DBL GLYCOPYRROLATE

Main information

  • Trade name:
  • DBL GLYCOPYRROLATE INJECTION glycopyrronium bromide (glycopyrrolate) 0.2 mg/1 mL solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DBL GLYCOPYRROLATE INJECTION glycopyrronium bromide (glycopyrrolate) 0.2 mg/1 mL solution for injection ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220017
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220017

DBL GLYCOPYRROLATE INJECTION glycopyrronium bromide (glycopyrrolate) 0.2 mg/1 mL solution for

injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

28/07/2015

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. DBL GLYCOPYRROLATE INJECTION glycopyrronium bromide (glycopyrrolate) 0.2 mg/1 mL solution for

injection ampoule

Product Type

Single Medicine Product

Effective date

21/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

As a preoperative antimuscarinic to reduce salivary, tracheobronchial and pharyngeal secretions, and to reduce the acidity and volume of the gastric

contents. As a preoperative or intra-operative antimuscarinic to attenuate or prevent intra¯operative bradycardia associated with the use of

suxamethonium or due to cardiac vagal reflexes. To protect against the peripheral muscarinic actions (e.g. bradycardia and excessive secretions) of

anticholinesterases such as neostigmine or pyridostigmine given to reverse neuromuscular blockade produced by non-depolarising muscle relaxants.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

5 ampoules per pack

(S4) Prescription Only Medicine

Components

1. DBL GLYCOPYRROLATE INJECTION glycopyrrolate 0.2 mg/1 mL solution for injection ampoule

Dosage Form

Injection, solution

Route of Administration

Intravenous

Intramuscular

Visual Identification

Clear, colourless solution in a clear glass ampoule

Active Ingredients

glycopyrronium bromide (glycopyrrolate)

.2 mg/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 03:03:08 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

16-11-2018

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