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Протромплекс 600

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Протромплекс 600

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Treatment option: Hemophilia

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Протромплекс 600

What is Prothromplex 600? (Overview)

Property Description
Active Ingredients Coagulation Factors II, VII, IX, X
Form Lyophilized powder for solution for injection
Pharmacological Class Antihaemorrhagic (Prothrombin Complex Concentrate)
Common Use Urgent reversal of Vitamin K antagonist (VKA) effects
Origin Human plasma
Manufacturer Takeda Manufacturing Austria AG

Prothromplex 600 (also marketed as Prothromplex TOTAL 600 IU) is a Prescription-Only Medicine (Rx) that is classified as a human prothrombin complex concentrate (PCC). It is prepared from screened and purified human plasma, which is treated to ensure its safety and purity.

The concentrate's active components are the four essential vitamin K-dependent coagulation factors: Factor II (prothrombin), Factor VII, Factor IX, and Factor X, along with the natural anticoagulation proteins C and S. The 600 IU in the name refers to the nominal Factor IX activity within the formulation. This concentration is designed to restore clotting factor levels.

Its primary medical function is the urgent reversal of acquired deficiencies in these factors, a condition frequently caused by treatment with Vitamin K antagonists (VKAs), which are common oral anticoagulants. Prothromplex TOTAL is indicated for the treatment of bleeding and prophylaxis in patients with such acquired deficiencies. Prothrombin Complex Concentrates provide a method for rapidly reversing VKA anticoagulation in emergency situations.

Prothromplex 600 is supplied as a lyophilized powder that requires reconstitution with a sterile solvent before being administered slowly into a vein (intravenously).

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What side effects are possible with Протромплекс 600?

Possible Side Effects and Safety Information

Протромплекс 600 (Prothromplex 600) is a human prothrombin complex concentrate, and its use is associated with risks primarily related to its procoagulant and plasma-derived nature. Safety information is based on official governmental regulatory documents.


Adverse Reaction Scope

The most significant documented adverse reactions fall into two main categories: Thromboembolic Events and Hypersensitivity Reactions.

  • Serious and Clinically Significant Adverse Reactions include life-threatening events such as disseminated intravascular coagulation (DIC), myocardial infarction, cerebrovascular accident (stroke), and pulmonary embolism.
  • Hypersensitivity reactions can range from common mild symptoms to severe, life-threatening anaphylactic shock.
  • Common Adverse Reactions (affecting up to 1 in 10 patients) include DIC, development of coagulation factor inhibitors (in congenital deficient patients), anaphylactic shock, hypersensitivity, cerebrovascular accident, headache, and various cardiovascular/skin reactions (e.g., tachycardia, hypotension, vomiting, urticaria, pyrexia).

Safety Limitations and Restrictions

Restriction Category Details
Contraindications Known allergy to heparin or history of heparin-induced thrombocytopenia ( HIT). Hypersensitivity to the active substance or any excipients.
High-Risk Patients Patients with a history of coronary heart disease, liver disease, or pre/post-operative status should be closely monitored due to an increased risk of thrombosis and DIC.
Viral Safety As a human plasma derivative, the theoretical risk of transmitting infectious agents (e.g., CJD, Parvovirus B19) cannot be completely excluded, despite rigorous viral inactivation and removal procedures.

Dose-Related Patterns: Repeated dosing carries an increased risk of thrombosis and DIC. The development of circulating antibodies (inhibitors) against the administered coagulation factors is a recognised risk, leading to insufficient clinical response.

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Overdose and Emergency Response

Overdose and when to seek help

The administration of human prothrombin complex concentrate, such as Протромплекс 600 (also known in official documents as Prothromplex TOTAL or Prothrombinex-VF), at doses exceeding those calculated may pose a risk of overcorrection, leading to thrombotic complications.

Overdose scope Feature Official Regulatory Statement
Documented overdose presentations Thromboembolic complications, including myocardial infarction (heart attack), venous thrombosis, arterial thrombosis, pulmonary embolism, and disseminated intravascular coagulation (DIC).
Physiological systems affected Vascular system, resulting in increased blood clotting (hypercoagulability).
Dose-related factors Overdosage may enhance the risk of the development of heart attacks and blood clots (thrombosis). Risk may be higher with repeated or high doses, or in treatment of isolated Factor VII deficiency.
Population-specific overdose notes Patients with a history of heart disease, liver disease, or those receiving repeat doses may require particularly close monitoring for signs of thrombosis or DIC.
Emergency-response statements Patients should be observed closely for signs and symptoms of intravascular coagulation or thrombosis. The treatment of overdose is generally supportive.
When immediate medical help is required If signs of thrombosis, thromboembolism, or consumption coagulopathy (DIC) are suspected, or if a severe sudden allergic reaction (anaphylaxis) occurs, the administration should be stopped immediately and urgent medical treatment sought.

Resulting overdose structure

  • Overdosage is officially associated with an enhanced risk of thromboembolic complications and potentially life-threatening conditions like Disseminated Intravascular Coagulation (DIC).
  • Official regulatory texts mandate that patients be closely observed for signs of intravascular coagulation or thrombosis, particularly following administration.
  • The development of symptoms like chest pain, sudden shortness of breath, or signs of a severe allergic reaction (e.g., swelling, breathing difficulties) must lead to the immediate cessation of administration and the seeking of urgent medical attention.

Connection to the overall overdose profile

Official regulatory documents define the overdose profile primarily by the risk of excessive clotting activity, contrasting the expected therapeutic effect of preventing bleeding. This risk profile dictates the need for precise dosing and continuous monitoring, with specific warnings to seek emergency medical attention if signs of abnormal clot formation or acute hypersensitivity reactions manifest.

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Therapeutic Uses of Протромплекс 600

What Протромплекс 600 Treats: Main Uses and Benefits

Протромплекс 600 is commonly used to manage and help control acute, uncontrolled major bleeding in patients who present with a deficiency of coagulation factors, generally acquired due to the use of Vitamin K antagonists (VKAs). The therapeutic benefit is factor replacement which supports the achievement of haemostasis, supports the patient during difficult episodes by easing distress. This concentrate is indicated for the urgent reversal of acquired coagulation factor deficiency.


The medication is applied in addressing the state of a deficiency of the Vitamin K-dependent coagulation factors (II, VII, IX, X). It is considered relevant for managing bleeding or is used to provide support in congenital factor deficiencies when the specific purified factor concentrate is not available, which may assist with providing additional symptomatic support during episodes of heightened discomfort. It also provides supportive assistance for urgent perioperative prophylaxis of bleeding in high-risk patients who require immediate surgical or invasive procedures. This use supports management of haemorrhage risk during intervention and assists with maintaining functional stability for the necessary procedure.


Quick Fact: Relief for Acute Major Bleeding Протромплекс 600 is commonly used in clinical settings that involve acute or unstable symptom patterns, where immediate correction of the factor deficiency helps address symptom clusters that may become intense or disruptive.


Regulatory References

  1. National Institutes of Health (NIH) StatPearls
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Eligibility and Restrictions for Use

Official Eligibility Status

Протромплекс 600 eligibility is strictly defined by regulatory guidelines concerning absolute exclusions, age limits, and risk profiles. The medicine is indicated for use only in Adults who have an acquired deficiency of vitamin K-dependent coagulation factors when rapid correction of clotting levels is medically necessary. It may also be used in cases of congenital factor deficiency if a specific factor concentrate is unavailable.


Absolute Contraindications

The medicine is strictly contraindicated for any patient with a known allergy or hypersensitivity to its active substances or excipients. Absolute prohibition also applies to individuals with a history of heparin-induced thrombocytopenia (HIT) or a heparin allergy.


Population Restrictions

Use is not recommended for the paediatric population (children and adolescents) as safety and efficacy have not been established in clinical trials. During pregnancy and lactation, use is restricted to being clearly indicated due to insufficient safety data. Close monitoring is mandatory for patients with elevated thromboembolic risk, including those with liver disease, coronary heart disease, or risk factors for Disseminated Intravascular Coagulation (DIC).

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Prothromplex 600 is defined by a mandatory functional relationship, administration constraints, and specific component-driven restrictions as outlined in regulatory documents. The most significant interaction is the functional antagonism it exhibits toward Vitamin K Antagonists (VKAs) such as Warfarin. The concentrate supplies the four missing Vitamin K-dependent coagulation factors (II, VII, IX, X), resulting in the neutralisation of the VKA's anticoagulant effect.

Administration and Component Restrictions

Interaction Type Interacting Substance/Condition Regulatory Constraint
Contraindication Heparin-Induced Thrombocytopenia (HIT Type II) Strictly contraindicated due to heparin content in the formulation.
Timing Rule Fibrinolytic Agents (e.g., Urokinase) Must not be mixed in the same infusion line due to physical incompatibility.
Population Restriction Disseminated Intravascular Coagulation (DIC) Use is restricted due to increased thromboembolic risk.

Co-administration with other procoagulant preparations is officially discouraged as it may increase the risk of thromboembolism. No specific interactions with food, alcohol, herbal products, or those mediated by cytochrome P450 enzymes are documented in the official prescribing information.

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Mechanism of Action

Протромплекс 600, a Prothrombin Complex Concentrate (PCC), modulates the hemostatic system by introducing a concentrated plasma-derived formulation of the vitamin K-dependent coagulation factors II (prothrombin), VII, IX, and X. These are the biological targets. .

Following intravenous administration, these coagulation factors enter the systemic circulation. Factors II, VII, IX, and X function as enzyme precursors (zymogens) in the coagulation cascade. Factor VII, upon complex formation with tissue factor (TF), rapidly generates activated Factor VIIa (FVIIa), initiating the extrinsic pathway. FVIIa then acts as an enzyme to convert Factor X to its active form, Factor Xa (FXa), and Factor IX to Factor IXa (FIXa).

FIXa, a component of the intrinsic tenase complex, and FXa, a component of the prothrombinase complex, further propagate the cascade. FXa, in combination with activated Factor Va (FVa), is a key enzyme that catalyzes the cleavage of prothrombin (Factor II) to generate the active enzyme, thrombin (Factor IIa). The generated thrombin (FIIa) is a serine protease that catalyzes the ultimate downstream cascade step: the conversion of soluble fibrinogen to insoluble fibrin monomers, which polymerize to form the structural scaffold of the hemostatic plug. The systemic physiological consequence is a concentrated re-establishment of the intrinsic and extrinsic coagulation pathways, promoting plasma-based clot formation.

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Dosage and Administration Information

How to Use Протромплекс 600

The administration of Prothromplex 600 IU is restricted to the intravenous (IV) route only and must be initiated under the supervision of a physician experienced in coagulation disorders. The product is supplied as a lyophilized powder that requires reconstitution with the provided solvent immediately before use. Administration must be slow; the official instruction specifies an infusion rate that should not exceed 2 ml/min or 60 IU/min.


Labeled Dosing Regimen

The dosage of Prothromplex 600 IU is highly individualized and is based on the patient’s pre-treatment International Normalized Ratio (INR) and body weight. The dosage is calculated in International Units (IU) of Factor IX activity per kilogram (kg) of body weight. The dose is based on body weight up to a maximum of 100 kg.

Pre-treatment INR Dose (IU Factor IX/kg) Maximum Dose (IU)
2.0 to <4.0 25 2500
4.0 to 6.0 35 3500
>6.0 50 5000

Frequency and Contextual Use

Administration is typically limited to a single dose in the acute setting, as the safety and effectiveness of repeat dosing are not established in the product labeling. To achieve sustained factor maintenance after the rapid, short-term correction, Vitamin K must be administered concurrently. There is currently insufficient data to recommend the administration of this concentrate in pediatric patients (under 18 years), thereby restricting its use to adults.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Протромплекс 600


Evidence for use in Acquired Deficiency of Coagulation Factors

Протромплекс 600 was studied for use in adult patients who have an acquired deficiency of clotting factors, frequently due to anticoagulants like warfarin. The available research includes observational reports, case series, and some smaller randomized trials. These studies monitored outcomes over short-term intervals, primarily examining outcomes related to systemic or functional imbalance.

Studies reported patterns of change in laboratory markers like the International Normalized Ratio (INR) and Prothrombin Time (PT) during the observed time period. The data focus on these laboratory changes, and long-term functional outcomes are not the primary measured endpoint. What remains uncertain is how these short-term laboratory changes translate into long-term functional outcomes. Follow-up durations were limited in many studies, and comparative evidence is lacking against all potential alternative treatments.


Evidence for use in Congenital Deficiency of Factor IX (Hemophilia B)

Протромплекс 600 was evaluated in the context of conditions characterized by fluctuating or episodic manifestations, specifically Hemophilia B. Research in this area relies on historical clinical trials and post-marketing surveillance related to the broader class of plasma-derived Factor IX concentrates.

These studies monitored patient outcomes describing episodic or acute changes, focusing on plasma Factor IX (FIX) activity levels and tracking the frequency of bleeding episodes when the product was observed in patients. Research describes patterns related to Factor IX recovery in the blood after infusion. Evidence quality varies across studies, and comparative evidence is lacking against other available Factor IX products. This means that definitive subgroup findings are uncertain due to limited comparative data.


Long-Term Evidence and Follow-Up Duration

Most available research focused on research exploring short-term symptom changes, meaning that the long-term effects are not fully established by existing high-quality studies. There is limited information for long-term outcomes that monitor patient well-being months or years after treatment. Data are still emerging regarding patterns of long-term outcomes associated with the use of the product, particularly for repeated use.


What is Still Uncertain About Протромплекс 600 Evidence

The research landscape indicates several areas where data remain insufficient. For instance, evidence is limited regarding many clinical outcomes. Comparative evidence is lacking in some key areas, and findings were mixed across different studies. The evidence highlights what is known — and what is still uncertain, providing context but not individual predictions.

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Frequently Asked Questions (FAQ)

Common questions about Протромплекс 600 (FAQ)

Q: How long do the effects of Протромплекс 600 typically last in the body?

The factors in this medication have different half-lives, meaning they stay active in the body for varying amounts of time. For instance, Factor VII has a short half-life of about 3 to 5 hours, while Factor IX lasts longer, typically 16 to 30 hours. The desired clinical effect, such as the rapid correction of the INR, is typically observed rapidly, often within 30 minutes, but the factor activity can decline over several hours to days.


Q: What are the most common side effects people experience with Протромплекс 600?

Based on official product information for this class of medicine, some of the most commonly reported side effects include headache, feelings of nausea or vomiting, and occasionally a drop in blood pressure (hypotension). These reactions are reported in official safety documents and post-marketing reports.


Q: What is the typical use of Протромплекс 600 outside of urgent bleeding reversal?

In addition to the urgent reversal of Vitamin K Antagonist (VKA) effects, this concentrate is officially indicated for treating or preventing bleeding in patients who have an acquired deficiency of certain clotting factors. It may also be used in cases where a patient has a congenital factor deficiency and a specific, single-factor concentrate is not readily available.


Q: What is the shelf life and storage requirement for the powdered form of Протромплекс 600?

The lyophilized powder form of the product must be stored in a refrigerator at a temperature between 2 C and 8 C to maintain its potency. The specific shelf life (the expiration date) is determined by the manufacturer and is clearly printed on the original packaging.


Q: How does Протромплекс 600 interact with newer blood thinners (DOACs/NOACs)?

The official indication is specifically for the reversal of Vitamin K Antagonists (VKAs) like warfarin. For newer anticoagulants (DOACs/NOACs), use is generally considered off-label, and clinical guidance is still developing. No specific interactions are formally documented in the official prescribing information for DOACs/NOACs.


Q: What is the role of Vitamin K in relation to Протромплекс 600's action?

This medication provides an immediate supply of the missing vitamin K-dependent factors. Vitamin K is required to support the sustained synthesis of new, functional clotting factors by the body. Therefore, concurrent administration is recommended to ensure a more complete and lasting correction of the deficiency.


Q: Why are people often given this medicine alongside Vitamin K?

People are often given Vitamin K alongside this medicine because while the concentrate acts immediately to stop bleeding, Vitamin K is given to support the body's own, long-term production of new clotting factors. This combined approach ensures both rapid and sustained correction of the factor deficiency.


Q: Is Протромплекс 600 considered a blood thinner or a clotting agent?

Протромплекс 600 is classified as an antihaemorrhagic medicine. It functions as a clotting agent by supplying concentrated coagulation factors that contribute to the formation of a blood clot, rather than thinning the blood.


Q: Are there any long-term side effects associated with repeated use of Протромплекс 600?

Official warnings state that the safety and effectiveness of repeated dosing are not fully established. Furthermore, repeat use is associated with an increased risk of serious clotting events, including thromboembolism and disseminated intravascular coagulation (DIC).


Q: Are there any food or dietary restrictions to consider with Протромплекс 600?

According to the official prescribing information, there are no specific adverse interactions documented with common substances such as food, alcohol, or herbal products that require mandatory dietary restrictions.


Q: Is it normal to feel dizzy or lightheaded after receiving Протромплекс 600?

Yes, regulatory documents note that adverse reactions such as dizziness or feeling lightheaded have been reported with this type of product. If a patient experiences this, they should inform their supervising clinician immediately, as it can sometimes be associated with low blood pressure (hypotension).


Q: Can Протромплекс 600 cause a rise in blood pressure?

Both a drop in blood pressure (hypotension) and an increase in blood pressure (hypertension) are listed among the reported adverse reactions for Prothrombin Complex Concentrates. These cardiovascular reactions can occur during or after administration.


Q: Can Протромплекс 600 cause joint pain or muscle stiffness?

Official information indicates that pain in the joints (arthralgia) and muscle stiffness have been reported as adverse reactions associated with the use of this medicine.


Q: Does this medicine have a warming or flushing effect during administration?

Yes, some patients have reported experiencing adverse reactions such as a feeling of warmth or redness of the skin (flushing) during the infusion. This information is noted in regulatory documents regarding possible side effects.


Q: Can it be administered in an outpatient setting or only in a hospital?

Official guidance requires administration to be initiated and monitored by a physician experienced in coagulation disorders. Due to its use in acute conditions and the need for close observation, the product is typically used in a hospital setting.


Q: What if the patient is allergic to one of the inactive ingredients like human albumin?

This medicine is strictly contraindicated (prohibited) for any patient who has a known allergy or hypersensitivity to the active substance or any of the inactive ingredients (excipients), such as human albumin. Allergic reactions, including severe ones, are a known risk.


Q: What is the half-life of the coagulation factors delivered by Протромплекс 600?

The four main factors delivered have distinct half-lives: Factor VII is the shortest, at approximately 3 to 5 hours; Factor IX is about 16 to 30 hours; Factor X is around 24 to 48 hours; and Factor II is the longest, at around 40 to 60 hours. These figures describe the time it takes for half of the factor activity to leave the blood.

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How should Протромплекс 600 be stored and disposed of?

Storage and Disposal Requirements for Prothromplex 600

The official label requires that the Prothromplex 600 (lyophilized powder and solvent) be stored in a refrigerator between 2 C and 8 C. It is mandatory to not freeze the product and to store it in the original package to protect it from light. The product must also be kept out of the sight and reach of children.

Stability and Handling

Within its shelf-life, the product may be stored at room temperature (up to 25 C) for a single, recorded period of up to six months. The reconstituted solution must be used immediately as it contains no preservative; it must not be refrigerated after preparation. Unused, expired product or waste material must be disposed of in accordance with local requirements and not via household waste or wastewater.

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

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