Generics: Insulin Human [rDNA]
Dosage Form: SC Injection.
Type 1 and Type 2 Diabetes Mellitus.
This 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.
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. 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.
Route of administration: Subcutaneously.
Insulin should be injected subcutaneously 15 minutes to one hour before meal. The exact time for administration is suggested by doctors with regard to each individual’s case.
Prepare before use: Firstly, clean your hands. Shake or rotate the vial gently to mix the solution uniformly and check if the insulin has the normal appearance. If using a new insulin bottle then flip off the plastic protective cap and wipe the rubber stopper with an alcohol swab. Draw air into your syringe equal to the amount of insulin needed. Puncture the needle into the vial and inject the air. Turn the bottle and syringe upside down. Withdraw correct dose of insulin into the syringe. Before pulling out the needle, check if there are any bubbles remain in the syringe. If so, put the syringe upright and tap the syringe to discharge the air bubbles.
Injection Site: Choose the area where skin is less tight, such as the upper arm, thigh, buttock and abdomen, etc. To avoid tissue damage, choose a site for each injection that is at least 1 cm from the previous injection site.
Injection Method: Cleanse the skin with alcohol where the injection is to be made. Put the needle in such a position as to form 45° angle with the skin. Puncture the needle into skin and inject insulin. Then pull the needle out and apply gentle pressure over the injected site for several seconds. Do not rub the injection site.
When using oral contraceptive drug, adrenal cortical hormone, thyroid hormone, etc., the drugs that can result in the rise of blood glucose; you might need to increase the amount of Insulin. When using drugs with hypoglycemic activities, salicylate, sulfanilamide and other anti-depressants, which will result in the decrease of blood glucose, the dosage of insulin should be reduced.
Hypoglycemia or the patients who have allergic reaction to insulin or any of the excipients.
Hypoglycemia is the most common adverse effect during insulin treatment and symptoms of hypoglycemia may occur suddenly. Few cases of the allergic reaction such as red and swollen or itching are reported. It usually disappears in a few days. In some instances, the allergy may be caused by other reasons rather than insulin, such as disinfectant and poor injection technique.
Pregnancy & Lactation:
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier. Insulin treatment of the nursing mother presents no risk to the baby.
Precautions & Warnings:
Inadequate dosing or discontinuation especially in type 1 diabetes, may lead to hyperglycemia. Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement. Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycemia.
Medium Acting Insulin.
Store at 2°C-8°C in a refrigerator. Do not freeze. In case of insulin for recent use need not be refrigerated, try to keep it in a cool place and keep away from heat and light. The insulin in use can be kept under the room temperature for a month.
Manufactured by: Novo Nordisk Pharma Pvt Ltd.