Revised: 11 December 2008 AN: 00962/2008 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Bob Martin All in One Dewormer 500mg Film Coated Tablets for Dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Active substance: mg Nitroscanate 500
Excipients: Titanium Dioxide (E171) 3.95 Iron Oxide Yellow (E172) 0.1306 Iron Oxide Black (E172) 0.00013 Iron Oxide Red (E172) 0.00013
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film coated tablet. Smooth yellow coloured film coated tablets, convex shaped (plain round concave).
4. CLINICAL PARTICULARS
4.1 Target species Dog
4.2 Indications for use, specifying the target species
For the routine control of Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum, Taenia hydatigena, Taenia pisiformis and Dipylidium caninum. The product gives a limited level of control of Echinococcus granulosus and is not indicated for the treatment of Trichuris vulpis.
For the treatment of roundworms, tapeworms and hookworms in dogs
4.3 Contraindications
When administered as recommended, Bob Martin All in One Dewormer Tablets for Dogs is unlikely to cause vomiting. However, if vomiting does occur after treatment, do not repeat the dose. Do not administer to sick and convalescing animals. If a hypersensitive reaction occurs, treatment with the product should be discontinued. The tablets should be given whole and not broken or divided.
4.4 Special warnings for each target species
It is recommended that adult dogs should be wormed routinely 2 – 4 times a year. Since the most common tapeworm of the dog (Dipylidium caninum) is transmitted by a flea and has a very short pre-patent period, it is important to pay attention to flea control to reduce the incidence of tapeworm in your pet. Revised: 11 December 2008 AN: 00962/2008
4.5 Special precautions for use
Special precautions for use in animals
Do not administer if your dog is sick or recovering from an illness. If a hypersensitive reaction occurs cease treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product can be an irritant to the skin and eyes. Tablets are film-coated and should not be broken or divided.
4.6 Adverse reactions (frequency and seriousness)
When administered as recommended Bob Martin All in One Dewormer Tablets for Dogs is unlikely to cause vomiting. Do not repeat treatment if vomiting occurs shortly after dosing.
4.7 Use during pregnancy, lactation or lay
Nursing bitches should be treated at the same time as their puppies until the puppies are weaned.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
For routine control of roundworm and tapeworm in dogs give 1 x 500 mg tablet per 10kg (22lb) bodyweight, equivalent to 50 mg nitroscanate per kg bodyweight.
For dogs weighing over 10 kg (22lb) give one additional tablet for every extra 10kg (22lb) in weight. For dogs weighing less than 6kg (13.2lb) use Bob Martin All in One Dewormer Tablets for Small Dogs & Puppies (100 mg).
Directions for use: Give the required number of tablets first thing in the morning when your dog’s stomach is empty, with about one fifth of his daily food ration. The tablets should be given whole, and should not be broken or divided.
Give the dog his remaining food in the evening at least 8 hours after the wormer dose.
It is advisable to treat young puppies regularly for roundworm with Bob Martin All in One Dewormer Tablets for Dogs for Small Dogs & Puppies (100 mg). Treat at two weeks old and every following two weeks until eight weeks of age. Then again at 12, 16 and 24 weeks of age. Thereafter, every 3 – 6 months is recommended. Nursing bitches should be treated at the same time as their puppies until they are weaned.
It is recommended to worm adult dogs every 3 – 6 months as a routine preventative measure.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No treatment specified. Revised: 11 December 2008 AN: 00962/2008
4.11 Withdrawal period
Not applicable.
5. PHARMACOLOGICAL IMMUNOLOGICAL PROPERTIES
Active Substance: Nitroscanate Pharmacotherapeutic group: Anthelmintic. ATCvet-code: QP52AX01
5.1 Pharmacodynamic properties
Nitroscanate is an isothiocyanate anthelmintic with established use in veterinary practice. It is effective against common gastrointestinal cestodes and nematodes
5.2 Pharmacokinetic particulars
None known
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Titanium Dioxide (E171) Iron Oxide Yellow (E172) Iron Oxide Black (E172) Iron Oxide Red (E172) Maize starch Sodium starch glycolate (Type A) Microcrystalline cellulose (E460) Sodium laurel sulphate Magnesium stearate (E572) HPMC 2910 Polydextrose FCC Macrogol 4000
6.2 Incompatibilities
Not applicable.
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 25C. Keep blister strip in outer carton.
6.5 Nature and composition of immediate packaging
Aluminium foil strips, low density polyethylene strip packs with heat sealed closures containing 2 x 500mg or 3 x 500mg or 4 x 500mg tablets.
Not all pack sizes may be marketed. Revised: 11 December 2008 AN: 00962/2008
6.6 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.
7. MARKETING AUTHORISATION HOLDER
Chanelle Animal Health Ltd., 7 Rodney St., Liverpool, UK L1 9HZ.
8. MARKETING AUTHORISATION NUMBER
Vm 11990/4028
9. DATE OF FIRST AUTHORISATION
15th April 2002
10. DATE OF REVISION OF THE TEXT
December 2008