Insuman Comb 25 suspension for injections 100 IU/ml. cartridge 3 ml. №5

Description

Insuman Comb Qualitative and quantitative composition
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).

Each cartridge contains 3 ml of suspension for injection, equivalent to 300 IU insulin.

One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin*.

Insuman Comb 25 is a biphasic isophane insulin suspension consisting of 25% dissolved insulin and 75% crystalline protamine insulin.

* Human insulin is produced by recombinant DNA technology in Escherichia coli.

For the full list of excipients, see section 6.1.

Insuman Comb Pharmaceutical form
Suspension for injection.

After resuspension, milky-white suspension.

Clinical particulars
Therapeutic indications
Diabetes mellitus where treatment with insulin is required.

Insuman Comb Posology and method of administration
Posology

The desired blood glucose levels, the insulin preparations to be used and the insulin dose regimen (doses and timings) must be determined individually and adjusted to suit the patient’s diet, physical activity and life-style.

Daily doses and timing of administration

There are no fixed rules for insulin dose regimen. However, the average insulin requirement is often 0.5 to 1.0 IU per kg body weight per day. The basal metabolic requirement is 40% to 60% of the total daily requirement. Insuman Comb 25 is injected subcutaneously 30 to 45 minutes before a meal.

Secondary dose adjustment

Improved metabolic control may result in increased insulin sensitivity, leading to a reduced insulin requirement. Dose adjustment may also be required, for example, if

– the patient’s weight changes,

– the patient’s life-style changes,

– other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia (see section 4.4).

Special populations

Elderly population (≧65 years old)

In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.

Renal impairment

In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.

Hepatic impairment

In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.