SODIUM CHLORIDE 0.45% Solution for Infusion Ref.[8050] Active ingredients: Sodium chloride

Posology

Adults, older people, Adolescents and Children

Fluid balance, serum electrolytes and acid-base balance should be monitored before and during administration, with particular attention to serum sodium in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs, due to the risk of hospital acquired hyponatraemia (see sections 4.4, 4.5 and 4.8). Monitoring of serum sodium is particularly important for hypotonic fluids.

Sodium Chloride 0.45% Solution for Infusion has a tonicity of 154 mOsm/l (approx.)

The infusion rate and volumedepend on age, weight, clinical condition (e.g. burns, surgery, head-injury, infections),and concomitant therapy should be determined by the consulting physician experienced in intravenous fluid therapy (see sections 4.4. and 4.8).

Recommended dosage

For adults, older people and adolescents: 500 ml to 3 litres/24h,

For babies and children: 20 to 100 ml per 24 h and per kg of body weight, depending on the age and the total body mass.

The recommended dosage when used as a vehicle or diluent ranges from 50 to 250 ml per dose of medicinal product to be administered.

Administration rate

The infusion rate depends on the patient clinical conditions. It is usually:

• 40 ml/kg/24h for adults, older people and adolescents,
  • 5 ml/kg/h in average for paediatric patients but the value varies with age:
  • 6-8 ml/kg/h for infants,
  • 4-6 ml/kg/h for toddlers,
  • 2-4 ml/kg/h for schoolchildren.

Note:

Infants and toddlers: age ranges from about 28 days to 23 months (a toddler is an infant who can walk).

Children and schoolchildren: age ranges from about 2 years to 11 years.

When Sodium Chloride 0.45% Solution for Infusion is used as a diluent for injectable preparations of other medicinal products, the infusion rate will also be dictated by the nature and the dose regimen of the prescribed medicinal products.

Method of Administration

The solution is for administration by intravenous infusion through a sterile and non-pyrogenic administration set, using aseptic technique. The equipment should be primed with the solution to prevent air entering the system.

The product should be inspected visually for particulate matter and discoloration prior to administration. Do not administer unless solution is clear, free from visible particles and the seal is intact.

Do not remove unit from overwrap until ready for use. The inner bag maintains the sterility of the solution. Administer immediately following the insertion of infusion set.

Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration. Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

Additives may be introduced before infusion or during infusion through the injection site. Adding other medication or using an incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens. If an adverse event occurs the patient evaluated and appropriate countermeasures started. If needed the infusion should be stopped.

For information on incompatibilities and preparation of the product with additives, please see sections 6.2 and 6.6.

An excessive volume of Sodium Chloride 0.45% Solution for Infusion may lead to:

• hypo- and hypernatremia (which can lead to CNS manifestations, including seizures, coma, cerebral oedema and death) and
• sodium overload (which can lead to central and/or peripheral oedema).

See also section 4.4.

Excessive administration of chloride salts may cause a loss of bicarbonate with an acidifying effect.

When Sodium Chloride 0.45% Solution for Infusion is used as a diluent for injectable preparations of other medicinal products, the signs and symptoms of over infusion will be related to the nature of the additives being used.

In the event of accidental over infusion, treatment should be discontinued and the patient should be observed for the appropriate signs and symptoms related to the drug administered. The relevant and supportive measures should be provided as necessary.

500 ml bags: 3 years.

In-use shelf-life: From a microbiological point of view, the diluted product must be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless reconstitution has taken place in controlled and validated aseptic conditions.

No special precautions for storage.

The bags known as Viaflo are composed of polyolefin/polyamide co-extruded plastic (PL 2442).

The bags are overwrapped with a protective plastic pouch composed of polyamide/polypropylene.

Bag size: 500 ml.

Outer carton contents: 20 bags of 500 ml.

Please see section 4.2 for information regarding the method of administration.

Before adding a drug, verify it is soluble and stable in water at the pH range of the Sodium Chloride 0.45% Solution for Infusion (pH 4.5 to 7.0). Additives may be introduced before infusion or during infusion through the injection site.

It is the responsibility of the healthcare professional to judge the incompatibility of an additive medication with the Sodium Chloride 0.45% Solution for Infusion, by checking for eventual colour change and/or eventual appearance of precipitate, insoluble complexes or crystals. The instruction for use of the medicinal product to be added must be consulted.

When additive is used, verify isotonicity prior to parenteral administration. Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately and not stored.

Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.
Do not remove unit from overwrap until ready for use. The inner bag maintains the sterility of the product.

Opening

• Remove the Viaflo container from the overpouch just before use.
• Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution, as sterility may be broken.
• Check the solution for clarity and absence of foreign matters. If solution is not clear or contains foreign matters, discard the solution.

Preparation for administration

Use sterile material for preparation and administration.

• Suspend container from eyelet support.
• Remove plastic protector from outlet port at bottom of container:
  • grip the small wing on the neck of the port with one hand,
  • grip the large wing on the cap with the other hand and twist,
  • the cap will pop off.
• Use an aseptic method to set up the infusion.
• Attach administration set. Refer to complete directions accompanying set for connection, priming of the set and administration of the solution.

Techniques for injection of additive medications

Warning: Additives may be incompatible.

To add medication before administration

• Disinfect medication site.
• Using syringe with 19 (1.10 mm) to 22 (0.70 mm) gauge needle, puncture resealable medication port and inject.
• Mix solution and medication thoroughly. For high-density medication such as potassium chloride, tap the ports gently while ports are upright and mix.

Caution: Do not store bags containing added medications.

To add medication during administration

• Close clamp on the set.
• Disinfect medication site.
• Using syringe with 19 (1.10 mm) to 22 (0.70 mm) gauge needle, puncture resealable medication port and inject.
• Remove container from IV pole and/or turn to an upright position.
• Evacuate both ports by tapping gently while the container is in an upright position.
• Mix solution and medication thoroughly.
• Return container to in use position, re-open the clamp and continue administration.