FrancophonIA/ELRC3.0 huggingface dataset:
English: Marketing Authorisation
Slovenian: Imetnik dovoljenja za promet z zdravilom
English: • inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever
Slovenian: • vnetje krvnih žil s simptomi, kot so izpuščaj, vijolično rdeče lise, zvišana telesna temperatura
English: • low level of sodium in the blood (sometimes with nausea, tiredness, confusion, malaise,
Slovenian: • nizka raven natrija v krvi (včasih s slabostjo s siljenjem na bruhanje, z utrujenostjo,
English: Always take Diovan Comp exactly as your doctor has told you.
Slovenian: KAKO JEMATI ZDRAVILO DIOVAN COMP Pri jemanju zdravila Diovan Comp natančno upoštevajte zdravnikova navodila.
English: Cardiac disorders Rare
Slovenian: Srčne bolezni redki srčne aritmije
English: Diovan Comp fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy.
Slovenian: Zdravilo Diovan Comp z že pripravljeno kombinacijo je indicirano za bolnike, pri katerih krvni tlak ni ustrezno urejen z monoterapijo z valsartanom ali s hidroklorotiazidom.
English: Medicinal products associated with potassium loss and hypokalaemia (e.g. kaliuretic diuretics, corticosteroids, laxatives, ACTH, amphotericin, carbenoxolone, penicillin G, salicylic acid and derivatives)
Slovenian: Sočasna uporaba, pri kateri je potrebna previdnost Zdravila, ki so povezana z izgubljanjem kalija in hipokaliemijo (na primer kaliuretični diuretiki, kortikosteroidi, odvajala, ACTH, amfotericin, karbenoksolon, penicilin G, salicilna kislina in derivati) Če je navedena zdravila treba predpisati hkrati s kombinacijo hidroklorotiazid-valsartan, je priporočeno spremljanje koncentracije kalija v plazmi.
English: • mild nausea and vomiting
Slovenian: • blaga slabost in bruhanje
English: • arthritis medicines
Slovenian: • zdravila za zdravljenje sklepnega vnetja
English: Netherlands Novartis Pharma B.V. Raapopseweg 1
Slovenian: Nizozemska Novartis Pharma B.V.
English: The kinetics of valsartan are not markedly affected by the co-administration of hydrochlorothiazide.
Slovenian: Sočasna uporaba hidroklorotiazida ne vpliva bistveno na kinetične lastnosti valsartana.
English: Periodic monitoring of serum potassium, creatinine and uric acid levels is recommended when Diovan Comp is used in patients with renal impairment.
Slovenian: Pri uporabi zdravila Diovan Comp pri bolnikih z okvaro ledvic je priporočeno redno spremljanje koncentracij kalija, kreatinina in sečne kisline v serumu.
English: Interactions related to both valsartan and hydrochlorothiazide
Slovenian: Interakcije v zvezi z valsartanom in s hidroklorotiazidom
English: Concomitant use of thiazide diuretics, including hydrochlorothiazide, with beta blockers may increase the risk of hyperglycaemia.
Slovenian: Zaviralci adrenergičnih receptorjev beta in diazoksid Sočasna uporaba zaviralcev adrenergičnih receptorjev beta in tiazidnih diuretikov, med katere sodi tudi hidroklorotiazid, lahko poveča tveganje za hiperglikemijo.
English: These doses in rat, respectively, represent 18 and 73 times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis.
Slovenian: Pri podganah pa ti odmerki predstavljajo 18 oziroma 73-kratnik najvišjega priporočenega odmerka za človeka za valsartan oziroma hidroklorotiazid glede na enoto mg/m2.
English: The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents, apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Slovenian: Antiholinergična sredstva (na primer atropin, biperiden) Antiholinergična sredstva lahko povečajo biološko uporabnost tiazidnih in njim podobnih diuretikov, verjetno zaradi zmanjšanja motilitete prebavil in hitrosti praznjenja želodca.
English: Interactions related to hydrochlorothiazide
Slovenian: Interakcije v zvezi s hidroklorotiazidom
English: Taking Diovan Comp with food and drink
Slovenian: Jemanje zdravila Diovan Comp skupaj s hrano in pijačo Zdravilo Diovan Comp je mogoče jemati s hrano ali brez nje.
English: Respiratory distress including pneumonitis and pulmonary oedema
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora zelo redki dihalna stiska, vključno s pljučnico in pljučnim edemom
English: • low level of potassium in the blood (sometimes with muscle weakness, muscle spasms,
Slovenian: • nizka raven kalija v krvi (včasih z oslabelostjo mišic, mišičnimi krči in nenormalnim ritmom bitja srca)
English: Coadministration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol.
Slovenian: Sočasna uporaba tiazidnih diuretikov, vključno s hidroklorotiazidom, lahko poveča pogostnost preobčutljivostnih reakcij na alopurinol.
English: In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 160/25 mg (81%) and valsartan/ hydrochlorothiazide 160/12.5 mg (76%) compared to placebo (29%) and the respective monotherapies, i.e. hydrochlorothiazide 12.5 mg (41%), hydrochlorothiazide 25 mg (54%), and valsartan 160 mg (59%).
Slovenian: Poleg tega je do odziva na zdravljenje (znižanje diastoličnega krvnega tlaka <90 mmHg ali za ≥10 mmHg) prišlo pri pomembno večjem deležu bolnikov, ki so jemali valsartan/ hidroklorotiazid 160/25 mg (81 %) in valsartan/ hidroklorotiazid 160/12,5 mg (76 %) v primerjavi s tistimi, ki so jemali placebo (29 %), in s tistimi, ki so jemali samo hidroklorotiazid 12,5 mg (41 %), samo hidroklorotiazid 25 mg (54 %) ali samo valsartan 160 mg (59 %).
English: In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 320/25 mg (85%) and 320/12.5 mg (83%) compared to placebo (45%) and the respective monotherapies, i.e. hydrochlorothiazide 12.5 mg (60%), hydrochlorothiazide 25 mg (66%), and valsartan 320 mg (69%).
Slovenian: Poleg tega je do odziva na zdravljenje (znižanje diastoličnega krvnega tlaka <90 mmHg ali za ≥10 mmHg) prišlo pri pomembno večjem deležu bolnikov, ki so jemali valsartan/ hidroklorotiazid 320/25 mg (85 %) in 320/12,5 mg (83 %) v primerjavi s tistimi, ki so jemali placebo (45 %), in s tistimi, ki so jemali samo hidroklorotiazid 12,5 mg (60 %), samo hidroklorotiazid 25 mg (66 %) ali samo valsartan 320 mg
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi [Izpolni država članica]
English: In a double-blind, randomised, placebo-controlled, factorial design trial comparing various dose combinations of valsartan/hydrochlorothiazide to their respective components, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 160/12.5 mg (17.8/13.5 mmHg) and 160/25 mg (22.5/15.3 mmHg) compared to placebo (1.9/4.1 mmHg) and the respective monotherapies, i.e., hydrochlorothiazide 12.5 mg (7.3/7.2 mmHg), hydrochlorothiazide 25 mg (12.7/9.3 mmHg) and valsartan 160 mg (12.1/9.4 mmHg).
Slovenian: V dvojno slepem, randomiziranem, s placebom kontroliranem preskušanju s faktorsko zasnovo, v katerem so primerjali uporabo različnih kombinacij odmerkov valsartana in hidroklorotiazida z uporabo posameznih učinkovin, so opažali pomembno večje znižanje povprečnega sistoličnega/diastoličnega krvnega tlaka pri uporabi kombinacije valsartan/ hidroklorotiazid 160/12,5 mg (17,8/13,5 mmHg) in 160/25 mg (22,5/15,3 mmHg) v primerjavi z jemanjem placeba (1,9/4,1 mmHg) ali z uporabo monoterapij s hidroklorotiazidom 12,5 mg (7,3/7,2 mmHg), s hidroklorotiazidom 25 mg (12,7/9,3 mmHg) ali z valsartanom 160 mg (12,1/9,4 mmHg).
English: In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 320/25 mg (75%) and 320/12.5 mg (69%) compared to valsartan 320 mg (53%).
Slovenian: Poleg tega je do odziva na zdravljenje (znižanje diastoličnega krvnega tlaka <90 mmHg ali za ≥10 mmHg) prišlo pri pomembno večjem deležu bolnikov, ki so jemali valsartan/ hidroklorotiazid 320/25 mg (75 %) in 320/12,5 mg (69%) v primerjavi s tistimi, ki so jemali samo valsartan 320 mg (53 %).
English: In a double-blind, randomised, active-controlled trial in patients not adequately controlled on hydrochlorothiazide 12.5 mg, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 160/12.5 mg (12.4/7.5 mmHg) compared to hydrochlorothiazide 25 mg (5.6/2.1 mmHg).
Slovenian: V dvojno slepem, randomiziranem, aktivno kontroliranem preskušanju pri bolnikih, pri katerih jemanje hidroklorotiazida 12,5 mg ni dovolj uravnalo visokega krvnega tlaka, so opažali pomembno večje znižanje povprečnega sistoličnega/diastoličnega krvnega tlaka pri uporabi kombinacije valsartan/hidroklorotiazid 160/12,5 mg (12,4/7,5 mmHg) v primerjavi z uporabo samo hidroklorotiazida 25 mg (5,6/2,1 mmHg).
English: • diuretics (water tablets), medicines for the treatment of gout, such as allopurinol, therapeutic vitamin D and calcium supplements, medicines for the treatment of diabetes (oral agents or insulins)
Slovenian: • diuretiki (zdravila za odvajanje vode), zdravila za zdravljenje protina, na primer alopurinol,
English: • breathing difficulty
Slovenian: • težave s požiranjem
English: Vascular disorders Uncommon
Slovenian: Žilne bolezni pogostnost neznana vaskulitis
English: In a double-blind, randomised, active-controlled trial in patients not adequately controlled on valsartan 160 mg, significantly greater mean systolic/diastolic BP reductions were observed with both the combination of valsartan/hydrochlorothiazide 160/25 mg (14.6/11.9 mmHg) and valsartan/hydrochlorothiazide 160/12.5 mg (12.4/10.4 mmHg) compared to valsartan 160 mg (8.7/8.8 mmHg).
Slovenian: V dvojno slepem, randomiziranem, aktivno kontroliranem preskušanju pri bolnikih, pri katerih jemanje valsartana 160 mg ni dovolj uravnalo visokega krvnega tlaka, so opažali pomembno večje znižanje povprečnega sistoličnega/diastoličnega krvnega tlaka pri uporabi obeh kombinacij valsartan/ hidroklorotiazid 160/25 mg (14,6/11,9 mmHg) in valsartan/ hidroklorotiazid 160/12,5 mg (12,4/10,4 mmHg) v primerjavi z uporabo samo valsartana 160 mg (8,7/8,8 mmHg).
English: In a double-blind, randomised, active-controlled trial in patients not adequately controlled on valsartan 80 mg, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 80/12.5 mg (9.8/8.2 mmHg) compared to valsartan 80 mg (3.9/5.1 mmHg) and valsartan 160 mg (6.5/6.2 mmHg).
Slovenian: V dvojno slepem, randomiziranem, aktivno kontroliranem preskušanju pri bolnikih, pri katerih jemanje valsartana 80 mg ni dovolj uravnalo visokega krvnega tlaka, so opažali pomembno večje znižanje povprečnega sistoličnega/diastoličnega krvnega tlaka pri uporabi kombinacije valsartan/hidroklorotiazid 80/12,5 mg (9,8/8,2 mmHg) v primerjavi z uporabo samo valsartana 80 mg (3,9/5,1 mmHg) ali valsartana 160 mg (6,5/6,2 mmHg).
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors and thiazide, including hydrochlorothiazide.
Slovenian: Pri sočasni uporabi z zaviralci ACE in s tiazidi, med katere sodi tudi hidroklorotiazid, so poročali o reverzibilnem zvišanju koncentracije litija v serumu in o toksičnosti.
English: In a double-blind, randomised, active-controlled trial in patients not adequately controlled on valsartan 320 mg, significantly greater mean systolic/diastolic BP reductions were observed with both the combination of valsartan/hydrochlorothiazide 320/25 mg (15.4/10.4 mmHg) and valsartan/hydrochlorothiazide 320/12.5 mg (13.6/9.7 mmHg) compared to valsartan 320 mg (6.1/5.8 mmHg).
Slovenian: V dvojno slepem, randomiziranem, aktivno kontroliranem preskušanju pri bolnikih, pri katerih jemanje valsartana 320 mg ni dovolj uravnalo visokega krvnega tlaka, so opažali pomembno večje znižanje povprečnega sistoličnega/diastoličnega krvnega tlaka pri uporabi obeh kombinacij valsartan/ hidroklorotiazid 320/25 mg (15,4/10,4 mmHg) in valsartan/ hidroklorotiazid 320/12,5 mg (13,6/9,7 mmHg) v primerjavi z uporabo samo valsartana 320 mg (6,1/5,8 mmHg).
English: Diovan Comp and associated names (see Annex I) 80 mg/12.5 mg film-coated tablets Diovan Comp and associated names (see Annex I) 160 mg/12.5 mg film-coated tablets Diovan Comp and associated names (see Annex I) 160 mg/25 mg film-coated tablets Diovan Comp and associated names (see Annex I) 320 mg/12.5 mg film-coated tablets Diovan Comp and associated names (see Annex I) 320 mg/25 mg film-coated tablets Valsartan/hydrochlorothiazide
Slovenian: Diovan Comp in povezana imena (glejte Dodatek I) 80 mg/12,5 mg filmsko obložene tablete Diovan Comp in povezana imena (glejte Dodatek I) 160 mg/12,5 mg filmsko obložene tablete Diovan Comp in povezana imena (glejte Dodatek I) 160 mg/25 mg filmsko obložene tablete Diovan Comp in povezana imena (glejte Dodatek I) 320 mg/12,5 mg filmsko obložene tablete Diovan Comp in povezana imena (glejte Dodatek I) 320 mg/25 mg filmsko obložene tablete valsartan/hidroklorotiazid
English: GROUNDS FOR AMENDMENT OF THE SUMMARYOF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
English: In each case, up- titration of individual components to the next dose should be followed in order to reduce the risk of hypotension and other adverse events.
Slovenian: Da se zmanjša tveganje za hipotenzijo in druge neželene učinke, naj se spremlja vsak primer do naslednjega odmerka povečane titracije posameznih sestavin.
English: Diovan Comp and associated names (see Annex I) 80 mg/12.5 mg film-coated tablets Diovan Comp and associated names (see Annex I) 160 mg/12.5 mg film-coated tablets Diovan Comp and associated names (see Annex I) 160 mg/25 mg film-coated tablets Diovan Comp and associated names (see Annex I) 320 mg/12.5 mg film-coated tablets Diovan Comp and associated names (see Annex I) 320 mg/25 mg film-coated tablets [See Annex I - To be completed nationally]
Slovenian: Diovan Comp in povezana imena (glejte dodatek I) 80 mg/12,5 mg filmsko obložene tablete Diovan Comp in povezana imena (glejte dodatek I) 160 mg/12,5 mg filmsko obložene tablete Diovan Comp in povezana imena (glejte dodatek I) 160 mg/25 mg filmsko obložene tablete Diovan Comp in povezana imena (glejte dodatek I) 320 mg/12,5 mg filmsko obložene tablete Diovan Comp in povezana imena (glejte dodatek I) 320 mg/25 mg filmsko obložene tablete [Glejte dodatek I - Izpolni država članica]
English: Hypokalaemia has been reported under treatment with thiazide diuretics, including hydrochlorothiazide.
Slovenian: Ob zdravljenju s tiazidnimi diuretiki, med katere sodi tudi hidroklorotiazid, so poročali o hipokaliemiji.
English: Respiratory, thoracic and mediastinal disorders Very rare
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni mialgija zelo redki artralgija
English: Cordinate plus 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Slovenian: Cordinate plus 80/12.5 mg 80 mg / 12,5 mg filmsko obložene tablete
English: In a double-blind, randomised, placebo-controlled, factorial design trial comparing various dose combinations of valsartan/hydrochlorothiazide to their respective components, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 320/12.5 mg (21.7/15.0 mmHg) and 320/25 mg (24.7/16.6 mmHg) compared to placebo (7.0/5.9 mmHg) and the respective monotherapies, i.e. hydrochlorothiazide 12.5 mg (11.1/9.0 mmHg), hydrochlorothiazide 25 mg (14.5/10.8 mmHg) and valsartan 320 mg (13.7/11.3 mmHg).
Slovenian: V dvojno slepem, randomiziranem, s placebom kontroliranem preskušanju s faktorsko zasnovo, v katerem so primerjali uporabo različnih kombinacij odmerkov valsartana in hidroklorotiazida z uporabo posameznih učinkovin, so opažali pomembno večje znižanje povprečnega sistoličnega/diastoličnega krvnega tlaka pri uporabi kombinacije valsartan/ hidroklorotiazid 320/12,5 mg (21,7/15,0 mmHg) in 320/25 mg (24,7/16,6 mmHg) v primerjavi z jemanjem placeba (7,0/5,9 mmHg) ali z uporabo monoterapij s hidroklorotiazidom 12,5 mg (11,1/9,0 mmHg), s hidroklorotiazidom 25 mg (14,5/10,8 mmHg) ali z valsartanom 320 mg (13,7/11,3 mmHg).
English: Reproductive system and breast disorders Common
Slovenian: Motnje reprodukcije in dojk pogosti impotenca
English: Diovan Comp and associated names (see Annex I) 80 mg/12.5 mg film-coated tablets Diovan Comp and associated names (see Annex I) 160 mg/12.5 mg film-coated tablets Diovan Comp and associated names (see Annex I) 160 mg/25 mg film-coated tablets Diovan Comp and associated names (see Annex I) 320 mg/12.5 mg film-coated tablets Diovan Comp and associated names (see Annex I) 320 mg/25 mg film-coated tablets [See Annex I - To be completed nationally] Valsartan/hydrochlorothiazide
Slovenian: Diovan Comp in povezana imena (glejte Dodatek I) 80 mg/12,5 mg filmsko obložene tablete Diovan Comp in povezana imena (glejte Dodatek I) 160 mg/12,5 mg filmsko obložene tablete Diovan Comp in povezana imena (glejte Dodatek I) 160 mg/25 mg filmsko obložene tablete Diovan Comp in povezana imena (glejte Dodatek I) 320 mg/12,5 mg filmsko obložene tablete Diovan Comp in povezana imena (glejte Dodatek I) 320 mg/25 mg filmsko obložene tablete [glejte Dodatek I - Izpolni država članica] valsartan/hidroklorotiazid
English: In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 80/12.5 mg (51%) compared to valsartan 80 mg (36%) and valsartan 160 mg (37%).
Slovenian: Poleg tega je do odziva na zdravljenje (znižanje diastoličnega krvnega tlaka <90 mmHg ali za ≥10 mmHg) prišlo pri pomembno večjem deležu bolnikov, ki so jemali valsartan/ hidroklorotiazid 80/12,5 mg (51 %) v primerjavi s tistimi, ki so jemali samo valsartan 80 mg (36 %) ali valsartan 160 mg (37 %).
English: In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 80/12.5 mg (60%) compared to hydrochlorothiazide 12.5 mg (25%) and hydrochlorothiazide 25 mg (27%).
Slovenian: Poleg tega je do odziva na zdravljenje (znižanje diastoličnega krvnega tlaka <90 mmHg ali za ≥10 mmHg) prišlo pri pomembno večjem deležu bolnikov, ki so jemali valsartan/ hidroklorotiazid 80/12,5 mg (60 %) v primerjavi s tistimi, ki so jemali hidroklorotiazid 12,5 mg (25 %) ali hidroklorotiazid 25 mg (27 %).
English: Each film-coated tablet contains 320 mg valsartan and 25 mg hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 320 mg valsartana in 25 mg hidroklorotiazida.
English: Co-Dalzad (160+25) mg 160 mg / 25 mg film-coated tablets oral
Slovenian: Co-Dalzad (160+25) mg 160 mg / 25 mg filmsko obložene tablete
English: These doses in rat, respectively, represent 3.0 and 12 times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis.
Slovenian: Pri podganah ti odmerki predstavljajo 3,0 oziroma 12-kratnik najvišjega priporočenega odmerka za človeka za valsartan oziroma hidroklorotiazid glede na enoto mg/m2.
English: Co- Novacard 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Slovenian: Co- Novacard 80/12.5 mg 80 mg / 12,5 mg filmsko obložene tablete
English: In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 160/25 mg (68%) and 160/12.5 mg (62%) compared to valsartan 160 mg (49%).
Slovenian: Poleg tega je do odziva na zdravljenje (znižanje diastoličnega krvnega tlaka <90 mmHg ali za ≥10 mmHg) prišlo pri pomembno večjem deležu bolnikov, ki so jemali valsartan/ hidroklorotiazid 160/25 mg (68 %) in 160/12,5 mg (62%) v primerjavi s tistimi, ki so jemali samo valsartan 160 mg
English: Co-Dalzad (160+12.5) mg 160 mg / 12,5 mg film-coated tablets oral
Slovenian: Co-Dalzad (160+12.5) mg 160 mg / 12,5 mg filmsko obložene tablete
English: Each film-coated tablet contains 160 mg valsartan and 25 mg hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 160 mg valsartana in 25 mg hidroklorotiazida.
English: Co-Dalzad (80+12.5) mg 80 mg / 12,5 mg film-coated tablets oral
Slovenian: Co-Dalzad (80+12.5) mg 80 mg / 12,5 mg filmsko obložene tablete
English: • facial rash associated with joint pain
Slovenian: • izpuščaj na obrazu v povezavi z bolečinami v sklepih
English: Cordinate plus 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral
Slovenian: Cordinate plus 320/12.5 mg 320 mg / 12,5 mg filmsko obložene tablete
English: Cordinate plus 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral
Slovenian: Cordinate plus 160/12.5 mg 160 mg / 12,5 mg filmsko obložene tablete
English: There have been isolated reports of haemolytic anaemia in patients receiving concomitant treatment with methyldopa and hydrochlorothiazide.
Slovenian: Pri bolnikih, ki so sočasno prejemali metildopo in hidroklorotiazid, so poročali o posameznih primerih hemolitične anemije.
English: Co- Novacard 160/25 mg 160 mg / 25 mg film-coated tablets oral
Slovenian: Co- Novacard 160/25 mg 160 mg / 25 mg filmsko obložene tablete
English: Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Slovenian: Ena tableta vsebuje 320 mg valsartana in 25 mg hidroklorotiazida.
English: In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 80/12.5 mg (64%) compared to placebo (29%) and hydrochlorothiazide (41%).
Slovenian: Poleg tega je do odziva na zdravljenje (znižanje diastoličnega krvnega tlaka <90 mmHg ali za ≥10 mmHg) prišlo pri pomembno večjem deležu bolnikov, ki so jemali valsartan/ hidroklorotiazid 80/12,5 mg (64 %) v primerjavi s tistimi, ki so jemali placebo (29 %), in s tistimi, ki so jemali hidroklorotiazid (41 %).
English: Co-Dalzad (320+25) mg 320 mg / 25 mg film-coated tablets oral
Slovenian: Co-Dalzad (320+25) mg 320 mg / 25 mg filmsko obložene tablete
English: Cotareg 160mg/25 mg 160 mg / 25 mg film-coated tablets oral
Slovenian: Cotareg 160mg/25 mg 160 mg / 25 mg filmsko obložene tablete
English: Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Slovenian: Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti, razen, če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
English: Co-Dalzad (320+12.5) mg 320 mg / 12,5 mg film-coated tablets oral
Slovenian: Co-Dalzad (320+12.5) mg 320 mg / 12,5 mg filmsko obložene tablete
English: • if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives
Slovenian: • če ste alergični (preobčutljivi) na valsartan, hidroklorotiazid, druga sulfonamidna zdravila (snovi, ki imajo sorodno kemijsko strukturo kot hidroklorotiazd) ali katerokoli drugo sestavino zdravila Diovan Comp.
English: Absorption of thiazide diuretics, including hydrochlorothiazide, is impaired in the presence of anionic exchange resins.
Slovenian: Izmenjevalni smoli holestiramin in holestipol Prisotnost anionskih izmenjevalnih smol ovira absorpcijo tiazidnih diuretikov, vključno s hidroklorotiazidom.
English: Each film-coated tablet contains 320 mg valsartan and 12.5 mg hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 320 mg valsartana in 12,5 mg hidroklorotiazida.
English: These doses in marmoset, respectively, represent 0.3 and 1.2-times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis.
Slovenian: Pri marmozetkah pa ti odmerki predstavljajo 0,3 oziroma 1,2-kratnik najvišjega priporočenega odmerka za človeka za valsartan oziroma hidroklorotiazid glede na enoto mg/m2.