natgillin/translations-raw huggingface dataset:
This medicine is not recommended for use in children and adolescents under 18 years, because it has not been studied in these patients.
To zdravilo se ne priporoča pri otrocih in mladostnikih, starih manj kot 18 let, saj ga pri teh bolnikih niso preučili.
Do not take Synjardy if you are pregnant.
Ne jemljite zdravila Synjardy, če ste noseči.
Metformin may act via 3 mechanisms:
Metformin lahko deluje na tri načine:
All patients should continue their diet with an adequate distribution of carbohydrate intake during the day.
Vsi bolniki morajo nadaljevati dieto z ustrezno porazdelitvijo vnosa ogljikovih hidratov preko dneva.
However, animal studies have shown adverse effects on postnatal development.
Vendar pa študije na živalih kažejo neželene učinke na postnatalni razvoj.
• if you have “type 1 diabetes” - this type usually starts when you are young and your body does not produce any insulin;
• če imate “sladkorno bolezen tipa 1” - ta tip se običajno pojavi v mladih letih in v tem primeru telo insulina sploh ne proizvaja;
Diet and exercise can help your body use its blood sugar better.
Dieta in telesna aktivnost vašemu telesu pomagata bolje porabiti krvni sladkor.
• Swallow the tablet whole with water.
• Tableto pogoltnite celo z vodo.
1 (97.5% CI)
1 (97,5-odstotni
• Severe renal failure (GFR <30 ml/min).
• Huda ledvična odpoved (GFR < 30 ml/min).
• if you are allergic to empagliflozin, metformin or any of the other ingredients of this medicine (listed in section 6);
• če ste alergični na empagliflozin, metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
The reduction of cardiovascular death in these patients was consistent with the overall study population.
Znižanje srčno-žilne umrljivosti pri teh bolnikih je bilo skladno s celotno raziskovano populacijo.
Your doctor will adjust your dose as necessary and tell you exactly which strength of the medicine to take.
Zdravnik vam bo ustrezno prilagodil odmerek in vam natančno povedal, katero jakost zdravila morate jemati.
Treatment with empagliflozin may be restarted when the ketone values are normal and the patient's condition has stabilised.
Zdravljenje z empagliflozinom je mogoče znova uvesti, ko so vrednosti ketonov normalne in se bolnikovo stanje stabilizira.
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), or very rare (<1/10,000), and not known (cannot be estimated from the available data).
Pogostnosti so opredeljene 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) in zelo redki (<1/10.000) ali neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
After the first 12 weeks glycaemic control was optimized independent of investigative treatment.
Po prvih 12 tednih se je urejenost glikemije optimizirala neodvisno od preiskušanega zdravljenja.
• if you have problems with your liver;
• če imate težave z jetri,
This medicinal product should not be used during breast feeding.
Tega zdravila se med dojenjem ne sme uporabljati.
• decreased vitamin B12 levels in the blood
• znižana raven vitamina B12 v krvi,
Do not stop taking Synjardy without first consulting your doctor.
Ne prenehajte jemati zdravila Synjardy, ne da bi se prej posvetovali z zdravnikom.
A limited amount of data suggests that the use of metformin in pregnant women is not associated with an increased risk of congenital malformations.
Manjše število podatkov kaže, da uporaba metformina pri nosečnicah ni povezana s povečano nevarnostjo kongenitalnih malformacij.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Ne uporabljajte tega zdravila, če opazite, da je ovojnina poškodovana ali so na njej vidni znaki odpiranja.
There is no experience with doses above 800 mg in humans.
Pri ljudeh ni izkušenj z odmerki nad 800 mg.
Figure 1 Time to occurrence of cardiovascular death in the EMPA-REG OUTCOME study
Slika 1: Čas do pojava srčno-žilne smrti v študij EMPA-REG OUTCOME
• Take the tablet twice daily by mouth.
• Tableto zaužijte dvakrat dnevno.
Initiation of therapy in this population is not recommended (see section 4.2).
Uvedba zdravljenja se pri tej populaciji ne priporoča (glejte poglavje 4.2).
Analysis of the results for overweight patients treated with metformin after failure of diet alone showed:
Analiza rezultatov pri bolnikih s preveliko telesno maso, ki so se zdravili z metforminom po neuspehu same diete, je pokazala:
After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Po peroralnem odmerjanju je bil neabsorbirani delež v blatu 20-30 %.
Improvement of surrogate markers of beta cell function including Homeostasis Model Assessment-β (HOMA-β) was noted.
Opazili so izboljšanje surogatnih markerjev delovanja beta-celic, vključno z oceno modela homeostaze delovanja β-celic (HOMA-β, Homeostasis Model Assessment-β).
• difficulty in breathing
• težave z dihanjem,
Blood sugar levels, which are too high because of your type 2 diabetes, are thereby reduced.
Ravni krvnega sladkorja, ki so previsoke zaradi sladkorne bolezni tipa 2, se s tem znižajo.
The European Medicines Agency has waived the obligation to submit the results of studies with Synjardy in all subsets of the paediatric population in type 2 diabetes (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Synjardy za vse podskupine pediatrične populacije s sladkorno boleznijo tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Possible signs are listed in section 4, ‘Possible side effects', dehydration;
Možni znaki so našteti v poglavju 4 “ Možni neželeni učinki”, dehidracija;
• in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products
• v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni pri bolnikih, ki niso zadostno urejeni z metforminom in temi zdravili;
• excessive hunger, headache
• pretirana lakota, glavobol.
• Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
• Vse vrste akutne metabolične acidoze (kot sta laktacidoza, diabetična ketoacidoza).
Metformin Concomitant use not recommended
Metformin Sočasna uporaba ni priporočljiva
However, as metformin is recommended to be given with meals, Synjardy is also proposed to be given with food.
Vendar ker se priporoča dajanje metformina s hrano, se tudi za zdravilo Synjardy priporoča dajanje s hrano.
Metformin must be discontinued at the time of surgery under general, spinal or epidural anaesthesia.
Uporabo metformina je treba v času kirurškega posega pod splošno, spinalno ali epiduralno anestezijo prekiniti.
The safety and efficacy of Synjardy in children and adolescents aged 0 to 18 years has not been established.
Varnost in učinkovitost zdravila Synjardy pri otrocih in mladostnikih od rojstva do 18. leta starosti še nista bili dokazani.
If no adequate strength of Synjardy is available, individual monocomponents should be used instead of the fixed dose combination.
Če ni na voljo ustrezna jakost zdravila Synjardy, je treba namesto fiksne kombinacije uporabiti posamične monokomponente.
• bronchodilators (beta-2 agonists) which are used to treat asthma.
• bronhodilatatorje (agonisti beta-2), ki se uporabljajo za zdravljenje astme;
• severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing)
• huda alergijska reakcija (lahko vključuje otekanje obraza, ustnic, ust, jezika ali žrela, kar lahko povzroči oteženo dihanje ali požiranje),
What Synjardy is and what it is used for 2.
Kaj je zdravilo Synjardy in za kaj ga uporabljamo 2.
If you are already taking both medicines separately, your doctor will start treatment with tablets of Synjardy that will supply the same amount of both.
Če obe zdravili prejemate ločeno, bo zdravnik pri vas zdravljenje začel s tabletami zdravila Synjardy, s katerimi boste prejeli enak odmerek obeh zdravil.
What you need to know before you take Synjardy 3.
Kaj morate vedeti, preden boste vzeli zdravilo Synjardy 3.
Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when Synjardy is used in combination with a sulphonylurea and/or insulin.
Bolnikom je treba svetovati, naj s preventivnimi ukrepi preprečijo hipoglikemijo med vožnjo in upravljanjem strojev, zlasti pri uporabi zdravila Synjardy v kombinaciji s sulfonilsečnino in/ali insulinom.
Possible signs of losing too much fluid from your body are listed in section 4 ‘Possible side effects'.
Možni znaki pretirane izgube tekočine iz telesa so našteti v poglavju 4, »Možni neželeni učinki«;
Biotransformation Metformin is excreted unchanged in the urine.
Biotransformacija Metformin se nespremenjen izloči z urinom.
The efficacy for preventing cardiovascular mortality has not been conclusively established in patients using empagliflozin concomitantly with DPP-4 inhibitors or in Black patients because the representation of these groups in the EMPA-REG OUTCOME study was limited.
Učinkovitost pri preprečevanju srčno-žilne umrljivosti niso neizpodbitno dokazali pri bolnikih, ki so sočasno prejemali empagliflozin in zaviralce DPP-4, ali pri temnopoltih bolnikih, ker je bila zastopanost teh skupin v študiji EMPA-REG OUTCOME omejena.
If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.
Če se spomnite, ko je že čas za naslednji odmerek, pozabljeni odmerek izpustite in nadaljujte z jemanjem po običajnem razporedu.
• medicines which increase urine production (diuretic), as Synjardy may increase the risk of losing too much fluid.
• zdravila, ki povečajo nastanek urina (diuretik), saj lahko zdravilo Synjardy poveča tveganje za pretirano izgubo tekočine.
Empagliflozin is not recommended.
Empagliflozina se ne priporoča.
No effects have been shown in breastfed newborns/infants of treated women.
Pri dojenih novorojencih/dojenčkih zdravljenih žensk ni bilo ugotovljenih učinkov.
Due to the limited therapeutic experience with empagliflozin in patients aged 85 years and older, initiation of therapy in this population is not recommended (see section 4.4).
Zaradi omejenih terapevtskih izkušenj z empagliflozinom pri bolnikih, starih 85 let in več, se uvedbe zdravljenja s tem zdravilom ne priporoča pri tej skupini bolnikov (glejte poglavje 4.4).
Subgroup analysis for patients on additional background of metformin (FAS, LOCF)
Analiza pri podskupinah bolnikov ob dodatni prisotnosti metformina (FAS, LOCF)
There are no data from the use of this medicinal product or empagliflozin in pregnant women.
Podatkov o uporabi tega zdravila ali empagliflozina pri nosečnicah ni.
During treatment with Synjardy, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Med zdravljenjem z zdravilom Synjardy bo zdravnik vsaj enkrat letno preveril delovanje ledvic, če pa ste starejša oseba in/ali se vam delovanje ledvic slabša, pa še pogosteje.
• redness of the skin (erythema)
• pordelost kože (eritem).
At baseline, 74% of patients were being treated with metformin, 48% with insulin, and 43% with a sulfonylurea.
Ob izhodišču je bilo 74 % bolnikov zdravljenih z metforminom, 48 % z insulinom in 43 % s sulfonilsečnino.
• Hepatic impairment, acute alcohol intoxication, alcoholism (see section 4.5).
• Jetrna okvara, akutna zastrupitev z alkoholom, alkoholizem (glejte poglavje 4.5).
Overweight patients should continue their energy restricted diet.
Bolniki s preveliko telesno maso morajo nadaljevati dieto z zmanjšano energijsko vrednostjo.
If necessary, the dose of the anti hyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Po potrebi je treba med zdravljenjem z drugim zdravilom in ob njegovi ukinitvi odmerek antihiperglikemičnega zdravila prilagoditi.
The majority of drug-related radioactivity recovered in faeces was unchanged parent drug and approximately half of drug-related radioactivity excreted in urine was unchanged parent drug.
Večina radioaktivnosti v blatu, povezane z zdravilom je bila nespremenjena izhodna učinkovina in približno polovica radioaktivnosti v urinu, povezane z zdravilom je bila nespremenjena izhodna učinkovina.
By blocking this protein, the medicine causes blood sugar, sodium (salt) and water to be removed via the urine.
Z zaviranjem te beljakovine zdravilo povzroča izločanje krvnega sladkorja, natrija (soli) in vode z urinom.
• if you have had a diabetic pre-coma;
• če ste kadar koli v preteklosti imeli diabetično predkomo,
The most effective method to remove lactate and metformin is haemodialysis.
Najučinkovitejša metoda odstranitve laktatov in metformina je hemodializa.
• medicines that contain alcohol (see section ‘Synjardy with alcohol').
• zdravila, ki vsebujejo alkohol (glejte poglavje “Zdravilo Synjardy skupaj z alkoholom”);
• other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
• druga zdravila, ki zmanjšujejo količino krvnega sladkorja, kot so insulin ali »sulfonilsečninska« zdravila.
Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 2).
Takoj prenehajte jemati to zdravilo in se obrnite na zdravnika ali takoj pojdite v bolnišnico (glejte poglavje 2).
• if you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) or have breathing difficulties.
• če se zdravite zaradi akutnega srčnega popuščanja ali ste pred kratkim imeli srčni infarkt, imate hude težave z obtočili, npr. “šok” ali težave z dihanjem.
In patients with stable chronic heart failure, Synjardy may be used with a regular monitoring of cardiac and renal function.
Pri bolnikih s stabilnim kroničnim srčnim popuščanjem se zdravilo Synjardy lahko uporablja ob rednem spremljanju delovanja srca in ledvic.
• in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilization,
• v mišicah s povečanjem občutljivosti za insulin izboljša periferni privzem glukoze in njeno izkoriščenje;
For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the population studied, see sections 4.4, 4.5 and 5.1.
Za rezultate študij glede kombiniranega zdravljenja, učinka na urejenost glikemije in srčno-žilne dogodke ter proučevano populacijo glejte poglavja 4.4, 4.5 in 5.1.
When the patient plans to become pregnant, and during pregnancy, it is recommended that diabetes is not treated with this medicinal product, but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus associated with abnormal blood glucose levels.
Če bolnica načrtuje nosečnost in med nosečnostjo, se priporoča, da se zdravljenje sladkorne bolezni s tem zdravilom prekine, za vzdrževanje ravni glukoze v krvi čim bližje normalnim vrednostim, pa se uporabi insulin, da bi zmanjšali nevarnost okvar ploda zaradi nenormalnih ravni glukoze v krvi.
Empagliflozin is a reversible, highly potent (IC50 of 1.3 nmol) and selective competitive inhibitor of SGLT2.
Empagliflozin je reverzibilen, izjemno močan (IC50 1,3 nmol) in selektiven kompetitiven zaviralec SGLT2.
• in patients already being treated with the combination of empagliflozin and metformin as separate tablets.
• pri bolnikih, ki se že zdravijo s kombinacijo empagliflozina in metformina v ločenih tabletah.
• certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• nekatera zdravila za zdravljenje visokega krvnega tlaka (zaviralci ACE in antagonisti receptorjev angiotenzina II),
• if you drink alcohol to excess, either every day or only from time to time (see section “Synjardy with alcohol”).
• če vsak dan ali samo občasno pijete prevelike količine alkohola (glejte poglavje “Zdravilo Synjardy skupaj z alkoholom”).
Your doctor may need to adjust your doses to control your blood sugar.
Zdravnik bo morda moral prilagoditi vaše odmerke, da bo zagotovil ustrezen nadzor krvnega sladkorja.
Animal studies show that empagliflozin crosses the placenta during late gestation to a very limited extent but do not indicate direct or indirect harmful effects with respect to early embryonic development.
Študije na živalih kažejo, da empagliflozin v pozni dobi gestacije v zelo omejenem obsegu prehaja skozi placento, vendar ne kažejo neposrednih ali posrednih škodljivih učinkov na zgodnji razvoj zarodka.
In the double-blind placebo-controlled extension of these studies, reduction of HbA1c, body weight and blood pressure were sustained up to Week 76.
V dvojno slepih, s placebom nadzorovanih podaljških teh študij, so se zmanjšane vrednosti HbA1c, telesne mase in krvnega tlaka ohranile do 76. tedna.
Other medicines and Synjardy
Druga zdravila in zdravilo Synjardy
Do not take Synjardy:
Ne jemljite zdravila Synjardy:
The following statements reflect the information available on the individual active substances.
Spodnje trditve temeljijo na informacijah, ki so na voljo za posamezni zdravilni učinkovini.
The dose of Synjardy varies depending on your condition and the doses of diabetes medicines you currently take.
Količina zdravila Synjardy, ki jo boste jemali, bo lahko različna, kar je odvisno od vašega stanja in odmerkov antidiabetikov, ki jih trenutno jemljete.
In the population pharmacokinetic analysis, AUC was estimated to be 13.5% higher in Asians with a body mass index of 25 kg/m2 compared to non-Asians with a body mass index of 25 kg/m
V populacijski farmakokinetični analizi so ocenili, da je vrednost AUC za 13,5 % večja pri Azijcih z indeksom telesne mase 25 kg/m2 v primerjavi z ne-Azijci z indeksom telesne mase 25 kg/m
Based on the population pharmacokinetic analysis, the apparent terminal elimination half-life of empagliflozin was estimated to be 12.4 hours and apparent oral clearance was 10.6 l/hour.
Na podlagi populacijske farmakokinetične analize je bil navidezni končni razpolovni čas empagliflozina ocenjen na 12,4 ure, navidezni peroralni očistek pa je bil 10,6 l/uro.
If Fournier´s gangrene is suspected, Synjardy should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Če obstaja sum na Fournierovo gangreno, je treba zdravilo Synjardy ukiniti in uvesti takojšnje zdravljenje (vključno z antibiotiki in kirurško odstranitvijo prizadetega tkiva).
It is unknown if this medicine is harmful to the unborn child.
Ni znano, ali zdravilo Synjardy škoduje nerojenemu otroku.
It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.
Ne stimulira izločanja insulina in tako ne povzroča hipoglikemije.
It is assumed that the pharmacokinetics of metformin absorption are non-linear.
Domneva se, da je farmakokinetika absorpcije metformina nelinearna.
Contact a doctor or the nearest hospital straight away if you have any of the following side effects:
Nemudoma se obrnite na zdravnika ali najbližjo bolnišnico, če opazite katerega od naslednjih neželenih učinkov:
It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.
Pomembno je, da nadaljujete z dieto in telesno aktivnostjo, kot vam je naročil zdravnik, farmacevt ali medicinska sestra.
If you have reduced kidney function, your doctor may prescribe a lower dose.
Če imate zmanjšano delovanje ledvic, vam bo morda zdravnik predpisal manjši odmerek.
In the EMPA-REG OUTCOME study, 10.1% of the patients were reported with cardiac failure at baseline.
V študiji EMPA-REG OUTCOME so pri 10,1 % bolnikih poročali o srčnem popuščanju v izhodišču študije.
See subsections below for additional information
Za dodatne informacije glejte spodnja podpoglavja.
The tablet is 19.2 mm long and has a width of 9.4 mm.
Tableta je dolga 19,2 mm in široka 9,4 mm.
Based on in vitro studies, empagliflozin is considered unlikely to cause interactions with medicinal products that are P-gp substrates.
Na podlagi študij in vitro ni verjetno, da bi empagliflozin povzročil medsebojno delovanje z zdravili, ki so substrati P-gp.
Animal studies with empagliflozin and metformin do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Študije na živalih z empagliflozinom in metforminom ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost (glejte poglavje 5.3).
The frequency of reported nocturia was comparable between placebo and empagliflozin (<1%).
Pogostnost, s katero so poročali o nokturiji, je bila primerljiva pri placebu in empagliflozinu (< 1 %).
• corticosteroids (given by mouth, as an injection, or inhaled), which are used to treat inflammation in diseases like asthma and arthritis.
• kortikosteroide (peroralne, inhalacijske ali v obliki injekcij), ki se uporabljajo za zdravljenje vnetij pri boleznih, kot sta astma in artritis;
Like for all diabetic patients it is important to counsel patients on routine preventative footcare.
Kot pri vseh bolnikih s sladkorno boleznijo je pomembno, da jih podučimo o rutinski preventivni negi stopal.
Due to the mechanism of action, decreased renal function will result in reduced glycaemic efficacy of empagliflozin.
Zaradi mehanizma delovanja bo zmanjšano delovanje ledvic povzročilo zmanjšano glikemično učinkovitost empagliflozina.
Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low (hypoglycaemia).
Vaš zdravnik bo morda zmanjšal odmerek teh zdravil, da prepreči pojav prenizke ravni krvnega sladkorja (hipoglikemija);
The tablet is 21.1 mm long and has a width of 9.7 mm.
Tableta je dolga 21,1 mm in široka 9,7 mm.
Synjardy is contraindicated in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3.
Synjardy je kontraindiciran pri bolnikih z GFR< 30 ml/min in ga je treba začasno ukiniti, če se pojavijo stanja, ki spremenijo delovanje ledvic, glejte poglavje 4.3.
Both doses provided similar statistically significant reductions in body weight, expressed as kg and percentage change.
Pri obeh odmerkih je bilo opaženo podobno statistično značilno zmanjšanje telesne mase s spremembo, izraženo v kilogramih in odstotni vrednosti.
• passing more urine than usual or needing to pass urine more often
• večje količine seča od običajnih ali potreba po pogostejšem uriniranju,
These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or Fournier´s gangrene which destroys the tissue under the skin.
Ti simptomi so lahko znak redke, vendar resne ali celo življenjsko nevarne okužbe, ki se imenuje nekrotizirajoči fasciitis presredka ali Fournierova gangrena, ki uniči tkivo pod kožo.
Because metformin is excreted by the kidney and elderly patients are more likely to have decreased renal function, Synjardy should be used with caution in these patients.
Ker se metformin izloča skozi ledvice in ker je pri starejših bolnikih večja verjetnost za zmanjšano delovanje ledvic, je treba zdravilo Synjardy pri tej skupini bolnikov uporabljati previdno.
Some responses were increased by the combination treatment, such as effects on renal physiology, electrolyte balance and acid/base state.
Zdravljenje s kombinacijo je povečalo določene učinke, kot so učinki na fiziologijo ledvic, elektrolitsko ravnovesje in kislinsko-bazično ravnovesje.
• pain in the pelvis, or mid-back pain (when kidneys are infected)
• bolečina v predelu medenice ali sredine hrbta (če so okužene ledvice).
These may be medicines taken by mouth or given by injection such as insulin.
To so lahko zdravila, ki se jemljejo peroralno (se zaužijejo) ali pa se jih injicira, tako kot insulin.
Food decreases the extent and slightly delays the absorption of metformin.
Hrana zmanjša obseg absorpcije metformina in jo nekoliko upočasni.