SODIUM CHLORIDE GRIFOLS

Posology Treatment of dehydration with salt loss, treatment of hypochloremic metabolic alkalosis and in management of hypovolemia: Dosage can be varied as directed by a physician. g. burns, surgery, head-injury, infections), electrolytes and fluid balance, and acid- base balance.

In general, it is recommended to administer the solution at an average infusion rate of 40 to 60 drops per minute (120-180 mL/h). 8). 4. 8). When administering this solution, the total daily fluid requirement must be considered. The daily recommended dose of fluid is the following: - adults: 25-35 mL/kg - children: < 10 kg body weight: 100 mL/kg 10-20 kg body weight: 1000 mL + 50 mL/kg for every kg over 10 kg > 20 kg body weight: 1500 mL + 20 mL/kg for every kg over 20 kg In adults, the maximum daily dose of fluid is 40 mL/kg (corresponding to 6 mmol of sodium/kg) not exceeding 3000 mL, and the maximum infusion rate is 5 mL/kg/h.

Children rarely need more than 2500 mL for males and 2000 mL for females. g. imminent or evident hypovolemic shock) the amount of solution should be 3 or 4 times the lost blood volume. 9% w/v is used as a vehicle for the administration of compatible drugs and electrolytes, the administered dosage and the speed of the infusion will depend on the nature and the dose of the prescribed medicinal product.

9% w/v is intended for intravenous administration by means of infusion.

Precautions to be taken before handling or administering the medicinal product:

Before administration, it must be checked that: - There is no leakage (by squeezing the bag firmly). - The solution is clear and without particles. Do not administer otherwise. 6.

Pain or local reaction, fever, infection, extravasation, venous thrombosis and phlebitis extending from the site of injection may occur if it is continuously administered in the same infusion site. Hyperhydration, hypernatremia, hyperchloremia, hypervolemia and related signs, such as formation of edemas or metabolic acidosis due to the decrease of bicarbonate concentration, may occur following an inadequate or excessive administration of normal saline solution.

Patients with non-osmotic vasopressin release, patients with heart-, liver- and kidney diseases and patients exposed to vasopressin agonists are at particular risk of acute hyponatraemia upon infusion of hypotonic and even isotonic fluids.

5). The frequency of these adverse reactions cannot be estimated from the available data.

List of adverse reactions:

System Organ Class Adverse reactions Frequency Metabolism and nutrition disorders Metabolic acidosis Hyperchloremia Hypernatremia Hyperhydration Hypervolemia Hospital acquired hyponatraemia Not known Nervous system disorders Acute hyponatraemic encephalopathy Not known Vascular disorders Venous thrombosis Phlebitis Not known General disorders and administration site conditions Edema Pyrexia Infection Injection site local pain or reaction Extravasation Not known If the solution is used as a vehicle for the administration of other compatible drugs, other adverse reactions attributable to the nature of these added drugs may also occur.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk or telephone 0808 100 3352.

9% w/v is an isotonic solution. 5). - The product should be administered with caution to patients with hypokalaemia because this condition may worsen the pre-existing electrolyte imbalance and cause cardiovascular complications, especially in patients with heart disease.

It also should be administered with great care to elderly patients because they are more likely to have impaired renal and cardiac function. - High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital acquired hyponatraemia (see below).

g. 5) are at particular risk of acute hyponatraemia upon infusion of hypotonic and even isotonic fluids. Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema) characterized by headache, nausea, seizures, lethargy and vomiting.

Patients with cerebral oedema are at particular risk of severe, irreversible and life-threatening brain injury. g. meningitis, intracranial bleeding and cerebral contusion) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

- Periodic laboratory determinations are necessary to monitor changes in fluid balance, serum electrolyte concentrations, and acid base balance during prolonged therapies or whenever the condition of the patient require such evaluation, as in the case of patients with imminent or existing acid-base imbalance.

9). 9% solution should be administered only for short period therapy as a prolonged administration could lead to a metabolic acidosis. 8). Extravasation may lead to tissue damage (local pain, erythema, burning, pruritus, swelling and ulceration) at the site of injection or along the vein.

Thrombophlebitis may occur if the solution is continuously administered in the same site of injection. In these cases, intravenous infusion should be stopped and appropriate therapeutic measures should be instituted. Possible signs of inflammation at the injection site must be checked periodically.

9% w/v is contraindicated in patients with: - Hyperhydration states - Hyperchloremia - Hypernatremia - Acidosis