HUMALOG 200 units/ml Solution for injection KwikPen pre-filled pen Ref.[8014] Active ingredients: Insulin lispro

Posology

The dosage should be determined by the physician, according to the requirement of the patient.

Humalog may be given shortly before meals. When necessary Humalog can be given soon after meals.

Humalog takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with soluble insulin. This rapid onset of activity allows a Humalog injection 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. The duration of action of Humalog is dependent on dose, site of injection, blood supply, temperature, and physical activity.

Humalog can be used in conjunction with a longer-acting insulin or oral sulphonylurea medicinal products, on the advice of a physician.

Humalog KwikPens

Humalog KwikPen is available in two strengths.The Humalog 200 units/ml KwikPen (and Humalog 100 units/ml KwikPen, see separate SmPC) delivers 1-60 units in steps of 1 unit in a single injection. The number of insulin units is shown in the dose window of the pen regardless of strength and no dose conversion should be done when transferring a patient to a new strength or to a pen with a different dose step.

Humalog 200 units/ml KwikPen should be reserved for the treatment of patients with diabetes requiring daily doses of more than 20 units of rapid-acting insulin. The insulin lispro solution containing 200 units/ml should not be withdrawn from the pre-filled pen (the KwikPen) or mixed with any other insulin (see section 4.4 and section 6.2).

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.

Method of administration

Humalog solution for injection should be given subcutaneously.

Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen. Use of injection sites should be rotated so that the same site is not used more than approximately once a month.

When administered subcutaneously care should be taken when injecting Humalog 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.

Humalog 200 units/ml KwikPen solution for injection should not be used in an insulin infusion pump. Humalog 200 units/ml KwikPen solution for injection should not be used intravenously.

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. Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure.

Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.

Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or saccharated products.

Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently. Patients who fail to respond to glucagon must be given glucose solution intravenously.

If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously. However, glucose solution must be given intravenously if glucagon is not available or if the patient fails to respond to glucagon. The patient should be given a meal as soon as consciousness is recovered.

Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.

Before use: 3 years.

After first use: 28 days.

Do not freeze. Do not expose to excessive heat or direct sunlight.

Before use: Store in a refrigerator (2°C-8°C).

After first use: Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached.

Type I glass cartridges, sealed with halobutyl disc seals and plunger heads and secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat the cartridge plunger, and/or the glass cartridge. The 3 ml cartridges which contain 600 units insulin lispro (200 units/ml), are sealed in a disposable pen injector, called the “KwikPen”. Needles are not included.

1 pre-filled pen of 3 ml.
2 pre-filled pens of 3 ml.
5 pre-filled pens of 3 ml.
Multipacks containing 10 (2 packs of 5) pre-filled pens of 3 ml.

Not all packs may be marketed.

Instructions for use and handling

To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed. The patient should discard the needle after every injection.

The Humalog solution should be clear and colourless. Humalog should not be used if it appears cloudy, thickened, or slightly coloured or if solid particles are visible.

Handling of the pre-filled pen

Before using the KwikPen the user manual included in the package leaflet must be read carefully. The KwikPen has to be used as recommended in the user manual.

Pens should not be used if any part looks broken or damaged.

Any unused product or waste material should be disposed of in accordance with local requirements.