Dermatonin

Melatonin Implanter

For Canine Use

Open Slowly

Hold needle upward

Veterinary use only as directed; complete instructions see www.MELATEK.net

CAUTION: Contains a new animal supplement not for use in humans. Edible products of investigational animals are not to be used for food unless authorization has been granted by the U.S. Food and Drug Administration or the U.S. Department or Agriculture. FDA has not evaluated this product.

STORAGE: Must remain out of UV light; Refrigerate or room temperature

Prescriber Highlights

- Melatonin Implants = Implantable pineal gland hormone

Alopecia in dogs, sleep and behavior disorders in cats and dogs, adjust seasonally controlled fertility in sheep, goats, skunk, cattle and horses.

- Adverse effects appear to be minimal to uncommon

- Potential contraindications include: pregnancy, sexually immature animals.

- Drug-drug interactions show no issues with use of melatonin implants.

Chemistry

A naturally occurring hormone produced in the pineal gland, melatonin occurs as a white/yellow crystalline solid and the implants are cylindrical in shape/off white color. It is derived from synthetic means.

PRODUCT NAME: N-[2(5-METHOXY-1H-INDOL-3-YL)ETHYL]ACETAMIDE

SYNONYMS: Melatonin, N-acetyl-5-methoxytryptamine (Pineal Gland Hormone)

SILICONE ELASTOMER: Polydimethylsiloxane

PRODUCT NUMBER 6382

FORMULA WEIGHT: 232.28

Storage/stability/compatibility

Unless otherwise labeled store at room temperature (15-25°C) and in tight containers and out of direct UV light. Note refrigeration is not necessary.

Pharmacology

Melatonin is involved with the neuroendocrine control of photoperiod dependent molting, hair growth and pelage color. Melatonin stimulates winter coat growth and spring shedding occurs when melatonin decreases. The mechanism of how melatonin induces these effects is not well understood. It may have direct effects on the hair follicle or alter the secretion of prolactin and/or melanocyte stimulating hormone.

Melatonin also increases serum prolactin levels, growth hormone, and increases response to growth hormone releasing hormone. Long-term use may decrease luteinizing hormone. Melatonin is also ostensibly a free radical scavenger.

Uses/indications

Dermatonin Implants may be useful to treat Alopecia-X in Nordic breeds, Canine pattern baldness, or canine recurrent flank alopecia in dogs and cats. They has also has been used anecdotally for the treatment of sleep cycle disorders in cats and geriatric dogs and to treat phobias and separation anxiety in dogs. Dermatonin implants are also used to improve early breeding and ovulation rates in sheep and goats. In cattle and sheep they are used to build size and develop a better seasonal coat.

Contraindications/precautions

Melatonin implants are considered contraindicated in pregnant or sexually immature animals. There are very specific times for administration depending on latitude, hemisphere, and breed. Animals that are nursing young may not benefit from implant therapy.

Adverse Effects/warnings

Dermatonin appears to be quite safe in dogs. Side effects in dogs when are rare, although sex hormone secretion and fertility may be affected, and in a few cases have been associated with sterile abscesses.

Overdosage/acute Toxicity

Unlikely to cause significant morbidity after a single overdose due to the animal currently produces melatonin naturally in the system.

Doses

1. For treatment of Alopecia-X in Nordic breeds, Canine pattern baldness, or canine recurrent flank alopecia or seasonal flank: Empirical dose of one melatonin implant based on weight of dog: Dermatonin implants are available in doses of 8.0mg, 12.0mg, and 18.0mg for canines whose weight is under 20lbs, between 20-40lbs, and over 40lbs, respectively. Retreatment may be necessary once or twice a year. Improvement is usually seen in the first month or two with maximal improvement in 3 to 4 months. (Merchant 2000)

2. For treatment in cats the recommend Dermatonin Implant dose is 8.0mg.

DERMATONIN INSTRUCTIONS

Sterilized Disposable Single Dose Melatonin Implanter Instructions

Instructions for Loading and Injection Implant

Step 1. Remove the sterilized Dermatonin syringe device. To load implant into syringe, use gloves or thumb forceps and load the pointed end of the needle.

Step 2. Have assistant hold the dog and clean injection site with an alcohol swab. Angle the device parallel to the skin plane.

Step 3. Pick up fold of loose skin over shoulders, and insert needle into loose subcutaneous tissue under skin. Must avoid deeper muscle layers.

Step 4. Inject Implant full distance of needle by depressing device rod fully.

Step 5. Remove needle slowly.

Step 6. Sterilize and clean with alcohol the needle and area before each use.

IMPLANTATION INSTRUCTIONS:

Step 1: Loading the implant is only necessary if during shipping the implant has become dislodged from the Dermatonin implanter needle. Only a one-time disposable, sterilized (with sterility expiry date) Dermatonin syringe should be used to avoid the risk of infection and transmittable diseases.

Step 2-3: To implant have the veterinary technician secure the dog. The use of local anesthetic is at the discretion of the implanting veterinarian. The dog must be positioned to expose the implantation site (loose skin, back of neck and between shoulder blades). Prepare injection site by wiping area thoroughly with alcohol. Lift the loose skin at the injection site between thumb and index finger. Insert needle subcutaneous the full length of needle, approximately 1 inch (2.5 cm). Needle must be positioned under and on a parallel plane to the surface of skin.

Step 4-6: Care must be taken not to penetrate muscle tissue or unintentionally damage the hair. With needle in proper position, depress fully injection device inserting implant. With injection device fully depressed, withdraw needle to insure that implant stays in place. Keep the dog restrained for a few minutes after injection, so that the thumb can be pressed on the injection hole for a few seconds to enable the animal tissue to become reorganized. It is up to the veterinarian to inspect the site and diagnose any further need to close the implanted hole (i.e. skin glue). In case of bleeding and swelling of animal tissue, the necessary medical treatment should be provided. For more information on Dermatonin, please refer to the website www.MELATEK.net.

Dated 2006

These instructions are to only guide the veterinarian through the process and the veterinarian is responsible for their own procedure

Veterinary Source:

Dermatonin (all dose sizes) implants available in the United States and Internationally from Melatek, LLC (and their distributors) www.melatek.net. See NADA 140-846 for approval status. All doses come pre-loaded in a gas sterilized disposable syringe unit.

CONTENTS Sterilized Implanter

DOSE 1

Distributed by Melatek, L.L.C., Middleton, WI 53562

CPN: 13800001