Insulet ASP: Insulet ASP dosing is individual and determined in accordance with the needs of the patient. It should normally be used in combination with intermediate-acting or long-acting insulin. Moreover Insulet ASP can be used for continuous subcutaneous insulin infusion (CSII) in pump systems or be administered intravenously by healthcare professionals. Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control.The individual insulin requirement in adults and children is usually between 0.5 and 1.0 unit/kg/day. In a basal-bolus treatment regimen 50-70% of this requirement may be provided by Insulet ASP and the remainder by intermediate-acting or long-acting insulin. Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. Insulet ASP 30/70: Insulet ASP 30/70 dosing is individual and determined in accordance with the needs of the patient. Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control. In patients with type 1 diabetes, the individual insulin requirement is usually between 0.5 and 1.0 Unit/kg/day. Insulet ASP 30/70 may fully or partially meet this requirement. In patients with type 2 diabetes, Insulet ASP 30/70 can be given as monotherapy. Insulet ASP 30/70 can also be given in combination with, oral antidiabetic drugs if the patient's blood glucose is inadequately controlled with these oral antidiabetic drugs alone. How to start: Insulin naive patients: For patients with type 2 diabetes, the recommended starting dose of Insulet ASP 30/70 is 6 Units at breakfast and 6 Units at dinner (evening meal). Insulet ASP 30/70 can also be initiated once daily with 12 units at dinner (evening meal). How to intensify: Insulet ASP 30/70 can be intensified from once daily to twice daily. When using Insulet ASP 30/70 once daily, it is generally recommended to move to twice daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses. From Insulet ASP 30/70 twice daily to thrice daily: If twice daily dosing with Insulet ASP 30/70 results in recurrent daytime hypoglycaemic episodes, the morning dose can be split into morning and lunchtime doses. The dinner doses remain unchanged. How to adjust the dose: - Adjust the dose of Insulet ASP 30/70 on the basis of the lowest pre-meal blood glucose level from the three previous days - Dose adjustment can be made once a week until target HbA1c is reached - The dose should not be increased if hypoglycemia occurred within three days - Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness The following titration guideline is recommended for dose adjustments: \n
\n \n \nPre-meal blood glucose level of Insulet ASP 30/70 | \nDose adjustment | \n
\n \n< 4.4 mmol/l | \n< 80 mg/dl | \n- 2 units | \n
\n \n4.4 – 6.1 mmol/l | \n80 – 110 mg/dl | \n0 | \n
\n \n6.2 – 7.8 mmol/l | \n111 – 140 mg/dl | \n+ 2 units | \n
\n \n7.9 – 10 mmol/l | \n141 – 180 mg/dl | \n+ 4 units | \n
\n \n> 10 mmol/l | \n> 180 mg/dl | \n+ 6 units | \n
\n \n
\nTransfer from other insulin medicinal products: Insulin Aspart products are equipotent to their respective human insulin products, in regards to hypoglycemic effect, receptor affinity and effect on lipogenesis. Patients currently treated with human insulin can be transferred to Insulet ASP on a unit for unit basis when administered just before a meal. Any change to insulin therapy should be made under medical supervision and blood glucose should be monitored. When transferring a patient from biphasic human insulin to Insulet ASP 30/70, start with the same dose and regimen. Then titrate according to individual needs (See the above titration guideline). As with all insulin products close glucose monitoring is recommended during the transfer and in the initial weeks thereafter. Method of administration: Preparation before use: - Clean your hands - Shake or rotate the vial gently - In case of using a new vial, flip off the plastic protective cap and wipe the rubber plug with an alcohol swab - Draw air into your syringe equal to the amount of medicine needed. Puncture the needle into the vial and inject the air - Turn the bottle and syringe upside down and withdraw correct dose of medicine 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: Subcutaneous Injection: Insulet ASP is administered subcutaneously by injection in the abdominal wall, the thigh, the upper arm, the deltoid region or the gluteal region. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy. Subcutaneous injection in the abdominal wall ensures a faster absorption than other injection sites. The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. When Insulet ASP is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection. The maximum effect is exerted between 1 and 3 hours after injection. The duration of action is 3 to 5 hours. Due to the faster onset of action, Insulet ASP should generally be given immediately before a meal. When necessary Insulet ASP can be given soon after a meal. Injection method (Incase of subcutaneous Injection): - 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 the medicine - Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected - Pull the needle out and apply gentle pressure over the injected site for several seconds - Do not rub the injection site Continuous Subcutaneous Insulin Infusion (CSII): Insulet ASP may be used for CSII in pump systems suitable for insulin infusion. CSII should be administered in the abdominal wall. Infusion sites should be rotated. When used with an insulin infusion pump, Insulet ASP should not be mixed with any other insulin medicinal products. Patients administering Insulet ASP by CSII must have an alternative insulin delivery method available in case of pump system failure. Intravenous use: If necessary, Insulet ASP can be administered intravenously which should be carried out by healthcare professionals. For intravenous use, infusion systems with Insulet ASP 100 units/ml at concentrations from 0.05 unit/ml to 1.0 unit/ml Insulin Aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or 10% dextrose inclusive 40 mmol/l potassium chloride using polypropylene infusion bags are stable at room temperature for 24 hours. Although stable over time, a certainamount of insulin will be initially adsorbed to the infusion bag. Monitoring of blood glucose is necessary during insulin infusion. Preparation before use: - Clean your hands - Insulet ASP 30/70 is a suspension that must be resuspended immediately before use. The vial should be rolled gently in your hands in a horizontal position 10 times to mix it. The rolling procedure must be repeated untill the suspension appears uniformly white and cloudy. Inject immediately. - In case of using a new vial, flip off the plastic protective cap and wipe the rubber plug with an alcohol swab - Draw air into your syringe equal to the amount of medicine needed. Puncture the needle into the vial and inject the air - Turn the bottle and syringe upside down and withdraw correct dose of medicine 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: Insulet ASP 30/70 is for subcutaneous administration only. Insulet ASP 30/70 is administered subcutaneously by injection in the thigh or in the abdominal wall. If convenient, the gluteal or deltoidregion may be used. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy. The influence of different injection sites on the absorption of Insulet ASP 30/70 has not been investigated. As with all insulin the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. After subcutaneous administration, the onset of action will occur within 10-20 minutes of injection. The maximum effect is exerted between 1 and 4 hours after injection. The duration of action is up to 24 hours. Insulet ASP 30/70 should generally be given immediately before a meal. When necessary, Insulet ASP 30/70 can be given soon after a meal.