Neostigmine

Main information

  • Trade name:
  • Neostigmine Juno neostigmine methylsulfate 2.5 mg/1 ml solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Neostigmine Juno neostigmine methylsulfate 2.5 mg/1 ml solution for injection ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219054
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219054

Neostigmine Juno neostigmine methylsulfate 2.5 mg/1 ml solution for injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Horizon Hospital Healthcare Pty Ltd

Postal Address

PO Box 175,CARNEGIE, VIC, 3163

Australia

ARTG Start Date

27/01/2015

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. Neostigmine Juno neostigmine methylsulfate 2.5 mg/1 ml solution for injection ampoule

Product Type

Single Medicine Product

Effective date

23/05/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Reversal of the effects of non-depolarising neuromuscular blocking agents (e.g. tubocurarine, pancuronium etc). Prophylaxis and treatment of

post-operative intestinal atony and urinary retention. Treatment of myasthenia gravis during acute exacerbations, when the condition is severe or in

neonates.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

36 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

10 ampoules

(S4) Prescription Only Medicine

50 ampoules

(S4) Prescription Only Medicine

Components

1. Neostigmine Juno neostigmine methylsulfate 2.5 mg/1 ml solution for injection ampoule

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Intravenous

Intramuscular

Visual Identification

Clear, colourless solution

Active Ingredients

neostigmine methylsulfate

2.5 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 26.11.2017 at 03:59:44 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

Patient Information leaflet

Neostigmine Juno Solution for Injection – Consumer Medicine Information

15.JU.M.1.0

Page 1

NEOSTIGMINE

Juno SOLUTION FOR

INJECTION

Neostigmine Methylsulfate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the

common questions about

Neostigmine Juno Solution for

Injection. It does not contain all

the information that is known

about Neostigmine Juno

Solution for Injection. It does not

take the place of talking to your

doctor or pharmacist.

All medicines have risks and

benefits. Your doctor will have

weighed the risks of you being

given Neostigmine Juno Solution

for Injection against the benefits

they expect it will have for you.

If you have any concerns

about this medicine talk to

your doctor or pharmacist.

Keep this leaflet. You may need

to read it again.

What Neostigmine

Juno Solution for

Injection is used for

Neostigmine Juno Solution for

Injection increases movement of

the muscles in the body.

It can be used:

To reverse the effects of

medicines that are used to stop

muscles moving;

To activate the muscles in the

bladder, stomach and

intestines following surgery

For myasthenia gravis.

Neostigmine is known as a

cholinesterase inhibitor. It works

by stopping a chemical called

acetylcholine, which stimulates

muscles movement, from

breaking down.

Your doctor will have explained

why you are being treated with

Neostigmine Juno Solution for

Injection.

Follow all directions given to

you by your doctor carefully.

They may differ from the

information contained in this

leaflet.

Your doctor may prescribe this

medicine for another use. Ask

your doctor if you want more

information.

Neostigmine Juno Solution for

Injection is not addictive.

Before you are given

Neostigmine Juno

Solution for Injection

You may already have been

given Neostigmine Juno Solution

for Injection. Your doctor will

have considered the situation

carefully and decided to use it.

However, if any of any of the

following applies to you, tell your

doctor immediately.

When you must not use it

You should not be given

Neostigmine Juno Solution for

Injection if you are

breastfeeding unless your

doctor says so. Ask your

doctor about the risks and

benefits involved.

It may make your baby arrive

early if you are given it in the last

weeks before your baby is due.

Your baby can take in very small

amounts of Neostigmine Juno

Solution for Injection from breast

milk if you are breastfeeding.

You must not be given

Neostigmine Juno Solution for

Injection if:

You are sensitive to

neostigmine

You have an allergy to any

ingredient listed at the end

of this leaflet or any other

related medicines.

If you have an allergic reaction,

you may get a skin rash,

hayfever, asthma or feel faint.

You should not be given

Neostigmine Juno Solution for

Injection if you have the

following medical conditions:

Blockage of the intestines or

urinary tract

Peritonitis

Neostigmine Juno Solution for

Injection will only be used if

the solution is clear, the

package is undamaged and

the use by (expiry) date

marked on the pack has not

been passed.

Before you are given it

You must tell your doctor if

you have any of these medical

conditions:

Recent surgery involving the

intestine or bladder

Other intestinal or bladder

problems

Asthma

Heart disease or other heart

problems

Epilepsy

Low blood pressure

Parkinsons disease

Stomach ulcer

Kidney problems

Addison’s disease

An overactive thyroid gland

It may not be safe for you to be

given Neostigmine Juno Solution

for Injection if you have any of

these conditions.

Taking other medicines

You must tell your doctor if

Neostigmine Juno Solution for Injection – Consumer Medicine Information

15.JU.M.1.0

Page 2

you are taking any other

medicines, including

medicines that you can buy at

the chemist, supermarket or

health food shop.

Some medicines and

Neostigmine Juno Solution for

Injection may interfere with each

other. These include:

Corticosteroids

Atropine

Antibiotics

Medicine for heart problems

including beta blockers

Lithium

Chloriquinine,

hydroxychloroquinine

Quinine

These medicines may affect the

way Neostigmine Juno Solution

for Injection works. Your doctor

or pharmacist can tell you what

to do if you are taking any of

these medicines.

If you have not told your

doctor about any of these

things, tell them before you

are given any Neostigmine.

How Neostigmine

Juno Injection is

given

Neostigmine Juno Solution for

Injection will be given to you by a

doctor or a specially trained

nurse.

It may be given just under the

skin, into a muscle, or directly

into the bloodstream. The dose

you will be given will be carefully

worked out depending on the

procedure and your body weight.

Overdose

The doctor or nurse giving

you Neostigmine Juno

Solution for Injection will be

experienced in its use, so it is

extremely unlikely that you

will be given too much.

However, the first signs of

overdose can be nausea,

vomiting, muscle cramps,

sweating, increased saliva and

changes in heart rate.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel well while you are receiving

Neostigmine Juno Solution for

Injection.

Neostigmine Juno Solution for

Injection helps most people with

muscle weakness but may have

some unwanted side effects in a

few people.

All medicines have side effects.

Sometimes they are serious,

most of the time they are not.

You may need medical

treatment if you get some of the

side effects.

Ask your doctor or pharmacist

to answer any questions you

may have.

Tell your doctor if you notice

any of the following and they

worry you:

Nausea and vomiting

Diarrhoea

Stomach cramps or flatulence

Involuntary urination or

defecation

Sweating

Increased saliva or mucous

production

Faintness, dizziness or

weakness

Changes in vision

Muscle cramps or twitching

Drowsiness or restlessness

Increased secretion of tears

from the eyes

Headache

Slurred speech

Agitation or fear

Itching

These are all mild side effects of

Neostigmine Juno Solution for

Injection.

Tell your doctor or nurse

immediately or go to casualty

at your nearest hospital if you

notice any of the following:

Slowed heart rate or

palpitations

Shortness of breath, tightness

in the chest or wheezing

Severe rash

Irritation

Swollen face

Convulsions

These are all serious side

effects. You may need urgent

medical attention.

Tell your doctor if you notice

anything else that is making

you feel unwell.

Storage

Neostigmine Juno Solution for

Injection will be stored by your

doctor or pharmacist under the

recommended conditions.

It should be kept in a cool, dry

place where the temperature

stays below 25 degrees C.

Disposal

Any Neostigmine Juno Solution

for Injection which is not used

will be disposed of in a safe

manner by your doctor or

pharmacist.

Product description

Neostigmine Juno Solution for

Injection is a clear, colourless

solution presented in clear glass

ampoules

It contains neostigmine

methylsulfate 2.5 mg/ml as the

active ingredient, plus sodium

chloride and Water for injections.

Sponsor

Horizon Hospital Healthcare Pty

3 Walnut Street,

Carnegie, VIC 3163

AUSTRALIA

This leaflet was prepared in

August 2014.

Australian Registration Number:

2.5 mg/ml ampoule AUSTR

219054

2-7-2018

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services is voluntarily recalling two (2) lots of Neostigmine Methylsulfate 5mL syringes to the user/hospital/clinic level. The specified product lots are being recalled because of a confirmed customer complaint that some syringe units containing Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL are incorrectly labelled as Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL. Secondary packages are properly labelled as Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL.

FDA - U.S. Food and Drug Administration

There are no news related to this product.