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Date: Friday, May 2, 2025 12:28

Release 3.464
On-Defence Wormer 175 mg/504 mg/525 mg Film-coated Tablets for Dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for dogs
Active ingredient: Febantel, Praziquantel, Pyrantel Embonate
Product:On-Defence Wormer 175 mg/504 mg/525 mg Film-coated Tablets for Dogs
Product index: On-Defence Wormer 175 mg/504 mg/525 mg Film-coated Tablets for Dogs
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 halves.
Uses
In adult dogs:
For the treatment of mixed infections with roundworms, hookworms, whipworms, and tapeworms of the following species:
Roundworms (Nematodes):
Ascarids (adult and late immature forms): Toxocara canis, Toxascaris leonina.
Hookworms (adults): Uncinaria stenocephala, Ancylostoma caninum.
Whipworms (adults): Trichuris vulpis.
Tapeworms (Cestodes):
Adult and immature forms of: Echinococcus species (E. granulosus, E. multilocularis), Taenia species (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum.
Dosage and administration
For oral administration only.
To ensure administration of a correct dose, body weight should be determined as accurately as possible.
Dosage:
1 tablet per 35 kg bodyweight.
This is equivalent to 15 mg febantel, 14.4 mg pyrantel embonate and 5 mg praziquantel per kilo bodyweight.
It is important to follow the treatment recommendations as presented here. Do not deviate from the recommendations without the advice of your veterinary surgeon.
Dosage table:
Bodyweight (kg)
Tablets
17.5kg
½
>17.5-35.0 kg
1
>35.0-52.5 kg
1 ½
>52.5-70 kg
2
Administration and Duration of Treatment
Not for use in dogs weighing less than 17.5 kg
The tablets can be given directly to the dog or disguised in food. No starvation is needed before or after treatment.
For routine worm control adult dogs should be treated with a single dose every 3 months.
For the control of Toxocara, nursing bitches should be dosed 2 weeks after giving birth and every two weeks until weaning.
In case of suspected heavy roundworm infestation, please contact your veterinary surgeon for diagnosis and treatment recommendations.
If there is a risk of re-infestation, the advice of a veterinarian should be sought regarding the need for and the frequency of repeat administration.
Contra-indications, warnings, etc
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Do not use simultaneously with piperazine compounds as piperazine may block the action of pyrantel embonate contained in this product. Other worming products may contain piperazine.
Do not use simultaneously with other deworming products without veterinary advice.
Do not exceed the stated dose.
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.
Dogs should also be prevented from scavenging or hunting as part of measures to prevent tapeworm reinfestation.
If your dog receives other veterinary medicinal products, check with a veterinary surgeon or pharmacist before using this product.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Special precautions for use
Special precautions for use in animals
Do not exceed the stated dose, especially when treating pregnant bitches.
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.
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 follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.
Adverse reactions (frequency and seriousness)
In very rare cases mild and transient digestive tract disorders such as vomiting and/or diarrhoea may occur. In individual cases these signs can be accompanied by nonspecific signs such as lethargy, anorexia, or hyperactivity.
The frequency of adverse reactions is defined using the following convention:
- Very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- Common (more than 1 but less than 10 animals in 100 animals treated)
- Uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- Rare (more than 1 but less than 10 animals in 10,000 animals treated)
- Very rare (less than 1 animal in 10,000 animals treated, including isolated
reports).
Use during pregnancy, lactation or lay
Consult a veterinary surgeon before treating pregnant animals.
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.
The product may be used in lactating bitches from two weeks after giving birth.
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 (e.g. neostigmine, propoxur, and bethanechol) 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
Shelf life of the veterinary medicinal product as packaged for sale: 5 years
Shelf life of half tablets: 14 days.
This veterinary medicinal product does not require any special temperature storage conditions.
Keep the blister in the outer carton in order to protect from light.
Each time an unused half tablet is stored, it should be returned to the open blister space and the blister inserted back into the outer carton.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
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: AVM-GSL
Packaging quantities
The product is presented in:
Blister packs made up of PVC/PE/PCTFE with 20µ hard tempered aluminium foil with 1, 2, 4, 5, 6, or 8 tablets per blister.
The blisters are packed into cartons containing either 1, 2, 4, 5, 6, or 8 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Number
Vm 40162/4036
Significant changes