Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
VOXIDEX is indicated in adults for prevention and treatment of inflammation, and prevention of infection associated with cataract surgery.
One drop instilled into the conjunctival sac directly after surgery, then every 6 hours thereafter. Duration of treatment is 7 days. Care should be taken not to discontinue therapy prematurely.
If one dose is missed, treatment should continue with the next dose as planned.
No dosage adjustment in elderly patients is necessary.
VOXIDEX has not been studied in patients with renal impairment.
VOXIDEX has not been studied in patients with hepatic impairment.
The safety and efficacy of VOXIDEX in children and adolescents below the age of 18 years have not been established. No data are available.
Ocular use.
Administer one drop in the affected eye.
Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures as this could cause injury to the eye.
Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
The total amount of levofloxacin and dexamethasone 21-Phosphate in vial of VOXIDEX is too small to induce toxic effects after an accidental oral intake.
In the case of topical overdose, the treatment should be stopped. In case of prolonged irritation, the eye(s) should be rinsed with sterile water. The symptomatology due to accidental ingestion is not known. The medical practitioner may consider emesis.
Unopened: 24 months.
Discard within 28 days after first opening.
Store at or below 30°C, in original packaging.
For storage conditions after opening, see section 6.3.
VOXIDEX is packaged in a white low-density polyethylene (LDPE) bottle, with a white low-density polyethylene (LDPE) dropper and sealed with a white high-density polyethylene (HDPE) screw cap. A sealed and labelled bottle, filled with 5 ml of the eye drops solution, is packed into an outer carton.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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