SALINE SOLUTION 0.9% glass bottle

Dosage form:Infusion solution Isotonic sodium chloride solution 0.9%

Braun infusion solution. 

Indications: for replacing fluids and salt in cases of fluid deficiency (isotonic dehydration) or simultaneous sodium and fluid deficiency (hypotonic dehydration), increased pH and simultaneously reduced chloride levels (hypochloremic alkalosis) and in cases of chloride loss. It is also used: for short-term refilling of the vascular system (intravascular volume replacement), as a carrier solution for electrolyte concentrates and compatible medications, for wound treatment and for moistening cloths and dressings.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Isotonic sodium chloride solution 0.9% Braun infusion solution
Active ingredient: sodium chloride

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

• Keep this leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice
• 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 ISOTONE SALINE SOLUTION 0.9% BROWN AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING ISOTONE SALINE SOLUTION 0.9% BROWN?
3. HOW SHOULD I USE ISOTONE SALINE SOLUTION 0.9% BROWN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ISOTONE SALINE SOLUTION 0.9% BROWN BE STORED?
6. MORE INFORMATION

1. WHAT IS ISOTONE SALINE SOLUTION 0.9% BROWN AND WHAT IS IT USED FOR?

Isotonic Saline Solution 0.9% Brown is a saline solution administered via a drip into your vein. The solution contains sodium chloride at a concentration equivalent to the salt concentration in your blood.

It is used to replace fluids and salt in the following cases:

• Fluid deficiency (isotonic dehydration) or simultaneous sodium and fluid deficiency (hypotonic dehydration),
• increased pH and simultaneously reduced chloride levels (hypochloremic alkalosis) and chloride losses.

It is also used:

• for short-term filling of the vascular system (intravascular volume replacement),
• as a carrier solution for electrolyte concentrates and compatible medications and
• for wound treatment and for moistening cloths and dressings.

2. WHAT SHOULD YOU CONSIDER BEFORE USING ISOTONIC SALINE SOLUTION 0.9% BROWN?

Isotonic Saline Solution 0.9% Brown should not be used if you suffer from overhydration.

Special care is required when using Isotonic Saline Solution 0.9% Brown if:

• low potassium levels in the blood (hypokalemia)
• increased sodium levels in the blood (hypernatremia)
• increased chloride levels in the blood (hyperchloremia)
• Diseases that require a limited 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)

If you are suffering from a lack of water and at the same time a high level of salt in your blood (hypertonic dehydration), the solution must be infused slowly enough to prevent a further increase in salt levels and especially sodium levels. Your water balance, acid-base balance and serum electrolyte levels will be monitored during the infusion.

When using Isotonic Saline Solution 0.9% Brown with other medicines:
Please inform your doctor or pharmacist if you are taking or have recently taken or used any other medicines, including medicines obtained without a prescription.

Pregnancy and breastfeeding:
Consult your doctor or pharmacist before taking any medicine. Isotonic Saline Solution 0.9% Brown should be used with caution in pregnancy-related conditions with high blood pressure, cramps and fluid retention in the tissues (eclampsia).

3. HOW SHOULD ISOTONE SALINE SOLUTION 0.9% BROWN BE USED?

For intravenous use or for rinsing and moistening.

Dosage:
The amount of solution you receive depends on your fluid and electrolyte requirements.

Maximum dose:
This is a maximum of 40 ml per kg body weight per day, which corresponds to 6 mmol of sodium per kg body weight per day. The solution is usually administered at a rate of up to 5 ml per kg body weight per hour. This corresponds to approximately 1.7 drops per kg body weight per minute. In exceptional cases, e.g. after major blood loss, the solution can also be administered at a much higher rate, as a pressure infusion. Care is taken to ensure that all air is removed from the container and tubing before the infusion begins to eliminate the risk of an air embolism. The amount required for wound treatment or for moistening depends on the individual need.

If you receive more Isotonic Saline Solution 0.9% Brown than you should (overdose):
An overdose can lead to increased sodium and chloride levels in the blood (hypernatremia, hyperchloremia), overhydration, and increased acidity of the blood (acidosis). In such a case, the infusion will be stopped immediately, and you may be given a substance that increases urine flow (a diuretic), with your serum electrolyte levels constantly monitored. Your doctor will decide on the administration of further medication or other measures to normalize your serum electrolyte levels, water balance, and acid-base balance.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, Isotonic Saline Solution 0.9% Brown can cause side effects, although not everybody gets them. The following side effects are possible: When used, increased sodium and chloride levels in the blood (hypernatremia and hyperchloremia) may occur.

Reporting of side effects:
If you notice 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 Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD ISOTONE SALINE SOLUTION 0.9% BROWN BE STORED?

Keep 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 container and carton. The expiry date refers to the last day of that month. Do not use Isotonic Saline Solution 0.9% Brown if you notice any of the following: cloudiness of the solution, suspended particles in the solution, damage to the container or cap. After first opening: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions between first opening and use are the responsibility of the user and should normally not exceed 24 hours at 2 to 8°C. Any unused infusion solution after one use should be discarded.

6. FURTHER INFORMATION

What Isotonic Saline Solution 0.9% Brown contains:
The active ingredient is sodium chloride. 1000 ml of infusion solution contains 9.0 g sodium chloride. The other ingredient is water for injections. Electrolytes: Sodium ion 154 mmol/l, Chloride ion 154 mmol/l.

What Isotonic Saline Solution 0.9% Brown looks like and contents of the pack:
Isotonic Saline Solution 0.9% Brown is an infusion solution (solution for administration as a venous drip). It is a clear, colorless aqueous solution. Theoretical osmolarity 308 mOsm/l, titration acidity (pH 7.4) <0.3 mmol/l, pH 4.5 - 7.0. Isotonic saline solution 0.9% brown is available in: Glass bottles: 1 x 100 ml, 10 x 100 ml, 20 x 100 ml, 1 x 250 ml, 10 x 250 ml, 1 x 500 ml, 10 x 500 ml, 1 x 1000 ml, 6 x 1000 ml. Plastic bottles: 1 x 50 ml, 20 x 50 ml, 1 x 100 ml, 10 x 100 ml, 20 x 100 ml, 1 x 250 ml, 10 x 250 ml, 1 x 500 ml, 10 x 500 ml, 1 x 1000 ml, 10 x 1000 ml. Plastic bags: 1 x 100 ml, 20 x 100 ml, 1 x 250 ml, 20 x 250 ml, 1 x 500 ml, 20 x 500 ml, 1 x 1000 ml, 10 x 1000 ml 1 x 3000 ml, 4 x 3000 ml and as a set consisting of 1 x 500 ml plastic bottle, infusion device and venipuncture set.

Pharmaceutical entrepreneur:
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen

Postal address:
B. Braun Melsungen AG
34209 Melsungen


Manufacturer:

B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen

or

B. Braun Medical SA
Carretera de Terrassa 121
08191 Rubí (Barcelona), Spain

or

B. Braun Pharmaceuticals SA
Louis Pasteur Street no. 2,
300264 Timisoara, Romania

This package leaflet was last revised in June 2025.

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

Indications: For replacing fluids and salt in cases of fluid depletion (isotonic dehydration) or simultaneous sodium and fluid depletion (hypotonic dehydration), elevated pH and simultaneously reduced chloride levels (hypochloremic alkalosis), and chloride loss. It is also used: for short-term replenishment of the vascular system (intravascular volume replacement), as a carrier solution for electrolyte concentrates and compatible medications, for wound treatment, and for moistening cloths and dressings.

Full electrolyte solution for infusion and drug preparation