Exitel Plus

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

FOR ANIMAL USE ONLY

EXITEL PLUS

Tablets for Dogs
Reg. No. G4226 (Act 36/1947)

INDICATIONS

For the treatment of mixed infections by nematodes and cestodes of the following species in 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. granulosus, E. multilocularis), Taenia species (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms). 

COMPOSITION

Each Exitel Plus tablet contains:

Praziquantel    50 mg
Pyrantel           50 mg (equivalent to 144 mg pyrantel embonate)
Febantel          150 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

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 1 Exitel Plus tablet per 10 kg body weight. 

Dosage table:

Body Weight (kg)Tablets
0,5 to 5 kg½ Exitel Plus tablet
5 to 10 kg1 Exitel Plus tablet
11 to 20 kg2 Exitel Plus tablets
21 to 30 kg3 Exitel Plus tablets
31 kg 40 kg4 Exitel Plus tablets
41 kg 50 kg5 Exitel Plus tablets

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 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. 

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 were done 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 during the first 4 weeks of pregnancy. Do not exceed the prescribed dose when pregnant bitches are treated.

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, circular, flavoured, tablet with a cross break-line on one side and plain on the other side.
The tablets can be divided into equal halves or equal quarters.
Packaged in blister packs made of PVC/PE/PCTFE with 20-micron aluminium foil with 20 tablets per blister. They are available in cartons of 20, 50, 100 and 1 000’s. (Not all presentations may be marketed.)

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

MANUFACTURER
Chanelle Pharmaceuticals Manufacturing Ltd.
Dublin Road, Loughrea
Co. Galway
Ireland

DATE OF PUBLICATION OF THIS PACKAGE INSERT

20 July 2017