Target species
Dogs.
Indications for use for each target species
Treatment of mixed infections by nematodes and cestodes of the following species:
Roundworms:
Ascarids (adult and late immature forms): Toxocara canis, Toxascaris leonina
Hookworms (adults): Uncinaria stenocephala, Ancylostoma caninum
Whipworms (adults): Trichuris vulpis
Tapeworms (adult and immature forms): Echinococcus granulosus, Echinococcus multilocularis, Dipylidium caninum Taenia spp.
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 section use during pregnancy, lactation or lay).
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
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.
Special precautions for the protection of the environment:
Not applicable.
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 events
Dogs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Digestive tract disorders (e.g., vomiting and diarrhoea)1 Anorexia, Lethargy, Hyperactivity. |
1Mild 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.
Use during pregnancy, lactation or lay
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 section contraindications).
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.
Concurrent use with other cholinergic compounds can lead to toxicity.
Administration routes and dosage
For oral administration only.
Dosage
For treatment of dogs, 1 tablet per 10 kg body weight (15 mg febantel, 14.4 mg pyrantel embonate and 5 mg praziquantel/kg body weight). Dosages are as follows:
Body weight (kg) | Tablet quantity |
2-5 | ½ |
>5-10 | 1 |
>10-15 | 1 ½ |
>15-20 | 2 |
For each additional 5 kg bodyweight, administer an additional half tablet.
Administration and Duration of Treatment
The tablets are flavoured and studies have shown that they are palatable and are taken voluntarily by the majority (88%) of dogs tested.
The tablets can be administered with or without food. Access to normal diet does not need to be limited before or after treatment.
Tablets should be given as a single administration.
The advice of a veterinarian should be sought regarding the need for and frequency of repeat treatment.
Not for use in dogs weighing less than 2 kg.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
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.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal period
Not applicable.