Product Dossier

Bridgewest

Product Dossier for Bridgewest (cetrimide, chlorhexidine gluconate, LumaCina). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

Bridgewest Water for Injections BP is a sterile, non-isotonic, clear, colourless solution in a ready-to-use, single dose presentation. It does not contain preservatives.

Approved indications

— Reconstitution and preparation of aqueous injections

Dosing overview

The dosage for Water for Injections is the amount required to reconstitute or prepare other agents. All solutions prepared with Water for Injections must be isotonic before use. Solutions prepared with Water for Injections may be administered intravenously, intramuscularly or subcutaneously.

Key safety warnings

Water for Injections is hypotonic and causes haemolysis if injected alone. It is contraindicated for intravenous administration if not adjusted to isotonicity by the addition of suitable solutes. The solution prepared with Water for Injections must be isotonic with blood before intravenous administration, as intravenous administration of water or hypotonic solution may cause haemolysis. If larger volumes of Water for Injections are inadvertently injected without first ensuring isotonicity, the hypotonic effects may include local cell damage or haemolysis, and electrolyte abnormalities are possible.

Contraindications

Water for Injections is contraindicated for intravenous administration if not adjusted to isotonicity by the addition of suitable solutes.

Regulatory history

Bridgewest Water for Injections BP was first listed on the ARTG on 22 June 1994 in a 20 mL ampoule presentation, with the 100 mL vial and 10 mL ampoule also listed on 22 June 1994, and the 2 mL ampoule on 22 June 1994, with the 5 mL ampoule following on 23 June 1994.