Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
VOXIDEX 5 mg/1 mg per 1 ml eye drops.
| Pharmaceutical Form |
|---|
|
Eye drops, solution (eye drops). A clear, greenish-yellow solution, free from visible particles, with a pH of 7,0 to 7,4 and osmolality of 270 to 330 mOsm/Kg. |
Each 1 ml of VOXIDEX eye drops, solution, contains levofloxacin hemihydrate equivalent to 5 mg of levofloxacin and dexamethasone sodium phosphate equivalent to 1 mg of free dexamethasone.
One drop (about 30 μl) contains about 0,150 mg of levofloxacin and 0,03 mg of dexamethasone.
Preservative: Benzalkonium chloride 0,005% m/v.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dexamethasone |
Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity. It has an approximately 7 times greater anti-inflammatory potency than prednisolone, another commonly prescribed corticosteroid. At high doses it reduces the immune response. |
|
| Levofloxacin |
Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class. As a fluoroquinolone antibacterial agent, levofloxacin acts on the DNA – DNA-gyrase complex and topoisomerase IV. |
| List of Excipients |
|---|
|
Benzalkonium chloride |
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.
PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
54/15.3/0836
14 September 2021
| Drug | Countries | |
|---|---|---|
| VOXIDEX | South Africa |
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