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MAGNESIUM SULFATE 10% W/V SOLUTION FOR INJECTION OR INFUSION

Active substance(s): MAGNESIUM SULFATE HEPTAHYDRATE / MAGNESIUM SULFATE HEPTAHYDRATE

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Package leaflet: Information for the user
Magnesium sulfate 10% w/v 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 10% w/v
Solution for injection or infusion. In the rest of this leaflet
the name of the medicine shall be Magnesium sulfate 10%.
What is in this leaflet
1. What Magnesium sulfate 10% is and what it is used for
2. What you need to know before you are given Magnesium
sulfate 10%
3. How Magnesium sulfate 10% is given
4. Possible side effects
5. How to store Magnesium sulfate 10%
6. Contents of the pack and other information
1. What Magnesium sulfate 10% is and what it is used
for
Magnesium sulfate 10% contains magnesium as
magnesium sulfate heptahydrate. Magnesium sulfate
heptahydrate is a magnesium salt.
Magnesium sulfate 10% 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 10%
Do not use Magnesium sulfate 10%:
 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.
The following information is intended for healthcare
professionals only:
Preparation and handling

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:
Up to 400 mL (40 g) Magnesium sulfate 10% w/v solution
(corresponding to 160 mmol = 4 g Mg2+) should be
administered by slow intravenous infusion over a period of
up to five days and titrated to clinical need. The usual
regimen is 80-120 mL (8-12 g) Magnesium sulfate 10% w/v
solution (corresponding to 33-50 mmol = 0.8-1.2 g Mg2+) in
the first 24 hours followed by 40-60 mL (4-6 g) Magnesium
sulfate 10% w/v solution (corresponding to 16-24 mmol =
0.4-0.6 g Mg2+) per day for 3 or 4 days.
Children and adolescents:
Neonate
1 mL/kg (100 mg/kg) Magnesium sulfate 10% w/v solution
(corresponding to 0.4 mmol/kg = 0.01 g/kg Mg2+) every 612 hours as required, to be given by intravenous injection
over at least 10 minutes.
Child 1 month-11 years
0.5 mL/kg (50 mg/kg) Magnesium sulfate 10% w/v solution
(corresponding to 0.2 mmol/kg = 0.005 g/kg Mg2+) every 12
hours as required, to be given by intravenous injection over
at least 10 minutes.
Adolescent 12-17 years
10 mL Magnesium sulfate 10% w/v solution (corresponding
to 4 mmol = 0.1 g Mg2+) every 12 hours as required, to be
given by intravenous injection over at least 10 minutes.
Elderly:

Warnings and precautions
Talk to your doctor or pharmacist or nurse before you are
given Magnesium sulfate 10% if:
 You have kidney problems, a reduction in the usual
dosage may be appropriate.
 You are taking or using other medicines (see ‘Other
medicines and Magnesium sulfate 10%’ below).
Other medicines and Magnesium sulfate 10%
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 is used for the control and prevention of
fits (seizures) related with severe pre-eclampsia 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 10%. If this
happens to you, do not drive or operate machinery.
3. How Magnesium sulfate 10% is given
Magnesium sulfate will be given to you by injection into a
vein (intravenously). 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 10% 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 blood level, symptoms may become more
serious and could lead eventually to coma or cardiac arrest.
As for adults, Magnesium sulfate 10% 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:
25-50 mL (2.5-5 g) Magnesium sulfate 10% w/v solution
(corresponding to 10-20 mmol = 0.25-0.5 g Mg2+) daily,
usual dose 30 mL (3 g) Magnesium sulfate 10% w/v
solution (corresponding to 12 mmol = 0.3 g Mg2+) daily, by
intravenous infusion.
Neonates and infants (up to 12 months):
0.5 mL/kg (50 mg/kg) Magnesium sulfate 10% w/v solution
(corresponding to 0.2 mmol/kg = 0.005 g/kg Mg2+) daily by
intravenous infusion
Children (1–13 years) and adolescents (14-18 years):
0.25 mL/kg (25 mg/kg) Magnesium sulfate 10% w/v solution
(corresponding to 0.1 mmol/kg = 0.0025 g/kg Mg2+) 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
40-50 mL (4-5 g) Magnesium sulfate 10% w/v solution
(corresponding to 16-20 mmol = 0.4-0.5 g Mg2+), diluted to
an appropriate volume over 5-15 minutes is followed by a
maintenance regimen of either an intravenous infusion of
Magnesium sulfate 10% w/v solution, or regular IM
injections using Magnesium sulfate 50% w/v solution for 24
hours after the last fit, provided respiratory rate is >16/min,
urine output >25 mL/min and knee jerks are present as
follows:
Intravenous maintenance regimen:
The IV loading dose (above) is followed by an infusion of
approximately 10 mL (1 g) Magnesium sulfate 10% w/v
solution (corresponding to 4 mmol = 0.1 g Mg2+) per hour
for at least 24 hours after the last fit.
Intramuscular maintenance regimen:
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+).
Thereafter, 10 mL (5 g) Magnesium sulfate 50% w/v
solution (corresponding to 20 mmol = 0.5 g Mg2+) is
administered every four hours ΙΜ, and continued for 24
hours after the last fit.

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.
If you forget to be given Magnesium sulfate 10%
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
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 10%
After opening, the product should be used immediately.
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 10% contains
- The active substance is magnesium as magnesium
sulfate heptahydrate. 1 mL of Magnesium sulfate 10% w/v
(1 g/10 mL) Solution for injection/infusion contains 100
mg of magnesium sulfate heptahydrate). Each 10 mL
ampoule contains 1 g magnesium sulfate heptahydrate.
- The other ingredients are water for injections and sulfuric
acid.
What Magnesium sulfate 10% looks like and contents of
the pack
Magnesium sulfate 10% w/v (1 g/10 mL) 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 Authorisation Holder and Manufacturer:
DEMO S.A., 21st km National Road Athens-Lamia, GR14568 Krioneri, Attiki, Greece, Tel: +30 210 8161802,
Fax: +30 210 8161587.

Recurrent convulsions: In both IV and IM regimens, a
further 20-40 mL (2-4 g) Magnesium sulfate 10% w/v
solution (corresponding to 8-16 mmol = 0.2-0.4 g Mg2+)
depending on body weight [if less than 70 kg 20 mL (2 g)
Magnesium sulfate 10% w/v solution (corresponding to 8
mmol = 0.2 g Mg2+)] are given IV over a period of 5 minutes.
Renal impairment
Magnesium sulfate 10% w/v solution is contraindicated in
patients with severe renal impairment.
Magnesium sulfate 10% w/v solution should be used with
caution in mild to moderate renal impairment. A reduction in
dosage to 200 mL (20 g) Magnesium sulfate 10% w/v
solution (corresponding to 80 mmol = 2 g Mg2+) 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
For the intravenous route the 10% solution does not require
dilution. Magnesium sulfate 10% w/v solution is not
appropriate for intramuscular administration. Only the 50%
w/v solution available may be used intramuscularly.
Intravenous use in children:
Rate of administration should not exceed 0.1 mL/kg/minute
(10 mg/kg/minute) Magnesium sulfate 10% w/v solution
(corresponding to 0.04 mmol/kg/minute = 0.001 g/kg/minute
Mg2+).
Use in adults and adolescents
Intravenous infusion: 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).
Deep intramuscular injection: Magnesium sulfate 10% w/v
solution is not recommended for intramuscular injection.
However, when using the IV loading/IM maintenance
regimen above, ensure that the 50% w/v solution is used
undiluted or diluted to 25% w/v solution. 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.

This medicinal product is authorised in the Member
States of the EEA under the following names:
United
Kingdom:
Greece:
Germany:

Magnesium sulfate 10% w/v Solution for
injection or infusion
Magnesium sulfate/DEMO 10% w/v Ενέσιμο
διάλσμα/διάλσμα προς έγτσση
Magnesiumsulfat 10% (m/v) Lösung zur
Injektion oder Infusion

This leaflet was last revised in 08/2017.

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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