natgillin/translations-raw huggingface dataset:
Studies of sitagliptin in combination with metformin In a 24-week, placebo-controlled clinical study to evaluate the efficacy and safety of the addition of sitagliptin 100 mg once daily to ongoing metformin, sitagliptin provided significant improvements in glycaemic parameters compared with placebo.
Ispitivanja sitagliptina u kombinaciji s metforminom U 24-tjednom placebom kontroliranom kliničkom ispitivanju procjene djelotvornosti i sigurnosti dodavanja sitagliptina u dozi od 100 mg jedanput na dan postojećem liječenju metforminom, sitagliptin je značajno poboljšao glikemijske parametre u usporedbi s placebom.
In 16-week studies in which dogs were treated with either metformin alone or a combination of metformin and sitagliptin, no additional toxicity was observed from the combination.
U istraživanjima na psima u trajanju od 16 tjedana nije opažena dodatna toksičnost kombinacije metformina i sitagliptina u odnosu na primjenu samog metformina.
Ristfor must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.3 and 4.4).
Primjena lijeka Ristfor se mora prekinuti prije ili u vrijeme pretrage metodom oslikavanja i s njegovom primjenom smije se ponovno započeti tek 48 sati poslije, pod uvjetom da je funkcija bubrega bila ponovno procijenjena i da je potvrđeno da je stabilna (vidjeti dijelove 4.3 i 4.4).
Improvements in surrogate markers of beta cell function, including HOMA-β (Homeostasis Model Assessment-β), proinsulin to insulin ratio, and measures of beta cell responsiveness from the frequently-sampled meal tolerance test were observed.
Homeostasis Model Assessment-ß, HOMA-ß), omjer proinzulina i inzulina te mjera odgovora beta stanica na temelju testa podnošljivosti često uzorkovanih obroka.
* Incidence rate per 100 patient-years is calculated as 100 × (total number of patients with ≥ 1 event during eligible exposure period per total patient-years of follow-up).
Hospitalizacija zbog nestabilne angine Smrt zbog bilo kojeg uzroka Hospitalizacija zbog zatajenja srca * Stopa incidencije na 100 bolesnik-godina izračunava se kao 100 × (ukupan broj bolesnika koji imaju ≥ 1 događaja tijekom primjenjivog razdoblja izloženosti po ukupnom broju bolesnik-godina praćenja).
Talk to your doctor or pharmacist before taking Ristfor: - if you have or have had a disease of the pancreas (such as pancreatitis) - if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
Obratite se svom liječniku ili ljekarniku prije nego uzmete Ristfor: - ako imate ili ste imali bolest gušterače (kao što je pankreatitis).
Ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.
Ristfor je indiciran kao dio trojne kombinirane terapije s agonistom receptora za aktivator proliferacije peroksisoma-gama (engl. peroxisome proliferator-activated receptor gamma, PPAR) (tj. tiazolidindionom) kao dopuna dijeti i tjelovježbi u bolesnika koji nisu odgovarajuće regulirani primjenom najviše podnošljive doze metformina i agonista PPAR.
depending on how your kidneys are working - if you have recently had a heart attack or have severe circulatory problems, such as ‘shock' or breathing difficulties - if you have liver problems - if you drink alcohol to excess (either every day or only from time to time) - if you are breast-feeding.
Morat ćete prestati uzimati Ristfor u vrijeme rendgenskog snimanja i 2 ili više dana nakon njega, što će odrediti Vaš liječnik ovisno o tome kako Vam rade bubrezi. - ako ste nedavno imali srčani udar ili imate teške probleme s cirkulacijom kao što su šok ili teškoće pri disanju - ako imate problema s jetrom - ako pijete previše alkohola (bilo svaki dan ili samo povremeno) - ako dojite
Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Ristfor who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Ako se razviju laboratorijski nalazi koji odstupaju od normalnih vrijednosti ili klinička bolest (posebno nejasna i loše definirana bolest) u bolesnika s prethodno dobro reguliranim dijabetesom tipa 2 lijekom Ristfor, treba odmah potražiti znakove ketoacidoze ili laktacidoze.
Some patients taking metformin have experienced the following side effects after starting sitagliptin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness
Često (mogu se javiti u do 1 na 10 osoba): nizak šećer u krvi, mučnina, vjetrovi, povraćanje Manje često (mogu se javiti u do 1 na 100 osoba): bol u trbuhu, proljev, zatvor, omamljenost
Close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when such products are co-administered.
Kad se takvi lijekovi primjenjuju istodobno, potrebno je razmotriti pažljivo praćenje glikemijske kontrole, prilagodbu doze unutar preporučenog raspona doziranja i promjene u liječenju šećerne bolesti.
Concomitant administration of OAT3 inhibitors has not been evaluated in vivo.
Nije ispitana istodobna primjena sitagliptina s inhibitorima OAT3 in vivo.
Frequency not known fatal and non-fatal haemorrhagic and necrotizing pancreatitis
Učestalost nuspojave povraćanje često akutni pankreatitis nepoznata učestalost hemoragijski i nekrotizirajući pankreatitis sa ili bez smrtnog ishoda nepoznata učestalost
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h. When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
Kad je oštećena funkcija bubrega, bubrežni se klirens smanjuje proporcionalno klirensu kreatinina te je poluvijek eliminacije produljen, što dovodi do povišenih razina metformina u plazmi.
Study of sitagliptin in combination with metformin and a PPAR agonist A 26-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to the combination of pioglitazone and metformin.
Ispitivanje sitagliptina u kombinaciji s metforminom i agonistom PPAR U 26-tjednom placebom kontroliranom ispitivanju cilj je bio ocijeniti djelotvornost i sigurnost sitagliptina (100 mg jedanput na dan) kao dodatka kombinaciji pioglitazona i metformina.
Film coating poly(vinyl alcohol) macrogol 3350 talc (E553b) titanium dioxide (E171) iron oxide red (E172) iron oxide black (E172)
Film ovojnica poli(vinilni alkohol) makrogol 3350 talk (E553b) titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, crni (E172)
A 24-week placebo-controlled study involving 660 patients was designed to evaluate the insulin-sparing efficacy and safety of sitagliptin (100 mg once daily) added to insulin glargine with or without metformin (at least 1,500 mg) during intensification of insulin therapy.
U 24- tjednom placebom kontroliranom ispitivanju sa 660 uključenih bolesnika ispitivane su djelotvornost sitagliptina u uštedi inzulina i sigurnost primjene sitagliptina (100 mg jedanput na dan) dodanog glargin inzulinu s metforminom (najmanje 1500 mg) ili bez njega tijekom intenziviranja inzulinske terapije.
Ristfor is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Ristfor je indiciran u kombinaciji sa sulfonilurejom (tj. kao dio trojne kombinirane terapije) kao dopuna dijeti i tjelovježbi u bolesnika koji nisu odgovarajuće regulirani primjenom najviše podnošljive doze metformina i sulfonilureje.
Sitagliptin phosphate is an orally-active, potent, and highly selective inhibitor of the dipeptidyl peptidase 4 (DPP-4) enzyme for the treatment of type 2 diabetes.
Sitagliptinfosfat je potentan i vrlo selektivan oralni inhibitor enzima dipeptidil peptidaze 4 (DPP-4), namijenjen liječenju dijabetesa tipa 2. Inhibitori DPP-4 pripadaju skupini lijekova koji pojačavaju djelovanje inkretina.
The addition of sitagliptin to glimepiride and metformin provided significant improvements in glycaemic parameters.
Dodatak sitagliptina glimepiridu i metforminu značajno je poboljšao glikemijske parametre.
The addition of sitagliptin to pioglitazone and metformin provided significant improvements in glycaemic parameters.
Dodatak sitagliptina pioglitazonu i metforminu značajno je poboljšao glikemijske parametre.
Administration of iodinated contrast agent
Primjena jodiranog kontrastnog sredstva
Least squares means adjusted for prior antihyperglycaemic therapy status and baseline value.
Srednje vrijednosti najmanjih kvadratnih pogrešaka prilagođene prema dotadašnjoj antihiperglikemijskoj terapiji i vrijednostima na početku liječenja.
Change from baseline in body weight was similar for patients treated with sitagliptin relative to placebo.
Promjena tjelesne težine u odnosu na početnu bila je slična u bolesnika liječenih sitagliptinom i onih koji su primali placebo.
Maximum daily dose is 25 mg.
Maksimalna dnevna doza je 25 mg.
The incidence of hypoglycaemia was also similar in patients treated with sitagliptin or placebo.
Incidencija hipoglikemije također je bila slična u bolesnika liječenih sitagliptinom ili onih koji su primali placebo.
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The addition of sitagliptin to insulin provided significant improvements in glycaemic parameters.
Dodatak sitagliptina inzulinu značajno je poboljšao glikemijske parametre.
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.
Prema kompozitnoj analizi farmakokinetičkih podataka iz faze I kao i podataka o populacijskoj farmakokinetici faze I i II, ove osobitosti nemaju klinički značajnog učinka na farmakokinetiku sitagliptina.
Maximum daily dose is 100 mg.
Maksimalna dnevna doza je 100 mg.
In this study there was a similar incidence of hypoglycaemia reported for patients treated with sitagliptin or placebo.
U ovom ispitivanju prijavljena je slična incidencija hipoglikemije u bolesnika liječenih sitagliptinom odnosno placebom.
After an oral dose of metformin, Tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60 % in healthy subjects.
Apsolutna bioraspoloživost tablete metformina u dozi od 500 mg u zdravih ispitanika bila je približno 50-60%.
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The observed incidence of hypoglycaemia in patients treated with sitagliptin was similar to placebo.
Opažena incidencija hipoglikemije u bolesnika liječenih sitagliptinom bila je slična onoj u skupini koja je primala placebo.
If bullous pemphigoid is suspected, Ristfor should be discontinued.
Pri sumnji na bulozni pemfigoid treba prekinuti liječenje lijekom Ristfor.
Maximum daily dose is 50 mg.
Maksimalna dnevna doza je 50 mg.
In addition, the film coating contains: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), iron oxide red (E172), and iron oxide black (E172).
Osim toga, ovojnica tablete sadrži : poli(vinilni alkohol), makrogol 3350, talk (E553b), titanijev dioksid (E171), crveni željezov oksid (E172) i crni željezov oksid (E172).
Study of sitagliptin in combination with metformin and insulin A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to insulin (at a stable dose for at least 10 weeks) with or without metformin (at least 1,500 mg).
U 24-tjednom placebom kontroliranom ispitivanju cilj je bio ocijeniti djelotvornost i sigurnost sitagliptina (100 mg jedanput na dan) dodanog inzulinu (u stabilnoj dozi tijekom najmanje 10 tjedana) s ili bez metformina (najmanje 1500 mg).
Ristfor 50 mg/850 mg film-coated tablets
Ristfor 50 mg/850 mg filmom obložene tablete
Body weight did not increase from baseline with sitagliptin therapy.
Terapija sitagliptinom nije dovela do porasta tjelesne težine u odnosu na početnu.
Study of sitagliptin in combination with metformin and a sulphonylurea A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride (alone or in combination with metformin).
Ispitivanje sitagliptina u kombinaciji s metforminom i sulfonilurejom U 24-tjednom placebom kontroliranom ispitivanju cilj je bio ocijeniti djelotvornost i sigurnost sitagliptina (100 mg jedanput na dan) kao dodatka liječenju glimepiridom (samom ili u kombinaciji s metforminom).
Common flatulence
Bulozni pemfigoid
These included hypoglycaemia (frequency very common with sulphonylurea or insulin), constipation (common with sulphonylurea), peripheral oedema (common with pioglitazone), and headache and dry mouth (uncommon with insulin).
Neke nuspojave su primijećene češće u ispitivanjima kombinirane primjene sitagliptina i metformina s drugim lijekovima za liječenje dijabetesa nego u ispitivanjima sitagliptina i metformina samih.To je uključivalo hipoglikemiju (učestalost vrlo česta sa sulfonilurejom ili inzulinom), konstipaciju (česta sa sulfonilurejom), periferni edem (česta s pioglitazonom) te glavobolju i suha usta (manje česta s inzulinom).
Ristfor 50 mg/1,000 mg film-coated tablets
Ristfor 50 mg/1000 mg filmom obložene tablete
Sitagliptin 50 mg + metformin 1,000 mg (N=178)
početna terapija (dvaput na dan) sitagliptin 50 mg + metformin 500 mg (n=183) početna terapija (dvaput na dan) sitagliptin 50 mg + metformin 1000 mg (n=178)
Adverse reactions were identified through post-marketing surveillance.
Nuspojave su utvrđene praćenjem nakon stavljanja lijeka u promet.
In addition, the film coating contains the following inactive ingredients: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), iron oxide red (E172), and iron oxide black (E172).
Osim toga, ovojnica tablete sadrži: poli(vinilni alkohol), makrogol 3350, talk (E553b), titanijev dioksid (E171), crveni željezov oksid (E172) i crni željezov oksid (E172).
See section 2, Do not take Ristfor.
Nemojte uzimati Ristfor.
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The reduction in HbA1c for patients treated with sitagliptin, metformin, and insulin was -1.35 % compared to -0.90 % for patients treated with placebo, metformin, and insulin, a difference of -0.45 % [95 % CI: -0.62, -0.29].
Sniženje vrijednosti HbA1c u bolesnika liječenih sitagliptinom, metforminom i inzulinom iznosilo je -1,35% u usporedbi s -0,90% u bolesnika koji su liječeni placebom, metforminom i inzulinom, što predstavlja razliku od -0,45% [95 % CI: -0,62; -0,29].
Marketing Authorisation Holder Merck Sharp & Dohme B.V. Waarderweg 39
Nositelj odobrenja za stavljanje gotovog lijeka u promet Merck Sharp & Dohme B.V.
Reporting of side effects
NAVOĐENJE DJELATNIH TVARI
Some patients have experienced the following side effects while taking this medicine with a sulphonylurea such as glimepiride:
Pri istodobnom uzimanju ovog lijeka sa sulfonilurejom, kao što je glimepirid, neki su bolesnici imali sljedeće nuspojave:
For patients inadequately controlled on maximal tolerated dose of metformin monotherapy For patients not adequately controlled on metformin alone, the usual starting dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
U bolesnika koji nisu odgovarajuće regulirani samo metforminom, uobičajena početna doza mora biti 50 mg sitagliptina dvaput na dan (ukupna dnevna doza 100 mg) plus dosadašnja doza metformina.
No treatment related effects on fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
Kod mužjaka i ženke štakora kojima je sitagliptin dan prije i tijekom parenja nisu zamijećeni učinci na plodnost povezani s primjenom lijeka.
Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
Jedna filmom obložena tableta (tableta) sadrži sitagliptinfosfat hidrat u količini od 50 mg sitagliptina i 850 mg metforminklorida.
Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.
Jedna filmom obložena tableta (tableta) sadrži sitagliptinfosfat hidrat u količini od 50 mg sitagliptina i 1000 mg metforminklorida.
- The active substances are sitagliptin and metformin.
- Djelatne tvari su sitagliptin i metformin.
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.
Prema analizi podataka populacijske farmakokinetike faze I i II, dob nije imala klinički značajan utjecaj na farmakokinetiku sitagliptina.
Initial Therapy (twice daily)
Nakon peroralne primjene doze [
Magyarország MSD Pharma Hungary Kft. Tel.: +36 1 888 53 00 hungary_msd@merck.com
Tel.: +36 1 888 53 00 hungary_msd@merck.com
Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
Jedna tableta sadrži sitagliptinfosfat hidrat u količini od 50 mg sitagliptina i 850 mg metforminklorida.
Ristfor 50 mg/1,000 mg tablets sitagliptin/metformin HCl
Ristfor 50 mg/1000 mg tablete sitagliptin/metforminklorid
Sitagliptin 100 mg once daily added to ongoing pioglitazone + metformin therapy (N=152)
sitagliptin 100 mg jedanput na dan dodan dotadašnjoj terapiji metforminom (n=453) sitagliptin 100 mg jedanput na dan dodan dotadašnjoj terapiji kombinacijom glimepirid + metformin (n=115) sitagliptin 100 mg jedanput na dan dodan dotadašnjoj terapiji kombinacijom pioglitazon + metformin (n=152) sitagliptin 100 mg jedanput na dan dodan dotadašnjoj terapiji kombinacijom inzulin + metformin (n=223)
Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.
Jedna tableta sadrži sitagliptinfosfat hidrat u količini od 50 mg sitagliptina i 1000 mg metforminklorida.
Ristfor 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride
Ristfor 50 mg/850 mg filmom obložene tablete sitagliptin/metforminklorid
Ristfor 50 mg/850 mg tablets sitagliptin/metformin HCl
Ristfor 50 mg/850 mg tablete sitagliptin/metforminklorid
Ristfor 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride
Ristfor 50 mg/1000 mg filmom obložene tablete sitagliptin/metforminklorid
For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin
Za bolesnike u kojih glikemija nije odgovarajuće regulirana monoterapijom najvišom podnošljivom dozom metformina
Some patients have experienced diarrhoea, nausea, flatulence, constipation, stomach ache or vomiting when starting the combination of sitagliptin and metformin together (frequency is common).
Pri istodobnom uzimanju kombinacije sitagliptina i metformina neki su bolesnici na početku liječenja imali proljev, mučninu, vjetrove, zatvor, bol u trbuhu ili su povraćali (učestalost je česta).
Mean change from baseline HbA1c (%)
Srednja vrijednost promjene u odnosu na početni HbA1c
Primary Composite Endpoint (Cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina)
Primarna objedinjena mjera ishoda (smrt zbog kardiovaskularnog uzroka, infarkt miokarda bez smrtnog ishoda, moždani udar bez smrtnog ishoda ili hospitalizacija zbog nestabilne angine) Sekundarna objedinjena mjera ishoda (smrt zbog kardiovaskularnog uzroka, infarkt miokarda bez smrtnog ishoda ili moždani udar bez smrtnog ishoda)
Cardiovascular death
(medularnog karcinoma štitnjače)
Some patients have experienced the following side effects while taking this medicine in combination with pioglitazone:
U nekih bolesnika koji su uzimali metformin nakon dodavanja sitagliptina javile su se sljedeće nuspojave:
Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines in Ristfor) or during post-approval use of Ristfor or sitagliptin alone or with other diabetes medicines:
Neki bolesnici koji su u kliničkim ispitivanjima uzimali samo sitagliptin (jednu od djelatnih tvari lijeka Ristfor), kao i bolesnici koji su koristili Ristfor ili sitagliptin, nakon njihova stavljanja u promet, same ili s drugim lijekovima za šećernu bolest, imali su sljedeće nuspojave: Često: nizak šećer u krvi, glavobolja, infekcija gornjih dišnih puteva, začepljen nos ili curenje iz nosa i grlobolja, osteoartritis, bolovi u rukama ili nogama Manje često: omaglica, zatvor, svrbež
Tel: + 386 1 5204201 msd_slovenia@merck.com
+370 5 278 02 47 msd_lietuva@merck.com
In a pre-/post-natal development study performed in rats sitagliptin showed no adverse effects.
Sitagliptin nije pokazao štetne učinke u istraživanju prenatalnog i postnatalnog razvoja provedenom na štakorima.
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Renal and urinary disorders impaired renal function
Poremećaji bubrega i mokraćnog sustava poremećaj funkcije bubrega nepoznata učestalost akutno zatajenje bubrega nepoznata učestalost