Vitlipid N Adult concentrate for emulsion for infusion

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

PHYTOMENADIONE, DL, ALFA, TOCOPHERYL ACETATE, ERGOCALCIFEROL, RETINOL

から入手可能:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

ATCコード:

B05XB

INN（国際名）:

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

医薬品形態:

EMULSION FOR INFUSION

構図:

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

処方タイプ:

POM

治療領域:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

認証ステータス:

Authorised

承認日:

2007-06-12

情報リーフレット

333 128 size: 210 x 148, 2:a korr 09-09-11, Johanna Eriksson
PACKAGE LEAFLET: INFORMATION FOR THE USER
VITLIPID
®
N ADULT CONCENTRATE FOR
EMULSION FOR INFUSION
Read all of this leaflet carefully before you start taking this
medicine.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.
What is Vitlipid
®
N Adult and what it is used for
2.
Before you receive Vitlipid
®
N Adult
3.
How you are given Vitlipid
®
N Adult
4.
Possible side effects
5.
How Vitlipid
®
N Adult is stored
6.
Further information
1.
WHAT IS VITLIPID
®
N ADULT AND WHAT IT IS
USED FOR
Vitlipid
®
N Adult provides fat soluble vitamins when used together with
Intralipid
®
into your bloodstream when you cannot eat normally.
It is usually used as part of a balanced intravenous diet, together
with
proteins, fat, carbohydrates, salts and other vitamins.
2.
BEFORE YOU RECEIVE VITLIPID
®
N ADULT
You should not receive Vitlipid
®
N Adult:
•
if you are allergic (hypersensitive) to Vitlipid
®
N Adult or any of
the ingredients of Vitlipid
®
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 suffered an allergic reaction to egg, soya or peanut
protein
•
if it is undiluted
.
It will be added to another solution known as
Intralipid
®
before it is given to you. Your doctor or nurse will make
sure it is prepared correctly before you receive Vitlipid
®
N Adult.
Care should be taken when administering Vitlipid
®
N Adult
Tell your doctor if:
•
you are taking other supplements with Vitamin A.
Your doctor may want to do regular blood tests t

製品の特徴

Page 1 of 3
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.
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
Page 2 of 3
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
, which may interact with anticoagulants of the
coumarin type.
4.6 PREGNANCY AND LACTATION
This product contains vitamin A. High doses of Vitamin A can cause
birth defects especially
if taken during the first trimester.
Should not be given if the patient is pregnant or likely to become
pregnant, without
evaluation of the total daily dose. The concomitant intake of Vitamin
A from food must be
considered.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not