Sterilized water for Injections BP 10ml

Sterilized water for Injections BP 10ml

Sterilized water for Injections BP 10ml

Sterilized water for injections BP 10ml does not contain a drug substance.

Mechanism of action

Not applicable, sterile water for injection used as a reconstitution of drug. Mechanism of action related to the added medicinal product should be considered.

Pharmacological action

Not applicable, sterile water for injection used as a reconstitution of drug. Pharmacological of action related to the added medicinal product should be considered.

Indication

The applicant has submitted the following

For the reconstitution, dilution and making-up of appropriate drugs where sterilized water for injection is the diluents of choice and for use as an irrigant.

Water for  injections has no pharmacological activity of its own and is used simply as a vehicle. The proposed indications are consistent with the original product and other water for injections products.

Contraindications

Water for injections should not be administered alone.

The contraindications related to the added medicinal product should be considered.

Precautions and warnings

Do not use if found hazy, suspended particles or leakage.

Water for injections is hypotonic and should not be administered alone.

Do not use for intravenous injection unless adjusted to appropriate isotonicity with a suitable solute.

When water for injections is used as a diluents for hypertonic solution, appropriate dilution should be applied to bring the solution close to isotonicity.

Haemolysis may occur following infusion of large volume of hypotonic solutions using sterile water for injections as a diluents. When administering large volumes, the ionic balance should be regularly monitored. The large volume presentations (500ml and 1000ml) are for use as a bulk source of diluents in pharmacy compounding. They are not for direct intravenous administration.

Adverse reactions

The adverse event profile of water for injections is not considered to be a point of issue providing excessive administration is avoided, with adverse events being extremely rare. Water for injections is widely used and has a well defined safety profile. The data provided confirms the conclusion that the product has a benign safety profile.

Intravenous injections of water for injections may cause haemolysis if water for injections is administered alone. The nature of the additive will determine the likelihood of any other undesirable effects.

Drug interactions

None known

The possible clinical interactions between the different medicinal products to be dissolved should be considered.

Dosage and administration

The dosage and administration is dependent on the nature of added drug.

Overdosage

Haemolysis may occur following infusion of large volume of hypotonic solutions using sterile water for injections as diluents.

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The signs and symptoms of overdose will also be related to the nature of the medicinal product being added. In the event of accidental over the treatment should be discontinued and the patient should be observed for the appropriate signs and symptoms related to the medicinal product administered.

Storage

Store below 30°c. Keep out of the children.

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