Before you start
	Read all the instructions carefully before using VABYSMO.
	The VABYSMO kit includes a glass vial and transfer filter needle. The glass vial is for a single dose only. The filter needle is for treatment of a single eye.
	VABYSMO should be stored refrigerated at temperatures between 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake.
	Allow VABYSMO to reach room temperature, 20°C to 25°C (68°F to 77°F) before proceeding with the administration. Keep the vial in the original carton to protect from light.
	The VABYSMO vial may be kept at room temperature for up to 24 hours.
	The VABYSMO vial should be inspected visually for particulate matter and discoloration prior to administration. VABYSMO is a clear to opalescent and colorless to brownish-yellow liquid solution. Do not use if particulates, cloudiness, or discoloration are visible. Do not use if the packaging, vial and/or transfer filter needle are expired, damaged, or have been tampered with (see Figure F).

	Figure F
Use aseptic technique to carry out the preparation of the intravitreal injection.
1	Gather the following supplies: One VABYSMO vial (included) One sterile 5-micron blunt transfer filter needle 18-gauge × 1½ inch (included) One sterile 1 mL Luer lock syringe with a 0.05 mL dose mark (not included) Note that a 30-gauge injection needle is recommended to avoid increased injection forces that could be experienced with smaller diameter needles. One sterile injection needle 30-gauge × ½ inch (not included) Alcohol swab (not included).
2	To ensure all liquid settles at the bottom of the vial, place the vial upright on a flat surface (for about 1 minute) after removal from packaging (see Figure G). Gently tap the vial with your finger (see Figure H), as liquid may stick to the top of the vial.

	Figure G	Figure H
3	Remove the flip-off cap from the vial (see Figure I) and wipe the vial septum with an alcohol swab (see Figure J).

	Figure I	Figure J
4	Aseptically and firmly attach the included 18-gauge × 1½ inch transfer filter needle onto a 1 mL Luer lock syringe (see Figure K).

	Figure K
5	Using aseptic technique, push the transfer filter needle into the center of the vial septum (see Figure L), push it all the way in, then tilt the vial slightly so that the needle touches the bottom edge of the vial (see Figure M).

	Figure L	Figure M
6	Hold the vial slightly inclined and slowly withdraw all the liquid from the vial (see Figure N). Keep the bevel of the transfer filter needle submerged in the liquid, to avoid introduction of air.

	Figure N
7	Ensure that the plunger rod is drawn sufficiently back when emptying the vial, in order to completely empty the transfer filter needle (see Figure N).
8	Disconnect the transfer filter needle from the syringe and dispose of it in accordance with local regulations.
	Do not use the transfer filter needle for the intravitreal injection.
9	Aseptically and firmly attach a 30-gauge × ½ inch injection needle onto the Luer lock syringe (see Figure O).

	Figure O
10	Carefully remove the plastic needle shield from the needle by pulling it straight off.
11	To check for air bubbles, hold the syringe with the needle pointing up. If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure P).

	Figure P
12	Carefully expel the air from the syringe and needle, and slowly depress the plunger to align the rubber stopper tip to the 0.05 mL dose mark. The syringe is ready for the injection (see Figure Q). Ensure that the injection is given immediately after preparation of the dose.

	Figure Q

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