Apidra SoloStar Units/ml solution for injection in a pre-filled pen – Patient The Patient Information Leaflet (PIL) is the leaflet included in the pack with a. Apidra SoloStar Units/ml solution for injection in a pre-filled pen . SoloStar, the Instructions for use included in the Package leaflet must be read carefully. APIDRA [insulin glulisine injection (rDNA origin)] is a recombinant . package insert, and the pump manufacturer’s manual (see DOSAGE AND.
|Published (Last):||14 April 2013|
|PDF File Size:||8.20 Mb|
|ePub File Size:||14.77 Mb|
|Price:||Free* [*Free Regsitration Required]|
Send the page ” ” to a friend, relative, colleague or yourself. We do not record any personal information entered above. Hormone secreted by pancreatic beta-cells of the islets of Langerhans essential for the metabolism and homeostasis of carbohydrate, fat, and protein.
Insulin glulisine is a rapid-acting insulin analog with a quicker onset and shorter duration of action compared to regular insulin. Apidra Intravenous Inj Sol: Insulin glulisine is equipotent to regular insulin, but with more rapid activity and a shorter duration of apisra when given via intermittent subcutaneous injection. When used for intermittent subcutaneous injection, the total daily dose is given as 2 to 4 pakcage injections, within 15 minutes before or 20 minutes after starting a meal to avoid hypoglycemia.
A oackage regimen is to administer insulin glulisine just prior to the beginning of each meal with a basal insulin i. Insulin glulisine can be given in combination with isophane insulin or lente insulin as 2 daily injections; about two-thirds of the daily insulin dose is given before breakfast and about one-third is given before the evening meal. An intermediate-to-insulin glulisine ratio of 2: Alternatively, the evening dose of intermediate insulin can be given at bedtime rather than at dinner.
Insulin requirements are highly variable and must be individualized based on patient-specific factors and type of insulin regimen. In general, more data are available for the use of insulin aspart and insulin lispro in pediatric patients compared to insulin glulisine. During partial remission phase, total combined daily insulin requirement is often less than 0.
Prepubertal children outside the partial remission phase usually require 0. Administer pre-meal doses of insulin glulisine within 15 minutes before a meal or within 20 minutes after starting a meal.
Use insulin glulisine in combination with intermediate- or long-acting insulin as part of twice-daily regimens or basal-bolus regimens. Twice daily insulin regimens consist of 2 subcutaneous insulin injections given per day; approximately two-thirds of the total inserr insulin dose is given in the morning and one-third in the evening.
Initially, for each insulin dose, approximately one-third is given as a rapid-acting insulin and iinsert other two-thirds onsert an intermediate-acting insulin. These ratios may change based on individual response. Basal-bolus regimens typically consist of 4 to 5 subcutaneous insulin injections given per day; 1 to 2 as an intermediate- or long-acting insulin plus 3 to 4 pre-meal rapid-acting insulin doses.
Paciage used in an external insulin pump via continuous subcutaneous insulin infusion CSIIthe total daily dose should be based on the insulin dose from the previous regimen.
When using the product in an external insulin pump via continuous subcutaneous insulin infusion CSIIbase the total daily subcutaneous dose on the total daily insulin dose from the previous regimen. Infuse prandial boluses within 15 minutes before meals or within 20 minutes after starting meals. Per the manufacturer, insulin glulisine may be administered IV for glycemic control under proper medical supervision in a clinical setting.
Although pharmacokinetic data are available and the drug has been used as packate intravenous infusion in healthy subjects, dosage information for the treatment of hyperglycemia is not available.
Due to cost, safety, and efficacy concerns, it may be prudent to avoid pacoage administration until more inserf is available. Dosage varies depending on previous regimen, concurrent medications, lifestyle, etc. Insulin glulisine may be used in combination with oral agents e. Specific dosage recommendations are not available; dosage should be individualized according to age, weight, activity level, and dietary habits.
Titrate dosage according to blood glucose apidrra A1C goals. Specific maximum dosage information is not available. Individualize dosage based on careful monitoring of blood glucose and other clinical parameters in all patient populations.
Dosage should be modified depending on clinical response and degree of hepatic impairment, but no quantitative recommendations are available. Some studies have noted increased circulating levels of insulin in patients with hepatic failure.
Individualize dosage based on blood glucose and other clinical parameters.
Fast-Acting, Mealtime Insulin | Apidra® (insulin glulisine [rDNA origin] injection)
The pharmacokinetics of insulin are generally unchanged with renal impairment, however, pharmacodynamic differences occur in insulin sensitivity as renal function declines, resulting in increased responses to a given dosage. Administer by subcutaneous injection or intravenously only. Do NOT administer by intramuscular injection. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Do not use injections which are unusually viscous, cloudy, or discolored. Patients using insulin vials should never share needles or syringes with another person. Insulin pens should never be shared among patients. Even if the disposable needle is changed, sharing may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens. Do not share pens among multiple patients in an inpatient setting; use multidose vials instead, or, if unavailable, reserve the use of any pen to 1 patient only.
Ensure that the patient knows how to use the type of pen needles being dispensed. For standard pen needles with an outer cover and an inner needle cover, remove both covers before use. For the safety pen needle, remove only the outer cover; the fixed inner needle shield remains in place. Continuous IV Infusion Close monitoring of blood glucose and potassium levels are required to avoid hypoglycemia and hypokalemia.
Use with infusion systems that use polyvinyl chloride PVC infusion bags and PVC tubing with a dedicated infusion line. Dilute insulin glulisine with Sodium Chloride injection to a final concentration of 0.
inseet The use of other diluents, infusion bags, or tubing has not been studied. Infusion bags are stable at room temperature for 48 hours. There may be differences in the way units are indicated, depending on the size of the syringe and the manufacturer.
Insulin syringes are manufactured with 0. Various lengths of needles are available: Insulin glulisine is preferably administered within 15 minutes before to 20 minutes after starting a meal. Subcutaneous injections are usually made into the anterior and lateral aspects of the thigh, the upper arms, buttocks, or the abdomen. Double-check dosage in syringe or injectable device prior to administration.
Lightly pinch a fold of skin; insert the needle; release the skin; inject at a 90 degree angle. Children or isert individuals can use a short needle and a 45 degree angle to avoid intramuscular injection.
Aspiration is not necessary. Inject over 2 to 4 seconds. The needle should be remain in the skin for 5 seconds after injection to ensure complete delivery of the insulin dose. Rotate administration sites with each injection to prevent lipodystrophy.
However, staying within the same area e. Mixing of insulin glulisine for subcutaneous intermittent administration only: Insulin glulisine can be mixed with NPH human insulin. The injection should be administered immediately after mixing. When mixing insulin glulisine with NPH insulin in a syringe, draw insulin glulisine into the syringe first. This prevents contamination of the remaining insulin glulisine in the vial by the NPH insulin. Data on the mixing of insulin glulisine with other insulins, including crystalline zinc preparations lente or ultralenteis not available.
A clinically significant interaction occurs when these insulins are mixed with regular insulin; zinc in these insulin solutions binds with insulin; ijsert in the onset and duration of action could result. Until data are available, insulin glulisine should not be mixed in the same syringe with any insulin other than NPH. Lente and Ultralente insulin apckage no longer commercially available.
Follow specific recommendations available from the manufacturer of insulin glulisine and the pump only. However, for in-use time or frequency of changing packate sets, follow information from the manufacturer of insulin glulisine only. Change the infusion sets and the insulin glulisine in packgae external insulin reservoir every 48 hours as insulin degradation inserf loss of m-cresol have been demonstrated after this time.
The injection site should be changed at least every 48 hours. Medical personnel should be contacted and a new injection site should be selected if a current site becomes erythematous, pruritic, or thickened, as skin reactions or alterations in absorption can occur. The patient must have an alternative insulin delivery system in case of pump apidta failure.
Preparation and Administration Instructions for Patients: To prepare a dose from a vial: Clean the rubber stopper of the vial with an alcohol wipe.
Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen
Pull back the plunger of a disposable syringe to fill the syringe with an amount of air equal to your dose of insulin if your dose is 30 units, pull the plunger to the 30 unit mark. Insert the needle into the rubber stopper of the vial, and inject the air into the vial this will make the insulin easier to remove.
Turn the vial and syringe upside down. Making sure the tip of the needle is in the insulin, pull back on the plunger to fill the syringe with the prescribed number of units of insulin. Before removing the needle from the vial, check your syringe for air bubbles. If bubbles are present, hold the syringe straight up and flick the syringe firmly with your finger until the bubbles float to the top.
Push them out with the plunger and withdraw the correct dose of insulin. Lift the vial off the syringe. Mixing of two types of insulin: Insulin glulisine should be mixed with NPH insulin only on the advice of your prescriber.
Insulin glulisine and NPH insulin should be mixed immediately before injection. Clean the rubber stopper of both vials of insulin with an alcohol wipe. Roll the vial of the Apkdra insulin gently between the palms of your hands to mix and warm the insulin. Be sure to mix the insulin well, but do not shake vigorously.
Pull back the plunger of a disposable syringe to fill the syringe with an amount of air equal to your dose of NPH insulin if your dose is 30 units, pull the plunger to the 30 unit mark.