Ampoules - Water for Injections B.P.
Sterile Water
Therapeutic Class
Water for Injections is a non-isotonic solution.
Description and Composition
A clear, colorless, sterile, non-isotonic solution, ready-to-use, each ampoule of which contains:
- Water for Injections B.P.: 10 mL
It does not contain any preservatives.
Indications
- Water for Injections is used for the reconstitution and preparation of medicines for parenteral administration and for dissolving or diluting substances or preparation for parenteral administration.
Dosage and Administration
The dosage for Water for Injections is the amount required to reconstitute or prepare other medicines for parenteral administration. Ensure that all solutions prepared with Water for Injections are isotonic before use (see Precautions).
Appropriate solubility, dilution, and compatibility with other additives must be ensured. The product information of the relevant product should be referred to for ascertaining the maximum time between aseptic preparation and administration.
Solutions prepared with Water for Injections may be administered intravenously, intramuscularly, or subcutaneously.
Adverse Effects
- No adverse reactions are known to be associated with Water for Injections. There should be no adverse reaction to Water for Injections if used as indicated to dissolve compatible substances to form an isotonic solution prior to injection.
- Injection of Water for Injections without the addition of solute may result in cell damage due to hypotonic effects (see Precautions and Overdosage).
Contraindications
- Incompatibility or inappropriate solubility with the substance / drug being reconstituted / prepared.
Precautions
- The product information of the substance / drug being prepared / reconstituted should be referred to before dissolving or diluting, to ensure that Water for Injections is the recommended solvent or diluent.
- Ensure that the solution prepared with Water for Injections is isotonic with blood before intravenous administration.
- Water for Injections has been administered to a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
- The Product Information of the medicine to be dissolved or diluted should be checked to ensure that it is appropriate for use during pregnancy.
- Water for Injections can be administered to women who are breast-feeding.
- The Product Information of the medicine to be dissolved or diluted should be checked to ensure that it is appropriate for use during lactation.
Overdosage
- Overdose with small volume presentations of Water for Injections is unlikely. If larger volumes of Water for Injections are inadvertently injected without first ensuring isotonicity, the hypotonic effects may include local cell damage or haemolysis.
- Electrolyte abnormalities are possible. The patient should be assessed and treated appropriately.
Tonicity and Osmolarity
- Non-isotonic solution.
- Hypo-osmolar solution.
Caloric Value
Nil.
Pharmaceutical Precautions
- Aseptic technique must be used when preparing and administering solutions for parenteral use.
- Usually, solutions are prepared immediately before use.
- Store below 25°C.
- Water for Injections is for use in one patient on one occasion only.
- Discard any unused portion.
Packaging
10 mL plastic ampoules.
Pharmacological Effects
- Water for Injections is considered to be a non-isotonic solution.
- Water for Injection is water for the preparation of medicines for parenteral administration in which water is used as a vehicle and for dissolving or diluting substances or preparation for parenteral administration.
- The chemical name is hydrogen oxide and its molecular formula is H₂O.
- The molecular weight is 18.02.