OLIMEL N9-840 Emulsion for Intravenous Infusion

Main information

Documents

Localization

  • Available in:
  • OLIMEL N9-840 Emulsion for Intravenous Infusion
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 197416
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

197416

OLIMEL N9-840 Emulsion for intravenous infusion

ARTG entry for

Medicine Registered

Sponsor

Baxter Healthcare Pty Ltd

Postal Address

PO Box 88,TOONGABBIE, NSW, 2146

Australia

ARTG Start Date

9/08/2013

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. OLIMEL N9-840 Emulsion for Intravenous Infusion

Product Type

Composite Pack

Effective date

22/07/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

OLIMEL/PeriOLIMEL is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Composite plastic

laminate

2 Years

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

2000 mL

Not scheduled. Not considered by committee

1500 mL

Not scheduled. Not considered by committee

1000 mL

Not scheduled. Not considered by committee

Components

1. Amino acid compartment

Dosage Form

Injection, intravenous infusion

Route of Administration

Intravenous Infusion

Visual Identification

middle of the three compartments containing a clear, colourless or slightly

yellow solution practically free from particles.

Active Ingredients

Alanine

8.24 g/L

Arginine

5.58 g/L

Aspartic acid

1.65 g/L

Glutamic acid

2.84 g/L

Glycine

3.95 g/L

Histidine

3.4 g/L

Isoleucine

2.84 g/L

Leucine

3.95 g/L

Lysine acetate

6.32 g/L

Methionine

2.84 g/L

Phenylalanine

3.95 g/L

Proline

3.4 g/L

Public Summary

Page 1 of

Produced at 28.11.2017 at 12:26:46 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

Serine

2.25 g/L

Threonine

2.84 g/L

Tryptophan

.95 g/L

Tyrosine

.15 g/L

Valine

3.64 g/L

2. Lipid compartment

Dosage Form

Injection, intravenous infusion

Route of Administration

Intravenous Infusion

Visual Identification

smallest outside compartment containing a homogeneous liquid with a

milky substance

Active Ingredients

Olive Oil

32 g/L

Soya Oil

8 g/L

3. Glucose compartment

Dosage Form

Injection, intravenous infusion

Route of Administration

Intravenous Infusion

Visual Identification

the largest outside compartment containing a clear, colourless or slightly

yellow solution, practically free from particles.

Active Ingredients

glucose

110 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 2 of

Produced at 28.11.2017 at 12:26:46 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

OLIMEL / PeriOLIMEL

Emulsion for Intravenous Infusion

Consumer Medicine Information

What is in this leaflet?

This leaflet answers some

common questions about

OLIMEL/PeriOLIMEL. It does

not contain all of the available

information. It does not take

the place of talking to your

doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has

weighed the risks of you using

OLIMEL/PeriOLIMEL against

the benefits he or she may

expect it will have for you.

If you have any concerns

about being administered

this medicine, ask your

doctor or pharmacist.

Keep this leaflet. You may

need to read it again.

What OLIMEL/PeriOLIMEL is

used for and how it works

OLIMEL/PeriOLIMEL is a

sterile mixture of fat (soya oil

and olive oil), amino acids and

glucose (with/without

electrolytes depending on the

formulation). It is used as a

source of energy, maintaining

the nitrogen/energy balance

and correcting essential fatty

acids deficiency. It is given as

an infusion directly into your

veins. OLIMEL/PeriOLIMEL is

intended to provide you with

nourishment (essential fatty

acids, proteins, glucose) whilst

you are unable to consume

food by mouth.

Before you are given

OLIMEL/PeriOLIMEL

OLIMEL/PeriOLIMEL should

not be given to you if:

you have had an allergic

reaction to egg or soya

proteins, peanut protein,

corn/corn products or to

any of the active or inactive

ingredients (listed at the

end of this leaflet).

you have any of the

following medical

conditions:

problems in processing

amino acids (congenital

abnormalities of amino

acid metabolism)

severe problems

metabolising/breaking

down fat resulting in

abnormally high blood

fat levels (severe

hyperlipidaemia or

hypertriglyceridaemia)

abnormally high blood

sugar levels (severe

hyperglycaemia)

abnormally high blood

levels of the electrolytes

- sodium, potassium,

magnesium, calcium

and/or phosphorus.

after the expiry date

printed on the pack or if the

packaging is torn or shows

signs of tampering.

OLIMEL/PeriOLIMEL should

not be used for newborn

babies and children less than

2 years old.

Tell your doctor if:

you are pregnant or plan to

become pregnant or are

breast-feeding

you have any heart, lung,

liver or kidney problems,

an infection, metabolic

acidosis (too much acid in

the blood), diabetes,

bleeding disorders,

anaemia and/or high level

of fat/lipids in the blood

(hyperlipidaemia)

you are taking any

medicines, including any

that you buy from your

pharmacy (with/without a

prescription), supermarket

or health food shop (e.g.

dietary/nutritional

supplements).

Ask your doctor if you have

any questions about

OLIMEL/PeriOLIMEL.

How is OLIMEL/PeriOLIMEL

to be given

How much will be given:

Your doctor will determine the

amount of OLIMEL/

PeriOLIMEL. Your doctor will

regularly monitor your

condition and test your blood

during treatment to ensure

that you receive the

OLIMEL/PeriOLIMEL Page 1 of 3

Baxter

appropriate amount of

OLIMEL/PeriOLIMEL.

How will it be given?

OLIMEL/PeriOLIMEL is given

as a slow continuous infusion

into a central vein, under the

supervision of a health care

professional (doctor or trained

nurse). PeriOLIMEL may be

given through a peripheral

vein. The recommended

duration of the infusion is

between 12 and 24 hours.

In case of overdose

As OLIMEL/PeriOLIMEL will

be given to you by a

doctor/nurse, it is unlikely that

you will be given an overdose.

However, if you are given too

much OLIMEL/PeriOLIMEL or

it is infused too quickly, you

may feel nausea, vomiting,

unwell and shivering. Your

doctor will regularly monitor

your condition and test your

blood and urine parameters to

prevent an overdose. Your

doctor has information on how

to recognise and treat an

overdose. Ask your doctor if

you have any concerns.

Side Effects

Most people do not

experience side effects.

However, as with most

medicines,

OLIMEL/PeriOLIMEL

sometimes cause unwanted

side effects. These may

include fast heart rate,

stomach pain, diarrhoea,

nausea, loss of appetite, fever

and/or chills. Tell your doctor

or pharmacist as soon as

possible if you have any of

these symptoms or do not feel

well while you are on

OLIMEL/PeriOLIMEL.

Tell your doctor or other health

care professional immediately,

if you notice any of the

following:

shortness of breath,

wheezing or difficulty

breathing

swelling of the face, lips,

tongue or other parts of

the body

rash, itching or hives on

the skin

abdominal pain, diarrhoea

and nausea

loss of appetite

reaction at injection site

These may be symptoms of

an allergic reaction. You may

need urgent medical attention.

Product Description

What do

OLIMEL/PeriOLIMEL look

like?

OLIMEL/PeriOLIMEL is

presented in a plastic bag

composed of 3 compartments

to be mixed before use. The

reconstituted mixture is a

milky white solution.

There are six different

strengths: PeriOLIMEL N4-

600E, OLIMEL N5-860E, N7-

960, N7-960E, N9-840 and

N9-840E, which contain

different amounts of the

nutrients.

Each formulation is available

in the following pack sizes:

PeriOLIMEL N4-600E -

1000 mL, 1500 mL, 2000

mL & 2500 mL

OLIMEL N5-860E - 1500

mL, 2000 mL & 2500 mL

OLIMEL N7-960 - 1000

mL, 1500 mL & 2000 mL

OLIMEL N7-960E - 1000

mL, 1500 mL & 2000 mL

OLIMEL N9-840 - 1000

mL, 1500 mL & 2000 mL

OLIMEL N9-840E - 1000

mL, 1500 mL & 2000 mL

Not all formulations and

pack sizes may be

marketed.

Ingredients:

OLIMEL/PeriOLIMEL

contains

the following active

ingredients:

17 amino acids: alanine,

arginine, aspartic acid,

glutamic acid, glycine,

histidine, isoleucine,

leucine, lysine,

methionine,

phenylalanine, proline,

serine, threonine,

tryptophan, tyrosine and

valine

Refined olive oil and

refined soya oil

Glucose

In addition, PeriOLIMEL N4-

600E and OLIMEL N5-860E,

OLIMEL/PeriOLIMEL Page 2 of 3

Baxter

N7-960E and N9-840E contain

the following electrolytes:

Calcium chloride

Magnesium chloride

Potassium chloride

Sodium acetate

Sodium glycerophosphate

hydrate

OLIMEL/PeriOLIMEL (all

formulations) also contains the

following inactive ingredients:

Egg lecithin (purified egg

phosphatide)

Glycerol

Sodium oleate

Sodium hydroxide

Glacial acetic acid

Hydrochloric acid

Water for injections

Storage Conditions

OLIMEL/PeriOLIMEL should

be stored in overpouch at a

temperature below 25

C. Do

not freeze.

Where to go for further

information?

You can get more information

about any aspect of your

treatment from your doctor or

pharmacist.

Name and Address of

Sponsor

Baxter Healthcare Pty Ltd.

1 Baxter Drive

Old Toongabbie, NSW 2146

Australia

Australian Registration

numbers:

PeriOLIMEL N4-600E -

AUST R 197419

OLIMEL N5-860E - AUST

R 197417

OLIMEL N7-960 - AUST

R 197421

OLIMEL N7-960E - AUST

R 197418

OLIMEL N9-840 - AUST

R 197416

OLIMEL N9-840E - AUST

R 197420

Date of preparation of this

leaflet: July 2016

OLIMEL and PeriOLIMEL and

Baxter are trademarks of Baxter

International Inc

OLIMEL/PeriOLIMEL Page 3 of 3

Baxter