Intra Venous Fluid

1. Name of the medicinal product

Sodium Chloride Injection BP 0.9% w/v

 

2. Qualitative and quantitative composition

Each ml contains 0.9% Sodium Chloride in Water for Injections.

 

3. Pharmaceutical form

Sterile Injection.

 

4. Clinical particulars4.1 Therapeutic indications

For use in prophylactic and replacement therapy, requiring the use of isotonic saline solution.

In the reconstitution, dilution and making up of certain drugs.

As a saline irrigant.

As a priming fluid for haemodialysis procedures and to initiate and terminate blood transfusions.

 

4.2 Posology and method of administration

In the prophylaxis or replacement therapy of extracellular fluid deficits, the dosage of sodium chloride injection BP 0.9% is dependent on the age, weight, clinical status and degree of deficiency, and must be determined on the individual basis.

 

4.3 Contraindications

There are no absolute contraindications to use of Sodium Chloride Injection BP 0.9% w/v.

 

4.4 Special warnings and precautions for use

Sodium Chloride Injection BP 0.9% w/v, should be administered with caution to patients with congestive cardiac failure, pre-eclampsia, impaired renal function or oedema with sodium retention. Care is also required with administering this solution to very young or to elderly patients. Pseudohyponatraemia is a condition in which spuriously low concentrations of sodium are found when plasma sodium is measured by conventional methods. It may occur when there is an abnormally high concentration of large molecules and hence an abnormally low percentage of plasma water. This may occur in hyperlipaemia and hyperproteinaemia and has also been reported in patients with diabetes mellitus. Correct values may be obtained by referring the concentration to plasma water.

Before use, ensure that the container is undamaged and the contents clear in appearance. After use, discard any remaining solution.

 

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant administration of other sodium salts, may contribute to the sodium load. Only use as a pharmaceutical diluent where indicated in the manufacturer's literature.

 

4.6 Pregnancy and lactation

The solution is physiological saline and may be used during pregnancy and lactation.

 

4.7 Effects on ability to drive and use machines

None known.

 

4.8 Undesirable effects

Injudicious intravenous saline therapy (e.g. post-operative and in patients with impaired cardiac or renal function) may cause hypernatraemia. Osmotically induced water shift decreases intracellular volume, resulting in dehydration of internal organs, especially the brain, which may lead to thrombosis and haemorrhage. General adverse effects of sodium chloride excess in the body include: nausea, vomiting, diarrhoea, abdominal cramps, thirst, reduced salivary and lachrymal secretions, sweating, fever, hypotension, tachycardia, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death. Excess chloride in the body may cause a loss of bicarbonate, with an acidifying effect. With judicious use of intravenous saline therapy these side effects can be avoided. If administered sub-cutaneously, any addition to the isotonic solution could render it hypertonic and cause pain at the site of injection.

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 Yellow Card Scheme at:

• Pay Mode Terms: L/C (Letter of Credit),T/T (Bank Transfer),D/P,D/A
• Port of Dispatch: Mundra
• Production Capacity: 150000 Ltr/Day
• Delivery Time: 15 Days
• Packaging Details: Export Worth Packing