SpectrumX BAC-STAT 0.9% 5ml Ampoules × 10

Instructions:

Professional Use Instructions

SpectrumX BAC-STAT Bacteriostatic Saline 0.9% must only be used by appropriately trained healthcare professionals and only where clinically appropriate.

Before use, confirm that bacteriostatic sodium chloride 0.9% is compatible with the medicine being diluted or reconstituted. Always follow the prescription, product SmPC, manufacturer instructions, local SOPs and professional judgement.

Directions for Use

1. Confirm that BAC-STAT is suitable for the intended medicine and patient.
2. Check the ampoule, packaging, batch number and expiry date before use.
3. Do not use if the ampoule is damaged, leaking, contaminated, expired or if the solution appears cloudy, discoloured or contains particles.
4. Prepare the product using appropriate aseptic technique.
5. Open the ampoule carefully according to local clinical procedure.
6. Withdraw the required volume using suitable sterile equipment.
7. Use only the volume required for the prescribed preparation.
8. Mix or reconstitute only in accordance with the medicine manufacturer’s instructions and clinical protocol.
9. Use immediately after opening unless the manufacturer guidance specifically states otherwise.
10. Dispose of any unused contents safely.
11. Record the product name, batch number, expiry date and amount used where required by local SOPs.

Important Compatibility Information

BAC-STAT contains sodium chloride 0.9% and benzyl alcohol. It must only be used with medicines that are compatible with both sodium chloride and benzyl alcohol.

Do not use BAC-STAT where the medicine being prepared specifically requires:

* Water for injection
* Preservative-free sodium chloride
* A different diluent
* A specific manufacturer-supplied solvent
* A diluent with no benzyl alcohol

If compatibility is unclear, do not use until confirmed by the medicine manufacturer, SmPC, prescriber, pharmacist or appropriate clinical reference.

Single Ampoule Use

Although BAC-STAT contains a bacteriostatic preservative, 5ml ampoules are not resealable multi-dose containers.

Once opened, the ampoule should be used immediately and any remaining solution should be discarded in accordance with local policy. Do not store an opened ampoule for later use.

Do Not Use If

Do not use BAC-STAT if:

* The patient has known hypersensitivity to benzyl alcohol or any component
* The medicine being prepared is not compatible with bacteriostatic saline
* The ampoule is damaged, opened, leaking or contaminated
* The solution is cloudy, discoloured or contains visible particles
* The product has expired
* A preservative-free diluent is required
* The intended use is outside professional training or local protocol

Benzyl Alcohol Warning

BAC-STAT contains benzyl alcohol.

Benzyl alcohol may cause allergic reactions and is associated with serious adverse effects in premature babies and neonates. It should not be used in neonates or infants unless specifically directed by an appropriate specialist and supported by product guidance.

Caution is required in patients who are pregnant, breastfeeding, have liver impairment, kidney impairment, or where repeated or high-volume exposure to benzyl alcohol may occur.

Important Safety Information

This product is for professional healthcare use only.

It should not be injected directly unless this is specifically clinically appropriate and supported by the relevant product information and prescriber direction.

It should not be used for:

* Neonates or premature babies
* Eye irrigation
* Wound washing
* General skin cleansing
* Intravenous flushing unless specifically indicated
* Reconstitution of medicines requiring preservative-free diluent
* Any medicine where sodium chloride or benzyl alcohol is incompatible

Possible Side Effects

Side effects may relate to the medicine being prepared, the route of administration, the patient’s condition or sensitivity to ingredients.

Possible reactions associated with components or administration may include:

* Injection site discomfort
* Irritation
* Redness
* Allergic reaction
* Hypersensitivity to benzyl alcohol
* Unexpected reaction related to incompatibility if used incorrectly

Seek urgent medical attention if symptoms of a severe allergic reaction occur, such as swelling of the face, lips, tongue or throat, difficulty breathing, severe rash or collapse.

Storage Instructions

Store in accordance with the instructions on the product packaging.

Keep ampoules in the original packaging until use. Protect from contamination, damage, heat and direct sunlight.

Keep out of the sight and reach of children.

Do not use after the expiry date printed on the packaging.

Disposal

Dispose of opened ampoules, unused solution, needles, syringes and clinical waste in accordance with local sharps and clinical waste procedures.

Do not reuse opened ampoules.

Disclaimer

This information is provided for general professional product guidance and does not replace the product packaging, manufacturer instructions, prescription directions, SmPC guidance for the medicine being prepared, local SOPs or professional judgement. Always confirm compatibility and suitability before using BAC-STAT Bacteriostatic Saline 0.9%.