OFTAQUIX Eye drops, solution Ref.[27926] Active ingredients: Levofloxacin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland

Product name and form

Oftaquix 5 mg/ml eye drops, solution.

Pharmaceutical Form

Eye drops, solution.

Clear, light yellow to light greenish-yellow solution, practically free of visible particulate matter.

Isotonic solution adjusted to physiological pH-value range.

Qualitative and quantitative composition

One ml of eye drops, solution, contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg of levofloxacin.

Excipient with known effect: One ml of eye drops solution contains 0.05 mg benzalkonium chloride and one drop contains approximately 0.002 mg of benzalkonium chloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
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 (0.05 mg in 1 ml eye drops, solution)
Sodium chloride
Sodium hydroxide or hydrochloric acid
Water for injections

Pack sizes and marketing

5 ml of solution is supplied in a 5 ml white low-density polyethylene (LDPE) bottle with a LDPE dropper tip and a tan high-density polyethylene (HDPE) screw cap.

Pack size: 1 × 5 ml.

Marketing authorization holder

Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland

Marketing authorization dates and numbers

PL 16058/0006

Date of latest renewal: 29 July 2006

Drugs

Drug Countries
OFTAQUIX Austria, Estonia, Finland, Lithuania, Malta, Poland, Romania, United Kingdom

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