natgillin/translations-raw huggingface dataset:
The Committee for Medicinal products for Human Use (CHMP) decided that Glustin’ s benefits are greater than its risks for the treatment of type 2 diabetes.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaklju il, da so koristi zdravila Glustin za zdravljenje sladkorne bolezni tipa 2 ve je od z njim povezanih tveganj.
The Committee recommended that Glustin be given marketing authorisation.
Zato je priporo il, da se za zdravilo Glustin odobri dovoljenje za promet.
In monotherapy (used on its own), the Committee decided that Glustin should be an alternative to the standard treatment, metformin, to be used when patients cannot take metformin.
Glede monoterapije (uporabe tega zdravila kot samostojnega zdravila) je Odbor odlo il, da se zdravilo Glustin uporablja kot alternativa standardnemu zdravljenju z metforminom, in sicer pri bolnikih, ki metformina ne morejo jemati.
The European Commission granted a marketing authorisation valid throughout the European Union for Glustin to Takeda Europe R & D Centre Limited on 11 October 2000.
Evropska komisija je dovoljenje za promet z zdravilom Glustin, veljavno po vsej Evropski uniji, odobrila družbi Takeda Europe R & D Centre Limited dne 11. oktobra 2000.
The marketing authorisation was renewed on 13 October 2005.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 13. oktobra 2005.
The full EPAR for Glustin is available here.
Celotno evropsko javno poro ilo o oceni zdravila (EPAR) za zdravilo Glustin je na voljo tukaj.
Glustin 15 mg tablets.
Glustin 15 mg tablete
The tablets are white to off-white, round, convex and marked ‘ 15 ’ on one face, AD4 on the other.
Tablete so bele do umazano bele barve, okrogle, izbočene, z oznako ‘ 15 ’ na eni strani in AD4 na drugi.
Pioglitazone is indicated in the treatment of type 2 diabetes mellitus:
Pioglitazon je indiciran za zdravljenje diabetesa mellitusa tipa 2:
- in patients (particularly overweight patients) inadequately controlled by diet and exercise for
- pri bolnikih (predvsem bolnikih s prekomerno telesno maso) nezadostno nadzorovanih z dieto
whom metformin is inappropriate because of contraindications or intolerance.
in gibanjem, pri katerih je metformin, zaradi kontraindikacij ali neprenašanja, neprimeren.
- metformin, in patients (particularly overweight patients) with insufficient glycaemic control
- z metforminom pri bolnikih (predvsem bolnikih s prekomerno telesno maso) z nezadostnim
despite maximal tolerated dose of monotherapy with metformin
nadzorom glikemije kljub najvišjemu dovoljenemu odmerku metformina v monoterapiji
- a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is
- s sulfonilsečnino, le pri bolnikih, ki ne prenašajo metformina ali je metformin pri njih
contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.
kontraindiciran, z nezadostnim nadzorom glikemije kljub najvišjemu dovoljenemu odmerku sulfonilsečnine v monoterapiji.
Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
Pioglitazon je indiciran tudi za kombinacijo z insulinom pri bolnikih s diabetesom mellitusom tipa 2 z nezadostnim nadzorom glikemije, ki se zdravijo z insulinom, za katere je metformin, zaradi kontraindikacij ali neprenašanja, neprimeren (glejte poglavje 4. 4).
Pioglitazone may be initiated at 15 mg or 30 mg once daily.
Zdravljenje s pioglitazonom lahko začnemo s 15 mg ali 30 mg enkrat dnevno.
2 Elderly No dosage adjustment is necessary for elderly patients (see section 5.2).
2 Starejši Pri starejših bolnikih odmerka ni treba prilagajati (glejte poglavje 5. 2).
Patients with renal impairment No dosage adjustment is necessary in patients with impaired renal function (creatinine clearance > 4 ml/ min) (see section 5.2).
Bolniki z okvarjenim delovanjem ledvic Pri bolnikih z okvarjenim delovanjem ledvic (očistek kreatinina > 4 ml/ min) odmerka ni treba prilagajati (glejte poglavje 5. 2).
Patients with hepatic impairment Pioglitazone should not be used in patients with hepatic impairment (see section 4.4).
Bolniki z okvarjenim delovanjem jeter Pioglitazona pri bolnikih z okvarjenim delovanjem jeter ne smemo uporabljati (glejte poglavje 4. 4).
Children and adolescents There are no data available on the use of pioglitazone in patients under 18 years of age, and therefore its use is not recommended in this age group.
Otroci in mladostniki Podatkov o uporabi pioglitazona pri bolnikih, mlajših od 18 let, ni na voljo, zato uporaba pioglitazona v tej starostni skupini ni priporočljiva.
- hepatic impairment.
- z okvarjenim delovanjem jeter.
Fluid retention and cardiac failure Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure.
Zastajanje tekočine in srčno popuščanje Pioglitazon lahko povzroči zastajanje tekočine, to pa lahko poslabša ali pospeši srčno popuščanje.
When treating patients who have at least one risk factor for development of congestive heart failure (e. g. prior myocardial infarction or symptomatic coronary artery disease), physicians should start with the lowest available dose and increase the dose gradually.
Pri zdravljenju bolnikov, ki imajo vsaj en dejavnik tveganja za razvoj kongestivnega srčnega popuščanja (npr. predhodni miokardni infarkt ali simptomatska koronarna arterijska bolezen), bi moral zdravnik začeti zdravljenje z najnižjim možnih odmerkom in ga postopoma zviševati.
Patients should be observed for signs and symptoms of heart failure, weight gain or oedema, particularly those with reduced cardiac reserve.
Bolnike je treba opazovati zaradi znakov in simptomov srčnega popuščanja, povečanja telesne mase ali edema, posebno tiste z zmanjšano srčno rezervo.
There have been cases of cardiac failure reported from the market when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure patients should be observed for signs and symptoms of heart failure, weight gain and oedema when pioglitazone is used in combination with insulin.
Bolnike je treba opazovati zaradi znakov in simptomov srčnega popuščanja, povečanja telesne mase in edema, ko se pioglitazon uporablja v kombinaciji z insulinom.
A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
Študijo s pioglitazonom, kjer so spremljali kardiovaskularni izid so opravili pri bolnikih, mlajših od 75 let z diabetesom mellitusom tipa 2 in že obstoječimi težjimi makrovaskularnimi boleznimi.
Monitoring of liver function There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
Spremljanje delovanja jeter V postmarketinških izkušnjah so poročali o redkih primerih hepatocelularne disfunkcije (glejte poglavje 4. 8).
Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 X upper limit of normal) or with any other evidence of liver disease.
Pri bolnikih s povišanimi izhodiščnimi ravnmi jetrnih encimov (ALT > 2, 5- kratna zgornja meja normalnih vrednosti) ali s kakršnimikoli drugimi znaki jetrne bolezni zdravljenja s pioglitazonom ne smemo začeti.
3 Following initiation of therapy with pioglitazone, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Če se med zdravljenjem s pioglitazonom ravni ALT zvišajo do 3- kratne zgornje meje
If ALT levels are increased to 3 X upper limit of normal during pioglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
3 normalnih vrednosti, je treba ravni jetrnih encimov čimprej ponovno kontrolirati.
Weight gain In clinical trials with pioglitazone there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention.
Pridobivanje telesne mase V kliničnih preskušanjih s pioglitazonom so opažali pridobivanje telesne mase povezano z odmerkom, ki je lahko posledica nabiranja maščob in v nekaterih primerih povezano z zadrževanjem tekočine.
Part of the treatment of diabetes is dietary control.
Del zdravljenja diabetesa je kontrola prehrane.
Hypoglycaemia As a consequence of increased insulin sensitivity, patients receiving pioglitazone in dual or triple oral therapy with a sulphonylurea or in dual therapy with insulin may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea or insulin may be necessary.
Hipoglikemija Kot posledica povečane občutljivosti na insulin, so lahko bolniki, ki prejemajo pioglitazon v dvojnem ali trojnem zdravljenju s sulfonilsečnino ali v dvojnem zdravljenju z insulinom, izpostavljeni tveganju za od odmerka odvisno hipoglikemijo, in je morda potrebno znižati odmerek sulfonilsečnine ali insulina.
Eye disorders Post-marketing reports of new-onset or worsening diabetic macular oedema with increased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Očesne bolezni Pri tiazolidindionih, vključno s pioglitazonom, so v postmarketinških poročilih poročali o novonastalih ali poslabšanjih diabetičnega makularnega edema z zmanjšanjem vidne ostrine.
The risk of fractures should be considered in the long term care of women treated with pioglitazone.
4 Pri dolgoročnem zdravljenju žensk s pioglitazonom, je potrebno upoštevati tveganje za zlome.
4 As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation.
Zaradi okrepitve delovanja insulina lahko zdravljenje s pioglitazonom pri bolnicah s sindromom policističnih jajčnikov povzroči obnovitev ovulacije.
Pioglitazone dose adjustment within the recommended Posology or changes I diabetic treatment should be considered (see section 4.5).
Pretehtati je potrebno prilagoditev odmerka pioglitazona v okviru priporočenega odmerjanja ali spremeniti zdravljenje diabetesa (glejte poglavje 4. 5).
Glustin tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Tablete Glustin vsebujejo laktozo monohidrat in se zato ne smejo dajati bolnikom z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze.
Use in pregnancy There are no adequate human data to determine the safety of pioglitazone during pregnancy.
Uporaba v nosečnosti Za ugotavljanje varnosti pioglitazona med nosečnostjo ni zadostnih podatkov iz preskušanj pri človeku.
Use in breast-feeding Pioglitazone has been shown to be present in the milk of lactating rats.
Uporaba v času dojenja Pioglitazon so dokazali v mleku doječih podgan.
5 4.8 Undesirable effects
5 4. 8 Neželeni učinki
Frequencies are defined as: very common > 1/ 10; common > 1/ 100 ,< 1/10; uncommon > 1/1000 ,< 1/100; rare > 1/ 10000 ,< 1/1000; very rare < 1/10000; not known (cannot be estimated from the available data).
Pogostnosti so določene kot: zelo pogosti > 1/ 10; pogosti > 1/ 100, < 1/ 10; občasni > 1/ 1. 000, < 1/ 100; redki > 1/ 10. 000, < 1/ 1. 000; zelo redki < 1/ 10. 000; neznano (ocena ni možna iz danih podatkov).
PIOGLITAZONE MONOTHERAPY
MONOTERAPIJA S PIOGLITAZONOM
Eye disorders Common: visual disturbance
Očesne bolezni
Infection and infestations Common: upper respiratory tract infection
okužba zgornjih dihal
Investigations Common: weight increased
Pogosti:
Nervous system disorders Common: hypoaesthesia
Bolezni živčevja
Blood and lymphatic system disorders Common: anaemia
Bolezni krvi in limfatičnega sistema
Gastrointestinal disorders Uncommon: flatulence
Bolezni prebavil
Musculoskeletal system and connective tissue disorders Common: arthralgia
Bolezni mišično- skeletnega sistema in vezivnega tkiva
Nervous system disorders Common: headache
Pogosti:
Renal and urinary disorders Common: haematuria
Bolezni živčevja
Reproductive system and breast disorders Common: erectile dysfunction
Bolezni sečil
Ear and labyrinth disorders Uncommon: vertigo
vrtoglavica
Eye disorders Uncommon: visual disturbance
Očesne bolezni
Gastrointestinal disorders Common: flatulence
Bolezni prebavil
General disorders and administration site conditions Uncommon: fatigue
Splošne težave in spremembe na mestu aplikacije
Metabolism and nutritional disorders Uncommon: appetite increased, hypoglycaemia
povečan apetit, hipoglikemija
Nervous system disorders Common: dizziness
Bolezni živčevja
Uncommon: headache
glavobol
Renal and urinary disorders Uncommon: glycosuria, proteinuria
glikozurija, proteinurija
Skin and subcutaneous tissue disorders Uncommon: sweating
Bolezni kože in podkožja
PIOGLITAZONE IN TRIPLE ORAL COMBINATION THERAPY WITH METFORMIN AND SULPHONYLUREA
7 POLIGLITAZON V TROJNEM PERORALNEM KOMBINIRANEM ZDRAVLJENJU Z METFORMINOM IN SULFONILSEČNINO
Investigations Common: weight increased, blood creatinine phosphokinase increased
povečana telesna masa, povišana kreatin- fosfokinaza v krvi
Metabolism and nutrition disorders Very common:
Zelo pogosti:
Musculoskeletal and connective tissue disorders Common: arthralgia
Bolezni mišično- skeletnega sistema in vezivnega tkiva
PIOGLITAZONE IN COMBINATION THERAPY WITH INSULIN
PIOGLITAZON V KOMBINIRANEM ZDRAVLJENU Z INSULINOM
Metabolism and nutrition disorders Common: hypoglycaemia
Presnovne in prehranske motnje
General disorders and administration site conditions Very common:
Splošne težave in spremembe na mestu aplikacije
oedema
edem
Infections and infestations Common: bronchitis
Infekcijske in parazitske bolezni
7 Investigations Common: weight increase
Pogosti:
Musculoskeletal system and connective tissue disorders Common: back pain, arthralgia
Bolezni mišično- skeletnega sistema in vezivnega tkiva
Respiratory, thoracic and mediastinal disorders Common: dyspnoea
Bolezni dihal, prsnega koša in mediastinalnega prostora
Cardiac disorders Common: heart failure
Pogosti:
POST-MARKETING DATA
srčno popuščanje
Eye disorders Not known: macular oedema
Očesne bolezni
Oedema was reported in 6 – 9% of patients treated with pioglitazone over one year in controlled clinical trials.
O edemih so poročali pri 6– 9% bolnikov, zdravljenih s pioglitazonom leto dni v kontroliranih kliničnih preskušanjih.
In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 – 3 kg over one year.
8 V kontroliranih preskušanjih z aktivno primerjavo je bilo povprečno povečanje telesne mase pri pioglitazonu, dajanemu kot monoterapija, 2– 3 kg v enem letu.
This is similar to that seen in a sulphonylurea active comparator group.
To je podobno opažanjem v aktivni primerjalni skupini na sulfonilsečnini.
In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo, when added to therapy that included insulin.
V študiji za ocenitev izida pri bolnikih z že obstoječimi težjimi makrovaskularnimi boleznimi, je bila incidenca resnega srčnega popuščanja 1, 6% višja s pioglitazonom kot s placebom, dodanim k zdravljenju, ki je vključevalo insulin.
8 In the 3.5 year PROactive study, 44/ 870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/ 905 (2.5%) of female patients treated with comparator.
V 3, 5 letni PROactive študiji, je 44/ 870 (5, 1%) žensk, zdravljenih s pioglitazonom imelo zlome, v primerjavi s 23/ 905 (2, 5%) žensk, zdravljenih s primerjalnim zdravilom.
Pharmacotherapeutic group: oral blood glucose lowering drugs; Thiazolidinediones; ATC code:
Farmakoterapevtska skupina: peroralni antidiabetiki; Tiazolidindioni; Oznaka ATC:
Pioglitazone effects may be mediated by a reduction of insulin resistance.
9 Na učinke pioglitazona lahko vpliva zmanjšanje insulinske rezistence.
Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus.
Nadzor glikemije med stradanjem in po obrokih se izboljša pri bolnikih z diabetesom mellitusom tipa 2.
Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
Bolniki, ki so prejemali pioglitazon, so imeli povprečno znižanje HbA1c za 0, 45% v primerjavi s tistimi, ki so nadaljevali zdravljenje samo z insulinom, in znižan odmerek insulina v skupini zdravljeni s pioglitazonom.
9 HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
V večini kliničnih preskušanj so opažali znižane skupne plazemske koncentracije trigliceridov in prostih maščobnih kislin ter povišane ravni HDL holesterola v primerjavi s placebom, z majhnimi, vendar ne klinično značilnimi povišanji ravni LDL holesterola.
In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and pre- existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
V PROaktivni študiji, ki ocenjuje kardiovaskularni izid, je bilo 5238 bolnikov z diabetesom mellitusom tipa 2 in že prej obstoječimi težjimi makrovaskularnimi boleznimi naključno dodatno zdravljenih s pioglitazonom ali placebom k že obstoječemu antidiabetičnemu in kardiovaskularnemu zdravljenju, v trajanju do 3, 5 let.
The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Starost populacije, vključene v študijo, je bila v povprečju 62 let; povprečno trajanje diabetesa je bilo 9, 5 let.
Approximately one third of patients were receiving insulin in combination with metformin and/ or a sulphonylurea.
Približno tretjina bolnikov je prejemala insulin v kombinaciji z metforminom in/ ali sulfonilsečnino.
To be eligible patients had to have one or more of the following: myocardial infarction, stroke, percutaneous cardiac intervention or coronary artery bypass graft, acute coronary syndrome, coronary artery disease, or peripheral arterial obstructive disease.
Da bi bolniki ustrezali kriterijem, so morali imeti v anamnezi eno ali več od sledečega: miokardni infarkt, kap, perkutano srčno intervencijo ali koronarni arterijski transplantatni obvod, akutni koronarni sindrom, koronarno arterijsko bolezen ali periferno
Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke.
Skoraj polovica bolnikov je predhodno doživela miokardni infarkt in približno 20% jih je doživela kap.
Approximately half of the study population had at least two of the cardiovascular history entry criteria.
Približno polovica populacije vključene v študijo je ustrezala vsaj dvema vstopnima kriterijema kardiovaskularne anamneze.
Almost all subjects (95%) were receiving cardiovascular medications (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Skoraj vsi preiskovanci (95%) so prejemali kardiovaskularna zdravila (beta blokatorje, ACE inhibitorje, antagoniste angiotenzina II, zaviralce kalcijevih kanalčkov, nitrate, diuretike, aspirin, statine, fibrate),
Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Čeprav je bila študija neuspešna v povezavi z primarnimi opazovanimi dogodki, ki so zajemali smrtnost zaradi vseh razlogov, neusodne miokardne infarkte, kapi, akutne koronarne sindrome, težje amputacije nog, koronarne revaskularizacije in revaskularizacije nog, izsledki kažejo, da v zvezi z kardiovaskularnim sistemom ni dolgoročnih pomislekov glede uporabe pioglitazona.
However, the incidence of oedema, weight gain and heart failure were increased.
Vendar je bila incidenca edemov, pridobivanja telesne mase in srčnih odpovedi povečana.
Steady state is achieved after 4-7 days of dosing.
Stanje dinamičnega ravnovesja je doseženo po 4– 7 dnevih odmerjanja.
10 Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin.
Študije medsebojnih delovanj so pokazale, da pioglitazon nima pomembnega učinka na farmakokinetiko ali farmakodinamiko digoksina, varfarina, fenprokumona in metoformina.
Concomitant administration of pioglitazone with gemfibrozil (an inducer of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5)
Poročali so, da sočasno dajanje pioglitazona z gemfibrozilom (zaviralec citokroma P450 2C8) ali rifampicina (induktor citokroma P450 2C8) poviša oziroma zniža plazemsko koncentracijo pioglitazona (glejte poglavje 4. 5).
Patients with renal impairment In patients with renal impairment, plasma concentrations of pioglitazone and its metabolites are lower than those seen in subjects with normal renal function, but oral clearance of parent substance is similar.
11 Bolniki z okvarjenim delovanjem ledvic Pri bolnikih z okvarjenim delovanjem ledvic so plazemske koncentracije pioglitazona in njegovih presnovkov nižje kot pri osebah z normalnim delovanjem ledvic, vendar je peroralni očistek izvorne učinkovine podoben.
Patients with hepatic impairment Total plasma concentration of pioglitazone is unchanged, but with an increased volume of distribution.
Bolniki z okvarjenim delovanjem jeter Celotna plazemska koncentracija pioglitazona ni spremenjena, povečan pa je volumen porazdelitve.
Carmellose calcium Hyprolose Lactose monohydrate Magnesium stearate
Kalcijev karmelozat Hiproloza Laktoza monohidrat Magnezijev stearat
11 October 2000.
11. oktober 2000.
11 October 2005
11. oktober 2005.
Glustin 30 mg tablets.
Glustin 30 mg tablete
The tablets are white to off-white, round, flat and marked ‘ 30 ’ on one face, AD4 on the other.
Tablete so bele do umazano bele barve, okrogle, ploščate, z oznako ‘ 30 ’ na eni strani in AD4 na drugi.
despite maximal tolerated dose of monotherapy with metformin
nadzorom glikemije kljub najvišjemu dovoljenjemu odmerku metformina v monoterapiji
Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
Pioglitazon je indiciran tudi za kombinacijo z insulinom pri bolnikih z diabetesom mellitusom tipa 2 z nezadostnim nadzorom glikemije, ki se zdravijo z insulinom, za katere je metformin, zaradi kontraindikacij ali neprenašanja, neprimeren (glejte poglavje 4. 4).
Elderly No dosage adjustment is necessary for elderly patients (see section 5.2).
Starejši Pri starejših bolnikih odmerka ni treba prilagajati (glejte poglavje 5. 2).
13 Patients with renal impairment No dosage adjustment is necessary in patients with impaired renal function (creatinine clearance > 4 ml/ min) (see section 5.2).
14 Bolniki z okvarjenim delovanjem ledvic Pri bolnikih z okvarjenim delovanjem ledvic (očistek kreatinina > 4 ml/ min) odmerka ni treba prilagajati (glejte poglavje 5. 2).
- hepatic impairment.
- z okvarjenim delovanjem jeter
When treating patients who have at least one risk factor for development of congestive heart failure (e. g. prior myocardial infarction or symptomatic coronary artery disease), physicians should start with the lowest available dose and increase the dose gradually.
Pri zdravljenju bolnikov, ki imajo vsaj en dejavnik tveganja za razvoj kongestivnega srčnega popuščanja (npr. predhodni miokardni infarkt ali simptomatska koronarna arterijska bolezen), bi moral zdravnik začeti zdravljenje z najnižjim možnih odmerkom in ga postopoma zviševati. Bolnike je treba opazovati zaradi znakov in simptomov srčnega popuščanja, povečanja telesne mase ali edema, posebno tiste z zmanjšano srčno rezervo.