Cestem Wormer Flavoured Tablets for Dogs

Cestem flavoured worming tablets are effective against all intestinal roundworms and tapeworms found in dogs. They are supplied in two different sizes. The small/medium tablet is designed to be used at a rate of one tablet for 5-10kg bodyweight. The large tablet is for bodyweights between 17.5kg and 35kg. The tablets can be easily broken in half and have a palatable flavour. They contain a mixture of ingredients to cover all the different worm species.

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

Company name: Ceva Animal Health Ltd
Address: Unit 3, Anglo Office Park
White Lion Road
Amersham, Bucks
HP7 9FB
Telephone: 0800 0086928
Telephone: 01494 781510
Fax: 01494 781519
Email: [email protected]
Website: www.ceva.com

Presentation

Cestem® Flavoured tablet for medium and small dogs is a yellow brown divisible tablet containing 150mg febantel, 50mg pyrantel and 50mg praziquantel with a liver flavouring.

Cestem® Flavoured tablet for large dogs is a yellow brown divisible tablet containing 525mg febantel, 175mg pyrantel and 175mg praziquantel with a liver flavouring.

Uses

For the treatment of the following gastrointestinal tapeworms and roundworms in adult dogs and puppies.

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).

Dosage and administration

The recommended dose rates are: 15 mg/kg bodyweight febantel, 5 mg/kg pyrantel (as embonate) and 5 mg/kg praziquantel. This is equivalent to 1 tablet of Cestem® Flavoured for medium and small dogs per 10 kg bodyweight or 1 tablet of Cestem® Flavoured for large dogs per 18-35kg, in one administration.
Dosages are as follows:
3-5 kg = ½ Cestem® Flavoured tablet for medium and small dogs
>5-10 kg = 1 Cestem® Flavoured tablet for medium and small dogs
>10-15 kg = 1½ Cestem® Flavoured tablet for medium and small dogs
>15-20 kg = 2 Cestem® Flavoured tablet for medium and small dogs
17.5 kg = ½ Cestem® Flavoured tablet for large dogs
>17.5-35 kg = 1 Cestem® Flavoured tablet for large dogs
>35-52.5 kg = 1½ Cestem® Flavoured tablet for large dogs
>52.5-70 kg = 2 Cestem® Flavoured tablet for large dogs

The smaller tablet size, Cestem® for medium and small dogs, should be used to achieve accurate dosing in dogs weighing less than 17.5 kg.
For oral administration, 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.

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.

Contra-indications, warnings, etc

Do not use in animals with a known sensitivity to the active ingredients or to any of the excipients.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of 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.

Interaction

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.
Overdose
In safety studies, single doses of 5 times (4 times in very young puppies) the recommended dose or greater gave rise to occasional vomiting.
Special precautions to be taken by the person administering the 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.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
For animal treatment only. Keep out of reach of children.

Pharmaceutical precautions

This veterinary medicinal product does not require any special storage conditions.
Return any halved tablet to the opened blister pack and use within 7 days.

Legal category

NFA-VPS

Packaging Quantities

Cestem® for medium and small dogs:
Box containing 1 blister of 2 tablets
Box containing 2 blisters of 2 tablets
Box containing 1 blister of 8 tablets
Box containing 13 blisters of 8 tablets
Box containing 52 blisters of 2 tablets
Cestem® for large dogs:
Box containing 1 blister of 2 tablets
Box containing 2 blisters of 2 tablets
Box containing 2 blisters of 4 tablets
Box containing 12 blisters of 4 tablets
Box containing 24 blisters of 2 tablets
Not all pack sizes may be marketed.

Further information

Pharmacodynamic properties
In this fixed combination pyrantel and febantel act against all relevant nematodes (ascarids, hookworms, and whipworms) in dogs. In particular the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum and Trichuris vulpis. This combination shows synergistic activity in the case of hookworms and febantel is effective against T. vulpis.
The spectrum of activity of praziquantel covers all important cestode species in dogs, in particular Taenia spp, Dipylidium caninum, Echinococcus granulosus and Echinococcus multilocularis. Praziquantel acts against all adult and immature forms of these parasites.
Praziquantel is very rapidly absorbed through the parasite’s surface and distributed throughout the parasite. Both in vitro and in vivo studies have shown that praziquantel causes severe damage to the parasite integument, resulting in the contraction and paralysis of the parasites. There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolisation of the syncytial tegument. This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.
Pyrantel acts as a cholinergic agonist. Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis of the nematodes and thereby allow removal from the gastro- intestinal (GI) system by peristalsis.
Within the mammalian system febantel undergoes ring closure forming fenbendazole and oxfendazole. It is these chemical entities which exert the anthelmintic effect by inhibition of tubulin polymerisation. Formation of microtubules is thereby prevented, resulting in disruption of structures vital to the normal functioning of the helminth. Glucose uptake, in particular is affected, leading to a depletion in cell ATP. The parasite dies upon exhaustion of its energy reserves, which occurs 2-3 days later.
Pharmacokinetic particulars
After oral administration to dogs, praziquantel is extensively and quickly absorbed from the gastro-intestinal tract. Maximum plasma concentration of 752 µg/L is obtained in less than 2 hours. It is rapidly and extensively metabolised in the liver into hydroxylated derivatives of the parent compound, then rapidly eliminated, mainly in urine.
After oral administration to dogs, febantel is moderately absorbed from the gastro-intestinal tract. Febantel is rapidly metabolised in the liver into fenbendazole and its hydroxy and oxidative derivatives like oxfendazole. Maximum plasma concentration of fenbendazole (173 µg/L) is obtained after about 5 hours. Maximum plasma concentration of oxfendazole (147 µg/L) is obtained after about 7 hours. The excretion occurs mainly in the faeces.
After oral administration to dogs, pyrantel embonate is poorly absorbed. Maximum plasma concentration of 79 µg/L is obtained after about 2 hours. It is rapidly and extensively metabolised in the liver, then rapidly excreted, mainly in the faeces (the unchanged form) and in urine (the metabolites).

Marketing authorisation number

Vm 15052/4040.
Vm 15052/4039.

GTIN

Cestem medium and small dogs:
03411111910602
Cestem large dogs:
03411111910619