Sava Healthcare Fiprofort for Dogs with 10 to 20 kg body Weight

Sava Healthcare Fiprofort for Dogs with 10 to 20 kg body Weight

Each pipette contains:

Fipronil .......9.7% w/v

Excipients q.s.

Fiprofort for Dog provides convenient and effective flea and tick control for dogs and puppies over 10 weeks of age. It provides protection upto 6 months against fleas and 3 months against ticks depending on the level of environmental challenge.

PHARMACODYNAMICS:

Fipronil is an insecticide acaricide belonging to the family phenylpyrazole. It works by inhibiting the GABA complex, thus blocking the transfer of chloride ions through the membrane at the pre and post-synaptic binding in the chloride channel. It thus causes uncontrolled activity of the central nervous system and death of insects and mites.

PHARMACOKINETICS:

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

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).

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. The concentration of fiproniland fipronil sulfone 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.

DIRECTIONS:

Cure and prevention of infestations by fleas, ticks and biting lice. The duration of protection against new infestation is two months for fleas and one month for ticks. The drug can be incorporated into a treatment of Flea Allergy Dermatitis.

APPLICATION

Break the pipette from the tip. 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.

CONTRA-INDICATIONS, WARNINGS, etc. :

• For treatment of dogs only. DO NOT USE ON CATS AND OTHER ANIMALS.

• FOR EXTERNAL USE ONLY.

• Dogs should be weighed accurately prior to treatment.

• Do not use in rabbits, as adverse reactions and even death could occur.

• Flammable.

• Dogs or operators with a known hypersensitivity to insecticides or alcohol should avoid contact with Fiprofort  Dog.

• The product should not be used on puppies less than 10 weeks old and/or weighing less than 2kg.

• Do not use on sick (systemic diseases, fever....) or convalescent dogs.

• This product is specifically developed for dogs. Does not use in cats as this could lead to overdosing.

• Do not overdose.

• It is important to apply the dose to an area where the dog cannot lick it off, and to make sure that dogs do not lick each other following treatment. If licking occurs, a brief period of hypersalivation may occur, mainly due to the nature of the carrier.

• Among the extremely rare suspected adverse reactions, transient cutaneous reactions at the application site (skin discolouration,local alopecia, pruritis, erythema) and general pruritis or alopecia have been reported after use.

• Exceptionally, hypersalivation, reversible neurological signs (hyperaesthesia, depression, nervous signs) or vomiting or respiratory signs have been observed after use.

• Dogs should not be allowed to swim in watercourses for 2 days after application.

OPERATOR WARNINGS:

• The product can cause mucous membrane and eye irritation, so avoid contact with the mouth and eyes.

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

• After accidental ocular exposure the eye should be rinsed carefully with plain water.

• Avoid contact with the dog’s eyes.

• Wash hands after use.

• Do not smoke, eat or drink during application.

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

• Ensure that treated dogs do not groom each other after treatment until dry.

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

PRECAUTIONS:

• Bathing / immersion in water within 2 days after application of the product and more frequent baths than once a week should be avoided in the absence of efficacy study in this regard. The emollient shampoos can be used before treatment, but decrease the duration of protection against fleas approximately 5 weeks when used weekly after application of the product.

• Weekly shampoo with 2% chlorhexidine did not decrease the effectiveness of the product against fleas in a study of 6 weeks.

PREGNANCY AND LACTATION:

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. Fiprofort for Dog can be used in breeding, pregnant and lactating bitches.

OVERDOSE:

The risk of experiencing adverse effects may however increase in cases of overdose.