FrancophonIA/ELRC3.0 huggingface dataset:
English: Periodic monitoring of serum potassium and ECG is recommended when Actelsar HCT is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes.
Slovenian: Priporočamo periodično spremljanje ravni kalija v serumu in EKG, kadar dajemo zdravilo Actelsar HCT hkrati z zdravili, na delovanje katerih vplivajo motnje serumskega kalija (npr. z glikozidi digitalisa ali antiaritmiki).
English: Actelsar HCT 40 mg/12.5 mg tablets Actelsar HCT 80 mg/12.5 mg tablets
Slovenian: Actelsar HCT 40 mg/12,5 mg tablete Actelsar HCT 80 mg/12,5 mg tablete
English: The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5% CI 0.93-1.10, p (non-inferiority)=0.0019 at a margin of 1.13).
Slovenian: Pri zdravljenju s telmisartanom je bilo razmerje ogroženosti v primerjavi z ramiprilom 1,01 (97,5odstotni IZ 0,93 do 1,10, p (enakovrednost) = 0,0019 pri mejni vrednosti 1,13).
English: Common (may affect up to 1 in 10 people): Dizziness
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): Omotica.
English: White or almost white, 6.55 x 13.6 mm oval-shaped and biconvex tablets marked with “TH” on one side.
Slovenian: Bele ali skoraj bele, ovalne in bikonveksne tablete velikosti 6,55 x 13,6 mm, z oznako “TH” na eni strani.
English: Aplastic anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis,
Slovenian: aplastična anemija, hemolitična anemija, odpoved kostnega mozga, levkopenija, nevtropenija, agranulocitoza,
English: The overall incidence of adverse reactions reported with telmisartan/hydrochlorothiazide was comparable to those reported with telmisartan alone in randomised controlled trials involving 1,471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Slovenian: V kliničnih preskušanjih je sodelovalo 1471 bolnikov, ki so bili naključno razvrščeni v skupini, od katerih je ena prejemala telmisartan in hidroklorotiazid (835), druga pa samo telmisartan (636).
English: Actelsar HCT fixed dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Slovenian: Zdravilo Actelsar HCT, fiksna kombinacija (80 mg telmisartana/25 mg hidroklorotiazida), je indicirano za odrasle, pri katerih krvnega tlaka ne moremo ustrezno uravnati z zdravilom Actelsar HCT 80 mg/12,5 mg (80 mg telmisartana in 12,5 mg hidroklorotiazida) ali za bolnike, ki jemljejo telmisartan in hidroklorotiazid posebej in imajo ustaljen krvni tlak.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for HDPE tablet container
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla za HDPE vsebnik za tablete
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING Label for HDPE tablet container
Slovenian: PODATKI NA STIČNI OVOJNINI Nalepka za HDPE vsebnik za tablete
English: Actelsar HCT 80 mg/25 mg tablets
Slovenian: Actelsar HCT 80 mg/25 mg tablete
English: - Actelsar HCT 80 mg/25 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Actelsar HCT 80 mg/12.5 mg or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Slovenian: - Zdravilo Actelsar HCT 80 mg/25 mg lahko dajemo enkrat na dan bolnikom, pri katerih krvnega tlaka ne moremo ustrezno nadzorovati z zdravilom Actelsar HCT 80 mg/12,5 mg ali bolnikom, ki jemljejo telmisartan in hidroklorotiazid posebej in imajo ustaljen krvni tlak.
English: The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Slovenian: Antagonisti adrenergičnih receptorjev beta in diazoksid Tiazidi lahko povečajo hiperglikemični učinek antagonistov adrenergičnih receptorjev beta in diazoksida.
English: Actelsar HCT 80 mg/12.5 mg tablets are white or almost white, 9.0 x 17.0 mm capsule-shaped tablets marked with “TH 12.5” on both sides.
Slovenian: Actelsar HCT 80 mg/12,5 mg tablete so bele ali skoraj bele tablete v obliki kapsule, velikosti 9,0 x 17,0 mm, z oznako “TH 12,5” na obeh straneh.
English: Reduction in blood platelets, which increases risk of bleeding or bruising (small purple-red marks in skin or other tissue caused by bleeding), high blood calcium level, headache.
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): zmanjšanje števila trombocitov, kar poveča tveganje za krvavitve ali nastanek modric (majhne vijoličnordeče lise na koži ali drugih tkivih, ki jih povzroča krvavitev), visoka raven kalcija v krvi,
English: Aplastic anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis
Slovenian: aplastična anemija, hemolitična anemija, odpoved kostnega mozga, levkopenija, nevtropenija, agranulocitoza
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 angiotensin II receptor blocker.
Slovenian: Uporabo zaviralca ACE v kombinaciji z antagonisti receptorjev angiotenzina II 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: Inflammation of the lungs (bronchitis), activation or worsening of systemic lupus erythematosus (a disease where the body's immune system attacks the body, which causes joint pain, skin rashes and fever); sore throat, inflamed sinuses, feeling sad (depression), difficulty falling asleep (insomnia), impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), feeling sick (vomiting), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are more likely to experience this side effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities, muscle cramps, flu-like-illness, pain, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.
Slovenian: Vnetje pljuč (bronhitis), aktiviranje ali poslabšanje sistemskega eritematoznega lupusa (bolezni, pri kateri telo napade človekov lastni imunski sistem, kar povzroči bolečine v sklepih, kožni izpuščaj in vročino), vnetje grla, vnetje sinusov, občutek žalosti (depresija), težave z uspavanjem (nespečnost), motnje vida, težave z dihanjem, trebušna bolečina, zaprtje, napenjanje (dispepsija), bruhanje, želodčno vnetje (gastritis), motnje delovanja jeter (pri japonskih bolnikih obstaja večja verjetnost pojavljanja tega neželenega učinka); rdečica na koži (eritem), alergijske reakcije, na primer srbenje ali izpuščaj; povečano znojenje, koprivnica (urtikarija), bolečine v sklepih (artralgija) in v okončinah, mišični krči, gripi podobna bolezen, bolečina, nizka raven natrija, zvišane ravni kreatinina, jetrnih encimov ali kreatin-fosfokinaze v krvi.
English: This can lead to permanent vision impairment, if not treated.
Slovenian: Brez zdravljenja lahko pride do trajne okvare vida;
English: If you experience any of these you should tell your doctor.
Slovenian: Če opazite katerikoli pojav od naštetih, obvestite zdravnika.
English: 28 tablets 56 tablets 84 tablets 90 tablets 98 tablets
Slovenian: 28 tablet 56 tablet 84 tablet 90 tablet 98 tablet
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 25620 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: 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,
English: Hepatic function abnormal/liver disorder
Slovenian: Nenormalno jetrno delovanje ali jetrna bolezen
English: Blood uric acid increased
Slovenian: povečana raven sečne kisline v krvi
English: Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Slovenian: Na receptorju A T1 nima nikakršnega delnega agonističnega učinka.
English: Actelsar HCT 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Slovenian: Actelsar HCT 80 mg/12,5 mg tablete Ena tableta vsebuje 80 mg telmisartana in 12,5 mg hidroklorotiazida.
English: In the “Prevention Regimen For Effectively avoiding Second Strokes” (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 1.00-2.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) vs. patients taking placebo (0.16 %) [RR 2.07 (95 % confidence interval 1.14-3.76)].
Slovenian: V preskušanju PRoFESS (“Prevention Regimen For Effectively avoiding Second Strokes”) se je pri bolnikih, starih 50 let in starejših, ki so pred kratkim doživeli možgansko kap, med jemanjem telmisartana povečala pojavnost sepse, in sicer pri 0,70 % v primerjavi z 0,49 % pri zdravljenih s placebom [RR 1,43 (95-odstotni interval zaupanja 1,00 do 2,06)].
English: Actelsar HCT is also available at the dose strength 80 mg/25 mg
Slovenian: Zdravilo Actelsar je na voljo tudi v jakosti 80 mg/25 mg.
English: The active substances are telmisartan and hydrochlorothiazide.
Slovenian: Kaj vsebuje zdravilo Actelsar HCT - Učinkovini sta telmisartan in hidroklorotiazid.
English: Actelsar HCT 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Slovenian: Actelsar HCT 40 mg/12,5 mg tablete Ena tableta vsebuje 40 mg telmisartana in 12,5 mg hidroklorotiazida.
English: - Medicines associated with low blood potassium (hypokalaemia) such as other diuretics, (“water tablets”), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
Slovenian: - zdravila z litijem za zdravljenje nekaterih oblik depresije; - zdravila, ki jih povezujejo z znižanjem krvne ravni kalija (hipokaliemijo), kot so drugi diuretiki (tablete za odvajanje vode), odvajala (npr. ricinusovo olje), kortikosteroidi (npr. prednizon), ACTH (hormon), amfotericin (antimikotik), karbenoksolon (zdravilo za zdravljenje razjed v ustih), natrijev penicilin G (antibiotik) in salicilna kislina in njeni derivati:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Actavis logo]
English: There is no clinical experience with Actelsar HCT in patients with hepatic impairment.
Slovenian: Z zdravilom Actelsar HCT pri bolnikih z zmanjšanim jetrnim delovanjem ni izkušenj.
English: Hydrochlorothiazide is 68% protein bound in the plasma and its apparent volume of distribution is 0.83-1.14 l/kg.
Slovenian: Njegov navidezen volumen porazdelitve je 0,83 do 1,14 l/kg.
English: Haemoglobin decreased
Slovenian: znižana raven hemoglobina
English: Actelsar HCT should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone.
Slovenian: Bolniki, pri katerih krvnega tlaka ne moremo ustrezno uravnati s samim telmisartanom, jemljejo zdravilo Actelsar HCT.
English: Actelsar HCT 40 mg/12.5 mg tablets
Slovenian: Actelsar HCT 40 mg/12,5 mg tablete
English: (≥1/10,000 to <1/1,000).
Slovenian: Redko se lahko pojavi resen angioedem (≥1/10.000 do <1/1.000).
English: Protect your skin from sun exposure and UV rays while taking Actelsar HCT
Slovenian: Med jemanjem zdravila Actelsar HCT zaščitite kožo pred izpostavljenostjo soncu in UV-žarkom.
English: No statistically significant difference in the incidence of the primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure) was found [15.7 % in the telmisartan and 17.0 % in the placebo groups with a hazard ratio of 0.92 (95 % CI 0.81 - 1.05, p=0.22)].
Slovenian: sestavljenega opazovanega dogodka (kot so srčnožilna smrt, neusodni miokardni infarkt, neusodna možganska kap ali bolnišnično zdravljenje zaradi zastojnega srčnega popuščanja) med skupinama ni bilo statistično značilne razlike [15,7 % v skupini s telmisartanom in 17,0 % v skupini s placebom ob razmerju ogroženosti 0,92 (95-odstotni IZ 0,81 do 1,05, p = 0,22)].
English: 14 tablets 28 tablets 56 tablets 84 tablets 90 tablets 98 tablets
Slovenian: 14 tablet 28 tablet 56 tablet 84 tablet 90 tablet 98 tablet
English: Actelsar HCT 40 mg/12.5 mg tablets are white or almost white, 6.55 x 13.6 mm oval-shaped and biconvex tablets marked with “TH” on one side.
Slovenian: Izgled zdravila Actelsar HCT in vsebina pakiranja Actelsar HCT 40 mg/12,5 mg tablete so bele ali skoraj bele ovalne in bikonveksne tablete, velikosti 6,55 x 13,6 mm, z oznako “TH” na eni strani.
English: Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), serious allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), upset stomach, eczema (a skin disorder), arthrosis, inflammation of the tendons, decreased haemoglobin (a blood protein), somnolence.
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): majhno število trombocitov (trombocitopenija), povečano število določene vrste belih krvničk (eozinofilija), resne alergijske reakcije (npr. preobčutljivost, anafilaktična reakcija, medikamentni izpuščaj), nizka raven krvnega sladkorja (pri bolnikih s sladkorno boleznijo), želodčne težave, ekcem (kožna bolezen), artroza, vnetje kit, znižana raven hemoglobina (krvne beljakovine), zaspanost.
English: 14 tablets 28 tablets 30 tablets 56 tablets 84 tablets 90 tablets 98 tablets
Slovenian: 14 tablet 28 tablet 30 tablet 56 tablet 84 tablet 90 tablet 98 tablet
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with Actelsar HCT (see section 4.5).
Slovenian: Če se bolniki zdravijo z zdravilom Actelsar HCT, moramo biti previdni pri sočasnem dajanju diuretikov, ki varčujejo s kalijem, dodatkov kalija ali nadomestkov soli, ki vsebujejo kalij (glejte poglavje 4.5).
English: Because no information is available regarding the use of telmisartan during breast-feeding, Actelsar HCT is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Slovenian: Med dojenjem, še zlasti med dojenjem novorojenčkov ali prezgodaj rojenih dojenčkov, je treba dajati prednost alternativnim zdravilom, katerih varnostne lastnosti so bolj raziskane.
English: No statistically significant difference in the incidence of the primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure) was found [15.7% in the telmisartan and 17.0% in the placebo groups with a hazard ratio of 0.92 (95% CI 0.81-1.05, p=0.22)].
Slovenian: sestavljenega opazovanega dogodka (kot so srčnožilna smrt, neusodni miokardni infarkt, neusodna možganska kap ali bolnišnično zdravljenje zaradi zastojnega srčnega popuščanja) med skupinama ni bilo statistično značilne razlike [15,7 % v skupini s telmisartanom in 17,0 % v skupini s placebom ob razmerju ogroženosti 0,92 (95-odstotni IZ 0,81 do 1,05, p=0,22)].
English: Dizziness or drowsiness may occasionally occur when taking Actelsar HCT.
Slovenian: Zdravilo Actelsar HCT lahko včasih povzroči omotico ali dremavost.
English: For Al/PVC/PVDC blister: 1 year.
Slovenian: Al/PVC/PVDC pretisni omot:
English: How to store Actelsar HCT
Slovenian: Shranjevanje zdravila Actelsar HCT
English: If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Slovenian: antagonistov receptorjev angiotenzina II ali aliskirena zato ni priporočljiva (glejte poglavji 4.5 in Če je zdravljenje z dvojno blokado res nujno, sme potekati le pod nadzorom specialista in s pogostimi natančnimi kontrolami delovanja ledvic, elektrolitov in krvnega tlaka.
English: There was no evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95 % CI 0.85 - 1.24).
Slovenian: Za srčnožilno umrljivost koristnost tega zdravljenja ni bila dokazana (razmerje ogroženosti 1,03, 95
English: Infections and infestations Uncommon:
Slovenian: Infekcijske in parazitske bolezni Redki:
English: Al/PVC/PVDC blister: 14, 28, 56, 84, 90 and 98 tablets Tablet container: 30, 90 and 250 tablets
Slovenian: Al/PVC/PVDC pretisni omot: 14, 28, 56, 84, 90 in 98 tablet Vsebniki za tablete: 30, 90 in 250 tablet
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: ramipril po 10 mg (n=8576) ali kombinacijo telmisartana po 80 mg in ramiprila po 10 mg (n=8502).
English: Immune system disorders Rare:
Slovenian: Bolezni imunskega sistema Neznana pogostnost:
English: ACE inhibitors, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporin or other medicinal products such as heparin sodium).
Slovenian: Zdravila, ki lahko povečajo raven kalija ali povzročijo hiperkaliemijo (npr. zaviralci ACE; diuretiki, ki varčujejo s kalijem; dodatki kalija; nadomestki soli, ki vsebujejo kalij; ciklosporin ali druga zdravila, kot je natrijev heparinat).
English: Most cases of hepatic function abnormal/liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
Slovenian: Nenormalno jetrno delovanje ali jetrna bolezen O večini primerov nenormalnega jetrnega delovanja ali jetrne bolezni so v obdobju po začetku trženja telmisartana poročali pri japonskih bolnikih, pri katerih tudi sicer obstaja večja verjetnost teh neželenih reakcij.
English: Decreased blood potassium levels, anxiety, fainting (syncope), sensation of tingling, pins and needles (paraesthesia), feeling of spinning (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability to get or keep an erection), chest pain, increased blood uric acid levels.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): Znižana raven kalija v krvi, tesnoba, omedlevanje (sinkopa), ščemenje, mravljinci (parestezija), vrtoglavica, hiter srčni utrip (tahikardija), motnje srčnega ritma, nizek krvni tlak, nenadno znižanje krvnega tlaka med vstajanjem, zasoplost (dispneja), driska, suha usta, napenjanje, bolečina v hrbtu, mišični krč, bolečina v mišicah, erektilna disfunkcija (nezmožnost erekcije ali vzdrževanja erekcije), bolečina v prsnem košu, povečana raven sečne kisline v krvi.
English: - Liver disease.
Slovenian: Žilne bolezni
English: Actelsar HCT 80 mg/25 mg tablets are white or almost white, 9.0 x 17.0 mm oval-shaped and biconvex tablets marked with “TH” on one side and “25” on the other side.
Slovenian: Izgled zdravila Actelsar HCT in vsebina pakiranja Actelsar HCT 80 mg/25 mg tablete so bele ali skoraj bele, ovalne in bikonveksne tablete, velikosti 9,0 x 17,0 mm, z oznako “TH” na eni strani in “25” na drugi strani.
English: Hypotension, orthostatic hypotension Respiratory, thoracic and mediastinal disorders Uncommon:
Slovenian: hipotenzija, ortostatska hipotenzija Bolezni dihal, prsnega koša in mediastinalnega prostora
English: - class Ia antiarrythmics (e.g. quinidine, hydroquinidine, disopyramide) - class III antiarrythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide) - some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine,
Slovenian: Enako velja za jemanje z naslednjimi zdravili, ki lahko povzročijo torsades de pointes (med njimi tudi z nekaterimi antiaritmiki), ker je hipokaliemija predisponirajoči dejavnik za pojav torsades de pointes: - antiaritmiki skupine Ia (npr. kinidin, hidrokinidin, dizopiramid) - antiaritmiki skupine III (npr. amiodaron, sotalol, dofetilid, ibutilid) - nekateri antipsihotiki: (npr. tioridazin, klorpromazin, levomepromazin,
English: There was evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.87 (95% CI 0.76-1.00, p=0.048)].
Slovenian: Podatki dokazujejo korist zdravljenja s telmisartanom v primerjavi s placebom na podlagi njegovega učinka na vnaprej opredeljen sekundarni, sestavljeni opazovani dogodek, ki je zajemal srčnožilno smrt, neusodni miokardni infarkt in neusodno možgansko kap [0,87 (95-odstotni IZ 0,76 do 1,00, p =
English: Actelsar 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.
Slovenian: Zdravila Actelsar HCT ne priporočajo materam, ki dojijo.
English: Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5% CI 0.90-1.08), p (non-inferiority) =0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.
Slovenian: [0,99 (97,5-odstotni IZ 0,90 do 1,08), p (enakovrednost) = 0,0004], in je bil primarni opazovani dogodek v referenčni raziskavi HOPE (The Heart Outcome Prevention Evaluation Study), v kateri so ramipril primerjali s placebom.
English: Musculoskeletal, connective tissue and bone disorders Uncommon:
Slovenian: Bolezni mišično-skeletega sistema, vezivnega tkiva in kosti Neznana pogostnost:
English: Summary of the safety profile The most commonly reported adverse reaction is dizziness.
Slovenian: Najpogostnejši neželeni učinek je bila omotica.
English: Endocrine disorders Not known:
Slovenian: Bolezni endokrinega sistema Neznana pogostnost:
English: Investigations Uncommon:
Slovenian: Preiskave Neznana pogostnost:
English: Actelsar HCT 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Slovenian: Actelsar HCT 80 mg/25 mg tablete telmisartan/hidroklorotiazid
English: For Al/Al blisters and HDPE tablet container: 2 years.
Slovenian: Al/Al pretisni omot in HDPE vsebnik za tablete: