Sodium chloride 0.9% 1000 ml bag - solution for infusion

Product Description

Fluid and sodium chloride replacement.

Indications

Sodium chloride Eurospital 0.9% solution for infusion.
Solutions that influence electrolyte balance.

Composition

Active ingredients

Excipients

Water for injections.

Directions for use and Posology

The medicinal product must be administered by intravenous infusion. Treatment of isotonic fluid depletion (extracellular dehydration). Adults and adolescents: 500 ml to 3 liters in 24 hours.
Infant and children (up to 12 years of age): 20 to 100 ml in 24 hours and per kg of body weight, depending on age and total body weight. The dosage should be appropriately reduced in patients with renal insufficiency. Treatment of sodium deficiency.
The dose depends on age, weight, clinical condition, electrolyte profile and osmolarity, and is related to the calculated sodium deficit. The theoretical sodium deficit can be calculated using the following formula: deficit (mEq) = (140-P) x V P = plasma sodium concentration (in mEq/l) V = body water volume (equal to 60% of body weight for children and adult males, 50% for adult females, 50% and 45% for males and elderly women, respectively). Using hypertonic solutions (2%-3%-5%), administer half the dose in the first 8 hours up to a maximum of 100 ml/hour; then administer the remaining dose until a plasma sodium concentration of 130 mEq/l is reached or until symptoms improve. In conditions of severe sodium depletion and in the treatment of severe symptoms related to chronic hyponatremia, administer hypertonic sodium chloride solutions to increase the plasma sodium concentration by 1-2 mmol/l/hour.
Be careful that the correction does not exceed 10-12 mmol/l in 24 hours and 18 mmol/l in 48 hours.
If sodium chloride solutions, particularly 0.9% solutions, are used as diluents for the intravenous administration of drugs that must be diluted beforehand, check the compatibility of these drugs with sodium chloride and the most suitable concentration for administration in the SPC of the drug to be diluted. If the concentration is not indicated, use the 0.9% solution.

Warnings

Sodium salts should be administered with caution in patients with hypertension, heart failure, peripheral or pulmonary edema, reduced renal function, pre-eclampsia, or other conditions associated with sodium retention. Solutions with a concentration higher than 0.9% (hypertonic solutions) should be used with caution, at a controlled infusion rate, and only when specifically prescribed. Use with great caution in patients with congestive heart failure, severe renal insufficiency, and in clinical conditions involving edema with salt retention; in patients being treated with corticosteroids or corticotropins.
Continuous administration without additional potassium may cause hypokalemia.
Use with caution in children.
During the infusion, it is good practice to monitor fluid balance, electrolytes, plasma osmolarity, and acid-base balance. The solution must be clear, colorless, and free of visible particles. Use immediately after opening the container. The container is for a single, continuous administration, and any residue cannot be used.

Contraindications

Hypernatremia. Hydrosaline plethoras.

Interactions

Corticosteroids are associated with sodium and water retention, resulting in edema and hypertension: therefore, caution should be exercised when administering sodium salts and corticosteroids simultaneously. Although sodium chloride is compatible with a large number of solutions and medicinal products, it is advisable to check its compatibility in the SPC of the medicinal product to be co-administered.

Undesirable effects

The following are the undesirable effects of sodium chloride, organized according to the MedDRA system organ classification. There are insufficient data to establish the frequency of the individual effects listed. Disturbances of water and electrolyte balance: hypernatremia, hypervolemia, plasma hypoosmolarity (for 0.45% solutions), hyperchloremia (which can cause bicarbonate loss resulting in acidosis). Nervous system disorders: headache, dizziness, restlessness, fever, irritability, weakness, muscle stiffness, convulsions, coma, death. Psychiatric disorders: drowsiness, confusional states.
Respiratory, thoracic, and mediastinal disorders: dyspnea, respiratory arrest.
Gastrointestinal disorders: thirst, decreased salivation, nausea, vomiting, diarrhea, abdominal pain.
Cardiac disorders: tachycardia. Eye disorders: decreased lacrimation. Renal and urinary disorders: renal failure. Vascular disorders: hypotension, hypertension, pulmonary and peripheral edema. Systemic disorders and conditions related to the administration site: infection at the infusion site, pain or local reaction, venous irritation, thrombosis or venous phlebitis extending from the infusion site, extravasation.

Pregnancy and breastfeeding

Although no effects on fetal development have been observed, the medicine should be administered only if clearly needed and only after evaluating the risk/benefit ratio. The medicine is compatible with breastfeeding.

Storage

Keep this medicine out of the sight and reach of children.
Do not release into the environment.
Store in normal ambient conditions.
Store in the tightly closed container.
Do not freeze or refrigerate.

Format

1000 ml bag