Profender Topical Parasiticide for Small Cats (Canada)

This page contains information on Profender Topical Parasiticide for Small Cats for veterinary use.
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  • Profender Topical Parasiticide for Small Cats Indications
  • Warnings and cautions for Profender Topical Parasiticide for Small Cats
  • Direction and dosage information for Profender Topical Parasiticide for Small Cats

Profender Topical Parasiticide for Small Cats

This treatment applies to the following species:
Manufacturer: Bayer

(emodepside/praziquantel)

Topical parasiticide for cats and kittens 8 weeks of age and older, weighing 0.5 to 2.5 kg.

DIN 02316137

Topical parasiticide for cats and kittens 8 weeks of age and older, weighing 2.6 to 5.0 kg.

DIN 02316145

Topical parasiticide for cats 8 weeks of age and older, weighing 5.1 to 8.0 kg.

DIN 02316153

VETERINARY USE ONLY

Description

Profender® (emodepside + praziquantel) topical parasiticide is a clear yellow to brownish ready-to-use solution packaged in unit dosing applicator tubes for treatment of cats and kittens 8 weeks of age and older. The formulation and dosage schedule is designed to provide a minimum of 3 mg of emodepside and 12 mg of praziquantel per kg of body weight.

Pharmacodynamics

Emodepside is a semi-synthetic compound belonging to the new chemical group of depsipeptides. It is active against roundworms (ascarids and hookworms). In this product, emodepside is responsible for the efficacy against Toxocara cati and Ancylostoma tubaeforme. It acts at the neuromuscular junction by stimulating presynaptic receptors belonging to the secretin receptor family which results in paralysis and death of the parasites.

Praziquantel is a pyrazinoisoquinoline derivative effective against tapeworms such as Dipylidium caninum and Taenia taeniaeformis.

Praziquantel is rapidly adsorbed via the surface of the parasites and acts primarily by changing the Ca++ permeability of the parasite membranes. This results in severe damage to the parasite integument, contraction and paralysis, disruption of metabolism and finally leads to the death of the parasite.

Pharmacokinetics

After topical application of this product to cats at the minimum therapeutic dose of 0.14 ml/kg bodyweight, mean maximum serum concentrations of 32.2 ± 23.9 µg emodepside/L and 61.3 ± 44.1 µg praziquantel/L were observed. Maximum concentrations were reached for emodepside 3.2 ± 2.7 days after application and 18.7 ± 47 hours for praziquantel. Both active substances are then slowly eliminated from the serum with a half-life of 9.2 ± 3.9 days for emodepside and 4.1 ± 1.5 days for praziquantel. After oral application in the rat, emodepside is distributed to all organs. Highest concentration levels are found in the fat. Faecal excretion predominates with unchanged emodepside and hydroxylated derivatives as the major excretion products. Studies in many different species show that praziquantel is rapidly metabolised in the liver. The main metabolites are monohydroxycyclohexyl derivatives of praziquantel. Renal elimination predominates.

Profender Topical Parasiticide for Small Cats Indications

Profender® topical parasiticide is indicated in cats and kittens, 8 weeks of age and older, for the treatment and control of parasitic infections caused by the developing L4, the sexually immature adult and the adult stages of hookworms (Ancylostoma tubaeforme) and ascarids (Toxocara cati) and all intestinal stages of tapeworms (Dipylidium caninum and Taenia taeniaeformis).

DOSAGE:

Apply to the skin at the recommended minimum dose of 3 mg of emodepside and 12 mg of praziquantel per kg of body weight, equivalent to 0.14 ml Profender® topical parasiticide per kg of body weight.

ADMINISTRATION:

Remove one pipette from package. Hold pipette in upright position, twist and pull off cap and use the opposite end of the cap to break the seal.

Part the fur on the cat’s neck the base of the shall until the skin is visible. Place the tip of the pipette on the skin and squeeze firmly several times to empty the contents directly onto the skin. Application on the base of the skull will minimize the ability of the cat to lick the product off.

Apply only to the skin surface and on intact skin as specified in the following table:

Body Weight of cat (kg)

Pipette size to be used

Volume (ml)

Emodepside
(mg/kg bw)

Praziquantel
(mg/kg bw)

≥ 0.5 - 2.5

Profender® for Small Cats

0.35

3 - 15

12 - 60

> 2.5 - 5

Profender® for Medium Cats

0.70

3 - 6

12 - 24

> 5 - 8

Profender® for Large Cats

1.12

3 - 4.8

12 - 19.2

* Cats over 8 kg should be treated with the appropriate combination of Profender® topical parasiticide tubes.

Treatment and Control of Intestinal Nematode and Cestode Infections:

Profender® will treat parasitic infections due to the developing L4, the sexually immature adult and the adult stages of hookworms (Ancylostoma tubaeforme) and ascarids (Toxocara cati) and all intestinal stages of tapeworms (Dipylidium caninum and Taenia taeniaeformis). Monthly administration of Profender®, or as directed by a veterinarian, will control the development of these intestinal nematodes and cestodes in cats.

Warning

Keep this product, and all drugs, out of the reach of children. May be irritating to skin and eyes. If contact with eyes occurs, flush eyes copiously with water. If eye irritation persists, contact a physician. Wash hands after use. Avoid direct contact with application area while it is wet. If contact with skin occurs, wash skin immediately with soap and water. If ingested, contact a physician immediately.

Profender Topical Parasiticide for Small Cats Caution

Use with caution in sick, debilitated, or underweight animals. Do not use in kittens under 8 weeks of age or weighing less than 0.5 kg. Do not administer orally or parenterally. Salivation and vomiting may occasionally occur. This is thought to occur as a result of the cat licking the application site immediately after treatment.

Emodepside is a substrate for P-glycoprotein. Co-treatment with other drugs that are P-glycoprotein substrates/inhibitors (for example, other antiparasitic macrocyclic lactones, erythromycin, prednisolone and cyclosporine) could give rise to pharmacokinetic drug interactions. The potential clinical consequences of such interactions have not been investigated. The solvent in this product may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

The reproductive safety of Profender® topical parasiticide has not been demonstrated in male breeding cats.

SAFETY IN CATS AND KITTENS:

General Safety In Kittens

The safety of Profender® topical parasiticide in kittens was assessed in one study in which approximately 7 week old kittens were dermally treated 6 times in 2 week intervals with three different dosages of Profender® which corresponded approximately to one (1X), three (3X) and five (5X) times the maximum dose a kitten would receive in the field. The control group was treated with five times (5X) the equivalent volume of placebo.

The clinical signs observed in this study were mild and attributable to oral exposure to the formulation. In two kittens of the highest dose-group tremors were observed on one occasion. In one of the kittens the tremors occurred on the day of the first treatment and were localized (formulation was seen on the forelimbs). The other kitten showed a mild tremor on the day after the first treatment. In both animals these signs were fully reversible. Three cats in the “5X” group salivated after treatment. Vomiting in close connection with a treatment was observed in two cats of the “3X” group on one occasion and in one cat of the placebo group on one occasion. No clinical signs attributable to the treatment were observed in the kittens of the “1X” group. No treatment effects were observed with regard to body weight, food intake, urinalysis, haematology/clinical chemistry and pathology. The results of the general safety study demonstrated a significant margin of safety following up to 6 topical administrations of Profender® to kittens at 14 day intervals.

Dose Tolerance Is Adult Cats

A study was conducted to demonstrate the dermal tolerance of Profender® when administered at 10 times the recommended unit dosage. There were no clinical signs in connection with the treatment other than those which are due to oral exposure like salivation (2 cats treated with Profender®, 1 cat treated with Placebo) and mild tremor followed by transient depression (1 cat treated with Profender®). The cat with the mild tremor was seen to have the application site wet from licking. No treatment effects were observed with regard to body weight, food intake, urinalysis, haematology and clinical chemistry. The results of the dose tolerance study demonstrated a significant safety margin for the dermal application of Profender® to adult cats.

Oral Safety In Adult Cats

An oral safety study was conducted to investigate the safely of an inadvertent oral uptake of Profender® in adult cats. Oral application of the recommended unit dosage lead to salivation in 6 cats and vomiting in 2 cats, one of which was also found to have vomited on the following day. Salivation and vomiting were clinical signs which were expected in reaction to the application of an oral irritant.

None of the cats in the control group which were treated with tap water showed any clinical signs in reaction to the treatment. A slight weight loss (~1.8%) in the group treated with investigational product was not considered to be biologically relevant. No treatment effects were observed with regard to food intake, urinalysis, haematology and clinical chemistry. This study demonstrated that the inadvertent oral administration of Profender® poses no serious safety concerns.

Safety In Pregnant And Lactating Queens

A study was conducted to investigate the safety of Profender® when applied during pregnancy and lactation. Profender® was administered three times during pregnancy and three times during lactation at one (1X) or three (3X) times the maximum therapeutic dose for medium sized cats and compared with a treatment with tap water. No local or general clinical signs associated with the treatment were observed in any of the queens and no clinical signs which could be related to the treatment given to the mothers were observed in the kittens. There were no biologically relevant differences between groups with regard to body weight, haematology and clinical chemistry of queens and kittens. Gestation rates, mean gestation length, litter size, viability index and the ratio of male to female kittens and percentage of postnatal losses were considered to be unaffected by the treatment. It was concluded that there was no effect of treatment of queens on mothering and on kitten viability. All 89 kittens born were free of externally visible defects. Thus it was concluded that there was no indication of a fetotoxic or teratogenic potential. The results of this study demonstrated a significant margin of safety for the administration of Profender® during pregnancy and lactation.

Clinical Field Study

The safety and efficacy of Profender® was confirmed in a clinical field study conducted with 146 client owned cats with natural nematode or cestode infection.

In this study 100 cats were treated with Profender® according to the proposed dose regimen. No adverse reactions were reported by owners or recorded by the investigators who carried out a clinical examination 7 to 13 days after treatment.

Target Animal Tolerance - Conclusions

A significant safety margin was demonstrated for dermal overdoses of Profender® in kittens (up to 5 times the maximum dose a kitten would receive in the field) and adult cats (10 times the recommended unit dosage). The clinical signs which were observed can all be attributed to oral uptake of the product. Although it was attempted in all of the target animal safety studies to apply the product in a manner that the cats could not easily reach the application site it was not possible to prevent them from oral uptake by grooming and licking the application site when high doses were applied, especially in kittens. The clinical signs which were associated with oral exposure were generally mild and reversible and included salivation and vomiting. In rare cases mild tremors were observed in cats which were treated with high overdoses. Similarly, direct oral application of the dermal therapeutic dose to adult cats caused transient salivation and vomiting in a few animals. These are normal defence mechanisms to an oral irritant, therefore these clinical signs were not unexpected. Profender® was safe in pregnant and lactating queens and their progeny. There is no evidence for a breed sensitivity or an incompatibility with concomitantly applied treatments. After use of the product within the scope of the pharmacokinetic and the efficacy studies very few clinical signs were observed.

Storage

Store at or below 30° C. Protect from freezing.

How Supplied

Code Number

Applications Per Package

81069388

40 - 0.35 mL tubes (10 blisters of 4 tubes)

81069361

40 - 0.70 mL tubes (10 blisters of 4 tubes)

81074217

24 - 1.12 mL tubes (6 blisters of 4 tubes)

® Bayer, Bayer Cross and Profender are trademarks of Bayer AG, used under license by Bayer Inc.

Bayer Inc., 77 Belfield Road, Toronto, ON., M9W 1G6

79572263

NAC No.: 12230450

BAYER HEALTHCARE
Animal Health Division, Bayer Inc.

77 BELFIELD ROAD, TORONTO, ON, M9W 1G6
Telephone:   416-248-0771 or 800-268-1331
Toll-Free:   800-62-BAYER
Order Desk:   800-387-9179
Order Desk Fax:   800-361-3306
Fax:   416-240-4918
Website:   www.animalhealth.bayer.ca
Every effort has been made to ensure the accuracy of the Profender Topical Parasiticide for Small Cats 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 © 2014 North American Compendiums. Updated: 2014-07-28

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