natgillin/translations-raw huggingface dataset:
Other medicines and Telmisartan Actavis
Druga zdravila in zdravilo Telmisartan Actavis
If you feel dizzy or tired, do not drive or use machines.
Ne upravljajte vozil in strojev, če ste omotični ali utrujeni.
If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Če je takšna kombinacija potrebna, je priporočljivo natančno kontrolirati koncentracijo litija v serumu.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Actavis logo
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Actavis logo
NAME OF THE MARKETING AUTHORISATION HOLDER Actavis logo
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Actavis logo
In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals.
V predkliničnih študijah varnosti so odmerki, ki so povzročili primerljivo izpostavljenost, kot je dosežena v kliničnem terapevtskem območju, pri normotenzivnih živalih povzročili zmanjšanje eritrocitnih parametrov (eritrocitov, hemoglobina, hematokrita), spremembe ledvične hemodinamike (zvišanje sečninskega dušika in kreatinina v krvi) ter zvišanje kalija v serumu.
Gender differences in plasma concentrations were observed, Cmax and AUC being approximately 3-and 2-fold higher, respectively, in females compared to males.
Pri ženskah je bila Cmax približno 3-krat večja, AUC pa približno 2-krat večja kot pri moških.
Cough and angioedema were less frequently reported in patients treated with telmisartan than in patients treated with ramipril, whereas hypotension was more frequently reported with telmisartan.
Kašelj in angioedem sta bila s telmisartanom redkejša kot z ramiprilom, hipotenzija pa je bila pogostejša s telmisartanom.
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to <1/1,000), and acute renal failure.
Resni neželeni učinki so anafilaktična reakcija in angioedem, ki sta redka (≥1/10,000 to <1/1,000) in akutna odpoved ledvic.
- The other ingredients are magnesium stearate, croscarmellose sodium, mannitol, povidone,
- Pomožne snovi so magnezijev stearat; premreženi natrijev karmelozat, manitol, povidon,
Elderly patients No dose adjustment is necessary for elderly patients.
Pri starejših bolnikih odmerka ni treba prilagoditi.
Common side effects (may affect up to 1 in 10 people): Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.
Pogosti neželeni učinki (pojavijo se pri največ 1 od 10 bolnikov): nizek krvni tlak (hipotenzija) pri osebah, pri katerih z zdravljenjem preprečujemo srčnožilne dogodke.
Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Telmisartan nima delnega agonističnega učinka na receptorjih AT1.
Most cases of hepatic function abnormal / liver disorder from post-marketing experience occurred in patients in Japan, who are more likely to experience these adverse reactions.
O večini primerov nenormalnega delovanja jeter ali jetrne bolezni so v obdobju po začetku trženja telmisartana poročali pri japonskih bolnikih, pri katerih tudi sicer obstaja večja verjetnost teh neželenih reakcij.
In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Nekaterim bolnikom s prizadetim delovanjem ledvic (npr. dehidriranim bolnikom ali starejšim bolnikom s prizadetim delovanjem ledvic) lahko sočasna uporaba antagonistov receptorjev angiotenzina II in zaviralcev ciklooksigenaze dodatno poslabša delovanje ledvic (vključno z akutno odpovedjo ledvic), kar pa je ponavadi reverzibilno.
The blood pressure lowering effects of two doses of telmisartan were assessed in 76 hypertensive, largely overweight patients aged 6 to < 18 years (body weight ≥ 20 kg and ≤ 120 kg, mean 74.6 kg), after taking telmisartan 1 mg/kg (n = 29 treated) or 2 mg/kg (n = 31 treated) over a four-week treatment period.
Učinek dveh odmerkov telmisartana na znižanje krvnega tlaka so ocenili pri 76 hipertenzivnih bolnikih, starih 6 do < 18 let, pretežno s preveliko telesno maso (telesna masa ≥ 20 kg in ≤120 kg, povprečna 74,6 kg), po štiritedenskem zdravljenju s telmisartanom po 1 mg/kg (n = 29 zdravljenih) ali
4.1 Therapeutic indications
4.1 Terapevtske indikacije Hipertenzija
A. MANUFACTUER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA
The elimination half-life is not changed in patients with renal impairment.
Eliminacijski razpolovni čas se pri bolnikih z okvaro ledvic ne spremeni.
These pharmacologicallymediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.
Te farmakološko posredovane neželene učinke, ki so znani iz predkliničnih študij zaviralcev angiotenzinske konvertaze in antagonistov receptorjev angiotenzina II, je bilo mogoče preprečiti s peroralnim dodajanjem raztopine soli.
When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as Telmisartan Actavis.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji V zvezi z vožnjo ali upravljanjem s stroji je treba upoštevati, da se lahko med antihipertenzivnim zdravljenjem, na primer z zdravilom Telmisartan Actavis, občasno pojavi omotica ali zaspanost.
After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 3 hours.
Zdravljenje esencialne hipertenzije Antihipertenzivno delovanje postane opazno postopoma v 3 urah po prvem odmerku telmisartana.
The concomitant use of Telmisartan Actavis 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
Sočasna uporaba zdravila Telmisartan Actavis in zdravil, ki vsebujejo aliskiren, je kontraindicirana pri bolnikih s sladkorno boleznijo ali ledvično okvaro (GFR < 60 ml/min/1,73 m2) (glejte poglavji 4.5
In addition, there was a significantly higher incidence of hyperkalaemia, renal failure, hypotension and syncope in the combination arm.
Poleg tega so bile v kraku s kombiniranim zdravljenjem značilno večje incidence hiperkaliemije, odpovedi ledvic, hipotenzije in sinkope.
What Telmisartan Actavis contains - The active substance is telmisartan.
Kaj vsebuje zdravilo Telmisartan Actavis - Zdravilna učinkovina je telmisartan.
The risk is particularly high in combination with potassium sparing-diuretics and when combined with salt substitutes containing potassium.
ki varčujejo s kalijem, in v kombinaciji z nadomestki soli, ki vsebujejo kalij.
If you stop taking Telmisartan Actavis
Če ste prenehali jemati zdravilo Telmisartan Actavis
Plasma aldosterone levels are decreased by telmisartan.
Telmisartan zniža koncentracijo aldosterona v plazmi.
Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion and in a risk of hypotension when initiating therapy with telmisartan.
Diuretiki (tiazidni diuretiki ali diuretiki zanke) Predhodno zdravljenje z velikimi odmerki diuretikov, kakršna sta furosemid (diuretik zanke) in hidroklorotiazid (tiaziden diuretik), lahko ob uvedbi zdravljenja s telmisartanom povzroči hipovolemijo in tveganje hipotenzije.
Telmisartan Actavis is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Če želite dojiti, vam bo zdravnik najbrž izbral drugo zdravilo, še zlasti če je vaš otrok novorojenček ali je bil rojen prezgodaj.
The elimination half-life is not changed in patients with hepatic impairment.
Eliminacijski razpolovni čas se pri bolnikih z okvaro jeter ne spremeni.
The tablet container contains a desiccant, do not eat the desiccant.
Vsebnik za tablete vsebuje sušilo; sušila ne smete zaužiti.
- Liver disease.
- Bolezen jeter.
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 0.901.08), 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.
Ugotovili so, da je telmisartan podobno učinkovit kot ramipril glede vnaprej opredeljenega sekundarnega opazovanega dogodka srčnožilne smrti, miokardnega infarkta brez smrtnega izida in možganske kapi brez smrtnega izida [0,99 (97, 5 % IZ 0,90-1,08), p (neinferiornost) = 0,0004], kar je bil primarni opazovani dogodek v referenčni študiji HOPE (The Heart Outcomes Prevention Evaluation Study), ki je proučevala učinek ramiprila v primerjavi s placebom.
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) pri bolnikih starih 50 let ali več, ki so pred kratkim imeli možgansko kap, so med uporabo telmisartana ugotovili večjo incidenco sepse kot med uporabo placeba, 0,70 % v primerjavi z 0,49 % [relativno tveganje 1,43 (95 % interval zaupanja 1,00-2,06)]; incidenca sepse s smrtnim izidom je bila med bolniki, ki so prejemali telmisartan, večja (0,33 %) kot med bolniki, ki so prejemali placebo (0,16 %) [relativno tveganje 2,07 (95 % interval zaupanja 1,14-3,76)].
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)].
Ugotovili niso nobenih statistično značilnih razlik v incidenci primarnega sestavljenega opazovanega dogodka (srčnožilna smrt, miokardni infarkt brez smrtnega izida, možganska kap brez smrtnega izida ali hospitalizacija zaradi kongestivnega srčnega popuščanja) [15,7 % v skupini s telmisartanom in 17,0 % v skupini s placebom, razmerje ogroženosti 0,92 (95 % IZ 0,81-1,05, p = 0,22)].
* The event may have happened by chance or could be related to a way that telmisartan works that is currently not known.
* To se je lahko zgodilo po naključju, lahko pa bi bilo povezano tudi z nekim učinkom telmisartana,
What Telmisartan Actavis looks like and contents of the pack 40 mg tablets are white, oval, biconvex, with a break line and logo T on one side.
Izgled zdravila Telmisartan Actavis in vsebina pakiranja 40 mg tablete so bele, ovalne, bikonveksne tablete s prelomno zarezo in oznako T na eni strani.
White, oval, biconvex tablets with logo T1 on one side.
Bele, ovalne, bikonveksne tablete z oznako T1 na eni strani.
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ni posebnih zahtev.
In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a maximum of 80 mg once daily.
Če ciljni krvni tlak ni dosežen, je odmerek telmisartana mogoče povečati do največ
Hypotension2, orthostatic hypotension Respiratory, thoracic and mediastinal disorders Uncommon:
hipotenzija2, ortostatska hipotenzija Bolezni dihal, prsnega koša in mediastinalnega prostora
Corticosteroids (systemic route) Reduction of the antihypertensive effect.
Kortikosteroidi (sistemska pot uporabe)
SPECIAL STORAGE CONDITIONS Keep the container tightly closed in order to protect from light.
POSEBNA NAVODILA ZA SHRANJEVANJE Vsebnik shranjujte tesno zaprt za zagotovitev zaščite pred svetlobo.
Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Če od drugega trimesečja nosečnosti naprej pride do izpostavljenosti antagonistom receptorjev angiotenzina II, je priporočljivo z ultrazvokom preveriti delovanje ledvic in lobanjo.
Do not take Telmisartan Actavis - if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
- če ste alergični na telmisartan ali katerokoli drugo sestavino tega zdravila (navedeno v poglavju
- Intercurrent events, in particular dehydratation, acute cardiac decompensation, metabolic acidosis, worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extend trauma).
- sočasne bolezni, zlasti dehidracija, akutno srčno popuščanje, metabolična acidoza, slabše delovanje ledvic, nenadno poslabšanje stanja ledvic (npr. infekcijske bolezni), liza celic (npr. akutna ishemija uda, rabdomioliza, obširna travma).
Urinary tract infection including cystitis, upper respiratory tract infection including pharyngitis and sinusitis Sepsis including fatal outcome1
okužbe sečil, vključno s cistitisom, okužba zgornjih dihal, vključno s faringitisom in sinuzitisom
In the elderly, in patients with renal insufficiency, in diabetic patients, in patients concomitantly treated with other medicinal products that may increase potassium levels, and/or in patients with intercurrent events, hyperkalaemia may be fatal.
sladkornih bolnikih, bolnikih, sočasno zdravljenih z drugimi zdravili, ki lahko povečajo koncentracijo kalija, in/ali bolnikih s sočasnimi boleznimi.
Gastric mucosal injury (erosion, ulcers or inflammation) also was noted in rats and dogs.
Pri podganah in psih so zabeležili tudi prizadetost želodčne sluznice (erozije, razjede ali vnetje).
Keep the container tightly closed in order to protect from light.
Vsebnik shranjujte tesno zaprt za zagotovitev zaščite pred svetlobo.
Telmisartan Actavis may also be used in combination with diuretics (‘water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with telmisartan.
Zdravilo Telmisartan Actavis se lahko uporablja tudi v kombinaciji z diuretiki ("tablete za odvajanje vode"), kot je hidroklorotiazid; dokazano je, da je tako dosežen aditiven učinek na znižanje krvnega tlaka s telmisartanom.
How to take Telmisartan Actavis
Kako jemati zdravilo Telmisartan Actavis
There is no linear relationship between doses and plasma levels.
Med odmerki in koncentracijo v plazmi ni linearnega razmerja.
Telmisartan Actavis contains the active substance telmisartan which belongs to a class of medicines known as angiotensin II receptor antagonists.
Kaj je zdravilo Telmisartan Actavis in za kaj ga uporabljamo Zdravilo Telmisartan Actavis vsebuje zdravilno učinkovino telmisartan, ki spada v skupino zdravil, imenovanih antagonisti receptorjev angiotenzina II.
Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Če nadaljnje zdravljenje z antagonistom receptorjev angiotenzina II ni nujno, je treba bolnice, ki načrtujejo nosečnost, prevesti na druga antihipertenzivna zdravila, katerih varnostne značilnosti med nosečnostjo so ugotovljene.
At the beginning of the preventive therapy with Telmisartan Actavis 80 mg, blood pressure should be frequently monitored.
Za zmanjšanje srčnožilnih dogodkov se običajno porablja odmerek 80 mg zdravila Telmisartan Actavis enkrat na dan. Na začetku preventivnega zdravljenja z zdravilom Telmisartan Actavis 80 mg je treba redno spremljati krvni tlak.
You must tell your doctor if you think you are (or might become) pregnant.
Zdravniku morate povedati, če se vam zdi, da ste noseči (ali bi lahko zanosili).
No posology adjustment is required for patients with mild to moderate renal impairment.
Bolnikom z blago do zmerno okvaro ledvic odmerjanja ni treba prilagoditi.
Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Znano je, da antagonisti receptorjev angiotenzina II v drugem in tretjem trimesečju pri človeku delujejo toksično na plod (zmanjšano delovanje ledvic, oligohidramnij, zapoznela osifikacija lobanje) in novorojenčka (odpoved ledvic, hipotenzija, hiperkaliemija) (glejte poglavje 5.3).
Reykjavíkurvegur 76-78, IS-220 Hafnarfjördur Iceland
Reykjavíkurvegi 76-78, IS-220 Hafnarfjörður Islandija
Patients with renal impairment
Posebne populacije Bolniki z okvaro ledvic
In dogs renal tubular dilation and atrophy were observed.
Pri psih so opazili dilatacijo in atrofijo ledvičnih tubulov.
Eosinophilia , thrombocytopenia
eozinofilija, trombocitopenija
White, oval, biconvex tablets with a break line and logo T on one side.
Bele, ovalne, bikonveksne tablete s prelomno zarezo in oznako T na eni strani.
Telmisartan Actavis is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Če ste noseči več kot 3 mesece, pa ga sploh ne smete jemati, kajti njegovo jemanje po tretjem mesecu nosečnosti lahko otroku resno škoduje.
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.
V študiji TRANSCEND, ki je imela sicer podobna merila za vključitev kot študija ONTARGET, so bolnike, ki niso prenesli zaviralca ACE, randomizirali na 80 mg telmisartana (n = 2954) ali placebo
Telmisartan Actavis is contraindicated in patients with severe hepatic impairment (see section 4.3).
Bolniki z okvaro jeter Zdravilo Telmisartan Actavis je kontraindicirano pri bolnikih s hudo jetrno okvaro (glejte poglavje
When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
Zdravljenje z antagonisti receptorjev angiotenzina II je treba prekiniti takoj po ugotovitvi nosečnosti in uvesti drugo zdravljenje, če je primerno.
White, round, flat tablets with logo T on one side.
Bele, okrogle, ploščate tablete z oznako T na eni strani.
Name and address of the manufacturer(s) responsible for batch release
SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serije
Some people feel dizzy or tired when taking Telmisartan Actavis.
Vpliv na sposobnost upravljanja vozil in strojev Nekateri ljudje so med zdravljenjem z zdravilom Telmisartan Actavis omotični ali utrujeni.
Reykjavikurvegi 76-78, IS-220 Hafnafjordur ICELAND
Reykjavikurvegi 76-78, IS-220 Hafnarfjörður ISLANDIJA
The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
Tveganje se lahko poveča med kombiniranim zdravljenjem z drugimi zdravili, ki prav tako povzročijo hiperkaliemijo (nadomestkov soli, ki vsebujejo kalij, diuretikov, ki varčujejo s kalijem, zaviralcev ACE, antagonistov receptorjev angiotenzina II, nesteroidnih protivnetnih zdravil (NSAID, vključno s selektivnimi zaviralci COX-2), heparina, imunosupresivov (ciklosporin ali takrolimus) ali trimetoprima).
Hypoglycaemia (in diabetic patients)
Pshiatrične motnje hipoglikemija (pri bolnikih s sladkorno boleznijo)
What you need to know before you take Telmisartan Actavis
Kaj morate vedeti, preden boste vzeli zdravilo Telmisartan Actavis Ne jemljite zdravila Telmisartan Actavis
For treatment of high blood pressure, the usual dose of Telmisartan Actavis for most patients is one 40 mg tablet once a day to control blood pressure over the 24-hour period.
Za večino bolnikov je običajen odmerek zdravila Telmisartan Actavis ena 40 mg tableta enkrat na dan za uravnavanje krvnega tlaka v 24-urnem obdobju.
Tablet
Zdravilo
PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING Label for tablet container
PODATKI NA ZUNANJI IN NA PRIMARNI OVOJNINI Nalepka za vsebnik za tablete
Some patients may already benefit at a daily dose of 20 mg.
Običajno učinkoviti odmerek je 40 mg enkrat na dan. Nekaterim bolnikom lahko koristi že dnevni odmerek 20 mg.
For treatment of high blood pressure, the usual dose of Telmisartan Actavis for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period.
Za večino bolnikov je običajen odmerek zdravila Telmisartan Actavis ena 40 mg tableta enkrat na dan za uravnavanje krvnega tlaka v 24 urnem obdobju.
Non-steroidal anti-inflammatory medicinal products NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
zaviralci COX-2 in neselektivna NSAID) lahko zmanjšajo antihipertenzivni učinek antagonistov receptorjev angiotenzina II.
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Sepsa* (pogosto poimenovana tudi" zastrupitev krvi", je huda okužba, pri kateri pride v vsem telesu do vnetnega odziva), hitro otekanje kože in sluznice (angioedem); ti neželeni učinki so redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov), toda zelo resni, zato morajo bolniki takoj prenehati z jemanjem zdravila in nemudoma poiskati zdravniško pomoč.
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 medicinal products that affect the renin-angiotensin-aldosterone system.
Ledvičnožilna hipertenzija Bolnike z bilateralno stenozo ledvične arterije ali stenozo arterije edine delujoče ledvice, ki dobivajo zdravila z vplivom na sistem renin-angiotenzin-aldosteron, bolj ogrožata huda hipotenzija in zmanjšano delovanje ledvic.
The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo (41.4% vs 43.9%) in placebo controlled trials in patients treated for hypertension.
V preskušanjih, kontroliranih s placebom pri bolnikih, zdravljenih zaradi hipertenzije, je bila celotna incidenca neželenih učinkov s telmisartanom po navadi primerljiva kot pri placebu (41,4% v primerjavi s 43,9 %).
Reduction of cardiovascular morbidity in adults with: - manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or - type 2 diabetes mellitus with documented target organ damage
Zmanjšanje srčnožilne ularne obolevnosti pri odraslih: - z manifestno aterotrombotično srčnožilno boleznijo (anamneza koronarne bolezni,možganske kapi ali bolezni perifernih žil) ali
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORIZATION
DRUGI POGOJI IN ZAHTEVE GLEDE OSKRBE IN UPORABE