Vitlipid N Infant concentrate for emulsion for infusion

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

PHYTOMENADIONE, DL, ALFA, TOCOPHEROL, ERGOCALCIFEROL, RETINOL

Dostopno od:

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

Koda artikla:

B05XB

INN (mednarodno ime):

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

Farmacevtska oblika:

EMULSION FOR INFUSION

Sestava:

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

Tip zastaranja:

POM

Terapevtsko območje:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Status dovoljenje:

Authorised

Datum dovoljenje:

2007-06-12

Navodilo za uporabo

333 133 size: 210 x 148, 2:a korr 09-09-11, Johanna Eriksson
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before your child starts 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 your child. 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 Infant and what it is used for
2.
Before your child receives Vitlipid
®
N Infant
3.
How your child will be given Vitlipid
®
N Infant
4.
Possible side effects
5.
How Vitlipid
®
N Infant is stored
6.
Further information
1.
WHAT IS VITLIPID
®
N INFANT AND WHAT IT
IS USED FOR
Vitlipid
®
N Infant is especially designed for babies and children. It provides
fat soluble vitamins in your child’s parenteral nutrition when your
child
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 YOUR CHILD RECEIVES VITLIPID
®
N INFANT
Your child should not receive Vitlipid
®
N Infant:
•
if he/she is allergic (hypersensitive) to Vitlipid
®
N Infant or any of
the ingredients of Vitlipid
®
N Infant 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 he/she has 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 your child. Your doctor or nurse will
make sure it is prepared correctly.
Care should be taken when administering Vitlipid
®
N Infant
Your doctor may want to do regular blood tests to check your
child’s condition.
Taking other medicines
Please

Lastnosti izdelka

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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
(MA1123/02301) be used.
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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
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
Not applicable.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable.
4.8
UNDESIRABLE EFFECTS
None known.
4.9
OVERDOSE
In general overdosage with Vitlipid N Infant is unlikely. If chronic
overdosage occurred
symptoms such as headache, nausea, vomit