Ametop

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Tetracaine hydrochloride 4.551%{relative} equivalent to 4.0% w/w amethocaine base

Available from:

Max Health Limited

INN (International Name):

Tetracaine hydrochloride 4.551% w/w (= 4.0% w/w amethocaine base)

Dosage:

4% w/w

Pharmaceutical form:

Topical gel

Composition:

Active: Tetracaine hydrochloride 4.551%{relative} equivalent to 4.0% w/w amethocaine base Excipient: Monobasic potassium phosphate Purified water Sodium chloride Sodium hydroxide Sodium methyl hydroxybenzoate Sodium propyl hydroxybenzoate Xanthan gum

Units in package:

Tube, aluminium, 1.5 g

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Siegfried Evionnaz SA

Therapeutic indications:

Used to relieve pain when needles are inserted into a vein for giving an injection or taking a blood sample. It can also be used to relieve pain of inserting cannulae for drips.

Product summary:

Package - Contents - Shelf Life: Tube, aluminium, - 1.5 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 1 months from date of manufacture stored at or below 25°C - Tube, aluminium, 12 x 1.5g - 12 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 1 months from date of manufacture stored at or below 25°C

Authorization date:

1996-11-11

Patient Information leaflet

NON-PRINT AREA
AMETOP
® 40MG/G TOPICAL GEL
Tetracaine 4%w/w
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Magenta text, keylines and shading are NOT to be printed
Product Title:
Ametop Gel Leaflet - NZ
Date:
17-12-18
Product Size:
240 x 120mm
Label Number:
18-0644
Colours Used:
BLACK
Fonts Used:
Volkswagen
Font size (min):
9pt
Version:
2
ABOUT THIS MEDICINE
The name of this medicine is AMETOP. It
is a white semi-transparent gel
containing 4%w/w of tetracaine.
The other ingredients are purified water,
sodium chloride, potassium phosphate,
xanthan gum (E415), sodium hydroxide
and sodium methyl and
propyl-p-hydroxybenzoates (E217 and
E219).
Each tube contains 1.5g of AMETOP
topical gel from which 1g (40mg
tetracaine) can be squeezed.
AMETOP topical gel is a type of
medicine known as a local anaesthetic.
WHO MAKES THIS MEDICINE?
Perstorp Specialty Chemicals AB,
Perstorp Pharma, SE-284 80 Perstorp,
Sweden manufacture this medicine on
behalf of Alliance Pharmaceuticals
Limited, Chippenham, United Kingdom
for Max Health Ltd, Auckland, New
Zealand.
WHAT IS THIS MEDICINE FOR?
AMETOP topical gel is a local
anaesthetic which produces numbness
of the skin. It is used to relieve the pain
when needles are inserted into a vein
for giving an injection or taking a blood
sample. It can also be used to relieve
the pain of inserting small plastic tubes
(cannulae) into veins for putting up drips.
Before using this medicine
•
Is the patient allergic to any of the
ingredients given in the section “About
this medicine’ above?
•
Is the patient allergic to any other
local anaesthetics?
•
Is the patient pregnant or breast
feeding?
ABOUT THIS MEDICINE
The name of this medicine is AMETOP. It
is a white semi-transparent gel
containing 4%w/w of tetracaine.
The other ingredients are purified water,
sodium chloride, potassium phosphate,
xanthan gum (E415), sodium hydroxide
and sodium methyl and
propyl-p-hydroxybenzoates (E217 and
E219).
Each tube contains 1.5g of AMETOP
topical gel from which 1g (40mg
tetraca

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page
1
of
7
1.
PRODUCT NAME
Ametop 4% w/w topical gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of gel contains 40 mg tetracaine (as hydrochloride)
equivalent to tetracaine
base 4.0% w/w.
Excipents with known effect:
Sodium methyl parahydroxybenzoate (E219) 2 mg/g
Sodium propyl parahydroxybenzoate (E217) 0.2 mg/g
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Topical gel.
Topical, white opalescent gel.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Used to relieve pain when needles are inserted into a vein for giving
an injection or taking
a blood sample. It can also be used to relieve pain of inserting
cannulae for drips.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Adults (including the elderly): A maximum of 5 tubes (approximately
5g) can be applied at
separate sites at a single time. 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.
_Paediatric population _
Ametop is contraindicated in premature babies or in full term infants
less than 1 month of
age (see section 4.3).
Infants over 1 month and children under 5 years of age: A maximum of 1
tube
(approximately 1 g) can be applied at separate sites at a single time.
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 2 tubes.
Children over 5 years of age: A maximum of 5 tubes (approximately 5 g)
can be applied
at separate sites at a single time. 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.
METHOD OF ADMINISTRATION
_Cutaneous route. _
_Precautions to be taken before handling or administering the
medicinal product_
_ _
It may be advisable to use a finger cot or rubber glove during
application and removal of
Ametop gel. Always wash hands thoroughly after use (see section 6.6).
Apply the con