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Dectomax* Pour-On Solution (Canada)

This page contains information on Dectomax* Pour-On Solution for veterinary use.
The information provided typically includes the following:
  • Dectomax* Pour-On Solution Indications
  • Warnings and cautions for Dectomax* Pour-On Solution
  • Direction and dosage information for Dectomax* Pour-On Solution

Dectomax* Pour-On Solution

This treatment applies to the following species:
Manufacturer: Zoetis

doramectin

pour-on solution

Veterinary Use Only

broad-spectrum parasiticide

for cattle

DIN 02236466

Description

Dectomax Pour-On solution is a ready-to-use, systemically active, clear, light blue solution containing 0.5% w/v doramectin (5 mg/mL). It is formulated to deliver the recommended dosage of 500 µg of doramectin per kg of body weight when given by topical administration at the rate of 1 mL per 10 kg of body weight.

CHARACTERISTICS: Dectomax Pour-On solution is a highly active, broad-spectrum parasiticide for topical administration to cattle. It contains doramectin, a novel fermentation-derived avermectin discovered by Pfizer Inc. Doramectin is isolated from fermentations of selected strains derived from the soil organism Streptomyces avermitilis.

A primary mode of action of avermectins is to modulate chloride ion channel activity in the nervous system of nematode and arthropod parasites. Avermectins bind to receptors that increase membrane permeability to chloride ions. This inhibits the electrical activity of nerve cells in nematodes and muscle cells in arthropods and causes paralysis and death of the parasites. In mammals, the neuronal receptors to which avermectins bind are localized within the central nervous system (CNS), a site reached by negligible concentrations of doramectin.

One dose of Dectomax Pour-On solution effectively eliminates a wide range of roundworm and arthropod parasites that impair the health and productivity of cattle.

Studies have demonstrated a wide safety margin of Dectomax Pour-On solution. In target animal safety trials, no toxic signs were seen in cattle given up to 25 times the recommended dose. In breeding animals (bulls, and cows in early and late pregnancy), a dose 3 times the recommended dose had no effect on breeding performance.

Dectomax* Pour-On Solution Indications

Dectomax Pour-On solution is indicated for the treatment of parasitic infections and infestations due to gastrointestinal roundworms, eyeworms, lungworms, grubs, biting and sucking lice, chorioptic and sarcoptic mange mites and horn flies in cattle, as outlined below. In addition, due to its persistent effect, Dectomax Pour-On solution also controls certain parasitic infections and infestations as outlined under PERSISTENT ACTIVITY.

GASTROINTESTINAL ROUNDWORMS

Ostertagia ostertagi (adults, L4 and inhibited L4)

O. lyrata (adults and L4)

Haemonchus placei (adults and L4)

Trichostrongylus axei (adults and L4)

T. colubriformis (adults and L4)

Cooperia oncophora (L4 only)

C. pectinata (adults only)

C. punctata (adults and L4)

C. surnabada (mcmasteri) (adults only)

Bunostomum phlebotomum (adults only)

Oesophagostomum radiatum (adults and L4)

Trichuris ovis (adults only)

Dectomax Pour-On solution is also indicated as an aid in the treatment of parasitic infections due to adult C. oncophora in cattle.

LUNGWORMS

Dictyocaulus viviparus (adults and L4)

EYEWORMS

Thelazia gulosa (adults only)

T. skrjabini (adults only)

CATTLE GRUBS (migrating larvae)

Hypoderma bovis

H. lineatum

MANGE MITES

Chorioptes bovis

Sarcoptes scabiei

HORN FLIES

Haemotobia irritans

BITING AND SUCKING LICE

Damalinia (Bovicola) bovis

Haematopinus eurysternus

Linognathus vituli

Solenopotes capillatus

Persistent Activity

ENDOPARASITES

Dectomax Pour-On solution, given at the recommended dosage of 500 µg of doramectin per kg body weight, effectively controls infections and reinfections with Cooperia oncophora for 21 days after treatment, Ostertagia ostertagi, Trichostrongylus axei and Oesophagostomum radiatum for 28 days after treatment, and Dictyocaulus viviparus for 42 days after treatment.

ECTOPARASITES

Dectomax Pour-On solution, given at the recommended dosage of 500 µg of doramectin per kg body weight, effectively controls infestations and reinfestations with Haemotobia irritans for 7 days after treatment, Damalinia (Bovicola) bovis and Linognathus vituli for 42 days after treatment and Solenopotes capillatus for 35 days after treatment.

DOSAGE: Administer Dectomax Pour-On solution to cattle topically at a dosage of 500 µg of doramectin per kg of body weight. Each mL contains 5 mg of doramectin, sufficient to treat 10 kg of body weight.

For the best results, Dectomax Pour-On solution should be a part of a parasite control program for both internal and external parasites based on the epidemiology of these parasites. Consult a veterinarian or an entomologist for information regarding the most effective timing of applications.

ADMINISTRATION: Dectomax Pour-On solution should be applied topically along the mid-line of the back in a narrow strip between the withers and tailhead.

EFFECT OF RAINFALL

Two clinical studies were conducted to evaluate the effect of simulated rainfall on the efficacy of Dectomax Pour-On solution against certain parasitic nematodes of cattle.

One study evaluated the therapeutic efficacy of Dectomax Pour-On solution in calves artificially infected with nematodes by assessing the effect of simulated rainfall on worm burdens recovered at necropsy; efficacy against D. viviparus, C. oncophora, and O. ostertagi infections was not affected when calves were exposed to simulated rainfall (duration=40 minutes) 60 minutes before treatment, 20 minutes after treatment, or 40 minutes after treatment.

The other study evaluated the therapeutic efficacy of Dectomax Pour-On solution in calves infected with nematodes by assessing effect of simulated rainfall on nematode egg count reduction; the product was ≥97% efficacious in reducing trichostrongylid-type egg counts when calves were exposed to simulated rainfall (duration=35 minutes) immediately before treatment, 90 minutes after treatment, or 24 hours after treatment.

Please note that data is not available regarding the effect of rainfall on the efficacy of this product against other internal parasites or any ectoparasites.

Do not apply to areas of skin which are caked with mud or manure.

DIRECTIONS FOR USE OF PHILLIPS POUR-ON APPLICATOR SYSTEM

1. Replace the shipping cap on 2.5 or 5.0 L backpack with draw-off cap provided. Tighten this draw-off cap.

2. Thread the draw-off tubing through the anti-kink spring. Attach the tube to the draw-off cap. Screw the spring counter clockwise over the tubing and draw-off spigot.

3. Invert the backpack.

4. Set the dose to maximum (50 mL). Gently prime the applicator, checking for leaks. To prime, place the nozzle into a clean, dry receptacle and depress lever fully. Then, pump 3 to 4 short strokes ensuring that the piston reaches the end of the cylinder, then release the lever completely to fill the cylinder. A small air bubble may appear within the cylinder. This will not affect the dosing accuracy.

5. Set the required dose and administer.

6. To disconnect the system, proceed as follows:

a) Set backpack in upward position.

b) Discharge residual material from the applicator and draw-off tubing into a separate, clean, dry receptacle.

c) Remove draw-off cap. Replace with the original cap and tighten firmly.

7. Follow the manufacturer’s recommendation for care and maintenance of the dosing applicator.

DIRECTIONS FOR USE OF SYRVET POUR-ON APPLICATOR SYSTEM

1. Replace the shipping cap on the 2.5 or 5.0 L backpack with the draw-off cap provided. Tighten the draw-off cap.

2. Thread the draw-off tubing through the anti-kink spring. Attach the tube to the draw-off cap. Screw the spring clockwise over the tubing and draw-off spigot.

3. Invert the backpack.

4. Set the dose at the maximum (50 mL) by unscrewing the adjuster at the base of the handle. Gently prime the applicator, checking for leaks. To prime, point the nozzle into a clean, dry receptacle and gently pump the lever back and forth to expel air from the system. When the barrel completely fills after every priming stroke, set the dose.

5. Set the dose as follows:

a) Use the handle to align the middle of the blue plunger ring with the chosen mark on the barrel. Tighten the adjuster screw against the handle.

b) Secure the dose with the adjuster screw locknut.

Note: Dose accuracy can be checked by dispensing a known number of set doses into a measuring cylinder. Correct any inaccuracy by adjusting the dose setting screw. Repeat this procedure until desired accuracy is achieved.

6. Administer each dose by fully depressing the handle so that the plunger travels its entire set length. Release the handle and the applicator will automatically refill.

7. To disconnect the system proceed as follows:

a) Set backpack in upward position.

b) Discharge residual material from the applicator and draw-off tubing into a separate, dry receptacle.

c) Remove draw-off cap. Replace with the original cap and tighten firmly.

8. Follow the manufacturer’s recommendation for care and maintenance of the dosing applicator.

DIRECTIONS FOR USE OF APPLICATOR SYSTEM FOR 22 L CONTAINER

1. Attach tube to hose barb on draw-off cap provided.

2. Remove shipping cap from container and replace with draw-off cap.

3. Place the external draw-up tube onto the external hose barb, positioned on the outside (top) of the draw-off cap. Screw the anti-kink spring over the tube and hose barb.

4. Attach the other end of the hose to the hose barb on the pour-on applicator. Screw the anti-kink spring over the tube and gun’s hose barb.

5. Set the applicator to the maximum dose. Prime the applicator. Check for leaks, or any air bubbles entering the hose. Place the nozzle of the applicator into a clean, dry receptacle and depress finger grip, pump these grips until the cylinder is full of product and the air is removed. A small bubble may appear in the cylinder. This will not affect dosing accuracy.

6. Select the desired dose and administer product.

7. To disconnect the system, proceed as follows:

a) Carefully unscrew the breather cap from the container. Lift the internal draw tube until it is clear of Dectomax Pour-On in the 22-L container.

b) Place the nozzle of the gun back into the 22-L container and squeeze the finger grips until all product is removed from the tube and applicator.

c) Replace original shipping cap onto the 22-L container.

8. Follow manufacturer’s recommendation for care and storage of the dosing applicator.

Warnings

(1) Treated animals must not be slaughtered for use as food for at least 55 days after the latest treatment with this drug. (2) This drug must not be used in lactating dairy cows. (3) Because a withdrawal time for milk has not been established, non-lactating dairy cows must not be treated within two months of calving. (4) Keep out of reach of children. (5) Avoid contact with skin and eyes.

CAUTIONS: Dectomax Pour-On solution is highly effective against the migrating larvae 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 Hypoderma 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 Pour-On solution, but can occur with any successful treatment of grubs. Cattle should be treated either before or after the migratory phase of grub development. Consult your veterinarian concerning the proper time for treatment.

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

This product is to be applied to skin surfaces only. Do not administer orally or parenterally. This product has been developed specifically for use in cattle only, and should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

Precautions

Flammable! Keep away from heat, sparks, open flame or other sources of ignition.

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 or certain water-borne organisms on which they feed. 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.

Storage

Store below 30°C. Protect from light by replacing partially used containers in the outer carton.

PACKAGE INFORMATION: Dectomax Pour-On solution is available in 2.5 L, 5 L and 22 L multi-dose containers. Not all pack sizes may be marketed.

Zoetis is a trademark and Dectomax is a registered trademark of Zoetis or its licensors, used under license by Zoetis Canada Inc.

Zoetis Canada Inc., Kirkland QC H9H 4M7

30378001

7518-11-1

NAC No.: 1198034.8

ZOETIS CANADA INC.
16,740 TRANS-CANADA HIGHWAY, KIRKLAND, QC, H9H 4M7
Order Desk:   800-663-8888
Technical Services Canada:   800-461-0917
Technical Services USA:   800-366-5288
Website:   www.zoetis.ca
Every effort has been made to ensure the accuracy of the Dectomax* Pour-On Solution information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2016 North American Compendiums. Updated: 2016-10-31

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