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Date: Tuesday, April 23, 2024 11:24

Description: Chanelle_Phara_Logo_cmyk
Release 3.246
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
Incorporating:
Presentation
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 parts.
Uses
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
Special precautions for safe use in the target species:
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.
Special precautions for the protection of the environment:
Not applicable.
Other precautions:
Echinococcosis represents a hazard for humans. As echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and followup, and on the safeguard of persons, need to be obtained from the relevant competent authority.
Adverse reactions (frequency and seriousness)
Dogs:
Very rare (<1 animal/10,000 animals treated, including isolated reports):
Digestive tract disorders (diarrhoea, emesis)
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the package leaflet for respective contact details.
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.
Interaction with Other medicnial 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.
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.
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.
Shelf life of the veterinary medicinal product as packaged for sale: 5 years
Shelf-life of half tablets: 14 days
UK (NI)
Medicines should not be disposed of via wastewater.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
UK (GB)
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category: NFA-VPS
Packaging quantities
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.
Marketing Authorisation Number
UK (GB) VM 08749/5042
UK (NI) VM 08749/3006
Significant changes