SpectrumX BAC-STAT 0.9% — 5 × 5ml

Instructions:

Professional Use Instructions

Bacteriostatic Sodium Chloride 0.9% Solution should only be used by appropriately trained healthcare professionals and in accordance with a valid prescription, the requirements of the medicinal product being prepared and appropriate clinical protocols.

This is an unlicensed medicinal product.

Before Use

Before using the solution:

Confirm the prescription
Confirm the patient
Confirm that bacteriostatic sodium chloride is the correct diluent
Check the medicine being reconstituted permits this diluent
Check the required dilution volume
Confirm sodium chloride concentration
Confirm benzyl alcohol content
Review allergy and hypersensitivity history
Check the ampoule batch number and expiry date
Inspect the ampoule for cracks or damage
Inspect the solution for particles, cloudiness or discolouration
Review any relevant contraindications

Do not use if the ampoule is damaged, expired, contaminated or if the solution appears abnormal.

Directions for Professional Use
Confirm that Bacteriostatic Sodium Chloride 0.9% is compatible with the medicine being prepared.
Wash or sanitise hands and prepare an appropriate clean working area.
Use aseptic technique throughout preparation.
Check the 5ml ampoule before opening.
Ensure fluid has moved away from the ampoule neck before opening.
Open the ampoule using an appropriate ampoule-opening technique or suitable ampoule snapper.
Withdraw only the amount required using appropriate sterile equipment.
Prepare or dilute the medicinal product exactly according to its manufacturer instructions and prescription.
Label the prepared medicine appropriately where required.
Administer the prepared medicine only by the route and method specified for that medicinal product.
Dispose of the opened ampoule and any remaining solution after use.
Do not retain an opened glass ampoule for subsequent treatment sessions.
Dispose of needles, syringes and broken ampoule glass through appropriate sharps and clinical waste routes.
Important Diluent Compatibility

Do not assume all injectable medicines can be mixed with bacteriostatic saline.

Before reconstitution, confirm:

Correct diluent
Correct concentration
Correct dilution volume
Compatibility with benzyl alcohol
Appropriate pH and formulation requirements
Stability after dilution
Permitted storage period
Route of administration

If the medicinal product specifies preservative-free sodium chloride or water for injection, do not substitute bacteriostatic saline unless authorised by appropriate manufacturer information and the prescriber.

Single-Ampoule Use

Each 5ml glass ampoule should be opened immediately before use.

Once opened:

Use the required solution promptly
Do not attempt to reseal the ampoule
Do not retain it for use on another patient
Do not store an opened ampoule for later use
Dispose of remaining solution safely

The presence of benzyl alcohol does not make an opened glass ampoule a reusable multi-dose vial.

Do Not Use If

Do not use if the patient:

Has known hypersensitivity to sodium chloride, benzyl alcohol or another component
Has previously experienced a serious reaction to a benzyl alcohol-containing product
Has a contraindication to the medicinal product being prepared
Has not been appropriately assessed for use of this unlicensed medicine

Product-specific UK supplier information also advises against use in pregnancy, breastfeeding and impaired liver or kidney function unless appropriately clinically assessed.

Important Benzyl Alcohol Warning

This product contains benzyl alcohol 0.9%.

Benzyl alcohol may cause allergic or hypersensitivity reactions.

Particular caution is required where cumulative exposure to benzyl alcohol may be significant.

Use in children, pregnancy, breastfeeding or patients with liver or kidney impairment should only occur where specifically assessed and prescribed by an appropriate healthcare professional.

Possible Adverse Effects

Potential reactions associated with use may include:

Local irritation
Pain or discomfort
Redness
Swelling
Hypersensitivity
Rash
Itching

Serious allergic reactions may occur in susceptible individuals.

Seek urgent medical assistance if symptoms include:

Difficulty breathing
Wheezing
Swelling of the face, lips, tongue or throat
Severe rash
Dizziness
Collapse

Adverse effects may also arise from the medicine that has been reconstituted rather than from the diluent itself.

Unlicensed Medicine Requirements

Tor-Bac bacteriostatic saline is supplied in the UK as an unlicensed medicine.

It should only be used to meet the special clinical needs of an individual patient where a suitable licensed medicine cannot meet those needs.

The prescriber assumes responsibility for:

Deciding that the unlicensed medicine is clinically necessary
Appropriate prescribing
Patient counselling
Monitoring
Follow-up
Management of adverse reactions
Storage Instructions

Store according to the conditions stated on the physical packaging.

Keep ampoules:

In their original packaging
Protected from excessive heat
Protected from direct light where stated
Clean and dry
Out of reach of children and unauthorised individuals

Do not use after the expiry date.

Do not freeze unless the physical packaging specifically permits it.

Disposal

Dispose of:

Opened ampoules
Unused remaining solution
Broken glass
Needles
Syringes
Contaminated clinical materials

according to appropriate sharps and clinical waste procedures.

Do not place broken ampoule glass or loose needles into general household waste.

Disclaimer

This information is provided for general professional product guidance and does not replace the prescription, product information, requirements of the medicinal product being diluted, prescriber instructions, professional training, local protocols or clinical judgement.

This is an unlicensed medicine and should only be used where specifically prescribed to meet an individual patient's clinical need.