SODIO 1,4% Инфузионный раствор

Содержание инструкции

1. SODIO BICARBONATO S.A.L.F. 1.4% solution for infusion, 8.4% solution for infusion
   1. What is SODIO BICARBONATO S.A.L.F. and what is it used for
   2. What you need to know before using SODIO BICARBONATO S.A.L.F.
   3. How to use SODIO BICARBONATO S.A.L.F.
   4. Possible side effects
   5. How to store SODIO BICARBONATO S.A.L.F.
   6. Contents of the pack and other information
2. SODIO BICARBONATO S.A.L.F. 10 mEq/10 ml concentrate for solution for infusion
   1. What is SODIO BICARBONATO S.A.L.F. and what is it used for
   2. What you need to know before using SODIO BICARBONATO S.A.L.F.
   3. How to use SODIO BICARBONATO S.A.L.F.
   4. Possible side effects
   5. How to store SODIO BICARBONATO S.A.L.F.
   6. Contents of the pack and other information

SODIO BICARBONATO S.A.L.F. 1.4% solution for infusion, 8.4% solution for infusion

Sodio bicarbonato

Equivalent medicine

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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even if not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What SODIO BICARBONATO S.A.L.F. is and what it is used for
• 2. What you need to know before you use SODIO BICARBONATO S.A.L.F.
• 3. How to use SODIO BICARBONATO S.A.L.F.
• 4. Possible side effects
• 5. How to store SODIO BICARBONATO S.A.L.F.
• 6. Contents of the pack and other information

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

SODIO BICARBONATO S.A.L.F. is an infusion solution to be administered directly into a vein that
contains the active ingredient sodium bicarbonate.
This medicine is indicated in emergency cases for:

• restoring the acid-base balance, if the blood has an acidic pH (metabolic acidosis);
• treating shock, characterized by reduced blood flow to the body with a consequent decrease in blood pressure;
• treating poisoning from high doses of certain drugs (barbiturates, salicylates and methanol);
• treating some diseases of the blood and muscles (hemolytic and rhabdomyolytic syndromes);
• reducing high levels of uric acid in the blood (hyperuricemia);
• providing the body with bicarbonate ions following significant losses due to diarrhea.

2. What you need to know before using SODIO BICARBONATO S.A.L.F.

Do not use SODIO BICARBONATO 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 increase in blood pH caused by respiratory (respiratory alkalosis) or metabolic problems;
• if you have low chlorine levels in the blood (hypochloremia) due to vomiting, gastrointestinal losses, or therapy with medicines that promote urine elimination (diuretics);
• if you have low calcium levels in the blood (hypocalcemia).

Warnings and precautions
Consult your doctor, pharmacist or nurse before using SODIO BICARBONATO S.A.L.F.
Use this medicine with cautionand 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 insufficiency and reduced renal function);
• if you suffer from fluid retention caused by sodium retention (edema with sodium retention and peripheral or pulmonary edema);
• if you are taking medicines to regulate your heartbeat (cardiac inotropic drugs);
• if you are taking anti-inflammatory corticosteroid medicines or hormonal medicines (corticotropinics);
• if you have high blood pressure (hypertension);
• if you are pregnant and suffering from fluid retention, high protein levels in the urine and high blood pressure (pre-eclampsia).

During treatment with this medicine, your doctor will need to periodically check the concentration
of mineral salts (electrolytes), fluids, osmolarity and pH of the blood, correcting if necessary
any excessive losses of potassium and calcium, to avoid episodes of tetany, a disease characterized by
pain and muscle spasms.

Other medicines and SODIO BICARBONATO S.A.L.F.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
SODIO BICARBONATO S.A.L.F. should be administered with cautionif you are taking the following
medicines:

• anti-inflammatory steroid medicines (corticosteroids) that can cause sodium and water retention, resulting in fluid accumulation (edema) and increased blood pressure (hypertension);
• medicines that promote the elimination of potassium, these can determine a decrease in blood chlorine levels (hypochloremic alkalosis);
• medicines used against bacterial infections such as tetracyclines, as it facilitates and increases 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 to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
This medicine should be used during pregnancy and breastfeeding only when absolutely
necessary and under strict medical supervision.

Driving and using machines
The use of this medicine does not interfere with the ability to drive vehicles or use machinery.

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

This medicine will be administered to you by a doctor or other specialized medical personnel. If you have doubts
consult your doctor, pharmacist or nurse.
This medicine must be administered with caution and at a controlled ratedirectly into
the vein (intravenous infusion), avoiding the infusion at a high speed of large volumes of solution.
The doctor will adjust the dosage based on age, weight and your health conditions and the levels of salts
minerals, to ensure normal pH and electrolyte values in the blood (in case of shock, hemolytic syndromes and
rhabdomyolysis and bicarbonate loss) or to increase the pH of the urine (alkalinize the urine) in case of
intoxication or hyperuricemia (at least to pH 7.0).
It is advisable not to achieve full correction of acidosis in the first 24 hours to avoid alkalosis related to
excessive respiratory correction.

Treatment of metabolic acidosisThe initial dose in adults ranges from 2 to 5 mEq per kg of body weight
over 4-8 hours depending on the severity. The dose may be modified (increase of 20-22 mmol/L) in
based on the amount of sodium bicarbonate in the blood or the results of analyzes that measure the
concentration of gases in the blood (blood gas analysis).

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 dosage of 8 mEq per kg of body weight per day to avoid
excessive decrease in cerebrospinal pressure and possible bleeding in the brain
(intracranial hemorrhages).

Use in the elderly
The maximum recommended dose in people 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 for single and uninterrupted
administration and any residue cannot be used.
Do not use the medicine if the solution does not appear clear, colorless or if it contains particles.
Take all usual 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 to you by a doctor or specialized personnel, it is unlikely that you
will be injected an excessive dose. However, if you think you have been given an excessive dose of
SODIO BICARBONATO S.A.L.F., immediately inform your doctor or go to the nearest hospital.
The first signs of intoxication may be an increase in the amount of sodium bicarbonate in the blood
(alkalemia), an increase in the amount of sodium in the blood (hypernatremia) and an increase in the volume of blood in
circulation (hypervolemia), loss of fluids from internal organs (dehydration), particularly from the brain,
and the accumulation of fluids that can affect the cerebral, pulmonary and peripheral circulation, leading to an
accumulation of fluid around the lung (pulmonary edema) or swelling in the legs and ankles
(peripheral edema).
The symptoms of alkalosis include muscle weakness associated with potassium loss, increased muscle tone,
muscle spasms and tetany, characterized by muscle cramps, involuntary muscle contraction and
tremors. These symptoms mainly occur in patients with low levels of chlorine in the
blood (hypochloremic).
In case of accidental ingestion of excessive doses of SODIO BICARBONATO S.A.L.F. the doctor or
the nurse must immediately stop administering the medicine and administer you a
corrective therapy that will serve to decrease the levels of excess ions 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 available data):

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through 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 SODIO BICARBONATO S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

• The active ingredient 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 ingredients are: disodium edetate dihydrate, water for injections.

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

• The active ingredient 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 ingredients 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 bags of 500 ml of solution for infusion.

Marketing Authorisation Holder and manufacturer
S.A.L.F. S.p.A. Pharmaceutical Laboratory – Via Marconi, 2 – Cenate Sotto (BG)

SODIO BICARBONATO S.A.L.F. 10 mEq/10 ml concentrate for solution for infusion

Sodio bicarbonato

Equivalent medicinal product

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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What SODIO BICARBONATO S.A.L.F. is and what it is used for
• 2. What you need to know before you use SODIO BICARBONATO S.A.L.F.
• 3. How to use SODIO BICARBONATO S.A.L.F.
• 4. Possible side effects
• 5. How to store SODIO BICARBONATO S.A.L.F.
• 6. Contents of the pack and other information

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

SODIO BICARBONATO S.A.L.F. is an infusion solution to be administered directly into a vein that
contains the active ingredient sodium bicarbonate.
This medicine is indicated in emergency cases for:

• treating cardiac and circulatory arrest (cessation of heart function);
• restoring acid-base balance, if the blood has an acidic pH (metabolic acidosis);
• treating shock, characterized by reduced blood flow to the body with a consequent decrease in blood pressure;
• treating poisoning from high doses of certain drugs (barbiturates, salicylates and methanol);
• treating some diseases of the blood and muscles (hemolytic and rhabdomyolytic syndromes);
• reducing high levels of uric acid in the blood (hyperuricemia);
• providing the body with bicarbonate ions following significant losses due to diarrhea.

2. What you need to know before using SODIO BICARBONATO S.A.L.F.

Do not use SODIO BICARBONATO S.A.L.F.

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

Warnings and precautions
Consult your doctor, pharmacist or nurse before using SODIO BICARBONATO S.A.L.F.
Use this medicine with cautionand 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 insufficiency and reduced renal function);
• if you suffer from fluid retention caused by sodium retention (edema with saline retention and peripheral or pulmonary edema);
• if you are taking medicines to regulate your heartbeat (cardiac inotropic drugs);
• if you are taking anti-inflammatory corticosteroid medicines or hormonal medicines (corticotropinics);
• if you have high blood pressure (hypertension);
• if you are pregnant and suffering from fluid retention, high protein levels in the urine and high blood pressure (pre-eclampsia).

During treatment with this medicine, your doctor will need to periodically check the concentration
of mineral salts (electrolytes), fluids, osmolarity and blood pH, correcting if necessary
any excessive loss of potassium and calcium, to avoid episodes of tetany, a disease characterized by
muscle pain and spasms.

Other medicines and SODIO BICARBONATO S.A.L.F.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
SODIO BICARBONATO S.A.L.F. should be administered with cautionif you are taking the following
medicines:

• anti-inflammatory steroid medicines (corticosteroids) that can cause sodium and water retention, resulting in fluid accumulation (edema) and increased blood pressure (hypertension);
• medicines that promote the elimination of potassium, these can determine a decrease in the levels of chloride in the blood (hypochloremic alkalosis);
• medicines used against bacterial infections such as tetracyclines, as it facilitates and increases 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 to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
This medicine should be used during pregnancy and breastfeeding only when absolutely
necessary and under strict medical supervision.

Driving and using machines
The use of this medicine does not interfere with the ability to drive vehicles or use machinery.

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

This medicine will be administered to you by a doctor or other qualified medical personnel. If you have doubts
consult your doctor, pharmacist or nurse.
This medicine must be administered with caution and at a controlled ratedirectly into
the vein (intravenous infusion), after appropriate dilution with compatible solutions until reaching 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 as is (without dilution) intravenously only in the case of
cardiac arrest.
The doctor will adjust the dosage based on age, weight and your health condition and mineral salt levels, to ensure normal pH and electrolyte levels in the blood (in cases of shock, hemolytic syndromes and
rhabdomyolysis and bicarbonate loss) or to increase the pH of the urine (alkalinize the urine) in case of
intoxication or hyperuricemia (at least to pH 7.0).
It is advisable not to achieve full correction of acidosis in the first 24 hours to avoid alkalosis related to
excessive respiratory correction.

Treatment of cardiac arrestThe recommended dose is from 50 to 100 mEq in a rapid
intravenous administration (bolus), followed by 50 mEq every 5-10 minutes based on blood pH values
(acid-base balance). The solution can also be administered as is, without dilution.

Treatment of metabolic acidosisThe initial dose in adults ranges from 2 to 5 mEq per kg of body
weight over 4-8 hours depending on the severity. The dose may be modified (increase of 20-22
mmol/L) based on the amount of sodium bicarbonate in the blood or the results of blood gas analysis.
(arterial blood gas analysis).

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 dosage of 8 mEq per kg of body weight per day to avoid
excessive decrease in cerebrospinal fluid pressure and possible bleeding in the brain
(intracranial hemorrhages).

Use in the elderly
The maximum recommended dose in people 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 must be clear, colorless and free of visible particles. Use immediately
after opening the container. Do not use with solutions containing norepinephrine, dobutamine and calcium.
The container is for single and uninterrupted administration only and any residue cannot be
used
Do not use the medicine if the solution is not clear, colorless or contains particles.
Take all usual 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 specialized personnel, it is unlikely that you will be injected an excessive dose. However, if you think you have been given an excessive dose of
SODIO BICARBONATO S.A.L.F., inform your doctor immediately or go to the nearest hospital.
The first signs of intoxication may be increased amount of sodium bicarbonate in the blood
(alkalemia), increased amount of sodium in the blood (hypernatremia) and increased blood volume in
circulation (hypervolemia), loss of fluids from internal organs (dehydration), especially from the brain,
and accumulation of fluids that can affect the cerebral, pulmonary and peripheral circulation, leading to an
accumulation of fluid around the lung (pulmonary edema) or swelling of the legs and ankles
(peripheral edema).
The 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 occur primarily in patients with low chlorine levels in the
blood (hypochloremic).
In case of accidental administration of excessive doses of SODIO BICARBONATO S.A.L.F. the doctor or
nurse must immediately stop administering the medicine and give you a
corrective therapy to lower the levels of excess ions 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(the frequency of which cannot be estimated based on available data):

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through
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 SODIO BICARBONATO S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

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

Description of the appearance of SODIO BICARBONATO S.A.L.F. and contents of the pack
Pack of 5 vials of 10 ml concentrate for solution for infusion.

Marketing authorisation holder and manufacturer
S.A.L.F. S.p.A. Farmacological Laboratory – Via Marconi, 2 – Cenate Sotto (BG) – Tel. 035 – 940097.