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MAGNESIUM SULFATE INJECTION BP 50% W/V

Active substance(s): MAGNESIUM SULFATE HEPTAHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Magnesium Sulfate 50%w/v Solution for Injection
Magnesium Sulfate Heptahydrate
5g/10ml, 2.5g/5ml and 1g/2ml

D0384200000

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 pharmacist.
• If you get any of the side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Magnesium Sulfate Injection is and what
it is used for
2. What you need to know before you are given
Magnesium Sulfate Injection.
3. How Magnesium Sulfate Injection will be given
4. Possible side effects
5. How to store Magnesium Sulfate Injection
6. Contents of the pack and other information

1.What Magnesium Sulfate Injection is
and what it is used for
Magnesium Sulfate Injection is used to treat low levels
of magnesium in the blood where it is not possible for
the medicine to be taken by mouth.
It may also be used to prevent seizures (fits) caused by a
serious complication of pregnancy known as eclampsia.
It is used in the treatment of acute hypomagnesaemia.

2.What you need to know before
you are given Magnesium Sulfate
Injection
You should not be given Magnesium Sulfate
Injection if:
· you are allergic to Magnesium Sulfate, its salts or any
of the other ingredients of this medicine listed in
section 6.
· you suffer from severe kidney failure.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before
receiving Magnesium Sulfate if you:
• suffer from any kidney problem.
• suffer from disease of the muscles causing drooping
eyelids, double vision, difficulty in speaking and
swallowing and sometimes muscle weakness in the
arms or legs known as myasthenia gravis.

Medicines which may interact with Magnesium Sulfate
Injection include:
• Digitalis glycosides e.g. digoxin (a medicine used to
treat heart problems)
• Barbiturates (e.g. amobarbital)
• Opioids ( e.g. morphine)
• Hypnotics ( e.g. nitrazepam)
• Muscle relaxants e.g. tubocurarine
• Calcium channel blockers e.g. nifedipine or
nimodipine (medicines used to treat high blood
pressure) which could result in calcium ion imbalance
causing abnormal muscle function.
• Aminoglycoside antibacterials (such as Streptomycin)
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
It is not advisable to administer magnesium sulfate
during pregnancy or breast-feeding unless considered
essential, and it must be administered under medical
supervision. If used in pregnant women the baby’s
heart rate will be monitored and will not be used
within 2 hours of delivery.
Driving and using machines
There are no known effects of Magnesium Sulfate
Injection on driving and using machines. Please speak
to your doctor before driving or operating machinery.

3.How Magnesium Sulfate Injection
will be given
Your doctor will give Magnesium Sulfate Injection
to you into a vein (intravenous) or into the muscle
(intramuscular) either by injection or infusion (drip).
Your doctor will decide how much Magnesium Sulfate
should be given to you.
For the treatment of low magnesium levels:
You will be given up to 40g by slow intravenous
infusion (drip) (in glucose 5%) over a period of up to
5 days.
To prevent fits associated with eclampsia:
After an initial intravenous dose you will be monitored
for 24 hours and then you may be given either an
intravenous infusion (drip) or regular intramuscular
injections.
Intramuscular Maintenance Regimen
A loading dose of 4g MgSO4 IV (usually in 20%
solution) over 5min (minimum, preferably 10-15 min) is
followed immediately by 5g MgSO4 (approx. 20mmol
Mg2+) (usually in 50% solution) as a deep IM injection
into the upper outer quadrant of each buttock.

During treatment
Your blood calcium levels will be routinely monitored
whilst taking Magnesium Sulfate.

Maintenance therapy is a further 5g MgSO4 IM every
4h, continued for 24h after the last fit (provided
the respiratory rate is >16/min, urine output >25ml/h,
and knee jerks are present).

Other medicines and Magnesium Sulfate Injection
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.

Intravenous Maintenance Regimen
A loading dose of 4g MgSO4 IV (or in some cases
5g MgSO4 IV, as described above, is followed by an
infusion of 1g/h continued for 24h after the last fit.

Recurrent Convulsions: In both the IM and IV
regimens, if convulsions recur, a further 2-4g
MgSO4 (depending on the woman’s weight, 2g
MgSO4 if less than 70Kg is given IV over 5 min.
Renal Failure:
Doses must be reduced in renal failure. Caution must
be observed to prevent exceeding the renal excretory
capacity. The dosage should not exceed 20g in
48 hours (100ml of a 20% solution or 80mmol of
magnesium ions).
Elderly
No special recommendation except in patients with
kidney problems.
If you are given too much or too little Magnesium
Sulfate Injection
As this medicine will be given to you whilst you are
in hospital, it is unlikely that you will be given too
much or too little, however, tell your doctor if you
have any concerns.

4.Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Contact your doctor or nurse immediately if you
get any of the following:
• Allergic reactions such as 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.
• High blood sugars causing severe dehydration
(Hyperosmolar dehydration).
Other side effects:
• feeling or being sick
• flushing of the skin
• feeling thirsty
• slowed reflexes
• temporarily low blood pressure
• drowsiness
• confusion
• muscle weakness
• slowed breathing
• irregular or slow heartbeat
• heart attack
• coma
• low calcium levels in the blood (Hypocalcaemia)
• low phosphate levels in the blood
(Hypophosphataemia)
• double vision
• slurred speech

5.How to store Magnesium Sulfate
Injection
Keep out of the sight and reach of children.
This Magnesium Sulfate Injection should not be used
after the expiry date which is printed on the carton
and ampoule label after EXP. The doctor or nurse
will check that the expiry date on the label has not
passed before administering the injection to you.
The expiry date refers to the last day of that month.
Do not store above 25°C.
After opening the ampoule, the solution for injection
must be used immediately.
The ampoule containing the injection will only be
used for you and if any injection is left over the
doctor/nurse will dispose of it.

6.Contents of the pack and other
Information
What Magnesium Sulfate Injection contains
The active substance is Magnesium Sulfate
Heptahydrate 2ml contains 1g Magnesium Sulfate
Heptahydrate (4mmol Mg2+)
5ml contains 2.5g Magnesium Sulfate Heptahydrate
(10mmol Mg2+)
10ml contains 5g Magnesium Sulfate Heptahydrate
(20mmol Mg2+)
The other ingredients are water for injection,
hydrochloric acid and sodium hydroxide.
What Magnesium Sulfate Injection looks like and
contents of the pack
Magnesium Sulfate sterile solution for injection/
concentrate for solution for infusion is a clear, solution
supplied in 2ml, 5ml and 10ml glass ampoules.
10 ampoules are packed in each carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurum Pharmaceuticals Ltd
Bampton Road
Harold Hill Romford RM3 8UG
United Kingdom
Manufacturer
Macarthys Laboratories Ltd
Bampton Road
Harold Hill
Romford RM3 8UG
United Kingdom
Product Licence No: PL 12064/0013
This leaflet was last revised in June 2017

Reporting of side effects
If you or your child gets any side effects, talk to
your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects, you can help provide more
information on the safety of this medicine.

Continued overleaf

D0384200000

100mm Measurement Verification Bar

100mm Measurement Verification Bar

3842-C

DEVELOPMENT ARTWORK
D03842
PIL MAGNESIUM SULFATE 50%
W/V
170 x 296 mm

09/06/17

NF

12/06/17

NF

19/06/17

NF

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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