Eylea Caution For Usage

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling: The vial/pre-filled syringe is for single use in one eye only.
The vial/pre-filled syringe contains more than the recommended dose of 2 mg aflibercept (equivalent to 0.05 mL). The excess volume must be discarded prior to administration.
The solution should be inspected visually for any foreign particulate matter and/or discolouration or any variation in physical appearance prior to administration. In the event of either being observed, discard the medicinal product.
For the intravitreal injection, a 30 G x ½ inch injection needle should be used.
40 mg/mL vial: Filter needle: BD Blunt Filter (Fill) Needle, not for skin injection.
Do not autoclave the BD Blunt Filter (Fill) Needle.
The filter needle is non-pyrogenic. Do not use it if individual packaging is damaged.
Discard the used BD Blunt Filter (Fill) Needle in approved sharps collector.
Caution: Re-use of the filter needle may lead to infection or other illness/injury.
Pre-filled syringe: Do not open the sterile pre-filled syringe blister outside the clean administration room.
Instructions for use of vial: 1. Remove the plastic cap and disinfect the outer part of the rubber stopper of the vial.
2. Attach the 18 G, 5-micron filter needle supplied in the carton to a 1-mL sterile, Luer-lock syringe.
3. Push the filter needle into the centre of the vial stopper until the needle is completely inserted into the vial and the tip touches the bottom or bottom edge of the vial.
4. Using aseptic technique withdraw all of the Eylea vial contents into the syringe, keeping the vial in an upright position, slightly inclined to ease complete withdrawal. To deter the introduction of air, ensure the bevel of the filter needle is submerged into the liquid. Continue to tilt the vial during withdrawal keeping the bevel of the filter needle submerged in the liquid.
5. Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle.
6. Remove the filter needle and properly dispose of it.
Note: Filter needle is not to be used for intravitreal injection.
7. Using aseptic technique, firmly twist a 30 G x ½ inch injection needle onto the Luer-lock syringe tip.
8. Holding the syringe with the needle pointing up, check the syringe for bubbles. If there are bubbles, gently tap the syringe with the finger until the bubbles rise to the top.
9. Eliminate all bubbles and expel excess medicinal product by slowly depressing the plunger so that the flat plunger edge aligns with the line that marks 0.05 mL on the syringe.
10. The vial is for single use only. Extraction of multiple doses from a single vial may increase the risk of contamination and subsequent infection.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Instructions for use of pre-filled syringe: 1. When ready to administer Eylea, open the carton and remove the sterilised blister. Carefully peel open the blister ensuring the sterility of its contents. Keep the syringe in the sterile tray until ready for assembly.
2. Using aseptic technique, remove the syringe from the sterilised blister.
3. To remove the syringe cap, hold the syringe in one hand while using the other hand to grasp the syringe cap with the thumb and fore finger. Note: Twist off (do not snap off) the syringe cap.
4. To avoid compromising the sterility of the product, do not pull back on the plunger.
5. Using aseptic technique, firmly twist the injection needle onto the Luer-lock syringe tip.
6. Holding the syringe with the needle pointing up, check the syringe for bubbles. If there are bubbles, gently tap the syringe with the finger until the bubbles rise to the top.
7. Eliminate all bubbles and expel excess medicinal product by slowly depressing the plunger to align the base of the plunger dome (not the tip of the dome) with the dosing line on the syringe (equivalent to 0.05 mL, i.e. 2 mg aflibercept).
Note: This accurate positioning of the plunger is very important, because incorrect plunger positioning can lead to delivering more or less than the labelled dose.
8. Inject while pressing the plunger carefully and with constant pressure. Do not apply additional pressure once the plunger has reached the bottom of the syringe. Do not administer any residual solution observed in the syringe.
9. The pre-filled syringe is for single use only. Extraction of multiple doses from a pre-filled syringe may increase the risk of contamination and subsequent infection. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
114.3 mg/mL vial: Extraction of multiple doses from a single vial may increase the risk of contamination and subsequent infection.
Do not use if the package or its components are expired, damaged, or have been tampered with. Check the label on the vial to make sure the patient has the strength of Eylea that they intended to use. The 8 mg dose requires use of the Eylea 114.3 mg/ml vial.
18 G, 5-micron filter needle: BD blunt filter (fill) needle, not for skin injection.
Do not autoclave BD blunt filter (fill) needle.
The filter needle is non-pyrogenic. Do not use it if individual packaging is damaged.
Discard the used BD Blunt Filter (Fill) Needle in approved sharps collector.
Caution: Re-use of the filter needle may lead to infection or other illness/injury.
The intravitreal injection should be performed with a 30 G × ½ inch injection needle (not included). Use of a smaller size needle (higher gauge) than the recommended 30 G × ½ inch injection needle may result in increased injection forces.
1. Prior to administration visually inspect the solution for injection.
Do not use the vial if particulates, cloudiness, or discolouration are visible.
2. Remove the plastic cap and disinfect the outer part of the rubber stopper of the vial.
3. Use aseptic technique to carry out steps 3-10. Attach the filter needle supplied in the carton to a 1-ml sterile, Luer-lock syringe.
4. Push the filter needle into the centre of the vial stopper until the needle is completely inserted into the vial and the tip touches the bottom or bottom edge of the vial.
5. Withdraw all of the Eylea vial content into the syringe, keeping the vial in an upright position, slightly inclined to ease complete withdrawal. To deter the introduction of air, ensure the bevel of the filter needle is submerged into the liquid. Continue to tilt the vial during withdrawal keeping the bevel of the filter needle submerged in the liquid.
6. Ensure that the plunger rod is drawn sufficiently back when emptying the vial to completely empty the filter needle. After injection any unused product must be discarded.
7. Remove the filter needle and properly dispose of it.
Note: The filter needle is not to be used for the intravitreal injection.
8. Firmly twist the 30 G × ½ inch injection needle onto the Luer-lock syringe tip.
9. Holding the syringe with the needle pointing up, check the syringe for bubbles. If there are bubbles, gently tap the syringe with the finger until the bubbles rise to the top.
10. To eliminate all bubbles and to expel excess medicinal product, slowly depress the plunger so that the flat plunger edge aligns with the line that marks 0.07 ml on the syringe.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.