Sodium bicarbonate S.A.L.F.: detailed information

Package leaflet: Information for the user

SODIUM BICARBONATE S.A.L.F. 1.4% infusion solution, 8.4% infusion solution

Sodium bicarbonate
Generic medicine
Please read this leaflet carefully before using this medicine because 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What SODIUM BICARBONATE S.A.L.F. is and what it is used for
What you need to know before using SODIUM BICARBONATE S.A.L.F.
How to use SODIUM BICARBONATE S.A.L.F.
Possible side effects
How to store SODIUM BICARBONATE S.A.L.F.
Contents of the pack and other information

1. What SODIO BICARBONATO S.A.L.F. is and what it is used for

SODIO BICARBONATO S.A.L.F. is an infusion solution administered directly into a vein and contains the active substance sodium bicarbonate.
This medicinal product is indicated in emergency situations for:

restoring acid-base balance when blood pH is acidic (metabolic acidosis);
treating shock state, characterized by reduced blood flow to the body leading to low blood pressure;
treating intoxication from high doses of certain drugs (barbiturates, salicylates, and methanol);
treating certain blood and muscle disorders (hemolytic and rhabdomyolytic syndromes);
reducing elevated levels of uric acid in the blood (hyperuricemia);
providing bicarbonate ions to the body following significant losses due to diarrhea.

2. What you need to know before using SODIUM BICARBONATE S.A.L.F.

Do not use SODIUM BICARBONATE S.A.L.F.

if you are allergic to sodium bicarbonate or to any of the other ingredients of this medicine (listed in section 6);
if you have an increased blood pH due to respiratory problems (respiratory alkalosis) or metabolic issues;
if you have low levels of chloride in the blood (hypochloremia) caused by vomiting, gastrointestinal losses, or treatment with medicines that promote urine elimination (diuretics);
if you have low levels of calcium in the blood (hypocalcemia).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using SODIUM BICARBONATE S.A.L.F.
Use this medicine with caution and inform your doctor in the following cases:

if you suffer from severe heart problems (congestive heart failure, cardiac insufficiency);
if you suffer from severe kidney problems (severe renal failure and reduced kidney function);
if you have fluid accumulation caused by sodium retention (edema with saline retention and peripheral or pulmonary edema);
if you are taking medicines to regulate heart rhythm (cardiac inotropic agents);
if you are taking corticosteroid anti-inflammatory medicines or hormonal medicines (corticotropins);
if you have high blood pressure (hypertension);
if you are pregnant and suffer from fluid retention, high levels of protein in the urine, and high blood pressure (pre-eclampsia).

During treatment with this medicine, your doctor should periodically monitor the levels of mineral salts (electrolytes), fluids, osmolarity, and blood pH, correcting if necessary any excessive losses of potassium and calcium, to prevent episodes of tetany, a condition characterized by muscle pain and spasms.
Other medicines and SODIUM BICARBONATE S.A.L.F.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
SODIUM BICARBONATE S.A.L.F. should be administered with caution if you are taking the following medicines:

anti-inflammatory steroid medicines (corticosteroids), which may cause sodium and water retention, leading to fluid accumulation (edema) and increased blood pressure (hypertension);
medicines that promote potassium loss, which may lead to decreased blood chloride levels (hypochloremic alkalosis);
medicines used against bacterial infections such as tetracyclines, as sodium bicarbonate may enhance and increase their elimination;
medicines used for heart problems such as quinidine;
medicines used for asthma and other respiratory problems such as ephedrine and pseudoephedrine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
This medicine should be used during pregnancy and breastfeeding only if absolutely necessary and under strict medical supervision.
Driving and operating machinery
The use of this medicine does not affect the ability to drive vehicles or operate machinery.

3. How to use SODIO BICARBONATO S.A.L.F.

This medicine will be administered to you by a doctor or other trained medical personnel. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine must be administered with caution and at a controlled rate directly into a vein (intravenous infusion), avoiding rapid infusion of large volumes of solution.
The doctor will adjust the dosage according to your age, body weight, and health condition, as well as your electrolyte levels, in order to maintain normal blood pH and electrolyte values (in cases of shock, hemolytic syndromes, rhabdomyolysis, and bicarbonate loss) or to increase urine pH (alkalinize the urine) in cases of intoxication or hyperuricemia (to at least pH 7.0).
It is advisable not to achieve complete correction of acidosis within the first 24 hours to prevent alkalosis due to excessive respiratory compensation.

Treatment of metabolic acidosis
The initial dose in adults ranges from 2 to 5 mEq per kg of body weight over 4–8 hours, depending on severity. The dose may be adjusted (increase by 20–22 mmol/L) based on blood bicarbonate levels or blood gas analysis results.

Use in children
The initial dose is 1 mEq per kg of body weight administered by slow intravenous infusion, diluting the solution to 0.5 mEq/mL, up to a maximum daily dosage of 8 mEq per kg of body weight, to avoid excessive reduction in cerebrospinal pressure and possible cerebral bleeding (intracranial hemorrhage).

Use in the elderly
The maximum recommended dose for individuals over 60 years of age is 90–100 mEq of sodium bicarbonate per day.

Preparation of the medicine:
The 1.4% solution is isotonic with blood; the 8.4% solution is hypertonic with blood.
Use the solution immediately after opening the container. It is intended for single, uninterrupted administration, and any unused portion must not be retained.
Do not use the medicine if the solution is not clear and colorless or if it contains particles.
Observe all standard precautions to maintain sterility before and during intravenous infusion.

If you use more SODIO BICARBONATO S.A.L.F. than you should
This medicine will be administered by a doctor or trained personnel, so it is unlikely that you will receive an excessive dose. However, if you think you have been given too much SODIO BICARBONATO S.A.L.F., inform your doctor immediately or go to the nearest hospital.
Early signs of overdose may include increased levels of sodium bicarbonate in the blood (alkalemia), increased sodium levels in the blood (hypernatremia), increased blood volume (hypervolemia), fluid loss from internal organs (dehydration), particularly from the brain, and fluid accumulation affecting the cerebral, pulmonary, and peripheral circulation, potentially leading to fluid buildup around the lungs (pulmonary edema) or swelling in the legs and ankles (peripheral edema).
Symptoms of alkalosis include muscle weakness associated with potassium loss, increased muscle tone, muscle spasms, and tetany, characterized by muscle cramps, involuntary muscle contractions, and tremors. These symptoms mainly occur in patients with low blood chloride levels (hypochloremic).
In case of accidental administration of excessive doses of SODIO BICARBONATO S.A.L.F., the doctor or nurse must immediately stop administration of the medicine and initiate corrective therapy to reduce excess ion levels in the blood.

4. Possible side effects

Like all medicines, SODIO BICARBONATO S.A.L.F. can cause side effects, although not everybody experiences them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data):

excessive increase in blood pH (alkalemia);
excessive increase in sodium levels (hypernatremia and hyperosmolarity);
increase in circulating blood volume (hypervolemia);
increase in body temperature (fever);
infection at the infusion site, pain or local reaction;
circulatory problems due to blood clot formation (thrombosis);
irritation and inflammation of veins at the injection site (phlebitis);
leakage of the medicine into the surrounding tissues at the injection site (extravasation) leading to tissue damage or tissue death.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SODIUM BICARBONATE S.A.L.F.

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp”.
The expiry date refers to the last day of that month.
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SODIO BICARBONATO S.A.L.F. contains
SODIO BICARBONATO S.A.L.F. 1.4% solution for infusion

The active substance is sodium bicarbonate. 1000 ml of solution contain 14 g of sodium bicarbonate (167 mEq of sodium and 167 mEq of bicarbonate), pH 7 - 8.5.
The other components are: disodium edetate dihydrate, water for injections.

SODIO BICARBONATO S.A.L.F. 8.4% solution for infusion

The active substance is sodium bicarbonate. 1000 ml of solution contain 84 g of sodium bicarbonate (1000 mEq of sodium and 1000 mEq of bicarbonate), pH 7 - 8.5.
The other components are: disodium edetate dihydrate, water for injections.

Description of the appearance of SODIO BICARBONATO S.A.L.F. and contents of the pack
Sodium bicarbonate S.A.L.F. 1.4% solution for infusion
Glass vials of 250 ml and 500 ml of solution for infusion.
Sodium bicarbonate S.A.L.F. 8.4% solution for infusion
Glass vials of 100 ml, 250 ml and 500 ml of solution for infusion.
15 PVC-free infusion bags of 500 ml of solution for infusion.
Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 – Cenate Sotto (BG)

Package leaflet: information for the user

SODIUM BICARBONATE S.A.L.F. 10 mEq/10 ml concentrate for solution for infusion

Sodium bicarbonate
Equivalent medicine
Please read this leaflet carefully before 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, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What SODIUM BICARBONATE S.A.L.F. is and what it is used for
What you need to know before using SODIUM BICARBONATE S.A.L.F.
How to use SODIUM BICARBONATE S.A.L.F.
Possible side effects
How to store SODIUM BICARBONATE S.A.L.F.
Contents of the pack and other information

2. What SODIO BICARBONATO S.A.L.F. is and what it is used for

SODIO BICARBONATO S.A.L.F. is an intravenous infusion solution administered directly into the vein, containing the active substance sodium bicarbonate.
This medicinal product is indicated in emergency situations for:

treating cardiocirculatory arrest (cessation of heart function);
restoring acid-base balance when blood pH is acidic (metabolic acidosis);
treating shock state, characterized by reduced blood flow to the body resulting in low blood pressure;
treating intoxication due to high doses of certain drugs (barbiturates, salicylates, and methanol);
treating certain blood and muscle disorders (hemolytic and rhabdomyolytic syndromes);
reducing high levels of uric acid in the blood (hyperuricemia);
providing bicarbonate ions to the body following significant losses due to diarrhea.

2. What you need to know before using SODIUM BICARBONATE S.A.L.F.

Do not use SODIUM BICARBONATE S.A.L.F.

if you are allergic to sodium bicarbonate or to any of the other ingredients of this medicine (listed in section 6);
if you have an increased blood pH due to respiratory problems (respiratory alkalosis) or metabolic disorders;
if you have low levels of chloride in the blood (hypochloremia) caused by vomiting, gastrointestinal losses, or treatment with medicines that promote urine excretion (diuretics);
if you have low levels of calcium in the blood (hypocalcemia).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using SODIUM BICARBONATE S.A.L.F.
Use this medicine with caution and inform your doctor in the following cases:

if you suffer from severe heart problems (congestive heart failure, cardiac insufficiency);
if you suffer from severe kidney problems (severe renal failure and reduced kidney function);
if you have fluid accumulation due to sodium retention (edema with saline retention and peripheral or pulmonary edema);
if you are taking medicines to regulate heart rhythm (cardiotonic inotropic drugs);
if you are taking corticosteroid anti-inflammatory medicines or hormonal medicines (corticotropins);
if you have high blood pressure (hypertension);
if you are pregnant and suffer from fluid retention, high levels of protein in the urine, and high blood pressure (pre-eclampsia).

During treatment with this medicine, your doctor should periodically monitor the concentrations
of minerals (electrolytes), fluids, osmolarity, and blood pH, correcting, if necessary,
excessive losses of potassium and calcium, to prevent episodes of tetany, a condition characterized by
muscle pain and spasms.
Other medicines and SODIUM BICARBONATE S.A.L.F.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
SODIUM BICARBONATE S.A.L.F. should be administered with caution if you are taking the following
medicines:

steroid anti-inflammatory medicines (corticosteroids), which may cause sodium and water retention, leading to fluid accumulation (edema) and increased blood pressure (hypertension);
medicines that promote potassium loss, which may lead to decreased blood chloride levels (hypochloremic alkalosis);
medicines used against bacterial infections such as tetracyclines, as sodium bicarbonate may enhance and increase their elimination;
medicines used for heart problems such as quinidine;
medicines used for asthma and other respiratory problems such as ephedrine and pseudoephedrine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
This medicine should be used during pregnancy and breastfeeding only if absolutely necessary and under strict medical supervision.
Driving and using machines
The use of this medicine does not affect the ability to drive vehicles or operate machinery.

3. How to use SODIO BICARBONATO S.A.L.F.

This medicine will be administered to you by a doctor or other trained medical personnel. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine must be administered with caution and at a controlled rate directly into a vein (intravenous infusion), after appropriate dilution with compatible solutions to achieve the same concentration as blood plasma and body fluids (isotonicity) (approximately 1.4% sodium bicarbonate, corresponding to 16 mEq of bicarbonate per 100 ml).
The solution may be administered undiluted (as is) intravenously only in the case of cardiac arrest.
The doctor will adjust the dosage based on your age, weight, health condition, and electrolyte levels to maintain normal blood pH and electrolyte values (in cases of shock, hemolytic and rhabdomyolytic syndromes, and bicarbonate loss) or to increase urine pH (urine alkalization) in cases of intoxication or hyperuricemia (to at least pH 7.0).
It is advisable not to achieve full correction of acidosis within the first 24 hours to avoid alkalosis due to excessive respiratory compensation.

Treatment of cardiac arrest
The recommended dose ranges from 50 to 100 mEq administered rapidly via intravenous injection (bolus), followed by 50 mEq every 5–10 minutes depending on blood pH values (acid-base balance). The solution may also be administered undiluted.

Treatment of metabolic acidosis
Initial adult dose ranges from 2 to 5 mEq per kg of body weight over 4–8 hours, depending on severity. The dose may be adjusted (increase of 20–22 mmol/L) based on serum bicarbonate levels or blood gas analysis results.

Use in children
The initial dose is 1 mEq per kg of body weight administered by slow intravenous infusion, diluting the solution to 0.5 mEq/ml, up to a maximum daily dose of 8 mEq per kg of body weight to avoid excessive reduction in cerebrospinal pressure and possible brain hemorrhages (intracranial hemorrhage).

Use in elderly patients
The maximum recommended dose for individuals over 60 years of age is 90–100 mEq of sodium bicarbonate per day.

Preparation of the medicine:
Dilute the solution immediately after opening the container; the diluted solution must be used immediately. The solution should be clear, colorless, and free from visible particles. Use immediately after opening the container. Do not use with solutions containing noradrenaline, dobutamine, or calcium.
The container is intended for single, uninterrupted administration; any remaining solution must not be used.
Do not use the medicine if the solution is not clear and colorless or if it contains particles.
Follow all standard precautions to maintain sterility before and during intravenous infusion.

If you use more SODIO BICARBONATO S.A.L.F. than you should
This medicine will be administered by a doctor or trained healthcare professional; therefore, it is unlikely that you will receive an excessive dose. However, if you think you have been given too much SODIO BICARBONATO S.A.L.F., inform your doctor immediately or go to the nearest hospital.
Early signs of overdose may include increased levels of sodium bicarbonate in the blood (alkalemia), increased sodium levels in the blood (hypernatremia), increased blood volume (hypervolemia), fluid loss from internal organs (dehydration), particularly from the brain, and fluid accumulation affecting the cerebral, pulmonary, and peripheral circulation, potentially leading to fluid buildup around the lungs (pulmonary edema) or swelling in the legs and ankles (peripheral edema).
Symptoms of alkalosis include muscle weakness associated with potassium loss, increased muscle tone, muscle spasms, and tetany, characterized by muscle cramps, involuntary muscle contractions, and tremors. These symptoms primarily occur in patients with low blood chloride levels (hypochloremic).
In case of accidental administration of excessive doses of SODIO BICARBONATO S.A.L.F., the doctor or nurse must immediately discontinue administration and provide corrective therapy to reduce excess ion levels in the blood.

4. Possible side effects

Like all medicines, SODIO BICARBONATO S.A.L.F. can cause side effects, although not everybody gets them.
The following side effects may occur.
Not known (frequency cannot be estimated from the available data):

excessive increase in blood pH (alkalosis);
excessive increase in sodium levels (hypernatraemia and hyperosmolarity);
increased blood volume in circulation (hypervolemia);
increased body temperature (fever);
infection at the infusion site, pain or local reaction;
circulatory problems due to blood clot formation (thrombosis);
irritation and inflammation of veins at the injection site (phlebitis);
leakage of the medicine into the surrounding tissues at the injection site (extravasation) leading to tissue damage or tissue death.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SODIUM BICARBONATE S.A.L.F.

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What SODIO BICARBONATO S.A.L.F. contains

The active substance is sodium bicarbonate. 10 ml of solution contain 0.84 g of sodium bicarbonate (10 mEq of sodium and 10 mEq of bicarbonate), pH 7 - 8.5.
The other components are: disodium edetate dihydrate, water for injections.

Description of the appearance of SODIO BICARBONATO S.A.L.F. and contents of the pack
Pack containing 5 ampoules of 10 ml of concentrate for solution for infusion.
Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 – Cenate Sotto (BG) – Tel. 035 – 940097.