Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ, Utrecht, The Netherlands
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus.
The dosage should be determined by the physician, according to the requirement of the patient.
Humalog 100 units/ml Junior KwikPen is suitable for patients who may benefit from finer insulin dose adjustments.
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 (or, in the case of administration by continuous subcutaneous infusion, a Humalog 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 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 agents, on the advice of a physician.
Humalog KwikPen is available in two strengths. The Humalog 100 units/ml KwikPen (and Humalog 200 units/ml KwikPen, see separate SmPC) delivers 1-60 units in steps of 1 unit in a single injection. The Humalog 100 units/ml Junior KwikPen delivers 0.5-30 units in steps of 0.5 units 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.
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.
Humalog can be used in adolescents and children (see section 5.1).
Humalog preparations should be given by subcutaneous injection.
The KwikPen and Junior KwikPen are only suitable for subcutaneous injections. Humalog in cartridges is only suitable for subcutaneous injections from a Lilly reusable pen or compatible pump systems for continuous subcutaneous insulin infusion (CSII).
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.
For subcutaneous injection of Humalog using a continuous infusion pump, you may fill the pump reservoir from a Humalog 100 units/ml vial. Some pumps are compatible with cartridges that can be inserted intact into the pump.
Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusing insulin lispro, the pump manufacturer’s instructions should be studied to ascertain the suitability for the particular pump. Use the correct reservoir and catheter for the pump. When filling the pump reservoir avoid damaging it by using the correct needle length on the filling system. 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 consider the need to reduce or stop an 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 pump product literature. When used with an insulin infusion pump, Humalog should not be mixed with any other insulin.
If necessary, Humalog 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. Humalog 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 practise for intravenous injections, for example by an intravenous bolus or by an infusion system. Frequent monitoring of the blood glucose levels is required.
Infusion systems at concentrations from 0.1 units/ml to 1.0 units/ml insulin lispro in 0.9% sodium chloride or 5% dextrose are stable at room temperature for 48 hours. It is recommended that the system is primed before starting the infusion to the patient.
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 and Junior KwikPen: Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached.
The solution is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat the vial stoppers.
10 ml Vial: Packs of 1 or 2 or a multipack of 5 (5 packs of 1). Not all packs may be marketed
The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads, and are secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat the cartridge plungers, and/or the glass cartridges.
3 ml Cartridge: Packs of 5 or 10. Not all packs may be marketed
The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads and are 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 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.
Junior KwikPen
Type I glass cartridges, sealed with halobutyl disc seals secured with aluminium seals and bromobutyl plunger heads. Dimeticone or silicone emulsion may be used to treat the cartridge plunger. The 3 ml cartridges are sealed in a disposable pen injector, called the “Junior KwikPen”. Needles are not included.
3 ml Junior KwikPen: Packs of 1, 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 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.
Do not mix insulin in vials with insulin in cartridges. See section 6.2.
Vial:
The vial is to be used in conjunction with an appropriate syringe (100 unit markings).
i) Humalog:
ii) Mixing Humalog with longer-acting Human Insulins (see section 6.2):
Cartridge:
Humalog 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 and Junior KwikPen:
Before using the pre-filled pen the user manual included in the package leaflet must be read carefully. The pre-filled pen 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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