Package leaflet: Information for the user

0,9% Sodium Chloride-BRAUN, 9 mg/ml, infusion solution
Sodium chloride
Please read the entire leaflet carefully before use, as it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
Consult your doctor, pharmacist, or nurse if you have any further questions.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
This medicine may harm another person, even if their symptoms are the same.
If any of the side effects worsens, or if you experience any side effects not listed in this leaflet, inform your doctor, nurse, or pharmacist.

Table of contents of the leaflet:

What 0,9% Sodium Chloride-BRAUN is and what it is used for
What you need to know before using 0,9% Sodium Chloride-BRAUN
How to use 0,9% Sodium Chloride-BRAUN
Possible side effects
How to store 0,9% Sodium Chloride-BRAUN
Contents of the pack and other information

1. What 0,9% Sodium Chloride-BRAUN is and what it is used for

0,9% Sodium Chloride-BRAUN is a sodium chloride solution administered intravenously via an infusion set.
The sodium chloride concentration in the solution is similar to the salt concentration in the human body.
This medicinal product is indicated in the following cases:

fluid and electrolyte replacement in hypochloremic alkalosis;
chloride deficiency;
short-term replacement of intravascular volume;
hypotonic or isotonic dehydration;
solvent for dilution of concentrated electrolytes and medicinal products without pharmaceutical incompatibilities;
for external use in wound irrigation and moistening of wound dressings and tampons.

The solution is also used as a solvent for other electrolytes or other medicinal products.
This product may also be used for wound irrigation and moistening of wound dressings and tampons.

2. Information before using 0,9% Sodium Chloride–Braun

When not to use 0,9% Sodium Chloride–Braun:

in case of excessive fluid content in the body (overhydration),
in case of severe hypernatremia,
in case of severe hyperchloremia.

Warnings and precautions
Exercise particular caution when using 0,9% Sodium Chloride–Braun in the following cases:

decreased potassium concentration in serum (hypokalemia),
increased sodium concentration in serum (hyponatremia),
increased chloride concentration in serum (hypochloremia),
heart disease,
severe kidney disease,
pulmonary edema caused by excess water in tissues (generalized edema),
lung disease or accumulation of water in the lungs (pulmonary edema),
high blood pressure (hypertension),
eclampsia, a condition occurring during pregnancy, associated with high blood pressure, seizures, and edema (edema).

To prevent the occurrence of osmotic demyelination syndrome, serum sodium concentration should not increase by more than 9 mmol/L per day. In most cases, considering the patient's condition and coexisting risk factors, a correction rate of 4 to 6 mmol/L per day is appropriate.
Monitoring of clinical parameters should include serum electrolyte concentrations and overall assessment of fluid and acid-base balance.
When rapid infusion of 0,9% Sodium Chloride–Braun is required, monitor cardiovascular status and respiratory function.
Note: When this product is used as a solvent for another medicinal product, the safety information provided by the manufacturer of the added medicinal product must be followed.

Children
Since the kidneys of premature infants and newborns are not fully developed, these patients may retain excessive amounts of sodium. Therefore, before reinfusing sodium chloride in premature infants and newborns, the patient's serum sodium chloride concentration should be determined.

0,9% Sodium Chloride–Braun and other medicinal products
Inform your doctor or pharmacist about all medicinal products currently used or recently used, as well as any medicinal products the patient plans to use.
Sodium-retaining drugs
Concomitant use of sodium-retaining drugs (such as corticosteroids and nonsteroidal anti-inflammatory drugs) may lead to edema.

0,9% Sodium Chloride–Braun with food and drink
Not applicable.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicinal product.

Pregnancy
There are no or limited data on the use of 0,9% Sodium Chloride–Braun in pregnant women. These data do not indicate any direct or indirect harmful effects of 0.9% sodium chloride solution on reproduction.
Since sodium and chloride concentrations are similar to those naturally occurring in the human body, harmful effects should not be expected, provided the product is used according to indications.
Therefore, 0,9% Sodium Chloride–Braun may be used according to indications. However, caution should be exercised in the presence of specific disorders occurring during pregnancy (eclampsia), characterized by high blood pressure, seizures, and edema.

Breastfeeding
Since sodium and chloride concentrations are similar to those naturally occurring in the human body, harmful effects should not be expected, provided the product is used according to indications.
0,9% Sodium Chloride–Braun may be used during breastfeeding.

Fertility
No data available.

Driving and operating machinery
0,9% Sodium Chloride–Braun has no or negligible influence on the ability to drive and operate machinery.

3. How to use 0,9% Sodium Chloride–Braun

This medicinal product is administered intravenously through a cannula or used externally for irrigation or moistening.
Dosing
The dose is determined according to the individual patient's current requirements for water and electrolytes.
Maximum daily dose
The maximum daily dose for adults is 40 ml per kg of body weight per day. This corresponds to 6 mmol of sodium per kg of body weight per day.
Any additional losses (e.g. due to fever, diarrhea, vomiting, etc.) should be replaced according to the volume and composition of the fluids lost.
In the treatment of acute fluid deficiency, for example in cases of threatened or established hypovolemic shock, higher doses may be administered, for instance via pressure infusion.
Infusion rate
The infusion rate depends on the patient's clinical condition.
Elderly patients
The same dosing regimen as for adult patients is usually applied. However, caution is advised when administering this medicinal product to elderly patients who may have conditions such as cardiac or renal insufficiency, which are common in this age group.
Use in children
The dose must be individually adjusted according to water and electrolyte requirements, age, body weight, and clinical condition of the patient.
In cases of severe dehydration, administration of a bolus of 20 ml/kg body weight during the first hour of treatment is recommended.
When administering this medicinal product, the total daily intake of fluids must be taken into account.
Solvent use
When 0,9% Sodium Chloride–Braun is used as a solvent, the dosing and infusion rate should primarily follow the recommended regimen of the drug being added.
Wound irrigation
The amount of solution used for wound irrigation or moistening depends on actual requirements.
Method of administration
Intravenous infusion or irrigation and moistening.
In cases where pressure infusion is required, which may be necessary in emergencies, it is essential to completely remove all air from the container and infusion set before starting administration of the solution.
Administration of a higher than recommended dose of 0,9% Sodium Chloride–Braun
If an excessive dose is administered, the following may occur: hypernatremia, hyperchloremia, overhydration, acute fluid overload, edema, serum hyperosmolality, and metabolic acidosis.
A rapid increase in serum sodium concentration in patients with chronic hypernatremia may lead to the development of osmotic demyelination syndrome.
Initial symptoms of overdose may include thirst, confusion, sweating, headache, weakness, drowsiness, or tachycardia. In cases of severe hypernatremia, hypertension or hypotension, respiratory disturbances, or coma may occur.
Depending on the severity of the disturbances, immediate discontinuation of the medicinal product may be necessary.
Additionally, diuretics (diuretic agents) may be administered. Serum electrolyte concentrations should be continuously monitored. The treating physician will decide on the possible administration of additional medications or other measures to stabilize electrolyte concentrations, fluid balance, and acid-base equilibrium.
If there are any further doubts regarding the use of this medicinal product, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions are not expected when the medicine is used according to recommendations.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine 0,9% Sodium Chloride–Braun

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container.
Do not use this medicine if it is cloudy, if there are visible particles in it, or if
the container is damaged.
After first opening:
From a microbiological point of view, the product should be used immediately after opening.
Otherwise, the preparation may be stored for a maximum of 24 hours at a temperature of 2 to 8°C.

6. Contents of the packaging and other information

What 0.9% Sodium Chloride–Braun contains
1 ml of solution contains 9 mg of sodium chloride and water for injections.

The active substance is sodium chloride
The other component is water for injections

What 0.9% Sodium Chloride–Braun looks like and contents of the pack
Clear, colourless aqueous solution
Theoretical osmolarity: 308 mOsm/l
Titratable acidity < 0.3 mmol/l
pH: 4.5 – 7.0

The packaging contains:
Glass bottles with rubber stoppers, with a capacity of: 100 ml, 500 ml, 1000 ml
available in multipacks of:
10 x 100 ml
10 x 500 ml
6 x 1000 ml

Polyethylene containers (Ecoflac plus), with a capacity of: 100 ml, 250 ml, 500 ml, 1000 ml
available in multipacks of:
20 x 100 ml
10 x 250 ml
10 x 500 ml
10 x 1000 ml

Marketing Authorisation Holder Manufacturer
B. Braun Melsungen AG B.Braun Medical SA
Carl-Braun-Strasse 1 Carretera de Terrassa, 121
34212 Melsungen 08191 Rubi (Barcelona)
Germany Spain
B. Braun Avitum AG
Schwarzenberger Weg 73-79
34212 Melsungen
Germany