118


EQUINE VETERINARY EDUCATION / AE / MARCH 2015


the stallion. The authors are aware of only 4 reports of a leiomyoma of the tunica albuginea of the testis in a stallion (Klug and von Lepel 1979; Johnson and Steinberg 1989; Wilborn et al. 2013; Stoll et al. 2015). Potentially significant questions that are not addressed by the current report are whether a leiomyoma of the tunica albuginea negatively affects the fertility of the stallion and whether radical excision including orchidectomy is essential. Any answers to these questions will remain speculative given the paucity of clinical cases. Nevertheless, a small leiomyoma located outside the testicular parenchyma would not be expected to have a direct negative effect on spermatogenesis. Over time or with enlargement, however, a leiomyoma in the neck of the scrotum could impede normal testicular movement and thermoregulation and even begin to impede normal vascular perfusion or efflux. The benign character of a leiomyoma suggests that complete local excision should probably be curative; however, in the current case the fact that the pathology was multicentric indicates multiple sites of origin and therefore a possibility of recurrence at other sites within the tunica albuginea, or as Stoll et al. (2015) suggest, elsewhere within the urogenital tract. Thus, while debulking the tumour would prevent pressure necrosis of underlying testicular parenchyma, it is difficult to determine whether tumour excision alone would have been sufficient to prevent local recurrence. In conclusion, while we agree with Stoll et al. that


neoplasia should be considered a possible cause of bilateral testicular enlargement, and there are also reports of bilateral neoplasia of testicular cell origin (Melo et al. 2007; Govaere et al. 2010), it is likely to be an unusual occurrence and would require a thorough diagnostic work-up involving, at the very least, ultrasonographic examination of the scrotal contents and possibly backed up by cellular level examination via semen collection or needle biopsy to assess effects on semen production and establish malignancy. Establishing that the tumour was benign would suggest that the prognosis in terms of survival is likely to be favourable even if treatment was


limited to local excision to salvage reproductive potential. However, giving a prognosis for future fertility, even if semen quality was initially unaffected, may be more difficult given the risks of local recurrence necessitating orchidectomy, or resulting in progressively compromised testicular function due to compression or thermoregulatory dysfunction.


Authors’ declaration of interests No conflicts of interests have been declared.


References


Govaere, J., Ducatelle, R., Hoogewijs, M., De Schauwer, C. and de Kruif, A. (2010) Case of a bilateral seminoma in a trotter stallion. Reprod. Domestic Anim. 45, 537-539.


Heijltjes, J.M., Rijkenhuizen, A.B.M., Hendriks,W.K. and Stout, T.A.E. (2009) Removal by laparoscopic partial ovariohysterectomy of a uterine leiomyoma assumed to have caused fetal death in a mare. Equine Vet. Educ. 21, 198-203.


Huang, D.Y. and Sidhu, P.S. (2012) Focal testicular lesions: colour Doppler ultrasound, contrast-enhanced ultrasound and tissue elastography as adjuvants to the diagnosis. Br. J. Radiol. 85, S41-S53.


Johnson, R.C. and Steinberg, H. (1989) Leiomyoma of the tunica albuginea in a horse. J. Comp. Pathol. 100, 465-468.


Klug, E. and von Lepel, J.D. (1979) Leiomyoma an hodenpaar eines 18jahrigen Warmbluthengstes. Dtsch. Tierarztl. Wochenschr. 12, 304.


Melo, C.M., Papa, F.O., Prestes, N.C., Alvarenga, M.A. and Laufer-Amorin, R. (2007) Bilateral leydig cell tumor in stallion. J. Equine Vet. Sci. 27, 450-453.


Muurlink, T.,Walmsey, J. and Whitton, C. (2008) Successful laparoscopic surgery for a uterine leioyoma in a mare. Equine Vet. Educ. 20, 508-511.


Sherman, K., Turner, T.A., Calderwood-Mays, M.B. and Asbury, A.C. (1990) Malignant seminoma in a horse. J. Equine Vet. Sci. 10, 272-274.


Stoll, A.L., Tucker, R., Witte, T.H. and Smith, K.C. (2015) Bilateral leiomyoma in the testes of a horse. Equine Vet. Educ. 27, 113-115.


Wilborn, R.R., Johnson, A.K., Dujovne, G.A., Albanese, V.Z., Caldwell, F.J. and Brittaina, L.C. (2013) Leiomyoma in the spermatic cord of a stallion. Clin. Theriogenol. 5, 366.


EQUIOXX®


(firocoxib) Oral Paste for Horses Non-steroidal anti-inflammatory drug for oral use in horses only.


control of pain and inflammation associated with osteoarthritis in horses. Oral Paste.


CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Indications: EQUIOXX®


Oral Paste is administered for up to 14 days for the


Contraindications: Horses with hypersensitivity to firocoxib or other NSAIDs should not receive EQUIOXX®


Warnings: For oral use in horses only. Do not use in horses intended for human consumption.


Human Warnings: Not for use in humans. Keep this and all medications out of the reach of children. Consult a physician in case of accidental ingestion by humans.


Animal Safety: Client should be advised to observe for signs of potential drug toxicity and be given a Client Information Sheet with each prescription.


For technical assistance or to report suspected adverse events, call 1-877- 217-3543.


Precautions: Horses should undergo a thorough history and physical examina- tion before initiation of NSAID therapy. Appropriate laboratory tests should be conducted to establish hematological and serum biochemical baseline data before and periodically during administration of any NSAID. Clients should be advised to observe for signs of potential drug toxicity and be given a Client Information Sheet with each prescription. See Information for Owner or Person Treating Horse section of this package insert.


Treatment with EQUIOXX® colic, abnormal feces, or lethargy are observed. should be terminated if signs such as inappetence,


As a class, cyclooxygenase inhibitory NSAIDs may be associated with renal and gastrointestinal toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Patients at greatest risk for adverse events are those that are dehydrated, on diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached or avoided. NSAIDs


The influence of concomitant drugs that may inhibit the metabolism of EQUIOXX® Oral Paste has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.


Oral Paste has not been studied in horses. The safe use of EQUIOXX® used for breeding, or in pregnant or lactating mares has not been evaluated.


of 0.045 mg/lb (0.1 mg/kg) orally once daily for up to 14 days. The following adverse reactions were observed. Horses may have experienced more than one of the observed adverse reactions during the study.


Adverse Reactions: In controlled field studies, 127 horses (ages 3 to 37 years) were evaluated for safety when given EQUIOXX®


Adverse Reactions Seen In U.S. Field Studies


Adverse Reactions


EQUIOXX®


Oral Paste was safely used concomitantly with other therapies, including vaccines, anthelmintics, and antibiotics, during the field studies.


(firocoxib)


Abdominal pain Diarrhea Excitation Lethargy


Loose stool Polydipsia Urticaria


EQUIOXX n=127


0 2 1 0 1 0 0


Active Control n=125


1 0 0 1 0 1 1


Information for Owner or Person Treating Horse: You should give the Client Information Sheet to the person treating the horse and advise them of the potential for adverse reactions and the clinical signs associated with NSAID intolerance. Adverse reactions may include erosions and ulcers of the gums,


Oral Paste at a dose Oral Paste in horses less than one year in age, horses


Consider appropriate washout times when switching from one NSAID to another NSAID or corticosteroid.


may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed. Since many NSAIDs possess the potential to produce gastrointestinal ulcerations, concomitant use with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided or closely monitored. The concomitant use of protein bound drugs with EQUIOXX®


tongue, lips and face, weight loss, colic, diarrhea, or icterus. Serious adverse reactions associated with this drug class can occur without warning and, in rare situations, result in death. Clients should be advised to discontinue NSAID therapy and contact their veterinarian immediately if any of these signs of intolerance are observed. The majority of patients with drug-related adverse reactions recover when the signs are recognized, drug administration is stopped, and veterinary care is initiated.


Effectiveness: Two hundred fifty-three client-owned horses of various breeds, ranging in age from 2 to 37 years and weighing from 595 to 1638 lbs, were randomly administered EQUIOXX or an active control drug in multi-center field studies. Two hundred forty horses were evaluated for effectiveness and 252 horses were evaluated for safety. Horses were assessed for lameness, pain on manipulation, range of motion, joint swelling, and overall clinical improvement in a non-inferiority evaluation of EQUIOXX compared to an active control. At study’s end, 84.4% of horses treated with EQUIOXX were judged improved on veterinarians’ clinical assessment, and 73.8% were also rated improved by owners. Horses treated with EQUIOXX showed improvement in veterinarian-assessed lameness, pain on manipulation, range of motion, and joint swelling that was comparable to the active control.


Storage Information: Store below 86°F (30°C). Brief excursions up to 104°F (40°C) are permitted.


How Supplied: EQUIOXX is available in packs of 20, 72 and 216 individually- boxed syringes. Each syringe contains 6.93 grams of EQUIOXX® to treat a 1250 lb. horse.


paste, sufficient


Marketed by: Merial LLC, Duluth, GA 30096-4640 Made in Brazil For technical assistance or to report suspected adverse reactions, call 1-877-217- 3543. NADA 141-253, Approved by FDA ©2010 Merial. All Rights Reserved. U.S. Pat. No.: 5981576, 6020343


®EQUIOXX is a registered trademark of Merial.


© 2015 EVJ Ltd


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88