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® 30 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.

In patients with type 2 diabetes, NovoMix 30 can be given as monotherapy. NovoMix 30 can also be given in combination with oral antidiabetic medicinal products if the patient's blood glucose is inadequately controlled with oral antidiabetic medicinal products alone. For patients with type 2 diabetes, the recommended starting dose of NovoMix 30 is 6 units at breakfast and 6 units at dinner (evening meal). NovoMix 30 can also be initiated once daily with 12 units at dinner (evening meal).
When using NovoMix 30 once daily, it is generally recommended to move to twice daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses. If twice daily dosing with NovoMix® 30 results in recurrent daytime hypoglycaemic episodes, the morning dose can be split into morning and lunchtime doses (thrice daily dosing).

The following titration guideline is recommended for dose adjustments: 
Pre-meal blood glucose level              NovoMix 30 dose adjustment
<4.4 mmol/l           <80 mg/dl                  -2 units
4.4–6.1 mmol/l       80–110 mg/dl                    0
6.2–7.8 mmol/l       111–140 mg/dl                +2 units
7.9–10 mmol/l        141–180 mg/dl                +4 units
>10 mmol/l             >180 mg/dl                  +6 units

The lowest of the three previous days’ pre-meal blood glucose levels should be used. The dose should not be increased if hypoglycaemia occurred within these days. Dose adjustments can be made once a week until target HbA1c is reached. Pre-meal blood glucose levels should be used to evaluate the adequacy of the preceding dose.

In patients with type 1 diabetes, the individual insulin requirement is usually between 0.5 and 1.0 unit/kg/day. NovoMix 30 may fully or partially meet this requirement.

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

Special populations

Elderly (≥65 years old)
NovoMix 30 can be used in elderly patients; however there is limited experience with the use of NovoMix 30 in combination with oral antidiabetic medicinal products in patients older than 75 years.
In elderly patients, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.

Renal and hepatic impairment
Renal or hepatic impairment may reduce the patient’s insulin requirements.
In patients with renal or hepatic impairment, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.

Paediatric population
NovoMix 30 can be used in adolescents and children aged 10 years and above when premixed insulin is preferred. There is limited clinical experience with NovoMix 30 in children aged 6–9 years (see section 5.1).
No data are available for NovoMix 30 in children below 6 years of age.

Transfer from other insulin medicinal products

When transferring a patient from biphasic human insulin to NovoMix 30, start with the same dose and regimen. Then titrate according to individual needs (see the titration guideline in the table above).
Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see section 4.4).

Method of administration

NovoMix 30 is a biphasic suspension of the insulin analogue, insulin aspart. The suspension contains rapid-acting and intermediate-acting insulin aspart in the ratio 30/70.

NovoMix 30 is for subcutaneous administration only.

NovoMix 30 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 30 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 30 has a faster onset of action than biphasic human insulin and should generally be given immediately before a meal. When necessary, NovoMix 30 can be given soon after a meal.

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

Administration with FlexPen
NovoMix 30 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 30 FlexPen is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used.