Novomix 30

/ Novo Nordisk

The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units. This product 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, this product can be given as monotherapy. This product 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 is 6 units at breakfast and 6 units at dinner (evening meal). This product can also be initiated once daily with 12 units at dinner (evening meal). When using this product 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 results in recurrent daytime hypoglycaemic episodes, the morning dose can be split into morning and lunchtime doses (thrice daily dosing). For titration guideline see prescribing information for full details.
Special populations
Older people (≥ 65 years old): This product can be used in older patients; however there is limited experience with the use in combination with oral antidiabetic medicinal products in patients older than 75 years. In older 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: This product can be used in adolescents and children aged 10 years and above when premixed insulin is preferred. There is limited clinical experience in children aged 6–9 years. No data are available in children below 6 years of age.
Transfer from other insulin medicinal products: When transferring a patient from biphasic human insulin, start with the same dose and regimen. Then titrate according to individual needs. Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter.
Method of administration: See prescribing information for full details.

Treatment of diabetes mellitus.

Hypersensitivity to the active substance or to any of the excipients.

This product must not be administered intravenously, as it may result in severe hypoglycaemia. Intramuscular administration should be avoided. This product is not to be used in insulin infusion pumps. Before travelling between different time zones, the patient should seek the doctor’s advice since this may mean that the patient has to take the insulin and meals at different times.
Hyperglycaemia: Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis. Usually, the first symptoms of hyperglycaemia develop gradually over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath. In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
Hypoglycaemia: Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. In case of hypoglycaemia or if hypoglycaemia is suspected, this product must not be injected. After stabilisation of the patient’s blood glucose, adjustment of the dose should be considered. Compared with biphasic human insulin, this product may have a more pronounced glucose lowering effect up to 6 hours after injection. This may have to be compensated for in the individual patient through adjustment of insulin dose and/or food intake. Patients whose blood glucose control is greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes. Tighter control of glucose levels can increase the potential for hypoglycaemic episodes and therefore require special attention during dose intensification. Since this product should be administered in immediate relation to a meal, the rapid onset of action should be considered in patients with concomitant diseases or treatment where a delayed absorption of food might be expected. Concomitant illness, especially infections and feverish conditions, usually increases the patient’s insulin requirements. Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in the insulin dose. When patients are transferred between different types of insulin medicinal products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin.
Transfer from other insulin medicinal products: Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type, origin (animal insulin, human insulin or insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dose. Patients transferred to this product from another type of insulin may require an increased number of daily injections or a change in dose from that used with their usual insulin medicinal products. If an adjustment is needed, it may occur with the first dose or during the first few weeks or months.
Injection site reactions: As with any insulin therapy, injection site reactions may occur and include pain, redness, hives, inflammation, bruising, swelling and itching. Continuous rotation of the injection site within a given area reduces the risk of developing these reactions. Reactions usually resolve in a few days to a few weeks. On rare occasions, injection site reactions may require discontinuation of this product.
Combination of thisproduct with pioglitazone: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and this product is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Insulin antibodies: Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.

Adverse reactions observed in patients using this product are mainly due to the pharmacological effect of insulin aspart. The most frequently reported adverse reaction during treatment is hypoglycaemia. The frequencies of hypoglycaemia vary with patient population, dose regimens and level of glycaemic control, please see section c in prescribing information for full details. At the beginning of the insulin treatment, refraction anomalies, oedema and injection site reactions (pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur. These reactions are usually of transitory nature. Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible. Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
See prescribing information for full details.

A number of medicinal products are known to interact with the glucose metabolism.
The following substances may reduce the patient’s insulin requirements: Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides. The following substances may increase the patient’s insulin requirements: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol. Beta-blockers may mask the symptoms of hypoglycaemia. Octreotide/lanreotide may either increase or decrease the insulin requirement. Alcohol may intensify or reduce the hypoglycaemic effect of insulin.

Pregnancy: There is limited clinical experience with this product in pregnancy. 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 first trimester and increase subsequently during the second and third trimesters. After delivery, insulin requirements return rapidly to pre-pregnancy levels.
See prescribing information for full details.
Lactation: There are no restrictions on treatment with this product during breast-feeding. Insulin treatment of the nursing mother presents no risk to the baby. However, the dose may need to be adjusted.              

A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’s requirement are administered: Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products. It is therefore recommended that the diabetic patient always carries sugar-containing products. Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional. Glucose must be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.

Patients should be advised to take precautions to avoid hypoglycaemia while driving or operating a machine. 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 or operating a machine should be considered in these circumstances. In absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Before opening: Store in a refrigerator (2°C – 8°C). Keep away from the cooling element. Do not freeze.
During use or when carried as a spare: Store below 30°C. Do not refrigerate. Do not freeze.
See prescribing information for full details.