WARNINGS
To achieve effective parasite control, treatment should be based on the results of the parasitological examination of feces. The decision to use the veterinary medicinal product should be based on confirmation of the parasitic species and the load, or the risk of infestation based on its epidemiological characteristics, for each individual animal. Resistance of parasites to a particular class of anthelmintics may develop due to frequent and repeated use of an anthelmintic from the same class. Unnecessary use of antiparasitics or use that deviates from the indications provided in the Summary of Product Characteristics may increase the selection pressure for resistance and lead to reduced efficacy. In the case of a single confirmed infestation by cestodes or nematodes, a monovalent product containing a single cestocide or nematocide should be preferred. Consideration should be given to the possibility that other animals in the same environment may be a source of reinfestation by nematodes and cestodes, and these should be treated as necessary with an appropriate veterinary medicinal product. In the case of infestations by Dipylidium caninum, to prevent reinfestation, adequate flea control measures must be implemented. Special precautions for safe use in target species: it is not necessary to administer purgatives or to enforce fasting on the animal during treatment; it is good practice during deworming to provide animals with lighter meals than usual. It is preferable to administer the veterinary medicinal product on an empty stomach and simultaneously with a small amount of palatable food. During treatment and even afterwards, it is necessary to carry out appropriate disinfestation operations in kennels or breeding facilities to avoid reinfestations. Furthermore, it is advisable to chemically denature the feces expelled by treated subjects to interrupt the continuation of the parasitic cycle. Special precautions to be taken by the person administering the veterinary medicinal product to animals: in case of accidental contact, wash hands thoroughly. Individuals with known hypersensitivity to Mebendazole and Praziquantel should administer the veterinary medicinal product with caution. Special precautions for environmental protection: not applicable. Administration of excessive doses may cause vomiting, which occurs for Mebendazole above 500 mg/kg in dogs and 300 mg/kg in cats, for Praziquantel at 200 mg/kg in dogs. Major incompatibilities: not applicable.
PHARMACOTHERAPEUTIC CATEGORY
Anthelmintics.
STORAGE
This veterinary medicinal product does not require any special storage conditions. Store in the original container. Keep the bottle tightly closed. Shelf life of the veterinary medicinal product packaged for sale: 5 years.
CONTRAINDICATIONS/ADVERSE EFFECTS
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
NAME
PRALEN 240 MG + 20 MG CHEWABLE TABLETS FOR SMALL AND MEDIUM DOGS AND CATS
DIAGNOSIS AND PRESCRIPTION
Veterinary medicinal product not subject to prescription.
EXCIPIENTS
Colorant E 110 (sunset yellow) 0.43 mg, colorant black PN (E 151) 0.23 mg, sucrose, corn starch, rice starch, fish meal, maltodextrins, lactose monohydrate, diastatic corn flour, chicken meat meal, magnesium stearate, sodium chloride, potassium dihydrogen phosphate, cellulose phthalate, talc.
ADVERSE EFFECTS
Dog and cat. Very rare (< 1 animal / 10,000 treated animals, including isolated reports): vomiting and diarrhea*, hepatic disorders.* mild and transient gastrointestinal disturbances. Reporting adverse events is important as it allows for continuous monitoring of the safety of a veterinary medicinal product. Reports should preferably be sent through a veterinarian to the marketing authorization holder or the national competent authority via the national reporting system. See the package leaflet for respective contacts.
PREGNANCY AND LACTATION
Pregnancy and lactation: although Mebendazole has not shown teratogenic or embryotoxic effects typical of other benzimidazoles, as a precautionary measure, use is not recommended during the first fifteen days of pregnancy. It can be used during lactation.
INDICATIONS
Treatment of parasitic infestations in dogs and cats caused by nematodes (roundworms) and cestodes (flatworms). Cat: Toxocara cati, Toxascaris leonina, Ancylostoma tubaeformae, Ancylostoma braziliense, Strongyloides spp., Taenia spp., Dipylidium caninum, Mesocestoides spp., Echinococcus spp.. Dog: Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Uncinaria stenocephala, Strongyloides stercoralis, Trichuris vulpis, Taenia ovis, Taenia pisiformis, Taenia hydatigena, Taenia multiceps, Dipylidium caninum, Mesocestoides spp., Echinococcus spp.. With the administration of the veterinary medicinal product according to the indicated methods, total disappearance of adult parasites is achieved; to eliminate larval forms of Ascarids and Ancylostoma, it is necessary to repeat the complete treatment after 60 days for Ascarid infestations and after 18 days for Ancylostoma infestations, from the end of the first treatment. The elimination of parasites begins with the first administration; the complete disappearance of eggs usually occurs within 10-15 days from the last administration. Therefore, the fecal examination for control should be performed after the aforementioned period of time.
INTERACTIONS
None noted.
DOSAGE
For oral use. One tablet for every 8 kg of body weight per day for two consecutive days, equivalent to 30 mg/kg body weight/day of Mebendazole and 2.5 mg/kg body weight/day of Praziquantel. To ensure the administration of a correct dosage, body weight must be determined as accurately as possible. Always round the animal’s weight to the next whole number. Underdosing may result in ineffective use and may promote the development of resistance. The chewable tablet is easily divisible into four parts, each usable to treat 2 kg of animal. Place the tablet on a flat surface with the side bearing the fracture lines facing up. Apply pressure with the thumb at the center of the tablet to achieve division into 4 quarters. The chewable tablets are palatable to animals; they are spontaneously consumed except in rare cases; in these cases, they can be crushed and incorporated into a small amount of palatable food or mixed with kibble. During treatment, the animal does not lose vitality or appetite.
ACTIVE INGREDIENTS
Each tablet contains the active substances: micronized Mebendazole 240 mg; Praziquantel (microencapsulated) 20 mg.
SAFETY IN TARGET SPECIES
Administration of excessive doses may cause vomiting, which occurs for Mebendazole above 500 mg/kg in dogs and 300 mg/kg in cats, for Praziquantel at 200 mg/kg in dogs.
TARGET SPECIES
Dog and Cat.
WITHDRAWAL TIME
Not applicable.
USE/ROUTE OF ADMINISTRATION
For oral use.