natgillin/translations-raw huggingface dataset:
Pseudoephedrine Hydrochloride ; Pholcodine ;
Psevdoefedrin Hydrochloride ; Folkodin ;
Ernest Jackson and company Limited, 29 High Street, Crediton,
Velika Britanija Ernest Jackson and company Limited,
Wimblehurst Road, Horsham,
Velika Britanija Novartis Consumer Health UK Limited, Wimblehurst Road, Horsham,
MYRTE (huile essentielle de) (deterpenee) ; pholcodine
Mirta (esencialno olje), ; folkodin
biclotymol ; chlorphénamine (maléate de) ; pholcodine
biklotimol ; klorfenaminijev maleat ; folkodin
Tixylix Dry cough
Tixylix Dry cough Peroralna raztopina Peroralna uporaba
Night time Cold relief
Night time Cold relief Peroralna raztopina Peroralna uporaba
Chlorpheniramine maleate
Klorfenaminijev maleat
Pholcodine, Ephedrine Hydrochloride, Chlorphenamine Maleate
Efedrinhidroklorid, Klorfenamin Maleate
Pseudoephedrine hydrochloride
Psevdoefedrin hydrochloride
Kalii guaiacolsulfonas 47,5 mg/5ml Natrii benzoas 50 mg/5ml
Natrii benzoas 50 mg/5ml
Capsule, hard Oral use
Kapsula, trda
Paracetamol, Pseudoephedrine hydrochloride, Pholcodine
Paracetamol, Psevdoefedrin hydrochloride, Folkodin
Trophires Adultes
Trophires Adultes Sirup
19,750mg/100 ml;
19,750mg/100ml; 131 mg/100ml
Pholcodine Linctus BP Oral solution
Pholcodine Linctus BP Peroralna raztopina Peroralna uporaba
9830 Sint-Martens-Latem Belgium pholcodine 5 mg/5ml Doxylaminii succinas 5 mg/5ml
Belgium folkodin 5 mg/5ml Doksilaminijev sukcinat 5 mg/5ml Kalii guaiakol sulfonas 47,5 mg/5ml
Diphenhydramine Psedoephedrine Hydrochloride
Diphenhydramine Psevdoefedrin
Paracetamol Pseudoephedrine Hydrochloride Pholcodine
Paracetamol Psevdoefedrinijev hidroklorid Folkodin
HEPATOUM
Pastila
pholcodine ; sodium (benzoate de)
folkodin ; Natrii benzoas
GlaxoSmithKline Consumer Healthcare (Ireland) Limited,
Velika Britanija LPC Medical (UK) Limited,
guaïfénésine ; pholcodine
cineol; folkodin
Pseudoephedrine Hydrochloride ; Pholcodine
Psevdoefedrin hydrochloride, Folkodin
chlorphénamine (maléate de) ; pholcodine
Klorfenaminijev maleat ; Folkodin
Hard capsules
Kapsula, trdas
pholcodine ; sulfogaïacol
Folkodin ; Efedrinhidroklorid
• Risk Management Plan (RMP)
• Načrt za obvladovanje tveganja (RMP - “Risk Management Plan”)
Not known (frequency cannot be estimated from the available data): - An allergic reaction.
Neznana (pogostosti iz razpoložljivih podatkov ni mogoče oceniti): - Alergijska reakcija.
Your doctor will tell you if you need to change the amount of other medicines you take.
Zdravnik vam bo povedal, če bo treba spremeniti količino drugih zdravil, ki jih jemljete.
Do not stop taking Vipidia without consulting your doctor first.
Ne prenehajte jemati zdravila Vipidia, ne da bi se pred tem posvetovali z zdravnikom.
ATC code: A10BH04.
Oznaka ATC: A10BH04
The absolute bioavailability of alogliptin is approximately 100%.
Absolutna biološka uporabnost alogliptina je približno 100 %.
Frequencies are defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Pogostnost neželenih učinkov je opredeljena kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Adults (≥ 18 years old)
Odrasli (stari 18 let in starejši)
Your doctor will help you to decide whether to continue breast-feeding or to continue using Vipidia.
Vaš zdravnik vam bo pomagal pri odločitvi, ali boste nadaljevali z dojenjem ali pa boste še naprej uporabljali zdravilo Vipidia.
It is important that you continue to take your other anti-diabetic medicine, and continue to follow the advice on diet and exercise that your nurse or doctor has given you.
Pomembno je, da nadaljujete z jemanjem drugih zdravil za zdravljenje sladkorne bolezni in se držite navodil glede diete in telesne vadbe, ki sta vam jih dala medicinska sestra ali zdravnik.
What Vipidia is and what it is used for
Kaj je zdravilo Vipidia in za kaj ga uporabljamo
Combination with other anti-diabetic medicinal products
Kombinacije z drugimi antidiabetiki
Vipidia should be taken once daily with or without food.
Zdravilo Vipidia je treba jemati enkrat na dan s hrano ali brez nje.
STOP taking Vipidia and contact a doctor immediately if you notice any of the following serious side effects:
PRENEHAJTE jemati zdravilo Vipidia in nemudoma poiščite zdravniško pomoč, če opazite katerega koli od naslednjih resnih neželenih učinkov:
This may be 12.5 mg or 6.25 mg once a day, depending on the severity of your kidney disease.
Ta je lahko 12,5 mg ali 6,25 mg enkrat na dan, odvisno od stopnje bolezni ledvic.
Vipidia should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Zdravila Vipidia se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
If you have kidney disease your doctor may prescribe you a reduced dose.
Če imate bolezen ledvic, vam zdravnik lahko predpiše manjši odmerek.
The recommended dose of Vipidia is 25 mg once a day.
Priporočeni odmerek zdravila Vipidia je 25 mg enkrat na dan.
Experience of alogliptin use in clinical studies in patients with congestive heart failure of New York Heart Association (NYHA) functional class III and IV is limited and caution is warranted in these patients.
Izkušnje z uporabo alogliptina iz kliničnih študij pri bolnikih s kongestivnim srčnim popuščanjem funkcijskih razredov III in IV po New York Heart Association (NYHA) so omejene, zato je pri teh bolnikih potrebna previdnost.
The European Medicines Agency has deferred the obligation to submit the results of studies with Vipidia in one or more subsets of the paediatric population in the treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Vipidia za eno ali več podskupin pediatrične populacije pri zdravljenju sladkorne bolezni tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The adverse reactions are listed by system organ class and frequency.
Neželeni učinki so navedeni po organskih sistemih in pogostnosti.
What you need to know before you take Vipidia
Kaj morate vedeti, preden boste vzeli zdravilo Vipidia
MARKETING AUTHORISATION NUMBER(S) EU/1/13/844/001-030
EU/1/13/844/001-030
It is used to lower blood sugar levels in adults with type 2 diabetes.
Zdravilo uporabljamo za zniževanje vrednosti krvnega sladkorja pri odraslih s sladkorno boleznijo tipa 2.
Your doctor will prescribe Vipidia together with one or more other medicines to control your blood sugar levels.
Zdravnik vam bo predpisal uporabo zdravila Vipidia skupaj z enim ali več drugimi zdravili za uravnavanje vrednosti krvnega sladkorja.
A decision on whether to discontinue breast-feeding or to discontinue alogliptin therapy should be made taking into account the benefit of breast-feeding for the child and the benefit of alogliptin therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem zdravljenja z alogliptinom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja z alogliptinom za mater.
Other medicines and Vipidia
Druga zdravila in zdravilo Vipidia
If you take more tablets than you should, or if someone else or a child takes your medicine, contact or go to your nearest emergency centre straight away.
Če ste vzeli večji odmerek zdravila Vipidia, kot bi smeli Če ste vzeli več tablet, kot bi smeli, ali pa je vaše zdravilo vzela druga oseba ali otrok, se nemudoma obrnite na najbližji center za nujno medicinsko pomoč ali se odpravite tja.
The safety of alogliptin between the elderly (≥ 65 years old) and non-elderly (< 65 years old) was similar.
Varnost alogliptina pri starostnikih (starih 65 let ali starejših) in mlajših bolnikih (mlajših od 65 let) je bila podobna.
Vipidia has no or negligible influence on the ability to drive and use machines.
Zdravilo Vipidia nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
What Vipidia is and what it is used for What you need to know before you take Vipidia How to take Vipidia
Kaj je zdravilo Vipidia in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Vipidia Kako jemati zdravilo Vipidia Možni neželeni učinki
The effect of alogliptin on fertility in humans has not been studied.
Učinek alogliptina na plodnost pri ljudeh ni bil raziskan.
Patients should be observed closely for possible liver abnormalities.
Bolnike je treba skrbno nadzirati glede možne okvare jeter.
Vipidia is available in blister packs containing 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 tablets.
Zdravilo Vipidia je na voljo v pretisnih omotih, ki vsebujejo 10, 14, 28, 30, 56, 60, 84, 90, 98 ali 100 tablet.
Immune system disorders hypersensitivity not known
Bolezni imunskega sistema preobčutljivost neznana
Pack sizes of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets.
Velikosti pakiranj: 10, 14, 28, 30, 56, 60, 84, 90, 98 ali 100 filmsko obloženih tablet.
The most common adverse reaction in patients treated with 25 mg alogliptin was headache.
Najpogostejši neželeni učinek pri bolnikih, ki so se zdravili z alogliptinom v odmerku 25 mg, je bil glavobol.
Vipidia works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body.
Zdravilo Vipidia deluje tako, da po obroku v telesu zviša koncentracijo insulina in zmanjša količino sladkorja.
The safety and efficacy of Vipidia in children and adolescents < 18 years old have not been established.
Varnost in učinkovitost zdravila Vipidia pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
Vipidia is taken when your blood sugar cannot be adequately controlled by diet, exercise and one or more of these other oral anti-diabetic medicines.
Zdravilo Vipidia uporabljamo, če krvnega sladkorja ni mogoče dovolj dobro nadzorovati z dieto, s telesno vadbo in z enim ali več drugimi peroralnimi zdravili za zdravljenje sladkorne bolezni.
Vipidia should not be used during pregnancy or breast-feeding.
Zdravila Vipidia med nosečnostjo ali dojenjem ne smete uporabljati.
However, as the distribution of AUC values for alogliptin in these patients was within the same range as control subjects, no dose adjustment for patients with mild renal impairment is necessary (see section 4.2).
Ker pa je bila porazdelitev vrednosti AUC alogliptina pri teh bolnikih v enakem razponu kot pri kontrolnih osebah, pri bolnikih z blago okvaro ledvic odmerka ni treba prilagajati (glejte poglavje 4.2).
Polychlorotrifluoroethylene (PCTFE)/polyvinyl chloride (PVC) blisters with push through aluminium lidding foil.
Pretisni omoti iz poliklorotrifluoroetilena (PCTFE)/polivinil klorida (PVC), prekriti s pretisno aluminijasto folijo.
Animal studies have shown excretion of alogliptin in milk (see section 5.3).
Študije na živalih kažejo na izločanje alogliptina v mleko (glejte poglavje 5.3).
Alogliptin may be administered without regard to the timing of dialysis.
Alogliptin se lahko uporablja ne glede na čas dialize.
Results from studies with metformin, pioglitazone (thiazolidinedione), voglibose (alpha-glucosidase inhibitor) and glyburide (sulphonylurea) have shown no clinically relevant pharmacokinetic interactions.
Rezultati študij z metforminom, s pioglitazonom (tiazolidindion), z voglibozo (zaviralec glukozidaze alfa) in gliburidom (sulfonilsečnina) ne kažejo klinično pomembnih farmakokinetičnih interakcij.
- Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
- Huda in trdovratna bolečina v trebuhu (v predelu želodca), ki lahko izžareva v hrbet, pa tudi siljenje na bruhanje in bruhanje, so lahko znak vnetja trebušne slinavke (pankreatitisa).
In addition, a prospective randomised cardiovascular outcomes safety study was conducted with 5,380 patients with high underlying cardiovascular risk to examine the effect of alogliptin compared with placebo (when added to standard of care) on major adverse cardiovascular events (MACE) including time to the first occurrence of any event in the composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke in patients with a recent (15 to 90 days) acute coronary event.
Poleg tega pa je bila izvedena tudi prospektivna randomizirana študija izidov kardiovaskularne varnosti, v katero je bilo vključenih 5.380 bolnikov z velikim osnovnim kardiovaskularnim tveganjem, za ovrednotenje učinka alogliptina v primerjavi s placebom (kot dodatek k standardnemu zdravljenju) na pomembne neželene kardiovaskularne dogodke (MACE, “major adverse cardiovascular events”), vključno s časom do prvega pojava katerega koli dogodka, sestavljenega iz kardiovaskularne smrti, neusodnega miokardnega infarkta in neusodne možganske kapi pri bolnikih z nedavnim (15 do 90 dni) akutnim koronarnim dogodkom.
Nonfatal Stroke *Overall there were 153 subjects (5.7%) in the alogliptin group and 173 subjects (6.5%) in the placebo group who died (all-cause mortality).
Neusodna možganska kap * V skupini, ki je prejemala alogliptin, je vsega skupaj umrlo 153 oseb (5,7 %), v skupini, ki je prejemala placebo, pa 173 oseb (6,5 %) (umrljivost zaradi vseh vzrokov).
In healthy subjects, alogliptin had no effect on prothrombin time or International Normalised Ratio (INR) when administered concomitantly with warfarin.
Pri zdravih osebah alogliptin pri sočasni uporabi z varfarinom ni vplival na protrombinski čas ali internacionalno normalizirano razmerje (INR - International Normalised Ratio).
Swallow your tablet(s) whole with water.
Tableto (tablete) pogoltnite celo (cele) skupaj z vodo.
As a precautionary measure, it is preferable to avoid the use of alogliptin during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi alogliptina bolje izogibati.
Additional symptoms may include general itching and feeling of heat especially affecting the scalp, mouth, throat, palms of hands and soles of feet (Stevens-Johnson syndrome).
Dodatni simptomi lahko vključujejo splošno srbenje in občutek vročine, še posebej v predelu lasišča, ust, žrela, dlani in podplatov (StevensJohnsonov sindrom).
10 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 60 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets 100 film-coated tablets
10 filmsko obloženih tablet 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 56 filmsko obloženih tablet 60 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet 98 filmsko obloženih tablet 100 filmsko obloženih tablet
A single-dose of 50 mg alogliptin was administered to 4 groups of patients with varying degrees of renal impairment (CrCl using the Cockcroft-Gault formula): mild (CrCl = > 50 to ≤ 80 mL/min), moderate (CrCl = ≥ 30 to ≤ 50 mL/min), severe (CrCl = < 30 mL/min) and end-stage renal disease on haemodialysis.
Enkratni odmerek 50 mg alogliptina so prejele 4 skupine bolnikov z različno stopnjo okvare ledvic ((CrCl po enačbi Cockcroft-Gault): blaga (CrCl = > 50 do ≤ 80 ml/min), zmerna (CrCl = ≥ 30 do ≤ 50 ml/min), huda (CrCl = <30 ml/min) in končna ledvična odpoved na hemodializi.
This was determined by clinically relevant and statistically significant reductions in glycosylated haemoglobin (HbA1c) and fasting plasma glucose compared to control from baseline to study endpoint.
To je bilo dokazano s klinično pomembnim in statistično značilnim zmanjšanjem vrednosti glikoziliranega hemoglobina (HbA1c - glycosylated haemoglobin) in vrednosti glukoze v plazmi na tešče v primerjavi s kontrolo od izhodišča do končne opazovane vrednosti v študiji.
Total exposure to alogliptin was approximately 10% lower and peak exposure was approximately 8% lower in patients with moderate hepatic impairment compared to healthy control subjects.
Pri bolnikih z zmerno okvaro jeter je bila skupna izpostavljenost alogliptinu približno za 10 % manjša, največja izpostavljenost pa približno za 8 % manjša v primerjavi z zdravimi kontrolnimi osebami.
If you stop taking Vipidia
Če ste prenehali jemati zdravilo Vipidia
Higher rates of hypoglycaemia were observed with triple therapy with thiazolidinedione and metformin and in combination with insulin, as observed with other DPP-4 inhibitors.
Večji deleži hipoglikemije so bili opaženi pri trotirnem zdravljenju s tiazolidindionom in z metforminom in v kombinaciji z insulinom, tako kot pri drugih zaviralcih DPP-4.
In the prospective randomised controlled cardiovascular outcomes study, investigator reported events of hypoglycemia were similar in patients receiving placebo (6.5%) and patients receiving alogliptin (6.7%) in addition to standard of care.
V prospektivni randomizirani nadzorovani študiji kardiovaskularnih izidov so raziskovalci poročali o podobni pojavnosti hipoglikemičnih dogodkov pri bolnikih, ki so poleg standardnega zdravljenja prejemali placebo (6,5 %), in bolnikih, ki so prejemali alogliptin (6,7 %).
Skin and subcutaneous tissue disorders pruritus common rash common exfoliative skin conditions including Stevens-Johnson syndrome erythema multiforme not known not known angioedema not known urticaria not known
Bolezni kože in podkožja pruritus pogosti izpuščaj pogosti eksfoliativne bolezni kože, vključno s stevens johnsonovim sindromom multiformni eritem neznana neznana angioedem neznana urtikarija neznana
- A severe allergic reaction: skin lesions or spots on your skin that can progress to a sore surrounded by pale or red rings, blistering and/or peeling of the skin possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores (Stevens-Johnson syndrome and Erythema multiforme).
- Huda alergijska reakcija: pojav kožnih sprememb ali lis na koži, ki lahko napredujejo do razjed, obdanih z bledimi ali rdečimi obročki, spremljajo pa jih lahko simptomi, kot so srbenje, zvišana telesna temperatura, splošno slabo počutje, bolečine v sklepih, težave z vidom, pekoče, boleče ali srbeče oči in razjede v ustih (Stevens-Johnsonov sindrom in multiformni eritem).
If you forget to take Vipidia
Če ste pozabili vzeti zdravilo Vipidia
Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate
Jedro tablete manitol mikrokristalna celuloza hidroksipropilceluloza premreženi natrijev karmelozat magnezijev stearat
Common (may affect up to 1 in 10 people): - Symptoms of low blood sugar (hypoglycaemia) may occur when Vipidia is taken in combination with insulin or sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide).
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - Simptomi nizkega krvnega sladkorja (hipoglikemije) se lahko pojavijo, če zdravilo Vipidia jemljete skupaj z insulinom ali s sulfonilsečninami (npr. glipizid, tolbutamid, glibenklamid).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl-peptidase-4 (DPP-4) inhibitor (see sections 4.4 and 4.8).
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali anamneza hude preobčutljivostne reakcije, vključno z anafilaktično reakcijo, anafilaktičnim šokom in angioedemom po uporabi katerega koli zaviralca dipeptidil-peptidaze-4 (DPP-4) (glejte poglavji 4.4 in
The studies included 5,744 patients with mild renal impairment, 1,290 patients with moderate renal impairment and 82 patients with severe renal impairment / end-stage renal disease treated with alogliptin.
V študijah se je z alogliptinom zdravilo 5.744 bolnikov z blago okvaro ledvic, 1.290 bolnikov z zmerno okvaro ledvic in 82 bolnikov s hudo okvaro ledvic/končno ledvično odpovedjo.
It is unknown whether alogliptin is excreted in human milk.
Ni znano, ali se alogliptin izloča v materino mleko.
In a clinical study of alogliptin as mono-therapy, the incidence of hypoglycaemia was similar to that of placebo, and lower than placebo in another study as add-on to a sulphonylurea.
V klinični študiji alogliptina kot samostojnega zdravila je bila pojavnost hipoglikemije podobna kot pri placebu in manjša od pojavnosti pri placebu v drugi študiji, kjer je bil alogliptin uporabljen kot dodatek k zdravljenju s sulfonilsečnino.
Pharmacotherapeutic group: Drugs used in diabetes; dipeptidyl peptidase 4 (DPP-4) inhibitors.
Farmakoterapevtska skupina: Zdravila za zdravljenje diabetesa, zaviralci dipeptidil-peptidaze 4 (DPP-4)
Based on mean dialysate concentrations, approximately 7% of the active substance was removed during a 3-hour haemodialysis session.)
Na osnovi povprečnih koncentracij dializata se je med 3-urnim postopkom dialize odstranilo približno 7 % učinkovine.)
Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Zdravilo Vipidia je indicirano za zdravljenje odraslih bolnikov, starih 18 let in starejših, s sladkorno boleznijo tipa 2 za izboljšanje urejenosti glikemije v kombinaciji z drugimi antidiabetiki, vključno z insulinom, če ta zdravila v kombinaciji z dieto in s telesno vadbo ne omogočajo zadostne urejenosti glikemije (za razpoložljive podatke o različnih kombinacijah glejte poglavja 4.4, 4.5 in 5.1).
Nervous system disorders headache common
Bolezni živčevja glavobol pogosti
Hypromellose Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Macrogol 8000
Filmska obloga hipromeloza titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172) makrogol 8000
Gastrointestinal disorders abdominal pain common gastroesophageal reflux disease common diarrhoea common acute pancreatitis not known
Bolezni prebavil bolečina v trebuhu pogosti gastroezofagealni refluks pogosti diareja pogosti akutni pankreatitis neznana
However patients should be alerted to the risk of hypoglycaemia especially when combined with a sulphonylurea, insulin or combination therapy with thiazolidinedione plus metformin.
Kljub temu pa je bolnike treba opozoriti na možnost pojava hipoglikemije, še posebej če se zdravilo uporablja skupaj s sulfonilsečnino, z insulinom ali pri kombiniranem zdravljenju s tiazolidindionom in z metforminom.
Importantly, despite alogliptin and glipizide having similar HbA1c and fasting plasma glucose changes from baseline, episodes of hypoglycaemia were notably less frequent in patients receiving 25 mg alogliptin (5.4%) compared to those receiving glipizide (26.0%).
Pomembno pa je, da so kljub temu, da sta alogliptin in glipizid povzročila podobne spremembe vrednosti HbA1c in vrednosti glukoze v plazmi na tešče glede na izhodiščne vrednosti, bile epizode hipoglikemije opazno manj pogoste pri bolnikih, ki so prejemali alogliptin v odmerku 25 mg (5,4 %), kot pri bolnikih, ki so prejemali glipizid (26,0 %).
(-infinity, 0.059)
(-neskončnost; 0,059)
For patients with mild renal impairment (creatinine clearance (CrCl) > 50 to ≤ 80 mL/min), no dose adjustment of alogliptin is necessary (see section 5.2).
Pri bolnikih z blago okvaro ledvic (kreatininski očistek (CrCl- “creatinine clearance”) > 50 do ≤ 80 ml/min) odmerka alogliptina ni treba prilagajati (glejte poglavje 5.2).
The efficacy and safety of the recommended doses of alogliptin were investigated separately in a subgroup of patients with type 2 diabetes mellitus and severe renal impairment/end-stage renal disease in a placebo-controlled study (59 patients on alogliptin and 56 patients on placebo for 6 months) and found to be consistent with the profile obtained in patients with normal renal function.
Učinkovitost in varnost priporočenih odmerkov alogliptina so v s placebom nadzorovani študiji raziskovali posebej pri podskupini bolnikov s sladkorno boleznijo tipa 2 in hudo okvaro ledvic/končno ledvično odpovedjo (59 bolnikov je 6 mesecev prejemalo alogliptin, 56 bolnikov pa placebo).