Exitel Plus XL

FOR ANIMAL USE ONLY

Exitel Plus XL

Dewormer for Dogs

Reg. No. G4227 (Act 36/1947)

Namibia Reg. No. V21/18.3.9/1488 [NS0]

INDICATIONS

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

Nematodes

Roundworms: 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).

COMPOSITION

Each Exitel Plus XL tablet contains:

Praziquantel    175 mg

Pyrantel            175 mg (equivalent to 504 mg pyrantel embonate)

Febantel            525 mg

STORAGE INSTRUCTIONS

Store at or below 25 °C in a cool, dry place.

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, rodents, 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.
• Do not use in animals with a known sensitivity to the active ingredients or to any of the excipients.
• 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 weighing 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 sought 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. 

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 Exitel Plus XL during pregnancy should be in accordance with a benefit-risk assessment done by the treating veterinarian.

It is recommended that Exitel Plus XL is not used in dogs during the first 4 weeks of pregnancy. Do not exceed the recommended 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.

Packaged in blister packs made of PVC/PE/PCTFE with 20-micron aluminium foil, within a carton box that contains 20 tablets.

REGISTRATION HOLDER

Intervet South Africa (Pty) Ltd.

20 Spartan Road

Spartan, 1619, RSA

Tel: +27 (0) 11 923 9300

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT

20 July 2017

ZIMBABWE ONLY Registration number: 2022/80.12.20/9825 Pharmacological classification: 80.12.20 Anthelmintics used in small animals Category for Distribution: V.M.G.D.