natgillin/translations-raw huggingface dataset:
The committee recommended that Actos be given marketing authorisation.
Zato je priporočil, da se za zdravilo Actos podeli dovoljenje za promet z zdravilom.
In monotherapy (used on its own), the committee decided that Actos should be an alternative to the standard treatment, metformin, to be used when patients cannot take metformin.
Pri monoterapiji (uporabi tega zdravila kot samostojnega zdravila) je odbor odločil, da bo zdravilo Actos alternativa standardnemu zdravljenju z metforminom in se bo uporabljalo pri bolnikih, ki metformina ne morejo jemati.
The European Commission granted a marketing authorisation valid throughout the European Union, for Actos to Takeda Europe R & D Centre Limited on 13 October 2000.
Evropska komisija je dovoljenje za promet z zdravilom Actos, veljavno po vsej Evropski uniji, odobrila družbi Takeda Europe R & D Centre Limited dne 13. oktobra 2000.
The marketing authorisation was renewed on 13 October 2005.
Dovoljenje za promet z zdravilom je bilo podaljšano 13. oktobra 2005.
The full EPAR for Actos is available here
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Actos je na voljo tukaj.
This summary was last updated in 01-2007.
Ta povzetek je bil nazadnje posodobljen 01- 2007.
EU/ 1/ 00/ 150/ 001 EU/ 1/ 00/ 150/ 002 EU/ 1/ 00/ 150/ 003 EU/ 1/ 00/ 150/ 004 EU/ 1/ 00/ 150/ 005 EU/ 1/ 00/ 150/ 006 EU/ 1/ 00/ 150/ 007 EU/ 1/ 00/ 150/ 008 EU/ 1/ 00/ 150/ 009 EU/ 1/ 00/ 150/ 010 EU/ 1/ 00/ 150/ 011 EU/ 1/ 00/ 150/ 012 EU/ 1/ 00/ 150/ 013 EU/ 1/ 00/ 150/ 014 EU/ 1/ 00/ 150/ 015 EU/ 1/ 00/ 150/ 016 EU/ 1/ 00/ 150/ 017 EU/ 1/ 00/ 150/ 018 EU/ 1/ 00/ 150/ 019 EU/ 1/ 00/ 150/ 020 EU/ 1/ 00/ 150/ 021 EU/ 1/ 00/ 150/ 022 EU/ 1/ 00/ 150/ 023 EU/ 1/ 00/ 150/ 024
Številka EU EU/ 1/ 00/ 150/ 001 EU/ 1/ 00/ 150/ 002 EU/ 1/ 00/ 150/ 003 EU/ 1/ 00/ 150/ 004 EU/ 1/ 00/ 150/ 005 EU/ 1/ 00/ 150/ 006 EU/ 1/ 00/ 150/ 007 EU/ 1/ 00/ 150/ 008 EU/ 1/ 00/ 150/ 009 EU/ 1/ 00/ 150/ 010 EU/ 1/ 00/ 150/ 011 EU/ 1/ 00/ 150/ 012 EU/ 1/ 00/ 150/ 013 EU/ 1/ 00/ 150/ 014 EU/ 1/ 00/ 150/ 015 EU/ 1/ 00/ 150/ 016 EU/ 1/ 00/ 150/ 017 EU/ 1/ 00/ 150/ 018 EU/ 1/ 00/ 150/ 019 EU/ 1/ 00/ 150/ 020 EU/ 1/ 00/ 150/ 021 EU/ 1/ 00/ 150/ 022 EU/ 1/ 00/ 150/ 023 EU/ 1/ 00/ 150/ 024
Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos
zaščiteno ime Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos Actos
15 mg 15 mg 15 mg 30 mg 30 mg 30 mg 15 mg 30 mg 15 mg 30 mg 45 mg 45 mg 45 mg 45 mg 45 mg 15 mg 15 mg 15 mg 30 mg 30 mg 30 mg 45 mg 45 mg 45 mg
jakost 15 mg 15 mg 15 mg 30 mg 30 mg 30 mg 15 mg 30 mg 15 mg 30 mg 45 mg 45 mg 45 mg 45 mg 45 mg 15 mg 15 mg 15 mg 30 mg 30 mg 30 mg 45 mg 45 mg 45 mg
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
farmacevtska oblika pot uporabe Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba Tableta Peroralna uporaba
blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu)
ovojnina Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu)
28 50 98 28 50 98 14 14 56 56 14 28 50 56 98 30 84 90 30 84 90 30 84 90
velikost pakiranja 28 50 98 28 50 98 14 14 56 56 14 28 50 56 98 30 84 90 30 84 90 30 84 90
Actos 15 mg tablets.
Actos 15 mg tablete
Each tablet contains 15 mg of pioglitazone as hydrochloride.
Ena tableta vsebuje 15 mg pioglitazona v obliki pioglitazonijevega klorida.
For a full list of excipients, see 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
The tablets are white to off-white, round, convex and marked ‘ 15’ on one face and ‘ ACTOS’ on the other face.
Tablete so bele do umazano bele barve, okrogle, izbočene, z oznako ‘ 15 ’ na eni strani in ‘ ACTOS ’ na drugi strani.
Pioglitazone is indicated in the treatment of type 2 diabetes mellitus:
Pioglitazon je indiciran za zdravljenje sladkorne bolezni tipa 2:
- in patients (particularly overweight patients) inadequately controlled by diet and exercise
- pri bolnikih (predvsem bolnikih s prekomerno telesno maso) nezadostno nadzorovanih z dieto in
for whom metformin is inappropriate because of contraindications or intolerance
gibanjem, pri katerih je metformin, zaradi kontraindikacij ali neprenašanja, neprimeren.
- metformin, in patients (particularly overweight patients) with insufficient glycaemic
- z metforminom pri bolnikih (predvsem bolnikih s prekomerno telesno maso) z nezadostnim
control despite maximal tolerated dose of monotherapy with metformin
nadzorom glikemije kljub najvišjemu toleriranemu odmerku monoterapije z metforminom
- a sulphonylurea, only in patients who show intolerance to metformin or for whom
- s sulfonilsečnino, le pri bolnikih, ki ne prenašajo metformina ali je metformin pri njih
metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.
kontraindiciran, z nezadostnim nadzorom glikemije kljub najvišjemu toleriranemu odmerku monoterapije s sulfonilsečnino.
as triple oral therapy in combination with
kot trojno peroralno zdravljenje v kombinaciji:
- metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient
- z metforminom ali sulfonilsečnino pri bolnikih (predvsem bolnikih s prekomerno telesno maso)
glycaemic control despite dual oral therapy.
z nezadostnim nadzorom glikemije kljub dvojnemu peroralnemu zdravljenju.
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 sladkorno boleznijo 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 tablets are taken orally once daily with or without food.
Pioglitazon tablete se jemljejo peroralno enkrat dnevno s hrano ali brez nje.
Pioglitazone may be initiated at 15mg or 30mg once daily.
Zdravljenje s pioglitazonom lahko začnemo s 15 mg ali 30 mg enkrat dnevno.
The dose may be increased in increments up to 45mg once daily.
Odmerek lahko postopoma zvišujemo do 45 mg enkrat dnevno.
2 In combination with insulin, the current insulin dose can be continued upon initiation of pioglitazone therapy.
V kombinaciji z insulinom lahko ob uvedbi zdravljenja s pioglitazonom nadaljujemo z dotedanjim odmerkom insulina.
Elderly:
2 Starejši:
No dosage adjustment is necessary for elderly patients (see section 5.2).
Pri starejših bolnikih odmerka ni treba prilagajati (glejte poglavje 5. 2).
Patients with renal impairment:
Bolniki z okvarjenim delovanjem ledvic:
No dosage adjustment is necessary in patients with impaired renal function (creatinine clearance > 4 ml/ min) (see section 5.2).
Pri bolnikih z okvarjenim delovanjem ledvic (očistek kreatinina > 4 ml/ min) odmerka ni treba prilagajati (glejte poglavje 5. 2).
Patients with hepatic impairment:
Bolniki z okvarjenim delovanjem jeter:
Pioglitazone should not be used in patients with hepatic impairment (see section 4.4).
Pioglitazona pri bolnikih z okvarjenim delovanjem jeter ne smemo uporabljati (glejte poglavje 4. 4).
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.
Podatkov o uporabi pioglitazona pri bolnikih, mlajših od 18 let, ni na voljo, zato uporaba pioglitazona v tej starostni skupini ni priporočljiva.
- hypersensitivity to the active substance or to any of the excipients
- s preobčutljivostjo za zdravilno učinkovino ali katerokoli pomožno snov
- cardiac failure or history of cardiac failure (NYHA stages I to IV)
- s srčnim popuščanjem ali srčnim popuščanjem v anamnezi (NYHA razredi od I do IV)
- hepatic impairment
- z okvarjenim delovanjem jeter
- diabetic ketoacidosis.
- z diabetično ketoacidozo.
Fluid retention and cardiac failure:
Zastajanje tekočine in 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 višati.
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 insulinor 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.
S trga so poročali o primerih srčnega popuščanja, ko so pioglitazon uporabljali v kombinaciji z insulinom ali pri bolnikih s srčnim popuščanjem v anamnezi; bolnike je treba opazovati zaradi znakov in simptomov srčnega popuščanja, povečanja telesne mase in edema, ko se pioglitazon uporablja v kombinaciji z insulinom.
Since insulin and pioglitazone are associated with fluid retention, concomitant administration may increase the risk of oedema.
Ker sta insulin in pioglitazon povezana z zastajanjem tekočine, lahko sočasno jemanje poveča tveganje za edeme.
Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years.
Pioglitazon ali placebo so dodajali k že obstoječemu antidiabetičnemu in kardiovaskularnemu zdravljenju v trajanju do 3, 5 let.
Caution should be exercised in patients over 75 years because of the limited experience in this patient group.
Previdnost je potrebna pri bolnikih nad 75 let zaradi omejenih izkušenj v tej skupini bolnikov.
3 Monitoring of liver function:
Spremljanje delovanja jeter:
There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
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
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.
Če se med zdravljenjem s pioglitazonom ravni ALT zvišajo do 3- kratne zgornje meje normalnih vrednosti, je treba ravni jetrnih encimov čimprej ponovno kontrolirati.
If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/ or dark urine, liver enzymes should be checked.
Če kak bolnik razvije simptome, ki kažejo na moteno delovanje jeter, kar lahko vključuje nepojasnjeno slabost, bruhanje, bolečine v trebuhu, utrujenost, anoreksijo in/ ali temen urin, je treba kontrolirati jetrne encime.
If jaundice is observed, drug therapy should be discontinued.
Če se pojavi zlatenica, je treba zdravljenje z zdravilom prekiniti.
Weight gain:
Pridobivanje telesne mase:
There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution.
Med zdravljenjem s pioglitazonom se je pojavljalo majhno znižanje povprečne vrednosti hemoglobina (4% relativno znižanje) in hematokrita (4, 1% relativno znižanje), skladno s hemodilucijo.
Similar changes were seen in metformin (haemoglobin 3 - 4% and haematocrit 3.6 – 4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1 – 2% and haematocrit 1 – 3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Podobne spremembe so opažali v primerjalnih kontroliranih preskušanjih s pioglitazonom pri bolnikih, zdravljenih z metforminom (hemoglobin 3– 4% in hematokrit 3, 6– 4, 1% relativna znižanja), in v manjšem obsegu pri bolnikih, zdravljenih s sulfonilsečnino in insulinom (hemoglobin 1– 2% in hematokrit 1– 3, 2% relativna znižanja).
Hypoglycaemia
Hipoglikemija:
An increased incidence in bone fractures in women was seen in a pooled analysis of adverse event reports of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.
V skupni analizi neželenih učinkov zlomov kosti iz randomiziranih, nadzorovanih, dvojno slepih kliničnih preskušanj pri več kot 8100 s pioglitazonom in 7400 s primerjalnim zdravilom zdravljenimi bolniki, ki so se zdravili do 3, 5 let, so opazili povečano incidenco zlomov kosti pri ženskah.
Fractures were observed in 2.6% of women taking pioglitazone compared to 1.7% of women treated with a comparator.
Zlome so opazili pri 2, 6% žensk, ki so jemale pioglitazon v primerjavi s 1, 7% žensk, zdravljenih s primerjalnim zdravilom.
No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Pri moških, zdravljenih s pioglitazonom, niso opazili povečane stopnje zlomov (1, 3%) v primerjavi s primerjalnim zdravilom (1, 5%).
4 The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator.
Izračunana incidenca zlomov je bila 1, 9 zlomov na 100 bolniških let pri ženskah, zdravljenih s pioglitazonom in 1, 1 zlomov na 100 bolniških let pri ženskah, zdravljenih s primerjalnim zdravilom.
The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use.
4 Opazovano povečano tveganje za zlom pri ženskah v tej skupini podatkov na pioglitazonu je torej 0, 8 zlomov na 100 bolniških let uporabe.
In the 3.5 year cardiovascular risk PROactive study, 44/ 870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/ 905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
V 3, 5 letni PROactive študiji kardiovaskualarnega tveganja, je 44/ 870 (5, 1%; 1, 0 zlom na 100 bolniških let) žensk, zdravljenih s pioglitazonom imelo zlome, v primerjavi s 23/ 905 (2, 5%; 0, 5 zlomov na 100 bolniških let) žensk, zdravljenih s primerjalnim zdravilom.
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Pri moških, zdravljenih s pioglitazonom, niso opazili povečane stopnje zlomov (1, 7%) v primerjavi s primerjalnim zdravilom (2, 1%).
The risk of fractures should be considered in the long term care of women treated with pioglitazone.
Pri dolgoročnem zdravljenju žensk s pioglitazonom, je potrebno upoštevati tveganje za zlome.
Patients should be aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, the treatment should be discontinued (see section 4.6).
Zato se morajo tveganja za zanositev zavedati, in če bolnica želi zanositi ali zanosi, je treba zdravljenje prekiniti (glejte poglavje 4. 6).
Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e. g. gemfibrozil) or inducers (e. g. rifampicin).
Pri uporabi pioglitazona in sočasnim dajanjem z zaviralci (npr. gemfibrozil) ali induktorji (npr. rifampicin) citokroma P450 2C8 je potrebna previdnost.
Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Pretehtati je potrebno prilagoditev odmerka pioglitazona v okviru priporočenega odmerjanja ali spremeniti zdravljenje sladkorne bolezni (glejte poglavje 4. 5).
Actos 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 Actos vsebujejo laktozo monohidrat in se zato ne smejo dajati bolnikom z redkimi podedovanimi težavami intolerance za galaktozo, s pomanjkanjem Lapp laktaze ali malabsorpcijo glukoze- galaktoze.
Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/ 9 and 3A4.
Študije pri človeku ne kažejo nobenih indukcij poglavitnih inducibilnih citokromov P450, 1A, 2C8/ 9 in 3A4.
Interactions with substances metabolised by these enzymes, e. g. oral contraceptives, cyclosporin, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected.
Interakcij s snovmi, ki jih presnavljajo ti encimi, npr. s peroralnimi kontracepcijskimi sredstvi, ciklosporinom, zaviralci kalcijevih kanalčkov in inhibitorji HMGCoA reduktaze, ni pričakovati.
Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of pioglitazone.
Poročali so, da sočasno dajanje pioglitazona z gemfibrozilom (zaviralec citokroma P450 2C8) povzroči 3- kratno povečanje AUC pioglitazona.
Close monitoring of glycaemic control should be considered (see section 4.4).
Pretehtati je potrebno skrbno spremljanje glikemičnega nadzora (glejte poglavje 4. 4).
Use in pregnancy:
Uporaba v nosečnosti:
5 Use in breast-feeding:
5 Uporaba v času dojenja:
No effects on ability to drive and use machines have been observed.
Učinkov na sposobnost vožnje in upravljanja s stroji niso opažali.
Adverse reactions reported in excess (> 0.5%) of placebo and as more than an isolated case in patients receiving pioglitazone in double-blind studies are listed below as MedDRA preferred term by system organ class and absolute frequency.
Neželeni učinki, o katerih so poročali večkrat (> 0, 5%) kot pri placebu in več kot enkrat pri bolnikih, ki so prejemali pioglitazon v dvojno slepih študijah, so našteti spodaj, in sicer po razredih organskih sistemov in absolutni pogostnosti, kot je priporočeno po MedDRA.
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/ 1000, < 1/ 100; redki > 1/ 10000, < 1/ 1000; zelo redki < 1/ 10000; neznano (ocena ni možna iz danih podatkov).
PIOGLITAZONE MONOTHERAPY Eye disorders
MONOTERAPIJA S PIOGLITAZONOM Očesne bolezni
visual disturbance
motnje vida
upper respiratory tract infection
okužba zgornjih dihal
weight increased
povečanje telesne mase
hypoaesthesia
hipestezije
Uncommon: insomnia
Občasni:
PIOGLITAZONE IN COMBINATION THERAPY WITH METFORMIN Blood and lymphatic system disorders
PIOGLITAZON V KOMBINIRANEM ZDRAVLJENJU Z METFORMINOM Bolezni krvi in limfatičnega sistema
Eye disorders
Očesne bolezni
Uncommon: flatulence
flatulenca
6 Musculoskeletal system and connective tissue disorders
6 Bolezni mišično- skeletnega sistema in vezivnega tkiva
haematuria
hematurija
erectile dysfunction
erektilna disfunkcija
PIOGLITAZONE IN COMBINATION THERAPY WITH SULPHONYLUREA Ear and labyrinth disorders
PIOGLITAZON V KOMBINIRANEM ZDRAVLJENJU S SULFONILSEČNINO Ušesne bolezni, vključno z motnjami labirinta
Uncommon: vertigo
vrtoglavica
Uncommon: visual disturbance
motnje vida
flatulence
flatulenca
Uncommon: fatigue
Občasni:
Uncommon: increased lactic dehydrogenase
Občasni:
Uncommon: appetite increased, hypoglycaemia
povečan apetit, hipoglikemija
Uncommon: headache
Občasni:
Renal and urinary disorders
glikozurija, proteinurija
Uncommon: glycosuria, proteinuria
Občasni:
PIOGLITAZONE IN TRIPLE ORAL COMBINATION THERAPY WITH METFORMIN AND SULPHONYLUREA
POLIGLITAZON V TROJNEM PERORALNEM KOMBINIRANEM ZDRAVLJENJU Z METFORMINOM IN SULFONILSEČNINO Preiskave
weight increased, blood creatine phosphokinase increased
povečana telesna masa, povišana kreatin fosfokinaza v krvi
Metabolism and nutrition disorders
Presnovne in prehranjske motnje
hypoglycaemia
hipoglikemija
connective tissue disorders
Bolezni mišično- skeletnega sistema in vezivnega tkiva
PIOGLITAZONE IN COMBINATION THERAPY WITH INSULIN Metabolism and nutrition disorders
PIOGLITAZON V KOMBINIRANEM ZDRAVLJENU Z INSULINOM Presnovne in prehranske motnje
Very common: oedema
Zelo pogosti:
weight increase
povečana telesna masa
Musculoskeletal system and connective tissue disorders
Bolezni mišično- skeletnega sistema in vezivnega tkiva
back pain, arthralgia
bolečine v hrbtu, artralgija
dyspnoea
dispneja
heart failure
srčno popuščanje
POST-MARKETING DATA
POSTMARKETINŠKI
Eye disorders Macular oedema: not known
Očesne bolezni Makularni edem:
8 Oedema was reported in 6 – 9% of patients treated with pioglitazone over one year in controlled clinical trials.
pri 6– 9% bolnikov, zdravljenih s pioglitazonom leto dni v kontroliranih
The oedema rates for comparator groups (sulphonylurea, metformin) were 2 – 5%.
Stopnje pojavnosti edemov primerjalnih skupin (sulfonilsečnina, metformin) so bile 2– 5%.
In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 – 3 kg over one year.
To je podobno opažanjem v aktivni
This is similar to that seen in a sulphonylurea active comparator group.
8 primerjalni skupini na sulfonilsečnini.
In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg and added to a sulphonylurea of 2.8 kg.
V preskušanjih kombiniranega zdravljenja je pioglitazon, dodan metforminu, povzročil povprečno povečanje telesne mase v enem letu za 1, 5 kg oziroma, dodan sulfonilsečnini, za 2, 8 kg.
In comparator groups addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg.
V primerjalnih skupinah je dodatek sulfonilsečnine metforminu povzročil povprečno povečanje telesne mase za 1, 3 kg in dodatek metformina sulfonilsečnini povprečno zmanjšanje telesne teže za 1, 0 kg.