⚠️ Warnings
Before travelling between different time zones, the patient should consult the physician. Travelling between different time zones may mean that the patient will need to use insulin and eat 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, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite and acetone odour of breath. Untreated hyperglycaemia in type 1 diabetics may ultimately lead to diabetic ketoacidosis and death.
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, 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 glycaemic control is significantly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be informed 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 disease of the kidneys, liver or disease affecting the adrenal glands, pituitary gland or thyroid gland may require changes in the insulin dose.
When the 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.
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 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 from that used with their previous insulin medicinal products. If dose adjustment is required, it may occur 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 the same 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 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 worsening of glycaemic control following injection into sites with these reactions. A sudden change in injection site to an unaffected area has been reported to result in hypoglycaemia. Monitoring of blood glucose is recommended following the change from an affected to an unaffected injection site, and dose adjustment of antidiabetic medicines may be considered.
Combination of Actrapid with pioglitazone
Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for the development of cardiac failure. This should be borne in mind if treatment with the combination of pioglitazone and Actrapid is considered. If the combination is used, patients should be observed 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
In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
