Name
PRALEN 120 MG/G + 10 MG/G ORAL DROPS, SUSPENSION FOR CATS, PUPPIES AND SMALL DOGS
Pharmacotherapeutic Group
Anthelmintics.
Active Ingredients
Each g contains the active substances: micronised mebendazole 120 mg; praziquantel (microencapsulated) 10 mg.
Excipients
Malt extract, hard paraffin (white petrolatum), potassium dihydrogen phosphate, cellulose acetate phthalate, saccharin sodium, light liquid paraffin (mineral oil).
Indications
Treatment of parasitic infestations in dogs and cats caused by nematodes (roundworms) and cestodes (flatworms). Cats: Toxocara cati, Toxascaris leonina, Ancylostoma tubaeformae, Ancylostoma braziliense, Strongyloides spp., Taenia spp., Dipylidium caninum, Mesocestoides spp., Echinococcus spp.. Dogs: 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.. When the veterinary medicinal product is administered as directed, adult parasites disappear completely; to eliminate the larval forms of ascarids and hookworms, the full treatment must be repeated 60 days after the end of the first treatment for ascarid infestations and 18 days after for hookworm infestations. Elimination of parasites begins from the very first administration; eggs usually disappear completely within 10-15 days of the last administration. Therefore the follow-up faecal examination should be carried out after this period has elapsed.
Contraindications/Undesirable Effects
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Safety in Target Species
Excessive doses may cause vomiting, which occurs for mebendazole above 500 mg/kg in dogs and 300 mg/kg in cats, and for praziquantel at 200 mg/kg in dogs.
Dosage
For oral use. One drop of suspension contains 3.75 mg of mebendazole and 0.312 mg of praziquantel. Give 8 drops per kg of body weight per day for two consecutive days, equal to 30 mg/kg b.w./day of mebendazole and 2.5 mg/kg b.w./day of praziquantel. To ensure a correct dose, body weight should be determined as accurately as possible. Always round the animal's weight up to the next whole number. Underdosing could result in ineffective use and may favour the development of resistance. The veterinary medicinal product can be given to puppies and kittens even in the first weeks of life. The drops are palatable to animals; they can be given directly into the mouth or mixed with food the animal likes. During treatment the animal loses neither liveliness nor appetite. Shake very vigorously before use until the sediment is completely redispersed.
Storage
Do not store above 25 °C. Keep the bottle tightly closed. Shelf life of the veterinary medicinal product as packaged for sale: 5 years.
Warnings
To achieve effective parasite control, treatment should be based on the results of a parasitological faecal examination. The decision to use the veterinary medicinal product should be based on confirmation of the parasite species and burden, or of the risk of infestation based on its epidemiological features, for each individual animal. Parasite resistance to a particular class of anthelmintics may develop following frequent, repeated use of an anthelmintic of the same class. Unnecessary use of antiparasitics, or use deviating from the instructions given in the Summary of Product Characteristics, may increase resistance selection pressure and lead to reduced efficacy. In the case of a confirmed single infestation by cestodes or nematodes, a monovalent product containing only a cestocide or a nematocide should be preferred. The possibility that other animals in the same environment may be a source of reinfestation by nematodes and cestodes should be considered, and these should be treated as necessary with an appropriate veterinary medicinal product. In the case of Dipylidium caninum infestations, appropriate control measures against fleas, which act as vectors, are necessary to prevent reinfestation. Special precautions for safe use in the target species: it is not necessary to give purgatives or to fast the animal during treatment; during deworming it is good practice to give animals lighter meals than usual. It is preferable to administer the veterinary medicinal product on an empty stomach together with a little food the animal likes. During and after treatment, especially in kennels or breeding facilities, appropriate disinfestation of the premises is necessary to prevent reinfestation. It is also advisable to chemically denature the faeces passed by treated animals in order to interrupt the parasite life cycle. Special precautions to be taken by the person administering the veterinary medicinal product to animals: in the event of accidental contact, wash hands thoroughly. People with known hypersensitivity to mebendazole and praziquantel should administer the veterinary medicinal product with caution. Special precautions for the protection of the environment: not applicable. Excessive doses may cause vomiting, which occurs for mebendazole above 500 mg/kg in dogs and 300 mg/kg in cats, and for praziquantel at 200 mg/kg in dogs. Incompatibilities: in the absence of compatibility studies, do not mix with other medicinal products.
Withdrawal Periods
Not applicable.
Target Species
Dogs and cats.
Interactions
None known.
Diagnosis and Prescription
Veterinary medicinal product not subject to prescription.
Undesirable Effects
Dogs and cats. Very rare (< 1 animal / 10,000 animals treated, including isolated reports): vomiting and diarrhoea*, liver disorders. * mild and transient gastrointestinal disorders. Reporting adverse events is important as it allows continuous monitoring of the safety of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to the marketing authorisation holder or to the national competent authority via the national reporting system. See the package leaflet for the respective contact details.
Pregnancy and Lactation
Pregnancy and lactation: although mebendazole has not shown the teratogenic or embryotoxic effects typical of other benzimidazoles, as a precaution its use is not recommended during the first fifteen days of pregnancy. Can be used during lactation.
