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Apidra

Apidra Caution For Usage

insulin glulisine

Manufacturer:

Kalventis Sinergi Farma
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Caution For Usage
Preparation and Handling: Apidra 100 Units/ml solution for injection in a vial: Subcutaneous use: Apidra vials are for use with insulin syringes with the corresponding unit scale and for use with an insulin pump system.
Inspect the vial before use. It must only be used if the solution is clear, colourless, with no solid particles visible. Since Apidra is a solution, it does not require resuspension before use. Insulin label must always be checked before each injection to avoid medication errors between insulin glulisine and other insulins.
Mixing with insulins: When mixed with NPH human insulin, Apidra should be drawn into the syringe first. Injection should be given immediately after mixing, as no data are available regarding the mixtures made up a significant time before injection.
Continuous subcutaneous infusion pump: Refer to Method of Administration under Dosage & Administration.
Intravenous use: Apidra should be used at a concentration of 1 Unit/ml insulin glulisine in infusion systems with sodium chloride 9 mg/ml (0.9%) solution for infusion with or without 40 mmol/l potassium chloride using coextruded polyolefin/polyamide plastic infusion bags with a dedicated infusion line. Insulin glulisine for intravenous use at a concentration of 1 Unit/ml is stable at room temperature for 48 hours.
After dilution for intravenous use, the solution should be inspected visually for particulate matter prior to administration. It must only be used if the solution is clear and colourless, not when cloudy or with visible particles.
Apidra was found to be incompatible with Glucose 5% solution and Ringer's solution and, therefore, must not be used with these solution fluids. The use of other solutions has not been studied.
Apidra 100 Units/ml solution for injection in a cartridge: Apidra 100 units/ml in a cartridge is only suitable for subcutaneous injections from a reusable pen. If administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used.
The Apidra cartridges are to be used only in conjunction with the pens: OptiPen, ClikSTAR, Autopen 24, Tactipen, AllStar.
The pen should be used as recommended in the information provided by the device manufacturer. The manufacturer's instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection. Inspect the cartridge before use. It must only be used if the solution is clear, colourless, with no solid particles visible. Before insertion of the cartridge into the reusable pen, the cartridge must be stored at room temperature for 1 to 2 hours. Air bubbles must be removed from the cartridge before injection (see instruction for using pen). Empty cartridges must not be refilled.
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
To prevent any kind of contamination, the re-usable pen should be used by a single patient only. Insulin label must always be checked before each injection to avoid medication errors between insulin glulisine and other insulins (see Precautions).
Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen: Apidra SoloStar 100 units/ml in a pre-filled pen is only suitable for subcutaneous injections. If administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used.
Before first use, the pen must be stored at room temperature for 1 to 2 hours. Inspect the cartridge before use. It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency. Since Apidra is a solution, it does not require resuspension before use. Empty pens must never be reused and must be properly discarded.
To prevent any kind of contamination, the use of the pre-filled pen should remain strictly for a single patient use.
Insulin label must always be checked before each injection to avoid medication errors between insulin glulisine and other insulins (see Precautions).
Patient Information: Accidental mix-ups between insulin glulisine and other insulins, particularly long-acting insulins, have been reported. To avoid medication errors between insulin glulisine and others insulin, patients should be instructed to always check the insulin label before each injection.
Incompatibilities: Apidra 100 Units/ml solution for injection in a vial: Subcutaneous use: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except NPH human insulin. When used with an insulin infusion pump, Apidra must not be mixed with other medicinal products.
Intravenous use: Apidra was found to be incompatible with Glucose 5% solution and Ringer's solution and, therefore, must not be used with these solution fluids. The use of other solutions has not been studied.
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