Accentrix Caution For Usage





Full Prescribing Info
Caution For Usage
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Instructions for Use and Handling: Vials (adults and preterm infants): Vials are for single use only (see DOSAGE & ADMINISTRATION). After injection any unused product must be discarded.
The vial is sterile. Do not use the vial if the packaging is damaged. The sterility of the vial cannot be guaranteed unless the packaging seal remains intact. Do not use the vial if the solution is discolored, cloudy, or contains particulates.
For preparation and intravitreal injection, the following single-use medical devices are needed: a 5 micrometer filter needle (18G); a 1 mL sterile syringe; an injection needle (30G x ½ inch).
The 1 mL sterile syringe and the injection needle are not supplied in the Accentrix pack that contains the vial and the filter needle.
To prepare Accentrix for intravitreal administration, please adhere to the following instructions: 1. Before withdrawal, remove the vial cap and clean the vial septum (e.g. with 70% alcohol swab).
2. Attach a 5 micrometer filter needle (18G) to a 1 mL syringe using aseptic technique. Push the blunt filter needle into the center of the vial stopper until the needle touches the bottom edge of the vial.
3. Withdraw all the liquid from the vial, keeping the vial in an upright position, slightly inclined to ease complete withdrawal.
4. Ensure that the plunger rod is drawn back sufficiently when emptying the vial in order to completely empty the filter needle.
5. Leave the blunt filter needle in the vial and disconnect the syringe from the blunt filter needle. The filter needle should be discarded after withdrawal of the vial contents and should not be used for the intravitreal injection.
6. Aseptically and firmly attach an injection needle (30G x ½ inch) to the syringe.
7. Carefully remove the cap from the injection needle without disconnecting the injection needle from the syringe.
Note: Grip at the yellow hub of the injection needle while removing the cap.
8. Carefully expel the air from the syringe and adjust the dose to the appropriate mark on the syringe. The dose for adults is 0.05 mL. The dose for preterm infants is 0.02 mL. The syringe is ready for injection.
Note: Do not wipe the injection needle. Do not pull back on the plunger.
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.
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