Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ, Utrecht, The Netherlands
Humalog Mix25 is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
The dosage should be determined by the physician, according to the requirement of the patient.
Humalog Mix25 may be given shortly before meals. When necessary, Humalog Mix25 can be given soon after meals. Humalog Mix25 should only be given by subcutaneous injection. Under no circumstances should Humalog Mix25 be given intravenously.
The rapid onset and early peak of activity of Humalog itself is observed following the subcutaneous administration of Humalog Mix25. This allows Humalog Mix25 to be given very close to mealtime. The duration of action of the insulin lispro protamine suspension component of Humalog Mix25 is similar to that of a basal insulin (NPH).
The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. As with all insulin preparations, the duration of action of Humalog Mix25 is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Insulin requirements may be reduced in the presence of renal 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.
Administration of Humalog Mix25 to children below 12 years of age should be considered only in case of an expected benefit when compared to soluble insulin.
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 Mix25 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.
The KwikPen delivers 1-60 units in steps of 1 unit in a single injection. The needed dose is dialled in units. The number of units is shown in the dose window of the pen.
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/after cartridge insertion: 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/after cartridge insertion:
Vial: Store in a refrigerator (2°C-8°C) or below 30°C.
Cartridge: Store below 30°C. Do not refrigerate. The pen with the inserted cartridge should not be stored with the needle attached.
KwikPen: Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached.
The suspension is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and secured with aluminium seals. Dimeticone or silicone emulsion may have been used to treat the vial stoppers.
10 ml Vial: Pack of 1. Not all packs may be marketed.
The suspension is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads and secured with aluminium seals. Dimeticone or silicone emulsion may have been used to treat the cartridge plunger, and/or the glass cartridge.
3 ml Cartridge: Packs of 5 or 10. Not all packs may be marketed.
The suspension is contained in type I flint glass cartridges, sealed with halobutyl disc seals and plunger heads and secured with aluminium seals. Dimeticone or silicone emulsion may have been used to treat the cartridge plunger, and/or the glass cartridge. The 3 ml cartridges are sealed in a disposable pen injector, called the “KwikPen”. Needles are not included.
3 ml KwikPen: Packs of 5 or a multipack of 10 (2 packs of 5). Not all packs may be marketed.
To prevent the possible transmission of disease, each cartridge or pen must be used by one patient only, even if the needle on the delivery device is changed. Patients using vials must never share needles or syringes. The patient should discard the needle after every injection.
The Humalog Mix25 should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the container, giving it a frosted appearance.
Vials containing Humalog Mix25 should be rotated in the palms of the hands before use to resuspend the insulin until it appears uniformly cloudy or milky. Cartridges and KwikPens containing Humalog Mix25 should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky.
If not, repeat the above procedure until contents are mixed. Cartridges contain a small glass bead to assist mixing.
Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose.
Vial:
The vial is to be used in conjunction with an appropriate syringe (100 unit markings).
Cartridge:
Humalog Mix25 cartridges are to be used with a Lilly reusable insulin pen and should not be used with any other reusable pen as the dosing accuracy has not been established with other pens.
The instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.
KwikPen:
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.
If using a pre-filled or reusable pen refer to the detailed instructions for preparing the pen and injecting
the dose, the following is a general description.
Any unused product or waste material should be disposed of in accordance with local requirements.
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