Minims Fluorescein Sodium 2%

2% w/v solution of Fluorescein Sodium PhEur.

Single-use, sterile eye drops.

As a diagnostic stain.

Fluorescein does not stain a normal cornea but conjunctival abrasions are stained yellow or orange, corneal abrasions or ulcers are stained a bright green and foreign bodies are surrounded by a green ring.

Fluorescein can be used in diagnostic examinations including Goldmann tonometry and in the fitting of hard contact lenses.

Adults, Children and the Elderly

Instil dropwise into the eye.

Sufficient solution should be applied to stain the damaged areas. Excess may be washed away with sterile saline solution.

Not to be used with soft contact lenses.

Special care should be taken to avoid microbial contamination. Pseudomonas aeruginosa grows well in fluorescein solutions, therefore, a single dose solution is preferred. Each Minims unit should be discarded after a single use.

None known.

Safety for use in pregnancy and lactation has not been established, therefore use only when considered essential by the physician.

May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery until vision is clear.

ADRs are very rare(<1/10,000),including isolated reports.

Symptoms of allergic-type reactions and anaphylaxis have been reported following topical ophthalmic administration of Fluorescein sodium and may manifest as:

Eye disorders: allergic conjunctivitis, peri-orbital oedema

Immune system disorders: anaphylactic reaction

Skin and subcutaneous tissue disorders: urticaria, rash

Overdose following the recommended use is unlikely.

Fluorescein acts as a diagnostic stain.

Fluorescein will resist penetration of a normal cornea and most excess solution will, therefore, be carried with the tear film away from the conjunctival sac. The majority will be lost through the naso-lacrimal ducts and absorbed via the gastro-intestinal tract from where it is converted rapidly to its glucuronide and excreted via the urine.

If fluorescein crosses the cornea it will enter the Bowman's membrane, stroma and possibly the anterior chamber. Aqueous flow and diffusion into the blood in the anterior chamber finally removes fluorescein from the eye and it is excreted unchanged in the urine.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of this SPC.

Purified Water

None known.

Unopened: 15 months.

Store below 25°C. Do not freeze. Protect from light.

A sealed conical shaped polypropylene container fitted with a twist and pull off cap. Each Minims unit contains approximately 0.5ml of solution. Each unit is overwrapped in a polypropylene/paper pouch. 20 units are packed into a suitable carton.

Each Minims unit should be discarded after use.

Chauvin Pharmaceuticals Ltd

106 London Road

Kingston-upon-Thames

Surrey

KT2 6TN

PL 0033/5008R

Date of first Authorisation: 23 April 1987

Date of renewal of Authorisation: 18 February 1992

June 2007