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VITLIPID N INFANT

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

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336 746 (replace 333 133)
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1:a korr 2017-03-09
Niklas Baudin
+46 18 64 43 69

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21211121211
Package leaflet: Information for the user

Vitalipid® N Infant
Concentrate for emulsion for infusion

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
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

3. How your child will be given 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).

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.

If your child develops a rash or other allergic
reactions (like itching, swollen lips or face
or shortness of breath), please inform your
doctor.

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.

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.

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.
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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.

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6. Contents of the pack and other information

This leaflet was last revised in March 2017.

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-alphatocopherol (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

V002
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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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