Liprolog - insulin lispro
PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is Liprolog?
Liprolog includes a number of injectable solutions and suspensions. It is supplied in ampoules, cartridges or pre-filled pens (Liprolog Pen and Liprolog KwikPen). The medicine contains insulin lispro as the active ingredient. The Liprolog range includes fast-acting insulin solutions (Liprolog), long-acting insulin suspensions (Liprolog Basal) and combinations of both in different strengths (Liprolog Mix):
- Liprolog: lispro insulin solution;
- Liprolog Basal: suspension of insulin lispro protamine;
- Liprolog Mix25: 25% lispro insulin solution and 75% lispro protamine insulin suspension;
- Liprolog Mix50: 50% insulin lispro solution and 50% insulin lispro protamine suspension.
What is Liprolog used for?
Liprolog is used to treat diabetic patients (adults and children) who need insulin to control their blood glucose (sugar) level, including patients who have recently been diagnosed with diabetes.
The medicine can only be obtained with a prescription.
How is Liprolog used?
Liprolog, Liprolog Basal and Liprolog Mix can be administered by subcutaneous injection in the upper arm, thigh, buttocks or abdomen. Liprolog can also be administered by continuous infusion via an insulin pump or intravenously.
Liprolog and Liprolog Mix are usually given shortly before meals, but they can also be given immediately after a meal if needed. Liprolog can be used with long-acting insulin or sulphonylureas (oral diabetes medicines).
Liprolog Basal can be taken alone or in combination with oral medications. If intensive insulin therapy is required, Liprolog Basal can be taken in the morning or evening, together with fast-acting insulin at mealtimes.
How does Liprolog work?
Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood or in which the body is unable to effectively use the insulin it produces. Liprolog is a "replacement insulin very similar to" insulin produced by the pancreas.
The active substance in Liprolog, insulin lispro, is produced by a so-called 'recombinant DNA' technology. This technique uses a bacterium into which a gene (DNA) is inserted which makes it capable of producing insulin lispro. Insulin lispro differs slightly from the insulin produced by the human body; the difference is that insulin lispro is absorbed more quickly by the body than normal human insulin and therefore acts faster. Insulin lispro it is available as Liprolog, in a soluble form, but which acts more or less immediately after injection, and as Liprolog Basal in the form of a "protamine suspension", which is absorbed much more slowly in order to act longer. Liprolog Mix contains a mixture of these two formulations.
Replacement insulin acts like naturally produced insulin and helps glucose enter cells from the blood. By controlling the blood glucose level, the symptoms and complications of diabetes are reduced.
How has Liprolog been studied?
Liprolog was initially the subject of eight clinical studies involving 2 951 patients with type 1 or type 2 diabetes. The efficacy of Liprolog was compared to that of Humulin R (human insulin in soluble form from recombinant DNA) when added to one or two daily doses of long-acting insulins. The studies measured the level in the blood of a substance, glycosylated hemoglobin (HbA1c), which provides an indication of how well the blood glucose and levels are controlled. blood glucose fasting (measured no less than eight hours after the last meal). Studies were also initiated which aimed to evaluate the use of Liprolog in 542 children and adolescents (aged 2 to 19 years) as well as "use of Liprolog in combination with sulphonylureas (oral diabetes medicines).
What benefit has Liprolog shown during the studies?
Based on HbA1c and fasting glucose levels, no significant differences were found between Liprolog and Humulin R in controlling diabetes.
What is the risk associated with Liprolog?
Liprolog can cause hypoglycaemia (low blood glucose level). For the full list of side effects reported with Liprolog, see the package leaflet.
Liprolog should not be used in patients who may be hypersensitive (allergic) to insulin lispro or any of the other ingredients. The doses of Liprolog may need to be changed when given with other medicines which may have an effect on blood glucose levels. the complete list of these medicines, please refer to the package leaflet. In no case Liprolog Mix and Liproglog Basal can be administered intravenously.
Why has Liprolog been approved?
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 and therefore recommended that it be given marketing authorization.
Other information about Liprolog:
On 1 August 2001, the European Commission issued Eli Lilly Nederland B.V. a "Marketing Authorization" for Liprolog, valid throughout the European Union. On 1 August 2006, the "Marketing Authorization" was renewed.
For the full version of Liprolog's EPAR, click here.
Last update of this summary: 06-2008
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