natgillin/translations-raw huggingface dataset:
The improved glycaemic control is associated with reductions in both fasting and postprandial glucose.
Izboljšana urejenost glikemije je povezana z zmanjšanjem koncentracije glukoze tako na tešče kot po jedi.
The absorption of rosiglitazone is not affected by increases in gastric pH.
Zvišanje želodčne pH-vrednosti ne vpliva na absorpcijo rosiglitazona.
In their entirety, the available data on the risk of cardiac ischaemia are inconclusive.
Razpoložljivi podatki v celoti ne omogočajo dokončnega sklepa o tveganju srčne ishemije.
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca, odgovornega za sproščanje serije
The frequency of metformin adverse reactions identified from clinical trial and postmarketing data
Pogostnost neželenih učinkov metformina na osnovi podatkov iz kliničnih preskušanj in podatkov po pridobitvi dovoljenja za promet
Total plasma clearance of rosiglitazone is around 3 l/h and the terminal elimination half-life of rosiglitazone is approximately 3-4 h. There is no evidence for unexpected accumulation of rosiglitazone after once or twice daily dosing.
Celoten očistek rosiglitazona iz plazme znaša okoli 3 l/uro, končna razpolovna doba izločanja rosiglitazona pa je približno 3 do 4 ure.
Triple oral therapy (rosiglitazone, metformin and sulphonylurea) (see section 4.4) - Patients on metformin and sulphonylurea: when appropriate AVANDAMET may be initiated at 4 mg/day rosiglitazone with the dose of metformin substituting that already being taken.
Peroralno zdravljenje s tremi zdravili (rosiglitazon, metformin in sulfonilsečnina) (glejte poglavje 4.4) - Bolniki, ki se zdravijo z metforminom in s sulfonilsečnino: če je primerno, se zdravilo AVANDAMET lahko uvede v odmerku 4 mg/dan rosiglitazona in odmerku metformina, ki zamenja odmerek metformina, ki ga bolnik že jemlje.
Rosiglitazone with metformin and sulphonylurea
Rosiglitazon z metforminom in sulfonilsečnino
Packs of 14, 28, 56, 112 (2x56), 168 (3x56) and 180 tablets.
Škatle s 14, 28, 56, 112 (2x56), 168 (3x56) in 180 tabletami.
Co-administration of rosiglitazone with gemfibrozil (an inhibitor of CYP2C8) resulted in a twofold increase in rosiglitazone plasma concentrations.
Sočasno dajanje rosiglitazona in gemfibrozila (zaviralca CYP2C8) je posledično za dvakrat povečalo koncentracije rosiglitazona v plazmi.
The maximum recommended daily dose of AVANDAMET is 8 mg rosiglitazone plus 2000 mg metformin hydrochloride.
Največji priporočeni dnevni odmerek zdravila AVANDAMET je 8 mg rosiglitazona in 2000 mg metforminijevega klorida.
In this study, the adverse events observed were consistent with the known adverse event profile for each of the treatments, including continuing weight gain with rosiglitazone.
V tej študiji so se opaženi neželeni učinki skladali z znanimi značilnostmi neželenih učinkov posameznih zdravil, vključno s stalnim povečanjem telesne mase med uporabo rosiglitazona.
Excipients: Each tablet contains lactose (approximately 6 mg).
Vsaka tableta vsebuje laktozo (približno 6 mg)
• stomach pain, nausea and vomiting.
• bolečino v želodcu, siljenje na bruhanje in bruhanje.
Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Metformin je bigvanid z antihiperglikemičnimi učinki in znižuje tako bazalno kot postprandialno koncentracijo glukoze v plazmi.
Packs of 28, 56, 112, 336 (3x112) and 360 tablets.
Škatle z 28, 56, 112, 336 (3x112) in 360 tabletami.
Frequency of adverse reaction by treatment regimen Rosiglitazone monotherapy
Pogostnost neželenega učinka glede na režim zdravljenja Rosiglitazon kot samostojno zdravilo
If you accidentally take too many tablets, contact your doctor or pharmacist for advice.
Če ste vzeli večji odmerek zdravila Avandamet, kot bi smeli Če po nesreči vzamete preveč tablet, se posvetujte s svojim zdravnikom ali farmacevtom.
- Patients on metformin and sulphonylurea: when appropriate AVANDAMET may be initiated at 4 mg/day rosiglitazone with the dose of metformin substituting that already being taken.
- Bolniki, ki se zdravijo z metforminom in s sulfonilsečnino: če je primerno, se zdravilo AVANDAMET lahko uvede v odmerku 4 mg/dan rosiglitazona in odmerku metformina, ki zamenja odmerek metformina, ki ga bolnik že jemlje.
• liver doesn't function as well as it should (increase in liver enzymes).
• okvara delovanja jeter (zvišana vrednost jetrnih encimov).
Decreased renal function in elderly patients is frequent and asymptomatic.
Pri starostnikih je zmanjšano delovanje ledvic pogosto in asimptomatsko.
In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with CYP2C9 as only a minor pathway.
Študije in vitro so pokazale, da se rosiglitazon pretežno presnavlja s CYP2C8, medtem ko je CYP2C9 zanj le manj pomembna presnovna pot.
Administration of iodinated contrast agent
Uporaba jodiranih kontrastnih sredstev
In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with a minor contribution by CYP2C9.
Študije in vitro so pokazale, da se rosiglitazon pretežno presnavlja s pomočjo CYP2C8, malenkostno pa pripomore tudi CYP2C9.
Therefore, as a precaution, the use of rosiglitazone is not recommended in these patients, particularly those with myocardial ischaemic symptoms.
Pri teh bolnikih, še posebej pri bolnikih s simptomi ishemije miokarda, zaradi previdnosti uporabe rosiglitazona ne priporočamo.
Ask your pharmacist how to dispose of tablets you don't need.
O načinu odstranjevanja tablet, ki jih ne potrebujete več, se posvetujte s farmacevtom.
Since NSAIDs, insulin and rosiglitazone are all associated with fluid retention, concomitant administration may increase the risk of oedema.
Ker so tako nesteroidna protivnetna zdravila kot tudi insulin in rosiglitazon povezani z zastajanjem tekočine v telesu, lahko njihovo sočasno jemanje poveča tveganje za nastanek edemov.
AVANDAMET must be discontinued if any deterioration in cardiac status occurs.
Če pride do kakršnega koli poslabšanja v srčnem statusu, je potrebno zdravljenje z zdravilom AVANDAMET prekiniti.
In addition, rosiglitazone preserved ß-cell function as shown by increased pancreatic islet mass and insulin content and prevented the development of overt hyperglycaemia in animal models of type 2 diabetes.
Poleg tega je rosiglitazon pri živalskih modelih s sladkorno boleznijo tipa 2 ohranjal tudi delovanje β-celic, kar dokazuje zvečanje mase pankreasnih otočkov in vsebnosti insulina, ter preprečeval nastanek očitne hiperglikemije.
However, in their entirety the available data on the risk of cardiac ischaemia are inconclusive (see section 4.8).
V celoti pa razpoložljivi podatki ne omogočajo dokončnega sklepa o tveganju za srčne ishemije(glejte poglavje 4.8).
• rapid increase in your weight
• hitro povečanje telesne mase.
The major metabolite (a para-hydroxy-sulphate) with high affinity to the soluble human PPARγ, exhibited relatively high potency in a glucose tolerance assay in obese mice.
Glavni metabolit (parahidroksisulfat) z močno afiniteto do topnega humanega PPARγ je v raziskavi, ki je preučevala toleranco za glukozo pri debelih miših, izkazal sorazmerno visoko učinkovitost.
Clinical trial data (addition of insulin to established AVANDAMET therapy) In a single study (n=322) where insulin was added to patients established on AVANDAMET, no new adverse events were observed in excess of those already defined for either AVANDAMET or rosiglitazone combination therapies.
V eni študiji (n=322), v kateri je bilo bolnikom, ki so se zdravili z zdravilom AVANDAMET, uvedeno še zdravljenje z insulinom, niso opazili novih neželenih dogodkov, ki bi bili pogostejši od že ugotovljenih, bodisi za zdravilo AVANDAMET bodisi za kombinirano zdravljenje z rosiglitazonom.
The active substances are rosiglitazone and metformin.
Zdravilni učinkovini sta rosiglitazon in metformin.
Skin and subcutaneous tissue disorders (see Immune system disorders) Angioedema
Bolezni kože in podkožja (glejte Bolezni imunskega sistema) angioedem
Increased monitoring of the patient and a reduction in the dose of the concomitant agent may be necessary.
Bolnika bo morda treba skrbno nadzirati, odmerek sočasno vzete zdravilne učinkovine pa zmanjšati.
2 An increased incidence of heart failure has been observed when rosiglitazone was added to treatment regimens with a sulphonylurea (either as dual or triple therapy), and appeared higher with 8 mg rosiglitazone compared to 4 mg rosiglitazone (total daily dose).
2 Če so rosiglitazon dodali k režimu zdravljenja s sulfonilsečnino (bodisi pri zdravljenju z dvema zdraviloma bodisi pri zdravljenju s tremi zdravili), so opazili večjo pojavnost srčnega popuščanja, ki je bila pri 8 mg odmerku rosiglitazona večja kot pri 4 mg odmerku (skupni dnevni odmerek).
Elderly: In the pooled population pharmacokinetic analysis, age was not found to influence the pharmacokinetics of rosiglitazone to any significant extent.
Starostniki: Pri preučevanju farmakokinetike znotraj posameznih skupin bolnikov niso opazili, da bi starost kakor koli pomembneje vplivala na farmakokinetiko rosiglitazona.
Adverse reactions are presented below for each of the component parts of AVANDAMET.
V nadaljevanju so navedeni neželeni učinki vsake od sestavin zdravila AVANDAMET.
An in vivo interaction study with warfarin indicated that rosiglitazone does not interact with CYP2C9 substrates in vivo.
Študija in vivo je o interakcijah z varfarinom pokazala, da rosiglitazon in vivo s substrati CYP2C2 medsebojno ne učinkuje.
AVANDAMET combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: rosiglitazone maleate, a member of the thiazolidinedione class and metformin hydrochloride, a member of the biguanide class.
Zdravilo AVANDAMET je kombinacija dveh antihiperglikemičnih učinkovin s komplementarnim mehanizmom delovanja, namenjeno pa je izboljšanju urejenosti glikemije pri bolnikih s sladkorno boleznijo tipa 2: rosiglitazonijevega maleata iz skupine tiazolidindionov in metforminijevega klorida iz skupine bigvanidov.
Rosiglitazone was associated with increases in weight.
Rosiglitazon so povezovali s povečevanjem telesne mase.
Premenopausal women have received rosiglitazone during clinical studies.
V kliničnih študijah so rosiglitazon dajali ženskam pred menopavzo.
There was a significant increase in heart failure (fatal and nonfatal) (HR 2.10, CI 1.35-3.27) and bone fractures (Risk Ratio 1.57, CI 1.26-1.97) in rosiglitazonecontaining treatments compared to active control (see sections 4.4 and 4.8).
Med zdravljenji, ki so vključevala rosiglitazon, so v primerjavi s primerjalno učinkovino ugotovili značilno več srčnega popuščanja (s smrtnim izidom ali brez njega) (razmerje ogroženosti 2,10, IZ 1,35-3,27) in zlomov kosti (razmerje tveganj 1,57, IZ 1,26-1,97) (glejte poglavji 4.4 in 4.8).
The relevance of this finding is unknown.
Klinični pomen teh ugotovitev ni poznan.
An adjusted mean reduction in HbA1c of 0.24% was seen for patients taking rosiglitazone added to sulphonylurea, versus a reduction in HbA1c of 0.10% for patients taking metformin added to sulphonylurea, (p=0.0083 for treatment difference).
Pri bolnikih, ki so jemali rosiglitazon dodan sulfonilsečnini, so ugotovili korigirano povprečno znižanje HbA1c za 0,24 %, pri bolnikih, ki so jemali metformin dodan sulfonilsečnini, pa znižanje za 0,10 % (p = 0,0083 za razliko med zdravljenji).
Not all pack sizes or tablet strengths may be available in your country.
Na trgu ni vseh navedenih pakiranj ali jakosti tablet.
Rosiglitazone treatment significantly reduced the risk of reaching monotherapy failure (FPG>10.0 mmol/L) by 63% relative to glibenclamide (HR 0.37, CI 0.30-0.45) and by 32% relative to metformin (HR 0.68, CI 0.55-0.85) during the course of the study (up to 72 months of treatment).
Med študijo (do 72 mesecev zdravljenja) je zdravljenje z rosiglitazonom statistično značilno zmanjšalo tveganje odpovedi monoterapije (glukoza v plazmi na tešče > 10,0 mmol/l) za 63 % v primerjavi z glibenklamidom (razmerje ogroženosti 0,37, interval zaupanja 0,30-0,45) in za 32 % v primerjavi z metforminom (razmerje ogroženosti 0,68, interval zaupanja 0,55-0,85).
If necessary, the dosage of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Če je potrebno, odmerek antidiabetikov prilagodimo bodisi zdravljenju z drugimi zdravili bodisi ukinitvi zdravljenja s takšnimi zdravili.
Non-clinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Predklinični podatki o metforminu, ki se naslanjajo na običajne farmakološke raziskave o varnosti, toksičnosti pri večkratnih odmerkih, kancerogenem delovanju in vplivih na sposobnost razmnoževanja, ne kažejo na posebno tveganje za ljudi.
After an oral dose of metformin, tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Pri zdravih posameznikih je absolutna biološka uporabnost 500 mg tablete metformina približno 50 do 60 %.
Renal insufficiency: There are no clinically significant differences in the pharmacokinetics of rosiglitazone in patients with renal impairment or end stage renal disease on chronic dialysis.
Insuficienca ledvic: Pri bolnikih z oslabljenim delovanjem ledvic ali v zadnjem stadiju ledvične bolezni in s kronično dializo niso zasledili klinično pomembnih razlik v farmakokinetiki rosiglitazona.
In the final analysis at 5 years, an adjusted mean reduction from baseline in HbA1c of 0.14% for patients on rosiglitazone added to metformin versus an increase of 0.17% for patients taking sulphonylurea added to metformin was seen during treatment with randomised dual-combination therapy (p<0.0001 for treatment difference).
V končni analizi po 5 letih so med uporabo randomiziranega dvotirnega kombiniranega zdravljenja pri bolnikih z rosiglitazonom dodanim metforminu ugotovili korigirano povprečno znižanje HbA1c v primerjavi z izhodiščem za 0,14 %, pri bolnikih s sulfonilsečnino dodano metforminu pa zvišanje za 0,17 % (p < 0,0001 za razliko med zdravljenji).
Following rosiglitazone treatment, there were no new safety concerns noted in children compared to adult patients with type 2 diabetes mellitus.
V primerjavi z odraslimi bolniki s sladkorno boleznijo tipa 2 pri otrocih pri zdravljenju z rosiglitazonom niso zaznali dodatnih težav z varnostjo.
AVANDAMET should be used with caution during concomitant administration of CYP2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin), due to the effect on rosiglitazone pharmacokinetics (see section 4.5).
V primeru sočasnega dajanja zaviralcev CYP2C8 (npr. gemfibrozil) ali induktorjev CYP2C8 (npr. rifampicin) in zdravila AVANDAMET je slednjega, zaradi učinka na farmakokinetiko rosiglitazona, potrebno uporabljati previdno (glejte poglavje 4.5).
Marketing Authorisation Holder: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Imetnik dovoljenja za promet z zdravilom: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Velika Britanija.
These may affect more than 1 in 10 people:
Pojavijo se lahko pri več kot 1 od 10 bolnikov:
Rosiglitazone treatment is associated with a dose-related reduction of haemoglobin levels.
Zdravljenje z rosiglitazonom je povezano z od odmerka odvisnim zmanjšanjem koncentracije hemoglobina.
These may affect up to 1 in 1,000 people:
Pojavijo se lahko pri do 1 od 1.000 bolnikov:
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h. When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
V primeru oslabljene funkcijske sposobnosti ledvic se ledvični očistek zmanjša v sorazmerju s kreatininskim in tako se razpolovna doba izločanja podaljša, kar vodi v zvečanje vrednosti metformina v plazmi.
The doctor will check your kidney function before restarting treatment.
Pred nadaljevanjem zdravljenja bo zdravnik preveril delovanje ledvic.
Avandamet contains lactose
Zdravilo Avandamet vsebuje laktozo
Blood and the lymphatic system disorders Anaemia granulocytopaenia
Bolezni krvi in limfatičnega sistema anemija
After oral administration, metformin absorption is saturable and incomplete.
Po peroralnem odmerku je absorpcija metformina nepopolna in poteka do zasičenja.
Î Tell your doctor as soon as possible if you get these symptoms.
Î Čimprej obvestite svojega zdravnika, če se pojavijo ti simptomi.
The usual starting dose of AVANDAMET is 4 mg/day rosiglitazone plus 2000 mg/day metformin hydrochloride.
Običajni začetni odmerek zdravila AVANDAMET je 4 mg/dan rosiglitazona in 2000 mg/dan metforminijevega klorida.
Therapy with AVANDAMET should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 times the upper limit of normal) or with any other evidence of liver disease.
Pri bolnikih z zvišanimi osnovnimi vrednostmi jetrnih encimov (ALT > 2,5-krat od zgornje meje normalne vrednosti) ali s katerimi koli drugimi znaki jetrnega obolenja se zdravljenje z zdravilom AVANDAMET ne sme uvesti.
An active controlled clinical trial (rosiglitazone up to 8 mg daily or metformin up to 2,000 mg daily) of 24 weeks duration was performed in 197 children (10-17 years of age) with type 2 diabetes.
Pri 197 otrocih (starih od 10 do 17 let) s sladkorno boleznijo tipa 2 je bilo izvedeno 24-tedensko z učinkovino nadzorovano klinično preskušanje (rosiglitazon do 8 mg na dan ali metformin do 2.000 mg na dan).
Gastrointestinal disorders gastrointestinal symptoms6
Bolezni prebavil prebavni simptomi6
The frequency of adverse reactions identified from clinical trial data with rosiglitazone Adverse reaction
Pogostnost neželenih učinkov na osnovi podatkov iz kliničnih preskušanj rosiglitazona
SmithKline Beecham Ltd 980 Great West Road Brentford, Middlesex TW8 9GS United Kingdom
SmithKline Beecham Ltd 980 Great West Road Brentford, Middlesex TW8 9GS Velika Britanija
No statistically significant difference was observed between the absorption characteristics of rosiglitazone and metformin from the AVANDAMET tablet and those obtained from rosiglitazone maleate and metformin hydrochloride tablets, respectively.
AVANDAMET Absorpcija Značilnost absorpcije rosiglitazona in metformina v zdravilu AVANDAMET se statistično značilno ne razlikuje od posamičnih absorpcij rosiglitazonijevega maleata in metforminijevega klorida.
• lower blood sugar than normal (hypoglycaemia)
• prekomerno znižanje vrednosti krvnega sladkorja (hipoglikemija).
• rapid and excessive weight gain caused by fluid retention
• hitro in močno povečanje telesne mase zaradi kopičenja tekočine v telesu.
Immune system disorders (see Skin and subcutaneous tissue disorders) anaphylactic reaction
Bolezni imunskega sistema (glejte Bolezni kože in podkožja) anafilaktična reakcija
- hypersensitivity to rosiglitazone, to metformin hydrochloride or to any of the excipients - cardiac failure or history of cardiac failure (New York Heart Association (NYHA) stages I to IV) - an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) (see section 4.4) - acute or chronic disease which may cause tissue hypoxia such as: - cardiac or respiratory failure - recent myocardial infarction - shock - hepatic impairment - acute alcohol intoxication, alcoholism (see section 4.4) - diabetic ketoacidosis or diabetic pre-coma - renal failure or renal dysfunction e.g. serum creatinine levels > 135 µmol/l in males and > 110 µmol/l in females and/or creatinine clearance < 70 ml/min (see section 4.4) - acute conditions with the potential to alter renal function such as: - dehydration - severe infection - shock - intravascular administration of iodinated contrast agents (see section 4.4) - lactation.
- oslabljenem delovanju jeter; - akutni zastrupitvi z alkoholom, alkoholizmu (glejte poglavje 4.4); - diabetični ketoacidozi ali diabetični komi; - ledvični odpovedi ali ledvični disfunkciji, npr. koncentracija kreatinina v serumu > 135 μmol/l pri moških ter serumska koncentracija kreatinina > 110 μmol/l pri ženskah in/ali očistek kreatinina < 70 ml/min (glejte poglavje 4.4); - akutnih stanjih, ki lahko spremenijo delovanje ledvic: - dehidracija - hude okužbe - šok - intravaskularna uporaba jodiranih kontrastnih sredstev (glejte poglavje 4.4);
These strengths are supplied in blister packs containing 14, 28, 56, 2x56, 3x56 or 180 film-coated tablets.
Pakiranje vsebuje 14, 28, 56, 2x56, 3x56 ali 180 filmsko obloženih tablet.
Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - 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 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) - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years (p=0.01).
Analize teh rezultatov pri bolnikih s čezmerno telesno maso, ki so bili po neuspešnem zdravljenju samo z dieto zdravljeni z metforminom, kažejo: - značilno zmanjšanje absolutnega tveganja za katero koli s sladkorno boleznijo povezano komplikacijo v skupini bolnikov, ki so se zdravili z metforminom (29,8 primerov/1.000 bolnikov letno), v primerjavi s skupino bolnikov, ki je imela predpisano zgolj dieto (43,3 primerov/1.000 bolnikov letno), 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 letno), p = 0,0034; - značilno zmanjšanje absolutnega tveganja za umrljivost, povezano s sladkorno boleznijo: metformin - 7,5 primerov/1.000 bolnikov letno, samo dieta - 12,7 primerov/1.000 bolnikov
The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors such as poorly controlled diabetes, ketosis,
Incidenco laktacidoze je možno in tudi potrebno zmanjševati z oceno drugih povezanih dejavnikov tveganja, kot so slabo nadzorovana sladkorna bolezen, ketoza, dolgotrajno stradanje, čezmerno uživanje alkohola, jetrna insuficienca in katera koli stanja, povezana s hipoksijo.
Cardiac disorders cardiac failure2
Srčne bolezni srčno popuščanje2
Dose titration with rosiglitazone (added to the optimal dose of metformin) may be considered before the patient is switched to AVANDAMET.
Preden se bolnika preusmeri na zdravljenje z zdravilom AVANDAMET, se lahko najprej pretehta možnost uravnavanja odmerka rosiglitazona (dodajanje k optimalnemu odmerku metformina).
The frequency of adverse reactions identified from post-marketing data with rosiglitazone
Pogostnost neželenih učinkov na osnovi podatkov po pridobitvi dovoljenja za promet rosiglitazona
Don't take Avandamet.
Ne jemljite zdravila Avandamet.
Rosiglitazone did not stimulate pancreatic insulin secretion or induce hypoglycaemia in rats and mice.
Rosiglitazon pri miših in podganah ni spodbujal izločanja insulina iz trebušne slinavke ali sprožil hipoglikemije.
• swelling (oedema) due to water retention
• oteklina (edem) zaradi zastajanja vode v telesu.
Heart failure was also reported more frequently in patients with a history of heart failure; oedema and heart failure was also reported more frequently in elderly patients and in patients with mild or moderate renal failure.
O edemih in srčnem popuščanju so pogosteje poročali tudi pri starostnikih in pri bolnikih z blago do zmerno odpovedjo ledvic.