natgillin/translations-raw huggingface dataset:
cardiac ischaemia3*
srčna ishemija3 *
constipation
obstipacija
Musculoskeletal and connective tissue disorders bone fractures4
Bolezni mišično- skeletnega sistema in vezivnega tkiva zlomi kosti4
*The frequency category for the background incidence of this event, as taken from placebo group data from clinical trials, is'common '.
* Kategorija pogostnosti glede na osnovno pojavnost tega dogodka, kot izhaja iz podatkov kliničnih preskušanj pri skupinah s placebom, je 'pogosti'.
1 Hypercholesterolaemia was reported in up to 5.3% of patients treated with rosiglitazone (monotherapy or dual oral therapy).
8 1 O hiperholesterolemiji so poročali pri do 5, 3% bolnikov, ki so se zdravili z rosiglitazonom (monoterapija ali peroralno zdravljenje z dvema zdravilnima učinkovinama).
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.
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.
The incidence of heart failure in combination with insulin (rosiglitazone added to established insulin therapy) was 2.4%, compared to insulin alone, 1.1%.
Pri kombiniranem zdravljenju z insulinom (rosiglitazon, dodan k že vpeljanemu zdravljenju z insulinom) je bila incidenca srčnega popuščanja 2, 4%, pri zdravljenju z insulinom samim pa 1, 1%.
Moreover in patients with congestive heart failure NYHA class I-II, a placebo- controlled one-year trial demonstrated worsening or possible worsening of heart failure in 6.4% of patients treated with rosiglitazone, compared with 3.5% on placebo.
V enoletnem s placebom kontroliranem preskušanju pri bolnikih s kongestivnim srčnim popuščanjem razredov I in II po NYHA so ugotovili poslabšanje ali možno poslabšanje srčnega popuščanja pri 6, 4% prejemnikov rosiglitazona in pri 3, 5% prejemnikov placeba.
This risk was increased when rosiglitazone was added to established insulin and
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)].
9 in patients receiving nitrates for known ischaemic heart disease.
Pri bolnikih, ki so se že zdravili z insulinom, in bolnikih, ki so prejemali nitrate zaradi znane ishemične bolezni srca, se je to tveganje po dodatni uvedbi rosiglitazona povečalo.
In a large observational study where patients were well-matched at baseline, the incidence of the composite endpoint myocardial infarction and coronary revascularization was 17.46 events per 1000 person years for rosiglitazone containing regimens and 17.57 events per 1000 person years for other anti-diabetic agents [Hazard ratio 0.93 (95% confidence interval 0.80 - 1.10)].
V obsežni opazovalni študiji, ki je vključevala bolnike z zelo identičnim zdravstvenim stanjem v izhodišču, je bila pojavnost sestavljenega opazovanega dogodka - miokardnega infarkta in koronarne revaskularizacije - pri režimih zdravljenja z rosiglitazonom 17, 46 dogodkov na 1. 000 oseb- let (“ person years ”), pri drugih antidiabetikih pa 17, 57 dogodkov na 1. 000 oseb- let [razmerje tveganja 0, 93 (95% interval zaupanja; 0, 80 - 1, 10)].
Three large long-term prospective randomised controlled clinical trials (mean duration 41 months; 14,067 patients), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk.
Tri obsežna, dolgotrajna, prospektivna, randomizirana in nadzorovana klinična preskušanja (srednji čas trajanja 41 mesecev; 14. 067 bolnikov), ki so primerjala rosiglitazon z nekaterimi drugimi odobrenimi peroralnimi antidiabetiki ali s placebom, tega tveganja niso ne potrdila ne ovrgla.
In their entirety, the available data on the risk of myocardial ischaemia are inconclusive.
Razpoložljivi podatki o tveganju za ishemijo miokarda ne omogočajo dokončnih zaključkov.
4 In a long-term randomised (4 to 6 year) monotherapy study in recently diagnosed patients with type 2 diabetes mellitus, an increased incidence of bone fractures was noted after the first year of treatment in female patients taking rosiglitazone (9.3%, 2.7 patients per 100 patient years) vs metformin (5.1%, 1.5 patients per 100 patient years) or glyburide/ glibenclamide (3.5%, 1.3 patients per 100 patient years).
4 V dolgotrajni (4 - do 6- letni) randomizirani študiji samostojnega zdravljenja, izvedeni pri bolnikih z nedavno diagnosticirano sladkorno boleznijo tipa 2, so pri bolnicah, ki so jemale rosiglitazon, po prvem letu zdravljenja opazili večjo pojavnost zlomov kosti (9, 3%, 2, 7 bolnic na 100 bolniških let [“ patient years ”]) v primerjavi z metforminom (5, 1%, 1, 5 bolnic na 100 bolniških let) ali gliburidom/ glibenklamidom (3, 5%, 1, 3 bolnic na 100 bolniških let).
This increased risk remained during the course of the study.
Tveganje je bilo večje ves čas trajanja študije.
The majority of the fractures in the females who received rosiglitazone were reported in the foot, hand and arm.
Pri ženskah, ki so prejemale rosiglitazon, so večinoma poročali o zlomih nog, rok in nadlakti.
In double-blind clinical trials with rosiglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo (0.2%) and less than that of the active comparators (0.5% metformin/ sulphonylureas).
V dvojno slepih kliničnih preskušanjih z rosiglitazonom je bila incidenca zvišanj ALT na več kot trikratno zgornjo normalno mejo enaka kot pri placebu (0, 2%) in manjša kot pri aktivnem primerjalnem zdravilu (0, 5% z metforminom/ sulfonilsečninami).
The incidence of all adverse events relating to liver and biliary systems was < 1.5% in any treatment group and similar to placebo.
Incidenca vseh neželenih pojavov, povezanih s hepatobiliarnim sistemom, je bila v vseh zdravljenih skupinah < 1, 5% in podobna, kot pri placebu.
Post-marketing data In addition to the adverse reactions identified from clinical trial data, the adverse reactions presented in Table 2 have been identified in post approval use of rosiglitazone.
Podatki po pridobitvi dovoljenja za promet Po pridobitvi dovoljenja za promet z rosiglitazonom so poleg neželenih učinkov, odkritih med kliničnimi preskušanji, poročali še o neželenih učinkih, ki so navedeni v preglednici 2.
Frequencies are defined as: rare ≥ 1/ 10,000, < 1/ 1000 and very rare < 1/ 10,000 including isolated reports.
Pogostnost je definirana kot: redki (≥ 1/ 10. 000, < 1/ 1. 000) in zelo redki (< 1/ 10. 000, vključno s posameznimi primeri).
Table 2.
9 Preglednica 2.
anaphylactic reaction
anafilaktična reakcija
Very
Zelo redki
rare
Očesne bolezni
Eye disorders
edem makule
congestive heart failure/ pulmonary oedema
kongestivno srčno popuščanje/ pljučni edem
Skin and subcutaneous tissue disorders (see Immune system disorders) 5
Bolezni kože in podkožja (glejte Bolezni imunskega sistema) 5
angioedema skin reactions (e. g. urticaria, pruritis, rash)
angioedem kožne reakcije (npr. urtikarija, srbenje, izpuščaj)
Rare cases of elevated liver enzymes and hepatocellular dysfunction have been reported.
V pomarketinškem obdobju so bili opisani redki primeri zvišanja jetrnih encimov in motenega delovanja jetrnih celic.
Clinical trial data and post-marketing data Table 3 presents adverse reactions by system organ class and by frequency category based on experience with glimepiride and other sulphonylureas.
Podatki iz kliničnih preskušanj in podatki po pridobitvi dovoljenja za promet V preglednici 3 so navedeni neželeni učinki glede na organski sistem in kategorijo pogostnosti na osnovi izkušenj z glimepiridom in drugimi sulfonilsečninami.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1000) and very rare (< 1/ 10,000 including isolated reports).
Pogostnost je definirana kot: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100, < 1/ 10), občasni (≥ 1/ 1. 000, < 1/ 100), redki (≥ 1/ 10. 000, < 1/ 1. 000) in zelo redki (< 1/ 10. 000, vključno s posameznimi primeri).
Table 3.
10 Preglednica 3.
agranulocytosis granulocytopenia pancytopenia haemolytic anaemia thrombocytopenia leukopenia erythrocytopenia
agranulocitoza granulocitopenija pancitopenija hemolitična anemija trombocitopenija levkopenija eritrocitopenija
Rare Rare Rare Rare Rare Rare Rare
Redki Redki Redki Redki Redki Redki Redki
Immune system disorders6 allergic vasculitis hypersensitivity reactions7
Bolezni imunskega sistema6 alergijski vaskulitis preobčutljivostne reakcije7
Gastrointestinal disorders vomiting diarrhoea nausea abdominal distension abdominal pain abdominal discomfort
Bolezni prebavil bruhanje driska navzea distenzija trebuha bolečine v trebuhu neugodje v trebuhu
Very rare Very rare Very rare Very rare Very rare Very rare
Zelo redki Zelo redki Zelo redki Zelo redki Zelo redki Zelo redki
hepatitis10 impairment of liver function (e. g. with cholestasis and jaundice)
hepatitis10 okvara delovanja jeter (npr. s holestazo in zlatenico)
Skin and subcutaneous tissue disorders11 hypersensitivity of the skin to light
Bolezni kože in podkožja11 preobčutljivost kože na svetlobo
serum sodium decrease 6
znižanje vrednosti natrija v serumu 6
Cross-allergenicity with sulphonylureas, sulphonamides or related substances 7
7 Blage preobčutljivostne reakcije se lahko razvijejo v resne reakcije z dispnejo, padcem krvnega tlaka in včasih šokom.
11 11 Hypersensitivity reactions of the skin may occur as itching, rash and urticaria.
11 Pojavijo se lahko preobčutljivostne reakcije kože, npr. srbenje, izpuščaj ali urtikarija.
4.9 Overdose
11 4. 9 Preveliko odmerjanje
In the event of an overdose, it is recommended that appropriate supportive treatment should be initiated as dictated by the patient’ s clinical status.
V primeru prevelikega odmerjanja je priporočljivo uvesti ustrezno podporno terapijo, kot jo zahteva bolnikovo klinično stanje.
Pharmacotherapeutic group:
Farmakoterapevtska skupina: kombinacije peroralnih antidiabetikov.
Combinations of oral blood glucose lowering drugs, ATC code:
Oznaka ATC:
Thiazolidinediones act primarily by reducing insulin resistance and sulphonylureas act primarily by stimulating release of insulin from functioning pancreatic β -cells.
Primarni učinek tiazolidindionov je zmanjšanje odpornosti proti insulinu, primarni učinek sulfonilsečnin pa spodbujanje sproščanja insulina iz delujočih celic β v pankreasu.
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 jedrnih receptorjev PPARγ (peroksisomski proliferatorski aktivirani receptor gama) in spada med tiazolidindionske antihiperglikemike.
12 Rosiglitazone was associated with increases in weight.
Rosiglitazon je bil povezan s povečanjem telesne mase.
Improved glycaemic control was also associated with significant decreases in free fatty acids.
Boljšo urejenost glikemije je spremljalo tudi pomembno znižanje
At 18 months, in an ongoing long term comparator study, rosiglitazone in dual oral therapy with metformin or a sulphonylurea was non-inferior to the combination of sulphonylurea plus metformin for lowering HbA1c.
V potekajoči 18- mesečni primerjalni študiji rosiglitazon v dvotirni peroralni terapiji z metforminom ali sulfonilsečnino glede znižanja HbA1c ni bil slabši od kombinacije sulfonilsečnine in metformina.
There are no studies completed assessing long-term cardiovascular outcome in patients receiving rosiglitazone.
Dokončanih študij o dolgoročnih srčno- žilnih izidih pri uporabnikih rosiglitazona ni.
Glimepiride Glimepiride is an orally active hypoglycaemic substance belonging to the sulphonylurea group.
Glimepirid Glimepirid je peroralno aktivno antidiabetično zdravilo, ki spada v skupino sulfonilsečnin.
Glimepiride increases the activity of glycosyl-phosphatidylinositol-specific phospholipase C, which may be associated with drug-induced lipogenesis and glycogenesis in isolated fat and muscle cells.
To je morda povezano z indukcijo lipogeneze in glikogeneze, ki jo zdravilo povzroči v izoliranih maščobnih in mišičnih celicah.
Glimepiride inhibits the hepatic glucose production by increasing the intracellular concentration of fructose-2,6 bisphosphate, which in turn inhibits gluconeogenesis.
Glimepirid poveča znotrajcelično koncentracijo fruktoza- 2, 6- bisfosfata, ki zavira glukoneogenezo, in zato zavira nastajanje glukoze v jetrih.
The minimum effective oral dose is approximately 0.6 mg.
Najmanjši učinkoviti peroralni odmerek je približno 0, 6 mg.
In diabetic patients, good metabolic control over 24 hours can be achieved with a single daily dose.
Pri diabetikih je mogoče dobro 24- urno presnovno urejenost doseči z enim samim odmerkom na dan.
Although the hydroxy metabolite of glimepiride caused a small but significant reduction in serum glucose, it accounts for only a minor part of the total drug effect.
Čeprav je hidroksi- presnovek glimepirida povzročil majhno, a pomembno znižanje glukoze v serumu, gre na račun tega le manjši del celotnega učinka zdravila.
13 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
In a bioequivalence study under fasted conditions, the AUC and Cmax of rosiglitazone and the AUC of glimepiride following a single dose of a 4 mg/ 4 mg combination tablet were bioequivalent to concomitant administration of rosiglitazone 4 mg and glimepiride 4 mg.
13 V bioekvivalenčni študiji na tešče sta bila AUC in Cmax rosiglitazona in AUC glimepirida po posamičnem odmerku kombinirane tablete 4 mg/ 4 mg bioekvivalentna sočasni uporabi 4 mg rosiglitazona in 4 mg glimepirida.
In the fed state, the rate and extent of absorption of the rosiglitazone-glimepiride 4 mg/ 4 mg combination were equivalent to concomitant administration of 4 mg rosiglitazone and 4 mg glimepiride.
Na poln želodec sta bila hitrost in obseg absorpcije kombinacije 4 mg/ 4 mg rosiglitazona in glimepirida enakovredna sočasni uporabi 4 mg rosiglitazona in 4 mg glimepirida.
Administration of the 4 mg/ 4 mg combination with food led to an increase in glimepiride exposure compared to that observed on administration in the fasted state.
Uporaba kombinacije 4 mg/ 4 mg s hrano je povzročila povečanje izpostavljenosti glimepiridu v primerjavi z uporabo na tešče.
Glimepiride AUC0-t, AUC0-inf and Cmax were increased by 30%, 19% and 55% respectively, on average.
55%.
For rosiglitazone, Cmax values were decreased by approximately 32% with food.
Vrednosti Cmax rosiglitazona so se s hrano zmanjšale za približno 32%.
The AUC and Cmax of glimepiride increased in a dose-proportional manner following administration of rosiglitazone-glimepiride 4 mg/ 1 mg, 4 mg/ 2 mg, and 4 mg/ 4 mg.
AUC in Cmax glimepirida sta se po uporabi kombinacij 4 mg/ 1 mg, 4 mg/ 2 mg in 4 mg/ 4 mg rosiglitazona in glimepirida povečali sorazmerno odmerku.
Rosiglitazone Absorption Absolute bioavailability of rosiglitazone following both a 4 and an 8 mg oral dose is approximately 99%.
Rosiglitazon Absorpcija Absolutna biološka uporabnost rosiglitazona je po 4- mg in po 8- mg peroralnem odmerku 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 fasted state.
Uporaba rosiglitazona s hrano ni spremenila celotne izpostavljenosti (AUC), zabeležili pa so majhno zmanjšanje Cmax (približno 20– 28%) in zapoznitev tmax (približno 1, 75 ure) v primerjavi z uporabo na tešče.
Distribution The volume of distribution of rosiglitazone is approximately 14 l in healthy volunteers.
Porazdelitev Volumen porazdelitve rosiglitazona je pri zdravih prostovoljcih približno 14 l.
Plasma protein binding of rosiglitazone is high (approximately 99.8%) and is not influenced by concentration or age.
Vezava rosiglitazona na beljakovine v plazmi je visoka (približno 99, 8%) in koncentracija ali starost nanjo ne vplivata.
The protein binding of the major metabolite (a para-hydroxy-sulphate) is very high (> 99.99%).
Vezava glavnega presnovka (parahidroksisulfata) na beljakovine je zelo visoka (> 99, 99%).
Metabolism Metabolism of rosiglitazone is extensive with no parent compound being excreted unchanged.
Presnova Rosiglitazon se v veliki meri presnovi in nič matične spojine se ne izloči nespremenjene.
The major routes of metabolism are N-demethylation and hydroxylation, followed by conjugation with sulphate and glucuronic acid.
Glavni poti presnove sta N- demetilacija in hidroksilacija, ki jima sledi konjugacija s sulfatom in glukuronsko kislino.
14 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.
Rosiglitazon in vitro ne zavira pomembno CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A ali 4A, tako da obstaja le majhna verjetnost za pomembne presnovno pogojene interakcije s snovmi, ki se presnavljajo s temi encimi P450.
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 le zmerno zavrtje CYP2C8 (IK50 18 µM) in majhno zavrtje CYP2C9 (IK50 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 Celotni plazemski očistek rosiglitazona je okrog 3 l/ uro, njegov terminalni razpolovni čas izločanja pa 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.
Tako se izločita približno dve tretjini odmerka, medtem ko gre na račun izločanja v blatu približno 25% odmerka.
The terminal half-life for radioactivity was about 130 h indicating that elimination of metabolites is very slow.
Terminalni razpolovni čas radioaktivnosti je okrog 130 ur, kar
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.
Po večkratnem odmerjanju je treba pričakovati kopičenje presnovkov v plazmi, zlasti kopičenje glavnega presnovka (parahidroksisulfata), za katerega je predvideno 8- kratno kopičenje.
Glimepiride Absorption After oral administration, glimepiride is completely (100%) absorbed from the gastrointestinal tract.
Glimepirid Absorpcija Po peroralni uporabi se glimepirid popolnoma (100%) absorbira iz prebavil.
Studies with single oral doses in normal subjects and with multiple oral doses in patients with type 2 diabetes mellitus have shown significant absorption of glimepiride within 1 h after administration and Cmax at approximately 2.5 h.
Študije s posamičnimi peroralnimi odmerki pri zdravih preiskovancih in z večkratnimi peroralnimi odmerki pri bolnikih z diabetesom mellitusom tipa 2 so pokazale pomembno absorpcijo glimepirida v 1 uri po uporabi in Cmax po približno 2, 5 ure.
Distribution After intravenous dosing in normal subjects, the volume of distribution was 8.8 l (113 ml/ kg), and the total body clearance was 47.8 ml/ min.
Porazdelitev Po intravenski uporabi pri zdravih preiskovancih je bil volumen porazdelitve 8, 8 l (113 ml/ kg), celotni telesni očistek pa 47, 8 ml/ min.
Protein binding was greater than 99.5%.
Vezava na beljakovine je bila več kot 99, 5%.
Metabolism Glimepiride is completely metabolised by oxidative biotransformation after either an intravenous or oral dose.
Presnova Glimepirid se tako po intravenski kot po peroralni uporabi povsem presnovi z oksidativno biotransformacijo.
The major metabolites are the cyclohexyl hydroxy methyl derivative (M1) and the carboxyl derivative (M2).
Glavna presnovka sta cikloheksilhidroksimetil- derivat (M1) in karboksil- derivat (M2).
M1, but not M2, possesses about 1/ 3 of the pharmacological activity as compared to its parent in an animal model.
M1, ne pa tudi M2, ima v živalskem modelu v primerjavi z matično spojino približno 1/ 3 farmakološke aktivnosti.
Elimination The elimination half-life of glimepiride is approximately 5 to 8 h.
Izločanje Razpolovni čas izločanja glimepirida je približno 5 do 8 ur.
When 14C-glimepiride was given orally, approximately 60% of the total radioactivity was recovered in the urine in seven days and M1 (predominant) and M2 accounted for 80 to 90% of that recovered in the urine.
Po peroralni uporabi 14C- glimepirida se je približno 60% celotne radioaktivnosti pojavilo v urinu v sedmih dneh; na račun M1 (pretežno) in M2 je šlo od 80 do 90% radioaktivnosti, izločene v urinu.
Approximately 40% of the total radioactivity was recovered in faeces and M1 and M2 (predominant) accounted for about 70% of that recovered in faeces.
V blatu se je izločilo približno 40% celotne radioaktivnosti; na račun M1 in M2 (pretežno) je šlo okrog 70% radioaktivnosti, izločene v blatu.
Special populations Gender:
Posebne populacije Spol:
In the pooled population pharmacokinetic analysis, there were no marked differences in the pharmacokinetics of rosiglitazone or glimepiride between males and females.
V kumulativni populacijski farmakokinetični analizi se farmakokinetika rosiglitazona ali glimepirida med moškimi in ženskami ni izrazito razlikovala.
In the pooled population pharmacokinetic analysis, age was not found to influence the pharmacokinetics of rosiglitazone or glimepiride to any significant extent.
Kumulativna populacijska farmakokinetična analiza ni pokazala, da bi starost kakorkoli pomembno vplivala na farmakokinetiko rosiglitazona ali glimepirida.
Hepatic impairment:
Okvara jeter:
Following rosiglitazone treatment in cirrhotic patients with moderate (Child- Pugh B) hepatic impairment, unbound Cmax and AUC were 2- and 3-fold higher than in normal subjects.
3- krat večji kot pri zdravih preiskovancih.
The inter-subject variability was large, with a 7-fold difference in unbound AUC between patients.
Interindividualna variabilnost je bila velika in razlika nevezane AUC je bila med bolniki 7- kratna.
Therefore AVAGLIM should not be used in patients with hepatic impairment (see section 4.3)
Zato AVAGLIMA ne smete uporabljati pri bolnikih z okvaro jeter (glejte poglavje 4. 3)
15 Renal insufficiency:
Insuficienca ledvic:
There are no clinically significant differences in the pharmacokinetics of rosiglitazone in patients with renal impairment or end stage renal disease on chronic dialysis.
Farmakokinetika rosiglitazona se pri bolnikih z okvaro ledvic ali končno boleznijo ledvic na kronični dializi ne razlikuje klinično pomembno.
There are no data from the use of glimepiride in patients on renal dialysis (see section 4.3).
O uporabi glimepirida pri bolnikih na dializi ni zadostnih podatkov (glejte poglavje 4. 3).
A multiple-dose titration study with glimepiride conducted in 16 patients with type 2 diabetes mellitus with renal impairment using doses ranging from 1 to 8 mg daily for three months showed that all patients with a creatinine clearance less than 22 ml/ min had adequate control of their glucose levels with a dosage regimen of only 1 mg daily (see section 4.2 and 4.4).
Študija je pokazala, da je bila pri vseh bolnikih, ki so imeli očistek kreatinina manj kot 22 ml/ min, koncentracija glukoze ustrezno urejena z odmerjanjem zgolj 1 mg na dan (glejte poglavji 4. 2 in 4. 4).
An increase in plasma volume accompanied by decrease in red cell parameters and increase in heart weight.
15 Rosiglitazon Neželeni učinki, ugotovljeni v študijah na živalih, ki bi lahko bili pomembni za klinično uporabo, so: povečanje količine plazme, ki jo spremlja zmanjšanje parametrov eritrocitov in povečanje mase srca.