VITLIPID N ADULT

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

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

Boleh didapati daripada:

Fresenius Kabi Limited

Kod ATC:

B05XC

INN (Nama Antarabangsa):

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

Dos:

10 Millilitre

Borang farmaseutikal:

Concentrate for Susp for Inf

Jenis preskripsi:

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

Kawasan terapeutik:

Vitamins

Status kebenaran:

Marketed

Tarikh kebenaran:

1988-05-16

Risalah maklumat

337 152
(replace 336 745)
Tryckspecifikation
Format:
296,3 x 210 mm
Color:
Black
Fontsize:
10 pt
1:a korr 2018-01-09
Niklas Baudin
[phone]
Kodens skalning 200%
337 152
Package leaflet: Information for the user
Vitamin A, Vitamin D
2
, Vitamin E and Vitamin K
1
Read all of this leaflet carefully before you are
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 side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Vitlipid N Adult is and what it is used for
2. What
you
need
to
know
before
you
are
given
Vitlipid N Adult
3. How you will be given Vitlipid N Adult
4. Possible side effects
5. How Vitlipid N Adult is stored
6. Contents of the pack and other information
1. What Vitlipid N Adult is 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. What you need to know before you are given
Vitlipid N Adult
You should not receive Vitlipid N Adult:
• if you are allergic (hypersensitive) to Vitamin A,
Vitamin
D
2
,
Vitamin
E
and
Vitamin
K
1
or
any
of
the other ingredients of Vitlipid N Adult (listed 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.
Warnings and precautions
Talk to your doctor or nurse before you are given
Vitlipid N Adult.
Your doctor or nurse will make sure Vitlipid N Adult is
prepared correctly before you receive it.
Your doctor may want to do regular blood tests to
check your condition.
Other medicines and Vitlipid N Adult
Tell your doctor or nurse if you are taking or have
recently taken or might take any other m

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitlipid N Adult 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)
99 micrograms (330 IU)
990 micrograms (3,300 IU)
Ergocalciferol
(Vitamin D
2
)
0.5 micrograms (20 IU)
5 micrograms (200 IU)
dl-alpha-tocopherol
(Vitamin E)
0.91 mg (1 IU)
9.1 mg (10 IU)
Phytomenadione
(Vitamin K
1
)
15 micrograms
150 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 Adult is indicated in adult patients and children from 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 ADULTS AND CHILDREN AGED 11 TO 18 YEARS
One ampoule (10 ml) Vitlipid N Adult added to 500 ml Intralipid 10%,
20% or 30%.
RECOMMENDED DOSAGE FOR THE ELDERLY
No adjustment of the adult dosage is required.
Do not exceed the recommended dose.
Method of administration
For intravenous infusion after dilution, see section 6.6.
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