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VITLIPID N INFANT

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

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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.

Dosage

Your child will receive this medicine by infusion (IV drip).
The doctor will decide on the correct dose for him/her to receive.

3. HOW YOUR CHILD WILL BE GIVEN VITLIPID® N
INFANT

Inform the doctor if your child is taking any medicines to stop his/her
blood from clotting (anticoagulants).

Taking other medicines
Please tell your doctor or pharmacist if your child is taking or has
recently taken any other medicines, including medicines obtained
without a prescription.

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

Care should be taken when administering Vitlipid® N Infant

• if he/she is allergic (hypersensitive) to Vitlipid® N Infant or any of
the ingredients of Vitlipid® N Infant 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 he/she has ever suffered 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 nurse will
make sure it is prepared correctly.

Your child should not receive Vitlipid® N Infant:

2. BEFORE YOUR CHILD RECEIVES VITLIPID® N INFANT

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Vitlipid® N Infant Concentrate
for emulsion for infusion
Read all of this leaflet carefully before your child starts 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 your child. 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 Infant and what it is used for
2. Before your child receives 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. Further information

1. WHAT IS VITLIPID® N INFANT 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 normally.
It is usually used as part of a balanced intravenous diet, together with
proteins, fat, carbohydrates, salts and other vitamins.

For all infants and children over 2.5 kg bodyweight and up to
11 years old
The daily dose is 10ml/day.
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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 product, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
No known side effects have been reported with Vitlipid® N Infant.
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.

5. HOW VITLIPID® N INFANT 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 Infant 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 Infant should be diluted immediately after opening. Any
solution remaining after treatment should be disposed of via approved
hospital procedures.

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6. FURTHER INFORMATION

What Vitlipid® N Infant infusions contain

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)
dl-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
(2,300IU)
Ergocalciferol (Vitamin D2) 10 micrograms (400 IU)
dl-alpha-tocopherol (Vitamin E) 6.4 mg (7 IU)
Phytomenadione (Vitamin K1) 200 micrograms

Vitlipid® N Infant also contains fractionated soybean oil, fractionated
egg phospholipids, glycerol, sodium hydroxide and water for injections.

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
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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