qanastek/EMEA-V3 huggingface dataset:
In a clinical study sitagliptin had a small effect on plasma digoxin concentrations indicating that sitagliptin may be a mild inhibitor of p-glycoprotein.
Klinikini tyrim metu sitagliptinas šiek tiek veik digoksino koncentracij plazmoje, taigi, gal t truput slopinti glikoprotein - P.
Characteristics in patients The pharmacokinetics of sitagliptin were generally similar in healthy subjects and in patients with type 2 diabetes.
Farmakokinetika speciali grupi pacient organizme Sveik žmoni ar pacient, sergan i II tipo cukriniu diabetu, organizme sitagliptino farmakokinetika paprastai buvo panaši.
Renal insufficiency A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a reduced dose of sitagliptin (50-mg) in patients with varying degrees of chronic renal insufficiency compared to normal healthy control subjects.
Inkst nepakankamumas Buvo atliktas vienos doz s atviras klinikinis tyrimas, kurio metu vertinta sumažintos sitagliptino doz s (50 mg) farmakokinetika pacient, sergan i vairaus sunkumo l tiniu inkst nepakankamumu, organizme, palyginti su farmakokinetika sveik kontrolin s grup s tiriam j organizme.
The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to < 80 ml/ min), moderate (30 to < 50 ml/ min), and severe (< 30 ml/ min), as well as patients with end-stage renal disease (ESRD) on hemodialysis.
ESRD).
Patients with mild renal insufficiency did not have a clinically meaningful increase in the plasma concentration of sitagliptin as compared to normal healthy control subjects.
Pacient, sergan i lengvu inkst nepakankamumu, kraujo plazmoje sitagliptino koncentracija nebuvo klinikai reikšmingai didesn, negu sveik kontrolin s grup s tiriam j.
An approximately 2-fold increase in the plasma AUC of sitagliptin was observed in patients with moderate renal insufficiency, and an approximately 4-fold increase was observed in patients with severe renal insufficiency and in patients with ESRD on hemodialysis, as compared to normal healthy control subjects.
Pacient, kuriems buvo vidutinio sunkumo inkst nepakankamumas, organizme sitagliptino AUC buvo maždaug 2 kartus, pacient, kuriems buvo sunkus inkst nepakankamumas ar kurie d l ESRD buvo gydomi hemodialize – maždaug 4 kartus didesn, negu sveik kontrolin s grup s tiriam j.
Sitagliptin was modestly removed by hemodialysis (13.5% over a 3- to 4-hour hemodialysis session starting 4 hours postdose).
Hemodialize sitagliptino buvo pašalinta nedaug (13, 5% per 3- 4 valand hemodializ, kuri buvo prad ta, pra jus 4 val. po doz s pavartojimo).
TESAVEL is not recommended for use in patients with moderate or severe renal insufficiency including those with ESRD since experience in these patients is too limited.
TESAVEL nerekomenduojama skirti pacientams, kuriems yra vidutinio sunkumo arba sunkus inkst nepakankamumas, skaitant ir tuos, kuriems yra ESRD, kadangi ši pacient gydymo patirties nepakanka (žr.
(See section 4.2.)
4. 2 skyri).
Hepatic insufficiency No dosage adjustment for TESAVEL is necessary for patients with mild or moderate hepatic insufficiency (Child-Pugh score ≤ 9).
Kepen nepakankamumas Pacientams, kuriems yra lengvas arba vidutinio sunkumo kepen nepakankamumas (Child- Pugh rodmuo 9), TESAVEL doz s keisti nereikia.
There is no clinical experience in patients with severe hepatic insufficiency (Child-Pugh score > 9).
Pacient, kuriems yra sunkus kepen nepakankamumas (Child- Pugh rodmuo > 9), klinikin s gydymo patirties n ra.
However, because sitagliptin is primarily renally eliminated, severe hepatic insufficiency is not expected to affect the pharmacokinetics of sitagliptin.
Vis d lto n ra tik tina, kad sunkus kepen nepakankamumas gal t paveikti sitagliptino farmakokinetik, nes daugiausiai vaistinio preparato pašalinama pro inkstus.
10 Elderly No dosage adjustment is required based on age.
Senyvi žmon s D l amžiaus doz s keisti nereikia.
Age did not have a clinically meaningful impact on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Remiantis populiacij farmakokinetikos duomen, gaut I ir II faz s tyrim metu, analize, amžius sitagliptino farmakokinetikai klinikai reikšmingo poveikio nedar.
Elderly subjects (65 to 80 years) had approximately 19% higher plasma concentrations of sitagliptin compared to younger subjects.
Pagyvenusi (65 - 80 met) žmoni kraujo plazmoje sitagliptino koncentracija buvo maždaug 19% didesn nei jaunesni asmen.
Paediatric No studies with TESAVEL have been performed in paediatric patients.
Vaikai Su vaikais klinikini TESAVEL tyrim neatlikta.
Other patient characteristics No dosage adjustment is necessary based on gender, race, or body mass index (BMI).
Kit grupi pacientai D l lyties, ras s ar k no mas s indekso (KMI) doz s keisti nereikia.
These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.
Remiantis bendra I faz s farmakokinetikos tyrim duomen ir populiacijos farmakokinetikos duomen, gaut I ir II faz s tyrim metu, analize, min ti veiksniai klinikai reikšmingo poveikio sitagliptino farmakokinetikai netur jo.
5.3 Preclinical safety data
11 5. 3 Ikiklinikini saugumo tyrim duomenys
Renal and liver toxicity were observed in rodents at systemic exposure values 58 times the human exposure level, while the no-effect level was found at 19 times the human exposure level.
Poveikio nesukelianti ekspozicija graužik organizme buvo 19 kart didesn už atsirandan i žmogaus organizme.
Incisor teeth abnormalities were observed in rats at exposure levels 67 times the clinical exposure level; the no- effect level for this finding was 58-fold based on the 14-week rat study.
Žiurk ms, kuri organizme medikamento ekspozicija buvo 67 kartus didesn už atsirandan i žmogaus organizme, buvo priešakini dant poky i.
The relevance of these findings for humans is unknown.
Ši duomen reikšm žmogui nežinoma.
Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/ or hunched posture were observed in dogs at exposure levels approximately 23 times the clinical exposure level.
Kai kurie iš j rodo toksin poveik nerv sistemai, pvz., kv pavimas prasižiojus, seil tekis, v mimas baltomis putomis, ataksija, drebulys, aktyvumo sumaž jimas ir (arba) kuprota laikysena.
In addition, very slight to slight skeletal muscle degeneration was also observed histologically at doses resulting in systemic exposure levels of approximately 23 times the human exposure level.
Be to, histologiniu tyrimu nustatyta labai lengva ar lengva skeleto raumen degeneracija, kai ekspozicija buvo maždaug 23 kartus didesn už atsirandan i žmogaus organizme.
A no-effect level for these findings was found at an exposure 6-fold the clinical exposure level.
Šio poky io nesukelianti ekspozicija buvo 6 kartus didesn už atsirandan i terapin doz vartojan io žmogaus organizme.
Sitagliptin has not been demonstrated to be genotoxic in preclinical studies.
Ikiklinikini tyrim metu sitagliptino genotoksinio poveikio nepasteb ta.
Sitagliptin was not carcinogenic in mice.
Pel ms sitagliptinas kancerogeninio poveikio nesuk l.
In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
Žiurk ms, kuri organizme ekspozicija buvo 58 kartus didesn už atsirandan i terapin doz vartojan io žmogaus organizme, dažniau atsirado kepen adenoma ar karcinoma.
Since hepatotoxicity has been shown to correlate with induction of hepatic neoplasia in rats, this increased incidence of hepatic tumors in rats was likely secondary to chronic hepatic toxicity at this high dose.
Kadangi rodyta, jog žiurk ms toksinis poveikis kepenims koreliuoja su kepen naviko atsiradimu, tod l tik tina, kad šis kepen naviko padažn jimas žiurk ms buvo antrinis d l šios didel s doz s sukeliamo l tinio toksinio poveikio kepenims.
Because of the high safety margin (19-fold at this no-effect level), these neoplastic changes are not considered relevant for the situation in humans.
Nemanoma, kad pasteb ti navikiniai poky iai gal t b ti svarb s gydant žmog, nes saugumo ribos yra didel s (ši poky i nesukelianti ekspozicija yra 19 kart didesn už atsirandan i terapin doz vartojan io žmogaus organizme).
No adverse effects upon fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
Nepageidaujamo poveikio žiurki pateli ir patin li, sitagliptino vartojusi prieš poravim si ir poravimosi metu, vaisingumui nepasteb ta.
In a pre-/ postnatal development study performed in rats sitagliptin showed no adverse effects.
Tyrim su žiurk mis metu nepageidaujamo poveikio vystymuisi prenataliniu ir postnataliniu laikotarpiu nepasteb ta.
Reproductive toxicity studies showed a slight treatment-related increased incidence of fetal rib malformations (absent, hypoplastic and wavy ribs) in the offspring of rats at systemic exposure levels more than 29 times the human exposure levels.
Toksinio poveikio reprodukcijai tyrim metu vaiking žiurki, kuri organizme ekspozicija buvo daugiau kaip 29 kartus didesn už atsirandan i terapin doz vartojan io žmogaus organizme, vaisiui šiek tiek dažniau atsirado nuo vaistinio preparato priklausom šonkauli sklaidos tr kum (ne visi šonkauliai, hipoplastiški ar banguoti šonkauliai).
Maternal toxicity was seen in rabbits at more than 29 times the human exposure levels.
Toksinis poveikis vaikingoms triuši patel ms pasireišk tada, kai j organizme ekspozicija buvo daugiau kaip 29 kartus didesn už atsirandan i terapin doz vartojan io žmogaus organizme.
Because of the high safety margins, these findings do not suggest a relevant risk for human reproduction.
Kadangi saugumo ribos yra pla ios, tod l šie duomenys reikšmingos rizikos žmogaus reprodukcinei funkcijai nerodo.
4:1).
Žindymo laikotarpiu žiurki pien patenka daug sitagliptino (koncentracijos piene ir plazmoje santykis yra 4: 1).
6.1 List of excipients
FARMACIN INFORMACIJA
Tablet core: microcrystalline cellulose (E460)
6. 1 Pagalbini medžiag s rašas
11 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Tablet s šerdis Mikrokristalin celiulioz (E460) Bevandenis kalcio- vandenilio fosfatas (E341) Kroskarmelioz s natrio druska (E468) Magnio stearatas (E470b) Natrio stearilfumaratas
Film coating: polyvinyl alcohol macrogol 3350 talc (E553b) titanium dioxide (E171) red iron oxide (E172) yellow iron oxide (E172)
Pl vel Polivinilo alkoholis Makrogolis 3350
This medicinal product does not require any special storage conditions.
Šiam vaistiniam preparatui speciali laikymo s lyg nereikia.
Opaque blisters (PVC/ PE/ PVDC and aluminum).
Nepermatomos lizdin s plokštel s (PVC/ PE/ PVDC ir aliuminio).
Packs of 14, 28, 56, 84 or 98 film-coated tablets and 50 x 1 film-coated tablets in perforated unit dose blisters.
Pakuot je yra 14, 28, 56, 84 ar 98 pl vele dengtos tablet s arba 50 pl vele dengt table i perforuotoje vienadoz je lizdin je plokštel je.
Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Hertford Road, Hoddesdon Hertfordshire EN11 9BU Jungtin Karalyst
10 January 2008
Rinkodaros teis s suteikimo data – 2008- 01- 10
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Naujausi išsami informacij apie š preparat galite rasti Europos vaist agent ros (EMEA) tinklalapyje: http: // www. emea. europa. eu.
TESAVEL 50 mg film-coated tablets
TESAVEL 50 mg pl vele dengtos tablet s
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
Kiekvienoje tablet je yra sitagliptino fosfato monohidrato, atitinkan io 50 mg sitagliptino.
Round, light beige film-coated tablet with “ 112” on one side.
Tablet yra apvali, šviesios sm lio spalvos, dengta pl vele, vienoje jos pus je yra žyma “ 112 ”.
14 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for TESAVEL is required.
15 Pacientai, sergantys inkst nepakankamumu Pacientams, sergantiems lengvu inkst nepakankamumu (kreatinino klirensas (KK) TESAVEL doz s keisti nereikia.
4.5 Interaction with other medicinal products and other forms of interaction
16 4. 5 S veika su kitais vaistiniais preparatais ir kitokia s veika
15 Metformin:
Metforminas.
4.7 Effects on ability to drive and use machines
17 4. 7 Poveikis geb jimui vairuoti ir valdyti mechanizmus
16 4.8 Undesirable effects
4. 8 Nepageidaujamas poveikis
Frequencies are defined as: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1000, < 1/ 100); rare (≥ 1/ 10000, < 1/ 1000); and very rare (< 1/ 10000).
Dažnis apib dinamas taip: labai dažni (1/ 10), dažni (nuo 1/ 100 iki < 1/ 10), nedažni (nuo 1/ 1 000 iki < 1/ 100), reti (nuo 1/ 10 000 iki < 1/ 1 000), labai reti (< 1/ 10 000), dažnis nežinomas (negali b ti vertintas pagal turimus duomenis)..
Investigations blood glucose decreased *
18 Tyrimai Gliukoz s kiekio sumaž jimas kraujyje *
17 In an additional 1-year study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to sulphonylurea/ metformin was 14.5% and 30.3%, respectively.
Papildomo vieneri met trukm s 100 mg kart per par sitagliptino doz s vartojimo kartu su metforminu klinikinio tyrimo metu, nepageidaujam reakcij, kurios vertintos kaip priklausomos nuo vaistinio preparato, dažnis pacientams, gydytiems sitagliptino ir metformino deriniu, buvo 14, 5%, pacientams, gydytiems sulfonilur jos darinio ir metformino deriniu, – 30, 3%.
In pooled studies of up to 1 year in duration comparing sitagliptin/ metformin to a sulphonylurea agent/ metformin, adverse reactions considered as drug-related reported in patients treated with sitagliptin 100 mg occurring in excess (> 0.2% and difference > 1 patient) of that in patients receiving the sulphonylurea agent are as follows: anorexia (Metabolism and nutritional disorders; frequency uncommon) and weight decreased (Investigations; frequency uncommon).
Vis vieneri met trukm s tyrim, kuri metu buvo lygintas gydymas sitagliptino ir metformino deriniu su gydymu sulfonilur jos ir metformino deriniu, nepageidaujam reakcij, kurios vertintos kaip priklausomos nuo vaistini preparat ir kuri dažnis (> 0, 2% ir skirtumas > 1 pacientas) 100 mg sitagliptino doze gydytiems pacientams buvo didesnis, negu gydytiems sulfonilur jos dariniu yra anoreksija (Metabolizmo ir mitybos sutrikimai: dažnis – nedažni) ir k no svorio sumaž jimas (Tyrimai: dažnis – nedažni).
In a 24-week study of initial combination therapy with sitagliptin and metformin administered twice daily (sitagliptin/ metformin 50 mg/ 500 mg or 50 mg/ 1000 mg), the overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin compared to patients treated with placebo was 14.0% and 9.7%, respectively.
19 24 savai i trukm s pradinio sud tinio gydymo 2 kartus per par vartojamu sitagliptino ir metformino deriniu (50 mg sitagliptino ir 500 mg metformino arba 50 mg sitagliptino ir 1 000 mg metformino) metu bendras nepageidaujam reakcij, kurios vertintos kaip priklausomos nuo vaistini preparat, dažnis pacientams, gydytiems sitagliptino ir metformino deriniu, buvo 14%, gydytiems placebu, – 9, 7%.
With higher insulin levels, tissue glucose uptake is enhanced.
20 pager ja beta l steli atsakas gliukoz, stimuliuojama insulino gamyba ir išskyrimas.
19 Overall, sitagliptin improved glycaemic control when given as monotherapy, when used in combination with metformin (initial or add-on therapy), in combination with a sulphonylurea (with or without metformin), and in combination with a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 2).
2 lentel).
In a 24-week placebo-controlled factorial study of initial therapy, sitagliptin 50 mg twice daily in combination with metformin (500 mg or 1000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy.
21 24 savai i trukm s placebu kontroliuojamo faktorialaus pradinio gydymo tyrimo metu pacientams, du kartus per par vartojusiems 50 mg sitagliptino doz kartu su metforminu (po 500 mg arba 1 000 mg 2 kartus per par), reikšmingai pager jo glikemijos parametrai, palyginti su tiriamaisiais, kuriems buvo taikyta monoterapija bet kuriuo iš min t vaistini preparat.
Week 24†
(%) pokytis 24 - j
at Week 24†
HbA1c kiekio (%) pokytis 24 -
(95% CI)
HbA1c kiekis
Sitagliptin 100 mg once daily§ (N= 193) Sitagliptin 100 mg once daily (N= 229) Combination Therapy Studies Sitagliptin 100 mg once daily added to
savait †, palyginti su
8.0 8.0
j savait †
-0.5 -0.6
(%)
ongoing metformin therapy (N=453)
pradiniu
8.0
(95% PI)
(-0.8, -0.5)
Monoterapijos metu Sitagliptinas 100 mg - 0, 6 ‡ kart per par § (N= 193) Sitagliptinas 100 mg
Mean
- 0, 5
Mean change from
(- 0, 8; - 0, 4) - 0, 8 ‡
change in HbA1c (%) at
kart per par (N= 229) Sud tinio gydymo metu Sitagliptinas 100 mg kart per par,
Study
8
baseline HbA1c (%)
(- 1; - 0, 6) - 0, 7 ‡
Sitagliptin 100 mg once daily added to
papildant juo gydym metforminu (N=453) Sitagliptinas 100 mg kart per par,
HbA1c (%)
8
(95% CI) -0.7‡
(- 0, 8; - 0, 5) - 0, 7 ‡
ongoing pioglitazone therapy (N=163) Sitagliptin 100 mg once daily added to
papildant juo gydym pioglitazonu (N=163) Sitagliptinas 100 mg kart per par,
* All Patients Treated Population (an intention-to-treat analysis). † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline value. ‡ p < 0.001 compared to placebo or placebo + combination treatment. § HbA1c (%) at week 18.
* Visi gydyti pacientai (intention- to- treat analiz). † Mažiausi j kvadrat vidurkiai koreguoti pagal ankstesn antihiperglikemin gydym ir bazin reikšm. ‡ p < 0, 001 palyginti su placebu arba placebu ir sud tiniu gydymu. § HbA1c (%) 18 - savait.
21 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Metabolizmas Sitagliptino metabolizuojama mažai, daugiausia jis pašalinamas su šlapimu nepakit s.
Approximately 79% of sitagliptin is excreted unchanged in the urine.
Maždaug 79% sitagliptino išsiskiria su šlapimu nepakitusio preparato pavidalu..
Elimination of sitagliptin occurs primarily via renal excretion and involves active tubular secretion.
23 Sitagliptinas šalinamas daugiausiai pro inkstus aktyvia sekrecija kanal lius.
In vitro, sitagliptin did not inhibit OAT3 (IC50=160 μ M) or p-glycoprotein (up to 250 μ M) mediated transport at therapeutically relevant plasma concentrations.
In vitro gydymui reikšminga sitagliptino koncentracija OAT3 (IC50=160 µM) ar glikoproteino P (iki 250 µM) vykdomos pernašos neslopino.
In a clinical study sitagliptin had a small effect on plasma digoxin concentrations indicating that sitagliptin may be a mild inhibitor of p-glycoprotein.
Klinikini tyrim metu sitagliptinas šiek tiek veik digoksino koncentracij plazmoje, taigi, gal t truput slopinti glikoprotein P.
TESAVEL is not recommended for use in patients with moderate or severe renal insufficiency including those with ESRD since experience in these patients is too limited.
TESAVEL nerekomenduojama skirti pacientams, kuriems yra vidutinio sunkumo arba sunkus inkst nepakankamumas, skaitant ir tuos, kuriems yra ESRD, kadangi ši pacient gydymo patirties nepakanka.
22 Elderly No dosage adjustment is required based on age.
Senyvi žmon s D l amžiaus doz s keisti nereikia.
5.3 Preclinical safety data
24 5. 3 Ikiklinikini saugumo tyrim duomenys
In addition, very slight to slight skeletal muscle degeneration was also observed histologically at doses resulting in systemic exposure levels of approximately 23 times the human exposure level.
Be to, histologiniu tyrimu nustatyta labai lengva ar lengva skeleto raumen degeneracija, kai ekspozicija buvo maždaug 23 kartus didesn uz atsirandan i žmogaus organizme.
23 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Tablet s šerdis Mikrokristalin celiulioz (E460) Bevandenis kalcio- vandenilio fosfatas (E341) Kroskarmelioz s natrio druska (E468) Magnio stearatas (E470b) Natrio stearilfumaratas
TESAVEL 100 mg film-coated tablets
TESAVEL 100 mg pl vele dengtos tablet s
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
Kiekvienoje tablet je yra sitagliptino fosfato monohidrato, atitinkan io 100 mg sitagliptino.
Round, beige film-coated tablet with “ 277” on one side.
Tablet yra apvali, rusvai gelsva, dengta pl vele, vienoje jos pus je yra žyma “ 277 ”.
26 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for TESAVEL is required.
28 Pacientai, sergantys inkst nepakankamumu Pacientams, sergantiems lengvu inkst nepakankamumu (kreatinino klirensas (KK) TESAVEL doz s keisti nereikia.
4.5 Interaction with other medicinal products and other forms of interaction
29 4. 5 S veika su kitais vaistiniais preparatais ir kitokia s veika
27 Metformin:
Metforminas.
4.7 Effects on ability to drive and use machines
30 4. 7 Poveikis geb jimui vairuoti ir valdyti mechanizmus
28 4.8 Undesirable effects
4. 8 Nepageidaujamas poveikis
In these trials, the rate of discontinuation due to adverse experiences considered drug-related was 0.8% with 100 mg per day and 1.5% with other treatments.
Ši tyrim metu d l nepageidaujamo poveikio, kuris vertintas kaip priklausantis nuo vaistinio preparato, gydym reik jo nutraukti 0, 8% pacient, vartojusi 100 mg TESAVEL paros doz 1, 5% kitaip gydyt tiriam j.
Investigations blood glucose decreased *
31 Tyrimai Gliukoz s kiekio sumaž jimas kraujyje *
29 In an additional 1-year study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to sulphonylurea/ metformin was 14.5% and 30.3%, respectively.
Papildomo vieneri met trukm s 100 mg kart per par sitagliptino doz s vartojimo kartu su metforminu klinikinio tyrimo metu, nepageidaujam reakcij, kurios vertintos kaip priklausomos nuo vaistinio preparato, dažnis pacientams, gydytiems sitagliptino ir metformino deriniu, buvo 14, 5%, pacientams, gydytiems sulfonilur jos darinio ir metformino deriniu, – 30, 3%.
In a 24-week study of initial combination therapy with sitagliptin and metformin administered twice daily (sitagliptin/ metformin 50 mg/ 500 mg or 50 mg/ 1000 mg), the overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin compared to patients treated with placebo was 14.0% and 9.7%, respectively.
32 24 savai i trukm s pradinio sud tinio gydymo 2 kartus per par vartojamu sitagliptino ir metformino deriniu (50 mg sitagliptino ir 500 mg metformino arba 50 mg sitagliptino ir 1 000 mg metformino) metu bendras nepageidaujam reakcij, kurios vertintos kaip priklausomos nuo vaistini preparat, dažnis pacientams, gydytiems sitagliptino ir metformino deriniu, buvo 14%, gydytiems placebu, – 9, 7%.
During post-marketing experience the following additional side effects have been reported (frequency not known): hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria and exfoliative skin conditions including Stevens-Johnson syndrome (see section 4.4).
4. 4 skyri).
With higher insulin levels, tissue glucose uptake is enhanced.
33 pager ja beta l steli atsakas gliukoz, stimuliuojama insulino gamyba ir išskyrimas.
31 Overall, sitagliptin improved glycaemic control when given as monotherapy, when used in combination with metformin (initial or add-on therapy), in combination with a sulphonylurea (with or without metformin), and in combination with a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 2).
2 lentel).
In a 24-week placebo-controlled factorial study of initial therapy, sitagliptin 50 mg twice daily in combination with metformin (500 mg or 1000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy.
34 24 savai i trukm s placebu kontroliuojamo faktorialaus pradinio gydymo tyrimo metu pacientams, du kartus per par vartojusiems 50 mg sitagliptino doz kartu su metforminu (po 500 mg arba 1 000 mg 2 kartus per par), reikšmingai pager jo glikemijos parametrai, palyginti su tiriamaisiais, kuriems buvo taikyta monoterapija bet kuriuo iš min t vaistini preparat.
(95% CI)
j savait †
Sitagliptin 100 mg once daily§ (N= 193) Sitagliptin 100 mg once daily (N= 229) Combination Therapy Studies Sitagliptin 100 mg once daily added to
HbA1c kiekis Monoterapijos metu Sitagliptinas 100 mg
-0.5 -0.6
pradiniu
-0.6‡ (-0.8, -0.4) -0.8‡ (-1.0, -0.6) -0.7‡
(95% PI) - 0, 6 ‡
ongoing metformin therapy (N=453)
kart per par § (N= 193) Sitagliptinas 100 mg
-0.7
- 0, 5
(-0.8, -0.5)
(- 0, 8; - 0, 4) - 0, 8 ‡
Placebo-corrected mean
kart per par (N= 229) Sud tinio gydymo metu Sitagliptinas 100 mg kart per par,
Mean
8
33 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Metabolizmas Sitagliptino metabolizuojama mažai, daugiausia jis pašalinamas su šlapimu nepakit s.
Elimination of sitagliptin occurs primarily via renal excretion and involves active tubular secretion.
36 Sitagliptinas šalinamas daugiausiai pro inkstus aktyvia sekrecija kanal lius.
However, cyclosporine, a p-glycoprotein inhibitor, did not reduce the renal clearance of sitagliptin.
Vis d lto glikoproteino P inhibitorius ciklosporinas sitagliptino inkst klirenso nemažina.
34 Elderly No dosage adjustment is required based on age.
Senyvi žmon s D l amžiaus doz s keisti nereikia.
5.3 Preclinical safety data
37 5. 3 Ikiklinikini saugumo tyrim duomenys
35 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Tablet s šerdis Mikrokristalin celiulioz (E460) Bevandenis kalcio- vandenilio fosfatas (E341) Kroskarmelioz s natrio druska (E468) Magnio stearatas (E470b) Natrio stearilfumaratas
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
RINKODAROS TEIS S S LYGOS
CONDITIONS OF THE MARKETING AUTHORISATION
SPECIFINIAI SIPAREIGOJIMAI RINKODAROS TEIS S TUR TOJUI
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
GAMYBOS LICENCIJOS TUR TOJAS, ATSAKINGAS UŽ SERIJ IŠLEIDIM
Name and address of the manufacturer responsible for batch release
Gamintojo, atsakingo už serij išleidim, pavadinimas ir adresas
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2 presented in Module 1.8.1. of the Marketing Authorisation Application and any subsequent updates, is in place and functioning before and whilst the product is on the market.
Farmakologinio budrumo sistema RTT privalo užtikrinti, kad prieš vaistiniam preparatui patenkant rink ir tol, kol jis bus rinkoje, bus sukurta ir veiks farmakologinio budrumo suistema, aprašyta 2 variante, pateiktame Paraiškos d l rinkodaros teis s 1. 8. 1 modulyje
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Rizikos valdymo planas RTT sipareigoja vykdyti tyrimus ir papildom farmakologinio budrumo veikl, aprašyt Farmakologinio budrumo plane, kaip nurodyta Rizikos valdymo plano (RVP) 1. 7 variante, pateiktame Paraiškos d l rinkodaros teis s 1. 8. 2 modulyje ir visuose Žmon ms skirt vaistini preparat komiteto (CHMP) v liau patvirtintuose Rizikos valdymo plano atnaujinimuose.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Vadovaujantis CHMP gair mis d l žmon ms skirt vaistini preparat Rizikos valdymo sistem, atnaujintas Rizikos valdymo planas turi b ti pateikiamas tuo pat metu, kaip ir kitas periodiškai atnaujinamas preparato vartojimo saugumo protokolas.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Be to, atnaujintas RVP turi b ti pateiktas: • gavus naujos informacijos, kuri gali takoti esam Saugumo specifikacij, Farmakologinio budrumo plan arba rizikos mažinimo veikl; • per 60 dien nuo svarbaus (farmakologinio budrumo arba rizikos mažinimo) etapo vykdymo; • pareikalavus EMEA.
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
44 INFORMACIJA ANT IŠORIN S PAKUOT S
Outer carton for TESAVEL 25 mg film-coated tablets
Išorin kartono d žut TESAVEL 25 mg pl vele dengtoms tablet ms
TESAVEL 25 mg film-coated tablets Sitagliptin
TESAVEL 25 mg pl vele dengtos tablet s Sitagliptinas
Each tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin.
Kiekvienoje tablet je yra sitagliptino fosfato monohidrato, atitinkan io 25 mg sitagliptino.
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 50 x 1 film-coated tablets
14 pl vele dengt table i 28 pl vele dengtos tablet s 56 pl vele dengtos tablet s 84 pl vele dengtos tablet s 98 pl vele dengtos tablet s 50x1 pl vele dengt table i
Oral use.
Vartoti per burn.
Read the package leaflet before use.
Prieš vartojim perskaitykite pakuot s lapel.
43 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
46 MINIMALI INFORMACIJA ANT LIZDINI PLOKŠTELI ARBA DVISLUOKSNI JUOSTELI
Blister for TESAVEL 25 mg film-coated tablets
Lizdin plokštel TESAVEL 25 mg pl vele dengtoms tablet ms
TESAVEL 25 mg tablets Sitagliptin
TESAVEL 25 mg pl vele dengtos tablet s Sitagliptinas
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
47 INFORMACIJA ANT IŠORIN S PAKUOT S
Outer carton for TESAVEL 50 mg film-coated tablets
Išorin kartono d žut TESAVEL 50 mg pl vele dengtoms tablet ms
TESAVEL 50 mg film-coated tablets Sitagliptin
TESAVEL 50 mg pl vele dengtos tablet s Sitagliptinas
Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin.
Kiekvienoje tablet je yra sitagliptino fosfato monohidrato, atitinkan io 50 mg sitagliptino.
GENERAL CLASSIFICATION FOR SUPPLY
PAPARDAVIMO (IŠDAVIMO) TVARKA
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
49 MINIMALI INFORMACIJA ANT LIZDINI PLOKŠTELI ARBA DVISLUOKSNI JUOSTELI
Blister for TESAVEL 50 mg film-coated tablets
Lizdin plokštel TESAVEL 50 mg pl vele dengtoms tablet ms
TESAVEL 50 mg tablets Sitagliptin
TESAVEL 50 mg pl vele dengtos tablet s Sitagliptinas
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
50 INFORMACIJA ANT IŠORIN S PAKUOT S
Outer carton for TESAVEL 100 mg film-coated tablets
Išorin kartono d žut TESAVEL 100 mg pl vele dengtoms tablet ms
TESAVEL 100 mg film-coated tablets Sitagliptin
TESAVEL 100 mg pl vele dengtos tablet s Sitagliptinas
Each tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.
Kiekvienoje tablet je yra sitagliptino fosfato monohidrato, atitinkan io 100 mg sitagliptino.
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
52 MINIMALI INFORMACIJA ANT LIZDINI PLOKŠTELI ARBA DVISLUOKSNI JUOSTELI
Blister for TESAVEL 100 mg film-coated tablets
Lizdin plokštel TESAVEL 100 mg pl vele dengtoms tablet ms
TESAVEL 100 mg tablets Sitagliptin
TESAVEL 100 mg pl vele dengtos tablet s Sitagliptinas
51 PACKAGE LEAFLET:
54 PAKUOT S LAPELIS:
Read all of this leaflet carefully before you start taking this medicine.
Atidžiai perskaitykite vis š lapel, prieš prad dami vartoti vaist.
You may need to read it again.
- Neišmeskite šio lapelio, nes v l gali prireikti j perskaityti.
- If you have any further questions, ask your doctor or pharmacist.
- Jeigu kilt daugiau klausim, kreipkit s gydytoj arba vaistinink.
- This medicine has been prescribed for you.
- Šis vaistas skirtas Jums, tod l kitiems žmon ms jo duoti negalima.
if their symptoms are the same as yours.
(net tiems, kuri ligos simptomai yra tokie patys kaip J s).
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jeigu pasireiškia sunkus šalutinis poveikis arba pasteb jote šiame lapelyje nenurodyt šalutin
please tell your doctor or pharmacist.
poveik, pasakykite gydytojui arba vaistininkui.
What TESAVEL is and what it is used for 2.
Kas yra TESAVEL ir kam jis vartojamas 2.
Before you take TESAVEL 3.
Kas žinotina prieš vartojant TESAVEL 3.
How to take TESAVEL 4.
Kaip vartoti TESAVEL 4.
How to store TESAVEL 6.
Kaip laikyti TESAVEL 6.
WHAT TESAVEL IS AND WHAT IT IS USED FOR
KAS YRA TESAVEL IR KAM JIS VARTOJAMAS
TESAVEL is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in patients with type 2 diabetes mellitus.
TESAVEL yra geriam j vaist klas s, vadinamos DPP- 4 inhibitoriais (dipeptidilpeptidaz s- 4 inhibitoriais), atstovas, kuris II tipo cukriniu diabetu sergantiems ligoniams mažina cukraus kiek kraujyje.
Type 2 diabetes is also called non-insulin-dependent diabetes mellitus, or NIDDM.
II tipo diabetas dar vadinamas nuo insulino nepriklausomu cukriniu diabetu (NINCD).
TESAVEL helps to improve the levels of insulin after a meal and decreases the amount of sugar made by the body.
TESAVEL padeda padidinti insulino kiek po valgio ir sumažina paties organizmo gaminamo cukraus kiek.
It is unlikely to cause low blood sugar because it does not work when your blood sugar is low.
Per daug cukraus kiek kraujyje jis netur t mažinti, nes neveikia, kai cukraus kraujyje yra mažai.
However, when TESAVEL is used in combination with a sulphonylurea medicine, low blood sugar (hypoglycaemia) can occur.
Vis d lto jeigu kartu su TESAVEL vartosite sulfonilur jos darinio, cukraus kiekis kraujyje gali sumaž ti per daug (pasireiškia hipoglikemija).
Your doctor has prescribed TESAVEL to help lower your blood sugar, which is too high because of your type 2 diabetes.
J s gydytojas skyr TESAVEL, kad jis pad t sumažinti cukraus kiek kraujyje, kadangi jis yra per didelis, nes sergate II tipo cukriniu diabetu.
TESAVEL is used in combination with certain other medicines that lower blood sugar, which you will already be taking for your diabetes together with a food and exercise plan.
TESAVEL vartojama kartu su kitais cukraus kiek kraujyje mažinan iais vaistais, kuri J s nuo cukrinio diabeto jau vartojate, vykdydami mitybos ir fizini pratim program.
Your doctor is now prescribing TESAVEL as an additional medicine to help control your blood sugar.
Gydytojas Jums skyr TESAVEL, kaip papildomo vaisto, kad jis pad t reguliuoti cukraus kiek kraujyje.
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
II tipo cukrinis diabetas yra b kl, kai J s organizmas gamina nepakankamai insulino, o tas insulinas, kur J s organizmas pagamina, neveikia taip gerai, kaip tur t veikti.
Your body can also make too much sugar.
Be to, J s organizmas gamina per daug cukraus.
When this happens, sugar (glucose) builds up in the blood.
Kai taip atsitinka, kraujyje jo (t. y. gliukoz s) padaug ja.
This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.
Tai gali lemti sunkius sveikatos sutrikimus, tarp j širdies ligas, inkst ligas, aklum ar gal ni amputacij (nupjovim).
BEFORE YOU TAKE TESAVEL
KAS ŽINOTINA PRIEŠ VARTOJANT TESAVEL
Do not take TESAVEL
TESAVEL vartoti negalima:
- if you are allergic (hypersensitive) to sitagliptin or any of the other ingredients of TESAVEL.
- jeigu yra alergija (padid j s jautrumas) sitagliptinui arba bet kuriai pagalbinei TESAVEL
Take special care with TESAVEL Tell your doctor if you have or have had:
Speciali atsargumo priemoni reikia Pasakykite savo gydytojui, jeigu buvo arba yra:
- type 1 diabetes
- I tipo cukrinis diabetas;
- diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss,
- diabetin ketoacidoz (diabeto komplikacija, kuomet labai padid ja cukraus kiekis kraujyje,
nausea or vomiting)
greitai krenta k no svoris, atsiranda pykinimas arba v mimas);
If you have kidney problems,
- bet koks inkst funkcijos sutrikimas ar bet koks kitoks esamas ar buv s sveikatos sutrikimas.
52
Jeigu inkst funkcija sutrikusi, TESAVEL Jums gali netikti;
- an allergic reaction to TESAVEL
- padid j s jautrumas TESAVEL.
If you are taking a sulphonylurea with TESAVEL you may experience low blood sugar.
Jeigu vartojate sulfonilur jos darinio kartu su TESAVEL, gali per daug sumaž ti cukraus kiekis kraujyje.
Your doctor may reduce the dose of your sulphonylurea medication.
Gydytojas gali sumažinti vartojamo sulfonilur jos darinio doz.
Taking other medicines TESAVEL may be taken with most medicines.
Kit vaist vartojimas TESAVEL galima vartoti kartu su daugeliu kit vaist.
This includes prescription and non-prescription medicines, and herbal supplements.
Jeigu vartojate arba neseniai vartojote kit vaist, skaitant sigytus su receptu ar be recepto vaistus bei vaistažoli preparatus, pasakykite gydytojui arba vaistininkui.
Taking TESAVEL with food and drink You can take TESAVEL with or without food and drink.
TESAVEL vartojimas su maistu ir g rimais TESAVEL galima vartoti su maistu ir g rimais arba be j.
Pregnancy and breast-feeding Women who are pregnant or plan to become pregnant should consult their doctor before taking TESAVEL.
N štumas ir žindymo laikotarpis Jeigu esate n š ia arba planuojate pastoti, prieš vartojant TESAVEL, b tina pasitarti su gydytoju.
You should not use TESAVEL during pregnancy.
N štumo metu TESAVEL vartoti negalima.
It is not known if TESAVEL passes into breast milk.
Ar TESAVEL patenka motinos pien, nežinoma.
You should not use TESAVEL if you are breast- feeding or plan to breast-feed.
Jei maitinate kr timi ar planuojate tai daryti, TESAVEL vartoti negalima.
Driving and using machines TESAVEL is not expected to interfere with your ability to drive or to use machines.
Vairavimas ir mechanizm valdymas TESAVEL paveiks geb jimui vairuoti ar valdyti mechanizmus n ra tik tinas.
However, when driving or operating machinery, it should be taken into account that dizziness and drowsiness have been reported.
Vis d lto vairuojant ir valdant mechanizmus reikia atsižvelgti tai, kad buvo pranešta apie galvos svaigimo ir mieguistumo atvejus.
HOW TO TAKE TESAVEL
KAIP VARTOTI TESAVEL
Always take TESAVEL exactly as your doctor has told you.
TESAVEL visada vartokite tiksliai taip, kaip nurod gydytojas.
The usual dose is: − one 100 mg film-coated tablet − once a day − by mouth
prasta doz yra: − viena 100 mg pl vele dengta tablet − kart per par − vartoti per burn
Your doctor will prescribe TESAVEL along with certain other medicines that lower blood sugar.
J s gydytojas TESAVEL Jums skirs vartoti kartu su kitais vaistais, mažinan iais cukraus kiek kraujyje.
Continue to take TESAVEL as long as your doctor prescribes it so you can continue to help control your blood sugar.
Gerkite TESAVEL tiek laiko, kiek skyr J s gydytojas, nes tai pad s toliau reguliuoti cukraus kiek kraujyje.
Diet and exercise can help your body use its blood sugar better.
Tam tikras maistas ir fiziniai pratimai gali pad ti J s organizmui geriau panaudoti kraujyje esant cukr.
It is important to stay on the diet, exercise and weight loss program recommended by your doctor while taking TESAVEL.
Vartojant TESAVEL, labai svarbu ir toliau maitintis, sportuoti bei mažinti k no svor taip, kaip gydytojo rekomenduota.
If you take more TESAVEL than you should If you take more than the prescribed dosage of TESAVEL, contact your doctor immediately.
Pavartojus per didel TESAVEL doz Jei išg r te didesn TESAVEL doz, nei gydytojo skirta, nedelsdami susisiekite su savo gydytoju.
If you forget to take TESAVEL If you miss a dose, take it as soon as you remember.
56 Pamiršus pavartoti TESAVEL Jei pamiršote išgerti vaisto doz, gerkite j tuoj pat, kai tik prisiminsite.
If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.
Jei neprisimin te iki tol, kol bus at j s kitos doz s vartojimo laikas, pamiršt doz praleiskite, o kitas dozes gerkite prastiniu laiku.
Do not take a double dose of TESAVEL.
Negalima vartoti dvigubos TESAVEL doz s, norint kompensuoti praleist doz.
Like all medicines, TESAVEL may cause side effects, although not everybody gets them.
TESAVEL, kaip ir visi kiti vaistai, gali sukelti šalutin poveik, nors jis pasireiškia ne visiems žmon ms.
53 Very common side effects (more than 1 per 10 patients) Common side effects (less than 1 per 10 but more than 1 per 100 patients) Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients)
Nedažnas (mažiau kaip 1 iš 100, bet daugiau kaip 1 iš 1 000 pacient) šalutinis poveikis.
Some patients have experienced the following side effects after adding sitagliptin to metformin:
Šalutinis poveikis, pasireišk s kai kuriems ligoniams, kuriems gydymas metforminu buvo papildytas sitagliptinu Dažnas: pykinimas.
Common: nausea Uncommon: weight loss, loss of appetite, abdominal pain, diarrhoea, low blood sugar, drowsiness.
Nedažnas: k no svorio sumaž jimas, apetito sumaž jimas, pilvo skausmas, viduriavimas, mažas cukraus kiekis kraujyje, mieguistumas.
Some patients have experienced stomach discomfort when starting the combination of sitagliptin and metformin together.
Kai kuriems pacientams, sitagliptino prad jusiems vartoti kartu su metforminu, atsirado nemalonus poj tis skrandyje.
Very common: low blood sugar
Šalutinis poveikis, pasireišk s kai kuriems ligoniams, TESAVEL vartojusiems kartu su sulfonilur jos dariniu Labai dažnas: mažas cukraus kiekis kraujyje.
Some patients have experienced the following side effects while taking TESAVEL in combination with a sulphonylurea and metformin:
Šalutinis poveikis, pasireišk s kai kuriems ligoniams, TESAVEL vartojusiems kartu su sulfonilur jos dariniu ir metforminu Labai dažnas: mažas cukraus kiekis kraujyje.
Very common: low blood sugar Common: constipation
Dažnas: viduri užkiet jimas.
Common: low blood sugar and flatulence.
Šalutinis poveikis, pasireišk s kai kuriems ligoniams, TESAVEL vartojusiems kartu su pioglitazonu Dažnas: mažas cukraus kiekis kraujyje ir viduri p timas.
In addition, some patients have reported foot swelling while taking TESAVEL and pioglitazone.
Be to, kai kuriems pacientams, TESAVEL vartojusiems kartu su pioglitazonu, patino p dos.
These side effects may be seen with sitagliptin and any glitazone (e. g., rosiglitazone).
Toks nepageidaujamas poveikis galimas tiek vartojant sitagliptino, tiek kitokio glitazono (pvz., roziglitazono).
Some patients have experienced the following side effects while taking TESAVEL alone:
Šalutinis poveikis, pasireišk s kai kuriems ligoniams, vartojusiems vien TESAVEL Dažnas: mažas cukraus kiekis kraujyje, galvos skausmas.
Common: low blood sugar, headache Uncommon: dizziness, constipation
Nedažnas: galvos svaigimas, viduri užkiet jimas.
In addition, some patients have reported the following side effects while taking TESAVEL:
Be to, kai kurie ligoniai, vartoj TESAVEL, praneš apie toliau išvardint šalutin poveik.
Common: upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain.
Dažnas: viršutini kv pavimo tak infekcin liga, nosies užgulimas ar sekreto tek jimas iš jos ir kartu gerkl s skausmas, kaulo ir s nario uždegimas, rankos arba kojos skausmas.
During post-marketing experience the following side effects have also been reported (frequency not known): allergic reactions, which may be serious, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Vaistu gydant po to, kai jis pateko rink, pranešta ir apie š šalutin poveik (jo dažnis nežinomas): galimai sunkios alergin s reakcijos, skaitant išb rim, dilg lin bei veido, l p, liežuvio ir gerkl s patinim, d l kurio gali pasunk ti kv pavimas arba rijimas.
If you have an allergic reaction, stop taking TESAVEL and call your doctor right away.
Jei Jums pasireišk alergin reakcija, nebevartokite TESAVEL ir tuojau pat kreipkit s gydytoj.
Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes.
Gydytojas gali Jums skirti vaist alerginei reakcijai gydyti ir kit vaist nuo cukrinio diabeto.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jeigu pasireiškia sunkus šalutinis poveikis arba pasteb jote šiame lapelyje nenurodyt šalutin poveik, pasakykite gydytojui arba vaistininkui.
HOW TO STORE TESAVEL
KAIP LAIKYTI TESAVEL
Do not use TESAVEL after the expiry date which is stated on the blister and the carton.
Ant lizdin s plokštel s ir d žut s po “ Tinka iki ” nurodytam tinkamumo laikui pasibaigus, TESAVEL vartoti negalima.
What TESAVEL contains
TESAVEL sud tis
Each film-coated tablet contains sitagliptin phosphate
Kiekvienoje pl vele dengtoje tablet je yra sitagliptino
monohydrate, equivalent to 25 mg sitagliptin.
fosfato monohidrato, atitinkan io 25 mg sitagliptino.
- The other ingredients are: microcrystalline cellulose (E460), calcium hydrogen phosphate,
- Pagalbin s medžiagos yra: mikrokristalin celiulioz (E460), bevandenis kalcio- vandenilio
anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b), and sodium stearyl fumarate.
fosfatas (E341), kroskarmelioz s natrio druska (E468), magnio stearatas (E470b) ir natrio stearilfumaratas.
The tablet film coating contains: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
Tablet s pl vel je yra polivinilo alkoholio, makrogolio 3350, talko (E553b), titano dioksido (E171), raudonojo geležies oksido (E172) ir geltonojo geležies oksido (E172).
What TESAVEL looks like and contents of the pack
TESAVEL išvaizda ir kiekis pakuot je
Round, pink film-coated tablet with “ 221” on one side.
TESAVEL tablet yra apvali, rausva, dengta pl vele, vienoje jos pus je yra žyma “ 221 ”.
Marketing Authorisation Holder and Manufacturer
Rinkodaros teis s tur tojas ir Gamintojas
Merck Sharp & Dohme Ltd.
Rinkodaros teis s tur tojas Merck Sharp & Dohme Ltd.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Jeigu apie š vaist norite sužinoti daugiau, kreipkit s vietin rinkodaros teis s tur tojo atstov.
Eλλάδα BIANEΞ Α .Ε Τηλ: +3 0210 80091 11 Mailbox@vianex. gr
E BIANE! ". # $%: +3 0210 80091 11 &
Τηλ: +357 22866700 info_cyprus@merck. com
59 Sverige Merck Sharp & Dohme (Middle East) Limited. $%: +357 22866700 &
56 This leaflet was last approved in {MM/ YYYY}.
Šis pakuot s lapelis paskutin kart patvirtintas {MMMM- mm}.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Naujausi išsami informacij apie š vaist galite rasti Europos vaist agent ros (EMEA) interneto svetain je http: // www. emea. europa. eu /.
57 PACKAGE LEAFLET:
60 PAKUOT S LAPELIS:
When this happens, sugar (glucose) builds up in the blood.
Kai taip atsitinka, kraujyje jo (t. y. gliukoz s) adaug ja.
If you have kidney problems,
- bet koks inkst funkcijos sutrikimas ar bet koks kitoks esamas arba buv s sveikatos sutrikimas.
58
Jeigu inkst funkcija sutrikusi, TESAVEL Jums gali netikti;
If you forget to take TESAVEL If you miss a dose, take it as soon as you remember.
62 Pamiršus pavartoti TESAVEL Jei pamiršote išgerti vaisto doz, gerkite j tuoj pat, kai tik prisiminsite.
59 Very common side effects (more than 1 per 10 patients) Common side effects (less than 1 per 10 but more than 1 per 100 patients) Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients)
Nedažnas (mažiau kaip 1 iš 100, bet daugiau kaip 1 iš 1 000 pacient) šalutinis poveikis.
monohydrate, equivalent to 50 mg sitagliptin.
fosfato monohidrato, atitinkan io 50 mg sitagliptino.