Medine.co.uk

Beaphar One Dose Wormer For Small Dogs And Puppies, 100 Mg Film Coated Tablets

Revised: June 2016

AN: 00240/2016


SUMMARY OF PRODUCT CHARACTERISTICS


1. NAME OF THE VETERINARY MEDICINAL PRODUCT


Beaphar One Dose Wormer for Small Dogs and Puppies, 100 mg film-coated tablets


2. QUALITATIVE AND QUANTITATIVE COMPOSITION


Active ingredient mg/tablet


Nitroscanate 100


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 ‘kx’ imprinted on one side and ‘CGV’ on the other.


4. CLINICAL PARTICULARS


4.1 Target Species


Dogs.


4.2 Indications for use, specifying the target species


A broad spectrum anthelmintic for use in small dogs and puppies up to 6 kg. 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 and Dipylidium caninum.


At the recommended dosage, the product gives limited control of Echinococcus granulosus.


4.3 Contraindications


Do not administer if your dog is sick or recovering from an illness.


4.4 Special warnings for each target species


None.



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 females 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


None known.


4.9 Amount(s) to be administered and administration route


For oral administration only. For the routine treatment of puppies and adult dogs up to 6 kg bodyweight, the dose of the product is 50 mg/kg (1 x 100 mg tablet per 2 kg/4.4 lb bodyweight).


Practical dosage regime: 100 mg tablets.


Bodyweight Number of Tablets


<2 kg 1 x 100 mg

2.1 – 4 kg 2 x 100 mg

4.1 – 6 kg 3 x 100 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)


Not applicable.


5. PHARMACOLOGICAL PROPERTIES


Anthelmintic.


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


Methylcellulose

Silica Colloidal Anhydrous

Maize starch

Cellulose Microcrystalline

Magnesium Stearate

Hypromellose

Macrogol 8000

Purified talc


6.2 Incompatibilities


None known.


6.3 Shelf-life


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

Lilly House

Priestley Road

Basingstoke

Hampshire

RG24 9NL


8. MARKETING AUTHORISATION NUMBER


Vm 00879/4057


9. DATE OF FIRST AUTHORISATION


30 June 2000


10. DATE OF REVISION OF THE TEXT


June 2016


Approved: 21 June 2106

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