BD ChloraPrep

Main information

  • Trade name:
  • BD ChloraPrep with Tint cutaneous solution applicator
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BD ChloraPrep with Tint cutaneous solution applicator
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221654
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221654

BD ChloraPrep with Tint cutaneous solution applicator

ARTG entry for

Medicine Registered

Sponsor

Becton Dickinson Pty Ltd

Postal Address

Locked Bag 3200,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

24/03/2014

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

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. BD ChloraPrep with Tint cutaneous solution applicator

Product Type

Single Medicine Product

Effective date

13/09/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Sterile tinted antiseptic applied to patient's skin prior to invasive medical procedures.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Not recorded

2 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

3, 10.5 and 26 mL

(S5) Caution

Components

1.

Dosage Form

Solution

Route of Administration

Topical

Visual Identification

Orange solution

Active Ingredients

chlorhexidine gluconate

20 mg/mL

isopropyl alcohol

.7 mL/mL

© 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 26.11.2017 at 12:51:03 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

1-11-2018

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Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

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Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

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Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

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2-10-2018

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27-9-2018

Health Canada reminds Canadians not to mix caffeinated drinks with alcohol

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September 27, 2018 Ottawa Health Canada

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6-9-2018

Beaumont Bio Med, Inc. Issues Voluntary Nationwide Recall of all their Homeopathic Aqueous/Alcohol-Based Medicines due to the Nationwide Recall by the Contract Manufacturer, King Bio, of all their Aqueous-Based Products due to Possible Microbial Contamina

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Beaumont Bio Med, Inc. is voluntarily recalling its entire aqueous/alcohol-based product line for human use, within expiry, to the consumer level. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

20-8-2018

Drug and Alcohol Use During Orientation Week

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Health Canada

26-6-2018

Blokhuis: 1 miljoen euro voor Caribisch Preventie- en Sportakkoord

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Voor Caribisch Nederland is er met ingang van 2019 jaarlijks zo’n 1 miljoen euro extra beschikbaar om roken, overgewicht en problematisch alcoholgebruik tegen te gaan en gezond eten, bewegen en sporten te bevorderen. Dat heeft staatssecretaris Paul Blokhuis (VWS) bekend gemaakt bij zijn bezoeken aan Saba en Sint Eustatius.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

23-5-2018

95% Ethyl Alcohol Product by Ethanol Extraction: Recall - Due to a Possible Contamination with Methanol

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Methanol,a highly toxic type of alcohol, can cause serious and sometimes fatal damage if ingested by humans or animals.

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Ethanol Extraction Recalls Alcohol Product Because of Possible Health Risk

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FDA - U.S. Food and Drug Administration

17-1-2013

Danish Pharmacovigilance Update, 15 November 2012

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In this issue of Danish Pharmacovigilance Update: Chlorhexidine and the risk of anaphylactic reaction.

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1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

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