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BAC STAT Bacteriostatic Saline 0.9% (30ml)

BAC STAT Bacteriostatic Saline 0.9% (30ml)

BAC-STAT

Prescription-only medicine / diluent
  • Sterile and pyrogen Free parenteral solution as indicated on the vial label.
  • Supplied and dispensed in the UK through registered General Pharmaceutical Council (GPhC) pharmacies and aesthetic wholesalers, typically classified and handled as a prescription Only medicine (POM).
  • Handled under temperature Controlled storage and distribution (store below 25°C) according to professional and regulatory standards for injectable medicinal products.
  • Use and in Use shelf life governed by local institutional policies for multi Dose bacteriostatic injection vials and professional guidelines on benzyl alcohol Containing parenterals.
Bacteriostatic 0.9% sodium chloride injection for reconstitution of injectable medications

Description

BAC-STAT Bacteriostatic Saline 0.9% (30ml) is a bacteriostatic 0.9% sodium chloride solution for injection preserved with benzyl alcohol. It is supplied as a sterile, pyrogen-free 30 mL multi-dose glass vial and is specifically designed as a diluent for the safe and efficient reconstitution or dilution of injectable medications (such as vaccines, peptides, hormones and biologics) that require 0.9% sodium chloride. The benzyl alcohol preservative inhibits bacterial growth between withdrawals, allowing repeated access to the vial over its in-use period and offering a cost-effective alternative to single-use sterile saline. The label specifies 0.9% Sodium Chloride (9 mg/mL), 0.9% Benzyl Alcohol (9 mg/mL) and Water for Injection, with the product clearly marked NOT FOR INHALATION and NOT FOR USE IN NEONATES, and intended FOR DRUG DILUENT USE ONLY.

Bnefits

  • Provides a bacteriostatic 0.9% sodium chloride injection with benzyl alcohol preservative, helping to inhibit bacterial growth between uses.
  • Multi-dose vial format allows safe repeated withdrawals from the same 30 mL vial when handled aseptically, improving convenience in clinical and research settings.
  • Reduces waste compared with single-use preservative-free saline, enabling fuller utilisation of vial contents and lowering per-dose cost of diluent.
  • Maintains isotonicity and compatibility for medications that require reconstitution or dilution with 0.9% sodium chloride solution.
  • Supports workflow efficiency by reducing frequency of vial changes and saline preparation in busy clinics, vaccine campaigns and research laboratories.
  • Clearly presented labelling (NOT FOR INHALATION, NOT FOR USE IN NEONATES, FOR DRUG DILUENT USE ONLY) to support safe, appropriate use under professional supervision.

Indications

  • Use as a bacteriostatic 0.9% sodium chloride diluent for the reconstitution or dilution of injectable medications that are compatible with benzyl alcohol-preserved saline.
  • Multi-dose diluent for injectable drugs used in clinical practice, such as vaccines, hormone therapies, peptides, biologics and other parenteral products that specify or permit 0.9% sodium chloride for reconstitution.
  • Diluent for injectable medications in clinical research settings where repeated sterile withdrawals from a single vial are required over a defined in-use period.
  • Intended for parenteral use (for example as part of IV, IM, or SC administration protocols) only when used as a diluent in accordance with each medication’s product information and under healthcare professional supervision.

Composition

  • 0.9% Sodium Chloride (9 mg/mL) in Water for Injection.
  • 0.9% Benzyl Alcohol (9 mg/mL) as a bacteriostatic preservative.
  • Sterile, pyrogen-free solution.
  • No added antimicrobial agents other than benzyl alcohol; no added buffers or electrolytes beyond sodium chloride.

Formulation

  • Pharmaceutical form: Bacteriostatic 0.9% sodium chloride solution for injection.
  • Active ingredient: Sodium chloride 0.9% (9 mg/mL).
  • Preservative: Benzyl alcohol 0.9% (9 mg/mL), providing bacteriostatic activity and allowing multi-dose use.
  • Vehicle: Water for Injection, sterile and pyrogen-free.
  • Presentation: Clear aqueous solution contained in a 30 mL multi-dose vial.
  • Label indications: NOT FOR INHALATION; WARNING: NOT FOR USE IN NEONATES; FOR DRUG DILUENT USE ONLY.

Packaging

  • 30 mL clear glass multi-dose vial with rubber stopper and crimped aluminium cap with plastic flip-off overseal.
  • Primary container clearly labelled with product name (BAC-STAT Bacteriostatic Saline 0.9% Sodium Chloride), strength, volume and key warnings (including NOT FOR INHALATION and NOT FOR USE IN NEONATES).
  • Supplied individually (1 x 30 mL vial) per box as listed by UK aesthetic and pharmacy wholesalers.
  • Intended for use as a prescription-only, temperature-controlled product within professional healthcare and aesthetic settings.

Usage

  • For use only by healthcare professionals or suitably trained individuals following the relevant medication’s product information and local protocols.
  • Use aseptic technique when puncturing the vial and withdrawing solution; disinfect the rubber stopper before each withdrawal.
  • Use BAC-STAT as a diluent to reconstitute or dilute injectable medications that specify or are compatible with 0.9% sodium chloride preserved with benzyl alcohol.
  • Withdraw the required volume of BAC-STAT using a sterile syringe and needle and transfer into the medication vial according to the manufacturer’s instructions for that medicine.
  • Gently mix after reconstitution until the medication is fully dissolved or homogeneously suspended; inspect the resulting solution visually and do not use if particulate matter, discolouration or turbidity is present (unless inherent to the product).
  • Do not use for inhalation or nebulisation and do not use as an oral preparation.
  • Do not use in neonates; exercise particular caution in paediatric populations and in patients with known benzyl alcohol sensitivity.
  • Discard the vial if contamination is suspected, if solution becomes discoloured or cloudy, or after the recommended in-use period as set by local policy or the supplying pharmacy.
  • As this is a diluent, dosing, route (IV, IM, SC) and administration schedule are determined by the medication being reconstituted, not by BAC-STAT itself.

Contraindications

  • Known hypersensitivity or allergy to benzyl alcohol or other benzyl alcohol-containing products.
  • Known hypersensitivity to sodium chloride or any component of the solution.
  • Use in neonates (newborn infants), due to the risk of benzyl alcohol toxicity (e.g. “gasping syndrome”) with preservative-containing injectable solutions.
  • Use in situations where the medication to be reconstituted is labelled as incompatible with benzyl alcohol or bacteriostatic diluents.
  • Use via inhalation or oral routes, as the product is labelled NOT FOR INHALATION and is intended only as a parenteral diluent under professional supervision.

Adverse Effects

  • As a diluent, no specific adverse effects are described beyond those associated with its components and route of administration; potential reactions are primarily related to benzyl alcohol and parenteral saline use.
  • Local injection-site reactions (such as pain, irritation or inflammation at the site of administration) may occur, particularly if the final reconstituted medication is given IV, IM or SC.
  • Systemic benzyl alcohol exposure can be harmful in neonates and very young infants, where high cumulative doses have been associated with serious toxicities (e.g. metabolic acidosis, respiratory distress, and "gasping" syndrome); hence the strong warning against neonatal use.
  • In individuals with benzyl alcohol hypersensitivity, possible allergic-type reactions (e.g. rash, pruritus, urticaria, bronchospasm or anaphylactoid reactions) may occur; use is contraindicated in such patients.
  • Excessive sodium load from large-volume parenteral use may be problematic in patients with clinically significant fluid or sodium retention, although BAC-STAT is generally used in small volumes as a reconstitution diluent rather than as a bulk IV fluid.

Storage Conditions

  • Store below 25°C as indicated on the vial label.
  • Keep the vial in its outer packaging where provided, and protect from excessive heat.
  • Do not freeze.
  • Keep out of the sight and reach of children.
  • Use within the in-use period defined by local policy or the supplying pharmacy once the multi-dose vial has been punctured; discard any remaining solution after that period or if contamination is suspected.
  • Do not use if the solution is discoloured, cloudy or contains particulate matter, or if the vial or closure is damaged.

Duration

Not applicable \u2013 BAC-STAT is a diluent with no independent therapeutic treatment course; duration of use is determined by the medication being reconstituted and by local multi-dose in-use policies.

Onset

Not applicable \u2013 BAC-STAT does not have a direct clinical effect; it provides a bacteriostatic diluent for injectable medications whose own onset of action depends on the active drug.

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