Sodium chloride 0.9% - infusion solution 500 ml

Product Description

Sodium chloride B. Braun 0.9% is An intravenous infusion solution used for fluid and electrolyte replacement and as a vehicle for compatible medicinal products.

Indications

• Fluid and electrolyte replacement in hypochloremic alkalosis
• Sodium deficiency
• Chloride loss
• Short-term intravascular volume replacement
• Hypotonic dehydration or isotonic dehydration
• Vehicle solution for electrolyte concentrations and compatible medicinal products for parenteral administration

Composition

Active substances

1000 ml contains: Sodium chloride 9.0 g; Electrolyte concentration: Sodium 154 mmol/l; Chloride 154 mmol/l. For a full list of excipients, see section 6.1.

Excipients

Water for injections

Directions for use and dosage

Dosage Adults The dose is adjusted according to the actual water and electrolyte requirements. Maximum daily dose Up to 40 ml per kg body weight per day, corresponding to 6 mmol sodium per kg body weight. Any additional losses (e.g., due to fever, diarrhea, vomiting, etc.) should be replaced based on the volume and composition of the fluid lost. In the management of acute volume deficit, i.e., impending or manifest hypovolemic shock, higher dosages may be applied, e.g., 1000 mg. by pressurized infusion. General recommendations for the treatment of sodium deficiency: The amount of sodium required to restore plasma sodium levels can be calculated using the equation: Sodium requirement [mmol] = (actual - desired serum Na) x Tbw where total body water (total body water, Tbw) is calculated as a percentage of body weight. The percentage is 0.6 in children; 0.6 and 0.5 in non-elderly males and females; 0.5 and 0.45 in elderly males and females, respectively. Infusion rate: The infusion rate depends on the individual patient's condition (see section 4.4). Elderly population Essentially, the same dosage applies as for adults, but caution should be exercised in patients with additional conditions such as cardiac or renal insufficiency, which may often be related to advanced age. Paediatric population The dose should be adjusted according to the individual water and electrolyte requirements as well as the patient's age, weight and clinical condition. In case of severe dehydration, a bolus of 20 ml/kg body weight is recommended for the first hour of treatment. When administering this solution, total daily fluid intake should be taken into account. Vehicle solution When Sodium chloride B. Braun 0.9% is used as a vehicle solution, the dosage and infusion rate depend mainly on the nature and dosage regimen of the additive. Method of administration Intravenous use When performing a pressurized infusion, using the solution placed in a flexible container, all air must be expelled from the container and the administration set before starting the infusion.

Interactions

Medicines causing sodium retention 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 medicinal products, please refer to the SPC for the medicinal product you intend to administer to verify compatibility.

Warnings

Intravenous infusion of Sodium chloride B. Braun 0.9% should be administered with caution in the following clinical conditions:

• hypokalaemia;
• hypernatremia;
• hyperchloremia;
• cardiac failure, generalized edema, pulmonary edema, hypertension, eclampsia, severe renal insufficiency, or other conditions associated with sodium retention (see section 4.5).

To prevent the development of osmotic demyelination syndrome, increased sodium levels Serum sodium should not exceed 9 mmol/l/day. As a general recommendation, a correction rate of 4 to 6 mmol/l/day is adequate in most cases, depending on the patient's condition and concomitant risk factors. Clinical monitoring should include checks of serum electrolytes, fluid balance and acid-base balance. Careful monitoring of cardiovascular and respiratory status should be performed if rapid infusion of Sodium chloride B. Braun 0.9% is necessary. Paediatric population Premature or full-term infants may retain excess sodium due to immature renal function. Therefore, repeated infusion of sodium chloride in premature or full-term infants should be administered only after determining serum sodium levels.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Sodium chloride B. Braun 0.9% should not be administered to patients with:

• hyperhydration;
• severe hypernatremia;
• severe hyperchloremia.

Undesirable effects

No effects known based on the instructions given. The following are the undesirable effects of sodium chloride, organised according to the Meddra system organ classification. There are insufficient data to establish the frequency of the individual effects listed. Fluid and electrolyte balance disorders: Hypernatraemia, hypervolaemia, plasma hypoosmolality (for 0.45% solutions), hyperchloremia (which may cause bicarbonate loss with subsequent acidosis). Nervous system disorders: Headache, dizziness, restlessness, fever, irritability, weakness, stiffness. muscle weakness, 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. General disorders and administration site conditions: Infusion site infection, local pain or reaction, venous irritation, venous thrombosis or phlebitis extending from the infusion site, extravasation. Reporting of suspected adverse reactions. Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are advised to keep informed of any suspected adverse reactions before use. You are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdose

Symptoms Overdose of Sodium Chloride B. Braun 0.9% may cause hypernatremia, hyperchloremia, overhydration, acute volume overload, peripheral or pulmonary edema, serum hyperosmolality, and hyperchloremic acidosis. A rapid increase in serum sodium level in patients with chronic hyponatremia may cause hyponatremia. lead to osmotic demyelination syndrome (see section 4.4). The first signs of overdose may be thirst, confusion, sweating, headache, weakness, drowsiness or tachycardia. In case of hypernatraemia, hypertension or hypotension, respiratory failure or coma may occur. Treatment Depending on the severity of the overdose, the patient should be monitored closely. If pathologies occur, the infusion should be stopped immediately, diuretics should be administered, serum electrolytes should be monitored continuously, and electrolyte and acid-base imbalances should be corrected. In severe cases of overdose, or in cases of oliguria or anuria, dialysis may be necessary.

Pregnancy and breastfeeding

Pregnancy Available data on the use of Sodium chloride B. Braun 0.9% in pregnant women are limited. These data do not indicate direct or indirect harmful effects of toxicity. Reproductive toxicity of Sodium chloride B. Braun 0.9% (see section 5.3). Since the concentrations of sodium and chloride are similar to those in the human body, no harmful effects are expected if the product is used as directed, therefore Sodium chloride B. Braun 0.9% can be administered during pregnancy, but with caution in the presence of eclampsia (see section 4.4). Breastfeeding Since the concentrations of sodium and chloride are similar to those in the human body, no harmful effects are expected if the product is used as directed, therefore Sodium chloride B. Braun 0.9% can be administered during pregnancy, but with caution in the presence of eclampsia (see section 4.4). It can be administered during breastfeeding, if necessary. Fertility There are no data available on the effect of sodium chloride on fertility. Animal studies do not indicate direct or indirect harmful effects of reproductive toxicity (see section 5.3).

Storage

This medicinal product does not require any special storage conditions. For storage conditions after dilution of the medicinal product, see section 6.3.

Format

500 ml bottle