SODIUM CHLORIDE Inf.-Lsg. 5.85% 1 molar glass

Dosage form:Infusion solution concentrate

Sodium chloride 1 molar 5.85% concentrate for infusion solution. 

Indications: Reduced blood sodium content (hyponatremia), reduced blood chloride content (hypochloremia), hypotonic hyperhydration.

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

SODIUM CHLORIDE Inf.-Lsg. 5.85% 1 molar glass

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium chloride 1 molar 5.85% concentrate for infusion solution

. This package insert contains:

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

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

Substance or indication group:
Electrolyte concentrate. 1 ml contains: 1 mmol Na+, 1 mmol Cl-.

Indications:

• reduced sodium content in the blood (hyponatremia)
• reduced chloride content of the blood (hypochloremia)
• hypotonic hyperhydration.

2. WHAT SHOULD YOU CONSIDER BEFORE USING SODIUM CHLORIDE 1 MOLAR 5.85%?

Contraindications:
Absolute contraindication:

• Overhydration states (isotonic, hypertonic hyperhydration states).

Relative contraindications:

• reduced potassium content in the blood (hypokalemia).
• increased sodium content in the blood (hypernatremia).
• increased chloride content of the blood (hyperchloremia).
• Diseases requiring restrictive sodium intake (e.g. heart failure, generalized edema, pulmonary edema, hypertension, eclampsia, severe renal insufficiency).

Precautions for use and warnings:
Electrolyte and fluid status must be monitored.

Interactions with other medicinal products:
No interactions are known to date. For information on incompatibility, see ###Additional information for healthcare professionals###.

Pregnancy and breastfeeding:
There are no concerns about use during pregnancy and breastfeeding.

3. HOW SHOULD SODIUM CHLORIDE 1 MOLAR 5.85% BE USED?

Dosage instructions:
The following formula can serve as a rough guide for the specific correction of existing deficiencies:
Na+ deficit (mmol) = (Na+ target - Na+ actual) x kg BW x 0.2. The extracellular volume is calculated from the body weight in kilograms x 0.2.

Maximum infusion rate:
Depends on the clinical situation.

Maximum daily dose:
The maximum daily dose is determined by the fluid and electrolyte requirements. The recommended daily dose is 3-6 mmol sodium/kg body weight for adults, and 3-5 mmol sodium/kg body weight for children. The concentrate should not be used undiluted, but only as an additive to infusion solutions.

Directions:
For central venous infusion after addition to infusion solutions.

Overdose:
Symptoms of an overdose include:

• Overwatering.
• Increased sodium and chloride levels in the blood (hypernatremia, hyperchloremia).
• Hyperosmolarity.
• Induction of an acidotic metabolic state.

Too rapid administration of a hypertonic solution can lead to acute volume overload, nausea, vomiting, diarrhea, and hypertensive crisis.

Treatment:
Interruption of the solution supply, accelerated elimination via the kidneys, and a corresponding negative balance.

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

4. POSSIBLE SIDE EFFECTS:

Increased sodium or chloride levels in the blood. If the infusion is too rapid, especially with concentrated solutions, the high electrolyte concentration and the associated osmotic load can lead to acute volume problems, as well as osmotic urination and diarrhea. Due to the high osmolarity, the highly concentrated solutions can cause vein irritation with subsequent inflammation of the vein wall and thrombophlebitis if administered quickly and undiluted.

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

Additional information for healthcare professionals:
Reporting suspected side effects:
Reporting suspected side effects after authorization is very important. It allows continuous monitoring of the benefit-risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de.

5. HOW SHOULD SODIUM CHLORIDE 1 MOLAR 5.85% BE STORED?

Do not use after the expiry date printed on the container and outer packaging! Keep out of the reach of children! Use immediately after opening! Use only clear solutions in undamaged containers. Never dispose of medicines via wastewater (e.g., not down the toilet or sink). Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

6. FURTHER INFORMATION

Composition:
1000 ml of concentrate for infusion solution contains: Active ingredients: Sodium chloride 58.44 g. Other ingredients: Water for injections. Molar concentration/ml: 1 mmol Na+, 1 mmol Cl-. Theoretical osmolarity: 2000 mOsm/l. pH: 4.5 - 7.0.

Dosage form:
Concentrate for infusion solution. Contents of one glass bottle: 100 ml, 250 ml.

Pharmaceutical Entrepreneur/Manufacturer:
Serag-Wiessner GmbH & Co. KG
Zum Kugelfang 8 - 12
95119 Naila, Germany


This leaflet was last revised in 07 2025.

Source: Information from the package leaflet
, as of: 08/2025

Indications: reduced sodium content of the blood (hyponatremia), reduced chloride content of the blood (hypochloremia), hypotonic hyperhydration.

SODIUM CHLORIDE Inf.-Lsg. 5.85% 1 molar glass

For the treatment of reduced sodium + chloride levels in the blood