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Date: Thursday, December 2, 2021 16:08

Description: LOG_VETOQUINOL_CMYK_TAGLINE 2015
Release 5.552
Profender Spot-on Solution
 
Species: Cats
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cats, Tapeworm products
Active ingredient: Emodepside, Praziquantel
Product:Profender® Spot-on Solution for small cats
Profender® Spot-on Solution for medium cats
Profender® Spot-on Solution for large cats
Product index: Profender Spot-on Solution
Incorporating:Profender 30 mg/7.5 mg spot-on solution for small cats
Profender 60 mg/15 mg spot-on solution for medium cats
Profender 96 mg/24 mg spot-on solution for large cats
Presentation
Profender spot-on solution for cats is a clear yellow to brown solution containing 21.4 mg/ml emodepside and 85.8 mg/ml praziquantel, with 5.4 mg/ml butylhydroxyanisole (E320) as antioxidant. The product is presented in a single use plastic pipette for dermal (spot-on) application.
Profender spot-on solution for small cats is a 0.35 ml pipette containing 7.5 mg emodepside and 30 mg praziquantel.
Profender spot-on solution for medium cats is a 0.70 ml pipette containing 15 mg emodepside and 60 mg praziquantel.
Profender spot-on solution for large cats is a 1.12 ml pipette containing 24 mg emodepside and 96 mg praziquantel.
Uses
For cats suffering from, or at risk from, mixed parasitic infections caused by roundworms, tapeworms and lungworms of the following species:
Roundworms (Nematodes)
Toxocara cati (mature adult, immature adult, L4 and L3)
Toxocara cati (L3 larvae) – treatment of queens during late pregnancy to prevent lactogenic transmission to the offspring
Toxascaris leonina (mature adult, immature adult and L4)
Ancylostoma tubaeforme (mature adult, immature adult and L4)
Tapeworms (Cestodes)
Dipylidium caninum (mature adult and immature adult)
Taenia taeniaeformis (adult)
Echinococcus multilocularis (adult)
Lungworms
Aelurostrongylus abstrusus (adult)
Dosage and administration
Dosage and Treatment Schedule
See Table 1.
The recommended minimum doses are 3 mg emodepside/kg body weight and 12 mg praziquantel/kg body weight, equivalent to 0.14 ml Profender/kg body weight.
Table 1:
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
>8
Use an appropriate combination of pipettes
For the treatment of roundworms and tapeworms a single administration per treatment is effective.
For the treatment of queens to prevent lactogenic transmission of Toxocara cati (L3 larvae) to the offspring, a single administration per treatment approximately seven days prior to expected parturition is effective.
For the lungworm Aelurostrongylus abstrusus, two treatments administered two weeks apart are effective.
Method of administration
For external use only.
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. See Figure 1.
Description: h-305
Figure 1: Opening a pipette
Part the fur on the cat’s neck at the base of the skull 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 minimise the ability of the cat to lick the product off. See Figure 2.
Description: h-306Description: h-307
Figure 2: Administration
Use During Pregnancy and Lactation
Profender can be used during pregnancy and lactation.
Contra-indications, warnings, etc
Do not use in kittens under 8 weeks of age or weighing less than 0.5 kg.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Apply only to the skin surface and on intact skin. Do not administer orally or parenterally.
Avoid the treated cat or other cats in the household licking the site of application while it is wet.
Salivation and vomiting may occur in very rare cases. Mild and transient neurological disorders such as ataxia or tremor may occur in very rare cases. These effects are thought to occur as a result of the cat licking the application site immediately after treatment. In very rare cases following administration of Profender transient alopecia, pruritus and/or inflammation were observed at the application site.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Salivation, vomiting and neurological signs (tremor) were observed occasionally when the product was administered at up to 10 times the recommended dose in adult cats and up to 5 times the recommended dose in kittens. These symptoms were thought to occur as a result of the cat licking the application site. The symptoms were completely reversible. There is no known specific antidote.
Emodepside is a substrate for P-glycoprotein. Co-treatment with other drugs that are P-glycoprotein substrates/inhibitors (for example, ivermectin and 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.
Shampooing or immersion of the animal in water directly after treatment may reduce the efficacy of the product. Treated animals therefore should not be bathed until the solution has dried.
There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a benefit-risk assessment for these animals.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
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.
User Safety
Read the package leaflet before use.
Do not smoke, eat or drink during application.
Avoid direct contact with application area while it is wet. Keep children away from treated animals during that time.
Wash hands after use.
In case of accidental spillage onto skin, wash off immediately with soap and water.
If the product accidentally gets into eyes, they should be thoroughly flushed with plenty of water.
If skin or eye symptoms persist, or in case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Care should be taken not to allow children to have prolonged intensive contact (for example, by sleeping) with treated cats during the first 24 hours after application of the product.
Environmental Safety
Profender should not be allowed to enter water courses as emodepside has shown harmful effects on aquatic organisms.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Pharmaceutical precautions
Store in the original package in order to protect from moisture.
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Legal category
Legal category: POM-V
Packaging quantities
White polypropylene pipettes with caps in aluminium blisters. Blister packs containing 2 or 20 unit dose pipettes.
Further information
Pharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code: QP52AA51.
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, Toxascaris leonina, Ancylostoma tubaeforme, and Aelurostrongylus abstrusus.
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, Echinococcus multilocularis, and Taenia taeniaeformis.
Praziquantel is rapidly absorbed 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.
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.
Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the OIE, specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Holder
Vetoquinol S.A.
Magny-Vernois
70200 Lure
France
Marketing Authorisation Number
UK (GB)06462/5011 Profender Spot on Solution for Small Cats
UK (GB)06462/5010 Profender Spot on Solution for Medium Cats
UK (GB)06462/5009 Profender Spot on Solution for Large Cats
UK (NI) EU/2/05/054/001 Profender Small Cats (2 pack)
UK (NI) EU/2/05/054/004 Profender Small Cats (20 pack)
UK (NI) EU/2/05/054/006 Profender Medium Cats (2 pack)
UK (NI) EU/2/05/054/009 Profender Medium Cats (20 pack)
UK (NI) EU/2/05/054/012 Profender Large Cats (2 pack)
UK (NI) EU/2/05/054/015 Profender Large Cats (20 pack)
Significant changes
GTIN
GTIN description:Profender Spot-on Solution for Small Cats (2 Pack)
GTIN:05032756401010
GTIN description:Profender Spot-on Solution for Small Cats (20 Pack)
GTIN:04007221040019
GTIN description:Profender Spot-on Solution for Medium Cats (2 Pack)
GTIN:05032756406015
GTIN description:Profender Spot-on Solution for Medium Cats (20 Pack)
GTIN:04007221040002
GTIN description:Profender Spot-on Solution for Large Cats (2 Pack)
GTIN:05032756412016
GTIN description:Profender Spot-on Solution for Large Cats (20 Pack)
GTIN:04007221040026