SODIUM CHLORIDE B BRAUN 0,9 % S perf Pouch ECOFLAC/500ml

Solution for infusion.

Clear and colourless solution, free from particles.

Osmolarity: 308 mOsm/L

pH between 4,5 and 7.

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

Per 100 mL of solution for infusion.

One pouch of 50 mL contains 0,45 g of sodium chloride.

One pouch of 100 mL contains 0,9 g of sodium chloride.

One pouch of 250 mL contains 2,25 g of sodium chloride.

One pouch of 500 mL contains 4,5 g of sodium chloride.

One pouch of 1000 mL contains 9 g of sodium chloride.

Sodium (Na+) : 154 mmol/L

Chlorides (Cl-) : 154 mmol/L

Excipients :

• Ionic re-equilibration by supply of chloride and sodium,

• Extra-cellular dehydration,

• Hypovolaemia,

• Vehicle or diluent for compatible medicinal products for therapeutic supply.

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 posology, 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, clinical and biological response to treatment. Fluid balance and serum electrolyte concentrations must be monitored carefully.

For the treatment of isotonic extra-cellular dehydration and sodium depletion the recommended posology 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 posology, rate and volume of infusion depend on the age, weight, clinical and metabolic status of the patient and concomitant treatment. The solution must be administered by experienced personnel.

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

Maximum infusion rate

The maximum infusion rate depends on the clinical condition.

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

Method of administration

Intravenous infusion, intramuscular or subcutaneous injection.

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

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

• Hyperchloraemia;

• Hypernatraemia;

• Severe cases of fluid overload and hydro-sodium retention particularly in case of decompensated cardiac failure, decompensated hepatic failure (oedemato-ascitic insufficiency of cirrhosis), pre-eclampsia/eclampsia.

The contraindications relating to the added medicinal product(s) must be taken into account.

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

Sodium re-equilibration must not be performed at too rapid a rate, particularly due to a 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, in particular peripheral oedema),

• clinically significant electrolyte disturbances and acid-base imbalance.

Use this medicinal product with caution in patients with hypertension, cardiac failure, hepatocellular insufficiency with oedema and ascites, liver cirrhosis, 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 hydro-sodium retention (see section Interactions).

This treatment must be carried out under strict medical supervision, the dosage having to be adapted according to hydroelectrolytic changes, in particular sodium and chloride ions. Administration must be performed 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 cannula or inserted catheter in place for immediate patient management. If possible, aspiration must be performed through the inserted cannula/catheter in order to reduce the amount of fluid present in the tissues before removing the cannula/catheter. If an extremity is affected, the affected limb must be elevated.

Depending on the extravasated product (including products mixed with SODIUM CHLORIDE 0,9 % B.BRAUN, solution for infusion, if 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 serial connections. This use could lead to gas embolism due to 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 cause gas embolism if the residual air contained in the container is not completely evacuated before administration.

• Use of an intravenous administration set with an open air vent could lead to gas embolism. Intravenous administration sets with an open air vent must not be used with flexible plastic containers.

Geriatric population

When selecting the type of infusion solution and the volume/infusion rate for an elderly patient, it is necessary to take into consideration 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 neonate and the premature infant, there may be excess sodium retention due to immature renal function. In these patients, repeated infusions of sodium chloride must be performed only after determination of plasma sodium concentrations.

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

In case of addition of medication, check the compatibility, the limpidity and the colour before use (see section Incompatibilities).

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

Combinations subject to precautions for use

+ Lithium 

The administration of SODIUM CHLORIDE 0,9 % B.BRAUN, solution for infusion may lead to a decrease in lithium concentrations and therefore a risk of reduced efficacy of lithium. Indeed, the renal clearance of sodium and lithium may be increased during the administration of SODIUM CHLORIDE 0,9 % B.BRAUN, solution for infusion. Caution is therefore recommended in patients who are on lithium treatment.

+ Corticosteroids

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

SODIUM CHLORIDE 0,9 % B.BRAUN, 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 0,9 % B.BRAUN, solution for infusion.

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

When a medication is added, the nature of the medication and its use during pregnancy and breastfeeding must be evaluated separately.

There is no information on the effects of SODIUM CHLORIDE 0,9 % B.BRAUN, 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 % B.BRAUN, solution for infusion by intravenous infusion are indicated below.

The adverse effects listed in this section are mentioned 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 determined (cannot be estimated from the available data).

System organ classes (SOC)	Adverse effects (MedDRA terms)	Frequency
Nervous system disorders	Tremors	Not determined
Metabolism and nutrition disorders	Hypervolaemia Hypernatraemia Hyperchloraemic metabolic acidosis	Not determined
Skin and subcutaneous tissue disorders	Urticaria Rash Pruritus	Not determined
Vascular disorders	Venous thrombosis Thrombophlebitis Hypotension	Not determined
General disorders and administration site conditions	Chills
	Fever
	Infection at the infusion site
	Irritation at the infusion site	Not determined
	Extravasation
	Local reaction
	Localized pain* Necrosis / ulcer*

 * Adverse effects that may be notably associated with extravasation

When CHLORURE DE SODIUM 0,9 % B.BRAUN, solution for infusion is used as a vehicle or diluent for injectable preparations of other medicines, other adverse effects associated with the medicine(s) added to the solution may 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. Healthcare professionals report any suspected adverse reaction via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr

.

Symptoms of sodium chloride overdose

Excessive administration of CHLORURE DE SODIUM 0,9 % B.BRAUN, solution for infusion may lead to hypernatremia resulting in intracellular dehydration, which must be treated in a specialized setting. The general adverse effects of excess sodium include nausea, vomiting, diarrhea, abdominal cramps, thirst, decreased secretion of saliva and tears, sweating, fever, tachycardia, hypertension, renal failure, cerebral edema, pulmonary and peripheral edema, respiratory arrest, headache, dizziness, restlessness, irritability, lipothymia, muscle contraction and stiffness, convulsions, coma and death.

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

Excess chlorides in the body can cause 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 natremia and administering glucose infusion solution. In case of convulsions, diazepam may be administered.

When CHLORURE DE SODIUM 0,9 % B.BRAUN, solution for infusion is used as a vehicle or diluent for injectable preparations of other medicines, signs and symptoms of excessive infusion may originate from the added medicine. In case of accidental excessive infusion, discontinue treatment and observe the patient for any appearance of clinical signs and symptoms related to the administered medicine. Initiate appropriate symptomatic and supportive treatment, according to needs.

ELECTROLYTE SOLUTIONS ATC code: B05XA03

(B: blood and hematopoietic organs)

CHLORURE DE SODIUM 0,9 % B.BRAUN, 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 hydroelectrolytic balance.

Ions such as sodium circulate through the cell membrane, using various transport mechanisms, among which 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 medicine, the pharmacodynamics of the preparation will also depend on the added medicine.

Absorption

Given that sodium chloride is administered intravenously, its absorption is complete, namely 100 %.

Elimination

Sodium and chloride ions are excreted primarily in the urine. Small quantities 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 particular data, sodium chloride being a physiological component of plasma both in animals and in humans.

The safety data of the additive must be considered separately.

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

The incompatibility of the medicinal product with respect to the CHLORURE DE SODIUM 0,9 % B.BRAUN solution must be determined by checking for a possible change in color and/or a possible formation of precipitate, insoluble complex or crystals. Also refer to the package insert 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 CHLORURE DE SODIUM 0,9 % B.BRAUN solution.

When a compatible medicinal product is added to the CHLORURE DE SODIUM 0,9 % B.BRAUN solution, the mixture must be administered immediately.

Medicinal products known to be incompatible must not be used.

Before opening:

ECOFLAC bags: 3 years.

ECOBAG bags of 50 mL: 11 months.

ECOBAG bags of 100 mL: 20 months

ECOBAG bags of 250 mL, 500 mL and 1 000 mL: 2 years.

Shelf life during use:

After opening/dilution, the product must be used immediately.

For ECOBAG bags of 50 mL: store at a temperature not exceeding 25°C.

For ECOFLAC bags of 50 mL, 100 mL, 250 mL, 500 mL and 1000 mL ECOBAG of 100 mL, 250 mL, 500 mL and 1000 mL: this medicinal product does not require any special storage precautions.

Do not use if the packaging/the bag is damaged.

Do not reuse: single use.

Discard any partially used bag.

Do not reconnect a partially used bag.

Remove the overwrap just before use (Ecobag bags). The primary packaging maintains the sterility of the product.

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 bag and any visible signs of deterioration before administration.

In case of addition of a medicinal product, 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 must be disposed of in accordance with current regulations.

Risk of gas embolism

• Do not use plastic bags for serial connections. This use could lead to gas embolism due to 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 cause gas embolism if the residual air contained in the container is not completely evacuated before administration.

• Use of an intravenous administration set with an open air vent could lead to gas embolism. Intravenous administration sets with an open air vent must not be used with flexible plastic containers.

List I

MA

CIP 3400936048799 (ECOFLAC pouch/50ml). CIP 3400936048850 (ECOFLAC pouch/100ml). CIP 3400936048911 (ECOFLAC pouch/250ml). CIP 3400936049161 (ECOFLAC pouch/500ml). CIP 3400936049222 (Ecoflac pouch/1000ml). CIP 3400936049451 (ECOBAG pouch/100ml). CIP 3400936049512 (ECOBAG pouch/250ml). CIP 3400936049680 (ECOBAG pouch/500ml). CIP 3400936049741 (pouch/1000ml). CIP 3400957583743 (20pouch/100ml). CIP 3400957583804 (20pouch/250ml). CIP 3400957583514 (10pouch/500ml). CIP 3400957583682 (10pouch/1000ml).

Price:

1,83 euros (ECOFLAC pouch/100ml). 1,86 euros (ECOFLAC pouch/250ml). 2,10 euros (ECOFLAC pouch/500ml). 2,71 euros (Ecoflac pouch/1000ml).

Social Security reimbursement at 65% (ECOFLAC pouch/100ml, ECOFLAC pouch/250ml, ECOFLAC pouch/500ml, Ecoflac pouch/1000ml).
Hospital model(s) (ECOFLAC pouch/50ml, ECOBAG pouch/100ml, ECOBAG pouch/250ml, ECOBAG pouch/500ml, pouch/1000ml, 20pouch/100ml, 20pouch/250ml, 10pouch/500ml, 10pouch/1000ml).
Collect.