Pfizer Animal Health
(doramectin)
Pour-On
Antiparasitic
0.5% pour-on solution for cattle
5 mg/mL
PRODUCT 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 mcg/kg (227 mcg/lb) of body
weight when given by topical administration at the rate of 1 mL/22 lb
(10 kg) of body weight.
PRODUCT CHARACTERISTICS: Dectomax
Pour-On solution is a highly active, broad-spectrum parasiticide for
topical administration to cattle. It contains doramectin, a novel
fermentation-derived macrocyclic lactone 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 macrocyclic lactones is to
modulate chloride ion channel activity in the nervous system of
nematodes and arthropods. Macrocyclic lactones 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 macrocyclic lactones bind are localized
within the central nervous system (CNS), a site reached by only
negligible concentrations of doramectin.
One dose of Dectomax Pour-On solution effectively treats
and controls a wide range of roundworm and arthropod parasites that
impair the health and productivity of cattle.
Studies have demonstrated the safety margin of
doramectin. In USA trials, no toxic signs were seen in cattle given up
to 25 times the recommended dose of Dectomax Injectable solution. A
study using Dectomax Injectable solution also demonstrated safety in
neonatal calves treated with up to 3 times the recommended dose. In
breeding animals (bulls, and cows during folliculogenesis,
organogenesis, implantation, and through gestation), a dose 3 times the
recommended dose of Dectomax Injectable solution had no effect on
breeding performance. A pharmacokinetic study demonstrated that systemic
exposure to doramectin from Dectomax Pour-On was less than systemic
exposure to doramectin from Dectomax Injectable solution.
PRODUCT INDICATIONS: Dectomax
Pour-On solution is indicated for the treatment and control of the
following species of gastrointestinal roundworms, lungworms, eyeworms,
grubs (see PRECAUTIONS), biting and sucking lice, horn flies, and mange
mites in cattle. Consult your veterinarian for assistance in the
diagnosis, treatment, and control of parasitism.
Gastrointestinal roundworms - Ostertagia
ostertagi (adults and L4, including
inhibited larvae), O. lyrata (adults), Haemonchus placei (adults and L4), Trichostrongylus axei
(adults), T. colubriformis (adults and L4), Cooperia oncophora
(adults1 and L4),
C. pectinata (adults), C.
punctata (adults and L4), C. surnabada (adults), Bunostomum
phlebotomum (adults), Oesophagostomum radiatum
(adults and L4), Trichuris
spp. (adults)
1 Efficacy below 90% was
observed against adult C. oncophora in some
clinical studies.
Lungworms (adults and fourth stage larvae) - Dictyocaulus viviparus
Eyeworms (adults) - Thelazia gulosa
(adults), T. skrjabini (adults)
Lice - Biting Lice: Damalinia bovis;
Sucking Lice: Haematopinus eurysternus,
Linognathus vituli, Solenopotes capillatus
Grubs - Hypoderma bovis, H. lineatum
Horn Flies - Haematobia irritans
Mange Mites - Chorioptes bovis,
Sarcoptes scabiei
Dectomax Pour-On solution has been proved to effectively
control infections and to protect cattle from reinfection with Cooperia oncophora, Dictyocaulus
viviparus, Ostertagia ostertagi, and Oesophagostomum
radiatum for 28 days; and Cooperia punctata
and Haemonchus placei for 35 days after
treatment.
Dectomax Pour-On solution has been proved to effectively
control infestations and to protect cattle from reinfestation with Bovicola (Damalinia) bovis for 77 days and Linognathus vituli for 42 days after treatment.
Management Considerations for Horn
Flies
Dectomax Pour-On solution provides 7 days of persistent
activity against horn flies. The product should be used as part of an
integrated control program and be combined with other methods for
extended horn fly control. For optimal horn fly control, consult with
your veterinarian or a livestock entomologist.
DOSAGE: Administer Dectomax Pour-On
solution to cattle topically at a dosage of 500 mcg doramectin per kg
(227 mcg/lb) of body weight. Each mL contains 5 mg of doramectin,
sufficient to treat 22 lb (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.
Dosing Cup (250-mL and 1-L bottles)
A dosing cup is provided for use with Dectomax Pour-On
solution supplied in 250-mL and 1-L bottles. The Dectomax Pour-On
solution dosing cup should be installed by rotating the cup on the
bottle neck until tight. When installed correctly, the spout is aligned
at the mid-point on the wide side of the bottle.
The curved end of the dosing cup tube should be
positioned at the bottom of the bottle on the side opposite the spout.
When the dosing cup is in the closed position (“zero” at set dosage mark
on screw), product does not enter the cup reservoir. Select a dose [1
mL per 22 lb (10 kg) of body weight] by twisting the dosing screw on the
top of the dosing cup to the desired position. The first complete turn
of the dosing screw will set the dose at 10 mL (“10” shows on the screw
at set dose mark). Each additional turn increases the dose in 5 mL
increments until a maximum dose of 50 mL (“50” is the bottom number
showing on screw at the set dose mark) is reached. When body weight is
between weight markings on the dosing cup, use the higher dose volume.
To fill the dosing reservoir, hold the bottle upright
and squeeze it until a slight excess has been delivered as indicated by
the calibration lines. Release the pressure and excess will
automatically drain from the reservoir and return to the bottle.
Tilt the bottle to deliver the dose. Dectomax Pour-On
solution should be delivered to cattle on the back in a single pass from
the withers to the tailhead.
Applicators (2.5-L and 5-L bottles)
Applicators are available for use with Dectomax Pour-On
solution supplied in 2.5- and 5-L backpacks. Directions for 2
recommended applicators are provided below. Some applicators may be
incompatible with this formulation.
Phillips Pour-on Applicator System
1. Replace the shipping cap on 2.5- or 5-L backpack with
the draw-off cap provided and tighten firmly.
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. Pump 3-4 short strokes ensuring
that the piston reaches the end of the cylinder, and 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.
7. Follow the manufacturer's recommendation for care and
maintenance of the dosing applicator.
8 Remove the draw-off cap. Replace with the original
cap and tighten firmly.
Syrvet Pour-on Applicator System
1. Replace the shipping cap on the 2.5- or 5-L backpack
with the draw-off cap provided and tighten firmly.
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.
8. Follow the manufacturer's recommendation for care and
maintenance of the dosing applicator.
9. Remove the draw-off cap. Replace with the original
cap and tighten firmly.
WARNING: Flammable! Keep away from heat,
sparks, open flame, and other sources of ignition. Not for human use.
Keep out of reach of children. The Material Safety Data Sheet (MSDS)
contains more detailed occupational safety information. To report
adverse effects in users, to obtain more information, or to obtain an
MSDS, call 1-800-366-5288.
Dectomax Pour-On solution for cattle may be irritating
to human skin and eyes, and users should be careful not to apply it to
themselves or to other persons. Operators should wear protective
clothing including a long-sleeved shirt, rubber gloves, and boots with a
waterproof coat when applying the product. Protective clothing should
be washed after use. If accidental skin contact occurs, wash the
affected area immediately with soap and water. If accidental eye
exposure occurs, flush the eyes immediately with water and get medical
attention.
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RESIDUE WARNING: Cattle must not be
slaughtered for human consumption within 45 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.
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PRECAUTIONS:
Dectomax Pour-On solution has been
developed specifically for use in cattle only. This product should not
be used in other animal species as severe adverse reactions, including
fatalities in dogs, may result.
This product is to be applied to skin surface only. Do
not administer orally or parenterally.
Do not apply to areas of skin which are caked with mud
or manure.
Wash hands after use.
Do not smoke or eat while handling the product.
Cloudiness in the formulation may occur when Dectomax
Pour-On solution is stored at temperatures below 0°C (32°F). Allowing to
warm to room temperature will restore the normal appearance without
affecting efficacy.
Dectomax Pour-On solution is highly effective against
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 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 Dectomax Pour-On 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.
USE CONDITIONS: Varying weather
conditions, including rainfall, do not affect the efficacy of Dectomax
Pour-On.
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 cattle to enter lakes, streams or ponds for at least 6 hours
after treatment. 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)
Protect From Light
HOW SUPPLIED: Dectomax Pour-On
solution is available in 250-mL, 1-L, 2.5-L, and 5-L multi-dose
containers.
NADA #141-095, Approved by FDA
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: Pfizer Animal
Health, Exton, PA 19341, USA, Div. of Pfizer Inc, NY, NY 10017
69-5269-00-9
NAC No.: 36900322