natgillin/translations-raw huggingface dataset:
Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic agents.
O motnjah vida so poročali predvsem zgodaj v poteku zdravljenja, povezane pa so s spremembami vrednosti glukoze v krvi zaradi začasnih sprememb turgidnosti in refrakcijskega indeksa leče, kot jih opažamo tudi pri drugih hipoglikemičnih učinkovinah.
In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
V kliničnih preskušanjih pioglitazona je bila incidenca povišanih vrednosti ALT, višjih kot trikratna zgornja meja normalnih vrednosti, enaka kot pri placebu, vendar nižja kot v primerjalnih skupinah metformina ali sulfonilsečnine.
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 izida bolnikov 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.
A pooled analysis was conducted of adverse event reports of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
Opravljena je bila skupna analiza neželenih učinkov zlomov kosti iz randomiziranih, s primerjalnim zdravilom nadzorovanih, dvojno slepih kliničnih preskušanj pri več kot 8100 bolnikov v skupini zdravljeni s pioglitazonom in 7400 v skupini zdravljeni s primerjalnim zdravilom, ki so trajale do 3, 5 let.
A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%).
Opazili so višjo stopnjo zlomov pri ženskah, ki so jemale pioglitazon (2, 6%) v primerjavi s primerjalnim zdravilom (1, 7%).
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.
Patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
Bolniki so jemali pioglitazon v višjem od najvišjega priporočenega odmerka 45 mg dnevno.
The maximum reported dose of 120 mg/ day for four days, then 180 mg/ day for seven days was not associated with any symptoms.
Najvišji poročani odmerek 120 mg/ dan štiri dni, zatem pa 180 mg/ dan sedem dni ni bil povezan s kakimi simptomi.
Pharmacotherapeutic group: oral blood glucose lowering drugs; Thiazolidinediones; ATC code:
Farmakoterapevtska skupina: peroralni antidiabetiki; tiazolidindioni; oznaka ATC:
9 Pioglitazone effects may be mediated by a reduction of insulin resistance.
9 gama), kar povzroča povečano občutljivost za insulin v celicah jeter, maščobnem tkivu ter celicah skeletnih mišic živali.
A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥ 8.0% after the first six months of therapy).
Za oceno časa do neuspeha zdravljenja (definirano kot pojav HbA1c ≥ 8, 0% po prvih šest mesecih zdravljenja) so klinično preskušanje pioglitazona v primerjavi z gliklazidom kot monoterapiji podaljšali na dve leti.
Kaplan-Meier analysis showed shorter time to treatment failure in patients treated with gliclazide, compared with pioglitazone.
Kaplan- Meier- jeva analiza je pokazala krajši čas do neuspeha zdravljenja pri bolnikih, zdravljenih z gliklazidom, v primerjavi s pioglitazonom.
At two years, glycaemic control (defined as HbA1c < 8.0%) was sustained in 69% of patients treated with pioglitazone, compared with 50% of patients on gliclazide.
Po dveh letih je nadzor glikemije (definiran kot HbA1c < 8, 0%) vztrajal pri 69% bolnikov, zdravljenih s pioglitazonom, v primerjavi s 50% bolnikov, ki so prejemali gliklazid.
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 znižan HbA1c za 0, 45% v primerjavi s tistimi, ki so nadaljevali zdravljenje samo z insulinom, in znižan odmerek insulina v skupini zdravljeni s pioglitazonom.
In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/ creatinine ratio compared to baseline.
V enoletnih kliničnih preskušanjih je pioglitazon vedno statistično značilno znižal razmerje albumin/ kreatinin v primerjavi z izhodiščnimi vrednostmi.
The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
Učinek pioglitazona (45 mg monoterapija v primerjavi s placebom) so preučevali v majhnem 18 - tedenskem preskušanju pri diabetikih tipa 2.
In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased 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 a 20-week study, as well as reducing fasting triglycerides, pioglitazone reduced post prandial hypertriglyceridaemia through an effect on both absorbed and hepatically synthesised triglycerides.
V 20 - tedenski študiji je pioglitazon znižal raven trigliceridov na tešče, pa tudi hipertrigliceridemijo po obroku prek učinkovanja na absorbirane in v jetrih sintetizirane trigliceride.
These effects were independent of pioglitazone’ s effects on glycaemia and were statistically significant different to glibenclamide.
Ti učinki niso bili odvisni od pioglitazonovih učinkov na glikemijo in so se statistično značilno razlikovali od glibenklamida.
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 kardiovaskularni študiji izida je bilo 5238 bolnikov s sladkorno boleznijo 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 študijske populacije je bila v povprečju 62 let; povprečno trajanje sladkorne bolezni je bilo 9, 5 let.
Approximately one third of patients were receiving insulin in combination with metformin and/ or a sulphonylurea.
Približno ena tretjina bolnikov je prejemala insulin v kombinaciji z metforminom in/ ali sulfonilsečnino.
Almost all subjects (95%) were receiving cardiovascular medications (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Skoraj vse osebe (95%) so prejemale kardiovaskularna zdravila (beta
10 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.
10 blokatorje, ACE inhibitorje, antagoniste angiotenzina II, zaviralce kalcijevih kanalčkov, nitrate, diuretike, aspirin, statine, fibrate),
Steady state is achieved after 4– 7 days of dosing.
Stanje dinamičnega ravnovesja je doseženo po 4– 7 dnevih odmerjanja.
The estimated volume of distribution in humans is 0.25 l/ kg.
Ocenjeni volumen porazdelitve pri človeku je 0, 25 l/ kg.
Three of the six identified metabolites are active (M-II, M-III, and M-IV).
Trije od šestih znanih presnovkov so aktivni (M- II, M- III in M- IV).
When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III contribute equally to efficacy.
Če upoštevamo aktivnost, koncentracije in vezavo na beljakovine, je delež učinkovitosti pioglitazona in presnovka M- III enak.
On this basis M-IV contribution to efficacy is approximately three-fold that of pioglitazone, whilst the relative efficacy of M-II is minimal.
Na tej podlagi je delež učinkovitosti M- IV enak približno trikratniku deleža pioglitazona, medtem ko je relativna učinkovitost M- II minimalna.
There is no induction of the main inducible P450 isoenzymes 1A, 2C8/ 9, and 3A4 in man.
Indukcije poglavitnih inducibilnih P450 izoencimov 1A, 2C8/ 9 in 3A4 pri človeku ni.
Concomitant administration of pioglitazone with gemfibrozil (an inhibitor 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).
11 Patients with renal impairment:
11 Bolniki z okvarjenim delovanjem ledvic:
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.
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.
These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure.
Te ugotovitve so potrdila opažanja pri vseh vrstah pri plazemskih koncentracijah ≤ 4- kratne plazemske koncentracije pri klinični izpostavitvi.
Hyperplasia of the urinary bladder was not seen in dogs or monkeys treated for up to 12 months.
Hiperplazije sečnega mehurja pri psih ali opicah, ki so prejemali pioglitazon do 12 mesecev, niso opažali.
Carmellose calcium Hyprolose Lactose monohydrate Magnesium stearate
kalcijev karmelozat hiproloza laktoza monohidrat magnezijev stearat
12 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
Aluminium/ aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90 and 98 tablets.
Aluminij/ aluminij pretisni omoti, pakiranja po 14, 28, 30, 50, 56, 84, 90 in 98 tablet.
6.6 Special precautions for disposal
12 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych London WC2B 4AE United Kingdom
Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych London WC2B 4AE Velika Britanija
13-10-2000 Date of last renewal:
Datum zadnjega podaljšanja:
13-10-2005
13. oktober 2005.
Actos 30 mg tablets.
Actos 30 mg tablete
Each tablet contains 30 mg of pioglitazone as hydrochloride.
Ena tableta vsebuje 30 mg pioglitazona v obliki pioglitazonijevega klorida.
The tablets are white to off-white, round, flat and marked ‘ 30’ on one face and ‘ ACTOS’ on the other face.
Tablete so bele do umazano bele barve, okrogle, ploščate, z oznako ‘ 30 ’ na eni strani in ‘ ACTOS ’ na drugi strani.
14 Elderly:
14 Starejši:
- hepatic impairment
- z okvarjenim delovanjem jeter.
Patients should be observed for signs and symptoms of heart failure, weight gain or oedema particularly those with reduced cardiac reserve.
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. Bolnike je treba opazovati zaradi znakov in simptomov srčnega popuščanja, povečanja telesne mase ali edema, posebno tiste z zmanjšano srčno rezervo.
Monitoring of liver function:
Spremljanje delovanja jeter:
Liver enzymes should be checked prior to the initiation of therapy with pioglitazone in all
Jetrne encime je treba pri vseh bolnikih kontrolirati pred uvedbo zdravljenja s pioglitazonom.
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.
15 zgornja meja normalnih vrednosti) ali s kakršnimikoli drugimi znaki jetrne bolezni zdravljenja s pioglitazonom ne smemo začeti.
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.
16 Opazovano povečano tveganje za zlom pri ženskah v tej skupini podatkov na pioglitazonu je torej 0, 8 zlomov na 100 bolniških let uporabe.
16 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.
Use in breast-feeding:
17 Uporaba v času dojenja:
17 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
PIOGLITAZONE MONOTHERAPY Eye disorders
MONOTERAPIJAS PIOGLITAZONOM Očesne bolezni
18 Nervous system disorders
18 Bolezni mišično- skeletnega sistema in vezivnega tkiva
headache
artralgija
haematuria
glavobol
Reproductive system and breast disorders
Bolezni sečil
Skin and subcutaneous tissue disorders
glikozurija, proteinurija
Uncommon: sweating
Občasni:
19 PIOGLITAZONE IN TRIPLE ORAL COMBINATION THERAPY WITH METFORMIN AND SULPHONYLUREA
19
Investigations
POLIGLITAZON V TROJNEM PERORALNEM KOMBINIRANEM ZDRAVLJENJU Z METFORMINOM IN SULFONILSEČNINO Preiskave
PIOGLITAZONE IN COMBINATION THERAPY WITH INSULIN Metabolism and nutrition disorders
PIOGLITAZON V KOMBINIRANEM ZDRAVLJENU Z INSULINOM Presnovne in prehranjske motnje
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
20 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.
20 primerjalni skupini na sulfonilsečnini.
Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals.
Videti je, da pioglitazon deluje prek aktivacije specifičnih jedrnih receptorjev (s peroksisomskim proliferatorjem aktiviran receptor
21 Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus.
21 gama), kar povzroča povečano občutljivost za insulin v celicah jeter, maščobnem tkivu ter celicah skeletnih mišic živali.
22 concerns regarding use of pioglitazone.
22 blokatorje, ACE inhibitorje, antagoniste angiotenzina II, zaviralce kalcijevih kanalčkov, nitrate, diuretike, aspirin, statine, fibrate),
Patients with renal impairment:
23 Bolniki z okvarjenim delovanjem ledvic:
23 Patients with hepatic impairment:
Bolniki z okvarjenim delovanjem jeter:
24 6.6 Special precautions for disposal
24 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Actos 45 mg tablets.
Actos 45 mg tablete
Each tablet contains 45 mg of pioglitazone as hydrochloride.
Ena tableta vsebuje 45 mg pioglitazona v obliki pioglitazonijevega klorida.
The tablets are white to off-white, round, flat and marked ‘ 45’ on one face and ‘ ACTOS’ on the other face.
Tablete so bele do umazano bele barve, okrogle, ploščate, z oznako ‘ 45 ’ na eni strani in ‘ ACTOS ’ na drugi strani.
26 Elderly:
26 Starejši:
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.
27 zgornja meja normalnih vrednosti) ali s kakršnimikoli drugimi znaki jetrne bolezni zdravljenja s pioglitazonom ne smemo začeti.
The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use.
28 Opazovano povečano tveganje za zlom pri ženskah v tej skupini podatkov na pioglitazonu je torej 0, 8 zlomov na 100 bolniških let uporabe.
28 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.
Use in breast-feeding:
29 Uporaba v času dojenja:
29 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
30 Nervous system disorders
30 Bolezni mišično- skeletnega sistema in vezivnega tkiva
31 PIOGLITAZONE IN TRIPLE ORAL COMBINATION THERAPY WITH METFORMIN AND SULPHONYLUREA
31
32 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.
32 primerjalni skupini na sulfonilsečnini.
33 Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus.
33 gama), kar povzroča povečano občutljivost za insulin v celicah jeter, maščobnem tkivu ter celicah skeletnih mišic živali.
34 concerns regarding use of pioglitazone.
34 blokatorje, ACE inhibitorje, antagoniste angiotenzina II, zaviralce kalcijevih kanalčkov, nitrate, diuretike, aspirin, statine, fibrate),
Patients with renal impairment:
35 Bolniki z okvarjenim delovanjem ledvic:
35 Patients with hepatic impairment:
Bolniki z okvarjenim delovanjem jeter:
36 6.6 Special precautions for disposal
36 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
MARKTEING AUTHORISATION NUMBER(S)
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
37 ANNEX II
37 DODATEK II
The Marketing Authorisation Holder will submit one additional 6 month Periodic Safety Update Report (PSUR) in September 2005 and thereafter yearly PSURs unless otherwise decided by the CHMP.
Imetnik dovoljenja za promet bo predal eno dodatno 6- mesečno periodično poročilo o varnosti zdravila (PSUR) v septembru 2005 ter nato letne PSUR- je, razen če CHMP ne bo odločil drugače.
The Marketing Authorisation Holder commits to performing the Pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Imetnik dovoljenja za promet se zavezuje, da bo izvajal farmakovigilančne aktivnosti, ki so opisane v farmakovigilančnem načrtu.
An updated Risk Management Plan should be provided as per the CHMP guideline on Risk Management Systems for medicinal products for human use.
Dopolnjen načrt o obvladovanju tveganja mora biti predložen v skladu s smernicami CHMP o sistemih obvladovanja tveganja za zdravila za uporabo v humani medicini.
39 ANNEX III
39 DODATEK III
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
41 PODATKI NA ZUNANJI OVOJNINI
CARTON
ŠKATLA
Pioglitazone (as hydrochloride)
pioglitazon (v obliki pioglitazonijevega klorida)
Read the package leaflet before use.
Pred uporabo natančno preberite priloženo navodilo.
{month/ year}
{MM/ LLLL}
EU/ 1/ 00/ 150/ 007 14 tablets EU/ 1/ 00/ 150/ 001 28 tablets EU/ 1/ 00/ 150/ 016 30 tablets EU/ 1/ 00/ 150/ 002 50 tablets EU/ 1/ 00/ 150/ 009 56 tablets EU/ 1/ 00/ 150/ 017 84 tablets EU/ 1/ 00/ 150/ 018 90 tablets EU/ 1/ 00/ 150/ 003 98 tablets
EU/ 1/ 00/ 150/ 007 14 tablet EU/ 1/ 00/ 150/ 001 28 tablet EU/ 1/ 00/ 150/ 016 30 tablet EU/ 1/ 00/ 150/ 002 50 tablet EU/ 1/ 00/ 150/ 009 56 tablet EU/ 1/ 00/ 150/ 017 84 tablet EU/ 1/ 00/ 150/ 018 90 tablet EU/ 1/ 00/ 150/ 003 98 tablet
MANUFACTURER’ S BATCH NUMBER
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
43 PODATKI NA ZUNANJI OVOJNINI
pioglitazone (as hydrochloride)
pioglitazon (v obliki pioglitazonijevega klorida)
EU/ 1/ 00/ 150/ 008 14 tablets EU/ 1/ 00/ 150/ 004 28 tablets EU/ 1/ 00/ 150/ 019 30 tablets EU/ 1/ 00/ 150/ 005 50 tablets EU/ 1/ 00/ 150/ 010 56 tablets EU/ 1/ 00/ 150/ 020 84 tablets EU/ 1/ 00/ 150/ 021 90 tablets EU/ 1/ 00/ 150/ 006 98 tablets
EU/ 1/ 00/ 150/ 008 14 tablet EU/ 1/ 00/ 150/ 004 28 tablet EU/ 1/ 00/ 150/ 019 30 tablet EU/ 1/ 00/ 150/ 005 50 tablet EU/ 1/ 00/ 150/ 010 56 tablet EU/ 1/ 00/ 150/ 020 84 tablet EU/ 1/ 00/ 150/ 021 90 tablet EU/ 1/ 00/ 150/ 006 96 tablet
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
45 PODATKI NA ZUNANJI OVOJNINI
EU/ 1/ 00/ 150/ 011 14 tablets EU/ 1/ 00/ 150/ 012 28 tablets EU/ 1/ 00/ 150/ 022 30 tablets EU/ 1/ 00/ 150/ 013 50 tablets EU/ 1/ 00/ 150/ 014 56 tablets EU/ 1/ 00/ 150/ 023 84 tablets EU/ 1/ 00/ 150/ 024 90 tablets EU/ 1/ 00/ 150/ 015 98 tablets
EU/ 1/ 00/ 150/ 011 14 tablet EU/ 1/ 00/ 150/ 012 28 tablet EU/ 1/ 00/ 150/ 022 30 tablet EU/ 1/ 00/ 150/ 013 50 tablet EU/ 1/ 00/ 150/ 014 56 tablet EU/ 1/ 00/ 150/ 023 84 tablet EU/ 1/ 00/ 150/ 024 90 tablet EU/ 1/ 00/ 150/ 015 98 tablet
47 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
47 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Pioglitazone (as HCl)
pioglitazon (v obliki pioglitazonijevega klorida)
ABBREVIATIONS FOR DAYS OF THE WEEK (PACK SIZES OF 14, 28, 56, 84 AND 98 TABLETS ONLY)
OKRAJŠAVE ZA DNI V TEDNU (SAMO VELIKOSTI PAKIRANJ PO 14, 28, 56, 84 IN 98 TABLET)
48 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
48 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
49 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
INFORMATION FOR THE USER ACTOS 15 MG TABLETS
51 NAVODILO ZA UPORABO ACTOS 15 mg TABLETE
(Pioglitazone (as hydrochloride))
pioglitazon (v obliki pioglitazonijevega klorida)
It may harm them,
Njim bi lahko celo
even if their symptoms are the same as yours.
škodovalo, čeprav imajo znake bolezni, podobne vašim.
please tell you doctor or pharmacist.
omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What Actos is and what it is used for 2.
Kaj je zdravilo Actos in za kaj ga uporabljamo 2.
Before you take Actos 3.
Kaj morate vedeti, preden boste vzeli zdravilo Actos 3.
How to take Actos 4.
Kako jemati zdravilo Actos 4.
How to store Actos 6.
Shranjevanje zdravila Actos 6.
WHAT ACTOS IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ACTOS IN ZA KAJ GA UPORABLJAMO
Actos 15mg tablets are an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus.
Actos 15 mg tablete so antidiabetično zdravilo za zdravljenje sladkorne bolezni tipa 2 (od insulina neodvisne sladkorne bolezni).