CLOROGEN Eye drops, solution Ref.[50229] Active ingredients: Chloramphenicol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: FDC International Ltd, Unit 6 Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FE, United Kingdom

Product name and form

Clorogen Eye Drops 0.5% w/v.

Pharmaceutical Form

Eye Drops, solution.

A bright, colourless to faint yellow aqueous solution.

Qualitative and quantitative composition

Clorogen Eye Drops 0.5% w/v contains 5mg/ml Chloramphenicol

Excipients with known effect: Phenylmercuric Nitrate 0.002 % w/v, Borax and Boric acid (one ml of solution contains 3.075 mg boron).

For the full list of excipients, see Section 6.1.

Active Ingredient Description
Chloramphenicol

Chloramphenicol is a broad spectrum antibiotic which has activity against many types of Gram-positive and Gram-negative bacteria. It acts by interfering with bacterial protein synthesis. Chloramphenicol is widely distributed in body tissues and fluids and enters the cerebrospinal fluid.

List of Excipients

Borax
Boric acid
Phenylmercuric nitrate
Water for injection

Pack sizes and marketing

Pack Type A: 10 ml Low density polyethylene bottle with polystyrene spiked cap.

Pack Type B: Low density polyethylene (LDPE )vial with insert-cap assembly, comprising of white coloured, HDPE screw-cap over a LDPE nozzle with tamper-evident LDPE dust-cover sealing the vial cap.

Pack size: 10 ml.

Marketing authorization holder

FDC International Ltd, Unit 6 Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FE, United Kingdom

Marketing authorization dates and numbers

PL 15872/0015

27 September 2010

Drugs

Drug Countries
CLOROGEN United Kingdom, South Africa

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