Beaphar One Dose Wormer For Dogs, 500 Mg Film Coated Tablets
Revised: June 2016
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Beaphar One Dose Wormer for Dogs, 500mg film coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient mg/tablet
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablet.
Yellowish-white to light beige round, film coated tablet, with ‘BCB’ imprinted on one side and ‘CGV’ on the other.
4. CLINICAL PARTICULARS
4.1 Target Species
4.2 Indications for use, specifying the target species
A broad spectrum anthelmintic for use in dogs. It is highly effective in a single dose against common canine nematodes and cestodes in the UK: Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Uncinaria stenocephala, Taenia ovis, Taenia hydatigena, Taenia pisiformis andDipylidium caninum.
At the recommended dosage, the product gives limited control of Echinococcus granulosus.
4.4 Special warnings for each target species
4.5 Special precautions for use
i. Special precautions for use in animals
Do not repeat treatment if vomiting occurs shortly after dosing.
ii. Special precautions to be taken by the person administering the medicinal product to animals
Tablets are film coated and should not be broken or divided.
4.6 Adverse reactions (frequency and seriousness)
The tablets, when administered as recommended are unlikely to cause vomiting. Do not repeat treatment if vomiting occurs shortly after dosing.
4.7 Use during pregnancy, lactation or lay
Not contraindicated in pregnant animals. Nursing bitches should be treated at the same time and as frequently as puppies up to 12 weeks of age (i.e. 2, 4, 6, 8, 12 weeks).
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amount(s) to be administered and administration route
For oral administration only. For the routine treatment of adult dogs, the dose of the product is 50 mg/kg (1 x 500 mg tablet per 10 kg/22 lb bodyweight).
Practical dosage regime: 500 mg tablets.
Bodyweight Number of Tablets
6.1 – 10 kg 1 x 500 mg
10.1 – 20 kg 2 x 500 mg
20.1 – 30 kg 3 x 500 mg
30.1 – 40 kg 4 x 500 mg
For best results give the product together with about one-fifth of the daily food ration in the morning when the dog’s stomach is empty. Give the remaining food ration in the evening. The tablets should be given whole.
4.10 Overdose (symptoms, emergency procedures and antidotes), if necessary
Overdose may cause nausea and vomiting. High doses may have CNS effects. Treat symptomatically.
4.11 Withdrawal period(s)
5. PHARMACOLOGICAL PROPERTIES
ATC code: QP52AX01
5.1 Pharmacodynamic properties
Nitroscanate is a broad spectrum anthelmintic.
5.2 Pharmacokinetic particulars
No current information is available.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Silica Colloidal Anhydrous
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.
6.4 Special precautions for storage
Store in a dry place.
Do not store above 25°C.
6.5 Nature and composition of immediate packaging
Pack size: 2, 3, 4, 6 or 100 tablets.
Container: Polyethylene-coated aluminium foil strip-pack.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Elanco Europe Ltd
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION
30 June 2000
10. DATE OF REVISION OF THE TEXT
Approved: 21 June 2016
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