SMOFKABIVEN ELECTROLYTE FREE amino acids 5.1% / lipids 3.8% / glucose 12.7% emulsion for intravenous infusion bag 1477 mL

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Localization

  • Available in:
  • SMOFKABIVEN ELECTROLYTE FREE amino acids 5.1% / lipids 3.8% / glucose 12.7% emulsion for intravenous infusion bag 1477 mL
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 180548
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

180548

SMOFKABIVEN ELECTROLYTE FREE amino acids 5.1% / lipids 3.8% / glucose 12.7% emulsion for

intravenous infusion bag 1477 mL

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

9/01/2012

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. SMOFKABIVEN ELECTROLYTE FREE amino acids 5.1% / lipids 3.8% / glucose 12.7% emulsion for

intravenous infusion bag 1477 mL

Product Type

Composite Pack

Effective date

26/04/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Parenteral nutrition for adult patients when oral or enteral nutrition is impossible, insufficient or contraindicated.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Composite plastic

laminate

2 Years

Store below 25

degrees Celsius

Not recorded

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

1 x 1477 mL, 4 x 1477 mL (Excel bag)

Not scheduled. Not considered by committee

1 x 1477 mL, 4 x 1477 mL (Biofine bag)

Not scheduled. Not considered by committee

Components

1. Glucose Solution

Dosage Form

Injection, intravenous infusion

Route of Administration

Intravenous Infusion

Visual Identification

A clear and colourless to slightly yellow solution free from particles.

Active Ingredients

glucose

420 g/L

2. Lipid Emulsion

Dosage Form

Injection, intravenous infusion

Route of Administration

Intravenous Infusion

Visual Identification

White homogenous emulsion.

Active Ingredients

Fish oil - rich in Omega-3 acids

30 g/L

medium chain triglycerides

60 g/L

Olive Oil

50 g/L

Soya Oil

60 g/L

3. Amino acid solution

Public Summary

Page 1 of

Produced at 29.11.2017 at 08:05:49 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

Dosage Form

Injection, intravenous infusion

Route of Administration

Intravenous Infusion

Visual Identification

A clear and colourless to slightly yellow solution.

Active Ingredients

Alanine

14 g/L

Arginine

12 g/L

Glycine

11 g/L

Histidine

3 g/L

Isoleucine

5 g/L

Leucine

7.4 g/L

Lysine acetate

9.3 g/L

Methionine

4.3 g/L

Phenylalanine

5.1 g/L

Proline

11.2 g/L

Serine

6.5 g/L

Taurine

1 g/L

Threonine

4.4 g/L

Tryptophan

2 g/L

Tyrosine

.4 g/L

Valine

6.2 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 29.11.2017 at 08:05:49 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

Page 1 of 2

SmofKabiven

®

Electrolyte Free

Amino acids 5.1%, lipids 3.8% & glucose 12.7%

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

SmofKabiven Electrolyte Free. It

does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

medicines

have

risks and benefits. Your doctor

has weighed the risks of you given

SmofKabiven

Electrolyte

Free

against any benefits they expect it

will have for you.

Please read this leaflet carefully.

If you have any questions or are

unsure

about

anything,

please

ask your doctor or pharmacist.

Keep this leaflet. You may need

to read it again.

What

is

SmofKabiven

Electrolyte

Free

used

for

SmofKabiven

Electrolyte

Free

an emulsion for infusion given into

your blood by a drip (intravenous

infusion).

product

contains

amino acids (components used to

build

proteins),

glucose

(carbohydrates) and lipids (fat) in a

plastic bag.

A health care professional will give

you SmofKabiven Electrolyte Free

when other forms of feeding are

good

enough

have

worked.

Before

you

are

given

SmofKabiven

Electrolyte Free

You must NOT use this product:

allergic

(hypersensitive) to any of

ingredients

SmofKabiven

Electrolyte

Free

if you are allergic to fish or

allergic

peanuts,

soya

corn

(maize)

SmofKabiven

Electrolyte

Free

contains

soya oil

if you have too much fat in

blood

(hyperlipidaemia)

have

serious

liver

disease

have

blood

clotting

problems

(coagulation

disorders)

if your body has problems

using amino acids

if you have serious kidney

disease without access to

dialysis

if you are in acute shock

if you have too much sugar

your

blood

(hyperglycaemia) which is

uncontrolled

if you have fluid in the lungs

(acute pulmonary oedema)

if you have too much body

fluid (hyperhydrated)

if you have heart failure that

is not treated

if you have a defect in your

blood

clotting

system

(haemophagocytotic

syndrome)

unstable

condition,

such

after

serious trauma, uncontrolled

diabetes, acute heart attack,

stroke, blood clot, metabolic

acidosis

disturbance

resulting in too much acid in

the blood), serious infection

(severe sepsis), coma and if

you don’t have enough body

fluid

(hypotonic

dehydration).

Special care has to be taken while

this product is given to you. Tell

your doctor if you have:

kidney problems

diabetes mellitus

pancreatitis (inflammation of

the pancreas)

liver problems

hypothyrodism (toxic goiter)

sepsis (serious infection)

If during the infusion you get fever,

rash,

swelling,

difficulty

breathing, chills, sweating, nausea

vomiting,

tell

health

care

professional immediately because

these symptoms might be caused

by an allergic reaction or that you

have been given too much of the

medicine.

Your doctor may regularly need to

check your blood for liver function

tests and other values.

SmofKabiven

Electrolyte

Free

not used for newborn babies or

children younger than 2 years of

age. At the moment, there is no

experience

SmofKabiven

Electrolyte

Free

children from 2 to 11 years old.

Please tell your doctor if you have

recently

have

taken

some

medicines,

even

without

prescription.

Tell your doctor if you are pregnant

or plan to become pregnant or are

breastfeeding.

SmofKabiven

Electrolyte

Free

should

only

given to pregnant or breast-feeding

womens

doctor

find

necessary.

How

SmofKabiven

Electrolyte

Free

is

given

How much will be given

Your doctor will decide on the dose

for you individually depending on

your

body

weight

function.

SmofKabiven Electrolyte Free will

Page 2 of 2

be given to you by a health care

professional.

How is it given

SmofKabiven

Electrolyte

Free

should

administered

continuous flow into a large main

vein using a sterile tubing and a

catheter needle. It should only be

administered

qualified

medical staff.

If

you

are

given

too

much

(overdose)

This

rarely

happens

SmofKabiven

Electrolyte

Free

usually

administered

under

care

trained

health

care

professional in a hospital or clinic

setting.

Your

doctor

information

recognise

treat

overdose. Ask your doctor if you

have any concerns.

Otherwise

immediately

telephone

your doctor or contact the Poisons

Information Centre in your country.

Australia: 13 11 26

New Zealand: 0800 764 766.

Side Effects

Like

medicines,

SmofKabiven

Electrolyte

Free

cause

side

effects,

although

everybody

gets them.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you:

Nausea and Vomiting

Flatulence

Abdominal pain

Swelling of hands, ankles

or feet

Fast heart beat

Difficulty in breathing

Lack of appetite

high

blood

pressure

Slight

increase

body

temperature

Chills

Dizziness

Headaches

Hypersensitivity

reactions

(skin rash)

Sensations of hot and cold

Pain

neck,

back,

bones, chest

Paleness

If any of these side effects occurs,

or if you notice any side effects not

listed in this leaflet, please contact

your doctor or a pharmacist.

Storage

SmofKabiven

Electrolyte

Free

should be stored in its overpouch

below 25

C and not be frozen. As

with

medicine,

SmofKabiven

Electrolyte Free should be stored

out of the reach of children. Do

not use infusion bags that have

been used, have expired or the

container is damaged.

Product Description

What it looks like

SmofKabiven

Electrolyte

Free

comes in a 3-chamber plastic bag,

each

chamber

contains

glucose,

amino acids and a lipid emulsion

separately. The glucose and amino

acid solutions are clear, colourless

slightly

yellow

free

from

particles.

lipid

emulsion

white and homogeneous.

Ingredients

SmofKabiven

Electrolyte

Free

contains

active

ingredients

Alanine,

Arginine,

Glycine,

Histidine,

Isoleucine,

Leucine,

Lysine

acetate,

Methionine,

Phenylalanine,

Proline,

Serine,

Taurine,

Threonine,

Tryptophan,

Tyrosine,

Valine,

Glucose

monohydrate,

Soya

oil,

Medium

chain

triglycerides,

Olive

Rich in omega-3 fish oil.

also

contains

other

inactive

ingredients such as glycerol, egg

lecithin,

dl-

-tocopherol,

sodium

hydroxide, sodium oleate, glacial

acetic acid, hydrochloric acid and

water for injections.

SmofKabiven

Electrolyte

Free

does not contain gluten, lactose,

sucrose,

tartrazine

other

azo dyes.

SmofKabiven

Electrolyte

Free

does not contain any preservative.

SmofKabiven

Electrolyte

Free

comes in a plastic container called

Excel

Biofine

pack

sizes. They can be identified by

the following AUST R numbers:

AUST R 173891: 986mL

AUST R 180548: 1477mL

AUST R 180549: 1970mL

AUST R 180550: 2463mL

Further Information

More

detailed

information

available

from

your

doctor

pharmacist. Therefore, if you have

concerns

about

information or about SmofKabiven

Electrolyte Free please ask your

doctor or pharmacist.

Sponsor

Fresenius

Kabi

Australia

Limited

Level 2, 2 Woodland Way

Mount Kuring-gai NSW 2080

Australia

Telephone: (02) 9391 5555

Fresenius

Kabi

Zealand

Limited

60 Pavilion Drive

Airport Oaks, Auckland 2022

New Zealand

Freecall: 0800 144 892

® = Registered Trademark

Date of information

April 2016.