Phebra MAGNESIUM SULFATE HEPTAHYDRATE 50% 5g/10mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

magnesium sulfate heptahydrate, Quantity: 500 mg/mL

Available from:

Phebra Pty Ltd

INN (International Name):

magnesium sulfate heptahydrate

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: water for injections

Administration route:

Intramuscular, Intravenous

Units in package:

10 x 10mL vials

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Parenteral administration of magnesium is indicated in the treatment of acute hypomagnesaemia. Magnesium salts are also indicated to prevent hypomagnesaemia in patients receiving total parenteral nutrition. Magnesium sulphate is also indicated in the prevention and treatment of life-threatening seizures in the treatment of toxemias of pregnancy (pre-eclampsia and eclampsia). For emegency treatment of some arrhythmias such as Torsade de Pointes and those associated with hypokalemia.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-07-13

Patient Information leaflet

Magnesium Sulfate Heptahydrate 50% Concentrated Injection
Page 1 of 3
_Version 07 _
MAGNESIUM SULFATE
HEPTAHYDRATE 50% CONCENTRATED
INJECTION
CONTAINS 500 MG/ML MAGNESIUM SULFATE HEPTAHYDRATE _ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Magnesium Sulfate
Heptahydrate 50% Concentrated
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 Magnesium Sulfate
Heptahydrate 50% Concentrated
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 MAGNESIUM
SULFATE HEPTAHYDRATE
50% CONCENTRATED
INJECTION IS USED FOR
Magnesium Sulfate Heptahydrate 50%
Concentrated Injection is used to
quickly increase the amount of
magnesium in your body. Other
reasons for treatment with Magnesium
Sulfate Heptahydrate 50%
Concentrated Injection are:
•
the prevention and treatment of
life-threatening seizures associated
with high blood pressure during
pregnancy
•
low potassium levels in the blood
•
to act as a source of nutrition for a
patient fed only by intravenous
means.
Magnesium Sulfate Heptahydrate 50%
Concentrated Injection works by
providing a source of magnesium for
your body to use.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Magnesium Sulfate Heptahydrate 50%
Concentrated Injection for another
reason.
BEFORE YOU ARE GIVEN
MAGNESIUM SULFATE
HEPTAHYDRATE 50%
CONCENTRATED INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU SHOULD NOT BE GIVEN MAGNESIUM
SULFATE HEPTAHYDRATE 50%
CONCENTRATED INJECTION IF HAVE AN
ALLERGY TO:
•
any medicine containing
magnesium or magnesium sulfate
heptahydrate
•
any of the ingredients listed at the
end of this leaflet.
Some symptoms of an allergic reaction
may in

Summary of Product characteristics

PRODUCT INFORMATION
Australian Product Information – Magnesium Sulfate Heptahydrate 50%
Concentrated Injection Page 1 of 8
Version 09
MAGNESIUM SULFATE HEPTAHYDRATE 50% CONCENTRATED INJECTION
(MAGNESIUM SULFATE HEPTAHYDRATE)
1
NAME OF THE MEDICINE
Magnesium sulfate heptahydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of injection contains magnesium sulfate heptahydrate 500 mg.
This is equivalent to 2 mmol (4 mEq) of
magnesium ions and 2 mmol (4 mEq) of sulfate ions in each mL.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Magnesium Sulfate Heptahydrate 50% Concentrated Injection is a clear,
colourless, slightly viscous, sterile
solution. The pH of the solution ranges between 5.5 and 7.0.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Parenteral administration of Magnesium Sulfate Heptahydrate 50%
Concentrated Injection is indicated for:
•
the treatment of acute hypomagnesaemia.
•
the prevention of hypomagnesaemia in patients receiving total
parenteral nutrition.
•
the prevention and treatment of life-threatening seizures in the
treatment of toxemias of pregnancy (pre-
eclampsia and eclampsia).
•
emergency treatment of some arrhythmias such as _ Torsade de Pointes_
and those associated with
hypokalemia.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Careful monitoring of plasma magnesium and other electrolyte
concentration is essential whenever using this
preparation. An intravenous preparation of a calcium salt should
always be available in case of toxicity.
Dosage should be reduced in renal impairment.
Magnesium Sulfate Heptahydrate 50% Concentrated Injection is
administered intravenously or intramuscularly.
INTRAVENOUS DOSE_ _
_Intravenous doses should be diluted to a concentration of 20%
magnesium or less. _
Each 5 mL vial of Magnesium Sulfate Heptahydrate 50% Concentrated
Injection should be diluted by adding at
least 7.5 mL of a compatible solution.
Each 10 mL vial of Magnesium Sulfate Heptahydrate 50% Concentrated
Injection should be diluted wit