SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 1970 mL

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Localization

  • Available in:
  • SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 1970 mL
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 180546
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

180546

SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for

intravenous infusion bag 1970 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 amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous

infusion bag 1970 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 1970 mL, 2 x 1970 mL (Excel bag)

Not scheduled. Not considered by committee

1 x 1970 mL, 4 x 1970 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 with Electrolytes

Public Summary

Page 1 of

Produced at 29.11.2017 at 08:07:00 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

calcium chloride dihydrate

.56 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

magnesium sulfate heptahydrate

2.47 g/L

Methionine

4.3 g/L

Phenylalanine

5.1 g/L

potassium chloride

4.48 g/L

Proline

11.2 g/L

Serine

6.5 g/L

Sodium acetate trihydrate

5.62 g/L

Sodium glycerophosphate

4.18 g/L

Taurine

1 g/L

Threonine

4.4 g/L

Tryptophan

2 g/L

Tyrosine

.4 g/L

Valine

6.2 g/L

Zinc sulfate heptahydrate

.023 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 08:07:00 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

®

Amino acids 5.1%, lipids 3.8%, glucose 12.7% & electrolytes 0.7%

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

SmofKabiven. It does not contain

available

information.

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 given SmofKabiven against

benefits

they

expect

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

used for

SmofKabiven

emulsion

infusion given into your blood by a

drip

(intravenous

infusion).

product

contains

amino

acids

(components

used

build

proteins), glucose (carbohydrates),

lipids (fat) and salts (electrolytes)

in a plastic bag.

A health care professional will give

SmofKabiven

when

other

forms

feeding

good

enough or have not worked.

Before

you

are

given

SmofKabiven

You must NOT use this product:

allergic

(hypersensitive) to any of

ingredients

SmofKabiven

if you are allergic to fish or

allergic

peanuts,

soya

corn

(maize)

SmofKabiven

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

have

high

blood

(serum) levels of the salts

(electrolytes)

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

suitable

use in neonates and infants below

2 years of age. There is at present

no clinical trial conducted on the

SmofKabiven

children

age 2 years to 11 years.

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

should only be given to pregnant

breast-feeding

women

doctor finds it necessary.

How

SmofKabiven

is

given

How much will be given

Your doctor will decide on the dose

for you individually depending on

your

body

weight

function.

SmofKabiven will be given to you

by a health care professional.

How is it given

SmofKabiven

should

administered

continuous

flow

into

large

main

vein

using

Page 2 of 2

sterile

tubing

catheter

needle.

should

only

administered

qualified

medical staff.

If

you

are

given

too

much

(overdose)

This

rarely

happens

SmofKabiven

usually

administered under the care of a

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

can cause side effects, although

not 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 should be stored in

its overpouch below 25

C and not

be frozen. As with any medicine,

SmofKabiven should be stored out

of the reach of children. Do not

use infusion bags that have been

used,

have

expired

container is damaged.

Product Description

What it looks like

SmofKabiven

comes

chamber

plastic

bag,

each

chamber contains glucose, amino

acids with electrolytes and a lipid

emulsion separately. The glucose

and amino acid solutions are clear,

colourless

slightly

yellow

free

from

particles.

lipid

emulsion

white

homogeneous.

Ingredients

SmofKabiven contains the

active

ingredients

Alanine,

Arginine,

Glycine,

Histidine,

Isoleucine,

Leucine,

Lysine

acetate,

Methionine,

Phenylalanine,

Proline,

Serine,

Taurine,

Threonine,

Tryptophan,

Tyrosine,

Valine, Calcium chloride dihydrate,

Sodium

glycerophosphate,

Magnesium

sulfate

heptahydrate,

Potassium

chloride,

Sodium

acetate

trihydrate,

Zinc

sulfate

heptahydrate,

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

does

contain

gluten, lactose, sucrose, tartrazine

or any other azo dyes.

SmofKabiven does not contain any

preservative.

SmofKabiven comes in a plastic

bag called Excel or Biofine bag in

pack

sizes.

They

identified by the following AUST R

numbers:

AUST R 173890: 986mL

AUST R 180543: 1477mL

AUST R 180546: 1970mL

AUST R 180547: 2463mL

Further Information

More

detailed

information

available

from

your

doctor

pharmacist. Therefore, if you have

concerns

about

information or about SmofKabiven

please

your

doctor

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

January 2019.