Consumer medicine information

Sterile Water for Injections BP

Water for injections

BRAND INFORMATION

Brand name

Baxter Water for Injections BP

Active ingredient

Water for injections

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Sterile Water for Injections BP.

What is in this leaflet?

This leaflet answers some common questions about Sterile Water for Injections BP. The letters BP following the name signify that it complies with the British Pharmacopoeia, which is the official reference standard for medicines in Australia.

It does not contain all of the available information.

All medicines have risks and benefits. Your doctor has ordered the use of Sterile Water for Injections for you in the knowledge that the benefits outweigh any possible risks. It does not take the place of talking to your doctor, nurse or pharmacist. If you have any concerns about receiving this medicine, ask your health care professional

What is Water for Injections used for?

Sterile Water for Injections is used for preparation of a medicine intended for injection or infusion by slow drip into a vein. It is only to be used for this purpose and should not be injected without the inclusion of medicine.

Before you are given Water for Injections

Water for Injections should not be given to you if:

  • it has not been mixed with a medicine to a concentration to match that of blood

You must tell your doctor if you:

  • have any other illness
  • are taking any other medicines including anything that you bought without a prescription from your pharmacy, supermarket or health food shop
  • are allergic to any type of medication
  • are pregnant
  • are breast feeding

How Water for Injections is given

How much it is given:

Your doctor knows that Water for Injections alone should not be injected into your vein. Your health professionals know how much medicine should be added to Water for Injections before this solution is injected or dripped into your vein.

How it is given:

The medicine added to Water for Injections will usually be given at a slow rate of injection (drip), or as a small volume injection into a muscle by a health professional.

Usually, you will be visiting a doctor’s surgery, or staying in a health institution (hospital, clinic, nursing home, etc). Special medical equipment is used to deliver the medicine into your bloodstream. This delivery should be attended by a health professional. For an intravenous drip, a cannula (administration needle) is normally placed in a vein by your doctor or nurse.

In case of overdose

A doctor or nurse injecting you has had experience in the use of Water for Injections, so it is unlikely that you will be given an overdose.

While you are receiving a medicine mixed in Water for Injections

As injections and IV drips are normally given in a doctor’s surgery, clinic or hospital, your doctor or nurse will make appropriate records during your treatment and will note any unexpected effects you may experience.

Side effects

In case you experience side effects during or after the treatment with a medicine mixed in Water for Injections, it is most likely caused by the added medicines.Some swelling of the hands, ankles and feet may be experienced due to retention fluid in your body. In rare circumstances, this may also involve the lungs, which may cause some breathing difficulty. Inflammation at the site of injection, or swelling of your veins near the site of injection is also possible.

Product descriptions

What Water for Injections looks like?

It is sterile, clear, colourless water packaged in flexible Viaflex plastic bags. Added medicine/s may cause its appearance to change, resembling that of the added solutions.

What is in Water for Injections?

Water for Injections does not contain either active ingredient or antimicrobial agent. The composition of this product is water only. It is supplied in flexible Viaflex plastic bags as a single unit dose of 1000 mL.

How to store Water for Injections

Water for Injections should be stored below 30°C. Do not freeze. Do not expose to heat. Keep out of reach of children.

Where can you get more information?

You can obtain more information from your doctor or pharmacist.

Name and address of the manufacturer (sponsor)

Baxter Healthcare Pty. Ltd.,
1 Baxter Drive,
Old Toongabbie N.S.W., 2146 Australia
www.baxterhealthcare.com.au.

This Consumer Medical Information was prepared: 4th March 2002 and revised 23rd December 2002

88-19-01-098

Baxter and Viaflex are registered trademarks of Baxter International, Inc.

Published by MIMS June 2019

BRAND INFORMATION

Brand name

Baxter Water for Injections BP

Active ingredient

Water for injections

Schedule

Unscheduled

 

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.
Intravenous administration of Baxter Water for Injections without added solute to non-pregnant or pregnant women is contraindicated as it causes haemolysis.
 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.

Summary Table of Changes