AMETOP 4% w/w Gel (2018)
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Περιεχόμενα
Name of the medicinal product
Ametop Gel 4% w/w.
Qualitative and quantitative composition
Tetracaine base 4.0% w/w.
Pharmaceutical form
Topical, white opalescent gel, each gram containing 40mg of tetracaine base.
Therapeutic indications
Percutaneous local anaesthetic to produce anaesthesia of the skin prior to venepuncture or venous cannulation.
Posology and method of administration
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. ...
Contraindications
Use in premature babies or in full term infants less than 1 month of age, where the metabolic pathway for Tetracaine may not be fully developed. For premature babies use of Ametop is not recommended before ...
Special warnings and precautions for use
Only apply to intact, normal skin. Not to be taken internally. Ametop gel, like other local anaesthetics may be ototoxic and should not be instilled into the middle ear or used for procedures which might ...
Interaction with other medicinal products and other forms of interaction
None known.
Pregnancy and lactation
There is no specific information as to the safety of Tetracaine in pregnancy, although Tetracaine has been in wide use for many years without apparent illconsequence. The rapid hydrolysis of Tetracaine ...
Effects on ability to drive and use machines
No adverse effects on the ability to drive or to use hazardous machinery are expected following use of Ametop Gel.
Undesirable effects
Slight erythema is frequently seen at the site of application and is due to the pharmacological action of Tetracaine in dilating capillary vessels. This may help delineating the anaesthetised area. Slight ...
Overdose
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 ...
Pharmacodynamic properties
Tetracaine is a local anaesthetic and is believed to act by blocking nerve conduction mainly by inhibiting sodium ion flux across the axon membrane. Tetracaine achieves this by acting upon specific receptors ...
Pharmacokinetic properties
The ester type caine anaesthetics are rapidly metabolised in blood mainly by plasma pseudocholinesterase. A 3.33μM (1μg/ml) concentration of tetracaine was fully metabolised in human plasma within 20 seconds. ...
Preclinical safety data
None stated.
List of excipients
In addition to the active ingredient, Ametop gel contains: Sodium Hydroxide B.P Sodium methyl-p-hydroxybenzoate B.P Sodium propyl-p-hydroxybenzoate B.P Monobasic potassium phosphate USNF Xanthan gum USNF ...
Incompatibilities
None known.
Shelf life
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 ...
Special precautions for storage
Store at 2-8°C. Do not freeze. Protect from heat.
Nature and contents of container
1.5g, internally lacquered, aluminium collapsible tubes, designed to deliver 1.0g of Ametop gel on squeezing.
Special precautions for disposal and other handling
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. ...
Marketing authorization holder
Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, United Kingdom
Marketing authorization number(s)
PL 16853/0150
Date of first authorization / renewal of the authorization
10/07/1995 / 09/10/2006
Date of revision of the text
09/03/2018
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