HUMALOG KWIKPEN 100 UNITS/ML [SIN13719P]

Product Info

HUMALOG KWIKPEN 100 UNITS/ML

[SIN13719P]

4.1 Therapeutic indications
KwikPen
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.

4.2 Posology and method of administration
Posology
The dose 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 (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 (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
Subcutaneous use
Humalog preparations should be given by subcutaneous injection.
The KwikPen are only suitable for subcutaneous injections.

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 (see section 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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
The Humalog 100 units/ml KwikPen 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.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Hypoglycaemia.