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Haemocomplettan

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Haemocomplettan

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Method of action: Antihemorrhagics, Fibrin Sealant

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Haemocomplettan

Property Description
Active ingredient Human Fibrinogen (Coagulation Factor I)
Form Lyophilized powder for solution for injection or infusion
Pharmacological class Haemostatics, Blood Coagulation Factors
Common use Replacement therapy for Fibrinogen deficiency
Origin Human plasma-derived product

What is Haemocomplettan and How is it Classified?

Haemocomplettan is a specialized medicine known as a fibrinogen concentrate, containing the active ingredient Human Fibrinogen (Coagulation Factor I). It is officially classified as an antihaemorrhagic belonging to the therapeutic class of Blood Coagulation Factors. The product, manufactured by CSL Behring, is a highly purified human plasma-derived product intended for intravenous administration to help control or prevent bleeding.

Its official classification places it under the Anatomical Therapeutic Chemical (ATC) code B02BB01, reinforcing its function in modifying blood coagulation. As a concentrate, it ensures that the active substance, Fibrinogen, is delivered in a potent, isolated form, having been subjected to strict purification and virus-inactivation procedures.


Composition, Origin, and Pharmaceutical Form

The medicine's composition is centered around its sole active ingredient, Human Fibrinogen, a vital plasma glycoprotein. It is supplied as a sterile lyophilized powder in a vial, a presentation designed for enhanced stability. Before use, the powder must be reconstituted with water for injections into a solution.

Its origin as a human plasma-derived product confirms the active substance is structurally identical to the Fibrinogen naturally found in the human circulatory system. The final solution is administered through the intravenous (IV) route.


What is the General Purpose of Fibrinogen Concentrate?

The general purpose of this medication is to provide the critical structural protein required for the blood to clot effectively, thereby restoring hemostasis. It functions as direct replacement therapy when a patient is deficient in Fibrinogen. By supplying the necessary Fibrinogen concentrate, the medicine ensures that the body can build the dense, final mesh—the fibrin clot—that is required to physically stop blood loss.

Regulatory References

  1. EMA Scientific Guideline: Core SmPC for Human Fibrinogen Products
  2. WHO Essential Medicines List for Cryoprecipitate (Pathogen-Reduced)
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What side effects are possible with Haemocomplettan ?

Possible side effects and safety information

The regulatory safety profile of Human Fibrinogen Concentrate focuses on adverse reactions classified by frequency and the physiological system affected, based on official regulatory documentation.

Frequency-Classified Adverse Reactions

Adverse reactions are formally categorized to reflect their frequency of occurrence, with the most clinically significant risks officially documented as uncommon (affecting 1 to 10 users in 1,000). Both thromboembolic events and hypersensitivity reactions fall into this uncommon classification. Other documented adverse reactions may include fever (pyrexia), an increase in heart rate (tachycardia), low blood pressure (hypotension), and gastrointestinal effects such as nausea and vomiting.

Serious Adverse Reactions and Systemic Effects

The most serious adverse reactions documented in official labeling include serious thromboembolic events, such as pulmonary embolism, deep vein thrombosis, and arterial thrombosis. The potential for anaphylactic reactions is also officially noted as the most severe form of hypersensitivity. These reactions are officially grouped by System-Organ Class, affecting the vascular and immune systems primarily, as well as the cardiac and gastrointestinal systems.

Population-Specific Safety Considerations and Restrictions

Official prescribing information includes specific safety considerations for patient populations with an increased risk of blood clotting, particularly individuals with a history of coronary artery disease, severe liver disease, or other risk factors for thrombosis. The medicine is formally contraindicated in cases of known hypersensitivity to the active substance or any excipients. Furthermore, as a human plasma-derived product, the official safety profile includes a mandatory disclosure regarding the theoretical risk of transmitting infectious agents, despite the application of regulatory-required virus-inactivation procedures.

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Overdose and Emergency Response

Overdose with Human Fibrinogen Concentrate is officially documented as leading to an enhanced risk of thromboembolic complications/events (TEE). These events are the critical manifestations of over-administration and are noted by regulatory authorities as carrying the risk of potentially fatal outcomes. The occurrence of these severe manifestations is associated with high dose or repeated dosing, a risk particularly noted in patients being treated for congenital fibrinogen deficiency. The documented physiological system affected is the blood coagulation system, leading to thrombosis.

The official emergency response requires specific actions when overdose is suspected or when severe acute reactions manifest. The injection or infusion must be stopped immediately, and urgent medical attention is required without delay if signs of thrombosis or any severe systemic reaction occur. If acute shock symptoms are present, standard medical treatment for shock should be implemented.

In the management of documented over-administration, no specific antidote is known to regulatory bodies, necessitating a reliance on symptomatic and supportive treatment. Official prescribing information mandates close observation for signs or symptoms of thrombosis and requires plasma fibrinogen level monitoring to guide clinical management in the overdose context. This structured approach outlines the official constraints and required actions.

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Therapeutic Uses of Haemocomplettan

What Haemocomplettan Treats: Main Uses and Benefits

The primary purpose of Human Fibrinogen Concentrate is generally applied as replacement therapy for individuals with insufficient or dysfunctional Fibrinogen, the protein essential for stable blood clot formation. It is applied in addressing and managing bleeding resulting from this deficiency across acute and chronic clinical scenarios. The concentrate is considered relevant for the management of bleeding and for use in a preventative context related to these conditions.

Managing Inherited Bleeding Disorders and Chronic Risk

This therapy is applied in addressing conditions marked by congenital Fibrinogen deficiencies, such as Afibrinogenaemia or Hypofibrinogenaemia. A primary benefit is its role in bleeding prophylaxis, which is relevant in a preventative context to manage the risk of spontaneous haemorrhage and may assist with minimizing the risk of significant blood loss during planned invasive procedures.


Control of Acute, Severe Hemorrhagic Episodes

The concentrate is applied in critical settings to support the management of acute, severe bleeding. This includes life-threatening haemorrhage associated with massive trauma, complex major surgery, or obstetrical complications like Postpartum Hemorrhage (PPH). The therapeutic benefit contributes to achieving stable coagulation, which assists in the management and control of blood loss and supports the patient's stabilization during these difficult episodes.


Treating Acquired Fibrinogen Depletion

Haemocomplettan is generally considered relevant when Fibrinogen is acutely depleted due to severe underlying illnesses or conditions. This includes secondary bleeding complications arising from systemic disorders such as Disseminated Intravascular Coagulation (DIC) or severe liver dysfunction. The treatment offers essential supportive benefit by managing these severe bleeding manifestations, which supports general well-being during symptomatic phases.


Quick Fact: Relief for Severe Bleeding Symptoms

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Eligibility and Restrictions for Use

Who Can and Cannot Use Haemocomplettan?

The official eligibility for Human Fibrinogen Concentrate is defined by specific population criteria and constraints outlined in government regulatory documents.


Contraindications (Who Must Not Use)

The medicine is contraindicated for patients with known hypersensitivity to Human Fibrinogen or any excipients. Use is also generally contraindicated in patients with existing manifest thrombosis or myocardial infarction. Regulatory guidance permits an exception in the latter cases only if the patient is experiencing a life-threatening hemorrhage.


Age and Condition-Based Restrictions

Haemocomplettan is approved for replacement therapy in adults and children with congenital fibrinogen deficiency. However, use in neonates requires close monitoring due to an increased risk of thromboembolic events.

Use requires special caution and monitoring for patients with comorbidities that increase thrombotic risk, including a history of coronary heart disease or liver disease, and in peri- or post-operative patients.

Safety for use during pregnancy and lactation has not been established in controlled clinical trials. Furthermore, the medicine is not indicated for the treatment of Dysfibrinogenaemia.

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What should I know about interactions with other medicines?

The official regulatory documentation for Haemocomplettan (Human Fibrinogen Concentrate) provides a highly specific interaction profile, defined by a lack of known systemic interactions alongside mandatory administration restrictions.

Interaction Category Official Regulatory Documentation Statement
Medicinal product categories with documented interactions None explicitly listed in regulatory interaction sections for pharmacokinetic or pharmacodynamic risk.
Mechanistic basis of interactions Not applicable. Official prescribing information states that no interactions of Human Fibrinogen Concentrate with other medicinal products are known.
Timing-based interaction rules Mandatory administration separation is required due to reconstitution and solution compatibility requirements.
Interaction-related restrictions The concentrate must not be mixed with other medicinal products or intravenous solutions; it is required to be administered through a separate intravenous line or injection site.

Interaction classifications (high-level)

Classification Official Regulatory Documentation Statement
Interaction severity classification Not classified as a systemic drug-drug interaction risk, but physical incompatibility leads to a mandatory procedural restriction across all official labels.
Regulatory basis Based on core prescribing information from major international health authorities, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Resulting interaction structure

Official interaction statements confirm that there are no known pharmacokinetic or pharmacodynamic interactions documented with other medicines. The only constraints documented relate to procedural requirements: the concentrate must not be mixed with any other solution. This structure confirms that Haemocomplettan's interaction-related constraints are confined to physical compatibility and dedicated intravenous administration, not systemic effects on co-administered drugs.

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Mechanism of Action

Mechanism of Action (Pharmacodynamics)

Haemocomplettan is a human fibrinogen concentrate (coagulation factor I) administered via the intravenous route. Its core mechanism involves supplementing the plasma concentration of the soluble precursor protein fibrinogen within the systemic circulation. This administered protein functions as a physiological substrate within the common coagulation pathway.

The key mechanistic cascade begins when the serine protease thrombin (factor IIa) cleaves specific amino terminal ends of the exogenous fibrinogen molecule. This proteolytic action releases fibrinopeptides A and B, which converts the soluble fibrinogen into insoluble fibrin monomers.

Fibrin monomers spontaneously undergo polymerization through end-to-end and side-to-side aggregation, forming the foundational, mesh-like protein network of the nascent thrombus. Subsequently, activated coagulation factor XIIIa catalyzes the covalent cross-linking of these fibrin polymers, introducing structural integrity and increasing the mechanical strength and elasticity of the clot. This system-level physiological consequence promotes the formation of a stabilized, cross-linked fibrin matrix that is more resistant to premature enzymatic degradation by the fibrinolytic system.

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Dosage and Administration Information

Official Administration Guidelines

Haemocomplettan is a prescription medicine that must be administered only under the supervision of a physician experienced in treating coagulation disorders. The instructions for its preparation and use are strictly defined.

Route and Rate

Administration is by intravenous infusion or injection only. The reconstituted solution should be warmed to room or body temperature and injected or infused slowly at a rate that the patient finds comfortable, not exceeding approximately 5 mL per minute.

Dosing and Monitoring

Dosage is determined on an individual patient basis by regular measurement of the plasma fibrinogen level and continuous monitoring of the patient's clinical condition. The dose needed can be calculated using a specific formula based on the measured fibrinogen level and the desired target level. If the patient's baseline fibrinogen level is unknown, the recommended initial dose is 70 mg per kg of body weight (bw) administered intravenously. The dosage for children (neonates, infants, and older children) is generally determined on the same basis as for adults, according to body weight and clinical need.

Preparation Requirements

Prior to administration, the powder must be reconstituted using the specified volume of Water for Injections. The product vial should be gently swirled to dissolve the powder; vigorous shaking must be avoided to prevent foaming. The reconstituted solution must be clear or slightly opalescent and should not be used if it is cloudy or contains visible particles. After administration, it is strongly recommended that the name and batch number of the product be recorded to maintain a link between the patient and the administered batch.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Haemocomplettan

Evidence for Use in Inherited Bleeding Disorders

Human Fibrinogen Concentrate was the focus of research involving people born with congenital fibrinogen deficiencies, such as Afibrinogenaemia. Because these conditions are rare, the research includes uncontrolled studies and observational data that look back at patient experiences over time. These studies included both children and adult populations. Researchers explored outcomes related to systemic imbalance, including how doctors clinically assessed the ability to stop bleeding and how certain laboratory markers of clotting changed after the concentrate was administered.

Research examined the concentrate both for acute bleeding episodes and for preventative (prophylactic) administration where studies explored whether it might affect the frequency of spontaneous bleeding. Findings describe patterns observed in the studies where the concentrate was used in research exploring coagulation parameters. Studies monitored the concentration of fibrinogen in the blood, and data show patterns related to pharmacokinetic principles.

Evidence for Use in Acute, Severe Bleeding

Research has explored the use of the concentrate during acute, severe bleeding that can occur during major surgery or obstetrical complications like Postpartum Hemorrhage (PPH). The research base here includes small, short-term Randomized Controlled Trials (RCTs). The concentrate was evaluated in trials that compared it to a placebo or other blood products like Fresh Frozen Plasma (FFP).

Studies monitored outcomes related to episodic or acute changes, specifically looking at the volume of blood loss and the need for allogeneic blood product transfusions (Red Blood Cells, FFP). Some trials described patterns of transfusion requirements that were monitored and compared against control groups. However, findings related to blood loss volume and overall clinical hemostasis were mixed and varied across studies.

Quality and Uncertainty: What Remains Unclear About the Evidence

The overall certainty remains low to moderate due to the small size of trials and the reliance on observational data. Follow-up durations were limited to short-term observation, meaning there is limited information on the long-term effects. More large-scale, controlled research is needed to resolve the mixed findings and expand the evidence base for use in highly variable, acute settings.

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Frequently Asked Questions (FAQ)

Common questions about Haemocomplettan (FAQ)


Q: What is Haemocomplettan used for besides the main condition?

A: Haemocomplettan, which is Human Fibrinogen Concentrate, is officially indicated for treating and preventing bleeding in patients who have certain low levels of fibrinogen. In addition to its use in inherited bleeding disorders, studies have explored its use in treating acute, severe bleeding that can occur during major surgery or complications like Postpartum Hemorrhage (PPH). The decision for its use is determined by a physician’s assessment.

Q: What are the most common things people misunderstand about Haemocomplettan?

A: Common misunderstandings often involve its role in the body. Official descriptions state this medicine is a highly concentrated source of human fibrinogen, which is the key protein (Factor I) necessary for forming a strong blood clot. It is important to understand that it is distinct from a complete blood transfusion and from medicines that supplement other specific clotting factors, such as Factor VIII or Factor XIII.

Q: Does Haemocomplettan interact with common painkillers like paracetamol or ibuprofen?

A: Official prescribing information states that no systemic interactions of Human Fibrinogen Concentrate with other medicinal products, including common painkillers, are known. However, the medicine must not be mixed with any other intravenous solutions or medicinal products in the same line. Providing a complete list of all medicines to the healthcare provider is part of the standard treatment process.

Q: Is it common for patients to develop Factor XIII inhibitors after using Haemocomplettan?

A: Regulatory information for this medicine focuses on its main component, fibrinogen (Factor I). The development of inhibitors against the active substance, fibrinogen, has not been identified as a common occurrence in the official product documentation.

Q: What should be done if an injection site reaction occurs?

A: Official guidelines state that if signs of a reaction occur (such as hives, generalized itching, tightness in the chest, or swelling at the injection site), the infusion may need to be stopped immediately by a healthcare professional. Any unusual or concerning symptoms should be reported to the administering healthcare professional.

Q: Can people who are allergic to certain proteins use Haemocomplettan?

A: The medicine is formally contraindicated (meaning it should not be used) in patients who have a known hypersensitivity or severe allergic reaction to the active substance, human fibrinogen, or any of the inactive ingredients (excipients). The appropriateness of the medicine is determined by a physician after reviewing a patient's medical history, including specific allergies.

Q: What should a patient tell their dentist about Haemocomplettan use?

A: It is important for any healthcare professional, including a dentist, to be informed about the use of Human Fibrinogen Concentrate treatment. This allows them to manage procedures, especially those that involve a risk of bleeding, and coordinate care with the physician managing the patient's coagulation disorder.

Q: Does Haemocomplettan affect liver or kidney function tests?

A: Official guidelines emphasize that dosage is determined by regularly measuring the plasma fibrinogen level and continuously monitoring the patient's clinical condition. There are no specific warnings in the official documentation regarding interference with general liver or kidney function tests.

Q: What is the difference between Factor XIII and Factor VIII?

A: Haemocomplettan provides Factor I (Fibrinogen) to the body, which is essential for forming a clot’s meshwork. Factor XIII is another protein that stabilizes this meshwork, making the clot stronger. Factor VIII is a separate clotting protein that is central to the process of generating thrombin, but it is not the active ingredient in Haemocomplettan.

Q: Is Haemocomplettan used for preventing bleeding or only for treating it?

A: Official documents and research indicate that the concentrate has been explored for both uses in specific patient populations. It is used to treat acute, severe bleeding episodes and has also been explored in studies for preventative (prophylactic) administration in patients with congenital fibrinogen deficiency.

Q: What does the research say about the effectiveness of Haemocomplettan in children?

A: Studies examining the use of the concentrate included both children and adult populations. Official guidelines confirm that dosage for children and infants is generally determined on the same basis as for adults, according to body weight and clinical need. Research focuses on how the concentrate affects laboratory markers of clotting in children.

Q: How quickly does Haemocomplettan start working after it's given?

A: Haemocomplettan is administered directly into a vein (intravenously). Because of this route, the functional protein is immediately available in the bloodstream. Its effect on the formation of a stabilized clot can be observed and measured by laboratory testing shortly after the injection is complete.

Q: How long does the effect of Haemocomplettan last?

A: The length of time the administered fibrinogen remains active in the body is described in official pharmacokinetic documents. The biological half-life—the time it takes for half of the substance to be eliminated—is stated to be approximately 3 to 5 days in adults, though official documents note it may be shorter in children.

Q: What is the half-life of Haemocomplettan Factor XIII in the body?

A: The half-life refers to the time it takes for the concentration of the active substance to reduce by half. The biological half-life of the fibrinogen in this medicine is typically stated as 3 to 5 days. For children and adolescents, official documents note that the half-life may be shorter and clearance may be faster than in adults.

Q: Are there different versions or strengths of Haemocomplettan?

A: The medicine is officially available as a powder for solution for injection or infusion. According to prescribing information, it is typically presented in vials containing either 1 gram or 2 grams of human fibrinogen concentrate.

Q: Is it normal to feel tired after receiving Haemocomplettan?

A: Official regulatory documents list 'unusual tiredness or weakness' as a possible side effect of human fibrinogen concentrate therapy. Any fatigue or weakness experienced should be reported to the healthcare professional managing the patient’s care so they can evaluate the cause.

Q: Do you need to be tested for certain things before using Haemocomplettan?

A: Regulatory guidelines indicate that the administration of the medicine is adapted based on the patient’s clinical status and regular measurement of laboratory results. The physician uses this information, especially the functional fibrinogen level, to determine the appropriate course of treatment.

Q: Is Haemocomplettan safe for older patients?

A: Official prescribing information includes specific safety considerations for all patients. This includes individuals who may be at an increased risk of blood clotting, such as those with certain cardiovascular conditions. Dosage decisions for older patients are made individually by a healthcare professional.

Q: Can children or infants use Haemocomplettan?

A: Yes, official regulatory documents state that the medicine is indicated for use in children and infants. The dosage for these populations is determined on the same basis as for adults, according to the child's body weight and specific clinical need.

Q: What is the general expectation for follow-up appointments after starting Haemocomplettan?

A: The prescribing physician determines the necessary frequency of follow-up by monitoring the patient’s clinical status and regularly measuring plasma fibrinogen levels. This monitoring is done to ensure the treatment approach remains optimal for the individual patient.

Q: Are there restrictions on driving or operating machinery after treatment?

A: Official prescribing information states that no effects on the ability to drive and use heavy machinery have been specifically observed or studied with this medicine. Any post-infusion instructions provided by a healthcare professional should be followed.

Q: How do I know if I'm eligible to receive Haemocomplettan?

A: The medicine is formally indicated for patients with specific congenital or acquired fibrinogen deficiencies that result in bleeding or the risk of bleeding. Eligibility is determined by a physician after reviewing the diagnosis and assessing for contraindications, such as known severe allergic reactions to the medicine's components.

Q: Does Haemocomplettan treat the underlying cause or just the symptom?

A: The medicine is described as a substitution therapy. It functions by temporarily increasing the level of fibrinogen in the blood to restore a patient's ability to form a stable blood clot. It addresses the immediate deficiency of the clotting protein rather than curing the underlying condition that causes the deficiency.

Q: What is the source material used to make Haemocomplettan?

A: Official documents describe the medicine as a concentrate produced from pooled human plasma. The source material is processed to obtain the human fibrinogen concentrate and undergoes required procedures to inactivate and remove potential infectious agents.

Q: How often do patients typically need Haemocomplettan treatment?

A: The frequency of administration is highly individual and depends on the specific condition being treated, such as acute bleeding or preventative therapy. Official guidance indicates that in the absence of continued consumption (rapid use by the body), repeated treatment with human fibrinogen is not usually required for the acute condition.

Q: Does Haemocomplettan affect blood pressure?

A: Yes, official documents list a decrease in blood pressure (hypotension) as an adverse reaction that has been observed with this medicine. This is sometimes associated with hypersensitivity or allergic reactions, and the healthcare team monitors the patient closely during and after administration.

Q: Can someone use Haemocomplettan if they have other pre-existing medical conditions?

A: Use is determined on an individual basis. Official information includes specific warnings for patients with certain pre-existing conditions that increase the risk of blood clotting, such as those with severe liver disease or a history of coronary artery disease. A physician assesses these risks when prescribing the medicine.

Q: Is it true that Haemocomplettan can be used to treat wounds?

A: Haemocomplettan is indicated for systemic treatment via intravenous infusion to help with bleeding associated with surgical procedures or trauma. Its function is to supplement the necessary protein in the bloodstream, and it is not indicated for topical application directly onto a wound.

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How should Haemocomplettan be stored and disposed of?

Official Storage and Disposal Requirements

Official regulatory documents define strict conditions for storing and discarding Haemocomplettan (Human Fibrinogen Concentrate).


Storage of Unopened Powder

Condition Requirement
Temperature Store refrigerated between 2 °C and 8 °C (36 °F to 46 °F).
Protection Keep the vial in its original outer carton to protect the powder from light and do not freeze.
Safety The medicine must be stored out of the sight and reach of children.

Stability and Handling

Condition Requirement
Post-Reconstitution The solution must be used immediately after preparation.
Maximum Stability Stability data supports use for up to 8 hours if stored at room temperature (le 25 °C). The solution must not be refrigerated.
Aseptic Conditions Reconstitution and handling must be performed under aseptic conditions.

Disposal

All unused product or waste material must be disposed of strictly in accordance with local requirements for pharmaceutical and biological waste. Partially used vials must be discarded.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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