Minimsa Fluorescein Sodium 2 %/10 mg Solution
PDF Leaflet Revision Date: 13 August 2020
Clinical Summary
Quick overview from the medicine insert
Indication
For detecting corneal abrasions and foreign bodies in the eye.
Dosage (summary)
Instil dropwise into the eye; sufficient to stain damaged areas.
Pregnancy & Breastfeeding
Safety in pregnancy and lactation not established.
Contraindications
- Hypersensitivity to fluorescein sodium
- Not to be used with soft contact lenses
Common side effects
- Anaphylactic reaction
- Allergic conjunctivitis
- Periorbital oedema
- Urticaria
- Rash
- Angioedema
Counselling Points
- Discard each unit after single use
- Do not drive or operate machinery until vision is clear
Serious warnings
- Avoid microbial contamination
- Transient blurring of vision may occur
Important Disclaimer
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
For use in detecting corneal abrasions and foreign bodies in the eye, in applanation tonometry, in assessing the patency of the nasolacrimal duct and in contact lens fitting procedures.
4.2 Posology and method of administration
Instil dropwise into the eye.
Sufficient solution should be applied to stain the damaged areas. Excess may be washed away with sterile saline solution. Each MINIMS u00ae unit should be discarded after use.
4.3 Contraindications
Hypersensitivity to fluorescein sodium, or any other ingredients (see 6.1 List of excipients). 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. Pseudomonas aeruginosa grows well in fluorescein solutions, therefore, a single dose solution is preferred. Each MINIMS u00ae unit should be discarded after a single use.
4.5 Interaction with other medicines and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
Safety for use in pregnancy and lactation has not been established.
4.7 Effects on ability to drive and use machines
May cause transient blurring of vision on instillation. Patients should be warned not to drive or operate hazardous machinery until vision is clear.
4.8 Undesirable effects
Symptoms of allergic-type reactions and anaphylaxis have been reported following topical ophthalmic administration of MINIMS u00ae Fluorescein eye drops and may manifest as:
Immune system disorders:
Less frequent : anaphylactic reaction
Eye disorders:
Less frequent : allergic conjunctivitis, periorbital oedema
Skin and subcutaneous tissue disorders:
Less frequent : urticaria, rash, angioedema
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit-risk of the medicine. Health care providers are asked to report any suspected adverse reactions to the Holder of the Certificate of registration using the following e-mail address: [email protected], or directly to SAHPRA using an ADR reporting form or the e-reporting portal available on SAHPRAu2019S website: https://www.sahpra.org.za/health-products-vigilance/
4.9 Overdose
Overdose following the recommended use is unlikely. Treatment is symptomatic and supportive.
