FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Med večkratno uporabo je največje znižanje krvnega tlaka pri vseh odmerkih praviloma doseženo v 2 do 4 tednih in se med dolgotrajnim zdravljenjem ohrani.
English: In elderly patients, caution is required when increasing the dosage.
Slovenian: Pri starejših bolnikih je treba odmerjanje povečevati previdno.
English: Valsartan is mostly eliminated unchanged via the bile.
Slovenian: Valsartan se večinoma izloči nespremenjen v žolču.
English: The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Slovenian: Kombinacija teh dveh učinkovin ima aditiven antihipertenziven učinek in znižuje krvni tlak v večji meri kot vsaka sestavina zase.
English: if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
Slovenian: če imate zoženje aortne zaklopke (aortno stenozo) ali kardiogeni šok (stanje, v katerem srce ne more črpati dovolj močno, da bi oskrbelo telo s krvjo).
English: As a result, the blood vessels relax and blood pressure is lowered.
Slovenian: Zato se žile sprostijo in krvni tlak se zniža.
English: This may involve itching, reddening of the skin or difficulty in breathing.
Slovenian: To lahko vključuje srbenje, rdečino kože ali oteženo dihanje.
English: Interactions linked to valsartan
Slovenian: Interakcije, povezane z valsartanom
English: if you have liver or kidney problems.
Slovenian: če imate težave z jetri ali ledvicami.
English: an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Slovenian: zaviralec ACE (na primer enalapril, lizinopril ali ramipril), zlasti če imate kakšne težave z ledvicami, ki so povezane s sladkorno boleznijo.
English: The safety and efficacy of Dafiro in children aged below 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Dafiro pri otrocih, starih manj kot 18 let, nista bili dokazani.
English: The following side effects have been reported.
Slovenian: Poročali so o naslednjih neželenih učinkih.
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.
Slovenian: Tako kot pri vseh vazodilatatorjih, je posebna previdnost potrebna pri bolnikih z mitralno stenozo ali s pomembno aortno stenozo, ki sicer ni močno izražena.
English: To date there is no experience of the safe use of Dafiro in patients who have had a recent kidney transplantation.
Slovenian: Doslej ni izkušenj glede varnosti uporabe zdravila Dafiro pri bolnikih, ki jim je bila nedavno presajena ledvica.
English: Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function.
Slovenian: Pregled bolnikov, ki imajo srčno popuščanje ali so v obdobju po miokardnem infarktu, mora vedno vključevati oceno ledvične funkcije.
English: Elimination: Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours.
Slovenian: Izločanje: Eliminacija amlodipina iz plazme je dvofazna s terminalnim razpolovnim časom eliminacije približno 30 do 50 ur.
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.
Slovenian: Pri marmozetkah so bile pri primerljivih odmerkih spremembe podobne, vendar bolj resne, še zlasti na ledvicah, kjer je prišlo do razvoja nefropatije, med drugim do zvišanja vrednosti dušika sečnine in kreatinina v krvi.
English: Stopping your treatment with Dafiro may cause your disease to get worse.
Slovenian: Če prenehate jemati zdravilo Dafiro, se lahko vaša bolezen poslabša.
English: if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Slovenian: če imate sladkorno bolezen ali okvarjeno delovanje ledvic in in se zdravite z zdravilom za zniževanje krvnega tlaka, ki vsebuje aliskiren.
English: Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000-fold) greater affinity for the AT1 receptor than for the AT2 receptor.
Slovenian: Valsartan nima delnega agonističnega učinka na receptorjih AT1, njegova afiniteta za receptorje AT1 pa je veliko (približno 20.000-krat) večja kot za receptorje AT2.
English: Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Slovenian: Valsartan se ne veže oz. ne zavira drugih hormonskih receptorjev ali ionskih kanalčkov, pomembnih za srčno-žilno regulacijo.
English: The usual dose of Dafiro is one tablet per day.
Slovenian: Običajni odmerek zdravila Dafiro je ena tableta na dan.
English: Abrupt withdrawal of Dafiro has not been associated with a rapid increase in blood pressure.
Slovenian: Nenadna prekinitev zdravila Dafiro ni povezana s hitrim zvišanjem krvnega tlaka.
English: - Heart attack, abnormal heart beat.
Slovenian: - srčni napad, nenormalen srčni utrip.
English: Other possible side effects of Dafiro:
Slovenian: Drugi možni neželeni učinki zdravila Dafiro:
English: if you have had heart failure or have experienced a heart attack.
Slovenian: če ste kdaj imeli srčno popuščanje ali ste preživeli srčni infarkt.
English: Other medicines and Dafiro
Slovenian: Druga zdravila in zdravilo Dafiro
English: For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Dafiro containing the same component doses.
Slovenian: Zaradi praktičnosti je možno bolnike, ki dobivajo valsartan in amlodipin v ločenih tabletah/kapsulah, prevesti na zdravilo Dafiro, ki vsebuje enaka odmerka sestavin.
English: 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.
Slovenian: Poleg tega lahko sočasna uporaba antagonistov angiotenzina II in NSAIDs poveča tveganje za poslabšanje delovanja ledvic ter povečanje kalija v serumu.
English: if you suffer from heart failure after a heart attack.
Slovenian: če imate srčno popuščanje po srčnem infarktu.
English: The recommended dose of Dafiro is one tablet per day.
Slovenian: Priporočeni odmerek zdravila Dafiro je ena tableta na dan.
English: The effect of amlodipine on infants is unknown.
Slovenian: Učinek amlodipina na dojene otroke ni znan.
English: Some of these patients previously experienced angioedema with other medicinal products, including ACE inhibitors.
Slovenian: Pri nekaterih od teh bolnikov je do angioedema prišlo že prej pri jemanju drugih zdravil; med drugim pri jemanju zaviralcev ACE.
English: Placebo-controlled trials
Slovenian: S placebom kontrolirana preskušanja
English: If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with Dafiro.
Slovenian: Če je uporabljen tudi diuretik, uporaba zdravila Dafiro predvidoma poveča toksične učinke litija.
English: If you have taken too many tablets of Dafiro, or if someone else has taken your tablets, consult a doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Dafiro, kot bi smeli Če ste vzeli preveč tablet zdravila Dafiro, ali je vaše tablete vzel kdo drug, se takoj posvetujte z zdravnikom.
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.
Slovenian: Zvišana koncentracija angiotenzina II po zavrtju receptorjev AT1 z valsartanom lahko stimulira nezavrte receptorje podvrste AT2, ki, kot kaže, izravnavajo učinek receptorjev AT1.
English: Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and degrades bradykinin.
Slovenian: Valsartan ne zavira ACE (znane tudi kot kininaza II), ki pretvarja angiotenzin I v angiotenzin II in razgrajuje bradikinin.
English: If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired.
Slovenian: Če se pri bolnikih, ki jemljejo amlodipin, pojavlja omotica, glavobol, utrujenost ali navzea, je njihova zmožnost reagiranja lahko zmanjšana.
English: No drug-drug interaction studies have been performed with Dafiro and other medicinal products.
Slovenian: Študij medsebojnega delovanja z zdravilom Dafiro in drugimi zdravili niso izvedli.
English: Pack sizes: 56, 98 or 280 film-coated tablets.
Slovenian: Velikosti pakiranj: 56, 98 ali 280 filmsko obloženih tablet.
English: If you think you may be allergic, talk to your doctor before taking Dafiro.
Slovenian: Če domnevate, da bi lahko bili alergični, se posvetujte z zdravnikom, preden vzamete zdravilo Dafiro.
English: • Haemodynamically unstable heart failure after acute myocardial infarction.
Slovenian: • Hemodinamično nestabilno srčno popuščanje po akutnem miokardnem infarktu.
English: Do not take Dafiro with grapefruit or grapefruit juice.
Slovenian: Zdravila Dafiro ne zaužijte skupaj z grenivko ali z grenivkinim sokom.
English: Co-administration of inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.
Slovenian: Sočasna uporaba zaviralcev privzemnega prenašalca (rifampicina, ciklosporina) ali zaviralcev izlivnega prenašalca (ritonavirja) lahko poveča sistemsko izpostavljenost valsartanu.
English: Caution should be exercised in patients with liver disease (see section 4.2).
Slovenian: Previdnost je potrebna pri bolnikih z boleznijo jeter (glejte poglavje 4.2).
English: if you have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries.
Slovenian: če so vam presadili ledvico ali vam povedali, da imate zožitev ledvičnih arterij.
English: if you are allergic to valsartan or any of the other ingredients of Dafiro this medicine (listed in section 6).
Slovenian: če ste alergični na valsartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: if your doctor has told you that you have a narrowing of the valves in your heart (called “aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “obstructive hypertrophic cardiomyopathy”).
Slovenian: če vam je zdravnik povedal, da imate zožene srčne zaklopke (t.i. aortno ali mitralno stenozo) ali nenormalno zadebeljeno srčno mišico (t.i. obstruktivno hipertrofično kardiomiopatijo).
English: A few patients have experienced these serious side effects (may affect up to 1 in 1,000 people).
Slovenian: Nekateri neželeni učinki so lahko resni in zahtevajo takojšnjo zdravniško obravnavo: Te resne neželene učinke je imelo nekaj bolnikov (pojavijo se lahko pri do 1 od 1.000 ljudi).
English: Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Slovenian: Amlodipin je raziskan pri bolnikih s kronično stabilno angino pektoris, vazospastično angino pektoris in angiografsko potrjeno boleznijo koronarnih arterij.
English: Interactions common to the combination
Slovenian: Interakcije pogoste ob kombinaciji
English: 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.
Slovenian: Zdravilo Dafiro je na voljo v pakiranjih, ki vsebujejo 7, 14, 28, 30, 56, 90, 98 ali 280 tablet in v skupnih pakiranjih s 4 škatlami, od katerih vsaka vsebuje 70 tablet, ali z 20 škatlami, od katerih vsaka vsebuje 14 tablet.
English: Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
Slovenian: Zaviralce kalcijevih kanalčkov, vključno z amlodipinom, je treba pri bolnikih s kongestivnim srčnim popuščanjem uporabljati previdno, ker lahko povečajo tveganje za nadaljnje srčnožilne zaplete in umrljivost.
English: What you need to know before you take Dafiro
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Dafiro
English: In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter brez holestaze je največji priporočeni odmerek 80 mg valsartana.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists, combinations; angiotensin II antagonists and calcium channel blockers, ATC code: C09DB01
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na sistem renin-angiotenzin; antagonisti angiotenzina II, kombinacije; antagonisti angiotenzina II in zaviralci kalcijevih kanalčkov, oznaka ATC: C09DB01.
English: * Based on patient weight of 50 kg
Slovenian: *temelječ na bolnikovi telesni masi 50 kg Valsartan
English: 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.
Slovenian: Bolnikov s primarnim hiperaldosteronizmom ne smete zdraviti z antagonistom angiotenzina II, valsartanom, ker tem bolnikom osnovna bolezen prizadene sistem renin-angiotenzin.
English: The amlodipine component of Dafiro inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Slovenian: Amlodipin v zdravilu Dafiro zavira transmembranski vstop kalcijevih ionov v srčne in žilne gladke mišice.
English: You should never take Dafiro again.
Slovenian: V tem primeru zdravila Dafiro nikoli več ne smete več jemati.
English: - Inflamed pancreas, which may cause severe abdominal and back pain accompanied with feeling of being very unwell.
Slovenian: - vnetje trebušne slinavke, ki lahko povzroči hude bolečine v trebuhu in hrbtu, ki jih spremlja zelo slabo počutje.
English: You can take Dafiro with or without food.
Slovenian: Zdravilo Dafiro lahko vzamete s hrano ali brez nje.
English: Adults with mild to moderate uncomplicated essential hypertension (mean sitting diastolic blood pressure 95 and <110 mmHg) were enrolled.
Slovenian: Vključeni so bili odrasli z blago do zmerno, nezapleteno esencialno hipertenzijo (srednji diastolični krvni tlak sede 95 in <110 mm Hg).
English: The combination of amlodipine and valsartan produces dose-related additive reduction in blood pressure across its therapeutic dose range.
Slovenian: Kombinacija amlodipina in valsartana povzroči od odmerka odvisno aditivno znižanje krvnega tlaka v celotnem območju terapevtskih odmerkov.
English: • Concomitant use of Dafiro with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Slovenian: • Sočasna uporaba zdravila Dafiro in zdravil, ki vsebujejo aliskiren, je kontraindicirana pri bolnikih s sladkorno boleznijo ali z okvaro ledvic (GFR <60 ml/min/1,73m2) (glejte poglavji 4.5 in 5.1).
English: What Dafiro is and what it is used for What you need to know before you take Dafiro How to take Dafiro
Slovenian: Kaj je zdravilo Dafiro in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Dafiro Kako jemati zdravilo Dafiro Možni neželeni učinki
English: 14 film-coated tablets.
Slovenian: 14 filmsko obloženih tablet.
English: Amlodipine has been shown to pass into breast milk in small amounts.
Slovenian: Dokazano je, da se amlodipin v majhnih količinah izloča v materino mleko.
English: 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.
Slovenian: Tako kot pri drugih zaviralcih kalcijevih kanalčkov so hemodinamske meritve delovanja srca v mirovanju in med obremenitvijo (ali stimulacijo s spodbujevalnikom) pri bolnikih z normalnim delovanjem prekatov, ki so dobivali amlodipin, na splošno pokazale majhno povečanje srčnega indeksa, a brez pomembnega vpliva na dP/dt in končni diastolični tlak ali volumen levega prekata.
English: 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.
Slovenian: Periferne edeme, ki so znan neželeni učinek amlodipina, so na splošno opažali manj pogosto pri bolnikih, ki so prejemali kombinacijo amlodipin/valsartan, v primerjavi z bolniki, ki so prejemali samo amlodipin.
English: Dafiro has not been studied in any patient population other than hypertension.
Slovenian: Zdravilo Dafiro ni raziskano pri nobeni drugi populaciji razen pri bolnikih s hipertenzijo.
English: 70 film-coated tablets.
Slovenian: 70 filmsko obloženih tablet.
English: Abrupt withdrawal of valsartan has not been associated with rebound hypertension or other adverse clinical events.
Slovenian: Nenadni prekinitvi valsartana niso sledili preobratna hipertenzija ali drugi neželeni klinični učinki.
English: If hypotension occurs with Dafiro, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Slovenian: Če se med uporabo zdravila Dafiro pojavi hipotenzija, je treba bolnika poleči in mu, če je potrebno, dati intravensko infuzijo fiziološke raztopine.
English: The no-observed-effect-level for developmental effects was observed at 3- (valsartan) and 4- (amlodipine) fold the clinical exposure (based on AUC).
Slovenian: Raven brez opaženega učinka na razvojne učinke je bila pri 3-kratni (valsartan) oz. 4-kratni (amlodipin) klinični izpostavljenosti (na podlagi AUC).
English: At higher exposures, there were ulceration and erosion of the stomach mucosa in both females and males.
Slovenian: Pri večjih izpostavljenostih so se pri samicah in samcih pojavile ulceracije in erozije želodčne sluznice.
English: 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.
Slovenian: Pogosto uporabljena antihipertenzivna zdravila (npr. zaviralci alfa, diuretiki) in druga zdravila, ki imajo lahko neželene hipotenzivne učinke (npr. triciklični antidepresivi, zaviralci alfa za zdravljenje benigne hiperplazije prostate), lahko povečajo hipotenzivni učinek kombinacije.
English: In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or ciclosporin.
Slovenian: V kliničnih študijah medsebojnega delovanja amlodipin ni vplival na farmakokinetiko atorvastatina, digoksina, varfarina ali ciklosporina.
English: Dafiro was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Slovenian: Zdravilo Dafiro so raziskali tudi v študiji, kontrolirani z učinkovino, pri 130 bolnikih s hipertenzijo, ki so imeli srednji diastolični krvni tlak sede ≥110 mm Hg in <120 mm Hg.
English: In patients with an activated renin-angiotensin system (such as volume- and/or salt-depleted patients receiving high doses of diuretics) who are receiving angiotensin receptor blockers, symptomatic hypotension may occur.
Slovenian: Pri bolnikih z aktiviranim sistemom reninangiotenzin (npr. pri bolnikih s pomanjkanjem volumna in/ali soli, ki dobivajo velike odmerke diuretikov), ki dobivajo antagoniste angiotenzinskih receptorjev, se lahko pojavi simptomatska hipotenzija.
English: Multipack: 280 (4 packs of 70) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Slovenian: Skupno pakiranje: 280 (4 pakiranja po 70) filmsko obloženih tablet Skupno pakiranje: 280 (20 pakiranj po 14) filmsko obloženih tablet
English: 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).
Slovenian: V povprečju je izpostavljenost valsartanu (merjena z vrednostmi AUC) pri bolnikih z blago do zmerno kronično boleznijo jeter dvakrat tolikšna kot pri zdravih prostovoljcih (usklajenih po starosti, spolu in telesni masi).
English: • Obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis).
Slovenian: • Zapora pretoka krvi iz levega prekata (npr. hipertrofična obstruktivna kardiomiopatija in močno izražena aortna stenoza).
English: 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.
Slovenian: V dolgoročni, s placebom kontrolirani študiji (PRAISE-2) amlodipina pri bolnikih s srčnim popuščanjem neishemične etiologije, ki so bili v razredih III in IV po NYHA (razvrstitev po New York Heart Association) je bil amlodipin povezan s številnejšimi opisanimi primeri pljučnega edema, čeprav se pojavnost poslabšanja srčnega popuščanja ni značilno razlikovala od tiste pri placebu.
English: Inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and of the hepatic efflux transporter MRP2.
Slovenian: Zaviralci privzemnega prenašalca (rifampicin, ciklosporin) ali izlivnega prenašalca (ritonavir) Rezultati in vitro študije na tkivu človeških jeter kažejo, da je valsartan substrat privzemnega prenašalca OATP1B1 v jetrih in izlivnega prenašalca MRP2 v jetrih.
English: 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.
Slovenian: Zdravilo Dafiro vsebuje dve antihipertenzivni učinkovini s komplementarnima mehanizmoma delovanja za obvladanje krvnega tlaka pri bolnikih z esencialno hipertenzijo: amlodipin spada med zaviralce kalcijevih kanalčkov, valsartan pa med antagoniste angiotenzina II.
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.
Slovenian: Pri bolnikih s hipertenzijo z normalnim delovanjem ledvic terapevtski odmerki amlodipina zmanjšajo žilni upor v ledvicah ter povečajo hitrost glomerularne filtracije in efektivni ledvični pretok plazme, ne da bi spremenili filtracijsko frakcijo ali proteinurijo.
English: The rate and extent of absorption of Dafiro are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Slovenian: Hitrost in obseg absorpcije zdravila Dafiro sta enakovredna biološki uporabnosti valsartana in amlodipina, uporabljenih v ločenih tabletah.