HYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER S dilute inj 10Amp/20ml

Sodium chloride ..................................................................................................................... 10,0 g

for 100 mL of solution to be diluted injectable.

One ampoule of 5 mL contains 0,5 g of sodium chloride.

One ampoule of 10 mL contains 1 g of sodium chloride.

One ampoule of 20 mL contains 2 g of sodium chloride.

Sodium (Na+): 1711 mmol/L, i.e. 1,711 mmol/mL

Chlorides (Cl-): 1711 mmol/L, i.e. 1,711 mmol/mL

• Correction of electrolyte losses when a limited water intake is desired during slow intravenous infusion.
• Supply of sodium in a reduced volume in parenteral nutrition solutions.

Dosage  :

Doses may be expressed in mEq or mmol of sodium, mass of sodium or mass of sodium salt (1 g NaCl = 394 mg of Na, 17,1 mEq or 17,1 mmol of Na and Cl).

The dosage, rate and duration of administration must be determined according to several factors including age, weight, clinical condition, concomitant treatment and in particular the patient's hydration status, sodium and chloride ion requirements, and the clinical and biological response to treatment. Fluid balance and serum electrolyte concentrations must be closely monitored.

• Adults : The daily dose is adjusted according to sodium and chloride requirements.
• Paediatric population  : the dosage, flow rate and infusion volume depend on the age, weight, clinical and metabolic status of the patient and on concomitant treatment. The solution must be administered by experienced personnel. Only children suffering from symptomatic hyponatremia should be treated with a hypertonic sodium chloride solution. For the paediatric population, the treatment of hyponatremia is identical to that of adults.

The serum sodium concentration should be gradually increased over several hours with small additions in order to avoid any hypernatremia.

Maximum infusion rate

The maximum infusion rate depends on the clinical condition.

Most reported cases of osmotic demyelination syndrome occurred following a high rate of correction (see sections Warnings and precautions and Overdose).

Method of administration  :

HYPERTONIC solution, to be diluted before use.

Intravenous infusion.

For precautions to be taken before handling or administering the medicinal product, see section Disposal and handling.

• Hyperchloraemia
• Hypernatraemia
• Severe cases of water overload and sodium-water retention, particularly in cases of decompensated heart failure, decompensated hepatic failure (oedematous-ascitic insufficiency of cirrhosis), pre-eclampsia / eclampsia.

HYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER, solution to be diluted for injectionHYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER, solution to be diluted for injection, is a HYPERTONIC solution.

Administration of hyperosmolar solutions may cause venous inflammation and phlebitis.

Sodium rebalancing must not be carried out at too rapid a rate, in particular due to the risk of serious neurological complications, such as osmotic demyelination syndrome (see sections Dosage and administration and Overdose).

Depending on the volume and infusion rate, intravenous administration of sodium chloride may cause:

• fluid and/or solute overload leading to hyperhydration/hypervolaemia (e.g., congestive states, including peripheral oedema);
• clinically significant electrolyte disturbances and acid-base imbalance.

Use this medicinal product with caution in patients with hypertension, heart failure, hepatocellular insufficiency with oedema and ascites, cirrhosis of the liver, peripheral or pulmonary oedema, impaired renal function, urinary tract obstruction, metabolic acidosis, pre-eclampsia, hyperaldosteronism, hypervolaemia, hypoproteinaemia or other conditions and treatments (e.g., corticosteroids) associated with sodium-water retention (see section Interactions).

This treatment must be carried out under strict medical supervision, the dosage being adapted according to fluid and electrolyte changes, in particular sodium and chloride ions. Administration must be carried out under regular and careful monitoring.

Extravasation

The catheter site must be regularly checked for signs of extravasation. In case of extravasation, administration must be stopped immediately, while keeping the inserted cannula or catheter in place for immediate management of the patient. If possible, aspiration should be performed through the inserted cannula/catheter to reduce the amount of fluid present in the tissues before removing the cannula/catheter.

Depending on the product extravasated (including products mixed with HYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER, where applicable) and the stage/extent of any lesions, appropriate specific measures should be taken. Therapeutic options may include non-pharmacological, pharmacological and/or surgical interventions. If the affected area deteriorates (continuous pain, necrosis, ulceration), a plastic surgeon must be consulted immediately (see section Adverse effects).

The extravasation site must be checked at least every 4 hours during the first 24 hours, then once a day.

Populationgeriatric

When selecting the type of infusion solution and the infusion volume/rate for an elderly patient, it is necessary to take into account the susceptibility of these patients to cardiac, renal, hepatic or other diseases, as well as their concomitant medicinal treatments.

Paediatric population

In neonates, infants and children, administration of the product requires increased monitoring.

In the newborn and the premature infant, there may be excess sodium retention due to an immature renal function. In these patients, repeated infusions of sodium chloride must only be carried out after determination of plasma sodium concentrations.

The intravenous infusion device and administration equipment must be checked regularly.

In case of addition of a medicinal product, check compatibility, clarity and colour before use (see section Incompatibilities).

Do not store the mixture (see section Disposal and handling).

Associations requiring precautions for use 

     Lithium 

Administration of HYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER, solution to be diluted for injectionHYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER, solution to be diluted for injection, may lead to a decrease in lithium concentrations and therefore a risk of reduced lithium efficacy. Indeed, the renal clearance of sodium and lithium may be increased during administration of HYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER, solution to be diluted for injectionHYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER, solution to be diluted for injection. Caution is therefore recommended in patients receiving lithium treatment.

     Corticosteroids

Corticosteroids are associated with hydrosodium retention (with oedema and hypertension). See section Warnings and precautions.

HYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER, solution for injection to be diluted, may be used during pregnancy or breastfeeding, if necessary.

The risks and benefits for each patient must be carefully considered before administering HYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER, solution for injection to be diluted.

Caution is recommended in patients suffering from pre-eclampsia (see sections Contraindications and Warnings and precautions).

When a medicinal product is added, the nature of the medicinal product and its use during pregnancy and breastfeeding must be assessed separately.

There is no information on the effects of HYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER, solution for injection to be diluted, on the ability to drive vehicles and use machines.

The adverse effects that may occur in patients treated with HYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER by intravenous infusion are listed below.

The adverse effects listed in this section are reported according to the following convention: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1000 and < 1/100), rare (≥ 1/10000 and < 1/1000), very rare (< 1/10000) and frequency not known (cannot be estimated from the available data).

* Adverse effects that may be associated with extravasation, among others

Other adverse effects associated with the medicinal product(s) added to the solution may occur.

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 asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website:www.signalement-sante.gouv.fr.

Symptoms of sodium chloride overdose

Excessive administration of HYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER, solution for injection to be diluted, may lead to hypernatraemia resulting in intracellular dehydration, which must be treated in a specialised setting. The general adverse effects of excess sodium include nausea, vomiting, diarrhoea, abdominal cramps, thirst, decreased secretion of saliva and tears, sweating, fever, tachycardia, hypertension, renal failure, cerebral oedema, pulmonary and peripheral oedema, respiratory arrest, headache, dizziness, restlessness, irritability, syncope, muscle contraction and stiffness, convulsions, coma and death.

The clinical signs of osmotic demyelination syndrome are progressive: confusion, dysarthria, dysphagia, limb weakness, then quadriplegia, delirium and finally coma. Clinical symptoms occur several days after too rapid and/or too large a correction of hyponatraemia (see sections Dosage and administration and Warnings and precautions).

Excess chloride in the body may cause a loss of bicarbonate with acidosis.

Treatment

The first measure to take is to reduce the infusion rate or stop the infusion.

Treatment consists of monitoring of serum sodium and administration of glucose solution for infusion. In case of convulsions, diazepam may be administered.

Pharmacotherapeutic class: ELECTROLYTE SOLUTIONS; ATC code: B05XA03

(B: blood and blood-forming organs)

HYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER, solution for injection to be diluted, is a hypertonic solution with an osmolarity of approximately 3420 mOsm/L.

The pharmacodynamic properties of the solution are those of sodium and chloride ions, which maintain fluid and electrolyte balance.

Ions such as sodium move across the cell membrane using various transport mechanisms, including the sodium pump (Na+, K+-ATPase). Sodium plays an important role in neurotransmission and cardiac electrophysiology, as well as in renal metabolism.

In case of addition of a medicinal product, the pharmacodynamics of the preparation will also depend on the added medicinal product.

Absorption

Since sodium chloride is administered intravenously, its absorption is complete, i.e. 100 %.

Elimination

Sodium and chloride ions are excreted mainly in the urine. Small amounts of sodium are eliminated in the feces and sweat.

In case of addition of a medicinal product, the pharmacokinetics of the preparation will also depend on the medicinal product added.

No specific data, as sodium chloride is a physiological component of plasma in both animals and humans.

The safety data of the additive should be considered separately.

As with all parenteral solutions, the compatibility of medicinal products with the solution must be checked before addition.

The incompatibility of the medicinal product with the HYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER solution must be determined by checking for any change in colour and/or any formation of precipitate, insoluble complex or crystals. Also refer to the package leaflet accompanying the medicinal product to be added.

When adding a medicinal product, check whether the medicinal product is compatible with the pH range of the HYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER solution.

When a compatible medicinal product is added to the HYPERTONIC SODIUM CHLORIDE 10 % LAVOISIER solution, the mixture must be administered immediately.

Medicinal products known to be incompatible must not be used.

Before opening:

Glass and polypropylene ampoules: 3 years.

Shelf life after first use:the product must be used immediately

Before opening: this medicine does not require any particular storage precautions.

For storage conditions of the medicine after opening, see section Shelf life.

Do not use if the ampoule is damaged.

Do not reuse: single use only.

Discard any partially used ampoule.

In case of addition of a medicinal product, mix the solution well before use.

The solution must be visually inspected to detect any particles, any damage to the ampoule and any visible sign of deterioration before administration.

In case of addition of medication, the solution must be administered with sterile equipment and using an aseptic technique. The equipment must be primed with the solution to avoid any introduction of air into the system.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.