natgillin/translations-raw huggingface dataset:
The Agency decided that Advate's benefits are greater than its risks and recommended that it be given marketing authorisation.
Agencija je sklenila, da so koristi zdravila Advate večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
What are the risks associated with Advate?
Kakšna tveganja so povezana z zdravilom Advate?
Three additional studies looked at the use of the medicine in the prevention of bleeding and in surgery in patients with severe or moderately severe haemophilia A, including one study in 53 children under the age of 6 years.
V treh dodatnih študijah so proučevali uporabo zdravila pri preprečevanju krvavitev in med kirurškim posegom pri bolnikih s hudo ali zmerno hudo hemofilijo A, vključno z eno študijo pri 53 otrocih, mlajših od 6 let.
The data provided on immune tolerance induction in patients with inhibitors were not considered sufficient to specifically approve the medicine for this use.
Predloženi podatki o indukciji imunske tolerance pri bolnikih z zaviralci niso bili zadostni za odobritev zdravila za to specifično uporabo.
What benefits of Advate have been shown in studies?
Kakšne koristi je zdravilo Advate izkazalo v študijah?
Patients or their carers may be able to administer Advate themselves at home once they have been trained appropriately.
Bolniki ali njihovi negovalci lahko po ustreznem usposabljanju zdravilo Advate dajejo sami doma.
Why is Advate approved?
Zakaj je bilo zdravilo Advate odobreno?
The dose and duration of treatment depend on whether Advate is used to treat or prevent bleeding or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Odmerek in trajanje zdravljenja sta odvisna od tega, ali se zdravilo uporablja za zdravljenje ali preprečevanje krvavitev ali med kirurškim posegom, ter od ravni faktorja VIII, resnosti hemofilije, obsega in mesta krvavitve ter bolnikovega stanja in telesne mase.
Octocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Proizvaja se z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri ga izdelajo celice, ki so prejele gen (DNK), kar jim omogoča njegovo tvorjenje.
Advate octocog alfa
Oktokog alfa
For more information about treatment with Advate, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Advate preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Advate have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Advate upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The Agency concluded that Advate has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.
Zaključila je, da se je zdravilo Advate izkazalo za učinkovito pri zdravljenju in preprečevanju krvavitev pri bolnikih s hemofilijo A in ima sprejemljiv varnostni profil.
Common side effects with Advate (affecting between 1 and 10 patients in 100) are headache and pyrexia (fever).
Pogosta neželena učinka zdravila Advate (ki se lahko pojavita pri 1 do 10 bolnikih od 100) sta glavobol in pireksija (povišana telesna temperatura).
For practical information about using Advate, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Advate naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Advate must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.
Zdravila Advate ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) humani koagulacijski faktor VIII, mišje ali hrčkove beljakovine ali katero koli drugo sestavino zdravila.
What is Advate and what is it used for?
Kaj je zdravilo Advate in za kaj se uporablja?
Patients with haemophilia A lack factor VIII, and this causes blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Bolnikom s hemofilijo A primanjkuje faktorja VIII, kar povzroča težave s strjevanjem krvi, kot so krvavitve v sklepe, mišice ali notranje organe.
Advate is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Advate je zdravilo, ki se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih vseh starosti s hemofilijo A (dedno motnjo strjevanja krvi, ki jo povzroča pomanjkanje faktorja VIII).
Advate is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Zdravilo Advate je na voljo v obliki praška in vehikla, ki se zmešata za pripravo raztopine za injiciranje v veno.
The active substance in Advate, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Zdravilna učinkovina zdravila Advate, oktokog alfa (humani koagulacijski faktor VIII), je snov, ki pomaga pri strjevanju krvi.
For the full list of all side effects reported with Advate, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Advate, glejte navodilo za uporabo.
Because of this Advate has been compared with Recombinate to show that the two medicines are equivalent in one main study including 111 patients with haemophilia A.
Da bi ugotovili, ali sta zdravili Advate in Recombinate enakovredni, so ju primerjali v eni glavni študiji, v katero je bilo vključenih 111 bolnikov s hemofilijo A.
Advate is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Zdravilo Advate se uporablja za odpravo pomanjkanja faktorja VIII z nadomeščanjem manjkajočega faktorja VIII, kar zagotovi začasno obvladovanje motnje strjevanja krvi.
It contains the active substance octocog alfa (human coagulation factor VIII).
Zdravilo vsebuje zdravilno učinkovino oktokog alfa (humani koagulacijski faktor VIII).
Advate can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia and with resuscitation equipment available in case of severe allergic reaction (anaphylaxis).
Predpisovanje in izdaja zdravila Advate je le na recept, zdravljenje z njim pa mora uvesti zdravnik z izkušnjami z zdravljenjem hemofilije, ki ima na razpolago opremo za oživljanje v primeru resne alergijske reakcije (anafilaksije).
Advate given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective.
Proučevali so, ali je zdravilo Advate, dano v velikih odmerkih, učinkovito pri odstranjevanju protiteles proti faktorju VIII iz krvi (postopek, znan kot indukcija imunske tolerance), tako da zdravljenje s faktorjem VIII ostane učinkovito.
How is Advate used?
Kako se zdravilo Advate uporablja?
Some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body's immune system produces against factor VIII and which can cause the medicine to stop working resulting in a loss of bleeding control.
Pri nekaterih bolnikih se lahko pojavijo zaviralci faktorja VIII, tj. protitelesa (beljakovine), ki jih proizvede imunski sistem proti faktorju VIII in lahko izničijo delovanje zdravila in tako povzročijo izgubo nadzora nad krvavitvijo.
There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Pri zdravilih s faktorjem VIII obstaja tveganje, da se bodo pri nekaterih bolnikih pojavili zaviralci (protitelesa) faktorja VIII, ki bodo izničili delovanje zdravila ter tako povzročili izgubo nadzora nad krvavitvijo.
The study went on to look at the number of bleeding episodes and rated Advate's effectiveness in stopping bleeding on a scale from ‘none' to ‘excellent' in 107 patients, all of whom received Advate.
V študiji so pri 107 bolnikih, ki so prejemali zdravilo Advate, proučevali tudi število epizod krvavitev in ocenili učinkovitost zdravila Advate pri prekinitvi krvavitve na lestvici od „brez“ do „odlična“.
For full details, see the package leaflet.
Za več informacij glejte navodilo za uporabo.
• Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure).
• Opozorilo o uporabi pri starejših glede na s starostjo povezana tveganja (zlasti za rak mehurja, zlome in srčno popuščanje).
Date of first authorisation: 16 November 2015
Datum prve odobritve: 16. november 2015
Subjects with mean daily insulin dose reduction of at least 10% (%)
Preiskovanci z znižanjem povprečnega dnevnega odmerka insulina za vsaj 10 % (%)
All randomised patients who took at least one dose of double-blind study medicinal product during the short-term double-blind period.
Vsi randomizirani bolniki, ki so prejeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila med kratkoročnim dvojno slepim obdobjem.
Bristol-Myers Squibb Company Contrada Fontana del Ceraso IT-03012 Anagni (FR) Italy
Bristol-Myers Squibb Company Contrada Fontana delCeraso IT-03012 Anagni (FR) Italija
More information is given below under ‘Other medicines and Ebymect'.
Več informacij najdete v poglavju "Druga zdravila in zdravilo Ebymect", spodaj.
The safety and efficacy of Ebymect in patients with type 1 diabetes have not been established and Ebymect should not be used for treatment of patients with type 1 diabetes.
Varnost in učinkovitost zdravila Ebymect pri bolnikih s sladkorno boleznijo tipa 1 nista ugotovljeni in zdravila Ebymect se ne sme uporabljati za zdravljenje takšnih bolnikov.
Treatment with dapagliflozin may be restarted when the ketone values are normal and the patient's condition has stabilised.
Zdravljenje z zdravilom Ebymect je mogoče znova uvesti, ko so vrednosti ketonov normalne in se bolnikovo stanje stabilizira.
To avoid overdose, do not continue taking dapagliflozin and metformin tablets, if you are taking Ebymect.
Da boste preprečili preveliko odmerjanje, ne nadaljujte jemanja tablet dapagliflozina in metformina, če jemljete zdravilo Ebymect.
If Fournier's gangrene is suspected, Ebymect should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Če obstaja sum na Fournierjevo gangreno, je treba zdravilo Ebymect ukiniti in uvesti takojšnje zdravljenje (vključno z antibiotiki in kirurško odstranitvijo prizadetega tkiva).
The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Metformin Prospektivna randomizirana študija (UKPDS) je ugotovila dolgoročne koristi intenzivnega obvladovanja glukoze v krvi pri sladkorni bolezni tipa 2.
• At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Posodobljen RMP je treba predložiti: na zahtevo Evropske agencije za zdravila; ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Patients should be alerted to the risk of hypoglycaemia when this medicinal product is used in combination with other glucoselowering medicinal products known to cause hypoglycaemia.
Bolnike je treba opozoriti na tveganje za hipoglikemijo, če je to zdravilo uporabljeno v kombinaciji z drugimi antidiabetiki za katere je znano, da povzročajo hipoglikemijo.
This may be another medicine taken by mouth and/or a medicine given by injection, such as insulin or a GLP-1 receptor agonist (helps your body to increase the production of insulin when your blood sugar is high).
To je lahko neko drugo zdravilo, ki ga zaužijete, ali ga dobite z injekcijo, kot na primer insulin ali agonist receptorjev GLP-1 (pomaga telesu, da lahko poveča tvorbo insulina, kadar so vrednosti krvnega sladkorja visoke).
• Lactic acidosis, seen very rarely (may affect up to 1 in 10,000 people) 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").
For patients insufficiently controlled on metformin monotherapy or metformin in combination with other medicinal products for the treatment of diabetes
Bolniki, ki niso zadostno urejeni z metforminom v monoterapiji ali metforminom v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni
Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and nonsteroidal anti-inflammatory drugs [NSAIDs]) should be initiated with caution in metformin-treated patients.
Zdravila, ki lahko akutno okvarijo delovanje ledvic (kot so antihipertenzivi, diuretiki in nesteroidna protivnetna zdravila), je treba pri bolnikih, ki se zdravijo z metforminom, uvesti previdno.
Ebymect has no or negligible influence on the ability to drive and use machines.
Zdravilo Ebymect nima vpliva ali ima le zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Ebymect is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise:
Zdravilo Ebymect je indicirano pri odraslih za zdravljenje sladkorne bolezni tipa 2 kot dodatek dieti in telesni dejavnosti:
At 1 year, mean eGFR was slightly lower, and at 4 years, mean eGFR was slightly higher in the dapagliflozin group compared with the placebo group.
1 letu je bil eGFR v skupini z dapagliflozinom rahlo nižji, po 4 letih pa rahlo višji v primerjavi s skupino s placebom.
Stop taking Ebymect and see a doctor as soon as possible if you notice any of the following serious or potentially serious effects:
Nehajte jemati zdravilo Ebymect in čim prej obiščite zdravnika, če opazite katerega od naslednjih resnih ali potencialno resnih neželenih učinkov:
Ebymect should not be used to treat this condition.
Za zdravljenje te bolezni se zdravila Ebymect ne sme uporabljati.
The primary assessment of safety and tolerability was conducted in a pre-specified pooled analysis of 13 short-term (up to 24 weeks) placebo-controlled studies with 2,360 subjects treated with dapagliflozin 10 mg and 2,295 treated with placebo.
Primarno oceno varnosti in prenašanja so izvedli v vnaprej opredeljeni kumulativni analizi 13 kratkotrajnih (do 24 tednov trajajočih) s placebom kontroliranih študij v katere je bilo vključenih 2.360 preiskovancev, zdravljenih z 10 mg dapagliflozina, in 2.295 preiskovancev, ki so prejemali placebo.
Stop taking Ebymect and see a doctor straight away if you notice any of the following serious or potentially serious side effects:
Nehajte jemati zdravilo Ebymect in takoj obiščite zdravnika, če opazite katerega od naslednjih resnih ali potencialno resnih neželenih učinkov:
Vulvovaginitis , balanitis and related genital infections
Infekcijske in parazitske bolezni vulvovaginitis, balanitis in sorodne okužbe spolovil
If you forget to take Ebymect
Če ste pozabili vzeti zdravilo Ebymect
Patients insufficiently controlled on metformin alone or in combination with other medicinal products for the treatment of diabetes 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 zdravili za zdravljenje sladkorne bolezni 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.
Ebymect is used for a type of diabetes called “type 2 diabetes” in adult patients (aged 18 years and older) and usually occurs when you are older.
Zdravilo Ebymect se uporablja za zdravljenje sladkorne bolezni, ki jo imenujemo "sladkorna bolezen tipa 2", pri odraslih bolnikih (starih 18 let in več).
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
Zdravilo Ebymect vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
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 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 SGLT2, in metforminijevega klorida, ki spada v skupino bigvanidov.
After administration of a 50 mg C]-dapagliflozin dose, 96% was recovered, 75% in urine and 21% in faeces.
C]-dapagliflozina se je izločenega pojavilo 96 %, in sicer 75 % v urinu in 21 % v blatu.
Mean eGFR was 85.2 mL/min/1.73 m of patients had eGFR < 60 mL/min/1.73 m2, and 30.3% of patients had micro- or macroalbuminuria (urine albumin to creatinine ratio [UACR] ≥ 30 to ≤ 300 mg/g or > 300 mg/g, respectively).
Povprečna eGFR je bila 85,2 ml/min/1,73 m2, 7,4 % bolnikov je imelo eGFR < 60 ml/min/1,73 m2 in 30,3 % bolnikov je imelo mikro- ali makroalbuminurijo (razmerje med albuminom in kreatininom v urinu [UACR] ≥ 30 do ≤ 300 mg/g [mikro-] oz. > 300 mg/g [makro-]).
The coadministration of dapagliflozin and metformin has been studied in subjects, with type 2 diabetes, inadequately controlled on diet and exercise alone, and in subjects 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, neustrezno urejenih samo z dieto in telesno dejavnostjo in pri preiskovancih, ki niso bili zadostno urejeni z metforminom samim ali v kombinaciji z zaviralcem DPP-4 (sitagliptin), sulfonilsečnino ali insulinom.
Renal composite endpoint defined as: sustained confirmed ≥ 40% decrease in eGFR to eGFR <60 mL/min/1.73 m 2 and/or end stage renal disease (dialysis ≥ 90 days or kidney transplantation, sustained confirmed eGFR < 15 mL/min/1.73 m 2) and/or renal or cardiovascular death.
Ledvični sestavljeni opazovani dogodek je bil opredeljen kot: trajno, potrjeno ≥ 40-odstotno zmanjšanje eGFR do eGFR < 60 ml/min/1,73 m2 in/ali končna odpoved ledvic (dializa ≥ 90 dni ali presaditev ledvice, trajno, potrjeno zmanjšanje eGFR na < 15 ml/min/1,73 m2) in/ali ledvična ali srčno-žilna smrt.
film-coating: polyvinyl alcohol (E1203), macrogol 3350 (E1521), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) (only Ebymect 5 mg/850 mg).
filmska obloga: polivinilalkohol (E1203), makrogol 3350 (E1521), smukec (E553b), titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172) (samo zdravilo Ebymect 5 mg/850 mg).
• diarrhoea or stomach ache • loss of appetite
• driska ali bolečine v trebuhu
In active- and placebocontrolled clinical trials (dapagliflozin, N=5936, All control, N=3403), the frequency of rash was similar for dapagliflozin (1.4%) and all control (1.4%), respectively.
5936, vse kontrolne osebe; n = 3403) je bila pogostnost izpuščaja z dapagliflozinom (1,4 %) podobna kot pri vseh kontrolnih osebah (1,4 %).
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
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 rešene preiskovance) [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).
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
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) v primerjavi z izhodiščem.
• Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): - increased levels of “ketone bodies” in your urine or blood - 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.
• Diabetična ketoacidoza, ki je redka (pojavi se lahko pri največ 1 od 1.000 bolnikov) Znaki diabetične ketoacidoze (glejte tudi 2. poglavje, Opozorila in previdnostni ukrepi) so: - zvišana raven "ketonskih teles" v urinu ali krvi - hitra izguba telesne mase - slabost ali bruhanje
Talk to your doctor, pharmacist or nurse before taking Ebymect, and during treatment:
Pred začetkom jemanja zdravila Ebymect in med zdravljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
The following adverse reactions have been identified in the placebo-controlled dapagliflozin plus metformin clinical studies, dapagliflozin clinical studies and metformin clinical studies and postmarketing experience.
V s placebom kontroliranih kliničnih študijah kombinacije dapagliflozina in metformina, kliničnih študijah dapagliflozina, kliničnih študijah metformina in med obdobjem po odobritvi dovoljenja za promet so ugotovili naslednje neželene učinke.
Ebymect should not be initiated in patients with GFR < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min (see section 4.2).
Zdravljenje je treba prekiniti pri GFR trajno pod 45 ml/min (glejte poglavje 4.2).