natgillin/translations-raw huggingface dataset:
Time to peak plasma amlodipine concentrations is similar in young and elderly patients.
Vrijeme do postizanja vršnih koncentracija amlodipina u plazmi slično je u mladih i starijih bolesnika.
The effect of amlodipine on infants is unknown.
Učinak amlodipina na dojenčad nije poznat.
14 film-coated tablets.
14 filmom obloženih tableta.
(calculations assume an oral dose of 320 mg/day and a 60-kg patient).
(u izračunima je korištena pretpostavka da je peroralna doza 320 mg/dan i da je tjelesna težina bolesnika 60 kg).
Allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, low blood pressure (feeling of faintness, light-headedness).
Alergijska reakcija sa simptomima poput osipa, svrbeža, oticanja lica ili usnica ili jezika, teškoće pri disanju, niski krvni tlak (osjećaj nesvjestice, ošamućenost).
Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Ukoliko nastavak terapije AIIRA-om nije neophodan, bolesnice koje planiraju trudnoću treba prebaciti na alternativna antihipertenzivna liječenja koja imaju utvrđen sigurnosni profil za primjenu u trudnoći.
Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers.
Reverzibilne biokemijske promjene u glavi spermija prijavljene su u nekih bolesnika liječenih blokatorima kalcijevih kanala.
These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing.
Ova sniženja krvnog tlaka nisu praćena značajnim promjenama srčane frekvencije ili razina katekolamina u plazmi kod kroničnog doziranja.
The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.
Kontraktilni procesi srčanog mišića i glatkog mišića krvnih žila ovise o kretanju izvanstaničnih iona kalcija u ove stanice kroz specifične ionske kanale.
If you get these symptoms, stop taking Dafiro and contact your doctor straight away.
Ako dobijete ove simptome, prekinite uzimati Dafiro i odmah se javite svom liječniku.
Toxic Epidermal Necrolysis
Toksična epidermalna nekroliza
Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease.
Bolesnici s primarnim hiperaldosteronizmom se ne bi trebali liječiti antagonistom angiotenzina II valsartanom, jer njihova primarna bolest utječe na sustav renin-angiotenzin.
Alopecia
Alopecija
Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function.
Evaluacija bolesnika sa zatajivanjem srca ili poslije infarkta miokarda uvijek mora uključivati i procjenu funkcije bubrega.
As expected for a compound where renal clearance accounts for only 30% of total plasma clearance, no correlation was seen between renal function and systemic exposure to valsartan.
Kao što se i očekuje za lijek čiji bubrežni klirens iznosi samo 30% ukupnog klirensa iz plazme, nije uočena korelacija između funkcije bubrega i sistemske izloženosti valsartanu.
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists, combinations; angiotensin II antagonists and calcium channel blockers, ATC code: C09DB01
Farmakoterapijska skupina: Lijekovi koji djeluju na renin-angiotenzinski sustav, antagonisti angiotenzina II, kombinacije; antagonisti angiotenzina II i blokatori kalcijevih kanala, ATK oznaka: C09DB01
Abrupt withdrawal of valsartan has not been associated with rebound hypertension or other adverse clinical events.
Nagli prekid liječenja valsartanom nije bio povezan s pojavom povratne hipertenzije ili drugih klinički štetnih događaja.
The safety of amlodipine in human pregnancy has not been established.
Sigurnost amlodipina u ljudskoj trudnoći nije utvrđen.
• Severe hypotension.
• Teška hipotenzija.
Co-administration of multiple doses of 10 mg amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone.
Istodobna primjena višestrukih doza od 10 mg amlodipina s 80 mg simvastatina rezultirala je povećanjem izloženosti simvastatinu za 77% u usporedbi sa samim simvastatinom.
The half life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established.
Poluvijek amlodipina je produljen i vrijednosti AUC-a su više u bolesnika s oštećenom jetrenom funkcijom; preporuke za doziranje nisu utvrđene.
There was no effect on the fertility of rats treated with amlodipine (males for 64 days and females 14 days prior to mating) at doses up to 10 mg/kg/day (8 times* the maximum recommended human dose of 10 mg on a mg/m basis).
Nije bilo učinka na plodnost štakora koji su primali amlodipin (mužjaci 64 dana i ženke 14 dana prije parenja) pri dozama od najviše 10 mg/kg/dan (8 puta* više od najviše preporučene doze za ljude od 10 mg izražene u mg/m2).
Not known Toxic Epidermal Necrolysis * mostly consistent with cholestasis
Nepoznato Toksična epidermalna nekroliza * uglavnom upućuje na kolestazu
Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or humans.
Amlodipin ne mijenja funkciju sinoatrijskog čvora ili atrioventrikularno provođenje u zdravih životinja ili ljudi.
The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4).
Primjena antagonista angiotenzin II receptora (AIIRA) se ne preporučuje tijekom prvog tromjesečja trudnoće (vidjeti dio 4.4).
Abrupt withdrawal of Dafiro has not been associated with a rapid increase in blood pressure.
Nagli prekid primjene Dafira nije bio povezan s naglim povišenjem krvnog tlaka.
This medicine may make you feel dizzy.
Ovaj lijek može uzrokovati omaglicu.
Amlodipine can have mild or moderate influence on the ability to drive and use machines.
Amlodipin može blago ili umjereno utjecati na sposobnost upravljanja vozilima i rada na strojevima.
This means that both of these substances help to stop the blood vessels tightening.
To znači da oba ova lijeka pomažu u sprečavanju sužavanja krvnih žila.
Amlodipine and valsartan exhibit linear pharmacokinetics.
Amlodipin i valsartan pokazuju linearnu farmakokinetiku.
To be taken into account with concomitant use
Što treba uzeti u obzir kod istodobne primjene
For therapeutic doses of valsartan in humans, the hypertrophy of the renal juxtaglomerular cells does not seem to have any relevance.
Kod terapijskih doza valsartana u ljudi čini se da hipertrofija jukstaglomerularnih bubrežnih stanica nema nikakav značaj.
• Obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis).
• Opstrukcija istisnog dijela lijevog ventrikula (npr. hipertrofična opstruktivna kardiomiopatija i aortalna stenoza visokog stupnja).
• Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere:
Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Intravenski kalcijev glukonat može pomoći u poništavanju učinaka blokade kalcijevih kanala.
The highest dose (for mice, similar to, and for rats twice* the maximum recommended clinical dose of 10 mg on a mg/m basis) was close to the maximum tolerated dose for mice but not for rats.
Najviša doza (za miševe slična, a za štakore jednaka dvostrukoj,* najvišoj preporučenoj kliničkoj dozi od 10 mg izraženoj u mg/m2) bila je blizu najviše podnošljive doze za miševe, ali ne i za štakore.
No drug-drug interaction studies have been performed with Dafiro and other medicinal products.
Nisu provedena ispitivanja interakcija među lijekovima s Dafirom i drugim lijekovima.
70 film-coated tablets.
70 filmom obloženih tableta.
Valsartan is an orally active, potent and specific angiotensin II receptor antagonist.
Valsartan je aktivan, potentan i specifičan antagonist angiotenzin II receptora pri peroralnoj primjeni.
Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Primjena antagonista angiotenzin II receptora (AIIRA - engl. angiotensin II receptor antagonists) ne smije se započeti tijekom trudnoće.
Amlodipine has been shown to pass into breast milk in small amounts.
Pokazalo se da amlodipin prelazi u majčino mlijeko u malim količinama.
What you need to know before you take Dafiro
Što morate znati prije nego počnete uzimati Dafiro
Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg/kg/day showed no evidence of carcinogenicity.
Štakori i miševi koji su dvije godine primali amlodipin s hranom u koncentracijama koje su prema izračunu osiguravale razine dnevnog doziranja od 0,5, 1,25 i 2,5 mg/kg/dan nisu pokazali nikakav dokaz karcinogenosti.
You can take Dafiro with or without food.
Dafiro možete uzimati s hranom ili bez nje.
On average, in patients with mild to moderate chronic liver disease exposure (measured by AUC values) to valsartan is twice that found in healthy volunteers (matched by age, sex and weight).
U bolesnika s blagom do umjerenom kroničnom bolešću jetre, izloženost (mjereno AUC vrijednostima) valsartanu u prosjeku je dva puta veća od one u zdravih dobrovoljaca (odgovarajuće uspoređenim s obzirom na dob, spol i težinu).
Patients with hepatic impairment have decreased clearance of amlodipine with resulting increase of approximately 40-60% in AUC.
Bolesnici s oštećenjem jetre imaju smanjeni klirens amlodipina s posljedičnim povećanjem AUC-a za otprilike 40-60%.
Furthermore, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Osim toga, istodobna primjena antagonista angiotenzina II i NSAIL-a može dovesti do povećanog rizika od pogoršanja bubrežne funkcije i do povećanja kalija u serumu.
In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalaemia after administration of verapamil and intravenous dantrolene.
U životinja su opaženi letalna ventrikularna fibrilacija i kardiovaskularni kolaps povezani s hiperkalijemijom nakon primjene verapamila i intravenskog dantrolena.
All packs are available with standard blisters; the 56, 98 and 280 tablet packs are additionally available with perforated unit dose blisters.
Sva pakiranja su dostupna sa standardnim blisterima; pakiranja s 56, 98 i 280 tableta su dodatno dostupna s perforiranim blisterima djeljivim na jedinične doze.
Dafiro is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets.
Dafiro je dostupan u pakiranjima koja sadrže 7, 14, 28, 30, 56, 90, 98 ili 280 tableta i u višestrukim pakiranjima koji sadrže 4 kutije, od kojih svaka sadrži 70 tableta, ili 20 kutija, od kojih svaka sadrži 14 tableta.
Multipack: 280 (4 packs of 70) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Višestruko pakiranje: 280 (4 pakiranja od 70) filmom obloženih tableta Višestruko pakiranje: 280 (20 pakiranja od 14) filmom obloženih tableta
In rats, maternally toxic doses (600 mg/kg/day) during the last days of gestation and lactation led to lower survival, lower weight gain and delayed development (pinna detachment and ear-canal opening) in the offspring (see section 4.6).
U štakora su doze pri kojima se javlja materinska toksičnost (600 mg/kg/dan) u posljednjim danima gestacije i laktacije dovele do nižeg preživljavanja, nižeg prinosa težine i odgođenog razvoja (odvojenost ušne školjke i otvaranje slušnog kanala) u mladunčadi (vidjeti dio 4.6).
As a result, the blood vessels relax and blood pressure is lowered.
Rezultat toga je opuštanje krvnih žila i snižavanje krvnog tlaka.
Food decreases exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (Cmax) by about 50%, although from about 8 h post dosing plasma valsartan concentrations are similar for the fed and fasted groups.
Hrana smanjuje izloženost (mjereno pomoću AUC) valsartanu za oko 40% i vršnu koncentraciju u plazmi (Cmax) za oko 50%, premda su koncentracije valsartana u plazmi oko 8 h nakon doziranja slične u skupini koja je uzimala hranu i skupini koja je bila natašte.
Experimental data suggest that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites.
Eksperimentalni podaci ukazuju da se amlodipin veže i na dihidropiridinska i na ne-dihidropiridinska vezna mjesta.
Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure.
Angiotenzin II se stvara u tijelu i dovodi do sužavanja krvnih žila te na taj način povećava krvni tlak.
Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Amlodipin je ispitivan u bolesnika s kroničnom stabilnom anginom, vazospastičnom anginom i angiografski dokumentiranom bolešću koronarnih arterija.
• Haemodynamically unstable heart failure after acute myocardial infarction.
• Hemodinamički nestabilno zatajivanje srca nakon akutnog infarkta miokarda.
The mean incidence of peripheral oedema evenly weighted across all doses was 5.1% with the amlodipine/valsartan combination.
Srednja vrijednost incidencije perifernih edema ravnomjerno raspoređena po svim dozama bila je 5,1% kod kombinacije amlodipin/valsartan.
Dafiro combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Dafiro kombinira dva antihipertenzivna sastojka s komplementarnim mehanizmima kontrole krvnog tlaka u bolesnika s esencijalnom hipertenzijom: amlodipin pripada skupini kalcijevih antagonista, dok valsartan pripada skupini antagonista angiotenzina II.
Do not use this medicine after the expiry date which is stated on the carton and blister.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake EXP.
Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and degrades bradykinin.
Valsartan ne inhibira ACE, poznat i kao kininaza II, koji pretvara angiotenzin I u angiotenzin II te razgrađuje bradikinin.
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Dojenčad čije su majke uzimale AIIRA-e treba pažljivo pratiti zbog hipotenzije (vidjeti dijelove 4.3 i
Erythema multiforme
Multiformni eritrem
Reproductive studies in rats and mice have shown delayed date of delivery, prolonged duration of labour and decreased pup survival at dosages approximately 50 times greater than the maximum recommended dosage for humans based on mg/kg.
Ispitivanja na reprodukciju štakora i miševa pokazala su odgodu okota, produljeno trajanje poroda i smanjeno preživljavanje mladunčadi pri dozama koje su otprilike 50 puta veće od najviše preporučene doze za ljude izražene u mg/kg.
Due to risk of hyperkalaemia, it is recommended that the co-administration of calcium channel blockers such as amlodipine be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.
Zbog rizika od hiperkalijemije preporučuje se izbjegavati istodobnu primjenu blokatora kalcijevih kanala kao što je amlodipin u bolesnika podložnih na malignu hipertermiju i u zbrinjavanju maligne hipertermije.
Dafiro can be used with or without food.
Dafiro se može primjenjivati s hranom ili bez nje.
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.
U bolesnika s blagim do umjerenim oštećenjem jetre, bez kolestaze, najviša preporučena doza valsartana je 80 mg.
Commonly used antihypertensive agents (e.g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e.g. tricyclic antidepressants, alpha blockers for treatment of benign prostate hyperplasia) may increase the antihypertensive effect of the combination.
Često primjenjivani antihipertenzivni lijekovi (npr. alfa-blokatori, diuretici) i drugi lijekovi koji mogu uzrokovati hipotenzivne nuspojave (npr. triciklički antidepresivi, alfa-blokatori za liječenje benigne hiperplazije prostate) mogu povećati antihipertenzivni učinak ove kombinacije.
Dafiro tablets contain two substances called amlodipine and valsartan.
Dafiro tablete sadrže dvije djelatne tvari koje se zovu amlodipin i valsartan.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Kada se trudnoća utvrdi, liječenje AIIRA-om treba odmah prekinuti te ako je prikladno, započeti alternativnu terapiju (vidjeti dijelove 4.3 i 4.6).
Co-administration of inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.
Istodobna primjena inhibitora prijenosnika pohrane (rifampicin, ciklosporin) ili efluksnog prijenosnika (ritonavir) može povećati sistemsku izloženost valsartanu.
Valsartan is mostly eliminated unchanged via the bile.
Valsartan se najvećim dijelom eliminira nepromijenjen putem žuči.
If hypotension occurs with Dafiro, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Ako se uz Dafiro pojavi hipotenzija, bolesnika treba poleći na leđa i po potrebi, mu dati intravensku infuziju fiziološke otopine.
No information is available regarding the use of Dafiro during breast-feeding, therefore Dafiro is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Budući da nisu dostupne informacije o primjeni Dafira tijekom dojenja, stoga se Dafiro tijekom dojenja ne preporučuje te se savjetuje alternativno liječenje s bolje utvrđenim sigurnosnim profilom tijekom dojenja, posebno kod dojenja novorođenčeta ili nedonoščeta.
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, including valsartan..
Prijavljena su reverzibilna povećanja koncentracija litija u serumu i toksičnost tijekom istodobne primjene litija s inhibitorima angiotenzin konvertirajućeg enzima ili antagonistima receptora angiotenzina II, uključujući valsartan.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Ako je do izloženosti AIIRA-ima došlo od drugog tromjesečja trudnoće nadalje, preporučuje se ultrazvučni pregled funkcije bubrega i lubanje.
If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.
Ako se u kombinaciji s valsartanom propisuje lijek koji utječe na razine kalija, savjetuje se praćenje razina kalija u plazmi.
The amlodipine component of Dafiro inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Amlodipinska komponenta Dafira inhibira transmembranski ulaz iona kalcija u srčani mišić i glatki mišić krvnih žila.
Dual blockade of RAAS through the combined use of ACE inhibitors, ARBs or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
Dvostruka blokada RAAS-a kombiniranom primjenom ACE inhibitora, ARB-ova ili aliskirena stoga se ne preporučuje (vidjeti dijelove 4.5 i 5.1).
For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Dafiro containing the same component doses.
Bolesnici koji primaju valsartan i amlodipin u odvojenim tabletama/kapsulama, mogu se radi jednostavnosti prebaciti na Dafiro koji sadrži iste doze sastojaka.
In a long-term, placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA (New York Heart Association Classification) III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
U dugotrajnom, placebo-kontroliranom ispitivanju (PRAISE-2) amlodipina u bolesnika sa zatajivanjem srca ne-ishemijske etiologije III. i IV. stupnja prema NYHA (New York Heart Association Classification), amlodipin je bio povezan s povećanim brojem izvještaja o plućnom edemu, unatoč beznačajnoj razlici u incidenciji pogoršanja zatajivanja srca u usporedbi s placebom.
Intrahepatic cholestasis, jaundice
Intrahepatična kolestaza, žutica
There is no experience of overdose with Dafiro.
Nema iskustva s predoziranjem Dafirom.
Clinical data are insufficient regarding the potential effect of amlodipine on fertility.
Nema dovoljno kliničkih podataka o mogućem učinku amlodipina na plodnost.
In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotaemia and (rarely) with acute renal failure and/or death.
U bolesnika s teškim zatajivanjem srca čija funkcija bubrega može ovisiti o aktivnosti sustava renin-angiotenzin-aldosteron, liječenje ACE inhibitorima i antagonistima receptora angiotenzina bilo je povezano s oligurijom i/ili progresivnom azotemijom, i (rijetko) s akutnim zatajenjem bubrega i/ili smrću.
As with other calcium channel blockers, haemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine have generally demonstrated a small increase in cardiac index without significant influence on dP/dt or on left ventricular end diastolic pressure or volume.
Kao i kod drugih blokatora kalcijevih kanala, hemodinamska mjerenja srčane funkcije u mirovanju i tijekom opterećenja (ili tempiranog hoda) u bolesnika s normalnom funkcijom ventrikula liječenih amlodipinom pokazala su općenito mali porast srčanog indeksa bez značajnog utjecaja na dP/dt ili na krajnji dijastolički tlak lijevog ventrikula ili volumen lijevog ventrikula.
ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE inhibitor or an ARB in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
ALTITUDE (eng. Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) je bilo ispitivanje osmišljeno za testiranje koristi dodavanja aliskirena standardnoj terapiji s ACE inhibitorom ili ARB-ovima u bolesnika sa šećernom bolešću tipa 2 i kroničnom bolešću bubrega, kardiovaskularnom bolešću ili oboje.
Peripheral oedema, a recognised side effect of amlodipine, was generally observed at a lower incidence in patients who received the amlodipine/valsartan combination than in those who received amlodipine alone.
Periferni edem, kao poznata nuspojava amlodipina, općenito je opažen s nižom incidencijom u bolesnika koji su primali kombinaciju amlodipina/valsartana, nego u onih koji su primali samo amlodipin.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Kada se trudnoća utvrdi, liječenje AIIRA-om treba odmah prekinuti te, ako je prikladno, započeti alternativnu terapiju.