Dogs (adults and puppies).

Treatment of mixed infections by adult cestodes and nematodes of the following species:

Nematodes:

Ascarids: Toxocara canis, Toxascaris leonina (adult and late immature forms).

Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults).

Whipworms: Trichuris vulpis (adults).

Cestodes:

Tapeworms: Echinococcus spp., Taenia spp., Dipylidium caninum (adult and immature forms).

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

Fleas serve as intermediate hosts for one common type of tapeworm – Dipylidium caninum. Tapeworm infestation may reoccur unless control of intermediate hosts such as fleas, mice etc is undertaken.

The product is not recommended for use in puppies of less than 3 kg bodyweight. Special precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hands after administration to the animal.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

People with known hypersensitivity to any of the ingredients should avoid contact with the veterinary medicinal product.

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.

Gastro-intestinal signs (vomiting, diarrhoea), possibly associated with lethargy, have been observed very rarely in spontaneous reports.

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)

Do not use in pregnant bitches during the first 4 weeks of pregnancy.

The product may be used during lactation (see amounts to be administered and administration route below).

Do not use simultaneously with piperazine, as the anthelmintic effects of pyrantel and piperazine may be antagonized.

Plasma concentrations of praziquantel may be decreased by concomitant administration with drugs that increase the activity of cytochrome P-450 enzymes (e.g. dexamethasone, phenobarbital). Concurrent use with other cholinergic compounds can lead to toxicity.

Oral use.

15 mg/kg bodyweight febantel, 5 mg/kg pyrantel (as embonate) and 5 mg/kg praziquantel. This is equivalent to 1 tablet per 10 kg bodyweight, in one administration.

Dosages are as follows:

The smaller tablet size should be used to achieve accurate dosing in dogs weighing less than 17.5 kg.

The tablets can be given to the dog with or without food. No starvation is needed before or after treatment.

To ensure administration of a correct dose, body weight should be determined as accurately as possible.

The dosing program should be established by the veterinary surgeon.

As a general rule, puppies should be treated at 2 weeks of age and every 2 weeks until 12 weeks of age. Thereafter they should be treated at 3 month intervals. It is advisable to treat the bitch at the same time as the puppies.

For the control of Toxocara canis, nursing bitches should be dosed 2 weeks after giving birth and every two weeks until weaning.

For routine worm control adult dogs should be treated every 3 months.

In case of confirmed single infestation by cestode or by nematode, a monovalent product containing a cestocide or a nematocide alone should be preferred.

For routine treatment a single dose is recommended.

In the event of heavy roundworm infestation a repeat dose should be given after 14 days.

If an infestation caused by Echinococcus (E.granulosus) is detected in dogs, a repetition of the treatment is recommended for safety purpose.

In safety studies, single doses of 5 times (4 times in very young puppies) the recommended dose or greater gave rise to occasional vomiting.

Not applicable.