Water for Injection

Description: Water for Injection is a clear, hypotonic, sterile, and apyrogenic injectable solution. It is a highly purified form of water, free from solutes, bacteriostats, antimicrobial agents, or added buffers.

Pharmacological Characteristics: It is a hypotonic solution, meaning it has a lower solute concentration compared to other physiological media. Its osmolarity is effectively zero (0 mOsmol/L) as it contains no added solutes. Water is an essential constituent of all body tissues and is crucial for maintaining fluid balance. When administered intravenously, it provides a source of water, but due to its hypotonicity, it must be made isotonic by adding appropriate solutes to prevent hemolysis (bursting of red blood cells).

Indications: Dilution or dissolution of medicines according to medical prescription. It serves as a sterile solvent or diluent vehicle for drugs or solutions suitable for parenteral administration (intravenous, intramuscular, or subcutaneous injection).

Contraindications: Due to its hypotonicity, it should not be administered directly intravenously on its own, as it can cause hemolysis. It is contraindicated for intravenous administration without the addition of suitable solutes to achieve approximate isotonicity.

Dosage and Directions for Use:

• The solution should only be administered intravenously after being made approximately isotonic with suitable solutes, and on an individual basis.
• Dosage should be determined by a physician and depends on the patient’s age, weight, clinical condition, the medication diluted in the solution, and laboratory determinations.
• Before administration, parenteral solutions (including the final admixture) should be visually inspected for particulate matter, cloudiness, cracks, and any breaches in the primary packaging.

Important Warnings:

• PARENTERAL SOLUTIONS MUST BE ADMINISTERED BY QUALIFIED HEALTHCARE PROFESSIONALS. Self-medication or administration by untrained individuals can result in serious complications.
• ADMINISTRATION OF PARENTERAL SOLUTIONS REQUIRES CAREFUL ATTENTION TO PRESCRIBED DOSAGES. Errors in dilution or quantity administered can lead to serious or fatal adverse effects.
• PRODUCTS MUST BE STORED CORRECTLY IN ACCORDANCE WITH THE MANUFACTURER’S INSTRUCTIONS. Improper storage may lead to product contamination and loss of effectiveness.
• PARENTERAL SOLUTIONS MUST BE MONITORED AND ADMINISTRATION PROCESSED. Changes in parameters such as blood pressure, heart rate, and oxygen levels may indicate complications that require immediate intervention.
• DO NOT USE if the vial seal is broken or the medication is cloudy.
• DO NOT USE medication that has PASSED ITS VALIDITY PERIOD, as this may result in loss of therapeutic efficacy and risk of adverse effects.
• Vials should be used immediately after opening and SHOULD NOT BE STORED for future use.
• Risk of Hemolysis: Direct intravenous administration without a solute can cause red blood cells to burst.
• Fluid Overload: While less common when used as a diluent, excessive volumes can lead to fluid overload, particularly in vulnerable patients like neonates.
• Local Reactions: Potential for pain, irritation, or thrombosis at the injection site.
• Incompatibilities: Always verify compatibility with any added medications.
• Air Embolism: Do not use plastic containers in series connections.

Presentation:

• Sol. Inj. IV of Water for Injection – Box. 200 Amp. Trans. Plas. with 10mL
• Sol. Inj. IV of Water for Injection – Box. 70 FR Trans. Plas. with 100mL – Closed Syst.
• Sol. Inj. IV of Water for Injection – Box. 40 FR Trans. Plas. with 250mL – Closed Syst.
• Sol. Inj. IV of Water for Injection – Box. 24 FR Trans. Plas. with 500mL – Closed Syst.
• Sol. Inj. IV of Water for Injection – Box. 12 FR Trans. Plas. with 1000mL – Closed Syst.

Composition (per mL):

• Water for Injection qsp……….1 mL

Physical Properties:

• Osmolarity ……………………………………..0 mOsmol/L (Hypotonic)
• pH…………………………………………………….. 5.0 – 7.0

Validity Period:

24 months after the date of manufacture.