Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name of the administered product should be clearly recorded. It is recommended to record the batch number as well.

Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, neutral protamine Hagedorn [NPH], lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose. Concomitant oral antidiabetic treatment may need to be adjusted.

Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia.
Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered.

Hyperglycaemia
The use of inadequate doses or discontinuation of treatment, especially in insulin-dependent diabetic, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.

Hypoglycaemia
The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed.

Conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease, medicinal products such as beta blockers or after transfer from animal-source insulin to human insulin.

Adjustment of dose may be also necessary if patients undertake increased physical activity or change their usual meal plan. Exercise taken immediately after a meal may increase the risk of hypoglycaemia.

When compared with soluble human insulin, if hypoglycaemia occurs after an injection with rapid acting analogues, it may occur earlier.

Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.

Insulin requirements may be altered during illness or emotional disturbances.

Medication errors
Medication errors have been reported in which other insulins, particularly long-acting insulins, have been accidentally administered instead of insulin glulisine. Insulin label must always be checked before each injection to avoid medication errors between insulin glulisine and other insulins.

Apidra 100 Units/ml solution for injection in a vial
Continuous subcutaneous insulin infusion
Malfunction of the insulin pump or infusion set or handling errors can rapidly lead to hyperglycaemia, ketosis and diabetic ketoacidosis. Prompt identification and correction of the cause of hyperglycaemia or ketosis or diabetic ketoacidosis is necessary.


Cases of diabetic ketoacidosis have been reported when Apidra has been given in continuous subcutaneous insulin infusion in pump systems. Most of the cases were related to handling errors or pump system failure.
Interim subcutaneous injections with Apidra may be required. Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin delivery system available in case of pump system failure (see sections 4.2 and 4.8).

Excipients
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e., it is essentially ‘sodium-free’.
Apidra contains metacresol, which may cause allergic reactions.

Combination of Apidra 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 heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Apidra is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema.
Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

Apidra Solostar 100 Units/ml solution for injection in a pre-filled pen Handling of the SoloStar pre-filled pen
Apidra SoloStar 100 units/ml in pre-filled pen is only suitable for subcutaneous injections.
If administration by syringe or infusion pump is necessary, a vial should be used.
Before using SoloStar, the Instructions for use included in the Package leaflet must be read carefully.
SoloStar has to be used as recommended in these Instructions for use (see section 6.6).

Effects on Driving

4.7      Effects on ability to drive and use machines
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machines).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.