Inadequate dosing or discontinuation of treatment especially insulin-dependent diabetics may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.
Compared with biphasic human insulin, NovoMix 30 may have a more pronounced glucose lowering effect up to 6 hrs after injection. This may have to be compensated for by the individual patient, through adjustment of insulin dose and/or food intake.
Patients whose blood glucose control is greatly improved eg, by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly.
Tighter control of glucose levels can increase the potential for hypoglycaemic episodes and therefore require special attention during dose intensification.
NovoMix 30 should be administered in immediate relation to a meal. The rapid onset of action should therefore be considered in patients with concomitant diseases or treatment with other medicinal products where a delayed absorption of food might be expected.
Concomitant illness, especially infections, usually increases the patient's insulin requirements.
When patients are transferred between different types of insulin products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin.
Transferring a patient to a new type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type, origin (animal, human, human insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dosage. Patients taking NovoMix 30 may need a change in dosage from that used with their usual insulins. If dosage adjustment is needed, it may be done with the 1st dose or during the 1st few weeks or months.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet. Exercise taken immediately after a meal may increase the risk of hypoglycaemia.
Insulin suspensions are not to be used in insulin infusion pumps.
As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation. Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions. Reactions usually resolve in a few days to a few weeks. On rare occasions, injection site reactions may require discontinuation of NovoMix 30.
Effects on the Ability to Drive or Operate Machinery: No studies on the effects on the ability to drive and use machines have been reported.
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (eg, driving a car or operating machinery).
Patients should be advised to take precautions in order to avoid hypoglycaemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.
Use in pregnancy & lactation: There is limited clinical experience with NovoMix 30 in pregnancy.
Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity or teratogenicity.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the 1st trimester and increase subsequently during the 2nd and 3rd trimesters. After delivery, insulin requirements return rapidly to pre-pregnancy levels.
There are no restrictions on treatment with NovoMix 30 during lactation. Insulin treatment of the breastfeeding mother presents no risk to the baby. However, the NovoMix 30 dosage may need to be adjusted.
Use in children: No studies have been performed with NovoMix 30 in children <6 years.