natgillin/translations-raw huggingface dataset:
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.
V dodatni 1- letni študiji s 100 mg odmerkom sitagliptina enkrat na dan v kombinaciji z metforminom je bila pojavnost z zdravilom povezanih neželenih u inkov pri bolnikih, ki so se zdravili s kombinacijo sitagliptin/ metformin 14, 5- odstotna, pri bolnikih, ki so prejemali kombinacijo sulfonilse nina/ metformin pa 30, 3- odstotna.
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.
20 V 24- tedenski študiji za etnega kombiniranega zdravljenja s sitagliptinom in metforminom dvakrat na dan (sitagliptin/ metformin 50 mg/ 500 mg ali 50 mg/ 1. 000 mg) je bila celotna pojavnost z zdravilom povezanih neželenih u inkov pri bolnikih, ki so prejemali kombinacijo sitagliptina in metformina, 14, 0- odstotna, pri bolnikih, ki so prejemali placebo pa 9, 7- odstotna.
For both GLP-1 and GIP, stimulation of insulin release is enhanced as glucose rises above normal concentrations.
Oba, GLP- 1 in GIP, mo neje stimulirata sproš anje insulina, ko se koncentracije glukoze zvišajo nad normalne vrednosti.
Sitagliptin is a potent and highly selective inhibitor of the enzyme DPP-4 and does not inhibit the closely-related enzymes DPP-8 or DPP-9 at therapeutic concentrations.
Sitagliptin je sicer mo an in visoko selektiven zaviralec encima DPP- 4 in pri terapevtskih koncentracijah ne zavira tesno povezanih encimov DPP- 8 ali DPP- 9.
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).
Pri samostojnem zdravljenju s sitagliptinom in pri zdravljenju v kombinaciji z metforminom (za etno zdravljenje ali dodatna uvedba sitagliptina), v kombinaciji s sulfonilse nino (z metforminom ali brez) ter v kombinaciji s tiazolidindionom, se je celotna urejenost glikemije izboljšala, kar je bilo dokazano s klini no pomembnim zmanjšanjem vrednosti HbA1c od izhodiš a pri opazovanem študijskem dogodku (glejte Tabela 2).
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.
22 V 24- tedenski s placebom nadzorovani faktorski študiji za etnega zdravljenja je sitagliptin v odmerku 50 mg dvakrat na dan v kombinaciji z metforminom (500 mg ali 1. 000 mg dvakrat na dan) pomembno izboljšal glikemi ne parametre v primerjavi z zdravljenjem z vsakim zdravilom posebej.
Table 2.
23 Tabla 2:
Week 24†
HbA1c od izhodiš a (%) v 24. tednu †
(95% CI)
Sitagliptin 100 mg
-0.5 -0.6
izhodiš u (%) Študije samostojnega zdravljenja
-0.6‡ (-0.8, -0.4) -0.8‡ (-1.0, -0.6) -0.7‡
(95% interval zaupanja) - 0, 6 ‡
20
enkrat na dan (N = 229) Sitagliptin 100 mg
baseline HbA1c (%)
(- 0, 8, - 0, 5)
Week 24†
metforminom (N = 453) Sitagliptin 100 mg enkrat na dan, dodan k - 0, 7 ‡ že potekajo emu
Sitagliptin 100 mg once daily added to
zdravljenju s
HbA1c (%)
8, 1
at Week 24†
- 0, 9
(95% CI) -0.7‡
(- 0, 9, - 0, 5)
ongoing pioglitazone therapy (N=163) Sitagliptin 100 mg once daily added to
pioglitazonom (N = 163) Sitagliptin 100 mg enkrat na dan, dodan k - 0, 6 ‡ že potekajo emu
8.1
8, 4
-0.9
- 0, 3
(-0.9, -0.5) -0.6‡
(- 0, 8, - 0, 3)
ongoing glimepiride therapy (N=102) Sitagliptin 100 mg once daily added to
Sitagliptin 100 mg enkrat na dan, dodan k že potekajo emu - 0, 9 ‡
8.4
8, 3
(-0.8, -0.3)
(- 1, 1, - 0, 7)
ongoing glimepiride + metformin therapy (N=115) Initial therapy (twice daily):
glimepiridom in metforminom (N = 115) Za etno zdravljenje (dvakrat na dan): - 1, 6 ‡
In a study comparing the efficacy and safety of the addition of TESAVEL 100 mg once daily or glipizide (a sulphonylurea agent) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA1c.
24 V študiji, kjer so pri bolnikih z nezadostno urejeno glikemijo pri zdravljenju samo z metforminom primerjali u inkovitost in varnost dodajanja zdravila TESAVEL v odmerku 100 mg enkrat na dan ali glipizida (sulfonilse nina), je bil sitagliptin pri zmanjšanju vrednosti HbA1c podobno u inkovit kot glipizid.
21 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Presnova je manj pomemben na in izlo anja.
However, cyclosporine, a p-glycoprotein inhibitor, did not reduce the renal clearance of sitagliptin.
Sitagliptin je tudi substrat za p- glikoprotein, ki je 25 prav tako lahko vklju en pri izlo anju sitagliptina preko ledvic, vendar pa ciklosporin, zaviralec p - glikoproteina, ni zmanjšal ledvi nega o istka sitagliptina.
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.
Faze starost ni imela klini nega pomena za farmakokinetiko sitagliptina.
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.
Faze te zna ilnosti nimajo klini nega pomena za farmakokinetiko sitagliptina.
23 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Jedro tablete: mikrokristalna celuloza (E460) kalcijev hidrogenfosfat, brezvodni (E341) natrijev karmelozat, premreženi (E468) magnezijev stearat (E470b) natrijev stearilfumarat
6.3 Shelf life
27 6. 3 Rok uporabnosti
26 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for TESAVEL is required.
29 Bolniki z ledvi no insuficienco Pri bolnikih z blago ledvi no insuficienco (kreatininski o istek [CrCl] ≥ 50 ml/ min) odmerka zdravila TESAVEL ni treba prilagajati.
If a hypersensitivity reaction is suspected, discontinue TESAVEL, assess for other potential causes for the event, and institute alternative treatment for diabetes (see section 4.8).
30 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Lactation It is unknown whether sitagliptin is excreted in human breast milk.
31 Dojenje Ni znano, e se sitagliptin izlo a v materino mleko pri ljudeh.
28 4.8 Undesirable effects
4. 8 Neželeni u inki
Investigations blood glucose decreased *
32 Preiskave Zmanjšana koncentracija glukoze v krvi *
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.
V dodatni 1- letni študiji s 100 mg odmerkom sitagliptina enkrat na dan v kombinaciji z metforminom je bila pojavnost z zdravilom povezanih neželenih u inkov pri bolnikih, ki so se zdravili s kombinacijo sitagliptin/ metformin 14, 5- odstotna, pri bolnikih, ki so prejemali kombinacijo sulfonilse nina/ metformin pa 30, 3- odstotna.
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.
33 V 24- tedenski študiji za etnega kombiniranega zdravljenja s sitagliptinom in metforminom dvakrat na dan (sitagliptin/ metformin 50 mg/ 500 mg ali 50 mg/ 1. 000 mg) je bila celotna pojavnost z zdravilom povezanih neželenih u inkov pri bolnikih, ki so prejemali kombinacijo sitagliptina in metformina, 14, 0- odstotna, pri bolnikih, ki so prejemali placebo pa 9, 7- odstotna.
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).
Postmarketinške izkušnje Dodatni neželeni u inki, o katerih so poro ali v asu trženja (pogostost ni znana): preob utljivostne reakcije, vklju no z anafilakti nimi reakcijami, angioedemom, izpuš ajem, urtikarijo in luš enjem kože, vklju no s Stevens- Johnson- ovim sindromom (glejte poglavje 4. 4).
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).
Pri samostojnem zdravljenju s sitagliptinom in pri zdravljenju v kombinaciji z metforminom (za etno zdravljenje ali dodatna uvedba sitagliptina), v kombinaciji s sulfonilse nino (z metforminom ali brez) ter v kombinaciji s tiazolidindionom, se je celotna urejenost glikemije izboljšala, kar je bilo dokazano s klini no pomembnim zmanjšanjem vrednosti HbA1c od izhodiš a pri opazovanem študijskem dogodku (glejte Tabela 2).
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.
35 V 24- tedenski s placebom nadzorovani faktorski študiji za etnega zdravljenja je sitagliptin v odmerku 50 mg dvakrat na dan v kombinaciji z metforminom (500 mg ali 1. 000 mg dvakrat na dan) pomembno izboljšal glikemi ne parametre v primerjavi z zdravljenjem z vsakim zdravilom posebej.
Table 2.
36 Tabla 2:
32
enkrat na dan (N = 229) Sitagliptin 100 mg
In a study comparing the efficacy and safety of the addition of TESAVEL 100 mg once daily or glipizide (a sulphonylurea agent) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA1c.
37 V študiji, kjer so pri bolnikih z nezadostno urejeno glikemijo pri zdravljenju samo z metforminom primerjali u inkovitost in varnost dodajanja zdravila TESAVEL v odmerku 100 mg enkrat na dan ali glipizida (sulfonilse nina), je bil sitagliptin pri zmanjšanju vrednosti HbA1c podobno u inkovit kot glipizid.
33 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Presnova je manj pomemben na in izlo anja.
However, cyclosporine, a p-glycoprotein inhibitor, did not reduce the renal clearance of sitagliptin.
Sitagliptin je tudi substrat za p- glikoprotein, ki je 38 prav tako lahko vklju en pri izlo anju sitagliptina preko ledvic, vendar pa ciklosporin, zaviralec p - glikoproteina, ni zmanjšal ledvi nega o istka sitagliptina.
35 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Jedro tablete: mikrokristalna celuloza (E460) kalcijev hidrogenfosfat, brezvodni (E341) natrijev karmelozat, premreženi (E468) magnezijev stearat (E470b) natrijev stearilfumarat
37 ANNEX II
41 DODATEK II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠ ANJE SERIJE
Merck Sharp & Dohme (Italia) S. p. A.
Ime in naslov izdelovalca, odgovornega za sproš anje serije Merck Sharp & Dohme (Italia) S. p. A.
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.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora pred za etkom trženja zdravila vzpostaviti sistem farmakovigilance, kot je opisan v razli ici 2 v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vklju no s kasnejšimi dopolnili, in ga vzdrževati ves as trženja zdravila.
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.
Na rt upravljanja tveganja Imetnik dovoljenja za promet z zdravilom mora izvesti študije in dodatne farmakovigilan ne aktivnosti, ki so podrobno opisane v na rtu farmakovigilance, sprejetem v 1. 1 na rta za upravljanje tveganja (RMP) v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vse naknadne dopolnitve na rta za obvladovanje tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
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).
V skladu s smernicami Odbora za zdravila za uporabo v humani medicini o sistemih za upravljanje tveganja je treba dopolnjen na rt upravljana tveganja predložiti so asno z naslednjim periodi nim poro ilom o varnosti zdravila (PSUR).
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
Poleg tega je dopolnjen na rt za obvladovanje tveganja treba predložiti: • e se pridobijo novi podatki, ki lahko vplivajo na trenutne podatke o varnosti, na rt farmakovigilance ali aktivnosti za zmanjševanje tveganja. • v 60 dneh po pomembnem novem spoznanju (farmakovigilan nem ali povezanem z zmanjševanjem tveganja). • na zahtevo Evropske agencije za zdravila (EMEA).
39 ANNEX III
43 DODATEK III
Outer carton for TESAVEL 25 mg film-coated tablets
Zunanja ovojnina za TESAVEL 25 mg filmsko obložene tablete
43 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
47 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Blister for TESAVEL 25 mg film-coated tablets
Pretisni omot za TESAVEL 25 mg filmsko obložene tablete
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
48 PODATKI NA ZUNANJI OVOJNINI
Outer carton for TESAVEL 50 mg film-coated tablets
Zunanja ovojnina za TESAVEL 50 mg filmsko obložene tablete
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
50 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Blister for TESAVEL 50 mg film-coated tablets
Pretisni omot za TESAVEL 50 mg filmsko obložene tablete
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
51 PODATKI NA ZUNANJI OVOJNINI
Outer carton for TESAVEL 100 mg film-coated tablets
Zunanja ovojnina za TESAVEL 100 mg filmsko obložene tablete
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
53 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Blister for TESAVEL 100 mg film-coated tablets
Pretisni omot za TESAVEL 100 mg filmsko obložene tablete
Read all of this leaflet carefully before you start taking this medicine.
Pred za etkom jemanja natan no preberite navodilo!
- If you have any further questions, ask your doctor or pharmacist.
- e imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
if their symptoms are the same as yours.
škodovalo, eprav imajo znake bolezni, podobne vašim.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- e katerikoli neželeni u inek postane resen ali e opazite katerikoli neželeni u inek, ki ni
What TESAVEL is and what it is used for 2.
Kaj je zdravilo TESAVEL in za kaj ga uporabljamo 2.
Before you take TESAVEL 3.
Kaj morate vedeti, preden boste vzeli zdravilo TESAVEL 3.
How to take TESAVEL 4.
Kako jemati zdravilo TESAVEL 4.
How to store TESAVEL 6.
Shranjevanje zdravila TESAVEL 6.
WHAT TESAVEL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO TESAVEL IN ZA KAJ GA UPORABLJAMO
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.
Ta zdravila pri bolnikih s sladkorno boleznijo tipa 2 znižujejo krvni sladkor.
TESAVEL helps to improve the levels of insulin after a meal and decreases the amount of sugar made by the body.
Zdravilo TESAVEL pomaga pove ati vrednosti insulina po obroku in zmanjšuje nastajanje sladkorja v telesu.
However, when TESAVEL is used in combination with a sulphonylurea medicine, low blood sugar (hypoglycaemia) can occur.
Pri uporabi zdravila TESAVEL v kombinaciji s sulfonilse nino pa se vrednost krvnega sladkorja lahko prekomerno zniža (hipoglikemija).
Your doctor has prescribed TESAVEL to help lower your blood sugar, which is too high because of your type 2 diabetes.
Zdravnik vam je zdravilo TESAVEL predpisal, da vam bo pomagalo pri zniževanju krvnega sladkorja, ki je previsok zaradi sladkorne bolezni tipa 2.
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.
Zdravilo TESAVEL se uporablja v kombinaciji z dolo enimi drugimi zdravili za zniževanje krvnega sladkorja, ki jih za zdravljenje sladkorne bolezni že jemljete, ob so asni na rtovani prehrani in telesni vadbi.
Your doctor is now prescribing TESAVEL as an additional medicine to help control your blood sugar.
Zdravnik vam je zdravilo TESAVEL predpisal kot dodatno zdravilo, ki vam bo pomagalo nadzirati krvni sladkor.
Your body can also make too much sugar.
Tudi telo lahko proizvaja preve sladkorja.
When this happens, sugar (glucose) builds up in the blood.
V takšnih primerih se sladkor (glukoza) kopi i v krvi.
This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.
To lahko povzro i resne zdravstvene težave, kot so bolezni srca, bolezni ledvic, slepota ter amputacije.
BEFORE YOU TAKE TESAVEL
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO TESAVEL
Do not take TESAVEL
Ne jemljite zdravila TESAVEL
- if you are allergic (hypersensitive) to sitagliptin or any of the other ingredients of TESAVEL.
- e ste alergi ni na (preob utljivi za) sitagliptin ali katerokoli sestavino zdravila TESAVEL.
Take special care with TESAVEL Tell your doctor if you have or have had:
Bodite posebno pozorni pri uporabi zdravila TESAVEL Obvestite svojega zdravnika, e imate ali ste kdaj imeli:
- diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss,
- diabeti no ketoacidozo (zaplet sladkorne bolezni z visokim krvnim sladkorjem, hitrim
52
e imate težave z ledvicami, zdravilo TESAVEL morda za vas ni primerno
- an allergic reaction to TESAVEL
- alergijsko reakcijo na zdravilo TESAVEL.
If you are taking a sulphonylurea with TESAVEL you may experience low blood sugar.
e jemljete sulfonilse nino skupaj z zdravilom TESAVEL, se lahko vrednost krvnega sladkorja prekomerno zniža.
Your doctor may reduce the dose of your sulphonylurea medication.
Zdravnik vam bo morda zmanjšal odmerek sulfonilse nine.
Taking other medicines TESAVEL may be taken with most medicines.
Jemanje drugih zdravil Zdravilo TESAVEL se lahko jemlje skupaj z ve ino drugih zdravil.
Tell your doctor or pharmacist about all the medicines you take or have recently taken.
Obvestite svojega zdravnika ali farmacevta, e jemljete ali ste pred kratkim jemali katerokoli zdravilo.
This includes prescription and non-prescription medicines, and herbal supplements.
To vklju uje zdravila, ki ste jih dobili na recept, zdravila, ki ste jih dobili brez recepta, ter pripravke rastlinskega izvora.
Taking TESAVEL with food and drink You can take TESAVEL with or without food and drink.
Jemanje zdravila TESAVEL skupaj s hrano in pija o Zdravilo TESAVEL lahko jemljete skupaj s hrano in pija o ali brez.
Pregnancy and breast-feeding Women who are pregnant or plan to become pregnant should consult their doctor before taking TESAVEL.
Nose nost in dojenje Nose nice in ženske, ki nameravajo zanositi, se morajo pred za etkom jemanja zdravila TESAVEL posvetovati s svojim zdravnikom.
You should not use TESAVEL during pregnancy.
Med nose nostjo zdravila TESAVEL ne smete uporabljati.
You should not use TESAVEL if you are breast- feeding or plan to breast-feed.
Ni znano, e se zdravilo TESAVEL izlo a z materinim mlekom. e dojite ali nameravate dojiti, zdravila TESAVEL ne smete uporabljati.
Driving and using machines TESAVEL is not expected to interfere with your ability to drive or to use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo TESAVEL naj ne bi vplivalo na sposobnost upravljanja vozil ali strojev.
However, when driving or operating machinery, it should be taken into account that dizziness and drowsiness have been reported.
Kljub temu se pri vožnji vozil in upravljanju s stroji morate zavedati, da so poro ali o pojavu omotice in zaspanosti.
HOW TO TAKE TESAVEL
KAKO JEMATI ZDRAVILO TESAVEL
You should check with your doctor or pharmacist if you are not sure.
Pri jemanju zdravila TESAVEL natan no upoštevajte zdravnikova navodila. e ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
Your doctor will prescribe TESAVEL along with certain other medicines that lower blood sugar.
Zdravnik vam je zdravilo TESAVEL predpisal skupaj s še nekaterimi drugimi zdravili za zniževanje krvnega sladkorja.
Continue to take TESAVEL as long as your doctor prescribes it so you can continue to help control your blood sugar.
Za urejenost sladkorne bolezni je pomembno, da zdravilo TESAVEL jemljete tako dolgo, kot vam to predpiše zdravnik.
It is important to stay on the diet, exercise and weight loss program recommended by your doctor while taking TESAVEL.
Med jemanjem zdravila TESAVEL je pomembno, da se držite predpisane diete, telesne vadbe in na rta za zmanjšanje telesne mase.
If you take more TESAVEL than you should If you take more than the prescribed dosage of TESAVEL, contact your doctor immediately.
e ste vzeli ve ji odmerek zdravila TESAVEL, kot bi smeli e ste vzeli ve ji odmerek zdravila TESAVEL od predpisanega, se takoj posvetujte s svojim zdravnikom.
If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.
57 e ste pozabili vzeti zdravilo TESAVEL Pozabljeni odmerek vzemite takoj, ko se spomnite. e se spomnite šele, ko je že as, da vzamete naslednji odmerek, pozabljeni odmerek izpustite in nadaljujte z jemanjem zdravila ob predpisanem asu.
Do not take a double dose of TESAVEL.
Ne vzemite dvojnega odmerka zdravila TESAVEL.
Like all medicines, TESAVEL may cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo TESAVEL neželene u inke, ki pa se ne pojavijo pri vseh bolnikih.
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)
Ob asni neželeni u inki (pri manj kot 1 od 100, vendar ve kot 1 od 1. 000 bolnikov).
Some patients have experienced the following side effects after adding sitagliptin to metformin:
Pri nekaterih bolnikih, ki so se zdravili z metforminom in jim je bilo dodatno uvedeno še zdravljenje s sitagliptinom, so se pojavili naslednji neželeni u inki:
Common: nausea Uncommon: weight loss, loss of appetite, abdominal pain, diarrhoea, low blood sugar, drowsiness.
Pogosti: siljenje na bruhanje Ob asni: zmanjšanje telesne mase, izguba apetita, bole ine v trebuhu, driska, nizek krvni sladkor, zaspanost.