Ultrix

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Ultrix

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Method of action: Immunostimulants

Treatment option: Influenza, Flu Prevention

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.

Overview of Ultrix

Quick Facts Summary

Property Description
Active Ingredient Purified surface antigens (split components) of four inactivated influenza virus strains.
Form Solution for intramuscular injection (pre-filled syringe).
Pharmacological Class Immunological Agents (Vaccines).
Common Use Proactive prevention of seasonal influenza (the flu).
Manufacturer & Origin FORT (part of Rostec State Corporation), Russia.

Ultrix Quadri: A Specialized Biological Product

Ultrix Quadri is an inactivated split influenza vaccine, classifying it as an Immunological Agent. This biological product is specifically engineered to stimulate the body’s own immune system to generate proactive protection against the seasonal influenza virus. The vaccine is manufactured by FORT, a Russian biopharmaceutical company, and is produced using a full-cycle production technology in compliance with international Good Manufacturing Practice (GMP) standards.

A key feature is its quadrivalent composition. This means it contains active components from four distinct virus strains—two subtypes of Influenza A and two lineages of Influenza B—providing broader coverage against circulating seasonal threats compared to older formulations.


The Components and Overall Health Purpose

The primary components of Ultrix Quadri are purified surface antigens (small fragments) derived from the four specific, inactivated virus strains. The formulation is often distinguished in its market by being produced without preservatives, stabilizers, or adjuvants (substances used to enhance the immune response).

This composition is clinically recognized for eliciting a balanced immune response across all targeted strains. The overall health purpose of using this vaccine is to significantly reduce the risk of severe flu illness, hospitalization, and potential complications associated with the seasonal flu. This preparatory defense action is part of public health efforts to protect vulnerable patient populations, such as adults and children (from 6 months of age), from the debilitating effects of influenza.

What side effects are possible with Ultrix?

Possible Side Effects and Safety Information

Regulatory documents classify the adverse reactions associated with this type of inactivated quadrivalent split influenza vaccine based on their frequency of occurrence, as determined in clinical studies.

Adverse Reaction Scope

Most reported events are temporary and localized. Systemic symptoms and administration site conditions are grouped using standardized System-Organ-Class (SOC) terminology in official labels.

Classification Examples of Reactions (SOC)
Very Common (geq1/10) Injection site pain/tenderness, headache, myalgia (muscle aches), fatigue. In children, this often includes irritability and drowsiness.
Common (geq1/100 to <1/10) Fever (pyrexia), chills, arthralgia (joint pain), and injection site erythema (redness) or ecchymosis (bruising).

Serious Adverse Reactions

The regulatory safety profile also documents rare, but clinically serious events observed post-marketing. These include: Anaphylactic shock (a severe allergic reaction), Guillain-Barré Syndrome (GBS), convulsions, and certain types of vasculitis.

Safety Restrictions and Patterns

The vaccine is contraindicated in individuals with a history of a severe allergic reaction (anaphylaxis) to any component of the vaccine or to a previous influenza vaccination. Caution is advised for individuals with bleeding disorders due to the risk of bleeding at the injection site. Most reported local and systemic reactions typically have an onset within the first 2 days and are expected to resolve spontaneously within 3 days of administration.

This official safety information structures the risk profile by distinguishing between high-incidence, generally transient adverse reactions and the low-incidence, potentially serious events, adhering strictly to regulatory safety standards.

Overdose and Emergency Response

Overdose and when to seek help

Overdose Scope: Official Regulatory Information

Official regulatory documents for inactivated split influenza vaccines, including those similar to Ultrix, typically state that specific data concerning the effects of an overdose are lacking.

Over-administration is generally not linked to specific unique severe symptoms but may lead to an increased incidence or severity of known common adverse reactions, such as temporary headache, fever, malaise, or localized injection site discomfort. No specific severe physiological complications (e.g., cardiotoxicity) are listed in the overdose sections of regulatory labeling.

Classification Regulatory Statement (As Labeled)
Antidote Availability No specific antidote is known for over-administration.
Required Management Management is limited to symptomatic and supportive treatment.
Special Populations No unique overdose risk profiles are specifically documented for pediatric, geriatric, or other special populations.

When Immediate Medical Help is Required

Regulatory authorities mandate that individuals seek immediate medical attention for a suspected overdose or if any clinically significant systemic reaction or severe adverse event occurs post-administration. Depending on the nature of the reaction, clinical monitoring and observation may be required in a controlled setting.

Therapeutic Uses of Ultrix

What Ultrix treats: main uses and benefits

Ultrix Quadri is used for active immunization to help prevent the seasonal influenza disease, generally known as the flu. This is a common preparatory step taken annually to help establish specific protective immunity against the four influenza virus strains—two Influenza A and two Influenza B—predicted to circulate. The protective support may assist with easing the overall symptom load during the flu season.

This use is centered on minimizing high morbidity risk, and the vaccine is recommended for all persons aged 6 months and older who do not have a contraindication. The clinical contexts of use include proactive support for the general population, and the product is considered relevant for older adults and individuals with chronic underlying medical conditions (such as cardiovascular or respiratory disorders).

“This approach is relevant for managing heightened systemic burden.”


Quick Fact: Relief for Severe Illness Risk

Focus Benefit Provided
Symptom Domain Prevention of acute febrile illness and severe respiratory distress.
Use Context Annual, proactive immunization before the predicted peak of flu activity.
Practical Support Helps patients cope more steadily when the risk of systemic symptoms is more noticeable.

Eligibility and Restrictions for Use

Population Eligibility Status

Ultrix Quadri is officially approved for active immunization in persons 6 months of age and older, establishing the minimum age threshold for use. Regulatory approval extends to all adult age groups, including the older adult population (60 years and over), and use is specifically permitted for pregnant women. Infants less than 6 months of age are not eligible for use.


Contraindications and Restrictions

The medicine is contraindicated and must not be used in individuals with a known severe allergic reaction (anaphylaxis) to any component of the vaccine, such as egg protein or specific manufacturing residues, or to a previous dose of any influenza vaccine.

Use is not recommended in persons currently experiencing a moderate or severe acute illness or fever, requiring postponement until recovery. Additionally, regulatory documents advise that immunosuppressed individuals may experience a diminished immune response. A history of Guillain-Barré Syndrome (GBS) related to a prior flu shot requires specific clinical risk assessment before use.

What should I know about interactions with other medicines?

Ultrix Interactions with other medicines and products

The interaction profile of this inactivated influenza vaccine is primarily defined by its effects on the immune system and its reported, though uncommon, effect on the clearance of certain drugs.

Classification Interacting Entity Official Interaction Outcome / Requirement
Pharmacodynamic Interference Immunosuppressive Treatments May result in a lower or reduced immune response to the vaccine, including diminished antibody formation.
Pharmacokinetic Modification Warfarin, Phenytoin, Theophylline Regulatory reports suggest a potential for reduced clearance leading to increased plasma concentrations and toxicity of the co-administered drug.

The labels detail that co-administration with immunosuppressive treatments (including high-dose corticosteroids or chemotherapy) may result in reduced immunogenicity, an effect particularly relevant for immunocompromised patients. The official documentation also includes a procedural restriction: the intramuscular injection requires caution in individuals receiving anticoagulant therapy or with bleeding disorders due to the risk of hematoma. Furthermore, government health guidance notes that high alcohol consumption around the time of administration may potentially hinder the body's immune reaction. No substance is formally classified as absolutely contraindicated for co-administration due to interaction risk.

Mechanism of Action

The mechanism of action for Ultrix Quadri is an immunological process that utilizes the body’s adaptive defense system to build a neutralizing barrier against four distinct influenza strains.

Targeted Activation of Humoral Immunity

The process begins with local Antigen-Presenting Cells (APCs) capturing purified viral surface proteins, primarily Hemagglutinin (HA). This molecular recognition initiates the adaptive immune cascade, resulting in B-lymphocyte activation and differentiation, leading to the systemic production of high-titer Immunoglobulin G (IgG) antibodies.

IgG-Mediated Viral Neutralization

The circulating IgG antibodies function as molecular blockers, binding with high affinity to the HA protein on the live, circulating virus. This physical obstruction prevents the virus from attaching to and entering host respiratory cells, establishing a preemptive immunological barrier.

Poly-Valency and Immunological Memory

The quadrivalent mechanism simultaneously and independently programs the immune system against four distinct viral strains, increasing the range of specific antibody populations induced. Crucially, the process generates long-lived memory B and T cells to ensure a rapid, amplified secondary antibody response upon future exposure.

Dosage and Administration Information

Official Administration Guidelines

Ultrix Quadri, as an inactivated split influenza vaccine, is administered via intramuscular injection. The administration follows a standardized annual schedule and specific procedural rules for dose preparation and site of injection.

Feature Official Labeled Instruction
Route of Administration Intramuscular (IM) injection only. The product must not be administered intravenously, subcutaneously, or intradermally.
Standard Adult Dose A single, fixed dose volume of 0.5 mL is administered annually.
Preparation The solution/suspension in the pre-filled syringe must be visually inspected for discoloration or particulate matter and shaken well immediately prior to use.
Injection Site The preferred site for individuals aged 12 months and older is the deltoid muscle of the upper arm. For infants aged 6 through 11 months, the anterolateral aspect of the thigh is recommended.

Population-Specific Dosing Rules

The frequency and total number of doses required depend on the recipient's age and past vaccination history:

  • Adults and Older Children (9 years and older): A single 0.5 mL dose is required annually.
  • Children 6 months through 8 years: If the child has not been previously vaccinated against influenza, a primary series of two 0.5 mL doses is required, administered with an interval of at least 4 weeks between the first and second dose. If the child has been vaccinated previously, one annual dose may be sufficient.

These official instructions define the standardized, procedural structure for the product's use within the annual immunization cycle.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Ultrix

Evidence for Proactive Prevention of Seasonal Influenza

Research for Ultrix was conducted to explore its use in proactive prevention of seasonal influenza illness, commonly known as the flu. The evidence landscape primarily consists of Randomized Controlled Trials (RCTs) which monitored the body's initial immune response, and Observational Studies which examined the rate of illness in real-world settings over flu seasons. In these studies, the primary focus was on measuring the immune response generated against the four specific virus strains. Findings describe patterns in how subjects achieved the target antibody levels (seroprotection and seroconversion rates) consistent with the standards for this class of vaccine.

However, this evidence is linked to a degree of uncertainty. The measured response is inherently dependent on how well the strains selected for the vaccine match the virus strains that actually circulate each flu season. The research describes group patterns, but research provides context but not individual predictions, as the measured response may vary from one year to the next.

Evidence in Special Populations

Ultrix was evaluated in several specific groups, including the General Adult Population, Children (from 6 months of age), Older Adults, and Pregnant Women. Studies also focused on individuals who face a higher risk from the flu, specifically those with Chronic Underlying Medical Conditions, such as cardiovascular disorders. This research examined outcomes related to systemic or functional imbalance, tracking complex clinical events such as the frequency of hospitalization or major cardiovascular events.

Durability and Key Research Gaps

For inactivated influenza vaccines, follow-up durations were limited. The immunological response is typically monitored only for a short-term period, though effectiveness was observed in studies over the full influenza season. Long-term effects are not fully established because the vaccine is designed for annual use. The evidence relies significantly on immunogenicity as a surrogate marker for protection, and data for the most severe clinical outcomes in certain high-risk groups remain insufficient to provide high certainty.

Key Studies & References

  1. Trial of Tolerability, Reactogenicity, Safety and Immunogenicity of Flu-M [Inactivated Split Influenza Vaccine] in Pregnant Women During the 2nd - 3rd Trimester
  2. Effect of Influenza Vaccination in Patients with Cardiovascular Disease: An Updated Meta-Analysis of Randomized Controlled Trial
  3. Association Between Influenza Vaccination and Cardiovascular Outcomes in High-Risk Patients: A Meta-analysis

Frequently Asked Questions (FAQ)

Common questions about Ultrix (FAQ)


Q: What is the difference between Ultrix and older medicines used for the same purpose?

According to the official product information, Ultrix Quadri is distinguished by its quadrivalent composition, meaning it covers four distinct influenza virus strains. Furthermore, official documentation notes that this vaccine is produced without the addition of preservatives, stabilizers, or adjuvants, which may differ from older vaccine formulations.


Q: Is a rash or hives listed as a potentially serious side effect of Ultrix?

Regulatory documents indicate that severe allergic reactions, such as anaphylaxis, are rare but serious adverse events linked to the vaccine. A rash or hives can be symptoms of such a reaction. Official guidance specifies that any signs of a severe allergic reaction warrant immediate medical attention.


Q: Are there any known long-term side effects associated with continuous Ultrix use?

Studies and official information indicate that long-term effects are not fully established because Ultrix is designed for annual use. The immunological response is typically monitored only for the duration of the influenza season. The limited follow-up periods are consistent with the design of seasonal vaccines.


Q: What are the official warnings and precautions listed on the Ultrix drug label?

Regulatory documents list several warnings and precautions for use. These include the risk of a lower immune response in immunosuppressed individuals, the need for caution for individuals with a bleeding disorder or those receiving anticoagulant therapy, and a prior history of Guillain-Barré Syndrome (GBS) following a flu shot also requires specific consideration.


Q: Is Ultrix safe to use if I have a pre-existing heart condition?

Research evidence confirms that clinical studies for Ultrix included individuals who have chronic underlying medical conditions, such as cardiovascular disorders. The goal was to examine outcomes related to systemic or functional imbalance in these higher-risk groups. Specific guidance regarding administration is not universally provided, as it is based on individual patient assessment.


Q: Is it true that stopping Ultrix suddenly can cause withdrawal symptoms or other issues?

According to the official product information, Ultrix Quadri is classified as an inactivated vaccine, an immunological agent. This type of product is used for prophylactic prevention and is not known to be associated with the development of dependence. Therefore, discontinuing its annual use is not linked to withdrawal symptoms or related issues.


Q: Are there specific medications that should not be taken at all with Ultrix?

The official product literature states that no substance is formally classified as absolutely contraindicated for co-administration due to interaction risk. The official labeling highlights that co-administration with immunosuppressive treatments may result in a diminished immune response.


Q: What does the research evidence say about the success rate or efficacy of Ultrix?

Studies and official information describe efficacy in terms of immunological measures such as seroprotection and seroconversion rates. These terms refer to the body’s achievement of protective antibody levels against the four specific virus strains contained in the vaccine. The measured response is subject to the annual match between the vaccine strains and the influenza virus strains that actually circulate.


Q: How quickly do patients typically see or feel the benefits of Ultrix, according to studies?

Public health guidance for this class of inactivated vaccine generally states that it generally takes about two weeks for the body to develop the intended protective immunity. This is the period required for the adaptive immune cascade to produce sufficient circulating antibodies.


Q: How long does the effect of a single administration of Ultrix last in the body?

The immunological protection is generally expected to last over the full influenza season. Studies tracked effectiveness for this duration, which aligns with the design of the vaccine for annual administration.


Q: Is it normal if I do not notice any immediate subjective changes after starting Ultrix?

Yes, the absence of immediate subjective changes is expected. Ultrix works proactively by preparing the immune system against future flu exposure, rather than treating an existing condition. Unlike a therapeutic drug, there are no expected feelings or sensations that indicate the preventative action has started.


Q: Are there common patient-reported signs that Ultrix is beginning to work?

Since the vaccine's benefits are purely preventative and rely on building an internal immunological barrier, there are no common subjective signs reported by patients that indicate the vaccine has started to work. The primary indication of effect is the measured immune response shown in studies.


Q: Can Ultrix potentially impair my ability to drive or operate machinery?

Official documents do not contain a specific driving restriction. However, commonly reported side effects include fatigue, headache, and dizziness. Because these symptoms can potentially affect concentration or reaction time, official safety information suggests awareness of how commonly reported symptoms may affect the ability to perform tasks that require full alertness.


Q: What biological systems or lab values should be monitored in patients taking Ultrix?

Regulatory warnings highlight the need for caution in certain populations. Individuals with bleeding disorders require care due to the intramuscular injection risk, and those receiving immunosuppressive treatments may require monitoring of their immune response. Any specific monitoring protocols are not detailed in the general regulatory text and are established based on individual patient circumstances.


Q: What is the official definition of an 'Adverse Reaction' compared to a 'Side Effect' for Ultrix?

According to public health guidance, the terms 'adverse reaction' and 'side effect' are often used interchangeably by the public. Officially, an Adverse Reaction is defined as any unintended medical occurrence following administration. A side effect generally refers to a known, expected, and non-therapeutic outcome of the vaccine.


Q: Is Ultrix considered a drug that has the potential to be habit-forming or lead to dependence?

Regulatory and pharmacological classification indicates that Ultrix Quadri, as an inactivated immunological agent (vaccine), does not have known potential to be habit-forming. It is administered for prophylactic immunity and is not associated with leading to physical or psychological dependence.


Q: Why do some people refer to Ultrix as a 'new generation' medicine?

The distinction of Ultrix Quadri as a newer type of vaccine is rooted in its composition. It is a quadrivalent formulation, meaning it targets four influenza strains for broader coverage. Furthermore, its production is noted for excluding the use of preservatives, stabilizers, or adjuvants in its final formulation.

How should Ultrix be stored and disposed of?

Official Storage Conditions

Ultrix Quadri, as an inactivated vaccine, must be stored within the strict regulatory temperature range of 2 C to 8 C (36 F to 46 F). It is essential to not freeze the product, as this can destroy its potency; any vaccine that has been frozen must be discarded immediately.

Protection and Handling

The vaccine must be kept in its original package to protect it from light. Prior to administration, the solution must be visually inspected for changes in physical properties or the presence of foreign particles. The product should be stored out of the sight and reach of children.

Disposal Instructions

Official disposal rules prohibit discarding the drug in household waste or flushing it down the sewer. Unused or expired Ultrix Quadri must be returned for proper disposal according to local environmental and pharmaceutical waste regulations, usually by consulting a healthcare professional or local waste authority.

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

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