Leitlinien & Arzneimittelsicherheit

HOS-093520 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most frequently reported adverse reaction during treatment is hypoglycaemia. The frequencies of hypoglycaemia vary with patient population, dose regimens and level of glycaemic control, please see Description of selected adverse reactions below. At the beginning of the insulin treatment, refraction anomalies, oedema and injection site reactions (pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur. These reactions are usually of a transitory nature. Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible. Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. Tabulated list of adverse reactions 6 The adverse reactions listed below are based on clinical trial data and classified according to MedDRA frequency and System Organ Class. Frequency categories are defined according to the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Immune system disorders Uncommon – Urticaria, rash Very rare – Anaphylactic reactions* Metabolism and nutrition Very common – Hypoglycaemia* disorders Nervous system disorders Very rare – Peripheral neuropathy (painful neuropathy) Eye disorders Very rare – Refraction disorders Uncommon – Diabetic retinopathy Skin and subcutaneous tissue Uncommon – Lipodystrophy* disorders Not known – Cutaneous amyloidosis*† General disorders and Uncommon – Injection site reactions administration site conditions Uncommon – Oedema * see Description of selected adverse reactions † ADR from postmarketing sources. Description of selected adverse reactions Anaphylactic reactions The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulty in breathing, palpitation and reduction

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HOS-093516 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-093515 · has-indication-information · PDF-Seite 2

Protaphane is indicated for treatment of diabetes mellitus.

HOS-093518 · has-interaction-information · PDF-Seite 5

A number of medicinal products are known to interact with glucose metabolism. The following substances may reduce the patient’s insulin requirement: Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides. The following substances may increase the patient’s insulin requirement: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol. 5 Beta-blockers may mask the symptoms of hypoglycaemia. Octreotide/lanreotide may either increase or decrease the insulin requirement. Alcohol may intensify or reduce the hypoglycaemic effect of insulin.

HOS-093519 · has-pregnancy-information · PDF-Seite 6

Pregnancy There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier. Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero. Intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters. After delivery, insulin requirements normally return rapidly to pre-pregnancy values. Breast-feeding There is no restriction on treatment with Protaphane during breast-feeding. Insulin treatment of the nursing mother presents no risk to the baby. However, the Protaphane dose may need to be adjusted. Fertility Animal reproduction studies with human insulin have not revealed any adverse effects on fertility.

HOS-093517 · has-warning-information · PDF-Seite 4

Before travelling between different time zones, the patient should seek the doctor’s advice since this may mean that the patient has to take the insulin and meals at different times. Hyperglycaemia Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis. Usually, the first symptoms of hyperglycaemia develop gradually over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath. In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal. 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 case of hypoglycaemia or if hypoglycaemia is suspected, Protaphane must not be injected. After stabilisation of the patient’s blood glucose, adjustment of the dose should be considered (see sections 4.8 and 4.9). Patients whose blood glucose control is greatly improved, 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 longstanding diabetes. Concomitant illness, especially infections and feverish conditions, usually increases the patient’s insulin requirement. Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in the insulin dose. When patients are transferred between different types of insulin medicinal products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin. 4 Transfer from other insulin medicinal products Transferring a patient to another type or brand of insulin should 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 versus animal source insulin) may result in a need for a change in dose. Patients transferred to Protaphane from another type of insulin may require an increased number of daily injections or a change in dose from that used with their usu

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