SODIUM CHLORIDE 5.85% Braun MPC Infusion Solution

Pack size:20 x 20 ml Dosage form:Infusion solution concentrate

Sodium chloride 5.85% brown, concentrate. Indications: For the treatment of severe metabolic alkalosis (alkali excess or hypoacidity) and in pediatrics (pediatrics) for reducing elevated concentrations of ammonia in the blood (hyperammonemia) caused by severe congenital metabolic disorders.

For risks and side effects, read the package insert and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium chloride 5.85% brown, concentrate for solution for infusion
Active ingredient: Sodium chloride

Read the entire package insert carefully before you start using this medicine.

• Keep this leaflet. You may want to read it again later.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with anyone else. It may harm others, even if they have the same symptoms as you.
• If any of the side effects listed affect you seriously or if you notice side effects not listed in this leaflet, please inform your doctor or pharmacist.

This package leaflet contains:

1. WHAT IS SODIUM CHLORIDE 5.85% BROWN AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING SODIUM CHLORIDE 5.85% BROWN?
3. HOW TO USE SODIUM CHLORIDE 5.85% BROWN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD SODIUM CHLORIDE 5.85% BROWN BE STORED?
6. MORE INFORMATION

1. WHAT IS SODIUM CHLORIDE 5.85% BROWN AND WHAT IS IT USED FOR?

Sodium Chloride 5.85% Brown is a concentrated solution of sodium chloride (table salt) for the preparation or enrichment of infusion solutions (solutions administered directly into the body via a venous drip) with sodium chloride. It is used to administer sodium chloride. Sodium Chloride 5.85% Brown is used to administer sodium chloride in the following cases:

• Low sodium levels in the blood (hyponatremia),
• Low chloride levels in the blood (hypochloremia),
• Excess fluid with reduced concentration of salts in the blood (hypotonic hyperhydration).

2. WHAT SHOULD YOU CONSIDER BEFORE USING SODIUM CHLORIDE 5.85% BROWN?

Sodium Chloride 5.85% Brown should not be used if:

• increased sodium levels in the blood (hypernatremia),
• increased chloride levels in the blood (hyperchloremia).

Special care is required when using Sodium Chloride 5.85% Brown in the following cases:

• low potassium levels in the blood (hypokalemia),
• Diseases that require a restrained sodium intake, such as heart failure, fluid accumulation in the tissues (generalized edema), fluid accumulation in the lungs (pulmonary edema), high blood pressure (hypertension), pregnancy-related conditions with high blood pressure, cramps and fluid accumulation in the tissues (eclampsia), severe kidney dysfunction (renal insufficiency),
• Treatment with corticoids or ACTH (hormones that reduce sodium excretion), see next section,
• Overacidification of the blood (metabolic acidosis).

Checks of electrolyte levels in the blood and water balance as well as the acid-base status are necessary.

When using Sodium Chloride 5.85% Brown with other medicines:
Please inform your doctor or pharmacist if you are taking or using or have recently taken or used any other medicines, including medicines obtained without a prescription. In particular, your doctor should know if you are being treated with adrenal hormones (corticoids) or medicines that affect the function of the adrenal glands (so-called ACTH), as these medicines can reduce the excretion of sodium chloride and water.

Pregnancy and breastfeeding:
Consult your doctor or pharmacist before taking or using any medicine. Caution is advised in the case of eclampsia.

Ability to drive and operate machinery:
Sodium Chloride 5.85% Brown has no influence on the ability to drive or operate machinery.

3. HOW SHOULD SODIUM CHLORIDE 5.85% BROWN BE USE?

This medicine will be administered to you by a doctor or healthcare professional.

Method of administration:
Sodium Chloride 5.85% Braun will be given to you as an intravenous infusion (via a vein drip) after it has been diluted in a suitable carrier solution.

Dosage:
Your doctor will determine the correct dose for you. Your doctor will calculate your sodium chloride requirement based on your serum sodium level and your body weight.

Maximum daily dose:
The maximum daily amount depends on the correction needs. For adults, a guideline value of 3-6 mmol sodium per kg body weight applies, and for children, 3-5 mmol sodium per kg body weight.

Maximum infusion and drip rate:
The maximum infusion and drip rate depends on your clinical condition.

If your sodium concentration is chronically low, your doctor will give you Sodium Chloride 5.85% Brown at a low infusion rate to prevent brain damage (see "If you have been given more Sodium Chloride 5.85% Brown than you should###").

Children and adolescents:
Hypertonic sodium chloride solutions should only be used in children and adolescents with symptomatic hyponatremia. 6 mmol/l sodium chloride per kg body weight leads to an increase in sodium chloride of a maximum of 5.85 mmol/l. The sodium chloride concentration should not be increased by more than 5.85 mmol/l per day and should not exceed the maximum concentration of 125 mmol/l. Likewise, the increase in the sodium chloride concentration should be slow to prevent hypernatremia.

If you have received more Sodium Chloride 5.85% Brown than you should:
Too rapid administration of a more concentrated solution can lead to acute volume overload. Overdose can lead to overhydration, increased sodium levels in the blood (hypernatremia), increased chloride levels in the blood (hyperchloremia), increased salt concentration in the blood (hyperosmolarity) and disturbances in the acid-base balance, particularly hyperacidity of the blood (acidosis). In patients with chronically low sodium concentrations, an excessively rapid increase in sodium concentration can lead to brain damage (osmotic demyelinating disease).

Countermeasures:
Stop the infusion, administer diuretics under constant monitoring of the electrolyte balance, correct the electrolyte imbalance and the acid-base imbalance.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, Sodium Chloride 5.85% Brown can cause side effects, although not everybody experiences them. The frequency of side effects is based on the following categories:

The frequency of possible side effects depends essentially on the dosage and the infusion rate.

Metabolic and nutritional disorders:
During use, increased sodium and chloride levels in the blood may occur. If the infusion is too rapid, acute volume overload may occur with solutions with a high sodium chloride content.

Disorders of the gastrointestinal tract:
If the infusion is too rapid, diarrhea may occur with solutions with a high sodium chloride concentration.

Disorders of the kidney and urinary tract:
If the infusion rate is too rapid, increased urine excretion may occur with solutions with a high sodium chloride concentration.

Disorders at the administration site:
If solutions with a high sodium chloride concentration are infused into smaller veins (arm or leg area), irritation and inflammation of the vein wall may occur.

Reporting of side effects:
If you experience any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly via the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, Germany. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD SODIUM CHLORIDE 5.85% BROWN BE STORED?

Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the container and carton after "%%%Use by### or "%%%Exp. by### or "%%%EXP###". The expiry date refers to the last day of that month. Do not store above 25°C. You may only use Sodium Chloride 5.85% Brown if the solution is clear and free from suspended particles and the container is intact. The containers are intended for single use. Discard any remaining contents after use!

6. FURTHER INFORMATION

What Sodium Chloride 5.85% Brown contains:
The active ingredient is sodium chloride. 1 ml of concentrate for solution for infusion contains 58.5 mg sodium chloride, equivalent to 1 mmol Na+ and 1 mmol Cl-. 1 ampoule of 20 ml contains 1.17 g sodium chloride. 1 vial of 100 ml contains 5.85 g Sodium chloride. The other ingredient is water for injections.

What Sodium Chloride 5.85% Brown looks like and what the pack contains:
Sodium Chloride 5.85% Braun is a concentrate for solution for infusion (i.e., it is administered as an infusion after being diluted in a carrier solution). It is a clear, colorless aqueous solution. It is available in 20-ml plastic ampoules made of colorless polyethylene, in packs of 20 ampoules, and in 10-ml glass vials, in packs of 20 vials.

Pharmaceutical Entrepreneur and Manufacturer:
B. Braun Melsungen AG,
Carl-Braun-Straße 1,
34212 Melsungen, Germany,

Postal Address:
34209 Melsungen , Germany


This package leaflet was last revised in July 2025.

Source: Information from the package leaflet,
as of: 07/2025

Areas of application: for the treatment of severe metabolic alkalosis (alkali excess or hypoacidity) and in pediatrics (pediatrics) to reduce elevated concentrations of ammonia in the blood (hyperammonemia) caused by severe congenital metabolic disorders.

For the preparation and enrichment of infusion solutions