Биогиал

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Биогиал

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Medically reviewed

Rosario Oropesa

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.

Overview of Биогиал

Quick Facts

Property Description
Active ingredient Hyaluronidase
Form Injectable solution
Pharmacological class Enzyme / Glycoside Hydrolase
General purpose Enhancing drug absorption and dispersion
Origin Biological product (often recombinant)

What is the Medicinal Nature and Classification of Биогиал?

Биогиал is a pharmaceutical preparation classified as a biological product whose sole active ingredient is the enzyme Hyaluronidase. Pharmacologically, it is defined as a Glycoside Hydrolase, functioning specifically as a protein designed to catalyze a specific chemical reaction in the body. The medication is supplied as a sterile injectable solution for parenteral administration, typically administered via subcutaneous injection. This enzyme preparation is widely recognized in medical literature for its specialized function as a modifier of tissue structure. It is fundamentally a single-active ingredient product where the enzyme is delivered dissolved in an aqueous solution.

Is Hyaluronidase a Recombinant Enzyme or Natural Product?

The active compound, Hyaluronidase, is an endogenous substance naturally found in human and animal tissues, where it plays a role in regulating the extracellular matrix. However, the Hyaluronidase used in pharmaceutical products like Биогиал is manufactured as a purified therapeutic agent. Depending on the specific formulation, the enzyme may be sourced from highly purified animal tissues or produced through advanced biotechnology as a recombinant human enzyme (rHuPH20). This distinction in origin is supported by pharmacological studies confirming the highly purified nature and specific enzymatic activity of recombinant forms.

What is the General Therapeutic Purpose of this Enzyme?

The general purpose of Биогиал is to function as a facilitating agent or adjuvant therapy, rather than as a primary treatment. This medication is intended to enhance the absorption and dispersion of other co-administered injectable medications or fluids. The enzyme achieves this effect by temporarily and reversibly degrading Hyaluronic Acid, thereby acting as a spreading factor that allows for faster movement of injected substances through the subcutaneous space. This mechanism is clinically recognized for its utility, for example, in increasing the rate of fluid delivery during subcutaneous fluid administration for hydration purposes.

Regulatory References

  1. Hyaluronidase - Mechanism of Action

What side effects are possible with Биогиал?

Possible Side Effects and Safety Information

The safety profile of Hyaluronidase, the active enzyme in Биогиал, is based on official government regulatory classifications, which primarily detail local effects and the risk of systemic reactions, consistent with an injectable biological product.


Officially Documented Adverse Reactions

Adverse reactions are classified by frequency and body system:

  • Frequency: Common adverse reactions typically include events at the injection site, while serious systemic events are classified as Rare.
  • System-Organ Classes: Reactions primarily involve Skin and Subcutaneous Tissue Disorders (injection site effects) and Immune System Disorders (hypersensitivity).

Common Adverse Reactions

Classification Examples from Regulatory Labeling
Local Reactions Pain, erythema (redness), and swelling (edema) at the injection site.
Systemic Reactions Nausea and vomiting have been reported as uncommon reactions.

Serious Safety Considerations

The most clinically significant safety risk documented in regulatory sources is the rare occurrence of Anaphylactic-like reactions and Severe Hypersensitivity reactions. These serious events, which include urticaria and angioedema, require immediate attention.

Safety-Related Restrictions

The medication is contraindicated in individuals with a known hypersensitivity to Hyaluronidase. Furthermore, regulatory labels state that it must not be injected into or around an acutely infected or inflamed area due to the concern of spreading localized infection. Administration near a solid tumor is also not recommended.

Population-Specific Notes

Official safety notes caution that the use of Hyaluronidase during Pregnancy and Lactation should only occur when clearly necessary. Pediatric use requires close monitoring, especially to prevent hypovolemia when administering electrolyte-free solutions subcutaneously. The label also notes that the enzyme may enhance the adverse reactions associated with other co-administered injectable medications.

Overdose and Emergency Response

The official regulatory documentation on Hyaluronidase primarily addresses the management of acute toxicity resulting from excessive administration, noting that no cases of overdose have been widely reported.

Documented Signs of Toxicity Required Immediate Actions
Systemic Effects Discontinuation
Local edema, erythema, urticaria The enzyme must be discontinued immediately upon suspicion of toxicity.
Chills, nausea, vomiting, dizziness Supportive Care
Cardiovascular Effects Supportive measures must be initiated immediately, as management is symptomatic and no specific antidote is explicitly known.
Tachycardia, Hypotension Urgent Attention
Seek immediate medical attention for severe systemic effects or life-threatening reactions.

Toxicity symptoms are documented to affect several physiological systems, including the cardiovascular system, which may present as tachycardia (rapid heart rate) and hypotension (low blood pressure). The most serious documented complications include thrombosis and severe allergic reactions, such as anaphylaxis. These severe manifestations necessitate seeking immediate medical attention.

Special regulatory considerations exist for certain populations during associated procedures; for instance, careful monitoring of the rate and volume of fluid administration is required in young children and the elderly to prevent over-hydration, particularly in the presence of renal impairment. All official guidance mandates that any suspected toxicity requires the immediate discontinuation of the enzyme and the rapid initiation of supportive care.

Therapeutic Uses of Биогиал

What Биогиал Treats: Main Uses and Benefits

Биогиал is commonly used as an adjuvant therapy, meaning it supports and enhances the function of other medical treatments. It is applied across domains where additional symptomatic support is needed, primarily in three distinct clinical areas.

The medication is used to manage systemic imbalance symptoms such as mild-to-moderate dehydration when intravenous access is challenging, localized discomfort and swelling from certain injections, and acute procedural pain requiring supporting the regional anesthesia process. Its use assists with maintaining functional stability by improving the absorption and delivery of co-administered fluids and medications, supports the resolution of localized issues like dermal filler complications, and assists with the spread of pain relief.

The core indications for which it is commonly used include: subcutaneous fluid administration (Hypodermoclysis) for hydration, improving the dispersion of co-administered injected drugs, and facilitating the spread of local anesthesia.

“The medication supports patients during difficult episodes and assists with maintaining functional stability during specialized procedures.”

Quick Fact: Relief for Key Symptom Domains
Supports fluid volume management in dehydration states.
Assists in the resolution of localized discomfort caused by complications.
Contributes to pain relief by assisting with anesthetic spread.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Биогиал (Hyaluronidase) — Official Regulatory Information

Populations for Whom Use is Contraindicated

Category Official Regulatory Prohibition
Absolute Contraindication Patients with known hypersensitivity to hyaluronidase or any components of the formulation.
Local Condition Use is contraindicated at or around an infected or acutely inflamed area due to the danger of spreading localized infection.
Drug-Specific Restriction Must not be used to enhance the absorption or dispersion of dopamine and/or alpha-agonist drugs.
Administration Route Must not be administered intravenously (enzyme is rapidly inactivated) or applied directly to the cornea.

Age- and Condition-Based Eligibility

Category Official Regulatory Status
Adults and Geriatric Patients Use is generally established, with no overall difference in safety or effectiveness noted compared to younger adults.
Pediatric Patients Use is established; however, special care is required for premature infants and neonates to prevent over-hydration.
Pregnancy Use is classified as Category C or requires the clinician to avoid use unless there is no safer alternative. Use is only if clearly needed.
Lactation (Nursing Mothers) Caution should be exercised, as it is unknown if the drug is excreted in human milk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation identifies drug interactions based primarily on the enzyme’s local effects and solution compatibility, as classic systemic metabolic interactions are not reported.

Documented Interaction Classifications

Interaction Type Interacting Substances / Categories
Incompatibility Furosemide, Phenytoin, Benzodiazepines, and Local Anesthetics containing Sodium Metabisulfite are incompatible for mixing in the same solution.
Functional Restriction Hyaluronidase must not be used to enhance the dispersion and absorption of Dopamine and Alpha Agonist Drugs.
Pharmacodynamic Modification Salicylates (in large doses), Cortisone, ACTH, Estrogens, and Antihistamines can render tissues partially resistant to the enzyme’s spreading action.

Local Pharmacokinetic Changes

Co-administration with Local Anesthetic Agents creates a change in local pharmacokinetics. The enzyme’s effect hastens the onset of analgesia and shortens its duration. This wider spread of the anesthetic solution increases its systemic absorption, which tends to increase the incidence of systemic reactions associated with the local anesthetic.

Regulatory documents do not state explicit mandatory timing separation rules for co-administered drugs nor do they report interactions with food, alcohol, or herbal products. The interaction profile is therefore defined by mandatory restrictions on co-administration and documented local efficacy changes.

Mechanism of Action

How Биогиал Works

Биогиал functions via a specific enzymatic mechanism that operates directly on the structure of the connective tissue, resulting in a physical alteration rather than chemical signal modulation.


Molecular Cleavage of the Extracellular Matrix

The drug's sole active ingredient, Hyaluronidase, acts as a \beta-1,4-glycoside hydrolase, targeting the high-molecular-weight polymer Hyaluronic Acid (HA), which is the primary component contributing to the viscosity of the extracellular matrix (ECM). The enzyme rapidly catalyzes the hydrolysis of the HA polymer, breaking the long chains into smaller, less viscous fragments.


Targeted Enhancement of Tissue Permeability

The cleavage of Hyaluronic Acid polymers directly reduces the structural resistance and viscosity of the interstitial space, initiating the "spreading factor" effect. This physiological change creates a temporary increase in tissue permeability at the injection site, allowing co-administered substances to disperse over a wider area and be absorbed with enhanced local kinetics and increased rate into the systemic circulation.


⏳ Transient and Reversible Action

The mechanism has a rapid onset due to the high catalytic efficiency of the enzyme upon contact with the substrate, but the effect is transient. This temporary action is governed by the natural clearance of the enzyme and the body’s continuous physiological process of synthesizing new Hyaluronic Acid, which ultimately restores the native tissue structure.

Dosage and Administration Information

The usage of Биогиал (Hyaluronidase) is defined by administration principles, structuring it as a single-dose procedural agent rather than a chronic medication. The enzyme is administered parenterally, primarily via subcutaneous injection (under the skin), although intradermal and intramuscular routes may also be utilized in specific clinical contexts. Intravenous administration is explicitly prohibited due to rapid enzymatic inactivation.

The medicine's dosage is highly specific to its intended purpose. For Hypodermoclysis (subcutaneous fluid administration), the standard adult dose is 150 Units to 200 Units to facilitate the dispersion of large fluid volumes. When used to enhance the absorption of co-administered injectable drugs, a typical dose of 150 Units is added to the drug solution prior to injection. The timing of administration is always concurrent with the primary fluid or medication; it is not a scheduled or maintenance therapy.

Usage rules also include mandatory adjustments for specific patient populations. In neonates and premature infants, the administration rate must not exceed 2 mL/minute, and the daily volume of subcutaneous fluid is strictly limited to 25 mL/kg of body weight. For children under three years old, the volume of a single subcutaneous infusion is limited to 200 mL. Furthermore, the rate and volume of any subcutaneous fluid must not exceed the parameters typically used for the corresponding intravenous administration route.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Биогиал (Hyaluronidase)


Evidence for Use in Subcutaneous Fluid Administration (Hydration)

Research has studied this medicine's role in subcutaneous fluid administration (hypodermoclysis), which is used when intravenous access is difficult. The studies observed how fast fluids are absorbed and the total volume of fluid that can be delivered. Trials often involved older adults and, in separate research, infants and children with temporary fluid imbalance, such as mild dehydration.

Research reported measurements related to the rate of absorption for the fluids when compared to the subcutaneous method without the enzyme. However, findings were mixed regarding whether the use of the enzyme changed the level of pain or swelling compared to the control group. Limited long-term data are available for these outcomes, as the follow-up durations were limited to the acute period of absorption.


Evidence for Enhancing Absorption of Co-Administered Drugs

Research has explored the role of this enzyme in helping other injected drugs disperse and absorb better after being injected under the skin. These studies examined how quickly the co-administered drug reached its maximum concentration ( C max) in the bloodstream and the overall drug amount entering the system (bioavailability). Study populations included individuals receiving certain chronic therapies, such as immunoglobulins.

Studies reported measurements related to the administration of larger volumes of medication in a single subcutaneous injection site. Scientific literature notes that the evidence quality varies across studies, and the link between measured changes in blood concentration and definite, long-term clinical outcomes is not fully established. Comparative evidence is lacking for many direct comparisons between using this enzyme and other standard treatment methods.


Evidence in Special Populations and Research Gaps

Research was evaluated in specific patient groups, including older adults and infants and children, for fluid delivery. While studies exist for these groups, the sample sizes were modest in many trials, and data for certain groups are limited. Therefore, subgroup findings are uncertain, and research does not determine whether an individual will respond similarly regardless of age or underlying condition.

Frequently Asked Questions (FAQ)

Common questions about Биогиал (FAQ)


Q: What are the common side effects of this drug?

According to official product information, common side effects may include nausea, vomiting, diarrhea, abdominal pain, headache, and dizziness. A full list of known side effects is available in the official regulatory documents, which your healthcare provider can discuss with you.

Q: Can I take this drug if I am pregnant?

Regulatory documents indicate that the medication is generally avoided during pregnancy unless a healthcare provider determines the potential benefits justify the potential risks for the patient. Use of this medicine for a long time during pregnancy may carry a potential risk to the unborn child, including possible issues with brain function, hearing, balance, and vision.

Q: Can this drug cause vision problems?

Yes, regulatory documents caution that this drug can cause a serious and potentially irreversible eye condition called retinopathy, which affects vision. Due to this risk, official guidance specifies the need for an ophthalmological examination (eye check-up) before treatment begins, with follow-up examinations scheduled periodically.

Q: Does this drug affect the heart?

Official warnings note that the drug may affect the heart, including causing cardiomyopathy (a disease of the heart muscle) and prolonging the QT interval (an electrical activity of the heart). Cases of serious heart rhythm problems, such as ventricular arrhythmias and Torsade de pointes, have been reported. Regulatory warnings state that the medication should be used with caution in individuals with pre-existing heart disorders.

Q: Is it safe to breastfeed while taking this drug?

The active ingredient of this medication is excreted in breast milk. Official guidance indicates that the drug is not recommended during breastfeeding unless a healthcare provider determines the potential benefits outweigh the risks, as infants may be sensitive to toxic effects.

Q: Can this drug cause mental health side effects?

Official safety information reports that side effects may involve the mind and mood. These include changes in mood and emotion (affect/emotional lability), nervousness, irritability, nightmares, psychosis, and even suicidal behavior. It is important to discuss any new or unusual changes in mood or behavior with a healthcare provider.

Q: Can children use this drug?

Regulatory information indicates that the safety and efficacy have not been established for long-term use in children for certain autoimmune conditions like systemic lupus erythematosus. However, it is used in patients 6 years of age and older for the prevention and treatment of certain forms of malaria. A healthcare provider must assess the situation to determine if the medication is appropriate for a child's specific condition.

Q: Can I take this drug if I have a pre-existing medical condition?

Official warnings emphasize the importance of communicating all existing medical conditions to the prescribing healthcare provider. This includes a history of liver or kidney problems, heart problems (especially a prolonged QT interval), blood disorders (such as G6PD deficiency), or the skin condition psoriasis. These conditions may require careful monitoring or adjustment of the treatment.

Q: Does this drug affect blood sugar?

Yes, official product information and drug guides state that this medication can cause changes in the body's metabolism, specifically leading to hypoglycemia (low blood sugar). Individuals with diabetes may need to monitor their blood sugar levels closely, as discussed with their healthcare provider.

How should Биогиал be stored and disposed of?

Storage and Disposal Requirements

Official regulatory documents define strict conditions for storing and disposing of Биогиал (Hyaluronidase) to maintain its quality and sterility.

Condition Type Official Requirement
Temperature Store in a refrigerator (2 C to 8 C) or at a controlled room temperature (do not exceed 25 C). Do not freeze.
Protection Store in the original package container to protect contents from light.
Stability The vial is single-use; the solution must be used immediately after preparation. Any unused portion must be discarded.
Child Safety Keep the medicine strictly out of the sight and reach of children.

Disposal

Unused or expired product must not be disposed of via wastewater or household trash. Disposal must be handled by a pharmacist or local pharmaceutical waste service according to official environmental regulations. Needles and syringes must be placed in an approved sharps container.

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

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