Accu-Fine Pen Needles: Instructions for Use

Introduction

Accu-Fine sterile, single-use pen needles are designed for subcutaneous injection of medications using pen injector devices. This guide provides essential information for safe and effective use.

Important Safety Information

Note: Always check the needle gauge and length on the seal to ensure you are using the correct pen needle. Seek assistance if you have impaired vision. Healthcare professionals, caretakers, and family members assisting patients should also follow this guidance.

Consult your healthcare professional for assistance in choosing the appropriate needle length, injection technique, and site. This is also recommended for individuals injecting large doses or those with limited dexterity or strength.

Avoid infections:

• Do not reuse or share pen needles.
• Do not use pen needles if the individual packaging is damaged, the seal is missing, or the needle appears damaged.
• To prevent accidental needlesticks, never handle someone else’s pen needles.
• Pen needles are single-use only and must be disposed of safely in accordance with local regulations.
• Keep out of reach of children without adult supervision.

Follow the instructions for use, specific storage, and handling recommendations of your pen injector device and the patient information leaflet of the drug. Seek immediate medical attention if you have any health concerns.

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the local competent authorities/government agencies, as applicable.

Needle Selection Guide

See the table below for suggested needle length based on age and BMI:

* Needle length recommendations may vary. Always consult your healthcare professional.

** Longer needles (10mm, 12mm) may be recommended for individuals with higher BMI or specific injection needs.

Instructions for Use

1. Remove the seal from the pen needle.
2. Push the pen needle straight onto the pen injector device and twist until it is tight (2a). Do not push the pen needle at an angle. Then, remove the outer protective cap and set it aside (2b). Do not discard; you will need it later to remove the needle.
3. Remove the inner protective cap by pulling it straight out to prevent bending or damaging the needle tip.
4. Prime your pen injector device as per your pen’s instructions for use to prevent incorrect dosage caused by air in the cartridge or a clogged needle. If no drug flow is seen after several attempts, attach a new pen needle.
5. Set your drug dose.
6. Make the injection as directed by your healthcare professional. Do not bend the needle. Inject slowly. Do not withdraw the needle immediately after injection. Do not change the direction of the pen needle while it remains in the body, as this can result in bending or breaking the needle.
7. Replace the outer protective cap.
8. Remove the pen needle from the pen injector device after each injection to prevent air from entering the cartridge and drug from leaking out.

Warning: Remove both the outer protective cap and the inner protective cap before an injection. Failure to remove these caps may result in the medication or dose not being injected, potentially causing serious injury or death.

Injection Techniques

Choose and disinfect the injection site. Change the injection site often to avoid tissue hardening. You can inject the drug into the fatty tissue of the abdomen, buttocks, or the outer side or front of the upper thigh. Injections into the upper arm or the inner side of the upper thigh are not recommended due to the high risk of injecting into a muscle.

Recommended Techniques:

• Injection with a skin fold at a 90° angle: Recommended for vertical injection into a skin fold to prevent deep injection and muscle contact. Pinch the skin between your thumb and forefinger without pulling up the muscle.
• Injection with a skin fold at a 45° angle: Recommended when there is very little subcutaneous fatty tissue. The minimum angle should be 45°. An angle less than 45° may result in the drug not reaching the subcutaneous fatty tissue, causing swelling or bruising.
• Injection without a skin fold at a 90° angle: Suitable if your layer of subcutaneous fatty tissue is very thick. It is recommended to inject at a 90° angle using a short or medium-length needle (up to 6 mm).

Product Information and Compatibility

Accu-Fine pen needles are available in 6 versions differing in needle diameter and length to meet individual needs. The available gauges and lengths are:

• 31G: 0.25mm x 5mm (31G x 3/16''), 0.25mm x 8mm (31G x 5/16''), 0.25mm x 6mm (31G x 1/4'')
• 32G: 0.23mm x 4mm (32G x 5/32''), 0.23mm x 6mm (32G x 1/4'')
• 33G: 0.20mm x 4mm (33G x 5/32'')

Compatibility: Accu-Fine pen needles are compatible with most pen injectors available on the market, including models from BBraun, Berlin-Chemie, Eli Lilly, Haselmeier, Owen Mumford, Sano Aventis, NovoNordisk, Bioton, Ganli Technology, YPSOMED, and Pharmstandard. For a detailed list of compatible devices, visit: www.htl-strefa.com/products/pen-needles/

Manufacturer and Distributor Information

Manufacturer: HTL-STREFA S.A., ul. Adamówek 7, 95-035 Ozorków, Poland

Distributed by: Roche Diabetes Care GmbH, Sandhofer Strasse 116, 68305 Mannheim, Germany

Website: www.accu-chek.com