Insulin (pork)

A decreased requirement for insulin may be observed in the early stages of pregnancy. However, in the second and third trimesters, insulin requirements may increase. Insulin requirements should therefore be assessed frequently by an experienced diabetic physician.

Maternal insulin requirements may decrease after delivery. As this decrease can be at an unpredictable rate, the maternal blood glucose should be closely monitored.

Congenital abnormality is more common in offspring of diabetic than non-diabetic women.

Caution should be exercised when prescribing to lactating women. Lactating women may require adjustments in insulin dose and diet.

The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).

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 signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.

Immune system disorders

Insulin hypersensitivity can occur with animal insulins, but appears less likely with purified insulins and there is minimal evidence that such effects occur with Hypurin insulins.

Neuropathic pain induced by rapid glycaemic control following insulin administration may occur.

Allergic reactions to phenol and m-cresol contained as preservative and to zinc and protamine may occur.

• Local hypersensitivity: Local allergic reactions to insulin such as pruritus, erythema and oedema may occur at the injection site.
• Generalised hypersensitivity: Generalised hypersensitivity may produce urticaria, rash, nausea, dyspnoea or wheezing and, in rare cases, anaphylactic reactions. Severe, angioedema is a rare adverse effect of insulin treatment occurring most often at the initiation of therapy.

Metabolism and nutrition disorders

• Hypoglycaemia is the most common adverse effect associated with insulin therapy. For symptoms of hypoglycaemia
• Hypokalaemia may occur with insulin therapy.
• Insulin therapy may lead to weight gain.

Skin and subcutaneous tissue disorders

Lipodystrophy and cutaneous amyloidosis (frequency not known) may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.

General disorders and administration site conditions

Stinging or sensations of warmth or burning at the site of injection may also occur.