Sodium chloride B. Braun

Package leaflet: Information for the user

SODIUM CHLORIDE B. BRAUN 0.9% injection solution

Sodium chloride
[For packages without medical prescription]:
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not notice improvement or if you notice worsening of symptoms.

For packages requiring a medical prescription:

• Keep this leaflet. You may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What SODIUM CHLORIDE B. BRAUN 0.9% is and what it is used for
2. What you need to know before using SODIUM CHLORIDE B. BRAUN 0.9%
3. How to use SODIUM CHLORIDE B. BRAUN 0.9%
4. Possible side effects
5. How to store SODIUM CHLORIDE B. BRAUN 0.9%
6. Contents of the pack and other information

1. What SODIO CLORURO B. BRAUN 0.9% is and what it is used for

SODIO CLORURO B. BRAUN 0.9% is a saline (electrolyte) solution administered by injection.
This medicinal product contains the active substance sodium chloride.
SODIO CLORURO B. BRAUN 0.9% is indicated for the preparation and dilution of compatible medicinal products to be administered intravenously, intramuscularly, or subcutaneously.

2. What you need to know before using SODIO CLORURO B. BRAUN 0.9%

Do not use SODIO CLORURO B. BRAUN 0.9%:

• if you are allergic to sodium chloride or to any of the other ingredients of this medicine (listed in section 6)
  • if you have very high levels of sodium in the blood (severe hypernatremia)
  • if you have very high levels of chloride in the blood (severe hyperchloremia)

For further information, please refer to the instructions related to the medicine you intend to administer together with SODIO CLORURO B. BRAUN 0.9%.
Warnings and precautions
Talk to your doctor or pharmacist before using SODIO CLORURO B. BRAUN 0.9%.
SODIO CLORURO B. BRAUN 0.9% will be administered to you with great caution if:

• you have high sodium levels in the blood (hypernatremia)
• you have high chloride levels in the blood (hyperchloremia)

Other medicines and SODIO CLORURO B. BRAUN 0.9%
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor will take special precautions if you are taking medicines that cause sodium retention (e.g. corticosteroids or non-steroidal anti-inflammatory drugs), as these may lead to fluid accumulation in body tissues (edema) and increased blood pressure.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Since sodium and chloride concentrations are similar to those in the human body, harmful effects are not expected when the product is used as directed. SODIO CLORURO B. BRAUN 0.9% may be used during pregnancy, if necessary.
Breastfeeding
Since sodium and chloride concentrations are similar to those in the human body, harmful effects are not expected when the product is used as directed. SODIO CLORURO B. BRAUN 0.9% may be used during breastfeeding, if necessary.
Fertility
There are no available data regarding the effect of sodium chloride on fertility. Animal studies do not indicate direct or indirect adverse effects on reproductive toxicity.
Driving and using machines
SODIO CLORURO B. BRAUN 0.9% does not affect the ability to drive or operate machinery.

3. How to use SODIUM CHLORIDE B. BRAUN 0.9%

This medicine is used as a solvent or diluent for compatible medicines to be administered by
intravenous, intramuscular or subcutaneous route.
Dosing
The amount of medicine you will be given depends on the instructions provided for the medicine to
be dissolved or diluted with Sodium Chloride B. Braun.
[For medicines available without a prescription:]
Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
If you use more SODIUM CHLORIDE B. BRAUN 0.9% than you should
Overdose may lead to abnormal levels of fluid, sodium and chloride in the blood and high levels of
acidic substances in the blood (the blood becomes acidic).
Depending on the severity of overdose symptoms, the infusion will be immediately stopped,
medicines that promote elimination of the medicine through urine (diuretics) will be administered,
blood electrolyte levels will be continuously monitored, and measures will be taken to normalize
electrolyte levels, fluid balance, and acid-base balance.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur:

Not known (frequency cannot be estimated from the available data)

• Increase in blood sodium levels (hypernatraemia), increase in blood volume (hypervolaemia), increase in blood chloride levels (hyperchloraemia)
• Infection at the injection site, pain or local reaction, venous irritation, formation of blood clots in the vein (thrombosis) or inflammation of the vein (phlebitis) extending from the injection site, leakage of the injected solution out of the vein (extravasation).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 CHLORIDE B. BRAUN 0.9%

Keep this medicinal product out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicinal product after the expiry date which is stated on the label of the vial and the outer carton.
The expiry date refers to the last day of that month.
Do not use this medicinal product if you notice that the solution appears cloudy or discoloured, if you see particulate matter in the solution, or if the container is leaking.

After dilution:
From a microbiological point of view, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and should normally not exceed 24 hours at a temperature of 2 to 8 °C.

6. Contents of the pack and other information

What SODIO CLORURO B. BRAUN 0.9% contains

• The active substance is sodium chloride. Each ml of solution contains 9 mg of sodium chloride.
• The other component is water for injections.

Description of the appearance of SODIO CLORURO B. BRAUN 0.9% and pack contents
SODIO CLORURO B. BRAUN 0.9% is a clear, colourless solution of sodium chloride in water.
SODIO CLORURO B. BRAUN 0.9%
Available in cartons containing 1 vial (LDPE) of 5 ml, 10 ml and 20 ml, or cartons containing 20 vials (LDPE) of 5 ml, 20 vials (LDPE) of 10 ml, 20 vials (LDPE) of 20 ml, 50 vials in polypropylene (PP) of 10 ml and 50 vials (PP) of 20 ml, 100 vials in polypropylene (PP) of 10 ml and 100 vials (PP) of 20 ml.
Marketing Authorization Holder
B. Braun Melsungen AG - Carl-Braun-Strasse, 1 D - 34212 Melsungen (Germany).
Manufacturer
B. Braun Melsungen AG - Mistelweg 2 - 12357 Berlin (Germany).

The following information is intended for healthcare professionals only:
Dosage
The dose, route of administration and duration of use depend on the instructions provided for the medicinal product to be dissolved or diluted.
Method of administration
For intravenous, intramuscular or subcutaneous use.
When using this solution as a solvent/diluent for compatible medicinal products, follow the instructions for use of the medicinal product to be added.
Special warnings and precautions for use
Sodium chloride B. Braun 0.9% must be administered with particular caution in cases of:

• hypernatraemia
• hyperchloraemia

Clinical monitoring should include checks of serum electrolyte levels, acid-base status and fluid balance.
Interaction with other medicinal products and other forms of interaction
Medicinal products causing sodium retention
Corticosteroids are associated with sodium and water retention, leading to oedema and hypertension; therefore caution is required when administering sodium salts concomitantly with corticosteroids (see section 4.4).
Although sodium chloride is compatible with a large number of medicinal products, refer to the Summary of Product Characteristics (SmPC) of the medicinal product to be administered to confirm compatibility.

Package leaflet: Information for the user

SODIUM CHLORIDE B. BRAUN 0.9% infusion solution

Sodium chloride
Generic medicinal product
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 or pharmacist.
• 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 effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What SODIUM CHLORIDE B. BRAUN 0.9% is and what it is used for
2. What you need to know before using SODIUM CHLORIDE B. BRAUN 0.9%
3. How to use SODIUM CHLORIDE B. BRAUN 0.9%
4. Possible side effects
5. How to store SODIUM CHLORIDE B. BRAUN 0.9%
6. Contents of the pack and other information

1. What SODIO CLORURO B. BRAUN 0.9% is and what it is used for

SODIO CLORURO B. BRAUN 0.9% is a saline (electrolyte) solution that is injected into a vein. This medicinal product contains the active substance sodium chloride.
SODIO CLORURO B. BRAUN 0.9% is indicated when:

• you have low blood chloride levels and high blood pH (hypochloremic alkalosis)
• you have loss of sodium or chloride
• immediate restoration of blood volume is required after blood loss
• you have a deficiency of body fluids and low blood sodium levels (hypotonic dehydration)
• you have a deficiency of body fluids (isotonic dehydration)
• it is necessary as a vehicle for other compatible electrolytes or medicines

2. What you should know before using SODIUM CHLORIDE B. BRAUN 0.9%

Do not use SODIUM CHLORIDE B. BRAUN 0.9%:

• if you are allergic to sodium chloride or to any of the other ingredients of this medicine (listed in section 6)
• if you have excessive body water (hyperhydration)
• if you have severe elevation of sodium or chloride levels in the blood (severe hypernatraemia or severe hyperchloraemia).

Warnings and precautions
Talk to your doctor or pharmacist before you are given SODIUM CHLORIDE B. BRAUN 0.9%.
SODIUM CHLORIDE B. BRAUN 0.9% will be administered to you with great caution if:

• you have low potassium levels in the blood (hypokalaemia)
• you have high sodium levels in the blood (hypernatraemia)
• you have high chloride levels in the blood (hyperchloraemia)
  • you suffer from heart failure (inability of the heart to supply sufficient blood to meet the body's needs)
  • you suffer from severe renal failure (severe reduction in kidney function)
  • you have fluid accumulation in body tissues (generalized oedema), fluid in the lungs (pulmonary oedema), high blood pressure (hypertension), or a condition occurring during pregnancy characterized by high blood pressure (eclampsia), or other conditions associated with sodium retention (see “Other medicines and SODIUM CHLORIDE B. BRAUN 0.9%”)

To prevent brain damage (osmotic demyelination syndrome), your doctor will ensure that your blood sodium level does not rise too rapidly.
If you are receiving this medicine, your serum electrolyte levels, fluid balance, and acid-base status will be monitored regularly.
Your cardiac and pulmonary functions will be monitored if rapid infusion of SODIUM CHLORIDE B. BRAUN 0.9% is required.

Children
Premature infants or full-term newborns may retain excess sodium due to insufficient kidney function. Therefore, repeated infusions of sodium chloride will be administered by the doctor only after determining serum sodium levels.

Other medicines and SODIUM CHLORIDE B. BRAUN 0.9%
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor will take special precautions if you are taking medicines that cause sodium retention (e.g. corticosteroids or non-steroidal anti-inflammatory drugs), as these may lead to fluid accumulation in body tissues (oedema) and increased blood pressure.

Pregnancy, breast-feeding and fertility

Pregnancy
SODIUM CHLORIDE B. BRAUN 0.9% may be administered during pregnancy, but special precautions must be taken if you have a specific condition that may occur during pregnancy, called eclampsia, which is characterized by the following symptoms: high blood pressure, seizures, swelling.

Breast-feeding
Since the concentrations of sodium and chloride are similar to those in the human body, harmful effects are not expected when the product is used as directed. SODIUM CHLORIDE B. BRAUN may be administered during breast-feeding, if necessary.

Fertility
There are no available data regarding the effect of sodium chloride on fertility. Animal studies do not indicate direct or indirect adverse effects on reproductive toxicity.

Driving and using machines
SODIUM CHLORIDE B. BRAUN 0.9% does not affect the ability to drive or use machinery.

3. How to use SODIUM CHLORIDE B. BRAUN 0.9%

This medicine is for intravenous use.
Dosage
Adults
The amount of medicine you will be given depends on your requirement for water and salts (electrolytes).
Maximum daily dose
You will be given up to 40 ml per kg of body weight per day. This means you will receive up to 6 mmol of sodium per kg of body weight per day.
In cases such as fever, diarrhoea or vomiting, your doctor will replace the additional losses according to the volume and composition of the fluids lost.
Elderly
The dosage for elderly patients is essentially the same as that for adults, but they must be closely monitored, as dosage adjustment may be necessary in cases of cardiac or renal insufficiency.
In exceptional cases, if you need urgent replacement of lost blood volume, you may receive SODIUM CHLORIDE B. BRAUN 0.9% rapidly via pressurised infusion.
Use in children
The doctor will determine the required dosage for your child based on age, weight and clinical condition.
In case of severe body water deficiency, administration of 20 ml/kg body weight intravenously during the first hour of treatment is recommended.
When administering this solution, the total daily fluid intake must be taken into consideration.
Vehicle solution
If the solution is used as a vehicle to administer other electrolytes or medicines, the doctor will take into account the safety information of the medicine to be dissolved or diluted in sodium chloride 9 mg/ml.
If you use more SODIUM CHLORIDE B. BRAUN 0.9% than you should
An overdose could lead to abnormal levels of fluids, sodium and chloride in the blood, fluid accumulation in tissues (oedema) and/or high levels of acidic substances in the blood (blood becomes acidic).
If your sodium levels rise too rapidly, brain damage may occur (osmotic demyelination syndrome).
Early signs of overdose may include thirst, confusion, sweating, headache, weakness, drowsiness or tachycardia. In cases of severe hypernatraemia, severe hypertension or hypotension, respiratory failure or coma may occur.
Depending on the severity of overdose symptoms, the infusion will be immediately stopped, medicines promoting elimination of the medicine via urine (diuretics) will be administered, blood electrolyte levels will be continuously monitored, and measures taken to normalise electrolyte levels, fluid balance and acid-base balance.
In severe cases of overdose, or in case of poor or no urine output (oliguria or anuria), sessions of blood filtration (dialysis) may be required.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data)

• Increased sodium levels in the blood (hypernatraemia), increased blood volume (hypervolaemia), increased chloride levels in the blood (hyperchloraemia), which may lead to loss of other salts (bicarbonates) and result in increased blood acidity (acidosis);
• Headache, dizziness, restlessness, fever, irritability, weakness, muscle stiffness, seizures, coma, death;
• Drowsiness, confusion;
• Reduced tear production;
• Increased heart rate (tachycardia);
• Low (hypotension) or high (hypertension) blood pressure, fluid accumulation in the lungs (pulmonary oedema) and in the legs and ankles (peripheral oedema);
• Breathing difficulties (dyspnoea), respiratory arrest (respiratory arrest);
• Thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain;
• Kidney function problems (renal failure);
• Infection at the infusion site, pain or local reaction, vein irritation, blood clot formation in the vein (thrombosis) or vein inflammation (phlebitis) extending from the infusion site, leakage of the infused solution from the vein (extravasation).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://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 CHLORIDE B. BRAUN 0.9%

This medicine does not require any special storage conditions. Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle or bag and on the outer carton. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the solution appears cloudy or discoloured, if you see particulate matter in the solution, or if the container is leaking.
The containers are for single use only. The container and any residual solution must be discarded after use.
After dilution or addition of additives:
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and should normally not exceed 24 hours at a temperature between 2 and 8 °C.

6. Package contents and other information

What SODIO CLORURO B. BRAUN 0.9% contains

• The active substance is sodium chloride. Each 1000 ml of solution contains 9.0 g of sodium chloride.
• The other component is water for injections.

Description of the appearance of SODIO CLORURO B. BRAUN 0.9% and package contents
Sodium chloride 9 mg/ml is a clear, colourless solution of sodium chloride in water.
It is available in polyethylene bottles containing: 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml.
Pack sizes: 1x50 ml, 1x100 ml, 1x250 ml, 1x500 ml, 1x1000 ml, 20x50 ml, 20x100 ml, 20x250 ml, 10x500 ml, 10x1000 ml.
Not all pack sizes may be marketed.

Marketing Authorization Holder
B. Braun Melsungen AG - Carl Braun Strasse, 1 - D-34212 Melsungen, Germany

Manufacturer
B. Braun Melsungen AG - Carl-Braun-Strasse 1 - Melsungen, Germany
B. Braun Medical SA - Carretera de Terrasa 121 - Rubi - Barcelona, Spain
B. Braun Avitum AG - Kattenvenner Str. 32 - 49219 Glandorf, Germany

The following information is intended exclusively for healthcare professionals:

Maximum daily dose
Up to 40 ml per kg body weight per day, corresponding to 6 mmol of sodium per kg body weight.
Any additional losses (e.g. due to fever, diarrhoea, vomiting, etc.) must be replaced according to the volume and composition of the fluids lost.
In the management of acute volume deficit, i.e. imminent or manifest hypovolemic shock, higher doses may be administered, e.g. by pressure infusion.

General recommendations for the treatment of sodium deficit:
The amount of sodium required to restore plasma sodium levels can be calculated using the following equation:
Sodium requirement [mmol] = (Actual serum Na – Desired Na) × TBW
where total body water (TBW) is calculated as a percentage of body weight. The percentage is 0.6 in children; 0.6 and 0.5 in non-elderly males and females, respectively; 0.5 and 0.45 in elderly males and females, respectively.

Method of administration
When performing a pressure infusion using a solution in a flexible container, all air must be expelled from the container and administration set before starting the infusion.

Special warnings and precautions for use
To prevent the development of osmotic demyelination syndrome, the increase in serum sodium levels must not exceed 9 mmol/l/day. As a general recommendation, a correction rate of 4 to 6 mmol/l/day is adequate in most cases, depending on the patient's condition and concomitant risk factors.
Clinical monitoring should include checks of serum electrolytes, fluid balance, and acid-base balance.
Careful monitoring of cardiovascular and respiratory status is required when rapid infusion of Sodio Cloruro B. Braun 0.9% is necessary.

Interactions with other medicinal products and other forms of interaction
Medicinal products causing sodium retention
Treatment with medicinal products such as corticosteroids or non-steroidal anti-inflammatory agents may be associated with increased sodium and water retention, which may lead to oedema and hypertension. Therefore, caution is required when administering sodium salts concomitantly.

PACKAGE LEAFLET: INFORMATION FOR THE USER

SODIUM CHLORIDE B. BRAUN 2 mEq/ml concentrate for solution for infusion

Sodium chloride
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What SODIUM CHLORIDE B. BRAUN 2 mEq/ml is and what it is used for
2. What you need to know before using SODIUM CHLORIDE B. BRAUN 2 mEq/ml
3. How to use SODIUM CHLORIDE B. BRAUN 2 mEq/ml
4. Possible side effects
5. How to store SODIUM CHLORIDE B. BRAUN 2 mEq/ml
6. Package contents and other information

1. What SODIO CLORURO B. BRAUN 2 mEq/ml is and what it is used for

SODIO CLORURO B. BRAUN 2 mEq/ml is a concentrated saline (electrolyte) solution that
is administered intravenously after dilution in an infusion solution. This medicinal product contains the
active substance sodium chloride.
SODIO CLORURO B. BRAUN 2 mEq/ml is indicated when:

• you have low levels of sodium or chloride
• you have salt loss associated with fluid retention

2. What you should know before using SODIUM CHLORIDE B. BRAUN 2 mEq/ml

Do not use SODIUM CHLORIDE B. BRAUN 2 mEq/ml

• if you are allergic to sodium chloride or to any of the other ingredients of this medicine (listed in section 6)
• if you have increased levels of sodium or chloride in your blood (hypernatraemia or hyperchloraemia).

Warnings and precautions
Please speak to your doctor before being administered SODIUM CHLORIDE B. BRAUN 2 mEq/ml.
SODIUM CHLORIDE B. BRAUN 2 mEq/ml will be administered to you with great caution if you:

• have low potassium levels in your blood (hypokalaemia)
• suffer from heart failure (inability of the heart to supply sufficient blood to meet the body's needs)
• have swelling of the limbs due to fluid accumulation in body tissues (generalized oedema)
• have fluid in the lungs (pulmonary oedema)
• have high blood pressure (hypertension)
• have eclampsia, a condition occurring during pregnancy, characterised by high blood pressure, convulsions and oedema
• suffer from severe renal failure (severe decrease in kidney function)
• have excessively high levels of acidic substances (acid) in your blood (acidosis)

Your doctor will also pay special attention if you are receiving certain hormones, such as corticosteroids or ACTH, because these substances may affect your fluid and electrolyte balance.
If you are receiving this medicine, your serum electrolyte levels, fluid balance and acid-base status will be monitored regularly.
Other medicines and SODIUM CHLORIDE B. BRAUN 2 mEq/ml
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Corticosteroids and ACTH may cause fluid and salt retention, which could lead to oedema and increased blood pressure. Therefore, your doctor must know if you are taking or receiving these medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
SODIUM CHLORIDE B. BRAUN 2 mEq/ml may be administered during pregnancy, but special precautions must be taken if you have a specific condition that may occur during pregnancy called eclampsia, which is characterised by the following symptoms: high blood pressure, convulsions, swelling.
Breastfeeding
Since the concentrations of sodium and chloride are similar to those in the human body, harmful effects are not expected when the product is used as directed. SODIUM CHLORIDE B. BRAUN 2 mEq/ml may be administered during breastfeeding, if necessary.
Fertility
There are no available data regarding the effect of sodium chloride on fertility.
Animal studies do not indicate any direct or indirect adverse effects on reproductive toxicity.
Driving and using machines
SODIUM CHLORIDE B. BRAUN 2 mEq/ml does not affect the ability to drive or use machinery.

3. How to use SODIUM CHLORIDE B. BRAUN 2 mEq/ml

The medicine will be injected into a vein after dilution with an infusion solution.
The amount of medicine you will receive will be determined by your doctor and calculated based on
your actual blood sodium levels, also taking into account body weight, age, and acid-base status.
If sodium levels have been chronically low, your doctor will administer SODIUM CHLORIDE B. BRAUN 2
mEq/ml at a slower infusion rate to avoid brain damage (see also section 'If you receive more SODIUM CHLORIDE B. BRAUN 2 mEq/ml than you should').

If you receive more SODIUM CHLORIDE B. BRAUN 2 mEq/ml than you should
If you have received an excessive amount of this medicine, you may experience abnormally high water content in the body, excessively elevated levels of sodium and chloride in the blood, and the blood may become much more concentrated than normal. Acidic substances may accumulate in the blood.

Too rapid an infusion may lead to volume overload. You may experience fluid accumulation in the limbs or water in the lungs, as well as high blood pressure. Diarrhea and increased urine flow may also occur due to excessively high salt concentration in the blood.

If sodium levels have been chronically low and rise too rapidly, brain damage may occur (osmotic demyelination syndrome).

Depending on the severity of overdose symptoms, the infusion will be immediately stopped, medications promoting elimination of the medicine through urine (diuretics) will be administered, blood electrolyte levels will be continuously monitored, and measures taken to normalize electrolyte levels, fluid balance, and acid-base balance.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur:
Not known (frequency cannot be estimated from the available data)

• increased levels of sodium in the blood (hypernatremia), decreased blood concentration (plasma hypoosmolality, for 0.45% solutions), increased blood volume (hypervolemia), increased levels of chloride in the blood (hyperchloremia) which may cause loss of other salts (bicarbonates) leading to increased blood acidity (acidosis);
• headache (cephalalgia), dizziness, restlessness, fever, irritability, weakness, muscle stiffness, seizures, coma, death;
• drowsiness, confusion;
• reduced tear production;
• increased heart rate (tachycardia);
• low (hypotension) or high (hypertension) blood pressure, fluid accumulation in the lungs (pulmonary edema), and swelling in the legs and ankles (peripheral edema);
• breathing difficulty (dyspnea), respiratory arrest;
• thirst, reduced salivation, nausea, vomiting, diarrhea, abdominal pain;
• problems with kidney function (renal failure);
• infection at the infusion site, pain or local reaction, vein irritation, formation of blood clots in the vein (thrombosis) or inflammation of the vein (phlebitis) extending from the infusion site, leakage of the injected solution from the vein (extravasation).

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

5. How to store SODIUM CHLORIDE B. BRAUN 2 mEq/ml

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Store below 25 °C.
The solution must not be used if it is not clear, colourless and free from visible particles.
Vials must be used immediately after opening the container; any unused medicinal solution remaining must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

SODIUM CHLORIDE B. BRAUN 2 mEq/mL contains

• The active substance is sodium chloride. 1 mL of concentrate for infusion solution contains 117 mg of sodium chloride.
• 1 mL of concentrate for infusion solution contains 2 mmol of sodium and 2 mmol of chloride.
• The other component is water for injections.
• The theoretical osmolarity is 4000 mOsmol/L and the pH is 4.5 – 7.0.

Description of the appearance of SODIUM CHLORIDE B. BRAUN 2 mEq/mL and contents of the
package
Sodium Chloride B. Braun 117 mg/mL concentrate for infusion solution is a clear, colourless solution of sodium chloride in water.
It is available in:

• Polyethylene vials, contents: 10 mL, 20 mL, available in packages of 1 x 10 mL, 1 x 20 mL, 20 x 10 mL, 20 x 20 mL.

Marketing Authorization Holder and Manufacturer
B. BRAUN Melsungen AG; Carl-Braun-Strasse 1; D-34212 Melsungen, Germany.
Postal address
34209 Melsungen, Germany
Tel.: +49/5661/71-0
Fax: +49/5661/71 4567

The following information is intended exclusively for physicians or healthcare professionals:
Dosage
The dose must be adjusted according to the calculated sodium deficit based on actual serum electrolyte concentrations and also on actual acid-base values.
Adults
General guideline
The amount of sodium required to restore plasma sodium levels can be calculated using the following equation:
Sodium requirement [mmol] = (desired serum Na – actual) × TBW [L]
where TBW (total body water) is calculated as a fraction of body weight.
The fraction is 0.6 in children; 0.6 and 0.5 in non-elderly men and women, respectively; 0.5 and 0.45 in elderly men and women, respectively.
Maximum daily dose
The maximum daily dose should be adjusted according to sodium and chloride requirements.
Paediatric population
Only children with symptomatic hyponatraemia should be treated with a hypertonic NaCl solution. In the paediatric population, treatment of symptomatic hyponatraemia is similar to that in adults.
A dose of 6 mmol of sodium chloride per kg of body weight generally increases sodium levels by approximately 10 mmol/L.
The initial rapid therapeutic increase in serum sodium levels should be limited to about 125 mmol/L, and serum sodium levels should not be increased by more than 10 mmol/L/day.
Subsequent increases in serum sodium concentration should be carried out in small increments over several hours to avoid hypernatraemia.
Maximum infusion rate
The maximum infusion rate depends on the prevailing clinical condition.
To prevent the development of osmotic demyelination syndrome in patients with chronic hyponatraemia, the administration rate must be sufficiently slow so that serum sodium does not rise faster than 0.35 – 0.5 mmol/L/h, corresponding to 8 – 12 mmol/L/day (see also section 4.9).
Method of administration
For intravenous use only, diluted solely by addition to a suitable infusion solution.
In general, the calculated amount of sodium chloride is added to 250 mL of fluid. In cases of fluid deficit, larger volumes of carrier solution may be used.
For infusion into peripheral veins, the solution must be diluted so that osmolarity does not exceed 800 mOsm/L.
Care must be taken to add the concentrated sodium chloride to the infusion solution under strictly aseptic conditions immediately before preparing the infusion. The infusion bottle should be gently shaken.
Incompatibilities
Potential incompatibilities must be considered when mixing with other medicinal products.
Shelf life
The product must be used immediately after opening the container.
The solution must be clear, colourless and free from visible particles. It is intended for single, uninterrupted administration and any residual solution must not be used.
Dilution
From a microbiological standpoint, diluted solutions must be used immediately after preparation.
If not used immediately, storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2 °C – 8 °C, unless the preparation was carried out under controlled and validated aseptic conditions.