natgillin/translations-raw huggingface dataset:
For patients with severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease requiring dialysis, one-quarter of the recommended dose of alogliptin should be administered (6.25 mg once daily).
Pri bolnikih s hudo okvaro ledvic (CrCl < 30 ml/min) in bolnikih s končno ledvično odpovedjo, ki potrebujejo dializo, je treba uporabiti četrtino priporočenega odmerka alogliptina (6,25 mg enkrat na dan).
Taking Vipidia in combination with other anti-diabetic medicines called sulphonylureas, insulin or combination therapy with thiazolidinedione plus metformin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines.
Pri jemanju zdravila Vipidia v kombinaciji z drugimi zdravili za zdravljenje sladkorne, imenovanimi sulfonilsečnine, insulinom ali pri kombiniranem zdravljenju s tiazolidindionom in metforminom se lahko vrednost krvnega sladkorja prekomerno zniža (hipoglikemija), kar lahko vpliva na sposobnost za vožnjo vozil in upravljanje s stroji.
When alogliptin is used in combination with a sulphonylurea or insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Če se alogliptin uporablja v kombinaciji s sulfonilsečnino ali z insulinom, je treba razmisliti o zmanjšanju odmerka sulfonilsečnine ali insulina, da se zmanjša tveganje za pojav hipoglikemije (glejte poglavje 4.4).
Therefore, in order to maintain systemic exposures to alogliptin that are similar to those observed in patients with normal renal function, lower doses of alogliptin should be used in patients with moderate or severe renal impairment, or end-stage renal disease requiring dialysis (see section 4.2).
Zaradi ohranjanja sistemskih izpostavljenosti alogliptinu, podobnih tistim, ki so bile opažene pri bolnikih z normalnim delovanjem ledvic, je pri bolnikih z zmerno ali s hudo okvaro ledvic ali bolnikih s končno ledvično odpovedjo, ki se zdravijo z dializo, treba uporabljati manjše odmerke alogliptina (glejte poglavje 4.2).
When alogliptin is used in combination with metformin and/or a thiazolidinedione, the dose of metformin and/or the thiazolidinedione should be maintained, and Vipidia administered concomitantly.
Če se alogliptin uporablja v kombinaciji z metforminom in/ali s tiazolidindionom, je treba odmerek metformina in/ali tiazolidindiona ohraniti, zdravljenje z zdravilom Vipidia pa uvesti sočasno.
DPP-4 is the principal enzyme involved in the rapid degradation of the incretin hormones, glucagon-like peptide-1 (GLP-1) and GIP (glucose-dependent insulinotropic polypeptide), which are released by the intestine and levels are increased in response to a meal.
DPP-4 je glavni encim, ki sodeluje pri hitri razgradnji inkretinov, glukagonu podobnega peptida-1 (GLP-1; “glucagon-like peptide-1”) in od glukoze odvisnega insulinotropnega polipeptida (GIP; “glucose-dependent insulinotropic polypeptide”), ki se izločata iz črevesa, njuna koncentracija pa se po obroku zviša.
Shellac Iron oxide black (E172)
Črnilo za tisk šelak črni železov oksid (E172)
In these studies, 2,257 alogliptin-treated patients were ≥ 65 years old and 386 alogliptin-treated patients were ≥ 75 years old.
V teh študijah se je z alogliptinom zdravilo 2.257 bolnikov, starih 65 let ali starejših, in 386 bolnikov, starih 75 let ali starejših.
Vipidia is not a substitute for insulin in insulin-requiring patients.
Pri bolnikih, ki potrebujejo zdravljenje z insulinom, zdravilo Vipidia ne more nadomestiti insulina.
Vipidia contains the active substance alogliptin which belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) which are “oral anti-diabetics”.
Učinkovina zdravila Vipidia je alogliptin, ki spada v skupino zdravil, imenovano zaviralci DPP-4 (zaviralci dipeptidil-peptidaze-4), ki so -“peroralni antidiabetiki”.
For the different dose regimens, Vipidia is available in strengths of 25 mg, 12.5 mg and 6.25 mg film-coated tablets.
Za različne režime odmerjanja je zdravilo Vipidia na voljo v različnih jakostih, in sicer v obliki 25 mg, 12,5 mg in 6,25 mg filmsko obloženih tablet.
Frequency of adverse reactions
Pogostnost neželenih učinkov
(-infinity, -0.006)
(-neskončnost, -0,006)
However, dosing of alogliptin should be conservative in patients with advanced age due to the potential for decreased renal function in this population.
Odmerka glede na starost ni treba prilagajati, vendar pa je pri bolnikih z višjo starostjo treba alogliptin odmerjati previdno, saj pri tej populaciji bolnikov obstaja tveganje za oslabljeno delovanje ledvic.
If an abnormality is found and an alternative etiology is not established, consider discontinuation of alogliptin treatment.
Če rezultati preiskav kažejo na nepravilnosti, drugi vzroki pa niso bili ugotovljeni, je treba razmisliti o prekinitvi zdravljenja z alogliptinom.
How to take Vipidia
Kako jemati zdravilo Vipidia
Due to the increased risk of hypoglycaemia in combination with a sulphonylurea, insulin or combination therapy with thiazolidinedione plus metformin, a lower dose of these medicinal products may be considered to reduce the risk of hypoglycaemia when these medicinal products are used in combination with alogliptin (see section 4.2).
Zaradi večjega tveganja za pojav hipoglikemije pri zdravljenju skupaj s sulfonilsečnino, z insulinom ali kombiniranem zdravljenju s tiazolidindionom in z metforminom, je treba razmisliti o zmanjšanju odmerka teh zdravil, če se ta zdravila uporabljajo v kombinaciji z alogliptinom, da se zmanjša tveganje za pojav hipoglikemije (glejte poglavje 4.2).
What Vipidia contains - The active substance is alogliptin.
Kaj vsebuje zdravilo Vipidia Učinkovina je alogliptin.
The recommended dose of alogliptin is one tablet of 25 mg once daily as add-on therapy to metformin, a thiazolidinedione, a sulphonylurea, or insulin or as triple therapy with metformin and a thiazolidinedione or insulin.
Priporočeni odmerek alogliptina je ena 25 mg tableta enkrat na dan kot dodatek k zdravljenju z metforminom, s tiazolidindionom, sulfonilsečnino ali z insulinom ali kot del trotirnega zdravljenja z metforminom in s tiazolidindionom ali z insulinom.
Elderly (≥ 65 years old)
Starostniki (bolniki, stari 65 let ali starejši)
It must be taken together with other anti-diabetic medicines, which your doctor will have prescribed for you, such as sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide), metformin and/or thiazolidinediones (e.g. pioglitazone) and metformin and/or insulin.
Zdravilo morate jemati skupaj z drugimi zdravili za zdravljenje sladkorne bolezni, ki vam jih je predpisal zdravnik, kot so sulfonilsečnine (npr. glipizid, tolbutamid, glibenklamid), metformin in/ali tiazolidindioni (npr. pioglitazon) ter metformin in/ali insulin.
Change at Week 104 (n=382)
Sprememba v 104. tednu (n=382)
Do not take Vipidia: - if you are allergic to alogliptin or any of the other ingredients of this medicine (listed in section 6) - if you have had a serious allergic reaction to any other similar medicines that you take to control your blood sugar.
Ne jemljite zdravila Vipidia: - če ste alergični na alogliptin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Vipidia may, therefore, be administered with or without food.
Zdravilo Vipidia se tako lahko jemlje skupaj s hrano ali brez nje.
Alogliptin has not been studied in combination with sodium glucose co-transporter 2 (SGLT-2) inhibitors or glucagon like peptide 1 (GLP-1) analogues nor formally as triple therapy with metformin and a sulphonylurea.
Uporaba alogliptina ni bila raziskana v kombinaciji z zaviralci prenašalnega proteina za natrij in glukozo v ledvicah (SGLT-2; “sodium glucose cotransporter 2”), analogi glukagonu podobnega peptida 1 (GLP-1; “glucagon like peptide 1”), niti formalno v okviru trotirnega zdravljenja z metforminom in s sulfonilsečnino.
Warnings and precautions Talk to your doctor or pharmacist before taking Vipidia: - if you have type 1 diabetes (your body does not produce insulin) - if you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to breakdown glucose because there is not enough insulin).
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Vipidia se posvetujte z zdravnikom ali s farmacevtom: - če imate sladkorno bolezen tipa 1 (telo ne proizvaja insulina).
Overall, treatment with the recommended daily dose of 25 mg alogliptin improved glycaemic control when given as monotherapy and as initial or add-on combination therapy.
Zdravljenje z alogliptinom v priporočenem dnevnem odmerku 25 mg je na splošno izboljšalo urejenost glikemije, tako pri samostojnem zdravljenju kot v okviru začetnega ali dodatnega kombiniranega zdravljenja.
LOCF = last observation carried forward † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values * p<0.001 compared to placebo or placebo+combination treatment
FAS = vsi vključeni bolniki (“full analysis set”) LOCF = prenos zadnjih opaženih vrednosti naprej (“last observation carried forward”) † Srednja vrednost najmanjših kvadratov, prilagojena gleda na predhodno antihiperglikemično zdravljenje in vrednosti v izhodišču * p<0,001 v primerjavi s placebom ali placebom + kombiniranim zdravljenjem
In a pooled analysis of the data from 13 studies, the overall rates of pancreatitis reports in patients treated with 25 mg alogliptin, 12.5 mg alogliptin, active control or placebo were 2, 1, 1 or 0 events per 1,000 patient years, respectively.
V združeni analizi podatkov iz 13 študij je celotni delež poročil o pankreatitisu pri bolnikih, ki so prejemali 25 mg alogliptina, 12,5 mg alogliptina, aktivno kontrolo ali placebo znašal 2, 1, 1 oziroma 0 dogodkov na 1.000 bolnikov-let (“patient years”).
As there is a need for dose adjustment in patients with moderate or severe renal impairment, or end-stage renal disease requiring dialysis, appropriate assessment of renal function is recommended prior to initiation of alogliptin therapy and periodically thereafter (see section 4.2).
Pri bolnikih z zmerno ali hudo okvaro ledvic in bolnikih s končno ledvično odpovedjo, ki potrebujejo zdravljenje z dializo, je treba odmerek prilagoditi, zato pred uvedbo zdravljenja z alogliptinom in v rednih časovnih presledkih med zdravljenjem priporočamo izvedbo ustreznih preiskav za oceno delovanja ledvic (glejte poglavje 4.2).
For patients with moderate renal impairment (CrCl ≥ 30 to ≤ 50 mL/min), one-half of the recommended dose of alogliptin should be administered (12.5 mg once daily; see section 5.2).
Pri bolnikih z zmerno okvaro ledvic (CrCl ≥ 30 do ≤ 50 ml/min) je treba uporabiti polovico priporočenega odmerka alogliptina (12,5 mg enkrat na dan, glejte poglavje 5.2).
No adverse effects on fertility were observed in animal studies (see section 5.3).
Pri študijah na živalih niso opazili neželenih učinkov na plodnost (glejte poglavje 5.3).
The no-observed-adverse-effect level (NOAEL) in the repeated dose toxicity studies in rats and dogs up to 26 and 39 weeks in duration, respectively, produced exposure margins that were approximately 147- and 227-fold, respectively, the exposure in humans at the recommended dose of 25 mg alogliptin.
Pri študijah toksičnosti pri ponavljajočih se odmerkih, ki so pri podganah trajale do 26 tednov, pri psih pa do 39 tednov, je bila mejna vrednost izpostavljenosti brez opaženih neželenih učinkov (NOAEL; “no-observed-adverse-effect level”) pri podganah 147-krat pri psih pa 227-krat večja od izpostavljenosti človeka pri priporočenem 25 mg odmerku alogliptina.
In vitro studies indicate that alogliptin does not induce CYP1A2, CYP2B6 and CYP2C9 and does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 at concentrations achieved with the recommended dose of 25 mg alogliptin.
Študije in vitro kažejo, da alogliptin pri koncentracijah, doseženih s priporočenim odmerkom 25 mg alogliptina, ne inducira CYP1A2, CYP2B6 in CYP2C9 ter ne zavira CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP3A4.
Adverse reaction Infections and infestations upper respiratory tract infections common nasopharyngitis common
Infekcijske in parazitske bolezni okužbe zgornjih dihal pogosti nazofaringitis pogosti
Alogliptin was eliminated with a mean terminal half-life (T1/2) of approximately 21 hours.
Povprečni končni razpolovni čas (T1/2) izločanja alogliptina znaša približno 21 ur.
In the cardiovascular outcomes study the rates of pancreatitis reports in patients treated with alogliptin or placebo were 3 or 2 events per 1,000 patient years, respectively.
V študiji kardiovaskularnih izidov je delež poročil o pankreatitisu pri bolnikih, ki so se zdravili z alogliptinom, znašal 3, pri bolnikih, ki so prejemali placebo, pa 2 dogodka na 1.000 bolnikov-let.
These studies evaluated the effects of alogliptin on glycaemic control and its safety as monotherapy, as initial combination therapy with metformin or a thiazolidinedione, and as add-on therapy to metformin, or a sulphonylurea, or a thiazolidinedione (with or without metformin or a sulphonylurea), or insulin (with or without metformin).
Te študije so vrednotile učinke alogliptina na urejenost glikemije in njegovo varnost v okviru samostojnega zdravljenja, začetnega kombiniranega zdravljenja z metforminom ali s tiazolidindionom ter kot dodatka k zdravljenju z metforminom ali s sulfonilsečnino ali tiazolidindionom (z metforminom ali s sulfonilsečnino ali brez) ali z insulinom (z metforminom ali brez).
Add-on combination therapy placebo-controlled studies Alogliptin 25 mg once daily with metformin (n=203)
S placebom nadzorovane študije dodatnega kombiniranega zdravljenja Alogliptin 25 mg enkrat na dan z metforminom (n=203)
By Week 104, mean change from baseline in fasting plasma glucose for 25 mg alogliptin and metformin was -3.2 mg/dL compared with 5.4 mg/dL for glipizide and metformin.
V 104. tednu je bila povprečna sprememba vrednosti glukoze v plazmi na tešče od izhodišča pri uporabi alogliptina v odmerku 25 mg in metformina -3,2 mg/dl v primerjavi s 5,4 mg/dl pri uporabi glipizida in metformina.
Metabolism and nutrition disorders hypoglycaemia common
Presnovne in prehranske motnje hipoglikemija pogosti
Experience in patients requiring renal dialysis is limited.
Pri bolnikih, ki potrebujejo hemodializo, so izkušnje omejene.
A causal relationship has not been established.
Vzročne povezave niso dokazali.
Change at Week 52 (n=382)
Sprememba v 52. tednu (n=382)
INFORMATION IN BRAILLE Vipidia 25 mg
PODATKI V BRAILLOVI PISAVI Vipidia 25 mg
The information provided is based on a total of 9,405 patients with type 2 diabetes mellitus, including 3,750 patients treated with 25 mg alogliptin and 2,476 patients treated with 12.5 mg alogliptin, who participated in one phase 2 or 12 phase 3 double-blind, placebo- or active-controlled clinical studies.
Navedeni podatki temeljijo na skupno 9.405 bolnikih s sladkorno boleznijo tipa 2, vključno s 3.750 bolniki, ki so se zdravili z alogliptinom v odmerku 25 mg, in 2.476 bolniki, ki so se zdravili z alogliptinom v odmerku 12,5 mg.
INFORMATION IN BRAILLE Vipidia 12.5 mg
PODATKI V BRAILLOVI PISAVI Vipidia 12,5 mg
Appropriate assessment of renal function is recommended prior to initiation of treatment and periodically thereafter (see section 4.4).
Pred uvedbo zdravljenja in v rednih časovnih presledkih med zdravljenjem priporočamo izvedbo ustreznih preiskav za oceno delovanja ledvic (glejte poglavje 4.4).
In addition, treatment with 25 mg alogliptin once daily resulted in improvements from baseline in HbA1c at Week 52 that were similar to those produced by glipizide (mean dose = 5.4 mg).
Razen tega je zdravljenje z alogliptinom v odmerku 25 mg enkrat na dan v 52. tednu povzročilo izboljšanja glede na izhodiščno vrednost HbA1c, ki so bila podobna tistim, doseženim z glipizidom (povprečni odmerek = 5,4 mg).
Vipidia is not known to affect your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni znano, če zdravilo Vipidia vpliva na sposobnost za vožnjo in upravljanje strojev.
The overall incidence of episodes of severe hypoglycaemia was comparable in patients treated with 25 mg alogliptin or 12.5 mg alogliptin, and lower than the incidence in patients treated with active control or placebo (0.1%, 0.1%, 0.4% and 0.4%, respectively).
Celotna pojavnost epizod hude hipoglikemije je bila pri bolnikih, zdravljenih z alogliptinom v odmerku 25 mg (0,1 %) ali 12,5 mg (0,1 %) primerljiva in manjša od pojavnosti pri bolnikih, zdravljenih s kontrolnim zdravilom (0,4 %) ali placebom (0,4 %).
If pancreatitis is suspected, Vipidia should be discontinued; if acute pancreatitis is confirmed, Vipidia should not be restarted.
Če je akutno vnetje trebušne slinavke potrjeno, se zdravljenja z zdravilom Vipidia ne sme več uvesti.
At Week 52, the HbA1c reduction by 25 mg alogliptin plus metformin (-0.76%, Table 3) was similar to that produced by glipizide (mean dose = 5.2 mg) plus metformin hydrochloride therapy (mean dose = 1,824 mg, -0.73%).
V 52. tednu je bilo pri uporabi alogliptina v odmerku 25 mg in metformina zmanjšanje vrednosti HbA1c (-0,76 %, tabela 3) podobno kot pri zdravljenju z glipizidom (povprečni odmerek = 5,2 mg) v kombinaciji z metforminijevim kloridom (povprečni odmerek = 1.824 mg, -0,73 %).
Alogliptin 25 mg once daily with a thiazolidinedione ± metformin or a sulphonylurea (n=195)
Alogliptin 25 mg enkrat na dan s tiazolidindionom ± metformin ali sulfonilsečnina (n=195)
INFORMATION IN BRAILLE Vipidia 6.25 mg
PODATKI V BRAILLOVI PISAVI Vipidia 6,25 mg
Alogliptin 25 mg once daily with insulin + metformin (n=126)
Alogliptin 25 mg enkrat na dan z insulinom ± metformin (n=126)
Patients with liver disease
Bolniki z boleznijo jeter
Therefore, no dose adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh scores of 5 to 9).
Obseg teh zmanjšanj ni klinično pomemben, zato pri bolnikih z blago do zmerno okvaro jeter (ocena po Child-Pugh-u od 5 do 9) odmerka ni treba prilagajati.
Postmarketing reports of hepatic dysfunction including hepatic failure have been received.
V obdobju trženja so poročali o okvari delovanja jeter, vključno z odpovedjo jeter.
Alogliptin 25 mg once daily with a thiazolidinedione + metformin vs a titrating thiazolidinedione + metformin
Alogliptin 25 mg enkrat na dan s tiazolidindionom + metforminom v primerjavi s titracijo tiazolidindiona + metformina
Alogliptin has been studied as monotherapy, as initial combination therapy with metformin or a thiazolidinedione, and as add-on therapy to metformin, or a sulphonylurea, or a thiazolidinedione (with or without metformin or a sulphonylurea), or insulin (with or without metformin).
Uporabo alogliptina so raziskovali v okviru samostojnega zdravljenja, začetnega kombiniranega zdravljenja z metforminom ali s tiazolidindionom ter kot dodatka k zdravljenju z metforminom ali s sulfonilsečnino ali tiazolidindionom (z metforminom ali s sulfonilsečnino ali brez) ali z insulinom (z metforminom ali brez).
Cardiac failure
Neusodni miokardni infarkt
Patients with kidney disease
Bolniki z boleznijo ledvic
Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling lips, paleness,
Simptomi lahko vključujejo: tresenje, znojenje, tesnobo, zamegljen vid, občutek ščemenja v ustnicah, bledico, spremembo razpoloženja ali zmedenost.
In a pooled analysis of the data from 13 studies, the overall incidences of adverse events, serious adverse events and adverse events resulting in discontinuation of therapy were comparable in patients treated with 25 mg alogliptin, 12.5 mg alogliptin, active control or placebo.
V združeni analizi podatkov iz 13 študij je bila celotna pojavnost neželenih učinkov, resnih neželenih učinkov in neželenih učinkov, zaradi katerih je bilo treba zdravljenje prekiniti, pri bolnikih, ki so prejemali alogliptin v odmerku 25 mg, alogliptin v odmerku 12,5 mg, aktivno kontrolo ali placebo, primerljiva.
Vipidia 25 mg film-coated tablets Vipidia 12.5 mg film-coated tablets Vipidia 6.25 mg film-coated tablets alogliptin
Vipidia 25 mg filmsko obložene tablete Vipidia 12,5 mg filmsko obložene tablete Vipidia 6,25 mg filmsko obložene tablete alogliptin
Clinically meaningful reductions in HbA1c compared to placebo were also observed with 25 mg alogliptin regardless of whether patients were receiving concomitant metformin therapy.
Klinično pomembna znižanja vrednosti HbA1c v primerjavi s placebom so bila opažena tudi pri uporabi alogliptina v odmerku 25 mg ne glede na to, ali so se bolniki sočasno zdravili z metforminom.
EU/1/13/844/019 10 film-coated tablets EU/1/13/844/020 14 film-coated tablets EU/1/13/844/021 28 film-coated tablets EU/1/13/844/022 30 film-coated tablets EU/1/13/844/023 56 film-coated tablets EU/1/13/844/024 60 film-coated tablets EU/1/13/844/025 90 film-coated tablets EU/1/13/844/026 98 film-coated tablets EU/1/13/844/027 100 film-coated tablets EU/1/13/844/030 84 film-coated tablets
EU/1/13/844/019 10 filmsko obloženih tablet EU/1/13/844/020 14 filmsko obloženih tablet EU/1/13/844/021 28 filmsko obloženih tablet EU/1/13/844/022 30 filmsko obloženih tablet EU/1/13/844/023 56 filmsko obloženih tablet EU/1/13/844/024 60 filmsko obloženih tablet EU/1/13/844/025 90 filmsko obloženih tablet EU/1/13/844/026 98 filmsko obloženih tablet EU/1/13/844/027 100 filmsko obloženih tablet EU/1/13/844/030 84 filmsko obloženih tablet
Add-on combination therapy studies Alogliptin 25 mg once daily with metformin vs a sulphonylurea + metformin
Študije dodatnega kombiniranega zdravljenja Alogliptin 25 mg enkrat na dan z metforminom v primerjavi s sulfonilsečnino + metforminom
How to store Vipidia
Shranjevanje zdravila Vipidia
EU/1/13/844/001 10 film-coated tablets EU/1/13/844/002 14 film-coated tablets EU/1/13/844/003 28 film-coated tablets EU/1/13/844/004 30 film-coated tablets EU/1/13/844/005 56 film-coated tablets EU/1/13/844/006 60 film-coated tablets EU/1/13/844/007 90 film-coated tablets EU/1/13/844/008 98 film-coated tablets EU/1/13/844/009 100 film-coated tablets EU/1/13/844/028 84 film-coated tablets
EU/1/13/844/001 10 filmsko obloženih tablet EU/1/13/844/002 14 filmsko obloženih tablet EU/1/13/844/003 28 filmsko obloženih tablet EU/1/13/844/004 30 filmsko obloženih tablet EU/1/13/844/005 56 filmsko obloženih tablet EU/1/13/844/006 60 filmsko obloženih tablet EU/1/13/844/007 90 filmsko obloženih tablet EU/1/13/844/008 98 filmsko obloženih tablet EU/1/13/844/009 100 filmsko obloženih tablet EU/1/13/844/028 84 filmsko obloženih tablet
Not known: - Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness,
Neznana (pogostosti iz razpoložljivih podatkov ni mogoče oceniti): - Težave z jetri, kot so siljenje na bruhanje, bruhanje, bolečina v trebuhu, neobičajna ali nepojasnjena utrujenost, izguba apetita, temen urin ali rumeno obarvanje kože ali očesnih beločnic.
EU/1/13/844/010 10 film-coated tablets EU/1/13/844/011 14 film-coated tablets EU/1/13/844/012 28 film-coated tablets EU/1/13/844/013 30 film-coated tablets EU/1/13/844/014 56 film-coated tablets EU/1/13/844/015 60 film-coated tablets EU/1/13/844/016 90 film-coated tablets EU/1/13/844/017 98 film-coated tablets EU/1/13/844/018 100 film-coated tablets EU/1/13/844/029 84 film-coated tablets
EU/1/13/844/010 10 filmsko obloženih tablet EU/1/13/844/011 14 filmsko obloženih tablet EU/1/13/844/012 28 filmsko obloženih tablet EU/1/13/844/013 30 filmsko obloženih tablet EU/1/13/844/014 56 filmsko obloženih tablet EU/1/13/844/015 60 filmsko obloženih tablet EU/1/13/844/016 90 filmsko obloženih tablet EU/1/13/844/017 98 filmsko obloženih tablet EU/1/13/844/018 100 filmsko obloženih tablet EU/1/13/844/029 84 filmsko obloženih tablet
In a pooled analysis of the data from 12 studies, the overall incidence of any episode of hypoglycaemia was lower in patients treated with 25 mg alogliptin than in patients treated with 12.5 mg alogliptin, active control or placebo (3.6%, 4.6%, 12.9% and 6.2%, respectively).
V združeni analizi podatkov iz 12 študij je bila skupna pojavnost kakršne koli epizode hipoglikemije manjša pri bolnikih, zdravljenih z alogliptinom v odmerku 25 mg (3,6 %), kot pri bolnikih, zdravljenih z alogliptinom v odmerku 12,5 mg (4,9 %), s kontrolnim zdravilom (12,9 %) ali placebom (6,2 %).