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Contra-indications, warnings, etc
Contraindications
Do not use in cases of hypersensitivity to the active substances or to any of the excipients. Do not use during the 1st and 2nd third of pregnancy (see “Special warnings” section).
Special warnings
Fleas serve as intermediate hosts for one common type of tapeworm - Dipylidium caninum. Tapeworm infestation is certain to re-occur unless control of intermediate hosts such as fleas, mice etc. is undertaken.
Special precautions for use in the target species:
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. To minimise the risk of reinfestation and new infestation, excreta should be collected and properly disposed of for 24 hours following treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. In the interests of good hygiene, persons administering the product directly to a dog or by adding it to the dog’s food should wash their hands afterwards.
Other precautions:
Since it contains praziquantel, the product is effective against Echinococcus spp. which do not occur in all EU member states but are becoming more common in some. Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.
Adverse reactions
Dogs :
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
Digestive tract disorders (e.g.,vomiting and diarrhoea)1 ,
Anorexia, Lethargy,
Hyperactivity.
1 Mild and transient.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details
Pregnancy and lactation
Teratogenic effects attributed to high doses of febantel administered during early pregnancy have been reported in rats, sheep and dogs. The safety of the product has not been investigated during the 1st and 2nd third of pregnancy. Do not use in pregnant dogs during the 1st and 2nd third of pregnancy (see “Contraindications” section).
A single treatment during the last third of pregnancy or during lactation has been demonstrated safe.
Interaction with other medicinal products and other forms of interaction
The anthelmintic effects of this product and piperazine containing products may be antagonized when the two drugs are used together.
Overdose
No signs of adverse reactions were observed in safety studies in dogs and pups following administration of 10 times the recommended dose of the product.
Disposal
UK: Medicines should not be disposed of via wastewater.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.