Magnesium sulfate Altan 150 mg/ml solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Magnesium Sulfate Altan 150 mg/ml injection and infusion solution EFG

Magnesium Sulfate heptahydrate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Magnesium Sulfate Altan is and what it is used for
2. What you need to know before using Magnesium Sulfate Altan
3. How to use Magnesium Sulfate Altan
4. Possible side effects
5. How to store Magnesium Sulfate Altan
6. Contents of the pack and other information

1. What Sulfato de Magnesio Altan is and what it is used for

Sulfato de Magnesio Altan is an anticonvulsant medicine.

This medicine is a solution that will be administered into a vein by injection or infusion. It is indicated for:

• the treatment of torsade de pointes (a heart rhythm disorder).

• magnesium supplementation to restore electrolyte balance:

  • treatment of hypomagnesemia (low magnesium levels in the blood)
  • treatment of acute hypokalemia (low potassium levels in the blood) associated with hypomagnesemia (low magnesium levels in the blood)
  • magnesium supplementation in parenteral nutrition.
  • eclampsia.

2. What you need to know before using Magnesium Sulfate Altan

Do not use Magnesium Sulfate Altan:

• if you are allergic to magnesium sulfate or to any of the other ingredients of this medicine (listed in section 6).
• if you have impaired kidney function (severe renal insufficiency).
• if you are being treated with any quinidine-derived medication (see section “Use of Magnesium Sulfate Altan with other medicines”).
• if you have heart problems such as heart failure, myocardial injury, or altered heart rate (tachycardia).
• if you have had a myocardial infarction.
• if you have impaired liver function.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use this medicine if:

• you have heart conduction disorders,
• you have gastrointestinal motility disorders,
• you have kidney function problems (renal insufficiency),
• you have myasthenia gravis or Eaton-Lambert syndrome, conditions characterized by muscle weakness.

Patients with mild to moderate magnesium deficiency may be treated with diet or oral magnesium supplements. Intravenous administration of Magnesium Sulfate Altan is reserved for emergency situations.

Your doctor should discontinue treatment if:

• blood pressure decreases (hypotension),
• heart rate decreases (bradycardia),
• serum magnesium levels rise above normal values,
• patellar reflex (deep tendon reflex) disappears.

Precautions:

• Administration of this medicine must be performed in a hospital setting.
• Blood pressure should be monitored during administration.
• Serum magnesium levels (magnesemia) should be monitored. Treatment should be discontinued once magnesemia has normalized.
• In cases of renal insufficiency (see section “3. How to use Magnesium Sulfate Altan”), the dose should be reduced and closer monitoring of renal function, blood pressure, and magnesemia is required.
• Magnesium Sulfate Altan must not be administered with calcium salts due to their antagonistic effect (see section “Use of Magnesium Sulfate Altan with other medicines”).

Use of Magnesium Sulfate Altan with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with Magnesium Sulfate Altan. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

It is especially important that you inform your doctor if you are taking any of the following medicines:

• Aminoglycoside antibacterials (used to treat certain infections).
• Neuromuscular blockers (curarizing agents): magnesium sulfate enhances the effect of neuromuscular blockers such as tubocurarine, suxamethonium, and vecuronium. This may prolong neuromuscular blockade and increase the risk of respiratory depression.
• Nifedipine (a medicine used to treat angina pectoris): enhances the effect of magnesium sulfate.
• Quinidine derivatives (medicines used to treat heart rhythm disorders): concomitant administration of magnesium sulfate and quinidine derivatives may increase plasma quinidine concentrations and increase the risk of overdose due to reduced renal elimination of quinidine.
• Medicines causing central nervous system depression: the central nervous system depressant effects may be enhanced when these medicines are used simultaneously with magnesium sulfate.
• Digitalis glycosides (medicines used to treat heart function disorders): magnesium sulfate should be administered with extreme caution in patients receiving digitalis glycosides, especially if calcium salts are also administered intravenously; cardiac conduction changes and heart block may occur.
• Calcium: simultaneous use may neutralize the effects of parenteral magnesium sulfate.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Treatment with Magnesium Sulfate Altan during pregnancy should only be considered if absolutely necessary. In such cases, monitoring of plasma magnesium levels, blood pressure, respiratory rate, and deep tendon reflexes is recommended.

Magnesium sulfate may cause fetal abnormalities such as decreased calcium levels (hypocalcemia) and skeletal demineralization when administered for more than 5–7 days to pregnant women.

When administered by intravenous infusion (it must not be administered within 2 hours before delivery) in cases of pregnancy toxemia, the newborn may show signs of magnesium-related toxicity, including neuromuscular depression or respiratory depression.

Breastfeeding

Magnesium sulfate is excreted in breast milk during treatment. It is recommended to discontinue treatment during breastfeeding.

Driving and use of machines

Not applicable.

This medicine contains less than 23 mg (1 mmol) of sodium per ampoule and is therefore considered essentially “sodium-free”.

3. How to use Magnesium Sulfate Altan

Magnesium Sulfate Altan can be administered:

• by slow intravenous injection
• by intravenous infusion, diluted in a glucose or saline solution.

For instructions on dilution of the medicine before administration, see section “Information for healthcare professionals” at the end of this leaflet.

The individual daily dose will be determined by your doctor. The recommended doses below may serve as a guide.

In adults:

Ventricular tachycardia with torsade de pointes:

An initial dose of 2 g of magnesium sulfate intravenously (IV) over 1–2 minutes is recommended, followed by an infusion of 2–4 mg/minute. Alternatively, the initial dose may be repeated up to a total of 6 g, with intervals of 5–15 minutes between doses.

Hypomagnesemia:

An initial dose of 8–12 g of magnesium sulfate intravenously within the first 24 hours is recommended, followed by 4–6 g/day for 3 or 4 days, until magnesium stores are replenished.

In cases of severe hypomagnesemia that are not life-threatening, an alternative regimen is an infusion of 1–2 g/h of magnesium sulfate for 3–6 hours, followed by a maintenance infusion of 0.5–1 g/h.

The maximum infusion rate should generally remain below 2 g/h, except in the treatment of life-threatening acute arrhythmias such as torsades de pointes and in eclampsia.

Parenteral nutrition:

The usual requirement is 2.4–3.6 g of magnesium sulfate (20–30 mEq of Mg)/24 h, administered by intravenous infusion.

Eclampsia:

Initially, 4 g of magnesium sulfate should be administered intravenously (infused over 5–10 minutes), followed by continuous infusion of 1–4 g/h of magnesium sulfate.

Special populations:

Elderly population:

Although adequate and well-controlled studies have not been conducted in elderly patients, age-related problems have not been reported to date. However, elderly patients often require lower doses due to reduced renal function.

Magnesium Sulfate Altan should be used under strict clinical monitoring. Electrocardiographic monitoring is advisable in elderly patients receiving high doses of magnesium sulfate.

Patients with renal impairment:

In patients with renal impairment, the initial dose should be reduced by 25%–50% of the recommended dose for patients with normal renal function.

Paediatric population:

Ventricular tachycardia with torsade de pointes:

If there is no pulse, a dose of 25–50 mg of magnesium sulfate/kg body weight by slow IV bolus is recommended.

If there is a pulse, the same dose may be administered by infusion over 10–20 minutes.

The maximum dose is 2 grams of magnesium sulfate.

Hypomagnesemia:

Recommended dose: 25–50 mg of magnesium sulfate/kg body weight, administered intravenously. This dose may be repeated every 4–6 hours, up to a maximum of 3–4 doses. The maximum single dose is 2 grams of magnesium sulfate.

Daily maintenance dose: 30–60 mg/kg/24 hours of magnesium sulfate administered intravenously (0.25–0.5 mEq of Mg/kg/24 hours).

The maximum dose is 1 gram/24 hours of magnesium sulfate.

Parenteral nutrition:

Generally, a dose of 30–60 mg/kg/24 hours of magnesium sulfate administered intravenously (0.25–0.5 mEq of Mg/kg/24 hours) is recommended.

The maximum dose is 1 gram/24 hours of magnesium sulfate.

If you use more Magnesium Sulfate Altan than you should

If the recommended doses are exceeded, symptoms such as the following may occur:

• nervous system disturbances including paralysis of limbs, muscles involved in speaking and swallowing, and potentially leading to paralysis of respiratory muscles.
• cardiovascular manifestations primarily consisting of a marked decrease in blood pressure, accompanied by increased heart rate (tachycardia) or decreased heart rate (bradycardia).

Magnesium intoxication manifests as a sudden drop in blood pressure and depression of the central nervous system, which may precede respiratory paralysis. The disappearance of the patellar reflex is a clinical sign indicating the onset of magnesium overdose.

Symptoms may include loss of deep tendon reflexes, somnolence, confusion, lethargy, etc. Inform your doctor if you experience any of these symptoms.

In the event of overdose, your doctor will administer the most appropriate treatment.

If you forget to use Magnesium Sulfate Altan

Do not use a double dose to make up for missed doses.

This medicine will be administered to you in the hospital according to the dosing schedule prescribed by your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects have been grouped according to the following organ classification:

General disorders and administration site conditions:

injection site pain, decrease in body temperature below normal limits (hypothermia), vasodilation with sensation of warmth

If magnesium sulfate is administered parenterally at high doses, it may cause hypermagnesemia, whose symptoms are as follows:

Nervous system disorders:

loss of reflex movement of muscle in response to a minor contusion or impact stimulus (loss of tendon reflex), headache, dizziness, coma, somnolence, confusion, central nervous system depression that may precede respiratory paralysis

Cardiac disorders:

cardiac arrest or circulatory collapse

Vascular disorders:

decrease in blood pressure (hypotension), decrease in heart rate (bradycardia), flushing

Respiratory, thoracic and mediastinal disorders:

difficulty breathing (respiratory depression)

Gastrointestinal disorders:

nausea, vomiting

Musculoskeletal and connective tissue disorders:

muscle weakness

Other disorders:

speech difficulties, visual disturbances, excessive sweating, and thirst.

Hypermagnesemia may be potentially fatal if you have a serious problem with kidney function (severe renal failure) or if magnesium sulfate is injected too rapidly.

Post-marketing experience

There are studies and clinical cases documenting fetal abnormalities such as decreased calcium levels (hypocalcemia) and bone abnormalities.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Magnesium Sulfate Altan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the label of the ampoule following Exp. The expiry date refers to the last day of the month indicated.

After opening: the product must be used immediately.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Magnesium Sulfate Altan

• The active substance is:

Magnesium sulfate heptahydrate: 150 mg/ml

One 10 ml ampoule contains 1.5 g of magnesium sulfate heptahydrate.

1 ml of injection/perfusion solution contains 150 mg of magnesium sulfate heptahydrate.

• Magnesium: 6.09 mmol (148.02 mg) / ampoule

• Sulfate: 6.09 mmol (585.02 mg) / ampoule

• The other components are: sodium hydroxide and water for injections.

Appearance of the product and contents of the pack

Magnesium Sulfate Altan is a clear, colourless solution for injection/perfusion.

Magnesium Sulfate Altan is supplied in packs containing 10 and 100 ampoules of 10 ml. Only certain pack sizes may be marketed.

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

C/Colquide, Nº 6, Portal 2, 1st floor, Office F.

Edificio Prisma - Las Rozas (Madrid) -28230 – Spain

Manufacturer

Altan Pharmaceuticals, S.A.

Avda. Constitución 198-199. Pol. Industrial Monte Boyal

45950 Casarrubios del Monte (Toledo)

Date of the most recent review of this leaflet: August 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

Information for healthcare professionals

Magnesium Sulfate Altan is a hypertonic solution for slow injection; administration must be performed at an infusion rate not exceeding 150 mg/min of magnesium sulfate heptahydrate.

Preparation of intravenous solution

When administered by intravenous injection or intravenous perfusion, the Magnesium Sulfate Altan solution may be diluted in 0.9% injectable sodium chloride solution.

In the case of intravenous perfusion, the Magnesium Sulfate Altan solution may also be diluted in 5% glucose solution.

For intravenous perfusion, dilute 4-5 grams in 250 ml of physiological saline or 5% glucose solution.

Treatment of overdose:

Treatment consists of:

• Rehydration, forced diuresis.
• Intravenous injection of calcium salts: 1 g of calcium gluconate administered intravenously slowly to reverse cardiac blockade or respiratory depression. Artificial respiration may be required.
• In case of renal failure, hemodialysis or peritoneal dialysis will be necessary.

Hyper-magnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation, as well as intravenous calcium.

Chemical and physical stability has been demonstrated for 24 hours at 20–25 °C and at 5 °C after dilution to 2% in physiological saline, 5% glucose solution, or 0.9% injectable sodium chloride.

From a microbiological standpoint, unless the opening method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the user is responsible for the storage times and conditions during use.