ISOTONIC NaCl solution 0.9% Eifelfango

Isotonic sodium chloride solution 0.9% Eifel fango, solution for infusion. Indications: Fluid and electrolyte replacement in hypochloremic alkalosis%%% Chloride loss%%% Short-term intravascular volume replacement%%% Hypotonic dehydration%%% Isotonic dehydration.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Isotonic sodium chloride solution 0.9% Eifel fango, solution for infusion

Dear user, Please read the following package leaflet carefully because it contains important information about what you should bear in mind when using this medicine. If you have any questions, please consult your doctor or pharmacist.

Substance or indication group:
Electrolyte solution. 1 ml contains: 0.154 mmol Cl-, 0.154 mmol Na+.

Indications:
Fluid and electrolyte replacement in hypochloremic alkalosis, chloride loss, short-term intravascular volume replacement, hypotonic dehydration, isotonic dehydration.

Contraindications:
Absolute contraindication:
Overhydration (hyperhydration).

Relative contraindications:

• reduced potassium content in the blood (hypokalemia),
• increased sodium content of 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).

Use during pregnancy and breastfeeding:
There are no concerns regarding use during pregnancy and breastfeeding.

Precautions for use:
Electrolyte and fluid status monitoring is required.

Interactions with other drugs:
None known to date.

Warnings:
None.

Dosage instructions, method, and duration of administration:
For intravenous infusion. The dosage is generally based on fluid and electrolyte requirements (40 ml/kg body weight/day or 2 mmol sodium/kg body weight/day). The following guidelines apply:

• Maximum infusion rate: Depends on the clinical situation.
• Maximum daily dose: The maximum daily dose is determined by fluid and electrolyte requirements. For adults, a value of 3-6 mmol sodium/kg body weight applies, and for children, 3-5 mmol sodium/kg body weight. In cases of hypertonic dehydration, excessively rapid infusion rates must be avoided (caution: increase in plasma osmolarity and plasma sodium concentration).

If you have any questions about use, please consult your doctor or pharmacist.

Advice in case of overdose:
Symptoms of an overdose include:

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

Treatment in case of overdose:
Interruption of the solution supply, accelerated elimination via the kidneys, and a reduced supply of the corresponding electrolytes.

Side effects:
Increased sodium and chloride levels in the blood (hypernatremia, hyperchloremia).

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, 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.

Information on shelf life of the medicine:
Do not use this medicine after the expiry date stated on the carton and bottle label. Use only clear solutions in undamaged containers! Use the solution immediately after opening! Discard any remaining contents!

Composition:
Active ingredients: 1000 ml contains 9.00 g of sodium chloride. Other ingredients: Water for injections, hydrochloric acid for pH adjustment. Titration acidity up to pH 7.4: <0.1 mmol/l. Theoretical osmolarity: 309 mOsm/l. pH: 4.5 - 7.0.

Dosage form and contents:
Infusion solution in 50 and 100 ml injection bottles. Packs of 1, 5, 10, and 20 bottles.

Pharmaceutical entrepreneur and manufacturer:
Eifelfango Chemisch Pharmazeutisches Werk GmbH & Co. KG
Ringener Straße 45
53474 Bad Neuenahr-Ahrweiler


This package leaflet was last revised in 07 2025.

Source: Information from the package leaflet
. Version: 01/2025

Areas of application: Fluid and electrolyte substitution in hypochloremic alkalosis%%% chloride losses%%% short-term intravascular volume replacement%%% hypotonic dehydration%%% isotonic dehydration.