Vitlipid N Infant
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitlipid N Infant
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
1 ml contains: |
10 ml contains: | ||
|
Retinolpalmitate corresponding to retinol |
Vitamin A |
69 micrograms (230 IU) |
690 micrograms (2,300 IU) |
|
Ergocalciferol |
Vitamin D2 |
1 microgram (40 IU) |
10 micrograms (400 IU) |
|
dl-alpha-tocopherol |
Vitamin E |
0.64 mg (0.7 IU) |
6.4 mg (7 IU) |
|
Phytomenadione |
Vitamin Ki |
20 micrograms |
200 micrograms |
pH: approx. 8
Osmolality: approx. 300 mosm/kg water
3 PHARMACEUTICAL FORM
Concentrate for emulsion for infusion.
A sterile, oil-in-water white emulsion containing fat soluble vitamins in the oil phase.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Vitlipid N Infant is indicated as a supplement to Intralipid 10% or 20% in the intravenous nutrition of infants and children (under 11 years of age) in order to cover the daily requirements of the fat soluble vitamins Ai, D2, E and Ki.
4.2. Posology and Method of Administration
Recommended dosage for infants and children (under 11 years of age) 4 ml/kg bw/day to pre-term and low birth weight infants up to 2.5 kg bodyweight. 10 ml/day for all infants and children weighing more than 2.5 kg up to 11 years.
Recommended dosage for children (over 11 years of age), adults and the elderly
It is recommended that the adult preparation Vitlipid N Adult (PL 8828/0124) be used.
4.3 Contraindications
Vitlipid N Infant 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 soybean oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut.
Vitlipid N Infant must not be administered undiluted.
The addition of the formulation to the infusion solutions should be made aseptically and the solution used within 24 hours of preparation. See section 6.3
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
Not applicable.
4.7. Effects on Ability to Drive and Use Machines
Not applicable.
Undesirable Effects
4.8.
None known.
4.9. Overdose
In general overdosage with Vitlipid N Infant 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 Infant. Spontaneous reversal of any symptoms should occur without requiring a specific antidote.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Vitlipid N Infant is formulated to supply the fat soluble vitamins A1, D2, E and K1 for intravenous infusion.
5.2 Pharmacokinetic properties
When infused intravenously, the fat-soluble vitamins in Vitlipid N Adult are metabolised in a similar way to fat-soluble vitamins from an oral diet.
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.
In-use shelf life: Chemical and physical in-use stability of Vitlipid N Adult should be established prior to use.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
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 contents of container
10 ml glass (Ph.Eur, Type 1) ampoule containing white, oil in water emulsion. Pack Size: 10 x 10 ml.
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
PL 8828/0125
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/03/2009
10 DATE OF REVISION OF THE TEXT
20/10/2015