Yesafili Caution For Usage

Incompatibilities: Yesafili must not be mixed with other medicinal products.
Special Instructions for Use, Handling and Disposal: Instructions for Use: 1. Remove the plastic cap and disinfect the outer part of the rubber stopper of the vial.
2. The 18 G × 1½-inch, 5-micron, filter needle is used for withdrawal of drug product from the vial.
Remove the 18 G × 1½-inch, 5-micron, filter needle and the 1 mL syringe from their packaging. Attach the filter needle to the syringe by twisting it onto the Luer lock syringe tip.
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 Yesafili 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. Ensure the 30 G × ½-inch injection needle is used for the intravitreal injection.
Remove the 30 G × ½-inch injection needle from its packaging and using aseptic technique, firmly twist onto the Luer-lock syringe tip.
8. When ready to administer, remove the plastic needle shield from the needle.
Holding the syringe with the needle pointing up, check the syringe for bubbles. If there are bubbles, gently tap the syringe with 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.
The vial is for single use in one eye only.
The vial 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.