AMETOP 40 MG/G GEL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TETRACAINE HYDROCHLORIDE

Available from:

Alliance Pharmaceuticals Ltd.

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:

tetracaine

Authorization status:

Marketed

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/g
Sodium propyl parahydroxybenzoate
(E217)
0.2 mg/g
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