Fluorets

Paper strips each impregnated with approximately 1mg Fluorescein Sodium Ph Eur.

Sterile, individually wrapped paper strips.

Fluorescein is a corneal stain and can be used in diagnostic examinations of the eye including Goldmann tonometry and in the fitting of contact lenses.

One Fluoret moistened with tear fluid, sterile water or sterile ophthalmic solution applied topically to the eye should be sufficient to provide adequate corneal staining.

Not for use in patients with a known hypersensitivity to fluorescein.

Not to be used with soft contact lenses.

Care should be taken to handle the strip by the non-impregnated end. The applicator should be used once and discarded.

None known.

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

May cause transient blurring of vision when applied. Warn patients not to drive or operate hazardous machinery unless 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

Not applicable.

Fluorescein sodium 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.

None.

None.

5 years.

Store below 25°C

Individually wrapped sterile paper strips, supplied in cartons containing 100 Fluorets.

Each Fluoret should be handled by the non-impregnated end. Fluorets should be used once and discarded.

Chauvin Pharmaceuticals Ltd

106 London Road

Kingston-upon-Thames

Surrey

KT2 6TN.

PL 0033/5095R

Date of First Authorisation: 1 October 1987

Date of Renewal of Authorisation: 25 January 1998

June 2007