natgillin/translations-raw huggingface dataset:
You may need more frequent blood glucose and kidney function tests, or your doctor may adjust the dosage of Ebymect. 
Morda boste morali pogosteje opravljati preiskave glukoze v krvi in delovanja ledvic, zdravnik pa bo morda moral prilagoditi odmerek zdravila Ebymect.
Your doctor may decide to temporarily or permanently stop your treatment with Ebymect. 
Zdravnik se bo morda odločil, da vam zdravljenje z zdravilom Ebymect začasno prekine ali trajno konča.
Ebymect with alcohol 
Zdravilo Ebymect skupaj z alkoholom
Ebymect may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. 
Zdravilo Ebymect lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza, zlasti če ledvice ne delujejo pravilno.
Gastrointestinal symptoms i,§ 
Bolezni prebavil gastrointestinalni simptomi i,§
• Lactic acidosis, seen very rarely (may affect up to 1 user in 10,000) Ebymect may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”). 
• Laktacidoza, ki se pojavi zelo redko (pojavi se lahko pri največ 1 od 10.000 bolnikov) Zdravilo Ebymect lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza (glejte poglavje "Opozorila in previdnostni ukrepi").
Avoid excessive alcohol intake while taking Ebymect since this may increase the risk of lactic acidosis (see “Warnings and precautions”). 
Med jemanjem zdravila Ebymect ne uživajte čezmernih količin alkohola, saj lahko to poveča tveganje za laktacidozo (glejte poglavje "Opozorila in previdnostni ukrepi").
• Metformin is contraindicated in patients with GFR of < 30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3). 
• Metforminom je kontraindiciran pri bolnikih z GFR < 30 ml/min in ga je treba začasno prenehati uporabljati v primeru motenj, ki lahko zmanjšajo delovanje ledvic (glejte poglavje 4.3).
Stop taking Ebymect for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. 
Za kratek čas prenehajte jemati zdravilo Ebymect, če imate stanje, ki je lahko povezano z dehidracijo (znatna izguba telesnih tekočin), kot je hudo bruhanje, driska, zvišana telesna temperatura, izpostavljenost vročini ali če pijete manj tekočine, kot običajno.
In case of dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake), Ebymect should be temporarily discontinued and contact with a health care professional is recommended. 
V primeru dehidracije (huda driska ali bruhanje, zvišana telesna temperatura ali zmanjšan vnos tekočine) je treba jemanje zdravila Ebymect začasno prekiniti; priporoča se posvet z zdravstvenim delavcem.
If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Ebymect before or at the time of the injection. 
Če vam bodo v krvni obtok injicirali kontrastno sredstvo, ki vsebuje jod, na primer zaradi rentgenskega ali drugega slikanja, morate pred časom injiciranja ali v tem času prenehati z jemanjem zdravila Ebymect.
• severe renal failure (GFR < 30 mL/min) (see sections 4.4 and 5.2); 
• hudo okvaro ledvic (GFR < 30 ml/min) (glejte poglavji 4.4 in 5.2),
The following statements reflect the preclinical safety data of the individual active substances of Ebymect. 
Naslednje navedbe temeljijo na predkliničnih podatkih o varnosti za posamezni učinkovini zdravila Ebymect.
• acute or chronic disease which may cause tissue hypoxia such as: - cardiac or respiratory failure, - recent myocardial infarction, - shock; 
• akutnimi ali kroničnimi boleznimi, ki lahko povzročijo hipoksijo tkiv, kot so npr.: srčno popuščanje ali respiratorna insuficienca, nedaven miokardni infarkt, šok,
If you stop taking Ebymect 
Če ste prenehali jemati zdravilo Ebymect
Combinations not studied Dapagliflozin has not been studied in combination with glucagon-like peptide 1 (GLP-1) analogues. 
Dapagliflozin ni raziskan v kombinaciji z analogi glukagonu podobnega peptida 1 (GLP-1).
If you need to have major surgery, you must stop taking Ebymect during and for some time after the procedure. 
Če morate na večji kirurški poseg, morate v času posega in še nekaj časa po tem prenehati z jemanjem zdravila Ebymect.
Ebymect should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin. 
Zdravilo Ebymect je treba uporabljati dvakrat na dan in s hrano, da bi zmanjšali z metforminom povezane neželene učinke na prebavilih.
Stop taking Ebymect and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma. 
Takoj prenehajte jemati zdravilo Ebymect in se obrnite na zdravnika ali najbližjo bolnišnico, če se pojavijo nekateri od simptomov laktacidoze, saj lahko to stanje vodi v komo.
Ebymect is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: 
Zdravilo Ebymect je indicirano pri odraslih, starih 18 let in več, ki imajo sladkorno bolezen tipa 2, kot dodatek dieti in telesni dejavnosti za izboljšanje urejenosti glikemije:
Therefore, this medicinal product is not recommended for use in patients with moderate to severe renal impairment (patients with GFR < 60 mL/min) (see section 4.2). 
Zato se uporabe tega zdravila ne priporoča pri bolnikih z zmerno do hudo okvaro ledvic (bolniki z GFR < 60 ml/min) (glejte poglavje 4.2).
There are no data from the use of Ebymect or dapagliflozin in pregnant women. 
O uporabi zdravila Ebymect ali dapagliflozina pri nosečnicah ni podatkov.
Do not take Ebymect 
Ne jemljite zdravila Ebymect
• hypersensitivity to the active substances or to any of the excipients listed in section 6.1; 
• preobčutljivostjo na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju
• if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat, contact a doctor or the nearest hospital straight away. 
• če se vam pojavijo hitra izguba telesne mase, slabost ali bruhanje, bolečine v trebuhu, prekomerna žeja, hitro in globoko dihanje, zmedenost, neobičajna zaspanost ali utrujenost, sladek vonj izdihanega zraka, sladek ali kovinski okus v ustih ali spremenjen vonj urina ali znoja; če se pojavi kar koli od tega, se takoj posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
• acute conditions with the potential to alter renal function such as: - dehydration, - severe infection, - shock; 
• akutnimi motnjami, ki lahko spremenijo delovanje ledvic, kot so npr.: dehidracija, huda okužba, šok,
No interaction studies have been performed for Ebymect. 
Študij medsebojnega delovanja z zdravilom Ebymect niso izvedli.
Uncommon (may affect up to 1 in 100 people) • thirst 
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) • žeja
What Ebymect looks like and contents of the pack 
Izgled zdravila Ebymect in vsebina pakiranja
Your doctor will decide when you must stop and when to restart your treatment with Ebymect. 
Zdravnik se bo odločil, kdaj morate z jemanjem zdravila Ebymect prenehati in kdaj lahko nadaljujete.
If you take more Ebymect tablets than you should, you may experience lactic acidosis. 
Če ste vzeli večji odmerek zdravila Ebymect, kot bi smeli Če ste vzeli več tablet zdravila Ebymect, kot bi smeli, se vam lahko pojavi laktacidoza.
Ebymect combines two anti-hyperglycaemic medicinal products with different and complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: dapagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and metformin hydrochloride, a member of the biguanide class. 
Zdravilo Ebymect je kombinacija dveh antihiperglikemičnih učinkovin z različnima in komplementarnima mehanizmoma delovanja, ki izboljšata urejenost glikemije pri bolnikih s sladkorno boleznijo tipa 2: dapagliflozina, zaviralca natrij-glukoznega soprenašalca 2 (SGLT2 - sodium glucose co-transporter 2), in metforminijevega klorida, ki spada v skupino bigvanidov.
• in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products (see sections 4.4, 4.5 and 5.1 
• v kombinaciji z drugimi antidiabetiki, vključno z insulinom, pri bolnikih, ki niso zadostno urejeni z metforminom in temi zdravili (glejte poglavja 4.4, 4.5 in 5.1 za razpoložljive podatke o različnih kombinacijah),
• hepatic impairment (see sections 4.2, 4.4 and 5.2); 
• okvaro jeter (glejte poglavja 4.2, 4.4 in 5.2),
For patients switching from separate tablets of dapagliflozin and metformin Patients switching from separate tablets of dapagliflozin (10 mg total daily dose) and metformin to Ebymect should receive the same daily dose of dapagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin. 
Bolniki, ki prehajajo z ločenih tablet dapagliflozina in metformina Bolniki, ki prehajajo z ločenih tablet dapagliflozina (celokupni dnevni odmerek 10 mg) in metformina na zdravilo Ebymect, morajo dobiti enak dnevni odmerek dapagliflozina in metformina, kot ga že jemljejo, ali najbližji terapevtsko ustrezni odmerek metformina.
Ebymect is not recommended for use in patients with GFR < 60 mL/min (see section 4.4). 
Uporaba zdravila Ebymect ni priporočljiva za bolnike, ki imajo GFR < 60 ml/min (glejte poglavje 4.4).
Ebymect combination tablets are considered to be bioequivalent to coadministration of corresponding doses of dapagliflozin and metformin hydrochloride administered together as individual tablets. 
Kombinirane tablete zdravila Ebymect veljajo za bioekvivalentne sočasni uporabi ustreznih odmerkov dapagliflozina in metforminijevega klorida, uporabljenih skupaj v ločenih tabletah.
In a pre-specified pooled analysis of 13 placebo-controlled studies, 2,360 subjects were treated with dapagliflozin 10 mg and 2,295 were treated with placebo. 
Vnaprej opredeljena kumulativna analiza 13 s placebom kontroliranih študij je zajela 2360 preiskovancev, zdravljenih z 10 mg dapagliflozina, in 2295 preiskovancev, ki so prejemali placebo.
If this happens you must stop taking Ebymect and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma. 
V tem primeru morate prenehati jemati zdravilo Ebymect in se takoj obrniti na zdravnika ali najbližjo bolnišnico, saj lahko laktacidoza vodi v komo.
Increased incidence or severity of renal pelvic dilatation was observed in adult offspring of treated dams, although only at the highest dose tested (associated maternal and pup dapagliflozin exposures were 1,415 times and 137 times, respectively, the human values at the maximum recommended human dose). 
Večjo incidenco in izrazitost razširitve ledvičnega meha so opažali pri odraslem potomstvu obravnavanih samic-mater, vendar le pri največjem testiranem odmerku (pri katerem je bila izpostavljenost mater dapagliflozinu 1415-krat in mladičev 137-krat večja od izpostavljenosti človeka pri največjem priporočenem odmerku za človeka).
Patients not adequately controlled on metformin alone or in combination with other glucose-lowering medicinal products, including insulin, should receive a total daily dose of Ebymect equivalent to dapagliflozin 10 mg, plus the total daily dose of metformin, or the nearest therapeutically appropriate dose, already being taken. 
Bolniki, ki niso zadostno urejeni s samim metforminom ali metforminom v kombinaciji z drugimi antidiabetiki, vključno z insulinom, morajo dobiti celokupni dnevni odmerek zdravila Ebymect, ki ustreza odmerku dapagliflozina 10 mg in celokupnemu dnevnemu odmerku metformina oziroma že uporabljanemu njegovemu najbližjemu terapevtsko ustreznemu odmerku.
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. 
Znaki hude okužbe sečil so: - zvišana telesna temperatura in/ali mrzlica - pekoč občutek pri odvajanju vode (uriniranju) - bolečine v hrbtu ali ledveno
Ebymect 5 mg/850 mg film-coated tablets EU/1/15/1051/001 5 mg/850 mg 14 tablets EU/1/15/1051/002 5 mg/850 mg 28 tablets EU/1/15/1051/003 5 mg/850 mg 56 tablets EU/1/15/1051/004 5 mg/850 mg 60 tablets EU/1/15/1051/005 5 mg/850 mg 60 x 1 tablet (unit dose) EU/1/15/1051/006 5 mg/850 mg 196 (2 x 98) tablets (multipack) 
Ebymect 5 mg/850 mg filmsko obložene tablete EU/1/15/1051/001 5 mg/850 mg 14 tablet EU/1/15/1051/002 5 mg/850 mg 28 tablet EU/1/15/1051/003 5 mg/850 mg 56 tablet EU/1/15/1051/004 5 mg/850 mg 60 tablet EU/1/15/1051/005 5 mg/850 mg 60 x 1 tableta (enkratni odmerek) EU/1/15/1051/006 5 mg/850 mg 196 (2 x 98) tablet (skupno pakiranje)
Following coadministration of dapagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes) a 22 % decrease in dapagliflozin systemic exposure (AUC) was observed, but with no clinically meaningful effect on 24-hour urinary glucose excretion. 
Po sočasnem jemanju dapagliflozina in rifampicina (induktorja različnih aktivnih prenašalcev in encimov za presnovo zdravil), so zabeležili 22-odstotno zmanjšanje sistemske izpostavljenosti (AUC) dapagliflozinu, vendar brez klinično pomembnega vpliva na 24-urno izločanje glukoze v urinu.
(95 % CI) Subjects (%) achieving: HbA1c < 7 % Adjusted for baseline Body weight (kg) Baseline (mean) Change from Baseline Difference from Placebo c 
(95 % IZ) Preiskovanci (%), ki so dosegli: HbA1c < 7 % Korigirano za izhodišče Telesna masa (kg) Izhodišče (povprečje) Sprememba od izhodišča Razlika v primerjavi s placebom c
When Ebymect is used in combination with insulin or an insulin secretagogue such as sulphonylurea, a lower dose of insulin or sulphonylurea may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8). 
Če se zdravilo Ebymect uporablja v kombinaciji z insulinom ali insulinskim sekretagogom, npr. s sulfonilsečnino, pride v poštev, za zmanjšanje tveganja za hipoglikemijo, zmanjšanje odmerka insulina ali sulfonilsečnine (glejte poglavji 4.5 in 4.8).
• diabetic pre-coma; 
• diabetično predkomo,
These reactions were more common in patients with baseline eGFR ≥ 30 and < 60 mL/min/1.73 m2 (18.5 % dapagliflozin 10 mg vs. 9.3 % placebo). 
ki so prejemali placebo.Te reakcije so bile pogostejše pri bolnikih z izhodiščno ocenjeno hitrostjo glomerularne filtracije [eGFR] ≥ 30 in < 60 ml/min/1,73 m2 (18,5 % z 10 mg dapagliflozina in 9,3 % s placebom).
The other ingredients are: tablet core: hydroxypropyl cellulose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium starch glycolate. 
• Druge sestavine zdravila so: jedro tablete: hidroksipropilceluloza (E463), mikrokristalna celuloza (E460(i)), magnezijev stearat (E470b), natrijev karboksimetilškrob.
Haematocrit values > 55 % were reported in 1.3 % of the subjects treated with dapagliflozin 10 mg versus 0.4 % of placebo subjects. 
Vrednosti hematokrita > 55 % so bile zabeležene pri 1,3 % preiskovancev, zdravljenih z 10 mg dapagliflozina, in pri 0,4 % tistih, ki so prejemali placebo.
• by delaying intestinal glucose absorption. 
• z upočasnitvijo absorpcije glukoze iz črevesa.
In two 12-week, placebo-controlled studies a total of 1,062 patients with inadequately controlled type 2 diabetes and hypertension (despite pre-existing stable treatment with an ACE-I or ARB in one study and an ACE-I or ARB plus one additional antihypertensive treatment in another study) were treated with dapagliflozin 10 mg or placebo. 
V dveh 12-tedenskih, s placebo kontroliranih študijah so uporabili 10 mg dapagliflozina ali placebo pri skupaj 1062 bolnikih, ki so imeli neustrezno urejeno sladkorno bolezen tipa 2 in hipertenzijo (kljub predhodnemu stabilnemu zdravljenju z zaviralcem ACE ali antagonistom angiotenzina v eni študiji oziroma z zaviralcem ACE ali antagonistom angiotenzina ter dodatnim antihipertenzivom v drugi študiji).
• if you have an increase in the amount of red blood cells in your blood, seen in tests. 
• če imate povečano število rdečih krvnih celic v krvi (to pokažejo laboratorijske preiskave)..
• The active substances are dapagliflozin and metformin hydrochloride (metformin HCl). 
• Zdravilni učinkovini sta dapagliflozin in metforminijev klorid.
What Ebymect contains 
Kaj vsebuje zdravilo Ebymect
• a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021); 
• značilno zmanjšanje absolutnega tveganja za celotno umrljivost: metformin 13,5 dogodka/1000 bolnik-let v primerjavi s samo dieto 20,6 dogodka/1000 bolnik-let (p = 0,011) in v primerjavi z združenimi podatki skupin monoterapije s sulfonilsečnino in z insulinom 18,9 dogodka/1000 bolnik-let, (p = 0,021);
Ebymect must be discontinued prior to, or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.2 and 4.4). 
Zdravilo Ebymect je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno, glejte poglavji 4.2 in 4.4.
Abbreviations: QD: once daily; BID: twice daily Metformin ≥ 1500 mg/day; Sitagliptin 100 mg/day LOCF: Last observation (prior to rescue for rescued subjects) carried forward Placebo-controlled 16-week study All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product p-value < 0.05 versus placebo + oral glucose-lowering medicinal product The percent change in body weight was analysed as a key secondary endpoint (p < 0.0001); absolute body weight change (in kg) was analysed with a nominal p-value (p < 0.0001). 
Metformin ≥ 1500 mg/dan Sitagliptin 100 mg/dan LOCF: prenos zadnjega opažanja (pred rešilnim zdravljenjem za preiskovance s takšnim zdravljenjem) [Last observation carried forward] S placebom kontrolirana 16-tedenska študija Vsi randomizirani preiskovanci, ki so prejeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila med kratkoročnim dvojno slepim obdobjem Povprečje najmanjših kvadratov, korigirano za izhodiščno vrednost Vrednost p < 0,0001 v primerjavi s kombinacijo placebo + peroralni antidiabetik Vrednost p < 0,05 v primerjavi s kombinacijo placebo + peroralni antidiabetik Odstotek spremembe telesne mase so analizirali kot sekundarni opazovani dogodek (p < 0,0001); absolutno spremembo telesne mase (v kg) so analizirali z nominalno vrednostjo p (p < 0,0001).
Ebymect has been demonstrated to be bioequivalent with coadministered dapagliflozin and metformin (see section 5.2). 
Zdravilo Ebymect je dokazano bioekvivalentno s sočasno uporabljenima dapagliflozinom in metforminom (glejte poglavje 5.2).
In patients with normal renal function or mild renal impairment (baseline eGFR ≥ 60 mL/min/1.73 m2) this grouping of reactions were reported in 1.3 % and 0.8 % of patients who received dapagliflozin 10 mg and placebo, respectively. 
Pri bolnikih z normalnim delovanjem ledvic ali blago okvaro ledvic (izhodiščna ocenjena hitrost glomerularne filtracije [eGFR] ≥ 60 ml/min/1,73 m2) je bila ta skupina učinkov opisana pri 1,3 % bolnikov, ki so prejemali 10 mg dapagliflozina, in pri 0,8 % tistih,
Ebymect should be discontinued prior to, or at the time of, the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.2 and 4.5). 
Zdravilo Ebymect je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno, glejte poglavji 4.2 in 4.5.
• a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017; 
• značilno zmanjšanje absolutnega tveganja za umrljivost, povezano s sladkorno boleznijo: metformin 7,5 dogodka/1000 bolnik-let, dieta sama 12,7 dogodka/1000 bolnik-let, p = 0,017;
Hydroxypropyl cellulose (E463) Microcrystalline cellulose (E460(i)) Magnesium stearate (E470b) Sodium starch glycolate type A 
Jedro tablete: hidroksipropilceluloza (E463) mikrokristalna celuloza (E460(i)) magnezijev stearat (E470b) natrijev karboksimetilškrob, vrsta A
How to take Ebymect 
Kako jemati zdravilo Ebymect
Hypoglycaemia (when used with SU or insulin) 
Presnovne in prehranske motnje hipoglikemija (med uporabo s sulfonilsečninami ali insulinom)
• Ebymect 5 mg/1,000 mg are 10.5 x 21.5 mm oval, yellow film-coated tablets. 
• Zdravilo Ebymect 5 mg/1000 mg so 10,5 x 21,5 mm velike, ovalne, rumene filmsko obložene tablete.
• a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01). 
• značilno zmanjšanje absolutnega tveganja za miokardni infarkt: metformin 11 dogodkov/1000 bolnik-let, dieta sama 18 dogodkov/1000 bolnik-let (p = 0,01).
EU/1/15/1051/009 5 mg/1000 mg 56 tablets EU/1/15/1051/010 5 mg/1000 mg 60 tablets EU/1/15/1051/011 5 mg/1000 mg 60 x 1 tablet (unit dose) EU/1/15/1051/012 5 mg/1000 mg 196 (2 x 98) tablets (multipack) 
Ebymect 5 mg/1000 mg filmsko obložene tablete EU/1/15/1051/007 5 mg/1000 mg 14 tablet EU/1/15/1051/008 5 mg/1000 mg 28 tablet EU/1/15/1051/009 5 mg/1000 mg 56 tablet EU/1/15/1051/010 5 mg/1000 mg 60 tablet EU/1/15/1051/011 5 mg/1000 mg 60 x 1 tableta (enkratni odmerek) EU/1/15/1051/012 5 mg/1000 mg 196 (2 x 98) tablet (skupno pakiranje)
Ebymect 5 mg/850 mg film-coated tablets and Ebymect 5 mg/1,000 mg film-coated tablets are available in PVC/PCTFE/Alu blister. 
Filmsko obložene tablete Ebymect 5 mg/850 mg in Ebymect 5 mg/1000 mg so na voljo v pretisnih omotih iz PVC/PCTFE/Alu.
Ebymect 5 mg/850 mg film-coated tablets 
Ebymect 5 mg/850 mg filmsko obložene tablete
An increase in cases of lower limb amputation (primarily of the toe) has been observed in ongoing longterm, clinical studies with another SGLT2 inhibitor. 
V dolgoročnih kliničnih študijah z drugim zaviralcem SGLT2, ki še potekajo, so opazili povečano število primerov amputacij na spodnjih okončinah (predvsem prstov na nogah).
Ebymect 5 mg/1,000 mg film-coated tablets 
Ebymect 5 mg/1000 mg filmsko obložene tablete
Yellow, biconvex, 10.5 x 21.5 mm oval, film-coated tablets engraved with “5/1000” on one side and “1069” engraved on the other side. 
Ebymect 5 mg/1000 mg filmsko obložene tablete Rumene, bikonveksne, 10,5 x 21,5 mm velike, ovalne filmsko obložene tablete z vtisnjeno oznako "5/1000" na eni strani in "1069" na drugi strani.
•Ebymect5mg/850mg are 9.5x20mm oval, brown film-coated tablets. 
•Zdravilo Ebymect5 mg/850 mg so 9,5 x 20 mm velike, ovalne, rjave filmsko obložene tablete.
Hepatic impairment 
Zelo redki hepatitis
Talc (E553b) Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) 
Filmska obloga: polivinilalkohol (E1203) makrogol 3350 (E1520(iii)) smukec (E553b) titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172)
Each Ebymect 5 mg/850 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg metformin hydrochloride. 
Ena filmsko obložena tableta (tableta) zdravila Ebymect 5 mg/850 mg vsebuje dapagliflozinpropandiol monohidrat v količini, ki ustreza 5 mg dapagliflozina, in 850 mg metforminijevega klorida.
Lactic acidosis Vitamin B1 
pomanjkanje volumna b,e žeja diabetična ketoacidoza laktacidoza pomanjkanje vitamina B12