Magnesium Sulfate Injection 50%w/v (10 x 2ml) IM solution IV concentrate
Misc (Generics)
Prescription-only injectable medicineMagnesium supplementation / anticonvulsant (IM/IV solution)
Certifications
- UK MHRA Authorised prescription Only medicine (e.g. PL 12064/0013 for Magnesium Sulfate 50%w/v Solution for Injection).
- Manufactured in facilities operating to EU and UK Good Manufacturing Practice (GMP) standards for sterile injectable products.
- Formulations of magnesium sulfate 50% w/v solution for injection are included within WHO prequalification and public assessment documentation for parenteral magnesium products.
- Labeling, packaging and strength expression updated in line with MHRA safety and labelling guidance for high Strength injectable electrolytes.
- UK MHRA Authorised prescription Only medicine (e.g. PL 12064/0013 for Magnesium Sulfate 50%w/v Solution for Injection).
- Manufactured in facilities operating to EU and UK Good Manufacturing Practice (GMP) standards for sterile injectable products.
- Formulations of magnesium sulfate 50% w/v solution for injection are included within WHO prequalification and public assessment documentation for parenteral magnesium products.
- Labeling, packaging and strength expression updated in line with MHRA safety and labelling guidance for high Strength injectable electrolytes.
Magnesium supplementation / anticonvulsant (IM/IV solution)
Description
Magnesium Sulfate Injection 50% w/v (10 x 2 ml) is a sterile, concentrated solution of magnesium sulfate heptahydrate intended for intramuscular injection or for use as a concentrate for intravenous infusion after dilution. Each 2 ml ampoule contains 1 g of magnesium sulfate heptahydrate, providing a reliable and accurate source of magnesium for clinical use. It is indicated for the treatment and prevention of magnesium deficiency (hypomagnesaemia) when oral administration is not suitable, and for the control and prevention of seizures associated with severe pre-eclampsia and eclampsia in pregnancy. The product is supplied as 10 single-use 2 ml glass ampoules in a carton, manufactured under pharmaceutical Good Manufacturing Practice (GMP) to ensure sterility, purity and batch-to-batch consistency. Use is restricted to qualified healthcare professionals who can determine appropriate dosing, dilution and monitoring in hospital, emergency and critical-care settings.
Bnefits
- Provides a concentrated source of magnesium (50% w/v, 500 mg/mL) for rapid correction of magnesium deficiency when oral therapy is not appropriate.
- Indicated for control and prevention of seizures in severe pre-eclampsia and eclampsia under specialist supervision.
- Can be administered by intramuscular injection or as a dilute intravenous infusion, allowing flexibility in clinical practice.
- Supplied in accurately dosed single-use 2 ml ampoules to support precise dosing and reduce risk of contamination.
- Manufactured under strict pharmaceutical quality standards (GMP) by an established injectable medicines manufacturer.
- Widely used and supported by formal Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) with defined indications, contraindications and safety profile.
Indications
- Treatment of proven magnesium deficiency (hypomagnesaemia) in adults, adolescents and children when oral administration is not possible or appropriate.
- Prevention and treatment of hypomagnesaemia in patients receiving total parenteral nutrition.
- Control and prevention of seizures in severe pre-eclampsia.
- Control and prevention of recurrent seizures in eclampsia.
- Use as an electrolyte replenisher and anticonvulsant in settings where parenteral magnesium therapy is clinically indicated, under specialist supervision.
Composition
- Active ingredient: Magnesium sulfate heptahydrate 50% w/v (500 mg/mL).
- Each 2 mL ampoule contains 1 g magnesium sulfate heptahydrate, providing approximately 4 mmol of magnesium (Mg2+) and 4 mmol of sulfate ions.
- Excipients: Sulfuric acid (for pH adjustment) and Water for Injections.
- Sterile, clear, colourless solution free from visible particles.
Formulation
- Pharmaceutical form: Solution for injection or concentrate for solution for infusion.
- Concentration: 50% w/v magnesium sulfate (500 mg/mL).
- Route of administration: Intramuscular injection or intravenous infusion after appropriate dilution.
- Single-use glass ampoule presentation intended for parenteral administration by healthcare professionals.
Packaging
- Pack size: 10 x 2 mL Type I glass ampoules.
- Ampoules supplied in a carton for hospital and clinical use.
- Sterile, single-use presentation; any unused solution must be discarded.
- Typical authorised pack corresponds to UK MHRA-licensed 50% w/v magnesium sulfate injection in 2 mL ampoules.
Usage
- For professional use only by suitably qualified healthcare practitioners.
- May be administered by deep intramuscular injection or by intravenous infusion after dilution in a suitable diluent, according to the SmPC and local protocols.
- Must be diluted before intravenous use; the final concentration and infusion rate must follow official product information and institutional guidelines.
- Dosage, route, and duration of treatment depend on the indication, patient age, weight, renal function and serum magnesium levels, and must be determined by the prescribing physician.
- During treatment, monitor serum magnesium and calcium levels, reflexes, respiratory rate, blood pressure, heart rhythm and urine output.
- Use with particular caution in patients with impaired renal function; dose reductions and close monitoring are required.
- Do not mix with other medicinal products in the same syringe or infusion unless compatibility is known.
- Intended for single use; discard any remaining solution after first opening the ampoule.
Contraindications
- Known hypersensitivity to magnesium sulfate, magnesium salts or any excipient in the formulation.
- Severe renal impairment, kidney failure or anuria, due to risk of magnesium accumulation and toxicity.
- Liver failure or hepatic encephalopathy (as specified in certain product information).
- Pre-existing heart block, significant cardiac conduction disturbances or severe heart disease where further depression of cardiac conduction could be dangerous.
- Myasthenia gravis (magnesium can worsen neuromuscular weakness, particularly with parenteral administration).
Adverse Effects
- Flushing, warmth and sweating due to vasodilation.
- Nausea and vomiting.
- Drowsiness, confusion, dizziness and slurred speech.
- Muscle weakness and loss or reduction of deep tendon reflexes.
- Hypotension and circulatory collapse with excessive doses or rapid administration.
- Respiratory depression or apnoea at high serum magnesium levels.
- Cardiac arrhythmias, bradycardia, electrocardiogram (ECG) changes and, in severe toxicity, cardiac arrest.
- Electrolyte disturbances including altered serum calcium levels.
- Coma and central nervous system depression in cases of severe overdose.
- Hypersensitivity reactions are possible but uncommon.
Storage Conditions
- Keep out of the sight and reach of children.
- Do not freeze.
- Store in accordance with the specific product label; many UK-authorised products specify not to store above 25°C and to keep within recommended room temperature ranges.
- Keep ampoules in the original carton until use and discard if the solution is not clear or contains visible particles.
- Do not use after the expiry date stated on the ampoule and carton.
- For single use only; discard any unused portion immediately after opening.
Duration
Treatment duration is individualised and determined by the prescribing physician based on indication, response and laboratory monitoring; typically short-term use for acute correction of magnesium deficiency or for seizure control in severe pre-eclampsia/eclampsia.
Onset
Therapeutic magnesium levels are generally reached almost immediately after appropriate intravenous dosing and within approximately 60 minutes following intramuscular injection when administered according to the SmPC.
