VITALIPID N ADULT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ERGOCALCIFEROL; PHYTOMENADIONE; RETINOL PALMITATE; TOCOPHEROL

Available from:

CURE MEDICAL & TECHNICAL SUPPLY

ATC code:

B05BA10

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

PHYTOMENADIONE 15 MCG/ML; ERGOCALCIFEROL 0.5 MCG/ML; TOCOPHEROL 0.91 MG/ML; RETINOL PALMITATE 194.1 MCG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

FRESENIUS KABI AB, SWEDEN

Therapeutic group:

COMBINATIONS

Therapeutic area:

COMBINATIONS

Therapeutic indications:

Vitalipid N adult is indicated in adult and children above 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 ADULT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
10 ml contains:
Retinol palmitate
(corresponding to
Retinol)
Vitamin A
194.1 micrograms
(corresponding to
99 micrograms
Retinol
(330 IU))
1941 micrograms
(corresponding to
990 micrograms
Retinol
(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 K1
15 micrograms
150 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 adult is indicated in adult patients and children from 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
For adult patients and children from 11 years of age, the recommended
daily dosage is
10 ml (one ampoule). See section 6.6
4.3. CONTRAINDICATIONS
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
soybean and peanut.
•
Vitalipid 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.
4.5. INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF
INTERACTIONS
This preparation contains Vitamin K1, which may interact with
anticoagulants of the
coumarin type.
4.6. PREGNANCY AND LACTATIO