HUMALOG MIX 25 SUSPENSION FOR INJECTION 100 IU/ML [SIN11227P]

Product Info

HUMALOG MIX 25 SUSPENSION FOR INJECTION 100 IU/ML

[SIN11227P]

4.1 Therapeutic indications

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

4.2 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
The safety and effectiveness of Humalog Mix25 in patients less than 18 years of age have not been established.

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, 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 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.

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.