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336 745 (replace 333 128)

297 x 210 mm
10 pt

1:a korr 2017-03-09
Niklas Baudin
+46 18 64 43 69

Package leaflet: Information for the user

Vitalipid N Adult

Concentrate for emulsion for infusion

Vitamin A, Vitamin D2, Vitamin E and Vitamin K1
Read all of this leaflet carefully before you
are given this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it
- If you have any further questions, ask your
doctor or nurse.
- If you get any side effects, talk to your doctor
or nurse. This includes any side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Vitlipid N Adult is and what it is used for
2. What you need to know before you are given
Vitlipid N Adult
3. How you will be given Vitlipid N Adult
4. Possible side effects
5. How Vitlipid N Adult is stored
6. Contents of the pack and other information
1. What Vitlipid N Adult is and what it is
used for
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. What you need to know before you are
given Vitlipid N Adult

You should not receive Vitlipid N Adult:
• if you are allergic (hypersensitive) to Vitamin A,
Vitamin D2, Vitamin E and Vitamin K1 or any of
the other ingredients of Vitlipid N Adult (listed
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.
Warnings and precautions
Talk to your doctor or nurse before you are given
Vitlipid N Adult.
Your doctor or nurse will make sure Vitlipid N
Adult is prepared correctly before you receive it.
Your doctor may want to do regular blood tests
to check your condition.
Other medicines and Vitlipid N Adult
Tell your doctor or nurse if you are taking or have
recently taken or might take any other medicines.
Inform your doctor if you are taking any medicines
to stop your blood from clotting (anticoagulants)
or any Vitamin A supplements.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or nurse for advice before using
this medicine.
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 antenatal clinic.
Driving and using machines
Vitlipid N Adult has no effect on driving or using
Vitlipid N Adult contains soya bean oil and
egg phospholipids.
Soya bean oil and egg phospholipids may cause
allergic reactions. If you are allergic to soya,
peanut or eggs, you must not be given this
medicinal product.

3. How you will be given Vitlipid® N Adult
Vitlipid N Adult will be given to you by a doctor or
nurse. You will receive your medicine by infusion
(an injection into a vein). Your doctor will decide
on the correct dose for you to receive.

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.
Vitlipid N Adult is not suitable for children under
11 years of age.
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 medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet.
In the UK you can also report side effects directly
via the Yellow Card Scheme at:
336 745

In Ireland you can report side effects to
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
In Malta via the ADR Reporting site
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How Vitlipid N Adult is stored
Keep this medicine out of the sight and reach of
Your doctor, pharmacist or nurse is responsible
for the correct storage, use and disposal of
Vitlipid N Adult.
Store below 25ºC. Do not freeze. Keep the
container in the outer carton to protect from
The solution must not be used after the expiry
date which is stated on the label.
The expiry date refers to the last day of that
Any solution remaining after treatment should
be disposed of using the approved hospital

tocopherol (Vitamin E) 0.91 mg (1 IU), Phytomenadione (Vitamin K1) 15 micrograms.
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),
dI-alpha-tocopherol (Vitamin E) 9.1 mg (10 IU),
Phytomenadione (Vitamin K1) 150 micrograms.

Other ingredients
Vitlipid® N Adult also contains purified soya-bean
oil, purified egg phospholipids, glycerol, sodium
hydroxide, nitrogen and water for injections. See
section 2 for further information.
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

6. Contents of the pack and other information

Fresenius Kabi AB,
S-751 74 Uppsala

What Vitlipid® N Adult contains

This leaflet was last revised in March 2017.

Active ingredients
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), dI-alpha-


336 745

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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.