SODIUM CHLORIDE 0,9 % LAVOISIER S perf Fl/125ml

Solution for infusion.

Clear, colourless liquid free from visible particles.

Osmolarity 308 mOsm/L

pH between 4,5 and 7

Sodium chloride ........................................................................................................................................0,9 g

For 100 ml of solution for infusion.

One ampoule of 2 mL contains 0,018 g of sodium chloride.

One ampoule of 5 mL contains 0,045 g of sodium chloride.

One ampoule of 10 mL contains 0,09 g of sodium chloride.

One ampoule of 20 mL contains 0,18 g of sodium chloride.

One bag/one bottle of 50 mL contains 0,45 g of sodium chloride.

One bag/one bottle of 100 mL contains 0,9 g of sodium chloride.

One vial of 125 mL contains 1,125 g of sodium chloride.

One bag/one bottle of 250 mL contains 2,25 g of sodium chloride.

One bag/one bottle of 500 mL contains 4,5 g of sodium chloride.

One bag/one bottle of 1000 mL contains 9 g of sodium chloride.

Sodium (Na+): 154 mmol/L, i.e. 0,154 mmol/mL

Chlorides (Cl-): 154 mmol/L, i.e. 0,154 mmol/mL

Excipients:

• Ionic rebalancing by supply of chloride and sodium;
• Extracellular dehydration;
• Hypovolemia;
• Vehicle or diluent for compatible medicinal products for parenteral administration.

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.

For the treatment of isotonic extracellular dehydration and sodium depletion, the recommended dosage is:

• Adults : 500 ml to 3000 ml /24 h.
• Paediatric population  : 20 to 100 mL per 24 h and per kg of body weight. The dosage, flow rate and infusion volume depend on the patient's age, weight, clinical and metabolic status, and concomitant treatment. The solution must be administered by experienced personnel.

When the solution of SODIUM CHLORIDE 0,9 % LAVOISIER is used as a vehicle or diluent for the injectable preparation of other medicinal products, the posology and infusion rate will depend mainly on the nature and posology of the medicinal product to be administered.

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  :

Intravenous infusion, intramuscular or subcutaneous injection.

When the solution is used for dilution and administration of additional medicinal products, the instructions for use of the added substances will determine the appropriate volumes, modes and routes of administration for each treatment.

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 water-sodium retention, particularly in cases of decompensated cardiac insufficiency, decompensated hepatic insufficiency (oedematous-ascitic insufficiency of cirrhosis), of pre-eclampsia / eclampsia.

The relative contraindications of the added medicinal product(s) must be taken into account.

SODIUM CHLORIDE 0,9 % LAVOISIER, solution for infusion, is an isotonic solution.

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 the event 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 in the tissues before removing the cannula/catheter. If an extremity is affected, the limb concerned must be elevated.

Depending on the extravasated product (including products mixed with SODIUM CHLORIDE 0,9 % LAVOISIER, where applicable) and the stage/extent of any lesions, appropriate specific measures must be taken. Therapeutic options may include non-pharmacological, pharmacological and/or surgical interventions. In case of deterioration of the affected area (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.

Risk of gas embolism(see section Disposal and handling)

• Do not use plastic bags for connections in series. This use could lead to gas embolism due to the aspiration of residual air from the first bag before the end of administration of solution from the second bag.
• Applying pressure to the flexible plastic container containing the intravenous solution to increase the flow rate may lead to gas embolism if the residual air contained in the container is not completely evacuated before administration.
• Use of an intravenous administration set with an air intake in the open position could result in a gas embolism. Intravenous administration sets with an air intake in the open position must not be used with flexible plastic containers.

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 SODIUM CHLORIDE 0,9 % LAVOISIER, solution for infusion, 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 when SODIUM CHLORIDE 0,9 % LAVOISIER, solution for infusion, is administered. 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.

SODIUM CHLORIDE 0,9 % LAVOISIER, solution for infusion, may be used during pregnancy or breastfeeding, if necessary.

The risks and benefits for each patient must be carefully considered before administering SODIUM CHLORIDE LAVOISIER 0,9 % solution.

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 SODIUM CHLORIDE 0,9 % LAVOISIER, solution for infusion, on the ability to drive vehicles and use machines.

The adverse effects that may occur in patients treated with SODIUM CHLORIDE 0,9 % 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).

System Organ Class (SOC)	Adverse reactions (MedDRA Terms)	Frequency
Nervous system disorders	Tremors	Not known
Metabolism and nutrition disorders	Hypervolaemia Hypernatraemia Hyperchloraemic metabolic acidosis	Not known
Skin and subcutaneous tissue disorders	Urticaria Skin rash Pruritus	Not known
Vascular disorders	Venous thrombosis Thrombophlebitis Hypotension	Not known
General disorders and administration site conditions	Chills
	Fever
	Infection at the infusion site
	Infusion site irritation	Not known
	Extravasation
	Local reaction
	Localised pain* Necrosis / ulcer*

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

When SODIUM CHLORIDE 0,9 % LAVOISIER, solution for infusion, is used as a vehicle or diluent for injectable preparations of other medicinal products, 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 SODIUM CHLORIDE 0,9 % LAVOISIER, solution for infusion, 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.

When SODIUM CHLORIDE 0,9 % LAVOISIER is used as a vehicle or diluent for injectable preparations of other medicines, signs and symptoms of excessive infusion may arise from the added medicine. In case of accidental excessive infusion, interrupt treatment and observe the patient for any appearance of clinical signs and symptoms related to the administered medicine. Institute appropriate symptomatic and supportive treatment, as needed.

Pharmacotherapeutic class: ELECTROLYTE SOLUTIONS; ATC code: B05XA03

(B: blood and blood-forming organs)

SODIUM CHLORIDE 0,9 % LAVOISIER, solution for infusion, is an isotonic solution whose osmolarity is approximately 308 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 SODIUM CHLORIDE 0,9 % LAVOISIER solution must be determined by checking for a possible change in colour and/or possible formation of a precipitate, insoluble complex or crystals. Also refer to the package leaflet accompanying the medicinal product to be added.

In case of addition of a medicinal product, check whether the medicinal product is compatible with the pH range of the SODIUM CHLORIDE 0,9 % LAVOISIER solution.

When a compatible medicinal product is added to the SODIUM CHLORIDE 0,9 % LAVOISIER solution, the mixture must be administered immediately.

Medicinal products known to be incompatible must not be used.

Before opening:

• Glass vial and glass ampoule and polypropylene ampoule: 3 years.
• Vial (polyethylene): 3 years.
• Bag (PP) of 50 ml: 2 years.
• Bag (PP) of 100 ml, 250 ml, 500 ml, and 1000 ml: 3 years.

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

• Vial and ampoule (colourless glass): This medicinal product does not require any special storage precautions before opening.
• Bag (PP): Store at a temperature not exceeding 25°C.

For storage conditions of the medicinal product after reconstitution, dilution or first opening, see section Shelf life.

Do not use if the pack/bag/vial/ampoule is damaged.

Do not reuse: single use only.

Discard any partially used bag/vial/ampoule.

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

The solution must be visually inspected for particles, damage to the bag/vial/ampoule and any visible signs 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.

Instructions for use of the overwrapped plastic bag:

Remove the overpouch immediately before use. The primary packaging maintains the sterility of the product.

Check the clarity of the solution and the integrity of the container.

For additions of medicinal products, inject with a syringe through the injection site.

For reconstitution of powders, use a double-needle transfer set.

Set up the appropriate infusion equipment by piercing the spike port, purge the infusion line. Adjust the infusion rate.

Do not reconnect a partially used bag.

Risk of gas embolism

• Do not use plastic bags for connections in series. This use could lead to gas embolism due to the aspiration of residual air from the first bag before the end of administration of solution from the second bag.
• Applying pressure to the flexible plastic container containing the intravenous solution to increase the flow rate may lead to gas embolism if the residual air contained in the container is not completely evacuated before administration.
• Use of an intravenous administration set with an air intake in the open position could result in a gas embolism. Intravenous administration sets with an air intake in the open position must not be used with flexible plastic containers.

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

List I

Marketing authorisation (AMM)

CIP 3400955579779 (24Fl/50-125ml). CIP 3400955579830 (24Fl/100-125ml). CIP 3400955351252 (12Fl/250ml). CIP 3400955351191 (12Fl/500ml). CIP 3400930578971 (Fl/250ml). CIP 3400930578391 (Fl/1000ml). CIP 3400930578452 (Fl/125ml). CIP 3400930579404 (Fl/500ml). CIP 3400955351023 (6Fl/1000ml). CIP 3400936340534 (10Amp/5ml). CIP 3400936340763 (10Amp/10ml). CIP 3400936340824 (10Amp/20ml). CIP 3400939077178 (10Fl/100ml). CIP 3400939077239 (Fl PE/250ml). CIP 3400939077468 (10Fl/250ml). CIP 3400939077529 (Fl PE/500ml). CIP 3400939077697 (10Fl/500ml). CIP 3400939077758 (Fl PE/1000ml). CIP 3400939077819 (10Fl/1000ml). CIP 3400957545604 (100AmpPP/5ml). CIP 3400939523330 (10AmpPP/10ml). CIP 3400957542061 (100AmpPP/10ml). CIP 3400939523569 (10AmpPP/20ml). CIP 3400939523620 (50AmpPP/20ml). CIP 3400930004241 (Poche PP/50ml). CIP 3400930004258 (Poche PP/100ml). CIP 3400930004265 (Poche PP/250ml). CIP 3400930004272 (Poche PP/500ml). CIP 3400930004289 (Poche PP/1000ml). CIP 3400955001614 (50Poche PP/100ml). CIP 3400955001621 (20Poche PP/250ml). CIP 3400955001645 (20Poche PP/500ml). CIP 3400955001652 (10Poche PP/1000ml).

Price:

2,01 euros (Fl/250ml). 2,95 euros (Fl/1000ml). 2,51 euros (Fl/125ml). 2,31 euros (Fl/500ml). 1,76 euros (Poche PP/50ml). 1,96 euros (Poche PP/100ml). 2,01 euros (Poche PP/250ml). 2,31 euros (Poche PP/500ml). 2,95 euros (Poche PP/1000ml).

Remb Séc soc à 65% (Fl/250ml, Fl/1000ml, Fl/125ml, Fl/500ml).
Remb Séc soc à 65% (Poche PP/50ml, Poche PP/100ml, Poche PP/250ml, Poche PP/500ml, Poche PP/1000ml) dans les indications :

• Indication(s) figurant dans l'AMM à la date de publication du présent arrêté (Poche PP/50ml, Poche PP/100ml, Poche PP/250ml, Poche PP/500ml, Poche PP/1000ml)

Non Remb Séc soc (10Amp/5ml, 10Amp/10ml, 10Amp/20ml, Fl PE/250ml, Fl PE/500ml, Fl PE/1000ml, 10AmpPP/10ml, 10AmpPP/20ml).
Modèle(s) hospitalier(s) (24Fl/50-125ml, 24Fl/100-125ml, 12Fl/250ml, 12Fl/500ml, 6Fl/1000ml, 10Fl/100ml, 10Fl/250ml, 10Fl/500ml, 10Fl/1000ml, 100AmpPP/5ml, 100AmpPP/10ml, 50AmpPP/20ml, 50Poche PP/100ml, 20Poche PP/250ml, 20Poche PP/500ml, 10Poche PP/1000ml).
Collect (24Fl/50-125ml, 24Fl/100-125ml, 12Fl/250ml, 12Fl/500ml, Fl/250ml, Fl/1000ml, Fl/125ml, Fl/500ml, 6Fl/1000ml, 10Amp/5ml, 10Amp/10ml, 10Amp/20ml, 10Fl/100ml, 10Fl/250ml, 10Fl/500ml, 10Fl/1000ml, 100AmpPP/5ml, 10AmpPP/10ml, 100AmpPP/10ml, 10AmpPP/20ml, 50AmpPP/20ml, Poche PP/50ml, Poche PP/100ml, Poche PP/250ml, Poche PP/500ml, Poche PP/1000ml, 50Poche PP/100ml, 20Poche PP/250ml, 20Poche PP/500ml, 10Poche PP/1000ml).