Frontline Spot On for extra large dogs 40-60kg (pack of 6)

The active ingredient in FRONTLINE® is Fipronil, an insecticide and acaricide. Fipronil works by causing uncontrolled activity of the central nervous system (CNS), and consequently death of fleas, biting lice, and ticks. 

Fipronil exhibits an insecticidal and acaricidal activity against fleas (Ctenocephalides spp), ticks (Rhipicephalus spp. Dermacentor spp. and Ixodes spp. including Ixodes ricinus, important as the vector of Lyme disease) and lice (Trichodectes canis) in the dog.

The product is effective against fleas for approximately 2 months and tick infestations for up to 1 month, depending on the level of environmental challenge. Newly arriving fleas are killed within 24 hours of landing on the animal.

After topical application of the product in the dog, absorption of fipronil through the skin is slight (approx. 15%).  Low levels of fipronil may be detected in the plasma, with a very high variability between dogs. After topical application, the product will spread from the site of treatment to cover the entire surface of the animal within 24 hours. A concentration gradient of fipronil is set up on the fur of the animal extending from the point of application to the peripheral areas (lumbar zones, flanks, …). The concentrations of fipronil on the hair decrease with time to attain a level of approximately 3 to 4 µg.g –1 56 days after treatment.

Active substance:

Fipronil……………………………10% w/v

Excipients:

Butylhydroxyanisole.. E320….…0.02% w/v
Butylhydroxytoluene.. E321……..0.01% w/v

Polyvidone K17
Polysorbate 80
Ethanol
Ethyl Digol

Application is only by topical application to the skin.

Apply 1 pipette of 4.02 ml FRONTLINE® Spot On topically per dog weighing over 40kg and up to 60kg bodyweight.

For dogs over 60kg use two pipettes of 2.68ml.

Treatment schedule:
The minimum treatment interval is 4 weeks.

When treating infestations of lice, all in-contact dogs should be treated with an appropriate product at the same time.

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

There may be an attachment of single ticks. For this reason transmission of infectious diseases cannot be completely excluded if conditions are unfavourable. 

Method of Administration

1. Hold pipette upright. Tap the narrow part of the pipette to ensure the contents are within the main body of the pipette.
   Break back the snap-off top from the spot-on pipette along the scored line.

2. Part the coat between the shoulder blades until the skin is visible.

3. Place the tip of the pipette against the skin and squeeze gently at one or two spots to empty its contents directly onto the skin, preferably at two spots, one at the base of the skull and a second 2-3cms further back.

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.

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 disappear within 24 hours post application.

Special precautions for use in animals

In the absence of available data, the product should not be used on puppies less than 8 weeks old and/or weighing less than 2 kg.
Do not use on animals that are unwell, are undergoing treatment for, or are recovering from illness.
Do not use in rabbits, as 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 in cases of hypersensitivity to the active substance or to any of the other ingredients.
Do not administer orally.

Animals should be weighed accurately prior to treatment.
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.
Avoid contact with the animal’s eyes.
Do not overdose.

Ticks already on the animal prior to treatment may not be killed within the first 48 hours after application of the product, but they may be killed within a week. Removal of ticks already on the animal at the time of application is recommended. The product does not prevent ticks from attaching to the animal. If the animal has been treated prior to exposure to the ticks, most ticks will be killed within 48 hours of infestation. This will usually be prior to engorgement, 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 pull.
Neither immediate nor persistent efficacy has been demonstrated against Ixodes ricinus.

The safety of the product was demonstrated in breeding, pregnant and lactating bitches treated with multiple consecutive doses with up to 3 times the maximum recommended dose.
The product can be used during pregnancy and lactation.

Bathing or shampooing the animal up to one hour prior to treatment does not affect the  effectiveness of the product. Bathing/immersion in water within 2 days after application of the product and more frequent bathing than once a week should be avoided, as no study has been performed to investigate how this affects the efficacy of the product.

Skin softening shampoos can be used prior to treatment, but reduce the duration of protection against fleas to approximately 5 weeks when used weekly after application of the product. Weekly bathing with a 2% chlorhexidine medicated shampoo did not affect efficacy against fleas during a 6 week long study.

Special precautions to be taken by the person administering the medicinal product to animals

Keep stored pipettes in the original packaging until ready to use.  In order to prevent children from getting access to used pipettes, dispose of used pipettes immediately.
This veterinary medicinal product can cause mucous and eye irritation. Therefore avoid contact of the product with mouth and eyes.
Should the veterinary medicinal product come into contact with the eyes, rinse thoroughly at once with water. If the eye irritation persists, seek medical help at once and show the package insert or label.
Avoid contact with the skin. Should the product come into contact with the skin, wash with soap and water. Wash hands after use.
Do not eat, drink or smoke during application.
People with a known hypersensitivity to insecticides or alcohol 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.

Other precautions

The product should not enter water courses as this may be dangerous for fish or other aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty container. Dogs should not be allowed to swim in watercourses for 2 days after application.

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

Adverse reactions (frequency and seriousness)

If licking occurs, a brief period of excessive salivation/drooling may be observed due mainly to the nature of the solvents in the product.
Among the extremely rare suspected adverse reactions,  short-lived skin reactions at the application site (scaling, local  hair loss,  itchiness,  reddening) and general  itchiness or hair loss have been reported after use. Exceptionally,  excessive drooling, reversible nervous signs including hyperaesthesia (increased sensitivity to light and sound or overexcited or unusual behavior), depression, or vomiting have been observed after use.

If any adverse reactions are noted, they should be reported to your veterinary surgeon.

MARKETING AUTHORISATION HOLDER

Merial Animal Health Limited
PO Box 327
Sandringham House
Harlow Business Park
Harlow
Essex
CM19 5TG

MARKETING AUTHORISATION NUMBER(S)

Vm 08327/4132

When treating infestations of lice, all in-contact dogs should be treated with an appropriate product at the same time.

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

There may be an attachment of single ticks. For this reason transmission of infectious diseases cannot be completely excluded if conditions are unfavourable. FRONTLINE SPOT ON DOG does not prevent ticks from attaching to the animals, but ticks will be killed in the first 24-48 hours after attachment,  before they are fully fed and therefore minimising the risk of transmission of diseases.  Once dead, ticks will often drop off the animal, but any remaining ticks may easily be removed by a gentle pull.

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 more information and advice on flea, tick and lice control from Frontline, click here.