natgillin/translations-raw huggingface dataset:
Det kan også være nødvendigt at justere doseringen af Levemir, når det gives sammen med en række andre lægemidler, der kan indvirke på blodsukkeret (den fuldstændige liste fremgår af indlægssedlen).
Levemir doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood sugar (the full list is available in the Package Leaflet).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Levemir er større end risiciene ved behandling af diabetes mellitus.
The Committee for Medicinal products for Human Use (CHMP) decided that Levemir’ s benefits are greater than its risks for the treatment of diabetes mellitus.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Levemir.
They recommended that Levemir be given marketing authorisation.
Andre oplysninger om Levemir:
Other information about Levemir:
Europa- Kommissionen udstedte en markedsføringstilladelse for Levemir med gyldighed i hele Den Europæiske Union til Novo Nordisk A/ S den 1. juni 2004.
The European Commission granted a marketing authorisation valid throughout the European Union for Levemir to Novo Nordisk A/ S on 1 June 2004.
Den europæiske offentlige vurderingsrapport (EPAR) for Levemir kan ses i sin helhed her.
The full EPAR for Levemir is available here.
Subkutan anvendelse
Pharmaceutical form
Levemir
Packaging
100 E/ ml
Content
1 fyldt pen
Package size
EU/ 1/ 04/ 278/ 005
EU/ 1/ 04/ 278/ 001 EU/ 1/ 04/ 278/ 002 EU/ 1/ 04/ 278/ 003 EU/ 1/ 04/ 278/ 004 EU/ 1/ 04/ 278/ 005 EU/ 1/ 04/ 278/ 006 EU/ 1/ 04/ 278/ 007 EU/ 1/ 04/ 278/ 008 EU/ 1/ 04/ 278/ 009
Cylinderampul (glas) i fyldt pen (FlexPen)
Levemir Levemir Levemir Levemir Levemir Levemir Levemir Levemir Levemir
Cylinderampul (glas) i fyldt pen (FlexPen)
100 U/ ml 100 U/ ml 100 U/ ml 100 U/ ml 100 U/ ml 100 U/ ml 100 U/ ml 100 U/ ml 100 U/ ml
3 ml
Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection
Cylinderampul (glas) i fyldt pen (InnoLet)
Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use Subcutaneous use
3 ml
Cartridge (glass) (Penfill) Cartridge (glass) (Penfill) Cartridge (glass) (Penfill) Cartridge (glass) in pre-filled pen (FlexPen) Cartridge (glass) in pre-filled pen (FlexPen) Cartridge (glass) in pre-filled pen (FlexPen) Cartridge (glass) in pre-filled pen (InnoLet) Cartridge (glass) in pre-filled pen (InnoLet) Cartridge (glass) in pre-filled pen (InnoLet)
Cylinderampul (glas) i fyldt pen (InnoLet)
3 ml 3 ml 3 ml 3 ml 3 ml 3 ml 3 ml 3 ml 3 ml
Cylinderampul (glas) i fyldt pen (InnoLet)
1 cartridge 5 cartridges 10 cartridges 1 pre-filled pen 5 pre-filled pens 10 pre-filled pens 1 pre-filled pen 5 pre-filled pens 10 pre-filled pens
Levemir 100 E/ ml, injektionsvæske, opløsning i cylinderampul
Levemir 100 U/ ml solution for injection in a cartridge.
1 ml indeholder 100 E insulin detemir (fremstillet ved rekombinant DNA- teknologi i Saccharomyces cerevisiae).
1 ml contains 100 U of insulin detemir (produced by recombinant DNA technology in Saccharomyces cerevisiae).
1 cylinderampul indeholder 3 ml svarende til 300 E.
1 cartridge contains 3 ml equivalent to 300 U.
1 enhed insulin detemir svarer til 0, 142 mg saltfrit insulin detemir anhydrat.
One unit of insulin detemir contains 0.142 mg salt-free anhydrous insulin detemir.
1 enhed (E) insulin detemir svarer til 1 IE humant insulin.
One unit (U) of insulin detemir corresponds to one IU of human insulin.
Penfill.
Penfill
Levemir er en langtidsvirkende insulinanalog, der anvendes som en basal insulin.
Levemir is a long-acting insulin analogue used as a basal insulin..
I kombination med orale antidiabetika anbefales det at initiere Levemir behandling med daglig engangsdosis, der administreres som doser på 10 E eller 0, 1- 0, 2 E/ kg.
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.
Doseringen af Levemir bør titreres baseret på det individuelle patientbehov.
The dose of Levemir should be titrated based on individual patients’ needs.
Baseret på studieresultater anbefales følgende titreringsguideline:
Based on study results, the following titration guideline is recommended:
> 10, 0 mmol/ l (180 mg/ dl) 9, 1- 10, 0 mmol/ l (163- 180 mg/ dl) 8, 1- 9, 0 mmol/ l (145- 162 mg/ dl) 7, 1- 8, 0 mmol/ l (127- 144 mg/ dl) 6, 1- 7, 0 mmol/ l (109- 126 mg/ dl) Hvis en hjemme- målt blodsukkerværdi er
Average pre-breakfast SMPG > 10.0 mmol/ L (180 mg/ dL) 9.1-10.0 mmol/ L (163-180 mg/ dL) 8.1-9.0 mmol/ L (145-162 mg/ dL) 7.1-8.0 mmol/ L (127-144 mg/ dL) 6.1-7.0 mmol/ L (109-126 mg/ dL) If one SMPG measurement
Når Levemir er anvendt som del af basal bolusinsulinregime, bør Levemir administreres en eller to gange dagligt baseret på patientens behov.
When Levemir is used as part of a basal-bolus insulin regimen Levemir should be administered once or twice daily depending on patients’ needs.
Dosering af Levemir er individuel.
Dosage of Levemir should be adjusted individually.
Patienter, der har behov for insulinbehandling to gange dagligt for at optimere blodglukosekontrollen, kan administrere anden dosis om aftenen eller ved sengetid.
2 For patients who require twice daily dosing to optimise blood glucose control, the evening dose can be administered in the evening or at bedtime.
2 Skift fra andre insulinpræparater:
Transfer from other insulins:
4. 4).
Transfer to Levemir from intermediate or long-acting insulins may require adjustment of dose and timing of administration (see section 4.4).
Som ved alle insulinpræparater anbefales hyppig blodglukosekontrol i overgangsperioden og de første behandlingsuger.
As with all insulins, close glucose monitoring is recommended during the transfer and in the initial weeks thereafter.
Samtidig behandling med andre antidiabetika skal muligvis justeres (dosis og/ eller tidspunkt for indgivelse af orale antidiabetika eller korttidsvirkende hurtig/ rapid- virkende insulinpræparater).
Concomitant antidiabetic treatment may need to be adjusted (dose and/ or timing of oral antidiabetic agents or concurrent short/ rapid-acting insulins).
Som ved alle andre insulinpræparater skal blodglukosekontrollen intensiveres, og insulin detemir dosis justeres individuelt hos ældre patienter og patienter med nedsat nyre - eller leverfunktion.
As with all insulins, in elderly patients and patients with renal or hepatic impairment, glucose monitoring should be intensified and insulin detemir dosage adjusted on an individual basis.
5. 1).
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).
Effekten og sikkerheden af Levemir er ikke undersøgt hos børn under 6 år.
The efficacy and safety of Levemir have not been studied in children below the age of 6 years.
Justering af dosis kan også blive nødvendig, såfremt patienter ændrer fysisk aktivitet eller kost, eller under sygdom.
Adjustment of dosage may also be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Indgivelsesmåde:
Administration:
Levemir administreres subkutant i låret, abdominalvæggen eller overarmen.
Levemir is administered subcutaneously by injection in the thigh, abdominal wall, or the upper arm.
Som ved humant insulin kan absorptionshastighed og - omfang af insulin detemir være højere efter subkutan indgivelse i abdominalvæggen eller deltoidregionen end i låret.
As with human insulins, the rate and extent of absorption of insulin detemir may be higher when administered s. c. in the abdomen or deltoid than in the thigh.
Injektionsstedet bør varieres inden for samme område.
Injection sites should therefore be alternated within the same region.
Følg instruktioner for brug og håndtering i den medfølgende indlægsseddel til Levemir Penfill.
Levemir Penfill is accompanied by a package leaflet with detailed instruction for use to be followed.
Levemir Penfill er beregnet til anvendelse sammen med Novo Nordisk insulindispenseringssystemer og NovoFine nåle.
Levemir Penfill is designed to be used with Novo Nordisk delivery systems and NovoFine needles.
Overfølsomhed over for insulin detemir eller over for et eller flere af hjælpestofferne.
Hypersensitivity to insulin detemir or to any of the excipients.
Utilstrækkelig dosering eller afbrydelse af behandlingen, specielt hos type 1 diabetikere, kan føre til hyperglykæmi og diabetisk ketoacidose.
Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis.
De første symptomer på hyperglykæmi kommer normalt gradvist over en periode på timer eller dage.
Usually the first symptoms of hyperglycaemia develop gradually over a period of hours or days.
4. 8 og 4. 9).
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see section 4.8 and 4.9).
Patienter, hvis blodglukosekontrol er væsentligt forbedret, f. eks. ved intensiveret insulinbehandling, kan opleve ændringer i deres sædvanlige advarselssymptomer på hypoglykæmi og bør orienteres herom.
3 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.
3 Anden sygdom, især infektioner og tilstande med feber, vil normalt øge patientens insulinbehov.
Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
Ændringer i styrke, mærke (fremstiller), type, oprindelse (animalsk insulin, humant insulin, human insulinanalog) og/ eller fremstillingsmetode (rekombinant DNA i modsætning til insulin af animalsk oprindelse) kan medføre et behov for ændring af dosis.
Changes in strength, brand (manufacturer), type, origin (animal, human, human insulin analogue) and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dosage.
Patienter, der skifter til Levemir, skal muligvis have ændret dosis i forhold til dosis af de sædvanlige insulinpræparater.
Patients taking Levemir may require a change in dosage from that used with their usual insulin.
Som ved anden insulinbehandling kan der opstå reaktioner på injektionsstedet og medføre smerte, kløe, hævelse og inflammation.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
Reaktionerne forsvinder sædvanligvis indenfor nogle få dage elleruger.
Reactions usually resolve in a few days to a few weeks.
Levemir må ikke indgives intravenøst, da dette kan medføre svær hypoglykæmi.
Levemir should not be administered intravenously as it may result in severe hypoglycaemia.
Intramuskulær indgivelse bør undgås.
Intramuscular administration should be avoided.
Hvis Levemir blandes med andre insulinpræparater, ændres det ene eller begge præparaters individuelle aktionsprofil.
If Levemir is mixed with other insulin preparations the profile of action of one or both individual components will change.
Blanding af Levemir med en hurtigtvirkende insulinanalog som insulin aspart giver en aktionsprofil med en lavere og forsinket maksimumeffekt i forhold til separate injektioner.
Mixing Levemir with a rapid acting insulin analogue like insulin aspart, results in an action profile with a lower and delayed maximum effect compared to separate injections.
Det bør derfor undgås at blande hurtigtvirkende insulin med Levemir.
Therefore, mixing of rapid acting insulin with Levemir should be avoided.
Levemir må ikke anvendes i insulininfusionspumper.
Levemir is not to be used in insulin infusion pumps.
Levemir indeholder metacresol, som kan forårsage allergiske reaktioner.
Levemir contains metacresol, which may cause allergic reactions.
Følgende lægemidler kan reducere behovet for insulin:
The following substances may reduce the insulin requirements:
Orale antidiabetika, monoaminooxidasehæmmere (MAOI), ikke- selektive betablokkere, ACE- hæmmere, salicylater og alkohol.
Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), non-selective beta- blocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates and alcohol.
Følgende lægemidler kan øge behovet for insulin:
The following substances may increase the insulin requirements:
Thiazider, glukokortikoider, thyreoideahormoner, beta- sympatomimetika, væksthormon og danazol.
Thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
Octreotid og lanreotid kan både øge og reducere insulinbehovet.
Octreotide/ lanreotide may both increase and decrease insulin requirement.
Graviditet:
4 Pregnancy:
Der er ingen klinisk erfaring med insulin detemir under graviditet.
There is no clinical experience with insulin detemir during pregnancy.
Reproduktionsstudier hos dyr har ikke vist forskelle mellem insulin detemir og humant insulin med hensyn til embryotoxicitet og teratogenicitet.
Animal reproduction studies have not revealed any differences between insulin detemir and human insulin regarding embryotoxicity and teratogenicity.
Forsigtighed tilrådes ved ordination til gravide.
Caution should be exercised when prescribing to pregnant women.
4 Intensiveret blodglukosekontrol anbefales normalt under graviditet, og hvis graviditet påtænkes.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
Efter fødslen vil insulinbehovet normalt hurtigt vende tilbage til før- graviditetsbehov.
After delivery, insulin requirements normally return rapidly to pre-pregnancy values.
Der er ingen klinisk erfaring med insulin detemir under amning.
There is no clinical experience with insulin detemir during lactation.
Forsigtighed tilrådes ved ordination til ammende kvinder.
Caution should be exercised when prescribing to lactating women.
Det kan være nødvendigt at justere insulindosis og kost under amning.
Lactating women may require adjustments in insulin dose and diet.
Patienter bør informeres om at tage forholdsregler for at undgå hypoglykæmi, når de kører bil.
Patients should be advised to take precautions to avoid hypoglycaemia while driving.
Bivirkninger observeret hos patienter, som anvender Levemir, er fortrinsvis dosisrelateret og forårsaget af insulins farmakologiske effekt.
Adverse drug reactions observed in patients using Levemir are mainly dose-dependent and due to the pharmacologic effect of insulin.
Hypoglykæmi er en almindeligt forekommende bivirkning.
Hypoglycaemia is a common undesirable effect.
Den kan opstå, hvis insulindosen er for høj i forhold til insulinbehovet.
It may occur if the insulin dose is too high in relation to the insulin requirement.
6% af de patienter, der bliver behandlet med Levemir.
From clinical investigations it is known that major hypoglycaemia, defined as requirement for third party intervention, occurs in approximately 6% of the patients treated with Levemir.
Svær hypoglykæmi kan føre til bevidstløshed og/ eller krampeanfald og kan resultere i midlertidig eller permanent hjerneskade eller død.
Severe hypoglycaemia may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
Reaktioner på injektionsstedet ses oftere under behandling med Levemir, end med human insulin.
Injection site reactions are seen more frequently during treatment with Levemir than with human insulin.
Disse reaktioner omfatter rødme, inflammation, blå mærker, hævelse eller kløe på injektionsstedet.
These reactions include redness, inflammation, bruising, swelling and itching at the injection site.
De fleste reaktioner overfor insulin på injektionsstedet er mindre og er for det meste forbigående, dvs. de forsvinder normalt ved fortsat behandling i løbet af få dage eller uger.
Most of the injection site reactions are minor and of a transitory nature, i. e. they normally disappear during continued treatment in a few days to a few weeks.
Den samlede procentdel af patienter i behandling, som ventes at opleve bivirkninger, vurderes til 12%.
The overall percentage of treated patients expected to experience adverse drug reactions is estimated to be 12%.
Hyppigheden af bivirkninger fra kliniske forsøg, som ved en samlet vurdering menes at skyldes Levemir, er angivet nedenfor.
Frequencies of adverse drug reactions from clinical trials, which by an overall judgement are considered related to Levemir are listed below.
Almindelig (> 1/ 100, < 1/ 10) Almene symptomer og reaktioner på administrationsstedet
Common (> 1/ 100, < 1/ 10)
Symptomerne på hypoglykæmi opstår normalt pludseligt.
They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness,
De kan omfatte koldsved, kold bleg hud, træthed, nervøsitet eller rysten, ængstelighed, usædvanlig træthed eller svaghed, forvirring, koncentrationsbesvær, døsighed, usædvanlig stor sult, synsændringer, hovedpine, kvalme og hjertebanken.
confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Reaktioner på injektionsstedet:
Injection site reactions:
5 Reaktioner på injektionsstedet (rødme, hævelse og kløe på injektionsstedet) kan forekomme ved insulinbehandling.
Injection site reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin.
Ikke almindelig (> 1/ 1. 000, < 1/ 100)
Uncommon (> 1/ 1,000, < 1/ 100)
Ødem:
Oedema:
I tre kliniske studier med personer, der blev behandlet med en kombination med orale antidiabetika, blev der observeret en højere frekvens (2, 2%) af allergiske reaktioner og potentielle allergiske reaktioner.
In three clinical studies with subjects treated in combination with oral antidiabetic agents a higher frequency (2.2%) of allergic reactions and potentially allergic reactions have been observed.
Ikke almindelig (> 1/ 1. 000, < 1/ 100) Øjne
Uncommon (> 1/ 1,000, < 1/ 100) Eye disorders
Allergiske reaktioner, potentielle allergiske reaktioner, nældefeber, udslæt og eksem:
Allergic reactions, potentially allergic reactions, urticaria, rash and eruptions:
Sådanne symptomer kan skyldes systemisk overfølsomhed.
Such symptoms may be due to generalised hypersensitivity.
Andre tegn på generelle overfølsomhedsreaktioner kan omfatte kløe, svedtendens, gastrointestinale gener, angioneurotisk ødem, åndedrætsbesvær, hjertebanken og fald i blodtrykket.
Other signs of generalised hypersensitivity may be itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure.
Generelle overfølsomhedsreaktioner er potentielt livstruende (anafylaktiske reaktioner).
Generalised hypersensitivity reactions are potentially life threatening (anaphylactic reactions).
Ikke almindelig (> 1/ 1. 000, < 1/ 100) Nervesystemet
Uncommon (> 1/ 1,000, < 1/ 100)
Refraktionsforstyrrelser:
Refraction disorders:
Der kan indledningsvis forekomme refraktionsanomalier under insulinbehandling.
Refraction anomalies may occur upon initiation of insulin therapy.
Diabetisk retinopati:
Diabetic retinopathy:
Blodglukosekontrol forbedret gennem lang tid nedsætter risikoen for forværring af diabetisk retinopati.
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Imidlertid kan en intensivering af insulinbehandlingen med en akut forbedring af blodglukosekontrollen være forbundet med en temporær forværring af den diabetiske retinopati.
However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Sjælden (> 1/ 10. 000, < 1/ 1. 000)
1/ 10,000, < 1/ 1,000)
Perifer neuropati:
Peripheral neuropathy:
Hurtig forbedring af blodsukkerkontrollen kan være forbundet med en tilstand som "akut smertefuld neuropati", der normalt er reversibel.
Fast improvement in blood glucose control may be associated with the condition “ acute painful neuropathy”, which is usually reversible.
4. 9 Overdosering
Overdose
Imidlertid kan hypoglykæmi udvikle sig over følgende stadier, hvis der indgives for høje doser i forhold til patientens behov:
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 • Mild hypoglykæmi som behandles med oral indtagelse af glukose eller sukkerholdige produkter.
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Det anbefales derfor, at diabetespatienten altid bærer sukkerholdige produkter på sig.
It is therefore recommended that the diabetic patient always carries sugar containing products.
• Svær hypoglykæmi, hvor patienten er blevet bevidstløs, kan behandles med glukagon (0, 5 - 1 mg) indgivet intramuskulært eller subkutant af en instrueret person, eller med glucose indgivet intravenøst af en medicinsk uddannet person.
• 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.
Glukose skal også gives intravenøst, hvis patienten ikke responderer på glukagon inden for 10- 15 minutter.
Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Lægemidler brugt mod diabetes.
Drugs used in diabetes.
Insulin detemir er en opløselig, langtidsvirkende, basal insulinanalog med forlænget virkning.
Insulin detemir is a soluble, long-acting basal insulin analogue with a prolonged duration of effect.
Tidsaktionsprofilen for insulin detemir er statistisk set væsentlig mindre variabel og derfor mere forudsigelig end for NPH- insulin ud fra den individuelle variationskoefficient (CV) for den samlede og maksimale farmakodynamiske virkning i tabel 1.
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.
Individuel variation i tidsaktionsprofilen for insulin detemir og NPH- insulin.
Within-Subject Variability of the time action profile of insulin detemir and NPH insulin
Insulin detemir NPH - Farmakodynamisk
Insulin
slutpunkt
Endpoint
CV (%)
detemir
insulin CV (%)
insulin
AUCGIR, 0- 24h * GIRmax **
AUCGIR,0-24h* GIRmax**
* Område under kurven ** Glukoseinfusionshastighed p- værdi < 0, 001 for alle sammenligninger med insulin detemir
** Glucose Infusion Rate p-value < 0.001 for all comparisons with
Den langtidsvirkende aktion af insulin detemir medieres af en kraftig association af molekylerne i insulin detemir på injektionsstedet og albuminbinding via fedtsyresidekæden.
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.
Insulin detemir fordeles langsommere til perifere væv end NPH- insulin.
Insulin detemir is distributed more slowly to peripheral target tissues compared to NPH insulin.
Disse mekanismer i kombination giver insulin detemir en mere reproducerbar absorption og aktionsprofil end NPH- insulin.
These combined mechanisms of protraction provide a more reproducible absorption and action profile of insulin detemir compared to NPH insulin.
Den blodglukosesænkende effekt af insulin detemir skyldes den faciliterede optagelse af glukose, som følge af binding til insulinreceptorer på muskel - og fedtceller samt den simultane hæmning af glukoseudskillelse fra leveren.
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.