Ionolyte

Main information

  • Trade name:
  • Ionolyte sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride, Injection for intravenous infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ionolyte sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride, Injection for intravenous infusion
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213304
  • Last update:
  • 10-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213304

Ionolyte sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride, Injection for

intravenous infusion 1000 mL Freeflex bag

ARTG entry for

Medicine Registered

Sponsor

Fresenius Kabi Australia Pty Ltd

Postal Address

Level 2, 2 Woodland Way,Mount Kuring-gai, NSW, 2080

Australia

ARTG Start Date

9/05/2014

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. Ionolyte sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride, Injection for

intravenous infusion 1000 mL Freeflex bag

Product Type

Single Medicine Product

Effective date

24/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Ionolyte is indicated for:,-mild metabolic acidosis,-as a source of water and electrolytes

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Plastic

36 Months

Store below 30

degrees Celsius

Not recorded

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

1000mL x 10 bags

Not scheduled. Not considered by committee

Components

1. Ionolyte sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride, Injection for intravenous infusion 1000

mL Freeflex bag

Dosage Form

Injection, intravenous infusion

Route of Administration

Intravenous Infusion

Visual Identification

Ionolyte solution for infusion is a clear and colourless solution.

Active Ingredients

magnesium chloride hexahydrate

.3 g/L

potassium chloride

.3 g/L

Sodium acetate trihydrate

4.63 g/L

sodium chloride

6.02 g/L

© 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 11:18:54 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

CMI for Ionolyte

Mar 2016

Filename: IonCMI210316-clean

Page 1 of 3

Change: Address Change + AAN

Ionolyte

®

Sodium

chloride,

sodium

acetate

trihydrate,

potassium

chloride

and

magnesium

chloride hexahydrate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Ionolyte. It does

contain

available

information. It does not take the

place of talking to your doctor or

pharmacist.

medicines

have

risks

benefits. Your doctor has weighed

the risk of you using this product

against the benefits they expect it

will have for you.

Please read this leaflet carefully.

If you have any concerns about

taking

this

medicine,

ask

your

doctor or pharmacist. Keep this

leaflet. You may need to read it

again.

What is Ionolyte used

for

Ionolyte is a sterile infusion solution

used

source

water

electrolytes (salts). It is also used

when there is an acid imbalance in

the body.

Ask your doctor if you have any

questions

about

why

this

medicine

has

been

prescribed

for you.

Ionolyte is not addictive.

Before

you

are

given

Ionolyte

When

you

must

not

be

given

Ionolyte

must

given

this

product if:

You have too much fluid in your

body and you have been told

that you have a condition known

as hyperhydration

have

been

told

that

have pulmonary edema where

too much fluid is in your lungs

have

been

told

that

have a congestive heart failure

(a condition in which your heart

cannot pump enough blood to

other organs of your body)

have

severely

impaired

kidney function

You have decreased acidity of

the blood caused by a metabolic

disorder

You have high potassium levels

in your blood

You are allergic (hypersensitive)

to any of the active and inactive

ingredients of this product

If you are not sure whether you

should be given this medicine,

talk to your doctor.

Before you are given Ionolyte

Your

doctor

need

take

special precautions and will decide

whether you can receive Ionolyte if:

You suffer from heart failure

suffer

from

severe

heart

rate disorders

You suffer from impaired kidney

function

have

severe

electrolyte

abnormalities

(e.g

high

blood

levels

potassium,

sodium, magnesium or chloride)

You have high blood pressure

suffer

from

eclampsia

(complication

pregnancy

mainly manifested by high blood

pressure

significant

amounts of protein in the urine)

suffer

from

aldosteronism

(syndrome

high

blood

pressure

blood

potassium levels caused by an

excess of the natural hormone

aldosterone)

have

other

treatments

conditions

associated

with

sodium

retention

(e.g.

corticoids/steroids)

taking

potassium-

sparing

diuretics

(used

increase the urine volume)

have

severe

potassium

deficiency

you have taken heavy doses of

digitalis

medicine

used

treatment of heart diseases)

suffer

from

myasthenia

gravis

disease

involving

severe muscle weakness)

you recently had an operation

where

muscle

relaxant

used (neuromuscular block)

larger volumes of this solution

are to be used

Tell

your

doctor

if

any

of

the

warnings listed above applies to

you or when this has been the

case in the past.

Taking other medicines

Tell your doctor or pharmacist if

you

are

taking

any

other

medicines,

including

any

that

you

get

without

a

prescription

CMI for Ionolyte

Mar 2016

Filename: IonCMI210316-clean

Page 2 of 3

Change: Address Change + AAN

from

your

pharmacy,

supermarket

or

health

food

shop.

Ionolyte is not recommended if you

are taking/using:

corticoids/steroids

(for

treatment

digestive

tract

ulcers) as these are associated

with

retention

sodium

water (with fluid accumulation

tissues

high

blood

pressure)

potassium-sparing

diuretics

(used

increase

urine

volume,

such

amiloride,

spironolactone,

triamterene,

given alone or in combination)

angiotensin converting enzyme

inhibitors (ACE inhibitors) and

angiotensin

receptor

antagonists (medicines that are

mainly

used

controlling

blood pressure, treating heart

failure)

tacrolimus

cyclosporine

(medicine

used

prevent

organ rejection)

muscle relaxants

salicylates (used to ease pains

and reduce fever)

lithium (anti-psychotic)

alkaline

drugs

like

sympathomimetics

(such

amphetamine).

Using

Ionolyte

with

food

and

drink

Ionolyte is not known to have any

negative effect when given at the

same time as food and drink.

Pregnancy and breast-feeding

Please tell your doctor if you are

pregnant,

you

think

you

are

pregnant,

planning

to

become

pregnant

or

if

you

are

breast-

feeding.

safety

product

pregnant

breast-feeding

women has not been investigated.

Your doctor will only give Ionolyte

after having weighed the benefits

versus

potential

risk

baby.

Driving and using machines

Ionolyte has no effect on the ability

to drive or use machines.

How Ionolyte is given

How much will you be given

Ionolyte

will

given

hospital by a doctor or nurse. You

will

receive

your

medicine

intravenous infusion (infusion into a

vein).

The amount and rate at which the

infusion is given depends on your

condition. Your doctor will decide

correct

dose

receive.

If you take too much (overdose)

very

unlikely

that

will

receive

more

infusion

than

should, because this medicine will

be given to you by your doctor or

nurse who will monitor you during

the treatment. However, tell your

doctor or nurse if you have any

concerns.

In the event of accidental overdose,

treatment will be stopped and you

will

observed

signs

symptoms

related

drug.

Therapeutic removal of excessive

fluid might be necessary.

If you have any further questions

on the use of this product, ask

your doctor or pharmacist.

information

management of overdose, contact

the Poison Information Centre on

13 11 26 (Australia) or 0800 764

766 (New Zealand).

Side Effects

Like

medicines

Ionolyte

cause

side

effects,

although

everybody gets them. If any of the

side effects gets serious, or if you

notice any side effects not listed in

this leaflet, please tell your doctor

or nursing staff immediately:

Very common (occurring in more

than 1 in 10 patients):

hyperhydration

(too

much

fluid

your

body)

heart failure in patients with

heart

disorder

pulmonary

oedema

(fluid

accumulation in the lungs)

Common (occurring in more than 1

in 100 patients, but less than 1 in

10 patients):

Large

volumes

this

solution

lead

dilution of components of

the blood and decrease in

the haematocrit (proportion

blood

volume

that

occupied

blood

cells)

Other side effects include:

fluid

accumulation

tissues (oedema)

fever

infection

site

injection,

local

pain

reaction

vein

irritation,

venous

thrombosis (formation of a

clot)

phlebitis

(inflammation of the vein)

extending from the site of

injection

extravasation (fluid leakage

from the vein)

will

monitored

your

doctor

nurse

during

treatment

with this medicine. If any of these

side effects appear, the treatment

will be stopped.

Other

side

effects

listed

above

occur

some

patients. Tell your doctor if you

notice

anything

else

that

making

feel

unwell.

this

occurs, the use of this product

should be stopped immediately.

Tell your doctor or pharmacist if

you

notice

anything

that

is

making you feel unwell. Discuss

CMI for Ionolyte

Mar 2016

Filename: IonCMI210316-clean

Page 3 of 3

Change: Address Change + AAN

any concerns you have with your

doctor.

Storage

Ionolyte

should

stored

below

C and not be frozen. As with

any medicine, Ionolyte should be

stored out of the reach of children.

Do not use the product after the

expiry date shown on the label or

the container is damaged.

Disposal

The hospital staff will dispose of

any unused Ionolyte.

Product Description

What Ionolyte looks like

Ionolyte

sterile,

clear

colourless solution for intravenous

infusion that comes in 500 mL and

1000 mL freeflex

bags.

Ingredients

Ionolyte

contains

active

ingredients:

sodium

chloride,

sodium

acetate

trihydrate,

potassium chloride and magnesium

chloride hexahydrate.

Ionolyte also contains the inactive

ingredients:

sodium

hydroxide,

hydrochloric

acid

water

injections.

Ionolyte does not contain lactose,

sucrose, gluten, tartrazine or any

other azo dyes.

Ionolyte

does

contain

preservative.

Ionolyte comes in 2 different sizes

of plastic (freeflex

®

) bag. They can

be identified by the following AUST

R numbers:

Australian Registration Number

Ionolyte

solution for

infusion 500

mL in packs of 20 bags:

AUST R 211732

Ionolyte solution for infusion 1000

mL in packs of 10 bags:

AUST R 213304

Further Information

More

detailed

information

available

from

your

doctor

pharmacist. Therefore, if you have

any concerns about the information

or about Ionolyte please ask your

doctor or pharmacist.

Sponsor

Supplied in Australia by:

Fresenius

Kabi

Australia

Limited

Level 2, 2 Woodland Way

Mount Kuring-gai NSW 2080

Australia

Tel: (02) 9391 5555

Supplied in New Zealand by:

Fesenius

Kabi

Zealand

Limited

60 Pavilion Drive

Airport Oaks, Auckland

New Zealand

Freecall: 0800 144 892

® = Registered Trademark

Date of Information

This leaflet was prepared in Mar

2016.

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