natgillin/translations-raw huggingface dataset:
If hydrochlorothiazide is used during breast-feeding, doses should be kept as low as possible.
Če doječe matere zdravilo Actelsar HCT uporabljajo med dojenjem, morajo biti njegovi odmerki karseda majhni.
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).
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).
Telmisartan: Following oral administration, peak concentrations of telmisartan are reached in 0.5-1.5 h after dosing.
Telmisartan: Telmisartan doseže po peroralnem dajanju največjo koncentracijo v 0,5 do 1,5 ure.
Hypochloraemic alkalosis
hipokloremična alkaloza
Visual disturbance, vision blurred
motnje vida, zamegljen vid
Slow heartbeat, dizziness, vomiting, reduced kidney function including kidney failure, have also been reported.
V poročilih navajajo še počasen srčni utrip, omotico, bruhanje in zmanjšano delovanje ledvic, tudi ledvično odpoved.
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.
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.
Pancreatitis, stomach discomfort
pankreatitis, želodčne težave
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.
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.
Al/PVC/PVDC blister: 28, 56, 84, 90 and 98 tablets Actelsar HCT 80 mg/12.5 mg tablets
Al/PVC/PVDC pretisni omot: 28, 56, 84, 90 in 98 tablet Actelsar HCT 80 mg/12,5 mg tablete
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
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).
Interstitial lung disease3
intersticijska pljučna bolezen3
How to take Actelsar HCT
Kako jemati zdravilo Actelsar HCT
Hypokalaemia
hipokaliemija
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.
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.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Al/Al blister
PODATKI NA ZUNANJI OVOJNINI Škatla za Al/Al pretisni omot
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.
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).
- digoxin.
- digoksin
Sialadenitis Neoplasms benign, malignant and unspecified (incl cysts and polyps) Not known
sialadenitis Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Neznana pogostnost:
cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol) - others (e.g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
haloperidol, droperidol) - drugo (npr. bepridil, cisaprid, difemanil, eritromicin i.v., halofantrin, mizolastin,
Actelsar HCT is also available at the dose strengths 40 mg/12.5 mg and 80 mg/12.5 mg
Zdravilo Actelsar HCT je na voljo tudi v jakostih 40 mg/12,5 mg in 80 mg/12,5 mg.
- 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.
- 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;
Back pain, muscle spasms, myalgia
bolečina v hrbtu, mišični spazem, mialgija
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Al/PVC/PVDC blister
PODATKI NA ZUNANJI OVOJNINI Škatla za Al/PVC/PVDC/ pretisni omot
What Actelsar HCT looks like and contents of the pack
Izgled zdravila Actelsar HCT in vsebina pakiranja
- 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
- 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.
Marketing Authorisation Holder Actavis Group PTC ehf.
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Actavis Group PTC ehf.
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.
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).
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.
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).
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).
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).
Common (may affect up to 1 in 10 people): Dizziness
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): Omotica.
White or almost white, 6.55 x 13.6 mm oval-shaped and biconvex tablets marked with “TH” on one side.
Bele ali skoraj bele, ovalne in bikonveksne tablete velikosti 6,55 x 13,6 mm, z oznako “TH” na eni strani.
Aplastic anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis,
aplastična anemija, hemolitična anemija, odpoved kostnega mozga, levkopenija, nevtropenija, agranulocitoza,
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).
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).
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.
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.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for HDPE tablet container
PODATKI NA ZUNANJI OVOJNINI Škatla za HDPE vsebnik za tablete
PARTICULARS TO APPEAR ON THE INNER PACKAGING Label for HDPE tablet container
PODATKI NA STIČNI OVOJNINI Nalepka za HDPE vsebnik za tablete
- 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.
- 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.
The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Antagonisti adrenergičnih receptorjev beta in diazoksid Tiazidi lahko povečajo hiperglikemični učinek antagonistov adrenergičnih receptorjev beta in diazoksida.
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.
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.
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.
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,
Aplastic anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis
aplastična anemija, hemolitična anemija, odpoved kostnega mozga, levkopenija, nevtropenija, agranulocitoza
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.
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).
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.
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.
This can lead to permanent vision impairment, if not treated.
Brez zdravljenja lahko pride do trajne okvare vida;
If you experience any of these you should tell your doctor.
Če opazite katerikoli pojav od naštetih, obvestite zdravnika.
28 tablets 56 tablets 84 tablets 90 tablets 98 tablets
28 tablet 56 tablet 84 tablet 90 tablet 98 tablet
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.
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,
Hepatic function abnormal/liver disorder
Nenormalno jetrno delovanje ali jetrna bolezen
Blood uric acid increased
povečana raven sečne kisline v krvi
Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Na receptorju A T1 nima nikakršnega delnega agonističnega učinka.
Actelsar HCT 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Actelsar HCT 80 mg/12,5 mg tablete Ena tableta vsebuje 80 mg telmisartana in 12,5 mg hidroklorotiazida.
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)].
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)].
Actelsar HCT is also available at the dose strength 80 mg/25 mg
Zdravilo Actelsar je na voljo tudi v jakosti 80 mg/25 mg.
The active substances are telmisartan and hydrochlorothiazide.
Kaj vsebuje zdravilo Actelsar HCT - Učinkovini sta telmisartan in hidroklorotiazid.
Actelsar HCT 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Actelsar HCT 40 mg/12,5 mg tablete Ena tableta vsebuje 40 mg telmisartana in 12,5 mg hidroklorotiazida.
- 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.
- 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:
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Actavis logo]
There is no clinical experience with Actelsar HCT in patients with hepatic impairment.
Z zdravilom Actelsar HCT pri bolnikih z zmanjšanim jetrnim delovanjem ni izkušenj.
Hydrochlorothiazide is 68% protein bound in the plasma and its apparent volume of distribution is 0.83-1.14 l/kg.
Njegov navidezen volumen porazdelitve je 0,83 do 1,14 l/kg.
Haemoglobin decreased
znižana raven hemoglobina
Actelsar HCT should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone.
Bolniki, pri katerih krvnega tlaka ne moremo ustrezno uravnati s samim telmisartanom, jemljejo zdravilo Actelsar HCT.
(≥1/10,000 to <1/1,000).
Redko se lahko pojavi resen angioedem (≥1/10.000 do <1/1.000).
Protect your skin from sun exposure and UV rays while taking Actelsar HCT
Med jemanjem zdravila Actelsar HCT zaščitite kožo pred izpostavljenostjo soncu in UV-žarkom.
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)].
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)].
14 tablets 28 tablets 56 tablets 84 tablets 90 tablets 98 tablets
14 tablet 28 tablet 56 tablet 84 tablet 90 tablet 98 tablet
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.
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.
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.
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.
14 tablets 28 tablets 30 tablets 56 tablets 84 tablets 90 tablets 98 tablets
14 tablet 28 tablet 30 tablet 56 tablet 84 tablet 90 tablet 98 tablet
Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with Actelsar HCT (see section 4.5).
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).
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.
Med dojenjem, še zlasti med dojenjem novorojenčkov ali prezgodaj rojenih dojenčkov, je treba dajati prednost alternativnim zdravilom, katerih varnostne lastnosti so bolj raziskane.
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)].
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)].
Dizziness or drowsiness may occasionally occur when taking Actelsar HCT.
Zdravilo Actelsar HCT lahko včasih povzroči omotico ali dremavost.
For Al/PVC/PVDC blister: 1 year.
Al/PVC/PVDC pretisni omot:
How to store Actelsar HCT
Shranjevanje zdravila Actelsar HCT
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.
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.
There was no evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95 % CI 0.85 - 1.24).
Za srčnožilno umrljivost koristnost tega zdravljenja ni bila dokazana (razmerje ogroženosti 1,03, 95
Infections and infestations Uncommon:
Infekcijske in parazitske bolezni Redki:
Al/PVC/PVDC blister: 14, 28, 56, 84, 90 and 98 tablets Tablet container: 30, 90 and 250 tablets
Al/PVC/PVDC pretisni omot: 14, 28, 56, 84, 90 in 98 tablet Vsebniki za tablete: 30, 90 in 250 tablet
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.
ramipril po 10 mg (n=8576) ali kombinacijo telmisartana po 80 mg in ramiprila po 10 mg (n=8502).