Product
Description:
PROFENDER [1.98% emodepside/7.94%
praziquantel] Topical Solution is a clear yellow ready-to-use solution
packaged in single unit dosing applicator tubes for topical (dermal)
treatment of cats 8 weeks of age and older and weighing at least 2.2 lbs (1
kg). The formulation and dosage schedule is designed to provide a minimum of
1.36 mg/lb (3 mg/kg) emodepside and 5.45 mg/lb (12 mg/kg) praziquantel based
on body weight.
Indications:
PROFENDER Topical Solution is
indicated for the treatment and control of hookworm infections caused by
Ancylostoma tubaeforme (adults, immature adults,
and fourth stage larvae), roundworm infections caused by
Toxocara cati (adults and fourth stage larvae), and tapeworm infections
caused by Dipylidium caninum (adults) and
Taenia taeniaeformis (adults) in cats.
Dosage and
Administration:
The recommended minimum dose
is 1.36 mg/lb (3 mg/kg) emodepside + 5.45 mg/lb (12 mg/kg) praziquantel as a
single topical dose. A single treatment is effective and a second treatment
should not be necessary. If re-infection occurs, the product can be
re-applied after 30 days.
1. Select the package that
correctly corresponds with the body weight of the cat. (See Table below.)
|
Cat
Weight* |
Profender Topical Solution |
Volume (mL) |
Emodepside (mg) |
Praziquantel (mg) |
|
2.2-5.5 lbs. |
Small |
0.35 |
7.5 |
30.0 |
|
>5.5-11 lbs. |
Medium |
0.70 |
15.0 |
60.1 |
|
>11-17.6 lbs. |
Large |
1.12 |
24.0 |
96.1 |
* Cats over 17.6 lbs. should
be treated with the appropriate combination of tubes.
2. Remove one unit dose tube
from the package.
3. While holding the tube in
an upright position, remove the cap from the tube.
4. Turn the cap over and place
the other end of cap onto the tip of the tube.
5. Twist the cap to break the
seal and then remove cap from the tube. Remove the cap from the tube.
6. Part the hair on the
back of the cat's neck at the base of the head, until the skin is
visible.
7. To ensure the entire
contents of the tube are administered, place the tip of the tube on the
skin and squeeze the entire contents directly onto the skin. Lift tube
away from the skin before releasing pressure on the tube.
Do not apply to broken
skin or if hair coat is wet. Do not get this product in the cat's mouth
or eyes or allow the cat to lick the application site for one hour. Oral
exposure can cause salivation and vomiting. Treatment at the base of the
head will minimize the opportunity for ingestion while grooming. In
households with multiple pets, keep animals separated to prevent licking
of the application site.
Stiff hair, a damp
appearance of the hair, or a slight powdery residue may be observed at
the treatment site. These effects are temporary and do not affect the
safety or effectiveness of the product.
Human
Warning:
Not for human use. Keep
out of reach of children.
To prevent accidental
ingestion of the product, children should not come in contact with the
application site for twenty-four (24) hours while the product is being
absorbed.
Pregnant women, or women
who may become pregnant, should avoid direct contact with, or wear
disposable gloves when applying, this product. Studies performed in rats
and rabbits suggest that emodepside may interfere with fetal development
in those species.
PROFENDER Topical Solution
may be irritating to skin and eyes. Reactions such as facial, tongue and
hand swelling have been reported in humans in rare instances. Avoid
contact with the application area while it is wet and wash hands
thoroughly with soap and warm water after handling. People with known
hypersensitivity to butylhydroxyanisole, emodepside or praziquantel
should administer the product with caution. If the product accidentally
gets into eyes, flush thoroughly with water. May be harmful if
swallowed. In case of accidental ingestion or if skin or eye irritation
occurs, call a poison control center or physician for treatment advice.
Precautions:
Safe use of this product
has not been evaluated in cats less than 8 weeks of age or weighing less
than 2.2 lbs (1 kg), in cats used for breeding, during pregnancy or in
lactating queens. The effectiveness of this product when used before
bathing has not been evaluated.
Use with caution in sick
or debilitated cats. Oral ingestion or exposure should be avoided.
Use with caution in
heartworm positive cats. The cats enrolled in the field study were
heartworm antigen and antibody negative prior to entering the study. In
a laboratory study, cats artificially infected with adult heartworms and
treated with PROFENDER Topical Solution had fewer worms recovered than
the placebo control group.
Effectiveness:
In a total of 13
controlled laboratory studies to establish effectiveness, 149 cats were
treated with PROFENDER Topical Solution. In the field study conducted at
13 veterinary clinics/hospitals, 837 purebred or crossbred cats from
single and multi-cat households were enrolled to evaluate safety and
effectiveness under field conditions of use. Of those, 606 received a
single treatment with PROFENDER Topical Solution. Cats ranged in age
between 2 months and 17 years and weighed between 0.8 lbs (0.36 kg) and
21 lbs (9.62 kg). Data from these studies demonstrated PROFENDER Topical
Solution is safe and effective for the treatment and control of hookworm
infections caused by Ancylostoma tubaeforme
(adults, immature adults, and fourth stage larvae), roundworm infections
caused by Toxocara cati (adults and fourth
stage larvae), and tapeworm infections caused by
Dipylidium caninum (adults) and Taenia
taeniaeformis (adults).
STORAGE
INFORMATION:
Store at or below 77°F
(25°C).
Protect from freezing.