Versican Plus DHPPi/L4

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Versican Plus DHPPi/L4

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Method of action: Immunologicals For Canidae

Treatment option:

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Overview of Versican Plus DHPPi/L4

Quick Facts

Property Description
Active Ingredients Live Attenuated CDV, CAV-2, CPV-2b, CPiV-2; Inactivated Leptospira Serovars (4)
Form Lyophilisate and Suspension for Injection (Dual-Component)
Pharmacological Class Immunologicals for Canidae (Veterinary Vaccine)
Common Use Active Immunisation (Prophylaxis)
Origin Biological Product (Viral and Bacterial Culture Derivatives)

Defining Versican Plus DHPPi/L4: Multivalent Veterinary Vaccine

Versican Plus DHPPi/L4 is classified as a Veterinary Medicinal Product that operates as an Immunological for Canidae with the primary purpose of establishing active immunisation in dogs. This product is defined as a multivalent combination vaccine because it contains multiple distinct active ingredients targeting several pathogens simultaneously, a formulation recognized for promoting efficiency in preventative care protocols. The distinction of this vaccine is its comprehensive, nine-way protection in a single administration, which provides defense against four viral diseases and four Leptospira serovars.

Composition and Form: Dual-Component Lyophilisate and Suspension

The formulation is supplied as a dual-component system, requiring the mixing of a freeze-dried lyophilisate and an aqueous suspension for injection just prior to subcutaneous administration. The active ingredients include both live attenuated viral antigens, which are modified to safely stimulate the immune system, and inactivated bacterial antigens. The specific formulation includes both the core viral antigens (Distemper, Adenovirus, Parvovirus) and the extended bacterial protection against the four most common Leptospira strains affecting dogs: Icterohaemorrhagiae, Canicola, Grippotyphosa, and Bratislava. This specific combination of the DHPPi viral fraction and the L4 bacterial fraction represents its differentiating compositional feature.

General Purpose: Prophylaxis Against Canine Infectious Disease

The general therapeutic purpose of Versican Plus DHPPi/L4 is to provide comprehensive prophylaxis—a preventative defense—against a core group of severe infectious diseases in dogs, a strategy particularly critical for puppies from six weeks of age and susceptible adult animals. By safely presenting the viral and bacterial antigens to the body, the product facilitates the development of a protective immune response, which is designed to resist clinical disease. This use scenario underscores the product’s function: preventing widespread conditions such as canine distemper and infectious leptospirosis before exposure occurs, thereby contributing significantly to canine public health.

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What side effects are possible with Versican Plus DHPPi/L4?

Possible Side Effects and Safety Information

The safety characteristics of Versican Plus DHPPi/L4 are structured according to regulatory classifications, detailing both common, expected reactions and rare, serious adverse events. The official safety data establishes a profile primarily defined by transient, localized effects following administration.

Frequency-Classified Adverse Reactions

The adverse reactions documented in regulatory sources are grouped by frequency, based on reports from clinical use:

Classification Examples of Documented Reactions
Common (1 to 10 in 100) Transient swelling, pain, warmth, or redness at the injection site.
Rare (1 to 10 in 10,000) Hypersensitivity reactions (e.g., anaphylaxis, angioedema), anorexia, and decreased activity.
Very Rare (<1 in 10,000) Immune-mediated disorders, such as immune-mediated haemolytic anaemia and immune-mediated polyarthritis.

These effects are classified under system-organ classes including General Disorders and Administration Site Conditions and Immune System Disorders.

Serious Adverse Reactions and Safety Constraints

Official labeling documents the potential for serious adverse reactions, including hypersensitivity reactions (e.g., anaphylaxis) that may require immediate symptomatic treatment. Furthermore, very rare reports include immune-mediated disorders which are clinically significant.

Safety is also defined by population-specific constraints. The regulatory documents state that the safety of the product has not been established during pregnancy and lactation, and use is therefore not recommended during these periods. The product is also restricted to administration in healthy animals only, as a fully competent immune system is necessary for an appropriate response.

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Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation structures the overdose profile based on observations following administration of a massive dose, focusing on explicit safety data. Studies evaluating the safety of Versican Plus DHPPi/L4 found no new systemic adverse reactions were documented in the target species (dogs) after receiving a 10-fold overdose, when compared to the established effects of the standard dose.

Documented Overdose Manifestations

The single clinical finding specifically noted after administration of the 10-fold overdose was transient pain at the injection site in a minority of animals. This localized, self-limiting reaction subsided without requiring any therapeutic intervention, according to regulatory records. The official documentation does not list a specific antidote for this product.

Mandated Emergency Actions

The necessity for urgent consultation or intervention is driven by two specific scenarios documented in the regulatory information:

  • Accidental Human Exposure: In the event of accidental self-injection, the person administering the product must seek medical advice immediately and present the package leaflet or label to the attending physician.
  • Severe Adverse Reaction: Should a rare, potentially life-threatening hypersensitivity reaction occur—which may include signs such as anaphylaxis, circulatory shock, or collapse—regulations mandate that appropriate treatment should be administered without delay.

This official overdose profile is constrained to the observed reaction patterns and explicit regulatory mandates for seeking help.

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Therapeutic Uses of Versican Plus DHPPi/L4

What Versican Plus DHPPi/L4 Treats: Main Uses and Benefits

Versican Plus DHPPi/L4's therapeutic area is the proactive defense against infection of dogs from six weeks of age. This product is commonly used to help protect against a wide array of severe, infectious conditions.

This product's primary use is proactive defense against infection against core viral conditions, including Canine Distemper Virus, Canine Parvovirus, and Infectious Canine Hepatitis (CAV-1). The proactive defense helps provide support in avoiding the most severe outcomes of these infections, which are conditions marked by heightened physiological stress, such as systemic imbalance and profound organ strain.

It is also commonly used to provide supportive defense against four key Leptospira serovars that may cause kidney and liver disease. This provides supportive benefit by contributing to a reduction in the risk of acute organ failure signs and may assist in limiting the spread of the bacteria, supporting a decrease in zoonotic risk.


“The primary benefit provided is support that helps ease the overall symptom burden by preventing the onset of acute, life-threatening manifestations.”

Quick Fact: Relief for Infectious Disease Consequences

This proactive approach contributes to improved comfort during periods of potential exposure and assists with maintaining functional stability by helping to limit the severe consequences of acute viral and bacterial diseases.

Regulatory References

  1. European Medicines Agency's (EMA) Summary of Product Characteristics
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Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Versican Plus DHPPi/L4

Eligibility scope

Classification Eligibility Status
Populations for whom use is allowed Dogs from 6 weeks of age for active immunisation, and pregnant dogs during the second and third stages of gestation.
Populations for whom use is not recommended Use is not recommended for animals that are not in good health, those with a compromised immune system, or those with suspected disease.
Populations for whom use is contraindicated The official regulatory Summary of Product Characteristics states "None" in the section for contraindications.

Age-related eligibility rules:

The minimum approved age for the initial vaccination course is 6 weeks for all components. Use is established for the general adult dog population.

Pregnancy and lactation eligibility status:

The safety of the product has not been investigated for use during the early stage of pregnancy or during lactation, resulting in a formal "not recommended" status for these two periods.

Connection to the overall eligibility profile:

The regulatory profile establishes the eligible population as healthy dogs from 6 weeks of age. While no absolute contraindications are listed, the label imposes conditional use restrictions concerning the animal’s current health status and specific reproductive stages where safety data has not been established. Use is otherwise permitted for the general target species population.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documentation for Versican Plus DHPPi/L4, a multivalent veterinary vaccine, defines its interaction profile primarily through constraints related to physical compatibility and co-administration with other immunological products.

Official Interaction Constraints

Interaction Type Documented Constraint
Pharmaceutical Mixing The product must not be mixed with any veterinary medicinal products other than those explicitly specified and authorized for combination, due to potential incompatibility.
Co-Administration Scope Safety and efficacy are documented only when used with the specific, compatible vaccines, such as Versiguard Rabies and Versican Plus L4.
Unstudied Combinations A decision to use this vaccine before or after any other unstudied veterinary medicinal product must be made on a case-by-case basis by the veterinarian.

Immunological Considerations

The official labeling notes a specific interaction related to passive immunity in young dogs:

  • Maternally Derived Antibodies (MDA): The immunological response to the viral components (Distemper, Adenovirus, and Parvovirus) may be delayed in puppies due to the presence of high levels of maternally derived antibodies. This requires a professional adjustment to the vaccination schedule.

No official regulatory information is available concerning metabolic (e.g., CYP-mediated) or transporter-based interactions, or interactions with food, alcohol, or herbal products.

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Mechanism of Action

The Versican Plus DHPPi/L4 vaccine provides a wide array of viral and bacterial antigens to the host immune system. Upon parenteral administration, these antigens are captured and processed by specialized antigen-presenting cells (APCs), which act as the primary biological target for initiating the mechanism. The APCs then migrate to lymphoid tissues, facilitating the interaction type of antigen presentation to T-lymphocytes. This molecular event activates the adaptive immune pathway, specifically involving the differentiation of B-lymphocytes into plasma cells, which is a key intracellular process. This downstream cascade results in the synthesis and release of pathogen-specific neutralizing antibodies (humoral immunity). Concurrently, T-lymphocytes differentiate into memory cells, establishing a state of immunological memory as the resultant system-level physiological consequence.

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Dosage and Administration Information

Versican Plus DHPPi/L4 is intended for active immunisation of dogs from six weeks of age against several key canine diseases.


Administration and Preparation

This product is administered as a single 1 ml dose via subcutaneous injection (under the skin). The veterinary medicinal product is presented as a lyophilisate (freeze-dried component) and a suspension (liquid solvent) that must be aseptically reconstituted immediately prior to use. Once mixed, the reconstituted vaccine should appear pinkish or yellowish with slight opalescence. It is essential to shake the mixture well and administer the entire contents immediately.


Dosage Schedule

Vaccination Type Age/Interval Dose Components Covered
Primary Two doses, 3–4 weeks apart, starting from 6 weeks of age 1 ml DHPPi/L4
Revaccination Every 3 years 1 ml CDV, CAV, CPV components
Annual Annually Single Dose (e.g., Versican Plus Pi/L4) Parainfluenza (Pi) and Leptospira (L4) components

The standard primary course requires two doses. For the Distemper (CDV), Adenovirus (CAV), and Parvovirus (CPV) components, a single dose is generally administered every three years. However, due to shorter durations of immunity for the Parainfluenza and Leptospira components, annual revaccination with a suitable compatible vaccine containing these components, such as Versican Plus Pi/L4, is required.

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Recent Clinical Evidence

Research evidence / Overview of studies for Versican Plus DHPPi/L4

Evidence for Active Immunisation Against Core Canine Viral Diseases

The primary research base for the viral components of this product (Canine Distemper Virus, Adenovirus, Parvovirus, and Parainfluenza) relies mainly on Controlled Virulent Challenge Trials. These are laboratory studies where healthy puppies are vaccinated and then monitored after intentional exposure to the live, targeted virus. This type of research setting examined outcomes related to physiological strain, such as mortality or severe clinical signs.

Research has explored patterns of measured antibody levels for the core components (Distemper, Adenovirus, Parvovirus) over extended periods. Studies examined patterns observed where antibody levels were tracked for at least three years following the initial vaccination course. For one of the viral components, the duration of antibody presence was primarily established by measuring the presence of antibodies (serology) over the three-year interval, rather than relying on a direct challenge at the three-year mark.

Evidence for Active Immunisation Against Leptospira Serovars

The research base for the L4 components (protecting against four Leptospira serovars) also relies primarily on Controlled Virulent Challenge Trials. These laboratory research scenarios were evaluated in healthy puppies to assess patterns of immune response against these bacterial pathogens. The outcomes evaluated included clinical signs (systemic illness), infection patterns, and urinary excretion (shedding of bacteria).

Controlled studies reported patterns observed related to clinical signs and measurements related to urinary excretion following exposure to the targeted Leptospira serovars. Immunogenicity testing reported how symptoms evolved in the observed populations and tracked the presence of measured antibody levels for all four bacterial components.

Duration of Immunity and Long-Term Follow-up

Research has explored the durability of the immune response across the different components of the vaccine. The evidence base tracks two distinct periods of sustained antibody presence. The core viral components (Distemper, Adenovirus, Parvovirus) was studied for patterns of antibody presence lasting at least three years.

However, the period of study for the Parainfluenza component and all four Leptospira bacterial components was tracked for at least one year. There is limited information for long-term outcomes beyond these established intervals.

Evidence in Specific Puppy Populations

Research specifically was studied for the use of this product in healthy puppies from six weeks of age. Sub-studies were applied in research contexts involving young puppies that still had Maternally Derived Antibodies (MDA), which are antibodies passed from the mother. Findings indicate that the immunological response may be delayed when high levels of maternally derived antibodies are present.

What is Still Uncertain About Versican Plus DHPPi/L4 Evidence

The evidence base for regulatory approval includes research that highlights what is known and what is still uncertain. Follow-up durations were limited for the Parainfluenza and Leptospira components. Long-term effects are not fully established beyond the one-year timeframe. Furthermore, the primary efficacy evidence stems from controlled laboratory challenge models, which, while highly standardized, do not fully replicate complex, long-term environmental factors.

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Frequently Asked Questions (FAQ)

Common questions about Versican Plus DHPPi/L4 (FAQ)


Q: What is the difference between Versican Plus DHPPi/L4 and other 5-in-1 type treatments?

Official documents describe Versican Plus DHPPi/L4 as a multivalent combination vaccine. This means its formulation contains multiple distinct components that are designed to stimulate an immune response against nine different targets simultaneously, which includes four viral diseases and four bacterial serovars.


Q: What does the 'L4' part of the name Versican Plus DHPPi/L4 mean?

The 'L4' in the name is a shorthand for the components that protect against leptospirosis, a bacterial disease. Specifically, it provides antigens for four distinct Leptospira serovars: Icterohaemorrhagiae, Canicola, Grippotyphosa, and Bratislava.


Q: Why do some people worry about allergic reactions to Versican Plus DHPPi/L4?

Concerns about allergic reactions stem from official safety data. Regulatory documents state that hypersensitivity reactions, such as anaphylaxis, are documented as rare side effects that may occur following administration. These events are generally uncommon but are the basis for patient and professional caution.


Q: What specific conditions make a dog ineligible for Versican Plus DHPPi/L4?

While the official regulatory label states 'none' under contraindications, use is not recommended for all animals. Official warnings advise against its use in animals that are not in good health or those with a compromised immune system, as a fully competent immune system is necessary to develop the intended protective response.


Q: Can older dogs still receive Versican Plus DHPPi/L4?

Yes, the product information indicates that it is for dogs starting from six weeks of age and for the general adult dog population. Regulatory documentation does not specify an upper age limit, meaning its use is generally permitted for the adult population, including older dogs.


Q: What is the intended purpose of the Parvovirus component in Versican Plus DHPPi/L4?

The intended purpose of the Parvovirus component (CPV-2b) is to establish active immunity against canine parvovirus disease. This is a core part of the overall strategy of prophylaxis (preventative defense) provided by this combination product.


Q: Why is it important to know if a dog has had a prior reaction before using it again?

Because of the possibility of rare, but serious, adverse events such as hypersensitivity reactions, official documentation mentions the potential need for careful assessment due to the risk of rare, serious events. This requires the administering professional to be aware of the patient's prior reaction history before product use.


Q: What are the general expectations for the dog's behavior immediately after administration?

Most commonly reported effects are localized reactions at the injection site, such as transient swelling, pain, or warmth. Regulatory documents also note that rare adverse reactions include a temporary decreased activity (appearing tired) and anorexia (loss of appetite).


Q: Is the protection guaranteed for the full duration specified in studies?

Official documents describe the duration of immunity based on research evidence that tracks measured antibody levels in study populations. Like all medical products, official regulatory documents do not contain statements that guarantee complete or absolute protection from clinical disease.


Q: What are the common signs of an uncommon, severe reaction to look out for?

Rare, severe reactions may present as signs of a hypersensitivity reaction shortly after administration, such as facial swelling, severe itching, vomiting, or difficulty breathing. Official documents also note the very rare reports of immune-mediated disorders which may require medical attention.


Q: Does regulatory information clarify what type of protection the Leptospirosis part provides?

Studies supporting the L4 component focused on two main areas of protection. Research evidence primarily examined outcomes related to the prevention of clinical signs (systemic illness) and the prevention of urinary excretion (shedding of the bacteria).


Q: Why does Versican Plus DHPPi/L4 protect against so many diseases?

Official information defines the product as a multivalent combination vaccine. This structure allows it to target a wide spectrum of infectious diseases because its formulation contains multiple distinct antigens that stimulate the immune response against nine different pathogens simultaneously.


Q: Can Versican Plus DHPPi/L4 be used for all dog breeds?

According to the official product information, the product is indicated for the target species, Canidae (dogs). Regulatory documents do not specify any restrictions based on breed.


Q: Does this product protect against all types of Canine Influenza?

The 'Pi' component of the vaccine is intended to protect against Canine Parainfluenza Virus, which is a common respiratory pathogen. This is a different illness from Canine Influenza Virus, which is caused by a separate type of virus.


Q: What is the difference in components between the Plus DHPPi and the Plus DHPPi/L4 versions?

The primary difference is the Leptospira component. The DHPPi/L4 version contains the antigens for four specific Leptospira serovars (L4) in addition to the viral components, providing extended protection not present in the base DHPPi version.


Q: What does 'recombinant' mean in the context of this product's technology?

Regulatory documents state that one of the viral components, Canine Parvovirus (CPV-2b), is produced using recombinant technology. This means the antigen used to stimulate the immune system was created using controlled genetic engineering methods.


Q: What does the acronym 'DHPPi' stand for?

The 'DHPPi' acronym is a shorthand used to describe the viral components of the product. These components are intended to provide active immunisation against Distemper (D), Adenovirus (H), Parvovirus (P), and Parainfluenza (Pi).


Q: Can a dog experience mild fever after receiving Versican Plus DHPPi/L4?

While mild fever is not listed as a common expected reaction, official safety data notes that pyrexia (fever) has been associated with the very rare reports of immune-mediated disorders.


Q: Why do official materials emphasize the importance of using the full primary course?

Official documents emphasize the need for the full two-dose primary course in puppies. The second dose is necessary because it helps overcome a potential delay in immunological response caused by maternally derived antibodies (MDA) that puppies receive from their mother.


Q: What should be done if the product container appears damaged before administration?

The product must maintain its sterility and integrity up until the moment of use. If any damage is observed that might compromise the product's sterile condition, the product is generally required to be discarded according to local guidelines for medical waste disposal.


Q: What is the difference between immunity and protection as described in the official documents?

The official documentation uses the terms active immunisation and protection largely interchangeably. Both concepts describe the establishment of immunological memory within the body that is intended to resist or defend against clinical disease if exposure occurs.

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How should Versican Plus DHPPi/L4 be stored and disposed of?

Storage and Disposal Requirements

Official regulatory documentation dictates specific storage conditions to maintain the stability of Versican Plus DHPPi/L4. The product must be stored and transported refrigerated at a temperature between 2 C and 8 C at all times.

Constraint Requirement
Temperature Store refrigerated (2 C – 8 C). Do not freeze.
Stability Shelf life as packaged is 2 years. After reconstitution, use immediately (no labeled post-reconstitution shelf life).
Protection Keep out of the sight and reach of children. Protect from light.

Disposal must adhere to specific pharmaceutical waste rules. The unused product or waste materials derived from its use should not be disposed of via wastewater or household waste. Disposal must occur through authorized take-back schemes in accordance with local and national requirements.

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

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