selenase ® 100 micrograms solution for injection (50 microgramsml)

Ország: Malajzia

Nyelv: angol

Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktív összetevők:

SODIUM SELENITE PENTAHYDRATE

Beszerezhető a:

IMEKS PHARMA SDN. BHD.

INN (nemzetközi neve):

SODIUM SELENITE PENTAHYDRATE

db csomag:

2ml mL

Gyártó:

WASSERBURGER ARZNEIMITTELWERK

Betegtájékoztató

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SELENASE
® SOLUTION FOR INJECTION
(50MCG/ML)
Sodium Selenite Pentahydrate (166.5mcg/ml)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Selenase is used for
2.
How Selenase works
3.
Before you use Selenase
4.
How to use Selenase
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Selenase
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT SELENASE IS USED FOR
Selenase is used to treat selenium deficiency,
which cannot be corrected by selenium
intake from food sources.
HOW SELENASE WORKS
Selenase contains active ingredient, sodium
selenite pentahydrate that provides a source
of selenium, which is an essential trace
element in nutrition that ensure your
metabolism functions efficiently.
BEFORE YOU USE SELENASE_ _
_- When you must not use it _
Do not take Selenase if you:
• Are allergic to sodium selenite
pentahydrate or any other ingredients in this
medicine.
• Have selenosis (selenium poisoning)
_- Before you start to use it _
Tell your doctor if you have allergies to:
• Any other substances, including foods,
preservative or dyes.
_- Taking other medicines _
Tell your doctor if you are taking any other
medicine, including any that you buy without
a prescription. You may need to use different
amounts of these medicines, or you may
need to take different medicines. Your doctor
will advise you. In particular, tell your doctor
if you take any of the following:
• Reducing substances (e.g. Vitamin C)
_- Pregnancy and lactation _
There are no adverse effect of Selenase on
the pregnancy of the unborn child is
expected, provided that it is used in case of
proven selenium deficiency. Selenase is
excreted into the breast milk but it is not
expected to exert adverse effect on the
breast-feeded infant.
Anyway, discuss with your doctor regarding
the use of Selenase during pregnancy or
breast-feeding.
HOW TO USE SELENASE
Take your medication exactly as directed by
your doctor.
_- How much to use_
_Daily Dose for adults

Termékjellemzők

BIOSYN ARZNEIMITTEL GMBH
SCHORNDORFER STRASSE 32
70734 FELLBACH, GERMANY
Product Information
1. NAME OF THE MEDICINAL PRODUCT
SELENASE® 100 micrograms,
solution for injection (50 micrograms/ml)
SELENASE® 500 micrograms,
solution for injection (50 micrograms/ml)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
selenase® 100 micrograms, solution for injection (50
micrograms/ml)
Each 2 ml injection ampoule contains 100 micrograms selenium in
the form of 333 micrograms sodium selenite pentahydrate
(Na2SeO3 · 5 H2O), corresponding to 50 μg/ml.
selenase® 500 micrograms, solution for injection (50
micrograms/ml)
Each 10 ml injection vial contains 500 micrograms selenium in the
form of 1.66 mg sodium selenite pentahydrate (Na2SeO3 · 5
H2O), corresponding to 50 μg/ml.
For excipients, see 6.1
3. PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of proven selenium deficiency that cannot be offset
from food sources.
4.2 POSOLOGY AND METHODS OF ADMINISTRATION
Daily dose:
100–200 micrograms selenium (equivalent to 1-2 ampoules). If
more selenium is necessary to reach the normal blood level, this
dose can be increased to 500 micrograms selenium (equivalent to
5 ampoules = 5 x 100 micrograms or 1 injection vial = 500
micrograms, respectively).
Method of administration
selenase
®
solution for injection is administered as an
intramuscular or intravenous injection. Selenium levels in whole
blood or serum should be determined in order to monitor the
success of therapy.
When selenase
®
solution for injection is administered as a
supplement to general infusion solutions for total parenteral
nutrition, a daily dose of 100 micrograms selenium must be
ensured. There is no time limit to the administration of selenase
®
solution for injection in a supplementary dose (100 micrograms
selenium per day, equivalent to 2 ml selenase
®
solution for
injection).
Do not take selenium together with or too close to strong reducing
substances as vitamin C. v