Dectomax: Product Information (Page 2 of 2)

RECOMMENDED TREATMENT PROGRAM FOR SWINE

To effectively initiate control of mange and sucking lice in swine, it is important to treat all animals in the herd. After initial treatment, use Dectomax regularly as follows:

Breeding Animals:

Sows: Treat 7–14 days prior to farrowing to minimize exposure of piglets to mites and sucking lice.

Gilts: Treat 7–14 days prior to breeding. Treat 7–14 days prior to farrowing.

Boars: Treat a minimum of 2 times per year.

Feeder Pigs

Treat any new feeder pigs upon arrival at farm or before placement in clean quarters.

Weaners, Growers, Finishers

Weaners and grow-out/finisher pigs should be treated before placement in clean quarters.

For effective mange elimination, care must be taken to prevent reinfestation from exposure to untreated animals or contaminated facilities.

ADMINISTRATION

Dry, sterile equipment and aseptic procedures should be used when withdrawing and administering Dectomax. For multiple treatments either automatic injection equipment or an aspirating needle should be used.

Cattle

FigureAdminister Dectomax injectable solution by SC or IM route. Injections should be made using a 16 gauge needle for adult cattle or an 18 gauge needle for young animals. Needles 1/2–3/4″ in length are suggested for SC administration. A 1-1/2″ needle is suggested for IM administration. SC injections should be administered under the loose skin in front of or behind the shoulder. IM injections should be administered into the muscular region of the neck. Beef Quality Assurance guidelines recommend SC administration as the preferred route.

Swine

FigureAdminister Dectomax injectable solution by the IM route. Inject in the neck region using an 18 gauge × 1″ needle for young animals; a 16 gauge × 1-1/2″ needle for sows and boars. To accurately meter doses administered to piglets, use of a tuberculin syringe and 20 gauge × 1″ needle is recommended.

WARNINGS

Not for human use. Keep out of reach of children. The safety data sheet (SDS) contains more detailed occupational safety information. To report adverse effects in users, to obtain more information, or to obtain an SDS, call 1-888-963-8471.

OTHER WARNINGS

Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in a drug’s effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.

RESIDUE WARNINGS

Cattle: Do not slaughter for human consumption within 35 days of treatment. Not for use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Swine: Do not slaughter for human consumption within 24 days of treatment.

PRECAUTIONS

Dectomax has been developed specifically for use in cattle and swine only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

For SC injection in cattle only. For IM injection in swine and cattle. This product is approved for the treatment and control of sucking lice. For treatment of biting lice in cattle, use of Dectomax Pour-On is recommended.

Dectomax is highly effective against all stages of cattle grubs. However, proper timing of treatment is important. For most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble) season.

Destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions including the possibility of fatalities. Killing H. lineatum when it is in the tissue surrounding the gullet may cause bloat; killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. These reactions are not specific to treatment with Dectomax, but can occur with any successful treatment of grubs. Cattle should be treated either before or after these stages of grub development. Consult your veterinarian concerning the proper time for treatment.

Cattle treated with Dectomax after the end of the heel fly season may be re-treated with Dectomax during the winter for internal parasites, mange mites, or sucking lice, without danger of grub-related reactions. A planned parasite control program is recommended.

ENVIRONMENTAL SAFETY

Studies indicate that when doramectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive over time. Free doramectin may adversely affect fish and certain aquatic organisms. Do not permit water runoff from feedlots to enter streams or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.

As with other avermectins, doramectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific.

When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

Store Below 30°C (86°F)

HOW SUPPLIED

Dectomax is available in 100-mL, 200-mL, and 500-mL multi-dose, rubber-capped glass vials.

Approved by FDA under NADA # 141-061

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

Not for human use.

Restricted Drug (CA) Use only as directed.

Distributed by:
Zoetis Inc.Kalamazoo, MI 49007

Product of China

Take Time Logo

Revised: March 2019

PRINCIPAL DISPLAY PANEL — 100 mL Multi-Dose Vial Label

100 mL Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mL Multi-Dose Vial Label

200 mL label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 500 mL Multi-Dose Vial Label

500 mL Label
(click image for full-size original)
DECTOMAX doramectin injection, solution
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:54771-5438
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DORAMECTIN (DORAMECTIN) DORAMECTIN 10 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-5438-1 100 mL in 1 VIAL, MULTI-DOSE None
2 NDC:54771-5438-2 200 mL in 1 VIAL, MULTI-DOSE None
3 NDC:54771-5438-3 500 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141061 07/30/1996
Labeler — Zoetis Inc. (828851555)

Revised: 11/2019 Zoetis Inc.

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