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Bacteriostatic 0.9% 30ml Bottle

Bacteriostatic 0.9% 30ml Bottle

Misc (Generics)

Unlicensed medicine / diluent
  • Unlicensed medicinal product (“special”) intended to be supplied only to meet the special needs of an individual patient when no suitable licensed alternative is available.
  • Supply and use subject to UK MHRA guidance on unlicensed medicinal products and General Pharmaceutical Council (GPhC) standards for registered pharmacies.
  • Handled in line with local governance protocols for unlicensed medicines, including documentation of indication, prescriber justification, and patient Specific supply.
  • Manufacture or assembly expected to occur under an MHRA Licensed specials manufacturer or under the professional responsibility of the supplying pharmacy in compliance with relevant quality standards.
Bacteriostatic 0.9% sodium chloride injection for drug reconstitution

Description

Bacteriostatic 0.9% 30ml Bottle is an unlicensed medicinal product consisting of sodium chloride 0.9% solution for injection containing 9 mg/mL benzyl alcohol as a preservative. It is supplied in a 30 mL multi-dose vial or bottle and is intended solely as a bacteriostatic diluent to reconstitute or dilute injectable medicines that are compatible with benzyl alcohol–preserved 0.9% sodium chloride. As an unlicensed “specials” product in the UK, it should only be prescribed or ordered where a licensed alternative cannot meet the specific clinical needs of an individual patient, and responsibility for determining those special needs rests with the prescribing healthcare professional.

Bnefits

  • Provides an isotonic 0.9% sodium chloride solution with 9 mg/mL benzyl alcohol to inhibit bacterial growth in the vial between withdrawals.
  • Multi-dose 30 mL presentation allows repeated aseptic withdrawals for drug reconstitution, reducing wastage compared with single-use, preservative-free saline.
  • Suitable as a diluent for compatible injectable medicines (e.g. toxins, peptides, vaccines, or other parenteral products) that require 0.9% sodium chloride for reconstitution and permit the use of benzyl alcohol–preserved diluents.
  • Supports efficient clinical workflow in settings such as aesthetic clinics, theatres and research units where multiple small diluent volumes are needed from a single container.
  • Unlicensed special-order preparation allows supply where a patient’s specific clinical needs cannot be met by an available licensed diluent.

Indications

  • Use as a bacteriostatic 0.9% sodium chloride diluent for the reconstitution or dilution of injectable medicines that are compatible with benzyl alcohol–preserved saline.
  • Intended to meet the special needs of an individual patient where an equivalent licensed medicinal product cannot meet those needs, as determined by the prescriber.
  • For parenteral use only as part of preparation of another medicine; not indicated as a stand-alone therapeutic infusion or treatment.

Composition

  • Sodium chloride 0.9% (9 mg/mL) in water for injection.
  • Benzyl alcohol 9 mg/mL (0.9%) as a bacteriostatic preservative.
  • Water for injection as vehicle.
  • May contain trace amounts of acid or alkali for pH adjustment (not routinely specified on summary listings).

Formulation

  • Pharmaceutical form: Bacteriostatic 0.9% sodium chloride solution for injection.
  • Active ingredient: Sodium chloride 9 mg/mL (0.9%).
  • Preservative: Benzyl alcohol 9 mg/mL (0.9%) providing bacteriostatic activity.
  • Vehicle: Sterile, pyrogen-free water for injection.
  • Supplied as a clear aqueous solution intended for multiple withdrawals from a single 30 mL container when handled aseptically.

Packaging

  • 30 mL multi-dose vial or bottle containing bacteriostatic 0.9% sodium chloride solution with benzyl alcohol preservative.
  • Container closed with a rubber stopper and sealed with a crimped cap or equivalent closure suitable for repeated needle puncture.
  • Label states: sodium chloride 0.9% with 9 mg/mL benzyl alcohol (preservative), 30 mL, and indicates that it is an unlicensed medicine supplied to meet special clinical needs.
  • Supplied as an individual 30 mL unit via The Crystal Pharmacy as an unlicensed special.
  • Accompanied by warnings that it is an unlicensed medicine and should only be supplied where no suitable licensed alternative can meet the patient’s special needs.

Usage

  • For use only by qualified healthcare professionals in accordance with local policies for unlicensed medicines and multi-dose bacteriostatic injections.
  • Use strict aseptic technique; disinfect the rubber stopper or closure before each needle puncture and withdrawal.
  • Use as a diluent to reconstitute or dilute injectable medicines that specify or permit 0.9% sodium chloride preserved with benzyl alcohol; follow the primary medicine’s summary of product characteristics or prescribing information for reconstitution volumes and technique.
  • Withdraw the required volume using a sterile syringe and needle and transfer to the vial or container of the medicine to be reconstituted; gently swirl until fully dissolved or homogeneously mixed.
  • Inspect the final reconstituted solution for particulate matter, turbidity or discolouration prior to administration; discard if abnormal.
  • Do not use for inhalation, oral administration, or as a stand-alone IV infusion; it is intended only as a drug diluent.
  • Do not use in neonates and avoid use in young infants unless the benefit clearly outweighs the risks associated with benzyl alcohol exposure and there is no suitable licensed alternative.
  • Discard any remaining solution after the locally defined in-use period for multi-dose bacteriostatic vials or sooner if contamination is suspected.

Contraindications

  • Known hypersensitivity to benzyl alcohol, sodium chloride, or any component of the solution.
  • Use in neonates, due to the risk of serious benzyl alcohol toxicity (e.g. “gasping syndrome”) associated with preservative-containing injectable solutions.
  • Use when an equivalent licensed product can adequately meet the clinical needs of the patient (as per UK guidance on unlicensed specials).
  • Use as a primary infusion fluid for patients requiring strict avoidance of benzyl alcohol or excessive sodium load.
  • Use with medicinal products that are explicitly labelled as incompatible with benzyl alcohol, bacteriostatic agents, or multi-dose diluents.

Adverse Effects

  • Local injection-site reactions related to the final reconstituted preparation (e.g. pain, erythema, or irritation at the administration site).
  • Potential systemic toxicity from benzyl alcohol with excessive cumulative exposure, particularly in neonates and infants (including metabolic acidosis, respiratory distress, and gasping syndrome), which underpins the strong recommendation against neonatal use.
  • Possible hypersensitivity reactions (e.g. rash, pruritus, urticaria, bronchospasm or anaphylactoid reactions) in individuals allergic to benzyl alcohol or other components.
  • Electrolyte or fluid imbalance if used inappropriately in large parenteral volumes, due to sodium chloride content, though in practice this product is typically used only in small volumes as a diluent.
  • Any adverse effects associated with the active medicine being reconstituted, which are not attributable to the diluent itself but to the primary drug.

Storage Conditions

  • Store at or below 25°C, as specified on the product label or by the supplying pharmacy.
  • Do not freeze.
  • Keep the container tightly closed and protect from excessive heat and contamination.
  • Keep out of the sight and reach of children.
  • Follow local policies for maximum in-use shelf life once the vial has been punctured; discard remaining contents after that period or immediately if contamination, discolouration or particulate matter is observed.
  • Do not use after the expiry date shown on the container label.

Duration

Not applicable \u2013 this product functions solely as a diluent for other injectable medicines; duration of therapy is determined by the medicine being reconstituted and the patient\u2019s clinical regimen.

Onset

Not applicable \u2013 Bacteriostatic 0.9% 30ml Bottle has no direct therapeutic effect; clinical onset relates to the active drug reconstituted with this diluent.

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