Posology : מינונים

4.2   Posology and method of administration
Posology

The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units.

NovoMix 50 dosing is individual and determined in accordance with the needs of the patient.
Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control.

The individual insulin requirement is usually between 0.5 and 1.0 unit/kg/day. NovoMix 50 may fully or partially meet this requirement.

In patients with type 2 diabetes, NovoMix 50 can be given as monotherapy or in combination with metformin when the blood glucose is inadequately controlled with metformin alone.

Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Special populations

In elderly patients (≥65 years old) and in patients with hepatic or renal impairment, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.

Renal or hepatic impairment may reduce the patient’s insulin requirements.

Paediatric population
The safety and efficacy of NovoMix 50 in children below 18 years of age have not been established. No data are available.

Transfer from other insulin medicinal products

Transfer to NovoMix 50 from other insulin preparations may require adjustment of dose and timing of administration. Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see section 4.4).

Method of administration

NovoMix 50 is a biphasic suspension of the insulin analogue, insulin aspart.
The suspension contains rapid-acting and intermediate-acting insulin aspart in the ratio 50/50.
NovoMix 50 is for subcutaneous administration only.

NovoMix 50 is administered subcutaneously by injection in the thigh or in the abdominal wall. If convenient, the gluteal or deltoid region may be used. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see sections 4.4 and 4.8). The influence of different injection sites on the absorption of NovoMix 50 has not been investigated. The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.

NovoMix 50 has a faster onset of action than biphasic human insulin and should generally be given immediately before a meal. When necessary, NovoMix 50 can be given soon after a meal.

For detailed user instructions, please refer to the package leaflet.

Administration with FlexPen
NovoMix 50 FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist needles. FlexPen delivers 1–60 units in increments of 1 unit. NovoMix 50 FlexPen is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used.