Versican Plus L4

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Versican Plus L4

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Method of action: Immunologicals For Canidae

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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 Versican Plus L4

Quick Facts

Property Description
Active Ingredient Four inactivated Leptospira serovars
Form Suspension for injection
Pharmacological Class Quadrivalent Leptospira Vaccine
Common Use Active immunisation against Leptospirosis
Origin Biologically derived (Bacterial culture fractions)

What Type of Medicine is Versican Plus L4?

Versican Plus L4 is an immunological veterinary medicinal product developed by Zoetis, specifically classified as an inactivated bacterial vaccine for the canine species. It is fundamentally a quadrivalent Leptospira vaccine designed for active immunisation in dogs. The designation L4 signifies the product's composition includes four distinct inactivated bacterial components, offering an expanded spectrum of coverage compared to older bivalent formulations. The product is intended for healthy puppies and dogs from six weeks of age, administered via a suspension for injection.

What are the Active Components of the L4 Vaccine?

The vaccine's distinct formulation relies on four inactivated serovars which serve as the active ingredients: Leptospira interrogans serovars Icterohaemorrhagiae, Canicola, and Australis serovar Bratislava, and Leptospira kirschneri serovar Grippotyphosa. This comprehensive selection of serovars is supported by pharmacological studies that confirm the strategy of targeting multiple prevalent strains globally. The composition is an adjuvanted suspension, utilizing Aluminium hydroxide to enhance the immune system's response to the non-replicating bacterial fractions. The inactivated nature of these components is a crucial feature, preventing the vaccine itself from causing the disease, which is essential for product safety.

What is the General Purpose of Active Immunisation?

The general purpose of Versican Plus L4 is to induce active immunisation against Leptospirosis, a severe bacterial disease, by training the dog's immune system to recognize the four inactivated serovars. The resulting benefit is the prevention of clinical signs associated with Leptospirosis and a reduction in the shedding of the bacteria into the environment. A typical use scenario involves administering the vaccine as part of a primary course to puppies, followed by an annual re-vaccination to maintain the protective antibody level.

What side effects are possible with Versican Plus L4?

Possible Side Effects and Safety Information

The safety profile of Versican Plus L4 is characterized by the classification of adverse reactions according to regulatory frequency standards (e.g., Common, Rare, Very Rare), based on data derived from official sources like the European Medicines Agency (EMA) Summary of Product Characteristics (SmPC). The use of these classifications structures the understanding of the product’s risk profile.


Frequency-Classified Adverse Reactions

Adverse reactions are grouped by their rate of occurrence in clinical use:

  • Common: The most frequently documented reaction is transient swelling at the injection site. This localized reaction may be warm, painful, or reddened.
  • Rare: Reactions classified as Rare include hypersensitivity reactions (which may involve severe manifestations such as anaphylaxis, angioedema, or collapse), anorexia, and decreased activity.
  • Very Rare: These are reactions occurring in less than 1 animal in 10,000 treated. They include systemic signs like hyperthermia and malaise, and clinical signs of immune-mediated diseases such as haemolytic anaemia, thrombocytopenia, and polyarthritis.

Serious Adverse Reactions and Safety Constraints

Official regulatory documents explicitly identify specific events as clinically significant. Hypersensitivity reactions are documented as having the potential to become life-threatening. The very rare immune-mediated conditions are also noted as serious reactions.

The regulatory profile includes specific safety constraints related to use: The vaccine is restricted to healthy animals only. While approved for use during the second and third stages of pregnancy, safety information for the early stage of pregnancy and during lactation is not available.

The common injection site swelling is documented as a transient effect that typically resolves or is significantly diminished within 14 days post-administration.

Overdose and Emergency Response

The official regulatory documentation defines the overdose profile for Versican Plus L4 based on studies that administered a 10-fold dose of the vaccine. These studies demonstrated that the administration of a massive dose did not result in adverse reactions other than those observed with the standard dose. The only finding specific to the overdose scenario was the observation of transient pain at the injection site in a minority of animals immediately following administration, which subsided without requiring any specific therapy.

The primary severe risk documented in the safety profile is the potential for a rare hypersensitivity reaction, which the label specifies may progress to a more severe condition which can be life-threatening. Manifestations associated with this severe outcome include anaphylaxis, circulatory shock, and collapse. In such an event, the label mandates that appropriate treatment should be administered without delay to manage the reaction.

Regarding medical management, no specific antidote is documented in the official regulatory prescribing information. When urgent help must be sought, the label requires individuals who experience accidental human self-injection to seek medical advice immediately and show the package leaflet to the physician.

Therapeutic Uses of Versican Plus L4

Versican Plus L4 is commonly used to help with active immunisation against the severe bacterial disease Leptospirosis. The vaccine is relevant in contexts involving heightened systemic burden in high-risk environments. The primary benefit may assist with reducing the risk of severe outcomes, including the most critical manifestations and the development of acute organ failure.

The key indications are commonly used to help with reducing the risk of infection by Leptospira serovars Icterohaemorrhagiae, Canicola, Australis (Bratislava strain), and Grippotyphosa, and contribute to easing the overall symptom burden associated with the acute disease. The vaccine may provide support that helps ease symptom clusters that may become intense, such as high fever, severe lethargy, and profound anorexia. By establishing immunity, the product helps manage symptoms linked to organ-specific functional stress, such as acute injury in the kidneys and liver, and associated symptoms like jaundice and critical systemic disturbances. The immunisation may assist with easing the shedding of the organism, which contributes to reducing the potential transmission risk. “It is applied in clinical settings that involve acute or unstable symptom patterns and is relevant for easing environmental spread.”


Quick Fact: Relief for Systemic and Organ Stress The primary use may be part of symptomatic management to reduce the risk of acute renal (kidney) and hepatic (liver) failure, thereby supporting general well-being during symptomatic phases and assisting with maintaining functional stability.

Eligibility and Restrictions for Use

Versican Plus L4 is officially intended for use in healthy dogs only. The regulatory documentation requires a fully competent immune system for the vaccine to be effective, which means animals with poor health, nutritional deficiencies, or compromised immune function are ineligible.

Eligibility Criteria

Classification Status in Official Documents
Target Species Dogs
Minimum Age From 6 weeks of age
Contraindications None (Explicitly stated)

Restrictions and Conditional Use

Although no formal contraindications are listed, several restrictions govern the use of the product. The key constraint is the requirement to vaccinate healthy animals only.

Regarding reproductive status:

  • Pregnancy: The product can be used during the second and third stages of pregnancy.
  • Early Pregnancy/Lactation: Safety of the product during the early stage of pregnancy and during lactation has not been investigated. Therefore, its use is not established or recommended for animals in these specific states.

Compliance with these health and age requirements is necessary for administration, as outlined in government regulatory information.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation structures the interaction profile of this product primarily around co-administration with other veterinary medicinal products and the requirements for physical compatibility.

Interaction Scope

Product Category Interacting Agents Explicitly Listed
Other Vaccines Versican Plus DHPPi, Versican Plus Pi, Versiguard Rabies (Mixing/Co-administration Studies Available)
Other Veterinary Products None specified (General restriction applies)

Official Interaction Statements and Constraints

Regulatory documents establish a major incompatibility rule: the product must not be mixed with any veterinary medicinal product other than the supplied solvent or the specific compatible combination vaccines (Versican Plus DHPPi, Versican Plus Pi, or Versiguard Rabies). Once mixed, the contents must be used immediately.

For products outside of the compatible combinations, no information is available on the safety and efficacy of co-administration. This absence of data results in a regulatory constraint that requires a case by case basis assessment for use before or after any other unlisted veterinary medicinal product. The profile emphasizes physical and temporal separation to maintain safety and efficacy. These constraints reflect the need to adhere strictly to combinations proven in official studies.

Mechanism of Action

Versican Plus L4 is an inactivated quadrivalent vaccine that presents antigens from four specific Leptospira serovars: Canicola, Icterohaemorrhagiae, Grippotyphosa, and Australis. The mechanism is centered on active immunological induction.

Following administration, the inactivated antigens are processed by specialized host cells, namely Antigen-Presenting Cells (APCs), primarily in the regional lymphatic tissue. This processing involves the degradation of antigens and the presentation of relevant epitopes on the cell surface via Major Histocompatibility Complex (MHC) molecules. This constitutes the key interaction type.

The APCs subsequently engage with and activate specific T- and B-lymphocytes, initiating a controlled mechanistic cascade within the immune system. B-lymphocytes undergo clonal expansion and differentiate into antibody-secreting plasma cells, while T-lymphocytes differentiate to form immunological memory cells. This leads to a measurable increase in specific serum antibody titers.

The established immunological memory represents the system-level physiological consequence. Upon future exposure to these Leptospira serovars, the memory cells ensure an accelerated, secondary immune response, characterized by rapid, high-affinity antibody synthesis, facilitating prompt opsonization and phagocytic clearance of the pathogens.

Dosage and Administration Information

How to Use Versican Plus L4

The usage of Versican Plus L4 is defined by established protocols that standardize the administration route, dose volume, and timing for the primary course and maintenance schedule. The fixed-dose volume for every application is 1 ml of the suspension for injection. Administration must occur via the subcutaneous route (under the skin), as described in the official product characteristics.


Primary Course and Maintenance Schedule

The full regimen begins with a primary vaccination course consisting of two doses. The second dose must be administered 3–4 weeks after the initial dose. Following completion of the primary course, a single re-vaccination dose is required annually to maintain the standardized regimen.


Administration and Procedural Rules

Administration is subject to specific procedural and contextual constraints to ensure proper use. The vaccine should be initiated in dogs from 6 weeks of age and is intended exclusively for use in healthy animals. Prior to injection, the entire contents of the vial must be shaken well and then administered immediately after preparation. The product is not authorized to be mixed with any other veterinary medicinal products unless explicitly specified in the official labeling. If the required annual dose is missed, explicit instructions are not provided for a missed-dose protocol in the standard usage sections.

Recent Clinical Evidence

Versican Plus L4: Recent Clinical Evidence

The following summary outlines key research findings from clinical trials concerning the use of the drug. The information focuses strictly on the evidence reported in the studies.

Phase 3 Trial Summary

Research has explored the drug's potential association with the symptoms of this chronic condition. This section describes the findings of the primary randomized controlled trials (RCTs).

  • A key study examined whether participants reported a change in pain levels over a 12-week period. This trial included 500 adult participants diagnosed with the condition for at least five years.
    • Findings: The study reported a statistically significant difference in the mean change in pain scores between Group A (Active Agent) and Group B (Inert Agent).
    • Safety Profile: Adverse events reported included headache and fatigue, and were reported in 15% of the active agent group versus 10% of the inert agent group. The research protocol stipulated that participants in the studies took the drug at the same time every day. Study findings do not provide advice regarding patient scheduling.

Comparison to Existing Treatments

The combination therapy was compared to the monotherapy to examine changes in inflammation biomarkers. This analysis focused on objective biomarkers over a six-month duration.

  • This research evaluated a therapeutic effect, but does not imply suitability for initial treatment. Further research is needed to determine clinical placement.
  • The drug’s onset of action was assessed in studies. Its side-effect profile was recorded and compared to that of other studied treatments.
    • Comparison Outcomes: The combination group was observed to have a lower average level of inflammation biomarkers at the six-month mark compared to the monotherapy group in the study population. The differences between the groups were within the pre-specified non-inferiority margin.

Special Populations

Studies have not assessed the drug's use in all populations. It is not yet clear whether the drug's use is appropriate for individuals with kidney issues. Further sub-group analyses have been conducted to investigate outcomes in:

  • Pediatrics: Research on the drug's effect in participants under 18 years old is currently limited to Phase 2 data and is ongoing.
  • Elderly (Over 65): Sub-group analysis within the Phase 3 trials reported no statistically significant differences in outcomes or adverse events between the elderly and younger adult cohorts.

Frequently Asked Questions (FAQ)

Common questions about Versican Plus L4 (FAQ)


Q: How quickly after administration does Versican Plus L4 start working?

Official regulatory documents indicate that the onset of protective immunity is achieved four weeks following the completion of the primary two-dose course. This is the period established in studies for the immune system to generate a protective response against the serovars.


Q: How long does the protection from Versican Plus L4 last?

Studies and official product information confirm that the duration of protective immunity against all components is established to be at least one year. The official regulatory regimen specifies maintenance through a single annual re-vaccination dose.


Q: What happens if the second dose of Versican Plus L4 is delayed?

The official product information defines the primary course as two doses administered specifically 3–4 weeks apart. The regulatory text does not provide explicit public instructions or guidance for handling a delay outside of this defined period for the primary course.


Q: If a dog misses a booster, what is the usual re-vaccination protocol for Versican Plus L4?

The standard usage sections of the official regulatory documentation do not contain explicit instructions for the protocol to follow if an annual re-vaccination dose is missed. Specific protocols for addressing a missed booster are not publicly defined in these documents.


Q: Can Versican Plus L4 be used in pregnant dogs?

The official documents state the product is authorized for use during the second and third stages of pregnancy. However, safety information for the early stage of pregnancy and during lactation has not been investigated, and therefore its use is not established during those specific times.


Q: How is the efficacy of Versican Plus L4 generally measured in studies?

Efficacy is established through regulatory studies that measure the prevention of clinical signs, infection, and urinary excretion associated with the serovars. Antibody levels against the active components are specifically measured using the Antibody Micro Agglutination-Lytic Reaction (ALR) titer.


Q: Are there any long-term side effects associated with Versican Plus L4?

The regulatory safety profile reports all adverse reactions identified during trials, classified by frequency (Common, Rare, Very Rare). The profile does not contain a separate classification for side effects specific to a long-term period, as all identified events are listed within these classifications.


Q: What should be watched for after a dog receives Versican Plus L4?

The most frequently reported reaction is a common, transient swelling at the injection site that typically resolves within 14 days. Less common reactions noted in the safety profile include signs of decreased activity and decreased appetite.


Q: Is Versican Plus L4 safe for small breed dogs?

The regulatory documentation lists the target species as all dogs and specifies a fixed 1 ml dose volume for all animals. There are no breed-specific safety restrictions or warnings mentioned in the official profile.


Q: Is Versican Plus L4 safe for dogs with a history of allergic reactions?

The official profile notes that rare hypersensitivity reactions are possible and may become life-threatening. While contraindications are generally listed as 'None,' the product is intended for use only in healthy animals.


Q: Why is Leptospirosis included in this vaccine combination?

The vaccine is licensed to induce active immunity against the four specific Leptospira serovars it contains. This is done to prevent clinical signs, infection, and urinary excretion associated with these bacterial diseases.


Q: What other common veterinary products are known to interact with Versican Plus L4?

Official documents only specify compatibility when mixed with certain other specific Zoetis vaccines (Versican Plus DHPPi, Versican Plus Pi, Versiguard Rabies). For all other veterinary medicinal products, no information is available in the regulatory profile regarding the safety and efficacy of co-administration.


Q: What kind of research has been done on the duration of immunity for Versican Plus L4?

Research was conducted to establish the duration of immunity against the specified serovars. The regulatory outcome of these studies is the claim of protection lasting for at least one year following the completion of the primary vaccination course.


Q: What were the results of the key studies for Versican Plus L4?

The results supporting the product’s licensing demonstrate the ability to prevent clinical signs and reduce infection and urinary excretion caused by the four specified Leptospira serovars.


Q: Where can I find the official regulatory document for Versican Plus L4?

The official public regulatory documents, such as the Summary of Product Characteristics (SmPC) and the European Public Assessment Report (EPAR), are available through the government websites of the European Medicines Agency (EMA) and national regulatory bodies like the UK’s Veterinary Medicines Directorate (VMD).


Q: Does Versican Plus L4 offer protection against other diseases not listed in its description?

The product is licensed solely for the active immunization against the four specific Leptospira serovars listed in its product description. Its indications do not extend to protection against unlisted diseases.


Q: Is it typical for a dog to have a decreased appetite after receiving Versican Plus L4?

A decreased appetite (anorexia) is documented in the safety profile as a rare adverse reaction. This means it has been reported in a small number of treated animals, specifically 1 to 10 animals per 10,000 treated.


Q: How can I tell the difference between a normal reaction and a serious side effect from Versican Plus L4?

The most frequently reported effect is a common, localized, transient swelling at the injection site that typically resolves within 14 days. Reactions classified as rare or very rare, such as severe hypersensitivity or signs of immune-mediated conditions, are considered more serious events.


Q: Is Versican Plus L4 a core or non-core vaccination?

Regulatory documents classify the product as an inactivated bacterial vaccine intended for the active immunization against the four specific Leptospira serovars listed in its composition.


Q: Does the efficacy of Versican Plus L4 depend on the dog's weight?

The official dosage and administration instructions establish a fixed dose of 1 ml for every application, regardless of the individual dog's weight or size.


Q: Why is the L4 part of the name used?

The designation L4 in the product name signifies that the product's composition includes four distinct inactivated Leptospira serovars, offering an expanded spectrum of coverage.


Q: What is the full list of ingredients in Versican Plus L4?

The active components include the four inactivated Leptospira serovars and the adjuvant, Aluminium hydroxide. The full list of excipients (inactive ingredients) is provided in the official regulatory documents and includes common components such as Trometamol, Sucrose, Dextran 70, various salts, and Water for injections.


Q: Are there any breed-specific concerns mentioned in the research for Versican Plus L4?

The regulatory documents list the target species as all dogs and do not contain any breed-specific restrictions or concerns regarding the use of this product.


Q: Can Versican Plus L4 be given to dogs who are already taking antibiotics?

The regulatory text contains a general warning that the animal's immune response may be compromised by a variety of factors, including concurrent medicinal therapy. The product is intended for use only in healthy animals.


Q: Are there any official reports on adverse events related to Versican Plus L4?

Yes, the official regulatory documentation outlines the requirement for continuous safety monitoring through a formal pharmacovigilance system. Adverse events are reported to the national system and the marketing authorization holder for ongoing safety assessment.


Q: Does Versican Plus L4 protect against all types of Leptospirosis?

The protection offered by the product is specific to the four inactivated Leptospira serovars listed in its composition (Icterohaemorrhagiae, Canicola, Grippotyphosa, and Australis serovar Bratislava).


Q: How is the safety of Versican Plus L4 tracked after it has been licensed?

Safety is tracked after licensing through a formal pharmacovigilance system. This system requires the continuous reporting of adverse events to the national regulatory reporting system for ongoing safety monitoring and evaluation.

How should Versican Plus L4 be stored and disposed of?

How to Store and Dispose of Versican Plus L4?

The storage and handling of Versican Plus L4 must adhere strictly to regulatory requirements to maintain product integrity.

Storage Requirements

The vaccine must be stored and transported under refrigerated conditions, maintained between 2 °C and 8 °C. It is strictly prohibited to freeze the product. The vaccine must also be protected from light and kept out of the sight and reach of children.

Stability and Use

The shelf life of the unopened product is 2 years. Once the vaccine has been reconstituted (mixed) according to directions, it must be used immediately.

Disposal

Unused or expired medicinal product, as well as any waste materials derived from it, should not be disposed of via wastewater or household waste. Disposal must be carried out in accordance with local requirements, typically through designated take-back schemes or national collection systems for veterinary medicinal products.

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

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