Bayer Procox toltrazuril for dogs, 7.5 ml

Bayer Procox is prescribed to puppies and adult dogs for the treatment and prevention of eimeriosis and worm infestation.

Procox oral suspension (emodepside, toltrazuril)

Description

Suspension from white to yellow.

1 ml of suspension contains the active substances:

emodepside – 0.9 mg,

toltrazuril – 18 mg.

Excipients: butylhydroxytoluene (E321), sorbic acid (E200).

Pharmacological properties

PBX vet: QP52AX60, endoparasitic veterinary drugs

The endoparasitic action of the suspension is due to the properties of the active substances – emodepside and toltrazuril.

Emodepside – endoparasiticide, belongs to the group of depsipeptides. Emodepside excites presynaptic latrophilin nerve receptors of gastrointestinal nematodes, leading to their paralysis and death.

Toltrazuril – endoparasiticide, is a derivative of triazinone, acts against eimeria of the genera Eitegia and Isospora. Toltrazuril is effective against all intracellular stages of eimeria development in the stages of merogonia (asexual reproduction) and gametogony (sexual phase), the action of toltrazuril is eimeriocidal.

It is indicated for dogs suffering
from, or at risk from, mixed parasitic infections caused by roundworms and coccidia of certain specified
species.
The benefits of Procox are its efficacy against the replication of coccidia and the shedding of oocysts at
all stages of coccidial infection. The most common side effects are slight and transient digestive tract
disorders, such as vomiting or loose stools.
The approved indication is:
For dogs, when mixed parasitic infections caused by roundworms and coccidia of the following
species are suspected or demonstrated:
Roundworms (Nematodes):
– Toxocara canis (mature adult, immature adult, L4)
– Uncinaria stenocephala (mature adult)
– Ancylostoma caninum (mature adult)
Coccidia:
– Isospora ohioensis complex
– Isospora canis
Procox is effective against the replication of Isospora and also against the shedding of oocysts.

Active substance (toltrazuril)
Toltrazuril is an established active substance but is not described in any pharmacopoeia. The synthesis
has been described in sufficient detail. Adequate information on the synthesis and control of the
starting materials has been provided. The process is evaluated based on representative batches. In the
absence of a pharmacopoeial monograph, emodepside is controlled by a comprehensive in-house
specification. The control tests and specifications for toltrazuril are suitable to ensure a product of
consistent quality is produced. The proposed limits for impurities are justified according to the VICH
guideline on impurities in drug substances. Appropriate validation and batch data have been provided.
Toltrazuril is considered to be a stable substance under VICH conditions. Formal VICH and stress
stability studies have been performed. A re-test period of 24 months in the specified packaging, with
no special storage conditions, is justified by long term data of up to 5 years and 6 months accelerated
stability results.

Active substance (emodepside)
Emodepside is an established active substance but is not described in any pharmacopoeia. It is a semisynthetic compound, the starting material for the chemical synthesis of which is produced by
fermentation of the fungus Mycelia sterilia. All steps in the manufacture of emodepside are well
described. The synthesis has been described in sufficient detail. Adequate information on the synthesis
and control of the starting materials has been provided and the specifications and methods for the
reagents, solvents and intermediates are appropriate. Routine in-process controls are included at each
stage of the process and are considered appropriate. The process is evaluated based on representative
batches. In the absence of a pharmacopoeial monograph, emodepside is controlled by a
comprehensive in-house specification. Methods are described and limits justified where appropriate.
Appropriate validation and batch data have been provided.
Based on the long term and accelerated stability data provided, a retest period of 36 months in the
specified packaging is justified.

Pharmacokinetics

After oral administration of the drug emodepside is transported to all organs, its highest concentration is found in adipose tissue. The main products of metabolism are unchanged emodepside and hydroxylated derivatives. Toltrazuril is slowly absorbed after oral administration. The main metabolite is toltrazuril sulfone. The maximum concentration of emodepside and toltrazuril is detected after 2 hours and after 18 hours, respectively.

Application

Treatment and prevention of dogs affected by mixed invasions caused by gastrointestinal nematodes (mature and immature adults, larvae of L4 Toxocara canis, mature adults Uncinaria stenocephala, mature adults Ancylostoma sapis) and eisomeris Iporapora (Isoporas Isoporais), complex esophagus (Isoporais Isopora).

To stop the division of eimeria and the release of oocysts into the environment.

Treatment of animals with the drug slows the spread of eimeriosis, but is not an effective treatment for the clinical manifestation of the disease.

Dosage

The recommended minimum dose is 0.5 ml of suspension / kg body weight, equivalent to 0.45 mg emodepside / kg body weight and 9 mg toltrazuril / kg body weight. The recommended doses of the drug are given in the table:

1 kilogram (kg) is equal to 2.20 pounds (lbs).1 kg = 2.20 lb

* = from 0.4 to 0.6 kg.

Application

Single use. At invasion by nematodes to repeat treatment in 14 days.

Before use, shake the vial with the drug, open the cap. Turn the vial with the drug upside down, dial the suspension to the required level in a disposable syringe. Return the vial to a vertical position and withdraw the syringe. Inject the suspension with a syringe directly into the animal’s mouth (per os).

To administer the drug to the animal, use a new syringe each time (reuse of the syringe is not possible).

Contraindication

Do not use in puppies under 2 weeks of age and dogs weighing up to 0.4 kg. Do not use in animals with hypersensitivity to the components of the drug.

Do not use in females during pregnancy and in the first two weeks of lactation.

Reservation

In the fight against eimeriosis of animals should be developed a set of measures aimed at eliminating the pathogen, treatment of animals with Procox® is one of such measures.

In dog kennels, if the clinical signs of eimeriosis recur, each offspring should be treated with Procox®. The treatment must be carried out for a long time. All dogs at risk should be treated at the same time, including adult animals, as they may be subclinically ill.

Collie puppies and their crossbreeds may be hypersensitive to Procox®.

The use of the drug in depleted animals, as well as with liver and kidney disease should be based on risk assessment and the need for treatment.

When treating animals with Procox®, do not eat, drink or smoke. Wash hands with soap and water after handling the product. In case of contact with skin, wash immediately with soap and water. In case of contact with eyes, rinse immediately with plenty of water. In case of accidental ingestion, seek medical advice and show the package leaflet or the label to the physician.

Release form

Yellow glass vials with polypropylene lids with a safety device against accidental opening of 7.5 or 20.0 ml are packed in cardboard boxes.

Storage

Store in a closed package in a dry place out of reach of children and animals, separate from food and feed, at a temperature of 0 to 30 ° C.

Shelf life – 2 years. Shelf life after opening the bottle – 10 weeks.

For veterinary use only!