Diasulin Cartridge^®

Diasulin^® is human insulin made by DNA recombinant technology so it has the same structure and function as natural insulin. The product can regulate the glucose metabolism and stimulate the ingestion and utilization of glucose by liver, muscles and fat tissue. It can accelerate the transformation from glucose to glycogen stored in muscles and liver and inhibit the gluconeogenesis, thus, to lower the blood glucose. Pharmacokinetic profiles of different Diasulin^Ⓡ preparations are as follows:

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Diasulin^® is indicated for the following conditions-

• Patients with type 1 diabetes mellitus

• Patients with type 2 diabetes mellitus who are not adequately controlled by diet and/or oral hypoglycemic agents Diabetes mellitus in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome and during periods of stress such as severe infections and major surgery in diabetic patients

• Gestational diabetes

Instructions for patient

Before injecting this insulin:

1. According to instruction given with Biopen flexi insulin device, insert the Diasulin^Ⓡ cartridge into the pen correctly, equip the needle and let the cartridge reach room temperature before using it.

2. In case of Diasulin^ⓇN and Diasulin^Ⓡ 30/70, gently move the pen up and down 20 times for new cartridge (for next injection at least 10 times) until the insulin in the cartridge becomes uniformly mixed suspension.

3. Remove the needle cap and discharge air bubbles in the cartridge.

4. Adjust the dosage button to get correct dose and inject to the specific site. 5. In order to avoid cross contamination, do not let the needle touch anything during the process of preparation.

To be used only with Biopen flexi insulin device. For detail description, please see the patient instruction manual provided with

Biopen flexi insulin device.

Dosage

The dosage form, the dosage and the administration time of the insulin are different due to the individual differences of each patient. In addition, the dosage is also affected by food, working style and exercising intensity. Therefore, patients should use the insulin under doctor's instruction. An injection should be followed by a meal or snack containing carbohydrates within minutes. The preparations are administered subcutaneously in the abdominal wall, the thigh, the gluteal region or the deltoid region. A subcutaneous injection into the abdominal wall results in a faster absorption than from other injection sites. Insulin suspensions are never to be administered intravenously.

The average range of total daily insulin requirement for maintenance therapy in type 1 diabetic patients lies between 0.5 and 1.0 IU/kg. In pre-pubertal children it usually varies from 0.7 to 1.0 IU/kg, whereas in insulin resistant cases, e.g. during puberty or due to obesity, the daily insulin requirement may be substantially higher. Initial dosages for type 2 diabetic patients are often lower, e.g., 0.3 to 0.6 IU/kg/day. Diasulin^Ⓡ should be given subqutaneously approximately 15-30 minutes before a meal.

If necessary, Diasulin^Ⓡ R can be administered intravenously. This should be carried out by healthcare professionals. For intravenous use, infusion systems with Diasulin^Ⓡ R at concentrations from 0.05 IU/ml to 1.0 IU/ml human insulin in the infusion fluids 0.9% sodium chloride or 5% dextrose or 10% dextrose with 40 mmol/l potassium chloride using polypropylene infusion bags, are stable at room temperature for 24 hours. Although stable over time, a certain amount of insulin will initially be adsorbed to the material of the infusion bag. Monitoring of blood glucose is necessary during the insulin infusion.

Pregnancy: There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.

Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for insulin and any potential adverse effects on the breastfed child from insulin or from the underlying maternal condition.

Use in children and adolescents

Soluble Insulin Human (regular) is indicated to improve glycemic control in pediatric patients with diabetes mellitus. The dosage of soluble Insulin Human (regular) must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose to reduce the risk of hypoglycemia. Isophane Insulin Human has not been studied in pediatric patients. As in adults, the dosage of isophane Insulin Human in pediatric patients must be individualized based on metabolic needs, treatment goal and blood glucose monitoring results. Safety and effectiveness of 30% soluble Insulin Human (regular) and 70% isophane Insulin Human in patients less than 18 years of age has not been established.

A Biopen should never be shared between patients, even if the needle is changed. If hyperglycemia or hypoglycemia occurs with changes in insulin regimen, changes need to be made to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. Hypoglycemia may be life-threatening. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. Accidental mix-ups between insulin products can occur. Patients should be instructed to check insulin labels before injection. Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. On that case, Insulin should be discontinued. The patient should be monitored and treated if indicated. Hypokalemia may be life-threatening. Potassium level in patients at risk of hypokalemia should be monitored and treated if indicated. Fluid retention and heart failure may occur with concomitant use of thiazolidinediones (TZD). Patients should be observed for signs and symptoms of heart failure and dosage reduction or discontinuation be considered of TZD if heart failure occurs.

Most common side effects are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, weight gain and edema.

During episodes of hypoglycemia and known hypersensitivity to human insulin or to any of the excipients.

A number of drugs may affect glucose metabolism and may require dose adjustment:

Drugs that may increase the risk of hypoglycemia: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide) and sulfonamide antibiotics. Dose reductions and increased frequency of glucose monitoring may be required when insulin is coadministered with these drugs.

Drugs that may decrease the blood glucose lowering effect of insulin: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens, protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline) and thyroid hormones. Dose increases and increased frequency of glucose monitoring may be required when insulin is coadministered with these drugs.

Drugs that may increase or decrease the blood glucose lowering effect of insulin: Alcohol, beta-blockers, clonidine and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Dose adjustment and increased frequency of glucose monitoring may be required when insulin is coadministered with these drugs.

Drugs that may blunt signs and symptoms of hypoglycemia: Beta-blockers, clonidine, guanethidine and reserpine. Increased frequency of glucose monitoring may be required when insulin is coadministered with these drugs.

Drug interaction with food and others: Not applicable.

Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Adjustments in drug dosage, meal patterns or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia. Hypokalemia must be corrected appropriately.

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Keep out of the reach and sight of children. Store at 2°C 8°C in a refrigerator. Do not freeze. Do not mix with other insulin. Protect from light. After first use, the insulin should be kept under below 30°C for 28 days and consumed within this time.

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Diasulin R cartridge: Each box contains 3 cartridges of 3 ml.

Diasulin N cartridge: Each box contains 3 cartridges of 3 ml.

Diasulin 30/70 cartridge: Each box contains 3 cartridges of 3 ml.