Vectra 3D 3Pip 0.8Ml Dogs 1.5-4Kg Yellow

Vectra 3d Dog 1.5-4 Kg Yellow 3 Pipettes

Holder of the marketing authorization and responsible manufacturer for the release of the manufacturing batches:

Ceva Santé Animale, 10 av. de La Ballastière, 33500 Libourne, France Each spot-on applicator dispenses:

Vectra® 3D spot-on solution for dogs from 1.5-4 kg
Vectra® 3D spot-on solution for dogs > 4-10 kg
Vectra® 3D spot-on solution for dogs > 10-25 kg
Vectra® 3D spot-on solution for dogs > 25-40 kg
Vectra® 3D spot-on solution for dogs > 40 kg

dinotefuran / piriproxyfen / permethrin

Each ml contains 54 mg of dinotefuran, 4.84 mg of piriproxifene and 397 mg of permethrin.

This veterinary medicinal product is a light yellow spot-on solution, packaged in single-use spot-on applicators.

INDICATIONS:

Fleas: This veterinary medicinal product kills fleas in infested animals and prevents further infestations for one month. It is effective against the following dog fleas (Ctenocephalides canis and
Ctenocephalides felis). This veterinary medicinal product also prevents flea multiplication for two months after application by inhibiting egg hatching (ovicidal activity) and inhibiting the development of immature fleas into adult fleas. The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD), an inflammation of the skin.

Ticks: This veterinary medicinal product kills and has repellent action against ticks (Rhipicephalus sanguineus and Ixodes ricinus are controlled for one month; Dermacentor reticulatus up to three weeks). If ticks are present when the veterinary medicinal product is applied, not all may be killed within the first 48 hours but may die within a week. To remove ticks, it is advised to use a specialized tick removal device.

Sandflies, mosquitoes, and flies: This veterinary medicinal product has repellent activity (prevents bites) against flying insects such as sandflies (Phlebotomus pernicious), mosquitoes (Culex pipiens, Aedes aegypti) and flies (Stomoxys calcitrans) for one month after application. It also kills mosquitoes (Aedes aegypti) and flies for one month after application.

CONTRAINDICATIONS: Do not use on cats (see "Special warnings"). Due to their particular physiology and inability to metabolize permethrin (one of the active ingredients of this
veterinary medicinal product), this veterinary medicinal product should not be used on cats. If applied to a cat, or ingested by a cat that has actively rubbed against a recently treated dog, this veterinary medicinal product may cause severe harmful reactions. Do not use in cases of hypersensitivity to the active ingredients or any of the excipients.

ADVERSE REACTIONS: Erythema, itching, or other signs of transient discomfort at the application site have been rarely reported, which usually disappear without treatment within 24 hours after administration of the veterinary medicinal product. In rare cases, behavioral disorders such as hyperactivity, vocalization or anxiety, systemic signs such as lethargy or anorexia, and neurological signs such as muscle tremors have been reported. In very rare cases, signs of ataxia such as unstable movements have been reported. Very rarely, gastrointestinal symptoms (stomach or intestines) such as vomiting or diarrhea have been reported. Very rarely, transient aesthetic effects (greasy appearance, ruffled fur and clumping) at the application site have been reported; however, these effects are usually not visible after 48 hours.

The frequency of adverse reactions is defined using the following conventions:

- very common (more than 1 in 10 treated animals show adverse reactions)
- common (more than 1 but less than 10 animals out of 100 treated animals)
- uncommon (more than 1 but less than 10 animals out of 1,000 treated animals)
- rare (more than 1 but less than 10 animals out of 1,000 treated animals)
- very rare (less than 1 animal out of 10,000 treated animals, including isolated reports)

If any side effects occur, including those not already mentioned in this leaflet or if the product is believed to have not worked, please inform the veterinarian.

TARGET SPECIES:

Dogs.

DOSAGE: Spot-on. Your veterinarian will determine the correct spot-on applicator for your dog (see also the section “Special warnings”). The minimum recommended dose is 6.4 mg dinotefuran/kg body weight, 0.6 mg piriproxifene/kg body weight, and 46.6 mg permethrin/kg body weight, equivalent to 0.12 ml of the veterinary medicinal product per kg of body weight. The following table shows the format of the spot-on applicator to be used based on the dog’s weight:

APPLICATION: Take care to apply the veterinary medicinal product only to intact skin (not broken).

How to apply: Remove the spot-on applicator from the package.

Recommendation 4a: Gently press the applicator and apply the veterinary medicinal product to the skin along the back of the dog, starting from the shoulders between the shoulder blades, with a number of applications
and sequence as illustrated in the figures below and pressing until the applicator is empty. Avoid surface application to the dog’s coat. The number of applications will depend on the weight of the dog.

Recommendation 4b: Regardless of the dog’s weight, using the rounded end of the applicator, part the hair at the base of the tail and start applying the product
directly to the skin in a continuous line from the base of the tail along the center of the back to the shoulders, as shown in the figure, pressing the applicator until it is empty.

Treatment schedule: Following a single application, the veterinary medicinal product will prevent infestation for one month. Treatment can be repeated once a month
if recommended by the veterinarian.

PARTICULAR STORAGE PRECAUTIONS: Keep out of the sight and reach of children. This veterinary medicinal product does not require any special storage conditions. Do not use this veterinary medicinal product after the expiration date stated on the box and on the spot-on applicator after "EXP/Exp." The expiration date refers to the last day of the month.

SPECIAL WARNINGS: Special warnings for each target species: All dogs in the household must be treated. Household cats must only be treated with a veterinary medicinal product authorized for use in that species. Fleas can infest the basket, kennel, and typical resting areas of the dog such as carpets and sofas and armchairs. In the event of severe flea infestation at the beginning of control measures, these areas should be treated with an appropriate insecticide and then cleaned with a vacuum cleaner regularly. Do not use on cats. If this veterinary medicinal product is accidentally ingested, it can cause seizures in cats which can be fatal. In case of accidental exposure, wash the cat with shampoo or soap, and seek immediate advice from a veterinarian. To prevent cats from accidentally coming into contact with this veterinary medicinal product, keep cats away from treated dogs until the application site is dry. It is important to ensure that cats do not rub against the application site of a dog that has been treated with this veterinary medicinal product. If such exposure occurs, seek immediate advice from a veterinarian.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Do not eat, drink or smoke while handling the veterinary medicinal product. Wash hands thoroughly and immediately after use. This veterinary medicinal product causes irritation to the eyes and skin. Avoid contact with the skin. In case of accidental spillage on the skin, wash immediately with soap and water. If the veterinary medicinal product accidentally comes into contact with the eyes, they must be thoroughly rinsed with water. If eye or skin irritation persists, or if the veterinary medicinal product is accidentally ingested, seek immediate medical attention showing the leaflet or label. People with known hypersensitivity to any of the components should avoid contact with the veterinary medicinal product. Children should not touch treated dogs for at least four hours after administration of the veterinary medicinal product. It is therefore advisable to treat dogs in the evening, or before taking them for a walk. On the day of treatment, treated dogs should not be allowed to sleep with their owners, especially if children are present. Used applicators must be disposed of immediately and not left in sight and reach of children. Wait for the application site to dry before allowing treated dogs to come into contact with fabrics or objects.

Pregnancy and lactation: The safety of the veterinary medicinal product in female dogs has not been established during pregnancy and lactation. The use of the veterinary medicinal product in pregnant and lactating dogs or in dogs intended for breeding should be based on the assessment of the risk-benefit ratio by the responsible veterinarian. Laboratory studies, with each of the components (dinotefuran, piriproxifene and permethrin) in rats and rabbits did not provide any evidence of toxic effects on the pregnant or lactating animal, or toxic effects on the embryo or fetus. It has been shown that dinotefuran crosses the blood-mammary barrier of lactating animals. N-methylpyrrolidone, an excipient of the veterinary medicinal product, has been shown to cause fetal malformations that resulted in birth defects in laboratory animals.

Incompatibility: Not known.

OVERDOSAGE (symptoms, emergency procedures, antidotes): Except for local redness of the skin and changes in the appearance of the coat where the veterinary medicinal product has been applied, no adverse reactions were observed in healthy puppies aged 7 weeks, treated topically 7 times at intervals of 2 weeks and up to 5 times the maximum recommended dosage. In case of accidental ingestion at the maximum recommended dosage, vomiting, salivation and diarrhea may occur, which should, however, resolve without treatment.