Magnesium sulfate 50% (magnesium 2mmol/ml) solution for injection 10ml ampoules

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Magnesium sulfate heptahydrate
Available from:
magnesium 2mmol/ml) solution for injection 10ml ampoules (Torbay Pharmaceuticals
ATC code:
A12CC02
INN (International Name):
Magnesium sulfate heptahydrate
Dosage:
500mg/1ml
Pharmaceutical form:
Solution for injection
Administration route:
Intramuscular; Intravenous
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 09050103; GTIN: 05060131261973
Authorization number:
PL 13079/0004

Read the complete document

Patient Information Leaflet

Magnesium Sulfate 50% w/v Solution for Injection or Infusion

Please read this leaflet carefully before you start using this medicine.

Keep this leaflet in a safe place, you may wish to read it again.

If you have any questions or are not sure about anything, ask your

doctor or pharmacist.

If any side effect gets serious, or if you notice any side effects

not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.

What Magnesium Sulfate Solution for Injection or Infusion is and what it is

used for

2.

Before you are given Magnesium Sulfate Solution for Injection or Infusion

3.

How Magnesium Sulfate Solution for Injection or Infusion is used

4.

Possible Side Effects

5.

How to store Magnesium Sulfate Solution for Injection or Infusion

6.

Further Information

1. What Magnesium Sulfate Solution for Injection or Infusion is and what it is used for

Magnesium Sulfate, the active ingredient, plays a number of important roles in the body, and

is involved in the regulation of the nervous and blood systems. This medicine is a solution

for injection or infusion and is used for magnesium deficiency and prevention (and control) of

seizures in patients with severe pre-eclampsia (high blood pressure associated with

pregnancy) or eclampsia (convulsions as a result of pre-eclampsia).

2. Before you are given Magnesium Sulfate Solution for Injection or Infusion

This medicine should NOT BE USED if you:

Are allergic to magnesium or its salts

Have suffered from a disease of the brain associated with cirrhosis of the liver

Have had liver failure

Have had kidney failure

Have myasthenia gravis (a chronic progressive muscular weakness disease)

Suffer from heart disease

Check with your doctor if you are concerned about any of the above.

This medicine should be used with caution in patients who are:

Suffering from impaired kidney function

Taking other medicines:

Please tell your doctor if you are taking any other medication especially digitalis glycosides,

nifedipine, muscle relaxants or central nervous system depressants such as sedatives.

Check with your doctor if you are concerned about any of the above.

3. How Magnesium Sulfate Solution for Injection or Infusion is used

The doctor will decide what dose of this medicine you should be given. Check the label

carefully. If you are not sure about anything, ask your doctor, nurse or pharmacist.

The usual dose for the treatment of magnesium deficiency is:

Up to 160mmol of magnesium given by slow intravenous infusion (using concentrations not

higher than 20% w/v) over a maximum of 5 days. If further treatment is required, for example

during prolonged feeding by drip, the usual daily dose is about 12mmol of magnesium.

The usual dose for the prevention and control of fits associated with severe

pre-eclampsia and eclampsia is:

An initial intravenous dose of 4g, given slowly over a period of 20 minutes or so, is followed

by an infusion of 1g/hour. If necessary, regular injections of 5g can be made into the

buttocks every 4 hours, for at least 24 hours after the last fit. If fits recur a further 2 - 4g is

given intravenously over 5 minutes.

You may be given (prescribed) a different dose by your doctor if you have problems

with your kidneys.

If swallowed this medicine may cause stomach irritation and watery diarrhoea.

If any of this medicine is swallowed tell your doctor immediately.

If a dose of this medicine is not given at the correct time – the dose should be given as

soon as it is remembered. The next dose should be given at the usual time.

If more of this medicine is given than should be – tell your doctor as soon as possible. If

you are a medical practitioner administering this medicine an overdose may be reversed

with calcium salts which should be administered slowly intravenously in a dose equivalent to

2.5 to 5mmol of calcium (please refer to the Summary of Product Characteristics).

4. Possible side effects of Magnesium Sulfate Solution for Injection or Infusion

As with all medicines, there may be some side effects with this medicine.

The most common side effects are:-

Respiratory depression (slow or shallow breathing) and abnormal heart beats

Nausea (feeling sick) and/or vomiting

Lowering of blood pressure

Sweating and high temperature

Thirst

Confusion

Drowsiness

Muscle weakness

Very rare side effects are:

Heart attack (shortness of breath, chest pain, feeling faint and/or dizzy)

Coma

Tell your doctor, nurse or pharmacist immediately if you think you have any of these,

or other problems.

Reporting of Side Effects

If you get any side effects, talk to your doctor, nurse or pharmacist. 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.

5. How to store Magnesium Sulfate Solution for Injection or Infusion

The medicine has an expiry date printed on the ampoule, vial and carton. Before use the

doctor or nurse will check the medicine has not passed this date and that the medicine does

not show any sign of deterioration. The expiry date refers to the last day of the month.

Only use this medicine if it is particle free.

After the expiry date, any unused medicine should be returned to a pharmacy.

Keep the container in the original outer carton.

Store between 2 - 25°C.

Store this medicine in a safe place where children cannot see or reach it.

6. Further information

What this medicine contains:

The active ingredient is Magnesium Sulfate (500g per litre).

It also contains the inactive ingredients Sulfuric Acid and Water for Injections.

What this medicine looks like and contents of the pack:

This medicine is a clear and colourless solution. This medicine is available in 2mL, 5mL and

10mL ampoules, and 20mL and 50mL vials. The medicine is packed into cartons containing

10 ampoules, 1 vial or 10 vials. Both pack sizes of vials may not be available at the same

time.

Marketing Authorisation Holder: Torbay and South Devon NHS Foundation Trust,

Torbay Pharmaceuticals, Wilkins Drive, Paignton, Devon, TQ4 7FG

Sites of Manufacture:

Torbay and South Devon NHS Foundation Trust

Torbay Pharmaceuticals

Wilkins Drive

Paignton

Devon

TQ4 7FG

This leaflet was last revised in: 03/2017

PL 13079/0004

PIL/4/7

Additional information for Healthcare Professionals

(as stated on the Summary of Product Characteristics)

Therapeutic Indications

(a) Treatment of magnesium deficiency in hypomagnesaemia.

(b) Prevention and control of generalised seizures in patients with severe pre-eclampsia or

eclampsia.

Posology and Method of Administration

Dosages should be adjusted according to the patient's needs and responses. Plasma levels

should also be monitored during treatment.

(a)

Treatment of magnesium deficiency in hypomagnesaemia:

Up to 160mmol Mg

by slow intravenous infusion (in glucose 5%) for up to 5 days, may be

required to replace the deficit (allowing for urinary losses). Concentrations of no higher than

20%w/v should be given intravenously.

Treatment may require repetition, for example during prolonged intravenous nutrition

magnesium deficiency can occur, then parenteral doses of magnesium are of the order of 10

to 20mmol Mg

daily (often about 12mmol Mg

daily).

Dosage for the elderly is similar to that for younger adults. Magnesium Sulfate 50% w/v

Solution for Injection or Infusion should not be given to children. Appropriate reductions in

dosage should be made for patients with renal impairment.

(b)

Prevention and control of seizures associated with severe pre-eclampsia and

eclampsia:

An initial intravenous (IV) loading dose of typically 4g (approximately 16mmol Mg

) given

slowly over a period of 20 minutes or so, at a strength no higher than 20% w/v, is followed

by ideally an IV infusion, or if this is not possible by regular intramuscular (IM) injections as

follows:

Intravenous Maintenance Regimen: The loading dose is followed by an intravenous

infusion of 1g (approximately 4mmol Mg

) per hour, continued for 24 hours after the last fit.

Intramuscular Maintenance Regimen: The loading dose is followed by 5g (approximately

20mmol Mg

), usually in 50% solution, as deep IM injection into the upper outer quadrant of

each buttock. The intramuscular injection is painful.

Maintenance therapy is a further 5g every 4 hours continued for 24 hours after the last fit

(provided the respiratory rate is >16 per minute, urine output >25mL per hour and knee jerks

are present).

Recurrent convulsions: In both the IV and IM regimens, if convulsions recur, a further 2 - 4g

(approximately 8 - 16mmol Mg

), depending on the woman's weight, 2g if less than 70kg, is

given IV over 5 minutes.

Appropriate reductions in dosage should be made for patients with renal impairment: a

suggested dose reduction in severe renal impairment is a maximum of 20g (approximately

80mmol Mg

) over 48 hours.

Incompatibilities

Not applicable.

Patient Information Leaflet

Magnesium Sulfate 50% w/v Solution for Injection or Infusion

Please read this leaflet carefully before you start using this medicine.

Keep this leaflet in a safe place, you may wish to read it again.

If you have any questions or are not sure about anything, ask your

doctor or pharmacist.

If any side effect gets serious, or if you notice any side effects

not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.

What Magnesium Sulfate Solution for Injection or Infusion is and what it is

used for

2.

Before you are given Magnesium Sulfate Solution for Injection or Infusion

3.

How Magnesium Sulfate Solution for Injection or Infusion is used

4.

Possible Side Effects

5.

How to store Magnesium Sulfate Solution for Injection or Infusion

6.

Further Information

1. What Magnesium Sulfate Solution for Injection or Infusion is and what it is used for

Magnesium Sulfate, the active ingredient, plays a number of important roles in the body, and

is involved in the regulation of the nervous and blood systems. This medicine is a solution

for injection or infusion and is used for magnesium deficiency and prevention (and control) of

seizures in patients with severe pre-eclampsia (high blood pressure associated with

pregnancy) or eclampsia (convulsions as a result of pre-eclampsia).

2. Before you are given Magnesium Sulfate Solution for Injection or Infusion

This medicine should NOT BE USED if you:

Are allergic to magnesium or its salts

Have suffered from a disease of the brain associated with cirrhosis of the liver

Have had liver failure

Have had kidney failure

Have myasthenia gravis (a chronic progressive muscular weakness disease)

Suffer from heart disease

Check with your doctor if you are concerned about any of the above.

This medicine should be used with caution in patients who are:

Suffering from impaired kidney function

Taking other medicines:

Please tell your doctor if you are taking any other medication especially digitalis glycosides,

nifedipine, muscle relaxants or central nervous system depressants such as sedatives.

Check with your doctor if you are concerned about any of the above.

3. How Magnesium Sulfate Solution for Injection or Infusion is used

The doctor will decide what dose of this medicine you should be given. Check the label

carefully. If you are not sure about anything, ask your doctor, nurse or pharmacist.

The usual dose for the treatment of magnesium deficiency is:

Up to 160mmol of magnesium given by slow intravenous infusion (using concentrations not

higher than 20% w/v) over a maximum of 5 days. If further treatment is required, for example

during prolonged feeding by drip, the usual daily dose is about 12mmol of magnesium.

The usual dose for the prevention and control of fits associated with severe

pre-eclampsia and eclampsia is:

An initial intravenous dose of 4g, given slowly over a period of 20 minutes or so, is followed

by an infusion of 1g/hour. If necessary, regular injections of 5g can be made into the

buttocks every 4 hours, for at least 24 hours after the last fit. If fits recur a further 2 - 4g is

given intravenously over 5 minutes.

You may be given (prescribed) a different dose by your doctor if you have problems

with your kidneys.

If swallowed this medicine may cause stomach irritation and watery diarrhoea.

If any of this medicine is swallowed tell your doctor immediately.

If a dose of this medicine is not given at the correct time – the dose should be given as

soon as it is remembered. The next dose should be given at the usual time.

If more of this medicine is given than should be – tell your doctor as soon as possible. If

you are a medical practitioner administering this medicine an overdose may be reversed

with calcium salts which should be administered slowly intravenously in a dose equivalent to

2.5 to 5mmol of calcium (please refer to the Summary of Product Characteristics).

4. Possible side effects of Magnesium Sulfate Solution for Injection or Infusion

As with all medicines, there may be some side effects with this medicine.

The most common side effects are:-

Respiratory depression (slow or shallow breathing) and abnormal heart beats

Nausea (feeling sick) and/or vomiting

Lowering of blood pressure

Sweating and high temperature

Thirst

Confusion

Drowsiness

Muscle weakness

Very rare side effects are:

Heart attack (shortness of breath, chest pain, feeling faint and/or dizzy)

Coma

Tell your doctor, nurse or pharmacist immediately if you think you have any of these,

or other problems.

Reporting of Side Effects

If you get any side effects, talk to your doctor, nurse or pharmacist. 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.

5. How to store Magnesium Sulfate Solution for Injection or Infusion

The medicine has an expiry date printed on the ampoule, vial and carton. Before use the

doctor or nurse will check the medicine has not passed this date and that the medicine does

not show any sign of deterioration. The expiry date refers to the last day of the month.

Only use this medicine if it is particle free.

After the expiry date, any unused medicine should be returned to a pharmacy.

Keep the container in the original outer carton.

Store between 2 - 25°C.

Store this medicine in a safe place where children cannot see or reach it.

6. Further information

What this medicine contains:

The active ingredient is Magnesium Sulfate (500g per litre).

It also contains the inactive ingredients Sulfuric Acid and Water for Injections.

What this medicine looks like and contents of the pack:

This medicine is a clear and colourless solution. This medicine is available in 2mL, 5mL and

10mL ampoules, and 20mL and 50mL vials. The medicine is packed into cartons containing

10 ampoules, 1 vial or 10 vials. Both pack sizes of vials may not be available at the same

time.

Marketing Authorisation Holder: Torbay and South Devon NHS Foundation Trust,

Torbay Pharmaceuticals, Wilkins Drive, Paignton, Devon, TQ4 7FG

Sites of Manufacture:

Torbay and South Devon NHS Foundation Trust

Torbay Pharmaceuticals

Wilkins Drive

Paignton

Devon

TQ4 7FG

This leaflet was last revised in: 03/2017

PL 13079/0004

PIL/4/7

Additional information for Healthcare Professionals

(as stated on the Summary of Product Characteristics)

Therapeutic Indications

(a) Treatment of magnesium deficiency in hypomagnesaemia.

(b) Prevention and control of generalised seizures in patients with severe pre-eclampsia or

eclampsia.

Posology and Method of Administration

Dosages should be adjusted according to the patient's needs and responses. Plasma levels

should also be monitored during treatment.

(a)

Treatment of magnesium deficiency in hypomagnesaemia:

Up to 160mmol Mg

by slow intravenous infusion (in glucose 5%) for up to 5 days, may be

required to replace the deficit (allowing for urinary losses). Concentrations of no higher than

20%w/v should be given intravenously.

Treatment may require repetition, for example during prolonged intravenous nutrition

magnesium deficiency can occur, then parenteral doses of magnesium are of the order of 10

to 20mmol Mg

daily (often about 12mmol Mg

daily).

Dosage for the elderly is similar to that for younger adults. Magnesium Sulfate 50% w/v

Solution for Injection or Infusion should not be given to children. Appropriate reductions in

dosage should be made for patients with renal impairment.

(b)

Prevention and control of seizures associated with severe pre-eclampsia and

eclampsia:

An initial intravenous (IV) loading dose of typically 4g (approximately 16mmol Mg

) given

slowly over a period of 20 minutes or so, at a strength no higher than 20% w/v, is followed

by ideally an IV infusion, or if this is not possible by regular intramuscular (IM) injections as

follows:

Intravenous Maintenance Regimen: The loading dose is followed by an intravenous

infusion of 1g (approximately 4mmol Mg

) per hour, continued for 24 hours after the last fit.

Intramuscular Maintenance Regimen: The loading dose is followed by 5g (approximately

20mmol Mg

), usually in 50% solution, as deep IM injection into the upper outer quadrant of

each buttock. The intramuscular injection is painful.

Maintenance therapy is a further 5g every 4 hours continued for 24 hours after the last fit

(provided the respiratory rate is >16 per minute, urine output >25mL per hour and knee jerks

are present).

Recurrent convulsions: In both the IV and IM regimens, if convulsions recur, a further 2 - 4g

(approximately 8 - 16mmol Mg

), depending on the woman's weight, 2g if less than 70kg, is

given IV over 5 minutes.

Appropriate reductions in dosage should be made for patients with renal impairment: a

suggested dose reduction in severe renal impairment is a maximum of 20g (approximately

80mmol Mg

) over 48 hours.

Incompatibilities

Not applicable.

Read the complete document

Object 1

Magnesium Sulfate 50%w/v Solution for

Injection or Infusion

Summary of Product Characteristics Updated 14-Jul-2017 | Torbay & South Devon NHS Foundation

Trust

1. Name of the medicinal product

Magnesium Sulfate 50% w/v Solution for Injection or Infusion

2. Qualitative and quantitative composition

Magnesium sulfate (heptahydrate) 50% w/v (approximately 2mmol Mg

/mL).

3. Pharmaceutical form

Solution for injection or infusion.

4. Clinical particulars

4.1 Therapeutic indications

(a) Treatment of magnesium deficiency in hypomagnesaemia.

(b) Prevention and control of generalised seizures in patients with severe pre-eclampsia or eclampsia.

4.2 Posology and method of administration

Dosages should be adjusted according to the patient's needs and responses. Plasma levels should also be

monitored during treatment.

(a) Treatment of magnesium deficiency in hypomagnesaemia:

Up to 160mmol Mg

by slow intravenous infusion (in glucose 5%) for up to 5 days, may be required to

replace the deficit (allowing for urinary losses). Concentrations of no higher than 20% w/v should be

given intravenously.

Treatment may require repetition, for example during prolonged intravenous nutrition magnesium

deficiency can occur, then parenteral doses of magnesium are of the order of 10 to 20mmol Mg

daily

(often about 12mmol Mg

daily).

Dosage for the elderly is similar to that for younger adults. Magnesium Sulfate 50% w/v Solution for

Injection or Infusion should not be given to children. Appropriate reductions in dosage should be made

for patients with renal impairment.

(b) Prevention and control of seizures associated with severe pre-eclampsia and eclampsia:

An initial intravenous (IV) loading dose of typically 4g (approximately 16mmol Mg

) given slowly over

a period of 20 minutes or so, at a strength no higher than 20% w/v, is followed by ideally an IV infusion,

or if this is not possible by regular intramuscular (IM) injections as follows:

Intravenous Maintenance Regimen: The loading dose is followed by an intravenous infusion of 1g

(approximately 4mmol Mg

) per hour, continued for 24 hours after the last fit.

Intramuscular Maintenance Regimen: The loading dose is followed by 5g (approximately 20mmol

), usually in 50% solution, as deep IM injection into the upper outer quadrant of each buttock. The

intramuscular injection is painful.

Maintenance therapy is a further 5g every 4 hours continued for 24 hours after the last fit (provided the

respiratory rate is >16 per minute, urine output >25mL per hour and knee jerks are present).

Recurrent convulsions: In both the IV and IM regimens, if convulsions recur, a further 2 - 4g

(approximately 8 - 16mmol Mg

), depending on the woman's weight, 2g if less than 70kg, is given IV

over 5 minutes.

Appropriate reductions in dosage should be made for patients with renal impairment: a suggested dose

reduction in severe renal impairment is a maximum of 20g (approximately 80mmol Mg

) over 48 hours.

4.3 Contraindications

Use of Magnesium Sulfate 50% w/v Solution for Injection or Infusion is contraindicated in patients with

known hypersensitivity to magnesium and its salts, hepatic encephalopathy, hepatic failure, renal failure,

myasthenia gravis or cardiac disease.

4.4 Special warnings and precautions for use

Magnesium salts should be administered with caution to patients with impaired renal function;

appropriate reductions in dosage should be made. Magnesium salts should be administered with caution

to those receiving digitalis glycosides. Parenteral administration of magnesium salts may enhance the

effects of neuromuscular blocking agents or of central nervous system depressants.

Magnesium Sulfate 50% w/v Solution for Injection or Infusion should not be used in hepatic coma if

there is a risk of renal failure.

4.5 Interaction with other medicinal products and other forms of interaction

Muscle relaxants: Non-depolarising muscle relaxants such as tubocurarine are enhanced by parenteral

magnesium salts.

Nifedipine: profound hypotension was produced in two women who were given oral nifedipine

(Martindale, 30th Ed).

4.6 Pregnancy and lactation

Magnesium Sulfate 50% w/v Solution for Injection or Infusion can be administered to a patient with

eclampsia if the condition is life threatening to mother and baby.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Excessive administration of magnesium leads to the development of hypermagnesaemia. Symptoms of

hypermagnesaemia may include nausea, vomiting, flushing, thirst, hypotension due to peripheral

vasodilation, drowsiness, confusion, loss of tendon reflexes due to neuromuscular blockade, muscle

weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest.

Acute ingestion of magnesium sulfate and similar magnesium containing compounds may also cause

gastrointestinal irritation and watery diarrhoea.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows

continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are

asked to report any suspected adverse reactions via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard.

4.9 Overdose

Appropriate action should be taken to reduce the blood level of magnesium to avoid hypermagnesaemia.

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.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Serum magnesium levels in the range of 1.5 - 2.5mmol/L cause vasodilation in the peripheral and

coronary circulation and corresponding increases of 20 - 25% in cardiac output and coronary blood flow.

There is little change in heart rate or blood pressure. The Atrium-His interval is slightly prolonged as a

result of the electrophysiological actions of magnesium. Any direct inhibition is offset by the reflex

response to a drop in peripheral vascular resistance and the QT interval is unchanged, thus the function of

the SAN is little altered. Within this concentration range there are no detectable effects on CNS function

or neuromuscular transmission. At a serum magnesium level of 1 - 3mmol/L platelet disaggregation has

been reported, possibly mediated by stimulation of prostacyclin release from the vascular endothelium.

5.2 Pharmacokinetic properties

The concentration of magnesium in plasma is normally tightly regulated in the range of 0.75 -

0.95mmol/L. Small and clinically irrelevant amounts are excreted in the breast milk. The major excretory

pathway is renal, and both oral and intravenous loads are rapidly eliminated in this way. In renal

impairment there may be accumulation of magnesium.

The potential for magnesium toxicity is greater in parenteral administration than with oral dosing. At

plasma concentrations of up to 4mmol/L the only adverse effect likely to be seen is flushing due to

peripheral vasodilation. At about 4 - 5mmol/L, concentration dependent toxicity is heralded by loss of

drop-tendon reflexes, then successively by hypotension, brachycardia, and ultimately neuromuscular

blockade leading to respiratory arrest.

When given intravenously magnesium sulfate has an immediate onset of action; its duration of activity is

about 30 minutes. The onset of action of intramuscular magnesium sulfate is about one hour and its

duration of action is three to four hours.

5.3 Preclinical safety data

Magnesium sulfate has been used for many years and its adverse reaction and clinical profile are well

understood, therefore no further data are provided.

6. Pharmaceutical particulars

6.1 List of excipients

Sulfuric Acid

Bulk Water for Injections

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store between 2 – 25°C.

6.5 Nature and contents of container

Magnesium Sulfate 50% w/v Solution for Injection or Infusion is presented in 2mL, 5mL and 10mL type

1 glass ampoules and in 20mL and 50mL 20mm type 1 glass vials closed with a bromobutyl rubber

stopper with an aluminium tamper-proof flip-top cap. The product is packed into cartons containing 10

ampoules, 1 vial or 10 vials. Both pack sizes may not be available at the same time.

6.6 Special precautions for disposal and other handling

A 25% or 50% solution should be used for intramuscular administration. Magnesium Sulfate 50% w/v

Solution for Injection or Infusion must be diluted before intravenous administration. Concentrations of up

to 20% are usually used.

Chemical and physical in-use stability has been demonstrated for both 50% and diluted (20% w/v)

solutions when stored protected from light in l0mL polypropylene syringes in the refrigerator and at 25°C

for 28 days. From a microbiological point of view, the product should be used immediately. If not used

immediately, in-use storage times and conditions prior to use are the responsibility of the user and would

normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and

validated aseptic conditions.

Only use the solution if it is particle free.

For single use only. Unused solution should be discarded in an appropriate manner.

7. Marketing authorisation holder

Torbay and South Devon NHS Foundation Trust,

Torbay Pharmaceuticals,

Wilkins Road,

Paignton,

Devon, TQ4 7FG

8. Marketing authorisation number(s)

PL 13079/0004

9. Date of first authorisation/renewal of the authorisation

01/2000 / 01/2005

10. Date of revision of the text

05/2017

DS11/8

Company Contact Details

Torbay & South Devon NHS Foundation Trust

Address

Wilkins Drive, Paignton, TQ4 7FG

Telephone

+44 (0)1803 660000

Medical Information Direct Line

+44 (0)7824 889143

Customer Care direct line

+44 (0)1803 664707

Stock Availability

+44 (0)1803 664707

http://www.torbaypharmaceuticals.nhs.uk

+44 (0)1803 664354

Medical Information e-mail

[email

protected]

Medical Information Fax

+44 (0)1803 664 354

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