FrancophonIA/ELRC3.0 huggingface dataset:
English: Swallow the tablets with a glass of water.
Croatian: Progutajte tablete s čašom vode.
English: Stevens-Johnson syndrome
Croatian: Stevens-Johnsonov sindrom -
English: CYP3A4 inhibitors
Croatian: CYP3A4 inhibitori
English: This will help you get the best results and lower the risk of side effects.
Croatian: To će Vam pomoći u postizanju najboljih rezultata i smanjenju rizika od nuspojava.
English: Use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and foetus.
Croatian: Primjena u trudnoći preporučuje se samo kad ne postoji sigurnija alternativa i kad sama bolest nosi veći rizik za majku i fetus.
English: Follow your doctor's instructions for the starting dose carefully.
Croatian: Pridržavajte se pažljivo uputa svog liječnika o početnoj dozi.
English: PVC/PVDC blisters.
Croatian: PVC/PVDC blisteri.
English: However, if it is almost time for your next dose, skip the dose you missed.
Croatian: Međutim, ako je već blizu vrijeme za sljedeću dozu, preskočite propuštenu dozu.
English: Paediatric population (age below 18 years) No pharmacokinetic data are available in the paediatric population.
Croatian: Pedijatrijska populacija (ispod 18 godina starosti) Nisu dostupni farmakokinetički podaci u pedijatrijskoj populaciji.
English: The clinical translation of these pharmacokinetic variations may be more pronounced in the elderly.
Croatian: Klinička translacija takvih farmakokinetičkih varijacija može biti izraženija u starijih osoba.
English: In elderly patients, caution is required when increasing the dosage.
Croatian: U starijih bolesnika je potreban oprez prilikom povećavanja doze.
English: Dafiro and older people (age 65 years or over) Your doctor should exercise caution when increasing your dose.
Croatian: Dafiro i starije osobe (starosti od 65 ili više godina) Vaš liječnik treba oprezno postupati kod povećavanja doze.
English: In two long-term follow-up studies the effect of Dafiro was maintained for over one year.
Croatian: U dva dugotrajna ispitivanja praćenja, učinak Dafira bio je održan tijekom više od jedne godine.
English: D-90429 Nuremberg Germany
Croatian: D-90429 Nuremberg Njemačka
English: Other medicines and Dafiro
Croatian: Drugi lijekovi i Dafiro
English: A few patients have experienced these serious side effects (may affect up to 1 in 1,000 people).
Croatian: Nekoliko bolesnika je imalo ove ozbiljne nuspojave (mogu se javiti kod 1 na 1000 osoba).
English: One blister contains 7, 10 or 14 film-coated tablets.
Croatian: Jedan blister sadrži 7, 10 ili 14 filmom obloženih tableta.
English: If any of these cause you problems or if they last for more than one week, you should contact your doctor.
Croatian: Ako Vam bilo koja od ovih nuspojava stvara probleme ili ako one potraju dulje od jednog tjedna, obratite se svojem liječniku.
English: Dafiro is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Croatian: Dafiro se ne preporučuje u ranoj trudnoći (prva 3 mjeseca) te se ne smije uzimati kada ste trudni više od 3 mjeseca, jer može ozbiljno naštetiti Vašem djetetu ako se uzima nakon trećeg mjeseca trudnoće.
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Croatian: Epidemiološki dokaz rizika teratogenosti nakon izlaganja ACE inhibitorima tijekom prvog tromjesečja trudnoće nije zaključan; međutim, mali porast rizika se ne može isključiti.
English: Given their similar pharmacodynamic properties, these results are also relevant for other ACE inhibitors and ARBs.
Croatian: S obzirom na njihova slična farmakodinamička svojstva, ti su rezultati relevantni i za druge ACE inhibitore i ARB-ove.
English: Elimination: Valsartan shows multiexponential decay kinetics (t½α <1 h and t½ß about 9 h).
Croatian: Eliminacija: Valsartan pokazuje multieksponencijalnu kinetiku raspadanja (t½α <1 h i t½ß oko 9 h).
English: Carcinogenesis, mutagenesis
Croatian: Karcinogeneza, mutageneza
English: Approximate size: diameter 8.20 mm.
Croatian: Približna veličina: promjer 8,20 mm.
English: Treatment can be continued once blood pressure has been stabilised.
Croatian: Liječenje se može nastaviti kada se krvni tlak stabilizira.
English: - Swelling of eyelids, face or lips.
Croatian: - Oticanje očnih kapaka, lica ili usnica.
English: What Dafiro is and what it is used for
Croatian: Što je Dafiro i za što se koristi
English: If you have taken too many tablets of Dafiro, or if someone else has taken your tablets, consult a doctor immediately.
Croatian: Ako ste uzeli previše tableta Dafira, ili ako je netko drugi uzeo Vaše tablete, odmah se posavjetujte s liječnikom.
English: Do not take Dafiro if you are allergic to amlodipine or to any other calcium channel blockers.
Croatian: Nemojte uzimati Dafiro ako ste alergični na amlodipin ili na bilo koji drugi blokator kalcijevih kanala.
English: Grapefruit or grapefruit juice
Croatian: Grejp ili sok od grejpa
English: Rare (may affect up to 1 in 1,000 people): Confusion.
Croatian: Rijetko (mogu se javiti kod 1 na 1000 osoba): Smetenost.
English: Peripheral neuropathy, neuropathy
Croatian: Periferna neuropatija, neuropatija
English: Clinical monitoring and dose adjustment may thus be required.
Croatian: Stoga može biti potrebno kliničko praćenje i prilagodba doze.
English: In double-blind, controlled clinical trials, the incidence of peripheral oedema by dose was as follows:
Croatian: U dvostruko slijepim, kontroliranim kliničkim ispitivanjima incidencija perifernih edema po dozi bila je sljedeća:
English: If you take more Dafiro than you should
Croatian: Ako uzmete više Dafira nego što ste trebali
English: Valsartan is highly bound to serum proteins (94-97%), mainly serum albumin.
Croatian: Valsartan se u velikoj mjeri veže na serumske proteine (94-97%), uglavnom na serumski albumin.
English: A total of 33,357 hypertensive patients aged 55 or older were randomised and followed for a mean of 4.9 years.
Croatian: Randomizirano je ukupno 33 357 hipertenzivnih bolesnika u dobi od 55 godina ili stariji randomizirano je u terapijske skupine i praćeno u prosjeku 4,9 godina.
English: Date of first authorisation: 16 January 2007 Date of latest renewal: 21 November 2011
Croatian: Datum prvog odobrenja: 16. siječanj 2007.
English: This metabolite is pharmacologically inactive.
Croatian: Taj metabolit nije farmakološki aktivan.
English: The following side effects have been reported.
Croatian: Prijavljene su sljedeće nuspojave.
English: Approximate size: 14.2 mm (length) x 5.7 mm (width).
Croatian: Približna veličina: 14,2 mm (dužina) x 5,7 mm (širina).
English: if you have had heart failure or have experienced a heart attack.
Croatian: ako ste imali zatajivanje srca ili ste doživjeli srčani udar.
English: There were only modest signs of maternal toxicity (moderate reduction of body weight) in this study.
Croatian: U ovom su ispitivanju nađeni tek skromni znakovi materinske toksičnosti (umjereno smanjenje tjelesne težine).
English: Mean absolute bioavailability is 23%.
Croatian: Srednja vrijednost apsolutne bioraspoloživosti je 23%.
English: Talk to your doctor before taking Dafiro: if you have been sick (vomiting or diarrhoea).
Croatian: Obratite se svom liječniku prije nego uzmete Dafiro: ako ste bili bolesni (povraćanje ili proljev).
English: Concomitant use not recommended
Croatian: Istodobna primjena nije preporučena
English: Your doctor will normally advise you to stop taking Dafiro before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Dafiro.
Croatian: Liječnik će Vas u pravilu savjetovati da prekinete uzimati Dafiro prije trudnoće ili čim saznate da ste trudni te će Vas savjetovati da uzmete drugi lijek umjesto Dafira.
English: Similar outcomes have been reported with valsartan.
Croatian: Slični ishodi prijavljeni su za valsartan.
English: • Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Croatian: • Drugo i treće tromjesečje trudnoće (vidjeti dijelove 4.4 i 4.6).
English: Placebo-controlled trials
Croatian: Placebo kontrolirana ispitivanja
English: Over 1,400 hypertensive patients received Dafiro once daily in two placebo-controlled trials.
Croatian: Više od 1400 hipertenzivnih bolesnika primalo je Dafiro jednom dnevno u dva placebo kontrolirana klinička ispitivanja.
English: Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption.
Croatian: Pokazano je da primjena aktivnog ugljena zdravim dobrovoljcima odmah ili do dva sata nakon ingestije amlodipina značajno smanjuje apsorpciju amlodipina.
English: Biotransformation: Amlodipine is extensively (approximately 90%) metabolised in the liver to inactive metabolites.
Croatian: Biotransformacija: Amlodipin se u velikoj mjeri (otprilike 90%) metabolizira u jetri do inaktivnih metabolita.
English: Valsartan is primarily eliminated in faeces (about 83% of dose) and urine (about 13% of dose), mainly as unchanged drug.
Croatian: Valsartan se primarno eliminira stolicom (oko 83% doze) i mokraćom (oko 13% doze), uglavnom kao nepromijenjen lijek.
English: The safety and efficacy of Dafiro in children aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost Dafira u djece u dobi ispod 18 godina nisu ustanovljene.
English: If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with Dafiro.
Croatian: Ako se diuretik također koristi, rizik od toksičnosti litija vjerojatno se može povećati i više s Dafirom.
English: Some side effects can be serious and need immediate medical attention:
Croatian: Neke nuspojave mogu biti ozbiljne i zahtijevati neodgodivo liječenje:
English: In vitro studies with amlodipine have shown that approximately 97.5% of circulating drug is bound to plasma proteins.
Croatian: In vitro ispitivanja s amlodipinom pokazala su da se u otprilike 97,5% cirkulirajućeg lijeka veže na proteine plazme.
English: You must tell your doctor if you think you are (or might become) pregnant.
Croatian: Morate obavijestiti svog liječnika ako mislite da ste (ili biste mogli postati) trudni.
English: Thrombocytopenia, sometimes with purpura
Croatian: Trombocitopenija, ponekad s purpurom
English: Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Croatian: Prijavljena je izražena i potencijalno produljena sistemska hipotenzija uključujući šok sa smrtnim ishodom.
English: This reduction in AUC is not, however, accompanied by a clinically significant reduction in the therapeutic effect, and valsartan can therefore be given either with or without food.
Croatian: Međutim, to smanjenje AUC-a nije praćeno klinički značajnim smanjenjem terapijskog učinka, te se stoga valsartan može davati s hranom ili bez nje.
English: The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3-7%, with a maximum of 15%.
Croatian: Procijenjen je udio majčine doze koju primi dojenče, i njegov interkvartilni raspon iznosio je od 3 - 7 %, uz maksimum od 15 %.
English: It is recommended to limit the dose of simvastatin to 20 mg daily in patients on amlodipine.
Croatian: Preporučuje se ograničiti dozu simvastatina na 20 mg dnevno u bolesnika na amlodipinu.
English: Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Croatian: Valsartan se ne veže niti blokira druge hormonske receptore ili ionske kanale, za koje se zna da su važni u kardiovaskularnoj regulaciji.
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Croatian: Dok nema kontroliranih epidemioloških podataka o riziku s antagonistima receptora angiotenzina II (AIIRA), slični rizici mogu postojati i za ovu skupinu lijekova.
English: Consult a doctor immediately if you experience any of the following very rare, severe side effects after taking this medicine: - Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing.
Croatian: Odmah se javite liječniku ako osjetite bilo koju od sljedećih vrlo rijetkih, teških nuspojava nakon uzimanja ovog lijeka: - Iznenadno piskanje pri disanju, bol u prsima, nedostatak zraka ili teškoće pri disanju.
English: Primary hyperaldosteronism
Croatian: Primarni hiperaldosteronizam
English: A hydroxy metabolite has been identified in plasma at low concentrations (less than 10% of the valsartan AUC).
Croatian: U plazmi je identificiran hidroksi-metabolit u niskoj koncentraciji (manje od 10% AUC valsartana).
English: Do not take Dafiro with grapefruit or grapefruit juice.
Croatian: Ne uzimajte Dafiro s grejpom ili sokom od grejpa.
English: Dry mouth
Croatian: Suha usta
English: Do not stop taking your medicine unless your doctor tells you to.
Croatian: Nemojte prestati uzimati lijek osim po uputi liječnika.
English: * Based on patient weight of 50 kg
Croatian: * na temelju tjelesne težine bolesnika od 50 kg Valsartan
English: if you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin converting enzyme inhibitors).
Croatian: ako ste uočili pojavu oticanja, osobito lica i grla, dok ste uzimali druge lijekove (uključujući inhibitore angiotenzin konvertirajućeg enzima).
English: Therefore, monitoring of renal function at the beginning of the treatment is recommended, as well as adequate hydration of the patient.
Croatian: Stoga se preporučuje praćenje bubrežne funkcije na početku liječenja, kao i odgovarajuća hidracija bolesnika.
English: Correction of this condition prior to administration of Dafiro or close medical supervision at the start of treatment is recommended.
Croatian: Preporučuje se korigiranje ovog stanja prije primjene Dafira ili pažljiv liječnički nadzor na početku liječenja.
English: Plasma concentrations correlate with effect in both young and elderly patients.
Croatian: Koncentracije u plazmi koreliraju s učinkom i u mladih i u starijih bolesnika.
English: if you have a condition affecting the renal glands called “primary hyperaldosteronism”.
Croatian: ako bolujete od stanja koje utječe na nadbubrežne žlijezde, a naziva se „primarni hiperaldosteronizam“.
English: Both of these substances help to control high blood pressure.
Croatian: Obje tvari pomažu u kontroli povišenog krvnog tlaka.
English: Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Nuspojave su podijeljene prema učestalosti koja se definira kao: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podatka).
English: All changes were considered to be caused by the pharmacological action of valsartan which produces prolonged hypotension, particularly in marmosets.
Croatian: Za sve se promjene smatralo da ih je uzrokovalo farmakološko djelovanje valsartana koji stvara produljenu hipotenziju, osobito u marmoseta.
English: Valsartan works by blocking the effect of angiotensin II.
Croatian: Valsartan djeluje tako što blokira učinak angiotenzina II.
English: To date there is no experience of the safe use of Dafiro in patients who have had a recent kidney transplantation.
Croatian: Do danas ne postoji iskustvo o sigurnoj primjeni Dafira u bolesnika kojima je nedavno transplantiran bubreg.
English: During repeated administration, the maximum reduction in blood pressure with any dose is generally attained within 2-4 weeks and is sustained during long-term therapy.
Croatian: Tijekom ponovljene primjene, maksimalno se sniženje krvnog tlaka s bilo kojom dozom općenito se postiže unutar 2-4 tjedna te se održava tijekom dugotrajne terapije.
English: Hypertrophy of the renal juxtaglomerular cells was also seen in both species.
Croatian: Hipertrofija jukstaglomerularnih bubrežnih stanica također je viđena u obje vrste.
English: Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to
Croatian: Dob, spol, rasa ili indeks tjelesne mase (≥30 kg/m2, <30 kg/m2) nisu utjecali na odgovor na Dafiro.
English: What Dafiro is and what it is used for What you need to know before you take Dafiro How to take Dafiro
Croatian: Što je Dafiro i za što se koristi Što morate znati prije nego počnete uzimati Dafiro Kako uzimati Dafiro
English: The usual dose of Dafiro is one tablet per day.
Croatian: Uobičajena doza Dafira je jedna tableta na dan.
English: Distribution: The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively.
Croatian: Distribucija: Volumen distribucije valsartana u stanju dinamičke ravnoteže nakon intravenske primjene je oko 17 litara, što upućuje na to da se valsartan ne distribuira u većoj mjeri u tkiva.
English: Exceptional cases of extrapyramidal syndrome have been reported.
Croatian: Prijavljeni su izolirani slučajevi ekstrapiramidnog sindroma.
English: Amlodipine/Valsartan
Croatian: Amlodipin/Valsartan
English: Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication particularly with strong CYP3A4 inducers (e.g. rifampicin, hypericum perforatum).
Croatian: Stoga je potrebno pratiti krvni tlak i razmotriti reguliranje doze tijekom i nakon istodobnog liječenja, osobito s jakim induktorima CYP3A4 (npr. rifampicin, Hypericum perforatum).
English: It acts selectively on the receptor subtype AT1, which is responsible for the known actions of angiotensin II.
Croatian: Djeluje selektivno na podvrstu receptora AT1, odgovornu za poznata djelovanja angiotenzina II.
English: Mean systemic AUC of valsartan is higher by 70% in the elderly than in the young therefore caution is required when increasing the dosage.
Croatian: Srednja sistemska vrijednost AUC valsartana viša je za 70% u starijih osoba nego u mladih osoba, te je stoga nužan oprez pri povećavanju doze.
English: If any of the following happen, tell your doctor straight away:
Croatian: Ako se dogodi nešto od sljedećeg, odmah obavijestite svog liječnika:
English: Patients taking Dafiro and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Croatian: Bolesnici koji uzimaju Dafiro i upravljaju vozilima ili rade na strojevima trebaju imati na umu da se katkada mogu javiti omaglica ili iscrpljenost.
English: Children and adolescents The use of Dafiro in children and adolescents is not recommended (aged below 18 years old).
Croatian: Primjena Dafira u djece i adolescenata se ne preporučuje (ispod 18 godina starosti).
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatne tvari, derivate dihidropiridina, ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Other possible side effects of Dafiro:
Croatian: Ostale moguće nuspojave Dafira:
English: Some of these patients previously experienced angioedema with other medicinal products, including ACE inhibitors.
Croatian: Neki od tih bolesnika imali su angioedem i ranije, s drugim lijekovima, uključujući i ACE inhibitore.
English: What Dafiro contains
Croatian: Što Dafiro sadrži
English: Photosensitivity reaction
Croatian: Fotosenzitivna reakcija
English: The antihypertensive effect persists over 24 hours after administration.
Croatian: Antihipertenzivni učinak traje više od 24 sata nakon primjene.
English: Amlodipine belongs to a group of substances called “calcium channel blockers”.
Croatian: Amlodipin pripada skupini tvari koje se nazivaju „blokatori kalcijevih kanala“.
English: if you are allergic to valsartan or any of the other ingredients of Dafiro this medicine (listed in section 6).
Croatian: ako ste alergični na valsartan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: As with all other vasodilators, special caution is indicated in patients suffering from mitral stenosis or significant aortic stenosis that is not high grade.
Croatian: Kao i sa svim drugim vazodilatatorima, nužan je poseban oprez u bolesnika koji boluju od mitralne stenoze ili značajne stenoze aorte koja nije visokog stupnja.
English: Elimination: Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours.
Croatian: Eliminacija: Eliminacija amlodipina iz plazme je bifazna, s poluvijekom eliminacije od otprilike 30 do 50 sati.
English: Stopping your treatment with Dafiro may cause your disease to get worse.
Croatian: Prestanak liječenja Dafirom može dovesti do pogoršanja bolesti od koje bolujete.
English: In animal studies, reproductive toxicity was observed at high doses (see section 5.3).
Croatian: U ispitivanjima na životinjama opažena je reproduktivna toksičnost pri visokim dozama (vidjeti dio 5.3).
English: an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Croatian: ACE inhibitor (primjerice enalapril, lisinopril, ramipril), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću.
English: OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
Croatian: VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (S PLAVIM OKVIROM)
English: Dafiro is not recommended for mothers who are breastfeeding, 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: Dafiro se ne preporučuje majkama koje doje, a ako želite dojiti liječnik Vam može odabrati drugo liječenje, posebno ako je Vaše dijete novorođenče ili je prijevremeno rođeno.
English: At higher exposures, there were ulceration and erosion of the stomach mucosa in both females and males.
Croatian: Pri višim izloženostima, nastale su ulceracije i erozije sluznice želuca i u ženki i u mužjaka.
English: The recommended dose of Dafiro is one tablet per day.
Croatian: Preporučena doza Dafira je jedna tableta na dan.
English: In marmosets at comparable doses, the changes were similar though more severe, particularly in the kidney where the changes developed to a nephropathy including raised blood urea nitrogen and creatinine.
Croatian: U marmoseta su pri usporedivim dozama promjene bile slične iako teže, osobito u bubrezima, gdje su se promjene razvile u nefropatiju uključujući povišen dušik iz ureje u krvi i kreatinin.
English: Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses up to 200 mg/kg/day.
Croatian: Valsartan nije imao štetnih učinaka na reprodukciju mužjaka ili ženki štakora pri peroralnim dozama od najviše 200 mg/kg/dan.
English: The increased plasma levels of angiotensin II following AT1 receptor blockade with valsartan may stimulate the unblocked receptor subtype AT2, which appears to counterbalance the effect of the AT1 receptor.
Croatian: Povišene razine angiotenzina II u plazmi, nakon blokade AT1 receptora valsartanom, mogu stimulirati neblokiran podtip AT2 receptora, što, čini se, djeluje kao protuteža učinku AT1 receptora.
English: Interactions linked to amlodipine
Croatian: Interakcije povezane s amlodipinom
English: Arrhythmias (including bradycardia, ventricular tachycardia, and atrial fibrillation)
Croatian: Aritmije (uključujući bradikardiju, ventrikularnu tahikardiju i fibrilaciju atrija)