Neocell

Exitel Plus XL Flavoured Tablets For Dogs

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active substances:
Praziquantel    175 mg
Pyrantel Embonate    504 mg (equivalent to 175 mg pyrantel)
Febantel    525 mg

PHARMACEUTICAL FORM
Tablet  
A yellow coloured oblong tablet with a breakline on both sides.
The tablets can be divided into equal halves.

Target species
Dogs.  
 
Indications for use, specifying the target species
In adult dogs: Treatment of mixed infections by nematodes and cestodes 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 species, (E. granulosus, E. multilocularis), Taenia species,
(T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms).  

Contraindications
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 for each target species
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.  
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

Special precautions for use
Special precautions for use in animals
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.  

Adverse reactions (frequency and seriousness)
None known.  

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.   

Amounts to be administered and administration route
For oral administration only.  
The recommended dose rates are: 15mg/kg bodyweight febantel, 5 mg/kg pyrantel (equivalent to 14.4 mg/kg pyrantel embonate) and 5 mg/kg praziquantel.  This is equivalent to 1 Exitel Plus XL tablet per 35 kg bodyweight.  
Dogs weighing approx 17.5kg bodyweight should be given ½ Prazitel Plus XL tablet.
Dogs of > 35 kg bodyweight should be given 1 Exitel Plus XL tablet plus the appropriate quantity of Exitel Plus tablets equivalent to 1 tablet per 10 kg bodyweight.
The tablets can be given directly to the dog or disguised in food.  No starvation is needed before or after treatment.  
If there is a risk for re-infestation, the advice of a veterinarian should be sought regarding the need for and the frequency of repeat administration.

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.  

Incompatibilities
Not Applicable  

Shelf life of the veterinary medicinal product as packaged for sale
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Unused half tablet must be used within 14 days.

Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Each time an unused half tablet is stored, it should be returned to the open blister space and inserted back into the cardboard box.
Insert the blister in the carton box.

Nature and composition of immediate packaging
The product is presented in:
Blister packs made up of PVC/PE/PCTFE with 20µ hard tempered aluminium foil with 2, 4, 5, 6, 8, 10, 12, 14, 16, 18 or 20 tablets per blister.
The Blisters are packed into cartons containing either 2, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 30, 32, 36, 40, 42, 44, 48, 50, 52, 56, 60, 64, 68, 70, 72, 76, 80, 84, 88, 92, 96, 98, 100, 104, 106, 108, 112, 116, 120, 140, 150, 180, 200, 204, 206, 208, 250, 280, 300, 500 or 1000 tablets.
Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.