VITALIPID N INFANT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ERGOCALCIFEROL; PHYTOMENADIONE; RETINOL PALMITATE; TOCOPHEROL

Available from:

CURE MEDICAL & TECHNICAL SUPPLY

ATC code:

B05XA30

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

PHYTOMENADIONE 20 MCG/ML; ERGOCALCIFEROL 1 MCG/ML; TOCOPHEROL 0.64 MG/ML; RETINOL PALMITATE 135.3 MCG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

FRESENIUS KABI AB, SWEDEN

Therapeutic group:

COMBINATIONS OF ELECTROLYTES

Therapeutic area:

COMBINATIONS OF ELECTROLYTES

Therapeutic indications:

Vitalipid N infants is indicated in infants and children up to 11 years of age as a supplement in IV nutrition to meet the daily requirement of the fat soluble vitamins A, D2, E,K1.

Authorization date:

2023-08-31

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
VITALIPID N INFANT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
10 ml contains:
Retinolpalmitate
corresponding to
retinol
Vitamin A
135.3 micrograms
(corresponding to
69 micrograms
Retinol
(230 IU)
1353 micrograms
(corresponding to
690 micrograms
Retinol
(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 K1
20 micrograms
200 micrograms
pH: approx. 8
Osmolality: approx. 300 mosm/kg water
Excipients with known effect: purified soybean oil.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for IV infusion.
A sterile, oil-in-water white emulsion containing fat soluble vitamins
in the oil phase.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Vitalipid N infant is indicated in infants and children up to 11 years
of age as a supplement in
intravenous nutrition to meet the daily requirement of the fat-soluble
vitamins A, D2, E, K1.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
4 ml/kg bodyweight/day to preterm and low birth weight infants up to
2.5 kg bodyweight,
and 10 ml/day for all infants and children weighing more than 2.5 kg
up to 11 years of
age. See section 6.6
4.3. CONTRAINDICATIONS
Vitalipid N Infant should not be administered undiluted.
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1
or to egg, soya or peanut protein.
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.
•
The addition of the formulation to the infusion solutions should be
made
aseptically and the solution used within 24 hours of preparation. See
section 6.6
4.5. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Vitamin K1 may interact with anticoagula