FIPROFORT PLUS SPOT-ON FOR DOGS (0-10KG)

FIPROFORT PLUS for Dogs

Each pipette contains:

Fipronil                       9.8% w/w

(S)-methoprene           8.8% w/w

Excipients                   q.s.

CATEGORY: Insecticide-acaricide

PHARMACODYNAMICS:

Fipronil is belonging to the family phenylpyrazole. It acts by interaction with complexes formed between the chloride channels and their ligands, especially the neurotransmitter GABA (gamma-amino butyric acid), thus blocking the transfer of chloride ions across cell membranes to levels pre and post synaptic. It thus causes uncontrolled activity on the central nervous system of insects and mites and causes their death. Fipronil kills fleas within 24 hours, ticks (Dermacentor variabilis, Rhipicephalus sanguineus, Ixodes scapularis, Ixodes ricinus, Haemaphysalis longicornis, Haemaphysalis flava and Haemaphysalis

campanulata) and lice within 48 hours after application of the product.

The (S)-methoprene is a regulator of insect growth (ROI) of the class of similar juvenile hormone, it inhibits the development of immature stages of insects. Mimicking the action of the juvenile hormone, the compound causes impaired development and death of immature stages of fleas. The ovicidal activity of (S)-methoprene applied to the dog results either from direct penetration into the shell flea eggs newly laid or its absorption through the cuticle of adult fleas. The (S)-methoprene is also effective in preventing the development of larvae and pupae chip, prevents contamination of the habitat of dogs treated with the immature stages of fleas.

PHARMACOKINETICS:

Reported studies showed that absolute bioavailability of fipronil was 9.5 %. The mean maximum concentration (C_max) was found to be 19 ng/ml in plasma found after 5 days (T_max). Plasma concentrations were below 1 ng/ml (limit of quantification) by max approximately 33 days following topical administration.

(S)-methoprene showed very low dermal absorption and all plasma concentrations were below the limit of quantification (10 ng/ml).

In Dogs, fipronil’s major metabolite on the haircoat of the dog and in the blood stream is the sulfone derivative. Fipronil sulfone is produced on the haircoat (mean concentrations < 16 % of fipronil during the first month after treatment).

(S)-methoprene is extensively degraded into carbon dioxide and acetate that are subsequently incorporated into endogenous materials.

In dogs after administration of the association topically, fipronil is poorly absorbed (11%) with average maximum plasma concentration of approximately 35 ng/ml for fipronil and 55 ng/ml for fipronil sulfone.

In dogs, the plasma fipronil concentrations slowly reached a peak average about 101 hours and decreasing slowly (half-life) by approximately 154 hours, the highest values are observed in males.

Plasma concentrations of (S)-methoprene are generally below the quantification (20 ng/ml) in dogs after topical administration.

The concentrations of fipronil, fipronil sulfone and (S)-methoprene in peeling decreases with time, but are detectable at least 60 days after application in dogs.

Parasites are killed mainly by contact and not by systemic exposure. No pharmacological interference between fipronil and

(S)-methoprene was detected.

INDICATION AND DOSAGE:

FIPROFORT PLUS provides fast, effective and convenient treatment and control of fleas, ticks and chewing lice.

Treatment and prevention of flea infestation (CtenocephaIides spp) and control of brown dog ticks (Rhipicephalus sanguineus), paralysis tick (Ixodes holocyclus) and biting lice (Trichodectes canis) on dogs.

FIPROFORT PLUS has a rapid onset of action and kills re-infections with newly acquired adult fleas for at least one month.

FIPROFORT PLUS also prevents the development of flea eggs, larvae and pupae produced by adult fleas acquired for three months in dogs after treatment.

FIPROFORT PLUS controls brown dog ticks for up to one month and paralysis ticks for up to two weeks after application in dogs. Daily searching of dog is necessary to minimize the risk of tick paralysis. Searching should continue throughout the paralysis tick season.

FIPROFORT PLUS may be used for the treatment and control of Flea Allergy Dermatitis in dogs.

FIPROFORT PLUS is used for flea control as it breaks the life cycle on the dog and in its surrounding by killing all stages of fleas.

TREATMENT FREQUENCY

For Fleas: Monthly application is recommended for dogs. All dogs in a household should be treated at the same time. It is especially important to treat all household dogs if any pet is allergic to fleas (flea allergy dermatitis).

Paralysis Ticks: Two-weekly application in dogs is recommended. FIPROFORT PLUS provides control of paralysis ticks for up to 2 weeks, use of this product does not guarantee prevention of tick paralysis because ticks are not killed immediately after attachment. Daily searching of dogs is necessary to minimize the risk of tick paralysis. Searching should continue throughout the paralysis tick season, which extends from Spring to Autumn, but may be year round in some localized areas.

Brown Dog Tick: Monthly application is recommended in dogs.

Biting Lice: Treat all household dogs at the same time.

APPLICATION:

Break the snap-off top from the pipette along the scored line. Part the hair at back of dog, at the base of the neck between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze gently at one or two spots to empty its contents onto the skin. Care should be taken to avoid excessive wetting of hair during treatment of dogs. Do not allow treated dogs to lick each other or rub against other animals until the application site is dry[RD1]

CAUTION: Hazardous to Human.

This product may cause irritation of mucous membranes, skin and eyes. So avoid contact of the product with the mouth, skin or eyes. Dogs or those who have known hypersensitivity to insecticides or alcohol should avoid contact with the drug. Avoid contact of contents with the fingers. If this occurs, wash hands with soap and water. In case of accidental exposure with eyes, rinse with clean water carefully. Do not handle treated dogs and don’t allow children to play with treated dogs until the application site is dry. It is therefore recommended that dogs are not treated in the day but in the early evening and that recently treated dogs are not allowed to sleep with owners, especially children. Do not smoke, drink or eat during application.

Do not apply FIPROFORT PLUS for more than 30 days.

SAFETY IN DOGS: For external use only.

FIPROFORT PLUS is safe for use in dogs and puppies over 8 weeks of age and in breeding, pregnant or lactating bitches. Do not use FIPROFORT PLUS if you or your pet has a known hypersensitivity to insecticides or alcohol.

STORAGE: Store below 30°C in dark place. Protect from heat.

PHYSICAL OR CHEMICAL HAZARDS: FLAMMABLE

Keep away from heat and open flame.

CONTAINER DISPOSAL: Fipronil and (S)-methoprene may adversely affect aquatic organisms. Do not discard the product or empty pipettes in ponds, rivers and streams. Securely wrap pipette in several layers of newspaper and discard in trash.

Veterinary. Not for human use. For animal treatment only. For external application only.

FOR THE TREATMENT OF DOGS ONLY.

PRESENTATION:

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs upto 10kg Pipette of 0.67 ml

(FOR USE ON PUPPIES FROM 8 WEEKS OF AGE)

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs over 10kg upto 20kg Pipette of 1.34 ml

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs over 20kg upto 40kg Pipette of 2.68 ml

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs over 40kg Pipette of 4.02 ml