LIDOCAINE INTAS 1% lidocaine (lignocaine) hydrochloride 20 mg/2 mL injection ampoule

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
lidocaine (lignocaine) hydrochloride
Available from:
Accord Healthcare Pty Ltd
Authorization status:
Registered
Authorization number:
309527

Public Summary

Summary for ARTG Entry:

309527

LIDOCAINE INTAS 1% lidocaine (lignocaine) hydrochloride 20 mg/2 mL injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

562 Heidelberg Road,ALPHINGTON, VIC, 3078

Australia

ARTG Start Date

20/09/2019

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. LIDOCAINE INTAS 1% lidocaine (lignocaine) hydrochloride 20 mg/2 mL injection ampoule

Product Type

Single Medicine Product

Effective date

20/09/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Lidocaine Intas solutions are indicated for the production of local or regional anaesthesia by the following techniques:

? infiltration

? intravenous regional anaesthesia

? peripheral nerve block

? epidural block

? subarachnoid block

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

36 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. LIDOCAINE INTAS 1% lidocaine (lignocaine) hydrochloride 20 mg/2 mL injection ampoule

Dosage Form

Injection, solution

Route of Administration

Intravenous

Infiltration

Epidural

Intrathecal

Visual Identification

A clear, colourless solution.

Active Ingredients

lidocaine (lignocaine) hydrochloride

20 mg

Public Summary

Page 1 of

Produced at 30.09.2019 at 11:13:19 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 30.09.2019 at 11:13:19 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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