Revised: June 2014
AN: 00137/2014
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bob Martin Clear Wormer 100mg Film Coated Tablets for Small Dogs &
Puppies
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active substance:
Nitroscanate
mg
100
Excipients:
Titanium Dioxide (E171)
Iron Oxide Yellow (E172)
Iron Oxide Black (E172)
Iron Oxide Red (E172)
0.778
0.0257
0.00003
0.00003
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
The tablets should be given whole and not broken or divided. For the routine
control of Toxocara canis, Toxascaris leonina, Uncinaria stenocephala,
Ancylostoma canium, 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.
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. If a
hypersensitive reaction occurs, treatment with the product should be
discontinued. Do not administer to sick or convalescing animals. Do not
administer to puppies weighing less than 0.5kg (1.1lb).
Revised: June 2014
AN: 00137/2014
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.
In the unlikely event of a pup vomiting repeatedly, following the use of this
product, seek advice of a veterinary surgeon. Do not repeat treatment if vomiting
occurs shortly after dosing.
4.5. Special precautions for use
i)
Special precautions for use in animals
Do not administer to puppies weighing less than 0.5kg (1.1lb)
Nursing bitches should be treated at the same time as their puppies
until weaning.
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 recommended, 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
weaning.
4.8. Interaction with other medicinal products and other forms of interaction
None known.
Revised: June 2014
AN: 00137/2014
4.9. Amounts to be administered and administration route
Dose: For routine control of roundworm and tapeworm in small dogs and puppies
give 1 x 100mg tablet per 2kg (4.4lb) bodyweight, equivalent to 50mg
nitroscanate/kg bodyweight.
For dogs weighing more than 8kg (17.5lb) use Bob Martin Clear Wormer 500mg
Film Coated Tablets for Dogs. For puppies weighing less than 0.5kg (1.1lb) seek
veterinary advice.
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.
Give your dog his remaining food in the evening at least eight hours after the
wormer dose.
Treat unweaned puppies first thing in the morning and restrict their suckling for 24 hours after dosing at which time they may be returned to the bitch.
When dosing recently weaned puppies (6-8 weeks of age) ensure fresh drinking
water is readily available.
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 treat 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 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.
Revised: June 2014
AN: 00137/2014
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
Sodium laurel sulphate
Magnesium stearate
HPMC 2910
Polydextrose FCC
Macrogoll 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
closure containing 4 x 100mg or 6 x 100mg tablets.
Carton containing 4 or 6 tablets
Not all pack sizes will 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.
Revised: June 2014
AN: 00137/2014
7.
MARKETING AUTHORISATION HOLDER
Chanelle Animal Health Ltd.
7 Rodney St.
Liverpool
L1 9HZ
8.
MARKETING AUTHORISATION NUMBER
Vm: 11990/4029
9.
DATE OF FIRST AUTHORISATION
Date: 16 April 2002
10. DATE OF REVISION OF THE TEXT
Date: June 2014
26 June 2014