PHEBRA SODIUM SELENATE DECAHYDRATE 467 microgram/2mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium selenate decahydrate, Quantity: 467 microgram (Equivalent: selenium, Qty 100 microgram)

Available from:

Phebra Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

2 mL x 10

Prescription type:

Not Scheduled after consideration by Committee

Therapeutic indications:

INDICATIONS AS AT 01 MARCH 1998 : This formulation is indicated for use as a supplement to IV solutions given for TPN. Administation of the solution in TPN solutions helps to maintain plasma levels of copper, manganese, and selenium and to prevent depletion of endogenous stores of these trace elements and subsequent deficiency symptoms. Cancer: Prophylaxis of malignant neoplasms via selenium supplementation.

Product summary:

Visual Identification: A clear, colourless to faintly straw coloured solution, practically free from visible particles.; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-14

Patient Information leaflet

SODIUM SELENATE
DECAHYDRATE (467ΜG/2ML) INJECTION
CONTAINS 100 MICROGRAMS OF SELENIUM IN 2 ML
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sodium Selenate
Decahydrate Injection. It does not
contain all the available information. It
does not take the place of talking to
your doctor.
All medicines have risks and benefits
.
Your doctor has weighed the risks of
you being given Sodium Selenate
Decahydrate Injection against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET
.
You may need to read it again.
WHAT SODIUM SELENATE
DECAHYDRATE INJECTION
IS USED FOR
Selenium is an essential trace mineral.
Sodium Selenate Decahydrate Injection
is added to intravenous solutions (IV)
that are given as a source of nutrition
(Total Parenteral Nutrition- TPN) for a
patient unable to ingest food. It
prevents a deficiency of copper,
manganese and selenium by
maintaining the levels of these trace
elements in the blood.
This medicine is also used in the
prevention of abnormal tissue growth.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
BEFORE YOU ARE GIVEN
SODIUM SELENATE
DECAHYDRATE INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU SHOULD NOT BE GIVEN SODIUM
SELENATE DECAHYDRATE INJECTION IF
YOU HAVE AN ALLERGY TO SELENIUM OR
SODIUM SELENATE DECAHYDRATE OR ANY
MEDICINE OR VITAMIN PREPARATION
CONTAINING SODIUM SELENATE.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash itching or hives on the skin.
YOU SHOULD NOT BE GIVEN THIS
MEDICINE IF
THE SOLUTION IS
DISCOLOURED, CLOUDY, TURBID, OR A
PRECIPITATE OR PARTICLES ARE PRESENT.
_ _
The solution is normally a clear,
colourless solution.
YOU SHOULD NOT BE GIVEN THIS
MEDICINE IF, WHEN ADDED TO ANOTHER

Summary of Product characteristics

PRODUCT INFORMATION
SODIUM SELENATE DECAHYDRATE 467 MICROGRAMS IN 2 ML
INJECTION
_ _
NAME OF MEDICINE
_Sodium Selenate Decahydrate_ - Na
2
SeO
4
10H
2
O.
The molecular weight is 369.09. The CAS Registry number is 10102-23-5.
DESCRIPTION
Sodium selenate is a colourless crystal or a white, crystalline
powder.
It is soluble in water.
SODIUM SELENATE DECAHYDRATE INJECTION is a clear, colourless to
faintly straw coloured sterile solution, practically free
from visible particles. SODIUM SELENATE DECAHYDRATE INJECTION contains
467 micrograms sodium selenate decahydrate
in water for injections in 2 mL
•
Equivalent to 1.26 micromoles of selenium ions per 2 mL
•
Equivalent to 100 micrograms of selenium per 2 mL
The pH is approximately 5.5 to 6.5.
PHARMACOLOGY
Selenium is generally readily absorbed from the gastrointestinal
tract. Selenium is stored in red blood cells, liver, spleen,
heart, and nails. It is converted in the tissues into metabolically
active forms. Selenium is excreted in the urine and to a lesser
extent in the faeces_. _Selenium is an essential trace element and a
cofactor for the enzymes, glutathione peroxidases, which
protect intracellular structures against free radicals and oxidative
damage. Other selenium binding proteins are involved with
thyroid hormone metabolism, muscle function, male fertility and immune
regulation. Selenium concentrations in the body are
diet and locale dependent. Diets based on foods from selenium
deficient regions may lead to low levels of serum selenium in
patients. The normal whole blood range for selenium is approximately
10 to 37 micrograms per 100 mL.
_ _
INDICATIONS
SODIUM SELENATE DECAHYDRATE INJECTION is indicated for use as a
supplement to IV solutions given for Total
Parenteral Nutrition (TPN). Administration of the solution in TPN
solutions helps to maintain plasma levels of copper,
manganese, and selenium and to prevent depletion of endogenous stores
of this trace element and subsequent deficiency
symptoms.
_Cancer_: Prophylaxis of malignant neoplasms via seleni