natgillin/translations-raw huggingface dataset:
angioedema skin reactions (e. g. urticaria, pruritis, rash) 5
Bolezni kože in podkožja (glejte Bolezni imunskega sistema) angioedem kožne reakcije (npr. urtikarija, srbenje, izpuščaj) 5
Rare cases of elevated liver enzymes and hepatocellular dysfunction have been reported.
Poročali so o redkih primerih zvišanja vrednosti jetrnih encimov in hepatocelularni disfunkciji.
Table 3.
V preglednici 3 so navedeni neželeni učinki glede na organski sistem in kategorijo pogostnosti.
Metabolism and nutrition disorders lactic acidosis vitamin B12 deficiency7
Presnovne in prehranske motnje laktacidoza pomanjkanje vitamina B127
Hepatobiliary disorders liver function disorders Hepatitis
Bolezni jeter, žolčnika in žolčevodov motnje v delovanju jeter hepatitis
urticaria erythema pruritis 6
urtikarija rdečina srbenje 6
Very rare Very rare Very rare
Zelo redki Zelo redki Zelo redki
Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Prebavni simptomi, kot so navzea, bruhanje, driska, abdominalne bolečine in izguba apetita so se najpogosteje pojavili ob začetku zdravljenja in so v večini primerov minili spontano.
7 Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e. g. megaloblastic anaemia).
7 Dolgotrajno zdravljenje z metforminom je bilo povezano z zmanjšanjem absorpcije vitamina B12, kar ima zelo redko lahko za posledico klinično pomembno pomanjkanje vitamina B12 (npr. megaloblastna anemija).
In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well tolerated.
V kliničnih študijah, kjer so prostovoljcem dajali v enkratnih peroralnih odmerkih do 20 mg rosiglitazona, so le- te prostovoljci dobro prenašali.
Combinations of oral blood glucose lowering medicinal products, ATC code:
Oznaka ATC:
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.
12 boleznijo tipa 2: rosiglitazonijevega maleata iz skupine tiazolidindionov in metforminijevega klorida iz skupine bigvanidov.
Rosiglitazone Rosiglitazone is a selective agonist at the PPARγ (peroxisome proliferator activated receptor gamma) nuclear receptor and is a member of the thiazolidinedione class of antihyperglycaemic agents.
Rosiglitazon Rosiglitazon je selektiven agonist za nuklearni receptor PPARγ (peroxisome proliferator activated receptor gamma) in sodi v tiazolidindionsko skupino antidiabetikov.
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.
Consistent with the mechanism of action, rosiglitazone in combination with metformin reduced insulin resistance and improved pancreatic ß-cell function.
V skladu z mehanizmom delovanja je rosiglitazon v kombinaciji z metforminom zmanjšal insulinsko rezistenco in izboljšal delovanje β- celic pankreasa.
At 18 months, in an ongoing long term comparator study, rosiglitazone in dual oral therapy with metformin was non-inferior to the combination of sulphonylurea plus metformin for lowering HbA1c.
V 18. mesecu dolgotrajne primerjalne študije, ki še poteka se je izkazalo, da rosiglitazon v sklopu peroralnega zdravljenja z dvema zdraviloma skupaj z metforminom ni slabši od kombinacije sulfonilsečnina in metformin glede na znižanje vrednosti HbA1c.
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).
12 There are no studies completed assessing long-term cardiovascular outcome in patients receiving rosiglitazone in combination with metformin.
Študije, ki bi ocenjevale vpliv na dolgoročni kardiovaskularni izid pri bolnikih, ki jemljejo rosiglitazon v kombinaciji z metforminom, še niso končane.
Metformin Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Metformin Metformin je bigvanid z antihiperglikemičnimi učinki in znižuje tako bazalno kot postprandialno koncentracijo glukoze v plazmi.
Metformin may act via three mechanisms:
13 Metformin lahko deluje na tri načine:
- by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis,
- zmanjšuje nastajanje glukoze v jetrih, tako da inhibira glukoneogenezo in glikogenolizo.
- in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and
- v mišicah zmerno poveča občutljivost za insulin, izboljša periferni vnos in izkoriščanje glukoze.
Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Metformin povečuje transportno zmožnost specifičnih tipov membranskih transporterjev za glukozo (GLUT- 1 in GLUT- 4).
This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDLc and triglyceride levels.
Slednje je bilo dokazano v kontroliranih, srednje dolgih ali dolgotrajnejših kliničnih raziskavah z uporabo terapevtskih odmerkov: metformin znižuje skupni holesterol, LDL- holesterol in raven trigliceridov.
- a significant reduction of the absolute risk of any diabetes-related complication in the metformin
- značilno zmanjšanje absolutnega tveganja za katero koli s sladkorno boleznijo povezano
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
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;
- a significant reduction of the absolute risk of diabetes-related mortality: metformin
- značilno zmanjšanje absolutnega tveganja za umrljivost, povezano s sladkorno boleznijo:
7.5 events/ 1,000 patient-years, diet alone 12.7 events/ 1,000 patient-years, p=0.017
metformin – 7, 5 primerov/ 1. 000 bolnikov letno, samo dieta – 12, 7 primerov/ 1. 000 bolnikov letno, p = 0, 017;
- a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/ 1,000
- značilno zmanjšanje absolutnega tveganja za skupno umrljivost: metformin –
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)
13, 5 primerov/ 1. 000 bolnikov letno, samo dieta – 20, 6 primerov/ 1000 bolnikov letno (p = 0, 011), v primerjavi s skupinama s kombiniranim zdravljenjem s sulfonilsečnino in monoterapijo z insulinom – 18, 9 primerov/ 1. 000 bolnikov letno (p = 0, 021);
- a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/ 1,000
- značilno zmanjšanje absolutnega tveganja za miokardni infarkt: metformin –
patient-years, diet alone 18 events/ 1,000 patient-years (p=0.01).
11 primerov/ 1. 000 bolnikov letno, dieta sama – 18 primerov/ 1. 000 bolnikov letno (p = 0, 01).
AVANDAMET Absorption 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.
In the fed state, Cmax was lower (22% rosiglitazone and 15% metformin) and tmax delayed (by approximately 1.5 h rosiglitazone and 0.5 h metformin).
Po obroku je bila Cmax nižja (22% za rosiglitazon in 15% za metformin) in tmax zakasnjen (za približno 1, 5 ure pri rosiglitazonu in za 0, 5 ure pri metforminu).
13 Absolute bioavailability of rosiglitazone following both a 4 and an 8 mg oral dose is approximately 99%.
Rosiglitazon Absorpcija Absolutna biološka uporabnost rosiglitazona po zaužitju tako 4 mg kot 8 mg peroralnega odmerka znaša približno 99%.
Administration of rosiglitazone with food resulted in no change in overall exposure (AUC), although a small decrease in Cmax (approximately 20-28%) and a delay in tmax (approximately 1.75 h) were observed compared to dosing in the fasting state.
14 Če se rosiglitazon zaužije s hrano, ne pride do spremembe celotne izpostavljenosti organizma (AUC), čeprav so v primerjavi z zaužitjem na tešče opazili manjše zmanjšanje Cmax (za približno 20 do 28%) in zakasnitev tmax (za približno 1, 75 ure).
The absorption of rosiglitazone is not affected by increases in gastric pH.
Zvišanje želodčne pH- vrednosti ne vpliva na absorpcijo rosiglitazona.
Distribution The volume of distribution of rosiglitazone is approximately 14 l in healthy volunteers.
Porazdelitev Pri zdravih prostovoljcih je volumen porazdelitve rosiglitazona znašal približno 14 litrov.
Plasma protein binding of rosiglitazone is high (approximately 99.8%) and is not influenced by concentration or age.
Stopnja vezave rosiglitazona na plazemske proteine je visoka (približno 99, 8%) in nanjo ne vplivata koncentracija zdravila ali bolnikova starost.
The protein binding of the major metabolite (a para-hydroxy-sulphate) is very high (> 99.99%).
Stopnja vezave glavnega metabolita (parahidroksisulfata) na proteine je zelo visoka (> 99, 99%).
Metabolism Metabolism of rosiglitazone is extensive with no parent compound being excreted unchanged.
Presnova Presnova rosiglitazona je zelo obsežna, saj se nobena začetna sestavina ne izloči v nespremenjeni obliki.
The major routes of metabolism are N-demethylation and hydroxylation, followed by conjugation with sulphate and glucuronic acid.
Glavni presnovni poti sta N- demetilacija in hidroksilacija, ki jima sledi konjugacija s sulfatom in z glukuronsko kislino.
Rosiglitazone showed moderate inhibition of CYP2C8 (IC50 18 µM) and low inhibition of CYP2C9 (IC50 50 µM) in vitro (see section 4.5).
Rosiglitazon je in vitro pokazal zmerno inhibicijo CYP2C8 (IC50 18 μM) in majhno inhibicijo CYP2C9 (IC50 50 μM) (glejte poglavje 4. 5).
Elimination Total plasma clearance of rosiglitazone is around 3 l/ h and the terminal elimination half-life of rosiglitazone is approximately 3-4 h.
Izločanje Celoten očistek rosiglitazona iz plazme znaša okoli 3 l/ uro, končna razpolovna doba izločanja rosiglitazona pa je približno 3 do 4 ure.
The major route of excretion is the urine with approximately two-thirds of the dose being eliminated by this route, whereas faecal elimination accounts for approximately 25% of dose.
Glavna pot izločanja je z urinom, s katerim se izločita približno dve tretjini zaužitega odmerka, medtem ko izločanje s fecesem predstavlja približno 25% zaužitega odmerka.
Accumulation of the metabolites in plasma is expected upon repeated dosing, especially that of the major metabolite (a para-hydroxy-sulphate) for which an 8-fold accumulation is anticipated.
Pri večkratnem jemanju odmerkov je pričakovati kopičenje metabolitov v plazmi, še posebno kopičenje glavnega metabolita (parahidroksisulfata), za katerega se pričakuje 8- kratna akumulacija.
Special populations Gender:
Posebne skupine bolnikov Spol:
In the pooled population pharmacokinetic analysis, there were no marked differences in the pharmacokinetics of rosiglitazone between males and females.
Pri preučevanju farmakokinetike znotraj posameznih skupin bolnikov ni bilo opaznih razlik med farmakokinetičnimi lastnostmi rosiglitazona pri moških in ženskah.
In the pooled population pharmacokinetic analysis, age was not found to influence the pharmacokinetics of rosiglitazone to any significant extent.
Pri preučevanju farmakokinetike znotraj posameznih skupin bolnikov niso opazili, da bi starost kakor koli pomembneje vplivala na farmakokinetiko rosiglitazona.
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.
Populacijska farmakokinetična analiza pri 96 otrocih, starih od 10 do 18 let in težkih od 35 do 178 kg je pokazala, da je srednji navidezni očistek (CL/ F) pri otrocih podoben kot pri odraslih.
Individual CL/ F in the paediatric population was in the same range as individual adult data.
Pri posameznem otroku je bil navidezni očistek v istem razponu kot podatki za posameznega odraslega bolnika.
CL/ F seemed to be independent of age, but increased with weight in the paediatric population.
Navidezni očistek pri otrocih dozdevno ni odvisen od starosti, vendar pa se veča s telesno maso.
14 Hepatic impairment:
15 Oslabljeno delovanje jeter:
In cirrhotic patients with moderate (Child-Pugh B) hepatic impairment, unbound Cmax and AUC were 2- and 3-fold higher than in normal subjects.
Pri bolnikih s cirozo in z zmerno oslabljenim delovanjem jeter (Child- Pugh B) sta bili Cmax in AUC nevezane učinkovine 2 - do 3- krat višji kot pri zdravih osebah.
The inter-subject variability was large, with a 7-fold difference in unbound AUC between patients.
Razlike med posamezniki so bile zelo velike, AUC nevezane učinkovine se je razlikoval tudi do 7- krat.
There are no clinically significant differences in the pharmacokinetics of rosiglitazone in patients with renal impairment or end stage renal disease on chronic dialysis.
Pri bolnikih z oslabljenim delovanjem ledvic ali v zadnjem stadiju ledvične bolezni in s kronično dializo niso zasledili klinično pomembnih razlik v farmakokinetiki rosiglitazona.
Metformin Absorption After an oral dose of metformin, tmax is reached in 2.5 h.
Metformin Absorpcija Po peroralnem odmerku metformina je tmax dosežen v 2, 5 urah.
At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ ml.
Pri običajnih odmerkih in shemah odmerjanja metformina je plazemska koncentracija v stanju dinamičnega ravnovesja dosežena v 24 do 48 urah, na splošno pa je manjša od 1 μg/ ml.
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/ ml, even at maximum doses.
V kontroliranih kliničnih preskušanjih, celo pri največjih dovoljenih odmerkih, maksimalna koncentracija metformina v plazmi (Cmax) ni presegla 4 μg/ ml.
Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
Po dajanju odmerka 850 mg je bila opažena za 40% manjša največja plazemska koncentracija, za 25% zmanjšana AUC in 35- minutno podaljšanje pri doseganju največje plazemske koncentracije.
Distribution Plasma protein binding is negligible.
Porazdelitev Vezava na plazemske proteine je zanemarljiva.
Elimination Renal clearance of metformin is > 400 ml/ min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Izločanje Ledvični očistek metformina je > 400 ml/ min, kar kaže na izločanje metformina z glomerularno filtracijo in tubulno sekrecijo.
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h.
Po peroralnem odmerku je bila končna razpolovna doba izločanja približno 6, 5 ur.
An increase in plasma volume accompanied by decrease in red cell parameters and increase in heart weight.
Rosiglitazon Neželeni učinki, ki so bili opaženi pri raziskavah na živalih in bi utegnili imeti posledice za klinično uporabo zdravila, so naslednji: porast volumna plazme, ki ga spremlja znižanje števila eritrocitov in povečanje mase srca.
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).
Poleg tega je rosiglitazon zaviral sintezo estradiola in progesterona v jajčnikih in zmanjševal koncentracijo obeh hormonov v plazmi, kar je posledično vplivalo na estrusne/ menstrualne cikluse in plodnost (glejte poglavje 4. 4).
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.
16 Pri živalskem modelu za familiarno adenomatozno polipozo (FAP) je zdravljenje z rosiglitazonom, ki so ga dajali v 200- kratni količini farmakološko aktivnega odmerka, povečalo število tumorjev v debelem črevesu.
However, rosiglitazone promoted differentiation and reversal of mutagenic
Rosiglitazon je in vitro pospeševal diferenciacijo in preobrat mutagenih sprememb v rakavih celicah humanega debelega črevesa.
Metformin 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.
Metformin 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.
Sodium starch glycollate Hypromellose (E464) Microcrystalline cellulose (E460) Lactose monohydrate Povidone (E1201) Magnesium stearate.
Jedro tablete: natrijev karboksimetilškrob hipromeloza (E464) mikrokristalna celuloza (E460) laktoza monohidrat povidon (E1201) magnezijev stearat
Hypromellose (E464) Titanium dioxide (E171) Macrogol Iron oxide yellow (E172).
Filmska obloga: hipromeloza (E464) titanov dioksid (E171) makrogol rumeni železov oksid (E172)
Opaque blisters (PVC/ PVdC/ aluminium).
Neprozorni pretisni omoti (PVC/ PVdC/ aluminij).
20 October 2003 Date of latest renewal:
20. oktober 2003 Datum podaljšanja dovoljenja za promet:
AVANDAMET 2 mg/ 500 mg film-coated tablets
AVANDAMET 2 mg/ 500 mg filmsko obložene tablete
Pale pink film-coated tablets marked "gsk" on one side and "2/ 500" on the other.
Bledo rožnate filmsko obložene tablete z oznako "gsk" na eni strani in "2/ 500" na drugi strani.
Patients with renal impairment AVANDAMET should not be used in patients with renal failure or renal dysfunction e. g. serum creatinine levels > 135 μ mol/ l in males and > 110 μ mol/ l in females and/ or creatinine clearance < 70 ml/ min (see sections 4.3 and 4.4).
Bolniki z oslabljenim delovanjem ledvic AVANDAMET se ne sme uporabljati pri bolnikih z ledvično odpovedjo ali ledvično disfunkcijo, npr. pri moških s koncentracijo kreatinina v serumu > 135 μmol/ l ter ženskah s serumsko koncentracijo kreatinina > 110 μmol/ l in/ ali z očistkom kreatinina < 70 ml/ min (glejte poglavji 4. 3 in 4. 4).
- hypersensitivity to rosiglitazone, metformin hydrochloride or to any of the excipients
- preobčutljivosti za rosiglitazon, za metforminijev klorid ali za katero koli pomožno snov;
IV)
Association (NYHA) stadiji I do IV)
4.4 Special warnings and precautions for use
dehidracija hude okužbe šok intravaskularna uporaba jodiranih kontrastnih sredstev (glejte poglavje 4. 4);
20 Acute Coronary Syndrome (ACS) Patients experiencing an ACS have not been studied in rosiglitazone controlled clinical trials.
Akutni koronarni sindrom (AKS) V nadzorovanih kliničnih preskušanjih uporabe rosiglitazona pri bolnikih z AKS niso raziskovali.
Surgery As AVANDAMET contains metformin hydrochloride, the treatment should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.
22 Kirurgija Ker AVANDAMET vsebuje metforminijev klorid, je potrebno zdravljenje prekiniti 48 ur pred načrtovanim operativnim posegom v splošni anesteziji, z njim pa običajno ne smemo nadaljevati prej kot v 48 urah po posegu.
21 Bone disorders In a long-term study an increased incidence of bone fractures (foot, hand and arm) was observed in female patients taking rosiglitazone as monotherapy (see section 4.8).
Bolezni kosti V dolgotrajni študiji so pri bolnicah, ki so jemale rosiglitazon kot samostojno zdravilo, opazili večjo pojavnost zlomov kosti (nog, rok in nadlakti) (glejte poglavje 4. 8).
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%.
23 sta se, pri dajanju cimetidina v odmerku 400 mg dvakrat na dan, sistemska izpostavljenost (AUC) metforminu in Cmax metformina povečali, in sicer AUC za 50%, Cmax pa za 81%.
22 Co-administration of rosiglitazone with rifampicin (an inducer of CYP2C8) resulted in a 66% decrease in rosiglitazone plasma concentrations.
Sočasno dajanje rosiglitazona in rifampicina (induktorja CYP2C8) je posledično za 66% zmanjšalo koncentracije rosiglitazona v plazmi.
Both rosiglitazone and metformin have been detected in the milk of experimental animals.
24 Tako rosiglitazon kot metformin so zasledili v mleku poskusnih živali.
23 Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
V nadaljevanju so neželeni učinki za vsakega od režimov zdravljenja navedeni glede na organski sistem in absolutno pogostnost.
24 Table 1.
25 Preglednica 1.
Blood and the lymphatic system disorders Anaemia granulocytopaenia
Bolezni krvi in limfatičnega sistema anemija granulocitopenija
Hyperlipaemia weight increase increased appetite
hiperlipemija povečanje telesne mase povečanje apetita
Gastrointestinal disorders Constipation
obstipacija
In a placebo-controlled one-year trial in patients with congestive heart failure NYHA class I-II, worsening or possible worsening of heart failure occurred in 6.4% of patients treated with rosiglitazone, compared with 3.5% on placebo.
26 Pri s placebom nadzorovanem enoletnem preskušanju pri bolnikih s kongestivnim srčnim popuščanjem (NYHA razred I- II) se je poslabšanje ali možno poslabšanje srčnega popuščanja pojavilo pri 6, 4% bolnikov, ki so prejemali rosiglitazon in 3, 5% bolnikov, ki so prejemali placebo.
25 3 In a retrospective analysis of data from 42 pooled short-term clinical studies, the overall incidence of events typically associated with cardiac ischaemia was higher for rosiglitazone containing regimens, 1.99% versus combined active and placebo comparators, 1.51% [Hazard ratio 1.31 (95% confidence interval 1.01 - 1.70)].
3 Pri retrospektivni analizi podatkov iz 42 združenih kratkotrajnih kliničnih študij je bila celotna pojavnost dogodkov, tipično povezanih s srčno ishemijo, višja pri režimih zdravljenja z rosiglitazonom (1, 99%) kot pri primerjalni kombinaciji učinkovine in placeba (1, 51%) [razmerje tveganja 1, 31 (95% interval zaupanja; 1, 01 - 1, 70)].
Table 2.
Po pridobitvi dovoljenja za uporabo rosiglitazona so poleg neželenih učinkov, odkritih med kliničnimi preskušanji poročali še o neželenih učinkih, ki so navedene v preglednici 2.
Angioedema skin reactions (e. g. urticaria, pruritis, rash) 5
Bolezni kože in podkožja (glejte Bolezni imunskega sistema) angioedem kožne reakcije (npr. urtikarija, srbenje, izpuščaj) 5
urticaria Erythema Pruritis 6
urtikarija rdečina srbenje 6
27 5.1 Pharmacodynamic properties
5. 1 Farmakodinamične lastnosti
Combinations of oral blood glucose lowering medicinal products, ATC code:
Kombinacije bigvanidnih in sulfonamidnih antidiabetikov, Oznaka ATC: