ACTRAPID 100 IU/ML Solution for injection in vial

Before travelling between different time zones, the patient should consult their physician.‍​‍‍‍​‍‍‍‍‍‍‍‍​‍ Travelling between 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, particularly in type 1 diabetics, may lead to hyperglycaemia and diabetic ketoacidosis. The first symptoms of hyperglycaemia usually appear 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 of the breath. Untreated hyperglycaemia in type 1 diabetics can eventually lead to diabetic ketoacidosis and subsequently to death. Hypoglycaemia Omitting 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 case of hypoglycaemia or suspected hypoglycaemia, Actrapid 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 has significantly 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 longstanding diabetes. Concomitant illness, particularly infections and febrile conditions, usually increases the patient's insulin requirements. 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 products, 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 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 production versus animal-sourced insulin) may result in the need for a change in dose. Patients being transferred to Actrapid from other types of insulin may require an increased number of daily injections or a change in dose from those used with their previous insulin medicinal products. If dose adjustment is necessary, it may be done with the first dose or during the first few 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 the same 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 worsening 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 development of cardiac failure. This should 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.