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Date: Monday, September 20, 2021 20:30

Description: Beaphar_CMYK_Logo_strapline_center
Release 2.178
WORMclear® Tablets for Cats
Species: Cats
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cats
Active ingredient: Praziquantel, Pyrantel Embonate
Product:WORMclear® Tablets for Cats
Product index: WORMclear® Tablets Cat
Qualitative and quantitative composition
Active ingredient
Each film-coated tablet contains Pyrantel embonate 230mg and Praziquantel 20mg.
Excipients
Titanium Dioxide (E171) 1.8mg. For the full list of excipients, see below.
Pharmaceutical form
Film-coated tablets. A white to off-white round, biconvex coated tablet with a break line on one side and plain on the other side. The tablet can be divided in half.
Clinical particulars
Target species
Cats
Indications for use
For the treatment of mixed infections caused by the following gastrointestinal roundworms and tapeworms. Roundworms:Toxocara cati, Toxascaris leonine. Tapeworms:Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis.
Contraindications
Do not use simultaneously with piperazine compounds. Do not use simultaneously with other deworming products without veterinary advice. Do not use in kittens less than 6 weeks of age. Do not use in animals with known hypersensitivity to the active substances or to any of the excipients.
Special warnings for target species
Do not use in cats weighing less than 1kg bodyweight. 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. 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 the interests of good hygiene, persons administering the tablets directly to the cat, or by adding them to the cat’s food, should wash their hands afterwards. In case of accidental ingestion, seek medical advice and show the package leaflet or carton to the physician.
Adverse reactions
Mild and short-lived digestive tract disorders such as excessive salivation and/or vomiting and mild and short-lived disorders of the nervous system such as loss of balance may occur in very rare cases (less than 1 animal in 10,000, including isolated reports).
Use during pregnancy and lactation
Do not use during pregnancy. The tablets can be used during lactation.
Interaction with other medicinal products
Do not use simultaneously with piperazine compounds.
Dosage and administration
The recommended dose rate is 1 tablet per 4kg bodyweight.
Bodyweight
Number of tablets
1–2kg
½
≥2–4
1
≥4–6
1 ½
≥6
2
Single oral administration. The tablet should be given directly to the cat, but if necessary can be disguised in food. In an ascarid infestation, especially in kittens, complete elimination cannot be expected, so a risk of infection for humans can persist. Repeated treatments should, therefore, be carried out with a suitable roundworm product at 14 day intervals until 2–3 weeks after weaning. If signs of disease persist or appear, consult a veterinary surgeon.
Pharmacological particulars
Pharmacotherapeutic group: Anthelmintic. ATC vet code: QP52AA51
Pharmacodynamic properties
This product contains anthelmintics active against gastrointestinal roundworms and tapeworms. The product contains two active substances, as follows: Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative and Praziquantel, a partially hydrogenated pyrazinoisoquinoline derivative. Pyrantel acts as a cholinergic agonist. Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis and thereby allow expulsion from the gastrointestinal (GI) system by peristalsis. Praziquantel is very rapidly absorbed 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 contraction and paralysis. 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. In this fixed combination, pyrantel is active against the following ascarids: Toxocara cati, and Toxascaris leonina. Praziquantel is effective against tapeworms in particular Dipylidium caninum and Taenia taeniaeformis. Since it contains praziquantel, the product is effective against Echinococcus multilocularis.
Pharmacokinetic particulars
Praziquantel is rapidly absorbed, metabolised and distributed in the body. It is also believed to be excreted back into the intestinal lumen by the mucous membrane. Following administration of the product to cats, peak plasma concentrations of praziquantel were achieved by approximately 2 hours. Pyrantel is poorly absorbed so it is expected that a large proportion of the administered dose remains in the GIT where it exerts its therapeutic effect and it is excreted largely unchanged in the faeces. Following administration of the product to cats, peak plasma concentrations of pyrantel were achieved by approximately 3 hours.
Pharmaceutical particulars
List of excipients
Core tablet: Maize starch, Microcrystalline cellulose, Crospovidone, Magnesium stearate, Colloidal anhydrous silica.Film coat: Grilled meat flavour, Opadry Complete Film Coating System 03F28415 White consisting of HPMC 2910/Hypromellose (E464), Macrogol/PEG 4000 (E1521), Titanium Dioxide (E171).
Incompatibilities
Not applicable.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 4 years.
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions. Unused halved tablets should be discarded. Do not remove tablets from strip packaging until required for use.
Nature and composition of immediate packaging
The product is presented in either: Individual blisters made up of a PVC/PE/PCTFE white opaque copolymer and a 20µm heat seal lacquer/aluminium containing 2 tablets,or Individual blisters made up of 45µm PVC/aluminium/orientated polyamide and a 20µm heat seal lacquer/aluminium containing 2 tablets. The blisters are packed into cartons containing: 2 tablets
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed 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 40162/4011
Significant changes
Date of the first authorisation or date of renewal
19 March 2015
Date of revision of the text
June 2016
Any other information
N/A.
Legal category
Legal category: AVM-GSL
GTIN
GTIN description:WORMclear® for Cats
GTIN:08711231117901