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VITLIPID N INFANT

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

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1. What Vitlipid N Infant is and what it is used for
Vitlipid N Infant is especially designed for babies and
children. It provides fat soluble vitamins in your child’s
parenteral nutrition when your child cannot eat
properly.
It is usually used as part of a balanced intravenous diet,
together with proteins, fat, carbohydrates, salts and
vitamins.
2. What you need to know before your child
receives Vitlipid N Infant
Your child should not receive Vitlipid N Infant:
• if he/she is allergic (hypersensitive) to Vitamin A,
Vitamin D2, Vitamin E and Vitamin K1 or any of
the other ingredients of Vitlipid N Infant (listed
in Section 6).

Package leaflet: Information for the user

Concentrate for emulsion for infusion

337 154

Vitalipid® N Infant

Vitamin A, Vitamin D2, Vitamin E and Vitamin K1
Read all of this leaflet carefully before your child is
given this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- 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 possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Vitlipid N Infant is and what it is used for
2. What you need to know before your child is given
Vitlipid N Infant
3. How your child will be given Vitlipid N Infant
4. Possible side effects
5. How Vitlipid N Infant is stored
6. Contents of the pack and other information

If your child develops 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 pharmacist before your
child is given Vitlipid N Infant:
- if he/she has ever suffered from an allergic reaction
to egg, soya or peanut protein
- if it is undiluted, it will be added to another solution
known as Intralipid® before it is given to your child.
Your doctor or pharmacist will make sure Vitlipid N
Infant it is prepared correctly before it is given to
your child.
Your doctor may want to do regular blood tests to
check your child’s condition.
Other medicines and Vitlipid N Infant
Tell your doctor or nurse if your child is taking or has
recently taken or might use any other medicines.
Inform the doctor if your child is taking any medicines
to stop his/her blood from clotting (anticoagulants).
Vitlipid N Infant contains soya bean oil and egg
phospholipids.
Soya bean oil and egg phospholipids may cause

allergic reactions. If your child is allergic to soya, peanut
or eggs, they must not be given this medicinal
product.
3. How your child will be given Vitlipid N Infant
Vitlipid N Infant will be given to your child by a doctor
or nurse. Your child will receive this medicine by infusion
(an injection into a vein). The doctor will decide on the
correct dose for him/her to receive.
Dosage
For preterm and low birth weight babies up to
2.5 kg bodyweight
The usual daily dose of Vitlipid N Infant is 4 ml for every
kg of body weight.
For all infants and children over 2.5 kg bodyweight
and up to 11 years old.
The daily dose is 10ml/day.
Children over 11 years old and the elderly.
The adult preparation Vitlipid N Adult is more suitable
for children older than 11 years.
If your child receives too much Vitlipid N Infant
It is very unlikely that your child will receive more
infusion than he/she should as doctor or nurse will
monitor him/her during the treatment.
However if you think that your child has received too
much Vitlipid N Infant, inform the 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 the doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Vitlipid N Infant 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 the
doctor or nurse straight away.

Reporting of side effects
If your child get any side effects, talk to the 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: www.mhra.gov.uk/yellowcard
In Ireland you can report side effects to
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
www.hpra.ie
medsafety@hpra.ie
In Malta via the ADR Reporting site
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How Vitlipid N Infant is stored
Keep this medicine out of the sight and reach of
children.
Your doctor, pharmacist or nurse is responsible for the
correct storage, use and disposal of Vitlipid N Infant.
Store below 25ºC. Do not freeze. Keep the container in
the outer carton to protect from light.
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 month.
Any solution remaining after treatment should be
disposed of using the approved hospital procedures.
6. Contents of the pack and other information
What Vitlipid N Infant contains

Active ingredients
Each 1 ml of emulsion contains:
Retinol (as palmitate) corresponding to retinol
(Vitamin A) 69 micrograms (230 IU), Ergocalciferol
(Vitamin D2) 1 micrograms (40 IU), dI-alpha-tocopherol

(Vitamin E) 0.64 mg (0.7 IU), Phytomenadione
(Vitamin K1) 20 micrograms.
Each 10 ml of emulsion contains:
Retinol (as palmitate) corresponding to retinol
(Vitamin A) 690 micrograms (2,300 IU), Ergocalciferol
(Vitamin D2) 10 micrograms (400 IU), dI-alpha-tocopherol
(Vitamin E) 6.4 mg (7 IU), Phytomenadione (Vitamin K1)
200 micrograms.

Other ingredients
Vitlipid N Infant also contains purified soybean oil,
purified egg phospholipids, glycerol, sodium hydroxide,
nitrogen and water for injections. See section 2 for
further information.
What Vitlipid N Infant looks like and contents of
the pack
Vitlipid N Infant 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
Cesterian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
UK
Manufacturer
Fresenius Kabi AB,
S-751 74 Uppsala, Sweden
This leaflet was last revised in March 2017.

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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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