natgillin/translations-raw huggingface dataset:
Allergic reactions, potentially allergic reactions, urticaria, rash and eruptions:
Alergijske reakcije, potencialne alergijske reakcije, urtikarija, izpuščaji in kožne spremembe:
Such symptoms may be due to generalised hypersensitivity.
Takšni simptomi se lahko pojavijo zaradi sistemske preobčutljivosti.
Other signs of generalised hypersensitivity may be itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure.
Med simptomi sistemske preobčutljivosti so lahko srbenje, znojenje, prebavne motnje, angionevrotični edem, težko dihanje, palpitacije in znižanje krvnega tlaka.
Generalised hypersensitivity reactions are potentially life threatening (anaphylactic reactions).
Sistemske preobčutljivostne reakcije so potencialno smrtno nevarne (anafilaktične reakcije).
Uncommon (> 1/ 1,000, < 1/ 100)
Občasno (> 1/ 1. 000, < 1/ 100) Bolezni živčevja
Refraction disorders:
Refrakcijske motnje:
Refraction anomalies may occur upon initiation of insulin therapy.
Po začetku zdravljenja z insulinom se lahko pojavijo refrakcijske anomalije.
Diabetic retinopathy:
Diabetična retinopatija:
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Dolgotrajno izboljšanje urejenosti glikemije zmanjša tveganje za napredovanje diabetične retinopatije.
1/ 10,000, < 1/ 1,000)
Redko (> 1/ 10. 000, < 1/ 1. 000)
Peripheral neuropathy:
Periferna nevropatija:
Fast improvement in blood glucose control may be associated with the condition “ acute painful neuropathy”, which is usually reversible.
Hitro izboljšanje urejenosti glukoze v krvi lahko spremlja motnja, imenovana akutna boleča nevropatija, ki je ponavadi reverzibilna.
4.9
4. 9 Preveliko odmerjanje
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’ s requirement are administered:
6 Specifičnega prevelikega odmerjanja insulina ni mogoče opredeliti, kljub temu pa se lahko ob prevelikem odmerjanju glede na bolnikove potrebe postopoma razvije hipoglikemija.
It is therefore recommended that the diabetic patient always carries sugar containing products.
Zato je priporočljivo, da bolniki s sladkorno boleznijo vedno nosijo pri sebi izdelke, ki vsebujejo sladkor.
• Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or by glucose given intravenously by a medical professional.
• Hude hipoglikemije, ko je bolnik nezavesten, je mogoče zdraviti z glukagonom (0, 5 do 1 mg), ki ga da intramuskularno ali subkutano ustrezno podučena oseba, ali z glukozo, ki jo da intravensko zdravstveni delavec.
Drugs used in diabetes.
Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa.
Insulins and analogues for injection, long-acting.
Insulini in analogi za injiciranje z dolgotrajnim delovanjem.
A10AE05.
A10AE 05.
Insulin detemir is a soluble, long-acting basal insulin analogue with a prolonged duration of effect.
Insulin detemir je topen dolgodelujoč analog bazalnega insulina s podaljšanim trajanjem učinka.
The time action profile of insulin detemir is statistically significantly less variable and therefore more predictable than for NPH insulin as seen from the within-subject Coefficients of Variation (CV) for the total and maximum pharmacodynamic effect in Table 1.
Časovni potek delovanja insulina detemir je statistično pomembno manj spremenljiv in zato bolj predvidljiv kot časovni potek delovanja insulina NPH, kar je razvidno iz Preglednice 1, ki prikazuje koeficiente spremenljivosti (CV) za celotni in največji farmakodinamični učinek.
Within-Subject Variability of the time action profile of insulin detemir and NPH insulin
Spremenljivost časovnega poteka delovanja insulina detemir in insulina NPH.
Pharmacodynamic
CV (%) insulina detemir CV (%) insulina NPH Farmakodinamična primerjava
*Area under the curve insulin detemir
* Površina pod krivuljo insulinom detemir
** Glucose Infusion Rate p-value < 0.001 for all comparisons with
** Hitrost infuzije glukoze p- vrednost < 0, 001 za vse primerjave z
The prolonged action of insulin detemir is mediated by the strong self-association of insulin detemir molecules at the injection site and albumin binding via the fatty acid side-chain.
Na podaljšano delovanje insulina detemir vpliva močna medsebojna povezava molekul insulina detemir na mestu injiciranja in vezava na albumin preko stranskih verig maščobnih kislin.
The blood glucose lowering effect of insulin detemir is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Insulin detemir znižuje glukozo v krvi tako, da olajša njen privzem po vezavi insulina na receptorje na mišičnih in maščobnih celicah in hkrati zavre sproščanje glukoze iz jeter.
7 Pharmacodynamic Parameters for Levemir and NPH Glucose infusion rate (mg/ kg/ min)
7 Farmakodinamični parametri za Levemir in NPH Hitrost infuzije glukoze (mg/ kg/ min)
Duration of action (hr) GIRmax (mg/ kg/ min) † estimated values
Trajanje delovanja (h) GIRmax (mg/ kg/ min) † ocenjene vrednosti
U/ kg U/ kg U/ kg
e. / kg e. / kg e. / kg
IU/ kg
i. e. / kg
Time Since Insulin Injection (hours)
Čas od injiciranja insulina (v urah)
0.2 U/ kg
0, 2 e. / kg
0.3 U/ kg... .0.4 U/ kg
0, 3 e. / kg.... 0, 4 e. / kg
Activity profiles of Levemir in patients with type 1 diabetes.
Potek delovanja zdravila Levemir pri bolnikih s sladkorno boleznijo tipa 1.
If administered twice daily, steady state will occur after 2-3 dose administrations.
Če apliciramo dvakrat dnevno, bo stanje dinamičnega ravnovesja doseženo po 2– 3 apliciranjih odmerka.
For doses in the interval of 0.2 - 0.4 U/ kg, Levemir exerts more than 50% of its maximum effect from 3-4 hours and up to approximately 14 hours after dose administration.
V odmerkih zdravila Levemir v območju od 0, 2– 0, 4 e. / kg znaša trajanje učinka, večjega od 50% največjega učinka, od 3– 4 ur do približno 14 ur po apliciranju odmerka.
Lower day-to-day variability in FPG was demonstrated during treatment with Levemir compared to NPH in long-term clinical trials.
V dolgoročnih kliničnih preskušanjih so med zdravljenjem z insulinom Levemir od dne do dne ugotovili manjšo variabilnost glukoze v plazmi na tešče kot z insulinom NPH.
Studies in patients with type 2 diabetes treated with basal insulin in combination with oral antidiabetic drugs demonstrated that glycaemic control (HbA1c) with Levemir is comparable to NPH insulin and insulin glargine and associated with less weight gain, please see Table 2 below.
Študije pri bolnikih z diabetesom tipa 2, zdravljenih z bazalnim insulinom v kombinaciji s peroralnimiantidiabetiki so pokazale, da je urejenost glikemije (HbA1c) ob insulinu Levemir primerljiva kot ob insulinu NPH in insulinu glarginu, obenem je manj povečanja telesne mase (glejte tabelo 2, spodaj).
In the study versus insulin glargine, insulin detemir was allowed to be administered once or twice daily whereas insulin glargine was to be administered once a day, 55% of the insulin detemir-treated subjects completed the 52 weeks of treatment on the twice daily regimen.
V študiji, ki je primerjala insulin glargin in insulin detemir, so bolniki detemir lahko aplicirali enkrat ali dvakrat na dan, glargin pa so morali aplicirati enkrat na dan; 55% preiskovancev, ki so dobivali insulin detemir, je 52- tedensko zdravljenje dokončalo z uporabo dvakrat na dan.
Change in body weight after insulin treatment Study duration Insulin detemir Insulin detemir NPH insulin once daily twice daily 20 week +0.7 kg +1.6 kg
Sprememba telesne mase po zdravljenju z insulinom Trajanje študije
26 weeks 52 weeks +2.3 kg
20 tednov 26 tednov
+1.2 kg +3.7 kg
+ 0, 7 kg
+2.8 kg
+ 1, 6 kg
+4.0 kg
+ 1, 2 kg
In trials with the use of OAD-insulin combination therapy Levemir treatment resulted lower risk of minor nocturnal hypoglycaemia compared to NPH insulin.
+ 2, 8 kg
in a 61-65%
52 tednov
In long-term treatment trials in patients with type 1 diabetes, fasting plasma glucose was improved with Levemir compared with NPH insulin when given as basal/ bolus therapy including in children and adolescents aged 6 to 17 years.
V preskušanjih, v katerih so uporabljali kombinirano zdravljenje s peroralnimi antidiabetiki in insulinom, je bil insulin Levemir povezan z 61- 65% manjšim tveganjem za blage nočne hipoglikemije kot insulin NPH.
Analyses of nocturnal hypoglycaemia in patients with type 1 diabetes showed a significantly lower risk of minor nocturnal hypoglycaemia (able to self-treat and confirmed by capillary blood glucose less than 2.8 mmol/ L or 3.1 mmol/ L if expressed as plasma glucose) than with NPH insulin, whereas no difference was seen in type 2 diabetes.
V preskušanjih z dolgotrajnim zdravljenjem pri bolnikih z diabetesom tipa I se je stanje plazemske glukoze na tešče ob bazalnem/ bolusnem zdravljenju z zdravilom Levemir v primerjavi z insulinom NPH izboljšalo, in sicer tudi pri otrocih in mladostnikih starih od 6 do 17 let.
Furthermore, the overall risk of 8 nocturnal hypoglycaemia in children and adolescents aged 6 to 17 years with type 1 diabetes was significantly lower with Levemir compared to NPH insulin.
Glikemično uravnavanje (HbA1c) z zdravilom Levemir je mogoče primerjati z insulinom NPH, pri čemer je tveganje za nočno hipoglikemijo nižje ter brez hkratnega pridobivanja na telesni masi.
However, this does not appear to have any impact on glycaemic control.
Klinična preskušanja, v katerih so uporabljali bazalno- bolusno zdravljenje z insulinom, so pokazala, da je celotna pogostost pojava hipoglikemije podobna pri zdravljenju z zdravilom Levemir ali
Absorption:
8 insulinom NPH.
Maximum serum concentration is reached between 6 and 8 hours after administration.
Največja koncentracija v serumu je dosežena v 6 do 8 urah po uporabi.
When administered twice daily, steady state serum concentrations are reached after 2-3 dose administrations.
Če apliciramo dvakrat dnevno, bodo koncentracije v serumu v stanju dinamičnega ravnovesja dosežene po 2– 3 odmerkih.
Within-patient variation in absorption is lower for Levemir than for other basal insulin preparations.
Razlike v absorpciji med bolniki so pri zdravljenju z zdravilom Levemir manjše kot pri drugih pripravkih bazalnega insulina.
There are no clinically relevant differences between genders in pharmacokinetic properties of insulin detemir.
Farmakokinetične lastnosti insulina detemir se med spoloma klinično pomembno ne razlikujejo.
The absolute bioavailability of insulin detemir when administered subcutaneous is approximately 60%.
Absolutna biološka uporabnost insulina detemir znaša pri subkutani uporabi približno 60%.
An apparent volume of distribution for insulin detemir (approximately 0.1 l/ kg) indicates that a high fraction of insulin detemir is circulating in the blood.
Navidezen volumen porazdelitve insulina detemir (približno 0, 1 l/ kg) kaže na to, da se velik delež zdravila nahaja v krvnem obtoku.
The terminal half-life after subcutaneous administration is determined by the rate of absorption from the subcutaneous tissue.
Terminalni razpolovni čas po subkutani uporabi je določen s hitrostjo absorpcije iz podkožnega tkiva.
The terminal half-life is between 5 and 7 hours depending on dose.
Terminalni razpolovni čas je odvisen od odmerka in znaša od 5 do 7 ur.
Dose proportionality in serum concentrations (maximum concentration, extent of absorption) is observed after subcutaneous administration in the therapeutic dose range.
Po subkutani uporabi v terapevtskem območju so koncentracije v serumu (največja vsebnost, obseg absorpcije) sorazmerne odmerku.
Special Populations:
Posebne skupine bolnikov:
The pharmacokinetic properties of insulin detemir were investigated in children (6– 12 years) and adolescents (13– 17 years) and compared to adults with type 1 diabetes.
Farmakokinetične lastnosti insulina detemir, določene pri otrocih (6– 12 let) in mladostnikih (13 – 17 let), so bile primerjane z lastnostmi pri odraslih bolnikih s sladkorno boleznijo tipa 1.
There was no clinically relevant difference in pharmacokinetic properties.
Klinično pomembne razlike niso bile ugotovljene.
There was no clinically relevant difference in pharmacokinetics of insulin detemir between elderly and young subjects or between subjects with renal or hepatic impairment and healthy subjects.
Klinično pomembne razlike v farmakokinetiki insulina detemir med starejšimi in mlajšimi bolniki ali med bolniki z ledvično ali jetrno okvaro in zdravimi ljudmi niso bile ugotovljene.
No clinically relevant differences in the pharmacokinetics of insulin detemir are expected between healthy subjects and subjects with renal or hepatic impairment, based on the studies performed.
Na osnovi opravljenih študij se ne pričakuje klinično pomembnih farmakokinetičnih razlik v presnovi insulina detemir med zdravimi ter bolniki z ledvično ali jetrno okvaro.
As the pharmacokinetics of insulin detemir has not been studied extensively in these populations, it is advised to monitor plasma glucose closely in these populations.
Zaželeno je nadziranje glukoze v plazmi, saj študije farmakokinetike insulina detemir pri teh bolnikih še niso opravljene.
9 5.3 Preclinical safety data
9 Neklinični podatki na podlagi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za ljudi.
Receptor affinity data and in-vitro mitogenicity tests revealed no evidence of an increased mitogenic potential compared to human insulin.
Podatki o receptorski afiniteti in in- vitro poskusi mitogenosti niso pokazali povečanega mitogenega potenciala v primerjavi s humanim insulinom.
Glycerol Phenol Metacresol Zinc acetate Disodium phosphate dihydrate Sodium chloride Hydrochloric acid 2N (pH adjustment) Sodium hydroxide 2N (pH adjustment) Water for injections
glicerol fenol metakrezol cinkov acetat natrijev hidrogenfosfat dihidrat natrijev klorid klorovodikova kislina 2N (za uravnavanje pH) natrijev hidroksid 2N (za uravnavanje pH) voda za injekcije
Substances added to Levemir may cause degradation of insulin detemir, e. g. if the medicinal product contains thiols or sulphites.
Učinkovine, dodane zdravilu Levemir, lahko povzročijo razgradnjo insulina detemir, npr. če zdravilo vsebuje tiole ali sulfite.
After first opening the product must be stored for a maximum of 6 weeks, not above 30°C.
Po prvem odprtju je dovoljeno zdravilo shranjevati največ 6 tednov pri temperaturi do 30 °C.
Store in a refrigerator (2°C - 8°C) not near a freezing compartment.
Shranjujte v hladilniku (pri temperaturi med 2°C in 8°C), ne v bližini zamrzovalnega razdelka!
Keep the cartridge in the outer carton in order to protect from light.
Za zaščito pred svetlobo shranjujte vložek v zunanji ovojnini!
Do not store above 30ºC.
Med uporabo: ne shranjujte v hladilniku ali pri temperaturi nad 30 ºC.
Levemir should be protected from excessive heat and sunlight.
Levemir je treba zaščititi pred čezmerno toploto in sončno svetlobo.
3 ml solution in a cartridge (type 1 glass), with a plunger (bromobutyl) and a stopper (bromobutyl/ polyisoprene) in a carton.
3 ml raztopina v injekcijskem vložku (steklo tipa I) z batom (brombutil) in zamaškom (brombutil/ poliizopren) v škatlici.
Pack size of 1, 5 and 10 cartridges.
Velikost pakiranja po 1, 5 in 10 vložkov.
Not all pack sizes may be marketed.
Na tržišču so lahko le nekatere velikosti pakiranj.
Levemir is for use by one person only.
Levemir je namenjen uporabi ene same osebe.
10 Levemir should not be used if it does not appear clear and colourless.
10 Zdravila Levemir ne smete uporabiti, če raztopina ni bistra in brezbarvna.
01 June 2004
01. junij 2004
Levemir 100 U/ ml solution for injection in a pre-filled pen.
Levemir 100 e. / ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
1 pre-filled pen contains 3 ml equivalent to 300 U.
1 napolnjen injekcijski peresnik vsebuje 3 ml, kar ustreza 300 e.
FlexPen
Raztopina za injiciranje v napolnjenem injekcijskem peresniku FlexPen.
Dosage: In combination with oral antidiabetic agents it is recommended to initiate Levemir treatment with once daily administration at a dose of 10 U or 0.1-0.2 U/ kg.
V kombinaciji s peroralnimi antidiabetiki je priporočljivo zdravljenje z insulinom Levemir začeti enkrat na dan z odmerkom 10 e. ali 0, 1– 0, 2 e. / kg.
12 Transfer from other insulins:
12 Prehod z drugih vrst insulina:
The efficacy and safety of Levemir were demonstrated in children and adolescents aged 6 to 17 years in studies up to 6 months (see section 5.1).
Učinkovitost in varnost uporabe zdravila Levemir sta bili dokazani pri otrocih in mladostnikih, starih od 6 do 17 let v do 6 mesecih trajajočih raziskavah (glejte poglavje 5. 1).
The efficacy and safety of Levemir have not been studied in children below the age of 6 years.
Učinkovitosti in varnosti zdravila Levemir pri otrocih mlajših od 6 let niso proučevali.
Levemir FlexPen is accompanied by a package leaflet with detailed instruction for use to be followed.
Zdravilu Levemir FlexPen je priloženo navodilo za uporabo s podrobnimi napotki za uporabo, ki jih je treba upoštevati.
Patients, whose blood glucose control is greatly improved, e. g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly.
Bolnikom, ki se jim uravnanost glukoze v krvi zelo izboljša, npr. z intenziviranim insulinskim zdravljenjem, se običajni opozorilni simptomi hipoglikemije lahko spremenijo in jih je s to možnostjo treba seznaniti.
13 Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
13 Prehod bolnika na novo vrsto ali znamko insulina mora potekati pod strogim zdravniškim nadzorom.
Animal reproduction studies have not revealed any differences between insulin detemir and human insulin regarding embryotoxicity and teratogenicity.
Reprodukcijske raziskave pri živalih niso pokazale razlik v embriotoksičnosti ali teratogenosti med insulinom detemir in humanim insulinom.
14 In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
Potreba po
Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimester.
14 insulinu se v prvem trimesečju ponavadi zmanjša, potem pa se v drugem in tretjem trimesečju zveča.
Common (> 1/ 100, < 1/ 10)
Pogosto (> 1/ 100, < 1/ 10) Splošne težave in spremembe na mestu aplikacije
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or
Obsegajo lahko hladno znojenje, hladno bledo kožo, utrujenost, živčnost ali tremor, tesnobnost, nenavadno izčrpanost ali šibkost, zmedenost, težave s koncentracijo, zaspanost, čezmerno lakoto, motnje vida, glavobol, slabost in palpitacije.
General disorders and administration site conditions
Huda hipoglikemija lahko povzroči nezavest, konvulzije ali oboje in ima za posledico lahko prehodno ali trajno okvaro delovanja možganov ali celo smrt.
Injection site reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin.
Te reakcije so
These reactions are usually transitory and normally they disappear during continued treatment.
15 ponavadi prehodne in med nadaljevanjem zdravljenja ponavadi izginejo.
Uncommon (> 1/ 1,000, < 1/ 100) Immune system disorders
Občasno (> 1/ 1. 000, < 1/ 100)
Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Lipodistrofija Če bolnik mest injiciranj znotraj posameznega predela ne menjava krožno, se lahko na mestu injiciranja pojavi lipodistrofija.
Rare (> 1/ 10,000, < 1/ 1,000)
Redko (> 1/ 10. 000, < 1/ 1. 000)
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’ s requirement are administered:
Specifičnega prevelikega odmerjanja insulina ni mogoče opredeliti, kljub temu pa se lahko ob prevelikem odmerjanju glede na bolnikove potrebe postopoma razvije hipoglikemija.
• Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or by glucose given intravenously by a medical professional.
16 • Hude hipoglikemije, ko je bolnik nezavesten, je mogoče zdraviti z glukagonom (0, 5 do 1 mg), ki ga da intramuskularno ali subkutano ustrezno podučena oseba, ali z glukozo, ki jo da intravensko zdravstveni delavec.
Pharmacodynamic
Insulin detemir Insulin NPH Farmakodinamična primerjava
(%) 68 46
CV (%) 68 46
*Area under the curve ** Glucose Infusion Rate p-value < 0.001 for all comparisons with insulin detemir
* Površina pod krivuljo ** Hitrost infuzije glukoze insulinom detemir
17 The blood glucose lowering effect of insulin detemir is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Insulin detemir znižuje glukozo v krvi tako, da olajša njen privzem po vezavi insulina na receptorje na mišičnih in maščobnih celicah in hkrati zavre sproščanje glukoze iz jeter.
Pharmacodynamic Parameters for Levemir and NPH Glucose infusion rate (mg/ kg/ min)
F a r m a k o d i n a m ič n i p a r a m e t r i z a L e v e m i r i n N P H
Duration of action (hr) GIRmax (mg/ kg/ min) † estimated values
Hitrost infuzije glukoze (mg/ kg/ min)
U/ kg U/ kg U/ kg
L e v e m ir
IU/ kg
e. / k g
Time Since Insulin Injection (hours)
Č a s o d in jic ira n ja in s u lin a (v u ra h)
Levemir …..
L e v e m ir …..
0.2 U/ kg
0, 2 e. / k g
0.3 U/ kg... .0.4 U/ kg
0, 3 e. / k g... 0, 4 e. / k g
Figure 1:
17 Slika 1:
If administered twice daily, steady state will occur after 2-3 dose administrations.
Če apliciramo dvakrat dnevno, bo stanje dinamičnega ravnovesja doseženo po 2 – 3 apliciranjih odmerka.
+1.2 kg +3.7 kg
+ 1, 6 kg + 2, 8 kg
+2.8 kg
52 tednov
+4.0 kg
+ 2, 3 kg
In trials with the use of OAD-insulin combination therapy Levemir treatment resulted lower risk of minor nocturnal hypoglycaemia compared to NPH insulin.
+ 3, 7 kg
in a 61-65%
+ 4, 0 kg
In long-term treatment trials in patients with type 1 diabetes, fasting plasma glucose was improved with Levemir compared with NPH insulin when given as basal/ bolus therapy including in children and adolescents aged 6 to 17 years.
V preskušanjih z dolgotrajnim zdravljenjem pri bolnikih z diabetesom tipa I se je stanje plazemske glukoze na tešče ob bazalnem/ bolusnem zdravljenju z zdravilom Levemir v primerjavi z insulinom NPH izboljšalo in sicer tudipri otrocih in mladostnikih starih od 6 do 17 let.
Glycaemic control (HbA1c) with Levemir is comparable to NPH insulin, with a lower risk of nocturnal hypoglycaemia and no associated weight gain.
Glikemično uravnavanje (HbA1c) z zdravilom Levemir je mogoče primerjati z insulinom NPH, pri čemer je tveganje za nočno hipoglikemijo nižje ter brez hkratnega pridobivanja na telesni masi.
In clinical trials using basal bolus insulin therapy, the overall rates of hypoglycaemia with Levemir and NPH insulin were similar.
Klinična preskušanja, v katerih so uporabljali bazalno- bolusno zdravljenje z insulinom, so pokazala, da je celotna pogostost pojava hipoglikemije podobna pri zdravljenju z zdravilom Levemir ali insulinom NPH.
Analyses of nocturnal hypoglycaemia in patients with type 1 diabetes showed a significantly lower risk of minor nocturnal hypoglycaemia (able to self-treat and confirmed 18 by capillary blood glucose less than 2.8 mmol/ L or 3.1 mmol/ L if expressed as plasma glucose) than with NPH insulin, whereas no difference was seen in type 2 diabetes.
Analize nočne hipoglikemije pri bolnikih s sladkorno boleznijo tipa 1 so pokazale bistveno nižje tveganje za blago nočno hipoglikemijo (kadar ni potrebno dodatno zdravljenje in je glukoza v kapilarni krvi nižja od 2, 8 mmol/ l ali 3, 1 mmol/ l, če je izražena kot plazemska glukoza) kot pri insulinu NPH, pri diabetesu tipa 2 pa ta razlika ni opazna.