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. Use of Admelog in an insulin infusion pump Admelog may be used for continuous subcutaneous insulin infusion (CSII) in pump systems suitable for insulin infusion.

Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusing insulin lispro, the manufacturer’s instructions should be studied to ascertain the suitability or otherwise for the particular pump.

Read and follow the instructions that accompany the infusion pump. Use the correct reservoir and catheter for the pump. The infusion set (tubing and cannula) should be changed in accordance with the instructions in the product information supplied with the infusion set.

In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or severe low blood glucose levels occur, notify your health care professional and consider the need to reduce or stop your insulin infusion.

A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels. If an interruption to insulin flow is suspected, follow the instructions in the product literature and if appropriate, notify your health care professional.

When used with an insulin infusion pump, Admelog should not be mixed with any other insulin. Intravenous administration of Admelog Admelog 100 units/ml is available in vials if administration of intravenous injection is necessary. Intravenous injection of insulin lispro should be carried out following normal clinical practice for intravenous injections, for example by an intravenous bolus or by an infusion system.

Frequent monitoring of the blood glucose levels is required. 9% sodium chloride or 5% glucose are stable at room temperature for 48 hours. It is recommended that the system is primed before starting the infusion to the patient.

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.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

Insulin requirements and dosage adjustment Insulin requirements may be increased during illness or emotional disturbances. Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet.

Exercise taken immediately after a meal may increase the risk of hypoglycaemia. A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycaemia occurs, it may occur earlier after an injection when compared with soluble human insulin.

Combination of Admelog with pioglitazone Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind, if treatment with the combination of pioglitazone and Admelog is considered.

If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued, if any deterioration in cardiac symptoms occurs. Avoidance of medication errors when using Admelog Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between Admelog and other insulin products.

When mixing insulin lispro with a longer acting insulin, the shorter-acting Admelog should be drawn into the syringe first, to prevent contamination of the vial by the longer-acting insulin. Mixing of the insulins ahead of time or just before the injection should be on advice of the physician.

However, a consistent routine must be followed. 6. Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

1. Hypoglycaemia.