Natrium bicarbonicum 8,4% Polpharma

Leaflet attached to the packaging: patient information

Sodium bicarbonate 8.4% Polpharma, 84 mg/ml, solution for injection

Sodium hydrogen carbonate

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, pharmacist, 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Sodium bicarbonate 8.4% Polpharma and what is it used for
• 2. Important information before using Sodium bicarbonate 8.4% Polpharma
• 3. How to use Sodium bicarbonate 8.4% Polpharma
• 4. Possible side effects
• 5. How to store Sodium bicarbonate 8.4% Polpharma
• 6. Contents of the packaging and other information

1. What is Sodium bicarbonate 8.4% Polpharma and what is it used for

Sodium bicarbonate 8.4% Polpharma is an alkalizing agent that, through dissociation, releases sodium and bicarbonate ions. It increases the bicarbonate concentration in blood serum and serum pH.

• Indications for use are:
• Metabolic acidosis (excess of acidic metabolic products in the blood), occurring in the course of severe kidney diseases, congestive heart failure, shock, and dehydration, as well as in cases of alcoholism and during the use of carbonic anhydrase inhibitor drugs (diuretics) and ammonium chloride.
• Lactic acidosis (increased lactic acid concentration in the blood).
• Necessity of rapid urine alkalization, e.g., in salicylate and barbiturate poisoning or in sulfonamide-induced kidney damage.

2. Important information before using Sodium bicarbonate 8.4% Polpharma

When not to use Sodium bicarbonate 8.4% Polpharma

• if the patient is allergic to sodium bicarbonate or any other component of the medicine (listed in section 6);
• if the patient has metabolic alkalosis;
• if the patient has respiratory alkalosis;
• if the patient has hyperventilation (weakened lung function leading to increased carbon dioxide levels in the blood);
• if the patient has hypernatremia (elevated sodium levels in serum) and conditions where sodium administration is contraindicated, e.g., congestive heart failure, edema, hypertension, eclampsia, or kidney failure;
• if the patient has hypocalcemia (reduced calcium levels in serum), which may cause tetany;

may cause tetany;

• in patients with excessive chloride loss due to vomiting;
• in patients at risk of developing alkalosis (caused by diuretic drugs).

Warnings and precautions

Before starting treatment with Sodium bicarbonate 8.4% Polpharma, the patient should discuss it with their doctor.

• Particular caution is required:
• if the patient is at risk of hypokalemia (reduced potassium levels in the blood);
• if sodium administration is not indicated, and kidney function is not impaired - in such cases, alkalization using trometamol (THAM) solution is recommended;
• if the patient has untreated congestive heart failure, other edematous conditions, or sodium retention;
• if the patient has severe kidney failure and oliguria or anuria.

Sodium bicarbonate 8.4% Polpharma may cause hypokalemia and hypocalcemia. Hypokalemia may lead to metabolic alkalosis, and hypocalcemia may cause tetany and foot cramps.

• To minimize the risk of hypocalcemia and hypokalemia, the doctor will correct electrolyte deficiencies before administering Sodium bicarbonate 8.4% Polpharma.
• The medicine should only be administered by qualified medical personnel, including:
• the medicine must be administered precisely into a vein, as extravascular administration may cause tissue necrosis;
• rapid injection (10 ml/min) of the hypertonic Sodium bicarbonate 8.4% Polpharma solution to newborns and children under 2 years may cause hypernatremia, decrease cerebrospinal fluid pressure, and lead to intracranial hemorrhage.

Sodium bicarbonate 8.4% 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, especially:

• lithium salts, as Sodium bicarbonate 8.4% Polpharma increases their excretion;
• corticosteroids or corticotropin (1 g of Sodium bicarbonate 8.4% Polpharma contains approximately 12 mEq of sodium);
• tetracycline antibiotics (especially doxycycline), as urine alkalization may lead to their faster excretion by the kidneys;
• quinidine, amphetamine derivatives, ephedrine, and pseudoephedrine (may lead to prolonged half-life of these medicines);
• bumetanide, ethacrynic acid, furosemide, and thiazide diuretics (concomitant administration may lead to hypochloremic alkalosis);
• potassium products (concomitant administration may lead to decreased potassium levels in the blood).

Due to the incompatibility of Sodium bicarbonate 8.4% Polpharma, it should not be mixed with solutions containing phosphates, calcium, or magnesium salts.

• 6% dextran in 5% glucose
• 6% dextran in 0.9% sodium chloride
• 5% glucose in 0.9% sodium chloride
• 0.45% and 0.9% sodium chloride.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Pregnancy

The safety of using Sodium bicarbonate 8.4% Polpharma in pregnant women has not been established. The medicine should only be used in pregnant women if the expected benefits outweigh the risk of fetal harm.

Breastfeeding

The medicine should be avoided during breastfeeding.

Driving and operating machinery

The medicine does not affect the ability to drive or operate machinery.

Sodium bicarbonate 8.4% Polpharma contains sodium

The medicine contains 23 mg of sodium (the main component of table salt) per 1 ml of solution. This corresponds to 1.15% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Sodium bicarbonate 8.4% Polpharma

The medicine can only be administered by qualified medical personnel.

Detailed dosing and administration instructions are provided at the end of the leaflet, in the section "Information intended for healthcare professionals".

Using a higher dose of Sodium bicarbonate 8.4% Polpharma than recommended

In case of overdose, the patient should immediately consult their doctor.

• Metabolic alkalosis may occur in case of overdose.
• Treatment of overdose
• The doctor will discontinue the infusion and monitor the symptoms of alkalosis.
• The patient will be given respiratory support with rebreathing of exhaled air.
• In severe cases, the doctor will administer a 0.9% sodium chloride solution intravenously.
• In case of hypokalemia, potassium chloride will be administered.
• In case of tetany that cannot be controlled with respiratory support, calcium gluconate will be administered intravenously.
• In case of reactions at the injection site, a warm compress and local lidocaine or hyaluronidase will be applied.

Missing a dose of Sodium bicarbonate 8.4% Polpharma

Since the medicine is administered under strict control, it is unlikely that a dose will be missed. If the patient thinks they have missed a dose, they should immediately inform their doctor or nurse.

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Sodium bicarbonate 8.4% Polpharma can cause side effects, although not everybody gets them.

Metabolic and nutritional disorders

• Metabolic alkalosis, tetany (especially in patients with hypocalcemia and after administration of large doses of the medicine)
• Hypokalemia
• Hypernatremia
• Hyperosmolality (severe hyperosmolality may occur during cardiopulmonary resuscitation and administration of the medicine in large doses).

General disorders and administration site conditions

• Local ulcers
• Tissue necrosis
• Edema (water and sodium retention, as well as edema, may occur during administration of large doses of the medicine, especially in patients with kidney failure, heart failure, and those prone to sodium retention and edema).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or nurse.

5. How to store Sodium bicarbonate 8.4% Polpharma

The medicine should be stored out of sight and reach of children.

Store at a temperature below 25°C. Do not store in the refrigerator.

Do not use the medicine after the expiration date stated on the packaging after: EXP.

The expiration 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 unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Sodium bicarbonate 8.4% Polpharma contains

• The active substance of the medicine is sodium bicarbonate. Each 20 ml ampoule contains 1.68 g of sodium bicarbonate.
• Other ingredients are: disodium edetate, water for injections.

What Sodium bicarbonate 8.4% Polpharma looks like and what the packaging contains

Each package contains 10 ampoules of colorless glass with a capacity of 20 ml, packed in a cardboard box.

Marketing authorization holder and manufacturer

Polpharma S.A.

Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Date of last revision of the leaflet:

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Information intended exclusively for healthcare professionals

Sodium bicarbonate 8.4% Polpharma can be administered:

• by direct intravenous injection undiluted (in life-threatening situations, e.g., during cardiac arrest);
• rarely subcutaneously, after dilution and adjustment to isotonicity (e.g., 1.5% solution), the degree of absorption is difficult to predict;
• by intravenous drip infusion, exclusively through a catheter inserted into a vein, in a diluted form with 5% glucose solution in a 1:1 ratio, at a rate of 60 drops/min.

The dose of Sodium bicarbonate 8.4% Polpharma depends on the patient's acid-base balance and body weight. It can be determined using the following formula:

NaHCO3 (mmol) = base deficit (mmol) x body weight x 0.3.

1 ml of the solution contains: 1 mmol of sodium and 1 mmol of bicarbonate (= 1 mEq of sodium bicarbonate NaHCO3).

Use in children

In children, it is recommended to administer Sodium bicarbonate 8.4% Polpharma by intravenous infusion in a dose not exceeding 8 mEq/kg body weight per day.

In infants and children under 2 years, the solution is administered by slow intravenous drip infusion at a dose of up to 8 mEq/kg body weight per day (8 ml/kg body weight per day).

The initial dose should be 1 mEq/kg body weight. Due to the risk of intracranial hemorrhage, the solution should be administered in a diluted form.

In case of need for rapid administration of the medicine by direct intravenous injection, the initial dose should be 33-50% of the calculated dose.

It is not recommended to aim for complete correction of the base deficit within 24 hours of therapy, as metabolic alkalosis and associated side effects may occur.

The Sodium bicarbonate 8.4% Polpharma solution for injection is not indicated for routine use to maintain cardiac function, e.g., during resuscitation. In case of use in patients with cardiac arrest, the initial dose of the medicine should not exceed 1 mEq/kg body weight. If there is no therapeutic effect, a subsequent dose of up to 0.5 mEq/kg body weight can be administered after 10 minutes.

In milder cases of metabolic acidosis, in older children and adults, the medicine is administered by intravenous infusion in a dose of 2 to 5 mEq/kg body weight (2 to 5 ml/kg body weight), every 4-8 hours.

The maintenance dose should depend on the therapeutic response to the medicine and laboratory test results: evaluation of acid-base balance.