Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about VITALIPID N. It does not contain all 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 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 by the intravenous route. When the intake of nutrients or food into the mouth or directly into the gut is not possible, or it is not enough to supply the body’s needs, then intravenous nutrients or foods can be given. This is especially important for people whose bodies are 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:

• You have an allergy to soya oil, eggs, peanuts or any of the ingredients listed at the end of this leaflet.
• You have very high levels of vitamins in your system.
• You have a sudden, dangerous drop in your blood pressure.
• You have an inability to break down fats.

If you are not sure whether any of these apply to you, check with your doctor.

You should tell your doctor BEFORE given VITALIPID N if the answer to any of the following questions is YES.

• Are you pregnant or trying to become pregnant?
• Are you breastfeeding?
• Are you allergic to soya-, egg- or peanut protein?
• Do you have liver or kidney disease?
• Are you taking anticoagulants (medicines for preventing blood clotting)?
• Are you taking any other medicines including any that you buy without a prescription from your pharmacy, supermarket or health food shop. These medicines may affect the action of VITALIPID N or may affect how 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 by the doctor or pharmacist. The doctor will supervise your treatment or your child’s treatment with VITALIPID N.

VITALIPID N is usually mixed in a bottle or a bag of 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 N has to be diluted with other nutrient solutions, it may cause unwanted effects in some people. All the unwanted effects associated with VITALIPID N may not yet 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 N, you or your child may experience a condition of high levels of vitamins in your system.

Your doctor has information on how to recognise and treat an 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 and do not 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 and then diluted for single infusion only.

Any unused VITALIPID N should be discarded.

Product Description

What it looks like

VITALIPID N is a 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
One mL contains the active ingredients Vitamin A (as retinol palmitate) 99 µg, Ergocalciferol 0.5 µg, dl-alpha-tocopherol 0.91 mg, Phytomenadione 15 µg and excipients Soya oil 100 mg, Egg lecithin 12 mg, Glycerol 22.0 mg, Sodium hydroxide to pH 8 and Water for Injections to 1 mL.

VITALIPID N INFANT
One mL contains the active ingredients Vitamin A (as retinol palmitate) 69 µg, Ergocalciferol 1.0 µg, dl-alpha-tocopherol 0.64 mg, Phytomenadione 20 µg and excipients Soya oil 100 mg, Egg lecithin 12 mg, Glycerol 22.0 mg, Sodium hydroxide to pH 8 and Water for Injections to 1 mL.

VITALIPID N does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

VITALIPID N does not contain any preservative.

Further Information

More detailed information is available from your doctor or pharmacist. Therefore, if you have any concerns about the 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 NSW 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 was prepared in January 2017.

Published by MIMS May 2017

1 Name of Medicine

Retinol palmitate (vitamin A palmitate), ergocalciferol (vitamin D₂), dl-alpha-tocopherol (vitamin E), phytomenadione (vitamin K₁).

2 Qualitative and Quantitative Composition

10 mL ampoule contains (see Table 1):

Excipients with known effect.

3 Pharmaceutical Form

Concentrated emulsion for injection.
A milky white emulsion. Sterile oil/water emulsion with pH: approx. 8 and osmolality: approx. 300 mOsm/kg water.

4 Clinical Particulars

4.1 Therapeutic Indications

Vitalipid N Adult is indicated as a supplement in complete intravenous nutrition to meet the daily requirements of the fat-soluble vitamins A, D₂, E and K₁.
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.

4.2 Dose and Method of Administration

Must be diluted before use.

Adults and children aged 11 years and above.

Must be diluted before use.

Infants and children under 11 years.

4.3 Contraindications

Vitalipid N is contraindicated in patients with known hypersensitivity to any of the components and a pre-existing hypervitaminosis.
Hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients.
As Vitalipid N is added to Intralipid 10% or 20% before use, it should be noted that Intralipid is contraindicated in patients with acute shock and those with severe disturbances in lipid metabolism such as pathologic hyperlipaemia. See Section 4.3 Contraindications of Intralipid product information.

4.4 Special Warnings and Precautions for Use

The Vitalipid N doses recommended are insufficient to correct severe deficiency states and may be insufficient in patients with markedly increased requirement.
In patients for whom total parenteral nutrition is continued for prolonged periods, periodic monitoring of blood levels of vitamins, particularly A and D, should be considered.
In patients receiving total parenteral nutrition, routine supplementation with both fat-soluble and water-soluble vitamins is recommended to prevent deficiency states and to obviate the need to speculate on individual vitamin status. However, daily vitamin requirements must be calculated to avoid overdosage and toxic effects, especially with regards to vitamins A and D, and particularly in paediatric patients. Hypervitaminosis A is characterised by fatigue, irritability, anorexia and loss of weight, vomiting and other gastrointestinal disturbances, polyuria and cracking and bleeding lips. Hypervitaminosis D is a metabolic bone disease characterised by hypercalciuria, intermittent hypercalcaemia, osteomalacia and bone pain.
Fractures have been reported in patients receiving prolonged parenteral nutrition. This syndrome regressed in some patients after withdrawal of vitamin D supplements.
Fat embolism has been reported as a complication in the rapid infusion of Intralipid (see Section 4.4 Special Warnings and Precautions for Use of Intralipid product information).
This product contains soya oil and egg lecithin which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Vitalipid N contains vitamin K₁ which may interact with anticoagulants of the coumarin type.
Interaction with Intralipid, see Section 4.4 Special Warnings and Precautions for Use of Intralipid product information.
Other drugs and solutions should not be added to Vitalipid N when mixed with Intralipid unless specified in Dose and Method of Administration.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

No adverse effects have been reported with Vitalipid N Adult or Vitalipid N Infant.

Reporting suspected adverse effects.

4.9 Overdose

The possibility of hypervitaminosis A and D should be considered.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia) or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

10 mL contains (see Table 2):

6.2 Incompatibilities

Vitalipid N may only be added to or mixed with other medicinal products for which compatibility has been documented. For compatibility information, please see Section 4.2 Dose and Method of Administration.

6.3 Shelf Life

Approved shelf life as packaged for sale.

Shelf life after addition or mixing according to directions.

6.4 Special Precautions for Storage

Unopened ampoule.

6.5 Nature and Contents of Container

Infusion concentrate (white emulsion).
10 mL Type I clear glass break-off ampoules.
Ampoules are for single use in one patient only. Discard any residue.

Pack sizes.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Retinol palmitate (vitamin A).

Ergocalciferol (vitamin D₂).

dl-alpha-tocopherol (vitamin E).

Phytomenadione (vitamin K₁).

CAS number.

7 Medicine Schedule (Poisons Standard)

Australia: Not Scheduled.

Summary Table of Changes