Description

This product is a sterile, isotonic solution containing 0.9% sodium chloride, commonly known as saline. It is clear, colourless, and free from preservatives, designed for medical use in various applications such as intravenous infusion, injection, or irrigation.

Composition

• Sodium Chloride (NaCl): 0.9%
• Excipients: Water for injection
• pH Adjustment: May include hydrochloric acid and/or sodium hydroxide

The solution is non-pyrogenic and maintains an osmolarity of approximately 308 mOsmol/L, with a pH ranging from 4.5 to 7.0.

Indications and Uses

This saline solution is intended for:

• Replenishing fluids and electrolytes
• Serving as a vehicle or diluent for compatible drugs
• Priming hemodialysis or blood transfusion sets
• Sterile irrigation of tissues, wounds, or body cavities

Administration

The administration route includes intravenous infusion, injection, or topical irrigation, depending on the specific presentation. Dosage should be individualized based on clinical needs, and the solution should only be used if it remains clear with an intact container seal. It is intended for single use, with any unused portion to be discarded.

Contraindications

Use is contraindicated in conditions such as:

• Congestive heart failure
• Severe renal impairment
• Sodium retention states
• Oedema
• Liver cirrhosis

Warnings and Precautions

Careful monitoring is advised for patients with cardiovascular, renal, or hepatic conditions. Fluid balance and serum electrolytes should be regularly checked. The solution should not be used with blood products through the same administration set to avoid complications.

Adverse Effects

Potential adverse effects include fluid overload, electrolyte imbalances, and local site reactions. In rare cases, hypersensitivity reactions may occur.

Storage

Store the solution below 25°C (or 30°C for some presentations), avoiding freezing and protecting from light as necessary. It should be used immediately after opening, with a typical shelf life of 2 to 3 years.

Packaging

The product is available in various sizes, ranging from 5 mL to 1000 mL, and is packaged in single-use ampoules, vials, or flexible plastic bags. Container materials include polyethylene, polypropylene, and glass.

Regulatory Information

This product is CE marked in the EU as a Class IIa medical device for irrigation purposes. It meets relevant pharmacopeial standards and is not classified as hazardous for transport.

Disposal

Unused solution and waste should be disposed of according to local regulations, ensuring no release into drains or the environment. Proper inspection and sterile techniques are essential for safe and effective use.