Vitalipid N infant 69mcg/ml+20mcg/ml+1mcg/ml+0,64mg/ml emulsion for infusion

Country: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

retinol (retinol palmitate), phytomenadione, ergocalciferol, alfa-tocopherol

Fáanlegur frá:

Fresenius Kabi AB

ATC númer:

A11BA

INN (Alþjóðlegt nafn):

retinol (retinol palmitate), phytomenadione, ergocalciferol, alfa-tocopherol

Skammtar:

69mcg/ml+20mcg/ml+1mcg/ml+0,64mg/ml

Lyfjaform:

emulsion for infusion

Einingar í pakka:

(10) ampoules 10ml blister

Gerð lyfseðils:

Prescription

Leyfisstaða:

Registered

Leyfisdagur:

2015-07-03

Vara einkenni

Title
Date
Page
Summary of Product Characteristics
2008-09-16
1 (5)
Product
SmPC number
Vitalipid N Infant
SmPC 08-340
Compiled by
Approved by
Replaces SmPC number
Evonne Strand
Karin Heimdahl
SmPC 05-279 EC
1.
NAME OF THE MEDICINAL PRODUCT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS
PER ML
Retinolpalmitate
135.3 µg
.
(corresponding to retinol)
69 µg
Phytomenadione
20 µg
Ergocalciferol
1.0 µg
all-rac-
α
-Tocopherol
0.64 mg
Corresponding to:
Vitamin A
69 µg
(230 IU)
Vitamin D
2
1.0 µg
(40 IU)
Vitamin E
0.64 mg
(0.7 IU)
Vitamin K
1
20 µg
pH: approx. 8
Osmolality: approx. 300 mosm/kg water
For excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Vitalipid N Infant is a sterile oil-in-water 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 requirements of
the fat-soluble
vitamins A, D
2
, E and K
1
.
Vitalipid N Infant, emulsion for infusion
Emulsion for infusion.
Product
SmPC number
Vitalipid N Infant
SmPC 08-340
2 (5)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
4 ml/kg bodyweight/day to preterm and low birth weight infants up to
2.5 kg
bodyweigh, 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
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.
Vitaipid N Infant must not be given undiluted.
4.5
INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
The presence of trace elements may cause some degradation of vitamin
A. Retinol
(vitamin A) may be broken down by exposure to ultraviolet light.
Vitamin K
1
interacts with anticoagu