FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 July 2000
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 11. julij 2000
English: Although hormonal imbalance has been seen in preclinical studies (see section 5.3), no significant undesirable effects associated with menstrual disorders have been observed.
Slovenian: Čeprav so v predkliničnih študijah opazili hormonsko neravnovesje (glejte poglavje 5.3), pa tu niso opazili nobenih značilnih neželenih učinkov v zvezi z menstrualnimi motnjami.
English: Î Tell your doctor as soon as possible if you get any of these symptoms - either for the first time or if they get worse.
Slovenian: Î Čimprej obvestite svojega zdravnika, če se pojavi katerikoli od teh simptomov - bodisi prvič ali pa če se simptom poslabša.
English: Rosiglitazone has been detected in the milk of experimental animals.
Slovenian: Rosiglitazon so zasledili v mleku poskusnih živali.
English: The protein binding of the major metabolite (para-hydroxy-sulphate) is very high (>99.99%).
Slovenian: Stopnja vezave glavnega presnovka (parahidroksisulfata) na proteine je zelo visoka (> 99,99 %).
English: Avandia can be used alone or in combination with other medicines to treat diabetes (such as metformin or a sulphonylurea).
Slovenian: Zdravilo Avandia se lahko uporablja samo ali skupaj z drugimi zdravili za zdravljenje sladkorne bolezni (npr. metformin ali sulfonilsečnina).
English: Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.
Slovenian: V kategorijah pogostnosti niso upoštevani drugi dejavniki, vključno z različnim trajanjem študij, prejšnjimi stanji bolnikov in njihovimi značilnostmi ob izhodišču.
English: • swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
Slovenian: • oteklino, včasih obraza ali ust (angioedem), kar povzroča težave pri dihanju
English: No long-term efficacy and safety data are available in paediatric patients.
Slovenian: Dolgoročni podatki o učinkovitosti in varnosti pri otrocih nisi na voljo.
English: However, this raises no safety concern regarding target or special populations as hepatic impairment is contraindicated and the phase III clinical studies included a considerable number of elderly patients and patients with mild to moderate renal impairment.
Slovenian: Vendar to ne vzbuja nikakršnih skrbi za varnost ciljnih ali posebnih skupin bolnikov, saj so jetrna obolenja kontraindicirana, klinične študije III. faze pa so vključevale znatno število starostnikov in bolnikov z blagimi do zmernimi motnjami v delovanju ledvic.
English: Î Check with your doctor, as Avandia may not be suitable for you.
Slovenian: Î Posvetujte se s svojim zdravnikom, saj zdravilo Avandia v tem primeru za vas morda ni primerno.
English: Individual CL/F in the paediatric population was in the same range as individual adult data.
Slovenian: Podatki o CL/F pri posameznem otroku so bili v enakem razponu kot podatki pri posameznem odraslem bolniku.
English: Use of rosiglitazone is contraindicated in patients with:
Slovenian: Uporaba rosiglitazona je kontraindicirana pri bolnikih:
English: WHAT AVANDIA IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO AVANDIA IN ZA KAJ GA UPORABLJAMO
English: Rosiglitazone should not be used during pregnancy.
Slovenian: Rosiglitazona med nosečnostjo ne smemo uporabljati.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Slovenian: V skladu s smernicami Odbora za zdravila za uporabo v humani medicini za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen načrt za obvladovanje tveganja predložen hkrati z naslednjim posodobljenim poročilom o varnosti zdravila (PSUR).
English: If you are pregnant or could be pregnant, tell your doctor.
Slovenian: Če ste noseči ali bi lahko bili noseči, o tem obvestite svojega zdravnika še preden začnete jemati zdravilo
English: Improvement in HbA1c from baseline achieved statistical significance only in the metformin group.
Slovenian: V primerjavi z izhodiščem je izboljšanje HbA1c doseglo statistični pomen le v skupini, ki je prejemala metformin.
English: Plasma protein binding of rosiglitazone is high (approximately 99.8%) and is not influenced by concentration or age.
Slovenian: Stopnja vezave rosiglitazona na plazemske proteine je zelo visoka (približno 99,8 %) in nanjo ne vplivata koncentracija zdravila ali bolnikova starost.
English: Like all medicines, Avandia can cause side effects, but not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Avandia neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Children and adolescents: Population pharmacokinetic analysis including 96 paediatric patients aged 10 to 18 years and weighing 35 to 178 kg suggested similar mean CL/F in children and adults.
Slovenian: Otroci in mladostniki: Populacijska farmakokinetična analiza za 96 otrok, starih od 10 do 18 let in s telesno maso od 35 do 178 kg kaže, da je srednji CL/F pri otrocih in odraslih podoben.
English: The usual starting dose is 4 mg a day.
Slovenian: Običajni začetni odmerek je 4 mg na dan.
English: This can be taken as one 4 mg tablet once a day, or as one 2 mg tablet taken twice a day.
Slovenian: Takšen odmerek lahko vzamete v obliki ene 4 mg tablete enkrat na dan ali dveh 2 mg tablet dvakrat na dan.
English: Avandia tablets contain a small amount of lactose.
Slovenian: Avandia tablete vsebujejo majhno količino laktoze.
English: Avandia helps to reduce your blood sugar towards a normal level, by helping your body make better use of the insulin it produces.
Slovenian: Avandia pomaga zmanjšati vrednost krvnega sladkorja na normalno vrednost tako, da omogoča boljšo izrabo v telesu nastalega insulina.
English: Mean doses at the end of randomised treatment are shown in the following table:
Slovenian: Povprečne odmerke na koncu randomiziranega zdravljenja prikazuje naslednja preglednica:
English: • if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting)
Slovenian: • če ste imeli diabetično ketoacidozo (zaplet sladkorne bolezni s hitrim hujšanjem, siljenjem na bruhanje ali bruhanjem).
English: In studies with a maximal duration of three years, rosiglitazone given once or twice daily produced a sustained improvement in glycaemic control (FPG and HbA1c).
Slovenian: V študijah, ki niso trajale več kot tri leta, je rosiglitazon, kadar so ga dajali enkrat ali dvakrat dnevno, povzročil dolgotrajno izboljšanje glikemičnega nadzora (FPG in HbA1c).
English: If you take more Avandia than you should If you accidentally take too many tablets, contact your doctor or pharmacist for advice.
Slovenian: Če ste vzeli večji odmerek zdravila Avandia, kot bi smeli Če po nesreči vzamete preveč tablet, se posvetujte s svojim zdravnikom ali farmacevtom.
English: There are no adequate data from the use of rosiglitazone in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi rosiglitazona pri nosečnicah.
English: The possible contribution of fluid retention to weight gain should be individually assessed as rapid and excessive weight gain has been reported very rarely as a sign of fluid retention.
Slovenian: Individualno je potrebno oceniti morebitni doprinos zastajanja tekočine k povečanju telesne mase, saj so o hitrem in pretiranem povečanju telesne mase kot znaku zastajanja tekočine poročali zelo redko.
English: An outcome study has not been completed with rosiglitazone, therefore the long-term benefits associated with improved glycaemic control have not been demonstrated.
Slovenian: Raziskave izidov zdravljenja z rosiglitazonom še niso bile narejene, zato dolgoročna korist zaradi izboljšanega glikemičnega nadzora še ni dokazana.
English: • if you are allergic (hypersensitive) to rosiglitazone or any of the other ingredients of
Slovenian: • če ste alergični na (preobčutljivi za) rosiglitazon ali katerokoli drugo sestavino zdravila
English: Do not use Avandia after the expiry date shown on the pack.
Slovenian: Zdravila Avandia ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Total plasma clearance of rosiglitazone is around 3 l/h and the terminal elimination half-life of rosiglitazone is approximately 3 to 4 hours.
Slovenian: Celokupen očistek rosiglitazona iz plazme znaša okoli 3 l/h, končna razpolovna doba izločanja rosiglitazona pa približno 3 do 4 ure.
English: The incidence of all adverse events relating to liver and biliary systems was < 1.5% in any treatment group and similar to placebo.
Slovenian: Pogostnost vseh neželenih učinkov, povezanih z jetri in žolčnim sistemom je bila < 1,5 % v katerikoli skupini zdravljenja in podobna pogostnosti pri placebu.
English: Rosiglitazone is a selective agonist at the PPARγ (peroxisomal proliferator activated receptor gamma) nuclear receptor and is a member of the thiazolidinedione class of anti-diabetic agents.
Slovenian: Rosiglitazon je selektiven agonist za jedrni receptor PPARγ (peroksisomalni receptor gama, ki ga aktivira proliferator) in sodi v tiazolidindionsko skupino antidiabetikov.
English: Adverse effects observed in animal studies with possible relevance to clinical use were as follows: An increase in plasma volume accompanied by decrease in red cell parameters and increase in heart weight.
Slovenian: Neželeni učinki, ki so jih opazili v raziskavah na živalih in bi utegnili biti pomembni za klinično uporabo zdravila, so naslednji: porast volumna plazme, ki ga spremlja znižanje parametrov rdečih krvničk in povečanje mase srca.
English: There are no data available on the use of rosiglitazone in patients under 10 years of age.
Slovenian: Podatki o uporabi rosiglitazona pri bolnikih, mlajših od 10 let niso na voljo.
English: Rosiglitazone should be used with caution in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Slovenian: Rosiglitazon je potrebno uporabljati previdno pri bolnikih s hudo ledvično insuficienco (očistek kreatinina < 30 ml/min).
English: • reduction in blood count (anaemia)
Slovenian: • zmanjšanje števila krvnih celic (anemija)
English: There is no evidence for unexpected accumulation of rosiglitazone after once or twice daily dosing.
Slovenian: Ni dokazov o tem, da bi se rosiglitazon zaradi uživanja enkrat ali dvakrat dnevno nepričakovano kopičil v telesu.
English: • increased weight, increased appetite
Slovenian: • zvečanje telesne mase, povečanje apetita
English: Very rare skin reactions (e.g. urticaria, pruritus, rash)
Slovenian: Zelo redki kožne reakcije (npr. urtikarija, srbenje, izpuščaj)
English: In females, this increased incidence was noted after the first year of treatment and persisted during long-term treatment.
Slovenian: Pri ženskah so to večjo pojavnost so opazili po prvem letu zdravljenja, ohranila pa se je tudi med dolgotrajnim zdravljenjem.
English: Women who are infertile due to a condition affecting their ovaries (such as Polycystic Ovarian Syndrome), may start ovulating again when they start taking Avandia.
Slovenian: Pri ženskah, ki so zaradi bolezni jajčnikov (kot je sindrom policističnega jajčnika) neplodne, se lahko po začetku jemanja zdravila Avandia ponovno pojavi ovulacija.
English: The major routes of metabolism are N-demethylation and hydroxylation, followed by conjugation with sulphate and glucuronic acid.
Slovenian: Glavni presnovni poti sta N-demetilacija in hidroksilacija, ki jima sledi konjugacija s sulfatom in glukuronsko kislino.
English: Frequencies are defined as: very common ≥ 1/10; common ≥ 1/100, < 1/10; and uncommon ≥ 1/1000, < 1/100.
Slovenian: Pogostnost je definirana kot: zelo pogosti ≥ 1/10; pogosti ≥ 1/100, < 1/10; in občasni
English: The elevated total cholesterol levels were associated with increase in both LDLc and HDLc, but the ratio of total cholesterol:HDLc was unchanged or improved in long term studies.
Slovenian: Povečane vrednosti skupnega holesterola so bile povezane s povečanjem obeh, LDLc in HDLc, razmerje skupni holesterol proti HDLc pa je ostalo nespremenjeno ali pa se je med dolgotrajnimi študijami izboljšalo.
English: In an animal model for familial adenomatous polyposis (FAP), treatment with rosiglitazone at 200 times the pharmacologically active dose increased tumour multiplicity in the colon.
Slovenian: Pri živalskem modelu za družinsko adenomatozno polipozo (FAP) je zdravljenje z rosiglitazonom, ki so ga dajali v 200-kratni količini farmakološko aktivnega odmerka, povečalo število tumorjev v debelem črevesu.
English: Increases in liver weight, plasma ALT (dog only) and fat tissue were also observed.
Slovenian: Opazili so tudi zvečanje mase jeter, porast plazemskih ALT (samo pri psih) in količine maščobnega tkiva.
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 se pri kakšnem bolniku pojavijo simptomi, ki kažejo na motnje jetrnega delovanja, kar lahko vključuje tudi nepojasnjeno navzeo, bruhanje, bolečine v trebuhu, utrujenost, anoreksijo in/ali temen seč, je treba bolniku preveriti jetrne encime.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO Navedba smiselno ni potrebna.
English: Monitoring of liver function
Slovenian: Nadziranje delovanja jeter
English: Each tablet contains either: 2 mg, 4 mg or 8 mg rosiglitazone.
Slovenian: Ena tableta vsebuje: 2 mg, 4 mg ali 8 mg rosiglitazona.
English: Common cardiac ischaemia3*
Slovenian: srčna ishemija3*
English: Avandia tablets come in different strengths.
Slovenian: Avandia tablete so na voljo v različnih jakostih.
English: 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).
Slovenian: Takšne bolnice se morajo zavedati tveganja, da lahko zanosijo, in če bi bolnica želela zanositi ali zanosi, je potrebno zdravljenje prekiniti (glejte poglavje 4.6).
English: The 4 mg tablet also contains purified talc and iron oxide yellow (E172).
Slovenian: 4 mg tablete vsebujejo tudi smukec in rumeni železov oksid (E172).
English: Avandia and other medicines for diabetes can make some existing conditions worse, or cause serious side effects.
Slovenian: Zdravilo Avandia in druga zdravila za zdravljenje sladkorne bolezni lahko poslabšajo nekatera že obstoječa bolezenska stanja ali povzročijo hude neželene učinke.
English: However, rosiglitazone promoted differentiation and reversal of mutagenic changes in human colon cancer cells in vitro.
Slovenian: Vendar je rosiglitazon in vitro pospeševal diferenciacijo in uničenje mutagenih sprememb v rakavih celicah človeškega debelega črevesa.
English: The contribution of the major metabolite (para-hydroxy-sulphate) to the overall anti-diabetic activity of rosiglitazone has not been fully elucidated in man and it cannot be ruled out that the metabolite may contribute to the activity.
Slovenian: Prispevka glavnega presnovka (parahidroksisulfata) na celotno antidiabetično delovanje rosiglitazona pri človeku še niso dodobra pojasnili in ni izključeno, da morda tudi ta presnovek prispeva k delovanju.
English: Contains lactose (approximately 209 mg).
Slovenian: Vsebuje laktozo (približno 209 mg)
English: The decision to initiate triple oral therapy should include consideration of the alternative to switch the patient to insulin.
Slovenian: Odločitev o uvedbi peroralnega zdravljenja s tremi zdravili mora vključevati tudi premislek o alternativi - zdravljenju z insulinom.
English: Avandia is used to treat type 2 diabetes.
Slovenian: Zdravilo Avandia uporabljamo za zdravljenje sladkorne bolezni tipa 2.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici 4 načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnih posodobitvah načrta za obvladovanje tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
English: The maximum dose is 8 mg of Avandia a day.
Slovenian: Največji odmerek je 8 mg zdravila Avandia na dan.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Slovenian: • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU Izdaja zdravila je le na recept.
English: You can take Avandia with or without food.
Slovenian: Zdravilo Avandia lahko jemljete skupaj s hrano ali brez nje.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency(EMEA) http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.ema.europa.eu
English: Allergic reactions: These are very rare in people taking Avandia.
Slovenian: Alergijske reakcije: Pri bolnikih, ki se zdravijo z zdravilom Avandia so alergijske reakcije zelo redke.
English: • if you have heart failure, or have had heart failure in the past
Slovenian: • če imate ali ste kdaj imeli srčno popuščanje
English: Since there is no significant in vitro inhibition of CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A or 4A with rosiglitazone, there is a low probability of significant metabolism-based interactions with substances metabolised by these P450 enzymes.
Slovenian: Ker z rosiglitazonom ne pride do značilnega in vitro zaviranja CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A ali 4A, obstaja le majhna verjetnost pojava značilnih presnovnih interakcij z zdravili, ki jih presnavljajo našteti encimi P450.
English: Rosiglitazone showed moderate inhibition of CYP2C8 (IC50 18 µM) and low inhibition of CYP2C9 (IC50 50 µM) in vitro (see section 4.5).
Slovenian: Rosiglitazon je in vitro pokazal zmerno zaviranje CYP2C8 (IC50 18 μM) in majhno zaviranje CYP2C9 (IC50 50 μM) (glejte poglavje 4.5).
English: Rosiglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Slovenian: Potrebno je razmisliti o prilagoditvi odmerka rosiglitazona znotraj priporočenega odmerjanja ali o spremembah pri zdravljenju sladkorne bolezni (glejte poglavje 4.5).
English: All patients, particularly those receiving concurrent insulin or sulphonylurea therapy, those at risk for heart failure, and those with reduced cardiac reserve, should be monitored for signs and symptoms of adverse reactions relating to fluid retention, including weight gain and heart failure.
Slovenian: Vse bolnike, še posebej pa bolnike, ki se sočasno zdravijo z insulinom ali sulfonilsečnino, bolnike pri katerih obstaja tveganje srčnega popuščanja in bolnike z zmanjšano srčno rezervo, je treba nadzirati glede pojava znakov in simptomov neželenih učinkov, povezanih z zastajanjem tekočine, vključno s povečanjem telesne mase in srčnim popuščanjem.
English: Common Common Very common Very common RSG - Rosiglitazone monotherapy; RSG + MET - Rosiglitazone with metformin; RSG + SURosiglitazone with sulphonylurea; RSG + MET + SU - Rosiglitazone with metformin and sulphonylurea
Slovenian: RSG - rosiglitazon kot samostojno zdravilo; RSG + MET - rosiglitazon z metforminom; RSG + SUrosiglitazon s sulfonilsečnino; RSG + MET + SU - rosiglitazon z metforminom in sulfonilsečnino
English: In mechanistic studies, the weight increase was predominantly shown to be due to increased subcutaneous fat with decreased visceral and intra-hepatic fat.
Slovenian: V raziskavah mehanizma delovanja se je pokazalo, da je prišlo do povečevanja telesne mase predvsem na račun povečevanja podkožnega maščevja in zmanjševanja količine visceralnih in intrahepatičnih maščob.
English: In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well tolerated.
Slovenian: V kliničnih študijah, kjer so prostovoljcem dali v enkratnih peroralnih odmerkih do 20 mg rosiglitazona, so jih prostovoljci dobro prenašali.
English: Clinically significant interactions with CYP2C9 substrates or inhibitors are not anticipated.
Slovenian: Klinično pomembnih interakcij s substrati ali zaviralci CYP2C9 ni pričakovati.
English: It reduces glycaemia by reducing insulin resistance at adipose tissue, skeletal muscle and liver.
Slovenian: Glikemijo zmanjšuje tako, da zmanjšuje rezistenco adipoznega tkiva, skeletnih mišic in jeter proti insulinu.
English: The use of rosiglitazone in triple oral therapy, in combination with metformin and a sulphonylurea, may be associated with increased risks for fluid retention and heart failure, as well as hypoglycaemia (see section 4.8).
Slovenian: Uporaba rosiglitazona pri peroralnem zdravljenju s tremi zdravili, v kombinaciji z metforminom in s sulfonilsečnino, je lahko povezana s povečanim tveganjem za zastajanje tekočine in srčno popuščanje, kot tudi za hipoglikemijo (glejte poglavje 4.8).
English: Administration of rosiglitazone with food resulted in no change in overall exposure (AUC), although a small decrease in Cmax (approximately 20% to 28%) and a delay in tmax (ca.1.75 h) were observed compared to dosing in the fasting state.
Slovenian: Če rosiglitazon zaužijemo s hrano, ne pride do spremembe celotne izpostavljenosti organizma (AUC), čeprav so v primerjavi z zaužitjem na tešče opazili majhno zmanjšanje Cmax (za približno 20 do 28 %) in zakasnitev tmax (približno 1,75 ure).
English: • Avandia is not recommended during pregnancy.
Slovenian: • Uporaba zdravila Avandia med nosečnostjo ni priporočljiva.
English: Caution should be exercised in patients over 75 years because of the limited experience in this patient group.
Slovenian: Zaradi omejenih izkušenj je pri bolnikih, starejših od 75 let, potrebna previdnost.
English: Consistent with the mechanism of action, rosiglitazone reduced insulin resistance and improved pancreatic ß-cell function.
Slovenian: Skladno z mehanizmom delovanja je rosiglitazon zmanjšal rezistenco proti insulinu in izboljšal delovanje celic beta trebušne slinavke.
English: The decision whether to continue the patient on therapy with rosiglitazone should be guided by clinical judgement pending laboratory evaluations.
Slovenian: Pri odločitvi, ali naj bolnika še naprej zdravimo z rosiglitazonom, naj bo v času, ko so laboratorijske preiskave še v teku, vodilo klinična presoja.
English: In addition, rosiglitazone inhibited ovarian oestradiol and progesterone synthesis and lowered plasma levels of these hormones resulting in effects on oestrus/menstrual cycles and fertility (see section 4.4).
Slovenian: Poleg tega je rosiglitazon zaviral sintezo estradiola in progesterona v jajčnikih in zmanjševal koncentracije obeh hormonov v plazmi, kar je posledično vplivalo na estrus/menstrualne cikluse in plodnost (glejte poglavje 4.4).
English: Low blood sugar (hypoglycaemia): If you are taking Avandia with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level.
Slovenian: Nizek krvni sladkor (hipoglikemija): Če zdravilo Avandia jemljete skupaj z drugimi zdravili za zdravljenje sladkorne bolezni, je verjetnost za prekomerno zmanjšanje krvnega sladkorja večja.
English: For children aged 10 to 17 years, there are limited data on rosiglitazone as monotherapy (see sections 5.1 and 5.2).
Slovenian: Podatki o uporabi rosiglitazona kot samostojnega zdravila pri otrocih, starih od 10 do 17 let so skopi (glejte poglavji 5.1 in 5.2).
English: Contains lactose (approximately 105 mg).
Slovenian: Vsebuje laktozo (približno 105 mg)
English: Combination with insulin
Slovenian: Kombinirano zdravljenje z insulinom