Baxter Water for Injections

MIMS Revision Date: 01 March 2021

1 Name of Medicine

Water for Injections.

2 Qualitative and Quantitative Composition

The composition of the Baxter Water for Injections is sterile water only.
Baxter Water for Injections is sterile, nonpyrogenic water, prepared from purified water by distillation and presented in Viaflex plastic bags as a single dose container. It is intended for intravenous administration after the addition of a suitable solute. It may also be used as a dispensing container, and a diluent for drugs requiring reconstitution. 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. The pH is 5.5 (4.5 - 7.0). The osmolality is 0 (zero) mOsm/kg as it does not contain any solute.

3 Pharmaceutical Form

Solution for Injection (for drug diluent use only).

4 Clinical Particulars

4.1 Therapeutic Indications

Baxter Water for Injections is employed as a vehicle for medicinal products when water is a suitable solvent for dissolving or diluting injectable therapeutic substances for parenteral administration.

4.2 Dose and Method of Administration

Dosage. As Baxter Water for Injection is indicated only as a vehicle for aseptic reconstituting and administration of drug admixture, the dosage limitations are not applicable to this product.
Do not administer Baxter Water for Injections unless it has been adjusted to an isotonic solution by using suitable solute. The medical literature, the package insert and other available sources of information for the intended therapeutic agent should be reviewed for information and incompatibility problems.
Admixtures using Baxter Water for Injections as a vehicle should be inspected visually for particulate matter and discolouration prior to the administration whenever solution and container permit. Additives may be incompatible, and complete information on all of these is not available. Those additives known to be incompatible with water or the Viaflex plastic bag should not be used. Consult with a Pharmacy Drug Information Service, if available.
Direction for use. Do not use Viaflex plastic bags in series connections. 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.
To open. Tear the over pouch sharply downwards at the slit and remove the Viaflex plastic bag. Some opacity of the plastic bag may be observed. This is due to moisture absorption during the sterilisation process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard the solution, as sterility may be impaired. If supplemental medication is desired, follow directions below.
Preparation for administration. Baxter Water for Injections is a sterile preparation. Thus, aseptic technique must be applied throughout the administration.
(1) Suspend container from eyelet support.
(2) Remove the blue plastic protector from the administration outlet port at the bottom of container.
(3) Attach administration set.
To add medication. Warning: Additives may be incompatible (see Section 6.2 Incompatibilities).
To add medication before solution administration. Hold bag with ports uppermost. Decontaminate the medication site with an agent in accordance with the institution's Infection Control Policy. Using a syringe with a 19 to 22-gauge needle (0.90 - 0.7 mm), puncture the resealable medication site and inject. Mix solution and medication thoroughly. Squeeze ports while the bags are upright and mix the solutions thoroughly.
To add medication during solution administration. Close clamp on the set. Decontaminate the medication site. Using syringe with 19 to 22-gauge needle (0.90 - 0.7 mm), puncture resealable medication site and inject. Remove container from IV pole and/or turn to upright position. Empty both ports by squeezing them while container is in the upright position. Mix solution and medication thoroughly. Return container to its in use position and continue administration.

4.3 Contraindications

Baxter Water for Injections is hypotonic causing haemolysis if it is injected alone. It is contraindicated for intravenous administration if not adjusted to isotonicity by the addition of suitable solutes.

4.4 Special Warnings and Precautions for Use

General. The safety of the Viaflex plastic bag containing Baxter Water for Injections has been confirmed in tests with animals as well as by tissue culture toxicity studies. Nevertheless, prior to addition of drugs into the bags, compatibility with the container should be ascertained (see Section 4.2 Dose and Method of Administration).
The medical literature, the package insert and other available sources of information should be reviewed for thorough understanding of possible of incompatibility problems. In particular, Baxter Water for Injections is slightly acidic resulting from a low level of HCl released from the Viaflex plastic bags during the sterilisation, pH of 5.5 (range of 4.5 - 7.0), which may cause degradation or precipitation of certain drugs.
Do not administer Baxter Water for Injections unless it has been adjusted to an approximately isotonic solution by using a suitable solute. Intravenous administration of Baxter Water for Injections without added solute is contraindicated as it causes haemolysis. Haemoglobin induced renal failure has been reported following haemolysis. Do not use Baxter Water for Injections unless the solution is clear and seal is intact.
Use in the elderly. No data available.
Paediatric use. No data available.
Effects on laboratory tests. The effect of this medicine on laboratory tests has not been established.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No data available.
Use in pregnancy. Intravenous administration of Baxter Water for Injections without added solute to non-pregnant or pregnant women is contraindicated as it causes haemolysis.
Use in lactation. Water is the main constituent of the body fluid and moves freely into nursing mother's milk. Even though no direct effect to the infant, intravenous administration of Baxter Water for Injections without added solutes should not be attempted because it causes haemolysis, resulting in harm to the nursing mother.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Intravenous administration of Baxter Water for Injections without added solutes causes haemolysis. Even in the presence of added substances, they may be insufficient to render the solution isotonic. Administration of such an admixture may still be associated with adverse reactions. Other adverse reactions may include fever, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. These may not necessary be due to the Baxter Water for Injection itself. There is also a possibility of unintentional hospital acquired infections.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient's status, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
Reporting suspected adverse effects. Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

No data available.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Water is the main constituent of the body fluids. Body weight is approximately 60% of water distributed in intracellular, interstitial and vascular compartments. The water content in the intracellular fluid, i.e. the water inside the cells, is about 40 to 45% of body weight. Water moves freely between these compartments. Thus, pharmacological action of the Baxter Water for Injection is as a vehicle for substances in maintaining the isotonicity across these compartments.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

As Baxter Water for Injections is solute-free with osmolarity of zero (a hypotonic solution), its entry into the systemic circulation will result in a dilution of the electrolytes in the extracellular fluid leading to the movement of water into the red blood cells causing haemolysis. Thus, Baxter Water for Injections should not be injected without adjusting it to isotonicity by the addition of suitable solute.

5.3 Preclinical Safety Data

Genotoxicity. Water is the main constituent of the body fluids and is not known as a mutagen.
Carcinogenicity. Water is the main constituent of the body fluids and is not known as a carcinogen.

6 Pharmaceutical Particulars

6.1 List of Excipients

There are no excipients in Baxter Water for Injections.
See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Additives may be incompatible, and complete information on all of these is not available. Those additives known to be incompatible with water or the Viaflex plastic bag should not be used. Consult with a Pharmacy Drug Information Service, if available.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Baxter Water for Injections is supplied in Viaflex plastic bags as a single unit dose. See Table 1.

Package size: 1000 mL.

6.6 Special Precautions for Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure. Water for injections. Molecular formula: H₂O.
Molecular Weight: 18.02.
CAS number. Water for injections. CAS No.: 7732-18-5.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Date of First Approval

30 September 1991

Date of Revision

25 January 2021

Summary Table of Changes