natgillin/translations-raw huggingface dataset:
This medicine is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
Uporaba tega zdravila ni priporočljiva pri otrocih in mladostnikih, starih manj kot 18 let, ker pri teh bolnikih zdravilo ni bilo raziskano.
Patients at risk is the number of patients at risk at the beginning of the period.
Podatek o številu bolnikov, izpostavljenih tveganju, pomeni število bolnikov, izpostavljenih tveganju na začetku obdobja.
If you miss a dose, take it as soon as you remember.
Če ste pozabili vzeti odmerek, ga vzemite takoj, ko se spomnite.
The number of first events for the single components are the actual number of first events for each component and does not add up to the number of events in the composite endpoint.
Števila prvih dogodkov posameznih elementov so dejanska števila prvih dogodkov za vsak element in se ne seštejejo v število dogodkov v sestavljenem opazovanem dogodku.
• if you have a severe infection.
• če imate hudo okužbo.
Results on primary and secondary endpoints are displayed in Figure 2.
Rezultati o primarnih in sekundarnih opazovanih dogodkih so prikazani na sliki 2.
• changes in taste
• spremembe okusa
The safety and efficacy of Xigduo in children and adolescents aged 0 to < 18 years have not yet been established.
Varnost in učinkovitost zdravila Xigduo pri otrocih in mladostnikih v starosti od 0 do < 18 let nista ugotovljeni.
Do not take this medicine if any of the above apply to you.
Ne jemljite tega zdravila, če kar koli od navedenega velja za vas.
Body weight reductions were sustained in long-term extensions up to 208 weeks.
Zmanjšanje telesne mase se je ohranilo v dolgoročnih podaljšanjih do 208 tednov.
Elderly (≥ 65 years)
Starejši (stari 65 let ali več)
• Take your tablet with food.
• Tableto vzemite s hrano.
This is to reduce the risk of side effects in the stomach.
Tako boste zmanjšali tveganje za neželene učinke v želodcu.
A GFR should be assessed before initiation of treatment with metformin containing medicinal products and at least annually thereafter.
GFR je treba oceniti pred uvedbo zdravljenja z zdravili, ki vsebujejo metformin, nato pa vsaj enkrat letno.
In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status.
V primeru prevelikega odmerjanja je treba uvesti ustrezno podporno zdravljenje, kot ga narekuje bolnikovo klinično stanje.
< 30 Metformin is contraindicated.
< 30 Metformin je kontraindiciran.
• if you are taking medicines which increase urine production (diuretics).
• če jemljete zdravila, ki povečujejo nastajanje urina (diuretike).
All randomised patients who took at least one dose of double-blind study medicinal product during the shortterm double-blind period.
Vsi randomizirani bolniki, ki so prejeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila med kratkoročnim dvojno slepim obdobjem.
This effect was observed at Week 1 of treatment and maintained in studies extended through Week 104.
Ta učinek je bil opazen 1. teden zdravljenja in se je ohranil v študijah, podaljšanih do 104. tedne.
It is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.
Pomembno je, da si redno pregledujete stopala in upoštevate ostale nasvete o negi stopal, ki ste jih prejeli od zdravstvenega delavca.
• Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter.
• Pred uvedbo sočasnih zdravil, ki lahko zmanjšajo delovanje ledvic, in redno pozneje.
The mean Vd ranged between 63-276 l.
Povprečni Vd je bil med 63 in 276 l.
None were found to be dose-related.
Za nobenega ni bilo ugotovljeno, da bi bil povezan z odmerkom.
Similar reductions were observed at up to 104 weeks.
Po obdobju do 104 tedne so opažali podobna znižanja.
Dapagliflozin is approximately 91% protein bound.
Dapagliflozin je približno 91-odstotno vezan na beljakovine.
Do not drive or use any tools or machines, if you start to feel these symptoms.
Ne upravljajte vozil in strojev, če se vam začnejo pojavljati ti simptomi.
After administration of a 50 mg [
Po uporabi odmerka 50 mg [
Both belong to a group of medicines called oral anti-diabetics.
Obe spadata v skupino zdravil, ki jih imenujemo peroralni antidiabetiki.
(95% CI) Difference from metformin c
(95 % IZ) Razlika od metformina c
Component of a multipack, can't be sold separately.
Del skupnega pakiranja, ni za ločeno prodajo.
The red blood cells most likely represent a secondary compartment of distribution.
Eritrociti najverjetneje predstavljajo sekundarni razdelek porazdelitve.
Do not stop taking this medicine without talking to your doctor first.
Ne prenehajte jemati tega zdravila, ne da bi se prej posvetovali z zdravnikom.
• if you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing.
• če ste nedavno imeli srčni infarkt, če imate srčno popuščanje ali hude težave s krvnim obtokom ali težave z dihanjem.
• if you drink large amounts of alcohol, either every day or only from time to time (please see section “Xigduo with alcohol”).
• če pijete veliko alkohola (vsak dan ali le od časa do časa) (glejte poglavje "Zdravilo Xigduo skupaj z alkoholom").
Biotransformation Metformin is excreted unchanged in the urine.
Biotransformacija Metformin se nespremenjen izloči v urinu.
In total, 22.4% had had diabetes for ≤ 5 years, mean duration of diabetes was 11.9 years.
V celoti jih je 22,4 % imelo sladkorno bolezen ≤ 5 let, povprečno trajanje sladkorne bolezni je bilo 11,9 leta.
• Before initiation of treatment and regularly thereafter (see sections 4.2, 4.8, 5.1 and 5.2).
• Pred uvedbo zdravljenja in redno po njej (glejte poglavja 4.2, 4.8, 5.1 in 5.2).
Therefore, the use of this medicinal product is not recommended during the second and third trimesters of pregnancy.
Zato tega zdravila ni priporočljivo uporabljati v drugem in tretjem trimesečju nosečnosti.
• decreased vitamin B12 levels in the blood
• zmanjšana koncentracija vitamina B12 v krvi
• This medicine is taken in combination with diet and exercise.
• To zdravilo morate jemati v kombinaciji z dieto in telesno dejavnostjo.
Measure your blood sugar if possible and rest.
Če je le mogoče, si izmerite vrednost sladkorja v krvi in počivajte.
Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 2).
Takoj nehajte jemati to zdravilo in nemudoma obvestite zdravnika ali najbližjo bolnišnico (glejte poglavje 2).
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 (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Kategorije pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
This medicine may cause urinary tract infections and your doctor may want to monitor you more closely.
To zdravilo lahko povzroči okužbe sečil in zdravnik vas bo morda želel natančneje kontrolirati.
Clinically relevant glycaemic effects were sustained in long-term extensions up to 104 weeks.
Klinično pomembni učinki na glikemijo so se ohranili v dolgoročnih podaljšanjih do 104 tedne.
In faeces, approximately 15% of the dose was excreted as parent drug.
V blatu se je približno 15 % odmerka izločilo kot matično zdravilo.
HR=Hazard ratio CI=Confidence interval.
HR = razmerje ogroženosti ("Hazard ratio") IZ = interval zaupanja.
If acidosis of either form occurs, treatment must be stopped immediately and other appropriate corrective measures initiated.
Če se pojavi kakršna koli oblika acidoze, je treba zdravljenje nemudoma prekiniti in uvesti ustrezne korektivne ukrepe.
Adverse reactions listed below are classified according to frequency and system organ class.
Spodaj našteti neželeni učinki so razvrščeni po pogostnosti in organskem sistemu.
• For renal function with GFR levels < 60 mL/min and in elderly patients, at least 2 to 4 times per year.
• V primeru delovanja ledvic z GFR < 60 ml/min in pri starejših bolnikih, vsaj 2- do 4-krat na leto.
A limited amount of data from the use of metformin in pregnant women does not indicate an increased risk of congenital malformations.
Maloštevilni podatki uporabe metformina pri nosečnicah ne kažejo večjega tveganja za prirojene malformacije.
The patient should be informed and more frequent blood glucose monitoring perfomed, especially at the beginning of treatment with such medicinal products.
Bolnika je treba s tem seznaniti in potrebne so pogostejše kontrole glukoze v krvi, zlasti na začetku zdravljenja s takšnimi zdravili.
The renal composite endpoint and all-cause mortality were therefore not tested as part of the confirmatory testing procedure.
Ledvični sestavljeni opazovani dogodek in umrljivost zaradi vseh vzrokov zato nista bila testirana kot del postopka potrditvenega testiranja.
• if you are allergic to dapagliflozin, metformin or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na dapagliflozin, metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Ketoacidosis is a condition in which substances called ‘ketone bodies' accumulate in the blood and which can lead to a diabetic pre-coma.
Ketoacidoza je stanje, pri katerem se snovi, imenovane 'ketonska telesa', kopičijo v krvi, kar lahko povzroči diabetično predkomo.
See corresponding subsection below for additional information.
Za dodatne informacije glejte ustrezno podpoglavje spodaj.
• The recommended dose is one tablet twice a day.
• Priporočeni odmerek je ena tableta dvakrat na dan.
Your doctor will check your kidney function.
Zdravnik vam bo preveril delovanje ledvic.
P-values are all adjusted p-values for multiplicity.
Vse vrednosti p so vrednosti p, prilagojene za večkratno testiranje.
Xigduo is contraindicated in patients with:
Zdravilo Xigduo je kontraindicirano pri bolnikih s:
To treat diabetes:
Zdravljenje sladkorne bolezni:
Figure 2: Treatment effects for the primary composite endpoints and their components, and the secondary endpoints and components
Slika 2: Terapevtski učinki glede primarnih sestavljenih opazovanih dogodkov in njihovih elementov ter sekundarnih opazovanih dogodkov in njihovih elementov
p-values for the secondary endpoints and for single components are nominal.
Vrednosti p za sekundarna opazovana dogodka in za posamezne elemente so nominalne.
More information is given below under ‘Other medicines and Xigduo'.
Več informacij najdete v poglavju "Druga zdravila in zdravilo Xigduo", spodaj.
p-values are two-sided.
Vrednosti p so dvostranske.
• The amount of this medicine that you will take varies depending on your condition and the doses you currently take of metformin and/or individual tablets of dapagliflozin and metformin.
• Koliko tega zdravila boste jemali, bo odvisno od vašega stanja in od tega, kolikšne odmerke metformina in/ali posameznih tablet dapagliflozina in metformina trenutno jemljete.
If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit juice.
Če imate simptome nizkega krvnega sladkorja, pojejte tablete z glukozo, prigrizek, ki vsebuje veliko sladkorja, ali popijte sadni sok.
The following statements reflect the pharmacokinetic properties of the individual active substances of this medicinal product.
Naslednje navedbe temeljijo na farmakokinetičnih lastnostih posameznih učinkovin tega zdravila.
The recommended dose is one tablet twice daily.
Priporočeni odmerek je ena tableta 2-krat na dan.
Monitoring of renal function:
Spremljanje delovanja ledvic:
CI=confidence interval.
IZ = interval zaupanja
The safety and efficacy of Xigduo in patients with type 1 diabetes have not been established and Xigduo should not be used for treatment of patients with type 1 diabetes.
Varnost in učinkovitost zdravila Xigduo pri bolnikih s sladkorno boleznijo tipa 1 nista ugotovljeni in zdravila Xigduo se ne sme uporabljati za zdravljenje takšnih bolnikov.
This leads to a high level of sugar (glucose) in your blood.
Posledica je visoka koncentracija sladkorja (glukoze) v krvi.
Do not use this medicine after the expiry date which is stated on the blister or carton after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu ali škatli poleg oznake "EXP".
The maximum daily dose of metformin should preferably be divided into 2-3 daily doses.
Zaželeno je, da se največji dnevni odmerek metformina razdeli v 2 do 3 dnevne odmerke.
Paediatric population Pharmacokinetics in the paediatric population have not been studied.
Pediatrična populacija Farmakokinetika pri pediatrični populaciji ni raziskana.
Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Metformin poveča prenašalno kapaciteto specifičnih vrst membranskih prenašalcev glukoze (GLUT-1 in GLUT-4).
Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Dolgotrajno zdravljenje z metforminom je bilo povezano z zmanjšanjem absorpcije vitamina B12; to lahko zelo redko povzroči klinično pomembno pomanjkanje vitamina B12 (npr. megaloblastno anemijo).
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.
The most effective method to remove metformin and lactate is haemodialysis.
Najučinkovitejši način za odstranitev metformina in laktata je hemodializa.
Maternal toxicity was evident only at the highest dose tested, and limited to transient reductions in body weight and food consumption at dose.
Maternalna toksičnost je bila opazna le pri najvišjem testiranem odmerku in je bila omejena na prehodna zmanjšanja telesne mase in uživanja hrane pri tem odmerku.
After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Po peroralnem odmerku je neabsorbirani delež, ki se pojavi v blatu, od 20 do 30 %.
Superiority of dapagliflozin over placebo was not demonstrated for MACE (p= 0.172).
Superiornost dapagliflozina v primerjavi s placebom za MACE ni bila dokazana (p = 0,172).
You should stop taking this medicine if you become pregnant, since it is not recommended during the second and third trimesters (the last six months) of pregnancy.
Če zanosite, morate prekiniti zdravljenje s tem zdravilom, saj uporaba zdravila v drugem in tretjem trimesečju (zadnjih šestih mesecih) nosečnosti ni priporočljiva.
• If you are already taking both dapagliflozin and metformin as single tablets, your doctor may ask you to switch to this medicine.
• Če že jemljete dapagliflozin in metformin v obliki ločenih tablet, vam bo zdravnik morda naročil, da preidete na to zdravilo.
Due to its mechanism of action, patients taking this medicinal product will test positive for glucose in their urine.
Zaradi mehanizma delovanja tega zdravila imajo bolniki, ki jemljejo to zdravilo, pozitiven izvid preiskave za glukozo v urinu.
Dapagliflozin Dapagliflozin is a highly potent (Ki: 0.55 nM), selective and reversible inhibitor of SGLT2.
Dapagliflozin Dapagliflozin je zelo močan (Ki: 0,55 nM), selektiven in reverzibilen zaviralec SGLT2.
What Xigduo is and what it is used for
Kaj je zdravilo Xigduo in za kaj ga uporabljamo
• if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhoea, or if you have vomited several times in a row.
• če ste izgubili veliko vode iz telesa (dehidracija), npr. zaradi dolgotrajne ali hude driske, ali če ste bruhali večkrat zapored.
Analyses exclude measurements post rescue therapy and post premature discontinuation of study medicinal product.
Analize ne vključujejo meritev po rešilnem zdravljenju in po predčasnem prenehanju uporabe raziskovanega zdravila.
• if you are taking medicines to lower blood pressure (anti-hypertensives) and have a history of low blood pressure (hypotension).
• če jemljete zdravila za znižanje krvnega tlaka (antihipertenzivna zdravila) in ste kdaj imeli nizek krvni tlak (hipotenzijo).
It may be more pronounced in patients with high blood glucose concentrations.
To je lahko izrazitejše pri bolnikih z visoko koncentracijo glukoze v krvi.
The most frequently reported adverse reactions across the clinical studies were genital infections.
Najpogosteje zabeleženi neželeni učinek v kliničnih študijah so bile okužbe spolovil.
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.
Ko bolnica načrtuje nosečnost in med nosečnostjo je priporočljivo, da se sladkorna bolezen ne zdravi s tem zdravilom ampak naj se za vzdrževanje krvnega sladkorja čim bližje normalnim vrednostim uporabi insulin in s tem zmanjša tveganje za pojav malformacij ploda, ki so povezane z nenormalnimi vrednostmi sladkorja v krvi.
It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Domnevajo, da je farmakokinetika absorpcije metformina nelinearna.
• if you have “type 1 diabetes” - the type that usually starts when you are young, and your body does not produce any insulin.
• če imate "sladkorno bolezen tipa 1" - to je oblika sladkorne bolezni, ki se po navadi začne v mladosti in pri kateri telo ne izdeluje nič insulina.
During treatment with Xigduo, your doctor will check your kidney function at least once every year or more frequently if you are elderly and/or if you have worsening kidney function.
Med zdravljenjem z zdravilom Xigduo bo zdravnik vsaj enkrat letno preveril delovanje ledvic, če pa ste starejša oseba in/ali se vam delovanje ledvic slabša, pa še pogosteje.
• 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,
Metformin 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.
This glucose excretion (glucuretic effect) is observed after the first dose, is continuous over the 24-hour dosing interval and is sustained for the duration of treatment.
To izločanje glukoze (glukuretični učinek) je opazno že po prvem odmerku, je stalno v 24-urnem intervalu odmerjanja in se med obdobjem zdravljenja ohrani.
Constipation Dry mouth
zaprtost suha usta
Of 17,160 randomised patients, 6,974 (40.6%) had established cardiovascular disease and 10,186 (59.4%) did not have established cardiovascular disease.
Od 17.160 randomiziranih bolnikov jih je 6.974 (40,6 %) imelo razvito srčno-žilno bolezen, 10.186 (59,4 %) pa jih razvite srčno-žilne bolezni ni imelo.
Patients with baseline HbA1c ≥ 9%
Bolniki z izhodiščnim HbA1c ≥ 9 %
• if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
• če jemljete druga zdravila, ki znižujejo sladkor v krvi, kot je insulin ali zdravilo iz skupine sulfonilsečnin.
Urinary uric acid excretion was also increased transiently (for 3-7 days) and accompanied by a sustained reduction in serum uric acid concentration.
Prehodno se je povečalo tudi izločanje sečne kisline z urinom (za 3 do 7 dni) in spremljalo ga je trajno znižanje koncentracije sečne kisline v serumu.
To avoid overdose, do not continue taking dapagliflozin and metformin tablets, if you are taking Xigduo.
Da boste preprečili preveliko odmerjanje, ne nadaljujte jemanja tablet dapagliflozina in metformina, če jemljete zdravilo Xigduo.
If no adequate strength of Xigduo is available, individual mono-components should be used instead of the fixed dose combination.
Če ustrezne jakosti zdravila Xigduo ni na voljo, je treba razmisliti o uporabi posameznih učinkovin namesto fiksne kombinacije odmerkov.
Elderly patients may be at a greater risk for volume depletion and are more likely to be treated with diuretics.
Starejši bolniki imajo lahko večje tveganje za pomanjkanje volumna in večjo verjetnost, da se zdravijo z diuretiki.
The reductions in HbA1c observed at Week 24 were sustained in the add-on combination studies.
Znižanje HbA1c, opaženo 24. teden, se je ohranilo v študijah kombinacij z dodatkom.
This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDL cholesterol and triglyceride levels.
To je bilo v terapevtskih odmerkih dokazano v kontroliranih srednjeročnih in dolgoročnih kliničnih študijah: metformin zniža koncentracijo celotnega holesterola, holesterola LDL in trigliceridov.
• if you are using bronchodilators (beta-2 agonists) which are used to treat asthma.
• če uporabljate bronhodilatatorje (agoniste adrenergičnih receptorjev beta-2), ki se uporabljajo za zdravljenje astme.
For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Za rezultate študij o kombinacijah zdravil, učinkih na urejenost glikemije, srčno-žilnih dogodkih in proučevanih populacijah glejte poglavja 4.4, 4.5 in 5.1.
INNER CARTON - PART OF MULTIPACK - WITHOUT BLUE BOX
NOTRANJA ŠKATLA - DEL SKUPNEGA PAKIRANJA - BREZ MODREGA OKENCA
The European Medicines Agency has waived the obligation to submit the results of studies with Xigduo in all subsets of the paediatric population in the treatment of 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 Xigduo za vse podskupine pediatrične populacije za zdravljenje sladkorne bolezni tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
There are insufficient data to draw conclusions regarding exposure in patients > 70 years old.
Za sklepanje o izpostavljenosti pri bolnikih, starejših od 70 let, ni dovolj podatkov.
• discomfort when passing water (urine), passing more water than usual or needing to pass water more often
• nelagodje pri odvajanju vode (uriniranju), odvajanje več vode kot po navadi ali potreba po pogostejšem odvajanju urina
After oral administration, metformin absorption is saturable and incomplete.
Po peroralni uporabi je absorpcija saturabilna in nepopolna.
The incidence of hypoglycaemia was similar to placebo.
Incidenca hipoglikemij je bila podobna kot pri placebu.
These infections were more frequent in females, and subjects with a prior history were more likely to have a recurrent infection.
Te okužbe so bile pogostejše pri ženskah, osebe z anamnezo pa so imele večjo verjetnost za pojav ponovne okužbe.
Most patients (98%) used one or more diabetic medications at baseline, including metformin (82%), insulin (41%) and sulfonylurea (43%).
Večina bolnikov (98 %) je izhodiščno uporabljala eno ali več zdravil za sladkorno bolezen, med njimi metformin (82 %), insulin (41 %) in sulfonilsečnino (43 %).
Combination requiring precautions for use
Kombinacije, ki zahtevajo previdnost
Events were generally balanced between treatment groups across subgroups of age, diuretic use, blood pressure and ACE-I/ARB use.
Učinki so bili med terapevtskima skupinama na splošno uravnoteženi glede na podskupine po starosti, uporabi diuretikov, krvnem tlaku in uporabi zaviralcev ACE/ARB.