FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions reported with the use of irbesartan alone General disorders and administration site conditions:
Slovenian: Neželeni učinki, o katerih so poročali pri uporabi irbesartana samega Splošne težave in spremembe na mestu aplikacije občasni bolečina v prsnem košu
English: Although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Slovenian: Na nekaj eksperimentalnih modelih so opazili genotoksično in karcinogeno delovanje hidroklorotiazida, vendar pa dokazi niso zanesljivi.
English: Undesirable effects where the frequency is not known are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.
Slovenian: Neželeni učinki, katerih pogostnost ni znana, so: glavobol, zvonenje v ušesih, kašelj, motnje okušanja, prebavne motnje, bolečine v sklepih in mišicah,
English: Antidiabetic medicinal products (oral agents and insulins) Dosage adjustment of the antidiabetic medicinal product may be required (see section 4.4);
Slovenian: Morda bo treba prilagoditi odmerek antidiabetika (glejte poglavje 4.4).
English: Drug substance
Slovenian: SEZNAM POMOŽNIH SNOVI
English: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg
Slovenian: Irbesartan/hidroklorotiazid Teva 150 mg/12,5 mg
English: Valsartan
Slovenian: ŠKATLA
English: When measured by ambulatory blood pressure monitoring, the trough to peak effects of irbesartan/hydrochlorothiazide 150 mg/12.5 mg were 100 %.
Slovenian: Med 24-urnim merjenjem krvnega tlaka pri bolnikih, ki so prejemali kombinacijo irbesartana in hidroklorotiazida 150 mg/12,5 mg, je bilo razmerje med najmanjšim in največjim učinkom 100 %.
English: Teva GmbH Tel: +49 73140208
Slovenian: Tel: +49 73140208
English: The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.
Slovenian: Koliko hidroklorotiazida se izloči s hemodializo,
English: The combination of irbesartan and hydrochlorothiazide has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Slovenian: Simptomatska hipotenzija se pri bolnikih z zvišanim krvnim tlakom, ki jemljejo kombinacijo irbesartana in hidroklorotiazida, nimajo pa drugih dejavnikov tveganja za hipotenzijo, pojavi le redko.
English: Given their similar pharmacodynamic properties, these results are also relevant for other ACE- inhibitors and angiotensin II receptor blockers.
Slovenian: Ti izsledki so pomembni tudi za druge zaviralce ACE in blokatorje receptorjev angiotenzina II, ker so njihove farmakodinamične lastnosti podobne.
English: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Slovenian: Dodatni podatki o medsebojnem delovanju z irbesartanom V kliničnih študijah hidroklorotiazid ni vplival na farmakokinetiko irbesartana.
English: Syncope, hypotension, tachycardia, oedema
Slovenian: Srčne bolezni občasni sinkopa, hipotenzija, tahikardija edem
English: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists.
Slovenian: Pri bolnikih z obojestransko zožitvijo ledvičnih arterij ali zožitvijo arterije delujoče ledvice se med jemanjem zaviralcev angiotenzinske konvertaze ali antagonistov angiotenzina II zveča nevarnost pojava hude hipotenzije in motnje v ledvičnem delovanju.
English: There were 0.6 % and 0 % of patients with hypotension and 2.8 % and 3.1 % of patients with dizziness as adverse reactions reported in the combination and monotherapy groups, respectively.
Slovenian: V skupini, ki je prejemala kombinacijo učinkovin so pri 0,6 % bolnikov poročali o pojavu hipotenzije in pri 2,8 % bolnikov o pojavu omotice.
English: Adequate monitoring of serum potassium in patients at risk is recommended.
Slovenian: Pri ogroženih bolnikih je priporočeno spremljanje serumske vrednosti kalija.
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg
Slovenian: Irbesartan/hidroklorotiazid Teva 300 mg/12,5 mg
English: Rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan.
Slovenian: koprivnica) in lokaliziranih oteklinah obraza, ustnic in/ali jezika.
English: Increases in blood urea nitrogen (BUN), creatinine and creatine kinase Decreases in serum potassium and sodium
Slovenian: kreatinina in kreatin-kinaze občasni znižanje vrednosti serumskega kalija in natrija
English: Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive 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: Irbesartan/Hydrochlorothiazide Teva is unlikely to affect your ability to drive or use machines.
Slovenian: Možnost, da bi zdravilo Irbesartan/hidroklorotiazid Teva vplivalo na sposobnost za upravljanje vozil in strojev je majhna.
English: Thiazides may increase the risk of adverse effects caused by amantadine.
Slovenian: Zaradi uporabe tiazidnih diuretikov se zveča nevarnost pojava neželenih učinkov amantadina.
English: Based on its pharmacodynamic properties, Irbesartan/Hydrochlorothiazide Teva is unlikely to affect the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Na osnovi farmakodinamičnih lastnosti je malo verjetno, da bi zdravilo Irbesartan/hidroklorotiazid Teva vplivalo na sposobnost vožnje in upravljanja s stroji.
English: Respiratory distress (including pneumonitis and pulmonary oedema)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora neznana respiratorni distres (vključno s pljučnico in pljučnim edemom)
English: Each film-coated tablet contains 300 mg irbesartan and 25 mg hydrochlorothiazide
Slovenian: Vsaka filmsko obložena tableta vsebuje 300 mg irbesartana in 25 mg hidroklorotiazida.
English: if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Slovenian: če imate hudo okvaro jeter ali ledvic če imate težave z odvajanjem seča če je zdravnik ugotovil, da imate stalno zvečano koncentracijo kalcija ali zmanjšano koncentracijo kalija v krvi če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren
English: Fertility
Slovenian: Litij
English: Thiazide diuretics may increase serum calcium levels due to decreased excretion.
Slovenian: Tiazidni diuretiki lahko zmanjšajo izločanje kalcija in tako zvišajo njegovo serumsko koncentracijo.
English: Co-administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol;
Slovenian: Med sočasnim zdravljenjem s tiazidnimi diuretiki so lahko preobčutljivostne reakcije na alopurinol pogostejše.
English: EU/1/09/583/049-072 EU/1/09/583/075 EU/1/09/583/078
Slovenian: EU/1/09/583/049-072 EU/1/09/583/075
English: DATE OF REVISION OF THE TEXT
Slovenian: DATUM PRIDOBITVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Furthermore, irbesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/kg/day, in macaques at ≥ 10 mg/kg/day).
Slovenian: Irbesartan je povzročil hiperplazijo/hipertrofijo jukstaglomerulnih celic (pri podganah po odmerku ≥
English: Pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite
Slovenian: draženje želodca, vnetje žleze slinavke, izguba apetita
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets are pink to dark pink, film coated capsule shaped tablet.
Slovenian: Irbesartan/hidroklorotiazid Teva 300 mg/25 mg filmsko obložene tablete so rožnate do temno rožnate filmsko obložene tablete v obliki kapsul.
English: Aplastic anaemia, bone marrow depression, neutopenia/agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
Slovenian: Bolezni krvi in limfatičnega sistema neznana aplastična anemija, zavora delovanja kostnega mozga, nevtopenija/agranulocitoza,
English: EU/1/09/583/025-048 EU/1/09/583/074 EU/1/09/583/077
Slovenian: EU/1/09/583/025-048 EU/1/09/583/074
English: However, another angiotensin-II antagonist affected fertility parameters in animal studies when given alone.
Slovenian: V študijah na živalih so ugotovili, da drugi antagonist angiotenzina II vpliva na plodnost.
English: The trough to peak effects measured by cuff during office visits were 68 % and 76 % for irbesartan/hydrochlorothiazide 150 mg/12.5 mg and irbesartan/hydrochlorothiazide 300 mg/12.5 mg, respectively.
Slovenian: Pri merjenju z manšeto v ambulanti je bilo pri bolnikih, ki so jemali kombinacijo irbesartana in hidroklorotiazida 150 mg/12,5 mg, to razmerje 68 %, pri tistih, ki so dobivali kombinacijo irbesartana in hidroklorotiazida 300 mg/12,5 mg, pa 76 %.
English: Keep this leaflet.
Slovenian: PRETISNI OMOT
English: Each film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide
Slovenian: Vsaka filmsko obložena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Slovenian: Med sočasno uporabo litija in zaviralcev angiotenzinske konvertaze so opazili reverzibilno zvečanje serumske koncentracije litija in toksičnost.
English: NDEA
Slovenian: Dojenje
English: The combination of 300 mg irbesartan and 12.5 mg hydrochlorothiazide resulted in an overall placebo-subtracted systolic/diastolic reductions of up to 13.6/11.5 mmHg.
Slovenian: Med kombiniranim zdravljenjem s 300 mg irbesartana in 12,5 mg hidroklorotiazida se je sistolični krvni tlak znižal do 13,6 mmHg, diastolični pa do 11,5 mmHg bolj kot po uporabi placeba.
English: EU/1/09/583/001-024 EU/1/09/583/073 EU/1/09/583/076
Slovenian: EU/1/09/583/001-024 EU/1/09/583/073
English: Antigout medicinal products
Slovenian: Pogoji dovoljenja za promet z zdravilom
English: Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in the irbesartan and hydrochlorothiazide combination, minimal or no effects were reported.
Slovenian: Pri bolnikih, ki so jemali po 12,5 mg hidroklorotiazida, kolikor ga vsebuje kombinacija irbesartana in hidroklorotiazida, je bil ta učinek zelo majhen ali pa ga sploh ni bilo.
English: The addition of 12.5 mg hydrochlorothiazide to 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mmHg.
Slovenian: Diastolični krvni tlak se je pri bolnikih, pri katerih zdravljenje s 300 mg irbesartana ni bilo dovolj učinkovito in so začeli jemati tudi po 12,5 mg hidroklorotiazida enkrat na dan, 24 ur po zaužitju odmerka znižal za povprečno 6,1 mmHg bolj kot po uporabi placeba.
English: A total of 697 patients were randomised in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systemically force-titrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
Slovenian: Po enem tednu zdravljenja so odmerek sistematično povečali (pred ovrednotenjem odziva na nižji odmerek) na irbesartan/hidroklorotiazid 300 mg/25 mg oziroma irbesartan 300 mg.
English: • Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg.
Slovenian: • Zdravilo Irbesartan/hidroklorotiazid Teva 300 mg/12,5 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem s 300 mg irbesartana ali z zdravilom Irbesartan/hidroklorotiazid Teva 150 mg/12,5 mg ni dovolj znižal.
English: Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Slovenian: C je v obtoku 80 do 85 % nespremenjene učinkovine.
English: Teva Nederland B.V. Tel: +31 8000228400
Slovenian: Tel: +31 8000228400
English: Each film-coated tablet contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide
Slovenian: Vsaka filmsko obložena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
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 (HCTZ) 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: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Slovenian: Irbesartan/hidroklorotiazid Teva 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: Food does not affect the bioavailability of irbesartan/hydrochlorothiazide.
Slovenian: Sočasno uživanje hrane na biološko uporabnost kombinacije irbesartana in hidroklorotiazida ne vpliva.
English: Although not specifically studied with irbesartan/hydrochlorothiazide, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Slovenian: Posebnih študij s kombinacijo irbesartana in hidroklorotiazida ni, kljub temu pa povratnega zvišanja krvnega tlaka pri bolnikih, ki so jemali bodisi irbesartan bodisi hidroklorotiazid, po prenehanju jemanja zdravila niso opazili.
English: Tablet coating for 300 mg/25 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, Indigotine (Indigo carmine aluminium lake FD&C blue #2) and iron oxide black.
Slovenian: (makrogol), polietilenglikol 400 (makrogol), rdeči železov oksid, indigotin (indigo karmin luminijevo rdeče FD&C modro #2), črni železov oksid.
English: Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics.
Slovenian: Pri bolnikih, ki jemljejo tiazidne diuretike, so opazili eksacerbacijo ali aktivacijo sistemskega eritematoznega lupusa.
English: Each Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablet contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Slovenian: Vsaka Irbesartan/ hidroklorotiazid Teva 300 mg/25 mg filmsko obložena tableta vsebuje 300 mg irbesartana in 25 mg hidroklorotiazida.
English: What Irbesartan/Hydrochlorothiazide Teva looks like and contents of the pack
Slovenian: Izgled zdravila Irbesartan/hidroklorotiazid Teva in vsebina pakiranja
English: Irbesartan/hydrochlorothiazide combination
Slovenian: Kombinacija irbesartan/hidroklorotiazid:
English: Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Slovenian: premreženi natrijev karmelozat, koloidni brezvodni silicijev dioksid, magnezijev stearat.
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
Slovenian: Irbesartan/hidroklorotiazid Teva 300 mg/25 mg filmsko obložene tablete Vsaka filmsko obložena tableta vsebuje 300 mg irbesartana in 25 mg hidroklorotiazida.
English: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Slovenian: Irbesartan/hidroklorotiazid Teva 150 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: • Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg.
Slovenian: • Zdravilo Irbesartan/hidroklorotiazid Teva 300 mg/25 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem z zdravilom Irbesartan/hidroklorotiazid Teva 300 mg/12,5 mg ni dovolj znižal.
English: Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Slovenian: Irbesartan/hidroklorotiazid Teva 150 mg/12,5 mg filmsko obložene tablete Vsaka filmsko obložena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
English: Nausea/vomiting Diarrhoea Dyspepsia, dysgeusia
Slovenian: Bolezni prebavil pogosti navzea/bruhanje občasni driska neznana dispepsija, paragevzija
English: Polyethylene Glycol 6000 (Macrogol) Polyethylene Glycol 400 (Macrogol) Iron Oxide Red
Slovenian: 6000 (makrogol), polietilenglikol 400 (makrogol), rdeči železov oksid, rumeni železov oksid,
English: Other medicines and Irbesartan/Hydrochlorothiazide Teva
Slovenian: Shranjevanje zdravila Irbesartan/hidroklorotiazid Teva
English: Protect your skin from sun exposure and UV rays while taking Irbesartan/Hydrochlorothiazide Teva
Slovenian: Med jemanjem zdravila Irbesartan/hidroklorotiazid Teva zaščitite kožo pred izpostavljenostjo soncu in UV-žarkom.
English: The two active ingredients in Irbesartan/Hydrochlorothiazide Teva work together to lower blood pressure further than if either was given alone.
Slovenian: Zdravilni učinkovini v zdravilu Irbesartan/hidroklorotiazid Teva znižujeta krvnitlak, in to še bolj kot če bi jemali vsako učinkovino posebej.
English: Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.
Slovenian: Če se intraokularni tlak kljub temu ne zniža, bo morda treba razmisliti o takojšnjem zdravljenju z zdravili ali kirurškem posegu.
English: Each Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Slovenian: Vsaka Irbesartan/hidroklorotiazid Teva 150 mg/12,5 mg filmsko obložena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
English: Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with Irbesartan/Hydrochlorothiazide Teva.
Slovenian: Dodatni podatki o posameznih učinkovinah: poleg zgoraj naštetih neželenih učinkov, ki se lahko pojavijo med uporabo kombiniranega zdravila, se utegnejo med jemanjem zdravila
English: Adequate monitoring of serum potassium in patients at risk is recommended (see section
Slovenian: Pri bolnikih s povečanim tveganjem je priporočljivo nadzirati vrednosti kalija v serumu (glejte poglavje 4.4).
English: Interstitial nephritis, renal dysfunction
Slovenian: Bolezni sečil neznana intersticijski nefritis, motnje delovanja ledvic
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Slovenian: Irbesartan/hidroklorotiazid Teva 300 mg/12,5 mg filmsko obložene tablete Vsaka filmsko obložena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
English: Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Slovenian: Irbesartan/hidroklorotiazid Teva 300 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: Fever
Slovenian: Plodnost
English: Each Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Slovenian: Vsaka Irbesartan/ hidroklorotiazid Teva 300 mg/12.5 mg filmsko obložena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
English: The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of Nnitrosamines and changed as necessary to minimise nitrosamine contamination as much as possible.
Slovenian: N-nitrozaminov in jih po potrebi spremeniti tako, da se onesnaženje z nitrozamini čim bolj zmanjša.
English: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1).
Slovenian: Nemelanomski kožni rak: Na podlagi obstoječih podatkov epidemioloških študij so ugotovili, da obstaja razmerje med kumulativnim odmerkom hidroklorotiazida in nemelanomskim kožnim rakom
English: No dosage adjustment of Irbesartan/Hydrochlorothiazide Teva is necessary in older people.
Slovenian: Zdravilo Irbesartan/hidroklorotiazid Teva je potrebno zaužiti.
English: Additional information on hydrochlorothiazide interactions When administered concurrently, the following medicinal products may interact with thiazide diuretics:
Slovenian: Ob sočasni uporabi se lahko pojavijo interakcije med tiazidnimi diuretiki in naslednjimi zdravili: Alkohol
English: This medicine has been prescribed for you only.
Slovenian: Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Tablet coating for 150 mg/12.5 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, iron oxide yellow and iron oxide black.
Slovenian: Filmska obloga za jakosti 150 mg/12,5 mg in 300 mg/12,5 mg: hipromeloza titanov dioksid polietilenglikol 6000 (makrogol) polietilenglikol 400 (makrogol)
English: Additional information on irbesartan interactions
Slovenian: Dodatni podatki o medsebojnem delovanju s hidroklorotiazidom
English: Tablet coating for 300 mg/12.5 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, iron oxide yellow and iron oxide black.
Slovenian: Filmska obloga za jakost 300 mg/25 mg: hipromeloza titanov dioksid polietilenglikol 6000 (makrogol) polietilenglikol 400 (makrogol)
English: Corticosteroids, ACTH Electrolyte depletion, particularly hypokalaemia, may be increased;
Slovenian: Znižanje elektrolitov, še posebej kalija (hipokaliemija).
English: Posology
Slovenian: Zdravila
English: Cardiac arrhythmias
Slovenian: hemolitična anemija,
English: Dosage adjustments of antigout medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Slovenian: Zdravila za zdravljenje protina Hidroklorotiazid lahko zveča serumsko koncentracijo sečne kisline, zato je treba v takem primeru odmerek zdravil za zdravljenje protina prilagoditi.
English: Jaundice (intrahepatic cholestatic jaundice)
Slovenian: Bolezni jeter, žolčnika in žolčevodov neznana zlatenica (intrahepatska holestatska zlatenica)
English: Package leaflet: information for the patient Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets irbesartan / hydrochlorothiazide
Slovenian: Navodilo za uporabo Irbesartan/hidroklorotiazid Teva 300 mg/25 mg filmsko obložene tablete irbesartan / hidroklorotiazid
English: Not known:
Slovenian: niso ugotavljali.
English: Vertigo, paraesthesia, lightheadedness, restlessness
Slovenian: Bolezni živčevja neznana vrtoglavica, parestezija, omotica, nemir
English: For N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora za N-nitrozodimetilamin (NDMA) in