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Haemaccel
Haemaccel
Haemaccel
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Haemaccel (a registered trademark) is a type of intravenous colloid used in the prevention or treatment of shock associated with reduction in effective circulating blood volume due to hemorrhage, loss of plasma (burns, peritonitis, pancreatitis, crush injuries), or loss of water and electrolytes from persistent vomiting and diarrhea. Haemaccel contains degraded gelatin.

It is used as an alternative to human albumin solution (HAS) and starch in supportive treatment of ascites following the procedure of paracentesis.

Polygelin is excreted via the kidneys and has a plasma half-life of three to six hours. This is increased to up to 16 hours in patients with kidney damage. Adverse drug reactions were observed in 0.78% of cases mainly due to histamine release (drop in blood pressure, bronchospasm and skin involvement such as urticaria).[1]

Haemaccel (also marketed as Emagel in Italy, Polygeline in China and Solucel in Venezuela) was originally brought to market by Hoechst AG and later acquired by Piramal Enterprises.

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Haemaccel

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Haemaccel is a synthetic plasma volume substitute consisting of 3.5% polygeline (a modified derived from bovine ) dissolved in an solution containing , , and , designed for intravenous to restore and maintain in cases of acute hypovolaemia. Developed as an alternative to natural plasma or crystalloid solutions, Haemaccel has a mean molecular weight of approximately 30-35 kDa, providing similar to human plasma but with a shorter intravascular of about 3-5 hours and no oxygen-carrying capacity. It is primarily indicated for the initial management of hypovolaemic shock due to haemorrhage (overt or concealed), burns, , , or crush injuries, as well as for fluid replacement during plasma exchange procedures, extra-corporeal circulation in , and isolated organ perfusion. In clinical use, Haemaccel is administered intravenously, with initial doses of 500-1,000 ml for adults in shock, potentially replacing up to 1,500 ml of loss entirely or combining with blood products for larger volumes (1,500-4,000 ml); for burns, the dosage is calculated as 1 ml per kg body weight per percentage of burned over 24 hours. The solution must be used cautiously in patients with , , or renal impairment due to risks of fluid overload and imbalances, and it is contraindicated in those with to its components or a history of severe anaphylactoid reactions to colloids. Common side effects include mild reactions such as urticaria or , while rare but serious risks involve or circulatory overload, necessitating immediate treatment with antihistamines, corticosteroids, or adrenaline. Originally authorised in the UK on 12 January 2005 and last revised in 2019, Haemaccel remains a key component in emergency and perioperative fluid therapy, though its use has evolved with ongoing debates about the comparative safety and efficacy of synthetic colloids versus crystalloids in resuscitation protocols.

Medical Uses

Hypovolemic Shock Treatment

Hypovolemic shock is a life-threatening condition characterized by a significant reduction in intravascular blood volume, leading to inadequate tissue perfusion and oxygenation despite compensatory mechanisms such as tachycardia and vasoconstriction. Common causes include acute hemorrhage from trauma or surgery, severe burns, peritonitis, pancreatitis, crush injuries, and substantial fluid losses from prolonged vomiting or diarrhea. In these scenarios, rapid restoration of circulating volume is essential to prevent organ failure and mortality. Haemaccel, a polygeline-based solution, serves as an effective plasma volume expander in the initial management of by increasing and maintaining intravascular volume. Clinical guidelines recommend infusing 500–1,000 ml intravenously as an initial bolus to stabilize . For blood losses up to 1,500 ml, Haemaccel can replace the entire volume without immediate need for blood products; for losses between 1,500 ml and 4,000 ml, replacement should use equal volumes of Haemaccel and to optimize volume expansion while addressing oxygen-carrying capacity. Evidence from clinical studies supports Haemaccel's efficacy in hypovolemic shock, particularly in trauma settings. A prospective of 60 adult patients with trauma-induced demonstrated that Haemaccel infusion significantly improved hemodynamic parameters, including and , achieving stability without major adverse events. Prospective studies in accidental trauma cases further confirmed its safety and effectiveness in restoring circulatory volume post-injury. Compared to crystalloids like , Haemaccel requires less volume for equivalent resuscitation while providing superior circulatory filling and longer duration of action due to its colloidal properties, as shown in postoperative fluid therapy trials. In settings, such as postoperative care or acute fluid during trauma, Haemaccel plays a critical role in bridging the gap until blood products are available, with its mean of about 5 hours allowing sustained volume support. This makes it particularly valuable in resource-limited environments where rapid infusion is needed to mitigate shock progression.

Supportive Therapy in Ascites

Ascites refers to the pathological accumulation of fluid in the , most commonly associated with advanced liver due to and . Large-volume , the therapeutic removal of more than 5 liters of ascitic fluid, is a standard procedure to alleviate symptoms such as and discomfort in patients with tense or ascites. However, this intervention carries a risk of post-paracentesis circulatory dysfunction (PPCD), characterized by a rapid decrease in systemic , leading to , accelerated ascites reaccumulation, dilutional , and potential renal impairment if not prophylactically managed. Although not a licensed indication, Haemaccel has been used off-label as a cost-effective alternative to human solution (HAS) for plasma volume expansion following large-volume in cirrhotic patients with . Clinical guidelines recommend human (8 g per liter of removed) as the preferred expander to prevent PPCD; Haemaccel serves as a lower-cost alternative in settings where is unavailable. It helps maintain effective circulating volume and prevent PPCD by providing similar to , with typical protocols recommending approximately 4-8 g of polygeline per liter of ascitic fluid removed (e.g., 125-150 mL of 3.5% Haemaccel solution per liter, equivalent to 4.4-5.3 g). Its composition, including sodium and , also supports salt replacement during fluid shifts. Clinical studies demonstrate that Haemaccel reduces the incidence of and renal impairment compared to no after . A randomized comparing Haemaccel to in 54 cirrhotic patients with refractory found no significant differences in complications, including renal function markers, indicating Haemaccel's efficacy in preventing PPCD-equivalent outcomes. Another study in patients with tense showed that 125 mL/L Haemaccel resulted in only minor, insignificant declines in serum sodium (from 134.9 ± 6.5 to 134.2 ± 4.3 mmol/L) and stable or slightly improved glomerular rates (from 75.5 ± 15.8 to 77.9 ± 2.4 mL/min), comparable to and superior to scenarios without volume expansion. Broader evidence from a Cochrane review of plasma expanders, including polygeline, confirms that colloids lower PPCD risk (RR 0.32, 95% CI 0.12-0.84) and associated and renal issues relative to no expander, though certainty is low due to study limitations. In resource-limited settings, Haemaccel offers advantages over synthetic starch solutions like due to its greater availability, lower cost (approximately one-tenth that of ), and established safety profile without increased risks of renal impairment or in short-term use.

Composition and Pharmacology

Chemical Composition

Haemaccel is formulated as a 3.5% w/v solution of , the , which is a succinylated derived from bovine with a mean molecular weight of 30–35 . This provides similar to plasma without contributing to oxygen transport, as it lacks or other oxygen-carrying components. The electrolyte profile per liter consists of supplying 145 mmol/L of Na⁺, providing 5.1 mmol/L of K⁺, and contributing 6.25 mmol/L of Ca²⁺, for a total chloride content of 145 mmol/L to maintain ionic balance compatible with plasma. With an osmolality of approximately 300 mOsm/L, the solution is iso-osmotic to human plasma, and its is maintained at 7.3 ± 0.3 to ensure stability and physiological tolerability. Haemaccel is supplied as a sterile, pyrogen-free solution in 500 ml plastic bottles designed for intravenous .

Pharmacokinetics and Mechanism

Haemaccel, a polygeline-based solution, functions primarily as a plasma by exerting comparable to that of plasma, which draws fluid from the extravascular space into the intravascular compartment to restore circulating in . This iso-oncotic property, derived from its mean molecular weight of 30,000 Daltons, enables it to remain predominantly within the vascular space without contributing to oxygen transport, distinguishing it from oxygen-carrying products. Unlike crystalloid solutions, which achieve only about 25% of the infused as effective plasma expansion due to rapid distribution into interstitial spaces, Haemaccel provides approximately 80% initial intravascular expansion relative to the infused amount, owing to its larger molecular size that limits leakage across walls. Upon intravenous administration, Haemaccel is rapidly distributed within the plasma compartment, achieving immediate expansion effects that peak shortly after . Its pharmacokinetic profile includes a mean of about 5 hours in individuals with normal renal function, during which it maintains hemodynamic stability for 4-6 hours, necessitating clinical monitoring for potential re-dosing to sustain support. In patients with renal impairment, this can extend up to 16 hours due to reduced excretion capacity. The solution undergoes metabolism via proteolysis by endogenous enzymes, breaking down into smaller peptides and , while a significant portion is excreted unchanged through the kidneys, with approximately 74% eliminated within four days post-administration. This dual pathway of elimination—metabolic degradation and renal clearance—contributes to its relatively short duration of action compared to other colloids, reducing the overall fluid volume required for while minimizing prolonged accumulation in the body.

Administration and Dosage

Dosage Recommendations

Haemaccel is typically administered intravenously to adults in at an initial dose of 500-1,000 ml, infused rapidly and titrated based on clinical response, such as normalization of and . For losses up to 1,500 ml, Haemaccel can replace the volume on a 1:1 basis; losses between 1,500 ml and 4,000 ml require equal volumes of Haemaccel and products, administered separately; for losses exceeding 4,000 ml, a 2:1 ratio of to Haemaccel is recommended, while maintaining above 25%. Although the safety and efficacy in children has not been established per the SmPC, studies in pediatric suggest an initial bolus of 20 ml/kg, with further boluses as needed up to hemodynamic stability, and close monitoring. For plasma exchange procedures, up to 2 litres may be used alone or in combination with other fluids. Use in burns is addressed in the Medical Uses section. In patients with renal or hepatic impairment, use is restricted, particularly in renal and post-renal , with special precautions required; no specific dose reductions are recommended. Dosing should be guided by monitoring parameters such as , urine output (target >0.5 ml/kg/hour), and overall clinical response to prevent over- or under-resuscitation. Re-dosing intervals may consider the solution's plasma of approximately 5 hours in normal renal function.

Administration Procedures

Haemaccel is administered solely by intravenous infusion, utilizing either a peripheral or central venous access line to ensure proper delivery into the bloodstream. Administration via intramuscular or subcutaneous routes is contraindicated, as it may lead to local tissue irritation, necrosis, or ineffective plasma volume expansion. Before infusion, the solution must be visually inspected for particulate matter, discoloration, or cloudiness, and the integrity of the container seal should be confirmed; discard if any abnormalities are present or if the solution has gelled due to exposure to low temperatures. To prepare, disinfect the bottle's rubber stopper, remove the protective seal, and firmly insert the spike of a sterile infusion set; if necessary, warm the solution to body temperature (approximately 37°C) using a water bath or approved warmer to enhance patient comfort and reduce viscosity, though in urgent situations, room-temperature infusion is acceptable. Water-soluble medications compatible with Haemaccel, such as insulin, may be added directly to the bottle through a designated injection port while strictly adhering to aseptic techniques to prevent contamination. Haemaccel can be co-administered with whole blood or blood components using a Y-type infusion set, allowing separate lines to merge at the patient end, but direct mixing in the same container should be avoided to prevent potential interactions. Infusion rates are tailored to the patient's clinical status, with a standard rate of 500 ml over at least (approximately 8–10 ml/min) for most adults to minimize risks such as fluid overload. In cases of acute or shock requiring rapid volume expansion, faster rates are permissible, guided by hemodynamic monitoring to achieve prompt stabilization. For elderly patients or those with underlying cardiac conditions, a reduced rate of around 10 ml/min or slower is advised to mitigate the potential for or exacerbated , with close observation of during administration. Haemaccel demonstrates good compatibility with common intravenous fluids including 0.9% , 5% dextrose, and Ringer's lactate, as well as heparinized blood, facilitating combined use in protocols. It is incompatible with citrated blood products owing to the presence of calcium ions, which can induce clotting; in such scenarios, the infusion line must be flushed between administrations. While stable with many IV medications—such as penicillins, corticosteroids, and insulin—specific incompatibilities exist, including precipitation with and heightened nephrotoxicity risk when combined with gentamicin; always consult compatibility data before co-infusion. Unopened containers of Haemaccel should be stored with no special precautions required. The is 2 years from the date of manufacture; once opened, the solution must be used immediately, and any remaining volume discarded to avoid bacterial contamination. Always verify the and discard if outdated or showing signs of compromise.

Adverse Effects and Safety

Common Reactions

Haemaccel, a polygeline-based solution, is associated with an incidence of adverse reactions of 0.78% as reported in a 1983 multicentre prospective study, with the majority being mild and transient in . Severe reactions are rare. These reactions are primarily histamine-mediated and include cutaneous manifestations such as urticaria (wheals), , and pruritus, as well as cardiovascular effects like , , or . Gastrointestinal symptoms, including and , are also commonly reported. Other frequent effects encompass flushing, pyrexia, and chills, while and occur less commonly but remain notable among mild reactions. These anaphylactoid reactions stem from the component of polygeline, which can trigger release. Patients with a history of or prior exposure to products face an increased likelihood of experiencing these reactions. For management of mild cases, reducing the infusion rate or administering antihistamines, such as an like chlorpheniramine (10-20 mg intravenously), is recommended to alleviate symptoms.

Contraindications and Precautions

Haemaccel is contraindicated in patients with known to any of its constituents, including polygeline or the electrolytes , , and . It is also absolutely contraindicated in individuals with a history of severe anaphylactoid reactions to gelatin-based colloids, as these can recur upon re-exposure. Relative precautions are advised in several patient populations due to the risk of exacerbating underlying conditions. Use is restricted in cases of , , oesophageal , pulmonary oedema, haemorrhagic diathesis, and renal or post-renal , where volume expansion may lead to circulatory overload or impaired . In patients with renal impairment, monitoring for polygeline accumulation is essential, as reduced clearance can prolong effects and heighten toxicity risks. Caution is recommended in or when administering cardiac glycosides, owing to Haemaccel's calcium content (approximately 0.102 g dihydrate per 500 ml), which may potentiate toxicity. Additionally, rapid infusion should be avoided to prevent the release of vasoactive substances and , particularly in allergic individuals or those recently exposed to histamine-liberating drugs; prophylactic administration of H1 and H2 receptor antagonists may be considered in high-risk cases. The solution's profile—containing 145 mmol/L sodium and 5 mmol/L —necessitates monitoring in patients on sodium- or potassium-controlled diets to avoid imbalances. Drug interactions with Haemaccel primarily involve its components and -expanding properties. Additive effects may occur when combined with other plasma expanders, increasing the risk of hypervolaemia. It should not be mixed directly with citrated products due to potential clotting from calcium ions neutralizing the citrate ; if sequential administration is required, the set must be flushed. Haemaccel is compatible with saline, dextrose solutions, Ringer's lactate, heparinized , and water-soluble drugs such as insulin or . No specific interactions with ACE inhibitors have been documented for Haemaccel, though general caution with hypotensive agents applies in volume-depleted states. Regarding pregnancy and lactation, official product information states it may be used for plasma volume replacement during pregnancy or childbirth when blood is unavailable, with no apparent ill effects on mother or fetus reported in clinical use. Limited data are available for lactation, but excretion into breast milk is unlikely due to its large molecular size; use only if benefits outweigh risks. Overdosage with Haemaccel primarily manifests as fluid overload, potentially leading to pulmonary oedema, especially in patients with compromised cardiac or renal function. Symptoms include dyspnoea, elevated , and disturbances; management involves discontinuing infusion, administering diuretics, and supportive care to restore . No specific exists.

History and Manufacturing

Development and Introduction

Haemaccel, a modified gelatin-based plasma substitute, was developed in the 1960s and 1970s by in to serve as an alternative to in situations of volume depletion, particularly to mitigate shortages of natural products during surgical and trauma care. The product was formulated as a urea-cross-linked polygeline solution to provide effective volume expansion with a favorable safety profile for use. This development occurred amid growing demand for synthetic colloids following advancements in and the need for stable, storable substitutes in medical settings. First marketed in during the , Haemaccel was introduced primarily for volume replacement in hypovolemic states associated with and trauma. Initial clinical trials emphasized its role in restoring circulatory volume rapidly without the risks of blood transfusions, such as incompatibility or transmission of infections. These early evaluations highlighted its utility in environments, where it was administered intravenously to stabilize patients experiencing blood loss. By the mid-, it had gained traction in European hospitals as a reliable option for perioperative fluid management. Haemaccel was withdrawn from the Australian market in 2004. Early studies in the and demonstrated Haemaccel's safety and efficacy in treating , with research focusing on its hemodynamic effects and duration of action. For instance, clinical investigations confirmed its ability to expand plasma volume effectively, with a reported of approximately 4-5 hours, allowing for sustained support in critical conditions. Key publications from this period also examined potential adverse events, including anaphylactoid reactions, reporting an incidence of about 0.05% in large patient cohorts, which informed guidelines for monitoring during administration. These findings established Haemaccel as a viable for short-term volume . Regulatory approvals for Haemaccel as a medicinal product were obtained in the during the 1970s, with approval in the granted on 12 January 2005. By the 1980s, it had achieved widespread global adoption, particularly in regions with limited access to blood banking infrastructure, solidifying its role in worldwide.

Ownership Changes

Haemaccel was originally produced by the German pharmaceutical company , which developed and marketed the product following its introduction in the 1970s. Hoechst retained ownership until its merger with France's Rhône-Poulenc S.A. in 1999, forming Aventis, a global life sciences firm that continued production and distribution. In 2004, the subsequent entity Sanofi-Aventis—resulting from Aventis's merger with Sanofi-Synthélabo—sold Haemaccel's rights in 76 countries, along with its manufacturing facility in , , to PlasmaSelect AG, a German biopharmaceutical company. In 2008, Piramal Healthcare, an Indian pharmaceutical firm, acquired the global Haemaccel brands from PlasmaSelect AG for €7.7 million, securing worldwide marketing rights, regulatory dossiers, and know-how while excluding the Marburg facility; PlasmaSelect handled manufacturing during the transition period. Separately, Piramal had entered the Indian market earlier by purchasing Haemaccel-related and a Mumbai manufacturing facility from Sanofi-Aventis in 1998. This acquisition positioned Piramal as a leader in polygeline-based plasma expanders, with combined annual revenues from Haemaccel and associated brands reaching €9.1 million at the time. Today, Haemaccel is manufactured by Piramal Critical Care Ltd., a of Piramal Enterprises, with production shifted to a dedicated facility in , ; this plant, established post-2008 acquisition, complies with European Directorate for the Quality of Medicines (EDQM) and Medicines and Healthcare products (UKMHRA) standards, boasting an initial capacity of 4.2 million units annually. The product is marketed under the Haemaccel brand in over 38 countries and as Haemageline in 17 others, with regional variations including Emagel in , Solucel in , and Polygeline in ; in certain markets, it is available as generic polygeline. A notable controversy arose between and , when reports of adverse reactions, particularly anaphylactoid events, increased markedly compared to prior years; investigations attributed this to a change in the manufacturing process implemented around that time. The issue was resolved through process adjustments, including reversion to earlier methods, which restored reaction rates to pre-1998 levels without further incidents linked to production.

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