FrancophonIA/ELRC3.0 huggingface dataset:
English: In case severe or rapid hyponatraemia develops during Dafiro HCT therapy, the treatment should be discontinued until normalisation of natraemia.
Slovenian: Če se v času zdravljenja z zdravilom Dafiro HCT razvije huda ali nenadna hiponatriemija, je treba zdravljenje prekiniti do normalizacije vrednosti natrija v krvi.
English: Candesartan 32 * These limits are not applicable for batches where more than one of the above N-nitrosamines has been identified simultaneously; such batches should be rejected.
Slovenian: Meja za NDMA v ppm v učinkovini valsartan losartan olmesartan 40 irbesartan 300 kandesartan 32 * Te meje ne veljajo za serije, v katerih so hkrati ugotovili več kot enega od zgornjih N-nitrozaminov; take serije je treba zavrniti.
English: The reductions in systolic/diastolic blood pressure with Dafiro HCT were 7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide, 6.2/3.3 mmHg greater than with amlodipine/valsartan, and 8.2/5.3 mmHg greater than with amlodipine/hydrochlorothiazide.
Slovenian: Znižanje sistoličnega/diastoličnega krvnega tlaka je bilo z zdravilom Dafiro HCT za 7,6/5,0 mmHg večje kot s kombinacijo valsartan/hidroklorotiazid, za 6,2/3,3 mmHg večje kot s kombinacijo amlodipin/valsartan in za 8,2/5,3 mmHg večje kot s kombinacijo amlodipin/hidroklorotiazid.
English: Administration of valsartan to patients with hypertension results in a drop in blood pressure without affecting pulse rate.
Slovenian: Klinična učinkovitost in varnost Valsartan pri bolnikih s hipertenzijo zniža krvni tlak, ne da bi vplival na srčno frekvenco.
English: Due to the hydrochlorothiazide component, Dafiro HCT is contraindicated in symptomatic hyperuricaemia.
Slovenian: Zaradi vsebnosti hidroklorotiazida je pri bolnikih s simptomatsko hiperurikemijo uporaba zdravila Dafiro HCT kontraindicirana.
English: thereby affecting electrolyte reabsorption mechanisms: directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly, by this diuretic action, reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
Slovenian: Tiazidi delujejo tako, da verjetno tekmujejo za vezavno mesto za Cl ione na skupnem prenašalcu Na in Cl ionov in ga na ta način zavirajo, s tem pa vplivajo na mehanizme reabsorpcije elektrolitov: neposredno povečajo izločanje natrija in klorida v približno enaki meri, posredno pa s takim diuretičnim delovanjem zmanjšajo volumen plazme, s tem povzročijo zvišanje delovanja renina v plazmi, izločanje aldosterona in izgubljanje kalija z urinom ter znižano koncentracijo kalija v serumu.
English: The following adverse reactions, listed by MedDRA System Organ Class and frequency, concern Dafiro HCT (amlodipine/valsartan/HCT) and amlodipine, valsartan and HCT individually.
Slovenian: Spodaj navedeni neželeni učinki, ki so našteti po MedDRA razvrstitvi organskih sistemov in po pogostnosti, se nanašajo na zdravilo Dafiro HCT (amlodipin/valsartan/hidroklorotiazid) in na amlodipin, valsartan in hidroklorotiazid posamezno.
English: Dafiro HCT should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Slovenian: Pri bolnikih z enostransko ali obojestransko stenozo ledvične arterije oz. s stenozo v primeru solitarne ledvice je pri zdravljenju hipertenzije z zdravilom Dafiro HCT potrebna previdnost, saj pri takih bolnikih lahko pride do zvišanja koncentracij sečnine v krvi in kreatinina v serumu.
English: Based on available data from epidemiological studies, cumulative dose-dependent association between hydrochlorothiazide and NMSC has been observed.
Slovenian: Na podlagi obstoječih podatkov epidemioloških študij so ugotovili, da obstaja razmerje med kumulativnim odmerkom hidroklorotiazida in nemelanomskim kožnim rakom.
English: Another study showed a possible association between lip cancer (SCC) and exposure to hydrochlorothiazide: 633 cases of lip cancer were matched with 63,067 population controls, using a risk-set sampling strategy.
Slovenian: S pomočjo strategije vzorčenja iz tveganih populacij so primerjali 633 primerov raka ustnice s kontrolno populacijo 63.067 bolnikov.
English: If any of the above applies to you, do not take Dafiro HCT and talk to your doctor.
Slovenian: Če kaj od naštetega velja za vas, ne vzemite zdravila Dafiro HCT, temveč povejte zdravniku.
English: Two large randomised, controlled trials (ONTARGET [ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial] and VA NEPHRON-D [The Veterans Affairs Nephropathy in Diabetes]) have examined the use of the combination of an ACE inhibitor with an ARB.
Slovenian: Uporabo zaviralca ACE v kombinaciji z antagonistom angiotenzinskih receptorjev so raziskali v dveh velikih randomiziranih, kontroliranih preskušanjih: ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) in VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes).
English: • abdominal bloating (gastritis)
Slovenian: • napenjanje v trebuhu (gastritis)
English: There is no experience of overdose with Dafiro HCT.
Slovenian: Izkušenj s prevelikim odmerjanjem zdravila Dafiro HCT ni.
English: Due to the valsartan component, Dafiro HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Slovenian: Zaradi vsebnosti valsartana je zdravilo Dafiro HCT kontraindicirano pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
English: Do not use any Dafiro HCT pack that is damaged or shows signs of tampering.
Slovenian: Zdravila Dafiro HCT ne uporabljajte, če je ovojnina poškodovana ali opazite, da je bila že odprta.
English: Before switching to Dafiro HCT patients should be controlled on stable doses of the monocomponents taken at the same time.
Slovenian: Preden bolnik preide na uporabo zdravila Dafiro HCT, mora biti njegov krvni tlak urejen s sočasno uporabo stabilnih odmerkov posameznih učinkovin.
English: At week 8, the mean reductions in systolic/diastolic blood pressure were 39.7/24.7 mmHg with Dafiro HCT, 32.0/19.7 mmHg with valsartan/hydrochlorothiazide, 33.5/21.5 mmHg with amlodipine/valsartan, and 31.5/19.5 mmHg with amlodipine/hydrochlorothiazide.
Slovenian: Po 8 tednih je bilo povprečno znižanje sistoličnega/diastoličnega krvnega tlaka 39,7/24,7 mmHg z zdravilom Dafiro HCT, 32,0/19,7 mmHg s kombinacijo valsartan/hidroklorotiazid, 33,5/21,5 mmHg s kombinacijo amlodipin/valsartan in 31,5/19,5 mmHg s kombinacijo amlodipin/ hidroklorotiazid.
English: The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Slovenian: Antiholinergične učinkovine (na primer atropin, biperiden) lahko povečajo biološko uporabnost diuretikov tiazidnega tipa, verjetno zaradi zmanjšanja motilitete prebavil in hitrosti praznjenja želodca.
English: Due to the valsartan component, Dafiro HCT is contraindicated in patients with hepatic impairment (see sections 4.2 and 4.3).
Slovenian: Zaradi vsebnosti valsartana je zdravilo Dafiro HCT kontraindicirano pri bolnikih z okvaro jeter (glejte poglavji 4.2 in 4.3).
English: There is no experience on the use of Dafiro HCT in pregnant women.
Slovenian: Z uporabo zdravila Dafiro HCT pri nosečnicah ni nobenih izkušenj.
English: • difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory distress,
Slovenian: • oteženo dihanje z zvišano telesno temperaturo, kašelj, piskajoče dihanje, zadihanost (dihalna stiska, pljučni edem, pljučnica)
English: Photosensitising actions of hydrochlorothiazide could act as a possible mechanism for NMSC.
Slovenian: Učinki hidroklorotiazida, ki povzročajo občutljivost na svetlobo, bi lahko delovali kot potencialni mehanizem za nemelanomski kožni rak.
English: In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan, and therefore, Dafiro HCT is not suitable in this group of patients (see sections 4.2, 4.3 and 5.2).
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter brez holestaze je najvišji priporočeni odmerek valsartana 80 mg, zato zdravilo Dafiro HCT ni primerno za to skupino bolnikov (glejte poglavja 4.2, 4.3 in 5.2).
English: If you forget to take Dafiro HCT
Slovenian: Če ste pozabili vzeti zdravilo Dafiro HCT
English: Treatment with Dafiro HCT should only start after correction of hypokalaemia and any coexisting hypomagnesaemia.
Slovenian: Zdravljenje z zdravilom Dafiro HCT je mogoče uvesti šele po korekciji hipokaliemije in morebitne sočasne hipomagneziemije.
English: In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan and therefore Dafiro HCT is not suitable in this group of patients (see sections 4.3, 4.4 and 5.2).
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter brez holestaze je najvišji priporočeni odmerek valsartana 80 mg, zato zdravilo Dafiro HCT ni primerno za to skupino bolnikov (glejte poglavja 4.3, 4.4 in 5.2).
English: Dafiro HCT should be used only after correction of any pre-existing sodium and/or volume depletion.
Slovenian: Zdravilo Dafiro HCT se sme uporabiti šele po ureditvi morebitnega že prisotnega primanjkljaja natrija in/ali hipovolemije.
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: Zdravnik bo morda pregledal tudi delovanje vaših ledvic; 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); če imate aldosteronizem, to je bolezen, pri kateri nadledvični žlezi tvorita preveč hormona aldosterona.
English: • heart attack
Slovenian: • srčni infarkt
English: If you stop taking Dafiro HCT
Slovenian: Če ste prenehali jemati zdravilo Dafiro HCT
English: Concomitant use of Dafiro HCT 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 HCT 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
English: Excessive hypotension, including orthostatic hypotension, was seen in 1.7% of patients treated with the maximum dose of Dafiro HCT (10 mg/320 mg/25 mg) compared to 1.8% of valsartan/hydrochlorothiazide (320 mg/25 mg) patients, 0.4% of amlodipine/valsartan (10 mg/320 mg) patients, and 0.2% of hydrochlorothiazide/amlodipine (25 mg/10 mg) patients in a controlled trial in patients with moderate to severe uncomplicated hypertension.
Slovenian: V kontroliranem preskušanju pri bolnikih z zmerno do hudo nezapleteno hipertenzijo so čezmerno hipotenzijo, vključno z ortostatsko hipotenzijo, opažali pri 1,7 % bolnikov, ki so prejemali najvišji odmerek zdravila Dafiro HCT (10 mg/320 mg/25 mg), v primerjavi z 1,8 % bolnikov, ki so prejemali valsartan/hidroklorotiazid (320 mg/25 mg), z 0,4 % bolnikov, ki so prejemali amlodipin/valsartan (10 mg/320 mg), in z 0,2 % bolnikov, ki so prejemali hidroklorotiazid/amlodipin (25 mg/10 mg).
English: Dafiro HCT 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 a newborn, or was born prematurely.
Slovenian: Če želite dojiti, bo zdravnik za vas izbral drugo zdravilo, še posebno če je vaš otrok še novorojenček ali je bil rojen prezgodaj.
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets
Slovenian: Dafiro HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete Dafiro HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete Dafiro HCT 5 mg/160 mg/25 mg filmsko obložene tablete Dafiro HCT 10 mg/160 mg/25 mg filmsko obložene tablete Dafiro HCT 10 mg/320 mg/25 mg filmsko obložene tablete
English: Tabulated list of adverse reactions
Slovenian: Tabelaričen pregled neželenih učinkov
English: Very rare (may affect up to 1 in 10,000 people):
Slovenian: Zelo redki (pojavijo se pri največ 1 od 10.000 bolnikov):
English: Amlodipine/Valsartan/Hydrochlorothiazide
Slovenian: Amlodipin/valsarta/hidroklorotiazid
English: Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Dafiro HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited.
Slovenian: Pri starejših bolnikih je priporočena previdnost, kar vključuje bolj pogosto merjenje krvnega tlaka, zlasti pri uporabi najvišjega odmerka zdravila Dafiro HCT 10 mg/320 mg/25 mg, saj je za to skupino bolnikov na voljo le malo podatkov.
English: Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Dafiro HCT, 10 mg/320 mg/25 mg, since available data in these patient populations is limited.
Slovenian: Pri bolnikih s srčnim popuščanjem in koronarno boleznijo je priporočena previdnost, zlasti pri uporabi najvišjega odmerka zdravila Dafiro HCT 10 mg/320 mg/25 mg, saj je pri teh skupinah bolnikov na voljo le malo podatkov.
English: Medicinal product subject to medical prescription.
Slovenian: Predisovanje in izdaja zdravila je le na recept.
English: • inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)
Slovenian: • vnetje krvnih žil s simptomi, kot so izpuščaj, vijolično-rdeče pike, zvišana telesna temperatura
English: Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Dafiro HCT, 10 mg/320 mg/25 mg.
Slovenian: Pri bolnikih s srčnim popuščanjem in koronarno boleznijo je priporočena previdnost, zlasti pri uporabi najvišjega odmerka zdravila Dafiro HCT 10 mg/320 mg/25 mg.
English: • disorder in passing urine
Slovenian: • motnje uriniranja
English: Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue, has been reported in patients treated with valsartan.
Slovenian: Pri bolnikih, ki so prejemali valsartan, so poročali o angioedemu, vključno z otekanjem grla in glasilk, ki povzroči obstrukcijo dihalnih poti in/ali otekanje obraza, ustnic, žrela in/ali jezika.
English: Rare (may affect up to 1 in 1,000 people):
Slovenian: Redki (pojavijo se pri največ 1 od 1.000 bolnikov):
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Slovenian: Dafiro HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete Dafiro HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete Dafiro HCT 5 mg/160 mg/25 mg filmsko obložene tablete Dafiro HCT 10 mg/160 mg/25 mg filmsko obložene tablete Dafiro HCT 10 mg/320 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
English: If you have accidentally taken too many Dafiro HCT tablets, talk to a doctor immediately.You may require medical attention.
Slovenian: Če ste vzeli večji odmerek zdravila Dafiro HCT, kot bi smeli Če ste nehote vzeli preveč tablet zdravila Dafiro HCT, se takoj posvetujte z zdravnikom.
English: Multipack: 280 (4 packs of 70x1) film-coated tablets.
Slovenian: Skupno pakiranje: 280 (20 škatel po 14) filmsko obloženih tablet Skupno pakiranje: 280 (4 škatle po 70x1) filmsko obloženih tablet
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 4. november 2009
English: How to take Dafiro HCT
Slovenian: Kako jemati zdravilo Dafiro HCT
English: Dafiro HCT should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Slovenian: Bolnikom, pri katerih pride do angioedema, je treba zdravilo Dafiro HCT takoj ukiniti.
English: You should never take Dafiro HCT again.
Slovenian: Ti bolniki ne smejo več prejemati zdravila Dafiro HCT.
English: if you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin converting enzyme inhibitors).
Slovenian: če vam je bilo slabo (bruhanje ali driska); če je v času jemanja drugih zdravil (kar vključuje tudi zaviralce angiotenzinske konvertaze) pri vas prišlo do otekanja, zlasti v obraz in grlo oziroma žrelo.
English: Grapefruit and grapefruit juice should not be consumed by people who are prescribed Dafiro HCT.
Slovenian: Zdravilo Dafiro HCT skupaj s hrano, pijačo in alkoholom Ljudje, ki jim je zdravnik predpisal zdravilo Dafiro HCT, ne smejo uživati grenivk in grenivkinega soka.
English: • skin discolouration
Slovenian: • obarvanost kože
English: There is limited experience with the use of Dafiro HCT, particulary at the maximum dose, in patients with heart failure and coronary artery disease.
Slovenian: Pri bolnikih s srčnim popuščanjem in koronarno boleznijo je le malo izkušenj z uporabo zdravila Dafiro HCT, zlasti z uporabo najvišjega odmerka.
English: Very common (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov)
English: Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets
Slovenian: Dafiro HCT 10 mg/320 mg/25 mg filmsko obložene tablete
English: What Dafiro HCT looks like and contents of the pack Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side.
Slovenian: Izgled zdravila Dafiro HCT in vsebina pakiranja Dafiro HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete so bele ovalne tablete z oznako “NVR” na eni strani in “VCL” na drugi.
English: • increased number of times of passing urine
Slovenian: • zvečana pogostnost uriniranja
English: Hypromellose, substitution type 2910 (3 mPa.s) Macrogol 4000
Slovenian: Obloga hipromeloza, substitucijski tip 2910 (3 mPa.s) titanov dioksid (E171) makrogol 4000 smukec
English: • stiffness
Slovenian: • vrtoglavost
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors, angiotensin II receptor antagonists including valsartan or thiazides.
Slovenian: Med sočasno uporabo litija in zaviralcev angiotenzinske konvertaze, antagonistov angiotenzinskih receptorjev tipa II, vključno z valsartanom ali tiazidov, so poročali o reverzibilnem povečanju koncentracije litija v serumu in povečanju njegovih toksičnih učinkov.
English: • weakness
Slovenian: • oslabelost
English: • visual impairment
Slovenian: • motnje okušanja
English: An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Slovenian: Dve epidemiološki študiji, izvedeni na podlagi podatkov registra raka za Dansko, sta pokazali, da zaradi izpostavljenosti povečanemu kumulativnemu odmerku hidroklorotiazida obstaja povečano tveganje za razvoj nemelanomskega kožnega raka (bazalnoceličnega karcinoma in ploščatoceličnega karcinoma).
English: What Dafiro HCT contains
Slovenian: Kaj vsebuje zdravilo Dafiro HCT
English: • purple skin patches
Slovenian: • vijolične kožne lise
English: if you had an allergic reaction to other high blood pressure medicines or diuretics (a type of medicine also known as “water tablets”), especially if you suffer from asthma and allergies if you have been sick (vomiting or diarrhoea).
Slovenian: Če imate to bolezen, uporaba zdravila Dafiro HCT za vas ni priporočena; če imate bolezen, ki se imenuje sistemski eritematozni lupus (ki ga kratko imenujemo tudi “lupus” ali s kratico “SLE”); če imate sladkorno bolezen (visoko raven sladkorja v krvi); če imate visoke ravni holesterola ali trigliceridov v krvi; če imate po izpostavljanju soncu kožne reakcije, npr izpuščaj; če ste že imeli alergijsko reakcijo na druga zdravila za uravnavanje visokega krvnega tlaka ali na diuretike (skupino zdravil, ki jim pravimo tudi “tablete za odvajanje vode”), zlasti če imate astmo ali alergije;
English: Multipack: 280 (20 packs of 14) film-coated tablets.
Slovenian: 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet)
English: Amlodipine, valsartan and hydrochlorothiazide exhibit linear pharmacokinetics.
Slovenian: Farmakokinetike amlodipina, valsartana in hidroklorotiazida so linearne.
English: Uncommon (may affect up to 1 in 100 people):
Slovenian: Občasni (pojavijo se pri največ 1 od 100 bolnikov):
English: • decrease in blood platelets which may result in unusual brusing or easy bleeding (red blood cell damage)
Slovenian: • znižanje števila trombocitov, kar lahko povzroči večjo nagnjenost k podplutbam ali krvavitvam
English: (haemolytic anaemia)
Slovenian: (poškodba rdečih krvnih celic)
English: Protect your skin from sun exposure and UV rays while taking Dafiro HCT.
Slovenian: Med jemanjem zdravila Dafiro HCT zaščitite kožo pred izpostavljenostjo soncu in UVžarkom.
English: Non cardiac chest pain
Slovenian: • bolečina v prsih
English: Pack sizes: 56, 98 or 280 film-coated tablets Multipacks of 280 tablets, comprising 4 cartons, each containing 70 tablets.
Slovenian: Skupna pakiranja po 280 tablet, ki vsebujejo 4 škatle, od katerih vsaka vsebuje 70 tablet.
English: Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VFL” on the other side.
Slovenian: Dafiro HCT 10 mg/320 mg/25 mg filmsko obložene tablete so rjavo rumene ovalne tablete z oznako “NVR” na eni strani in “VFL” na drugi.
English: Amlodipine dose recommendations have not been established in patients with mild to moderate hepatic impairment.
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter priporočljivega odmerka amlodipina niso ugotavljali.
English: Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Slovenian: Dafiro HCT 10 mg/320 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
English: No dose adjustment of Dafiro HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic (GFR ≥30 ml/min/1,73 m 2) odmerka zdravila Dafiro
English: Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “VEL” on the other side.
Slovenian: Dafiro HCT 5 mg/160 mg/25 mg filmsko obložene tablete so rumene ovalne tablete z oznako “NVR” na eni strani in “VEL” na drugi.
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets
Slovenian: Dafiro HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete
English: Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side.
Slovenian: Dafiro HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete so bledo rumene ovalne tablete z oznako “NVR” na eni strani in “VDL” na drugi.
English: Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets
Slovenian: Dafiro HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete
English: Common Uncommon Orthostatic hypotension Uncommon
Slovenian: Bolezni imunskega sistema preobčutljivost zelo redki pogostnost neznana zelo redki
English: Common (may affect up to 1 in 10 people):
Slovenian: Pogosti (pojavijo se pri največ 1 od 10 bolnikov):
English: Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets
Slovenian: Dafiro HCT 5 mg/160 mg/25 mg filmsko obložene tablete
English: Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets
Slovenian: Dafiro HCT 10 mg/160 mg/25 mg filmsko obložene tablete