NOAH Compendium

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Date: Friday, July 30, 2021 17:25

Description: Chanelle_Phara_Logo_cmyk
Release 3.170
Prazitel Plus XL Tablets for Dogs
Species: Dogs
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for dogs
Active ingredient: Febantel, Praziquantel, Pyrantel Embonate
Product:Prazitel Plus XL Tablets for Dogs
Product index: Prazitel Plus XL Tablets
1 pork flavoured tablet contains 175 mg Praziquantel, 504 mg Pyrantel Embonate (equivalent to 175 mg pyrantel) and 525 mg Febantel.
The tablets can be divided into equal halves.
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).
Dosage and administration
For oral administration.
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 Prazitel Plus XL tablet per 35 kg bodyweight.
Dogs of > 35 kg bodyweight should be given 1 Prazitel Plus XL tablet plus the appropriate quantity of Prazitel Plus tablets equivalent to 1 tablet per 10 kg bodyweight.
Dogs weighing approx 17.5kg bodyweight should be given ½ Prazitel Plus XL tablet.
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.
To ensure administration of a correct dose, body weight should be determined as accurately as possible.
Contra-indications, warnings, etc
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
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.
Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:
∙ Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
∙ Underdosing, which may be due to underestimation of body weight, misadministration of the product.”
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)
In very rare cases, gastrointestinal disorders (diarrhoea, emesis) have been observed.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals )
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
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.
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.
Pharmaceutical precautions
Keep out of the reach and sight of children
This veterinary medicinal product does not require any special storage conditions Do not use after expiry date stated on the label.
Each time an unused half tablet is stored, it should be returned to the open blister space and inserted back into the outer carton.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life of half tablets: 14 days
Legal category
Legal category: NFA-VPS
Packaging quantities
10 and 50 tablets.
Marketing Authorisation Number
Vm 08749/4035
Significant changes