MOXIVIG Eye drops Ref.[7001] Active ingredients: Moxifloxacin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland.

Therapeutic indications

Topical treatment of purulent bacterial conjunctivitis, caused by moxifloxacin susceptible strains (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Posology and method of administration

Use in adults including the elderly (≥65 years)

The dose is one drop in the affected eye(s) 3 times a day.

The infection normally improves within 5 days and treatment should then be continued for a further 2-3 days. If no improvement is observed within 5 days of initiating therapy, the diagnosis and/or treatment should be reconsidered. The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection.

Paediatric patients

No dosage adjustment is necessary.

Use in hepatic and renal impairment

No dosage adjustment is necessary.

Method of administration

For ocular use only. Not for injection. Moxivig 0.5% w/v eye drops, solution should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye.

To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.

In order to prevent the drops from being absorbed via the nasal mucosa, particularly in new-born infants or children, the nasolacrimal ducts should be held closed for 2 to 3 minutes with the fingers after administering the drops. After cap is removed, if tamper evident snap collar is loose, remove before using the product.

If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart. Eye ointments should be administered last.

Overdose

The limited holding capacity of the conjunctival sac for ophthalmic products practically precludes any overdosing of the medicinal product.

The total amount of moxifloxacin in a single container is too small to induce adverse effects after accidental ingestion.

Shelf life

3 years.

Discard 4 weeks after first opening.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

5 ml bottle with DROP-TAINER dispensing system consisting of a transparent low density polyethylene bottle and dispensing plug and white polypropylene closure. Tamper evidence is provided by a security seal around the closure of the bottle.

Pack size: box containing 1 bottle.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

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