VITALIPID

Main information

  • Trade name:
  • VITALIPID N INFANT 10mL injection emulsion ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VITALIPID N INFANT 10mL injection emulsion ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 40253
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

40253

VITALIPID N INFANT 10mL injection emulsion ampoule

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

21/08/1992

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. VITALIPID N INFANT 10mL injection emulsion ampoule

Product Type

Single Medicine Product

Effective date

6/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Vitalipid N Infant is indicated as a supplement in complete intravenous nutrition to meet the daily requirements of the fat- soluble Vitamins A, D2, E and

K1 in paediatric patients up to 11 years of age.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Not recorded

2 Years

Store below 25

degrees Celsius

Not recorded

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

10 x 10mL ampoules

Not scheduled. Not considered by committee

Components

1. Medicine Component

Dosage Form

Injection, concentrated

Route of Administration

Intravenous

Visual Identification

A milky white emulsion.

Active Ingredients

dl-alpha-Tocopherol

.64 mg/mL

Ergocalciferol

1 microgram/mL

Phytomenadione

20 microgram/mL

retinol palmitate

69 microgram/mL

© 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 01.12.2017 at 06:06:16 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

Vitalipid N

®

Infant and Adult

Retinol Palmitate, Ergocalciferol, dl-alpha-tocopherol and Phytomenadione

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

VITALIPID N. It does not contain

available

information.

does not take the place of talking

to your doctor or pharmacist.

medicines

have

risks

benefits. Your doctor has weighed

the risks of you or your child given

VITALIPID N against any benefits

they expect it will have for you or

your child.

Please read this leaflet carefully

before you are given VITALIPID

N. If you have any questions or

are

unsure

about

anything,

please

ask

the

doctor

or

pharmacist.

Keep

this

leaflet

with

the

medicine. You may need to read

it again.

What

is

VITALIPID

N

used for

VITALIPID N is a sterile emulsion

which provides the body with fat-

soluble

multivitamins

intravenous route. When the intake

of nutrients or food into the mouth

directly

into

possible,

enough

supply

body’s

needs,

then

intravenous nutrients or foods can

given.

This

especially

important for people whose bodies

under

physical

stress

from

illness or recent surgery. During

illness or after surgery the body

requires nutrition or food.

Before

you

are

given

VITALIPID N

You or your child should not be

given VITALIPID N if:

have

allergy

soya oil, eggs, peanuts or

ingredients

listed

this

leaflet.

You have very high levels

of vitamins in your system.

have

sudden,

dangerous

drop

your

blood pressure.

have

inability

break down fats.

If you are not sure whether any of

these apply to you, check with your

doctor.

should

tell

your

doctor

BEFORE given VITALIPID N if the

answer

following

questions is YES.

Are you pregnant or trying

to become pregnant?

Are you breastfeeding?

Are you allergic to soya-,

egg- or peanut protein?

have

liver

kidney disease?

taking

anticoagulants

(medicines

preventing

blood

clotting)?

Are you taking any other

medicines

including

that

without

prescription

from

your

pharmacy, supermarket or

health food shop. These

medicines may affect the

action of VITALIPID N or

affect

well

VITALIPID N works.

If you have not told your doctors

about any of the above, tell them

before you are given VITALIPID N.

How to take VITALIPID

N

The dose of VITALIPID N will be

determined

doctor

pharmacist.

doctor

will

supervise your treatment or your

child’s

treatment

with

VITALIPID

VITALIPID N is usually mixed in a

bottle

amino

acids,

glucose

and/or

fats,

fat-soluble

vitamins and given as a continuous

infusion into a central vein. An

electronic pump may be used to

control the speed of the infusion of

drip.

Side Effects

Since

VITALIPID

diluted

with

other

nutrient

solutions, it may cause unwanted

effects

some

people.

unwanted effects associated with

VITALIPID

been

detected.

If you or your child have/has any

unwanted effects during treatment,

tell your doctor or pharmacist.

If

you

are

given

too

much

(overdose)

This rarely happens as VITALIPID

N is administered under the care of

a trained professional in a hospital

or clinic setting. However if you or

your

child

is given too

much of

VITALIPID

your

child

may experience a condition of high

levels of vitamins in your system.

Page 2 of 2

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.

Storage

Store below 25ºC.

Protect

from

light

freeze.

Do not use this medicine after the

expiry date which is stated on the

carton label and embossed on the

ampoule.

The contents of each ampoule of

VITALIPID N should be dissolved

first

then

diluted

single

infusion only.

Any unused VITALIPID N should

be discarded.

Product Description

What it looks like

VITALIPID

sterile,

white

emulsion in an ampoule. It comes

in a carton pack of 10 ampoules.

VITALIPID N can be identified by

the following:

Vitalipid N Adult – AUST R 40252

Vitalipid N Infant – AUST R 40253

Ingredients

VITALIPID N ADULT

contains

active

ingredients

Vitamin

retinol

palmitate) 99

g, Ergocalciferol 0.5

dl-alpha-tocopherol

0.91

Phytomenadione

excipients Soya oil 100 mg, Egg

lecithin 12 mg, Glycerol 22.0 mg,

Sodium

hydroxide

Water for Injections to 1 mL.

VITALIPID N INFANT

contains

active

ingredients

Vitamin

retinol

palmitate) 69

g, Ergocalciferol 1.0

dl-alpha-tocopherol

0.64

Phytomenadione

excipients Soya oil 100 mg, Egg

lecithin 12 mg, Glycerol 22.0 mg,

Sodium

hydroxide

Water for Injections to 1 mL.

VITALIPID

does

contain

gluten, lactose, sucrose, tartrazine

or any other azo dyes.

VITALIPID N does not contain any

preservative.

Further Information

More

detailed

information

available

from

your

doctor

pharmacist. Therefore, if you have

concerns

about

information or about VITALIPID N

ask your doctor or pharmacist.

Sponsor

Australia:

Fresenius Kabi Australia Pty

Limited

Level 2, 2 Woodland Way,

Mount

Kuring-gai

2080

Australia

Telephone: (02) 9391 5555

New Zealand:

Fresenius Kabi New Zealand

Limited

60 Pavilion Drive

Airport Oaks, Auckland 2022

New Zealand

Freecall: 0800 144 892

® = Registered Trademark

Date of Information

This

leaflet

prepared

January 2017.