FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with type 1 diabetes mellitus, treatment with Ryzodeg o.d. plus IAsp for the remaining meals demonstrated similar glycaemic control (HbA1c and fasting plasma glucose) with a lower rate of nocturnal hypoglycaemia compared to a basal/bolus regimen with IDet plus IAsp at all meals (Table
Slovenian: Bolniki s sladkorno boleznijo tipa 1 dosežejo pri zdravljenju z zdravilom Ryzodeg 1x/dan v kombinaciji z IAsp ob preostalih obrokih podobno urejenost glikemije (HbA1c in glukoza v plazmi na tešče) in z manjšim deležem nočnih hipoglikemij kot z bazalno-bolusno shemo IDet v kombinaciji z
English: Seven multinational, randomised, controlled, open-label, treat-to-target clinical studies of between 26 and 52 weeks' duration were conducted exposing a total of 1,761 patients with diabetes mellitus (1 study involving 362 patients in type 1 diabetes mellitus and 6 studies involving 1,399 patients in type 2 diabetes mellitus) to Ryzodeg.
Slovenian: V teh študijah je zdravilo Ryzodeg prejemalo 1.761 bolnikov s sladkorno boleznijo (v eno študijo je bilo vključenih 362 bolnikov s sladkorno boleznijo tipa 1, v 6 študij pa 1.399 bolnikov s sladkorno boleznijo tipa 2).
English: Do not use this medicine after the expiry date which is stated on the pen label and carton, after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki injekcijskega peresnika in škatli, poleg oznake »Uporabno do«.
English: Ryzodeg is administered subcutaneously by injection in the abdominal wall, the upper arm or the thigh.
Slovenian: Zdravilo Ryzodeg se injicira subkutano v trebušno steno, nadlaket ali stegno.
English: Ryzodeg showed a lower rate of nocturnal hypoglycaemia compared to IGlar o.d. plus IAsp during 26 weeks (0.42 vs 0.76 estimated rates per patient year of exposure) and 38 weeks (0.51 vs 0.83 estimated rates per patient year of exposure).
Slovenian: Pri uporabi zdravila Ryzodeg je bil opažen manjši delež nočnih hipoglikemij v primerjavi z IGlar 1x/dan v kombinaciji z IAsp med 26 tedni zdravljenja (ocenjena deleža na bolniklet izpostavljenosti 0,42 v primerjavi z 0,76) in 38 tedni zdravljenja (ocenjena deleža na bolnik-let izpostavljenosti 0,51 v primerjavi z 0,83).
English: Non-inferiority in HbA1c change from baseline to end-of-trial was confirmed in 6 of the 7 studies against all comparators when treating patients to target, whereas non-inferiority was not confirmed in one study (comparing IDegAsp b.i.d.
Slovenian: Neinferiornost zdravila Ryzodeg glede spremembe HbA1c med začetkom in koncem preskušanja je bila ugotovljena v 6 od 7 študij v primerjavi z vsemi primerjanimi zdravili, kjer so zdravili bolnike do ciljnih vrednosti, v eni študiji pri sladkorni bolezni tipa 2 pa neinferiornost zdravila ni bila potrjena (primerjava IDegAsp 2x/dan z IDeg 1x/dan v kombinaciji z IAsp 2-4-krat na dan).
English: 70% insulin degludec / 30% insulin aspart
Slovenian: 70 % insulina degludek/30 % insulina aspart
English: For this age group, Ryzodeg should be considered on an individual basis.
Slovenian: Pri tej starostni skupini je treba o primernosti uporabe zdravila Ryzodeg presoditi pri vsakem bolniku posebej.
English: • you often get too low blood sugar
Slovenian: • se vam krvni sladkor pogosto preveč zniža,
English: There is no experience with the use of this medicine in children below the age of 2 years.
Slovenian: Izkušenj z uporabo tega zdravila pri otrocih, mlajših od 2 let, ni na voljo.
English: • how much Ryzodeg you will need each day and at which meal(s) • when to check your blood sugar level and if you need a higher or lower dose.
Slovenian: • kdaj morate preveriti koncentracijo krvnega sladkorja in ali potrebujete višji ali nižji odmerek.
English: If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use the pen without help.
Slovenian: Če ste slepi ali slabo vidite in ne morete odčitati števila izbranih enot na števcu odmerka na injekcijskem peresniku, sami ne uporabljajte injekcijskega peresnika.
English: There is no clinical experience with the use of this medicinal product in children below the age of 2 years.
Slovenian: Kliničnih izkušenj z uporabo tega zdravila pri otrocih, mlajših od 2 let, ni.
English: There is no clinically relevant development of insulin antibodies after long-term treatment of Ryzodeg.
Slovenian: Po dolgotrajnem zdravljenju z zdravilom Ryzodeg ni klinično pomembnega razvoja protiteles proti insulinu.
English: However, hypoglycaemia may develop over sequential stages if a patient is dosed with more insulin than required:
Slovenian: Vseeno pa se lahko postopoma razvije hipoglikemije, če so uporabljeni odmerki preveliki glede na bolnikovo potrebo:
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Za številna zdravila je znano, da vplivajo na presnovo glukoze.
English: Difference: 0.23 [-0.46;0.91]
Slovenian: Razlika: 0,23 [-0,46;0,91]
English: Gender There is no gender difference in the pharmacokinetic properties of Ryzodeg.
Slovenian: Farmakokinetične značilnosti zdravila Ryzodeg se med spoloma ne razlikujejo.
English: was compared with IDeg o.d. plus IAsp (2-4 daily injections) in patients with type 2 diabetes mellitus treated with basal insulin in need of treatment intensification with mealtime insulin.
Slovenian: Zdravilo Ryzodeg 2x/dan so primerjali z IDeg 1x/dan v kombinaciji z IAsp (2-4 injekcije na dan) pri bolnikih s sladkorno boleznijo tipa 2, ki so se zdravili z bazalnim insulinom, in so potrebovali intenziviranje zdravljenja z insulinom ob obroku.
English: After 26 weeks, the Ryzodeg dose could be split into b.i.d.
Slovenian: Po 26 tednih zdravljenja z zdravilom Ryzodeg so odmerek lahko razdelili v odmerjanje 2x/dan.
English: If you use too much insulin, your blood sugar may get too low (hypoglycaemia), see advice in section 4 ‘Too low blood sugar'.
Slovenian: Če ste uporabili večji odmerek zdravila Ryzodeg, kot bi smeli Če ste si injicirali preveč insulina, se vam lahko krvni sladkor preveč zniža (hipoglikemija) - glejte nasvete v poglavju 4, podpoglavje »Prenizek krvni sladkor«.
English: Difference: 0.51 [0.09;0.93]
Slovenian: Razlika: 0,51 [0,09;0,93]
English: A lower rate of nocturnal hypoglycaemia (defined as episodes between midnight and 6 a.m. confirmed by plasma glucose < 3.1 mmol/L or by patient needing third party assistance) was observed with Ryzodeg relative to IGlar (Table 1).
Slovenian: Z zdravilom Ryzodeg je bilo opaženih manj nočnih hipoglikemij kot pri IGlar (opredeljenih kot epizode med polnočjo in 6. uro zjutraj, s potrjeno koncentracijo glukoze v plazmi < 3,1 mmol/l ali potrebo po pomoči druge osebe) (preglednica 1).
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen Before first use:
Slovenian: Ryzodeg 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Pred prvo uporabo:
English: EU/1/12/806/005 10 pens of 3 mL
Slovenian: EU/1/12/806/005 10 injekcijskih peresnikov po 3 ml
English: After first opening: Can be stored in a refrigerator (2°C - 8°C).
Slovenian: Po prvem odprtju: shranjujete lahko v hladilniku (2 °C - 8 °C).
English: Ratio: 0.80 [0.49;1.30]
Slovenian: Razmerje: 0,80 [0,49;1,30]
English: Ryzodeg dosed once daily with the main meal plus insulin aspart for the remaining meals showed similar reduction in HbA1c at week 16 and no differences in FPG and SMPG compared to comparator insulin detemir dosed once or twice daily plus mealtime insulin aspart.
Slovenian: Pri uporabi zdravila Ryzodeg enkrat na dan z glavnim obrokom in insulinom aspart pri ostalih obrokih je bilo v 16. tednu doseženo podobno zmanjšanje vrednosti HbA1c kot pri uporabi insulina detemir v odmerku enkrat ali dvakrat na dan in insulina aspart v času obroka, vrednosti glukoze v plazmi na tešče in samoizmerjene vrednosti glukoze v plazmi pa se niso razlikovale.
English: Ratio: 0.29 [0.13;0.65]
Slovenian: Razmerje: 0,29 [0,13;0,65]
English: Injection site reactions (including injection site haematoma, pain, haemorrhage, erythema, nodules, swelling, discolouration, pruritus, warmth and injection site mass) occurred in patients treated with Ryzodeg.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Ryzodeg, so se pojavile reakcije na mestu injiciranja (vključno s hematomom na mestu injiciranja, bolečino, krvavitvijo, eritemom, vozlički, oteklino, spremembo barve, srbenjem, toploto in zatrdlino na mestu injiciranja).
English: Difference: -1.06 [-1.43;-0.70]
Slovenian: Razlika: -1,06 [-1,43;-0,70]
English: Stop using Ryzodeg and see a doctor straight away if the reactions become serious.
Slovenian: Če reakcije postanejo resne, prenehajte uporabljati zdravilo Ryzodeg in nemudoma obiščite zdravnika.
English: When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.
Slovenian: Ko je injekcijski peresnik prazen, ga zavrzite brez nameščene igle, kot vam je to naročil zdravnik,
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Drugi neželeni učinki so: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: Ratio: 0.68 [0.52;0.89]
Slovenian: Razmerje: 0,68 [0,52;0,89]
English: It delivers 1-80 units in steps of 1 unit.
Slovenian: Omogoča aplikacijo od 1 do 80 enot, v koraku po 1 enoto.
English: Difference: 0.33 [-0.11;0.77]
Slovenian: Razlika: 0,33 [-0,11;0,77]
English: FPG (mmol/L) End of trial Mean change
Slovenian: Glukoza v plazmi na tešče (mmol/l) Na koncu preskušanja Povprečna sprememba
English: • Check the name and strength on the label to make sure it is Ryzodeg 100 units/mL.
Slovenian: • Preverite ime in jakost na nalepki, da se prepričate, da imate res zdravilo Ryzodeg 100 enot/ml.
English: Ratio: 1.00 [0.76;1.32]
Slovenian: Razmerje: 1,00 [0,76;1,32]
English: Swelling around your joints: When you first start using your medicine, your body may keep more water than it should.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) Otekanje sklepov: ko začnete uporabljati zdravilo, lahko v telesu zastaja več vode, kot je normalno.
English: There is no experience with the use of Ryzodeg in children below the age of 2 years.
Slovenian: Izkušenj z uporabo zdravila Ryzodeg pri otrocih, mlajših od 2 let, ni na voljo.
English: Keep the cartridges in the outer carton in order to protect from light.
Slovenian: Vložke shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Solution for injection (FlexTouch) Multipack: 10 (2 packs of 5) 3 mL pre-filled pens
Slovenian: Skupno pakiranje: 10 (2 škatli po 5) napolnjenih injekcijskih peresnikov po 3 ml
English: Ratio: 0.27 [0.18;0.41]
Slovenian: Razmerje: 0,27 [0,18;0,41]
English: Patients switching from more than once-daily basal or premix insulin therapy can be converted unit-to-unit to once- or twice-daily Ryzodeg at the same total insulin dose as the patient's previous total daily insulin dose.
Slovenian: Odmerek bolnikov, ki prehajajo z bazalnega insulinskega zdravljenja ali insulinskega zdravljenja s pripravljeno mešanico večkrat dnevno, lahko pretvorimo v odmerek zdravila Ryzodeg enkrat ali dvakrat na dan, v razmerju enot ena proti ena, pri čemer je celotni dnevni odmerek zdravila Ryzodeg enak celotnemu dnevnemu odmerku prej uporabljanega insulina.
English: Ryzodeg 100 units/mL solution for injection in cartridge Ryzodeg comes in a cartridge (Penfill) designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist injection needles.
Slovenian: Ryzodeg 100 enot/ml raztopina za injiciranje v vložku Zdravilo Ryzodeg je na voljo v vložku (Penfill) in je namenjeno za uporabo s sistemi za dajanje insulina Novo Nordisk in injekcijskimi iglami NovoFine ali NovoTwist.
English: Ratio: 0.91 [0.76;1.09]
Slovenian: Razmerje: 0,91 [0,76;1,09]
English: • Check the name and strength on the label of your pen, to make sure that it contains Ryzodeg 100 units/mL.
Slovenian: • Preverite ime in jakost na nalepki injekcijskega peresnika, da se prepričate, da res vsebuje zdravilo Ryzodeg 100 enot/ml.
English: Component of a multipack, cannot be sold separately
Slovenian: 5 x 3 ml. Škatla je del skupnega pakiranja in se je ne sme izdajati posamično.
English: Ryzodeg o.d.or b.i.d demonstrated similar glycaemic control (HbA1c) compared to IGlar o.d. plus IAsp 13 times daily after 38 weeks (the estimated mean reductions are -1.17% vs -1.26%).
Slovenian: Pri uporabi zdravila Ryzodeg 1x/dan ali 2x/dan je bila urejenost glikemije (HbA1c) po 38 tednih podobna kot pri uporabi IGlar 1x/dan v kombinaciji z IAsp 1-3-krat na dan (ocenjeno povprečno zmanjšanje -1,17 % v primerjavi z -1,26 %).
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen One pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
Slovenian: Ryzodeg 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjen injekcijski peresnik vsebuje 300 enot insulina degludek/insulina aspart v 3 ml raztopine.
English: • Use with the main meal(s); you can change the time of dosing as long as Ryzodeg is dosed with the largest meal(s).
Slovenian: • Zdravilo Ryzodeg se lahko uporabi enkrat ali dvakrat na dan. • Uporabite ga ob glavnem obroku (obrokih); zdravilo Ryzodeg lahko vsak dan uporabite ob drugem času dneva, pomembno je le, da ga uporabite ob najobilnejšem obroku (obrokih) dneva.
English: The signs may include: pain, redness, hives, swelling and itching.
Slovenian: Znaki so: bolečina, pordelost,
English: Table 2 Result from two 26-weeks' trials in type 2 diabetes mellitus with Ryzodeg given twice daily
Slovenian: Rezultati dveh 26-tedenskih preskušanj pri sladkorni bolezni tipa 2 z zdravilom Ryzodeg dvakrat na dan
English: Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Slovenian: V primeru večje telesne aktivnosti, spremenjene običajne prehrane ali spremljajoče bolezni bo morda potrebna prilagoditev odmerka.
English: The half-life after subcutaneous administration of Ryzodeg is determined by the rate of absorption from the subcutaneous tissue.
Slovenian: Hitrost absorpcije iz podkožnega tkiva je tista, ki določa razpolovni čas po subkutani uporabi zdravila Ryzodeg.
English: dosing in the Ryzodeg arm and additional IAsp doses could be administered at other meals (up to 3 times daily) in the IGlar arm.
Slovenian: Po 26 tednih so v skupini z zdravilom Ryzodeg odmerek zdravila Ryzodeg lahko razdelili v odmerjanje 2x/dan, v skupini z IGlar pa so bolniki lahko uporabljali dodatne odmerke IAsp ob drugih obrokih (do 3-krat na dan).
English: Ratio: 0.63 [0.49;0.81]
Slovenian: Razmerje: 0,63 [0,49;0,81]
English: 24 units selected
Slovenian: izbranih 5 enot izbranih 24 enot primera
English: Difference: 0.05 [-0.10;0.20]
Slovenian: Razlika: 0,05 [-0,10;0,20]
English: • Caregivers must be very careful when handling used needles to reduce the risk of needle injury and cross-infection.
Slovenian: • Osebe, ki skrbijo za bolnika, morajo biti pri ravnanju z uporabljenimi iglami zelo pazljive,
English: Instructions on how to use Ryzodeg 100 units/mL solution for injection in pre-filled pen (FlexTouch)
Slovenian: Navodila za uporabo zdravila Ryzodeg 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku (FlexTouch)
English: Fatty tissue under the skin may shrink (lipoatrophy) or get thicker (lipohypertrophy).
Slovenian: Podkožno maščevje se lahko skrči (lipoatrofija) ali zadebeli (lipohipertrofija).
English: • In all subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Slovenian: • novorojenčke in dojenčke, od rojstva do manj kot 12 mesecev starosti, s sladkorno boleznijo tipa 1, • vse podskupine pediatrične populacije, s sladkorno boleznijo tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Ryzodeg (o.d.)2 Insulin users
Slovenian: (2x/dan)2 Uporabniki insulina
English: Figure 1: Pharmacodynamics, single dose - Mean glucose infusion rate profile - Patients with type 1 diabetes - 0.8 U/kg Ryzodeg - Trial 3539
Slovenian: Slika 1: Farmakodinamika, enkraten odmerek - profil povprečne hitrosti infundiranja glukoze - bolniki s sladkorno boleznijo tipa 1 - 0,8 e. zdravila Ryzodeg/kg - preskušanje 3539 Celotni učinek in največje znižanje koncentracije glukoze se pri zdravilu Ryzodeg povečujeta linearno s povečevanjem odmerka.
English: Use only clear, colourless solution Single patient use only
Slovenian: Uporabite le bistro, brezbarvno raztopino.
English: Ryzodeg 100 units/mL solution for injection in cartridge The cartridge (Penfill) is designed to be used with Novo Nordisk delivery systems (durable devices for repeated use not included in the pack) and NovoFine/NovoTwist injection needles up to a length of 8 mm.
Slovenian: Ryzodeg 100 enot/ml raztopina za injiciranje v vložku Vložek (Penfill) je namenjen za uporabo s sistemi za dajanje insulina družbe Novo Nordisk (trajne naprave za večkratno uporabo, ki niso priložene posameznemu pakiranju) in injekcijskimi iglami NovoFine/NovoTwist, dolžine do 8 mm. Upoštevati je treba podrobna navodila, priložena sistemu za apliciranje insulina.
English: Each cartridge contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
Slovenian: En vložek vsebuje 300 enot insulina degludek/insulina aspart v 3 ml raztopine.
English: Difference: -0.05 [-0.18;0.08]
Slovenian: Razlika: -0,05 [-0,18;0,08]
English: Batch
Slovenian: MACE)
English: Ryzodeg o.d. demonstrated similar glycaemic control (HbA1c) compared to IGlar o.d. plus IAsp o.d. after 26 weeks (the estimated mean reductions are -1.01% vs -1.09%).
Slovenian: Pri uporabi zdravila Ryzodeg 1x/dan je bila urejenost glikemije (HbA1c) po 26 tednih podobna kot pri uporabi IGlar 1x/dan v kombinaciji z IAsp 1x/dan (ocenjeno povprečno zmanjšanje -1,01 % v primerjavi z -1,09 %).
English: 3 Select your dose • Make sure the dose counter shows 0 before you start.
Slovenian: • Preden začnete se prepričajte, da števec odmerka kaže 0.
English: Table 3 Result of a 26-weeks' trial in type 1 diabetes mellitus with Ryzodeg given once daily
Slovenian: Rezultati 26-tedenskega preskušanja pri sladkorni bolezni tipa 1 z zdravilom Ryzodeg enkrat na dan
English: Ryzodeg 100 units/mL solution for injection 70% insulin degludec / 30% insulin aspart FlexTouch
Slovenian: Ryzodeg 100 enot/ml raztopina za injiciranje 70 % insulina degludek/30 % insulina aspart FlexTouch
English: EU/1/12/806/007 5 cartridges of 3 mL EU/1/12/806/008 10 cartridges of 3 mL
Slovenian: 12. ŠTEVILKI DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/12/806/007 5 vložkov po 3 ml EU/1/12/806/008 10 vložkov po 3 ml
English: Flushed, dry skin; feeling sleepy or tired; dry mouth, fruity (acetone) breath; urinating more often, feeling thirsty; losing your appetite, feeling or being sick (nausea or vomiting).
Slovenian: Opozorilni znaki previsokega krvnega sladkorja - običajno se pojavijo postopoma Pordela, suha koža, občutek zaspanosti ali utrujenosti, suha usta in zadah z vonjem po sadju (acetonu), pogostejše uriniranje, občutek žeje, izguba apetita, občutek slabosti (siljenje na bruhanje ali bruhanje).
English: Ratio: 1.43 [1.07;1.92]
Slovenian: Razmerje: 1,43 [1,07;1,92]
English: Both treatments improved glycaemic control with an estimated mean reduction with Ryzodeg (-1.23%) against IDeg plus IAsp (-1.42%) for the primary endpoint of change from baseline in HbA1c at 26 weeks.
Slovenian: Pri obeh oblikah zdravljenja se je urejenost glikemije izboljšala, pri čemer pa ocenjeno povprečno zmanjšanje pri primarnem opazovanem dogodku, tj. spremembi vrednosti HbA1c od izhodišča do 26. tedna, pri uporabi zdravila Ryzodeg (-1,23 %) v primerjavi z uporabo IDeg v kombinaciji z IAsp (-1,42 %) ni doseglo vnaprej določene meje neinferiornosti 0,4 % [0,18 (-0,04; 0,41)].
English: Ryzodeg administered once daily o.d. was compared to insulin glargine (100 units/mL) (IGlar) o.d. in two trials in type 2 diabetes mellitus (Table 1).
Slovenian: Zdravilo Ryzodeg enkrat na dan (1x/dan) so primerjali z insulinom glargin (100 enot/ml) (IGlar)
English: Ryzodeg 100 units/mL solution for injection 70% insulin degludec / 30% insulin aspart Penfill
Slovenian: Ryzodeg 100 enot/ml raztopina za injiciranje 70 % insulina degludek/30 % insulina aspart Penfill
English: Always keep Ryzodeg Penfill in the outer carton when you are not using it in order to protect from light.
Slovenian: Kadar zdravila Ryzodeg Penfill ne uporabljate, ga shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a multidose disposable pre-filled pen made of polypropylene.
Slovenian: Ryzodeg 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku 3 ml raztopine v vložku (steklo tipa 1) z batom (halobutil) in plastjo laminirane gume
English: Initiation
Slovenian: Izhodiščna vrednost
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen Ryzodeg comes in a pre-filled pen (FlexTouch) designed to be used with NovoFine or NovoTwist injection needles.
Slovenian: Ryzodeg 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Zdravilo Ryzodeg je na voljo v napolnjenem injekcijskem peresniku (FlexTouch) in je namenjeno za uporabo z injekcijskimi iglami NovoFine ali NovoTwist.
English: Common (may affect up to 1 in 10 people)
Slovenian: (pojavi se lahko pri več kot 1 od 10 bolnikov).
English: Few severe hypoglycaemic episodes were reported in each group; the observed rate of severe hypoglycaemia within the Ryzodeg arm was higher for subjects aged 2-5 years compared to subjects aged 6-11 years or 12-17 years (0.42 vs 0.21 and 0.21 respectively).
Slovenian: starimi od 6 do 11 let, ali od 12 do 17 let (0,42 v primerjavi z 0,21 in 0,21).
English: Insulins and analogues for injection, intermediateor long-acting combined with fast-acting, ATC code: A10AD06.
Slovenian: Oznaka ATC: A10AD06.
English: Each pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
Slovenian: En napolnjen injekcijski peresnik vsebuje 300 enot insulina degludek/insulina aspart v 3 ml raztopine.
English: in two trials in type 2 diabetes mellitus (Table 2) and to insulin degludec (IDeg) o.d. plus insulin aspart (IAsp) 2-4 times daily in one trial in type 2 diabetes mellitus.
Slovenian: Zdravilo Ryzodeg dvakrat na dan (2x/dan) so primerjali z dvofaznim insulinom aspart 30 (BIAsp 30) 2x/dan v dveh preskušanjih pri sladkorni bolezni tipa 2 (preglednica 2) in z insulinom degludek (IDeg) 1x/dan v kombinaciji z insulinom aspart (IAsp) 2-4 krat na dan v enem preskušanju pri sladkorni bolezni tipa 2.
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch).
Slovenian: Ryzodeg 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku raztopina za injiciranje (FlexTouch)
English: Table 1 Result from two 26-weeks' trials in type 2 diabetes mellitus with Ryzodeg given once daily
Slovenian: Rezultati dveh 26-tedenskih preskušanj pri sladkorni bolezni tipa 2 z zdravilom Ryzodeg enkrat na dan
English: 1 mL solution contains 100 units insulin degludec/insulin aspart* in the ratio 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart).
Slovenian: 1 ml raztopine vsebuje 100 enot insulina degludek/insulina aspart* v razmerju 70/30 (kar ustreza 2,56 mg insulina degludek in 1,05 mg insulina aspart).
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi glicerol metakrezol fenol natrijev klorid cinkov acetat klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
English: Ryzodeg allows for flexibility in the timing of insulin administration as long as it is dosed with the main meal(s).
Slovenian: Prilagodljivost časa odmerjanja Zdravilo Ryzodeg omogoča prilagodljivost v času apliciranja, pomembno je le, da si bolnik zdravilo aplicira ob glavnih obrokih.
English: )1 Insulin users
Slovenian: Uporabniki insulina