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VITLIPID N ADULT

Active substance(s): DL-ALPHA TOCOPHEROL / ERGOCALCIFEROL / PHYTOMENADIONE / RETINOL PALMITATE

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This product contains Vitamin A. High doses of Vitamin A can cause birth
defects, especially if taken during the first trimester of pregnancy. You
will receive this medicine only if considered essential by your doctor or
an antenatal clinic.

Pregnancy and breast-feeding
You should tell your doctor if you are pregnant, if you think you are
pregnant or if you are breast-feeding.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Inform your doctor if you are taking any medicines to stop your blood
from clotting (anticoagulants) or any Vitamin A supplements.

Your doctor may want to do regular blood tests to check your condition.

Care should be taken when administering Vitlipid® N Adult
Tell your doctor if:
• you are taking other supplements with Vitamin A.

• if it is undiluted. It will be added to another solution known as
Intralipid® before it is given to you. Your doctor or nurse will make
sure it is prepared correctly before you receive Vitlipid® N Adult.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Vitlipid® N Adult Concentrate for
emulsion for infusion
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What is Vitlipid® N Adult and what it is used for
2. Before you receive Vitlipid® N Adult
3. How you are given Vitlipid® N Adult
4. Possible side effects
5. How Vitlipid® N Adult is stored
6. Further information

1. WHAT IS VITLIPID® N ADULT AND WHAT IT IS
USED FOR

Driving and using machines
Vitlipid® N Adult has no effect on driving or using machines.

3. HOW YOU ARE GIVEN VITLIPID® N ADULT

You will receive your medicine by infusion (IV drip).
Your doctor will decide on the correct dose for you to receive.

Vitlipid® N Adult provides fat soluble vitamins when used together with
Intralipid® into your bloodstream when you cannot eat normally.
It is usually used as part of a balanced intravenous diet, together with
proteins, fat, carbohydrates, salts and other vitamins.

2. BEFORE YOU RECEIVE VITLIPID® N ADULT

Adults and children over 11 years
The usual dose of Vitlipid® N Adult for adults and children over 11 years
of age is 10 millilitres (10 ml) each day.

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Vitlipid® N Adult is not suitable for children under 11 years of age.

Dosage

You should not receive Vitlipid® N Adult:
• if you are allergic (hypersensitive) to Vitlipid® N Adult or any of
the ingredients of Vitlipid® N Adult mentioned in Section 6. If you
develop a rash or other allergic reactions (like itching, swollen
lips or face or shortness of breath), please inform your doctor.
• if you have ever suffered an allergic reaction to egg, soya or peanut
protein

If you receive too much Vitlipid® N Adult
It is very unlikely that you will receive more infusion than you should as
your doctor or nurse will monitor you during the treatment. However
if you think that you have received too much Vitlipid® N Adult, inform
your doctor or nurse immediately. Symptoms of overdose include:
headache, nausea, vomiting and drowsiness.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
No known side effects have been reported with Vitlipid® N Adult.
Vitlipid® N Adult contains soya-bean oil and egg phospholipids, which
may rarely cause allergic reactions. Cross allergic reaction has been
observed between soya-bean and peanut.
If you notice any unwanted effects, please tell your doctor or
nurse straight away.

5. HOW VITLIPID® N ADULT IS STORED
Keep out of the reach and sight of children
Your doctor and hospital pharmacist are responsible for the correct
storage, use and disposal of Vitlipid® N Adult infusion.
Store below 25 °C. Do not freeze. Keep the container in the outer
carton to protect from light. The solution must not be used after the
expiry date shown on the label. The expiry date refers to the last day
of that month. Vitlipid N Adult should be diluted immediately after
opening. Any solution remaining after treatment should be disposed of
via approved hospital procedures.

6. FURTHER INFORMATION
What Vitlipid® N Adult infusions contain
Each 1 ml of emulsion contains:
Retinol (as palmitate) corresponding to retinol (Vitamin A) 99
micrograms (330 IU) Ergocalciferol (Vitamin D2) 0.5 micrograms (20 IU)
dl-alpha-tocopherol (Vitamin E) 0.91 mg (1 IU)
Phytomenadione (Vitamin K1) 15 micrograms

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Each 10 ml of emulsion contains:
Retinol (as palmitate) corresponding to retinol (Vitamin A) 990
micrograms (3,300 IU) Ergocalciferol (Vitamin D2) 5 micrograms (200 IU)
dl-alpha-tocopherol (Vitamin E) 9.1 mg (10 IU)
Phytomenadione (Vitamin K1) 150 micrograms

Vitlipid® N Adult also contains fractionated soya-bean oil, fractionated
egg phospholipids, glycerol, sodium hydroxide and water for injections.

What Vitlipid® N Adult looks like and contents of the pack
Vitlipid® N Adult is a sterile white emulsion (a mixture of oil and water)
containing fat soluble vitamins.Each ampoule (small glass container)
holds 10 millilitres (10 ml) of emulsion.
Marketing authorisation holder
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
UK
Manufacturer:
Fresenius Kabi AB,
S-751 74 Uppsala
Sweden.

This leaflet was last approved in September 2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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