natgillin/translations-raw huggingface dataset:
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.
This study showed an increase in reports of heart failure; however this did not lead to an increase in mortality in this study.
Ta študija je pokazala povečanje poročil srčnega popuščanja, vendar to ni vodilo k dvigu smrtnosti v tej študiji.
What Glubrava is and what it is used for
Kaj je zdravilo Glubrava in za kaj ga uporabljamo
The maximum daily dose of metformin should preferably be divided into 2-3 daily doses.
Najbolje je, da se največji dnevni odmerek metformina razdeli v 2 do 3 dnevne odmerke.
Tmax was delayed by food by approximately 1.9 h for pioglitazone and 0.8 h for metformin.
Tmax je bil zakasnjen za približno 1,9 ure pri pioglitazonu in za 0,8 ure pri metforminu.
if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye), talk to your doctor if you notice any change to your vision.
- če imate posebno obliko diabetične očesne bolezni, imenovano makularni edem (otekanje zadnjega dela očesa), se pogovorite s svojim zdravnikom, če opazite spremembe vida.
In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
V kliničnih študijah so bolniki jemali odmerek pioglitazona, ki je višji od najvišjega priporočenega odmerka 45 mg dnevno.
The safety profile seen in this study reflected the known adverse reactions seen with the individual products and did not suggest any new safety issues.
Varnostni profil v tej študiji je pokazal že znane neželene učinke na posamična zdravila in ni razkril novih težav z varnostjo.
The mean plasma elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Povprečni razpolovni čas plazemskega izločanja nespremenjenega pioglitazona pri človeku je 5 do 6 ur in za njegove skupne aktivne presnovke 16 do 23 ur.
Based on the data presented, the risk minimisation measures in the approved product information are considered adequate for the listed safety concerns.
Na podlagi predloženih podatkov se ukrepi za zmanjševanje tveganj v odobrenih informacijah o zdravilu štejejo za ustrezne za navedene varnostne zadržke.
if you have a problem with your liver.
- če imate težave z jetri.
if you have heart failure or have had heart failure in the past.
- če imate srčno popuščanje ali ste imeli srčno popuščanje v preteklosti.
The safety and efficacy of Glubrava in children and adolescents under 18 years of age have not been established.
Varnost in učinkovitost zdravila Glubrava pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
However, in the case of metformin, in the fed state the mean AUC and Cmax were lower (13% and 28% respectively).
Vendar sta bila po obroku v primeru metformina povprečna AUC in Cmax nižja (13% in 28% v tem zaporedju).
If 3 to 6 months after starting Glubrava your sugar control is not improved, the medicine should be discontinued.
Če se po 3 do 6 mesecih po začetku jemanja zdravila Glubrava nadzor sladkorja ne izboljša, morate prenehati uporabljati zdravilo.
In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g every 3-6 months.
Pri bolnikih s povečanim tveganjem dodatnega napredovanja okvare ledvic in pri starejših je treba delovanje ledvic oceniti pogosteje, na primer vsake 3 do 6 mesecev.
Signs and symptoms include blood in your urine, pain when urinating or a sudden need to urinate.
Znaki in simptomi vključujejo kri v urinu, bolečine med uriniranjem ali nenadno potrebo po uriniranju.
Do not take a double dose to make up for a forgotten tablet.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, da bi nadomestili izpuščeno tableto.
Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood and which can lead to diabetic pre-coma.
Ketoacidoza je stanje, pri katerem se snovi, imenovane 'ketonska telesa', kopičijo v krvi, kar lahko povzroči diabetično predkomo.
Your doctor may take blood tests to monitor your blood cell levels and liver function.
Zdravnik lahko opravi pregled krvi za nadzor ravni krvnih celic ali delovanja jeter.
The most effective method to remove lactate and metformin is haemodialysis.
Najučinkovitejši način za odstranitev laktata in metformina je hemodializa.
In case of suspected symptoms, the patient should stop taking Glubrava and seek immediate medical attention.
Ob sumu na simptome mora bolnik prenehati z jemanjem Glubrava in takoj poiskati zdravniško pomoč.
After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Po peroralno vzetem odmerku je v fecesu odkrit neabsorbiran delež znašal 20 do 30%.
In some cases weight increase may be a symptom of cardiac failure; therefore weight should be closely monitored.
V nekaterih primerih je povečanje telesne mase lahko simptom srčnega popuščanja, zato je treba telesno maso skrbno spremljati.
very rare very rare lactic acidosis very rare very rare
zelo redki zelo redki laktacidoza zelo redki zelo redki
HOMA analysis shows that pioglitazone improves beta cell function as well as increasing insulin sensitivity.
Analiza HOMA kaže, da pioglitazon izboljša delovanje beta celic in tudi povečuje občutljivost za insulin.
Previous anti-diabetic medicinal products were discontinued for 12 weeks prior to baseline measurements.
Predhodna zdravila proti sladkorni bolezni so bila ukinjena 12 tednov pred opravljenimi izhodiščnimi preiskavami.
It is unknown whether pioglitazone and metformin are excreted in human milk.
Ni znano, ali se pioglitazon in metformin izločata v materino mleko.
When starting or using such products in combination with Glubrava, close monitoring of renal function is necessary.
Ob uvedbi ali uporabi teh zdravil v kombinaciji z Glubrava je potrebno skrbno spremljanje delovanja ledvic.
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.
If you take Glubrava with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Če ste vzeli zdravilo Glubrava z drugimi zdravili za zdravljenje sladkorne bolezni, je bolj verjetno, da vam vrednost krvnega sladkorja pade pod normalno raven (hipoglikemija).
If you have reduced kidney function, your doctor may prescribe a lower dose, which may need to be given as separate tablets of pioglitazone and metformin.
Če imate zmanjšano delovanje ledvic, vam bo morda zdravnik predpisal manjši odmerek, ki ga bo morda treba vzeti kot ločeni tableti pioglitazona in metformina.
Other medicines and Glubrava
Druga zdravila in zdravilo Glubrava
What you need to know before you take Glubrava
Kaj morate vedeti, preden boste vzeli zdravilo Glubrava
They are supplied in aluminium/aluminium blister in packs of 14, 28, 30, 50, 56, 60, 90, 98 or 180 tablets.
Na voljo so v pretisnih omotih iz aluminija/aluminija v pakiranjih po 14, 28, 30, 50, 56, 60, 90, 98 ali 180 tablet.
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.
Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Po peroralnem dajanju radioaktivno označenega pioglitazona človeku so označevalec zaznali predvsem v blatu (55%) in manjšo količino v urinu (45%).
Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.
Metformin ni imel vpliva na plodnost samcev ali samic podgan, ko je bil uporabljen v visokih odmerkih 600 mg/kg/dan, kar je približno trikratni največji priporočeni dnevni odmerek za ljudi na podlagi primerjave telesne površine.
This type 2 diabetes usually develops in adulthood particularly as a result of the person being overweight and where the body either does not produce enough insulin (a hormone that controls blood sugar levels), or cannot effectively use the insulin it produces.
Ta sladkorna bolezen tipa 2 se običajno razvije v odrasli dobi zlasti kot rezultat prekomerne telesne mase in če telo bodisi ne proizvaja dovolj insulina (hormon, ki nadzira raven sladkorja v krvi), ali ni zmožno učinkovito uporabljati insulin, ki ga proizvaja.
No increase in mortality from heart failure was observed.
Dviga smrtnosti zaradi srčne odpovedi niso opazili.
In an animal model of familial adenomatous polyposis (FAP), treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
Pri živalskem modelu familiarne adenomatozne polipoze (FAP) je zdravljenje z dvema drugima tiazolidindionoma povečalo število tumorjev v kolonu.
Glycaemic control should be monitored closely.
Potrebno je skrbno spremljanje glikemičnega nadzora.
If ALT levels remain > 3 x the upper limit of normal, therapy should be discontinued.
Če ravni ALT ostanejo > 3-kratne zgornje meje normalnih vrednosti, je treba zdravljenje prekiniti.
Animal studies have not revealed teratogenic effects or do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Študije na živalih niso pokazale teratogenih učinkov ali ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
The MAH provided updates on new information related to the important identified and important potential risks as listed in the summary of safety concerns.
Imetnik dovoljenja za promet z zdravilom je predložil posodobitve novih informacij v zvezi s pomembnimi ugotovljenimi in pomembnimi možnimi tveganji, navedenimi v povzetku varnostnih zadržkov.
Talk to your doctor for further instructions.
Za več navodil se posvetujte z zdravnikom.
You should swallow the tablets with a glass of water.
Tablete pogoltnite s kozarcem vode.
NAME OF THE MARKETING AUTHORISATION HOLDER Takeda (logo)
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Takeda (logotip)
There are no adequate human data from the use of pioglitazone in pregnant women.
Ni zadostnih podatkov o uporabi pioglitazona pri nosečnicah.
If you take anti-inflammatory medicines which can also cause fluid retention and swelling, you must also tell your doctor.
Če jemljete protivnetna zdravila, ki tudi lahko povzročijo zastajanje tekočine v telesu in otekanje, morate o tem prav tako obvestiti svojega zdravnika.
Film-coated tablet (tablet).
Filmsko obložena tableta (tableta)
In light of age- related risks (especially bladder cancer, fractures and heart failure), the balance of benefits and risks should be considered carefully both before and during treatment in the elderly.
Glede na s starostjo povezana tveganja (zlasti rak sečnega mehurja, zlomi in srčno popuščanje), je treba pri starejših ravnovesje med koristmi in tveganji skrbno pretehtati pred in med zdravljenjem.
If no adequate strength of Glubrava is available, individual monocomponents should be used instead of the fixed dose combination.
Če ni na voljo ustrezna jakost zdravila Glubrava, je treba namesto fiksne kombinacije uporabiti posamične monokomponente.
You may take your tablets with or just after food to reduce the chance of an upset stomach.
Tablete lahko jemljete med obrokom ali tik po njem, da se zmanjša možnost želodčnih težav.
A 24-month mechanistic study in male rats demonstrated that administration of pioglitazone resulted in an increased incidence of hyperplastic changes in the bladder.
24 mesecev trajajoča mehanska raziskava na samcih podgan je pokazala, da je dajanje pioglitazona povzročilo povečano incidenco hiperplastičnih sprememb v mehurju.
Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Farmakokinetiki stanja dinamičnega ravnovesja sta pri bolnikih, starih 65 let in več, ter mladih osebah podobni.
Epidemiological studies have also suggested a small increased risk of bladder cancer in diabetic patients treated with pioglitazone, although not all studies identified a statistically significant increased risk.
Tudi epidemiološke študije kažejo malo večje tveganje za rak sečnega mehurja pri bolnikih s sladkorno boleznijo, zdravljenih s pioglitazonom, čeprav pri vseh študijah povečanje tveganja ni bilo statistično signifikantno.
There is no clinical experience of pioglitazone in triple combination with other oral antidiabetic medicinal products.
Kliničnih izkušenj s pioglitazonom v trojni kombinaciji z drugimi peroralnimi antidiabetiki ni.
Glubrava helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Zdravilo Glubrava pomaga nadzorovati raven sladkorja v krvi, če imate sladkorno bolezen tipa 2, in sicer tako, da telesu pomaga bolje izkoristiti insulin, ki ga izdela.
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 splošno pa je manjša od 1 µg/ml.
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.
3 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.
3 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.
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 or the elderly), 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 simptomatsko koronarno arterijsko bolezen ali v primeru starejših bolnikov), mora zdravnik začeti zdravljenje z najnižjim možnim odmerkom in ga postopoma višati.
Similar changes in body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity.
Podobne spremembe porazdelitve telesnega maščevja med jemanjem pioglitazona je spremljalo izboljšanje občutljivosti za insulin.
Analysis of the results for overweight patients treated with metformin after failure of diet alone showed:
Analize teh rezultatov pri bolnikih s čezmerno telesno maso, ki so bili po neuspešnem zdravljenju samo z dieto zdravljeni z metforminom, kažejo:
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.
The rate of deterioration of HbA1c during the second year was less with pioglitazone than with gliclazide.
Stopnja slabšanja HbA1c v drugem letu je bila pri pioglitazonu nižja kot pri gliklazidu.
Pioglitazone effects may be mediated by a reduction of insulin resistance.
Na učinke pioglitazona lahko vpliva zmanjšanje insulinske rezistence.
Pioglitazone and metformin combination
Kombinacija pioglitazona in metformina
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 zaviralci reduktaze HMGCoA, ni pričakovati.
As Glubrava contains metformin hydrochloride, it must be discontinued at the time of surgery under general, spinal or epidural anesthesia.
Ker zdravilo Glubrava vsebuje metformin hidroklorid, je treba jemanje le-tega prekiniti v času operativnega posega pod splošno, spinalno ali epiduralno anestezijo.
- do not use this medicine if you are breastfeeding or are planning to breast-feed (see section “Do not take Glubrava”).
- Ne jemljite tega zdravila, če dojite ali nameravate dojiti (glejte poglavje "Ne jemljite zdravila Glubrava").
EU/1/07/421/001 14 tablets EU/1/07/421/002 28 tablets EU/1/07/421/003 30 tablets EU/1/07/421/004 50 tablets EU/1/07/421/005 56 tablets EU/1/07/421/006 60 tablets EU/1/07/421/007 90 tablets EU/1/07/421/008 98 tablets EU/1/07/421/009 180 tablets
EU/1/07/421/001 14 tablet EU/1/07/421/002 28 tablet EU/1/07/421/003 30 tablet EU/1/07/421/004 50 tablet EU/1/07/421/005 56 tablet EU/1/07/421/006 60 tablet EU/1/07/421/007 90 tablet EU/1/07/421/008 98 tablet EU/1/07/421/009 180 tablet
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.
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).
Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
Simptomi vključujejo bolečine v trebuhu, hitro in globoko dihanje, zaspanost ali zadah z nenavadnim sadnim vonjem.
Glubrava has no or negligible influence on the ability to drive and use machines.
Zdravilo Glubrava nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
After 24 weeks of treatment, the primary endpoint of mean change from baseline in HbA1c was -1.83% in the combination group versus -0.96% in the pioglitazone group (p< 0.0001) and -0.99% in the metformin group (p< 0.0001).
Po 24 tednih zdravljenja je bila primarna končna točka povprečne spremembe od izhodišča za HbA1c -1,83% v skupini s kombinacijo v primerjavi z -0,96% v skupini s pioglitazonom (p < 0,0001) in -0,99% v skupini z metforminom (p < 0,0001).
After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were 7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups.
Ko so izločili bolnike, ki so bili v času diagnoze rak sečnega mehurja preiskovanemu zdravilu izpostavljeni manj kot eno leto, so ugotovili 7 primerov (0,06%) raka mehurja pri pioglitazonu in 2 primera (0,02%) v kontrolnih skupinah.
not known not known liver function tests abnormal5
neznana neznana nenormalni testi delovanja jeter5
The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes mellitus.
Prospektivne randomizirane raziskave (UKPDS) ugotavljajo dolgoročno korist intenzivne urejenosti glukoze v krvi pri sladkorni bolezni tipa 2.
Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (> 5 mmol/L) and an increased anion gap and lactate/pyruvate ratio.
Diagnostični laboratorijski izvidi so zmanjšan pH krvi (< 7,35), zvišane ravni laktata v plazmi (> 5 mmol/l) in povečana anionska vrzel ter razmerje laktat/piruvat.
30-44 Maximum daily dose is 1,000 mg.
30 do 44 Največji dnevni odmerek je 1.000 mg.
If you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing stop taking this medicine and talk to your doctor immediately.
Če imate resno alergijsko reakcijo, ki vključuje koprivnico in otekanje obraza, ustnic, jezika ali žrela, kar lahko povzroči težave pri dihanju ali požiranju, takoj prenehajte z jemanjem tega zdravila in nemudoma poiščite zdravniško pomoč.
The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment.
O slednjem je potrebno bolnika informirati, potrebno pa je tudi pogosteje določati koncentracijo glukoze v krvi, še posebno na začetku zdravljenja.
Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Ledvični očistek metformina je > 400 ml/min, kar kaže na izločanje metformina z glomerularno filtracijo in tubulno sekrecijo.
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 študija ni dosegla svojega prvotnega cilja, ki je bil sestavljen iz umrljivosti iz vseh vzrokov, neusodnih miokardnih infarktov, kapi, akutnih koronarnih sindromov, težjih amputacij nog, koronarnih revaskularizacij in revaskularizacij nog, rezultati kažejo, da ni dolgoročnih kardiovaskularnih skrbi glede uporabe pioglitazona.
Metformin is contraindicated in patients with GFR < 30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3.
Metformin je kontraindiciran pri bolnikih z GFR < 30 ml/min in ga je treba začasno ukiniti, če se pojavijo stanja, ki spremenijo delovanje ledvic, glejte poglavje 4.3.
Glubrava contains pioglitazone and metformin which are anti-diabetic medicines, used to control blood sugar level.
Zdravilo Glubrava vsebuje pioglitazon in metformin, ki sta antidiabetika, ki se uporabljata za nadzor sladkorja v krvi.
The mean Vd ranged between 63-276 L.
Srednja vrednost volumna porazdelitve (Vd) se giblje med 63 in 276 litri.
Close monitoring of glycaemic control should be considered (see section 4.4).
Upoštevati je treba skrbno spremljanje glikemičnega nadzora (glejte poglavje 4.4).
Patients should be advised to promptly seek the attention of their physician if macroscopic haematuria or other symptoms such as dysuria or urinary urgency develop during treatment.
Bolnikom je treba svetovati, naj nemudoma poiščejo pomoč svojega zdravnika, če se med zdravljenjem pojavi makroskopska hematurija ali drugi simptomi, kot so disurija ali povečana potreba po uriniranju.
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.
If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart-beating, vision disorders or difficulty in concentration, you should take some sugar to increase your blood sugar level again.
Če opazite simptome hipoglikemije, kot so šibkost, vrtoglavica, povečano znojenje, hitro utripanje srca, motnje vida ali težave s koncentracijo, zaužijte sladkor, da si boste znova dvignili raven sladkorja v krvi.
Taking Glubrava with, or just after food, may reduce gastrointestinal symptoms associated with metformin.
Jemanje zdravila Glubrava med obrokom ali neposredno po njem lahko ublaži gastrointestinalne simptome, ki so povezani z metforminom.
common common macular oedema not known not known
pogosti pogosti makularni edem neznana neznana