Ranibizumab

FOR OPHTHALMIC INTRAVITREAL INJECTION. Vials : A 5-micron sterile filter needle (19-gauge × 1-1/2 inch), a 1-mL Luer lock syringe and a 30-gauge × 1/2 inch sterile injection needle are needed but not included. 2.2 Neovascular (Wet) Age-Related Macular Degeneration (AMD) CIMERLI 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days). Although not as effective, patients may be treated with 3 monthly doses followed by less frequent dosing with regular assessment. In the 9 months after three initial monthly doses, less frequent dosing with 4-5 doses on average is expected to maintain visual acuity while monthly dosing may be expected to result in an additional average 1-2 letter gain.

for Administration Vial: Using aseptic technique, all of the CIMERLI vial contents are withdrawn through a 5-micron (19-gauge × 1-1/2 inch), sterile filter needle attached to a 1 mL syringe (not included). The filter needle should be discarded after withdrawal of the vial contents and should not be used for intravitreal injection. The filter needle should be replaced with a sterile 30-gauge × 1/2 inch needle for the intravitreal injection. Use aseptic technique to carry out the following preparation steps: 1. Prepare for intravitreal injection with the following medical devices

for use in a single eye (not included): • a 5-micron sterile filter needle (19-gauge × 1-1/2 inch) • a 1 mL sterile Luer lock syringe (with marking to measure 0.05 mL) • a sterile injection needle (30-gauge × 1/2-inch) 2. Before withdrawal, disinfect the outer part of the rubber stopper of the vial. 3. Place a 5-micron filter needle (19-gauge × 1-1/2 inch) onto a 1 mL Luer lock syringe using aseptic technique. 4. Push the filter needle into the center of the vial stopper until the needle touches the bottom edge of the vial. 5. Withdraw all the liquid from the vial, keeping the vial in an upright position, slightly inclined to ease complete withdrawal. 6. Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle. 7.