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Contra-indications, warnings, etc
Do not use simultaneously with piperazine compounds.
Do not use in animals with a known sensitivity to the active ingredients or to any of the excipients.
Special warnings
Fleas serve as intermediate hosts for one common type of tapeworm – Dipylidium caninum. Tapeworm infestation is certain to reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken.
Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:
∙ Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
∙ Underdosing, which may be due to underestimation of body weight, misadministration of the product.”
Special precautions for use in animals
Special precautions for safe use in the target species:
To ensure administration of a correct dose, body weight should be determined as accurately as possible.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental ingestion, seek medical advice and show the package leaflet to the physician.
In the interests of good hygiene, persons administering the tablets directly to the dog, or by adding them to the dog’s food, should wash their hands afterwards.
Special precautions for the protection of the environment:
Not applicable.
Other precautions:
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 followup, and on the safeguard of persons, need to be obtained from the relevant competent authority.
Adverse reactions (frequency and seriousness)
Dogs:
Very rare (<1 animal/10,000 animals treated, including isolated reports):
Digestive tract disorders (diarrhoea, emesis)
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 its local representative or the national competent authority via the national reporting system. See also the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Teratogenic effects attributed to high doses of febantel have been reported in sheep and rats. No studies have been performed in dogs during early pregnancy. Use of the product during pregnancy should be in accordance with a benefit risk assessment by the responsible veterinarian. It is recommended that the product is not used in dogs during the first 4 weeks of pregnancy. Do not exceed the stated dose when treating pregnant bitches.
Interaction with other medicinal products and other forms of interaction
Do not use simultaneously with piperazine compounds as the anthelmintic effects of pyrantel and piperazine may be antagonized.
Concurrent use with other cholinergic compounds can lead to toxicity.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The combination of praziquantel, pyrantel embonate and febantel is well tolerated in dogs. In safety studies, a single dose of 5 times the recommended dose or greater gave rise to occasional vomiting.
Withdrawal period(s)
Not applicable.
Interaction with Other medicnial products and other forms of interaction
Do not use simultaneously with piperazine compounds as the anthelmintic effects of pyrantel and piperazine may be antagonised.
Concurrent use with other cholinergic compounds can lead to toxicity.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The combination of praziquantel, pyrantel embonate and febantel is well tolerated in dogs. In safety studies, a single dose of 5 times the recommended dose or greater gave rise to occasional vomiting.