natgillin/translations-raw huggingface dataset:
11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years (p=0.01).
11 dogodkov/ 1. 000 bolnikov- let, samo dieta 18 dogodkov/ 1. 000 bolnikov- let (p=0, 01).
Eucreas Absorption Bioequivalence has been demonstrated between Eucreas at three dose strengths (50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg) versus free combination of vildagliptin and metformin hydrochloride tablets at the corresponding doses.
Zdravilo Eucreas Absorpcija Za zdravilo Eucreas so dokazali bioekvivalenco treh jakosti (50 mg/ 500 mg, 50 mg/ 850 mg in 50 mg/ 1000 mg) s kombinacijo ločenih tablet vildagliptina in metforminijevega klorida v skladnih odmerkih.
The rate and extent of absorption of metformin from Eucreas 50 mg/1000 mg were decreased when given with food as reflected by the decrease in Cmax by 26%, AUC by 7% and delayed Tmax (2.0 to 4.0 h).
Hitrost in obseg absorpcije metformina iz zdravila Eucreas 50 mg/ 1000 mg pa sta bili pri jemanju s hrano zmanjšani, kar se je odražalo na znižanju Cmax za 26%, zmanjšanju AUC za 7% in na podaljšanem Tmax (2, 0 do 4, 0 ure).
Vildagliptin Absorption Following oral administration in the fasting state, vildagliptin is rapidly absorbed with peak plasma concentrations observed at 1.7 hours.
10 Vildagliptin Absorpcija Po peroralni aplikaciji na tešče se vildagliptin hitro absorbira in doseže najvišje koncentracije v plazmi po 1, 7 ure.
Food slightly delays the time to peak plasma concentration to 2.5 hours, but does not alter the overall exposure (AUC).
Hrana nekoliko podaljša čas do najvišje plazemske koncentracije na 2, 5 ure, ne spremeni pa celotne izpostavljenosti zdravilu (AUC).
Administration of vildagliptin with food resulted in a decreased Cmax (19%) compared to dosing in the fasting state.
Zaradi uživanja vildagliptina skupaj s hrano se je znižala Cmax (19%) v primerjavi z odmerjanjem na tešče.
The absolute bioavailability is 85%.
Absolutna biološka uporabnost je 85%.
Distribution The plasma protein binding of vildagliptin is low (9.3%) and vildagliptin distributes equally between plasma and red blood cells.
Porazdelitev Vildagliptin se v majhni meri veže na proteine v plazmi (9, 3%) in se enakomerno porazdeli med plazmo in eritrocite.
10 Biotransformation Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose.
Biotransformacija Glavna pot izločanja vildagliptina pri človeku je njegova presnova, ki odstrani 69% odmerka.
The major metabolite (LAY 151) is pharmacologically inactive and is the hydrolysis product of the cyano moiety, accounting for 57% of the dose, followed by the amide hydrolysis product (4% of dose).
Glavni presnovek (LAY 151) nima farmakološkega učinka in nastane s hidrolizo ciano skupine ter predstavlja 57% odmerka, sledi pa mu produkt hidrolize amida (4% odmerka).
DPP-4 contributes partially to the hydrolysis of vildagliptin based on an in vivo study using DPP-4 deficient rats.
Glede na izsledke in vivo študije na podganah s pomanjkanjem DPP- 4 kaže, da DPP- 4 deloma sodeluje pri hidrolizi vildagliptina.
Vildagliptin is not metabolised by CYP 450 enzymes to any quantifiable extent, and accordingly the metabolic clearance of vildagliptin is not anticipated to be affected by co- medications that are CYP 450 inhibitors and/or inducers.
Glede na to ni pričakovati, da bi na presnovni očistek vildagliptina vplivala sočasna uporaba zdravil, ki so zaviralci in/ ali induktorji encimov CYP 450.
In vitro studies demonstrated that vildagliptin does not inhibit/induce CYP 450 enzymes.
In vitro študije so pokazale, da vildagliptin ne zavira/ inducira encimov CYP 450.
Therefore, vildagliptin is not likely to affect metabolic clearance of co-medications metabolised by CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 or CYP 3A4/5.
Zato ni verjetno, da bi vildagliptin vplival na presnovni očistek sočasno uporabljanih zdravil, ki se presnavljajo z encimi CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 ali CYP 3A4/ 5.
Elimination Following oral administration of [14C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose was recovered in the faeces.
Izločanje Po peroralni aplikaciji s 14C označenega vildagliptina se je približno 85% odmerka izločilo z urinom, 15% odmerka pa so našli v blatu.
Renal excretion of the unchanged vildagliptin accounted for 23% of the dose after oral administration.
Po peroralni aplikaciji je izločanje nespremenjenega vildagliptina preko ledvic predstavljalo 23% odmerka.
After intravenous administration to healthy subjects, the total plasma and renal clearances of vildagliptin are 41 and 13 l/h, respectively.
Po intravenski aplikaciji zdravim osebam je znašal celotni plazemski očistek vildagliptina 41 l/ h, ledvični očistek pa 13 l/ h.
Linearity / non-linearity The Cmax for vildagliptin and the area under the plasma concentrations versus time curves (AUC) increased in an approximately dose proportional manner over the therapeutic dose range.
Linearnost / nelinearnost Cmax vildagliptina in površina pod krivuljo časovne porazdelitve koncentracij v plazmi (AUC) sta se v okviru terapevtskih odmerkov povečevali približno sorazmerno z velikostjo odmerka.
Characteristics in patients Gender:
Značilnosti pri bolnikih Spol:
DPP-4 inhibition by vildagliptin is not affected by gender.
Spol ne vpliva na zaviranje DPP- 4 z vildagliptinom.
In healthy elderly subjects (≥ 70 years), the overall exposure of vildagliptin (100 mg once daily) was increased by 32%, with an 18% increase in peak plasma concentration as compared to young healthy subjects (18-40 years).
V primerjavi z zdravimi mladimi osebami (18- 40 let) je bila pri zdravih starejših osebah (≥ 70 let) pri odmerjanju 100 mg enkrat dnevno skupna izpostavljenost vildagliptinu večja za 32% z 18- odstotnim zvišanjem najvišje koncentracije v plazmi.
DPP-4 inhibition by vildagliptin is not affected by age.
Starost ne vpliva na inhibicijo DPP- 4 z vildagliptinom.
In subjects with mild, moderate or severe hepatic impairment (Child-Pugh A-C) there were no clinically significant changes (maximum ~30%) in exposure to vildagliptin.
Pri bolnikih z blago, zmerno in hudo okvaro jeter (razredi A do C po Child- Pughovi lestvici) ni prišlo do klinično pomembnih sprememb izpostavljenosti vildagliptinu (največ ~30%).
In subjects with mild, moderate, or severe renal impairment, systemic exposure to vildagliptin was increased (Cmax 8-66%; AUC 32-134%) and total body clearance was reduced compared to subjects with normal renal function.
Pri bolnikih z blago, zmerno ali hudo okvaro ledvic je bila izpostavljenost vildagliptinu večja (Cmax 8- 66%; AUC 32- 134%), celotni telesni očistek pa je bil manjši v primerjavi z osebami z normalnim delovanjem ledvic.
Ethnic group:
11 Etnična pripadnost:
Metformin Absorption After an oral dose of metformin, the maximum plasma concentration (Cmax) is achieved after about 2.5 h..
Metformin Absorpcija Po peroralni aplikaciji metformin doseže najvišjo koncentracijo v plazmi po približno 2, 5 ure (Cmax).
Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Pri zdravih odraslih je absolutna biološka uporabnost 500- miligramske tablete metformina približno 50- 60%.
After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Po peroralnem odmerjanju je neabsorbirani delež v blatu znašal 20- 30%.
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 se plazemske koncentracije v stanju dinamičnega ravnovesja dosežejo v 24- 48 urah, večinoma pa so nižje 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 najvišje koncentracije metformina v plazmi (Cmax) niso presegale 4 µg/ ml niti pri najvišjih odmerkih.
11 Food slightly delays and decreases the extent of the absorption of metformin.
Hrana nekoliko upočasni absorpcijo metfomina in zmanjša njen obseg.
Following administration of a dose of 850 mg, the plasma peak concentration was 40% lower, AUC was decreased by 25% and time to peak plasma concentration was prolonged by 35 minutes.
Po aplikaciji odmerka 850 mg je bila najvišja koncentracija v plazmi 40% nižja, AUC manjša za 25%, čas do najvišje koncentracije v plazmi pa daljši za 35 minut.
Distribution Plasma protein binding is negligible.
Porazdelitev Obseg vezave na plazemske proteine je zanemarljiv.
The mean volume of distribution (Vd) ranged between 63-276 litres.
Povprečni volumen porazdelitve (Vd) je bil v okviru 63- 276 litrov.
Elimination Metformin is eliminated by renal excretion.
Izločanje Metformin se izloča preko ledvic.
Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Ledvični očistek metformina je > 400 ml/ min, kar nakazuje, da se metformin izloča z glomerulno filtracijo in tubulno sekrecijo.
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h.
Po peroralnem odmerku je navidezni končni razpolovni čas izločanja približno 6, 5 ur.
Vildagliptin Intra-cardiac impulse conduction delays were observed in dogs with a no-effect dose of 15 mg/kg (7- fold human exposure based on Cmax).
Vildagliptin Pri psih so opažali upočasnjeno prevajanje impulzov v srcu, pri tem je bil odmerek brez učinka 15 mg/ kg (kar pomeni izpostavljenost, ki je 7- krat večja od izpostavljenosti pri človeku glede na Cmax).
The no- effect dose in rats was 25 mg/kg (5-fold human exposure based on AUC) and in mice 750 mg/kg (142- fold human exposure).
Pri podganah je bil odmerek brez učinka 25 mg/ kg (kar pomeni izpostavljenost, ki je 5- krat večja od izpostavljenosti pri človeku glede na AUC), pri miših pa 750 mg/ kg (izpostavljenost, ki je 142- krat večja od izpostavljenosti pri človeku).
Embryofoetal toxicity was evaluated in rats and rabbits.
Pri podganah so opažali zvišano incidenco valovite deformacije reber v povezavi s parametri zmanjšane telesne mase
An increased incidence of wavy ribs was observed in rats in association with reduced maternal body weight parameters, with a no-effect dose of 75 mg/kg (10-fold human exposure).
12 mater, pri tem je bil odmerek brez učinka 75 mg/ kg (kar pomeni izpostavljenost, ki je 10- krat večja od izpostavljenosti pri človeku).
In rabbits, decreased foetal weight and skeletal variations indicative of developmental delays were noted only in the presence of severe maternal toxicity, with a no-effect dose of 50 mg/kg (9-fold human exposure).
Pri kuncih so samo v primerih hude toksičnosti za mater zabeležili zmanjšano telesno maso zarodkov in skeletne različice, ki nakazujejo zaostanke v razvoju, pri tem je bil odmerek brez učinka 50 mg/ kg (kar pomeni izpostavljenost, ki je 9- krat večja od izpostavljenosti pri človeku).
Findings were only observed in association with maternal toxicity at ≥ 150 mg/kg and included a transient decrease in body weight and reduced motor activity in the F1 generation.
Učinke so opažali samo v povezavi s toksičnostjo za mater pri odmerkih ≥ 150 mg/ kg, vključevali pa so prehodno zmanjšanje telesne mase in zmanjšano motorično aktivnost v F1 generaciji.
A two-year carcinogenicity study was conducted in rats at oral doses up to 900 mg/kg (approximately 200 times human exposure at the maximum recommended dose).
Dvoletno študijo karcinogenosti so opravili na podganah s peroralnimi odmerki do 900 mg/ kg (kar pomeni izpostavljenost, ki je približno 200- krat večja od izpostavljenosti pri človeku pri največjih priporočenih odmerkih).
Another two-year carcinogenicity study was conducted in mice at oral doses up to 1000 mg/kg.
Drugo dvoletno študijo karcinogenosti so opravili na miših s peroralnimi odmerki do 1. 000 mg/ kg.
An increased incidence of mammary adenocarcinomas and haemangiosarcomas was observed with a no-effect dose of 500 mg/kg (59-fold human exposure) and 100 mg/kg (16-fold human exposure), respectively.
Opažali so višjo incidenco adenokarcinomov dojke, pri čemer je bil odmerek brez učinka 500 mg/ kg (izpostavljenost, ki je 59- krat večja od izpostavljenosti pri človeku), in hemangiosarkomov, pri čemer je bil odmerek brez učinka 100 mg/ kg (izpostavljenost, ki je 16- krat večja od izpostavljenosti pri človeku).
12 In a 13-week toxicology study in cynomolgus monkeys, skin lesions have been recorded at doses ≥ 5 mg/kg/day.
V 13- tedenski toksikološki študiji na opicah (vrste javanski makak) so zabeležili kožne spremembe pri odmerkih ≥ 5 mg/ kg/ dan.
At 5 mg/kg/day (approximately equivalent to human AUC exposure at the 100 mg dose), only blisters were observed.
Pri odmerku 5 mg/ kg/ dan (kar približno ustreza izpostavljenosti AUC pri človeku pri odmerku 100 mg) so opažali samo mehurčke.
Flaking skin, peeling skin, scabs and tail sores with correlating histopathological changes were noted at doses ≥ 20 mg/kg/day (approximately 3 times human AUC exposure at the 100 mg dose).
Pri odmerku ≥ 20 mg/ kg/ dan (kar približno ustreza 3- kratni izpostavljenosti AUC pri človeku pri odmerku 100 mg) so opažali luskavost in luščenje kože, kraste in ranice na repu z ustreznimi histopatološkimi spremembami.
Necrotic lesions of the tail were observed at ≥ 80 mg/kg/day.
Pri odmerku ≥ 80 mg/ kg/ dan so opažali nekrotične lezije na repu.
Skin lesions were not reversible in the monkeys treated at 160 mg/kg/day during a 4-week recovery period.
Pri opicah, ki so prejemale 160 mg/ kg/ dan, kožne lezije niso bile reverzibilne v 4- tedenskem obdobju okrevanja.
Metformin Non-clinical data on metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
Metformin Neklinični podatki o metforminu na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Hydroxypropylcellulose Magnesium stearate
Jedro tablete: hidroksipropilceluloza magnezijev stearat
Hypromellose Titanium dioxide (E 171) Iron oxide, yellow (E 172) Macrogol 4000 Talc
Filmska obloga: hipromeloza titanov dioksid (E 171) železov oksid, rumeni (E 172) makrogol 4000 smukec
Aluminium/Aluminium (PA/Al/PVC//Al) blister Available in packs containing 10, 30, 60, 120,180 or 360 film-coated tablets and in multi-packs containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
pretisni omot iz aluminija/ aluminija (PA/ Al/ PVC // Al) Na voljo so v pakiranjih, ki vsebujejo po 10, 30, 60, 120, 180 ali 360 filmsko obloženih tablet, in v skupnih pakiranjih, ki vsebujejo po 120 (2x60), 180 (3x60) ali 360 (6x60) filmsko obloženih tablet.
Not all pack sizes and tablet strengths may be marketed.
Na trgu ni vseh navedenih pakiranj in jakosti tablet.
Eucreas 50 mg/1000 mg film-coated tablets
Eucreas 50 mg/ 1000 mg filmsko obložene tablete
Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).
Vsaka filmsko obložena tableta vsebuje 50 mg vildagliptina in 1000 mg metforminijevega klorida (kar ustreza 780 mg metformina).
Dark yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “FLO” on the other side.
Temno rumena ovalna filmsko obložena tableta z zaobljenim robom in vtisnjeno oznako “ NVR ” na eni strani in “ FLO ” na drugi.
Adults Based on the patient’s current dose of metformin, Eucreas may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.
Odrasli Glede na odmerek metformina, ki ga je bolnik uporabljal do tedaj, je mogoče začeti z uporabo zdravila Eucreas bodisi jakosti 50 mg/ 850 mg ali 50 mg/ 1000 mg dvakrat dnevno in sicer eno tableto zjutraj, drugo pa zvečer.
Additional information on special populations Renal impairment Eucreas should not be used in patients with creatinine clearance < 60 ml/min (see sections 4.3, 4.4 and 5.2).
Dodatni podatki o posebnih skupinah bolnikov Okvara ledvic Bolniki z očistkom kreatinina < 60 ml/ min ne smejo uporabljati zdravila Eucreas (glejte poglavja 4. 3, 4. 4 in 5. 2).
Hepatic impairment Eucreas should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8).
15 3- kratno zgornjo mejo normalnih vrednosti (upper limit of normal - ULN) (glejte poglavja 4. 3, 4. 4 in 4. 8).
15 Elderly (≥ 65 years) As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Eucreas should have their renal function monitored regularly (see section 4.4).
Starejši (≥ 65 let) Metformin se izloča preko ledvic, pri starejših bolnikih pa je delovanje ledvic pogosto zmanjšano, zato je treba starješim bolnikom, ki jemljejo zdravilo Eucreas, redno pregledovati delovanje ledvic (glejte poglavje 4. 4).
− Hypersensitivity to the active substances or to any of the excipients − Diabetic ketoacidosis or diabetic pre -coma − Renal failure or renal dysfunction defined as creatinine clearance < 60 ml/min (see section 4.4) − Acute conditions with the potential to alter renal function, such as:
- ledvična odpoved oziroma moteno delovanje ledvic, opredeljeno z očistkom kreatinina
4.5 Interaction with other medicinal products and other forms of interaction
17 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
17 Vildagliptin Vildagliptin has a low potential for interactions with co-administered medicinal products.
Vildagliptin Vildagliptin ima le majhno možnost medsebojnega delovanja z drugimi sočasno uporabljenimi zdravili.
Drug-drug interaction studies with digoxin (P-glycoprotein substrate) and warfarin (CYP2C9 substrate) in healthy subjects have shown no clinically relevant pharmacokinetic interactions after co- administration with vildagliptin.
Študije medsebojnega delovanja z digoksinom (substratom P- glikoproteina) in z varfarinom (substratom CYP2C9) na zdravih prostovoljcih niso pokazale nobenih klinično pomembnih farmakokinetičnih interakcij pri sočasni uporabi vildagliptina.
Angiotensin converting enzyme (ACE) inhibitors may decrease the blood glucose levels.
18 Zaviralci angiotenzinske konvertaze (zaviralci ACE) lahko znižujejo koncentracije glukoze v krvi.
19 Table 1
Preglednica 1
20 In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively).
Telesna masa se v kliničnih preskušanjih ni bistveno spremenila od izhodiščne: pri jemanju 100 mg vildagliptina v monoterapiji se je zmanjšala za 0, 3 kg, pri uporabi vildagliptina skupaj s placebom pa se je zmanjšala za 1, 3 kg.
Management The most effective method of removing metformin is haemodialysis.
21 Obravnava Hemodializa je najučinkovitejši način odstranjevanja metformina.
Metformin Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
22 Metformin Metformin je bigvanid z antihiperglikemičnimi učinki in znižuje tako bazalno kot postprandialno koncentracijo glukoze v plazmi.
The prospective randomised UKPDS (UK Prospective Diabetes Study) study has established the long - term benefit of intensive blood glucose control in type 2 di abetes.
V prospektivni randomizirani študiji UKPDS (UK Prospective Diabetes Study - Britanska prospektivna študija diabetesa) so ugotovili dolgoročno koristnost intenzivnega uravnavanja koncentracije glukoze pri diabetesu tipa 2.
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;
metforminom (29, 8 dogodkov/ 1. 000 bolnikov- let) v primerjavi s skupino bolnikov, zdravljenih samo z dieto (43, 3 dogodkov/ 1. 000 bolnikov- let), p=0, 0023, in v primerjavi z združeno skupino bolnikov, zdravljenih samo s sulfonilureo, in bolnikov, zdravljenih samo z insulinom (40, 1 dogodek/ 1. 000 bolnikov- let), p=0, 0034;
7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017;
12, 7 dogodkov/ 1. 000 bolnikov- let, p=0, 017;
13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years (p=0.0 11), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/ 1,000 patient- years (p=0.021);
13, 5 dogodkov/ 1. 000 bolnikov- let v primerjavi s skupino bolnikov, zdravljenih samo z dieto, 20, 6 dogodkov / 1. 000 bolnikov- let (p=0, 011) in v primerjavi z združeno skupino bolnikov, zdravljenih samo s sulfonilureo, in bolnikov, zdravljenih samo z insulinom, 18, 9 dogodkov/ 1. 000 bolnikov- let (p=0, 021);
Vildagliptin Absorption Following oral administration in the fasting state, vildagliptin is rapidly absorbed with peak plasma concentrations observed at 1.7 hours.
23 Vildagliptin Absorpcija Po peroralni aplikaciji na tešče se vildagliptin hitro absorbira in doseže najvišje koncentracije v plazmi po 1, 7 ure.
23 Biotransformation Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose.
Biotransformacija Glavna pot izločanja vildagliptina pri človeku je njegova presnova, ki odstrani 69% odmerka.
Ethnic group:
24 Etnična pripadnost:
Metformin Absorption After an oral dose of metformin, the maximum plasma concentration (Tmax) is achieved after about 2.5 h..
Metformin Absorpcija Po peroralni aplikaciji metformin doseže najvišjo koncentracijo v plazmi po približno 2, 5 ure (Cmax).
24 Food slightly delays and decreases the extent of the absorption of metformin.
Hrana nekoliko upočasni absorpcijo metfomina in zmanjša njen obseg.
An increased incidence of wavy ribs was observed in rats in association with reduced maternal body weight parameters, with a no-effect dose of 75 mg/kg (10-fold human exposure).
25 mater, pri tem je bil odmerek brez učinka 75 mg/ kg (kar pomeni izpostavljenost, ki je 10- krat večja od izpostavljenosti pri človeku).
25 In a 13-week toxicology study in cynomolgus monkeys, skin lesions have been recorded at doses ≥ 5 mg/kg/day.
V 13- tedenski toksikološki študiji na opicah (vrste javanski makak) so zabeležili kožne spremembe pri odmerkih ≥ 5 mg/ kg/ dan.
6.3 Shelf life
26 6. 3 Rok uporabnosti
Aluminium/Aluminium (PA/Al/PVC//Al) blister Available in packs containing 10, 30, 60, 120,180 or 360 film-coated tablets and in multi-packs containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
pretisni omot iz aluminija/ aluminija (PA/ Al/ PVC/ Al) Na voljo so v pakiranjih, ki vsebujejo po 10, 30, 60, 120, 180 ali 360 filmsko obloženih tablet, in v skupnih pakiranjih, ki vsebujejo po 120 (2x60), 180 (3x60) ali 360 (6x60) filmsko obloženih tablet.
Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany
Novartis Pharma GmbH Roonstraße 25 D- 90429 Nürnberg Nemčija
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 (17 June 2008) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3. 0 (z dne 17. junija 2008), predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.