AMETOP 40 mg/g Gel
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
17-09-2016
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Active ingredient:
TETRACAINE HYDROCHLORIDE
Available from:
Smith & Nephew Healthcare Limited
ATC code:
N01BA03
INN (International Name):
TETRACAINE HYDROCHLORIDE
Dosage:
40 mg/g
Pharmaceutical form:
Gel
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Esters of aminobenzoic acid
Authorization status:
Transfer Pending
Authorization date:
1996-05-21
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ametop 40 mg/g Gel.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of gel contains 40 mg tetracaine (as hydrochloride) equivalent to tetracaine base 4.0% w/w.
Excipients:
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gel
White, opalescent gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Percutaneous local anaesthetic to produce anaesthesia of the skin prior to venepuncture, venous cannulation or non-
ablative dermal laser procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elderly) and children over 1 month of age:
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.
Adequate anaesthesia can usually be achieved following a thirty minute application time for venepuncture, and a forty-
five minute application time for venous cannulation and an application time of one to two hours for laser procedures,
after which the gel should be removed with a gauze swab and the site prepared with an antiseptic wipe in the normal
manner.
Up to five tubes of Ametop Gel can be applied for dermal laser procedures, however no more than one tube should be
applied to children under 5 years of age.
Application of Ametop Gel can be repeated after a maximum 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.
Sodium methyl parahydroxbenzoate
(E219) 2 mg/
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