Pulmonar Om

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Pulmonar Om

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Method of action: Immunostimulants, Vaccine, Vacciness

Treatment option:

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 Pulmonar Om

Property Description
Active ingredient Polybacterial Lisade (Polybacterial Lysate)
Form Tablets (often sublingual) or Capsules
Pharmacological class Immunobiological preparation, Immunomodulator
Common purpose Prophylaxis of recurrent respiratory tract infections
Origin Biologically derived (inactivated bacterial fragments)

What Type of Medicine is Pulmonar Om?

Pulmonar Om is fundamentally an immunobiological preparation classified as an immunomodulator, which is designed to engage and support the body’s natural defense systems. This medicinal entity is intended to regulate the immune response and operates with an anticipatory purpose, distinguishing it from antibiotics used for active infection treatment. The preparation, which is biologically derived, is clinically recognized for its role in stimulating host defenses against respiratory pathogens.

This class of medicines consists of bacterial cells that are broken down and used to stimulate the immune system to recognize and fight infections. This general classification establishes its function in preemptive health support for patient groups, including children and adults, who experience frequent respiratory illnesses.

Composition and Origin: The Polybacterial Lisade

The single active ingredient in Pulmonar Om is Polybacterial Lisade, which is a complex compound consisting of fragments from multiple inactivated species of bacteria common to the respiratory tract. This substance is defined as a Polyvalent Bacterial Lysate because it incorporates the antigens from several distinct bacterial strains, obtained through mechanical or chemical cell disruption.

Bacterial lysate-based preparations comprise antigen-rich cell fragments that stimulate the immune system to recognize and combat infections. The Polybacterial Lisade is typically presented in a lyophilized state within a solid dosage form, such as tablets or capsules, intended for mucosal administration, providing a non-invasive route for immune system exposure.

What is the General Purpose of Pulmonar Om?

The general purpose of Pulmonar Om is to strengthen and prime the respiratory tract's immune system against future bacterial exposure. It achieves this by stimulating mucosal immunity, which leads to the enhanced production of protective antibodies.

Polyvalent bacterial lysates are utilized in both children and adults for the prevention of recurrent respiratory tract infections (RRTIs). The preparation’s defined function is centered on immune function support for the prophylaxis of future recurrent illnesses, rather than treating acute conditions or symptoms.

Regulatory References

  1. Bacterial lysates-containing medicinal products referral

What side effects are possible with Pulmonar Om?

Possible side effects and safety information

The safety profile for Pulmonar Om (Polybacterial Lisade) is structured based on official regulatory findings, classifying potential adverse events according to frequency and the body systems affected. This information reflects data from clinical trials and post-marketing surveillance, as documented by government health authorities.


Official Adverse Reaction Groupings

The officially documented adverse effects are categorized into System-Organ Classes (SOC) and frequency bands:

  • Common / Uncommon Adverse Effects: These include Gastrointestinal disorders (such as abdominal pain, nausea, or diarrhea) and effects on the Nervous system disorders (most frequently headache). General disorders, such as a temporary rise in body temperature (fever), are also documented.
  • Serious Adverse Reactions: Reactions affecting the Immune system disorders, specifically hypersensitivity and allergic reactions, are documented. These clinically significant events are formally classified as Rare in regulatory labeling.

Population and Contextual Safety Notes

The safety profile has been assessed for use in both adults and children. The applicable use in children typically begins from a specified minimum age, such as three or four years, as defined in specific national regulatory labels.

An important safety constraint documented in official labeling is that this preparation is restricted to use only for the prevention (prophylaxis) of recurrent respiratory tract infections. Regulatory text explicitly states that it is not authorized for the treatment of existing, acute respiratory infections or the prevention of pneumonia. This restriction establishes clear boundaries for the medicine’s authorized application.

Overdose and Emergency Response

The official regulatory profile for Pulmonar Om (Polybacterial Lisade) indicates a substantial lack of documented acute toxicity, meaning a defined toxic overdose syndrome is not classified or recognized in government regulatory documents. The information provided below reflects the status reported in official prescribing information, such as the Summary of Product Characteristics (SmPC) and FDA labeling.

Overdose Status Official Regulatory Statement
Documented Manifestations No specific manifestations are documented. Official sources confirm that "No cases of overdose have been reported" or observed in clinical studies and post-marketing surveillance for this immunobiological preparation.
Life-Threatening Outcomes No specific severe or life-threatening outcomes are officially listed as a direct result of overdose, aligning with the product’s lack of acute toxicity.
Antidote Availability No specific antidote is known or required, as a specific toxic mechanism is not implicated.

Should the administered quantity exceed the recommended dosage, the official regulatory guidance requires that any resulting effects be managed through symptomatic and supportive treatment. No product-specific procedural steps, such as gastric lavage, are detailed in the official overdose section. Immediate emergency medical assistance is not mandated for the overdose itself, but it is necessary for any serious or life-threatening adverse reaction (such as a severe hypersensitivity reaction) that may occur, consistent with general pharmaceutical safety protocols. The official labels do not contain specific population-based overdose considerations for children or adults with organ impairment.

Therapeutic Uses of Pulmonar Om

What Pulmonar Om Treats: Main Uses and Benefits

The primary role of Pulmonar Om is as a prophylactic measure, supporting the body against the pattern of recurrent respiratory tract infections (RRTIs). This preparation is indicated for use in situations involving recurrent or episodic manifestations of respiratory tract illnesses.

The preparation is commonly used to help manage symptom clusters related to cough, fever, and heightened sputum production that frequently return. Its application is relevant across patient groups, including children and adults with a history of recurrent issues, and may also be used as supportive therapy for conditions like chronic bronchitis to ease the frequency of infectious exacerbations. This preemptive support contributes to easing the overall symptom load and clinical need that arises from frequent sickness.

Lowering the frequency and duration of illnesses may assist with minimizing disruptions, helping to reduce illness-related missed days of work or school. The preparation ultimately supports general well-being during symptomatic phases.


Quick Fact: Relief for Recurrent Respiratory Infections

Eligibility and Restrictions for Use

Eligibility for Pulmonar Om: Official Regulatory Information

Pulmonar Om's eligibility profile is defined by regulatory bodies based on its authorization as an immunobiological agent for prophylaxis.

Populations Authorized for Use

The medicine is authorized for use in adults and children (typically starting at 1 year of age) for the prophylaxis (prevention) of recurrent respiratory tract infections (RRTIs). The regulatory label strictly limits use to prevention; it must not be used for the treatment of an existing acute infection, such as pneumonia.

Populations Who Must Not Use (Contraindicated)

Pulmonar Om is formally contraindicated in patients with a known hypersensitivity to the active substance (Polybacterial Lisade) or any excipients. Furthermore, due to its action as an immunomodulator, it is contraindicated in patients with confirmed or suspected autoimmune diseases.

Populations Where Use is Not Recommended

Regulatory authorities generally state that the medicine is Not Recommended for infants under 1 year of age, as established safety data is insufficient in this specific age group. Use is also typically Not Recommended during pregnancy and lactation (breastfeeding) unless deemed strictly necessary. In case of an acute, severe febrile illness, initiation of the medicine should be postponed.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The interaction profile of Pulmonar Om (Polybacterial Lisade) is structured around its classification as an immunobiological preparation, which results in specific regulatory cautions rather than typical pharmacokinetic interactions.

Documented Interaction Patterns

Official regulatory information asserts that there are no known pharmacokinetic interactions with commonly co-administered medicinal products. This means the preparation is not reported to affect the metabolic enzymes (CYP450) or drug transport proteins (e.g., P-gp) responsible for altering the blood levels of other drugs.

Interaction Type Official Regulatory Statement
Pharmacokinetic No documented effects on systemic metabolic enzymes or transporters.
Food/Alcohol/Herbal No clinically relevant interactions are explicitly documented in regulatory labels.

Immunological Cautions and Restrictions

Co-administration with other immunobiological products, such as vaccines, requires official caution due to the potential for immunological interference with the intended immune response. The product's mechanism as an immunomodulator is the basis for this pharmacodynamic consideration.

Furthermore, regulatory authorities restrict the use of this product to the prophylaxis of recurrent respiratory tract infections. This restriction prohibits its use in combination with or for the purpose of the treatment of existing, acute respiratory infections.

Mechanism of Action

How Pulmonar Om Works

Pulmonar Om is a human monoclonal antibody (IgG2) designed to specifically target the Receptor Activator of NF-kappaB Ligand (RANKL), a key protein produced by osteoblasts and T cells. By binding to and neutralizing soluble and membrane-bound RANKL, Pulmonar Om prevents its subsequent interaction with the RANK receptor expressed on the surface of pre-osteoclasts and mature osteoclasts.

This antagonistic action effectively inhibits the signaling cascade necessary for osteoclast formation, function, and survival. The consequence of this targeted molecular interaction is a systemic decrease in osteoclast activity across skeletal surfaces, leading to a modulation of bone metabolism characterized by a reduction in the rate of bone resorption.

Dosage and Administration Information

How to Use Pulmonar Om: Official Administration Guidelines

Pulmonar Om is administered according to a precise, label-based cyclic schedule designed for prophylactic use against recurrent respiratory tract infections. The standard administration route for the tablet form is oral, specifically via the sublingual method.


Official Dosing and Schedule

Feature Instruction Age Group
Dose 7 mg of Polybacterial Lisade taken once daily. Adults and Children 6 years
Frequency 10 consecutive days per month. All applicable groups
Course Duration A full treatment consists of three consecutive cycles (3 months total). All applicable groups

Administration Requirements

Administration of Pulmonar Om should occur on an empty stomach, such as before breakfast, to maximize mucosal exposure. The procedural instruction is to place the tablet under the tongue and allow it to fully dissolve. The tablet must not be chewed or swallowed whole, as this bypasses the intended sublingual route.

Procedural Summary

This structure establishes a defined intermittent cyclic regimen. The dose is taken daily for 10 days, followed by a 20-day break, with this pattern repeated for a total of three months. If a daily dose is missed, the regimen continues with the next scheduled dose, without taking a double dose to compensate.

Recent Clinical Evidence

Evidence for use in Reducing Bronchial Inflammation

Research explored Pulmonar Om in studies examining conditions linked to inflammatory or irritative states within the airways. Studies were conducted during periods of increased symptom activity, primarily focusing on outcomes related to physical discomfort and outcomes linked to inflammatory states. These trials were relevant in trials assessing short-term or episodic symptom patterns in patients with conditions characterized by fluctuating or episodic manifestations.

Studies examined how symptoms changed in the observed populations over defined time intervals. Research describes patterns observed where the use of Pulmonar Om was monitored alongside changes measured during the study period. For instance, some data show patterns related to patient-reported outcomes describing perceived discomfort. However, certainty remains low, and findings were mixed across the different studies.


Evidence for use in Improving Lung Function

Pulmonar Om was evaluated in studies monitoring outcomes reflecting daily functioning or activity level. These studies monitored physiological strain or stress using standard lung function measurements, which help describe how much air a person can move through their lungs. This research was relevant in trials assessing short-term changes in conditions marked by functional limitations.

Studies monitored responses over defined time intervals, and research describes that during these studies, data show patterns related to measured lung function values. While studies report how symptoms evolved in the observed populations during the study period, comparative evidence is lacking, and evidence quality varies across studies.


What is Still Uncertain about Pulmonar Om

A number of key research questions about Pulmonar Om are still being explored. While various studies have been conducted, there are important evidence gaps and limitations that affect the overall certainty of the findings.

For example, comparative evidence is lacking. Furthermore, the findings were mixed across various studies, and the data are still emerging. The evidence highlights what is known—and what is still uncertain. Research provides context, but the overall certainty remains low until more comprehensive, long-term, and large-scale studies can fill these gaps.

Key Studies & References

  1. A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease. (AEOLUS)

Frequently Asked Questions (FAQ)

Common questions about Pulmonar Om (FAQ)


Q: Can individuals with kidney problems use Pulmonar Om?

A: According to official product information, there is generally no specific requirement for dose adjustment or special restrictions for individuals who have kidney impairment. This indicates that the body's process for handling the drug (systemic clearance) is not primarily reliant on kidney function.

Q: Can people with liver conditions use Pulmonar Om?

A: Official regulatory documents typically do not list specific warnings or contraindications related to individuals with liver conditions (hepatic impairment). As an immunomodulator, Pulmonar Om is not metabolized by the liver in a way that commonly requires a change in the amount used or special caution.

Q: Is there information about using Pulmonar Om during pregnancy?

A: Official regulatory bodies generally advise that using Pulmonar Om during pregnancy and lactation (breastfeeding) is not recommended unless a healthcare professional deems it strictly necessary. This caution is primarily due to the limited availability of complete safety data on the product's effects on the developing baby or infant.

Q: Are there any known restrictions on driving or operating machinery while using Pulmonar Om?

A: Regulatory documents do not typically specify any formal restrictions on driving or operating machinery while using this product. However, if any official side effects affecting the nervous system, such as a headache or restlessness, are experienced, the decision to drive or operate machinery should be made cautiously based on how an individual perceives and experiences any potential side effects.

Q: What happens if I miss a regular dose of Pulmonar Om?

A: Regulatory guidance instructs that if an individual misses a dose during the 10-day cycle, they should continue the regimen by taking the next scheduled dose as planned. There is a specific instruction not to take a double dose to try and make up for the missed one.

Q: What is the longest period someone can generally use Pulmonar Om?

A: Official product information defines the standard course of treatment as a total of three months, which consists of three separate 10-day cycles. Any decision to restart the regimen or use the product for a longer-term period is not detailed in the general patient labeling and is based on a healthcare professional’s evaluation.

Q: Is it true that Pulmonar Om can cause temporary changes in taste?

A: Yes, regulatory lists of possible adverse reactions include dysgeusia, which is the official term for an alteration in the sense of taste. This is generally reported as a less common side effect.

Q: Can Pulmonar Om be used by people with a history of heart issues?

A: Heart issues are generally not listed as a contraindication (a formal reason to avoid the drug) in the regulatory labels for this type of immunomodulator. The official restrictions primarily focus on conditions like autoimmune diseases and known hypersensitivity to the ingredients.

Q: Is Pulmonar Om suitable for older adults?

A: The medicine is authorized for use in adults, and the official label generally does not require a specific dose change or special precautions for the elderly population (geriatric use). The official label indicates it is authorized for this age group.

Q: Do regulatory bodies classify Pulmonar Om as a high-risk medication?

A: Official regulatory classification identifies certain events, like severe hypersensitivity and allergic reactions, as rare but serious adverse events. These events necessitate specific warnings, but the drug is not generally categorized as 'high-risk' in its broad patient labeling.

Q: Where can I find the official prescribing information for Pulmonar Om?

A: Official prescribing information is published and maintained by national regulatory authorities. You can find this information in databases like the FDA DailyMed in the United States, or in the Summary of Product Characteristics (SmPC) published on the European Medicines Agency (EMA) website.

Q: Does Pulmonar Om have a known potential for dependence?

A: Official regulatory documents clearly state that this product has no known potential for dependence or abuse. It is not classified as a controlled substance by regulatory bodies.

Q: Is it normal to feel a bit restless after starting Pulmonar Om?

A: While restlessness is not often listed among the most common adverse effects, the official safety data does classify certain Nervous system disorders as common or uncommon. If an individual experiences restlessness that is persistent or bothersome, they should refer to their product’s official safety information.

Q: Are there any known interactions between Pulmonar Om and herbal supplements?

A: Official regulatory labels state there are no known clinically relevant interactions documented with herbal products, food, or alcohol. Official guidance indicates that all concomitant medicines and supplements should be disclosed to a healthcare provider.

Q: Does Pulmonar Om need to be taken consistently every day for it to work?

A: The treatment is based on a specific sequence where it is taken for 10 consecutive days per month. Following the specific, consecutive daily schedule within the 10-day cycle is considered important for adhering to the regimen used in clinical studies.

Q: How does the official research describe the long-term outcomes of using Pulmonar Om?

A: Regulatory documents summarize clinical studies focused on the prevention of recurrent respiratory tract infections. The official evaluation often notes that comprehensive long-term studies and comparative evidence against all other options may still be limited, which affects the overall certainty of findings beyond the standard treatment duration.

Q: Why is it described that Pulmonar Om affects a certain receptor?

A: Pulmonar Om is officially classified as an immunobiological preparation (or immunomodulator). This means it works by supporting the body's defense system. The mechanism involves interacting with and activating immune cells to enhance the production of protective antibodies in the respiratory tract.

Q: Is Pulmonar Om the same type of drug as a steroid?

A: No, it is not. Regulatory documents classify Pulmonar Om as an immunobiological preparation and an immunomodulator. It is derived from inactivated bacterial fragments to support the immune system and is not classified as a corticosteroid (steroid).

Q: Are there different versions or strengths of Pulmonar Om?

A: The product is generally available in a single, standard strength, typically 7 mg of the active ingredient, Polybacterial Lisade. Regulatory labels specify the exact dosage form, such as a sublingual tablet or capsule.

Q: Have there been any major updates to the safety information for Pulmonar Om recently?

A: Regulatory agencies, such as the FDA and EMA, continually monitor the safety of all marketed products. They maintain records of all product label revisions and safety updates, and the current official status of the prescribing information can always be verified on their respective official websites.

Q: What is the purpose of the 'Risk Evaluation and Mitigation Strategy' (REMS) if one exists for Pulmonar Om?

A: A REMS is a specific strategy required by the FDA to manage a known or potential serious risk associated with a medicine. If Pulmonar Om requires a REMS, its purpose is to ensure that the public health benefits of the product continue to outweigh the specific serious risk being managed.

Q: Can Pulmonar Om affect the results of certain lab tests?

A: Regulatory information does not commonly list interference with standard lab tests. However, because the drug is an immunomodulator, there is an official caution regarding its co-administration with other immunobiological products, such as vaccines, due to the potential for affecting the immune response.

Q: What if I'm using an over-the-counter supplement with Pulmonar Om?

A: Official regulatory documents indicate that there are no known pharmacokinetic interactions with commonly co-administered products, which includes most over-the-counter medicines or general supplements. The official documentation cautions regarding co-administration with other immune-affecting substances.

Q: Does Pulmonar Om help prevent disease, or only manage symptoms?

A: The drug is specifically and officially indicated for the prophylaxis (prevention) of recurrent respiratory tract infections. It is explicitly not authorized for the treatment of existing, acute infections or for managing acute symptoms.

Q: What are the main topics covered in the 'Black Box Warning' section, if present?

A: The Boxed Warning section (sometimes called a Black Box Warning) is used by the FDA to call attention to a risk of a serious adverse event that may lead to death or severe injury. If present, the content of this section would detail the specific, highest-level safety information defined by the FDA.

Q: Is the effectiveness of Pulmonar Om influenced by body weight?

A: The official authorized dosing is a fixed dosage of 7 mg once daily for all adults and children above the specified minimum age. This fixed dose, detailed in regulatory labels, indicates that the treatment is not typically adjusted based on individual body weight for the authorized population.

Q: Can Pulmonar Om be used by people who have diabetes?

A: Official contraindications focus on autoimmune diseases and hypersensitivity to the ingredients. Diabetes is generally not listed as a contraindication for this type of product, but all existing medical conditions should be reviewed with a healthcare practitioner before use.

Q: Are there any restrictions on alcohol consumption while using Pulmonar Om?

A: Official regulatory labels state that no clinically relevant interactions are explicitly documented with alcohol. Therefore, there is no formal restriction on alcohol consumption noted in the general patient information.

Q: Does Pulmonar Om have any known interactions with vaccines?

A: Yes, official labels include a warning about Immunological Cautions. Co-administration with other immunobiological products, such as vaccines, requires caution due to the potential for the product to interfere with the expected immune response.

How should Pulmonar Om be stored and disposed of?

How to Store and Dispose of Pulmonar Om (Polybacterial Lisade)

Official regulatory documents define strict conditions for storing and disposing of this immunobiological preparation to preserve the integrity of the Polybacterial Lisade.

Storage Requirements

  • Temperature and Protection: Store the product at or below 25 C or 30 C (depending on the region). The medicine must be protected from heat, light, and moisture.
  • Packaging: Keep Pulmonar Om in the original container or package until use, and do not use it after the printed expiration date.
  • Child Safety: The product must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired medicine must not be disposed of via wastewater or household waste. Disposal must strictly comply with local regulatory requirements for pharmaceutical waste.

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

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