ADMELOG

Posology The dose should be determined by the physician, according to the requirement of the patient. Insulin lispro may be given shortly before meals. When necessary insulin lispro can be given soon after meals. Insulin lispro takes effect rapidly and has a shorter duration of activity (2 – 5 hours) given subcutaneously as compared with regular insulin.

This rapid onset of activity allows an Admelog injection (or, in the case of administration by continuous subcutaneous infusion, an Admelog bolus) to be given very close to mealtime. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual.

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 insulin lispro is dependent on dose, site of injection, blood supply, temperature, and physical activity.

Admelog can be used in conjunction with a longer-acting insulin or oral sulphonylurea medicinal products, on the advice of a physician. Special populations Renal impairment Insulin requirements may be reduced in the presence of renal impairment.

Hepatic impairment 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.

1). 2) and may, although not recommended, also be given by intramuscular injection. If necessary, Admelog 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.

Subcutaneous administration of Admelog Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen. 8). When administered subcutaneously care should be taken when injecting Admelog to ensure that a blood vessel has not been entered.

After injection, the site of injection should not be massaged. Patients must be educated to use the proper injection techniques. Insulin lispro in pre-filled pen is available in two strengths (100 units/ml and 200 units/ml). However, Admelog in pre-filled pen is available in one strength only: 100 units/ml.

Summary of the safety profile Hypoglycaemia is the most frequent adverse reaction of insulin therapy that a patient with diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. g. a patient`s level of diet and exercise.

Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000) and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. MedDRA system organ classes Common Uncommon Rare Not known Immune system disorders Local allergy X Systemic allergy X Skin and subcutaneous tissue disorders Lipodystrophy X Cutaneous amyloidosis X Description of selected adverse reactions Local allergy Local allergy in patients is common.

Redness, swelling, and itching can occur at the site of insulin injection. This condition usually resolves in a few days to a few weeks. 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.

Systemic allergy Systemic allergy, which is rare but potentially more serious, is a generalised allergy to insulin. It may cause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating.

Severe cases of generalised allergy may be life-threatening. Skin and subcutaneous tissue disorders Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. 4). Oedema Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Transferring a patient to another type or brand of insulin Transferring a patient to another type or brand of insulin should be done under strict medical supervision.

), species (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. 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.

Injection technique Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions.

A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered.

Hypoglycaemia or hyperglycaemia 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.

A few patients who have experienced hypoglycaemic reactions after transfer from animal-source insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.

Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death. The use of doses which are inadequate or discontinuation of treatment, especially in insulin-dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.

1. Hypoglycaemia.