• 2250 mg sodium chloride

• water for injections

Areas of ISOTONIC saline solution 0.9% Bernburg application

- Hypotonic dehydration
- Isotonic dehydration
- Plasma isotonic fluid replacement in the event of loss of extracellular fluids
- Short-term, intravascular volume replacement
- Carrier solution for drugs that are compatible with the isotonic saline solution 0.9%.

Posology, method and duration of administration
The concentration and dosage of sodium chloride intravenous solutions depend on various factors including age, weight and the clinical condition and particularly the hydration status of the patient. Serum electrolyte concentrations should be carefully monitored.

Recommended dosage for treating isotonic extracellular dehydration:
Adults: 500 ml - 3 l/24 h or 40 ml/kg body weight/24 h
Babies, small children and children: 20 - 100 ml/24 h/kg body weight, depending on age and total body mass

In pediatrics In the case of dehydration with shock (without the laboratory findings being available), 20 – 30 ml/kg body weight can initially be administered. The subsequent procedure for rehydration depends on the laboratory findings (slow correction – eg in the case of isonatraemia, replacement of 2/3 of the extracellular fluid loss with isotonic saline solution “Serumwerk” 0.9% – infusion solution within 24 hours).

Maximum infusion rate
The infusion rate is 5 ml/kg body weight and hour on average, but varies depending on age:

6 - 8 ml/kg body weight and hour for infants,
4 - 6 ml/kg body weight and hour for infants and children up to 6 years,
2 - 4 ml/kg body weight and hour for children from 6 to 12 years.

The infusion rate and total volume depend on the patient's clinical condition and may be higher in surgery and as needed. When sodium chloride 0.9% is used as a carrier solution or diluent, the recommended dosage is 50-250 ml per dose of drug to be administered. The dosing guidelines of additional active ingredients must be taken into account.

Type/ duration of use
The duration of use depends on the clinical requirements.

Contraindications
Proven hypernatremia, hyperchloremia, acidosis, hypertonic dehydration, hypokalemia. General contraindications to infusion therapy, such as pulmonary and cerebral edema, congestive heart failure, renal dysfunction (oliguria or anuria) and hyperhydration (edema) must be taken into account. The contraindications of any added active ingredients must be taken into account.

Special warnings and precautions for use
During the use of "Serumwerk" 0.9% isotonic saline solution, the serum ionogram, the water balance and the acid-base balance must be monitored. Sodium retention can occur in both premature and term infants due to immature kidney function. For this reason, repeated sodium chloride infusions should only be given to infants born prematurely or at term only after determination of the serum sodium level.

"Serumwerk" 0.9% isotonic saline solution should only be used with particular caution in patients with
- hypertension,
- cardiac insufficiency,
- impaired kidney function,
- aldosteronism or
- other diseases and treatments (eg with corticosteroids) associated with sodium retention.

Eclampsia should be excluded from treatment with "Serumwerk" 0.9% isotonic saline solution. If "Serumwerk" 0.9% isotonic saline solution is used as a carrier solution for other pharmaceuticals, it must be taken into account that the solution becomes hypertonic and can cause pain at the puncture site when administered subcutaneously.

Interaction with other medicinal products and other forms of interaction
None known.

Pregnancy and lactation
"Serumwerk" 0.9% isotonic saline solution can be administered during pregnancy and lactation.

Effects on ability to drive and use machines
Not known.

Overdose
Overdose can lead to hypernatraemia, hyperchloremia, overhydration and metabolic acidosis. Common symptoms of hypernatremia, which require specialist attention, include nausea, vomiting, diarrhea, abdominal cramps, thirst, decreased salivation and lacrimation, sweating, fever, tachycardia, hypertension, renal failure, peripheral and pulmonary edema, respiratory arrest, headache , dizziness, restlessness, irritability, weakness, muscle twitching and rigidity, convulsions, coma and death.