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Compound Sodium Lactate EP Infusion Solution 500ml
Compound Sodium Lactate EP Infusion Solution 500ml
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Product Overview
Compound Sodium Lactate EP Infusion Solution (also known as Ringer's Lactate or Hartmann's Solution equivalent) is a balanced isotonic crystalloid manufactured by B. Braun to European Pharmacopoeia monograph standards. The formulation provides a physiologically balanced electrolyte profile with sodium, potassium, calcium, chloride, and lactate ions at concentrations designed to minimise the risk of iatrogenic electrolyte disturbances during large-volume intravenous fluid administration.
The solution is supplied in 500 mL Ecoflac Plus polyethylene bottles, a closed infusion system designed to reduce the risk of airborne contamination during fluid administration. The Ecoflac Plus container collapses progressively as fluid is delivered, eliminating the need for an air inlet and reducing microbial contamination risk compared to traditional glass bottle systems. The lactate component undergoes hepatic gluconeogenesis and oxidation to yield bicarbonate, providing a mild alkalinising effect that assists in correcting metabolic acidosis commonly encountered in surgical, trauma, and critically ill patients.
Specifications
| Manufacturer | B. Braun Melsungen AG (Germany) / B. Braun Medical Industries (Penang, Malaysia) |
| Product | Compound Sodium Lactate EP Infusion Solution |
| Pharmacopoeia Standard | European Pharmacopoeia (EP) |
| Sodium Chloride | 6.0 g/L (Na⁺ 131 mmol/L, Cl⁻ 111 mmol/L) |
| Sodium Lactate | 3.17 g/L (lactate 29 mmol/L) |
| Potassium Chloride | 0.4 g/L (K⁺ 5 mmol/L) |
| Calcium Chloride Dihydrate | 0.27 g/L (Ca²⁺ 2 mmol/L) |
| Theoretical Osmolarity | Approximately 278 mOsmol/L |
| pH Range | 5.0 – 7.0 |
| Appearance | Clear, colourless, sterile solution |
| Sterility | Sterile, pyrogen-free; terminally sterilised |
| Container System | Ecoflac Plus 500 mL polyethylene bottle (closed system, no air inlet required) |
| Packaging | 10 bottles per carton |
| Shelf Life | 3 years from date of manufacture (unopened, stored below 25°C) |
| Latex Content | Latex-free |
| Regulatory | HSA Singapore registered; CE marked; manufactured under ISO 13485 quality management and cGMP; compliant with European Pharmacopoeia monograph |
Clinical Indications and Key Applications
- Intravenous fluid replacement for isotonic dehydration resulting from surgical fluid losses, gastrointestinal losses, or insensible fluid deficit
- Perioperative fluid management during general and regional anaesthesia for maintenance and intraoperative volume replacement
- Initial fluid resuscitation in trauma, haemorrhage, and burn injury per established volume replacement protocols
- Correction of mild to moderate metabolic acidosis through hepatic lactate-to-bicarbonate conversion
- Paediatric and neonatal intravenous fluid therapy where balanced crystalloid composition is preferred over normal saline
- Vehicle for dilution of compatible intravenous medications requiring an electrolyte-balanced infusion diluent
Frequently Asked Questions
Q: What is the difference between Compound Sodium Lactate EP and BP formulations?
A: Both EP (European Pharmacopoeia) and BP (British Pharmacopoeia) formulations of Compound Sodium Lactate contain identical active electrolyte components at the same concentrations. The EP and BP monographs share the same specifications for sodium lactate, sodium chloride, potassium chloride, and calcium chloride dihydrate. The distinction is primarily in the pharmacopoeia standard under which the product is manufactured and tested, with the EP standard being the harmonised European reference and the BP incorporating additional UK-specific quality requirements.
Q: Why is a balanced crystalloid preferred over normal saline for large-volume fluid replacement?
A: Normal saline (0.9% NaCl) contains 154 mmol/L of both sodium and chloride, which is supraphysiological for chloride (plasma reference: 96–106 mmol/L). Large-volume normal saline infusion can induce hyperchloraemic metabolic acidosis and renal afferent arteriolar vasoconstriction. Balanced crystalloids like Compound Sodium Lactate provide a chloride concentration (111 mmol/L) closer to physiological levels. Evidence from the SMART trial published in the New England Journal of Medicine (2018) showed reduced major adverse kidney events with balanced crystalloids compared with normal saline in critically ill patients.
Q: What medications are incompatible with Compound Sodium Lactate Solution?
A: Ceftriaxone must not be administered simultaneously with calcium-containing solutions including Compound Sodium Lactate due to the risk of ceftriaxone-calcium particulate precipitation. Blood products anticoagulated with citrate should not be infused through the same line, as calcium ions may chelate with citrate and promote clot formation. Phosphate-containing additives may precipitate with calcium. Always verify drug compatibility using current pharmaceutical references or consult a clinical pharmacist before admixture.
Q: How should Compound Sodium Lactate be stored?
A: Store below 25°C. Do not freeze. The Ecoflac Plus polyethylene container has a shelf life of 3 years from the date of manufacture when stored unopened under recommended conditions. Once opened or connected to an administration set, the solution should be used immediately and any unused portion discarded. Do not use if the solution is cloudy, contains particulate matter, or if the container seal is compromised.
Q: Is Compound Sodium Lactate EP available for purchase in Singapore?
A: Yes. B. Braun Compound Sodium Lactate EP 500 mL is available in Singapore through EMIS (Essential Medical International Supplies Pte Ltd). The product is HSA-registered and supplied in cartons of 10 Ecoflac Plus bottles. Orders can be placed through emis.asia for healthcare facility procurement, clinic supply, and home infusion therapy requirements.
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