Vitlipid N Adult
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitlipid N Adult
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
1 ml contains: |
10 ml contains: | ||
|
Retinolpalmitate corresponding to retinol |
Vitamin A |
99 micrograms (330IU) |
990 micrograms (3,300 IU) |
|
Ergocalciferol |
Vitamin D2 |
0.5 micrograms (20 IU) |
5 micrograms (200 IU) |
|
dl-alpha-tocopherol |
Vitamin E |
0.91 mg (1 IU) |
9.1 mg (10 IU) |
|
Phytomenadione |
Vitamin Ki |
15 micrograms |
150 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 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) in order to provide the daily requirements of the fat soluble vitamins Ai, D2, E and Ki.
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 soybean oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut.
Vitlipid N Adult 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 Fertility, pregnancy and lactation
No animal studies have been performed with Vitlipid N Adult. However, there are published reports on safe and successful use of vitamins as part of a total parenteral nutrition regimen during pregnancy in this patient group.
The intake of more than 8000 IU of vitamin A is not recommended during pregnancy due to the risk of birth defects especially if taken during the first trimester. If the patient is pregnant or is likely to become pregnant the total daily dose needs to be evaluated considering the concomitant intake of vitamin A from food. Provided the dosage recommendations for Vitlipid N Adult are followed there should be a satisfactory safety margin for pregnant women.
4.7. Effects on Ability to Drive and Use Machines
Not applicable.
4.8. Undesirable Effects
None known.
4.9. Overdose
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
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(S)
PL 8828/0124
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/03/2009
10 DATE OF REVISION OF THE TEXT
20/10/2015