Instructions for use and handling: Instructions for use of the Pagenax vial kit: Storage and inspection: Store Pagenax in the refrigerator (2°C to 8°C/36°F to 46°F); do not freeze. Keep the vial in the outer carton to protect from light.
After opening the vial, proceed under aseptic conditions.
Pagenax is a clear to slightly opalescent and colorless to slightly brownish-yellow solution.
The solution should be inspected visually upon removal from the refrigerator and prior to administration. If particulates or cloudiness are visible, the vial must not be used and appropriate replacement procedures followed.
The contents of the vial and filter needle are sterile and for single use only. Do not use if the packaging, vial and/or filter needle are damaged or expired.
How to prepare and administer Pagenax: The intravitreal injection procedure must be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis equipment (if required). Adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection.
For preparation and intravitreal injection the following single use medical devices are needed: A 30G x ½" injection needle, sterile.
A 1 mL syringe with a 0.05 mL dose mark, sterile.
The 5 μm blunt filter needle (18G x 1½", 1.2 mm x 40 mm), sterile.
The injection needle and the syringe are not included in the Pagenax vial kit.
Note: The dose must be set to 0.05 mL.
Ensure that the injection is given immediately after preparation of the dose (Step 8).
Injection procedure: 1 Remove the vial cap and clean the vial septum (e.g. with 70% alcohol swab).
2 Assemble the filter needle onto a 1 mL syringe using aseptic technique.
3 Push the filter needle into the center of the vial septum until the needle touches the bottom of the vial.
4 To withdraw the liquid, hold the vial slightly inclined and slowly withdraw all the liquid from the vial and filter needle.
Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle.
5 Disconnect the filter needle from the syringe in an aseptic manner and dispose of it.
The filter needle is not to be used for intravitreal injection.
6 Aseptically and firmly assemble a 30G x ½" injection needle onto the syringe.
7 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.
8 Carefully expel the air from the syringe and adjust the dose to the 0.05 mL mark. The syringe is ready for the injection.
9 Inject slowly until the rubber stopper reaches the end of the syringe to deliver the volume of 0.05 mL. Confirm delivery of the full dose by checking that the rubber stopper has reached the end of the syringe barrel.
Note: Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Commonly asked questions and answers: Q: What if I have difficulty withdrawing sufficient liquid from the vial?
A: Do not shake the vial before withdrawal but let the liquid settle to the bottom of the vial. Ensure the vial is in an upright, slightly inclined position. Slowly withdraw the plunger and wait for the liquid to appear in the syringe barrel. Continue to withdraw slowly to completely empty the vial and the filter needle.
Q: What if I cannot remove all the air bubbles from the liquid?
A: It is important that the liquid is air free. However, tiny air bubbles that are attached to the stopper usually do not detach from the stopper during the injection and therefore do not affect the dose volume.
Special precautions for disposal and other handling: Vial: The vial contains more than the recommended dose of 6 mg. The extractable volume of the vial (0.23 ml) is not to be used in total. The excess volume should be expelled prior to injection. Injecting the entire volume of the vial could result in overdose. The injection dose must be set to the 0.05 ml dose mark, i.e. 6 mg brolucizumab.
The solution should be inspected visually upon removal from the refrigerator and prior to administration. If particulates or cloudiness are visible, the vial must not be used, and appropriate replacement procedures must be followed.
The content of the vial and the filter needle are sterile and for single use only. Do not use if the packaging, vial and/or filter needle are damaged or expired. Detailed instructions for use are provided in the package leaflet.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.