Лонгидаза

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Лонгидаза

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Overview of Лонгидаза

What is Лонгидаза? Identity, Composition, and General Purpose

Property Description
Active ingredient Bovhyaluronidaze Azoximer
Forms Lyophilizate (for injection), Suppositories
Pharmacological class Enzyme preparation, Tissue permeability modulator
General purpose Modulating tissue rigidity and aiding restoration
Origin Biotechnological product (semi-synthetic conjugate)

What is Лонгидаза: Identity and Pharmacological Class

Лонгидаза is a unique, typically prescription-only biotechnological pharmaceutical product that functions as an enzyme preparation and tissue permeability modulator. This classification is based on its primary biological activity of altering the properties of connective tissue structures. The drug entity is supplied in two primary pharmaceutical forms: a lyophilizate for preparation of solutions intended for parenteral administration (subcutaneous or intramuscular injection) and suppositories for local administration (rectal or vaginal use). The core of its function involves Hyaluronidase activity, recognized for its role in the breakdown of hyaluronic acid, a major component of the extracellular matrix.


The Composition and Origin of Bovhyaluronidaze Azoximer

The active ingredient is Bovhyaluronidaze Azoximer, a covalent polymer conjugate that defines the drug's sustained activity, a key differentiating feature. This complex structure is chemically formed by bonding the enzyme Bovhyaluronidaze (derived from bovine hyaluronidase) to Azoximer bromide, a high-molecular-weight synthetic polymer stabilizer. The stabilized structure is offered to provide a sustained therapeutic profile, distinguishing it from simpler hyaluronidase preparations that are subject to rapid inactivation. This conjugation enhances the stability of the enzyme, allowing for a longer therapeutic effect compared to the free enzyme.


General Purpose: What does this Enzyme Preparation help to achieve?

The general purpose of Лонгидаза is to modulate the structural rigidity of connective tissue and enhance tissue restoration, typically in contexts following injury or inflammation. The enzyme component catalyzes the depolymerization of glycosaminoglycans such as hyaluronic acid, which increases tissue permeability. By facilitating the loosening of dense and stiffened tissue structures, the preparation generally supports the body’s ability to soften scar tissue and encourages the reversal of pathological changes, thereby promoting improved flexibility and restoration in affected areas.

Regulatory References

  1. National Library of Medicine Source
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What side effects are possible with Лонгидаза?

Possible Side Effects and Safety Information for Longidaza (Bovhyaluronidaze Azoximer)

The official safety profile for Bovhyaluronidaze Azoximer, as classified by government regulatory authorities, details adverse reactions primarily related to the administration site and potential systemic hypersensitivity. All statements adhere strictly to the information documented in official prescribing labels.


Documented Adverse Reactions and Frequency

Adverse effects are categorized by frequency based on clinical data:

Classification System-Organ Class Examples
Common General disorders and administration site conditions Local discomfort, redness (hyperemia), or mild swelling at the injection or insertion site.
Not Known Immune system disorders; General disorders Allergic reactions (hypersensitivity), fever, chills, or general malaise (frequency cannot be estimated from available data).

Local reactions are typically described as transient and may be observed immediately following administration.


Serious Reactions and Safety Constraints

Serious Adverse Reactions officially noted include the potential for severe allergic reactions, such as anaphylaxis. These events are considered rare but clinically significant.

Use of Лонгидаза is subject to several contraindications explicitly stated in regulatory documents:

  • Active Malignancy: The medicine is generally contraindicated in patients with active or acute malignant processes.
  • Pediatric and Reproductive Groups: It is contraindicated in children under 18 years of age, and during pregnancy and breastfeeding, due to insufficient data establishing safety in these populations.
  • Acute Conditions: Contraindicated in the presence of acute hemorrhages or known severe hypersensitivity to the active ingredient or bovine hyaluronidase preparations.

Furthermore, its mechanism can enhance tissue permeability, which regulatory documents note may increase the safety risk of certain co-administered drugs like corticosteroids and diuretics.

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Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for Bovhyaluronidase Azoximer (Лонгидаза) defines the overdose profile through specific clinical presentations and mandatory procedural actions, drawing strictly from the documented prescribing information.

Documented Clinical Manifestations

Overdose manifestations described in the official instructions include a cluster of systemic signs such as chills, a noticeable increase in body temperature (fever), and general dizziness. A significant clinical sign is the occurrence of hypotension, or low blood pressure. Additionally, formal physiological findings from high-dose toxicology reports indicate that exposure can be associated with elevated blood serum markers, including increases in creatinine, urea, and transaminases, although no specific life-threatening outcomes are explicitly documented.

Official Emergency Actions and Supportive Management

The regulatory guidance outlines the necessary procedural steps for overdose management. If manifestations consistent with an overdose are observed, the primary mandated action is the immediate discontinuation of the drug administration. Following this procedural step, the officially defined management measure is the institution of symptomatic therapy. The documentation does not specify the availability or absence of a specific antidote, and it does not contain explicit language mandating the immediate contact of emergency services. No specific warnings regarding heightened overdose risk for particular patient populations are listed in the regulatory summary.

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Therapeutic Uses of Лонгидаза

The primary therapeutic role of Лонгидаза is generally applied in conditions characterized by the excessive formation of dense connective tissue (fibrosis) and internal adhesions. Its use is focused on managing symptoms related to structural conditions and addressing complications associated with fibrosis and its sequelae.

The medication is commonly applied across therapeutic areas including gynaecology, urology, pulmonology, and general surgery, where chronic inflammation is associated with physical restrictions. It helps address symptom clusters that may become intense or disruptive, such as restricted joint movement, chronic pelvic discomfort, and dyspnoea linked to lung scarring.

“The core benefit sought is to help address functional limitations associated with tissue changes that have been affected by long-term inflammation or trauma.”

This supportive therapeutic approach may assist with supporting flexibility and helps address conditions that interfere with daily functioning and comfort. It is commonly used in scenarios where additional management of discomfort is required in conditions like chronic prostatitis, tubo-peritoneal infertility, pneumosclerosis, and post-traumatic contractures.


Quick Fact: Support for Stiffness and Chronic Discomfort linked to tissue changes.

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Eligibility and Restrictions for Use

The eligibility for using Лонгидаза (Bovhyaluronidaze Azoximer) is strictly defined by official regulatory documentation. The medicine is contraindicated and must not be used by specific populations due to the potential for significant risk.

Absolute Prohibitions

Absolute contraindications include the presence of malignant neoplasms (cancer) and critical conditions such as acute renal failure, active pulmonary hemorrhage, or fresh bleeding into the vitreous body of the eye. Individuals with a known hypersensitivity to the active substance must also not use this medicine.

Use is formally prohibited across vulnerable life stages: the medicine is contraindicated during pregnancy and the lactation/breastfeeding period.

Age-Group and Formulation Rules

Eligibility is defined by age and formulation. The medicine is contraindicated for all children under 12 years of age for any formulation. The injectable form is strictly reserved for use in adults 18 years and older, while the suppository form is permitted for adolescents aged 12 to 17 years.

Conditional Use

Certain populations require restricted or conditional use. Individuals with chronic renal failure may use the medicine with caution, but administration is officially limited to a maximum frequency of once per week. Similarly, application in the presence of acute infectious inflammation is restricted and must be combined with appropriate antimicrobial agents.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Лонгидаза (Bovhyaluronidaze Azoximer) is defined primarily by its officially documented effect on tissue permeability. This results in a pharmacokinetic interaction that increases the absorption and enhances the effect of other medicinal products when administered concurrently by subcutaneous or intramuscular injection. Medicines documented to have increased bioavailability include antibiotics, local anesthetics, and diuretics.

A separate interaction category is defined by agents that reduce the enzymatic activity of the product. Co-administration with high doses of salicylates, cortisone, adrenocorticotrophic hormone (ACTH), estrogens, or certain antihistaminic drugs is officially stated to potentially decrease the enzyme’s activity. This inhibitory effect also extends to non-medicinal substances, with enzyme activity documented to be reduced by high doses of Vitamin C and other reducing agents.

The regulatory documentation includes strict timing-based restrictions on co-administration with specific medicinal products. It is officially advised not to use Лонгидаза simultaneously with medicines containing furosemide, benzodiazepines, or phenytoin. The drug may also cause degradation of hyaluronic acid-based fillers, reducing their effectiveness. No population-specific interaction considerations (e.g., geriatric or hepatic impairment) are explicitly stated in the regulatory interaction sections.

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Mechanism of Action

Enzymatic Remodeling of Pathological Connective Tissue

The core action of Лонгидаза is centered on its Hyaluronidase component, an enzyme that specifically hydrolyzes the beta-(1 o4)-glycosidic bonds within Hyaluronic Acid (HA). HA is a major structural glycosaminoglycan (GAG) in the pathological Extracellular Matrix (ECM). This hydrolysis leads to the physical breakdown of the dense fibrous structure resulting from excessive ECM deposition, causing a reduced tissue rigidity and an increase in local tissue permeability within the affected area.

️ Polymer-Mediated Mechanism Stabilization and Anti-Fibrotic Modulation

The drug is a conjugate containing the high-molecular-weight carrier polymer Polyoxidonium. This polymer serves a dual function: it significantly stabilizes the enzyme, increasing its resistance to degradation and prolonging its half-life. Independently, the polymer provides an intrinsic anti-inflammatory effect by modulating molecular signaling associated with chronic inflammation. This combined action acts on both the structural density of the matrix and the associated inflammatory signaling, contributing to persistent connective tissue matrix degradation.

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Dosage and Administration Information

The administration of Лонгидаза (Bovhyaluronidaze Azoximer) is based on established application methods, adhering to specific parenteral and local routes.

Administration Routes and Dosing Patterns

The medication is supplied as a lyophilizate for solution preparation and as suppositories. The lyophilizate is administered via subcutaneous (SC) injection or intramuscular (IM) injection. Suppositories are designated for local rectal or vaginal administration.

The standard unit dose for the injectable form is 3000 IU (International Units). Dosing follows an intermittent schedule, typically administered once every 3 days or once every 5 days, rather than daily. Treatment consists of a predetermined course length, ranging from 5 to 20 total administrations.

Preparation and Procedural Conditions

Required Dilution: The lyophilizate must be reconstituted before injection. Standard preparation involves dissolving the contents of the vial in 1.0–2.0 mL of 0.5% procaine solution. In cases of procaine intolerance, 0.9% sodium chloride solution for injection or water for injection is an alternative diluent.

Administration Constraints: The prepared solution for injection must be used immediately as it must not be stored, and the solution must not be administered intravenously. Rectal administration of suppositories should occur after the bowels have been evacuated.

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Recent Clinical Evidence

Лонгидаза: Recent Clinical Evidence

Clinical research on bovhyaluronidase azoximer (Longidaza) has focused primarily on its use as an adjunct therapy in conditions characterized by fibrosis and connective tissue changes.

Studies in Post-COVID Pulmonary Sequelae

A randomized, double-blind, placebo-controlled trial (Long-CoV-III-21) evaluated the drug's use in adult patients with pulmonary sequelae of COVID-19. Subjects received the drug or placebo over a 71-day period, with follow-up to Day 180. Key areas of investigation included measures of exercise capacity and pulmonary function:

  • Exercise Indicators: Studies examined the proportion of patients experiencing exertional desaturation and dyspnea after the six-minute walk test (6MWT) compared to placebo.
  • Pulmonary Function: The primary endpoint focused on the change from baseline in predicted Forced Vital Capacity (FVC) in the study population.

Limited subgroup analysis in patients with cardiovascular comorbidities suggested a significantly greater change in FVC in that group compared to placebo. Research into an inhaled form of the drug for interstitial lung diseases, such as idiopathic pulmonary fibrosis, is also underway.


Other Areas of Investigation

Clinical trials and observational studies have explored the drug's role in combination therapy for several other conditions:

Condition Studied Primary Research Focus
Chronic Prostatitis Evaluating whether the addition of the drug to standard therapy is associated with changes in lower urinary tract symptoms (LUTS) and prostate volume.
Endometriosis Comparing outcomes in patients receiving hormonal therapy combined with the drug versus hormonal monotherapy, focusing on changes in pelvic pain severity and quality of life measures.
Pelvic Adhesions Assessing changes in pelvic adhesions and inflammatory markers in women with chronic pelvic inflammatory disease.
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Frequently Asked Questions (FAQ)

Common questions about Лонгидаза (FAQ)

Q: Is Лонгидаза primarily used for treating inflammation or scar tissue?

A: Лонгидаза's core function, according to official information, is centered on its hyaluronidase component to break down the dense fibrous structure of the extracellular matrix, which is associated with scar tissue and reduced tissue rigidity. The unique polymer component of the drug also provides an independent anti-inflammatory effect. Therefore, it is associated with both the anti-fibrotic action and managing aspects of associated inflammation.

Q: Can Лонгидаза be used to treat internal scar tissue or only external scars?

A: Official prescribing information lists administration routes, including intramuscular injection, as well as rectal and vaginal suppositories. These administration methods allow the medicine to address internal conditions characterized by fibrosis. Examples include chronic prostatitis and adhesive processes in the lesser pelvis.

Q: Is it normal to feel slightly unwell or fatigued after an injection of Лонгидаза?

A: The official safety profile lists malaise (a general feeling of being unwell) as a potential adverse reaction, but the frequency is listed as 'not known.' This means official data cannot determine its commonality. Fatigue is not specifically listed as a reported side effect in the official documentation.

Q: Can I take non-prescription pain relievers while using Лонгидаза?

A: Regulatory documents on drug interactions state that co-administration with high doses of salicylates, a drug class that includes certain non-prescription pain relievers, may reduce the enzymatic activity of Лонгидаза. Official documents recommend reviewing the use of all medications with a healthcare professional.

Q: How is the effect of Лонгидаза measured or monitored during treatment?

A: The method of monitoring the effect of Лонгидаза depends entirely on the medical condition being addressed. For example, clinical studies related to pulmonary sequelae (lung changes after illness) used measures like the change in Forced Vital Capacity (FVC), while monitoring for other conditions relies on clinical examination of specific symptoms.

Q: What is the duration of activity of one single application of Лонгидаза?

A: The active ingredient is a polymer conjugate specifically designed to offer a sustained therapeutic profile, meaning its activity is prolonged compared to the free enzyme. The official product information does not specify an exact duration of activity in hours or days for a single application.

Q: What kind of scarring or fibrosis is Лонгидаза typically prescribed for?

A: Approved applications listed in official documents include chronic conditions characterized by fibrosis and scarring in specific internal systems. These include chronic prostatitis, interstitial cystitis, and adhesive processes in gynecology and urology. It is also approved for certain pulmonary conditions like pneumosclerosis and fibrosing alveolitis.

Q: How long does pain or redness at the injection site typically last?

A: Redness, pain, or mild swelling at the administration site are common local reactions described in the official safety profile. These reactions are typically considered transient (short-lasting) and are often reported to resolve within 48 to 72 hours.

Q: Can Лонгидаза be used simultaneously with other forms of physical therapy?

A: Regulatory safety documents list specific contraindications that apply when the drug is administered in conjunction with certain physiotherapy procedures. These precautions cover scenarios such as a patient having hypersensitivity to ultrasonic or laser exposure while receiving the drug.

Q: What should be done if an application of Лонгидаза is missed?

A: The patient labeling advises that in case of an omission of administration, the usual regimen should be continued and a duplicate dose should not be administered. This guidance helps maintain the intended intermittent schedule of the treatment.

Q: Are there any reported long-term health concerns from using multiple courses of Лонгидаза?

A: Official non-clinical safety data indicates that the compound is considered practically non-toxic. With prolonged administration, it has been reported to not impair the normal functioning of major systems, including the nervous, immune, cardiovascular, and respiratory systems, liver, or kidneys.

Q: Does the active ingredient in Лонгидаза affect healthy, non-scarred tissue?

A: The drug's enzymatic action primarily focuses on breaking down the pathological Hyaluronic Acid within the scarred extracellular matrix. Official safety information includes a caution that incorrect application or over-dosing can lead to excessive breakdown of hyaluronic acid, which may result in tissue damage.

Q: Are there specific types of joint contractures that respond better to Лонгидаза?

A: The drug is listed as an approved application in Orthopaedics for the treatment of joint contracture. However, the official documentation does not differentiate or specify which particular types or severity levels of joint contracture respond better to the treatment.

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How should Лонгидаза be stored and disposed of?

Official Storage and Disposal Requirements

The storage and handling of Лонгидаза® (Longidaza®) must comply strictly with the conditions specified in the regulatory labeling to maintain product integrity throughout its shelf life.

Storage Requirement Conditions Mandated by Regulatory Labeling
Temperature Control Lyophilisate and suppositories must be stored within a specific controlled range, typically 2 C to 15 C.
Environmental Protection The product must be stored in a dry place and protected from light.
Prohibited Conditions The medicine must not be frozen and must not be used beyond its 2-year shelf life.
Stability After Preparation The reconstituted injection solution is not subject to storage and must be used immediately.
Child Safety The product must be kept out of the reach and sight of children.

Disposal instructions require that any unused or expired medicinal product be handled with specific precautions and discarded in accordance with local regulatory requirements for pharmaceutical waste.

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

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