Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Lignocaine hydrochloride; Fluorescein sodium
Bausch & Lomb UK Limited
S01JA; S01JA51
Lignocaine hydrochloride; Fluorescein sodium
4.0/0.25 % percent weight/volume
Eye drops, solution
Product subject to prescription which may not be renewed (A)
Colouring agents; fluorescein, combinations
Marketed
1983-03-24
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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Baca dokumen lengkap