Special precautions for disposal and other handling: APROKAM must be administered by intracameral injection, by an ophthalmic surgeon in the recommended aseptic conditions of cataract surgery.
VIAL IS FOR SINGLE USE ONLY.
USE ONE VIAL FOR ONE PATIENT. Stick the flag label of the vial on the patient's file.
To prepare the product for intracameral administration, please adhere to the following instructions: 1. Withdraw flip-off cap.
2. Before inserting a sterile needle, the outer part of the rubber stopper of the vial should be disinfected.
3. Push the needle vertically into the center of the vial stopper, keeping the vial in an upright position. Then, inject into the vial 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection using aseptic technique.
4. Shake gently until the solution is free from visible particles.
5. Assemble a sterile needle (18G x 1½", 1.2 mm x 40 mm) with 5-micron filter (acrylic copolymer membrane on a non-woven nylon) onto a 1 ml sterile syringe. Push this syringe vertically into the center of the vial stopper, keeping the vial in an upright position.
6. Aseptically aspire at least 0.1 ml of the solution.
7. Disconnect the 5-micron filter needle from the syringe and assemble the syringe with an appropriate anterior chamber cannula.
8. Carefully expel the air from the syringe and adjust the dose to the 0.1 ml mark on the syringe. The syringe is ready for injection.
The reconstituted solution should be visually inspected and should only be used if it is a colourless to yellowish solution free from visible particles. It has a pH and osmolality closed to the physiological values (pH about 7.3 and osmolality about 335 mosmol/kg).
After use, discard the remaining of the reconstituted solution. Do not keep it for subsequent use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Discard used needles in a sharps container.
Incompatibilities: This medicinal product must not be mixed with other medicinal products except those previously mentioned in Special precautions for disposal and other handling.