Exitel Plus XL

FOR ANIMAL USE ONLY

Exitel Plus XL

Tablets for Dogs
Reg. No. G4227 (Act 36/1947) 

INDICATIONS
For the treatment of mixed infections by nematodes and cestodes of the following species in adult dogs.

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. granulosis, E. multilocularis), Taenia species (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms).

COMPOSITION
Each Exitel Plus XL tablet contains:
Praziquantel      175 mg
Pyrantel            175 mg (equivalent to 504 mg pyrantel embonate)
Febantel           525 mg 

STORAGE
Store at or below 25 °C.
Each time an unused half tablet is stored, it should be returned to the open blister space and inserted back into the original carton. Unused half tablets must be used within 14 days. 

WARNINGS
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. 
Tapeworm infestation is unlikely in pups less than 6 weeks of age.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
Although this remedy has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

PRECAUTIONS
Special precautions for use in animals
To ensure administration of a correct dose, body weight should be determined as accurately as possible.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

For oral administration only.

Recommended dosage:
The recommended dose rates are 15 mg/kg body weight febantel, 5 mg/kg pyrantel (equivalent to 14,4 mg/kg pyrantel embonate) and 5 mg/kg praziquantel. 
This is equivalent to one Exitel Plus XL tablet per 35 kg body weight. 
Dogs of more than 35 kg body weight should be given one Exitel Plus XL tablet plus the appropriate quantity of Exitel Plus (G4226) tablets equivalent to one tablet per 10 kg body weight (please refer to below table).
The tablets can be given directly to the dog or disguised in food.  No starvation is needed before or after treatment.  

Dosage table:

Body Weight (kg)	Tablets
Approx. 17,5 kg	½ Exitel Plus XL tablet
31 – 35 kg	1 Exitel Plus XL tablet
36 – 40 kg	1 Exitel Plus XL tablet and ½ Exitel Plus tablet
41 – 45 kg	1 Exitel Plus XL tablet and 1 Exitel Plus tablet
46 – 50 kg	1 Exitel Plus XL tablet and 1½ Exitel Plus tablets
51 – 55 kg	1 Exitel Plus XL tablet and 2 Exitel Plus tablets
56 – 60 kg	1 Exitel Plus XL tablet and 2½ Exitel Plus tablets
61 – 65 kg	1 Exitel Plus XL tablet and 3 Exitel Plus tablets
66 – 70 kg	2 Exitel Plus XL tablets

If there is a risk for reinfestation, the advice of a veterinarian should be ought regarding the need for and the frequency of repeat administration.

OVERDOSE
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.  

CONTRA-INDICATIONS
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.

SIDE EFFECTS
None known.

PREGNANCY AND LACTATION
Teratogenic effects can be caused by high doses of febantel and was 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 done 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 antagonised.
Concurrent use with other cholinergic compounds can lead to toxicity.    

PRESENTATION
A yellow uncoated, oblong, flavoured tablet with a cross break-line on both sides.
The tablets can be divided into equal halves.
The tablets are packaged in blister packs made of aluminium foil and packed into carton boxes containing 20 tablets per carton. 

REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd.
20 Spartan Road
Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za 

DATE OF PUBLICATION OF THIS PACKAGE INSERT
20 July 2017