SUMMARY OF PRODUCT CHARACTERISTICS

Bob Martin Clear Spot On Solution 402mg for Extra Large Dogs

One 4.02 ml pipette contains:

Active substance:

Fipronil 402 mg

Excipients:

Butyhydroxyanisole E320 0.804mg

Butylhydroxytoluene E321 0.402mg

For the full list of excipients, see section 6.1.

Spot-on solution.

Clear, pale amber solution.

Dogs.

Treatment of flea (Ctenocephalidesspp.) and tick (Rhipicephalus sanguineus[the brown dog tick] and Ixodes ricinus [the castor bean or sheep tick]) infestations.

The product protects against new infestations with adult fleas for 8 weeks.
The product offers protection for 4 weeks against ticks (Rhipicephalus sanguineus, Ixodes ricinus, Dermacentor reticulatus[European meadow tick]).

If ticks of some species (Dermacentorreticulatus) are already present when the product is applied, all of the ticks may not be killed within the first 48 hours.

Do not use on puppies less than 2 months old and /or weighing less than 2kg.

Do not use in rabbits!Adverse drug reactions and even death could occur. This product is specifically developed for dogs. Do not use in cats, as this could lead to overdosing.

Do not use on animals with known hypersensitivity to the active substance or to any of the excipients.

Do not use in animals that are unwell, are undergoing treatment for or are recovering from illness.

Avoid frequent swimming or shampooing the animal because the maintenance of effectiveness of the product in these cases has not been tested.

The product does not prevent ticks from attaching to the animals. If the animal has been treated prior to exposure to the ticks, the ticks will be killed in the first 24-48 hours after attachment. This will usually be prior to their having fed, minimising but not excluding the risk of transmission of diseases. Once dead, ticks will often drop off the animal, but any remaining ticks may be removed with a gentle twist.

Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings which should be treated, in case of massive infestation and at the beginning of the control measures, with a suitable insecticide and vacuumed regularly.

For optimal control of flea infestation in multi-pet household, all dogs and cats in the household should be treated with a suitable insecticide.

Animals should be weighed accurately prior to treatment.

Avoid contact with the animal’s eyes. In the case of accidental eye contact, immediately and thoroughly flush the eyes with water.

It is important to make sure that the product is applied to an area where the animal cannot lick it off, and to make sure that animals do not lick each other following treatment.

Do not apply the product on wounds or damaged skin.

This product can cause mucous membrane and eye irritation. Therefore, contact between the product and the mouth or eyes should be avoided.

In the case of accidental eye contact, immediately and thoroughly flush the eyes with water. If eye irritation persists seek medical advice and show the package leaflet or the label to the physician.

Do not smoke, drink or eat during application.

Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water. Wash hands after use.

People with a known hypersensitivity to fipronil or any of the other ingredients should avoid contact with the product.

Treated animals should not be handled until the application site is dry, and children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended that animals are not treated during the day, but should be treated during the early evening, and that recently treated animals should not be allowed to sleep with owners, especially children.

Fipronil may adversely affect aquatic organisms. Dogs should not be allowed to swim in water courses for 2 days after application.

The product may have adverse effects on painted, varnished or other household surfaces or furnishings.

If licking occurs, a brief period of excessive salivation / drooling may be observed due mainly to the solvents in the product.

Among the extremely rare suspected adverse reactions, short duration skin reactions at the application site (scaly skin, hair loss at the application site, skin irritation, itching and reddening) and general skin irritation or hair loss have been reported after use. Rarely, excessive drooling / salivation, and reversible nervous signs (e.g. excitability, depression) or vomiting have been observed after use.

Not recommended for use in pregnant dogs/cats or where the dog/cat is providing milk for puppies/kittens. If in doubt, seek the advice of your usual veterinary surgeon.

None known.

Route of administration and dosage:

External use only. Administer by topical application to the skin according to the bodyweight as follows: 1 pipette of 4.02 ml per dog weighing over 40 kg and up to 60 kg bodyweight.

Method of administration:

Remove the pipette from the blister packaging. Hold the pipette in an upright position and snap off the top section of the cap, thereby opening the pipette.

Part your dog’s coat until the skin is visible. Place the tip of the pipette directly against the bared skin and squeeze gently. Empty approximately half the contents at each of two points along the dog’s back, preferably at the base of the head and between the shoulder blades. Squeeze the pipette several times to ensure dosing is complete. Avoid applying the solution onto the fur and do not rub into the skin.

Application of the solution as directed minimises the possibility that the animal will lick the solution off. Do not allow pets to lick each other after treatment.

Care should be taken to avoid excessive wetting of the hair with the product since this will cause a sticky appearance of hairs at the treatment spot. However, should this occur, it will usually disappear within 24-48 hours post application. Crystals may be seen on the hair and slight scaling may occur within 24-48 hours after application.

Where treating young animals, do not use this product on puppies of less than 2 months of age. Weigh the puppy firstand ensure that the correct product is used based on the weight of the puppy. This product would treat a puppy weighing 40 - 60kg. Do not use on puppies weighing less than 40kg.

For dogs over 60kg use two2.68ml tubes 268mg Fipronil (Bob Martin Clear Spot On Solution 268mg for Large Dogs).

Treatment schedule:

The minimum interval between two treatments is 4 weeks, but longer intervals may be appropriate in some cases. For advice speak to your veterinary surgeon.

No adverse effects were observed in safety studies in 2 month-old puppies, growing dogs and dogs weighing about 2 kg treated with 5 times the recommended dose once a month for 3 consecutive months. The risk of adverse effects (see section 4.6) may increase in cases of overdose. Be certain to select and use the correct product for your pet.

Not applicable.

Pharmacotherapeutic group:Ectoparasiticides for topical use.

ATCVet Code:QP53AX15

Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. It acts by inhibiting the GABA complex, binding to the chloride channel and thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. This results in uncontrolled activity of the central nervous system and death of insects or acarids.

Fipronil exhibits an insecticidal and acaricidal activity against fleas (Ctenocephalidesspp), ticks (Rhipicephalusspp, Ixodesspp including Ixodesricinus) in the dog.

Fleas will be killed within 24 h. Ticks will usually be killed within 48 h after contact with Fipronil, however if ticks of some species (Dermacentorreticulatus) are already present when the product is applied, all of the ticks may not be killed within the first 48 hours.

Fipronil is mainly metabolised to its sulfone derivative (RM1602), which also possesses insecticidal and acaricidal properties. The concentrations of fipronil on the hair decrease with time.

Butylhydroxyanisole E320

Butylhydroxytoluene E321

Propylene glycol

Benzyl alcohol

Diethylene glycol monoethyl ether

None known.

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Store below 25C, in a dry place in the original packaging.

White opaque or purple or red translucent polypropylene single-dose pipettes containing an extractable volume of 4.02 ml packaged in a clear PVC blister closed by heat sealing with aluminium foil and placed in a carton box or blister card.

Blister cards or boxes of 1, 2, 3, 4, 5 or 6 pipettes.

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Fipronil may adversely affect aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty container.

Bob Martin (UK) Ltd

Wemberham Lane

Yatton

North Somerset

BS49 4BS

Vm 00715/4117

27 May 2011

March 2016

Approved: 23 March 2016