⚠️ Warnings
Before travelling across time zones, the patient should consult a physician. Travelling across time zones may mean that the patient will need to use insulin and have meals at different times.
Hyperglycaemia
Inadequate dosing or discontinuation of treatment, especially in type 1 diabetic patients, may lead to hyperglycaemia and diabetic ketoacidosis. The first symptoms of hyperglycaemia usually appear gradually over 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 diabetic patients may eventually lead to diabetic ketoacidosis, which can be fatal.
Hypoglycaemia
Skipping a meal or unplanned strenuous physical activity may lead to hypoglycaemia.
Hypoglycaemia may occur if the insulin dose is too high relative to the insulin requirement. In case of hypoglycaemia or suspected hypoglycaemia, Actrapid must not be administered. After the patient's blood glucose has stabilised, dose adjustment must be considered (see sections 4.8 and 4.9).
Patients whose glycaemic control has improved significantly, 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 long-standing diabetes.
Concomitant illness, particularly infections and febrile conditions, usually increases the patient's insulin requirements. Concomitant illness affecting the kidneys, liver, or the adrenal glands, pituitary gland, or thyroid gland may necessitate changes in insulin dose.
When a patient is switched to a different 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
Switching patients to a different 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 dose change. Patients switched to Actrapid from other types of insulin may require an increased number of daily injections or a dose change compared with those used with their previous insulin medicinal products. If dose adjustment is necessary, it may be made at the first dose or during the first several weeks or months.
Injection site reactions
As with any insulin therapy, injection site reactions may occur, presenting as pain, redness, urticaria, inflammation, bruising, swelling, and itching. Regular rotation of the injection site within one region 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 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 led to hypoglycaemia. Blood glucose monitoring is recommended following a change of injection site from an affected to an unaffected area, and dose adjustment of antidiabetic medications may be considered.
Combination of Actrapid with pioglitazone
Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, 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 such a 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 always 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.
