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Date: Tuesday, September 29, 2020 10:05

Description: Beaphar_CMYK_Logo_strapline_center
Release 2.147
WORMclear® Tablets for Dogs
Species: Dogs
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for dogs
Active ingredient: Febantel, Praziquantel, Pyrantel Embonate
Product:WORMclear® Tablets for Dogs
Product index: WORMclear® Tablets Dog
Qualitative and quantitative composition
Active ingredient
Each film-coated tablet contains Praziquantel 50mg, Pyrantel 50mg (equivalent to 144mg pyrantel embonate), Febantel 150mg
Excipients
For the full list of excipients, see below.
Pharmaceutical form
Film-coated tablets. Pale yellow, with a cross break line on one side. The tablets can be divided into halves or quarters.
Clinical particulars
Target species
Dogs.
Indications for use
For the treatment of mixed infections with the following gastrointestinal tapeworms and roundworms in dogs and puppies. Roundworms (nematodes) Ascarids: Toxocara canis, Toxascaris leonina (adult and late immature forms). Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults). Whipworms: Trichuris vulpis (adults). Tapeworms (cestodes): Echinococcus species (E. granulosus, E. multilocularis), Taenia species (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms).
Contraindications
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 use in animals with a known sensitivity to the active ingredients or to any of the excipients.
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 puppies less than 6 weeks of age. Development of parasite resistance to anthelmintics of a certain class can occur after frequent and repeated use of an anthelmintic from that class.
Special precautions to be taken by the person administering the veterinary medicinal product
In case of accidental ingestion, seek medical advice and show the package leaflet or carton 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. 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
In very rare cases (1 animal in 10,000, including isolated reports), gastrointestinal disorders (diarrhoea, emesis) have been observed.
Use during pregnancy and lactation
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 veterinary surgeon. 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
Do not use simultaneously with piperazine compounds. Concurrent use with other cholinergic compounds can lead to toxicity.
Dosage and method of administration
The recommended dose rate is 1 tablet per 10kg bodyweight as a single dose. It is important to follow the treatment recommendations presented here. Do not deviate from these recommendations without the advice of your veterinary surgeon.
Bodyweight
Number of tablets
≥3–5kg
½
≥5–10kg
1
≥10–15kg
1 ½
≥15–20kg
2
≥20–25kg
2 ½
≥25–30kg
3
≥30–35kg
3 ½
≥35–40kg
4
For oral administration only. The tablets can be given directly to the dog or disguised in food. No starvation is needed before or after treatment. Not for use in dogs weighing less than 3kg. Puppies should be treated at 2 weeks of age and every 2 weeks until 12 weeks of age. Thereafter they should be treated at 3 month intervals. It is advisable to treat the bitch at the same time as the puppies. For the control of Toxocara, nursing bitches should be dosed 2 weeks after giving birth and every two weeks until weaning. For routine worm control adult dogs should be treated every 3 months. For routine treatment a single dose is recommended. In case of suspected heavy roundworm infestation, please contact your veterinary surgeon for diagnosis and treatment recommendations.
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.
Pharmacological particulars
Pharmacotherapeutic group: Anthelmintic. ATC vet code: QP52AA51
Pharmacodynamic properties
This product contains anthelmintics active against gastrointestinal roundworms and tapeworms. The product contains three active substances, as follows: Febantel, a probenzimidazole, Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative, Praziquantel, a partially hydrogenated pyrazinoisoquinoline derivative. In this fixed combination, pyrantel and febantel act against all relevant nematodes (ascarids, hookworms, and whipworms) in dogs. In particular, the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum and Trichuris vulpis. This combination shows synergistic activity in the case of hookworms and febantel is effective against T. vulpis. The spectrum of activity of praziquantel covers all important cestode species in dogs, in particular Taenia spp., Dipylidium caninum, Echinococcus granulosus and Echinococcus multilocularis. Praziquantel acts against all adult and immature forms of these parasites. Praziquantel is very rapidly absorbed through the parasite’s surface and distributed throughout the parasite. Both in vitro and in vivo studies have shown that praziquantel causes severe damage to the parasite integument, resulting in the contraction and paralysis of the parasites. There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolization of the syncytial tegument. This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium. Pyrantel acts as a cholinergic agonist. Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis of the nematodes and thereby allow removal from the gastrointestinal system by peristalsis. Within the mammalian system, febantel undergoes ring closure, forming fenbendazole and oxfendazole. It is these chemical entities which exert the anthelmintic effect by inhibition of tubulin polymerisation. Formation of microtubules is thereby prevented, resulting in disruption of structures vital to the normal functioning of the helminth. Glucose uptake in particular is affected, leading to a depletion in cell ATP. The parasite dies upon exhaustion of its energy reserves, which occurs 2–3 days later.
Pharmacokinetic particulars
Orally administered praziquantel is absorbed almost completely from the intestinal tract. After absorption, the drug is distributed to all organs. Praziquantel is metabolized into inactive forms in the liver and secreted in bile. It is excreted within 24 hours to more than 95% of the administered dosage. Only traces of non-metabolised praziquantel are excreted. Following administration of the product to dogs, peak plasma concentrations of praziquantel were achieved by approximately 2.5 hours. The pamoate salt of pyrantel has low aqueous solubility, an attribute that reduces absorption from the gut and allows the drug to reach and be effective against parasites in the large intestine. Following absorption, pyrantel pamoate is quickly and almost completely metabolized into inactive metabolites that are excreted rapidly in the urine. Febantel is absorbed relatively rapidly and metabolized to a number of metabolites including fenbendazole and oxfendazole, which have anthelmintic activity. Following administration of the product to dogs, peak plasma concentrations of fenbendazole and oxfendazole were achieved by approximately 7–9 hours.
Pharmaceutical particulars
List of excipients
Lactose monohydrate, Microcrystalline cellulose, Magnesium stearate, Colloidal anhydrous silica, Croscarmellose sodium, Sodium laurilsulfate, pork flavour.
Incompatibilities
None Known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions. Discard any unused divided tablets immediately.
Nature and composition of immediate packaging
The product is presented in either: Individual strips composed of aluminium foil 30µm/30gsm extruded polythene, containing 2 and 4 tablets; or individual blisters composed of 45µm, soft temper aluminium foil and 25µm hard temper aluminium foil, containing 2 tablets. The strips or blisters are packed into cartons containing either 2 or 4 tablets. Not all pack sizes may be marketed.
Disposal
Dispose of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
C&H Generics Ltd, c/o Michael McEvoy and Co, Seville House, New Dock Street, Galway, Ireland
Marketing Authorisation Number
Vm 40162/4016
Significant changes
Date of the first authorisation or date of renewal
10 March 2015
Date of revision of the text
June 2016
Any other information
N/A.
Legal category
Legal category: AVM-GSL
GTIN
GTIN description:2 tablet pack
GTIN:08711231117932
GTIN description:4 tablet pack
GTIN:08711231117956