natgillin/translations-raw huggingface dataset:
Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 4).
Takoj nehajte jemati to zdravilo in nemudoma obvestite zdravnika ali najbližjo bolnišnico (glejte poglavje 4).
Avoid alcohol, including medicines containing alcohol, while taking this medicine since alcohol may increase the risk of lactic acidosis (see section 4 ‘Possible side effects').
Med jemanjem tega zdravila se izogibajte alkoholu - tudi zdravilom, ki vsebujejo alkohol, kajti alkohol lahko poveča tveganje za laktacidozo (glejte poglavje 4 "Možni neželeni učinki").
Metformin The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Prospektivna randomizirana študija (UKPDS) je ugotovila dolgoročne koristi intenzivnega obvladovanja glukoze v krvi pri sladkorni bolezni tipa 2.
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 5 μg/ml, even at maximum doses.
V kontroliranih kliničnih preskušanjih največja koncentracija metformina v plazmi (Cmax) tudi ob največjih odmerkih ni presegla 5 µg/ml.
Cardiovascular death, MI and stroke were observed with a hazard ratio of 0.77 (95% CI: 0.54, 1.10).
Srčno-žilno smrt, MI in možgansko kap so zabeležili z razmerjem ogroženosti 0,77 (95 % IZ: 0,54, 1,10).
Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Ledvični očistek metformina je > 400 ml/min, kar kaže, da se zdravilo izloča z glomerularno filtracijo in tubularno sekrecijo.
Gender The mean dapagliflozin AUCss in females was estimated to be about 22% higher than in males.
Ocenjena povprečna AUCss dapagliflozina pri ženskah je približno 22 % večja kot pri moških.
• if you experience “lactic acidosis”: metformin, one of the active substances in this medicine, can cause a rare but serious side effect called lactic acidosis (a build up of lactic acid in the blood) that can lead to death.
• če se vam pojavi "laktacidoza": metformin, ena od zdravilnih učinkovin tega zdravila, lahko povzroči redek, toda resen neželen učinek, imenovan laktacidoza (kopičenje mlečne kisline v krvi), ki lahko vodi v smrt.
You should stop taking Xigduo at least 48 hours before planned surgery with general anaesthesia and should not start again until at least 48 hours afterwards; follow your doctor's instructions before stopping and re-starting your medicine.
Zdravilo Xigduo morate nehati jemati vsaj 48 ur pred načrtovano operacijo v splošni anesteziji in ga ne smete znova začeti jemati vsaj še 48 ur po operaciji; preden nehate jemati zdravilo in preden ga znova začnete jemati, upoštevajte zdravnikova navodila.
Biotransformation Metformin is excreted unchanged in the urine.
Metformin se nespremenjen izloči v urinu.
This may induce metformin accumulation which may increase the risk for lactic acidosis.
Ta pa lahko povzroči kopičenje metformina, kar lahko poveča tveganje za laktacidozo.
After administration of a 50 mg [14C]-dapagliflozin dose, 96% was recovered, 75% in urine and 21% in feces.
Po uporabi odmerka 50 mg [14C]-dapagliflozina se je izločenega pojavilo 96 %, in sicer 75 % v urinu in 21 % v blatu.
Constipation** Dry mouth**
zaprtost** suha usta**
• if you need to have an injection of a medicine called a contrast agent that contains iodine, for example before an X-ray or scan.
• če vam bodo injicirali zdravilo, imenovano kontrastno sredstvo, ki vsebuje jod, na primer pred rentgenskim slikanjem ali preiskavo.
Special caution should be exercised in situations where renal function may become impaired, for example when initiating anti-hypertensive or diuretic therapy or when starting treatment with a nonsteroidal anti-inflammatory drug (NSAID).
Posebna previdnost je potrebna v okoliščinah, ko bi se lahko pojavila okvara delovanja ledvic, npr. na začetku zdravljenja z antihipertenzivi ali diuretiki ali ob uvedbi zdravljenja z nesteroidnimi protivnetnimi zdravili (NSAID).
• Swallow the tablet whole with half a glass of water.
Jemanje tega zdravila • Tableto zaužijte celo s pol kozarca vode.
Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Kategorije pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10),
The hazard ratio comparing dapagliflozin to comparator was 0.79 (95% Confidence interval [CI]: 0.58, 1.07), indicating that in this analysis dapagliflozin is not associated with an increase in cardiovascular risk in patients with type 2 diabetes mellitus.
Razmerje ogroženosti z dapagliflozinom v primerjavi s primerjalnim zdravilom je bilo 0,79 (95 % interval zaupanja [IZ]: 0,58, 1,07); to kaže, da dapagliflozin v tej analizi ni bil povezan s povečanjem srčno-žilnega tveganja pri bolnikih s sladkorno boleznijo tipa 2.
If renal function falls below CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2, treatment must be discontinued.
Če delovanje ledvic upade na CrCl < 60 ml/min ali eGFR na < 60 ml/min/1,73 m2, je treba z zdravljenjem prekiniti.
PHARMACEUTICAL FORM AND CONTENTS Multipack: 196 (2 packs of 98) film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA Skupno pakiranje: 196 (2 pakiranji po 98) filmsko obloženih tablet
At the usual metformin doses and dosing schedules, steady-state plasma concentrations are reached within 24-48 hours and are generally less than 1 μg/ml.
Ob običajnih odmerkih in odmernih shemah metformina je koncentracija v stanju dinamičnega ravnovesja v plazmi dosežena v 24 do 48 urah in je na splošno nižja od 1 µg/ml.
In addition, metformin is excreted by the kidney, and moderate to severe renal insufficiency increases the risk of lactic acidosis (see section 4.4).
Poleg tega se metformin izloča skozi ledvice in zmerna do huda insuficienca ledvic poveča tveganje za laktacidozo (glejte poglavje 4.4).
• if you have or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or drink.
• če imate ali se vam pojavi občutek slabosti s siljenjem na bruhanje (navzea), bruhate, imate zvišano telesno temperaturo ali ne morete jesti ali piti.
Xigduo is contraindicated in patients with:
4.3 Kontraindikacije Zdravilo Xigduo je kontraindicirano pri bolnikih s:
The treatment may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and only if normal renal function has been established.
Zdravljenja se ne sme uvesti prej kot 48 ur po operaciji ali ponovni vzpostavitvi oralne prehrane in se ga lahko uvede samo, če je bilo vzpostavljeno normalno delovanje ledvic.
Diuretics, especially loop diuretics, may increase the risk of lactic acidosis due to their potential to decrease renal function.
Diuretiki, zlasti diuretiki zanke, lahko povečajo tveganje za laktacidozo, ker lahko zmanjšajo delovanje ledvic.
The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any conditions associated with hypoxia.
Incidenco laktacidoze je mogoče in jo je treba zmanjšati tudi z ocenitvijo drugih spremljajočih dejavnikov tveganja, npr. slabe urejenosti sladkorne bolezni, ketoze, dolgotrajnega postenja, čezmernega uživanja alkohola, insuficience jeter in vseh motenj, povezanih s hipoksijo.
bSee corresponding subsection below for additional information.
bZa dodatne informacije glejte ustrezno podpoglavje spodaj.
Difference from placebod
Razlika v primerjavi s placebomc
(95% CI) Subjects (%) achieving: HbA1c < 7% Adjusted for baseline
(95 % IZ) Preiskovanci (%), ki so dosegli: HbA1c < 7% Korigirano za izhodišče
The metabolism of dapagliflozin is primarily via glucuronide conjugation mediated by UDP-glucuronosyltransferase 1A9 (UGT1A9).
Presnova dapagliflozina poteka predvsem z glukuronidno konjugacijo, ki poteka z UDP-glukuronoziltransferazo 1A9 (UGT1A9).
Nocturia** Renal impairment**,b
*,f nikturija** okvara ledvic**,b
Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l, and an increased anion gap and lactate/pyruvate ratio.
Diagnostični laboratorijski izvidi so znižan pH krvi, koncentracija laktata v plazmi nad 5 mmol/l, povečana anionska vrzel in zvišano razmerje laktat/piruvat.
If acidosis of either form occurs, treatment must be stopped immediately and other appropriate corrective measures initiated.
je treba zdravljenje nemudoma prekiniti in uvesti ustrezne korektivne ukrepe.
The mean Vd ranged between 63-276 l.
Povprečni Vd je bil med 63 in
• Low blood sugar levels (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) - when taking this medicine with a sulphonylurea or other medicines that lower the amount of sugar in your blood, such as insulin.
• Nizka koncentracija krvnega sladkorja (hipoglikemija), pojavi se zelo pogosto (pojavi se lahko pri več kot 1 od 10 bolnikov) - če jemljete to zdravilo skupaj s sulfonilsečnino ali drugimi zdravili,
− film-coating: polyvinyl alcohol (E1203), macrogol 3350 (E1520(iii)), talc (E553b), titanium dioxide (E171), iron oxides (E172).
− filmska obloga: polivinilalkohol (E1203), makrogol 3350 (E1520(iii)), smukec (E553b), titanov dioksid (E171), železovi oksidi (E172).
Race There were no clinically relevant differences in systemic exposures between White, Black or Asian races.
Sistemska izpostavljenost se med belsko, črnsko in azijsko raso ni klinično pomembno razlikovala.
The intravascular administration of iodinated contrast agents in radiological studies can lead to renal failure.
Intravaskularna uporaba jodiranih kontrastnih sredstev pri radioloških preiskavah lahko povzroči odpoved ledvic.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/900/012
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/13/900/012
The intravascular administration of iodinated contrast agents in radiological studies may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis.
Intravaskularna uporaba jodiranih kontrastnih sredstev pri radioloških preiskavah lahko povzroči odpoved ledvic ter s tem kopičenje metformina in tveganje za laktacidozo.
In a study with add-on insulin therapy, higher rates of hypoglycaemia were observed (see section 4.5).
V študiji z dodatkom insulinskemu zdravljenju so opažali večje deleže hipoglikemij (glejte poglavje 4.5).
Other medicines and Xigduo Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Primary episodes occurred at a rate of 1.62% per patient-year in subjects treated with dapagliflozin and 2.06% in comparator-treatment subjects, per patient-year.
Delež primarnih dogodkov je bil pri prejemnikih dapagliflozina 1,62 % na bolnik-leto in pri prejemnikih primerjalnega zdravila 2,06 % na bolnik-leto.
Dapagliflozin or metformin have no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Dapagliflozin in metformin nimata vpliva ali imata le zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma.
Za laktacidozo so značilne acidotična dispneja, bolečine v trebuhu in hipotermija, ki jim sledi koma.
Liver function disorders§ Hepatitis§
žolčnika in žolčevodov motnje delovanja jeter§ hepatitis§
Combinations not recommended
Neraziskane kombinacije
Experience in NYHA class I-II is limited, and there is no experience in clinical studies with dapagliflozin in NYHA class III-IV.
Srčno popuščanje Izkušenj v razredih I in II po NYHA je malo, izkušenj iz kliničnih študij dapagliflozina v razredih III in IV
The risk of lactic acidosis must be considered in the event of non-specific signs such as muscle cramps with digestive disorders, abdominal pain and severe asthenia.
Na možnost laktacidoze je treba pomisliti v primeru nespecifičnih znakov, npr. mišičnih krčev s prebavnimi motnjami, bolečinami v trebuhu in hudo astenijo.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/900/006
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/13/900/006
Manufacturer AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany
Izdelovalec AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel
This medicinal product must not be used in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2, see sections 4.3, 4.4, 4.8, 5.1 and 5.2).
Tega zdravila se ne sme uporabljati pri bolnikih z zmerno do hudo okvaro ledvic (bolniki z očistkom kreatinina [CrCl] < 60 ml/min ali ocenjeno hitrostjo glomerularne filtracije [eGFR] < 60 ml/min/1,73 m2, glejte poglavja 4.3, 4.4, 4.8, 5.1 in 5.2).
Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Zviševanje insulinskih shem (vključno s kratkodelujočim, srednjedolgodelujočim in bazalnim insulinom) je bilo dovoljeno le, če so bolniki izpolnjevali vnaprej določena merila glukoze v plazmi na tešče.
Contents of the pack and other information
Shranjevanje zdravila Xigduo Vsebina pakiranja in dodatne informacije
Urinary tract infections were more frequently reported for dapagliflozin compared with placebo (4.7% versus 3.5%, respectively; see section 4.4).
Okužbe sečil so bile pogosteje opisane z dapagliflozinom kot s placebom (4,7 % v primerjavi s 3,5 %;
Elderly patients are more likely to have impaired renal function, and/or to be treated with anti-hypertensive medicinal products that may cause changes in renal function such as angiotensin-converting enzyme inhibitors (ACE-I) and angiotensin II type 1 receptor blockers (ARB).
Pri starejših bolnikih je verjetnejša okvara ledvic in/ali zdravljenje z antihipertenzivnimi zdravili, ki lahko povzročijo spremembe v delovanju ledvic, na primer z zaviralci angiotenzinske konvertaze (ACE-I
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING INNER CARTON - PART OF MULTIPACK - WITHOUT BLUE BOX
NOTRANJA ŠKATLA - DEL SKUPNEGA PAKIRANJA - BREZ MODREGA OKENCA
Following coadministration of dapagliflozin with mefenamic acid (an inhibitor of UGT1A9), a 55% increase in dapagliflozin systemic exposure was seen, but with no clinically meaningful effect on 24-hour urinary glucose excretion.
Po sočasni uporabi dapagliflozina in mefenaminske kisline (zaviralca UGT1A9), so zabeležili 55 % povečanje sistemske izpostavljenosti dapagliflozinu, vendar brez klinično pomembnega učinka na 24-urno izločanje glukoze v urinu.
• genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual discharge or odour)
• okužba spolovil (glivice) na spolnem udu ali v nožnici (med znaki so lahko draženje, srbenje, nenavaden izcedek ali neprijeten vonj)
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Pri sladkornih bolnikih, ki so prejemali metformin, se je laktacidoza pojavila predvsem pri bolnikih s pomembno odpovedjo ledvic.
Therefore, this medicinal product must not be used in patients with moderate to severe renal impairment (patients with CrCl < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2; see section 4.3).
Zato se tega zdravila ne sme uporabljati pri bolnikih z zmerno do hudo okvaro ledvic (bolniki z očistkom kreatinina < 60 ml/min ali ocenjeno hitrostjo glomerularne filtracije < 60 ml/min/1,73 m2; glejte poglavje 4.3).
What you need to know before you take Xigduo
Kaj morate vedeti, preden boste vzeli zdravilo Xigduo Ne jemljite zdravila Xigduo
− tablet core: hydroxypropyl cellulose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium starch glycolate.
− jedro tablete: hidroksipropilceluloza (E463), mikrokristalna celuloza (E460(i)), magnezijev stearat (E470b), natrijev karboksimetilškrob.
Your doctor may ask you to stop taking this medicine until you recover in order to prevent dehydration.
Za preprečitev dehidracije vam lahko zdravnik naroči, da nehajte jemati to zdravilo, dokler si ne opomorete.
INFORMATION IN BRAILLE xigduo 5 mg/850 mg
PODATKI V BRAILLOVI PISAVI xigduo 5 mg/850 mg
INFORMATION IN BRAILLE xigduo 5 mg/1,000 mg
PODATKI V BRAILLOVI PISAVI xigduo 5 mg/1000 mg
- hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - diabetic ketoacidosis, diabetic pre-coma; - moderate and severe renal impairment (creatinine clearance < 60 ml/min; eGFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4 and 5.2); - acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock; - acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock; - hepatic impairment (see sections 4.2, 4.4 and 5.2); - acute alcohol intoxication, alcoholism (see section 4.5).
- preobčutljivostjo na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, - diabetično ketoacidozo, diabetično predkomo, - zmerno in hudo okvaro ledvic (očistek kreatinina < 60 ml/min, eGFR < 60 ml/min/1,73 m2) (glejte poglavja 4.2, 4.4 in 5.2), - akutnimi motnjami, ki lahko spremenijo delovanje ledvic, kot so npr.: dehidracija, huda okužba, šok,
In a pre-specified pooled analysis of 13 placebo-controlled studies, treatment with dapagliflozin 10 mg resulted in a systolic blood pressure change from baseline of -3.7 mmHg and diastolic blood pressure of1.8 mmHg versus -0.5 mmHg systolic and -0.5 mmHg diastolic blood pressure for placebo group at Week 24.
Krvni tlak V vnaprej opredeljeni kumulativni analizi 13 s placebom kontroliranih študij je zdravljenje z 10 mg dapagliflozina po 24 tednih spremenilo sistolični krvni tlak od izhodišča za -3,7 mmHg in diastolični krvni tlak za -1,8 mmHg v primerjavi z -0,5 mmHg za sistolični in -0,5 mmHg za diastolični krvni tlak v skupini s placebom.
Combination of a single dose of dapagliflozin 20 mg and simvastatin (a CYP3A4 substrate) resulted in a 19% increase in AUC of simvastatin and 31% increase in AUC of simvastatin acid.
CYP3A4) je povzročila 19 % povečanje AUC simvastatina in 31 % povečanje AUC simvastatinske kisline.
Fungal infection**
srbenje spolovil**
Add-on combination
Kombinacija z dodatkom
Metformin, one of the active substances in this medicine, can cause a very rare (may affect up to 1 in 10,000 people) but serious side effect called ‘lactic acidosis'.
• Laktacidoza: metformin, ena od zdravilnih učinkovin v tem zdravilu, lahko povzroči zelo redek neželen učinek (pojavi se lahko pri največ 1 od 10.000 bolnikov), ki pa je resen; imenujemo ga "laktacidoza".
In the placebo group there was an increase of 10.5 IU/day and 18.3 IU/day from baseline (mean average dose of 84 and 92 IU/day) at Weeks 48 and 104, respectively.
V skupini s placebom so 48. teden ugotovili povečanje za 10,5 i.e./dan (povprečni odmerek 84 i.e./dan) in 104. teden povečanje za 18,3 i.e./dan (povprečni odmerek 92 i.e./dan)
Placebo + insulin ± oral glucose-lowering medicinal products2
Placebo + insulin ± peroralni antidiabetiki2
Adverse reactions in dapagliflozin and metformin immediate-release clinical trial and postmarketing dataa
Neželeni učinki dapagliflozina in metformina s takojšnjim sproščanjem na podlagi kliničnih preskušanj in postmarketinških podatkova
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic impairment) due to the metformin active substance of this medicinal product (see section 4.4).
Nepriporočljive kombinacije Zaradi vsebnosti metformina v tem zdravilu obstaja večje tveganje za laktacidozo v primeru akutne intoksikacije z alkoholom (zlasti v primeru postenja, podhranjenosti ali okvare jeter) (glejte poglavje 4.4).
Titanium dioxide (E171) Iron oxide yellow (E172)
Rdeči železov oksid (E172)
Dapagliflozin 10 mg + insulin ± oral glucose-lowering medicinal products2
Dapagliflozin 10 mg + insulin ± peroralni antidiabetiki2
• Dehydration: loss of too much fluid from your body, seen uncommonly (may affect up to 1 in 100 people).
• Dehidracija: čezmerna izguba tekočine iz telesa, ki se pojavi občasno (pojavi se lahko pri največ
• abnormalities in liver function tests, inflammation of the liver (hepatitis)
• zmanjšana koncentracija vitamina B12 v krvi • nenormalni izvidi preiskav delovanja jeter, vnetje jeter (hepatitis)
The mean steady-state volume of distribution of dapagliflozin was 118 l.
Povprečni volumen porazdelitve dapagliflozina v stanju dinamičnega ravnovesja je 118 litrov.
Vulvovaginitis, balanitis and related genital infections*,b,c
Infekcijske in parazitske bolezni vulvovaginitis, balanitis in sorodne okužbe spolovil*,b,c okužba sečil*,b,d glivična okužba**
PHARMACEUTICAL FORM AND CONTENTS 98 film-coated tablets.
98 filmsko obloženih tablet.
Hydroxypropyl cellulose (E463) Microcrystalline cellulose (E460(i)) Magnesium stearate (E470b) Sodium starch glycolate type A
Hidroksipropilceluloza (E463) Mikrokristalna celuloza (E460(i)) Magnezijev stearat (E470b)
Diabetic ketoacidosisk Lactic acidosis Vitamin B12 deficiencyh,
ketoacidozak laktacidoza pomanjkanje vitamina
These are signs of a severe infection of the urinary tract: - fever and/or chills - burning sensation when passing water (urinating) - pain in your back or side.
- pekoč občutek pri odvajanju vode (uriniranju) - bolečine v hrbtu ali ledveno
At Weeks 24, HbA1c change from baseline in subjects treated with dapagliflozin plus insulin with metformin was -0.93%.
Po 24 tednih se je HbA1c pri preiskovancih, zdravljenih z dapagliflozinom v kombinaciji z insulinom in metforminom, v primerjavi z izhodiščem spremenil za -0,93 %.
Effect of dapagliflozin on other medicinal products
Vpliv drugih zdravil na dapagliflozin
Hepatic impairment This medicinal product must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and
Pri bolnikih z okvaro jeter se tega zdravila ne sme uporabljati (glejte poglavja 4.3, 4.4 in 5.2).
The coadministration of dapagliflozin and metformin has been studied in subjects with type 2 diabetes inadequately controlled on metformin alone or in combination with a DPP-4 inhibitor (sitagliptin), sulphonylurea or insulin.
Sočasno uporabo dapagliflozina in metformina so raziskali pri preiskovancih s sladkorno boleznijo tipa 2, ki niso bili zadostno urejeni z metforminom samim ali v kombinaciji z zaviralcem DPP-4 (sitagliptin),
Reported by the investigator as possibly related, probably related or related to study treatment and reported in ≥ 0.2% of subjects and ≥ 0.1% more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
**Po navedbi raziskovalca morda povezano, verjetno povezano ali povezano s preizkušanim zdravilom ter opisano pri ≥ 0,2 % preiskovancev ter pri ≥ 0,1 % več in pri vsaj 3 preiskovancih več med uporabo 10 mg dapagliflozina kot med uporabo placeba.
Results of a 24-week placebo-controlled study of dapagliflozin in add-on combination with metformin and a sulphonylurea
Rezultati 24-tedenske, s placebom kontrolirane študije dapagliflozina v kombinaciji z dodatkom metformina in sulfonilsečnine
Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Med bolniki s potencialno večjim tveganjem za DKA so bolniki z majhno funkcijsko rezervo celic beta (npr. bolniki s sladkorno boleznijo tipa 2 z nizko vrednostjo C-peptida ali latentno avtoimunsko sladkorno boleznijo odraslih (LADA - latent autoimmune diabetes in adults) ali bolniki z anamnezo pankreatitisa),