natgillin/translations-raw huggingface dataset:
• 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
For the 14, 28, 56, 84 and 98 tablets pack sizes, you can check the day on which you last took a tablet of Glidipion by referring to the calendar printed on the blister.
Pri pakiranih s 14, 28, 56, 84 in 98 tabletami lahko dan, ko ste vzeli zadnjo tableto zdravila Glidipion, preverite na koledarčku, ki je natisnjen na pretisnem omotu.
5 Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials.
O edemih so poročali pri 6 do 9 % bolnikov, ki so v kontroliranih kliničnih preskušanjih prejemali pioglitazon več kot eno leto.
Although in very rare cases fatal outcome has been reported, causal relationship has not been established.
V zelo redkih primerih so bolniki umrli, vendar vzročna povezanost ni ugotovljena.
If ALT levels are increased to 3 X upper limit of normal during pioglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Če se raven ALT med zdravljenjem s pioglitazonom zviša na 3-kratno zgornjo normalno mejo, je treba čim prej znova določiti raven jetrnih encimov.
This medicine does not require any special storage precautions.
Za shranjevanje zdravila niso potrebni posebni previdnostni ukrepi.
- if you have heart failure or have had heart failure in the past.
- če imate ali ste kdaj v preteklosti imeli srčno popuščanje.
In patients who fail to show an adequate response, pioglitazone should be discontinued.
Pri bolnikih, pri katerih ni ustreznega odziva, je treba zdravljenje s pioglitazonom končati.
The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Delež edemov v skupinah s primerjalnim zdravilom (sulfonilsečnina, metformin) je bil od 2 do 5 %.
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.
Po izključitvi bolnikov, pri katerih je izpostavljenost raziskovanemu zdravilu ob postavitvi diagnoze raka sečnega mehurja trajala manj kot eno leto, je bilo med prejemniki pioglitazona 7 primerov (0,06 %) in v kontrolnih skupinah 2 primera (0,02 %).
This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser degree.
To poteka predvsem preko citokroma P450 2C8, v manjši meri pa so lahko vpletene še druge izooblike.
No dose adjustment is necessary for elderly patients (see section 5.2).
Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
In a placebo controlled trial, patients with inadequate glycaemic control despite a three month insulin optimisation period were randomised to pioglitazone or placebo for 12 months.
V preskušanju, kontroliranem s placebom, so bolnike z nezadostno urejenostjo glikemije kljub trimesečni optimizaciji insulina randomizirali na pioglitazon ali placebo za 12 mesecev.
It is an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus, when metformin is not suitable or has failed to work adequately.
Je zdravilo za zdravljenje sladkorne bolezni tipa 2 (ki ni odvisna od insulina), ko metformin ni primeren ali ne deluje na ustrezen način.
Similar changes in body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity.
Podobne spremembe v porazdelitvi telesnega maščevja med zdravljenjem s pioglitazonom je spremljalo izboljšanje občutljivosti za insulin.
As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation.
Zaradi povečanega delovanja insulina lahko zdravljenje s pioglitazonom pri bolnicah s sindromom policističnih jajčnikov povzroči obnovitev ovulacije.
Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin
Kombinacija z metformino m s sulfonilsečnino z metformino m in sulfonilsečnino z insulinom
Monitoring of liver function
Nadzor delovanja jeter
In animals, only a small amount of unchanged pioglitazone can be detected in either urine or faeces.
Pri živalih se v urini ali blatu pojavi le malo nespremenjenega pioglitazona.
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 študija mehanizma pri podganjih samcih je pokazala, da uporaba pioglitazona poveča incidenco hiperplastičnih sprememb v sečnem mehurju.