"The U.S. Food and Drug Administration today approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP). The device, which includes a small video camera, transmitter "...
DOSAGE AND ADMINISTRATION
Miochol®-E (acetylcholine chloride intraocular solution) is instilled into the anterior chamber before or after securing one or more sutures. Instillation should be gentle and parallel to the iris face and tangential to pupil border.
If there are no mechanical hindrances, the pupil starts to constrict in seconds and the peripheral iris is drawn away from the angle of the anterior chamber. Any anatomical hindrance to miosis must be released to permit the desired effect of the drug. In most cases, 0.5 to 2 mL produces satisfactory miosis. Note that the syringe filter supplied with Miochol-E (acetylcholine chloride intraocular solution) has a priming volume of 0.6 mL (approximately).
In cataract surgery, use Miochol-E only after delivery of the lens.
Aqueous solutions of acetylcholine chloride are unstable. Prepare solution immediately before use. Do not use solution which is not clear and colorless. Discard any solution that has not been used.
DIRECTIONS FOR PREPARING MIOCHOL®-E (acetylcholine chloride intraocular solution) :
STERILE UNLESS PACKAGE OPEN OR BROKEN
- Inspect the unopened blister, vial and ampoule to ensure that they are all intact. Peel open the blister under a sterile field. Maintain sterility of the outer containers of the vial and ampoule during preparation of solution.
- Aseptically attach a sterile 18-20 gauge, beveled needle to the luer tip of a sterile disposable syringe with a twisting motion to assure a secure fit.
- Break open the ampoule containing the diluent. The One Point Cut (OPC) ampoule must be opened as follows: Hold the bottom part of the ampoule with the thumb pointing to the colored dot. Grasp the top of the ampoule with the other hand, positioning the thumb at the colored dot, and press back to break at the existing cut under the dot.
- Remove the needle protector and withdraw the diluent from the ampoule into the syringe. Discard the ampoule.
- Remove and discard the cap from the top of the vial.
- Insert the needle through the center of the vial stopper, and transfer the diluent from the syringe to the vial. Shake gently to dissolve the powder.
- Slowly withdraw the solution from the vial through the needle into the syringe. Discard the needle.
- Aseptically open the syringe filter pouch, and attach the filter onto the luer tip of the syringe with a twisting motion to assure a secure fit.
- Aseptically attach a sterile blunt tip irrigation cannula to the male luer of the filter prior to intraocular irrigation.
Discard the filter appropriately after use.
Do not reuse the syringe filter.
Do not aspirate and inject through the same filter.
Miochol®-E (acetylcholine chloride intraocular solution). . . . . . . . . NDC 0078-0474-61
One blister pack containing the following components:
- Vial of 20 mg acetylcholine chloride powder for intraocular solution
- Ampoule of 2 mL diluent
One 0.2 micron sterile filter
- Priming volume 0.6 mL (approximately)
Store at 4° -25°C (39° -77°F).
KEEP FROM FREEZING.
REV: MARCH 2007. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. FDA revision date: 5/30/2006
Last reviewed on RxList: 11/18/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Miochol-E Information
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