Special precautions for disposal and other handling: The pre-filled syringe is for single use only. The pre-filled syringe is sterile. Do not use the product if the packaging is damaged. The sterility of the pre-filled syringe cannot be guaranteed unless the tray remains sealed. Do not use the pre-filled syringe if the solution is discoloured, cloudy or contains particles.
The pre-filled syringe contains more than the recommended dose of 0.5 mg. The extractable volume of the pre-filled syringe (0.1 ml) is not to be used in total. The excess volume should be expelled prior to injection. Injecting the entire volume of the pre-filled syringe could result in overdose. To expel the air bubble along with the excess medicinal product, slowly push the plunger until the edge below the dome of the rubber stopper is aligned with the black dosing line on the syringe (equivalent to 0.05 ml, i.e., 0.5 mg ranibizumab).
For the intravitreal injection, a 30G x ½" sterile injection needle should be used.
To prepare Lucentis for intravitreal administration, please adhere to the instructions for use: Introduction: Read all the instructions carefully before using the pre-filled syringe.
The pre-filled syringe is for single use only. The pre-filled syringe is sterile. Do not use the product if the packaging is damaged. The opening of the sealed tray and all subsequent steps should be done under aseptic conditions.
Note: The dose must be set to 0.05 ml.
Prepare: 1. Make sure that the pack contains: a sterile pre-filled syringe in a sealed tray.
2. Peel the lid off the syringe tray and, using aseptic technique, carefully remove the syringe.
Check syringe: 3. Check that: the syringe cap is not detached from the Luer lock; the syringe is not damaged; the solution looks clear, colourless to pale yellow and does not contain any particles.
4. If any of the previously mentioned is not true, discard the pre-filled syringe and use a new one.
Remove syringe cap: 5. Snap off (do not turn or twist) the syringe cap.
6. Dispose of the syringe cap.
Attach needle: 7. Attach a 30G x ½" sterile injection needle firmly onto the syringe by screwing it tightly onto the Luer lock.
8. Carefully remove the needle cap by pulling it straight off.
Note: Do not wipe the needle at any time.
Dislodge air bubbles: 9. Hold the syringe upright.
10. If there are any air bubbles, gently tap the syringe with the finger until the bubbles rise to the top.
Set dose: 11. Hold the syringe at eye level and carefully push the plunger until the edge below the dome of the rubber stopper is aligned with the dose mark. This will expel the air and the excess solution and set the dose to 0.05 ml.
Note: The plunger rod is not attached to the rubber stopper - this is to prevent air being drawn into the syringe.
Inject: The injection procedure should be carried out under aseptic conditions.
12. The injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe.
13. Inject slowly until the rubber stopper reaches the bottom of the syringe to deliver the volume of 0.05 ml.
14. A different scleral site should be used for subsequent injections.
15. After injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe together with the needle in a sharps disposal container or in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.