Ini. Magnesii Sulfurici 20% Polpharma

Leaflet attached to the packaging: patient information

Inj. Magnesii Sulfurici 20% Polpharma 200 mg/ml, solution for injection

Magnesium sulfate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Inj. Magnesii Sulfurici 20% Polpharma and what is it used for
• 2. Important information before using Inj. Magnesii Sulfurici 20% Polpharma
• 3. How to use Inj. Magnesii Sulfurici 20% Polpharma
• 4. Possible side effects
• 5. How to store Inj. Magnesii Sulfurici 20% Polpharma
• 6. Contents of the packaging and other information

1. What is Inj. Magnesii Sulfurici 20% Polpharma and what is it used for

Magnesium sulfate - the active substance of Inj. Magnesii Sulfurici 20% Polpharma - when administered parenterally, inhibits the excitability of the central nervous system and neuromuscular conduction.
After intravenous administration, the effect of the medicine occurs immediately and lasts for about 30 minutes. After intramuscular administration, the effect occurs after about 1 hour and lasts 3-4 hours. Magnesium sulfate is excreted by the kidneys in proportion to the concentration in serum and the state of glomerular filtration.

Indications for use

• Pregnancy complicated by hypertension (gestosis EPH), starting from gestosis EPH with one symptom, through multi-symptomatic, threatened eclampsia, to eclampsia. The medicine is used for prevention and treatment.
• States of acute magnesium deficiency in the syndrome of impaired absorption, alcoholism, liver cirrhosis, acute pancreatitis, or during long-term use of infusion fluids that do not contain magnesium.
• As a medicine to prevent magnesium deficiency in patients receiving parenteral nutrition.
• Convulsive states caused by magnesium deficiency in the course of epilepsy, kidney disease, or hypothyroidism.
• Paroxysmal atrial tachycardia without signs of heart muscle damage, if other treatment methods have been ineffective.
• Torsade de pointes(a heart rhythm disorder that can lead to death).
• Treatment of mild and moderate asthma attacks.

2. Important information before using Inj. Magnesii Sulfurici 20% Polpharma

When not to use Inj. Magnesii Sulfurici 20% Polpharma:

if the patient is allergic to magnesium and its salts, or any of the other ingredients of this medicine (listed in section 6);

• if the patient has a heart block or heart muscle damage;
• if the patient has muscle weakness ( myasthenia gravis);
• if the patient has kidney failure.

Warnings and precautions

• To avoid poisoning during parenteral administration of magnesium sulfate, the patient should be closely monitored and the concentration of magnesium ions in the blood serum should be measured.
• The number of breaths should be controlled during the administration of the medicine and before the next dose (it should not be less than 16/minute).
• Treatment should not be continued if the patient has excreted less than 100 ml of urine within 4 hours.
• The medicine should be used with caution in patients with kidney function disorders due to the risk of poisoning.
• Magnesium sulfate should not be used in patients with hepatic coma if there is a risk of kidney failure.

Inj. Magnesii Sulfurici 20% Polpharma and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Magnesium salts enhance the effect of muscle relaxants of the tubocurarine type.
• During parenteral administration of magnesium sulfate and drugs that block neuromuscular junctions, neuromuscular blockade may occur.
• Magnesium sulfate enhances the effect of barbiturates, opioids, anesthetics, and other central nervous system depressants.
• Magnesium sulfate should be used with particular caution in patients treated with digitalis glycosides, as cardiac conduction disorders may occur.
• Calcium salts administered intravenously counteract the effect of magnesium.
• Magnesium salts enhance the effect of calcium ion antagonists. Concurrent use with nifedipine may rarely lead to calcium balance disorders and cause muscle function disorders.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
The safety of use during pregnancy and breastfeeding has not been established. Therefore, the use of the medicine during pregnancy or breastfeeding is not recommended unless the doctor considers it necessary. In such cases, the administration of the medicine must be under the close supervision of a doctor.
The medicine should not be administered intravenously 12 hours before delivery, as this increases the risk of magnesium poisoning in newborns.
Magnesium ions pass into the breast milk of nursing mothers. After parenteral administration, higher magnesium concentrations in milk persist for about 24 hours.
Breastfeeding should not be done during treatment with the medicine.

Driving and operating machinery

There are no controlled studies on the effect of the medicine on psychophysical fitness. Due to the inhibitory effect of magnesium ions on the central nervous system, driving and operating machinery during treatment is not recommended.

The medicine contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".
The medicine can be diluted, for example, in a 0.9% NaCl solution or a 5% glucose solution. The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the medicine. To obtain accurate information about the sodium content in the solution used to dilute the medicine, the patient information leaflet of the diluent should be consulted.

3. How to use Inj. Magnesii Sulfurici 20% Polpharma

The medicine should be used strictly according to the doctor's instructions. The doses of the medicine may vary for different patients.
Inj. Magnesii Sulfurici 20% Polpharma is intended for intravenous or intramuscular injections in adults and children.
Detailed dosing and instructions for preparing and administering the medicine are provided at the end of the leaflet, in the section "Information intended exclusively for medical professionals".

Using a higher dose of Inj. Magnesii Sulfurici 20% Polpharma than recommended

If the patient suspects they have received too high a dose of the medicine, they should inform their doctor, as symptomatic treatment may be necessary.
In the event of an overdose, side effects occur, listed in the section "Possible side effects". Treatment of poisoning involves intravenous administration of calcium salts and the use of artificial respiration. In adults, the administration of 5-10 mEq of calcium intravenously (e.g., 10-20 ml of 10% Calcium gluconate) should eliminate respiratory depression or heart block caused by magnesium poisoning.
In the case of normal kidney function, appropriate amounts of fluids should be administered to facilitate the excretion of magnesium ions from the body.
In the case of severe hypermagnesemia, peritoneal dialysis or hemodialysis is recommended.

Missing a dose of Inj. Magnesii Sulfurici 20% Polpharma

If the patient suspects they have missed a dose of the medicine, they should inform their doctor as soon as possible.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although they may not occur in everyone.
Side effects after parenteral administration of magnesium sulfate are most often related to hypermagnesemia and include:

• muscle weakness, reduced reflexes, paresis;
• drowsiness, disorientation, coma;
• increased sweating, feeling of thirst;
• respiratory depression;
• heart rhythm disorders and cardiac arrest, bradycardia, hypotension;
• kidney function disorders;
• flushing of the face, hypothermia;
• nausea and vomiting.

To reduce the risk of magnesium salt poisoning, the concentration of magnesium in the serum should be controlled.
During treatment of eclampsia, significant hypocalcemia and hypocalcemic tetany may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Inj. Magnesii Sulfurici 20% Polpharma

The medicine should be stored out of sight and reach of children.
Do not store above 25°C. Protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Inj. Magnesii Sulfurici 20% Polpharma contains

• The active substance of the medicine is magnesium sulfate. 1 ml of the solution contains 200 mg of magnesium sulfate.
• The other ingredients of the medicine are: water for injections, 0.1 M hydrochloric acid (for pH adjustment), and 0.1 M sodium hydroxide (for pH adjustment).

What Inj. Magnesii Sulfurici 20% Polpharma looks like and what the packaging contains

The packaging contains 10 glass ampoules with 10 ml of the solution each.

Marketing authorization holder and manufacturer

Polpharma S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of the last update of the leaflet: -----------------------------------------------------------------------------------------------------------------

Information intended exclusively for medical professionals:

Inj. Magnesii Sulfurici 20% Polpharma 200 mg/ml, solution for injection

Magnesium sulfate

How to use Inj. Magnesii Sulfurici 20% Polpharma

The medicine should be used strictly according to the doctor's instructions. The doses of the medicine may vary for different patients.
Inj. Magnesii Sulfurici 20% Polpharma is intended for intravenous or intramuscular injections in adults and children.
It is recommended that the injection rate does not exceed 1.5 ml per minute of 10% solution or its equivalent. Inj. Magnesii Sulfurici 20% Polpharma can be diluted if necessary in a 5% glucose solution or 0.9% sodium chloride solution. Doses should be reduced in renal failure. During treatment, magnesium levels should be monitored.
Usually, the following dosing is recommended:

In threatened eclampsia and eclampsia:

• 1. 30 ml of 20% magnesium sulfate solution, intramuscularly;
• 2. After 4 hours, the next 30 ml of 20% magnesium sulfate solution, intramuscularly;
• 3. After 4 hours, the next 30 ml of 20% magnesium sulfate solution, intramuscularly;
• 4. A break in administration - 12 hours. If symptoms of poisoning persist, repeat the administration as above;
• 5. In the control of convulsions, 1-2 g of the medicine per hour can be used in continuous infusion.

Dosing in patients with renal function disorders:

In severe renal failure, the dose of magnesium sulfate is 20 g over 48 hours.

In acute magnesium deficiency:

Intramuscularly 250 mg/kg body weight at intervals greater than 4 hours.
Alternatively: intravenously, 5 g of magnesium sulfate in 1 liter of 5% glucose solution or 0.9% NaCl (physiological saline) over 3 hours.

In moderate magnesium deficiency:

Intramuscularly 1 g of magnesium sulfate every 6 hours (in 4 divided doses).

As an additive to parenteral nutrition:

In adults: 0.5-3 g of magnesium sulfate (4-24 mEq Mg) per day.
In infants: 0.25-1.25 g of magnesium sulfate (2-10 mEq Mg) per day.

In the control of convulsions of epileptic origin, related to kidney disease or hypothyroidism:

In adults: 1 g of magnesium sulfate intramuscularly or intravenously.
In children with hypertensive disease, encephalopathy, and convulsions occurring in acute kidney disease, the medicine is administered intramuscularly in a dose of 100 mg/kg body weight, if necessary, every 4-6 hours.
In the control of convulsions in children, the medicine can also be administered intramuscularly in a dose of 20-40 mg/kg body weight (0.1-0.2 ml/kg body weight of 20% magnesium sulfate solution).
In severe conditions, the medicine is administered intravenously in a slow infusion, as a 1-3% solution in a dose of 100-200 mg/kg body weight, continuously controlling blood pressure.
The total dose should be administered over 1 hour, and half of this dose over the first 15-20 minutes.

In the treatment of rhythm disorders:

Paroxysmal supraventricular tachycardia: 3-4 g of magnesium sulfate intravenously over 30 seconds. Great caution should be exercised when administering the medicine.
Life-threatening arrhythmias (e.g., ventricular tachycardia and torsade de pointes):
with cardiac arrest: 1-2 g diluted in 10 ml of 5% glucose solution intravenously or intracardially over 5-20 minutes.
with a pulse: 1-2 g diluted in 50-100 ml of 5% glucose solution intravenously over 5-60 minutes as an initial dose, and then in intravenous infusion at 0.5-1 g per hour.

In the treatment of acute asthma attack:

1.2 g to 2 g of magnesium sulfate intravenously over 20 minutes.