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MAGNESIUM SULFATE INJECTION BP MINIJET 50% W/V SOLUTION FOR INJECTION - summary of medicine characteristics

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Summary of medicine characteristics - MAGNESIUM SULFATE INJECTION BP MINIJET 50% W/V SOLUTION FOR INJECTION

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Magnesium Sulfate Injection BP Minijet 50% w/v solution for injection

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Magnesium Sulfate Heptahydrate 500mg per ml, equivalent to 2mmol magnesium ions per ml.

The product is available as a vial containing Magnesium Sulfate Heptahydrate 2g in 4ml.

For excipients, see 6.1.

3 PHARMACEUTICAL FORM

Solution for injection.

A clear, colourless solution practically free from visible particles.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Treatment of magnesium deficiency where the oral route of administration may be inappropriate.

4.2 Posology and method of administration

Magnesium sulfate injection may be administered by intramuscular or intravenous routes. IM therapy should be used only when peripheral venous access is impossible.

For intravenous administration, a concentration of 20% or less should be used; the rate of injection not exceeding 1.5ml/minute of a 10% solution or its equivalent.

Magnesium Sulfate Injection Minijet 50% may be diluted as needed in either 5% dextrose solution or in 0.9% saline solution.

Dosage should be reduced in renal impairment. Plasma magnesium concentrations should be monitored throughout therapy.

Fluid balance, serum electrolytes and acid-base balance may need to be monitored before and during administration, with particular attention to serum sodium in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients comedicated with vasopressin agonist drugs, due to the risk of hospital acquired hyponatraemia (see sections 4.4, 4.5 and 4.8).

Monitoring of serum sodium is particularly important for hypotonic fluids. Magnesium sulfate Injection Minijet 50% tonicity: 4060 mOsmol/L (calc.) undiluted.

The infusion rate and volume depend on the age, weight, clinical condition (e.g. burns, surgery, head-injury, infections), and concomitant therapy should be determined by the consulting physician experienced in paediatric intraveneous fluid therapy (see sections 4.4. and 4.8).

Adults

The dosage should be individualised according to patient’s needs and responses.

To treat refractory ventricular fibrillation in the presence of hypomagnesaemia, treat with 8mmol (4ml) intravenously.

Mild magnesium deficiency

1g intramuscularly every 6 hours for 4 doses.

Severe magnesium deficiency

Up to 250mg/kg intramuscularly given within a period of 4 hours or 5g/litre of infusion solution intravenously over 3 hours.

Children

It is recommended that the solution be diluted to 20% w/v prior to intramuscular injection.

Elderly

No special recommendations except in renal impairment, see above.

4.3 Contraindications

Hypersensitivity to magnesium and it salts. Magnesium sulfate is contraindicated in patients with severely impaired renal function.

4.4 Special warnings and precautions for use

Magnesium sulfate must be used with caution in patients suspected of or known to have renal impairment.

Magnesium Sulfate should not be used in hepatic coma if there is a risk of renal failure.

Parenteral magnesium salts should be used with caution in patients with myasthenia gravis.

Serum calcium levels should be routinely monitored in patients receiving magnesium sulfate.

High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatraemia (see below).

Hyponatraemia

Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, postoperative stress, infections, burns, and CNS diseases), patients with heart-, liver-and kidney diseases and patients exposed to vasopressin agonists (see section 4.5) are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids.

Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with cerebral oedema are at particular risk of severe, irreversible and life-threatening brain injury.

Children, women in the fertile age and patients with reduced cerebral compliance (e.g. meningitis, intracranial bleeding, cerebral contusion and brain oedema) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

4.5 Interaction with other medicinal products and other forms of interaction

Administer with caution to patients receiving digitalis glycosides. Magnesium sulfate should not be administered concomitantly with high doses of barbiturates, opioids or hypnotics due to the risk of respiratory depression.

The action of non-depolarising muscle relaxants such as tubocurarine is potentiated and prolonged by parenteral magnesium salts.

Concomitant use of calcium channel blockers such as nifedipine or nimodipine may rarely lead to a calcium ion imbalance and could result in abnormal muscle function.

The neuromuscular blocking effects of parenteral magnesium and aminoglycoside antibacterials may be additive.

Drugs leading to an increased vasopressin effect

The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water excretion and may increase the risk of hospital acquired hyponatraemia following inappropriately balanced treatment with i.v. fluids (see sections 4.2, 4.4 and 4.8).

Drugs stimulating vasopressin release include:

Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics

Drugs potentiating vasopressin action include:

Chlorpropamide, NSAIDs, cyclophosphamide

Vasopressin analogues include:

Desmopressin, oxytocin, vasopressin, terlipressin

Other medicinal products increasing the risk of hyponatraemia also include diuretics in general and antiepileptics such as oxcarbazepine.

4.6 Fertility, pregnancy and lactation

Safety in human pregnancy and during breastfeeding has not been established, therefore, as with all drugs it is not advisable to administer magnesium sulfate during pregnancy or breastfeeding unless considered essential, and it must be administered under medical supervision.

Magnesium crosses the placenta. When used in pregnant women, foetal heart rate should be monitored and use within 2 hours of delivery should be avoided.

Magnesium Sulfate Injection BP Minijet 50% should be administrated with special caution for pregnant women during labour particularly as to serum-sodium if administered in combination with oxytocin (see section 4.4, 4.5 and 4.8).

Magnesium sulfate can cause skeletal adverse effects when administered continuously for more than 5 to 7 days to pregnant women. There are retrospective epidemiological studies and case reports documenting fetal adverse effects including hypocalcaemia, skeletal demineralization, osteopenia and other skeletal adverse effects with maternal administration of magnesium sulfate for more than 5 to 7 days. The clinical significance of the observed effects is unknown.

If prolonged or repeated exposure to magnesium sulfate occurs during pregnancy, monitoring of neonates for abnormal calcium or magnesium levels and skeletal adverse effects should be considered.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable effects

– Hospital acquired hyponatraemia*

– Acute hyponatraemic encephalopathy

Hospital acquired hyponatraemia may cause irreversible brain injury and death, due to development of acute hyponatraemic encephalopathy, frequency unknown (see sections 4.2. 4.4, 4.5).

Hypersensitivity reactions.

Metabolism and nutrition disorders

Electrolyte/fluid abnormalities (hypophosphataemia, hypertonic dehydration)

There have been isolated reports of maternal and fetal hypocalcaemia with high doses of magnesium sulfate (see section 4.6).

Hypocalcaemia.

Hypermagnesaemia characterised by flushing, thirst, hypotension, drowsiness, nausea, vomiting, confusion, slurred speech, double vision, loss of tendon reflexes due to neuromuscular blockade, muscle weakness, respiratory depression, electrolyte/fluid abnormalities (hypophosphataemia, hyperosmolar dehydration), ECG changes (prolonged PR, QRS and QT intervals), bradycardia, cardiac arrhythmias, coma and cardiac arrest.

There is a risk of respiratory depression if magnesium sulfate is administered concomitantly with high doses of barbiturates, opioids or hypnotics (see ‘Interactions’).

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

4.9 Overdose

Symptoms: Hypermagnesaemia characterised by flushing, thirst, hypotension, drowsiness, nausea, vomiting, confusion, slurred speech, double vision, loss of tendon reflexes due to neuromuscular blockade, muscle weakness, respiratory depression, electrolyte/fluid abnormalities (hypophosphataemia, hyperosmolar dehydration), ECG changes (prolonged PR, QRS and QT intervals), bradycardia, cardiac arrhythmias, coma and cardiac arrest.

Patients with renal failure and metabolic derangements develop toxicity at lower doses.

Treatment: Maintain respiration with 10% calcium gluconate administered intravenously in a dose of 10–20ml. If renal function is normal adequate fluids should be given to assist removal of magnesium from the body. Dialysis may be necessary in patients with renal impairment or severe hypermagnesaemia.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Mineral Supplements, ATC code: A12CC 02.

Magnesium is the second most abundant cation in intracellular fluid and is an essential body electrolyte. Magnesium is a factor in a number of enzyme systems, and is involved in neurochemical transmission and muscular excitability.

Parenterally administered magnesium sulfate exerts a depressant effect on the central nervous system and acts peripherally to produce vasodilation.

5.2 Pharmacokinetic properties

Following intravenous administration, the onset of action is immediate and the duration approximately 30 minutes. Following intramuscular administration the onset of action occurs after approximately one hour and the duration of action is 3–4 hours.

Magnesium sulfate is excreted by the kidneys with small amounts being excreted in breast milk and saliva.

5.3 Preclinical safety data

5.3 Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sulfuric acid

Sodium hydroxide

Water for injections

6.2 Incompatibilities

Magnesium sulfate is incompatible with alkali hydroxides (forming insoluble magnesium hydroxide), alkali carbonates (forming insoluble magnesium carbonate) and salicylates. Streptomycin sulfate and tetramycin sulfate activity is inhibited by magnesium ions.

6.3 Shelf life

2 years

Discard any unused solution immediately after first use.

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.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

The solution is contained in a type I glass vial with an elastomeric closure and a plastic vial cap. The product is available as 4ml.

An IMS Minijet injector is supplied in the carton.

6.6 Special precautions for disposal

6.6 Special precautions for disposal

The container is specially designed for use with the IMS Minijet injector.

See 4.2 Posology for information regarding the dilution of this product.