⚠️ Warnings
Before travelling across time zones, the patient should consult their physician. Travelling across different time zones may mean that the patient will need to use insulin and take meals at different times.
Hyperglycaemia
Inadequate dosing or discontinuation of treatment, especially 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. They include thirst, frequent urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite, and acetone odour on the breath. In type 1 diabetes, untreated hyperglycaemic events may lead to diabetic ketoacidosis, which can be 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 in relation to the insulin requirement. In the event of hypoglycaemia or suspected hypoglycaemia, Actraphane must not be administered. After the patient's blood glucose level has been stabilised, dose adjustment must be considered (see sections 4.8 and 4.9).
Patients whose glycaemic control is markedly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia. Patients should be informed accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes.
Concomitant illness, particularly infections and febrile conditions, usually increases the patient's insulin requirement. Concomitant disease of the kidneys, liver, or disease affecting the adrenal glands, pituitary gland, or thyroid gland may require changes in insulin dose.
When a patient is transferred to another type of insulin medicinal product, the early warning symptoms of hypoglycaemia may change or be attenuated compared with those experienced with the previous insulin.
Transfer from other insulin medicinal products
Transfer of a patient to another type or brand 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 technology versus animal-source insulin) may result in the need for a change in dosage. Patients transferred to Actraphane from other types of insulin may require an increased number of daily injections or a change in dosage compared with those used with their previous insulin medicinal products. If a dose adjustment is necessary, it may be made with the first dose or during the first several weeks or months.
Injection site reactions
As with any insulin therapy, injection site reactions may occur, manifesting as pain, redness, urticaria, inflammation, bruising, swelling, and itching. Regular rotation of the injection site within a given area reduces the risk of these reactions. Reactions usually resolve within a few days to weeks. In rare cases, injection site reactions may require discontinuation of Actraphane.
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. It has been reported that a sudden change of injection site to an unaffected area has resulted in hypoglycaemia. Blood glucose monitoring is recommended following a change of injection site from an affected to an unaffected area, and dose adjustment of antidiabetic medicinal products may be considered.
Combination of Actraphane 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 failure. This should be taken into account if treatment with the combination of pioglitazone and Actraphane is considered. If the combination is used, patients must be observed for signs and symptoms of heart failure, weight gain, and oedema. Pioglitazone should 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 of Mixtard with 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.
