Fluorets

1. Name Of The Medicinal Product

Fluorets

2. Qualitative And Quantitative Composition

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

3. Pharmaceutical Form

Sterile, individually wrapped paper strips.

4. Clinical Particulars

4.1 Therapeutic Indications

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.

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

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

Not to be used with soft contact lenses.

4.4 Special Warnings And Precautions For Use

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

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

4.7 Effects On Ability To Drive And Use Machines

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

4.8 Undesirable Effects

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

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Fluorescein sodium acts as a diagnostic stain.

5.2 Pharmacokinetic Properties

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.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

None.

6.2 Incompatibilities

None.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

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

6.6 Special Precautions For Disposal And Other Handling

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

7. Marketing Authorisation Holder

Chauvin Pharmaceuticals Ltd

106 London Road

Kingston-upon-Thames

Surrey

KT2 6TN.

8. Marketing Authorisation Number(S)

PL 0033/5095R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Authorisation: 1 October 1987

Date of Renewal of Authorisation: 25 January 1998

10. Date Of Revision Of The Text

June 2007