natgillin/translations-raw huggingface dataset:
Glidipion has no or negligible effect on the ability to drive and use machines. 
Glidipion nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
Kljub temu naj imetnik dovoljenja za promet z zdravilom odda redno posodobljena poročila o varnosti za to zdravilo v skladu z zahtevami določenimi na seznamu referenčnih datumov Unije (seznam EURD) opredeljen v členu 107c(7) Direktive 2001/83/ES in objavljen na evropskem spletnem portalu o zdravilih.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
In particular, patients have experienced the following serious side effects: 
Še zlasti so se bolnikom pojavljali naslednji neželeni učinki:
However patients who experience visual disturbance should be cautious when driving or using machines. 
Vendar pa morajo biti bolniki, ki se jim pojavi motnja vida, previdni, če vozijo ali upravljajo s stroji.
Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland 
Reykjavíkurvegi 76-78 220 Hafnarfjörđur Islandija
Patients should be advised to adhere strictly to a calorie-controlled diet. 
Bolnikom je treba naročiti, naj se strogo držijo kalorično kontrolirane diete.
However if you miss a dose, just carry on with the next dose as normal. 
A če ste pozabili vzeti odmerek, zgolj nadaljujte z naslednjim, kot po navadi.
The study population had an average age of 62 years; the average duration of diabetes was 9.5 years. 
Povprečna starost bolnikov v populaciji študije je bila 62 let in povprečno trajanje sladkorne bolezni 9,5 leta.
Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%). 
Pioglitazon in vsi njegovi aktivni presnovki so v veliki meri vezani na beljakovine v plazmi (> 99 %).
In addition, increased fatty deposition and infiltration were observed. 
Poleg tega so opažali tudi povečano odlaganje in infiltracijo maščob.
Absorption is not influenced by food intake. 
Uživanje hrane ne vpliva na absorpcijo.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor. 
Redno morate kontrolirati telesno maso; če se vam poveča, obvestite zdravnika.
Talk to your doctor before you start to take this medicine: - if you retain water (fluid retention) or have heart failure problems and in particular if you are over 75 years old. 
Pred začetkom jemanja tega zdravila morate zdravniku povedati: - če vam zastaja voda (zastajanje tekočine) ali imate težave s srčnim popuščanjem, še zlasti, če ste starejši od 75 let.
If you experience any of these, especially if you are over the age of 65, seek medical advice straight away. 
Če se vam pojavi kateri od teh, morate takoj poiskati zdravniški nasvet, še zlasti, če ste starejši od 65 let.
These patients may be at risk of pregnancy. 
Pri takšnih bolnicah lahko obstaja tveganje, da zanosijo.
Pioglitazone tablets are taken orally once daily with or without food. 
Tablete pioglitazona je treba jemati peroralno enkrat na dan s hrano ali brez nje.
If ALT levels remain > 3 X the upper limit of normal, therapy should be discontinued. 
Če raven ALT ostaja > 3-kratno zgornjo normalno mejo, je treba zdravljenje prekiniti.
Your blood sugar could fall below the normal level and can be increased by taking sugar. 
Krvni sladkor vam lahko pade pod normalno raven; znova ga lahko zvišate tako, da zaužijete sladkor.
Talk to your doctor before stopping this treatment. 
Posvetujte se z zdravnikom, preden prenehate jemati to zdravilo.
You may also experience a reduction in blood count (anaemia). 
Pojavi se vam lahko tudi zmanjšanje števila rdečih krvnih celic (anemija).
Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years. 
Pioglitazon ali placebo so dodali že obstoječemu antidiabetičnemu in kardiovaskularnemu zdravljenju za obdobje do 3,5 leta.
• This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level. 
• Namen izobraževalnega gradiva je okrepiti ozaveščenost o pomembnih ugotovljenih tveganjih za raka sečnega mehurja in srčno popuščanje ter o splošnih priporočilih za izboljšanje meje koristi in tveganja na ravni bolnika.
Signs and symptoms include blood in your urine, pain when urinating or a sudden need to urinate. 
Med znaki in simptomi so kri v urinu, bolečine pri uriniranju ali nenadna potreba po uriniranju.
Approximately half of the study population had at least two of the cardiovascular history entry criteria. 
Približno polovica bolnikov v populaciji študije je ustrezala vsaj dvema meriloma kardiovaskularne anamneze za vključitev.
Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: 
Pioglitazon je indiciran kot drugi ali tretji izbor za zdravljenje sladkorne bolezni tipa 2, kot je opisano spodaj:
Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority. 
Imetnik dovoljenja za promet mora pred distribucijo vodnika za predpisovanje v vsaki posamezni državi članici s pristojnim nacionalnim organom uskladiti vsebino in obliko izobraževalnega gradiva, vključno s komunikacijskim načrtom.
Thus free (unbound) pioglitazone concentration is unchanged. 
Zato koncentracija prostega (nevezanega) pioglitazona ni spremenjena.
Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare 
Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment. 
Edemi so bili v splošnem blagi do zmerni in po navadi niso zahtevali prekinitve zdravljenja.
There are no adequate human data to determine the safety of pioglitazone during pregnancy. 
Pri človeku ni dovolj podatkov za ugotovitev varnosti uporabe pioglitazona med nosečnostjo.
This leaflet was last revised in {MM/YYYY}. 
Navodilo je bilo nazadnje revidirano
The European Medicines Agency has waived the obligation to submit the results of studies with pioglitazone in all subsets of the paediatric population in Type 2 Diabetes Mellitus. 
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij s pioglitazonom za vse skupine pediatrične populacije pri sladkorni bolezni tipa 2.
No information is available from dialysed patients, therefore pioglitazone should not be used in such patients. 
Informacij o dializiranih bolnikih ni, zato se pioglitazona pri takšnih bolnikih ne sme uporabljati.
• Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure). 
• Previdnosti pri uporabi pri starejših bolnikih v luči tveganj, povezanih s starostjo (zlasti raka sečnega mehurja, zlomov in srčnega popuščanja).
- if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye). 
- če imate posebno vrsto diabetične bolezni očesa, imenovano edem makule (oteklost na zadnji strani očesa).
• Patient selection criteria including that Pioglitazone should not be used as first line therapy and emphasising the need for regular review of treatment benefit. 
• Merilom za izbiro bolnikov; vključeno mora biti dejstvo, da se pioglitazona ne sme predpisovati kot zdravila prve izbire, in poudarjena mora biti potreba po rednem ocenjevanju koristi zdravljenja.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravilana na nacionalni center za poročanje, ki je naveden v Prilogi V.
This is similar to that seen in a sulphonylurea active comparator group. 
To je podobno kot v primerjalni skupini s sulfonilsečnino.
Pioglitazone is contraindicated in patients with: 
Pioglitazon je kontraindiciran pri bolnikih s:
The relevance of such a mechanism in humans is unclear and pioglitazone should not be used in pregnancy. 
Pomen takega mehanizma pri človeku ni jasen in pioglitazona se med nosečnostjo ne sme uporabljati.
After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). 
Po uvedbi zdravljenja s pioglitazonom je treba bolnike po 3 do 6 mesecih kontrolirati za oceno ustreznosti odziva na zdravljenje (npr. znižanje HbA1c).
These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure. 
Te izsledke so opažali v različnih živalskih vrstah pri plazemskih koncentracijah, ki so bile ≤ 4-krat večje od klinične izpostavljenosti.
Many of these patients reported concurrent peripheral oedema. 
Številni od teh bolnikov so navajali sočasne periferne edeme.
Symptomatic and general supportive measures should be taken in case of overdose. 
V primeru prevelikega odmerjanja je treba uporabiti splošne podporne ukrepe in simptomatsko zdravljenje.
Take Glidipion daily as prescribed. 
Zdravilo Glidipion vzemite vsak dan, kot je predpisano.
In animal fertility studies there was no effect on copulation, impregnation or fertility index. 
V študijah plodnosti na živalih ni bilo vpliva na parjenje, oploditev ali indeks plodnosti.
At the time of granting the marketing authorisation, the submission of periodic safety update reports is not required for this medicinal product. 
V času pridobitve dovoljenja za promet za to zdravilo ni potrebno oddati rednih poročil o varnosti.
The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use Pioglitazone. 
Imetnik dovoljenja za promet bo zagotovil izobraževalno gradivo, namenjeno vsem zdravnikom, ki bodo po pričakovanju predpisovali/uporabljali pioglitazon.
What Glidipion is and what it is used for 
Kaj je zdravilo glidipion in za kaj ga uporabljamo
In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily. 
V kliničnih študijah so bolniki prejemali pioglitazon odmerku, večjem od priporočenega največjega odmerka 45 mg na dan.
You should swallow the tablets with a glass of water. 
Zaužiti jih morate s kozarcem vode.
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 plazemski eliminacijski razpolovni čas nespremenjenega pioglitazona pri človeku je od 5 do 6 ur in njegovih skupnih aktivnih presnovkov od 16 do 23 ur.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu.O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
If you have the impression that the effect of Glidipion is too weak, talk to your doctor. 
Če menite, da je učinek zdravila Glidipion prešibak, se posvetujte z zdravnikom.
In an animal model of familial adenomatous polyposis (FAP), treatment with two other thiazolidinediones increased tumour multiplicity in the colon. 
V živalskem modelu familiarne adenomatozne polipoze (FAP) je zdravljenje z dvema drugima tiazolidindionoma povečalo število tumorjev v kolonu.
The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use. 
Opaženo čezmerno tveganje zlomov pri ženskah v tem naboru podatkov s pioglitazonom je tako 0,8 zloma na 100 bolnik-let uporabe.
Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%). 
Po peroralni uporabi radioaktivno označenega pioglitazona pri človeku se je označevalec izločil predvsem v blatu (55 %) in v manjši količini v urinu (45 %).
Kaplan-Meier analysis showed shorter time to treatment failure in patients treated with gliclazide, compared with pioglitazone. 
Kaplan-Meierjeva analiza je pokazala krajši čas do neuspeha zdravljenja pri bolnikih, zdravljenih z gliklazidom, v primerjavi s pioglitazonom.
No increase in mortality from heart failure was observed. 
Povečanja umrljivosti zaradi srčnega popuščanja niso opažali.
Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates). 
Skoraj vsi preiskovanci (95 %) so prejemale kardiovaskularna zdravila (blokatorje beta, zaviralce ACE, antagoniste angiotenzina II, zaviralce kalcijevih kanalčkov, nitrate, diuretike, acetilsalicilno kislino, statine, fibrate),
Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke. 
Skoraj polovica bolnikov je predhodno imela miokardni infarkt in približno 20 % možgansko kap.
Pioglitazone has been shown to be present in the milk of lactating rats. 
Dokazano je, da je pioglitazon prisoten v mleku doječih podgan.
HOMA analysis shows that pioglitazone improves beta cell function as well as increasing insulin sensitivity. 
Analiza HOMA kaže, da pioglitazon izboljša delovanje celic beta in poveča občutljivost za insulin.
Pioglitazone should not be used in patients with hepatic impairment (see section 4.3 and 4.4). 
Pioglitazona se ne sme uporabljati pri bolnikih s okvaro jeter (glejte poglavji 4.3 in 4.4).
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). 
Bolnice se morajo tega tveganja zavedati; če bolnica želi zanositi ali če zanosi oz. zanosi med zdravljenjem, je treba zdravljenje prekiniti (glejte poglavje 4.6).
If you stop using Glidipion, your blood sugar may go up. 
Če prenehate jemati zdravilo Glidipion, se vam lahko krvni sladkor zviša.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.Zdravnik vam bo svetoval, da prenehate uporabljati to zdravilo.
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 natančno kontrolirati.
When Glidipion is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines. 
Če uporabljate zdravilo Glidipion v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni (npr. z insulinom, klorpropamidom, glibenklamidom, gliklazidom, tolbutamidom), vam bo zdravnik povedal, ali morate uporabiti manjši odmerek zdravil.
Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected. 
Medsebojnih delovanj s snovmi, ki se presnavljajo s temi encimi, npr. s peroralnimi kontraceptivi, ciklosporinom, zaviralci kalcijevih kanalčkov in zaviralci reduktaze HMGCoA, ni pričakovati.
The rate of deterioration of HbA1c during the second year was less with pioglitazone than with gliclazide. 
Delež poslabšanja HbA1c v drugem letu je bil s pioglitazonom manjši kot z gliklazidom.
Glidipion should be used every day to work properly. 
Zdravilo Glidipion morate vzeti vsak dan, da bo delovalo pravilno.
If patients report hypoglycaemia, the dose of insulin should be decreased. 
Če bolnik navaja hipoglikemije, je treba odmerek insulina zmanjšati.
Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin. 
Študije medsebojnega delovanja so pokazale, da pioglitazon ne vpliva pomembno na farmakokinetiko ali farmakodinamiko digoksina, varfarina, fenprokumona in metformina.
Total plasma concentration of pioglitazone is unchanged, but with an increased volume of distribution. 
Celotna koncentracija pioglitazona v plazmi ni spremenjena, volumen porazdelitve pa je večji.
• The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide. 
• Izobraževalno gradivo za zdravnike mora obsegati povzetek glavnih značilnosti zdravila, navodilo za uporabo in vodnik za predpisovanje.
The relevance to humans of the tumourigenic findings in the male rat cannot be excluded. 
Pomena teh izsledkov o tumorigenosti pri podganjih samcih za človeka ni mogoče izključiti.
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. 
V luči s starostjo povezanih tveganj (zlasti raka sečnega mehurja, zlomov in srčnega popuščanja) je treba pri starejših ravnovesje koristi in tveganj natančno pretehtati tako pred zdravljenjem kot med zdravljenjem.
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. 
V primeru zdravljenja bolnikov, ki imajo vsaj en dejavnik tveganja za kongestivno srčno popuščanje (npr. predhoden miokardni infarkt ali simptomatsko bolezen koronarnih arterij, ali so starejši), je treba zdravljenje začeti z najmanjšim možnim odmerkom in ga postopoma povečevati.
As a consequence of increased insulin sensitivity, patients receiving pioglitazone in dual or triple oral therapy with a sulphonylurea or in dual therapy with insulin may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea or insulin may be necessary. 
Zaradi večje občutljivosti za insulin lahko bolnike, ki dobivajo pioglitazon v dvo- ali tritirnem peroralnem zdravljenju s sulfonilsečnino ali v dvotirnem zdravljenju z insulinom, bolj ogroža od odmerka odvisna hipoglikemija; potrebno utegne biti zmanjšanje odmerka sulfonilsečnine ali insulina.
Glycaemic control should be monitored closely. 
Natančno je treba kontrolirati urejenost glikemije.
Combination use with insulin should be considered with caution in the elderly because of increased risk of serious heart failure. 
Pri starejših se je treba za kombinirano uporabo z insulinom odločati previdno zaradi večjega tveganja resnega srčnega popuščanja.
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. 
Kaže, da pioglitazon deluje z aktivacijo specifičnih jedrnih receptorjev (peroksisomski proliferacijski aktivirani receptor gama); to pri živalih poveča občutljivost jeter, maščevja in skeletnih mišičnih celic za insulin.
Tablets should be swallowed with a glass of water. 
Bolnik jih mora zaužiti s kozarcem vode.
These effects were independent of pioglitazone's effects on glycaemia and were statistically significant different to glibenclamide. 
Ti učinki niso bili odvisni od učinkov pioglitazona na glikemijo in so se statistično značilno razlikovali od glibenklamida.
Your blood sugar will be checked, and your dose of Glidipion may need to be changed. 
Kontroliral vam bo krvni sladkor in morda bo treba prilagoditi odmerek zdravila Glidipion.
It is unclear whether or not there is a direct association between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity; an appropriate ophthalmological referral should be considered. 
Ni jasno, ali sta pioglitazonom in makularni edem neposredno povezana, vendar morajo biti zdravniki pozorni na možnost makularnega edema, če bolnik navaja motnje ostrine vida; v poštev pride napotitev bolnika k oftalmologu.
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 primarnega cilja (sestavljen dogodek umrljivosti zaradi vseh vzrokov, miokardnega infarkta brez smrtnega izida, možganske kapi, akutnega koronarnega sindroma, velike amputacije na nogah, koronarne revaskularizacije in revaskularizacije na nogah) rezultati kažejo, da glede uporabe pioglitazona ni dolgoročnih kardiovaskularnih pomislekov.
If you take Glidipion with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia). 
Če jemljete zdravilo Glidipion skupaj z drugimi zdravili za sladkorno bolezen, obstaja večja možnost za znižanje krvnega sladkorja pod normalno raven (hipoglikemija).
Do not use Glidipion after the expiry date which is stated on the carton and the blister pack after the word “EXP”. 
Zdravila Glidipion ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake "EXP".
Physicians should start treatment with the lowest available dose and increase the dose gradually, particularly when pioglitazone is used in combination with insulin (see section 4.4 Fluid retention and cardiac failure). 
Zdravljenje je treba začeti z najmanjšim dostopnim odmerkom in odmerek povečevati postopoma, zlasti če je pioglitazon uporabljen v kombinaciji z insulinom (glejte poglavje 4.4, Zastajanje tekočine in srčno popuščanje).
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. 
Zdravljenja s pioglitazonom se ne sme uvesti pri bolnikih z izhodiščno zvišanimi jetrnimi encimi (ALT > 2,5-kratna zgornja normalna meja) ali kakšnimi drugimi znaki bolezni jeter.
Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure. 
Pioglitazon lahko povzroči zastajanje tekočine; to lahko poslabša ali izzove srčno popuščanje.
Within each frequency grouping, adverse reactions are presented in order of decreasing incidence and seriousness. 
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči incidenci in resnosti.
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 bila urejenost glikemije (opredeljena kot HbA1c < 8,0 %) ohranjena pri 69 % bolnikov, zdravljenih s pioglitazonom, in pri 50 % bolnikov, zdravljenih z gliklazidom.
not known not known not known not known not known 
Preobčutljivost in alergijske reakcije ni znano ni znano ni znano ni znano ni znano