Vitlipid N Infant

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PHYTOMENADIONE; DL-ALFA-TOCOPHEROL; ERGOCALCIFEROL; RETINOL

Available from:

Fresenius Kabi Limited

ATC code:

B05BA10

INN (International Name):

PHYTOMENADIONE; DL-ALFA-TOCOPHEROL; ERGOCALCIFEROL; RETINOL

Pharmaceutical form:

EMULSION FOR INFUSION

Composition:

PHYTOMENADIONE 20 µg/ml; DL-ALFA-TOCOPHEROL 0.64 mg/ml; ERGOCALCIFEROL 1 µg/ml; RETINOL 69 µg/ml

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2007-06-12

Patient Information leaflet

333 133 size: 210 x 148, 2:a kor
r 09-09-11, Johanna Eriksson
2212112222 2212112222
333 133
P
ACKAGE LEAFLET
: INFORMA
TION FOR THE USER
V
ITLIPID
®
 N INFANT CONCENTR
ATE 
FOR EMULSION FOR INFUSION
Read all of this leafl
 et carefully before your child starts taking 
this medicine.
• 
Keep this leafl
 et. Y
ou may need to r
ead it again.
• 
If you have any further questions, ask your doctor or phar
macist.
• 
This medicine has been pr
escribed for your child. Do not pass it on 
to others. It may har
m them, even if their symptoms ar
e the same 
as yours.
• 
If any of the side ef
fects get serious, or if you notice any side ef
fects 
not listed in this leafl
 et, please tell your doctor or phar
macist.
In this leafl
 et: 
1. 
What is V
itlipid
®
 N Infant and what it is used for
2. 
Befor
e your child r
eceives V
itlipid
®
 N Infant
3. 
How your child will be given V
itlipid
® 
N Infant
4. 
Possible side ef
fects
5. How 
V
itlipid
®
 N Infant is stor
ed
6. Further 
infor
mation
1. 
WHA
T IS VITLIPID
®
 N INF
ANT AND WHA
T IT 
IS USED FOR
V
itlipid
® 
N Infant is especially designed for babies and childr
en. It pr
ovides 
fat soluble vitamins in your child’
s par
enteral nutrition when your child 
cannot eat nor
mally
. 
It is usually used as part of a balanced intravenous diet, together
with 
pr
oteins, fat, carbohydrates, salts and other vitamins. 
2. 
BEFORE YOUR CHILD RECEIVES VITLIPID
®
 N INF
ANT
Y
our child should not receive V
itlipid
®
 N Infant:
•  if he/she is aller
gic (hypersensitive) to V
itlipid
®
 N Infant or any of 
the ingr
edients of V
itlipid
®
 N Infant mentioned in Section 6.  If you 
develop a rash or other aller
gic r
eactions (like itching, swollen lips or 
face or shortness of br
eath), please infor
m your doctor
.
• 
if he/she has ever suf
fer
ed an aller
gic r
eaction to egg, soya or peanut 
pr
otein 
• 
if it is undiluted. It will be added to another solution known as 
Intralipid
®
 befor
e it is given to

Summary of Product characteristics

 
Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Vitlipid N Infant 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One ml contains: 

Retinol palmitate 

69 micrograms 
corresponding to retinol 

(230 IU) 

Ergocalciferol   

1 micrograms (40 IU) 
dl-alpha-tocopherol 

0.64 mg (0.7 IU) 
Phytomenadione 

20 micrograms 

3. 
PHARMACEUTICAL FORM 

Concentrate for emulsion for infusion. 
White oil in water emulsion for infusion. 

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 A
1
, D
2
, E and K
1
. 

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 (MA 134/00301) be used. 

Page 2 of 4 

4.3 
CONTRA-INDICATIONS 

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 soya-bean oil and egg phospholipids, which may rarely cause 
allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut. 

4.5 
IN