MAGNESIUM SULFATE BASE 200 mg/mL INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Magnesium Sulfate Basi 200 mg/ml Solution for Injection and Infusion

magnesium sulfate heptahydrate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Magnesium Sulfate Basi and what is it used for
2. What you need to know before you are given Magnesium Sulfate Basi
3. How Magnesium Sulfate Basi is given
4. Possible side effects
   1. Storage of Magnesium Sulfate Basi
   2. Contents of the pack and further information

1. What is Magnesium Sulfate Basi and what is it used for

Magnesium Sulfate Basi contains magnesium (as magnesium sulfate heptahydrate). Magnesium sulfate heptahydrate (hereafter referred to as magnesium sulfate) is a magnesium salt. It is used:

• to treat magnesium deficiency;
• to prevent and treat low magnesium levels in the blood in patients receiving total parenteral nutrition (nutrients are infused into the bloodstream);
• to treat a heart rhythm disorder known as "torsade de pointes";
• to control and prevent seizures in severe pre-eclampsia (a serious complication of pregnancy characterized by high blood pressure and proteins in the urine);
• to control and prevent recurrent seizures in eclampsia (seizures resulting from pre-eclampsia).

The medicine is intended for use in adults, adolescents, and children.

2. What you need to know before you are given Magnesium Sulfate Basi

You should not be given Magnesium Sulfate Basi

• if you are allergic to magnesium sulfate, its salts, or any of the other ingredients of this medicine (listed in section 6).
• if you have high magnesium levels in the blood;
• if you have severe kidney impairment or renal failure (if dialysis or other blood purification methods are not available).

If any of the above applies to you, tell your doctor or nurse before you are given magnesium sulfate.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given magnesium sulfate:

• if you have a disease that causes muscle weakness and fatigue called "myasthenia gravis";
• if you have kidney problems (you may need a reduced dose);
• if you are prone to kidney stones (diathesis of calcium, magnesium, ammonium, or phosphate stones);
• if you have liver problems;
• if you have heart problems.

Too rapid administration can cause a rapidly developing dilation of blood vessels and a reduction in blood pressure.

Tell your doctor or nurse if you experience flushing and sweating.

Pain, redness, swelling, or warmth at the injection site, drainage at the injection site, prolonged bleeding, cellulitis, sterile abscess, signs of an allergic reaction, such as difficulty breathing or facial swelling, injury to nearby structures (blood vessels, bones, or nerves), accidental injection into a blood vessel, tissue necrosis, and poor absorption due to high injection volume relative to magnesium sulfate injections.

As with all parenteral medicines, this medicine may irritate the veins; leakage of the medicine from a blood vessel into the surrounding tissue can cause tissue damage.

During treatment, your blood magnesium and calcium levels will be monitored.

Your reflexes, breathing, and urine production will also be monitored while you are receiving magnesium sulfate.

Other medicines and Magnesium Sulfate Basi

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Medicines that may interact with magnesium sulfate include:

• Muscle relaxants, e.g., vecuronium
• Nifedipine (used to treat high blood pressure or chest pain)
• Calcium channel blockers (medicines to treat high blood pressure and chest pain)
• Diuretics (medicines that increase urine production) such as thiazides and furosemide
• Calcium salts
• Digitalis glycosides, e.g., digoxin (a medicine used to treat heart problems)
• Neuromuscular blocking agents
• Aminoglycoside antibacterial agents (medicines used to treat bacterial infections)
• Barbiturates (medicines for anxiety, insomnia)
• Opioids (medicines for chronic pain) such as morphine
• Hypnotics (medicines for sleep disorders)

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Magnesium sulfate can be used to treat seizures associated with pre-eclampsia and eclampsia, serious complications of pregnancy. If you are pregnant and are given magnesium sulfate, your baby's heart rate will be closely monitored, and its use will be avoided in the 2 hours before delivery.

Magnesium sulfate has no effect on fertility.

Driving and using machines

It is unlikely that magnesium sulfate will affect your ability to drive or use machines. However, some people may feel dizzy or drowsy after receiving a magnesium sulfate injection. If you experience these side effects, do not drive or use machines.

3. How Magnesium Sulfate Basi is given

You will be given magnesium sulfate into a muscle or into a vein by slow injection or infusion.

Your doctor will decide how much magnesium sulfate you should be given. The dose depends on your individual needs and response to treatment.

Adults

Treatment of magnesium deficiency

The usual dose is 8-12 g of magnesium sulfate (32.8-49.2 mmol) in the first 24 hours, followed by 4-6 g/day (16.4-24.6 mmol/day) for 3 or 4 days, to replenish body stores.

In patients receiving total parenteral nutrition, the dose is strictly individual. As a general recommendation, 1-3 g/day (4.1-12.3 mmol/day) is administered into a vein.

Prevention and control of seizures in severe pre-eclampsia and eclampsia

An initial loading dose of 4 g of magnesium sulfate (16.4 mmol), diluted to an appropriate volume, administered into a vein, followed by an intravenous infusion of 1-2 g/hour or regular intramuscular injections, until seizures cease.

Torsade de pointes

A single dose of 2 g (8.2 mmol) administered over 2-3 minutes. An intravenous infusion is started at a rate of 2-4 mg/min.

If torsade de pointesrecurs, a further 2 g is administered and the infusion rate is increased to 6-8 mg/min.

Patients with kidney problems

A reduced dose will usually be given to patients with kidney problems.

Patients with liver problems

There are no specific dose recommendations.

Elderly patients

There are no specific dose recommendations. However, caution should be exercised as renal and/or hepatic disorders are more frequent in this age group, and side effects are more likely to occur.

Use in children

In children, magnesium sulfate can be administered into a vein to replenish body stores. In children receiving total parenteral nutrition, the dose is adjusted according to age, body weight, and individual needs.

If you are given too much Magnesium Sulfate Basi

Since the administration of this medicine will be carried out by a doctor or nurse, it is unlikely that you will be given too much. However, tell your doctor or nurse if you have any concerns.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount ingested.

If you miss a dose of Magnesium Sulfate Basi

It is unlikely that you will miss a dose, as it will be given to you by your doctor or nurse. You should not receive a double dose to make up for a missed dose. Ask your doctor or nurse when you should receive the next dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Frequency not known(cannot be estimated from the available data)

• Allergic reactions
• High magnesium levels in the blood
• Electrolyte/fluid disturbances
• Breathing difficulties
• Feeling or being sick
• Drowsiness
• Confusion
• Slurred speech
• Double vision
• Loss of tendon reflexes
• Irregular heartbeats
• Cardiac arrest
• Abnormal electrocardiogram
• Slow heart rate
• Flushing of the skin and low blood pressure due to dilation of blood vessels
• Muscle weakness
• Thirst
• Coma

Low calcium levels in the blood have been reported in pregnant women and their developing babies in extremely rare cases with high doses of magnesium sulfate.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national pharmacovigilance system for human use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Magnesium Sulfate Basi

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

Store below 25°C.

For single use only. If only part of an ampoule is used, the remaining solution should be discarded.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month stated.

Do not use this medicine if you notice visible signs of deterioration (e.g., particles).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Magnesium Sulfate Basi 200 mg/ml injectable and perfusion solution

• The active ingredient is magnesium sulfate heptahydrate.

Each ml of solution contains 200 mg of magnesium sulfate heptahydrate.

Each 10 ml ampoule contains 2,000 mg of magnesium sulfate heptahydrate.

• The other component (excipient) is water for injectable preparations.

Product Appearance and Container Content

Clear, colorless or almost colorless solution, free from visible particles.

10 ml of solution in transparent glass ampoules type I with breaking point.

Container size:

10 ampoules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua

Portugal

Tel.: + 351 231 920 250 | Fax: + 351 231 921 055

E-mail: [email protected]

Manufacturer

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15, 16

3450-232 Mortágua

Portugal

Local Representative

Laphysan, S.A.U.

Calle Anabel Segura 11,

Complejo Empresarial Albatros, Edificio A, Planta 4, puerta D,

28108 Alcobendas (Madrid) España

This medicinal product is authorized in the Member States of the European Economic Areawith the following names:

Portugal Magnesium Sulfate Basi

Spain Magnesium Sulfate Basi 200 mg/ml injectable and perfusion solution

Date of the last revision of this leaflet: April 2024

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

------------------------------------------------------------------------------------------------------------------------

This information is intended exclusively for healthcare professionals:

Posology

1 g of magnesium sulfate heptahydrate = 98.6 mg or 4.1 mmol of magnesium.

Adults

Hypomagnesemia

The dose is strictly individual. As a general guideline, 8-12 g of magnesium sulfate (32.8-49.2 mmol) can be administered in the first 24 hours, followed by 4-6 g/day (16.4-24.6 mmol/day) for 3 or 4 days, to replenish body stores.

The maximum perfusion rates should not exceed 2 g/h. The goal should be to maintain serum magnesium concentrations above 0.4 mmol/l.

Prevention and treatment of hypomagnesemia in total parenteral nutrition

The dose is strictly individual. As a general recommendation, 1-3 g/day of magnesium sulfate can be administered intravenously (4.1-12.3 mmol/day).

Severe pre-eclampsia or eclampsia

By intravenous route, an initial loading dose of 4 g diluted to an appropriate volume, for example, 4 g of magnesium sulfate (16.4 mmol) in 250 ml of 5% glucose solution or 0.9% sodium chloride solution at a maximum of 4 ml/min (= 64 mg/min) can be perfused. This is followed by a maintenance regimen of intravenous perfusion of 1-2 g/hour, or regular intramuscular injections, depending on the continued presence of the patellar reflex and adequate respiratory and urinary function. Treatment should continue until seizures cease.

It is essential that when administering magnesium sulfate through any of these schemes, certain clinical observations should be made before each injection:

• deep tendon reflexes should be present;
• respiration should be at least 16 breaths/minute;
• at least 100 ml of urine should have been excreted since the previous injection.

Additionally, 1 g of calcium gluconate should be available as an antidote for hypermagnesemia.

Torsades de pointes

As a general recommendation, a single intravenous bolus of 2 g (8.2 mmol) can be administered over a period of 10 to 15 minutes. An intravenous magnesium perfusion should be started at a rate of 2-4 mg/min. If torsades de pointes recurs, another bolus of 2 g of magnesium should be administered and the intravenous perfusion rate should be increased to 6-8 mg/min. A third bolus of 2 g (8.2 mmol) is rarely required.

Pediatric Population

Hypomagnesemia

Magnesium Sulfate Basi can be administered intravenously to children. For intravenous use in children, the administration rate should not exceed 10 mg/kg/minute of magnesium sulfate (corresponding to 0.04 mmol/kg/minute = 0.001 g/kg/minute of magnesium).

Prevention and treatment of hypomagnesemia in total parenteral nutrition

The dose is strictly individual. As a general recommendation, the following doses of magnesium sulfate can be administered intravenously:

Renal Impairment

Patient with renal impairment should receive 25-50% of the initial recommended dose for patients with normal renal function. ECG monitoring is recommended with high doses and in elderly patients.

Hepatic Impairment

Due to insufficient data, no special dosage instructions are recommended for patients with impaired hepatic function.

Elderly

Parenteral magnesium sulfate should be used with caution in elderly patients, as renal disorders are more frequent in this age group and tolerance to adverse effects may be lower.

Administration Route

For intravenous (injection or perfusion) or intramuscular use, according to the information provided for each indication.

The medication should be administered with caution if redness and sweating occur.

Too rapid administration can cause rapid development of vasodilation and reduction of blood pressure.

Like all parenteral medications, magnesium sulfate injections can irritate veins; extravasation can cause tissue damage.

The medication should not be administered in demarcated or atrophied muscles. For intramuscular administration, the dorsogluteal muscle and the sciatic nerve should be avoided. If the total dose to be administered exceeds 5 ml, the injection volume should be divided between more than one deep muscle injection site.

Intramuscular injections are painful and complicated by the formation of local abscesses in 0.5% of cases. Therefore, the intravenous route is preferred. However, the intramuscular regimen becomes the best option when intravenous perfusion pumps are not available or continuous monitoring is not feasible.

Use with caution in elderly or thin patients who can only tolerate up to 2 ml in a single injection. Do not use an injection site that has evidence of infection or injury. If repeating an intramuscular dose, alternate injection sites to avoid muscle injury or discomfort.

Instructions for Use, Disposal, and Other Handling

For single use.

May be diluted with 0.9% sodium chloride and 5% glucose solutions.

The medication should be used immediately after opening the ampoule. Any unused portion should be discarded.

Instructions for opening the ampoule

1. Turn the ampoule with the colored point facing upwards. If there is solution in the upper part of the ampoule, gently tap with your finger to ensure all the solution reaches the lower part of the ampoule.
2. Use both hands to open; while holding the lower part of the ampoule with one hand, use the other to separate the upper part of the ampoule from the colored point (see images below).

An antidote of 1 g of calcium gluconate injectable solution should be available immediately.

Disposal of unused medication and all materials that have come into contact with it should be carried out in accordance with local regulations.