Descriptions
The blood glucose lowering effect of Insulin is due to the facilitated uptake of glucose following binding of Insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Indications
Treatment of diabetes mellitus. Furthermore indicated for the initial stabilisation of diabetes, during treatment of diabetic ketoacidosis and the hyperosmolar non ketotic syndrome, and during stress situations such as severe infections and major surgery in diabetic patients.
Instructions to be given to the patient
Vial
Before injecting this Insulin:
- Disinfect the rubber stopper.
- If suspension, roll the vial between the palms of the hands until the liquid is uniformly white and cloudy.
- Draw into the syringe the same amount of air as the dose of insulin to be injected.
- Inject the air into the vial.
- Turn the vial and syringe upside down and draw the correct insulin dose into the syringe. Withdraw the needle from vial and expel the air from the syringe and check that the dose is correct.
- Inject immediately.
Cartridge
Before injecting this Insulin:
- According to the instruction given with ConviPen, insert the Maxsulin cartridge into the pen correctly & equip the needle
- In case of Maxsulin 30/70 and Maxsulin 50/50, gently turn the pen upside down for 8-10 times until the insulin in the cartridge becomes uniformly mixed suspension
- Remove the needle cap, discharge air bubbles in the catridge
- Adjust the dosage button to get correct dose & inject to the specific site
- In order to avoid cross contamination, do not let the needle touch anything during the process of preparation.
For detail description, please see the Patient Instruction Leaflet provided with ConviPen.
Dosage & Administration
Dosage is individualized and determined by the physician in accordance with the needs of the patient.
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. However, in pre-pubertal children it usually varies from 0.7 to 1.0 IU/kg, but can be much lower during the period of partial remission. In Insulin resistance, 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.
An injection should be followed by a meal or snack containing carbohydrates within 30 minutes.
The preparations are administered subcutaneously in the thigh or abdominal wall. 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.
Side Effects
Hypoglycaemia, severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.
Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure.
Fast improvement in blood glucose control may be associated with a condition termed acute painful neuropathy, which is usually reversible. Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area. Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may occur during treatment with Insulin. Most reactions are transitory and disappear during continued treatment. Oedema may occur upon initiation of Insulin therapy. These symptoms are usually of transitory nature.
Storage:
Store at 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.
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