Sodium chloride 0.9% - fluid replacement and sodium chloride 250 ml

Product Description

This product, Eurospital sodium chloride 0.9% in 250ml solution, is Indicated for fluid replacement and sodium chloride.

Indications

Fluid replacement and sodium chloride.

Composition

Active ingredients

1g Nacl = 394mg Na⁺ or 17.1meq oo 17.1 mmol of Na⁺ and Cl^- 1 mmol Na⁺ = 23 mg Na⁺ For a full list of excipients, see section 6.1.

Excipients

Water for injections.

Method of administration Directions for use and Dosage

The medicine must be administered by intravenous infusion. Treatment of isotonic fluid depletion (extracellular dehydration) Adults and adolescents: 500 ml to 3 litres in 24 hours Neonatals 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 is dependent on age, weight, clinical condition, electrolyte profile and osmolarity, and is in relation 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 men 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. Ensure 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.

Interactions

Corticosteroids are associated with sodium and water retention, resulting in edema and hypertension. Therefore, it is important to carefully monitor the compatibility of these drugs with sodium chloride. Caution should be exercised when administering sodium salts and corticosteroids concomitantly (see section 4.4). Although sodium chloride is compatible with a large number of solutions and medicinal products, compatibility should be checked in the SmPC of the medicinal product to be co-administered.

Warnings

Sodium salts should be administered with caution in patients with hypertension, cardiac 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) must 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 in which edema with salt retention exists; 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 osmolality and acid-base balance. The solution must be clear, colorless, and free from visible particles. Use immediately after opening the container. The container is for a single, uninterrupted administration, and any residue cannot be used.

Contraindications

Hydrosaline plethora.

Undesirable effects

The following are the undesirable effects of sodium chloride, organized according to the Meddra system organ classification. There are insufficient data to determine the frequency of the individual effects listed. Fluid and electrolyte balance disorders Hypernatremia, Hypervolemia, Hypoosmolality plasma (for 0.45% solutions), hyperchloraemia (which may cause bicarbonate loss resulting in acidosis). Nervous system disorders Headache, dizziness, restlessness, fever, irritability, weakness, muscle rigidity, convulsions, coma, death. Psychiatric disorders Drowsiness, confusional states. Respiratory, thoracic and mediastinal disorders Dyspnoea, 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 oedema. Systemic disorders and conditions related to the administration site Infection at the infusion site, pain or local reaction, venous irritation, venous thrombosis or phlebitis extending from the infusion site, extravasation.

Overdose

Symptoms The 0.45% solution is hypotonic with blood and causes a reduction in plasma osmolality: overdose can therefore lead to plasma hypoosmolality. The administration of excessive doses of isotonic and hypertonic sodium chloride solutions can cause hypoosmolality. lead, depending on the patient's clinical conditions, to hypernatremia, hyperchloremia and/or hypervolemia. Hypernatremia (mainly associated with the administration of hypertonic solutions) and excessive sodium retention where there is defective sodium excretion at the renal level determine dehydration of the internal organs, particularly the brain, and the accumulation of extracellular fluids with edema that can affect the cerebral, pulmonary and peripheral circulation with the appearance of pulmonary and peripheral edema. The accumulation of chloride ions determines a reduction in the concentration of bicarbonate ions leading to acidosis. Treatment In case of accidental excessive infusion, treatment should be suspended and the patient should be kept under observation for the appearance of any signs and symptoms related to the drug administered, ensuring the patient receives the relevant symptomatic and supportive measures as needed. In case of overdose, therapy must be aimed at restoring physiological sodium ion concentrations. In these cases, intravenous administration of 5% glucose or hypotonic or isotonic sodium chloride solutions is recommended (as they are hypotonic for the hypernatremic patient). In case of high serum natremia, loop diuretics can be used. A serum natremia greater than 200 mmol/l may be considered a risk factor for hypernatremia. Pregnancy and breastfeeding may require the use of dialysis.

Pregnancy and breastfeeding

Although no effects on fetal development have been observed, the medicine should be administered only if strictly necessary 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 a tightly closed container. Do not freeze or refrigerate.

Size

250ml