Minims Fluorescein Sodium 1%, w/v Eye Drops, Solution

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Fluorescein sodium

Pieejams no:

Bausch + Lomb Ireland Limited

ATĶ kods:

S01JA; S01JA01

SNN (starptautisko nepatentēto nosaukumu):

Fluorescein sodium

Zāļu forma:

Eye drops, solution

Ārstniecības joma:

Colouring agents; fluorescein

Autorizācija statuss:

Not marketed

Autorizācija datums:

1983-04-01

Lietošanas instrukcija

Bausch & Lomb
MINIMS® FLUORESCEIN SODIUM 1% W/V
MINIMS® FLUORESCEIN SODIUM 2% W/V
EYE DROPS, SOLUTION
FLUORESCEIN SODIUM
Read all this leaflet carefully BEFORE you start using your medicine.
It contains a summary of
the information available on your medicine. If you have any questions
or are not sure about
anything, ask your doctor or pharmacist.
Remember this medicine is for you. Do not give it to someone else.
IN THIS LEAFLET:
1.
What Minims® Fluorescein sodium eye drops are and what they are used
for
2.
Before you use your eye drops
3.
How to use your eye drops
4.
Possible side effects
5.
How to store your eye drops
6.
Further information
1. WHAT MINIMS® FLUORESCEIN SODIUM EYE DROPS ARE AND WHAT THEY ARE
USED FOR
Minims® Fluorescein sodium contains a diagnostic agent. The active
substance, fluorescein sodium,
is a temporary dye used to:
.
help your doctor or eye specialist to examine your eye,
.
help your doctor or eye specialist to measure the pressure inside your
eye by a test called
tonometry,
.
help in the fitting of hard contact lenses.
Scratches on the conjunctiva (the lining of the inside of the eyelids
and part of the eye) are stained
yellow or orange by fluorescein.
Damages to the cornea (the transparent membrane covering the surface
of the eye) are stained
green.
Any foreign bodies which are stuck in your eye are surrounded by a
green ring.
This medicine is indicated for children, adults and the elderly.
2. BEFORE YOU USE YOUR EYE DROPS DO NOT USE THESE DROPS IF
.
you are allergic to the active substance (fluorescein).
.
you wear soft contact lenses.
IF YOU ARE PREGNANT, MAY BE PREGNANT, OR ARE BREASTFEEDING
Tell your doctor or eye specialist, he/she may decide to use these
drops or to prescribe you an
alternative.
CONTACT LENSES
Your doctor will ask you to remove your soft contact lenses prior to
the administration of the drops.
There is no information on the effect of this product on soft contact
lenses. Therefore, do not wear
your soft contact lenses until the effects of the drops have
comple

Produkta apraksts

Health Products Regulatory Authority
03 June 2022
CRN00CTV7
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Fluorescein Sodium 1%, w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1% w/v solution of Fluorescein Sodium
_For a full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Eye Drops, Solution (Eye Drops)
Clear, orange-red, aqueous single-use eye drop solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
4.3 CONTRAINDICATIONS
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
Special care should be taken to avoid microbial contamination.
Each Minims unit should be discarded after a single use.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
Safety for use in pregnancy and lactation has not been established,
therefore use only when considered essential by the
physician.
Health Products Regulatory Authority
03 June 2022
CRN00CTV7
Page 2 of 3
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
May cause transient blurring of vision on instillation. Warn patients
not to drive or operate hazardous machinery until 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 oph