VITLIPID N INFANT

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

RETINOL PALMITATE ; ERGOCALCIFEROL ; DL-ALFA-TOCOFEROL ; PHYTOMENADIONE

Saatavilla:

Fresenius Kabi Limited

ATC-koodi:

B05XC

INN (Kansainvälinen yleisnimi):

RETINOL PALMITATE ; ERGOCALCIFEROL ; DL-ALFA-TOCOFEROL ; PHYTOMENADIONE

Annos:

10 Millilitre

Lääkemuoto:

Concentrate for Susp for Inf

Prescription tyyppi:

Product subject to prescription which may not be renewed (A)

Terapeuttinen alue:

Vitamins

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1988-05-16

Pakkausseloste

337 154
(replace 336 746)
Tryckspecifikation
Format:
296,3 x 210 mm
Color:
Black
Fontsize:
10 pt
1:a korr 2018-01-09
Niklas Baudin
[phone]
Kodens skalning 200%
337 154
Package leaflet: Information for the user
Vitamin A, Vitamin D
2
, Vitamin E and Vitamin K
1
Read all of this leaflet carefully before your child is
given this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
or nurse.
- If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Vitlipid N Infant is and what it is used for
2. What you need to know before your child is given
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. Contents of the pack and other information
1. What Vitlipid N Infant is 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
properly.
It is usually used as part of a balanced intravenous diet,
together with proteins, fat, carbohydrates, salts and
vitamins.
2. What you need to know before your child
receives Vitlipid N Infant
Your child should not receive Vitlipid N Infant:
• if he/she is allergic (hypersensitive) to Vitamin A,
Vitamin
D
2
,
Vitamin
E
and
Vitamin
K
1
or
any
of
the
other
ingredients
of
Vitlipid
N
Infant
(listed
in Section 6).
If your child develops a rash or other allergic
reactions
(like
itching,
swollen
lips
or
face
or
shortness of breath), please inform your doctor.
Warnings and precautions
Talk to your doctor, or pharmacist before your
child is given Vitlipid N Infant:
- if he/she has ever suffered from 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

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitlipid N Infant concentrate for emulsion for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of
Each 10 ml of
emulsion contains:
emulsion contains:
Retinol palmitate
corresponding to retinol
(Vitamin A)
69 micrograms (230 IU)
6990 micrograms (2,300 IU)
Ergocalciferol
(Vitamin D
2
)
1 micrograms (40 IU)
10 micrograms (400 IU)
dl-alpha-tocopherol
(Vitamin E)
0.64 mg (0.7 IU)
6.4 mg (7 IU)
Phytomenadione
(Vitamin K
1
)
20 micrograms
200 micrograms
Excipients: Each 10ml contains 1g of purified soyabean oil
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Concentrate for emulsion for infusion
A sterile, oil-in-water white emulsion containing fat soluble vitamins
in the oil phase.
pH: approx. 8
Osmolality: approx. 300 mosm/kg water
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vitlipid 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
.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous infusion after dilution, see section 6.6
RECOMMENDED DAILY DOSAGE FOR INFANTS AND CHILDREN AGED 11 TO 18 YEARS
4ml/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 of age.
RECOMMENDED DOSAGE FOR THE CHILDREN (OVER 11 YEARS OF AGE), ADULTS AND
THE ELDERLY
It is recommended that the adult preparation Vitlipid N Adult (PA
566/17/1) be used.
Do not exceed the recommended dose.
Method of administration
For intravenous infusion after dilution, see section 6.6.
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