Lantigen B

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Lantigen B

Method of action: Immunostimulants, Vaccine, Vacciness

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Lantigen B

What is Lantigen B? Defining the Immunomodulator

Property Description
Active ingredient Polybacterial Lysate
Form Oral Suspension (Drops)
Pharmacological Class Immunomodulator, Oral Vaccine
Common Use Prophylaxis of Recurrent Respiratory Tract Infections
Origin Biologically derived (from inactivated bacterial cultures)

Lantigen B is classified as an oral vaccine and immune-stimulating agent, belonging to the high-level pharmacological class of Immunomodulators. The preparation is presented as an oral suspension (drops), utilizing the sublingual administration route. This mode of delivery is a key differentiating feature for this Polybacterial Lysate compared to traditional injectable vaccines, aiming for targeted exposure to the immune cells of the oral mucosa.

Bacterial lysate preparations are used in the prophylaxis of acute respiratory infections in adults and children. The product is manufactured and widely distributed by Bruschettini Srl, with a significant presence in European markets.

Composition: A Polyvalent Chemical Lysate

The Polybacterial Lysate active ingredient is biologically derived and polyvalent, incorporating antigenic material from multiple inactivated bacterial strains that are commonly responsible for respiratory illness. These include, but are not limited to, Streptococcus pneumoniae, Haemophilus influenzae, and Klebsiella pneumoniae. The preparation utilizes a chemical lysate process, where bacterial cells are intentionally broken down to yield antigenic fragments, which are then stabilized in an aqueous vehicle base. This specific combination and preparation method ensures a controlled, broad-spectrum immunological challenge suitable for prophylaxis.

General Purpose: Preparing the Body’s Defenses

The primary purpose of Lantigen B is to provide a prophylactic treatment that enhances the body’s resistance against common respiratory pathogens. Its use is clinically recognized for supporting individuals prone to repeated seasonal infections, such as children, by strengthening their immune response. The medicine is intended to train and strengthen the immune system, primarily to prevent the recurrence of recurrent respiratory tract infections, and is not used to treat an existing, acute illness.

Regulatory References

  1. EMA's Referral on Bacterial Lysate Medicines

What side effects are possible with Lantigen B?

Official Safety Profile and Possible Side Effects

The safety profile for this polybacterial lysate preparation is organized according to standardized regulatory categories, such as frequency and the affected body system, based on official prescribing information.

Classification Examples of Reactions
Common (Affects 1 to 10 in 100 people) Cough, Diarrhea, Abdominal pain, Nausea, Vomiting, Fever, Headache, Pharyngitis, and Fatigue. These frequently observed reactions primarily involve the gastrointestinal and respiratory systems.
Uncommon (Affects 1 to 10 in 1,000 people) Allergic reactions, which may include hives (urticaria) and swelling of the face or throat (angioedema). Dizziness has also been officially reported in this frequency class.

Certain systemic reactions, such as a fever or flu-like symptoms, are explicitly documented in regulatory sources as potentially being more prominent at the initiation of therapy and may lessen with continued use. The product is approved for use in susceptible patient groups, including children, for its indicated prophylactic purpose.

Safety-Related Restrictions

Official regulatory documents define specific limitations regarding the use of this medicine. The product is contraindicated and must not be used in individuals with a known hypersensitivity to the active substance or any of its components. Furthermore, due to its function as an immune-stimulating agent, it is formally restricted from use in patients who have autoimmune diseases, as stated in the official prescribing labels.

Overdose and Emergency Response

Overdose and When to Seek Help

Official Regulatory Profile: Low Systemic Toxicity

The official regulatory documents for Lantigen B, which is classified as a polybacterial lysate immunomodulator, provide specific guidance regarding over-administration. Due to the product’s biological nature, the official profile suggests that overdose is generally classified as having a low potential for severe systemic toxicity. Regulatory information explicitly states that over-administration is unlikely to cause any severe systemic adverse reactions. This means that no specific toxic clinical signs or laboratory abnormalities are typically associated with taking a quantity beyond the prescribed dose. Furthermore, regulatory documents specify that no specific antidote is known for managing polybacterial lysate overdose. No specific differential risks are documented for any patient groups, such as children or the elderly, beyond general emergency procedures.

Emergency Actions and Required Management

Immediate medical assessment is mandatory following any suspected over-administration. Government regulatory statements explicitly require patients to seek immediate medical attention for professional evaluation of their clinical status and to rule out potential adverse effects. Management of the situation is strictly defined as symptomatic and supportive treatment. The official profile indicates that hospital monitoring may be required in this circumstance, ensuring appropriate clinical oversight. This comprehensive approach is mandated by regulators to address any potential adverse effects that may occur and manage the over-administration appropriately.

Therapeutic Uses of Lantigen B

What Lantigen B Treats: Main Uses and Benefits

The primary and established purpose of Lantigen B is to provide prophylactic treatment; it is not used to treat acute, existing infections. Its utility is focused on supporting the management of recurrent illness patterns.

Lantigen B is commonly used for managing a pattern of recurrent respiratory tract infections (RTIs). The medicine is relevant for the prevention of recurrent respiratory infections. It is applied in clinical settings where patients, particularly children and adults prone to frequent sickness, experience repeated infectious episodes such as pharyngitis, tonsillitis, or otitis.

The core therapeutic benefit may help reduce the overall frequency of acute infectious episodes across the respiratory system during high-risk seasons. Regarding the infectious episodes that may occur, the treatment may assist with reducing their impact. Clinical use suggests that Lantigen B may assist with easing the severity of typical acute symptoms, and supports a more manageable experience of the illness course.

“The primary purpose is to support patients during periods of recurrent respiratory illness.”

This supportive benefit contributes to improved comfort and assists with maintaining functional stability during symptomatic periods. The medication is commonly used in a seasonal preventive regimen for susceptible patient groups.


Quick Fact: Relief for Recurrent Infections Lantigen B is applied when conditions involve recurrent or episodic manifestations, assisting with easing the overall symptom load associated with frequent respiratory illnesses.


Regulatory References

  1. European Medicines Agency therapeutic overview

Eligibility and Restrictions for Use

Who can and cannot use Lantigen B? — Official Regulatory Information

Eligibility Scope

Category Status / Restriction
Allowed Populations Adults and children from 3 years of age for the prophylaxis of recurrent respiratory tract infections.
Contraindicated Patients with known hypersensitivity to the active substance (Polybacterial Lysate) or any excipients.
Age-Related Rule Children below 3 years of age are generally not recommended due to use not being established in this group.
Use Prohibited For Treatment of existing, acute respiratory infections; prophylaxis of pneumonia.
Conditional Use Use is not recommended during pregnancy or lactation due to insufficient specific safety data.

Connection to the Overall Eligibility Profile

Official regulatory documents define who can and cannot use Lantigen B by severely restricting its eligible use. The medicine is formally indicated only for prophylaxis of recurrent respiratory tract infections in adults and children from 3 years of age. Use is strictly prohibited for treating acute infections and for pneumonia prevention. Furthermore, the medicine is contraindicated in patients with a history of hypersensitivity to its components. Regulatory bodies also state that use is not recommended during pregnancy or breastfeeding due to a lack of sufficient clinical safety data.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Lantigen B is an oral vaccine, and its official interaction profile is strictly defined by government regulatory documents based on potential conflicts with the body’s immune response.

Interaction Scope Official Regulatory Statement
Interacting Product Categories Immunosuppressive Agents and Other Vaccines (e.g., inactivated and live-attenuated).
Mechanistic Basis of Interaction Pharmacodynamic antagonism. The official description is based on counteracting the drug's intended immune-stimulating goal.
Timing-based Interaction Rules The use of Lantigen B must be postponed if the patient is receiving other specific vaccines or immunotherapies.
Food, Alcohol, or Supplements None documented in official regulatory sources.

Interaction Classifications

The most significant interaction is categorized as a Contraindication for co-administration with other vaccines, a formal prohibition established in the regulatory labeling. Additionally, the use of Immunosuppressive Agents may result in a Clinically Significant Interaction, as these treatments may reduce or inhibit the desired therapeutic effect of the polybacterial lysate. No interactions based on common metabolic pathways (e.g., CYP enzymes) or drug transporters are cited in regulatory documents.

Official Interaction Statements:

  • Co-administration with other vaccines is formally contraindicated.
  • Immunosuppressive treatments may reduce or inhibit the desired immune-stimulating effect.
  • Administration must be postponed if the patient is receiving other specific vaccines or immunotherapies.

Connection to the overall interaction profile:

The regulatory documents define the interaction structure for Lantigen B primarily around pharmacodynamic conflicts, focusing on substances that interfere with the intended immune response. This structure results in a formal prohibition on co-administration with other vaccines. The profile explicitly notes the potential for reduced efficacy when co-administered with immunosuppressive agents, reflecting its classification as an immune-stimulating agent.

Mechanism of Action

Lantigen B operates primarily as an immunomodulator, engaging mechanisms that induce specific local and systemic immune responses.

Inducing Specific Mucosal Immunity

Lantigen B, a bacterial lysate, is recognized by the mucosa-associated lymphoid tissue (MALT), initiating the adaptive immune cascade. This engagement stimulates the differentiation of B-cells into plasma cells that are specifically "homed" to the respiratory tract to produce secretory Immunoglobulin A (sIgA). The resulting physiological effect involves the enhanced production of sIgA within the respiratory tract, which contributes to the localized immune capacity of the mucosal surface.

Stimulating Innate Immune Response and Phagocytosis

The bacterial antigens act as Pathogen-Associated Molecular Patterns (PAMPs), binding to Toll-like receptors (TLRs) on innate immune cells like macrophages and neutrophils. This receptor engagement triggers signaling pathways that lead to the upregulation of phagocytic activity and the accelerated release of immune mediators. This mechanism promotes enhanced phagocytic activity and cellular mobilization, which assists in the processing and degradation of foreign antigens.

Developing Systemic Immunological Memory

Beyond local effects, the processed antigens stimulate a broader systemic adaptive response, driving the proliferation of T-cells and the generation of memory B and T cells. This process builds a comprehensive, specific antibody repertoire, including serum IgG, which supports the establishment of a robust, long-term immunological memory.

Dosage and Administration Information

How to Use Lantigen B: Official Administration Guidelines

Lantigen B is administered via the sublingual route using an oral suspension (drops). The administration is structured as a prophylactic seasonal protocol involving specific cyclic usage patterns.


Administration Scope

Instruction Detail
Route of Administration Sublingual (beneath the tongue). For very young children, drops may be placed between the lower lip and gum.
Standard Dosing Adults and Children >10 years: 15 drops per dose. Children 3 months to 10 years: 7 to 8 drops per dose (half dose).
Frequency Pattern Typically twice daily (morning and evening). Alternatively, a once-daily dose can be taken in the morning, preferably on an empty stomach.
Procedural Condition The dose must be held in the mouth for approximately 2 minutes without swallowing to allow for mucosal absorption. The bottle must be shaken before use.
Missed-Dose Guidance If a dose is missed, do not take a double dose to compensate.

Cyclic Use Protocol

The treatment follows a defined seasonal schedule designed to cover high-risk periods.

Official Cycle Sequence:

  • The initial course typically begins in September.
  • After the first course is completed (e.g., two bottles for adults), treatment is suspended for a period of 2 to 3 weeks.
  • A subsequent recall treatment cycle is administered, often starting in January, to maintain the full seasonal coverage.

This structured approach defines the required duration and timing of the polybacterial lysate administration, separating the initial phase of use from the later recall phase, which ensures adherence to the high-level label-based protocol.

Recent Clinical Evidence

Research evidence / Overview of studies for Lantigen B

Evidence for Prophylaxis of Recurrent Respiratory Tract Infections

Clinical evaluation for Lantigen B has focused on its use in the prophylaxis (prevention) of recurrent respiratory tract infections (RTIs). This area has been evaluated through formal Randomized Controlled Trials (RCTs) and systematic research reviews that combine the findings from multiple trials. These studies were conducted during periods of increased symptom activity, monitoring responses over defined time intervals that covered a typical high-risk respiratory season.

Research describes the collection of data on the overall reporting of acute episodes in conditions characterized by fluctuating or episodic manifestations, such as repeated colds, pharyngitis, and tonsillitis. The research was reviewed by regulatory authorities for the specific prophylactic indication. Evidence is limited and remains insufficient for research on the use for treating an existing, acute infection.

Primary Outcomes Examined in Clinical Trials

Studies monitored the number and severity of infection episodes experienced by the observed populations. Other study outcomes examined the need for supportive medications, specifically the incidence and duration of antibiotic use and other relief medications. Research provides insight into the changes measured during the study period and how patients reported their experience during periods where symptoms become more noticeable. Research describes how these symptom patterns evolved in the observed populations under the specific conditions of the trials.

Evidence in Specific Patient Groups

Lantigen B was evaluated in study populations that included broad cohorts of both adults and children who presented with cycles of stability and flare-ups related to frequent respiratory illnesses. The studies were designed to monitor the response to the product across a wide age range. The evidence reflects what was observed so far in these groups, and findings describe group patterns, not personal outcomes.

Long-Term Follow-up and Durability of Study Data

The follow-up durations for many of the key studies were intermediate-term, with observation periods typically lasting up to eight months to cover the season when infections are most common. It is not yet clear whether any observed pattern continues after the treatment course ends. Research has explored short-term changes, but the long-term effects are not fully established. Therefore, there is limited information for long-term outcomes, and follow-up durations were limited to the study period itself.

Research Gaps and Areas of Uncertainty

There are specific research gaps where data for Lantigen B remains insufficient. Limited evidence exists for long-term outcomes. Evidence is explicitly for the prophylactic setting; comparative evidence is lacking or insufficient for treating an established, acute infection. The research base is subject to regulatory requirement for further investigation to address existing limitations. Companies have been required to provide further data from new clinical studies by a specified deadline.

Key Studies & References

  1. Prevention of recurrent respiratory tract infections: a literature review of the activity of the bacterial lysate Lantigen B
  2. Polyvalent mechanical bacterial lysate for the prevention of recurrent respiratory infections: A meta-analysis

Frequently Asked Questions (FAQ)

Common questions about Lantigen B (FAQ)


Q: How should I plan the full treatment course over the season?

According to the official product information, the administration of Lantigen B follows a prophylactic seasonal protocol. The treatment is structured as a defined cyclic sequence, often designed to cover typical high-risk seasonal periods. This cycle typically includes an initial course, a suspension period that usually lasts 2 to 3 weeks, and a subsequent recall treatment cycle.


Q: What is the active ingredient and what are the specific bacteria strains in the lysate?

The active ingredient in Lantigen B is a Polybacterial Lysate. This means it is polyvalent, incorporating antigenic material from multiple inactivated bacterial strains often associated with respiratory illness. These may include Streptococcus pneumoniae, Haemophilus influenzae, and Klebsiella pneumoniae, among others, as indicated in regulatory documents.


Q: Does Lantigen B have any interactions with other prescription medicines?

Official regulatory documents define significant interactions based primarily on the drug's intended immune-stimulating function. These documents highlight interactions with Immunosuppressive Agents, which may reduce the medicine's intended therapeutic action, and list a formal contraindication with Other Vaccines. No interactions based on common metabolic pathways, such as CYP enzymes, are cited in the regulatory profile.


Q: Where can I get a copy of the official Patient Information Leaflet (PIL)?

The official Patient Information Leaflet (PIL) or package insert is included with the product packaging when the medicine is dispensed. For digital access, this documentation is also typically available on the website of the relevant national regulatory authority or through the product manufacturer's authorized representatives.


Q: What is the process for reporting a side effect I've experienced?

In the event of side effects, the official process defined by regulatory bodies involves reporting them to the local national pharmacovigilance system. Reporting of adverse reactions may also be done directly to the product manufacturer or the marketing authorization holder, as this assists in ongoing safety monitoring.


How should Lantigen B be stored and disposed of?

How to Store and Dispose of Lantigen B?

The storage and disposal of Lantigen B must strictly follow official regulatory requirements to ensure the stability of the Polybacterial Lysate oral suspension.

Mandatory Storage Conditions

The product must be stored at a temperature below 25°C (77°F). It is explicitly required to protect the medicine from freezing and excessive heat, as these conditions can compromise the medicine's stability. For safety, the medicine must be kept out of the sight and reach of children and stored in its original container to maintain its stated shelf-life.

Official Disposal Rules

Unused or expired Lantigen B must be disposed of according to local regulations. This means the product should not be thrown away via wastewater or household waste. Instead, return the medication to a pharmacist or designated collection point.

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

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