Vitlipid N Adult

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

PHYTOMENADIONE; DL-ALFA-TOCOPHERYL ACETATE; ERGOCALCIFEROL; RETINOL

Dostępny od:

Fresenius Kabi Limited

Kod ATC:

B05BA10

INN (International Nazwa):

PHYTOMENADIONE; DL-ALFA-TOCOPHERYL ACETATE; ERGOCALCIFEROL; RETINOL

Forma farmaceutyczna:

EMULSION FOR INFUSION

Skład:

PHYTOMENADIONE 15 µg/ml; DL-ALFA-TOCOPHERYL ACETATE 0.91 mg/ml; ERGOCALCIFEROL 0.5 µg/ml; RETINOL 99 µg/ml

Typ recepty:

POM

Dziedzina terapeutyczna:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Status autoryzacji:

Authorised

Data autoryzacji:

2007-06-12

Ulotka dla pacjenta

333 128 size: 210 x 148, 2:a kor
r 09-09-11, Johanna Eriksson
2212112221 2212112221
333 128
P
ACKAGE LEAFLET
: INFORMA
TION FOR THE USER
VITLIPID
®
 N 
ADULT CONCENTR
ATE FOR 
EMULSION FOR INFUSION
Read all of this leafl
 et carefully before you start 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 you. 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 Adult and what it is used for
2. 
Befor
e you r
eceive V
itlipid
®
 N Adult
3. 
How you ar
e given V
itlipid
®
 N Adult
4. 
Possible side ef
fects
5. How 
V
itlipid
®
 N Adult is stor
ed
6. Further 
infor
mation
1. 
WHA
T IS VITLIPID
®
 N ADUL
T AND WHA
T IT IS 
USED FOR
V
itlipid
®
 N Adult pr
ovides fat soluble vitamins when used together with 
Intralipid
® 
into your bloodstr
eam when you 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 YOU RECEIVE VITLIPID
®
 N ADUL
T
Y
ou should not receive V
itlipid
®
 N Adult:
•  if you ar
e aller
gic (hypersensitive) to V
itlipid
®
 N Adult or any of 
    the ingr
edients of V
itlipid
®
 N Adult mentioned in Section 6.  
If you 
     develop a rash or other allergic reactions (like itching,
swollen 
     lips or face or shortness of breath), please inform your
doctor
.
• 
 if you have 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 you. Y
our doctor or nurse will make 
sur
e it is pr
epar
ed cor
rectly befor

Charakterystyka produktu

 
Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.

NAME OF THE MEDICINAL PRODUCT 

Vitlipid N Adult 

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION 

10ml of Vitlipid N Adult contains: 
Retinol palmitate 

990 micrograms 
corresponding to retinol 

(3,300 IU) 

Ergocalciferol   

5 micrograms (200 IU) 
dl-alpha-tocopherol 

9.1 mg (10 IU) 
Phytomenadione 

150 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 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 A
1
, D
2
, E and K
1
. 

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 Infant should not be administered undiluted.   

Page 2 of 4 

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 
INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION 

This preparation contains Vitamin K
1
,