natgillin/translations-raw huggingface dataset:
EU Number EU/ 1/ 07/ 421/ 001 EU/ 1/ 07/ 421/ 002 EU/ 1/ 07/ 421/ 003 EU/ 1/ 07/ 421/ 004 EU/ 1/ 07/ 421/ 005 EU/ 1/ 07/ 421/ 006 EU/ 1/ 07/ 421/ 007 EU/ 1/ 07/ 421/ 008 EU/ 1/ 07/ 421/ 009
EU/ 1/ 07/ 421/ 001 EU/ 1/ 07/ 421/ 002 EU/ 1/ 07/ 421/ 003 EU/ 1/ 07/ 421/ 004 EU/ 1/ 07/ 421/ 005 EU/ 1/ 07/ 421/ 006 EU/ 1/ 07/ 421/ 007 EU/ 1/ 07/ 421/ 008 EU/ 1/ 07/ 421/ 009
Invented name Glubrava Glubrava Glubrava Glubrava Glubrava Glubrava Glubrava Glubrava Glubrava
Glubrava Glubrava Glubrava Glubrava Glubrava Glubrava Glubrava Glubrava Glubrava
Strength 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg
15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg 15 mg/ 850 mg
Pharmaceutical Form Film-coated Tablet Film-coated Tablet Film-coated Tablet Film-coated Tablet Film-coated Tablet Film-coated Tablet Film-coated Tablet Film-coated Tablet Film-coated Tablet
Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
Packaging 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)
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)
Package size 14 28 30 50 56 60 90 98 180
14 28 30 50 56 60 90 98 180
Glubrava 15 mg/ 850 mg film-coated tablets.
Glubrava 15 mg/ 850 mg filmsko obložene tablete
The tablets are white to off-white, oblong, film-coated, embossed ‘ 15 / 850’ on one face and ‘ 4833M’ on the other.
Tablete so bele do sivkastobele barve, podolgovate, filmsko obložene, z oznako ‘ 15/ 850 ’ na eni strani in ‘ 4833M ’ na drugi.
Glubrava is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
Zdravilo Glubrava je indicirano za zdravljenje sladkorne bolezni tipa 2, še posebno pri bolnikih s čezmerno telesno maso, pri katerih ni možno vzdrževati primerne koncentracije glukoze v krvi z največjim dovoljenim peroralnim odmerkom metformina samega.
Dosage in adults The usual dose of Glubrava is 30 mg/ day pioglitazone plus 1700 mg/ day of metformin hydrochloride (this dosage is achievable with one tablet of Glubrava 15 mg/ 850 mg, taken twice a day).
Odmerjanje pri odraslih Običajni odmerek zdravila Glubrava je 30 mg/ dan pioglitazona in 1700 mg/ dan metforminijevega klorida (dan v obliki ene tablete zdravila Glubrava 15 mg/ 850 mg dvakrat na dan).
Taking Glubrava with, or just after food, may reduce gastrointestinal symptoms associated with metformin.
Jemanje zdravila Glubrava sočasno s hrano ali neposredno po obroku lahko ublaži gastrointestinalne simptome, ki so povezani z metforminom.
Elderly As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Glubrava should have their renal function monitored regularly (see sections 4.3 and 4.4).
Starejši bolniki Zaradi izločanja metformina skozi ledvice in zaradi starostnega nagnjenja k zmanjšanju ledvičnega delovanja je pri starejših bolnikih, ki jemljejo zdravilo Glubrava, potrebno redno spremljati delovanje ledvic (glejte poglavji 4. 3 in 4. 4).
Patients with renal impairment Glubrava should not be used in patients with renal failure or renal dysfunction (creatinine clearance < 60 ml/ min)(see sections 4.3 and 4.4).
Bolniki z oslabljenim delovanjem ledvic Zdravilo Glubrava se ne sme uporabljati pri bolnikih z ledvično odpovedjo ali ledvično disfunkcijo, očistek kreatinina < 60 ml/ min (glejte poglavji 4. 3 in 4. 4).
Patients with hepatic impairment Glubrava should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
Bolniki z okvarjenim delovanjem jeter Zdravila Glubrava pri bolnikih z okvarjenim delovanjem jeter ne smemo uporabljati (glejte poglavji 4. 3 in 4. 4).
2 Children and adolescents There are no data available on the use of pioglitazone in patients under 18 years of age and therefore the use of Glubrava in this age group is not recommended.
O uporabi pioglitazona pri bolnikih, mlajših od 18 let, ni razpoložljivih podatkov in zato uporaba zdravila Glubrava pri tej starostni skupini ni priporočljiva.
Lactic acidosis Lactic acidosis is a very rare, but serious, metabolic complication that can occur due to metformin accumulation.
Lacktacidoza Laktacidoza je redek, vendar resen metabolni zaplet, ki se lahko pojavi zaradi kopičenja metformina.
Diagnosi Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma.
Diagnoza Za laktacidozo so značilne acidozna dispneja, abdominalna bolečina in hipotermija, ki jim sledi koma.
Renal Function As metformin is excreted by the kidney, serum creatinine concentrations should be determined regularly:
Delovanje ledvic Zaradi izločanja metformina skozi ledvice je potrebno redno določati koncentracije kreatinina v serumu:
- at least two to four times a year in patients with serum creatinine levels at the upper limits of
- vsaj dvakrat do štirikrat letno pri bolnikih, ki imajo vrednosti kreatinina v serumu na
normal and in elderly subjects
zgornjidovoljeni meji, in pri starejših bolnikih.
3 Fluid retention and cardiac failure Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure.
3 (npr. predhodni miokardni infarkt ali simptomatska koronarna arterijska bolezen), mora zdravnik začeti zdravljenje z najnižjim možnim odmerkom in ga postopoma višati.
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.
Poročali so o primerih srčnega popuščanja, ko so pioglitazon uporabljali v kombinaciji z insulinom ali pri bolnikih s srčnim popuščanjem v anamnezi.
Since insulin and pioglitazone are associated with fluid retention, concomitant administration of insulin and Glubrava may increase the risk of oedema.
Ker sta insulin in pioglitazon povezana z zastajanjem tekočine, lahko sočasno jemanje insulina in zdravila Glubrava poveča tveganje za edeme.
Monitoring of Liver Function There have been rare reports of hepatocellular dysfunction during post-marketing experience with pioglitazone (see section 4.8).
Spremljanje delovanja jeter V postmarketinških izkušnjah s pioglitazonom so poročali o redkih primerih hepatocelularne disfunkcije (glejte poglavje 4. 8).
Therapy with Glubrava 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 vrednostmi jetrnih encimov (ALT > 2, 5- kratna zgornja meja normalnih vrednosti) ali s kakršnimikoli drugimi znaki jetrne bolezni zdravljenja z zdravilom Glubrava ne smemo začeti.
If ALT levels are increased to 3 X upper limit of normal during Glubrava therapy, liver enzyme levels should be reassessed as soon as possible.
Če se med zdravljenjem z zdravilom Glubrava ravni ALT zvišajo do 3- kratne zgornje meje 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.
Haematology There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution.
Hematologija Med zdravljenjem s pioglitazonom se je pojavljalo majhno znižanje povprečne vrednosti hemoglobina (4% relativno znižanje) in hematokrita (4, 1% relativno znižanje), skladno s hemodilucijo.
Hypoglycaemia Patients receiving pioglitazone in dual oral therapy with a sulphonylurea may be at risk for dose- related hypoglycaemia, and a reduction in the dose of the sulphonylurea may be necessary.
Hipoglikemija Bolniki, ki prejemajo pioglitazon v dvojnem zdravljenju s sulfonilsečnino, so lahko izpostavljeni tveganju za od odmerka odvisno hipoglikemijo, in je morda potrebno znižati odmerek sulfonilsečnine.
Eye disorders Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Očesne bolezni Pri postmarketinškem spremljanju zdravila so poročali o nastopu ali poslabšanju diabetičnega makularnega edema s poslabšanjem ostrine vida pri tiazolidindionih, vključno s pioglitazonom.
4 Surgery As Glubrava contains metformin hydrochloride, the treatment should be discontinued 48 hours before elective surgery with general anaesthesia and should not be usually resumed earlier than 48 hours afterwards.
4 Kirurgija Ker zdravilo Glubrava vsebuje metforminijev klorid, je potrebno zdravljenje prekiniti 48 ur pred načrtovanim operativnim posegom v splošni anesteziji, z njim pa običajno ne smemo nadaljevati prej kot v 48 urah po posegu.
Administration of iodinated contrast agent The intravascular administration of iodinated contrast agents in radiological studies can lead to renal failure.
Uporaba jodiranih kontrastnih sredstev Intravenska uporaba jodiranih kontrastnih sredstev med radiološkimi preiskavami lahko povzroči odpoved ledvic.
Therefore, due to the metformin active substance, Glubrava should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Zaradi vsebnosti zdravilne učinkovine metformin je potrebno zdravilo Glubrava ukiniti pred preiskavo ali v času preiskav, ponovno pa se sme uvesti šele po 48 urah in le v primeru, da je bilo pri ponovnem vrednotenju ugotovljeno normalno delovanje ledvic (glejte poglavje 4. 5).
Polycystic ovarian syndrome As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation.
Sindrom policističnih jajčnikov Zaradi okrepitve delovanja insulina lahko zdravljenje s pioglitazonom pri bolnicah s sindromom policističnih jajčnikov povzroči obnovitev ovulacije.
Others 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.
Drugo 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.
5 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.
5 Poročali so, da sočasno dajanje pioglitazona z gemfibrozilom (zaviralec citokroma P450 2C8) povzroči 3- kratno povečanje AUC pioglitazona.
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Glubrava (see section 4.4).
Ker je v zdravilu Glubrava zdravilna učinkovina metformin, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience) povečana nevarnost laktacidoze (glejte poglavje 4. 4).
For Glubrava no preclinical or clinical data on exposed pregnancies or lactation are available.
Predklinični ali klinični podatki o uporabi zdravila Glubrava med nosečnostjo ali dojenjem niso na voljo.
Risk related to pioglitazone There are no adequate human data from the use of pioglitazone in pregnant women.
Tveganja, ki jih predstavlja pioglitazon Ni zadostnih podatkov o uporabi pioglitazona pri nosečnicah.
Risk related to metformin Animal studies have not revealed teratogenic effects.
Tveganja, ki jih predstavlja metformin Študije na živalih niso pokazale teratogenih učinkov.
However, Glubrava should not be used during pregnancy and in women of child-bearing age not using contraceptive measures.
Vendar se zdravila Glubrava ne sme dajati ženskam v času nosečnosti in ženskam v rodni dobi, ki ne jemljejo kontracepcijskih sredstev.
If a patient wishes to become pregnant or if a pregnancy occurs, treatment with Glubrava should be discontinued.
Če bolnice želijo zanositi ali če pride do nosečnosti, je potrebno zdravljenje z zdravilom Glubrava prekiniti.
Both pioglitazone and metformin have been shown to be present in the milk of lactating rats.
6 Tako pioglitazon kot metformin so dokazali v mleku doječih podgan.
Glubrava must therefore not be used in women who are breast-feeding (see section 4.3).
Zdravila Glubrava se torej ne sme uporabljati pri ženskah, ki dojijo (glejte poglavje 4. 3).
6 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
There have been no therapeutic clinical trials conducted with Glubrava tablets however bioequivalence of Glubrava with co-administered pioglitazone and metformin has been demonstrated (see section 5.2).
Klinična terapevstka preskušanja z zdravilom Glubrava tabletami niso opravljena, vendar je bila bioekvivalenca zdravila Glubrava dokazana s sočasno uporabo pioglitazona in metformina (glejte poglavje 5. 2).
visual disturbance
Bolezni prebavil
Gastrointestinal disorders Uncommon:
Občasni:
Musculoskeletal system and connective tissue disorders Common:
Bolezni mišično- skeletnega sistema in vezivnega tkiva Pogosti:
Nervous system disorders Common:
Pogosti:
Renal and urinary Common:
Bolezni sečil Pogosti:
disorders haematuria
hematurija
In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 – 3 kg over one year.
V kontroliranih preskušanjih z aktivno primerjavo je bilo povprečno povečanje telesne mase pri pioglitazonu, dajanemu kot monoterapija, 2- 3 kg v enem letu.
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.
7 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.
7 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.
Eye disorders Macular oedema:
Očesne bolezni Makularni edem:
not known
neznani
Metabolism and nutrition disorders Very rare:
Presnovne in prehranske motnje Zelo redko:
Decrease of vitamin B12 absorption with decrease of serum levels during long-term use of metformin.
zmanjšana absorpcija vitamina B12 in posledično zmanjšane koncentracije v serumu med dolgotrajnim jemanjem metformina.
Nervous system disorders Common:
Motnje živčevja Pogosto:
Taste disturbance
Bolezni prebavil
Gastrointestinal disorders Very common:
Zelo pogosto:
Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite.
gastrointestinalne motnje, kot so slabost, bruhanje, diareja, bolečine v trebuhu in izguba apetita.
Liver function tests abnormalities or hepatitis resolving upon metformin discontinuation.
Bolezni jeter, žolčnika in žolčevodov Posamezni primeri: nenormalni testi delovanja jeter ali hepatitis, stanje se normalizira po ukinitvi zdravljenja z metforminom
Skin and subcutaneous tissue disorders Very rare:
Bolezni kože in podkožnih tkiv Zelo redko:
Skin reactions such as erythema, pruritis, urticaria.
reakcije kože kot so eritem, pruritis, urtikarija.
A higher rate of
8 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.
8 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%).
Glubrava combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: pioglitazone, a member of the thiazolidinedione class and metformin hydrochloride, a member of the biguanide class.
Zdravilo Glubrava je kombinacija dveh antihiperglikemičnih učinkovin s komplementarnim mehanizmom delovanja, namenjeno pa je izboljšanju urejenosti glikemije pri bolnikih s sladkorno boleznijo tipa 2: pioglitazona iz skupine tiazolidindionov in metforminijevega klorida iz skupine bigvanidov.
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.
In a two-year study of combination therapy comparing pioglitazone with gliclazide when added to metformin, glycaemic control measured as mean change from baseline in HbA1c was similar between treatment groups after one year.
V dvoletni študiji kombiniranega zdravljenja, kjer so primerjali pioglitazon z gliklazidom, kadar jih uporabljamo v kombinaciji z metforminom, je bil nadzor glikemije, ki ga merimo kot povprečno spremembo HbA1c od izhodiščne vrednosti, po
Patients receiving
V študiji, kontrolirani s placebom, so bili bolniki z nezadostnim nadzorom glikemije, kljub trimesečnemu obdobju optimizacije insulina, 12 mesecev naključno zdravljeni s pioglitazonom ali placebom.
9 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 v skupini, zdravljeni s pioglitazonom, ki je prejemala nižji odmerek insulina.
Pioglitazone did not cause statistically significant increases in LDL-cholesterol levels compared with placebo, whilst reductions where observed with metformin and gliclazide.
Pioglitazon ni povzročil statistično značilnih povišanj ravni LDL holesterola v primerjavi s placebom, pri metforminu in gliklazidu pa so opazili znižanja teh vrednosti.
In a 20-week study, as well as reducing fasting triglycerides, pioglitazone reduced postprandial 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.
Metformin may act via three mechanisms:
10 Metformin lahko deluje na tri načine:
10 Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Metformin stimulira znotrajcelično sintezo glikogena tako, da deluje na glikogen sintazo.
patient-years versus diet alone 20.6 events/ 1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/ 1,000 patient-years (p=0.021)
13, 5 primerov/ 1000 bolnikov letno, samo dieta – 20, 6 primerov/ 1000 bolnikov letno (p = 0, 011), v primerjavi s skupinama s kombiniranim zdravljenjem s sulfonilsečnino in monoterapijo z insulinom – 18, 9 primerov/ 1. 00 bolnikov letno (p = 0, 021);
patient-years, diet alone 18 events/ 1,000 patient-years, (p=0.01).
11 primerov/ 1000 bolnikov letno, dieta sama – 18 primerov/ 1. 000 bolnikov letno (p = 0, 01).
Absorption Following oral administration, pioglitazone is rapidly absorbed, and peak plasma concentrations of unchanged pioglitazone are usually achieved 2 hours after administration.
Absorpcija Po peroralnem dajanju se pioglitazon hitro absorbira, maksimalne plazemske koncentracije nespremenjenega pioglitazona so običajno dosežene 2 uri po dajanju.
Steady state is achieved after 4– 7 days of dosing.
Stanje dinamičnega ravnovesja je doseženo po
Distribution The estimated volume of distribution in humans is 0.25 l/ kg.
Porazdelitev Ocenjeni volumen porazdelitve pri človeku je 0, 25 l/ kg.
Metabolism Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups.
Presnova Pioglitazon je podvržen obsežni jetrni presnovi s hidroksilacijo alifatskih metilenskih skupin.
This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser
Ta poteka predvsem preko citokromov P450 2C8, v manjši meri pa so lahko vpletene tudi druge izooblike.
Elimination Following oral administration of radiolabeled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Izločanje Po peroralnem dajanju radioaktivno označenega pioglitazona človeku so označevalec zaznali predvsem v blatu (55%) in manjšo količino v urinu (45%).
Elderly Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Starejši Farmakokinetiki stanja dinamičnega ravnovesja sta pri bolnikih, starih 65 let in več, ter mladih osebah podobni.
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.
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.
Celotna plazemska koncentracija pioglitazona ni spremenjena, povečan pa je volumen porazdelitve.
Absorption After an oral dose of metformin, tmax is reached in 2.5 h.
Absorpcija Po peroralnem odmerku metformina je tmax dosežen v 2, 5 urah.
At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ ml.
Pri običajnih odmerkih in shemah odmerjanja metformina je plazemska koncentracija v stanju dinamičnega ravnovesja dosežena v 24 do 48 urah, na
12 Elimination Renal clearance of metformin is > 400ml/ min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Izločanje Ledvični očistek metformina je > 400 ml/ min, kar kaže na izločanje metformina z glomerularno filtracijo in tubulno sekrecijo.
No animal studies have been conducted with the combined products in Glubrava.
Raziskave s kombinacijo učinkovin v zdravilu Glubrava na živalih niso bile narejene.