Consumer medicine information

STERILE WATER FOR IRRIGATION

Water for irrigation

BRAND INFORMATION

Brand name

Water for Irrigation (Baxter)

Active ingredient

Water for irrigation

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using STERILE WATER FOR IRRIGATION.

What is in this leaflet?

This leaflet answers some common questions about the Sterile Water for Irrigation [Water for Irrigation]. It does not contain all of the available information. All medicines have risks and benefits. Your doctor has weighed the risks against the benefits for you to use the Water for Irrigation in the treatment of your illness.

This leaflet does not take the place of talking to your doctor or pharmacist. If you have any concerns about having this treatment, ask your doctor or pharmacist.

What the Water for Irrigation is used for.

Water for Irrigation is used for general irrigation of body cavities, wounds, or indwelling urethral catheters. It is also used for rinsing or soaking surgical dressings that are in contact with wounds.

Before you are treated with Water for Irrigation

Water for Irrigation should not be used for your treatment if:

  • you are undergoing a major surgical procedure (as a significant amount of water may enter your circulation causing destruction of the red blood cells).
  • the solution is not clear and the seal intact.

You must tell your doctor if you:

  • have any other illness
  • are taking any prescription medicine or even non-prescription medicines
  • are allergic to any type of medication
  • are pregnant

How Water for Irrigation is used

How much is used:

Your health professionals know how much washing solution should be used for your treatment. As this medicine is a washing solution, there is no dosage limitation with this product as normally applied to other medicines.

How it is given:

Your doctor and health professionals know that the Water for Irrigation should not be injected into you. It is for external use. The Water for Irrigation in plastic bottle is for washing or rinsing of the wounds during a minor surgical procedure, whereas that in Viaflex plastic bags is for urethral irrigation given via an indwelling catheter and your health professionals know how to use them.

Water for Irrigation is for single use in a single patient

Overdose

Water for Irrigation is a washing solution; an overdose is unlikely to occur during the application of this solution for your treatment.

You should notify your nurse or doctor immediately if you have any unexpected effects. See Side Effects.

While you are using Water for Irrigation

Discuss with your doctor the progress you have experienced after the treatment, and whether any complication has occurred, especially during the first few days after the treatment.

Side effects

Adverse reactions rarely occur with the use of Water for Irrigation.

There may be undesirable effects if water damages tissues or enters the circulation. Symptoms may include fever, pain, blood in the urine, breathlessness or confusion.

If you experience any unexpected effect during or after the treatment with Water for Irrigation, you must tell your doctor or trained nurses immediately.

Product descriptions

What Water for Irrigation looks like

It is sterile, clear, colourless water filled in collapsible Viaflex plastic bags and plastic bottles. The Viaflex plastic bag is over wrapped with a plastic for protection of the product.

What is in Water for Irrigation?

Water for Irrigation does not contain any additive or antimicrobial agent. These products are only sterile water

They are supplied in flexible Viaflex plastic bags and plastic bottles as a single unit dose shown in the following

Sterile Water for Irrigation in plastic bottle (AHFCode) and Viaflex plastic bag (AHB Code) containers

Code No. AHF 7974
water (no antibacterial agent added)
Osmolarity 0 (zero) mOsmol/L
ARTG/AUSTR 35657
Pack Size 100 mL (1's)

Code No. AHF 7113
water (no antibacterial agent added)
Osmolarity 0 (zero) mOsmol/L
ARTG/AUSTR 35657
Pack Size 500 mL (1's)

Code No. AHF 7114
water (no antibacterial agent added)
Osmolarity 0 (zero) mOsmol/L
ARTG/AUSTR 35657
Pack Size 1000 mL (1's)

Code No. AHB 7606
water (no antibacterial agent added)
Osmolarity 0 (zero) mOsmol/L
ARTG/AUSTR 19457
Pack Size 2000 mL (1's)

Code No. AHB 7117
water (no antibacterial agent added)
Osmolarity 0 (zero) mOsmol/L
ARTG/AUSTR 19457
Pack Size 3000 mL (1's)

Note: under dilute condition osmolarity is approximately the same as osmolality (The products do not contain any substance other than water; thus osmolarity is zero)

How to store the Water for Irrigation

Exposure to heat should be minimised. Avoid excessive heat. Store below 25 °C.

Where can you get more information?

You can get more information from your doctor or pharmacist.

Name and address of the Sponsor

Baxter Healthcare Pty Ltd
ACN Number: 000 392 781
1 Baxter Drive
Old Toongabbie NSW 2146, Sydney

Last revision (final): 18th November 2002.

Proposed CMI in Australia. 18th Nov. 2002

Published by MIMS May 2003

BRAND INFORMATION

Brand name

Water for Irrigation (Baxter)

Active ingredient

Water for irrigation

Schedule

Unscheduled

 

Name of the medicine

Water for irrigation.

Description

Water for irrigation is sterile and nonpyrogenic water presented in plastic bottles and Viaflex plastic bags for use as a single dose for general irrigation purposes, such as washing body cavities, tissues or wounds, indwelling urethral catheters or rinsing surgical instruments aseptically.
The use of Water for irrigation is based on a mechanical cleansing action on the body tissues and cavities under sterile conditions. The pH is 5.5 (4.5-7.0) with osmolarity of zero, as it does not contain any solute. No antimicrobial agent or other substance has been added.

Pharmacology

Water is the main constituent of body fluid. Body weight is approximately 50-60% water. Total body water is distributed in the intracellular compartment (40-45% of body weight), and the extracellular compartment. The extracellular fluid is further subdivided into extravascular (interstitial) and intravascular (plasma water) spaces in the ratio 3:1. Water moves freely between these compartments.

Indications

Water for irrigation is used for general irrigation procedures (washing out) of body cavities, wounds, urethral catheters including rinsing and soaking of surgical dressings and/or instruments.

Precautions

For irrigation only. Not for injection or infusion by usual parenteral routes.
Water for irrigation is a hypotonic with an osmolarity of zero mOsmol/L.
Absorption of water for irrigation (through perforations, open wounds or body cavities) has resulted in fatal complications or permanent morbidity. Immediate intervention may be required to prevent these outcome.
Absorption can result in hyponatremia, hypo-osmolality, as well as fluid overload.
Possible complications include, but are not limited to, cerebral oedema, encephalopathy, pulmonary oedema, massive haemolysis, rhabdomyolysis, renal failure, and hyperkalaemia and their secondary manifestations and complications.
These complications can manifest after irrigation has ended.
The development of these complications is dependent on factors such as rate, volume, pressure and duration of irrigation.
If absorption of clinically relevant amounts of fluid is suspected, administration should be interrupted and the patient evaluated for signs of fluid absorption.
Close monitoring during and/or after the procedure is required in patients with increased risk for developing hyponatraemic encephalopathy, such as:
paediatric patients (< 16 years of age);
women, in particular premenopausal women;
patients with hypoxemia;
patients with underlying central nervous system disease.
In cases where significant absorption may occur (e.g. transurethral resection of prostate), Water for irrigation must, if at all, only be used with extreme caution.
Very close monitoring is required during and for an appropriate period after the procedure to allow for timely intervention.
Water for irrigation must be used only by physicians familiar with the treatment of possible complications.
Close monitoring during and/or after the procedure is required in patients at increased risk for developing a fluid overload syndrome (e.g. patients with severely impaired renal function, impaired cardiac function or other clinical conditions associated with oedematous states).
Excessive volume or pressure during irrigation may cause undue distention of body cavities and/or disruption of tissue.
When using Water for irrigation for pour irrigation, prevent contact of the fluid with the external surface of the container (including the thread for the bottle cap).

Use in pregnancy.

Safety and effectiveness in pregnant and lactated women have not been established.

Use in lactation.

Safety and effectiveness in pregnant and lactated women have not been established.

Use in paediatric patients.

Safety and effectiveness in paediatric patients have not been established. Paediatric patients (< 16 years of age) are at increased risk for developing hyponatremic encephalopathy, even with mild hyponatremia.

Use in geriatric patients.

When deciding on volume of irrigant and on duration and pressure of irrigation for a geriatric patient, consider that geriatric patients are more likely to have cardiac, renal, hepatic, and other diseases or concomitant drug therapy.

Only for Water for Irrigation in flexible containers.

The container must not be vented.
Vented administration sets with the vent in the open position should not be used with flexible plastic containers. Use of a vented administration set with the vent in the open position could result in air embolism.
Pressurising fluids contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to use.
Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.
When using Water for irrigation for pour irrigation, prevent contact of the fluid with the external surface of the container.

Adverse Effects

The following adverse events have been reported in the post-marketing experience:
hyponatremia, fluid overload, fluid absorption, electrolyte imbalance;
cerebral oedema;
burning sensation (with irrigation of eyes and skin wounds);
rhabdomyolysis (myoglobinuria);
renal failure.
Adverse reactions which may occur in association with absorption of water for irrigation include:
haemolysis (haemoglobinemia, haemoglobinuria);
hypervolemia, hypo-osmolality, hyperkalaemia, electrolyte imbalance, acid/base balance disorder;
encephalopathy (convulsion, loss of vision, lethargy, disorientation, irritability, vomiting, nausea, headache);
cardiac arrest, cardiac failure, bradycardia and electrocardiogram abnormal;
hypertension, postoperative hypotension;
respiratory arrest, respiratory failure and pulmonary oedema.

Directions For Use

General administration.

For single use only. Not be administered intravenously, orally or by other usual parenteral routes.
Volume and/or rate of irrigation depend on the type of the procedure and the capacity or the surface area of the structure to be irrigated.
Water for irrigation should be inspected visually for particulate matter and discoloration prior to use whenever fluid and container permit. Do not use if the fluid is not clear or the seal is not intact.
Aseptic technique must be used.
The contents of the opened container should be used immediately to minimize potential for bacterial growth and pyrogen formation, and the unused contents of opened containers must be discarded, since Water for irrigation does not contain an antimicrobial agent.
Microwave heating of irrigation fluids is not recommended.
Water for irrigation that has been warmed must not be returned to storage.

To open (Viaflex bag).

1. Tear the overpouch sharply downwards at the slit and remove the Viaflex plastic bag. Some opacity of the plastic 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.
2. Check for minute leaks by squeezing the bag firmly. If leaks are found, discard the solution, as sterility may be impaired.
3. Suspend the container using the hanger hole.
4. Remove the plastic protector from the outlet at the bottom of the container (blue tip).
5. Attach irrigation set. Refer to the complete directions accompanying the set.
6. Discard unused portions.

Incompatibilities.

Additives may be incompatible. Compatibility of additives with Water for irrigation must be assessed before addition, by checking for, e.g. a possible colour change and/or the appearance of precipitates, insoluble complexes, or crystals.
Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Water for irrigation is appropriate.
The instructions for use of the medication to be added and other relevant literature must be consulted. Additives known or determined to be incompatible should not be used.
When making additions; aseptic technique must be used. Mix thoroughly when additives have been introduced. Do not store Water for irrigation containing additives.

Storage

Viaflex bags.

Store below 30°C. Do not Freeze. Do not heat unit in excess of 65°C. Shelf life is 2 years.

Steri-bottles.

Store below 30°C. Do not freeze. Do not heat unit in excess of 80°C. Shelf life is 2 years.

Poison Schedule

Unscheduled.