Vitlipid N Infant
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 S. 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.
2. BEFORE YOUR CHILD RECEIVES VITLIPID® N INFANT
Your child should not receive 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.
Care should be taken when administering Vitlipid® N Infant
Your doctor may want to do regular blood tests to check your child's condition.
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.
Inform the doctor if your child is taking any medicines to stop his/her blood from clotting (anticoagulants).
3. HOW YOUR CHILD WILL BE GIVEN VITLIPID® N INFANT
Your child will receive this medicine by infusion (IV drip).
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 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.
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 (250 IU) Ergocalciferol (Vitamin D=) 1 micrograms (40 IU) dl-alpha-tocopherol (Vitamin E) 0.64 mg (0.7 IU)
Phytomenadione (Vitamin Ki) 20 micrograms
Each 10 ml of emulsion contains:
Retinol (as palmitate) corresponding to retinol (Vitamin A) 690 micrograms (2.500IU)
Ergocalciferol (Vitamin DO 10 micrograms (400 IU) dl-alpha-tocopherol (Vitamin E) 6.4 mg (7 IU)
Phytomenadione (Vitamin K.,) 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
WA71NT
UK
Manufacturer:
Fresenius Kabi AB,
S-751 74 Uppsala Sweden.
This leaflet was last approved in September 2009
555 155