Antimicrobial Stewardship in Canine Prostatitis: Diagnosis and Treatment
By Dr. Zubair Khalid, DVM, MS, PhD ·

Key Takeaways
- Prostatic fluid, semen, or prostatic tissue are the preferred diagnostic samples for bacterial prostatitis; urine is a fallback due to potential discordance with prostatic pathogens, especially in chronic cases.
- Culture and susceptibility testing is paramount for accurate diagnosis and targeted antimicrobial selection, as Escherichia coli is the predominant pathogen and resistance is common.
- Fluoroquinolones and trimethoprim-sulfonamide combinations are recommended first-line antimicrobial classes due to their lipid-soluble, weak base properties facilitating penetration into prostatic tissue.
- Treatment duration for acute prostatitis is typically 2-4 weeks, while chronic prostatitis requires 4-6 weeks or longer to ensure microbiologic cure and prevent relapse.
- Antimicrobial stewardship mandates de-escalation of therapy once susceptibility results are available and emphasizes repeat prostatic fluid or semen culture 1-2 weeks post-therapy to confirm eradication.
- Abscessation necessitates drainage in addition to antimicrobial therapy, and castration is a recommended adjunct in intact males to reduce prostatic hyperplasia and improve treatment outcomes.
This article provides a clinical framework for diagnosing and managing bacterial prostatitis in dogs, with emphasis on culture-based antimicrobial selection and stewardship principles. It serves the practicing veterinarian who must balance effective resolution of prostatic infection against the broader obligation to preserve antimicrobial efficacy. The procedural focus is on sample acquisition, interpretation of culture results, drug selection based on prostatic pharmacokinetics, and duration of therapy. The guidance draws on comparative human urology literature, canine-specific pharmacology, and current professional stewardship standards.
Bacterial prostatitis in dogs is a diagnostically challenging condition because clinical signs overlap with other lower urinary tract diseases and because the blood-prostate barrier restricts antimicrobial penetration. Treatment failures are frequently attributable to inappropriate drug selection, inadequate duration, or sampling errors that misidentify the causative organizm. A disciplined approach to diagnosis and therapy reduces the risk of relapse and limits unnecessary antimicrobial exposure.
At a Glance
| Parameter | Recommendation | Rationale |
|---|---|---|
| Diagnostic sample | Prostatic fluid, semen, or prostatic tissue, urine is a fallback | Urine alone may not reflect the prostatic pathogen |
| Culture method | Aerobic culture and susceptibility testing | Escherichia coli predominates, resistance is common |
| Imaging | Ultrasonography to characterize prostatic parenchyma | Differentiates abscess, cyst, and diffuse inflammation |
| First-line drug class | Fluoroquinolones or trimethoprim-sulfonamide | Lipid-soluble, weak bases that penetrate prostatic tissue |
| Duration | 4 to 6 weeks for chronic prostatitis | Relapse is common with shorter courses |
| Recheck | Repeat culture 1 to 2 weeks after therapy ends | Confirms microbiologic cure, also clinical resolution |
| Stewardship trigger | De-escalate once susceptibility results return | Reduces selection pressure for resistance |
Pathophysiology of Prostatic Infection
The canine prostate is a tubuloalveolar gland that secretes a slightly acidic fluid. The blood-prostate barrier, composed of capillary endothelium and prostatic epithelial tight junctions, restricts the passage of many antimicrobials. Lipid-soluble drugs with low protein binding and favorable pKa values diffuse readily into prostatic secretions, whereas hydrophilic agents achieve subtherapeutic concentrations. This pharmacokinetic principle, established in comparative urology, explains why certain drug classes fail despite in vitro susceptibility. The diffusion characteriztics of antimicrobials into the prostate have been studied extensively in canine models, and these data inform current clinical selection pharmacokinetics of antibiotic diffusion in chronic bacterial prostatitis.
Acute bacterial prostatitis is characterized by intense inflammation that disrupts the blood-prostate barrier, allowing broader drug penetration. Chronic prostatitis, by contrast, presents with less inflammation and a more intact barrier, making drug selection more critical. The distinction between acute and chronic disease is therefore also descriptive, it directly influences the likelihood of therapeutic success.
Etiologic Agents and Resistance Patterns
Escherichia coli is the most commonly isolated pathogen in canine bacterial prostatitis, consistent with human data where uropathogenic E. coli strains possess a repertoire of virulence-associated genes that enable prostatic colonization bacterial prostatitis bacterial virulence and clinical outcomes. Other Enterobacteriaceae, Enterococcus species, Staphylococcus species, and occasionally Pseudomonas or Proteus species are identified. The prevalence of multidrug-resistant organizms in companion animal practice is rising, and empiric therapy without culture risks both clinical failure and amplification of resistance.
The laboratory diagnosis of acute bacterial prostatitis is straightforward when appropriate samples are submitted. Chronic bacterial prostatitis presents greater difficulty because organizms may be present in low numbers, and the distinction between true infection and contamination of samples with urethral flora requires careful interpretation prostatitis laboratory diagnosis and clinical challenges. Clinicians should expect the microbiology laboratory to report quantitative growth and should correlate colony counts with the sample type.
Diagnostic Sampling Techniques
Prostatic Fluid Collection
Ejaculation is the preferred method for obtaining prostatic fluid in intact male dogs. The third fraction of the ejaculate originates from the prostate and should be collected separately for culture. Manual prostatic massage, performed after urethral lavage, is an alternative but carries a higher risk of urethral contamination. Prostatic wash samples should be interpreted with caution, growth of organizms that are also present in the pre-massage urethral sample may represent contamination instead of prostatic infection.
Urine Sampling
Cystocentesis urine culture is commonly performed because it is technically simple and non-invasive. However, urine culture results do not always correlate with prostatic infection, particularly in chronic cases where the prostate may harbor organizms without significant bacteriuria. A survey of Italian veterinary practitioners found that urine was the most commonly used diagnostic matrix for acute prostatitis, used in 54.9% of cases, while prostatic samples were used in only 20.9% diagnostic and therapeutic approaches to acute prostatitis in dogs. This practice pattern likely underestimates the true prostatic pathogen and may lead to suboptimal antimicrobial selection.
Imaging-Guided Sampling
Ultrasonography is indicated in all suspected prostatitis cases to assess for abscessation, cysts, or neoplasia. Prostatic abscesses require drainage in addition to antimicrobial therapy, and medical management alone is rarely curative. Ultrasound-guided fine-needle aspiration of the prostatic parenchyma can provide diagnostic material when ejaculation is not possible, but the risk of seeding infection along the needle tract should be considered.
Antimicrobial Selection Principles
Pharmacokinetic Considerations
Drug selection must account for the physicochemical properties that govern prostatic penetration. Fluoroquinolones are lipid-soluble, weakly basic, and achieve concentrations in prostatic fluid that exceed serum concentrations. Trimethoprim-sulfonamide combinations similarly penetrate well because both components are lipid-soluble and become trapped in the slightly acidic prostatic environment. Macrolides and tetracyclines also penetrate adequately but have narrower spectra and are not first-line for gram-negative pathogens.
Beta-lactams, aminoglycosides, and nitrofurantoin penetrate prostatic tissue poorly and should not be used as sole therapy for bacterial prostatitis, even when susceptibility testing suggests activity. The discrepancy between in vitro susceptibility and in vivo efficacy is a well-recognized failure mode in prostatic infection management.
Culture-Guided Therapy
Culture and susceptibility testing is strongly recommended before initiating antimicrobial therapy for prostatitis, according to International Society for Companion Animal Infectious Diseases guidelines cited in the veterinary literature diagnostic and therapeutic approaches to acute prostatitis in dogs. When clinical severity demands immediate empiric therapy, a fluoroquinolone is the most reasonable choice pending culture results. Once susceptibility data are available, therapy should be narrowed to the most targeted agent that achieves adequate prostatic penetration.
The duration of therapy for acute prostatitis is typically 2 to 4 weeks, while chronic prostatitis requires 4 to 6 weeks. Relapse after discontinuation is common, and a repeat culture should be performed 1 to 2 weeks after the end of therapy to confirm microbiologic cure.
Initial Assessment and Staging
The diagnostic sequence begins with signalment, history, and physical examination. Acute bacterial prostatitis typically presents with systemic signs including fever, lethargy, and caudal abdominal pain. Chronic bacterial prostatitis presents more subtly with recurrent urinary tract infections, hematuria, or dysuria without systemic illness. The distinction matters because it changes sampling urgency, empiric drug choice, and treatment duration.
A complete blood count, serum biochemistry panel, and urinalysis with culture should accompany prostate evaluation. The biochemistry panel assesses renal function and hepatic status, both of which influence antimicrobial elimination and toxicity risk. Ultrasonography of the prostate and urinary tract identifies abscessation, cysts, or neoplasia that would alter the treatment plan. Survey radiography adds little in most cases but may detect prostatic mineralization or caudal abdominal masses.
The International Society for Companion Animal Infectious Diseases guidelines strongly recommend culture and sensitivity testing, ideally from prostatic samples when feasible, before antimicrobial therapy is initiated. A survey of Italian veterinary practitioners found that urine was the most commonly used diagnostic matrix at 54.9% of respondents, while samples of prostatic origin were used in only 20.9% of cases. This gap between recommendation and practice is a stewardship failure point. Urine culture from a free-catch sample may reflect urethral or bladder flora instead of prostatic infection, particularly in chronic cases where the prostate serves as a nidus for recurrent cystitis.
Empiric Therapy While Awaiting Culture
Empiric antimicrobial therapy is indicated when the patient is systemically ill, when sampling is delayed, or when culture results will not be available for several days. The choice must cover the most likely pathogens, predominantly Escherichia coli, with consideration of Staphylococcus spp., Streptococcus spp., and Proteus spp. E. coli strains causing prostatitis carry an exceptional repertoire of extraintestinal pathogenic virulence-associated genes and belong to a highly virulent subset of uropathogenic variants. Antimicrobial resistance in these strains is an increasing concern, so empiric selection should favour agents with both prostate penetration and a favourable resistance profile in the local region.
Fluoroquinolones remain the most reliable empiric choice for canine prostatitis because they achieve therapeutic concentrations in prostatic tissue and secretion. The pharmacokinetic theory of drug diffusion into the prostate explains why lipid-soluble, weakly basic drugs with low protein binding penetrate the prostatic epithelium most effectively. Fluoroquinolones meet these criteria. Trimethoprim-sulfonamide combinations also penetrate the prostate well and provide a reasonable alternative, though resistance rates vary regionally. Third-generation cephalosporins penetrate moderately but are best reserved for culture-confirmed susceptibility.
The empiric window should be narrow. Once culture and sensitivity results return, therapy must be adjusted to the narrowest effective agent. This de-escalation step is central to antimicrobial stewardship and is explicitly endorsed in professional guidance on judicious antimicrobial use.
Treatment Duration and Monitoring
Acute bacterial prostatitis requires a minimum of four weeks of antimicrobial therapy. Chronic bacterial prostatitis requires six to eight weeks or longer. The extended duration reflects the difficulty of eradicating bacteria from the prostatic ducts and acini, where drug penetration is limited and organizms may persist in biofilm-like communities. Antibiotic therapy is the gold standard of treatment for chronic bacterial prostatitis, but long-term therapy carries risks of side effects and bacterial resistance.
Monitoring parameters during treatment include:
| Parameter | Frequency | What It Detects |
|---|---|---|
| Clinical signs (fever, dysuria, stranguria) | Weekly for first month | Resolution of active infection |
| Serial urinalysis with culture | At 2 weeks, then 1 week after stopping therapy | Persistent bacteriuria or early recurrence |
| Prostatic fluid culture | At end of therapy if clinically indicated | Bacterial persistence despite negative urine culture |
| Serum biochemistry | At 2 weeks and at end of therapy | Drug-related renal or hepatic injury |
| Prostatic ultrasound | At end of therapy | Abscess resolution, cyst formation, or progressive change |
Clinical improvement without culture confirmation is insufficient. The prostate can harbour bacteria while the urine remains sterile, particularly in chronic bacterial prostatitis where the prostatic infection seeds the bladder intermittently. A negative urine culture at the end of therapy does not confirm prostatic cure unless prostatic fluid or semen was also cultured.
Recurrence after an appropriate course should prompt re-culture, not re-treatment with the same drug. The original isolate may have developed resistance during therapy, or a different organizm may have emerged. Repeat sampling should include prostatic fluid or semen whenever possible.
Abscessation and Surgical Considerations
Prostatic abscessation changes the treatment paradigm. Antimicrobial therapy alone rarely resolves a mature abscess because the pus-filled cavity has poor drug penetration and the pH environment reduces the activity of many agents. Ultrasound-guided drainage or surgical marsupialization is often required. The decision to drain depends on abscess size, number, and the patient's systemic status. Multiple small abscesses may respond to medical therapy alone, while a single large abscess or a ruptured abscess with peritonitis requires surgical intervention.
Castration is recommended as an adjunct in intact males with prostatic disease. Testosterone drives prostatic hyperplasia, which predisposes to infection and impairs drainage of prostatic secretions. Hormonal management is part of the therapeutic approach evaluated in the Italian practitioner survey, though the survey did not report the proportion of respondents who recommended castration. The evidence base for castration as a therapeutic adjunct is limited, but the physiological rationale is sound and the procedure carries low morbidity in most patients.
Documentation and Stewardship Reporting
Every prostatitis case should be documented with the following elements: the sampling method and site, the culture result with quantitative counts, the antimicrobial susceptibility profile, the empiric drug selected and the rationale, the date of de-escalation or change, the planned treatment duration, and the monitoring schedule. This record supports individual patient care and contributes to practice-level antimicrobial use surveillance.
Practices should track the proportion of prostatitis cases with culture confirmation, the rate of fluoroquinolone use, and the recurrence rate within six months. These metrics identify drift toward empiric-only management and guide educational interventions. Professional guidance from the AVMA emphasizes that stewardship is a practice-wide commitment that includes monitoring and reporting of antimicrobial use patterns. Regulatory oversight of antimicrobial use varies by jurisdiction, and practitioners must consult their local veterinary authority for current requirements. Approved animal drug labeling and extralabel use policy are maintained by the relevant national regulatory body, such as the FDA Center for Veterinary Medicine in the United States.
Recognized Complications and Early Detection
Acute prostatitis can progress to abscessation, septic peritonitis, or systemic inflammatory response syndrome. Abscess formation should be suspected when a dog with prostatitis remains febrile or painful after 48 to 72 hours of appropriate antimicrobial therapy. Palpation may reveal a fluctuant or asymmetrically enlarged prostate, but imaging is the discriminating test. Ultrasonography identifies cavitary lesions with echogenic fluid, and computed tomography provides superior definition when surgical planning is required. Serial ultrasound examinations every 48 hours during the first week of treatment detect abscessation before clinical deterioration becomes obvious.
Prostatic neoplasia can mimic bacterial prostatitis on imaging and clinical examination. Failure to respond to culture-guided therapy within 5 to 7 days should prompt cytologic or histologic sampling instead of an automatic change in antibiotics. Elevated serum prostate-specific antigen is not a reliable marker in dogs, so tissue diagnosis remains the standard.
Recurrent infection after an apparently successful course suggests an anatomic sequestrum, a foreign body, or a resistant subpopulation. Repeat culture of prostatic fluid or urine should be performed before retreatment, and imaging should exclude calculi or diverticula. The historical difficulty of eradicating chronic bacterial prostatitis is well documented in human medicine, and the same pharmacokinetic barriers apply in dogs pharmacokinetics of antibiotic diffusion in chronic bacterial prostatitis.
Common Errors and Corrective Actions
The most frequent error is treating on the basis of a urine culture when the urine sample was collected by cystocentesis through a prostate that is not infected. A negative urine culture does not exclude prostatitis, and a positive urine culture may reflect lower urinary tract infection alone. Prostatic fluid or semen culture is required when the prostate is the suspected source diagnostic and therapeutic approaches to acute prostatitis in dogs.
A second error is selecting an antibiotic with poor prostatic penetration because it appears susceptible on in vitro testing. Fluoroquinolones and trimethoprim-sulfonamide achieve therapeutic concentrations in prostatic tissue, whereas many beta-lactams and aminoglycosides do not. Susceptibility testing must be interpreted in the context of the drug's diffusion characteriztics, not as a standalone result pharmacokinetics of antibiotic diffusion in chronic bacterial prostatitis.
A third error is stopping therapy at the first sign of clinical improvement. Prostatitis requires a longer treatment course than uncomplicated urinary tract infection, and premature discontinuation selects for resistant organizms. The clinician should set a defined recheck date at the initiation of therapy and confirm bacteriologic cure before stopping.
A fourth error is neglecting hormonal manipulation in intact males. Castration reduces prostatic volume and improves antibiotic penetration into the gland. Delaying castration until after antimicrobial therapy is complete prolongs the infection and increases the risk of recurrence.
Troubleshooting Table
| Observation | Likely Cause | Discriminating Check |
|---|---|---|
| Fever persists beyond 72 hours of therapy | Abscessation or resistant organizm | Ultrasound for cavitary lesions, repeat culture of prostatic fluid |
| Clinical improvement but positive culture at recheck | Inadequate duration or poor penetration | Confirm drug selection against penetration data, extend therapy |
| Negative urine culture with prostatic signs | Prostatic infection without lower urinary tract involvement | Culture prostatic fluid or semen directly |
| Recurrence within 4 weeks of stopping therapy | Anatomic sequestrum or untreated source | Imaging, consider prostatic wash and repeat culture |
| No response to culture-guided therapy | Incorrect diagnosis, neoplasia | Cytology or histopathology of prostatic tissue |
Evidence Limitations and Expert Divergence
The evidence base for canine prostatitis is thinner than for human disease. Most pharmacokinetic data on antibiotic diffusion into the prostate derive from older canine models developed for human drug development, and these models may not reflect spontaneous disease in client-owned dogs pharmacokinetics of antibiotic diffusion in chronic bacterial prostatitis. The human literature recognizes that chronic bacterial prostatitis is difficult to culture and that molecular methods may detect organizms missed by routine culture laboratory diagnosis of bacterial prostatitis. Whether this applies to dogs is unknown, and routine molecular testing is not currently recommended.
Expert opinion diverges on the optimal duration of therapy. Some authorities recommend a fixed 4 week course, while others advocate treatment until a negative culture is obtained. Both approaches are defensible, and the choice should be documented in the medical record. The role of adjunctive therapies such as anti-inflammatory doses of carprofen or physical therapies is not established in dogs.
Referral and Reporting Indications
Referral to a specialist is warranted when abscessation requires surgical drainage, when repeated culture-guided therapy fails, or when imaging findings suggest neoplasia. A veterinary clinical pathologist should be consulted when prostatic fluid cytology is ambiguous or when unusual organizms are isolated. Laboratory involvement is also appropriate when antimicrobial susceptibility testing shows resistance to all first-line agents, as alternative drug selection may require synergy testing or specialised media.
Regulatory reporting obligations vary by jurisdiction. Veterinarians in the United States should consult the FDA Center for Veterinary Medicine for current requirements on extralabel drug use reporting and adverse event submission FDA animal drug information. Professional stewardship expectations are outlined by the AVMA, and international practitioners should be aware of the World Organization for Animal Health standards on prudent antimicrobial use AVMA antimicrobial stewardship guidance, WOAH terrestrial animal health standards.
Frequently Asked Questions
How Should I Manage Prostatitis When the Owner Cannot Afford Prostatic Sampling or Culture?
When financial constraints preclude prostatic culture, collect a urine sample by cystocentesis before initiating therapy. Urine culture is less ideal than prostatic tissue or fluid culture, but it remains the most commonly used diagnostic matrix in practice and provides useful guidance in most cases. Survey data from Italian practitioners show that urine is used in 54.9% of acute prostatitis cases, while prostatic-origin samples are used in only 20.9%. If culture is declined entirely, select an agent with proven prostatic penetration, such as a fluoroquinolone, and document the limitation in the medical record. Recheck the patient clinically and with urine culture at the end of therapy. Refer to AVMA antimicrobial stewardship resources for guidance on balancing cost constraints with judicious use.
What Do I Do When Prostatic Fluid or Tissue Cannot Be Collected Safely?
If the prostate is painful, the patient is unstable, or ultrasound-guided sampling is unavailable, do not attempt blind aspiration. Collect urine by cystocentesis for culture and begin empiric therapy with a drug that concentrates in prostatic tissue. Reevaluate sampling once the patient is stabilized on therapy, ideally within 48 to 72 hours. Serial urine cultures can serve as a surrogate marker of prostatic infection clearance, though they may underestimate persistence. The diagnostic approach to acute prostatitis relies on clinical examination, bloodwork, urinalysis, and ultrasound in most practices, and this combination is acceptable when sampling is deferred. Document the reason for deferral and the planned follow-up interval in the record.
How Does Canine Prostatitis Management Differ from Human Bacterial Prostatitis?
Human medicine recognizes four prostatitis syndromes, including acute bacterial, chronic bacterial, chronic pelvic pain syndrome, and asymptomatic prostatitis. Canine practice typically distinguishes acute from chronic bacterial prostatitis without the formal syndrome classification used in people. The pharmacokinetic principles governing drug diffusion into the prostate were largely derived from canine models, so the translational basis for drug selection is strong. However, human chronic bacterial prostatitis is often resistant to antimicrobial chemotherapy, and the same difficulty applies to chronic canine cases. The human literature emphasizes that Escherichia coli requires multiple virulence traits to establish prostatic infection, a finding relevant to canine cases given the predominance of E. coli as a pathogen in both species.
What Records Should I Keep for Antimicrobial Stewardship Audits?
Record the clinical indication, sampling method, culture results, antimicrobial chosen, dose, route, and planned duration for every prostatitis case. Note whether therapy was empiric or culture-guided and document the date of treatment completion. If the owner declined recommended diagnostics, record that discussion and the rationale for proceeding empirically. These records support practice-level stewardship audits and facilitate review of resistance trends within your caseload. The FDA Center for Veterinary Medicine provides regulatory context on approved drug use and extralabel therapy documentation, while AVMA practice resources offer templates and guidance for stewardship programs. Consistent documentation also protects you if a case is reviewed by a regulatory body or referral service.
How Should I Explain the Need for Culture to a Client Who Wants Immediate Antibiotics?
Explain that prostatic infections are frequently caused by bacteria that resist commonly used antibiotics, and that choosing a drug without culture data risks treatment failure and a second, longer course of therapy. Emphasize that the prostate is difficult for many antibiotics to penetrate, so the first drug choice must be correct. Culture results allow targeted therapy, which is often shorter and less expensive overall than failed empiric courses. The International Society for Companion Animal Infectious Diseases guidelines strongly recommend culture and sensitivity testing, ideally on prostatic samples, before antimicrobial therapy. Frame the culture as the single most cost-effective step in the case, not an optional extra.
When Should I Refer a Prostatitis Case to a Specialist?
Refer when prostatic abscessation is suspected or confirmed, when the patient fails to improve despite culture-guided therapy, when recurrent infection follows an appropriate treatment course, or when imaging expertise for ultrasound-guided drainage is unavailable. Referral is also appropriate when the practice lacks the ability to perform prostatic sampling safely or when the patient requires surgical intervention such as drainage or prostatectomy. Chronic bacterial prostatitis is historically resistant to antimicrobial chemotherapy, and persistent cases benefit from specialist evaluation and advanced imaging. The MSD Veterinary Manual provides background on prostatic disease complications that warrant referral. Early referral is preferable to repeated antibiotic trials, which increase resistance pressure and delay definitive management.
Related Clinical & Scientific Guides
- Veterinary Formulary Essentials: Navigating Drug References
- Drug Interactions with Antiepileptic Drugs in Veterinary Patients: Managing Polypharmacy
- Drug Interactions with Corticosteroids in Veterinary Patients: A Comprehensive Review
References and Further Reading
- Prostatitis.. 1998.
- Synergistic effect between catechin and ciprofloxacin on chronic bacterial prostatitis rat model.. 2005.
- Bacterial Prostatitis: Bacterial Virulence, Clinical Outcomes, and New Directions.. 2016.
- Diagnostic and therapeutic approaches to acute prostatitis in dogs: a survey of Italian veterinary practitioners.. 2026.
- The pharmacokinetics of antibiotic diffusion in chronic bacterial prostatitis.. 1982.
- FDA Center for Veterinary Medicine: Animal Drug Information. FDA CVM.
- AVMA Antimicrobial Use and Stewardship. American Veterinary Medical Association.
- MSD Veterinary Manual, Professional Edition. MSD Veterinary Manual.
- American Veterinary Medical Association Practice Resources. American Veterinary Medical Association.
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- Antimicrobial Stewardship in Canine Respiratory Infections: Differentiating Viral from Bacterial
- Antimicrobial Stewardship in Canine Sepsis: Empiric Therapy and De-escalation
This article is educational professional reference material for veterinary audiences. It is not a substitute for veterinary diagnosis, individual clinical judgment, current product labeling, or applicable regulatory requirements.