Vitlipid N Adult
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitlipid N Adult
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
990 mcg (3,300 IU)
5 mcg (200 IU) 9.1 mg (10 IU) 150 mcg
Retinol palmitate corresponding to retinol Ergocalciferol di-alpha-tocopherol Phytomenadione
3. PHARMACEUTICAL FORM
White oil in water emulsion for infusion.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Vitlipid N Adult is indicated for use as a supplement to Intralipid 10% or 20% for the intravenous nutrition of adults and children (over 11 years of age) i order to provide the daily requirements of the fat soluble vitamins A1, D2, and K1.
4.2. Posology and Method of Administration
Do not exceed the recommended dose.
Recommended dosage for adults and children (over 11 years of age)
One ampoule (10 ml) Vitlipid N Adult added to 500 ml Intralipid 10% or
20%.
Recommended dosage for the elderly
No adjustment of the adult dosage is required.
4.3 Contraindications
Vitlipid N Adult should not be administered undiluted.
Hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients.
4.4 Special warnings and special precautions for use
This medicinal product contains soya-bean oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut.
The addition of the formulation to the infusion solutions should be made aseptically and the solution used within 24 hours of preparation.
4.5 Interaction with other medicinal products and other forms of interaction
This preparation contains Vitamin K1, which may interact with anticoagulants of the coumarin type.
4.6. Pregnancy and Lactation
This product contains vitamin A. High doses of Vitamin A can cause birth defects especially if taken during the first trimester.
Should not be given if the patient is pregnant or likely to become pregnant, without evaluation of the total daily dose. The concomitant intake of Vitamin A from food must be considered.
4.7. Effects on Ability to Drive and Use Machines
Not applicable.
4.8. Undesirable Effects
None known.
Overdose
4.9.
In general overdosage with Vitlipid N Adult is unlikely. If chronic overdosage occurred symptoms such as headache, nausea, vomiting and drowsiness may be observed. Treatment should be symptomatic along with withdrawal of Vitlipid N Adult. Spontaneous reversal of any symptoms should occur without requiring a specific antidote.
5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmacodynamic Properties
Vitlipid N Adult is formulated to supply the fat soluble vitamins A1, D2, E and K1 for intravenous infusion.
5.2. Pharmacokinetic Properties
Vitlipid N Adult is a formulation of fat soluble vitamins without interest for pharmacokinetic studies.
5.3. Pre-clinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Fractionated soybean oil Fractionated egg phospholipids Glycerol
Sodium hydroxide Water for injections
6.2.
Incompatibilities
None known.
6.3. Shelf-Life
24 months.
6.4 Special precautions for storage
Store below 25°C Do not freeze
Keep container in the outer container to protect from light 6.5. Nature and Content of Container
10 ml glass (Ph.Eur, Type 1) ampoule containing white, oil in water emulsion.
6.6. Instructions for Use, Handling and Disposal
None.
7 MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited Cestrian Court Eastgate Way Manor Park Runcorn Cheshire WA7 1NT UK
8. MARKETING AUTHORISATION NUMBER(S)
PL 8828/0124
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/03/2009
10 DATE OF REVISION OF THE TEXT
01/06/2009