ROCAN 0.75% (w/v) ropivacaine hydrochloride (as monohydrate) 150 mg/20 mL solution for injection ampoule

Main information

  • Trade name:
  • ROCAN 0.75% (w/v) ropivacaine hydrochloride (as monohydrate) 150 mg/20 mL solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ROCAN 0.75% (w/v) ropivacaine hydrochloride (as monohydrate) 150 mg/20 mL solution for injection ampoule
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 190569
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

190569

ROCAN 0.75% (w/v) ropivacaine hydrochloride (as monohydrate) 150 mg/20 mL solution for injection

ampoule

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

27/02/2013

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. ROCAN 0.75% (w/v) ropivacaine hydrochloride (as monohydrate) 150 mg/20 mL solution for injection

ampoule

Product Type

Single Medicine Product

Effective date

13/11/2013

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Surgical anaesthesia (Adults and children over 12 years of age),?epidural block for surgery including caesarean section,?intrathecal

anaesthesia,?field block (minor nerve block and infiltration),?major nerve block,Analgesia (Adults and children over 12 years of age),?continuous

epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain,?field block (minor nerve block and

infiltration),?continuous peripheral nerve block infusion or intermittent injections for post operative pain management,?continuous wound infusion for

postoperative pain management (adults only),Analgesia (Children aged 0 - 12 years),?Caudal epidural block in neonates (> 37 weeks gestation and

over 2500 g weight), infants and children up to and including 12 years,?Continuous epidural infusion in infants (> 30 days and over 2500 g weight) and

children up to and including 12 years,?Peripheral nerve block in children aged 1 up to and including 12 Years,For peri- and postoperative pain

management.,There are no safety or efficacy data to support the use of ROPIVACAINE ACTAVIS for analgesia for longer than 72 hours. (Data for

peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for

up to 48 hours only).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

24 Months

Store below 25

degrees Celsius

Not recorded

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

5 ampoules

(S4) Prescription Only Medicine

Components

1. ROCAN 0.75% (w/v) ropivacaine hydrochloride (as monohydrate) 150 mg/20 mL solution for injection ampoule

Dosage Form

Injection, solution

Route of Administration

Infiltration

Epidural

Intracutaneous

Intradermal

Intramuscular

Intraneural

Subcutaneous

Mucosal

Visual Identification

clear colourless solution for injection

Active Ingredients

Ropivacaine hydrochloride monohydrate

158.7 mg

Public Summary

Page 1 of

Produced at 28.11.2017 at 10:52:01 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

© 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 28.11.2017 at 10:52:01 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