AMETOP GEL 4%

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TETRACAINE (TETRACAINE HYDROCHLORIDE)

Available from:

VALEO PHARMA INC

ATC code:

D04AB06

INN (International Name):

TETRACAINE

Dosage:

40MG

Pharmaceutical form:

GEL

Composition:

TETRACAINE (TETRACAINE HYDROCHLORIDE) 40MG

Administration route:

TOPICAL

Units in package:

1.5G

Prescription type:

Ethical

Therapeutic area:

ANTIPRURITICS AND LOCAL ANESTHETICS

Product summary:

Active ingredient group (AIG) number: 0108851002; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-07-09

Summary of Product characteristics

_Product Monograph _
_ _
_AMETOP GEL 4% (_Tetracaine Hydrochloride Gel)_ _
_Page 1 of 14 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
AMETOP® GEL 4%
Tetracaine (as tetracaine hydrochloride)
Gel, Tetracaine 4% w/w, for topical administration
Topical Analgesic
Valeo Pharma Inc.
16667 Hymus Blvd.
Kirkland (Québec)
Canada H9H 4R9
Date of Initial Authorization:
JAN 17, 1997
Date of Revision:
April 5, 2022
Submission Control Number: 257974
AMETOP is a registered trademark of Alliance Pharmaceuticals Limited
© Alliance Pharmaceuticals Limited 2022
_Product Monograph _
_ _
_AMETOP GEL 4% (_Tetracaine Hydrochloride Gel)_ _
_Page 2 of 14 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
04/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 4
4.4
Administration
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5
5
OVERDOS