BIOLUZ SODIUM CHLORIDE 0,9 % S for injection in bag Perfudom bag/100ml

Solution for injection.

Clear and colourless solution, free from visible particles.

Osmolarity: 308 mOsm/L

pH between 4,5 and 7,0

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

per 100 mL of injectable solution.

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

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

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

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

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

One bag of 2000 mL contains 18 g of sodium chloride.

Sodium (Na+): 154 mmol/L

Chloride (Cl-): 154 mmol/L

Excipients:

• Ionic rebalancing by supply of chloride and sodium;
• Extracellular dehydration;
• Hypovolaemia;
• 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, flow 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, requirements for sodium and chloride ions, 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, rate and volume of infusion depend on the age, weight, clinical and metabolic status of the patient and on concomitant treatment. The solution must be administered by experienced personnel.

When the SODIUM CHLORIDE 0,9 % BIOLUZ solution is used as a vehicle or diluent for the preparation of injectable other medicinal products, the dosage and infusion rate will depend mainly on the nature and dosage 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 the 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 sodium-water retention, particularly in cases of decompensated heart failure, decompensated hepatic failure (oedematous-ascitic insufficiency of cirrhosis), pre-eclampsia / eclampsia.

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

SODIUM CHLORIDE 0,9% BIOLUZ, solution for injection, bag, is an isotonic solution.

Administration of hyperosmolar solutions may cause venous inflammation and phlebitis.

Sodium rebalancing must not be carried out too rapidly, in particular because of 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:

• water 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, 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 sodium-water 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 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 % BIOLUZ, 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. 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.

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 injectable solution and the volume/infusion rate for an elderly patient, it is necessary to take into consideration these patients' susceptibility to cardiac, renal, hepatic or other diseases, as well as their concomitant drug treatments.

Paediatric population 

In newborns, 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 should be performed only 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% BIOLUZ, injectable solution, bag, may lead to a decrease in lithium concentrations and therefore a risk of reduced lithium efficacy. Indeed, renal clearance of sodium and lithium may be increased during administration of SODIUM CHLORIDE 0,9% BIOLUZ, injectable solution, bag. 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% BIOLUZ, injectable solution in bag, may be used during pregnancy or breastfeeding, if necessary.

The risks and benefits for each patient should be carefully considered before administering the SODIUM CHLORIDE 0,9% BIOLUZ 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 should be evaluated separately.

There is no information on the effects of SODIUM CHLORIDE 0,9% BIOLUZ, injectable solution, bag, on the ability to drive vehicles and use machines.

The adverse reactions that may occur in patients treated with SODIUM CHLORIDE 0,9% BIOLUZ 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 Classes (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, in particular, with extravasation

When SODIUM CHLORIDE 0,9% BIOLUZ, solution for injection, bag, 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.ansm.sante.fr.

Symptoms of sodium chloride overdose

Excessive administration of SODIUM CHLORIDE 0,9% BIOLUZ, solution for injection, bag, 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 extensive correction of hyponatraemia (see sections Dosage and administration and Warnings and precautions).

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

Treatment

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

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

When SODIUM CHLORIDE 0,9% BIOLUZ, solution for injection, is used as a vehicle or diluent for injectable preparations of other medicinal products, signs and symptoms of excessive infusion may originate from the added medicinal product. In case of accidental excessive infusion, interrupt treatment and observe the patient for any appearance of clinical signs and symptoms related to the administered medicinal product. 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% BIOLUZ, solution for injection, bag, is an isotonic solution with an osmolarity of approximately 308 mOsm/L.

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

Mechanism of action

Ions such as sodium move across the cell membrane, using a variety of 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.

Pharmacodynamiceffects

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

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

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 faeces and sweat.

No specific data, sodium chloride being 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 SODIUM CHLORIDE 0,9 % BIOLUZ 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.

If a medicinal product is added, check whether the medicinal product is compatible with the pH range of SODIUM CHLORIDE 0,9 % BIOLUZ solution.

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

Medicinal products known to be incompatible must not be used.

Before opening: 

50 ml : 1 year

100 ml : 2 years

250 ml, 500 ml, 1000 ml and 2000 ml : 3 years

Shelf life after first use:

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

Store at a temperature not exceeding 25°C.

Do not use if the outer pack/bag is damaged.

Do not reuse: single use.

Discard any partially used bag.

Do not reconnect a partially used bag.

Remove the overpouch immediately before use. 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 sign of deterioration before administration.

In case of adding 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.

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 product or waste must be disposed of in accordance with the regulations in force.

List I

Marketing authorisation (AMM)

CIP 3400932687435 (Perfudom bag/1000ml). CIP 3400932687374 (Perfudom bag/500ml). CIP 3400933308964 (Perfudom bag/50ml). CIP 3400933308674 (Perfudom bag/250ml). CIP 3400933308735 (Perfudom bag/100ml).

Price:

2,95 euros (Perfudom bag/1000ml). 2,31 euros (Perfudom bag/500ml). 1,76 euros (Perfudom bag/50ml). 2,01 euros (Perfudom bag/250ml). 1,96 euros (Perfudom bag/100ml).

Social security reimbursement at 65% (Perfudom bag/1000ml, Perfudom bag/500ml, Perfudom bag/50ml, Perfudom bag/250ml, Perfudom bag/100ml).
Collection.