AMETOP 4% w/w Gel Ref.[7959] Active ingredients: Tetracaine

Adults (including the elderly) and children over 5 years: A maximum of 5 tubes (approximately 5g) can be applied.

Children over 1 month of age and under 5 years: No more than 1 tube should be applied.

Apply the contents of the tube to the centre of the area to be anaesthetised and cover with an occlusive dressing. The contents expellable from 1 tube (approximately 1 gram) are sufficient to cover and anaesthetise an area of up to 30 sq.cm. (6x5cm). Smaller areas of anaesthetised skin may be adequate in infants and small children. Each tube is intended for use on a single occasion only.

Adequate anaesthesia can usually be achieved following a thirty minute application time for venepuncture, and a forty-five minute application time for venous cannulation, after which the gel should be removed with a gauze swab and the site prepared with an antiseptic wipe in the normal manner.

It is not necessary to apply Ametop gel for longer than 30-45 minutes and anaesthesia remains for 4-6 hours in most patients after a single application.

Application of Ametop gel can be repeated after a minimum of 5 hours if necessary.

The maximum cumulative dose in a 24 hour period should not exceed 7 tubes for adults and 2 tubes for children.

Not recommended for infants under 1 month of age.

Overdosage with Ametop gel is unlikely to result from application to intact skin. If accidentally ingested systemic toxicity may occur, and signs will be similar to those observed after administration of other local anaesthetics. These signs have been described as: signs of inebriation, tingling, numbness of the tongue, tinnitus, nystagmus, nausea or vomiting, twitching and ultimately convulsions. Oxygen is recommended as the first line treatment for systemic toxicity.

The shelf-life should not exceed 24 months from the date of manufacture.

Within the recommended shelf-life of 2 years at 2-8°C, the product, following dispensing may be stored for up to 1 month at 25°C at point of use.

Store at 2-8°C. Do not freeze. Protect from heat.

1.5g, internally lacquered, aluminium collapsible tubes, designed to deliver 1.0g of Ametop gel on squeezing.

As tetracaine can cause contact sensitisation reactions, particularly with repeated contact, healthcare professionals should take care to minimise contact with Ametop gel during application and removal.