SODIO KLORURO B. BRAUN 0,9% Infusion solution

Зміст інструкції

1. SODIO CLORURO B. BRAUN 0,9% injectable solution
   1. What is SODIO CLORURO B. BRAUN 0,9% and what is it used for?
   2. What you need to know before you take SODIO CLORURO B. BRAUN 0,9%
   3. How to use SODIO CLORURO B. BRAUN 0,9%
   4. Possible side effects
   5. How to store SODIO CLORURO B. BRAUN 0,9%
   6. Package contents and other information
2. SODIO CLORURO B. BRAUN 0,9% infusion solution
   1. What is SODIO CLORURO B. BRAUN 0,9% and what is it used for
   2. What you need to know before you use SODIO CLORURO B. BRAUN 0,9%
   3. How to use SODIO CLORURO B. BRAUN 0,9%
   4. Possible side effects
   5. How to store SODIO CLORURO B. BRAUN 0,9%
   6. Package contents and other information
3. SODIO CLORURO B. BRAUN 2 mEq/ml concentrate for solution for infusion
   1. What is SODIO CLORURO B. BRAUN 2 mEq/ml and what is it used for?
   2. What you need to know before using SODIO CLORURO B. BRAUN 2 mEq/ml
   3. How to use SODIO CLORURO B. BRAUN 2 mEq/ml
   4. Possible side effects
   5. How to store SODIO CLORURO B. BRAUN 2 mEq/ml
   6. Contents of the pack and other information

SODIO CLORURO B. BRAUN 0,9% injectable solution

Sodium chloride

[For packages without a prescription]:

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen

For packages with a prescription:

• 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 you, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What SODIO CLORURO B. BRAUN 0,9% is and what it is used for
• 2. What you need to know before you are given SODIO CLORURO B. BRAUN 0,9%
• 3. How to use SODIO CLORURO B. BRAUN 0,9%
• 4. Possible side effects
• 5. How to store SODIO CLORURO B. BRAUN 0,9%
• 6. Contents of the pack and other information

1. What is SODIO CLORURO B. BRAUN 0,9% and what is it used for?

SODIO CLORURO B. BRAUN 0,9% is a saline (electrolytic) solution that is administered by
injection. This medicine contains the active ingredient sodium chloride.
SODIO CLORURO B. BRAUN 0,9% is indicated for the preparation and dilution of compatible
medicines to be administered by intravenous, intramuscular or subcutaneous route.

2. What you need to know before you take 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)

You should also refer to the information relating to the medicine that 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 a high sodium level in the blood (hypernatremia)
• you have a high chloride level in the blood (hyperchloremia)

Other medicines and SODIO CLORURO B. BRAUN 0,9%
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The 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 can cause fluid accumulation
in the body tissues (edema) and increased blood pressure.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Since the concentrations of sodium and chloride are similar to those of the human body, no harmful effects are expected if the product is used as directed. SODIO CLORURO B. BRAUN 0,9% can be used
during pregnancy, if necessary.

Breastfeeding
Since the concentrations of sodium and chloride are similar to those of the human body, no harmful effects are expected if the product is used as directed. SODIO CLORURO B. BRAUN 0,9% can be used
during breastfeeding, if necessary.

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

Driving and using machines
SODIO CLORURO B. BRAUN 0,9% does not affect the ability to drive vehicles and use machinery.

3. How to use SODIO CLORURO B. BRAUN 0,9%

The medicine is used as a solvent or diluent for compatible medicines to be administered via
intravenous, intramuscular or subcutaneous route.

Dosage
The amount of medicine that will be administered to you depends on the instructions provided for the drug to
be dissolved or diluted with Sodio Cloruro B Braun.
[For over-the-counter medicines:]
Always use this medicine exactly as described in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

If you use more SODIO CLORURO B. BRAUN 0,9% than you should
An overdose may lead to abnormal levels of fluids, sodium and chloride in the blood and high levels of
acidic substances in the blood (the blood becomes acidic).
Depending on the severity of the overdose symptoms, the infusion will be immediately stopped, medicines that promote the elimination of the medicine with 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 gets them.
The following side effects can occur:

Not known(frequency cannot be estimated from available data)

• Increased levels of sodium in the blood (hypernatremia), increased blood volume (hypervolemia), increased levels of chlorine in the blood (hyperchloremia)
• Infection at the injection site, pain or local reaction, irritation of the vein, formation of blood clots in the vein (thrombosis) or inflammation of the vein (phlebitis) extending from the injection site, leakage of the injected solution from the vein (extravasation).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 SODIO CLORURO B. BRAUN 0,9%

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine 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 medicine if you notice that the solution appears cloudy or colored, if you notice particulate matter in the
solution or if the container has any leaks

After dilution:
From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times and conditions before 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 ingredient 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 package contents
SODIO CLORURO B. BRAUN 0,9% is a transparent and colourless solution of sodium chloride in water.

SODIO CLORURO B. BRAUN 0,9%
It is available in packs of 1 vial (LDPE) of 5 ml, 10 ml and 20 ml, or in packs of 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 authorisation 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 exclusively for healthcare professionals:
Dosage
The dose, route of administration and duration of use depend on the instructions provided for the medicinal
product to be dissolved or diluted.
Route of administration
Intravenous, intramuscular or subcutaneous use.
For the use of this solution as a solvent/diluent for compatible medicinal products, observe the instructions for
use relating to 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 must include checks of serum electrolytes, acid-base status and
fluid balance.

Interaction with other medicinal products and other forms of interaction
Medicinal products that cause sodium retention
Corticosteroids are associated with sodium and water retention, resulting in oedema and hypertension:
therefore caution is required when administering sodium salts and corticosteroids concurrently
(see section 4.4).
Although sodium chloride is compatible with a large number of medicinal products, refer to the Summary of Product Characteristics (SmPC) relating to
the medicinal product to be administered, in order to verify its compatibility.

SODIO CLORURO B. BRAUN 0,9% infusion solution

Sodium chloride

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 or pharmacist.
• 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 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 CLORURO B. BRAUN 0,9% is and what it is used for
• 2. What you need to know before using SODIO CLORURO B. BRAUN 0,9%
• 3. How to use SODIO CLORURO B. BRAUN 0,9%
• 4. Possible side effects
• 5. How to store SODIO CLORURO B. BRAUN 0,9%
• 6. Contents of the pack and other information

1. What is SODIO CLORURO B. BRAUN 0,9% and what is it used for

SODIO CLORURO B. BRAUN 0,9% is a saline (electrolytic) solution that is injected into
a vein. This medicine contains the active ingredient sodium chloride.
SODIO CLORURO B. BRAUN 0,9% is indicated when:

• you have a low level of chloride in the blood and the pH of the blood is high (hypochloremic alkalosis)
• you have a loss of sodium or chloride
• it is necessary to immediately restore blood volume after blood loss
• you have a deficiency of body fluids and your sodium level in the blood is low (hypotonic dehydration)
• you have a deficiency of body fluids (isotonic dehydration)
• it is needed as a vehicle for other electrolytes or compatible medicines

2. What you need to know before you use 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 a high amount of water in your body (hyperhydration)
• if you have a severe increase in the concentration of sodium or chloride in the blood (severe hypernatremia or severe hyperchloremia).

Warnings and precautions
Talk to your doctor or pharmacist before you are given Sodio Cloruro B. Braun
0,9%.
SODIO CLORURO B.Braun 0,9 % will be administered to you with great caution if:

• you have a low level of potassium in your blood (hypokalemia)
• you have a high level of sodium in your blood (hypernatremia)
• you have a high level of chloride in your blood (hyperchloremia)
• you suffer from heart failure (inability of the heart to provide blood in an adequate quantity to the needs of the body)
• you suffer from severe kidney failure (severe decrease in kidney function)
• you have an accumulation of water in the body tissues (generalized edema), water in the lungs (pulmonary edema), high blood pressure (hypertension), or a disease that occurs during pregnancy, with high blood pressure (eclampsia), or other conditions associated with sodium retention (see “Other medicines and SODIO CLORURO B. BRAUN 0,9%”)

To avoid brain damage (osmotic demyelination syndrome), your doctor will ensure
that your blood sodium level does not increase too quickly.
If you are receiving this medicine, your electrolyte levels
in the serum, fluid balance and acid-base status will be checked from time to time.
Your heart and lung function will be monitored in case rapid
infusion of Sodio Cloruro B. Braun 0,9% is necessary.

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

Other medicines and SODIO CLORURO B. BRAUN 0,9%
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The doctor will take special precautions if you are taking medicines that cause retention of
sodium (e.g. corticosteroids or non-steroidal anti-inflammatory drugs), as these can cause
accumulation of fluid in the body tissues (edema) and increased blood pressure.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Sodio Cloruro B. Braun 0,9 % can be administered during pregnancy, but special precautions must be taken
if you have a specific condition that may occur during pregnancy,
called eclampsia, which manifests with the following symptoms: high blood pressure, cramps,
swelling.

Breastfeeding
Because the concentration of sodium and chloride is similar to that of the human body, no harmful
effects are expected if the product is used as directed. Sodio Cloruro B. Braun can be
administered during breastfeeding, if necessary.

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

Driving and operating machinery
Sodio Cloruro B. Braun 0,9% does not affect the ability to drive and operate machinery.

3. How to use SODIO CLORURO B. BRAUN 0,9%

The medicine is for intravenous use.

Dosage

Adults
The amount of medicine that will be administered to you depends on your fluid and salt
(electrolyte) requirements.

Maximum daily dose
You will be administered up to 40 ml per kg of body weight per day. This means that you will receive
up to 6 mmol of sodium per kg of body weight per day.
In case of, for example, fever, diarrhea or vomiting, your doctor will replace the additional loss based on the
volume and composition of the fluids lost.

Elderly
The dosage for elderly patients is substantially the same as provided for adults, but they must
be carefully monitored, as it may be necessary to adjust the dosage in case of
heart or kidney failure.
In exceptional cases, if you need to urgently replace the lost blood volume, you may
receive Sodio Cloruro B. Braun 0,9% rapidly via pressure infusion.

Use in children
The doctor will determine the necessary dosage for your child based on age, weight and their
clinical condition.
In case of severe dehydration, it is recommended to administer 20 ml/kg of body weight intravenously
for the first hour of treatment.
When administering this solution, the overall 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 consider the safety information of the medicine that must be dissolved or
diluted in sodium chloride 9 mg/ml.

If you use more Sodio Cloruro B. Braun 0,9 % than you should
An overdose may lead to abnormal levels of fluids, sodium and chloride in the blood,
accumulation of fluid in the tissues (edema) and/or high levels of acidic substances in the blood (the blood
becomes acidic).
If your sodium levels rise too quickly, the brain could be damaged
(osmotic demyelination syndrome).
The first signs of overdose may be thirst, confusion, sweating, headache, weakness,
drowsiness or tachycardia. In case of severe hypernatremia, hypertension or hypotension, may
occur respiratory failure or coma.
Depending on the severity of the overdose symptoms, the infusion will be immediately stopped,
medicines that promote the elimination of the medicine with urine will be administered
(diuretics), blood electrolyte levels will be continuously monitored, and measures will be taken to
normalize 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), blood filtration sessions (dialysis) may be necessary.
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 gets them.
The following side effects may occur:

Not known(frequency cannot be estimated based on available data)

• Increased levels of sodium in the blood (hypernatremia), increased blood volume (hypervolemia), increased levels of chlorine in the blood (hyperchloremia) which can cause a loss of other salts (bicarbonates) resulting in increased blood acidity (acidosis);
• Headache, dizziness, restlessness, fever, irritability, weakness, muscle stiffness, convulsions, coma, death;
• Drowsiness, confused states;
• Reduced tear production;
• Increased heart rate (tachycardia);
• Decrease (hypotension) or increase (hypertension) in blood pressure, fluid accumulation in the lungs (pulmonary edema) and in the legs and ankles (peripheral edema);
• Difficulty breathing (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 side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 SODIO CLORURO 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 which is stated on the label of the bottle or sachet and the outer packaging. 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 discolored, if you notice particulate matter
in the solution or if the container has any leaks.
The containers are for single use only. The container and any remaining contents must be
disposed of after use.

After dilution or addition of additives:
From a microbiological point of view, the product must be used immediately. If it is not
used immediately, the storage times and conditions before use are the responsibility of the user, and should normally not exceed 24 hours at a temperature
ranging from 2 to 8 °C.

6. Package contents and other information

What SODIO CLORURO B. BRAUN 0,9% contains

• The active ingredient 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 contents of the pack
Sodium chloride 9 mg/ml is a transparent and colourless solution of sodium chloride in water.
It is presented in polyethylene bottles, containing: 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml
Packs of: 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 Authorisation 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 of body weight per day, corresponding to 6 mmol of sodium per kg of body
weight.
Any additional loss (due to e.g. fever, diarrhoea, vomiting, etc.) must be replaced based on the volume and composition of the fluids lost.
In the management of acute volume deficit, i.e. imminent or manifest hypovolemic shock, higher dosages may be applied, 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
equation:
Sodium requirement [mmol] = (Serum Na effective - desired) × TBW
where total body water (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; 0.5 and 0.45 in elderly males and females, respectively.

Route of administration
When performing a pressure infusion, using the solution placed in a flexible container, all air must be expelled from the container and the 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 level should 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 the cardiovascular and respiratory status is required if rapid infusion of Sodium chloride B. Braun 0,9% is necessary.

Interactions with other medicines and other forms of interaction
Medicines that cause sodium retention
Therapy with medicines, e.g. corticosteroids or non-steroidal anti-inflammatory agents, may be
associated with increased sodium and water retention, which likely leads to oedema and
hypertension, therefore caution is required when co-administering with sodium salts.

SODIO CLORURO B. BRAUN 2 mEq/ml concentrate for solution for infusion

Sodium chloride

Equivalent medicinal product

Read this leaflet carefully before you start to use 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What SODIO CLORURO B. BRAUN 2 mEq/ml is and what it is used for
• 2. What you need to know before you use SODIO CLORURO B. BRAUN 2 mEq/ml
• 3. How to use SODIO CLORURO B. BRAUN 2 mEq/ml
• 4. Possible side effects
• 5. How to store SODIO CLORURO B. BRAUN 2 mEq/ml
• 6. Contents of the pack and other information

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

SODIO CLORURO B. BRAUN 2 mEq/ml is a concentrated saline (electrolytic) solution that
is injected intravenously after dilution in an infusion solution. This medicine contains the
active ingredient sodium chloride.
SODIO CLORURO B. BRAUN 2 mEq/ml is indicated when:

• you have low levels of sodium or chloride
• you have a loss of salts with fluid retention

2. What you need to know before using SODIO CLORURO B. BRAUN 2 mEq/ml

Do not use SODIO CLORURO B. BRAUN 2 mEq/ml

• if you are allergic to sodium chloride or any of the other ingredients of this medicine (listed in section 6)
• if you have an increase in the concentration of sodium or chloride in the blood (hypernatremia or hyperchloremia).

Warnings and precautions
Talk to your doctor before you are given SODIO CLORURO B. BRAUN 2 mEq/ml.
SODIO CLORURO B. BRAUN 2 mEq/ml will be administered to you with great caution if:

• you have a low level of potassium in the blood (hypokalaemia)
• you suffer from heart failure (inability of the heart to supply blood in adequate quantities to the needs of the body)
• swelling of the limbs due to an accumulation of water in the body tissues (generalized edema)
• water in the lungs (pulmonary edema)
• high blood pressure (hypertension)
• eclampsia, a disease that occurs during pregnancy, with high blood pressure, cramps and edema
• you suffer from severe kidney failure (severe decrease in kidney function),
• too high levels of acidic substances (acid) in the blood (acidosis)

The doctor will also pay particular attention if you are receiving certain hormones, namely corticosteroids or
ACTH, because these substances can affect the water-electrolyte balance.
If you are receiving this medicine, your electrolyte levels in the serum, water balance and acid-base status will be checked from time to time.

Other medicines and SODIO CLORURO B. BRAUN 2 mEq/ml
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Corticosteroids and ACTH can lead to fluid and salt retention, which likely causes
edema and increased blood pressure. The doctor must therefore know if you are taking or
receiving these medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
SODIO CLORURO B. BRAUN 2 mEq/ml can be administered during pregnancy, but
special precautions must be taken if you have a specific condition that may occur during
pregnancy, called eclampsia, which manifests with the following symptoms: high blood pressure,
cramps, swelling.
Breastfeeding
Because the concentration of sodium and chloride is similar to that of the human body, no adverse effects are expected if the product is used as directed. Sodium Chloride B. Braun 2 mEq/ml can
be administered during breastfeeding, if necessary.
Fertility
No data are available regarding the effect of sodium chloride on fertility.
Animal studies do not indicate any direct or indirect harmful effects of reproductive toxicity.

Driving and using machines
SODIO CLORURO B. BRAUN 2 mEq/ml does not affect the ability to drive and use
machinery.

3. How to use SODIO CLORURO B. BRAUN 2 mEq/ml

The medicine will be injected into a vein after dilution with an infusion solution.
The amount of medicine that will be administered to you will be determined by the doctor and calculated based
on the actual level of sodium in the blood, also taking into consideration body weight, age and
acid-base status.
If sodium levels have been chronically low, the doctor will give you Sodio cloruro B. Braun 2
mEq/ml at a lower infusion rate to avoid brain damage (see also paragraph
‘If you receive more SODIO CLORURO B. BRAUN 2 mEq/ml than you should’).

If you receive more SODIO CLORURO B. BRAUN 2 mEq/ml than you should
If you have received an excessive amount of this medicine, you may have an excessively high water content in
the body, excessively high 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.
Infusion that is too fast can lead to volume overload. You may experience fluid accumulation
in the limbs or fluid in the lungs as well as high blood pressure. Diarrhea and increased urine flow may also
occur due to an excessively high concentration of salt in the blood.
If sodium levels have been chronically low and increase too rapidly, the brain
may be damaged (osmotic demyelination syndrome).
Depending on the severity of the overdose symptoms, the infusion will be stopped immediately,
medicines that promote the expulsion of the medicine with the urine will be administered
(diuretics), 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Not known(frequency cannot be estimated from available data)

• increased levels of sodium in the blood (hypernatremia), decreased blood concentration (hypoosmolality plasma, for 0.45% solutions), increased blood volume (hypervolemia), increased levels of chlorine in the blood (hyperchloremia) which can cause a loss of other salts (bicarbonates) resulting in increased blood acidity (acidosis);
• headache, dizziness, restlessness, fever, irritability, weakness, muscle stiffness, convulsions, coma, death;
• drowsiness, confusion;
• reduced tear production;
• increased heart rate (tachycardia);
• lowering (hypotension) or increase (hypertension) of blood pressure, fluid accumulation in the lungs (pulmonary edema) and in the legs and ankles (peripheral edema);
• difficulty breathing (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 side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 SODIO CLORURO 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 which is stated on the packaging after
“Expiry”.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25 ˚C.
The solution must not be used if it is not clear, colourless and free from visible particles.
The vials are to be used immediately after opening the container and any unused residual medicine
must be discarded.
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

SODIO CLORURO B. BRAUN 2 mEq/ml contains

• The active ingredient is sodium chloride. 1 mL of concentrate for solution for infusion contains 117 mg of sodium chloride.
• 1 mL of concentrate for solution for infusion 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 SODIO CLORURO B. BRAUN 2 mEq/ml and contents of the pack
Sodio cloruro B. Braun 117 mg/ml concentrate for solution for infusion is a clear and colourless solution of sodium chloride in water.
It is available in:

• Polyethylene vials, content: 10 mL, 20 mL available in packs of 1 x 10 ml, 1 x 20 ml, 20 x 10 mL, 20 x 20 mL

Marketing authorisation 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 doctors or healthcare professionals:
Dosage
The dose must be corrected based on the sodium deficit calculated from actual serum electrolyte concentrations and also based on actual acid-base values.
Adults
General guideline
The amount of sodium required to restore plasma sodium levels can be calculated using the equation:
Sodium requirement [mmol] = (Desired – actual serum Na) × 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; 0.5 and 0.45 in elderly men and women, respectively.

Maximum daily dose
The maximum daily dose is corrected based on sodium and chlorine requirements.

Paediatric population
Only children with symptomatic hyponatraemia should be treated with a hypertonic solution of NaCl. In the paediatric population, the treatment of symptomatic hyponatraemia is similar to that of adults.
A dose of 6 mmol of sodium chloride per kg of body weight generally increases the sodium level by approximately 10 mmol/L.
The initial rapid therapeutic increase in serum sodium levels should be only 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 with small increments over several hours to avoid hypernatraemia.

Maximum infusion rate
The maximum infusion rate depends on the prevailing clinical situation.
To prevent the development of osmotic demyelination syndrome in patients with chronic hyponatraemia, the rate of administration must be sufficiently slow, so that the serum sodium does not increase 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, diluted only with the addition of a suitable infusion solution.
In general, the calculated amount of sodium chloride is added to 250 mL of liquid. In case of fluid deficit, larger volumes of vehicle solution can be used.
For infusion into peripheral veins, the solution must be diluted so as not to exceed an osmolarity of 800 mOsm/L.
Take care to add concentrated sodium chloride to the infusion solution under strictly aseptic conditions immediately before preparing the infusion. The infusion bottle must be shaken gently.

Incompatibilities
When mixed with other medicinal products, possible incompatibilities must be considered.

Shelf life
The product must be used immediately after opening the container.
The solution must be clear, colourless and free of visible particles. It is for single use only and any remaining solution must not be used

Dilution
From a microbiological point of view, dilutions must be used immediately after preparation.
If not used immediately, the storage times during use and the conditions before use are the responsibility of the user and are normally not more than 24 hours at 2 °C - 8 °C unless the preparation has taken place under controlled and validated aseptic conditions.