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MAGNESIUM SULFATE 50% W/V SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSI

Active substance(s): MAGNESIUM SULFATE HEPTAHYDRATE

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Package leaflet: Information for the user
Magnesium sulfate 50% w/v solution for injection or
concentrate for solution for injection or infusion
magnesium
Read all of this leaflet carefully before you start
taking 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 or nurse.
- This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, or
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Magnesium sulfate 50%
w/v solution for injection or concentrate for solution
for injection or infusion. In the rest of this leaflet the
name of the medicine shall be Magnesium sulfate 50%.
What is in this leaflet
1. What Magnesium sulfate 50% is and what it is used for
2. What you need to know before you are given
Magnesium sulfate 50%
3. How Magnesium sulfate 50% is given
4. Possible side effects
5. How to store Magnesium sulfate 50%
6. Contents of the pack and other information
1. What Magnesium sulfate 50% is and what it is used
for
Magnesium sulfate 50% contains magnesium as
magnesium sulfate heptahydrate. Magnesium sulfate
heptahydrate is a magnesium salt.
Magnesium sulfate 50% is given:
 To increase the amount of magnesium in the body in
conditions where, because of a variety of causes, the
blood level of magnesium is below normal
(hypomagnesaemia) and especially when it is followed
by tetany symptoms.
 For the prevention and control of further fits (seizures)
occurring because of very high blood pressure in
pregnancy (eclampsia).
 For the prevention and control of fits (seizures) in
severe pre-eclampsia.
 For the prevention and treatment of hypomagnesaemia
in patients receiving Total Parenteral Nutrition.
2. What you need to know before you are given
Magnesium sulfate 50%
Do not use Magnesium sulfate 50%:
 If you are allergic to magnesium sulfate and magnesium
salts or any of the other ingredients of this medicine
(listed in section 6).
 If you have liver problems (particularly in hepatic coma
if there is a risk of kidney failure).
 If you have kidney failure or severe kidney problems, or
you cannot make or pass urine (anuria).
 If you have heart problems
 If you have a disease causing muscle weakness and
fatigue called myasthenia gravis.
Warnings and precautions
Talk to your doctor, or pharmacist or nurse before you are
given Magnesium sulfate 50% if:
 You have kidney problems, a reduction in the usual
dosage may be appropriate.
The following information is intended for healthcare
professionals only:
Preparation and handling

The 50% w/v solution MUST be diluted before use for IV
administration; concentrations up to 20% w/v are usually
employed.
Incompatibilities
Magnesium sulfate is incompatible with alkali hydroxides
(forming insoluble magnesium hydroxide), alkali carbonates
(forming insoluble magnesium carbonate) and salicylates.
The activities of streptomycin sulfate and tetramycin sulfate
are inhibited by magnesium ions.
Posology and method of administration
Treatment of magnesium deficiency in proven
hypomagnesaemia
Adults:
Intravenous Route:
Up to 80 mL (40 g) Magnesium sulfate 50% w/v solution
(corresponding to 160mmol = 4 g Mg2+) diluted should be
administered by slow intravenous infusion over a period of up
to five days and titrated to clinical need. The usual regimen is
16-24 mL (8-12 g) Magnesium sulfate 50% w/v solution
(corresponding to 33-50 mmol = 0.8 - 1.2 g Mg2+) diluted in
the first 24 hours followed by 8-12 mL (4-6 g) Magnesium
sulfate 50% w/v solution (corresponding to 16-25 mmol = 0.40.6 g Mg2+) diluted per day for 3 or 4 days.
Intramuscular Route:
2-4 mL (1-2 g) Magnesium sulfate 50% w/v solution
(corresponding to 4-8 mmol = 0.1-0.2 g Mg2+) undiluted
or 4-8 mL (2-4 g) of Magnesium sulfate 50% w/v solution
diluted to 25% w/v solution can be given intramuscularly
every 6 hours for 24 hours (a total of 4 doses).
Children and adolescents:
Neonate
0.2 mL/kg (100 mg/kg) Magnesium sulfate 50% w/v
solution (corresponding to 0.4 mmol/kg = 0.01 g/kg Mg2+)
diluted to 20% w/v solution (i.e. 0.5 mL/kg of a 20% w/v
solution) every 6-12 hours as required, to be given by
intravenous injection over at least 10 minutes.

 You are taking or using other medicines (see ‘Other
medicines and Magnesium sulfate 50%’ below).
Other medicines and Magnesium sulfate 50%
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. Tell
your doctor if you are taking any of the following
medicines:
 Hypnotics (medicines for sleep disorders) such as
nitrazepam or temazepam.
 Barbiturates (medicines for anxiety, insomnia) such as
amylobarbitone.
 Opioids (medicines for chronic pain) such as morphine
or codeine.
 Muscle relaxants (used during anaesthesia) such as
tubocurarine.
 Digoxin or other digitalis glycosides (medicines used for
the treatment of heart problems).
 Nifedipine (may be used to treat high blood pressure or
chest pain (angina)), suxamethonium (medicine used
for anaesthesia).
 Aminoglycoside antibacterial medicines (medicines
used to treat bacterial infections) such as streptomycin.
 Calcium channel blockers (medicines used to treat high
blood pressure and chest pain) such as amlodipine or
diuretics (medicines that increase the passage of urine),
such as thiazides and furosemide.
 Calcium salts.
Pregnancy and breast-feeding
Magnesium sulfate 50% is used for the control and
prevention of fits (seizures) related with severe preeclampsia and eclampsia, two serious complications of
pregnancy. Magnesium sulfate crosses the placenta.
Small amounts of magnesium get into breast milk.
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.
Driving and using machines
Your medicine is unlikely to affect your ability to drive or
to operate machinery. However, some people may feel
dizzy or drowsy when given Magnesium sulfate 50%. If
this happens to you, do not drive or operate machinery.
3. How Magnesium sulfate 50% is given
Magnesium sulfate will be given to you by injection either
into a muscle (intramuscularly) or into a vein
(intravenously) after being diluted. The dose depends on
your individual needs and responses to treatment. Your
blood levels will be monitored during treatment. If you
have doubts about the treatment or want more
information about your medicine or the monitoring
procedure, do ask the doctor or nurse.
If you are given more Magnesium sulfate 50% than
you should be
As this medicine will be given to you by a doctor or nurse,
it is unlikely that you will be given too much.
Excessive administration of magnesium leads to the
development of hypermagnesaemia, i.e. high blood levels
of magnesium. Hypermagnesaemia may only be
associated with mild symptoms initially - see "Possible
side effects" below - but if treatment is not terminated or
efforts made to reduce the blood level, symptoms may
become more serious and could lead eventually to coma
or cardiac arrest. Tell the doctor if you are experiencing
any side effects or think you may be reacting badly so
that he/she can give appropriate treatment.
If you have already left the medical premises, contact
your nearest hospital, doctor or pharmacist.
Child 1 month-11 years
0.1 mL/kg (50 mg/kg) Magnesium sulfate 50% w/v solution
(corresponding to 0.2 mmol/kg = 0.005 g/kg Mg2+) diluted to
20% w/v solution (i.e. 0.25 mL/kg of a 20% w/v solution)
every 12 hours as required, to be given by intravenous
injection over at least 10 minutes.
Adolescent 12-17 years
2 mL (1 g) Magnesium sulfate 50% w/v solution
(corresponding to 4 mmol = 0.1 g/kg Mg2+) diluted to 20% w/v
solution (i.e. 5 mL of a 20% w/v solution) every 12 hours as
required, to be given by intravenous injection over at least 10
minutes.
Elderly:
As for adults, Magnesium sulfate 50% w/v solution should be
used with caution in elderly because of often renal
impairment in this age group.
Prevention of hypomagnesaemia in patients receiving
Total Parenteral Nutrition
Adults:
5-10 mL (2.5-5 g) Magnesium sulfate 50% w/v solution
(corresponding to 10-20 mmol = 0.25-0.5 g Mg2+) diluted
daily, usual dose 6 mL (3 g) Magnesium sulfate 50% w/v
solution (corresponding to 12 mmol = 0.3 g Mg2+) diluted
daily, by intravenous infusion or intramuscular injection.
Neonates and infants (up to 12 months):
0.1 mL/kg (50 mg/kg) Magnesium sulfate 50% w/v solution
(corresponding to 0.2 mmol/kg = 0.005 g/kg Mg2+) diluted
daily by intravenous infusion.
Children (1–13 years) and adolescents (14-18 years):
0.05 mL/kg (25 mg/kg) Magnesium sulfate 50% w/v solution
(corresponding to 0.1 mmol/kg = 0.0025 g/kg Mg2+) diluted
daily by intravenous infusion.
Control and prevention of recurrent seizures in severe
pre-eclampsia and eclampsia
Adult women:
Loading dose: An initial IV loading dose of approximately 810 mL (4-5 g) Magnesium sulfate 50% w/v solution
(corresponding to 16-20 mmol = 0.4-0.5 g Mg2+) diluted to an
appropriate volume is administered over 5-15 minutes
followed either by maintenance intravenous infusion or
regular IM injections for 24 hours, as follows:
Intravenous maintenance regimen:
The IV loading dose (above) is followed by an infusion of
approximately 2 mL (1 g) Magnesium sulfate 50% w/v
solution (corresponding to 4 mmol = 0.1 g Mg2+) diluted per
hour for at least 24 hours after the last fit.
Intramuscular maintenance regimen:

If you forget to be given Magnesium sulfate 50%
It is unlikely that you will miss a dose as your doctor or
nurse will be giving it to you. However, it is important not
to have a double dose if you have missed one. Ask your
doctor, pharmacist or nurse, when you should have the
next dose.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Seek immediate medical help if you have an allergic
reaction. This includes any of the following symptoms:
 Difficulty in breathing - slow and/or shallow breathing.
 Swelling of your eyelids, face or lips.
 Rash or itching especially those covering your whole
body.
The frequency of side effects is not known (cannot be
estimated from the available data).
Nervous System disorders
 Feeling sick (nausea)
 Vomiting
 Drowsiness
 Feeling confused
 Coma
 Slurred speech
 Double vision
Heart problems
 Drop in blood pressure
 Flushing of the skin
 Irregular heart beats
 Heart attack
Other effects
 Loss of the knee jerk reflex
 Muscle weakness
 Feeling thirsty
 Low blood calcium levels in pregnant women and their
developing babies have been reported extremely rarely
 Low levels of calcium in your blood. (This may cause
you to have pins and needles or twitching muscles)
 Vein irritation
 Tissue damage due to extravasation (medication
injected or leaked outside the vein into the surrounding
tissue)
 Dilatation of blood vessels
 Pain,
 Redness
 Swelling or warmth at the injection site
 Drainage at the injection site
 Continuing bleeding
 Skin infection (cellulitis)
 Abscess (especially near injection site),
 Injury to nearby structures (blood vessels, bones, or
nerves)
 Accidental injection into a vein or a bone
 Death of tissue cells (tissue necrosis)
 Poor absorption due to high volume injected.
Reporting of side effects
If you get any side effects, talk to your doctor or
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, Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow
Card in the Google Play or Apple App Store. By reporting
side effects you can help provide more information on the

safety of this medicine.
5. How to store Magnesium sulfate 50%
After dilution, the product should be used immediately. If
not used immediately, in-use storage times and
conditions prior to use are the responsibilities of the user
and would normally not be longer than 48 hours at 23 27°C and 2 - 8°C when diluted to a concentration of not
more than 200 mg/mL in Sodium chloride 0.9 % or
Glucose 5%, unless reconstitution/dilution has taken
place in controlled and validated aseptic conditions.
This medicinal product does not require any special
storage conditions. Keep this medicine out of the sight
and reach of children.
Do not use this medicine after the expiry date which is
stated on the ampoule and carton after EXP. The expiry
date refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information
What Magnesium sulfate 50% contains
- The active substance is magnesium as magnesium
sulfate heptahydrate. 1 mL of Magnesium sulfate 50%
w/v (5 g/10 mL) Solution for injection or concentrate for
solution for injection or infusion contains 500 mg of
magnesium sulfate heptahydrate. Each 10 mL ampoule
contains 5 g magnesium sulfate heptahydrate.
- The other ingredients are water for injections and
sulfuric acid.
What Magnesium sulfate 50% looks like and contents
of the pack
Magnesium sulfate 50% w/v (5 g/10 mL) Solution for
injection or concentrate for solution for injection or
infusion is a clear, colourless solution. The product is
available in 10 mL polypropylene ampoules in packs of
10, 20, and 50 ampoules.
Marketing Authorization Holder and Manufacturer:
DEMO S.A., 21st km National Road Athens-Lamia, GR14568 Krioneri, Attiki, Greece,Tel: +30 210 8161802, Fax:
+30 210 8161587.
This medicinal product is authorised in the Member
States of the EEA under the following names:
United
Magnesium sulfate 50% w/v Solution for
Kingdom:
injection or concentrate for solution for
injection or infusion
Greece:
Magnesium sulfate/DEMO 50% w/v Ενέζιμο
διάλσμα ή πσκνό διάλσμα για παραζκεσή
ενέζιμοσ διαλύμαηος/διαλύμαηος προς
έγτσζη
Germany: Magnesiumsulfat 50% (m/v) Lösung zur
Injektion oder Konzentrat zur Herstellung
einer Injektion oder Infusion
This leaflet was last revised in 08/2017.

The IV loading dose (above) is immediately followed by deep
IM injection of 10 mL (5 g) Magnesium sulfate 50% w/v
solution (corresponding to 20 mmol = 0.5 g Mg2+) undiluted.
Maintenance therapy is a further 10 mL (5 g) Magnesium
sulfate 50% w/v solution (corresponding to 20 mmol = 0.5 g
Mg2+) undiluted IM every four hours, continued for 24 hours
after the last fit (provided respiratory rate is >16/min, urine
output >25 mL/min and knee jerks are present).
Recurrent convulsions: In both IV and IM regimens, a further
4-8 mL (2-4 g) Magnesium sulfate 50% w/v solution
(corresponding to 8-16 mmol = 0.2-0.4 g Mg2+) diluted
depending on body weight [if less than 70 kg 4 mL (2 g)
Magnesium sulfate 50% w/v solution (corresponding to 8
mmol = 0.2 g Mg2+) diluted] are given IV over a period of 5
minutes.
Renal impairment
Magnesium sulfate 50% w/v solution is contraindicated in
patients with severe renal impairment.
Magnesium sulfate 50% w/v solution should be used with
caution in mild to moderate renal impairment. A reduction
in dosage to 40 mL (20 g) Magnesium sulfate 50% w/v
solution (corresponding to 80 mmol = 2 g Mg2+) diluted over
48 hours may be given.
Patients with impaired liver function
There are no recommended special dosage instructions for
patients with impaired liver function because of insufficient
data.
Method of administration
Intravenous use in adults and adolescents
Intravenous infusion: For the intravenous route, the 50% w/v
solution requires dilution to a concentration of not
more than 20% (≤ 200 mg/ mL) – with a suitable diluent, such
as Glucose 5% or sodium chloride 0.9%. Infuse via a
volumetric infusion device at a rate appropriate to the
indication (see posology above).
Intravenous injection: Give by slow IV injection at a rate
appropriate to the indication (see posology above).
Intravenous use in children:
Rate of administration should not exceed 0.02 mL/kg/minute
(10 mg/kg/minute) of appropriately diluted Magnesium sulfate
50% w/v solution (corresponding to 0.04 mmol/kg/minute =
0.001 g/kg/minute Mg2+).
Deep Intramuscular injection (adults only)
For the intramuscular route, the 50% w/v solution should be
used undiluted or diluted to 25% w/v. If the total dose to be
administered exceeds 5 mL, the injection volume should be
divided between more than one deep muscular injection site.

For the intramuscular route, use good clinical practice for
intramuscular injections. Avoid muscles which are emaciated
or atrophied. Avoid the dorsogluteal muscle and sciatic nerve.
If the total dose to be administered exceeds 5 mL, the
injection volume should be divided between more than one
deep muscular injection site. Use caution in older or thin
patients who may only tolerate up to 2 ml in a single injection.
Do not use an injection site that has evidence of infection or
injury. If repeating an intramuscular dose, rotate injection
sites to avoid injury or discomfort to the muscles.
Disposal
Any unused medicinal product or waste material should be
disposed of in accordance with local requirements.
Overdose
Signs
Excessive administration of magnesium leads to the
development of hypermagnesaemia.
Magnesium intoxication is manifested by a sharp drop in
blood pressure and respiratory paralysis. Disappearance of
the patellar reflex is a useful clinical sign to detect the onset
of magnesium intoxication.

If this leaflet is difficult to see or
read, please contact the following
address for help:
Athlone Laboratories, Ballymurray,
Co. Roscommon, Ireland,
Tel: +353-9066-61109,
Email: medical@athlonelaboratories.com

Mg plasma
concentration
(mmol/L)
2 to 3

3 to 5

>5

> 7.0

Symptoms and undesirable effects

nausea, flushing, headache, lethargy,
drowsiness, diminished deep tendon
reflexes, platelet disaggregation
somnolence, hypocalcemia, absent deep
tendon reflexes, hypotension, bradycardia,
and ECG changes
muscle paralysis, respiratory paralysis,
coma. In most cases, respiratory failure
precedes cardiac collapse
Complete heart block and cardiac arrest

Patients with renal failure and metabolic derangements
develop toxicity at lower doses.
Treatment
Appropriate action should be taken to reduce the blood level
of magnesium. In the event of overdosage, artificial
ventilation must be provided until a calcium salt can be
injected IV to antagonize the effects of magnesium.
Neuromuscular blockade associated with hypermagnesaemia
may be reversed with calcium salts, such as calcium
gluconate, which should be administered intravenously in a
dose equivalent to 2.5 to 5 mmol of calcium.

+ 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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