Magnesium sulfate 10% (magnesium 0.4mmol/ml) solution for injection 10ml ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Magnesium sulfate heptahydrate

Available from:

magnesium 0.4mmol/ml) solution for injection 10ml ampoules (Martindale Pharmaceuticals Ltd

ATC code:

B05XA05

INN (International Name):

Magnesium sulfate heptahydrate

Dosage:

100mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09050103; GTIN: 5014124170216

Patient Information leaflet

100MM MEASUREMENT VERIFICATION BAR
D03307
D03307
3307-C
3. HOW MAGNESIUM SULFATE INJECTION WILL BE
GIVEN
Your doctor will give Magnesium Sulfate Injection to you into a
vein (intravenous).
ADULTS, CHILDREN AND THE ELDERLY
The usual dose is 35-50 mmol diluted in 1 litre of 5% Glucose
Intravenous Infusion or 0.9%w/v Sodium Chloride Injection ,
given over a period of 12-24 hours.
Patients suffering from kidney problems will need a reduced
dose.
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, Magnesium Sulfate Injection can cause side
effects, although not everybody gets them.
Possible side effects include:
• shock, symptoms of which include sweating, fainting and a
fluttering heartbeat
• slowed reflexes
• flushing of the skin
• temporarily low blood pressure
• low body temperature
• slow or irregular heartbeat
• feeling or being sick
• feeling thirsty
• drowsiness
• confusion
• muscle weakness
• slowed breathing
• heart attack
• coma
• hypersensitivity reactions
• Hypocalcaemia
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.
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.
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

Summary of Product characteristics

OBJECT 1
MAGNESIUM SULFATE 1G/10ML INJECTION
Summary of Product Characteristics Updated 20-Mar-2017 | Martindale
Pharma
1. Name of the medicinal product
Magnesium Sulfate 1g/10ml Injection
2. Qualitative and quantitative composition
Magnesium Sulfate Heptahydrate 10% w/v
For full list of excipients, see section 6.1
3. Pharmaceutical form
Sterile solution for injection
A clear colourless solution free from visible particulate
contamination
4. Clinical particulars
4.1 Therapeutic indications
Treatment of magnesium deficiency in hypomagnesaemia.
Treatment of magnesium deficiency where the oral route of
administration may be inappropriate.
To prevent further seizures associated with eclampsia.
4.2 Posology and method of administration
By intravenous infusion.
_Adult, Children and the Elderly_
35-50 mmol in 1 litre of 5% Glucose Intravenous Infusion or 0.9% w/v
Sodium Chloride Injection given
over a period of 12 – 24 hours.
Patients with renal impairment, the dosage will need to be reduced.
4.3 Contraindications
Hypersensitivity to the Magnesium sulfate heptahydrate or to any of
the excipients listed in section 6.1.
Hepatic encephalopathy, hepatic failure or renal failure.
Parenteral magnesium salts should generally be avoided in patients
suffering from heart block.
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 (Refer to 'Posology
and Method of Administration'
above).
Parenteral magnesium should be used with caution in individuals with
myasthenia gravis, to prevent an
exacerbation of the condition or the precipitation of a myasthenic
crisis. A risk-benefit assessment should
be performed in individual cases prior to initiation of treatment.
Magnesium sulfate should not be used in hepatic coma if there is risk
of renal failure.
Serum calcium levels should be routinely monitored in patients
receiving magnesium sulfate.
4.5 Interaction with other medicinal products and other forms