⚠️ Warnings
Patients should consult their physician before travelling between time zones, as this may mean that the patient will need to use insulin and take meals at different times.
Hyperglycaemia
Inadequate dosing or discontinuation of treatment, particularly in type 1 diabetics, may lead to hyperglycaemia and diabetic ketoacidosis. The first symptoms of hyperglycaemia usually develop gradually over a period of hours or days. These symptoms include thirst, frequent urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite, and acetone odour on the breath. Untreated hyperglycaemia in type 1 diabetics can eventually lead to diabetic ketoacidosis, which is potentially fatal.
Hypoglycaemia
Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia.
Hypoglycaemia may occur if the insulin dose is too high relative to the insulin requirement. In the event of hypoglycaemia or suspected hypoglycaemia, Actrapid must not be administered. After the patient's blood glucose has been stabilised, dose adjustment must be considered (see sections 4.8 and 4.9).
Patients whose blood glucose control has been greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and must be advised accordingly. Usual warning symptoms may disappear in patients with long-standing diabetes.
Concomitant illness, particularly infections and febrile conditions, usually increases the patient's insulin requirement. Concomitant diseases of the kidneys, liver, or diseases affecting the adrenal glands, pituitary gland, or thyroid gland may require changes in the insulin dose.
When a patient is transferred to another type of insulin product, the early warning symptoms of hypoglycaemia may change or be attenuated compared with those experienced with the previous insulin.
Switching from other insulin medicinal products
Transfer of patients to another type of insulin must be carried out 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 production versus animal-sourced insulin) may result in the need for a change in dose. Patients being transferred to Actrapid from another type of insulin may require an increased number of daily injections or a change in dose compared with those used with their previous insulin products. If dose adjustment is necessary, it may be made with the first dose or during the first few weeks or months.
Injection site reactions
As with all insulin therapy, injection site reactions may occur, manifesting as pain, redness, urticaria, inflammation, bruising, swelling, and itching. Regular rotation of the injection site within the same area reduces the risk of these reactions. Reactions usually resolve within a few days to a few weeks. In rare cases, injection site reactions may require discontinuation of Actrapid.
Skin and subcutaneous tissue disorders
Patients must be instructed to continuously rotate the injection site to reduce the risk of lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following injection of insulin into sites with these reactions. Cases have been reported where a sudden change of injection site to an unaffected area resulted in hypoglycaemia. After changing the injection site from an affected to an unaffected area, blood glucose monitoring is recommended, and dose adjustment of antidiabetic medicinal products may be considered.
Combination of Actrapid with pioglitazone
When pioglitazone was used in combination with insulin, cases of cardiac failure were reported, particularly in patients with risk factors for the development of cardiac failure. This must be taken into account if combination treatment with pioglitazone and Actrapid is considered. If this combination is used, patients must be monitored for signs and symptoms of cardiac failure, weight gain, and oedema. Pioglitazone must be discontinued if any deterioration in cardiac symptoms occurs.
Prevention of accidental mix-ups/medication errors
Patients must be instructed to check the insulin label before each injection to avoid accidental mix-ups between Actrapid and other insulin products.
Traceability
To improve the traceability of biological medicinal products, the name of the administered product and the batch number should be clearly recorded.
