Special precautions for disposal and other handling: 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).
Handling of the pen: The patient should be advised to read the instructions for use before using SoloStar.
Important information for use of SoloStar: Before each use, a new needle must always be carefully attached and a safety test must be performed. A dose should not be selected and/or the injection button should not be pressed without a needle attached. Only use needles that are compatible for use with SoloStar.
Special caution must be taken to avoid accidental needle injury and transmission of infection.
SoloStar must never be used if it is damaged or if the patient is not sure if it is working properly.
The patient must always have a spare SoloStar available in case the SoloStar is lost or damaged.
Storage instructions: Check Special precautions for storage under Storage for instructions on how to store SoloStar.
If SoloStar is in cool storage, it should be taken out 1 to 2 hours before injecting to allow it to warm up. Cold insulin is more painful to inject.
The used SoloStar must be discarded as required by local authorities.
Maintenance: SoloStar has to be protected from dust and dirt.
The outside of the SoloStar can be cleaned by wiping it with a damp cloth.
The pen must not be soaked, washed or lubricated as this may damage it.
SoloStar is designed to work accurately and safely. It should be handled with care. The patient should avoid situations where SoloStar may be damaged. If the patient is concerned that the SoloStar may be damaged, he must use a new one.
Step 1 Check the insulin: The label on the pen should be checked to make sure it contains the correct insulin. The Apidra SoloStar is blue. It has a dark blue injection button with a raised ring on the top. After removing the pen cap, the appearance of insulin should also be checked: the insulin solution must be clear, colourless, with no solid particles visible, and must have a water-like consistency.
Step 2 Attach the needle: Only needles that are compatible for use with SoloStar should be used.
A new sterile needle will be always used for each injection. After removing the cap, the needle should be carefully attached straight onto the pen.
Step 3 Perform a safety test: Prior to each injection a safety test has to be performed to ensure that pen and needle work properly and to remove air bubbles.
A dose of 2 units has to be selected.
The outer and inner needle caps should be removed.
While holding the pen with the needle pointing upwards, the insulin reservoir should be tapped gently with the finger so that any air bubbles rise up towards the needle.
Then the injection button should be pressed in completely.
If insulin has been expelled through the needle tip, then the pen and the needle are working properly. If no insulin appears at the needle tip, step 3 should be repeated until insulin appears at the needle tip.
Step 4 Select the dose: The dose can be set in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If a dose greater than 80 units is required, it should be given as two or more injections.
The dose window must show "0" following the safety test. The dose can then be selected.
Step 5 Inject the dose: The patient should be informed on the injection technique by his health care professional.
The needle should be inserted into the skin.
The injection button should be pressed in completely. Then the injection button should be held down 10 seconds before withdrawing the needle. This ensures that the full dose of insulin has been injected.
Step 6 Remove and discard the needle: The needle should always be removed after each injection and discarded. This helps prevent contamination and/or infection, entry of air into the insulin reservoir and leakage of insulin. Needles must not be reused.
Special caution must be taken when removing and disposing the needle. Recommended safety measures for removal and disposal of needles must be followed (e.g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
The pen cap should be replaced on the pen.
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