Revised: June 2014
AN: 00137/2014
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bob Martin Clear Wormer 500mg Film Coated Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active substance:
Nitroscanate
mg
500
Excipients:
Titanium Dioxide (E171)
Iron Oxide Yellow (E172)
Iron Oxide Black (E172)
Iron Oxide Red (E172)
3.95
0.1306
0.00013
0.00013
For the 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, the product 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.
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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.
4.5. Special precautions for use
i)
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.
ii)
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 filmcoated and should not be broken or divided.
4.6. Adverse reactions (frequency and seriousness)
When administered as the product 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.
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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
Clear Wormer 100mg Film Coated Tablets for Small Dogs & Puppies.
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. 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.
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
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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 25C. 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.
Carton containing 2, 3 or 4 tablets
Not all pack sizes may be marketed.
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.
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7.
MARKETING AUTHORISATION HOLDER
Chanelle Animal Health Ltd.
7 Rodney St.
Liverpool
L1 9HZ
8.
MARKETING AUTHORISATION NUMBER
Vm: 11990/4028
9.
DATE OF FIRST AUTHORISATION
Date: 15 April 2002
10. DATE OF REVISION OF THE TEXT
Date: June 2014
26 June 2014
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