natgillin/translations-raw huggingface dataset:
Ændringen betyder, at insulin lispro absorberes hurtigere af kroppen end almindeligt humant insulin og derfor kan virke hurtigere.
The change means that insulin lispro is absorbed faster by the body than human regular insulin, and can therefore act faster.
Insulin lispro fås som Liprolog i opløselig form, der virker mere eller mindre omgående efter injektion og som Liprolog Basal i ’ protamin- suspensionsformen ’, der absorberes meget langsommere og medfører en længere virkningsperiode.
Insulin lispro is available as Liprolog in the soluble form, which acts more or less immediately after injection, and as Liprolog Basal in the ‘ protamine suspension’ form, which is absorbed much more slowly so that it works for longer.
Liprolog Mix er en blanding af disse to formuleringer.
Liprolog Mix is a mixture of these two formulations.
Ved at holde bloksukkeret under kontrol mindskes sukkersygesymptomerne og - komplikationerne.
By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.
Liprolog blev først undersøgt i otte kliniske undersøgelser med 2951 patienter med diabetes type 1 eller type 2.
Liprolog was originally studied in eight clinical trials including 2,951 patients with type 1 or type 2 diabetes.
Virkningen af Liprolog blev sammenlignet med Humulin R (et opløseligt rekombinant DNA humant insulin) ved tilsætning til en eller to daglige doser langtidsvirkende insuliner.
The effectiveness of Liprolog was compared with that of Humulin R (a soluble recombinant DNA human insulin), when they were added to long-acting insulins given once or twice a day.
I undersøgelserne målte man niveauerne for glykosyleret hæmoglobin (HbA1c), der viser, hvor godt blodets glukose holdes under kontrol, og glukoseniveauerne i fastende tilstand (målt mindst otte timer efter et måltid).
The studies measured the level of a substance in the blood called ‘ glycosylated haemoglobin’ (HbA1c), which gives an indication of how well the blood glucose is controlled, and ‘ fasting’ blood glucose levels (measured at least eight hours after eating).
Der blev også gennemført undersøgelser af brugen af Liprolog hos 542 børn og unge (i alderen to til 19 år) og anvendelsen af Liprolog i kombination med sulfonylurinstoffer (lægemidler mod sukkersyge som indtages gennem munden).
Studies were also done looking at the use of Liprolog in 542 children and adolescents (aged between two and 19 years), and the use of Liprolog in combination with sulphonylureas (antidiabetic medicines taken by mouth).
Virkningen af Liprolog og Humulin R svarede til hinanden med hensyn til regulering af diabetes målt i glykosyleret hæmoglobin eller glukoseniveauer i fastende tilstand.
Liprolog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and fasting glucose levels.
Liprolog kan medføre hypoglykæmi (lavt blodsukker).
Liprolog may cause hypoglycaemia (low blood glucose).
Den fuldstændige beskrivelse af de indberettede bivirkninger ved Liprolog fremgår af indlægssedlen.
For the full description of all side effects reported with Liprolog, see the Package Leaflet.
Liprolog må ikke anvendes af personer, der kan være overfølsomme over for nogen af indholdsstofferne.
Liprolog should not be used in people who may be hypersensitive (allergic) to insulin lispro or any of the other ingredients.
Det kan også være nødvendigt at justere doseringen af Liprolog, når det gives sammen med en række andre lægemidler, der kan indvirke på blodsukkeret.
Liprolog doses might need to be adjusted when given with other medicines that may have an effect on blood glucose levels.
Liprolog Mix og Liprolog Basal må aldrig indgives i en vene.
Liprolog Mix and Liprolog Basal should never be given into a vein.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Liprolog er større end risiciene ved behandling af diabetes mellitus.
The Committee for Medicinal Products for Human Use (CHMP) decided that Liprolog’ s benefits are greater than its risks for the treatment of diabetes mellitus.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Liprolog.
The Committee recommended that Liprolog be given marketing authorisation.
Andre oplysninger om Liprolog:
Other information about Liprolog:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Liprolog til Eli Lilly Netherland B. V. den 1. august 2001.
The European Commission granted marketing authorisations valid throughout the European Union for Liprolog to Eli Lilly Nederland B V. on 1 August 2001.
Den fuldstændige EPAR for Liprolog findes her.
The full EPAR for Liprolog is available here.
EU- nummer EU/ 1/ 01/ 195/ 001
EU Number EU/ 1/ 01/ 195/ 001
Særnavn Liprolog
Invented name Liprolog
Styrke 100 E/ ml
Strength 100 U/ ml
Lægemiddelform Injektionsvæske, opløsning
Pharmaceutical Form Solution for injection
Indgivelsesvej Intravenøs anvendelse eller Subkutan anvendelse
Route of Administration Subcutaneous or intravenous use
Emballage Hætteglas
Packaging vial (glass)
Indhold (Koncentration) 10 ml (3, 5 mg/ ml)
Content 10 ml (3.5 mg/ ml)
Paknings- størrelse 1 hætteglas
Package size 1 vial
5 x 1 hætteglas
5 x (1 x 10 ml) vials
2 x 5 cylinderampuller
2 x (5 x 3 ml) cartridges
2 x 5 fyldte penne
2 x (5 x 3 ml) pre-filled pens
5 cylinderampuller
5 x cartridges
Liprolog 100 E/ ml, injektionsvæske, opløsning, i hætteglas
Liprolog 100 U/ ml, solution for injection in vial
4. 2), men kan også gives som intramuskulær injektion, hvilket dog ikke anbefales.
Liprolog preparations should be given by subcutaneous injection or by continuous subcutaneous infusion pump (see section 4.2) and may, although not recommended, also be given by intramuscular injection.
Dette kan f. eks. være for at kontrollere blodglukoseniveauet under en ketoacidose, i forbindelse med akut sygdom eller under/ efter en operation.
If necessary, Liprolog may also be administered intravenously, for example; for the control of blood glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods.
Liprolog har en hurtigt indsættende virkning og en kortere virkningsvarighed (2- 5 timer), ved subkutan injektion, end opløselig insulin.
Liprolog takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with regular insulin.
I samråd med en læge må Liprolog bruges sammen med længerevirkende human insulin eller orale sulfonylurinstoffer.
2 Liprolog can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.
2 Brug af Liprolog i en insulin infusionspumpe Kun visse CE- mærkede insulininfusionspumper kan anvendes til infusion af insulin lispro.
Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro.
Overfølsomhed over for insulin lispro eller over for et eller flere af hjælpestofferne.
Hypersensitivity to insulin lispro or to any of the excipients.
De patienter, som anvender hurtigt virkende insulin samtidigt med middellangt virkende insulin, skal optimere dosis af begge typer insulin for at opnå glucosekontrol over hele døgnet, specielt natlig og fastende glucosekontrol.
For fast-acting insulins, any patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across the whole day, particularly nocturnal/ fasting glucose control.
Tilstande, der kan medføre, at de tidlige advarselssymptomer på hypoglykæmi er anderledes eller mindre udtalte, omfatter langvarig diabetes, intensiveret insulinterapi, diabetisk nervesygdom eller behandling med lægemidler såsom beta- blokkere.
Conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease or medications such as beta-blockers.
Insulinbehovet kan være reduceret ved nyrefunktionsnedsættelse.
3 Insulin requirements may be reduced in the presence of renal impairment.
Insulinbehovet kan være reduceret hos patienter med nedsat leverfunktion på grund af reduceret glukoneogenesekapacitet og reduceret
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements.
Insulinbehovet kan være nedsat under samtidig behandling med lægemidler med hypoglykæmisk aktivitet, f. eks. orale antidiabetika, salicylater (f. eks. acetylsalicylsyre), sulfapræparater, visse antidepressiva (monoaminooxidasehæmmere), visse angiotensin konverteringsenzym (ACE) - hæmmere (captopril, enalapril), angiotensin II- receptorblokkere, beta- blokkere, octreotid eller alkohol.
Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-blockers, octreotide or alcohol.
Lægen bør konsulteres, når der tages anden medicin samtidig med Liprolog.
The physician should be consulted when using other medications in addition to Liprolog.
Dette er af særlig betydning hos de patienter, som har nedsat eller mistet evnen til at mærke advarselstegn på hypoglykæmi, eller har hyppige tilfælde af hypoglykæmi.
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Der er ikke anført nogen specifik hyppighed for hypoglykæmi, eftersom hypoglykæmi er et resultat af både insulindosis og andre faktorer såsom patientens diæt og motionsniveau.
No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors e. g. a patient`s level of diet and exercise.
4 Lokale allergiske reaktioner er almindeligt forekommende (≥ 1/ 100 til < 1 / 10).
Local allergy in patients is common (1/ 100 to < 1/ 10).
Systemisk allergi, som er sjælden (≥1 / 10. 000 til < 1/ 1. 000), men potentielt mere alvorlig, er en generaliseret overfølsomhed over for insulin.
Systemic allergy, which is rare (1/ 10,000 to < 1/ 1,000) but potentially more serious, is a generalised allergy to insulin.
Lipodystrofi ved indstiksstedet er ikke almindeligt forekommende (≥ 1/ 1. 000 til < 1/ 100).
Lipodystrophy at the injection site is uncommon (1/ 1,000 to < 1/ 100).
Der foreligger ingen specifikke definitioner på overdosering af insulin, idet serum glukose - koncentrationen er et resultat af komplekse interaktioner mellem insulinniveau, glukosetilgængelighed og andre metaboliske processer.
Insulins have no specific overdose definitions because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes.
De patienter, som ikke responderer på glukagon, skal gives intravenøs glukose.
Patients who fail to respond to glucagon must be given glucose solution intravenously.
ATCkode:
ATC code:
15 minutter), hvorfor insulin lispro kan gives tættere på et måltid (inden for 0- 15 minutter) sammenlignet med opløselig insulin (30- 45 minutter før).
5 Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given closer to a meal (within zero to 15 minutes of the meal) when compared to regular insulin (30 to 45 minutes before).
De glukodynamiske forskelle mellem insulin lispro og opløselig human insulin, som blev målt med en glukose- clamp- procedure, blev opretholdt over varierende grader af nyrefunktionsnedsættelse.
Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a glucose clamp procedure, were maintained over a wide range of renal function.
Det er vist, at insulin lispro på molekylært niveau er lige så potent som human insulin, men dets effekt er hurtigere og af kortere varighed.
6 Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more rapid and of a shorter duration.
Undersøgelser in vitro, der inkluderer binding til insulinreceptorer og virkning på celler i vækst, har vist, at insulin lispro virker på en måde, som minder nøje om human insulin.
In in vitro tests, including binding to insulin receptor sites and effects on growing cells, insulin lispro behaved in a manner that closely resembled human insulin.
4. 2.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Opløsningen skal anvendes inden for 28 dage, efter at hætteglasset er taget i brug.
After first use of the vial, the solution should be used within 28 days when stored below 30°C.
Væsken opbevares i Type 1 flintglas hætteglas, forseglede med butyl eller halobutyl gummimem - braner og sikrede med aluminiumforseglinger.
7 The solution is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and secured with aluminium seals.
1 x 10 ml Liprolog hætteglas 2 x 10 ml Liprolog hætteglas
2 x 10 ml Liprolog vials.
7 5 x (1 x 10 ml) Liprolog hætteglas
5 x (1 x 10 ml) Liprolog vials.
Kontroller Liprolog- opløsningen.
Inspect the Liprolog solution.
Sug en mængde luft svarende til den ordinerede Liprolog- dosis op i sprøjten.
Draw air into the syringe equal to the prescribed Liprolog dose.
Stik nålen igennem gummimembranen på Liprolog - hætteglasset og sprøjt luften ind i hætteglasset.
Put the needle through the rubber top of the Liprolog vial and inject the air into the vial.
Vær sikker på, at spidsen af nålen befinder sig i Liprolog- opløsningen og træk den korrekte dosis op i sprøjten.
Making sure the tip of the needle is in the Liprolog, withdraw the correct dose into the syringe.
Før nålen fjernes fra hætteglasset, undersøges sprøjten for luftbobler, da disse nedsætter mængden af Liprolog- opløsning.
Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Liprolog in it.
ii) Blanding af Liprolog med længerevirkende human insulin (se punkt 6. 2)
ii) Mixing Liprolog with longer-acting Human Insulins (see section 6.2)
Sprøjt nu luft ind i Liprolog- hætteglasset på samme måde som tidligere omtalt, men træk ikke nålen ud bagefter.
Now inject air into the Liprolog vial in the same manner, but do not withdraw the needle.
Vær sikker på, at spidsen af nålen befinder sig i Liprolog- opløsningen, og træk den korrekte dosis Liprolog op i sprøjten.
Making sure the tip of the needle is in the Liprolog, withdraw the correct dose of Liprolog into the syringe.
Før nålen fjernes fra hætteglasset undersøges sprøjten for luftbobler, da disse nedsætter mængden af Liprolog- opløsningen.
Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Liprolog in it.
1 x 10 ml Liprolog hætteglas 2 x 10 ml Liprolog hætteglas 5 x (1 x 10 ml) Liprolog hætteglas
1 x 10 ml Liprolog vial 2 x 10 ml Liprolog vials 5 x (1 x 10 ml) Liprolog vials
1. august 2001 Dato for sidste fornyelse af markedsføringstilladelse:
1st August 2001 Date of last renewal:
1. august 2006
1st August 2006
Liprolog 100 E/ ml, injektionsvæske, opløsning, i cylinderampuller
Liprolog 100 U/ ml, solution for injection in cartridge
4. 2) men kan også gives som intramuskulær injektion, hvilket dog ikke anbefales.
Liprolog preparations should be given by subcutaneous injection or by continuous subcutaneous infusion pump (see section 4.2) and may, although not recommended, also be given by intramuscular injection.
Som med alle insulinpræparater afhænger virkningsvarigheden af Liprolog af dosis, indstikssted, blodtilførsel, temperatur og fysisk aktivitet.
The faster onset of action compared to soluble human insulin is maintained regardless of injection site As with all insulin preparations, the duration of action of Liprolog is dependent on dose, site of injection, blood supply, temperature, and physical activity.
I samråd med en læge må Liprolog bruges sammen med længerevirkende human insulin eller orale sulfonylurinstoffer.
11 Liprolog can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.
10 Brug af Liprolog i en insulin infusionspumpe Kun visse CE- mærkede insulininfusionspumper kan anvendes til infusion af insulin lispro.
Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro.
Hos patienter med kronisk leverfunktionsnedsættelse kan øget insulinresistens imidlertid medføre et øget insulinbehov.
12 Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements.
11 Justering af insulindosis kan også være nødvendig, hvis patienterne øger den daglige fysiske aktivitet eller ved kostændringer.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.
4. 8 Bivirkninger
13 4.8 Undesirable effects
Lokale allergiske reaktioner er almindeligt forekommende (≥ 1/ 100 til < 1/ 10).
Local allergy in patients is common (1/ 100 to < 1/ 10).
I
This condition usually resolves in a few days to a few weeks.
12 nogle tilfælde kan disse reaktioner relateres til andre faktorer end insulinet, såsom overfølsomhed ved rensning af huden eller dårlig injektionsteknik.
In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.
Systemisk allergi, som er sjælden (≥ 1/ 10. 000 til < 1/ 1. 000), men potentielt mere alvorlig, er en generaliseret overfølsomhed over for insulin.
Systemic allergy, which is rare (1/ 10,000 to < 1/ 1,000) but potentially more serious, is a generalised allergy to insulin.
15 minutter), hvorfor insulin lispro kan gives tættere på et måltid (inden for 0- 15 minutter) sammenlignet med opløselig insulin (30- 45 minutter før).
14 Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given closer to a meal (within zero to 15 minutes of the meal) when compared to regular insulin (30 to 45 minutes before).
Det glukodynamiske respons på insulin lispro påvirkes ikke af nedsat nyre - eller leverfunktion.
15 The glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment.
Opløsningen skal anvendes inden for 28 dage, efter at cylinderampullen er monteret i en pen.
After insertion of the cartridge in a pen, the solution should be used in 28 days when stored below 30°C.
Opbevares i køleskab (2°C – 8°C).
16 Store in a refrigerator (2°C - 8°C).
5 x 3 ml Liprolog cylinderampuller til brug i en 3 ml pen 2 x (5 x 3 ml) Liprolog cylinderampuller til brug i en 3 ml pen
5 x 3 ml Liprolog cartridges for a 3 ml pen 2 x (5 x 3 ml) Liprolog cartridges for a 3 ml pen
15 Instruktioner vedrørende anvendelse og håndtering Liprolog cylinderampuller er beregnet til at blive brugt sammen med en CE mærket pen, som anbefalet i brugsanvisningen fra fremstilleren af pennen.
Instructions for use and handling Liprolog cartridges are to be used with a CE marked pen as recommended in the information provided by the device manufacturer.
Liprolog Mix25 100 E/ ml injektionsvæske, suspension i cylinderampul.
Liprolog Mix25 100 U/ ml suspension for injection in cartridge
Liprolog Mix25 er indiceret til behandling af patienter med diabetes mellitus, der kræver insulin til opretholdelse af normal glukose homøostase.
Liprolog Mix25 is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
Virkningsvarigheden af insulin lispro protaminsuspension (BASAL) - delen af Liprolog Mix25 svarer til virkningsvarigheden af basal insulin (isophan).
The duration of action of the insulin lispro protamine suspension (Basal) component of Liprolog Mix25 is similar to that of a basal insulin NPH.
18 4. 3 Kontraindikationer
4.3 Contraindications
Overfølsomhed over for insulin lispro eller over for et eller flere af hjælpestofferne.
19 Hypersensitivity to insulin lispro or to any of the excipients.
Insulinbehovet kan være nedsat under samtidig behandling med lægemidler med hypoglykæmisk aktivitet, f. eks. orale antidiabetika, salicylater (f. eks. acetylsalicylsyre), sulfapræparater, visse antidepressiva (monoaminooxidasehæmmere), visse angiotensin konverteringsenzym (ACE) - hæmmere (captopril, enalapril), angiotensin II- receptorblokkere, beta- blokkere, octreotid eller alkohol.
Insulin requirements may be reduced in the presence of substances with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-blockers, octreotide or alcohol.
Lægen bør konsulteres, når der tages anden medicin samtidig med Liprolog Mix25.
The physician should be consulted when using other medications in addition to Liprolog Mix25.
19 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Data fra et stort antal eksponerede graviditeter indikerer ingen bivirkninger af insulin lispro på graviditeten eller på fosterets/ spædbarnets helbred.
20 Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/ newborn.
20 Hvis patienten er bevidstløs, bør glukagon gives intramuskulært eller subkutant.
21 If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.
ATCkode:
ATC Code:
15 minutter), hvorfor insulin lispro kan gives tættere på et måltid (inden for 0- 15 minutter) sammenlignet med opløselig insulin (30- 45 minutter før).
Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given closer to a meal (within zero to 15 minutes of the meal) when compared to regular insulin (30 to 45 minutes before).
15 timer.
Liprolog Basal has an activity profile that is very similar to that of a basal insulin (NPH) over a period of approximately 15 hours.
Kliniske forsøg med type 1 - og type 2- diabetikere har vist nedsat postprandial hyperglykæmi med Liprolog Mix25 sammenlignet med human insulin blanding 30/ 70.
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial hyperglycaemia with Liprolog Mix25 compared to human insulin mixture 30/ 70.
Farmakodynamikken for Liprolog Mix25 og Liprolog BASAL illustreres nedenfor.
In the figure below the pharmacodynamics of Liprolog Mix25 and Liprolog Basal are illustrated.
Hypoglykæmisk aktivitet
Hypoglycaemic activity Liprolog Mix25 Liprolog Basal
21 De ovenfor anførte kurver illustrerer den relative mængde glukose, som over tid er nødvendig for at opretholde blodglukose- koncentrationer nær fasteniveau, og viser samtidig den tidsrelaterede effekt af disse insuliner på glukosemetabolismen.
22 The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.
Patienterne var enten nye i insulinbehandling eller brugte i forvejen en eller to insulininjektioner dagligt.
In two 8-month open label crossover studies, type 2 diabetes patients who were either new to insulin therapy or already using one or two injections of insulin, received 4 months of treatment with Liprolog Mix25 (used twice daily with metformin) and insulin glargine (used once daily with metformin) in a randomised sequence.
Gennemsnitlig total daglig insulin dosis ved endpoint
Mean total daily insulin dose at endpoint 1
1, 30% (gns. ved baseline = 8, 7%)
(mean at baseline = 8.7%)
1, 00% (gns. ved baseline = 8, 5%)
(mean at baseline = 8.5%)