The evolution of neutering is here.

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1 The evolution of neutering is here. Zinc Gluconate Neutralized by Arginine Training Manual

2 ZEUTERIN NEUTER KIT: The following information is a suggestion of materials for the Zeuterin Injection which includes everything necessary for doing examination, measurement, sedation, tattooing and NSAID medication as well as post-injection care along with any emergency medications needed for allergic reaction or other emergency. EXAMINATION: 1. Thermometer 2. Stethoscope 3. Record Materials: Medical Form, Client Information Sheet, Calculator 4. Hand Sanitizer ZEUTERIN INJECTION: 1. 3 ml vial of Zeuterin Injectable Solution (Zinc Gluconate Neutralized by Arginine) 2. Zeuterin Caliper 3. Chlorhexidine scrub 2% 4. Chlorhexidine solution diluted 1:10 5. Gauze sponges 3x3 6. Alcohol wipes or squirt bottle (for IV s and tattoo wipes) 7. Cotton balls 8. 1 inch cotton adhesive tape 9. 3 Needles (28-30 gauge) per dog ml syringes (Luer Lock if available) ml syringes for sedation ml syringes for NSAID as needed 13. Tattoo pen w/ batteries and extras needles 14. Green ink for tattoo 15. Triple antibiotic skin ointment 16. Zeuterin tags 17. Sterilization certificates SUGGESTED MEDICATIONS FOR PROCEDURE Sedation 1. Dexmedetomidine HCL (Dexdomitor 0.5 mg/ml) 2. Butorphanol 10 mg/ml 3. Atipamezole HCL (Antisedan 5.0 mg/ml) Other medications: 1. Diphenhydramine 50 mg/ml 2. Emergency meds (Epinephrine/Glycopyrrolate/other) 3. NSAID (Meloxicam, Rimadyl ) 1

3 ZEUTERIN VETERINARY TRAINING MANUAL INDICATIONS: Zeuterin (Zinc Gluconate Neutralized by L-Arginine) is indicated for non-surgical sterilization in 3 to 10 month old male dogs with healthy scrotal skin and testis size in the 10-27mm range. PHYSICAL EXAM: The veterinarian should perform a routine physical exam before and subsequent follow-up exams after the sterilization procedure and must pay particular attention to the dog's response to palpation of the testes. PRE-TREATMENT EXAMINATION: 1. Breed, description, color 2. Medical/Health history 3. Estimated age 4. Ambulatory status 5. Body weight 6. Rectal temperature 7. Scrotal and inguinal skin area 8. Testicular palpation and examination of penis (check for transmissible venereal tumor) 9. Heart and respiratory rate 10. Examination of thorax, forelegs, neck (hydration, integument, shoulder and neck muscle mass, prescapular lymph nodes, inducible cough) 11. Examination of hind legs, perineum, abdomen (popliteal and inguinal lymph nodes, tail, perineum, testis, penis, abdominal palpation, integument) 12. Examination of head (mandibular lymph nodes, eyes, mouth and mucous membranes, ears, nose, and integument) POST-TREATMENT EXAMINATIONS: 1. General attitude 2. Ambulatory status 2

4 CONTRAINDICATIONS: Do not use Zeuterin in dogs that have the following conditions: Undescended testicles (cryptorchid). A disease or malformation of the testicle (including fibrosis of the testicles or epididymides). A history of allergic reaction to any of the components of the drug. Pre-existing scrotal irritation or dermatitis. Infected bite wounds. Testicular cancers of any kind. Transmissible venereal tumor. Warning: Human warnings; Keep this and all drugs out of reach of children. Not for human use. Wash the skin with soap and water and flush eyes with water if contact occurs. Flush mouth with water and drink plenty of water if accidental ingestion occurs. Contact a physician of accidental exposure by any route (oral, skin, injection). MATERIALS AND METHOD: Zeuterin is a sterile injectable aqueous solution containing zinc gluconate neutralized to ph 7.0 with L arginine (13.1 mg zinc per ml). The solution contains no preservatives, therefore only sterile hypodermic needles should be used to remove the solution from the vial. The drug should be stored at room temperature and does not need refrigeration. One dose of Zeuterin injected with strict observance of the following guidelines will safely and permanently sterilize the male dog. Withholding food from the dog for 12 hours before administering the drug is recommended. DOSAGE AND ADMINISTRATION: 1. Calculating Exact Dose of Zeuterin : Dosage is calculated by measuring the maximum width of each testicle with an approved caliper, which gives the corresponding dosage. Zeuterin should not be used in male dogs with testicles measuring less than 10mm or greater than 27mm. Range of Testicular Width (mm) Dose Per Testis (ml/cc) Example Dosage Calculation: When the veterinarian measures the width of the left testicle to be 17mm and the right testicle measures 15mm then the appropriate dose would be 0.5mL for the left testicle and 0.3mL for the right testicle. 3

5 2. TESTICULAR MEASUREMENT: 1. Confirm that the caliper is clean. 2. With the dog lying dorso-laterally, measure the width of each testicle by placing the testicle inside the two measuring points and then slide the ruler until it rests gently against the testicle. 3. Read the dose corresponding to the measurement by noting the position of the indicator line on the sliding ruler. If the indicator line exceeds the dosage line, use the next higher dose (See Diagram A). 4. The testicle is too small for injection if the indicator line does not fall on or below the minimum position marked on the caliper (See Diagram B). 5. The testicle is too large for injection if the indicator line falls beyond the maximum position for the 1.0 ml dose marked on the caliper (See Diagram C). Diagram A Diagram B Diagram C 3. ZEUTERIN ADMINISTRATION TECHNIQUE: 1. After passing the physical examination and approval of the dog as a candidate for the procedure, the veterinarian determines whether the male dog needs chemical restraint or standard human manual restraint, at his/her discretion. If chemical restraint is necessary, restrain the dog using an approved sedative/tranquilizer that the veterinarian is familiar with its affects. General anesthesia is not necessary. It is highly recommended that for the first 10 dogs, the veterinarian use chemical restraint to make it easier to handle the dogs while learning this new procedure. 4

6 2. Place the dog in a dorso or dorso-lateral position. At this time the veterinarian should take the opportunity to reevaluate the genitalia and carefully palpate the testes one final time for any fibrotic tissue, tumors, cryptorchidism, inguinal hernia, etc. If there is chronic inflammation of the scrotal skin and/or bacterial of fungal infections the veterinarian may at his/her discretion postpone the Zeuterin injection procedure until these infections have been properly treated and the scrotal skin returned to normal. Chronic fleabite allergies and other dermatologic conditions (e.g. mange) of the scrotal skin may have resulted in the habitual licking and biting behavior and should be noted and carefully watched following the injection procedure. Do NOT inject a dog with a bite wound or ulcer in the scrotal/inguinal area. Treat the wound first and when resolved, schedule the dog for the procedure. 3. Measure the width of each testis at the widest part using the caliper as explained above. Gently, but firmly, stabilize each testicle using the scrotal skin underneath and hold the testis from moving front to back with one hand. Using the caliper measure the testis at its widest point. Set the caliper so it just slides over the widest part of the testis and note the dosage for that particular testicle, then repeat for other testicle. Do not squeeze the caliper into the scrotal tissue. 4. Remove dirt and debris from the scrotum with a standard 2% chlorhexidine-gluconate surgical scrub diluted with water to make a lather. Gently clean the injection site especially at the cranial aspect of the scrotum. Follow with a 1:10 dilution of chlorhexidine-gluconate solution and allow to dry. Do not clip the scrotal area as with standard surgical preps. (The scrotum should not be scrubbed with abrasive sponges or brushes and use of alcohol or strong iodine solution should be avoided because it may irritate the scrotal skin of some dogs and stimulate a cycle of biting and licking.) Disinfection between patients with ethyl alcohol type gels for the veterinarian is advised. Strict adherence to the principles of aseptic technique will greatly reduce the risk of injection contamination and prevent infections from developing. 5. A 1 ml Luer Lock syringe with a removable 28 gauge or finer, ½-1 inch needle is recommended for injection of the drug. The length of the needle is dependent on the size of the testicle. Larger testis may require a longer needle, at the discretion of the veterinarian. Please choose the right length needle to ensure the product is delivered to the center of the testicle. 6. First use a separate sterile needle to withdraw the volume of Zeuterin provided from the caliper measurement into two sterile 1mL/cc syringes for the right and left testis followed by placing a new sterile needle on both syringes after loading syringes with the appropriate dose. Place the syringes on the appropriate sides of the dog to ensure correct dosage for 5

7 each side left and right. Again stabilize the testis with one hand by holding the scrotal skin front to back from underneath and inject with the opposite hand. [Caution: inject each testis with a new separate sterile needle. Using the same needle for the two testes may lead to infection]. To summarize, the veterinarian will need THREE NEW STERILE NEEDLES to administer the drug properly: one needle to withdraw and load both syringes with the drug, and two more new needles placed on both syringes in preparation for injection. PROPER INJECTION TECHNIQUE IS AS FOLLOWS: 1. Humanely restrain the dog to reduce movement. Inject Zeuterin into the dorsal cranial portion of the testis beside the caput (head) epididymis so that the drug not only diffuses into the testis and rete testis but also into the caput epididymis (see Fig 1). This will prevent maturation of sperm and cause atrophy of the ductuliefferentes and rete testis that prevents passage of sperm to the caput epididymis, thereby achieving sterilization by shutting down sperm maturation and transportation. Expect only a mild pain prick reaction from the dog as the needle passes through the scrotal skin. When needle has been placed into the testis and during injection continue humane restraint if the dog is not sedated. Depth of the needle will vary with the size of the testicles, but the tip of the needle must be long enough to deposit the drug near the center of the testicle. Important - do not aspirate. Figure Do not inject the drug into the scrotum, subdermally or intradermally into the scrotal skin. The skin of the scrotum should be pulled tightly over the testis by the hand stabilizing the testis because loose scrotal tissue over the testis may lead to injection into the scrotum. Caution: if the veterinarian injects the drug into the wrong site, he/she must stop the procedure. 6

8 3. After proper placement of the needle into the testis, inject the drug slowly while keeping the testis firmly stabilized. A slow rate of injection of Zeuterin should not cause pain. The injection speed should routinely take at least 5 seconds but depending on the volume of drug and gauge of needle, the time may be closer to 8 to 12 seconds. Remember towards the last 1/3 of the injection, to reduce the pressure applied to the testicle to accommodate the volume of fluid being injected. Rapid injection rate may stimulate contraction of the seminiferous tubules and the drug may leak from the injection site. Caution: a rapid injection (less than 5 seconds) could trigger a contraction of the seminiferous tubules and the pressure sensors in the testicle causing leakage from the parenchyma into the scrotal sac which may lead to infection and/or ulceration. 4. Do not use excessive injection pressure to force the drug into the testicle. If resistance is felt, discontinue the injection. If the drug is abnormally hard to inject into the testis, the dog should be disqualified from this procedure. 5. After normal, slow injection, remove needle quickly while simultaneously releasing the testicle. If there is any trace amount of Zeuterin on the scrotal skin, use a mild surgical soap or solution to clean and dry gently. If the veterinarian injects the same testicle twice by error, he or she should stop the procedure. POST INJECTION CARE: Please see the package insert for complete information. SWELLING: All dogs will get some level of swelling in the testicles which will be evident in the scrotum as firm, turgid testicles on palpation but generally without pain on palpation. This is due to the inflammatory action the zinc is initiating on the sertoli cells, seminiferous tubules and the rete testis. This can be mistaken for scrotal or preputial swelling which is not expected following a normal injection procedure. The swelling should peak 3-7 days post injection. PAIN: Expect some dogs (6.3% in the FDA study) to have a mild to moderate pain for up to one week post injection. It is recommended to use an NSAID to treat this following injection procedure and some dogs may require 3-5 days additional analgesic medication after the procedure. The attending veterinarian should always treat pain at their discretion to keep the patient comfortable. VOMITING: Expect some dogs to vomit following the procedure especially if they have been sedated with Xylazine. This may occur for up to four hours post-injection and the owner/guardian of the dog should be advised. This is generally transitory however if the vomiting is prolonged, antiemetics can be prescribed at the veterinarian's discretion. REDNESS: Expect some dogs to have erythema in the scrotal area. Take special care to watch these dogs for any further development of symptoms of irritation that may lead to licking or biting behavior. If this occurs, immediately have the dog wear an E-collar to prevent licking or selfmutilation. Topical antibiotics such as Neosporin or Mupricin may be administered along with 7

9 systemic antibiotics as needed. Watch this dog carefully for any progression of signs like irritation, severe swelling, ulcer or necrosis. ULCER: Ulceration of the scrotal skin may occur post-injection (1 incidence was reported among 224 dogs in the FDA trial). A potential ulcer will begin with only a red spot on the scrotum 1-2 days post-injection and then develop into ulceration 2-3 days post-injection. If this occurs, the dog should be treated immediately E-collared and monitored for further progression. Some ulcers may be due to necrosis of the testicle or epididymis from vasculitis following zinc injection. These need to be treated aggressively with saline or chlorhexidine flushes, and may require surgical debridement, scrotal ablation and/or castration. If needed, castration should be performed via a scrotal approach to allow dependent drainage of the affected tissue. The veterinarian should treat any cases of adverse reaction at their medical discretion. If you have a severe reaction please contact Ark Sciences for consultation with our veterinary team. We can assist you in managing the case. Ark Sciences, Inc. (877) vet@arksciences.com 8

10 ZEUTERIN TREATMENT FORM Ark Sciences, Inc. (877) DATE of INJECTION: / / ORGANIZATION: TEACHING VET: VET INJECTING: DOG NAME: AGE: years BREED: WEIGHT: lbs. SEDATED (Y) (N) TAG # GREEN TATTOO (Y) (N) NSAID INJ (Y) (N) NSAID TGH (Y) (N) NEEDLE GAUGE: 28 (3/4 ) 30 (1/2 ) RIGHT TESTIS: MEASURE: mm DOSAGE ml LEFT TESTIS: MEASURE: mm DOSAGE ml PROBLEMS WITH INJECTION OF RIGHT TESTIS? (NO) YES: PROBLEMS WITH INJECTION OF LEFT TESTIS? (NO) YES: NOTES of TREATMENTS, OUTCOMES: DAY THREE FOLLOW-UP 1. PHYSICAL CHECK-UP: 2. PHONE FOLLOW-UP: 3. PICTURE TAKEN: Please return the completed form to Ark Sciences, Inc. Fax: (646) vet@arksciences.com 9

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