ARTG Entry
Baxter
ARTG entry for Baxter (potassium chloride, sodium chloride), ARTG 159379 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Baxter Healthcare
- Active ingredient: potassium chloride, sodium chloride
- Therapeutic area: Other
What it is
Baxter Water for Injections is sterile water prepared for injection. It is sterile, nonpyrogenic water, prepared from purified water by distillation and presented in VIAFLEX plastic bags as a single dose container. No antimicrobial agents or other substances have been added. Baxter Water for Injections is slightly acidic, due to a low level of HCl released from VIAFLEX plastic bags during sterilisation, with pH of 5.5 (range 4.5–7.0).
Approved indications
— Vehicle for medicinal products when water is a suitable solvent for dissolving or diluting injectable therapeutic substances for parenteral administration.
Dosing overview
As Baxter Water for Injection is indicated only as a vehicle for aseptic reconstituting and administration of drug admixture, dosage limitations are not applicable to this product. Baxter Water for Injections must not be administered unless it has been adjusted to an isotonic solution by using suitable solute.
Key safety warnings
Baxter Water for Injections is hypotonic causing haemolysis if it is injected alone and is contraindicated for intravenous administration if not adjusted to isotonicity by the addition of suitable solutes. Intravenous administration of Baxter Water for Injections without added solute causes haemolysis, and haemoglobin-induced renal failure has been reported following haemolysis. Baxter Water for Injections is slightly acidic, which may cause degradation or precipitation of certain drugs. Additives may be incompatible, and those additives known to be incompatible with water or the VIAFLEX plastic bag should not be used. VIAFLEX plastic bags should not be used in series connections, as such use could result in embolism due to residual air being drawn from the primary bag before administration of the fluid from the secondary bag container is completed.
Contraindications
Baxter Water for Injections is contraindicated for intravenous administration if not adjusted to isotonicity by the addition of suitable solutes, as it causes haemolysis.
Regulatory history
Baxter Water for Injections was first approved on 30 September 1991. ARTG 19456 records Baxter Water for Injections 1000 mL injection BP bag, first listed 1991-09-30.