data from controlled clinical studies with the Fixed Dose Combination or with the individual components are available.
Croatian: Nisu dostupni podaci iz kontroliranih kliničkih studija s fiksnom dozom kombinacije niti s individualnim komponentama.
English: The functional role of these receptors is not known, nor is the effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan.
Croatian: Funkcionalna uloga ovih receptora nije poznata, a niti učinak njihove moguće pretjerane stimulacije angiotenzinom II, čije vrijednosti se povećavaju telmisartanom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Onduarp in all subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata studija Onduarpa u svim podskupinama pedijatrijske populacije u hipertenziji (vidjeti dio 4.2 radi podataka o pedijatrijskoj primjeni).
English: There are no adequate data from the use of Onduarp in pregnant women.
Croatian: Ne postoje odgovarajući podaci o primjeni Onduarpa u trudnoći.
English: • if you suffer from low heart output because of a serious heart problem.
Croatian: • ako patite od slabog minutnog volumena srca zbog teškog problema sa srcem.
English: Plasma aldosterone levels are decreased by telmisartan.
Croatian: Vrijednosti aldosterona u plazmi smanjuju se telmisartanom.
English: Absorption of telmisartan is rapid although the amount absorbed varies.
Croatian: Apsorpcija telmisartana je vrlo brza, iako apsorbirana količina varira.
English: Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek uzimajte lijek točno prema uputama liječnika.
English: Patients with rare hereditary problems of fructose intolerance should not take Onduarp.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze ne smiju uzimati Onduarp.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 November 2011
Croatian: Datum prvog odobrenja: 24. studeni 2011.
English: • Heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris).
Croatian: • Bol u prsima povezana sa srcem u stanju mirovanja ili uz minimalan napor (nestabilna angina pektoris).
English: No dose adjustment is necessary for elderly patients.
Croatian: Nije potrebna prilagodba doze za starije bolesnike.
English: Amlodipine is extensively (approximatively 90 %) metabolised by the liver to inactive metabolites.
Croatian: Amlodipin se u velikoj mjeri (oko 90%) metabolizira u jetri u neaktivne metabolite.
English: • Diltiazem (cardiac medicine).
Croatian: • diltiazem (lijek za srce).
English: Store in the original package in order to protect from light and moisture.
Croatian: Čuvati u originalnom pakovanju radi zaštite od svjetlosti i vlage.
English: Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours consistent with once daily dosing.
Croatian: Eliminacija amlodipina iz plazme je bifazna, s terminalnim poluvremenom eliminacije od oko 30 do 50 sati uz jednokratno dnevno doziranje.
English: Such conditions should be corrected before the administration of telmisartan.
Croatian: Ovakva stanja moraju biti korigirani prije početka primjene telmisartana.
English: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Croatian: Bolesnici s primarnim aldosteronizmom općenito neće reagirati na antihipertenzivne lijekove koji djeluju putem inhibicije sustava renin-angiotenzin.
English: By 3 hours after administration, plasma concentrations are similar whether telmisartan is taken fasting or with food.
Croatian: 3 sata nakon primjene, koncentracije u plazmi su slične, bez obzira je li telmisartan primjenjivan sa ili bez hrane.
English: There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Croatian: Nema dokaza mutagenosti i relevantne klastogene aktivnosti u in vitro studijama te nema dokaza kancerogenosti kod štakora i miševa.
English: Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:
Croatian: Molimo, obavijestite liječnika ako imate ili ste imali neko od sljedećih stanja ili bolesti:
English: Since the non-clinical toxicity profiles of telmisartan and amlodipine are not overlapping, no exacerbation of toxicity was expected for the combination.
Croatian: S obzirom da se neklinički profili toksičnosti telmisartana i amlodipina ne preklapaju, nije se očekivalo pogoršanje toksičnosti za kombinaciju.
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.
Croatian: Podaci o ograničenom broju izloženih trudnoća ne ukazuju da amlodipin ili drugi antagonisti kalcijevih receptora imaju štetan učinak na zdravlje fetusa.
English: Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment values over a period of several days without evidence of rebound hypertension.
Croatian: Nakon naglog prekida liječenja telmisartanom, krvni tlak se postupno vraća na vrijednosti prije liječenja tijekom nekoliko dana, bez dokaza o povratnoj hipertenziji.
English: In case of surgery or anaesthesia, you should tell your doctor that you are taking Onduarp.
Croatian: U slučaju kirurškog zahvata ili anestezije, potrebno je obavijestiti liječnika da uzimate Onduarp.
English: Onduarp has moderate influence on the ability to drive and use machines.
Croatian: Onduarp ima umjeren utjecaj na sposobnost upravljanja vozilima i strojevima.
English: Therefore, in these patients an appropriate blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required when indicated.
Croatian: Stoga je kod ovih bolesnika potrebno razmoriti odgovarajuće praćenje glukoze u krvi; može biti potrebno prilagođavanje doze inzulina ili antidijabetika, kada je indicirano.
English: • if you are allergic to telmisartan or amlodipine or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na telmisartan ili amlodipin ili neki drugi sastojak ovog lijeka (naveden u dijelu
English: - Amlodipine belongs to a group of substances called “calcium channel blockers”.
Croatian: - Amlodipin pripada skupini lijekova koji se nazivaju „blokatori kalcijevih kanala“.
English: Serious syncope may occur rarely (less than 1 case per 1,000 patients).
Croatian: Rijetko može doći do pojave teške sinkope (manje od 1 slučaja na 1000 bolesnika).
English: The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Croatian: Kombinacija ovih tvari ima dodatan antihipertenzivni učinak, snižujući krvni tlak u većoj mjeri nego svaka od komponenti zasebno.
English: The clinical relevance of this observation is not known.
Croatian: Klinički značaj ove opservacije nije poznat.
English: For telmisartan the posology should not exceed 40 mg once daily (see section 4.4).
Croatian: Doza telmisartana ne smije prelaziti 40 mg jedanput dnevno (vidjeti dio 4.4).
English: After oral (and intravenous) administration, telmisartan is nearly exclusively excreted with the faeces, mainly as unchanged compound.
Croatian: Nakon peroralne (i intravenske) primjene telmisartan se gotovo isključivo izlučivao fecesom, uglavnom u nepromijenjenom stanju.
English: The antihypertensive effect of Onduarp was similar irrespective of age and gender, and was similar in patients with and without diabetes.
Croatian: Antihipertenzivni učinak Onduarpa bio je sličan, bez obzira na dob i spol, te je bio sličan kod bolesnika sa i bez dijabetesa.
English: Infections and infestations cystitis
Croatian: Infekcije i infestacije cistitis
English: Onduarp is indicated for long term treatment.
Croatian: Onduarp je indicirana u dugotrajnom liječenju.
English: The overall incidence of adverse reactions with Onduarp in the clinical trial programme was low with only 12.7 % of patients on treatment experiencing adverse reactions.
Croatian: Ukupna incidencija nuspojava uz Onduarp u kliničkim ispitivanjima je bila niska, samo 12,7% bolesnika koji su liječeni Onduarpom je imalo nuspojave.
English: Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination half-life of >20 hours.
Croatian: Telmisartan je karakteriziran bieksponencijalnom eliminacijskom farmakokinetikom, s terminalnim poluvremenom eliminacije od >20 sati.
English: Your doctor will normally advise you to stop taking Onduarp before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Onduarp.
Croatian: Liječnik će Vam savjetovati prekid primjene Onduarpa prije početka trudnoće ili čim saznate da ste trudni, te će Vam preporučiti drugi lijek umjesto Onduarpa.
English: Psychiatric disorders depression, anxiety, insomnia
Croatian: Psihijatrijski poremećaji depresija, anksioznost, nesanica
English: The most common adverse reactions were peripheral oedema and dizziness, see also section 4.8.
Croatian: Najčešće nuspojave bile su periferni edem i omaglica, vidjeti također dio 4.8.
English: In this respect data concerning diastolic blood pressure (DBP) are inconsistent.
Croatian: U ovom pregledu podaci koji se tiču dijastoličkog krvnog tlaka (DKT) nisu dosljedni.
English: Ten per cent of original amlodipine and 60 % of amlodipine metabolites are excreted in urine.
Croatian: Deset posto originalnog amlodipina i 60% metabolita amlodipina se izlučuje putem urina.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Croatian: POSEBNO UPOZORENJE DA lIJEK TREBA ČUVATI IZVAN POGLEDA
English: Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of medicinal products.
Croatian: Iako nema kontroliranih epidemioloških podataka o riziku nakon izloženosti antagonistima receptora angiotenzina II, mogu postojati slični rizici uz ovu skupinu lijekova.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG lIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU
English: The maximum reduction in blood pressure is generally attained 4 to 8 weeks after the start of treatment and is sustained during long-term therapy.
Croatian: Maksimalno sniženje krvnog tlaka općenito se postiže 4-8 tjedana nakon početka liječenja te se održava tijekom duljeg razdoblja liječenja.
English: No interactions between the two components of this fixed dose combinations have been observed in clinical studies.
Croatian: Nisu primijećene interakcije između dviju komponenti ove fiksne kombinacije u kliničkim studijama.
English: When amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.
Croatian: Kada su se amlodipin i sildenafil primjenjivali u kombinaciji, svaki lijek je zasebno imao svoj vlastiti učinak snižavanja krvnog tlaka.
English: Total plasma clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 1,500 ml/min).
Croatian: Ukupni plazmatski klirens (Cltot) je visok (približno 1000 ml/min) u usporedbi s protokom krvi u jetri (oko 1 500 ml/min).
English: Steady-state plasma levels are reached after continuous administration for 7-8 days.
Croatian: Vrijednosti u plazmi pri stanju dinamičke ravnoteže postiže se nakon stalne primjene od 7-8 dana.
English: • Lithium-containing medicines to treat some types of depression.
Croatian: • Lijekovi koji sadrže litij za liječenje određenih tipova depresije.
English: This is confirmed by trough to peak ratios consistently above 80 % seen after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies.
Croatian: Ovo je potvrđeno odnosom minimalnih i maksimalnih vrijednosti stalno iznad 80%, a koje su zabilježene nakon doza od 40 i 80 mg telmisartana u placebom kontroliranim kliničkim ispitivanjima.
English: Amlodipine exhibits linear pharmacokinetics.
Croatian: Amlodipin pokazuje linearnu farmakokinetiku.
English: If you have the impression that the effect of Onduarp is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako imate dojam da je učinak Onduarpa prejak ili preslab, posavjetujte se s liječnikom ili ljekarnikom.
English: Telmisartan/Amlodipine
Croatian: Telmisartan/Amlodipin
English: There is no data available regarding the effect of CYP3A4 inducers on amlodipine.
Croatian: Ne postoje dostupni podaci s obzirom na učinak CYP3A4 induktora na amlodipin.
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Croatian: Bolesnici se moraju odgovarajuće hidrirati, treba razmotriti praćenje bubrežne funkcije nakon početka istovremene terapije i povremeno nakon toga.
English: Grapefruit juice and grapefruit should not be consumed when you take Onduarp.
Croatian: Grejp i sok od grejpa se ne bi trebali uzimati tijekom primjene Onduarpa.
English: • Medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g.
Croatian: • Lijekovi koji se primjenjuju u HIV/AIDS-u (npr. ritonavir) ili u liječenju gljivičnih infekcija
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.
Croatian: Nadalje, kao i uz sve antagoniste kalcija, poluživot amlodipina je produljen kod bolesnika s oštećenom funkcijom jetre, a preporučene doze nisu utvrđene.
English: Similarly, no effects on male and female fertility were reported for amlodipine (see section 5.3).
Croatian: Slično tome, nisu prijavljeni učinci amlodopina na mušku i žensku plodnost (vidjeti dio 5.3).
English: Telmisartan works by blocking the effect of angiotensin II.
Croatian: Telmisartan djeluje blokadom učinka angiotenzina II.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Poput svih lijekova, Onduarp može izazvati nuspojave, iako se one ne javljaju kod svih osoba.
English: The contribution of the medicinal product's diuretic and natriuretic effect to its hypotensive activity has still to be defined.
Croatian: Utjecaj diuretskog i natriuretskog djelovanja lijeka na njegov hipotenzivni učinak još nije definiran.
English: Overdose with amlodipine may result in excessive peripheral vasodilatation and possibly reflex tachycardia.
Croatian: Predoziranje amlodipinom može rezultirati prekomjernom perifernom vazodilatacijom i mogućom refleksnom tahikardijom.
English: The majority of the antihypertensive effect was attained within 2 weeks after initiation of therapy.
Croatian: Antihipertenzivni učinak postignut je u većini slučajeva 2 tjedna nakon početka liječenja.
English: Individual dose titration with the components (i.e. amlodipine and telmisartan) is recommended before changing to the fixed dose combination.
Croatian: Preporučuje se titracija pojedinačnih doza obje komponente (tj. amlodipina i telmisartana) prije prijelaza na fiksnu kombinaciju.
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.
Croatian: Primijećene su razlike koncentracija telmisartana u plazmi, tako što su Cmax i AUC oko 3 odnosno 2 puta veći, kod žena u usporedbi s muškarcima.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru nakon “Rok valjanosti”.
English: Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Croatian: Telmisartan ne inhibira enzim koji pretvara angiotenzin (kininaza II), enzim koji također razgrađuje bradikinin.
English: In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
Croatian: U jednom ispitivanju koadministracija telmisartana i ramiprila dovela je do porasta od 2,5 puta u AUC0-24 i Cmax ramiprila i ramiprilata.
English: When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 6 % (40 mg dose) to approximately 19 % (160 mg dose).
Croatian: Kada se telmisartan uzima s hranom, smanjenje u površini pod krivuljom (AUC0-00) telmisartana varira od približno 6% (doza od 40 mg) do približno 19% (doza od 160 mg).
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.
Croatian: Istovremena primjena 240 ml soka od grejpa s jednostrukom oralnom dozom od 10 mg amlodipina na 20 zdravih dobrovoljaca nije pokazala značajan učinak na farmakokinetička svojstva amlodipina.
English: No clinical relevance has been established.
Croatian: Nije utvrđen klinički značaj.
English: • Rasilez, a medicine used to treat high blood pressure.
Croatian: • Rasilez, lijek koji se primjenjuje u liječenju visokog krvnog tlaka.
English: Limited experience is available in patients with severe renal impairment or haemodialysis.
Croatian: Ograničena iskustva dostupna su za bolesnike s teškim oštećenjem bubrega ili bolesnike na hemodijalizi.
English: The time to reach peak plasma concentrations of amlodipine is similar in elderly and younger subjects.
Croatian: Vrijeme do postizanja maksimalnih koncentracija amlodipina u plazmi je slično kod starijih i mlađih ispitanika.
English: Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 28 tablets.
Croatian: Aluminij/aluminij blisteri (PA/Al/PVC/Al) u kutiji koja sadrži 28 tableta.
English: When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Croatian: U klinički prikladnim slučajevima, može se razmotriti izravan prijelaz s monoterapije na fiksnu kombinaciju.
English: Corticosteroids (systemic route) Reduction of the antihypertensive effect.
Croatian: Kortikosteroidi (sistemski put primjene) Smanjenje anithipertenzivnog učinka.
English: There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 10 mg amlodipine/kg/day (about 10 times the Maximum Recommended Human Dose of 10 mg/day on an mg/m2 basis).
Croatian: Nije bilo učinka na plodnost štakora oralno liječenih amlodipinmaleatom (mužjaci 64 dana i ženke 14 dana prije parenja) pri dozama do 10 mg amlodipin/kg/dan (oko 10 puta više od maksimalnih preporučenih doza za ljude od 10 mg/dan na mg/m baze).
English: Experimental data indicate that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites.
Croatian: Eksperimentalni podaci ukazuju da se amlodipin veže na dihidropiridinska i nedihidropiridinska vezna mjesta.
English: Values are adjusted for baseline and country.
Croatian: Vrijednosti su prilagođene prema početnoj vrijednosti i zemlji.
English: The safety and tolerability of Onduarp has been evaluated in five controlled clinical studies with over 3500 patients, over 2500 of whom received telmisartan in combination with amlodipine.
Croatian: Sigurnost i podnošljivost Onduarpa su ocjenjivane u pet kontroliranih kliničkih studija na više od 3500 bolesnika, od kojih je preko 2500 primalo telmisartan u kombinaciji s amlodipinom.
English: • if you have severe liver problems or biliary obstruction (problems with drainage of the bile from the liver and gall bladder).
Croatian: • ako imate teških problema s jetrom ili opstrukciju žuči (problemi s drenažom žuči iz jetre i žučnog mjehura).
English: The small reduction in AUC for telmisartan is not expected to cause a reduction in the therapeutic efficacy.
Croatian: Ne smatra se da malo smanjenje AUC-a za telmisartan dovodi do smanjenog terapijskog učinka.
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability of telmisartan up to nearly 100 %.
Croatian: Farmakokinetička ispitivanja bolesnika s oštećenjem jetre pokazala su povećanje apsolutne bioraspoloživosti telmisartana do gotovo 100%.
English: If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, posavjetujte se s liječnikom prije uzimanja ovog lijeka.
English: Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Croatian: Intravenski kalcijev glukonat može imati pozitivne učinke u prekidanju učinaka blokade kalcijevih kanala.
English: * Most cases of abnormal liver function and liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
Croatian: * Većina slučajeva abnormalne jetrene funkcije i poremećaja jetre iz iskustva nakon stavljanja lijeka u promet u vezi s telmisartanom se javio kod Japanskih bolesnika.
English: • Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis)
Croatian: • Opstrukcija izlaznog dijela lijevog ventrikula (npr. stenoza aorte visokog stupnja)
English: Management depends on the time since ingestion and the severity of the symptoms.
Croatian: Liječenje ovisi o vremenu proteklom od unosa i težini simptoma.
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.
Croatian: Ovo je potvrđeno u subkroničnoj (13-tjednoj) toksikološkoj studiji na štakorima, u kojoj su bile ispitivane razine doza od 3,2/0,8, 10/2,5 i 40/10 mg/kg telmisartana i amlodipina.
English: Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist.
Croatian: Telmisartan je oralno učinkovit i specifičan antagonist receptora angiotenzina II (tipa AT1).
English: Ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Posavjetujte se s liječnikom ili ljekarnikom prije početka primjene bilo kojeg lijeka.
English: Onduarp is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Croatian: Onduarp se ne preporučuje majkama koje doje, a liječnik može odabrati drugo liječenje za Vas ako želite dojiti, osobito ako je vaša beba novorođenče ili je prijevremeno rođena.