FrancophonIA/ELRC3.0 huggingface dataset:
English: The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use.
Slovenian: Opazovano povečano tveganje za zlom pri ženskah v tej skupini podatkov na pioglitazonu je torej 0,8 zlomov na 100 bolnikov-let uporabe.
English: Avoid excessive alcohol intake while taking Glubrava since this may increase the risk of lactic acidosis (see section “Risk of lactic acidosis”).
Slovenian: Med jemanjem zdravila Glubrava ne uživajte čezmernih količin alkohola, saj lahko to poveča tveganje za laktacidozo (glejte poglavje "Tveganje za laktacidozo").
English: 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.
Slovenian: V kliničnih preskušanjih s pioglitazonom so opažali z odmerkom povezano pridobivanje telesne mase, ki je lahko posledica nabiranja maščob in v nekaterih primerih povezano z zadrževanjem tekočine.
English: This can lead to a risk of hyperglycaemia (high blood sugar level): - rifampicin (to treat tuberculosis and other infections) - glucocorticoids (to treat allergies and inflammation) - beta-2-agonists (to treat asthma) - medicines which increase urine production (diuretics, to treat high blood pressure)
Slovenian: To lahko povzroči tveganje za hiperglikemijo (visoka raven sladkorja v krvi): - rifampicin (za zdravljenje tuberkuloze in drugih okužb) - glukokortikoidi (za zdravljenje alergij in vnetja) - beta-2-agonisti (za zdravljenje astme) - zdravila, ki povečajo nastajanje urina (diuretiki, za zdravljenje previsokega krvnega tlaka)
English: Bioequivalence studies in healthy volunteers have shown Glubrava to be bioequivalent to the administration of pioglitazone and metformin given as separate tablets.
Slovenian: Biokvivalenčne študije pri zdravih prostovoljcih so pokazale, da je zdravilo Glubrava bioekvivalentno sočasnemu jemanju pioglitazona in metformina kot dveh posameznih tablet.
English: Uncommon inflammation of the sinuses (sinusitis) gas difficulty sleeping (insomnia)
Slovenian: Občasni - vnetje sinusov (sinuzitis) - vetrovi - težave s spanjem (nespečnost)
English: In case of dehydration (severe diarrhoea or vomiting, fever, heat, reduced fluid intake), Glubrava should be temporarily discontinued and contact with a health care professional is recommended.
Slovenian: V primeru dehidracije (huda driska ali bruhanje, zvišana telesna temperatura ali zmanjšan vnos tekočine) je treba jemanje Glubrava začasno prekiniti; priporoča se posvet z zdravstvenim delavcem.
English: Risk of lactic acidosis
Slovenian: Tveganje za laktacidozo
English: Given the accumulation of data since the implementation of the additional risk minimisation measures, the PRAC agreed with the MAH's proposal to remove the additional risk minimisation measures.
Slovenian: Glede na podatke, zbrane od izvedbe dodatnih ukrepov za zmanjševanje tveganj, se Odbor za oceno tveganja na področju farmakovigilance (PRAC) strinja s predlogom imetnika dovoljenja za promet z zdravilom, da se dodatni ukrepi za zmanjševanje tveganj odpravijo.
English: If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked.
Slovenian: Če bolnik razvije simptome, ki kažejo na moteno delovanje jeter, kar lahko vključuje nepojasnjeno slabost, bruhanje, bolečine v trebuhu, utrujenost, anoreksijo in/ali temen urin, je treba kontrolirati jetrne encime.
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Slovenian: Raziskava pri sedmih zdravih prostovoljcih je pokazala, da je cimetidin, ki ga je bolnik prejemal v odmerku 400 mg dvakrat na dan, povečal sistemsko izpostavljenost metforminu (AUC) za 50% in
English: Reproductive system and breast disorders erectile dysfunction common
Slovenian: Motnje reprodukcije in dojk erektilna disfunkcija pogosti
English: Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin.
Slovenian: Študije medsebojnega delovanja so pokazale, da pioglitazon nima pomembnega učinka na farmakokinetiko ali farmakodinamiko digoksina, varfarina, fenprokumona in metformina.
English: In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg.
Slovenian: V preskušanjih kombiniranega zdravljenja je pioglitazon, dodan metforminu, povzročil povprečno povečanje telesne mase v enem letu za 1,5 kg.
English: a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034 a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017 a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 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)
Slovenian: - značilno zmanjšanje absolutnega tveganja za katerikoli s sladkorno boleznijo povezan zaplet v skupini bolnikov, ki so se zdravili z metforminom (29,8 primerov/1.000 bolnikov-let), v primerjavi s skupino bolnikov, ki je imela predpisano zgolj dieto (43,3 primerov/1.000 bolnikov-let), p = 0,0023 ter v primerjavi s skupino, ki se je kombinirano zdravila s sulfonilsečnino, in skupino, ki je imela monoterapijo z insulinom (40,1 primerov/1.000 bolnikov-let), p = 0,0034; - značilno zmanjšanje absolutnega tveganja za umrljivost, povezano s sladkorno boleznijo: metformin - 7,5 primerov/1.000 bolnikov-let, samo dieta - 12,7 primerov/1.000 bolnikov-let, p = 0,017; - značilno zmanjšanje absolutnega tveganja za skupno umrljivost: metformin13,5 primerov/1000 bolnikov-let, samo dieta - 20,6 primerov/1.000 bolnikov-let (p = 0,011), v primerjavi s skupinama s kombiniranim zdravljenjem s sulfonilsečnino in monoterapijo z insulinom - 18,9 primerov/1.000 bolnikov-let (p = 0,021); - značilno zmanjšanje absolutnega tveganja za miokardni infarkt: metformin11 primerov/1.000 bolnikov-let, dieta sama - 18 primerov/1.000 bolnikov-let (p = 0,01).
English: Consideration of such aetiology is recommended if a patient presents with megaloplastic anaemia.
Slovenian: Upoštevanje tega se priporoča pri bolnikih z megaloblastno anemijo.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Glubrava in all subsets of the paediatric population in type 2 diabetes mellitus.
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Glubrava za vse skupine pediatrične populacije s sladkorno boleznijo tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The fixed dose combination tablet of pioglitazone 15 mg/metformin 850 mg BID (N=201), pioglitazone 15 mg BID (N=189), and metformin 850 mg BID (N=210) were evaluated in type 2 diabetes mellitus patients with mean baseline HbA1c of 9.5% in a randomised double-blind, parallel-group study.
Slovenian: Fiksni odmerki kombinacije tablet pioglitazona 15 mg/metformina 850 mg dvakrat na dan (N = 201), pioglitazona 15 mg dvakrat na dan (N = 189) in metformina 850 mg dvakrat na dan (N = 210) so bili ocenjeni pri bolnikih s sladkorno boleznijo tipa 2 s povprečno izhodiščno HbA1c vrednostjo 9,5% v randomizirani, dvojno slepi študiji s paralelnimi skupinami.
English: 5 Isolated reports: liver function tests abnormalities or hepatitis resolving upon metformin discontinuation.
Slovenian: 5 Posamezni primeri: nenormalni testi delovanja jeter ali hepatitis, stanje se normalizira po ukinitvi zdravljenja z metforminom
English: The tablets are white to off-white, oblong, film-coated, embossed ‘15 / 850' on one face and ‘4833M' on the other.
Slovenian: Tablete so bele ali skoraj bele barve, podolgovate, filmsko obložene, z oznako ‘15 / 850' na eni in ‘4833M' na drugi strani.
English: Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
Slovenian: 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, so bolnikom znižali odmerek insulina.
English: Skin and subcutaneous tissue disorders erythema very rare very rare pruritis very rare very rare urticaria very rare very rare
Slovenian: Bolezni kože in podkožja eritem zelo redki zelo redki pruritis zelo redki zelo redki urtikarija zelo redki zelo redki
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/mL, even at maximum doses.
Slovenian: V kontroliranih kliničnih preskušanjih, celo pri največjih dovoljenih odmerkih, maksimalna koncentracija metformina v plazmi (Cmax) ni presegla 4 µg/ml.
English: Glubrava may cause a very rare (may affect up to 1 in 10,000), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Slovenian: Zdravilo Glubrava lahko povzroči zelo redek (pojavi se lahko pri do 1 od 10.000 bolnikov), a zelo resen neželeni učinek, imenovan laktacidoza (glejte poglavje "Opozorila in previdnostni ukrepi").
English: Glubrava should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
Slovenian: Zdravila Glubrava pri bolnikih z okvarjenim delovanjem jeter ne smemo uporabljati (glejte poglavji 4.3 in 4.4).
English: The other ingredients are microcrystalline cellulose, povidone (K30), croscarmellose sodium magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide (E171).
Slovenian: - Druge sestavine zdravila so mikrokristalna celuloza, povidon (K 30), premreženi natrijev karmelozat, magnezijev stearat, hipromeloza, makrogol 8000, smukec in titanov dioksid (E171).
English: This was attributable to the action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy thereby reducing the availability of metabolic substrates for foetal growth.
Slovenian: To so pripisovali delovanju pioglitazona pri zniževanju materine hiperinsulinemije in povečani rezistenci na insulin, ki se pojavi v nosečnosti, in posledičnemu zmanjšanju razpoložljivosti presnovnih substratov za rast plodu.
English: 1 Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
Slovenian: 1 V poročilih po pridobitvi dovoljenja za promet so poročali o preobčutljivostnih reakcijah pri bolnikih zdravljenih s pioglitazonom.
English: Blood and lymphatic system disorders anaemia common
Slovenian: Bolezni krvi in limfatičnega sistema anemija pogosti
English: 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).
Slovenian: 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).
English: Eye disorders visual disturbance3
Slovenian: Očesne bolezni motnje vida3
English: Since insulin and pioglitazone are both associated with fluid retention, concomitant administration of insulin and Glubrava may increase the risk of oedema.
Slovenian: Ker sta tako insulin kot pioglitazon povezana z zastajanjem tekočine, lahko sočasno jemanje insulina in zdravila Glubrava poveča tveganje za edeme.
English: Concomitant use not recommended Alcohol
Slovenian: Sočasna uporaba ni priporočljiva
English: Other:
Slovenian: Drugo:
English: Very rare - decrease in amount of vitamin B12 in the blood - redness of the skin - itchy skin - raised and itchy rash (hives)
Slovenian: Zelo redki - znižanje vrednosti vitamina B12 v krvi - rdečica kože - srbeča koža - otekel in srbeč izpuščaj (koprivnica)
English: De uts chland Takeda GmbH Tel: 0800 825 3325 medinfo@takeda.de
Slovenian: Deutschland Takeda GmbH Tel: 0800 825 3325 medinfo@takeda.de
English: The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
Slovenian: Tveganje za razvoj laktacidoze je večje tudi ob sočasni nenadzorovani sladkorni bolezni, resnih okužbah, dolgotrajnem postenju ali čezmernem uživanju alkohola, dehidraciji (glejte dodatne informacije spodaj), težavah z jetri ali katerih koli bolezenskih stanjih, pri katerih je oskrba dela telesa s kisikom zmanjšana (na primer akutna huda bolezen srca).
English: Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma.
Slovenian: Za laktacidozo so značilni acidozna dispneja, bolečina v trebuhu, mišični krči, astenija in hipotermija, ki ji sledi koma.
English: Metabolism and nutrition disorders Vitamin B12 absorption decreased2
Slovenian: Presnovne in prehranske motnje zmanjšana absorpcija vitamina B122
English: In vitro studies have shown no inhibition of any subtype of cytochrome P450.
Slovenian: Študije in vitro niso pokazale inhibicije nobenega podtipa citokroma P450.
English: In PROactive, a cardiovascular outcome study, 5,238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
Slovenian: V PROaktivni kardiovaskularni študiji izida je bilo 5.238 bolnikov s sladkorno boleznijo tipa 2 in že prej obstoječimi težjimi makrovaskularnimi boleznimi naključno dodatno zdravljenih s pioglitazonom ali placebom k že obstoječemu antidiabetičnemu in kardiovaskularnemu zdravljenju, v trajanju do 3,5 let.
English: Musculoskeletal and connective tissue disorders bone fracture6
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva zlomi kosti6
English: Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups.
Slovenian: Pioglitazon je podvržen obsežni jetrni presnovi s hidroksilacijo alifatskih metilenskih skupin.
English: Angiotensin-converting enzyme (ACE) inhibitors may decrease the blood glucose levels.
Slovenian: Zaviralci angiotenzinske konvertaze (zaviralci ACE) lahko zmanjšajo koncentracijo glukoze v krvi.
English: Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Slovenian: Pretehtati je treba prilagoditev odmerka pioglitazona v okviru priporočenega odmerjanja ali spremeniti zdravljenje sladkorne bolezni (glejte poglavje 4.5).
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Glubrava.
Slovenian: Sledeče ugotovitve odražajo farmakokinetične lastnosti individualnih zdravilnih učinkovin v zdravilu Glubrava.
English: There is no induction of the main inducible P450 isoenzymes 1A, 2C8/9, and 3A4 in man.
Slovenian: Indukcije poglavitnih inducibilnih P450 izoencimov 1A, 2C8/9 in 3A4 pri človeku ni.
English: Pioglitazone did not cause statistically significant increases in LDL-cholesterol levels compared with placebo, whilst reductions where observed with metformin and gliclazide.
Slovenian: Pioglitazon ni povzročil statistično pomembnih povišanj ravni LDL holesterola v primerjavi s placebom, pri metforminu in gliklazidu pa so opazili znižanja teh vrednosti.
English: Ne de rland Takeda Nederland bv Tel: +31 23 56 68 777
Slovenian: Nederland Takeda Nederland bv Tel: +31 23 56 68 777
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Glubrava before or at the time of the injection.
Slovenian: Če vam bodo v krvni obtok injicirali kontrastno sredstvo, ki vsebuje jod, na primer zaradi rentgenskega ali drugega slikanja, morate pred časom injiciranja ali v tem času prenehati z jemanjem zdravila Glubrava.
English: Take Glubrava daily as prescribed.
Slovenian: Zdravilo Glubrava jemljite vsak dan, kakor vam je predpisano.
English: Visceral fat was significantly decreased, while there was an increase in extra-abdominal fat mass.
Slovenian: Količina visceralnega maščevja se je občutno zmanjšala, medtem ko se je masa ekstraabdominalnega maščevja zvečala.
English: Clinical trials have been conducted with Glubrava tablets and co-administered pioglitazone and metformin (see section 5.1).
Slovenian: Izvedli so klinična preskušanja s tabletami zdravila Glubrava in sočasnim dajanjem pioglitazona in metformina (glejte poglavje 5.1).
English: if you have uncontrolled diabetes with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see section “Risk of lactic acidosis”) or ketoacidosis.
Slovenian: - če imate nenadzorovano sladkorno bolezen, na primer s hudo hiperglikemijo (visoko ravnjo sladkorja v krvi), siljenjem na bruhanje, bruhanjem, drisko, hitro izgubo telesne mase, laktacidozo (glejte poglavje "Tveganje za laktacidozo") ali ketoacidozo.
English: If you are following a special diet for diabetes, you should continue with this while you are taking Glubrava.
Slovenian: Če ste na posebni dieti za sladkorno bolezen, morate z dieto med jemanjem zdravila Glubrava nadaljevati.
English: 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.
Slovenian: 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 enem letu v obeh skupinah podoben.
English: Your doctor will decide when you must stop and when to restart your treatment with Glubrava.
Slovenian: Zdravnik se bo odločil, kdaj morate z jemanjem zdravila Glubrava prenehati in kdaj lahko nadaljujete.
English: 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 (< 1/10,000); not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki, o katerih so poročali v dvojno slepih študijah in postmarketinških izkušnjah, so našteti spodaj, in sicer po razredih organskih sistemov in absolutni pogostnosti, kot je priporočeno po MedDRA. Pogostnosti so določene kot: 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); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Post-marketing, bone fractures have been reported in both male and female patients (see section 4.4).
Slovenian: V obdobju trženja zdravila so poročali o zlomih kosti tako pri bolnikih kot bolnicah (glejte poglavje 4.4).
English: Metformin is excreted unchanged in the urine.
Slovenian: Biotransformacija Metformin se izloča z urinom v nespremenjeni obliki.
English: 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.
Slovenian: Pri bolnikih z ledvično okvaro so plazemske koncentracije pioglitazona in njegovih presnovkov nižje kot pri osebah z normalnim delovanjem ledvic, vendar je peroralni očistek izvorne učinkovine podoben.
English: In animal fertility studies with pioglitazone, there was no effect on copulation, impregnation or fertility index.
Slovenian: V študijah plodnosti pri živalih s pioglitazonom ni bilo vpliva na parjenje, oploditev ali rodnost.
English: Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus.
Slovenian: Nadzor glikemije med stradanjem in po obrokih se izboljša pri bolnikih s sladkorno boleznijo tipa 2.
English: Unite d Kingdom Takeda UK Ltd Tel: +44 (0)1628 537 900
Slovenian: United Kingdom Takeda UK Ltd Tel: +44 (0)1628 537 900
English: Inform your doctor as soon as possible if you develop symptoms suggesting a problem with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite and/or dark urine) as your liver function should be checked.
Slovenian: Obvestite svojega zdravnika kakor hitro je mogoče, če se pojavijo simptomi, ki kažejo na težave z jetri (kot je občutek slabosti brez razloga, bruhanje, bolečine v trebuhu, utrujenost, izguba apetita in/ali temen urin), ker je potrebno preveriti delovanje jeter.
English: Single dose studies demonstrate linearity of pharmacokinetics in the therapeutic dose range.
Slovenian: Linearnost/Nelinearnost Študije z enim odmerkom kažejo na linearnost farmakokinetike v razponu terapevtskega odmerka.
English: Symptoms of lactic acidosis include: vomiting stomach ache (abdominal pain) muscle cramps a general feeling of not being well with severe tiredness difficulty in breathing reduced body temperature and heartbeat
Slovenian: Simptomi laktacidoze vključujejo: - bruhanje - bolečina v trebuhu (abdominalna bolečina) - mišične krče - splošno slabo počutje s hudo utrujenostjo - težave z dihanjem - znižano telesno temperaturo in počasen srčni utrip
English: 8 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year.
Slovenian: 8 V kontroliranih preskušanjih z aktivno primerjavo je bilo povprečno povečanje telesne mase pri pioglitazonu, danemu kot monoterapija, 2-3 kg v enem letu.
English: The formation and presence of urinary calculi with subsequent irritation and hyperplasia was postulated as the mechanistic basis for the observed tumourigenic response in the male rat.
Slovenian: Domnevali so, da je nastajanje in prisotnost kamnov v sečilih s poznejšim draženjem in hiperplazijo predstavljalo mehansko osnovo opaženega tumorogenega odgovora pri samcih podgan.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon uncommon
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) rak sečnega mehurja občasni občasni
English: Mean levels of liver enzymes decreased with treatment with pioglitazone.
Slovenian: Povprečne koncentracije jetrnih encimov so se z zdravljenjem s pioglitazonom nižale.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za glimepirid/pioglitazon hidroklorid, metformin/pioglitazon, pioglitazon je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: When clinically appropriate, direct change from metformin monotherapy to Glubrava may be considered.
Slovenian: Če je klinično sprejemljivo, se sme razmisliti o neposredni zamenjavi iz monoterapije z metforminom na zdravljenje z zdravilom Glubrava.
English: The observed excess risk of fractures for women on pioglitazone in this study is therefore 0.5 fractures per 100 patient years of use.
Slovenian: Presežek tveganja za zlome pri ženskah, zdravljenih s pioglitazonom, opažen v tej študiji, je torej 0,5 zlomov na 100 bolnikov-let uporabe.