Profender 150 mg/30 mg Modified-Release Tablets for Large Dogs

Procox is effective against the replication of coccidia and against the shedding of
oocysts. Replication of the parasite damages the dog’s intestinal mucosa, which may
cause enteritis. Therefore, treatment with Procox does not resolve clinical symptoms
arising from mucosal damage (e.g. diarrhoea) that have arisen before treatment. In
such cases supportive treatment may be necessary.
Treatment against should aim to minimize the shedding of oocysts into the
environment, thereby reducing the risk for reinfection in groups/kennels with known
and recurring Isospora infections.
A prevention strategy, including efforts to eliminate the infection, should be initiated.
Treatment with Procox is included as one of several measures necessary in such a
strategy.
It is important that hygienic measures are implemented, in particular to ensure the
environment is as dry and clean as possible, in order to prevent reinfection from the
environment. Isospora oocysts are resistant to many disinfectants and can survive in
the environment for extensive periods of time. Prompt removal of faeces before
oocyst sporulation (within 12 hours) reduces the likelihood of transmission of
infection. One administration of Procox to a litter/group is generally sufficient to
reduce the shedding of Isospora
of clinical disease due to infection, each litter should be treated for an
extended period of time in order to control, and gradually reduce, the level of
infection. All dogs at risk of infection within the group should be treated at the same
time, including adult animals as they may be subclinically infected. Diagnostic
methods (faecal flotation) to determine the presence and level of oocyst shedding
within groups of animals could be useful at the end of a control program in order to
monitor its success.
As with any parasiticide product, the frequent and long term use of anthelmintics or
antiprotozoals may lead to the development of resistance. An appropriate treatment
regimen established by a veterinarian will ensure adequate parasite control and
reduce the likelihood of resistance developing. Unnecessary use of the product
should be avoided. Repeated treatment is indicated only if mixed infection with
coccidia and nematodes, as described in section 4.2, is still suspected or
demonstrated.

Revised: November 2023
AN: 01821/2023

Special precautions for use in animals
Procox is not recommended to be used in dogs of Collie or related breeds that carry
or are suspected to carry the mdr1 -/- mutation, because the tolerance of the product
in mdr1 -/- mutant puppies has been shown to be lower than in other puppies.
Emodepside is a substrate for P-glycoprotein.
There is limited experience with severely debilitated dogs or dogs with seriously
compromised kidney or liver function. Therefore, the veterinary medicinal product
should only be used in such animals according to a benefit/risk assessment by the
responsible veterinarian.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Do not eat, drink or smoke while handling the veterinary medicinal product.
Wash hands after use.
In case of accidental spillage onto skin, wash off immediately with soap and water.
If the veterinary medicinal product accidentally gets into the eyes, they should be
thoroughly flushed with plenty of water.
In case of accidental ingestion, especially in the case of children, seek medical
advice immediately and show the package leaflet or the label to the physician.