Vitlipid N Adult
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Vitlipid® N Adult Concentrate for emulsion for infusion_
Read all of this leaflet carefully before you start 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 you. 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 Adult and what it is used for
2. Before you receive Vitlipid® N Adult S. How you are given Vitlipid® N Adult
4. Possible side effects
5. How Vitlipid® N Adult is stored
6. Further information
1. WHAT IS VITLIPID® N ADULT 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. BEFORE YOU RECEIVE VITLIPID® N ADULT
You should not receive Vitlipid® N Adult:
• if you are allergic (hypersensitive) to Vitlipid® N Adult or any of the ingredients of Vitlipid® N Adult 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 you have 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 you. Your doctor or nurse will make sure it is prepared correctly before you receive Vitlipid® N Adult.
Care should be taken when administering Vitlipid® N Adult Tell your doctor if:
• you are taking other supplements with Vitamin A.
Your doctor may want to do regular blood tests to check your condition. Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Inform your doctor if you are taking any medicines to stop your blood from clotting (anticoagulants) or any Vitamin A supplements. Pregnancy and breast-feeding
You should tell your doctor if you are pregnant, if you think you are pregnant or if you are breast-feeding.
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 an antenatal clinic.
Driving and using machines
Vitlipid® N Adult has no effect on driving or using machines.
3. HOW YOU ARE GIVEN VITLIPID® N ADULT
You will receive your medicine by infusion (IV drip).
Your doctor will decide on the correct dose for you to receive.
Dosage
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.
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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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
No known side effects have been reported with Vitlipid® N Adult.
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 straightaway.
5. HOW VITLIPID® N ADULT 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 Adult 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 Adult 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 Adult infusions contain
Each 1 ml of emulsion contains:
Retinol (as palmitate) corresponding to retinol (Vitamin A) 99 micrograms (550 IU) Ergocalciferol (Vitamin D=) 0.5 micrograms (20 IU) dl-alpha-tocopherol (Vitamin E) 0.91 mg (1 IU)
Phytomenadione (Vitamin Ki) 15 micrograms
Each 10 ml of emulsion contains:
Retinol (as palmitate) corresponding to retinol (Vitamin A) 990 micrograms (5,500 IU) Ergocalciferol (Vitamin D=) 5 micrograms (200 IU) dl-alpha-tocopherol (Vitamin E) 9.1 mg (10 IU)
Phytomenadione (Vitamin Ki) 150 micrograms Vitlipid® N Adult also contains fractionated soya-bean oil, fractionated egg phospholipids, glycerol, sodium hydroxide and water for injections. 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
Runcorn
Cheshire
WA71NT
UK
Manufacturer:
Fresenius Kabi AB,
S-751 74 Uppsala Sweden.
This leaflet was last approved in September 2009
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