Humalog ® (insulin lispro)

För fullständig produktresumé för Humalog® se FASS

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Humalog® 100 enheter/ml (insulin lispro): Dosering och administreringssätt

Doseringen är individuell och bestäms av läkaren

Posology

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

Junior KwikPen

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.

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

Humalog can be used in adolescents and children.

Method of administration

Subcutaneous use

Humalog preparations should be given by subcutaneous injection.

The KwikPen, Junior KwikPen and Tempo Pen 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 in order to reduce the risk of lipodystrophy and cutaneous amyloidosis.

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 KwikPens

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.

Humalog Tempo Pen

The Humalog 100 units/ml Tempo Pen 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. The Tempo Pen can be used with the optional transfer module Tempo Smart Button.

As with any insulin injection, when using the Tempo Pen, Smart Button and the mobile application, the patient should be instructed to check their blood sugar levels when considering or making decisions about another injection if they are unsure how much they have injected.

Use of Humalog in an insulin infusion pump

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.

Intravenous administration of 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.

Reference

Humalog 100 Units/ml [Summary of Product Characteristics]. Utrecht, The Netherlands: Eli Lilly Nederland B.V.

Datum fӧr senaste ӧversyn 2020 M09 21


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