APO-Metaraminol metaraminol (as tartrate) 10 mg/1 mL solution for injection ampoule

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

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Active ingredient:
metaraminol tartrate
Available from:
Apotex Pty Ltd
Authorization status:
Registered
Authorization number:
309264

Public Summary

Summary for ARTG Entry:

309264

APO-Metaraminol metaraminol (as tartrate) 10 mg/1 mL solution for injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

26/09/2019

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. APO-Metaraminol metaraminol (as tartrate) 10 mg/1 mL solution for injection ampoule

Product Type

Single Medicine Product

Effective date

26/09/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Prevention and treatment of the acute hypotensive state occurring with spinal anaesthesia; adjunctive treatment of hypotension due to haemorrhage,

reactions to medications, surgical complications, and shock associated with brain damage due to tumour or trauma.,It may also be useful as an adjunct

in the treatment of hypotension due to cardiogenic shock or septicaemia.

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

12 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APO-Metaraminol metaraminol (as tartrate) 10 mg/1 mL solution for injection ampoule

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

clear colorless solution

Active Ingredients

metaraminol tartrate

18.976 mg

© 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 1 of

Produced at 30.09.2019 at 12:11:15 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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