FrancophonIA/ELRC3.0 huggingface dataset:
English: When initiating, adjusting, and discontinuing telmisartan, monitor digoxin levels in order to maintain levels within the therapeutic range.
Slovenian: Ob uvedbi telmisartana, prilagoditvi njegovega odmerka ali prenehanju njegove uporabe je treba kontrolirati koncentracijo digoksina, da bi jo ohranili v terapevtskem območju.
English: Actelsar HCT once daily produces effective and smooth reductions in blood pressure across the therapeutic dose range.
Slovenian: Actelsar HCT v enem odmerku na dan učinkovito in enakomerno znižuje krvni tlak v celotnem razponu odmerjanja.
English: There is no experience regarding the administration of telmisartan/hydrochlorothiazide in patients with recent kidney transplantation.
Slovenian: Z uporabo kombinacije telmisartan/hidroklorotiazid pri bolnikih z nedavno presajeno ledvico ni izkušenj.
English: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Slovenian: Na splošno se bolniki s primarnim aldosteronizmom ne odzivajo na antihipertenzive, ki delujejo z zaviranjem renin-angiotenzinskega sistema, zato zanje zdravljenja z zdravilom Actelsar HCT ne priporočamo.
English: If you forget to take Actelsar HCT
Slovenian: Če ste pozabili vzeti zdravilo Actelsar HCT
English: Gastric lesions could be prevented/ameliorated by oral sodium chloride solution supplementation and group housing of animals.
Slovenian: Poškodbe v želodcu so lahko preprečili ali ublažili s peroralnim dajanjem raztopine natrijevega klorida in s skupinsko nastanitvijo živali.
English: Dose adjustment of the antidiabetic medicinal products may be required (see section 4.4).
Slovenian: Včasih je treba prilagoditi odmerek antidiabetika (glejte poglavje 4.4).
English: Actelsar HCT may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Slovenian: Zdravilo Actelsar HCT lahko poveča znižanje krvnega tlaka, ki ga povzročijo druga zdravila za zdravljenje visokega krvnega tlaka ali zdravila, ki lahko povzročijo znižanje krvnega tlaka (npr.
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and if appropriate, alternative therapy should be started.
Slovenian: Ob potrjeni nosečnosti je treba zdravljenje z antagonisti angiotenzina II takoj prekiniti in, če je primerno, začeti alternativno zdravljenje.
English: Telmisartan: The pharmacokinetics of orally administered telmisartan are non-linear over doses from 20-160 mg with greater than proportional increases of plasma concentrations (Cmax and AUC) with increasing doses.
Slovenian: Telmisartan: Farmakokinetika peroralno apliciranega telmisartana ni linearna v razponu odmerkov od 20 do 160 mg, koncentracije v plazmi (Cmax in AUC) se pri naraščajočih odmerkih večajo več kot proporcionalno.
English: Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of Actelsar HCT, hyperkalaemia might occur.
Slovenian: Zaradi antagonističnega delovanja telmisartana v zdravilu Actelsar HCT na receptorje za angiotenzin II (AT1) je možna tudi hiperkaliemija.
English: Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Slovenian: Podatki kliničnih preskušanj so pokazali, da je dvojna blokada sistema renin-angiotenzin aldosteron (RAAS) s hkratno uporabo zaviralcev ACE, antagonistov receptorjev angiotenzina II ali aliskirena povezana z večjo pogostnostjo neželenih učinkov, npr. hipotenzije, hiperkaliemije in zmanjšanega delovanja ledvic (vključno z akutno odpovedjo ledvic) kot uporaba enega samega zdravila, ki deluje na RAAS (glejte poglavja 4.3, 4.4. in 5.1).
English: Other medicines and Actelsar HCT
Slovenian: Druga zdravila in zdravilo Actelsar HCT
English: Abdominal pain, constipation, dyspepsia, vomiting, gastritis
Slovenian: abdominalna bolečina, zaprtje, dispepsija, bruhanje, gastritis
English: Metformin should be used with precaution: risk of lactic acidosis induced by a possible functional renal failure linked to hydrochlorothiazide.
Slovenian: Moramo ga dajati previdno zaradi nevarnosti laktacidoze, ki jo povzroči funkcionalna motnja ledvičnega delovanja, povezana s hidroklorotiazidom.
English: Diarrhoea, dry mouth, flatulence
Slovenian: driska, suha usta, napenjanje
English: Actelsar HCT is not indicated in patients with severe hepatic impairment.
Slovenian: Zdravilo Actelsar HCT ni indicirano za bolnike s hudim jetrnim odpovedovanjem.
English: TRANSCEND randomized ACE-I intolerant patients with otherwise similar inclusion criteria as ONTARGET to telmisartan 80 mg (n=2954) or placebo (n=2972), both given on top of standard care.
Slovenian: V preskušanju TRANSCEND so bolnike, ki ne prenašajo zaviralcev ACE, na podlagi vključitvenih meril, ki so bila podobna kot v raziskavi ONTARGET, naključno razvrstili v dve skupini: s telmisartanom po 80 mg (n = 2954) ali placebom (n = 2972), ki so ju jemali dodatno ob standardni zdravstveni oskrbi.
English: Angioedema (also with fatal outcome), erythema, pruritus, rash, hyperhidrosis, urticaria
Slovenian: angioedem (lahko s smrtnim izidom), eritem, pruritus, izpuščaj, hiperhidroza, urtikarija
English: Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Slovenian: Z veliko afiniteto spodriva angiotenzin II z njegovega vezivnega mesta na podtipu receptorja A T1, ki je odgovoren za znane učinke angiotenzina II.
English: In patients with mild to moderate hepatic impairment the posology should not exceed Actelsar HCT 40 mg/12.5 mg once daily.
Slovenian: Odmerek za bolnike z blago do zmerno zmanjšanim delovanjem jeter ne sme prekoračiti odmerka zdravila Actelsar HCT 40 mg/12,5 mg 1-krat na dan.
English: Thiazides may increase the risk of adverse events caused by amantadine.
Slovenian: Tiazidi lahko povečajo nevarnost neželenih učinkov amantadina.
English: Triglycerides increased
Slovenian: povečana raven trigliceridov
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Slovenian: Bolniki morajo biti ustrezno hidrirani na začetku sočasnega zdravljenja in v rednih razmikih med njim pa je treba presoditi tudi o spremljanju ledvičnega delovanja.
English: This is confirmed by measurements made at the point of maximum effect and immediately prior to the next dose (through to peak ratios consistently above 80% after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies).
Slovenian: Enakomerno trajanje učinka so potrdile meritve pri največjem učinku in tik pred naslednjim odmerkom (v s placebom nadzorovanih kliničnih preskušanjih je bil količnik med pojemanjem učinka in največjim učinkom vedno nad 80 %).
English: In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Slovenian: Hidroklorotiazid Pri bolnikih, ki so jemali samo hidroklorotiazid, so poročali še o naslednjih neželenih učinkih:
English: Toxicological findings also well known from preclinical studies with angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists were: a reduction of red cell parameters (erythrocytes, haemoglobin, haematocrit), changes of renal haemodynamics (increased blood urea nitrogen and creatinine), increased plasma renin activity, hypertrophy/hyperplasia of the juxtaglomerular cells and gastric mucosal injury.
Slovenian: Toksikološki izvidi, ki so znani tudi iz predkliničnih raziskav o zaviralcih angiotenzinske konvertaze in antagonistih angiotenzina II, so bili: zmanjšanje parametrov rdečih krvničk (eritrocitov, hemoglobina, hematokrita); spremembe ledvične hemodinamike (povečana raven sečninskega dušika in kreatinina v krvi); povečana aktivnost renina v plazmi; hipertrofija oz. hiperplazija jukstaglomerulnih celic in poškodba želodčne sluznice.
English: The use of hydrochlorothiazide during breast feeding is not recommended.
Slovenian: Uporabe zdravila Actelsar HCT med dojenjem ne priporočajo.
English: 1 Based on post-marketing experience 2 For further description, please see sub-section “Description of selected adverse reactions”
Slovenian: 2 Za podrobnejši opis glejte podpoglavje »Opis izbranih neželenih učinkov«
English: Hydrochlorothiazide exhibits linear pharmacokinetics.
Slovenian: Hidroklorotiazid kaže linearno farmakinetiko.
English: As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Slovenian: Enako kot za uporabo drugih vazodilatatorjev velja posebna previdnost pri dajanju zdravila Actelsar HCT bolnikom z zožitvijo aorte ali mitralne zaklopke ali obstruktivno hipertrofično kardiomiopatijo.
English: Syncope, paraesthesia
Slovenian: sinkopa, parestezija
English: Increased incidence of sepsis has been observed with telmisartan only, however it can not be ruled out for Actelsar HCT.
Slovenian: Kljub temu, da so povečano pojavnost sepse opazili le pri uporabi telmisartana samega, je med jemanjem zdravila Actelsar HCT ni možno izključiti.
English: Hydrochlorothiazide: Following oral administration of telmisartan/hydrochlorothiazide, peak concentrations of hydrochlorothiazide are reached in approximately 1.0-3.0 hours after dosing.
Slovenian: Hidroklorotiazid: Po peroralnem dajanju zdravila Actelsar HCT doseže hidroklorotiazid največjo koncentracijo v plazmi približno v 1,0 do 3,0 urah.
English: What you need to know before you take Actelsar HCT Do not take Actelsar HCT
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Actelsar HCT
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking Actelsar HCT.
Slovenian: Oba sta lahko tudi simptoma zvišanega očesnega tlaka, ki se pojavita nekaj ur do nekaj tednov po začetku jemanja zdravila Actelsar HCT.
English: Actelsar HCT 40 mg/12.5 mg tablets EU/1/13/817/043
Slovenian: Actelsar HCT 40 mg/12,5 mg tablete EU/1/13/817/043
English: Actelsar HCT is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Slovenian: Zdravilo Actelsar HCT je kombinacija antagonista receptorjev angiotenzina II telmisartana in tiazidnega diuretika hidroklorotiazida.
English: Due to the hydrochlorothiazide component, markedly low blood pressure and low blood levels of potassium can also happen, which may result in nausea, sleepiness and muscle cramps and/or irregular heartbeat associated with the concomitant use of medicinal products such as digitalis or certain anti-arrhythmic treatments.
Slovenian: Zaradi hidroklorotiazida v zdravilu se lahko znatno znižata krvni tlak in raven kalija v krvi, kar lahko povzroči siljenje na bruhanje, zaspanost in mišične krče in/ali neenakomerno bitje srca v povezavi s sočasno uporabo zdravil, na primer digitalisa ali nekaterih zdravil za zdravljenje aritmije.
English: Rare cases have also been reported with angiotensin II receptor antagonists (including telmisartan/hydrochlorothiazide).
Slovenian: O redkih tovrstnih primerih poročajo tudi za antagoniste angiotenzina II (vključno z zdravilom Actelsar HCT).
English: Actelsar HCT 80 mg/12.5 mg tablets EU/1/13/817/014
Slovenian: Actelsar HCT 80 mg/12,5 mg tablete EU/1/13/817/014
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.23
Slovenian: Veliki odmerki hidroklorotiazida (kumulativno ≥ 50.000 mg) so bili povezani s prilagojenim razmerjem obetov (OR) 1,29 (95-odstotni IZ: 1,23-1,35) za bazalnocelični karcinom in 3,98 (95-odstotni IZ:
English: ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25,620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Slovenian: V preskušanju ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) so primerjali učinke telmisartana, ramiprila in kombinacije telmisartana in ramiprila na srčnžilne izide pri 25.620 bolnikih, starih 55 let ali starejših, ki so imeli v anamnezi koronarno arterijsko bolezen, možgansko kap, prehodni ishemični napad (TIA), periferno arterijsko bolezen ali sladkorno bolezen tipa 2 z dokazano okvaro tarčnih organov (npr. retinopatijo, hipertrofijo levega prekata, makro- ali mikroalbuminurijo), torej pri populaciji s povečanim tveganjem za srčnožilne dogodke.
English: Medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid and derivatives)
Slovenian: Zdravila, ki povzročajo izgubo kalija in hipokaliemijo (npr. drugi kaliuretični diuretiki, laksativi, kortikosteroidi, ACTH, amfotericin, karbenoksolon, natrijev benzilpenicilinat, salicilna kislina in derivati).
English: For Al/PVC/PVDC blister Do not store above 30ºC.
Slovenian: Al/PVC/PVDC pretisni omot Shranjujte pri temperaturi do 30°C.
English: Sepsis* (often called “blood poisoning”), is a severe infection with whole-body inflammatory response, rapid swelling of the skin and mucosa (angioedema); blistering and peeling of the top layer of skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Slovenian: Sepsa* (pogosto poimenovana tudi “zastrupitev krvi”), je huda okužba, pri kateri pride v vsem telesu do vnetnega odziva in je lahko usodna; hitro otekanje kože in sluznice (angioedem); mehurji in luščenje vrhnjega sloja kože (toksična epidermalna nekroliza); ti neželeni učinki so redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) ali neznane pogostnosti (toksična epidermalna nekroliza), toda zelo resni, zato morajo bolniki takoj prenehati z jemanjem zdravila in nemudoma poiskati zdravniško pomoč.
English: Exacerbation or activation of systemic lupus erythematosus1 Metabolism and nutrition disorders Uncommon:
Slovenian: poslabšanje ali aktiviranje sistemskega eritematoznega lupusa1
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Not known
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
English: Actelsar HCT fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide and 80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
Slovenian: Zdravilo Actelsar HCT, fiksna kombinacija (40 mg telmisartana/12,5 mg hidroklorotiazida oz. 80 mg telmisartana/12,5 mg hidroklorotiazida), je indicirano za odrasle, pri katerih krvnega tlaka ne moremo ustrezno uravnati s samim telmisartanom.
English: If hydrochlorothiazide is used during breast-feeding, doses should be kept as low as possible.
Slovenian: Če doječe matere zdravilo Actelsar HCT uporabljajo med dojenjem, morajo biti njegovi odmerki karseda majhni.
English: The concomitant use of Actelsar HCT with aliskiren-containing products is contraindicated 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 Actelsar HCT in zdravil, ki vsebujejo aliskiren, je kontraindicirana pri bolnikih s sladkorno boleznijo ali z okvaro ledvic (hitrost glomerularne filtracije < 60 ml/min/1,73 m2) (glejte poglavja 4.5 in 5.1).
English: Telmisartan: Following oral administration, peak concentrations of telmisartan are reached in 0.5-1.5 h after dosing.
Slovenian: Telmisartan: Telmisartan doseže po peroralnem dajanju največjo koncentracijo v 0,5 do 1,5 ure.
English: Hypochloraemic alkalosis
Slovenian: hipokloremična alkaloza
English: Visual disturbance, vision blurred
Slovenian: motnje vida, zamegljen vid
English: Slow heartbeat, dizziness, vomiting, reduced kidney function including kidney failure, have also been reported.
Slovenian: V poročilih navajajo še počasen srčni utrip, omotico, bruhanje in zmanjšano delovanje ledvic, tudi ledvično odpoved.
English: Adverse reactions reported with one of the individual components may be potential adverse reactions with Actelsar HCT, even if not observed in clinical trials with this product.
Slovenian: Neželeni učinki, o katerih so poročali za eno od posameznih sestavin, se lahko pojavijo tudi pri zdravilu Actelsar HCT, četudi jih v kliničnem preskušanju tega zdravila niso zasledili.
English: Pancreatitis, stomach discomfort
Slovenian: pankreatitis, želodčne težave
English: Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract infections, deficiency in red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), kidney impairment including acute kidney failure, weakness, cough.
Slovenian: Okužba zgornjih dihal (npr. vnetje grla, vnetje sinusov, navadni prehlad), okužbe sečil, pomanjkanje rdečih krvničk (anemija), visoka raven kalija, počasen srčni utrip (bradikardija), ledvična okvara, tudi akutna ledvična odpoved; oslabelost, kašelj.
English: Al/PVC/PVDC blister: 28, 56, 84, 90 and 98 tablets Actelsar HCT 80 mg/12.5 mg tablets
Slovenian: Al/PVC/PVDC pretisni omot: 28, 56, 84, 90 in 98 tablet Actelsar HCT 80 mg/12,5 mg tablete
English: In a double-blind controlled clinical trial (n=687 patients evaluated for efficacy) in non-responders to the 80 mg/12.5 mg combination, an incremental blood pressure lowering effect of the 80 mg/25 mg combination compared to continued treatment with the 80 mg/12.5 mg combination of 2.7/1.6 mm Hg
Slovenian: V dvojno slepi, nadzorovani klinični raziskavi (n = 687 bolnikov, pri katerih so ocenili učinkovitost) pri bolnikih, ki se niso odzivali na zdravljenje s kombinacijo 80 mg/12,5 mg, je kombinacija 80 mg/25 mg v primerjavi s stalnim zdravljenjem s kombinacijo 80 mg/12,5 mg dodatno znižala krvni tlak za 2,7/1,6 mm Hg (SKT/DKT) (razlika v prilagojenih srednjih spremembah glede na izhodiščno vrednost).
English: Interstitial lung disease3
Slovenian: intersticijska pljučna bolezen3
English: How to take Actelsar HCT
Slovenian: Kako jemati zdravilo Actelsar HCT
English: Hypokalaemia
Slovenian: hipokaliemija
English: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
Slovenian: Endpoints) je preučevala koristi dodatka aliskirena standardnemu zdravljenju z zaviralcem ACE ali antagonistom receptorjev angiotenzina II pri bolnikih s sladkorno boleznijo tipa 2 in kronično boleznijo ledvic, kardiovaskularno boleznijo ali obojim.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Al/Al blister
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla za Al/Al pretisni omot
English: Patients were randomized to one of the three following treatment groups: telmisartan 80 mg (n=8542), ramipril 10 mg (n=8576), or the combination of telmisartan 80 mg plus ramipril 10 mg (n=8502), and followed for a mean observation time of 4.5 years.
Slovenian: Bolnike so naključno razvrstili v tri skupine, ki so prejemale telmisartan po 80 mg (n = 8542), ramipril po 10 mg (n = 8576) ali kombinacijo telmisartana po 80 mg in ramiprila po 10 mg (n = 8502).
English: - digoxin.
Slovenian: - digoksin
English: Sialadenitis Neoplasms benign, malignant and unspecified (incl cysts and polyps) Not known
Slovenian: sialadenitis Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Neznana pogostnost:
English: cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol) - others (e.g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
Slovenian: haloperidol, droperidol) - drugo (npr. bepridil, cisaprid, difemanil, eritromicin i.v., halofantrin, mizolastin,
English: Actelsar HCT is also available at the dose strengths 40 mg/12.5 mg and 80 mg/12.5 mg
Slovenian: Zdravilo Actelsar HCT je na voljo tudi v jakostih 40 mg/12,5 mg in 80 mg/12,5 mg.
English: - Anti-cholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia) such as atropine and biperiden.
Slovenian: - antiholinergična zdravila (zdravila za zdravljenje različnih obolenj, na primer krčev v prebavilih, krčev sečnega mehurja, astme, potovalne slabosti, mišičnih krčev, Parkinsonove bolezni, in za uporabo pri anesteziji), kot sta atropin in biperiden;
English: Back pain, muscle spasms, myalgia
Slovenian: bolečina v hrbtu, mišični spazem, mialgija
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Al/PVC/PVDC blister
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla za Al/PVC/PVDC/ pretisni omot
English: What Actelsar HCT looks like and contents of the pack
Slovenian: Izgled zdravila Actelsar HCT in vsebina pakiranja
English: - Actelsar HCT 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 40 mg - Actelsar HCT 80 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 80 mg
Slovenian: - Zdravilo Actelsar HCT 40 mg/12,5 mg lahko dajemo enkrat na dan bolnikom, pri katerih krvnega tlaka ne moremo ustrezno nadzorovati s telmisartanom 40 mg. - Zdravilo Actelsar HCT 80 mg/12,5 mg lahko dajemo enkrat na dan bolnikom, pri katerih krvnega tlaka ne moremo ustrezno nadzorovati s telmisartanom 80 mg.
English: Marketing Authorisation Holder Actavis Group PTC ehf.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Actavis Group PTC ehf.
English: In a pooled analysis of two similar 8 week double-blind placebo-controlled clinical trials vs. valsartan/hydrochlorothiazide 160 mg/25 mg (n=2,121 patients evaluated for efficacy) a significantly greater blood pressure lowering effect of 2.2/1.2 mm Hg (SBP/DBP) was demonstrated (difference in adjusted mean changes from baseline, respectively) in favour of telmisartan/hydrochlorothiazide 80 mg/25 mg combination.
Slovenian: V analizi združenih podatkov iz dveh podobnih 8-tedenskih, dvojno slepih, s placebom nadzorovanih kliničnih raziskav, v katerih je bilo primerjano zdravilo kombinacija valsartan/hidroklorotiazid 160 mg/25 mg (n = 2121 bolnikov, pri katerih so ocenili učinkovitost), je bilo znižanje krvnega tlaka pri kombinaciji telmisartan/hidroklorotiazid 80 mg/25 mg značilno večje, in sicer za 2,2/1,2 mm Hg (SKT/DKT) (razlika v prilagojenih srednjih spremembah glede na izhodiščno vrednost).