HUMALOG Mix25 100 units/ml Suspension for injection in vial / cartridge / KwikPen pre-filled pen Ref.[8012] Active ingredients: Insulin lispro

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ, Utrecht, The Netherlands

Therapeutic indications

Humalog Mix25 is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.

Posology and method of administration

Posology

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.

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.

Paediatric population

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.

Method of administration

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.

KwikPen

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.

Overdose

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.

Shelf life

Before use: 3 years.

After first use/after cartridge insertion: 28 days.

Special precautions for storage

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.

Nature and contents of container

Vial

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.

Cartridge

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.

KwikPen

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.

Special precautions for disposal and other handling

Instructions for use and handling

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.

Preparing a dose

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).

  1. Wash your hands.
  2. If using a new vial, flip off the plastic protective cap, but do not remove the stopper.
  3. Draw air into the syringe equal to the prescribed Humalog Mix25 dose. Wipe the top of the vial with a swab. Put the needle through rubber top of the Humalog Mix25 vial and inject the air into the vial.
  4. Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand.
  5. Making sure the tip of the needle is in the Humalog Mix25, withdraw the correct dose into the syringe.
  6. Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Humalog Mix25 in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.
  7. Remove the needle from the vial and lay the syringe down so that the needle does not touch anything.

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.

Injecting a dose

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.

  1. Wash your hands.
  2. Choose a site for injection.
  3. Clean the skin as instructed.
  4. Stabilise the skin by spreading it or pinching up a large area. Insert the needle and inject as instructed.
  5. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
  6. Dispose of the syringe and needle safely. For an injection device use the outer needle cap, unscrew the needle and dispose of it safely.
  7. Use of the injection sites should be rotated so that the same is not used more than approximately once a month.

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

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