PHENYLEPHRINE INTAS phenylephrine hydrochloride 10 mg/1 mL solution for injection vial

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

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Active ingredient:
phenylephrine hydrochloride
Available from:
Accord Healthcare Pty Ltd
Authorization status:
Registered
Authorization number:
327731

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Public Summary

Summary for ARTG Entry:

327731

PHENYLEPHRINE INTAS phenylephrine hydrochloride 10 mg/1 mL solution for injection vial

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street, Melbourne, VIC, 3000

Australia

ARTG Start Date

16/11/2020

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 . PHENYLEPHRINE INTAS phenylephrine hydrochloride 10 mg/1 mL solution for injection vial

Product Type

Single Medicine Product

Effective Date

16/11/2020

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

For the maintenance of an adequate level of blood pressure during spinal and inhalation anaesthesia and for the treatment of vascular failure in shock,

shock-like states, and drug-induced hypotension, or hypersensitivity. It is also employed to overcome paroxysmal supraventricular tachycardia, to prolong

spinal anaesthesia, and as a vasoconstrictor in regional analgesia

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1 . PHENYLEPHRINE INTAS phenylephrine hydrochloride 10 mg/1 mL solution for injection vial

Dosage Form

Injection, solution

Route of Administration

Intramuscular

Subcutaneous

Intravenous

Visual Identification

A clear colourless solution

Active Ingredients

Public Summary

Page 1 of

Produced at 12.01.2021 at 06:23:11 AEDT

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

phenylephrine hydrochloride

10 mg

Other Ingredients (Excipients)

citric acid monohydrate

hydrochloric acid

sodium chloride

sodium citrate dihydrate

sodium hydroxide

sodium metabisulfite

water for injections

© 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 12.01.2021 at 06:23:11 AEDT

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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