SELENIUM 10 Microgram/ML Concentrate for Soln for Inf

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

SELENIUM

Disponibil de la:

Laboratoire AGUETTANT

Codul ATC:

A12CE02

INN (nume internaţional):

SELENIUM

Dozare:

10 Microgram/ML

Forma farmaceutică:

Concentrate for Soln for Inf

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Selenium

Statutul autorizaţiei:

Authorised

Data de autorizare:

2016-03-04

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SELENIUM 10 MICROGRAMS/ML CONCENTRATE FOR SOLUTION FOR INFUSION
SODIUM SELENITE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet.
The name of this medicine product is Selenium 10 micrograms/ml
concentrate for solution for infusion but
will be referred as Selenium throughout the whole leaflet.
WHAT IS IN THIS LEAFLET
1.
What Selenium is and what it is used for
2.
What you need to know before you use Selenium
3.
How to use Selenium
4.
Possible side effects
5.
How to store Selenium
6.
Contents of the pack and other information
1.
WHAT SELENIUM IS AND WHAT IT IS USED FOR
Selenium contains the active substance sodium selenite. It belongs to
a group of mineral supplements and
provides a nutritional source of Selenium. Selenium is an essential
trace element that ensures your
metabolism functions efficiently.
Selenium is used to:
-
Prevent Selenium deficiency in patients receiving parenteral nutrition
(artificial feeding through a vein).
-
Treat Selenium deficiency that cannot be compensated by intake from
food alone.
Selenium can be used in adults and in children.
Selenium is a trace element. It means your body needs only very small
quantity of this nutriment. Selenium
is essential for some of your organs (thyroid gland, liver, muscles),
and your defence against risk of
infection (immune system). Selenium also enhances the protection of
your cell membranes against potential
attack from diseases. Any Selenium deficiency in your body might
induce weakness of these organs or
systems which could lead to tiredness, shortness of breath, muscular
discomfort, abnormalities in nails or
hair.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SELENIUM
DO NOT USE SELENIUM:
-

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Selenium 10 micrograms/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 10 ml solution contains 219 micrograms of sodium
selenite, equivalent to 100 micrograms of selenium.
Each ml of solution contains 21.9 micrograms of sodium selenite,
equivalent to 10 micrograms of selenium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear colourless solution.
pH 8.0 – 9.5
Osmolarity = 20 mOsm/l
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of selenium deficiency in patients receiving parenteral
nutrition.
Treatment of proven selenium deficiency that cannot be compensated by
nutrition alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
1 ml of solution contains 10 micrograms of selenium.
The dose must be adapted individually according to selenium deficiency
and selenium status.
For monitoring of therapy the selenium concentration in whole blood or
serum should be determined.
In long term
parenteral nutrition, control of blood levels should be performed at
6-12 months intervals, except if clinical symptoms
of a deficiency are suspected.
Adults:
Plasma selenium concentrations from 80 to 120 µ/L (in whole blood:
100 to 140 µg/l) have been proposed to be
adequate in adults. At levels above the normal selenium levels, the
dose should be reduced.
Pediatric population:
Age specific reference values for normal selenium concentrations apply
for monitoring of therapy.
The recommended posology is:
-
Adults:
o
Supplementation to total parenteral nutrition: 60 to 100 micrograms
daily.
o
Other situation with proven selenium deficiency: 100 micrograms up to
a maximum of 400 micrograms daily for a
short-term until normalization of laboratory monitoring values.
-
Paediatric population:
o
Infants: 2 micrograms/kg/day and infants with low birth weight: 2 to 3
micrograms/kg/day.
o
Children: 2 micrograms/kg/day, up to a maximum of 30 microgra