• B Braun Sterile Water for Injection Mini Plasco 10 ml or 20 ml Box of 20
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B. Braun

B Braun Sterile Water for Injection Mini Plasco 10 ml or 20 ml Box of 20

B Braun Sterile Water for Injection Mini Plasco 10 ml or 20 ml Box of 20

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Clinical Summary: B. Braun Sterile Water for Injection (Mini Plasco) is a sterile, non-pyrogenic, preservative-free water for injection (WFI) supplied in 10 mL or 20 mL polyethylene single-dose ampoules, manufactured by B. Braun Melsungen AG to Ph. Eur. and USP monograph standards. The product is indicated solely as a parenteral diluent and reconstitution vehicle for compatible lyophilised drugs (e.g. ceftriaxone, vancomycin, hydrocortisone, oxytocin) and is not intended for direct intravenous administration without prior tonicity adjustment, since it is hypotonic and would cause haemolysis if injected undiluted. The product is HSA Singapore registered, CE-marked under MDR 2017/745, manufactured under ISO 13485:2016 quality management.

Product Overview

B. Braun Mini Plasco Sterile Water for Injection is a single-dose, hypotonic, preservative-free water for injection (WFI) compliant with the European Pharmacopoeia (Ph. Eur.) and United States Pharmacopeia (USP) monographs for water for injection. Its primary clinical role is as a vehicle for the reconstitution of lyophilised parenteral drugs whose Summary of Product Characteristics (SmPC) specifies water for injection as the validated diluent — commonly cephalosporins (ceftriaxone, cefepime), glycopeptides (vancomycin, teicoplanin), corticosteroids (hydrocortisone sodium succinate), and select hormones (oxytocin, octreotide).

The Mini Plasco container is a polyethylene plastic ampoule with twist-off opening, eliminating glass particulate risk, and supports needle-free aseptic transfer when paired with B. Braun Mini-Spike, NRFit, or Luer-access dispensing devices. The container is PVC-free, latex-free, and DEHP-free. Sterile water is hypotonic (0 mOsm/L) — critical that clinicians confirm the reconstituted final solution is iso-osmotic before parenteral administration; pure WFI must never be administered intravenously without dilution due to the risk of haemolysis and electrolyte disturbance.

Specifications

Manufacturer B. Braun Melsungen AG, Germany
Composition Water for Injection (Aqua ad iniectabilia) Ph. Eur. / USP
Tonicity Hypotonic, 0 mOsm/L — not for direct IV use
pH 5.0–7.0
Volume 10 mL or 20 mL polyethylene Mini Plasco ampoule
Container Single-dose, twist-off polyethylene; PVC-free, latex-free, DEHP-free
Sterility Sterile, non-pyrogenic, preservative-free, antimicrobial-free
Pharmacopoeia Ph. Eur. monograph 0169 Water for Injections; USP monograph Water for Injection
Endotoxin Limit <0.25 EU/mL per Ph. Eur. monograph
Packaging Box of 20 ampoules
Regulatory HSA Singapore registered; CE Mark MDR 2017/745; ISO 13485:2016 quality management; ISO 15378 primary packaging materials for medicinal products
Storage Store below 25°C; do not freeze; protect from light; single-use — discard residual

Clinical Indications

  • Reconstitution of lyophilised IV antibiotics (ceftriaxone, cefepime, vancomycin, teicoplanin) per the manufacturer SmPC
  • Reconstitution of lyophilised corticosteroids (hydrocortisone sodium succinate, methylprednisolone) for IV bolus or infusion
  • Reconstitution of select hormones and biologicals (oxytocin, octreotide, growth hormone) where WFI is the validated diluent
  • Diluent for nebulizer therapy where the prescribed medication SmPC specifies water for injection
  • Reconstitution of intramuscular injections and depot preparations per product-specific SmPC
  • Pharmacy-compounded sterile preparations (CSPs) per USP <797> standards where WFI is required

Frequently Asked Questions

Q: Why can’t Sterile Water for Injection be administered intravenously on its own?
A: WFI is hypotonic (0 mOsm/L). Direct intravenous infusion of pure WFI causes acute intravascular haemolysis, haemoglobinuria, and electrolyte disturbance. WFI must be combined with the prescribed lyophilised drug to produce a final iso-osmotic or near-iso-osmotic solution before administration, in line with the drug’s SmPC reconstitution instructions.

Q: What is the difference between Sterile Water for Injection and Bacteriostatic Water for Injection?
A: Sterile WFI is preservative-free and intended for single-dose use. Bacteriostatic Water for Injection contains 0.9% benzyl alcohol as a preservative and supports multi-dose use. Benzyl alcohol is contraindicated in neonates (gasping syndrome) and certain paediatric populations — always use preservative-free Sterile WFI in those groups per FDA and AAP guidance.

Q: Can the ampoule be used to reconstitute multiple vials?
A: No. Mini Plasco is a single-dose container. ASHP, USP <797>, and Singapore healthcare infection control standards require any residual to be discarded immediately after first puncture or opening. Multi-vial reconstitution from a single ampoule is a recognised compounding error and source of microbial contamination.

Q: Is the product HSA Singapore registered?
A: Yes. B. Braun Sterile Water for Injection Mini Plasco is HSA-registered for use in Singapore healthcare facilities. It also carries CE Mark under EU MDR 2017/745 and is manufactured to ISO 13485:2016 quality management with ISO 15378 primary packaging compliance.

Q: How does Mini Plasco compare with glass ampoules of WFI?
A: Mini Plasco polyethylene eliminates glass particulate (a recognised contaminant of glass ampoule fracture per ISMP advisories), reduces sharps injury risk during opening, and supports needle-free aseptic transfer using B. Braun spike or transfer devices. The pharmaceutical content of WFI is identical and meets the same Ph. Eur. and USP specifications.

References: Ph. Eur. monograph 0169 Water for Injections; USP monograph Water for Injection; USP <797> Pharmaceutical Compounding Sterile Preparations; FDA guidance on benzyl alcohol in neonates; ISMP guidance on glass particulate; HSA Singapore therapeutic product framework; CE MDR 2017/745; ISO 13485:2016; ISO 15378.

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