SODIUM CHLORIDE 0.9% Solution for infusion Ref.[8051] Active ingredients: Sodium chloride

Posology

Adults, older people and children

Doses may be expressed in terms of mEq or mmol of sodium, mass of sodium, or mass of sodium salt (1 g NaCl = 394 mg, 17.1 mEq or 17.1 mmol of Na and Cl).

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 0.9% intravenous infusion has a tonicity of 308 mOsm/l (approx.)

The infusion rate and volume depend 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

The recommended dosage for treatment of isotonic extracellular dehydration and sodium depletion is:

For adults: 500 ml to 3 litres/24h.

For babies and children: 20 to 100 ml per 24h and per kg of body weight, depending of 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.

When Sodium Chloride 0.9 % is used as a diluent for injectable preparations of other drugs, the dosage and the infusion rate will also be dictated by the nature and the dose regimen of the prescribed drug.

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 in order 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.

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

General adverse effects of sodium excess in the body include nausea, vomiting, diarrhea, abdominal cramps, thirst, reduced salivation and lacrimation, sweating, fever, tachycardia, hypertension, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma, and death.

An excessive volume of Sodium Chloride 0.9% may lead to hypernatraemia (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) and should be treated by an attending specialised physician.

Excess chloride in the body may cause a loss of bicarbonate with an acidifying effect.

When Sodium Chloride 0.9% is used as a diluent for injectable preparations of other drugs, 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.

Shelf life as packaged:

50 ml bag: 15 months.

100 ml bag: 2 years.

250 and 500 ml bags: 2 years.

1000 ml bags: 3 years.

In-use shelf life: Additives.

Chemical and physical stability of any additive at the pH of Sodium Chloride 0.9% Intravenous Infusion in the Viaflo container should be established prior to use.

From a microbiological point of view, the diluted product must be used immediately unless dilution has taken place in controlled and validated aseptic conditions. If not used immediately, in-use storage times and conditions are the responsibility of the user.

50 and 100 ml bags: Do not store above 30°C.

250, 500 and 1000 ml bags: This medicinal product does not require any special storage conditions.

Bag sizes: 50, 100, 250, 500 or 1000 mL

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.

Pack sizes:

• 50 bags of 50 ml per carton
• 75 bags of 50 ml per carton
• 1 bag of 50 ml
• 50 bags of 100 ml per carton
• 60 bags of 100 ml per carton
• 1 bag of 100 ml
• 30 bags of 250 ml per carton
• 1 bag of 250 ml
• 20 bags of 500 ml per carton
• 1 bag of 500 ml
• 10 bags of 1000 ml per carton
• 1 bag of 1000 ml

Not all pack sizes may be marketed.

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 0.9% Intravenous Infusion solution. Additives may be introduced before infusion or during infusion through the injection site.

It is the responsibility of the physician to judge the incompatibility of an additive medication with the Sodium Chloride 0.9% Intravenous Infusion solution by checking for eventual color change and/or eventual precipitate, insoluble complexes or crystals apparition. The Instructions for Use of the medication 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.

Adding other medication or using an incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of adverse reaction, infusion must be stopped immediately.

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.

Instructions for use

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 impaired
• Check solution for limpidity and absence of foreign matter. If solution is not clear or contains foreign matter, 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 directions of the 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 gauge (1.10 mm) to 22 gauge (0.70 mm) 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 gauge (1.10 mm) to 22 gauge (0.70 mm) 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.