0.9% sodium chloride solution for infusion 250 ml

Product Description

Sodium Chloride 0.9% Solution for Infusion

Indications

Replacement of fluids and sodium chloride.

Composition

Active ingredients

1000 ml contain:Active ingredient: sodium chloride 9 g. mEq/l: Na⁺154 mEq/l: Cl^– 154 Theoretical osmolarity (mOsm/l): 308 pH: 4.5 – 7.0 1 g NaCl = 394 mg Na⁺or 17.1 mEq or 17.1 mmol Na⁺and Cl^{– 1 mmol Na+= 23 mg Na+For the full list of excipients, see section 6.1.}

Excipients

Water for injections.

Method of use and Posology

The medicinal product should be administered by intravenous infusion.Treatment of isotonic fluid depletion (extracellular dehydration)Adults and adolescents: from 500 ml to 3 liters in 24 hours.Neonatal 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 deficiencyThe dose depends on age, weight, clinical conditions, electrolyte profile and osmolarity, and is related to the calculated sodium deficit. The theoretical sodium deficit can be 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/h; then administer the remaining dose until a plasma sodium concentration of 130 mEq/l is achieved 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/h. Care should be taken 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 its 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 (see section 4.5). Solutions with concentrations greater 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 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, uninterrupted administration, and any residue cannot be discarded. be used.

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 (see section 4.4). 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 you intend to co-administer.

Pregnancy and breastfeeding

Although no effects on fetal development have been observed, the medicinal product should be administered only if strictly necessary and only after evaluating the risk/benefit ratio with your doctor. The medicinal product is compatible with breastfeeding.

Storage

Store in a tightly closed container. Do not freeze or refrigerate. The solution should be clear, colorless and free from visible particles.

Format

250 ​​ml