⚠️ Warnings
Before travelling across time zones, the patient should consult their physician. Travelling across time zones may mean that the patient has to use insulin and eat 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 the course 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 relative 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).
In patients whose glycaemic control has been markedly improved, e.g. by intensified insulin therapy, the usual warning symptoms of hypoglycaemia may change. Patients must be adequately informed of this possibility. In patients who have had diabetes for a long time, the usual warning symptoms may disappear.
Concomitant illness, particularly infections and febrile conditions, usually increases the patient's insulin requirements. Concomitant diseases of the kidneys, liver, or diseases affecting the adrenal glands, pituitary gland, or thyroid gland may require changes in insulin dose.
When a patient is switched to another type of insulin medicinal product, the early warning signs of hypoglycaemia may change or be attenuated compared with those experienced with the previous insulin.
Switching from other insulin medicinal products
Switching a patient to a different type or brand of insulin must 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 technology versus animal-sourced insulin) may result in the need for a change in dosage. Patients being transferred to Actraphane from another type of insulin may require an increased number of daily injections or a change in dosage from those used with their previous insulin medicinal products. If a dosage 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, including 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 worsening of glycaemic control following insulin injection into sites with these reactions. Cases have been reported where a sudden change of injection site to an unaffected area resulted in hypoglycaemia. Monitoring of blood glucose is recommended following the 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 developing cardiac failure. This must be taken into account if treatment with pioglitazone in combination with Actraphane is considered. If this combination is used, patients must be observed for signs and symptoms of heart failure, weight gain, and oedema. Pioglitazone must be discontinued if any worsening of 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 Mixtard and other insulin products.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
