natgillin/translations-raw huggingface dataset:
A lower proportion of patients in the saxagliptin group (1.1%) compared to the glimepiride group (15.3%) experienced a confirmed or severe hypoglycaemic event.
Potrjeno ali hudo hipoglikemijo je imel manjši delež bolnikov v skupini s saksagliptinom (1,1 %) kot v skupini z glimepiridom (15,3 %).
Saxagliptin (n=250) provided significant improvements in HbA1c, FPG, and PPG compared to titration to a higher dose of glibenclamide (n=264).
Saksagliptin (n = 250) je izboljšal HbA1c, glukozo v plazmi na tešče in postprandialno glukozo bistveno bolj kot titriranje do večjega odmerka glibenklamida (n = 264).
At high doses in rats, saxagliptin caused reduced ossification (a developmental delay) of the foetal pelvis and decreased foetal body weight (in the presence of maternal toxicity), with a NOEL 303 and 30 times the human exposure for saxagliptin and the major metabolite, respectively, at RHD.
V večjih odmerkih pri podganah je saksagliptin zmanjšal osifikacijo (razvojna upočasnitev) medenice plodov, prav tako je zmanjšal telesno maso plodov (v prisotnosti maternalnih toksičnih učinkov); NOEL je bila 303-kratnik človeške izpostavljenosti saksagliptinu in 30-kratnik človeške izpostavljenosti njegovemu glavnemu presnovku pri RHD.
The HbA1c change for saxagliptin compared to placebo was -0.7% at Week 24.
Sprememba HbA1c s saksagliptinom v primerjavi s placebom je bila -0,7 % 24. teden.
Infections and infestations Upper respiratory infection
Infekcijske in parazitske bolezni okužba zgornjih dihal okužba sečil gastroenteritis sinuzitis nazofaringitis
Following a 5 mg single oral dose of saxagliptin to healthy subjects, the mean plasma AUC values for saxagliptin and its major metabolite were 78 ng·h/ml and 214 ng·h/ml, respectively.
Pri zdravih preiskovancih je bila po uporabi enega 5 mg odmerka saksagliptina povprečna AUC saksagliptina v plazmi 78 ng·h/ml, njegovega glavnega presnovka pa 214 ng·h/ml.
Table 3 HbA1c at Week 24 in active-controlled study comparing the combination of saxagliptin and dapagliflozin added concurrently to metformin with either saxagliptin or dapagliflozin added to metformin
Preglednica 3 HbA1c po 24 tednih v študiji, kontrolirani z učinkovino, ki je primerjala kombinacijo saksagliptina in dapagliflozina, dodano metforminu, s saksagliptinom ali dapagliflozinom, dodanem metforminu.
No dose adjustment is recommended for patients with mild renal impairment or in patients with moderate renal impairment that have GFR ≥ 45 mL/min.
Bolnikom z blago okvaro ledvic ali bolnikom z zmerno okvaro ledvic, ki imajo GFR ≥ 45 ml/min, odmerka ni treba prilagoditi.
Following a single 50 mg dose of C-saxagliptin, 24%, 36%, and 75% of the dose was excreted in the urine as saxagliptin, its major metabolite, and total radioactivity respectively.
C-saksagliptina se je v urinu izločilo 24 % radioaktivnosti v obliki saksagliptina, 36 % v obliki njegovega glavnega presnovka in 75 % celotne radioaktivnosti.
Saxagliptin add-on to metformin compared with sitagliptin add-on to metformin An 18-week study was conducted to evaluate the efficacy and safety of saxagliptin 5 mg in combination with metformin (403 patients), compared with sitagliptin 100 mg in combination with metformin (398 patients) in 801 patients with inadequate glycaemic control on metformin alone.
Dodatek saksagliptina metforminu v primerjavi z dodatkom sitagliptina metforminu Izvedena je bila 18-tedenska študija za oceno učinkovitosti in varnosti 5 mg saksagliptina v kombinaciji z metforminom (403 bolniki) v primerjavi s 100 mg sitagliptina v kombinaciji z metforminom (398 bolnikov) pri 801 bolniku z neustrezno urejeno glikemijo med prejemanjem samega metformina.
In subjects with moderate or severe renal impairment or in subjects with ESRD on haemodialysis, the AUC values of saxagliptin and its major metabolite were up to 2.1- and 4.5-fold higher, respectively, than AUC values in subjects with normal renal function.
Pri preiskovancih z zmerno ali hudo okvaro ledvic in pri preiskovancih s končno odpovedjo ledvic na hemodializi pa je bila AUC saksagliptina 2,1-krat, njegovega glavnega presnovka pa 4,5-krat večja kot pri preiskovancih z normalnim delovanjem ledvic.
• Film-coating: polyvinyl alcohol; macrogol 3350; titanium dioxide (E171); talc (E553b) and iron oxide red (E172).
• Filmska obloga: polivinilalkohol, makrogol 3350, titanov dioksid (E171), smukec (E553b) in rdeči železov oksid (E172).
• Study CV181040: add-on to SU (n=250)
• preskušanje CV181040: dodatek SU (n = 250)
A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a 10 mg oral dose of saxagliptin in subjects with varying degrees of chronic renal impairment compared to subjects with normal renal function.
Za primerjalno oceno farmakokinetike 10 mg peroralnega odmerka saksagliptina pri preiskovancih z različno stopnjo kronične okvare ledvic in pri preiskovancih z normalnim delovanjem ledvic je bila narejena odprta študija z enkratnim odmerkom.
They have “5” printed on one side and “4215” printed on the other side, in blue ink.
Z modrim barvilom imajo na eni strani natisnjeno “5” in na drugi strani “4215”.
Individuals treated with saxagliptin added to dapagliflozin and metformin (n=153) achieved statistically significantly (p-value < 0.0001) greater reductions in HbA1c versus the group with placebo added to dapagliflozin plus metformin (n=162) at 24 weeks (see Table 2).
Bolniki, ki so dobili saksagliptin kot dodatek dapagliflozinu in metforminu (n = 153), so imeli po 24 tednih statistično značilno (vrednost p < 0,0001) nižji HbA1c kot bolniki, ki so kot dodatek dapagliflozinu in metforminu dobili placebo (n = 162) (glejte preglednico 2).
Therefore, a lower dose of sulphonylurea or insulin may be required to reduce the risk of hypoglycaemia when used in combination with Onglyza.
Zato utegne biti med kombiniranim zdravljenjem z zdravilom Onglyza potreben manjši odmerek sulfonilsečnine ali insulina, da bi zmanjšali tveganje za hipoglikemijo.
Saxagliptin with a thiazolidinedione
Saksagliptin s tiazolidindionom
Difference from saxagliptin + metformin (adjusted mean (95% CI)
Razlika v primerjavi s kombinacijo saksagliptin + metformin (prilagojeno povprečje (95 % IZ)
• Film-coating: polyvinyl alcohol; macrogol 3350; titanium dioxide (E171); talc (E553b) and iron oxide yellow (E172).
• Filmska obloga: polivinilalkohol, makrogol 3350, titanov dioksid (E171), smukec (E553b) in rumeni železov oksid (E172).
• Study CV181013: add-on to TZD (n=183)
• preskušanje CV181013: dodatek TZD (n = 183)
Onglyza is not recommended for patients with end-stage renal disease (ESRD) requiring haemodialysis (see section 4.4).
Zdravilo Onglyza ni priporočljivo za bolnike s končno odpovedjo ledvic, ki potrebujejo hemodializo (glejte poglavje 4.4).
Talk to your doctor or pharmacist before taking Onglyza:
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Onglyza, se posvetujte z zdravnikom ali farmacevtom:
In subjects with mild renal impairment, the mean AUC values of saxagliptin and its major metabolite were 1.2- and 1.7- fold higher, respectively, than mean AUC values in subjects with normal renal function.
Pri preiskovancih z blago okvaro ledvic je bila povprečna AUC saksagliptina 1,2-krat, njegovega glavnega presnovka pa 1,7-krat večja kot povprečna AUC pri preiskovancih z normalnim delovanjem ledvic.
Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome, have not been studied in the Onglyza clinical program.
Zdravilo Onglyza v kliničnem programu ni bilo raziskano pri imunsko oslabelih bolnikih, npr. bolnikih po presaditvi organa ali bolnikih s sindromom človeške imunske pomanjkljivosti.
Saxagliptin add-on combination therapy with insulin (with or without metformin) A total of 455 patients with type 2 diabetes participated in a 24-week randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin in combination with a stable dose of insulin (baseline mean: 54.2 Units) in patients with inadequate glycaemic control (HbA1c ≥ 7.5% and ≤ 11%) on insulin alone (n=141) or on insulin in combination with a stable dose of metformin (n=314).
Saksagliptin kot dodatek zdravljenju z insulinom (z ali brez metformina) V 24-tedenski, randomizirani, dvojno-slepi, s placebom kontrolirani študiji je sodelovalo 455 bolnikov s sladkorno boleznijo tipa 2 z namenom oceniti učinkovitost in varnost saksagliptina v kombinaciji s stabilnim odmerkom insulina (povprečno izhodišče: 54,2 enot) pri bolnikih z neustrezno urejeno glikemijo (HbA1c ≥ 7.5 % in ≤ 11 %) z zgolj insulinom (n = 141) ali z insulinom v kombinaciji s stabilnim odmerkom metformina (n = 314).
Saxagliptin improves glycaemic control by reducing fasting and postprandial glucose concentrations in patients with type 2 diabetes.
Saksagliptin bolnikom s sladkorno boleznijo tipa 2 izboljša urejenost glikemije, ker se zmanjša koncentracija glukoze na tešče in postprandialno.
In both studies, once-daily treatment with saxagliptin provided significant improvements in HbA1c (see Table 2).
Saksagliptin enkrat na dan je v obeh značilno izboljšal HbA1c (glejte preglednico 2).
Indigo carmine aluminium lake (E132)
Barvilo za napis: šelak indigotin (E132)
Saxagliptin add-on to metformin compared with SU add-on to metformin A 52-week study was conducted to evaluate the efficacy and safety of saxagliptin 5 mg in combination with metformin (428 patients) compared with a sulphonylurea (glipizide, 5 mg titrated as needed to 20 mg, mean dose of 15 mg) in combination with metformin (430 patients) in 858 patients with inadequate glycaemic control (HbA1c 6.5%-10%) on metformin alone.
Dodatek saksagliptina metforminu v primerjavi z dodatkom sulfonilsečnine metforminu Izvedena je bila 52-tedenska študija za oceno učinkovitosti in varnosti 5 mg saksagliptina v kombinaciji z metforminom (428 bolnikov) v primerjavi s sulfonilsečnino (glipizid, 5 mg s prilagajanjem po potrebi do 20 mg, povprečni odmerek 15 mg) v kombinaciji z metforminom (430 bolnikov) pri 858 bolnikih, ki so imeli med prejemanjem samega metformina neustrezno urejeno glikemijo (HbA1c od 6,5 % do 10 %).
• Study CV181014: add-on to metformin (n=186)
• preskušanje CV181014: dodatek metforminu (n = 186)
The proportion of patients achieving HbA1c < 7% at Week 24 was higher in the saxagliptin 5 mg plus dapagliflozin plus metformin group 35.3% (95% CI [28.2, 42.4]) compared to the placebo plus dapagliflozin plus metformin group 23.1% (95% CI [16.9, 29.3]).
Delež bolnikov, ki so po 24 tednih dosegli HbA1c < 7,0 %, je bil v skupini, ki je prejemala kombinacijo 5 mg saksagliptina ter dapagliflozina in metformina, večji (35,3 %; 95 % IZ: 28,2, 42,4) kot v skupini, ki je prejemala kombinacijo placeba ter dapagliflozina in metformina (23,1 %; 95 % IZ: 16,9, 29,3).
Onglyza 5 mg film-coated tablets Each tablet contains 5 mg saxagliptin (as hydrochloride).
Onglyza 5 mg filmsko obložene tablete Ena tableta vsebuje 5 mg saksagliptina (v obliki klorida).
Postmarketing reports of rash have been described in the DPP4 inhibitor class.
V skupini zaviralcev DPP4 je bil v obdobju trženja opisan izpuščaj.
One component of the secondary composite endpoint, hospitalisation for heart failure, occurred at a greater rate in the saxagliptin group (3.5%) compared with the placebo group (2.8%), with nominal statistical significance favouring placebo [HR = 1.27; (95% CI 1.07, 1.51); P = 0.007].
Delež enega elementa sekundarnega sestavljenega opazovanega dogodka, sprejemov v bolnišnico zaradi srčnega popuščanja, je bil v skupini s saksagliptinom večji (3,5 %) kot v skupini s placebom (2,8 %); nominalna statistična značilnost je bila v korist placeba [razmerje ogroženosti = 1,27, (95 % IZ 1,07, 1,51), p = 0,007].
• Common (may affect 1 to 10 users in 100): infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), inflamed nose or throat (nasopharyngitis) (signs of this may include a cold or a sore throat), headache, muscle pain (myalgia), vomiting, inflammation of the stomach (gastritis), stomach ache and indigestion (dyspepsia).
• Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): okužba zgornjega dela prsnega koša ali pljuč, okužba sečil, vnetje želodca ali črevesa, ki je po navadi posledica okužbe (gastroenteritis), okužba sinusov z bolečinami in občutkom polnosti v licih in za očmi (sinuzitis), vnetje nosu ali žrela (nazofaringitis), med njegovimi znaki so lahko nahod ali vnetje žrela, glavobol, bolečine v mišicah (mialgija), bruhanje, vnetje želodca (gastritis), bolečine v trebuhu in motnje prebavne funkcije (dispepsija).
The incidence of hypersensitivity reactions was 1.1% in both Onglyza-treated patients and placebotreated patients.
Incidenca preobčutljivostnih reakcij je bila 1,1 % tako pri bolnikih, ki so prejemali zdravilo Onglyza, kot pri tistih, ki so prejemali placebo.
• Common: infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), headache, vomiting, stomach ache and swelling of the hands, ankles or feet (peripheral oedema).
• Pogosti: okužba zgornjega dela prsnega koša ali pljuč, okužba sečil, vnetje želodca ali črevesa, ki je po navadi posledica okužbe (gastroenteritis), okužba sinusov z bolečinami in občutkom polnosti v licih in za očmi (sinuzitis), glavobol, bruhanje, bolečine v trebuhu in oteklost dlani, gležnjev ali stopal (periferni edemi).
Onglyza 2.5 mg film-coated tablets Each tablet contains 2.5 mg saxagliptin (as hydrochloride).
Onglyza 2,5 mg filmsko obložene tablete Ena tableta vsebuje 2,5 mg saksagliptina (v obliki klorida).
Saxagliptin add-on combination therapy with metformin and sulphonylurea A total of 257 patients with type 2 diabetes participated in a 24-week randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin (5 mg once daily) in combination with metformin plus sulphonylurea (SU) in patients with inadequate glycemic control (HbA1c ≥ 7% and ≤ 10%).
Dodatek saksagliptina kombiniranemu zdravljenju z metforminom in sulfonilsečnino Skupno 257 bolnikov s sladkorno boleznijo tipa 2 je sodelovalo v 24-tedenski randomizirani, dvojno slepi, s placebom kontrolirani študiji za oceno učinkovitosti in varnosti saksagliptina (5 mg enkrat na dan) v kombinaciji z metforminom in sulfonilsečnino (SU - sulphonylurea) pri bolnikih z nezadostno urejeno glikemijo (HbA1c ≥ 7 % in ≤ 10 %).
The incidence of adjudicated pancreatitis events was 0.3% in both Onglyza-treated patients and placebo-treated patients in the intent-to-treat population.
Incidenca presojenih pankreatitičnih dogodkov je bila v populaciji z namenom zdravljenja 0,3 % tako med bolniki, ki so prejemali zdravilo Onglyza, kot med tistimi, ki so prejemali placebo.
MONOTHERAPY STUDIES
PRESKUŠANJA MONOTERAPIJE
Across clinical studies, the incidence of laboratory adverse events was similar in patients treated with saxagliptin 5 mg compared to patients treated with placebo.
Incidenca laboratorijskih neželenih učinkov je bila v kliničnih študijah med uporabo 5 mg saksagliptina in med uporabo placeba podobna.
Mean HbA1c change is the difference between the saxagliptin+dapagliflozin+metformin and dapagliflozin+metformin groups (p< 0.0001).
povprečna sprememba HbA1c je razlika med skupinama saksagliptin+metformin in samim metforminom (p < 0,0001) povprečna sprememba HbA1c je razlika med skupinama saksagliptin+metformin in samim metforminom povprečna sprememba HbA1c je razlika med skupinama saksagliptin+dapagliflozin+metformin in dapagliflozin+metformin (p < 0,0001)
In patients with GFR < 45 mL/min, the recommended dose is 2.5 mg once daily.
Bolnikom z zmerno okvaro ledvic, ki imajo GFR < 45 ml/min, in bolnikom s hudo okvaro ledvic je treba odmerek zmanjšati na 2,5 mg enkrat na dan.
Onglyza 2.5 mg film-coated tablets Onglyza 5 mg film-coated tablets
Onglyza 2,5 mg filmsko obložene tablete Onglyza 5 mg filmsko obložene tablete
Each film-coated tablet contains 2.5 mg saxagliptin (as hydrochloride).
Ena filmsko obložena tableta vsebuje 2,5 mg saksagliptina (v obliki klorida).
Saxagliptin add-on to dapagliflozin plus metformin therapy A 24-week randomised, double-blind, placebo-controlled study conducted in patients with type 2 diabetes mellitus compared saxagliptin 5 mg with placebo as add-on therapy in individuals with HbA1c 7-10.5% treated with dapagliflozin (a SGLT2-inhibtor) and metformin.
Dodatek saksagliptina zdravljenju s kombinacijo dapagliflozin + metformin 24-tedenska randomizirana, dvojno slepa, s placebom kontrolirana študija pri bolnikih s sladkorno boleznijo tipa 2 je primerjala 5 mg saksagliptina in placebo kot dodatek zdravljenju pri bolnikih, ki so imeli med zdravljenjem z dapagliflozinom (zaviralec SGLT2) in metforminom HbA1c od 7 do 10,5 %.
Saxagliptin (n=186) provided significant improvements in HbA1c, FPG, and PPG compared to placebo (n=175).
Saksagliptin (n = 186) je izboljšal HbA1c, glukozo v plazmi na tešče in postprandialno glukozo bistveno bolj kot placebo (n = 175).
From a baseline mean absolute lymphocyte count of approximately 2,200 cells/μl, a mean decrease of approximately 100 cells/μl relative to placebo was observed in the placebo-controlled-pooled analysis.
V kumulativni analizi petih s placebom kontroliranih kliničnih študij je bilo povprečno izhodiščno število limfocitov približno 2.200 celic/μl in se je v primerjavi s placebom v povprečju zmanjšalo za približno 100 celic/μl.
Saxagliptin (n=183) provided significant improvements in HbA1c, FPG, and PPG compared to placebo (n=180).
Saksagliptin (n = 183) je izboljšal HbA1c, glukozo v plazmi na tešče in postprandialno glukozo bistveno bolj kot placebo (n = 180).
Each film-coated tablet contains 5 mg saxagliptin (as hydrochloride).
Ena filmsko obložena tableta vsebuje 5 mg saksagliptina (v obliki klorida).
Symptoms can include, but are not limited to, increasing shortness of breath, rapid increase in weight and swelling of the feet (pedal oedema);
Med simptomi so lahko kratka sapa, hiter porast telesne mase in oteklost stopal, lahko pa se pojavijo še drugi simptomi,
The HbA1c change for saxagliptin 5 mg (n=82) compared to TZD plus placebo (n=53) was -0.9% at Week 76.
Sprememba HbA1c s 5 mg saksagliptina (n = 82) je bila 76. teden v primerjavi s TZD v kombinaciji s placebom (n = 53) -0,9 %.
Saxagliptin in combination with metformin as initial therapy A 24-week study was conducted to evaluate the efficacy and safety of saxagliptin 5 mg in combination with metformin as initial combination therapy in treatment-naïve patients with inadequate glycaemic control (HbA1c 8-12%).
Saksagliptin v kombinaciji z metforminom kot uvodno zdravljenje Narejena je bila 24-tedenska študija za oceno učinkovitosti in varnosti 5 mg saksagliptina v kombinaciji z metforminom kot uvodnega kombiniranega zdravljenja pri bolnikih, ki še niso bili zdravljeni in niso imeli ustrezno urejene glikemije (HbA1c od 8 % do 12 %).
Nausea†
Okvara jeter
How to store Onglyza
Shranjevanje zdravila Onglyza
Saxagliptin produced gastrointestinal toxicity in dogs, including bloody/mucoid faeces and enteropathy at higher doses with a NOEL 4 and 2 times the human exposure for saxagliptin and the major metabolite, respectively, at RHD.
Saksagliptin je povzročil gastrointestinalne toksične učinke pri psih, vključno s krvavim ali mukoidnim blatom, in enteropatijo pri večjih odmerkih.
• Study CV181038 (n=69)
• preskušanje CV181011 (n = 103) • preskušanje CV181038 (n = 69)
This may be used to treat fungal infections.
• ketokonazol; uporablja se lahko za zdravljenje glivičnih okužb.
Talk to your doctor if you want to breast-feed while taking this medicine.
Če želite med jemanjem tega zdravila dojiti, se morate posvetovati z zdravnikom.
Onglyza 5 mg film-coated tablets
Onglyza 5 mg filmsko obložene tablete
The HbA1c change for saxagliptin 5 mg (n=56) compared to uptitrated glibenclamide plus placebo (n=27) was -0.7% at Week 76.
Sprememba HbA1c v skupini s 5 mg saksagliptina (n = 56) je bila 76. teden v primerjavi s povečanim odmerkom glibenklamida v kombinaciji s placebom (n = 27) -0,7 %.
In a pooled analysis of 1,681 patients with type 2 diabetes including 882 patients treated with Onglyza 5 mg, randomised in five double-blind, placebo-controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control, the overall incidence of adverse events in patients treated with saxagliptin 5 mg was similar to placebo.
Kumulativna analiza petih dvojno slepih, s placebom kontroliranih kliničnih študij varnosti in učinkovitosti, narejenih za ovrednotenje vpliva saksagliptina na urejenost glikemije, je zajela 1.681 bolnikov s sladkorno boleznijo tipa 2, vključno z 882 bolniki, ki so prejemali 5 mg zdravila Onglyza.
Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated blisters.
Velikosti pakiranj: 14, 28, 56 in 98 filmsko obloženih tablet v neperforiranih pretisnih omotih.
These may be used to control fits (seizures) or chronic pain.
(konvulzij) ali kroničnih bolečin.
Some patients have had the following side effects while taking Onglyza and metformin and a sulphonylurea:
Nekateri bolniki so imeli med jemanjem zdravila Onglyza, metformina in sulfonilsečnine naslednje neželene učinke:
There was also no apparent change in body weight associated with saxagliptin.
Uporabe saksagliptina tudi ni spremljala opazna sprememba telesne mase.
BLISTERS (PERFORATED/NON-PERFORATED) for Onglyza 5 mg tablets
PRETISNI OMOTI (PERFORIRANI/NEPERFORIRANI) Onglyza 5 mg tablete
BLISTERS (PERFORATED/NON-PERFORATED) for Onglyza 2.5 mg tablets
PRETISNI OMOTI (PERFORIRANI/NEPERFORIRANI) Onglyza 2,5 mg tablete
Onglyza 2.5 mg film-coated tablets
Onglyza 2,5 mg filmsko obložene tablete
Some patients have had the following side effects while taking Onglyza and metformin:
Nekateri bolniki so imeli med jemanjem zdravila Onglyza in metformina naslednje neželene učinke:
Pack sizes of 14, 28, and 98 film-coated tablets in non-perforated calendar blisters.
Velikosti pakiranj: 14, 28 in 98 filmsko obloženih tablet v neperforiranih koledarskih pretisnih omotih.
Only in the initial combination therapy.
PRESKUŠANJA Z DODATKOM V KOMBINIRANEM ZDRAVLJENJU
Dyslipidaemia
Odmerjanje
If you have reduced kidney function, your doctor may prescribe a lower dose.
Če imate zmanjšano delovanje ledvic, vam bo lahko zdravnik predpisal nižji odmerek, eno 2,5 mg tableto enkrat na dan.
Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated calendar blisters.
Velikosti pakiranj: 14, 28, 56 in 98 filmsko obloženih tablet v neperforiranih koledarskih pretisnih omotih.
In studies conducted in healthy subjects, neither the pharmacokinetics of saxagliptin nor its major metabolite, were meaningfully altered by metformin, glibenclamide, pioglitazone, digoxin, simvastatin, omeprazole, antacids or famotidine.
Metformin, glibenklamid, pioglitazon, digoksin, simvastatin, omeprazol, antacidi in famotidin v študijah zdravih prostovoljcev niso bistveno spremenili farmakokinetike saksagliptina niti njegovega glavnega presnovka.
Hepatic impairment
Bolezni živčevja omotica glavobol
printed on one side and “4214” printed on the other side, in blue ink.
Z modrim barvilom imajo na eni strani natisnjeno “2,5” in na drugi strani “4214”.
Two double-blind, placebo-controlled studies of 24-week duration were conducted to evaluate the efficacy and safety of saxagliptin monotherapy in patients with type 2 diabetes.
Za oceno učinkovitosti in varnosti monoterapije s saksagliptinom sta bili pri bolnikih s sladkorno boleznijo tipa 2 narejeni dve dvojno slepi, s placebom kontrolirani 24-tedenski študiji.
Improvements in HbA1c, PPG and FPG following initial therapy with saxagliptin 5 mg plus metformin were sustained up to Week 76.
Izboljšanja HbA1c, postprandialne glukoze in glukoze v plazmi na tešče so se po uvodnem zdravljenju s 5 mg saksagliptina v kombinaciji z metforminom ohranila do 76. tedna.