Zaza In-Outs Spot On For Cats

Active Ingredient (s):

Imidacloprid 10% w/v & Moxidectin 1% w/v Solution

ONCE-A-MONTH TOPICAL SOLUTION

For Cats less than 4 Kgs

• Fleas
• Flea Larvae
• Heartworms
• Intestinal Worms
• Ear Mites

Composition

Each ml contains:

Imidacloprid ................ 100mg

Moxidectin BP ............ 10mg

Excipients ................... q.s.

Indications

For Cats / Ferrets suffering from, or at risk from, mixed parasitic infections for the:

• Treatment and prevention of flea infestation (Ctenocephalidesfelis).
• Treatment of ear mite infestation (Otodectescynotis).
• Prevention of heartworm disease (L3 and L4 larvae of Dirofilariaimmitis).
• Treatment & control of Sarcoptic mange.
• Treatment & control of roundworm and hookworm treatment (Toxocara cati and Ancylostoma tubaeforme).
• Treatment of the eye worm Thelaziacallipaeda (adults).

 The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

Dosage and Administration

The recommended minimum doses are 10 mg/kg bodyweight Imidacloprid and 1mg/kg bodyweight Moxidectin, equivalent to 0.1 ml of this product per kg bodyweight.

Apply each dose once every 30 days.

Administer in accordance with the following table:

Or as directed by the veterinarian.

Treatment and prevention of flea infestation (Ctenocephalidesfelis)

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine treatment with this veterinary medicinal product with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Treatment of ear mite infestation (Otodectes cynotis)

A single dose of the product should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Prevention of heartworm disease (L3 and L4 larvae of Dirofilariaimmitis)

Cats in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with the product, the advice provided in section 4.5 should be considered.

For prevention of heartworm disease, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm larvae) are present. The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with the product must be given within 1 month of the last dose of the former medication.

In non-endemic areas there should be no risk of cats having heartworm. Therefore they can be treated without special precautions.

Treatment & control of Sarcoptic mange

A single dose of the product should be administered.

Roundworm and hookworm treatment (Toxocara cati and Ancylostoma tubaeforme)

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of reinfection caused by the respective roundworms and hookworms. In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.

Treatment of the eye worm Thelazia callipaeda (adults)

A single dose of the product should be administered.

TARGET SPECIES

Cats

Directions for Use

Apply to the skin at the base of the neck in front of the shoulder blades.

1. Remove the tube from its packaging.
2. Part the hair on the back of your cat's / Ferret's neck at the base of the head, until the skin is visible. Place the tip of the tube on the skin and apply the entire contents directly on the exposed skin. Lift tube away from skin before releasing pressure on tube.

EFFECTS OF IMIDALCOPRID AND MOXIDECTIN

Imidacloprid: is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it can be classified as a chloronicotinyl nitroguanidine. Imidacloprid is effective against adult fleas and larval flea stages. In addition to the adulticide flea efficacy of imidacloprid, a larvicidal flea efficacy in the surroundings of the treated pet has been demonstrated. Larval stages in the pet`s immediate surroundings are killed following contact with a treated animal. It has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) in insects. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death of the parasite.

Moxidectin: 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages of Dirofilariaimmitis (L1, L3, L4) and Dirofilariarepens (L1, L3). It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

HOW DO MOXIDECTIONS INTERACT WITH THE BODY

After topical administration of the product, imidacloprid is rapidly distributed over the animal's skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1 to 2 days after treatment in cats. Following absorption from the skin, moxidectin is distributed systemically and is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

Warning & Precautions

• Wear gloves during application.
• Avoid contact with eyes, skin & clothing. If the product is in contact with eyes, rinse immediately with plenty of water.
• Keep treated animals away from flame until animal gets dry.
• Wash the hands thoroughly after use.
• Used applicators should be disposed of immediately and not left within the sight or reach of children.
• ZAZA IN-OUTS SPOT ON is to be applied to the skin surface only. Do not administer orally or parenterally.
• The treatment of cats weighing less than 1 kg should be based on a benefit-risk assessment.
• Separation of treated pets may be necessary.
• Do not apply when the animal's hair coat is wet. However, shampooing or soaking the animal 2 or more hours after treatment will not reduce the efficacy of the product.
• Do not smoke, drink or eat while handling the product.
• Do not allow the Cats or any other treated animals to lick any of the application sites for first 30 minutes.

CONTRAINDICATIONS

Do not use in kittens under 9 weeks of age.

Do not administer to animals other than those for which it is indicated.

Do not use on canaries.

Hypersensitivity to any of the ingredients.

Adverse Effects

Use of the product may result in transient pruritus in cats. On rare occasions greasy fur, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases, cause local hypersensitivity reactions. If the animal licks the application site after treatment, serious adverse reactions including depression, salivation, dilated pupils, in coordination, panting, and generalized muscle tremors is caused.

The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimize licking of the application site.

Overdose

Symptoms of overdose may include depression, increased salivation, tremors, or in coordination. However Up to 10 times the recommended dose was well-tolerated in cats & up to 5 times the recommended dose to Ferrets with no evidence of adverse effects or undesirable clinical signs.

Withdrawal Period

Not applicable.

Storage

Store below 30°C in a dry place.

Container Disposal

Any unused product or waste material should be disposed of in accordance with local requirements. Imidacloprid and Moxidectin may adversely affect fish or certain water-borne organisms on which they feed. Containers and residual contents should be disposed of to avoid contamination of any water courses.

PRESENTATION

ZAZA IN-OUTS SPOT ON For Cats & Ferrets less than 4 Kgs

6 Lami tube of 0.4 ml

VETERINARY.

FOR ANIMAL TREATMENT ONLY.

NOT FOR HUMAN USE.

FOR EXTERNAL APPLICATION ONLY.

SHAKE WELL BEFORE USE.

KEEP OUT OF REACH OF CHILDREN & PETS, AWAY FROM FOOD.

Carefully read the accompanying instructions before use.