Minims Lidocaine & Fluorescein
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Lidocaine & Fluorescein.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clear, slightly yellow, slightly viscous eye drops containing Lidocaine Hydrochloride Ph.Eur 4% w/v and Fluorescein Sodium BP 0.25% w/v.
3 PHARMACEUTICAL FORM
Single-use, sterile eye drops.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
As a diagnostic stain and topical anaesthetic combined. Minims Lidocaine & Fluorescein can be used in the measurement of intraocular pressure by Goldmann tonometry.
4.2 Posology and method of administration
Adults (including the elderly):
One or more drops, as required.
Children:
As directed by the physician.
4.3 Contraindications
Do not use in patients with a known hypersensitivity to fluorescein or Lidocaine and other amide-type local anaesthetics.
4.4 Special warnings and precautions for use
The anaesthetised eye should be protected from foreign body contamination, particularly in elderly patients in whom the duration of anaesthesia may exceed 30 minutes.
Use with caution in an inflamed eye as hyperaemia greatly increases the rate of systemic absorption through the conjunctiva.
Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, Pregnancy and lactation
This combination has been used for a number of years without apparent ill-consequence.
4.7 Effects on ability to drive and use machines
None known.
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
Overdose is not expected to cause any adverse effects, however, overuse of local anaesthetics can cause keratitis, with loss of corneal epithelium and stromal opacity.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Lidocaine is an established topical anaesthetic which blocks the sensory nerve endings of the cornea.
The fluorescein moiety 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.
5.2 Pharmacokinetic properties
None relevant.
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 the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Polyvidone Hydrochloric Acid Purified Water
6.2 Incompatibilities
None known.
6.4
6.5
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Nature and contents of container
A sealed, conical shaped container fitted with a twist and pull-off cap. Each Minims unit is overwrapped in an individual polypropylene/paper pouch. Each container holds approximately 0.5ml of solution.
MARKETING AUTHORISATION HOLDER
Bausch & Lomb UK Limited Bausch & Lomb House 106 London Road Kingston-Upon-Thames Surrey, UK KT2 6TN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first Authorisation: 14th June 1978
24/03/2015