Minims Lidocaine Hydrochloride 4% w/v & Fluorescein Sodium 0.25% w/v Eye Drops, solution

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

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Prenos Lastnosti izdelka (SPC)
20-12-2014

Aktivna sestavina:

Lignocaine hydrochloride; Fluorescein sodium

Dostopno od:

Bausch & Lomb UK Limited

Koda artikla:

S01JA; S01JA51

INN (mednarodno ime):

Lignocaine hydrochloride; Fluorescein sodium

Odmerek:

4.0/0.25 % percent weight/volume

Farmacevtska oblika:

Eye drops, solution

Tip zastaranja:

Product subject to prescription which may not be renewed (A)

Terapevtsko območje:

Colouring agents; fluorescein, combinations

Status dovoljenje:

Marketed

Datum dovoljenje:

1983-03-24

Lastnosti izdelka

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Lidocaine Hydrochloride 4% w/v & Fluorescein Sodium 0.25% w/v
Eye Drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine Hydrochloride 4 % w/v and Fluorescein Sodium 0.25 % w/v
_For a full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Eye drops, solution (eye drops)
Single use, sterile, clear, slightly yellow, slightly viscous eye
drops, solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a diagnostic stain and local 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 to two drops, as required.
_Children:_
As directed by the physician.
4.3 CONTRAINDICATIONS
Do not use in patients with a known hypersensitivity to either of the
active ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use with caution on an inflamed eye, as hyperaemia greatly increases
the rate of systemic absorption through the
conjunctiva.
The cornea may be damaged by prolonged application of anaesthetic eye
drops.
The anaesthetised eye should be protected from dust and contamination.
Systemic absorption may be minimised by compressing the lacrimal sac
at the medial canthus for one minute during and
after 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.
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