Sodium chloride 0.9% - physiological solution 500 ml

Product Description

Sodium Chloride 0.9% Bag

Composition:

1000 ml contain:

0.9% 3% 5%
Sodium chloride 9.0g 30.0g 50.0g
mEq/l: Na+ 154 513 856
Cl – 154 513 856

Theoretical osmolarity: (mOsm/l) 308 1026 1712
pH: 4.5 – 7.0 4.5 – 7.0 4.5 – 7.0

1g 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.

Therapeutic indications

Fluid and sodium chloride replacement.

Contraindications

Hypernatraemia. Hydrosaline plethoras.

Posology

The medicinal product must be administered by intravenous infusion. Treatment of isotonic fluid depletion (extracellular dehydration) Adults and adolescents: 500 ml to 3 litres in 24 hours. Infants and children (up to 12 years of age): 20 to 100 ml per 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 (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/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 such 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 and precautions

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 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 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 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, uninterrupted administration, and any residue cannot 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 SmPC of the medicinal product you intend to co-administer.

Undesirable effects

The following are the undesirable effects of sodium chloride, organized according to the MedDRA system organ class. There are insufficient data to determine the frequency of the individual effects listed. Water and electrolyte balance disorders: Hypernatremia, hypervolemia, plasma hypoosmolarity (for 0.45% solutions), hyperchloremia (which may 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: Dyspnoea, respiratory arrest. Gastrointestinal disorders: Thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain. Cardiac disorders: Tachycardia. Eye disorders: Decreased lacrimation. Renal and urinary disorders: Renal failure. Vascular disorders: Hypotension, hypertension, pulmonary and peripheral oedema. General disorders and administration site conditions: Infection at the infusion site, local pain or reaction, venous irritation, venous thrombosis or phlebitis extending from the infusion site, extravasation.

Pregnancy and breastfeeding

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