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Ультрикс

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Ультрикс

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Treatment option: Influenza, Flu Prevention

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.

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Overview of Ультрикс

Quick Facts: Ultrix Vaccine

Property Description
Active ingredient Influenza Vaccine (Split Virion), Inactivated
Form Solution for Intramuscular Injection
Pharmacological Class Immunobiological Medicinal Product (Vaccine)
Common Use Prophylactic Immunization against Influenza
Origin / Manufacturer Biologically derived, Russian manufacturer (Fort)

The Identity and Classification of Ultrix

Ultrix is an inactivated influenza vaccine that belongs to the class of immunobiological medicinal products used for active prophylactic immunization to prevent seasonal influenza. The preparation is a sterile solution for intramuscular administration, a formulation preferred for routine vaccination programs. Ultrix is specifically a split virion vaccine, a type that contains purified viral fragments (antigens) rather than the entire virus particle, which is clinically recognized for balancing immunogenicity with safety.

Composition and the Role of Tetravalent Protection

Its most current formulation, Ultrix Quadri, is a tetravalent vaccine, designed to provide comprehensive protection against two subtypes of Influenza A virus and both lineages of Influenza B virus. This inclusion of four strains is strictly guided by annual recommendations from the World Health Organization (WHO), recognizing the crucial need for broad coverage. The active ingredients are the Haemagglutinin (HA) and Neuraminidase (NA) antigens. A key feature is its status as a non-adjuvanted formulation, using a simple phosphate-buffered saline solution as its vehicle.

General Purpose and Immune Formation

The core purpose of Ultrix is the prevention of influenza disease and the mitigation of associated serious complications. By introducing the inactivated antigens, the vaccine safely stimulates the body to produce specific humoral antibodies, initiating the formation of active immunity. This protective response ensures the body is prepared to neutralize the actual virus upon exposure. Ultrix is commonly included in national immunization schedules, serving as a primary tool in annual public health campaigns.

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What side effects are possible with Ультрикс?

Possible Side Effects and Safety Information

This section describes the adverse reactions and safety characteristics of the Ultrix Quadri inactivated influenza vaccine as documented in official regulatory prescribing information. The information is structured by frequency and physiological system, defining the officially recognized risk profile.


Adverse Reaction Scope

The most frequent adverse reactions are classified based on regulatory frequency categories:

Category Description
Very Common Pain and hyperemia (redness) at the injection site.
Common to Uncommon Induration (hardening), edema, itching at the injection site, along with systemic effects including pyrexia (fever), chills, weakness, and fatigue.

Adverse events are classified across System-Organ Classes, with the majority documented under General disorders and administration site conditions. Other affected systems include Musculoskeletal and Connective Tissue Disorders (e.g., joint and muscle pain) and Respiratory, Thoracic and Mediastinal Disorders (e.g., cough, sore throat).


Serious Adverse Reactions and Safety Constraints

The regulatory label documents Serious Adverse Reactions that are subject to official monitoring, including anaphylaxis, febrile seizures, pyrexia above 40 °C, and brachial neuritis. Local complications such as a sterile or infectious abscess at the injection site are also noted in this category.

Time-related safety patterns indicate that common reactions typically develop on the day of vaccination and resolve spontaneously within 1–3 days. However, the development of an abscess may occur with a delay of approximately one week.

Use is subject to formal safety constraints: the vaccine is contraindicated in individuals with known hypersensitivity to chicken protein or any component of the vaccine, and following a history of a severe reaction (e.g., high fever) to a previous influenza vaccination. For special populations, the vaccine is officially approved for use starting from the second trimester of pregnancy.

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Overdose and Emergency Response

Overdose and When to Seek Help

This section addresses the official information regarding overdose as described in government regulatory documents for this inactivated influenza vaccine.

Domain Official Regulatory Statement
Documented Overdose Presentations No specific clinical manifestations, symptoms, or toxicity profiles are documented in the official overdose section.
Physiological Systems Affected No specific physiological systems are officially listed as being affected by an overdose event.
Exposure-Related Factors Regulatory prescribing information explicitly states that overdosage is unlikely to have any untoward effect.
Emergency-Response Statements No specific emergency actions unique to a confirmed overdose are mandated in the official overdose section.

Official Overdose Statements

  • The official regulatory documentation for the vaccine states that no cases of overdose have been reported in post-marketing surveillance.
  • Prescribing information confirms that the administration of an excess quantity is unlikely to cause any untoward effect.
  • Due to the low risk profile, there are no required procedural instructions or specific antidote information documented in the dedicated overdose section of the official label.

Connection to the Overall Overdose Profile

The regulatory profile of this vaccine is defined by the official absence of reported toxicity, which indicates a low inherent risk from over-administration. This classification ensures that urgent medical help-seeking criteria are not required for an isolated overdose event itself. Instead, the focus of emergency guidance remains on managing documented adverse reactions, rather than a classic overdose syndrome.

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Therapeutic Uses of Ультрикс

Ультрикс is utilized in a supportive capacity to help manage symptoms associated with specific conditions. Its use is focused on providing relief from various types of discomfort and helping to address minor, temporary limitations in physical function. This medication is typically considered as part of a broader therapeutic plan established by a healthcare professional.

The primary therapeutic applications involve the temporary mitigation of generalized patient discomfort, the supportive care for transient inflammatory signs, and the management of occasional functional limitations that may interfere with daily activities. The aim is to support the patient's capacity for comfort and well-being during the course of their condition.

Quick Fact: Relief for Occasional Discomfort

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Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Ультрикс — Official Regulatory Information

The eligibility profile for the Ultrix Inactivated Influenza Vaccine is strictly defined by regulatory documents, outlining populations permitted to use the medicine and those who are formally excluded or restricted.

Eligibility scope

  • Populations for whom use is allowed (as stated in label): Children from 6 months of age, adolescents, and adults, including persons over 60 years of age.
  • Populations for whom use is contraindicated: Individuals with a history of a severe allergic reaction to any vaccine component (e.g., chicken protein) or to a previous influenza vaccination dose.
  • Age-related eligibility rules: Approved from 6 months of age; prohibited for children under 6 months.
  • Condition-specific eligibility rules: Vaccination must be postponed if the individual has an acute febrile condition, is suffering from an acute illness, or is experiencing an exacerbation of a chronic disease; administration is permitted only after recovery or during remission.
  • Pregnancy and lactation eligibility status (if explicitly documented): Use is permitted for pregnant women from the second trimester onward; use is contraindicated during lactation (breastfeeding).
  • Eligibility-related restrictions: Use is conditional upon the patient not experiencing an acute phase of illness.

Eligibility classifications (high-level)

  • Eligibility severity classification (as defined in official documents): Contraindicated (severe allergy, lactation, infancy); Permitted Conditional (acute illness, pregnancy II/III trimester).

Resulting eligibility structure

  • The vaccine is approved for prophylactic use starting at 6 months of age.
  • Use is contraindicated in patients with a severe allergy to vaccine components or a history of prior vaccine reaction.
  • Vaccination must be postponed during acute febrile conditions or the exacerbation of chronic diseases.

Connection to the overall eligibility profile: Official regulatory documents define who can and cannot use Ultrix by establishing non-negotiable absolute contraindications based on allergic history, a minimum age threshold, and specific physiological states like lactation. These rules govern who can and cannot use the medicine under its label-specified conditions.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Interactions Affecting Vaccine Efficacy

The most significant interaction concerns medicinal products that suppress the immune system. As an influenza vaccine, Ультрикс relies on an adequate immune response from the body to establish protective immunity. Therefore, co-administration with immunosuppressive medicinal products—which include corticosteroids, cytotoxic drugs, and radiation therapy—may lead to a suboptimal or absent immune response and a failure to achieve full protection against influenza.

Patients with primary or secondary immunodeficiency may also exhibit a diminished response to the vaccine. A delay in vaccination may be warranted for individuals receiving intensive immunosuppressive therapy. Specifically, an optimal immune response is generally anticipated if the vaccine is administered at least 2 to 4 weeks after the cessation of such therapy.

Timing and Condition-Based Constraints

Conversely, patients receiving low-dose, local, or short-course rectal corticosteroid therapy typically do not require a vaccination delay. However, in the event of minor acute respiratory or other infectious diseases, vaccination should be postponed until symptoms have fully resolved to avoid interfering with the immune system's general readiness.

Patients on basic therapy for most chronic diseases, excluding immunosuppression, may typically proceed with vaccination. This careful consideration of co-administration timing and the status of the patient’s immune system is critical for maximizing the vaccine's protective effect.

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Mechanism of Action

How Ультрикс Works: Mechanism of Action

Targeting Specific Receptor-Mediated Signaling

Ультрикс initiates its effect by engaging mechanisms that involve receptor-mediated signaling, thereby modifying early molecular steps that shape systemic physiological outcomes. This primary engagement results in the adjustment of initial signaling dynamics where specific transmitters or mediators dominate.

Modulation of Dysregulated Pathway Cascades

The drug modifies early molecular steps within mechanistic cascades that lead to downstream effects associated with elevated physiological signaling. The drug’s molecular activity involves rapid modulation kinetics to adjust pathway activity that may undergo transition toward higher activation states, facilitating the attainment of an adjusted signaling steady-state within targeted pathways.

Physiological Stabilization via Feedback Regulation

Ультрикс engages mechanisms that influence feedback regulation within pathways, modulating overactive or dysregulated processes. This action results in the stabilization of activated physiological responses and influences the scope of excessive mediator activity.

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Dosage and Administration Information

Official Administration Guidelines for Ультрикс

Ультрикс (Ultrix Quadri) is administered according to the standardized usage protocol for inactivated quadrivalent influenza vaccines, which is guided by established clinical practices and public health bodies.

Administration Detail Official Requirement
Route of Administration Intramuscular (IM) injection is the standard route, delivered into the deltoid muscle for most adults and older children.
Standard Dose Volume A single dose of 0.5 mL containing the full 60 mu g total Hemagglutinin antigen is used for most individuals.
Dosing Frequency The vaccine is administered once annually for seasonal prophylaxis.
Preparation The suspension must be shaken well immediately before use, and visually inspected for any particulate matter or discoloration before administration.

Population-Specific Dosing

Usage rules vary primarily for younger children based on their history of vaccination:

  • Persons 9 years and older: A single 0.5 mL dose is required annually.
  • Children 6 months through 8 years: A two-dose primary series is required if the child has no previous history of influenza vaccination. The two doses of 0.5 mL must be administered at an interval of at least four weeks apart.

Procedural Constraints

The vaccine must be administered via the intramuscular route only; the product must not be administered intravenously. The choice of injection site is procedural, using the anterolateral thigh for infants 6 through 11 months, and the deltoid muscle for persons 12 months and older.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Ультрикс


Evidence for Prophylactic Immunization for Seasonal Influenza

The research base for inactivated influenza vaccines (IIVs) like Ultrix is focused on active prophylactic immunization—that is, introducing antigens for the purpose of stimulating an immune response before natural exposure. Studies were evaluated in general populations to examine outcomes related to systemic or functional imbalance. The evidence for this use primarily comes from Randomized Controlled Trials (RCTs), which are highly controlled studies, and from Real-World Effectiveness (RWE) studies, which examine how the vaccine preparation was observed in public health settings. Some trials also explored whether the immune response patterns were similar to those seen when compared to other licensed influenza vaccines.

Research examined two main areas. The first involves whether the vaccine preparation was associated with patterns in the occurrence of laboratory-confirmed influenza illness during a flu season. The second area, called immunogenicity, involves monitoring physiological strain or stress by looking at antibody levels in the blood. Findings describe patterns observed in the studies over the course of the flu season.


Immunogenicity Trials: Measuring the Antibody Response

The earliest trials for this type of vaccine was studied for its ability to stimulate an immune response, a factor studied in research known as immunogenicity. These trials research examined how quickly and to what degree the body produced specific antibodies after vaccination. The outcomes measured include the Seroprotection Rate (SPR) and Seroconversion Rate (SCR), which are technical ways of measuring antibody levels in the blood, often applied in research contexts involving fluctuating or unstable symptoms of the disease.

These studies typically studies monitored the antibody response up to about 21 days following the injection. Findings indicate that the vaccine preparation was observed in healthy adults and children to show an antibody response consistent with the expected profile for this type of inactivated vaccine. This evidence contributes to understanding symptom patterns by showing the body's initial response to the antigens.


Understanding Evidence Gaps and Uncertainties

The evidence landscape, while extensive, highlights what is known—and what is still uncertain. Evidence quality varies across studies, and there are key limitations to note. One of the main uncertainties relates to Antigenic Match, meaning the observed performance of the vaccine may fluctuate each year. The effectiveness was observed in some studies to be dependent on how closely the vaccine strains align with the influenza strains actually circulating in the community.

Additionally, results apply only to the populations studied, meaning the patterns observed in healthy adults research does not determine whether an individual will respond similarly if they have a complex health profile. Studies help show what has been observed so far, but research provides context but not individual predictions.

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Frequently Asked Questions (FAQ)

Common questions about Ультрикс (FAQ)


Q: How long does it take for Ультрикс to start providing protection?

A: According to general information for inactivated influenza vaccines like Ультрикс, protection from the vaccine typically begins to develop about two weeks after the injection. This timeframe is consistent with the general time required for the body to start an immune response.

Q: How long does the protection from Ультрикс last?

A: Studies and official information indicate that the protective effect of the vaccine generally lasts for up to one year. Because the circulating influenza strains often change annually, and protection may decline over time, annual vaccination is generally recommended for seasonal coverage.

Q: Is Ультрикс considered an 'enhanced' or 'high-dose' vaccine?

A: No, Ультрикс (Ultrix Quadri) is a standard-dose quadrivalent vaccine. It contains the amount of antigen recommended by the World Health Organization (WHO) for each of the four strains. It is not classified as an 'enhanced' or 'high-dose' formulation, which are specific products containing higher antigen concentrations.

Q: Can people who are pregnant receive the Ультрикс vaccine?

A: Official product information states that the use of the Ультрикс vaccine is permitted for pregnant women, provided administration occurs from the second trimester onward. The official documentation permits use starting from the second trimester.

Q: Can a person receive Ультрикс if they have a history of Guillain–Barré syndrome (GBS)?

A: Regulatory guidance suggests that a history of Guillain–Barré syndrome (GBS), particularly if it occurred within six weeks of a previous influenza vaccination, is a factor that should be carefully considered.

Q: What should I do if I experience a severe reaction to the vaccine?

A: While serious allergic reactions like anaphylaxis are rare, official safety guidelines state that appropriate medical treatment must be immediately available at the vaccination site. If any signs of a severe allergic reaction occur after leaving the site, immediate emergency medical attention is the official course of action described.

Q: If I have a mild cold, should I still get the Ультрикс injection?

A: Vaccination must be postponed if a person has a moderate to severe acute illness or an acute febrile condition (fever). If a person has a very mild cold without a fever, vaccination may typically proceed. However, assessment by a healthcare provider prior to administration is typically used to confirm eligibility.

Q: What is the difference between an inactivated and a live flu vaccine?

A: Ультрикс is classified as an inactivated vaccine, which means the influenza viruses in the shot have been killed and cannot cause the flu. Live attenuated influenza vaccines (LAIVs) contain weakened forms of the virus and are administered differently, often as a nasal spray.

Q: Does Ультрикс contain a preservative like thimerosal?

A: No, the official composition details confirm that Ультрикс is a non-preserved formulation. This means that the product does not contain thimerosal or other preservatives.

Q: Does Ультрикс contain egg protein?

A: The vaccine is prepared using an egg-based manufacturing process, and therefore may contain trace amounts of egg white protein (ovalbumin). Hypersensitivity to chicken protein is noted as a specific contraindication.

Q: Can Ультрикс be given to people with certain chronic conditions?

A: Persons with most stable chronic diseases typically do not need to delay or avoid vaccination. However, official guidance requires vaccination to be postponed if the person is currently experiencing an acute exacerbation (worsening) of a chronic disease. Postponing vaccination during an exacerbation is consistent with official protocol.

Q: What are the rare, but serious, side effects associated with Ультрикс?

A: Serious adverse reactions that are officially monitored and documented include severe allergic reactions (anaphylaxis) and certain neurological or nervous system disorders, such as brachial neuritis. Very high fever (pyrexia above 40 C) and febrile seizures are also noted.

Q: Can Ультрикс be given at the same time as other vaccines?

A: Yes, regulatory guidance indicates that Ультрикс can be administered at the same time as other vaccines. When co-administering multiple vaccines, regulatory guidance requires that a separate syringe be used for each product.

Q: What should I avoid taking before or after receiving Ультрикс?

A: The main concern regarding interaction is with immunosuppressive medicinal products, as they can reduce the immune response to the vaccine. There are no general contraindications regarding common over-the-counter medications like pain relievers or cold medicines around the time of vaccination.

Q: Is there any risk associated with taking blood thinners around the time of the Ультрикс injection?

A: The use of blood thinners (anticoagulants) does not prevent vaccination. Regulatory guidelines often recommend procedural adjustments during administration, such as using the smallest appropriate needle size, to minimize the risk of bruising or bleeding at the site.

Q: Is it true that the vaccine's effectiveness changes each year?

A: Yes, regulatory documents note that the observed performance of the vaccine may fluctuate yearly. This is because the effectiveness depends on a good alignment, known as 'Antigenic Match,' between the vaccine strains and the influenza strains actively circulating in the community that season.

Q: Are there different formulations of Ультрикс for different age groups?

A: Ультрикс is one single formulation, administered as a standard 0.5 mL dose for all approved age groups, starting from 6 months of age. There are no differences in the concentration of the active ingredients based on age.

Q: Why is the vaccine important even for healthy adults?

A: General public health guidance highlights that vaccination is important for healthy adults to prevent illness in themselves and to mitigate the risk of transmitting the influenza virus to others. Preventing spread helps protect high-risk individuals and the community.

Q: Can Ультрикс protect against the 'stomach flu' or common colds?

A: No, Ультрикс is specifically indicated for active immunization against seasonal influenza only. It does not provide protection against the common cold or other illnesses, such as gastroenteritis, which is often mistakenly called 'stomach flu.'

Q: How is Ультрикс made or produced?

A: The vaccine is prepared from influenza viruses that are propagated (grown) in embryonated chicken eggs. The virus is chemically disrupted and purified to obtain the essential parts of the virus, called antigens, which are used in this split virion type of vaccine.

Q: What happens if I miss the 'optimal' time to get the Ультрикс vaccine?

A: While vaccination is generally recommended before the start of the influenza season, official guidance states that the vaccine can still be beneficial as long as influenza viruses are actively circulating. The protective effect can last for up to a year.

Q: Can people with autoimmune conditions receive Ультрикс?

A: There is no blanket contraindication for all autoimmune conditions, but the primary regulatory concern is a compromised immune response. For stable, non-exacerbated conditions, there is generally no need to postpone vaccination, but the individual's overall health and current treatment status are factors for consideration.

Q: What should I know about the ingredients in Ультрикс?

A: The vaccine contains the active hemagglutinin antigens from the four influenza strains. The suspension is prepared in a phosphate-salt buffer solution. Other non-active components include Polysorbate 80 and Octoxinol-10, with a possibility of trace amounts of egg protein remaining from the manufacturing process.

Q: Is it necessary to take time off work after getting Ультрикс?

A: Common adverse reactions, such as pain at the injection site, headache, or fatigue, typically resolve spontaneously within one to three days. Most individuals can resume their normal daily activities and work without needing to take time off.

Q: Why is the vaccine administered by injection and not as a nasal spray?

A: Ультрикс is an inactivated split virion vaccine, which means the formulation is designed to be administered exclusively by the intramuscular injection route. This specific route is necessary to properly stimulate the body's immune system and achieve the protective effect.

Q: Is there a different recommendation for people over 65 years old regarding this vaccine?

A: The official approved dosage for persons over 60 years of age is the standard single 0.5 mL dose annually, which is the same as the recommendation for all adults. This vaccine is not a high-dose or specifically formulated senior vaccine.

Q: Are there any long-term side effects noted for Ультрикс?

A: The majority of common adverse reactions are short-lived, resolving within a few days. Regulatory documents do not indicate that there are common, officially recognized long-term side effects associated with the use of this vaccine.

Q: Can people with a known latex allergy receive the injection?

A: Official guidance recommends that special consideration be given to patients with a history of severe latex allergy. Information regarding latex content in the packaging components is typically found in the product precautions, which should be reviewed.

Q: Does Ультрикс have an adjuvant?

A: No, the official composition details confirm that Ультрикс is a non-adjuvanted formulation. An adjuvant is an ingredient that is sometimes added to vaccines to help create a stronger immune response.

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How should Ультрикс be stored and disposed of?

Official Storage and Handling

Ультрикс (Ultrix), as a refrigerated vaccine, must be stored under strict cold chain conditions, which is essential to maintain product potency and quality as defined by regulatory standards. The product must be stored in a refrigerator and maintained within the narrow temperature range of +2 C to +8 C (36 F to 46 F). Freezing is strictly prohibited and can render the product unsuitable for use. The vaccine should be protected from light by keeping it in its original packaging until administration.

Stability and Disposal Requirements

Official guidelines require continuous temperature monitoring, and any product exposed to temperatures outside the +2 C to +8 C range may require disposal following manufacturer or public health authority advice. The product should not be used past the expiration date on the label. For disposal, the product must be managed as pharmaceutical waste, either through designated drug take-back programs or by securing it in a sealed container and discarding it in household trash, if no specific instructions are provided, avoiding disposal via flushing.

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

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