natgillin/translations-raw huggingface dataset:
The studies measured the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
V študijah so merili koncentracijo snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je glukoza v krvi nadzorovana.
What benefit has Avaglim shown during the studies?
Kakšne koristi je zdravilo Avaglim izkazalo med študijami?
In all four studies, the combination of rosiglitazone and glimepride was shown to be more effective than either of its components used on its own in lowering the levels of HbA1c.
V vseh štirih študijah se je kombinacija rosiglitazona in glimepirida pri zniževanju ravni HbA1c izkazala za učinkovitejšo kot katera koli ob obeh učinkovin, uporabljena sama.
The most common side effects of Avaglim (seen in more than 1 patient in 10) are hypoglycaemia and oedema (swelling).
Najpogostejša neželena učinka pri uporabi zdravila Avaglim (opažena pri več kot 1 bolniku od 10) sta hipoglikemija in edem (oteklina).
It should also not be used in patients with insulin-dependent diabetes or who have complications of diabetes (diabetic ketoacidosis or diabetic coma).
Uporabljati ga ne smejo bolniki s srčnim popuščanjem, „ akutnim koronarnim sindromom “, kot so nestabilna angina pektoris (huda vrsta bolečine v prsih, katere jakost se naglo spreminja) ali določene oblike srčnega napada, težavami z jetri in hudimi obolenji ledvic. prav tako ga ne smejo uporabljati bolniki, ki imajo od insulina odvisno sladkorno bolezen ali bolniki z zapletom sladkorne bolezni (diabetično ketoacidozo ali diabetično komo).
Avaglim doses may need to be adjusted when given with certain other medicines such as gemfibrozil or rifampicin.
Odmerke zdravila Avaglim bo morda treba prilagoditi, če se hkrati jemljejo tudi katera druga zdravila (kot na primer gemfibrozil ali rifampicin).
The Committee for Medicinal Products for Human Use (CHMP) concluded that the effectiveness of adding rosiglitazone to sulphonylureas, especially glimepiride, had been shown sufficiently.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da je bila učinkovitost dodajanja rosiglitazona sulfonilsečninam, zlasti glimepiridu, zadostno dokazana.
The Committee decided that Avaglim’ s benefits are greater than its risks for the treatment of type 2 diabetes in patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.
Odbor je odločil, da so koristi zdravila Avaglim pri zdravljenju sladkorne bolezni tipa 2 pri bolnikih, pri katerih z optimalnim odmerkom samostojnega zdravljenja s sulfonilsečnino ni mogoče doseči zadostnega glikemičnega nadzora, in pri bolnikih, za katere metformin ni primeren, ker je pri njih kontraindiciran ali ga ne prenašajo, večje od z njim povezanih tveganj.
The Committee recommended that Avaglim be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Avaglim odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the EU for Avaglim to SmithKline Beecham plc on 27 June 2006.
Evropska komisija je dovoljenje za promet z zdravilom Avaglim, veljavno po vsej EU, odobrila družbi SmithKline Beecham plc dne 27. junija 2006.
This summary was last updated in 03-2008.
Povzetek je bil nazadnje posodobljen 03- 2008.
AVAGLIM 4 mg/ 4 mg film-coated tablets.
AVAGLIM 4 mg/ 4 mg filmsko obložene tablete
- contains lactose (approximately 104 mg)
- vsebuje laktozo (približno 104 mg).
Pink, rounded triangular tablet with “ gsk” debossed on one side and “ 4/ 4” on the other side.
Rožnate, zaokrožene trikotne tablete z vtisnjeno oznako "gsk" na eni strani in "4/ 4" na drugi.
Before therapy is initiated with AVAGLIM appropriate clinical evaluation should be made to assess the patient’ s risk of developing hypoglycaemia (see section 4.4).
Pred uvedbo terapije z AVAGLIMOM je treba ustrezno klinično oceniti bolnikovo ogroženost s hipoglikemijami (glejte poglavje 4. 4).
The starting dose is 4 mg/ day rosiglitazone plus 4 mg/ day glimepiride (given as one tablet AVAGLIM 4 mg/ 4 mg).
Začetni odmerek je 4 mg/ dan rosiglitazona in 4 mg/ dan glimepirida (uporabljenih v obliki ene tablete AVAGLIM 4 mg/ 4 mg).
Patients unable to achieve glycaemic control on at least half-maximum dose of other sulphonylurea monotherapy (except chlorpropamide, see section 4.4).
Bolniki, ki ne morejo doseči urejenosti glikemije z vsaj polovico največjega odmerka druge sulfonilsečnine v monoterapiji (razen klorpropamida, glejte poglavje 4. 4).
Once glycaemic control is stable at these doses, AVAGLIM may be introduced at a starting dose of 4 mg rosiglitazone/ 4 mg glimepiride once daily.
Ko je glikemija s temi odmerki urejena, je mogoče uvesti AVAGLIM v začetnem odmerku 4 mg rosiglitazona/ 4 mg glimepirida enkrat na dan.
The maximum recommended daily dose is 8 mg rosiglitazone/ 4 mg glimepiride (given as one AVAGLIM tablet 8 mg/ 4 mg, once daily).
Največji priporočeni dnevni odmerek je 8 mg rosiglitazona/ 4 mg glimepirida (v obliki ene tablete AVAGLIM 8 mg/ 4 mg enkrat na dan).
An increase in the rosiglitazone component to 8 mg/ day should be undertaken
Pri povečanju odmerka rosiglitazona na 8 mg/ dan je potrebna previdnost.
2 cautiously following appropriate clinical evaluation to assess the patient’ s risk of developing adverse reactions relating to fluid retention (see 4.4 and 4.8).
2 povezanih z zastajanjem tekočine (glejte poglavji 4. 4 in 4. 8).
Elderly Due to the potential for decreased renal function the initiation and maintenance of therapy with AVAGLIM in elderly patients should be under close medical supervision due to an increased susceptibility to hypoglycaemia (see section 4.4).
Starejši Pri starejših bolnikih mora uvedba in vzdrževanje terapije z AVAGLIMOM zaradi možnosti zmanjšanega delovanja ledvic potekati pod natančnim zdravniškim nadzorom, ker obstaja večja dovzetnost za hipoglikemijo (glejte poglavje 4. 4).
Patients with renal impairment Mild or moderate renal impairment (creatinine clearance 30 to 80 ml/ min):
Bolniki z okvaro ledvic Blaga ali zmerna okvara ledvic (očistek kreatinina od 30 do 80 ml/ min):
- Patients changing to AVAGLIM from sulphonylurea therapies other than glimepiride may be at
- Bolnike, ki preidejo na AVAGLIM z drugih sulfonilsečnin kot z glimepirida, lahko bolj ogroža
an increased risk of hypoglycaemia (see section 4.4).
hipoglikemija (glejte poglavje 4. 4).
AVAGLIM is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 ml/ min, see section 4.3).
AVAGLIM je kontraindiciran pri bolnikih s hudo okvaro ledvic (očistek kreatinina manj kot 30 ml/ min, glejte poglavje 4. 3).
Patients with hepatic impairment AVAGLIM is contraindicated in patients with hepatic impairment (see section 4.3).
Bolniki z okvaro jeter AVAGLIM je kontraindiciran pri bolnikih z okvaro jeter (glejte poglavje 4. 3).
Children and adolescents AVAGLIM is not recommended for use in children below 18 years of age as there are no data available on its safety and efficacy.
Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba AVAGLIMA pri otrocih mlajših od 18 let ni priporočljiva.
− hypersensitivity to rosiglitazone, glimepiride, other sulphonylureas or sulphonamides or to any of the excipients − cardiac failure or history of cardiac failure (NYHA class I to IV) − an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) (see section 4.4) − hepatic impairment − severe renal impairment i. e. creatinine clearance less than 30 ml/ min (including renal dialysis). − insulin dependant diabetes − diabetic ketoacidosis or diabetic coma.
– preobčutljivostjo za rosiglitazon, glimepirid, druge sulfonilsečnine ali sulfonamide ali za katero koli pomožno snov, – srčnim popuščanjem ali anamnezo srčnega popuščanja (razred od I do IV po NYHA), – akutnim koronarnim sindromom (nestabilna angina pektoris, NSTEMI in STEMI) (glejte poglavje 4. 4), – okvaro jeter, – hudo okvaro ledvic, tj. očistkom kreatinina manj kot 30 ml/ min (vključno z dializo), – diabetesom, odvisnim od insulina, – diabetično ketoacidozo ali diabetično komo.
Hypoglycaemia Patients receiving AVAGLIM may be at risk of dose-related hypoglycaemia (see section 4.8).
Hipoglikemija Bolnike, ki dobivajo AVAGLIM, lahko ogroža z odmerkom povezana hipoglikemija (glejte poglavje 4. 8).
If risk factors for hypoglycaemia are present (including renal insufficiency, low body weight, malnourishment, co-administration with certain other medicinal products (see section 4.5) or if the patient’ s life-style changes) it may be necessary to revert to concomitant therapy and down titrate the glimepiride dose.
Če so prisotni dejavniki tveganja za hipoglikemijo (vključno z insuficienco ledvic, nizko telesno maso, nezadostno prehranjenostjo, sočasno uporabo določenih drugih zdravil (glejte poglavje 4. 5) ali če se bolnikov način življenja spremeni) utegne biti potrebna vrnitev na sočasno terapijo in zmanjšanje odmerka glimepirida.
A switch to insulin should be considered in stress situations (e. g. trauma, surgery, infections).
V stresnih okoliščinah (npr. poškodba, operacija, okužbe) pride v poštev prehod na insulin.
3 Fluid retention and cardiac failure Thiazolidinediones can cause fluid retention which may exacerbate or precipitate signs or symptoms of congestive heart failure.
3 Tiazolidindioni lahko povzročijo zastajanje tekočine, ki lahko poslabša ali povzroči znake ali simptome kongestivnega srčnega popuščanja.
Combination with insulin An increased incidence of cardiac failure has been observed in clinical trials when rosiglitazone is used in combination with insulin.
Kombinacija z insulinom V kliničnih preskušanjih so pri uporabi rosiglitazona v kombinaciji z insulinom poročali o večji pojavnosti srčnega popuščanja.
Myocardial Ischaemia The available data indicate that treatment with rosiglitazone may be associated with an increased risk of myocardial ischaemic events (see section 4.8).
Ishemija miokarda Razpoložljivi podatki kažejo, da je zdravljenje z rosiglitazonom lahko povezano z večjim tveganjem za pojav ishemičnih miokardnih dogodkov (glejte poglavje 4. 8).
There are limited clinical trial data in patients with ischaemic heart disease and/ or peripheral arterial disease.
Podatki iz kliničnih preskušanj pri bolnikih z ishemično boleznijo srca in/ ali boleznijo perifernih arterij so pomanjkljivi.
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.
In view of the potential for development of heart failure in these patients, rosiglitazone should therefore not be initiated in patients having an acute coronary event and it should be discontinued during the acute phase (see section 4.3).
Glede na možno tveganje za pojav srčnega popuščanja pri teh bolnikih, se zdravljenja z rosiglitazonom ne sme uvesti pri bolnikih, ki imajo akutni koronarni dogodek, oziroma je treba zdravljenje med akutno fazo prekiniti (glejte poglavje 4. 3).
Monitoring of liver function There have been rare reports of hepatocellular dysfunction during post-marketing experience with rosiglitazone (see section 4.8).
Nadzor delovanja jeter Med obdobjem pomarketinške uporabe rosiglitazona so poročali o redkih primerih motenega delovanja jetrnih celic (glejte poglavje 4. 8).
There is limited experience with rosiglitazone in patients with elevated liver enzymes (ALT > 2.5X upper limit of normal).
Izkušnje pri bolnikih z zvišanimi jetrnimi encimi (ALT > 2, 5- krat zgornja normalna meja) so omejene.
Therapy with AVAGLIM should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5X upper limit of normal) or with any other evidence of liver disease.
Terapije z AVAGLIMOM ne smete uvesti pri bolnikih, ki imajo izhodiščno zvišano raven jetrnih encimov (ALT > 2, 5- kratna zgornja normalna meja) ali kakšne druge znake bolezni jeter.
If ALT levels are increased to > 3X upper limit of normal during rosiglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Če se raven ALT med zdravljenjem z rosiglitazonom zviša na > 3- kratno zgornjo normalno mejo, je treba čim prej znova določiti raven jetrnih encimov.
If ALT levels remain > 3X the upper limit of normal, therapy should be discontinued.
Če raven ALT ostaja > 3- kratno zgornjo normalno mejo, je treba zdravljenje prekiniti.
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.
Če se pojavijo simptomi, ki nakazujejo moteno delovanje jeter – med takšnimi so lahko nepojasnjena navzeja, bruhanje, bolečine v trebuhu, utrujenost, anoreksija in/ ali temen urin – je treba preveriti jetrne encime.
Eye disorders Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including rosiglitazone.
Očesne bolezni Po pridobitvi dovoljenja za promet so, pri uporabi tiazolidindionov, vključno z rosiglitazonom, poročali o primerih na novo nastalega diabetičnega edema makule z zmanjšano ostrino vida ali njegovega poslabšanja.
It is unclear whether or not there is a direct association between rosiglitazone and macular oedema but prescribers should be alert to the possibility of macular
Neposredna povezava med uporabo rosiglitazona in edemom makule sicer ni pojasnjena, vendar pa se morajo predpisovalci zavedati, da pri bolnikih z motnjami ostrine vida obstaja možnost pojava edema makule.
4 oedema if patients report disturbances in visual acuity and appropriate ophthalmologic referral should be considered.
V takšnih primerih morajo pridobiti ustrezno mnenje okulista.
Patients with renal impairment Patients with mild or moderate renal impairment (creatinine clearance 30 to 80 ml/ min) may be at an increased risk of hypoglycaemia (see sections 4.2, 4.3 and 4.4).
4 Bolniki z okvaro ledvic Bolnike z blago ali zmerno okvaro ledvic (očistek kreatinina od 30 do 80 ml/ min) lahko bolj ogroža hipoglikemija (glejte poglavja 4. 2, 4. 3 in 4. 4).
Premenopausal anovulatory women Premenopausal women have received rosiglitazone during clinical studies.
Ženske pred menopavzo brez ovulacije V kliničnih študijah so rosiglitazon dobivale ženske pred menopavzo.
Although hormonal imbalance has been seen in preclinical studies (see section 5.3), no significant undesirable effects associated with menstrual disorders have been observed.
V predkliničnih študijah (glejte poglavje 5. 3) so sicer opazili hormonsko neravnovesje, ne pa pomembnih neželenih učinkov, kar zadeva motnje menstruacije.
Patients should be aware of the risk of pregnancy (see section 4.6).
Bolnice se morajo zavedati tveganja nosečnosti (glejte poglavje 4. 6).
Weight gain In clinical trials with rosiglitazone there was evidence of dose-related weight gain, which was greater when used in combination with insulin.
Povečanje telesne mase V kliničnih preskušanjih z rosiglitazonom so ugotovili z odmerkom povezano povečanje telesne mase, ki je bilo pri uporabi v kombinaciji z insulinom večje.
Haematological monitoring Rosiglitazone treatment is associated with a dose-related reduction of haemoglobin levels.
Hematološko spremljanje Zdravljenje z rosiglitazonom spremlja z odmerkom povezano znižanje koncentracije hemoglobina.
Treatment of patients with G6PD-deficiency with sulphonylurea agents can lead to haemolytic anaemia.
Zdravljenje bolnikov, ki imajo pomanjkanje glukoze- 6- fosfat- dehidrogenaze (G6PD), z učinkovinami iz skupine sulfonilsečnin lahko vodi do hemolitične anemije.
Since glimepiride belongs to the chemical class of sulphonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulphonylurea alternative should be considered.
Ker glimepepirid sodi v kemijsko skupino zdravil, imenovanih sulfonilsečnine, je potrebna previdnost pri bolnikih s pomanjkanjem glukoze- 6- fosfat- dehidrogenaze in je potrebno pretehtati o možnosti zdravljenja z zdravili, ki ne sodijo v skupino sulfonilsečnin.
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).
This increased incidence was noted after the first year of treatment and remained during the course of the study.
Pojavnost je ostala večja ves čas trajanja študije.
Glimepiride should be used with caution during concomitant administration of CYP2C9 inhibitors (e. g. fluconazole) or inducers (see section 4.5).
Uporaba z drugimi zdravili Rosiglitazon je treba uporabljati previdno med sočasnim zdravljenjem z zaviralci CYP2C8 (npr. gemfibrozilom) ali njegovimi induktorji (npr. rifampicinom), glimepirid pa med sočasnim zdravljenjem z zaviralci CYP2C9 (npr. flukonazolom) ali njegovimi induktorji (glejte poglavje 4. 5).
Lactose intolerance AVAGLIM tablets contain lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Intoleranca za laktozo Tablete AVAGLIM vsebujejo laktozo, zato bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
5 Rosiglitazone In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with CYP2C9 as only a minor pathway.
5 Rosiglitazon Študije in vitro kažejo, da se rosiglitazon presnavlja predvsem s CYP2C8, CYP2C9 pa je le manj pomembna pot.
Close monitoring of glycaemic control should be considered (see section 4.4).
Natančno je treba spremljati urejenost glikemije (glejte poglavje 4. 4).
Co-administration of rosiglitazone with rifampicin (an inducer of CYP2C8) resulted in a 66% decrease in rosiglitazone plasma concentrations.
Sočasna uporaba rosiglitazona in rifampicina (induktorja CYP2C8) je povzročila 66% zmanjšanje koncentracije rosiglitazona v plazmi.
It cannot be excluded that other inducers (e. g. phenytoin, carbamazepine, phenobarbital, St John’ s wort) may also affect rosiglitazone exposure.
Vpliva drugih induktorjev (npr. fenitoina, karbamazepina, fenobarbitala, šentjanževke) ni mogoče izključiti.
Close monitoring of glycaemic control should be considered (see section 4.4).
Potrebno je natančno spremljanje urejenosti glikemije (glejte poglavje 4. 4).
Glimepiride If glimepiride is taken simultaneously with certain other medicines, both undesired increases and decreases in the hypoglycaemic action of glimepiride can occur.
Glimepirid Med sočasno uporabo glimepirida z nekaterimi drugimi zdravili se lahko pojavi tako neželeno povečanje kot zmanjšanje učinka glimepirida na znižanje krvnega sladkorja.
Its metabolism is known to be influenced by concomitant administration of CYP2C9 inducers (e. g. rifampicin) or inhibitors (e. g. fluconazole
Znano je, da na njegovo presnovo vpliva sočasna uporaba induktorjev CYP2C9 (npr. rifampicina) ali zaviralcev CYP2C9 (npr. flukonazola).
Results from an vivo interaction study reported in literature show that glimepiride AUC is increased approximately 2-fold by fluconazole, one of the most potent CYP2C9 inhibitors.
Rezultati interakcijske študije in vivo, opisani v literaturi, kažejo, da flukonazol (eden najmočnejših zaviralcev CYP2C9) približno 2- krat poveča AUC glimepirida.
Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur when one of the following drugs is taken, for example:
Takšna zdravila so npr.:
phenylbutazone, azapropazon and oxyfenbutazone, insulin and oral antidiabetic products, metformin, salicylates and p-amino-salicylic acid, anabolic steroids and male sex hormones, chloramphenicol, coumarin anticoagulants, fenfluramine, fibrates, ACE inhibitors, fluoxetine, allopurinol, sympatholytics, cyclo-, tro-and iphosphamides,
fenilbutazon, azapropazon ali oksifenbutazon, insulin in peroralni antidiabetiki, metformin, salicilati in p- aminosalicilna kislina, anabolni steroidi in moški spolni hormoni, kloramfenikol, kumarinski antikoagulansi, fenfluramin, fibrati, zaviralci ACE, fluoksetin, alopurinol, simpatikolitiki, ciklo -, tro - in ifosfamidi,
sulphinpyrazone, certain long acting sulphonamides, tetracyclines, MAO-inhibitors, quinolone antibiotics, probenecid, miconazol, pentoxifylline (high dose parenteral), tritoqualine, fluconazole.
sulfinpirazon, nekateri dolgodelujoči sulfonamidi, tetraciklini, zaviralci MAO, kinolonski antibiotiki, probenecid, mikonazol, pentoksifilin (velik parenteralen odmerek), tritokalin, flukonazol.
6 Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur when one of the following drugs is taken, for example:
Takšna zdravila so npr.:
oestrogens and progestagens, saluretics, thiazide diuretics, thyroid stimulating agents, glucocorticoids, phenothiazine derivatives, chlorpromazine, adrenaline and sympathicomimetics, nicotinic acid (high dosages) and nicotinic acid derivatives, laxatives (long term use), phenytoin, diazoxide, glucagon, barbiturates and rifampicin, acetozolamide.
estrogeni in progestogeni, saluretiki, tiazidni diuretiki, sredstva, ki stimulirajo ščitnico, glukokortikoidi, fenotiazinski derivati, klorpromazin, adrenalin in simpatikomimetiki, nikotinska kislina (veliki odmerki) in derivati nikotinske kisline, odvajala (dolgotrajna uporaba), fenitoin, diazoksid, glukagon, barbiturati in rifampicin, acetazolamid.
Therefore, AVAGLIM should not be used during pregnancy and the use of insulin is recommended.
Priporočljiva je uporaba insulina.
Nevertheless, the potential for hypoglycaemia should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (e. g. driving).
Pri ocenjevanju bolnikove zmožnosti za izvajanje opravil, ki zahtevajo presojo in motorične ali kognitivne sposobnosti (npr. upravljanje vozil), je kljub temu treba upoštevati možnost hipoglikemije.
An adverse reaction is only presented for the fixed dose combination if it has not been seen in one of the component parts of AVAGLIM or if it occurred at a higher frequency than that listed for a component part.
AVAGLIM Podatki dvojno slepih študij potrjujejo, da so varnostne značilnosti skupaj uporabljenega rosiglitazona in glimepirida podobne kombiniranim značilnostim neželenih učinkov obeh zdravilnih učinkovin.
7 AVAGLIM Data from double-blind studies confirm that the safety profile of concomitant rosiglitazone and glimepiride is similar to that of the combined adverse reaction profile for the two active substances.
7 Rosiglitazon
Clinical trial data Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
Podatki iz kliničnih preskušanj V nadaljevanju so neželeni učinki za vsakega od režimov zdravljenja navedeni glede na organski sistem in absolutno pogostnost.
Frequencies are defined as: very common ≥ 1/ 10; common ≥ 1/ 100, < 1/ 10; and uncommon ≥ 1/ 1000, < 1/ 100.
Pogostnost je definirana kot: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100, < 1/ 10) in občasni (≥ 1/ 1. 000, < 1/ 100).
Table 1 lists adverse reactions identified from an integrated clinical trial population of over 5,000 rosiglitazone-treated patients.
Preglednica 1.
Blood and the lymphatic system disorders anaemia leucopaenia thrombocytopaenia
Bolezni krvi in limfatičnega sistema anemija levkopenija trombocitopenija
Common Common Common
Pogosti Pogosti Pogosti
Metabolism and nutrition disorders hypercholesterolaemia1 hypertriglyceridaemia hyperlipaemia weight increase increased appetite hypoglycaemia
hiperholesterolemija1 hipertrigliceridemija hiperlipemija povečanje telesne mase povečanje apetita hipoglikemija
Common Common Common Common Common
Pogosti Pogosti Pogosti Pogosti Pogosti
Common Common Common Common Uncommon Very common
Pogosti Pogosti Pogosti Pogosti Občasni Zelo pogosti
dizziness*
omotica *