Vectra 3D 3Pip 1.6Ml Dogs 4-10Kg Green

Vectra 3d Dog 4-10 Kg Green 3 Pipette

Holder of the commercialization authorization and responsible manufacturer for issuing manufacturing batch:

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 / pyriproxyfen / permethrin

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

This veterinary medicine is a clear yellow spot-on solution, packaged in single-use spot-on applicators.

INDICATIONS:

Fleas: This veterinary medicine 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 medicine also prevents flea multiplication for two months after application by inhibiting egg laying (ovicidal activity) and preventing immature fleas from developing into adult fleas. The veterinary medicine can be used as part of a treatment strategy for flea allergy dermatitis (FAD), an inflammation of the skin.

Ticks: This veterinary medicine kills and has a repellent effect 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 medicine is applied, they may not all be killed within the first 48 hours but may die within a week. To remove ticks, it is recommended to use a special tick removal device.

Sandflies, mosquitoes, and flies: This veterinary medicine has a repellent activity (prevents bites) against flying insects such as sandflies (Phlebotomus perniciosus), 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 medicine), this veterinary medicine must not be used on cats. If applied to a cat or ingested by a cat that has actively rubbed itself on a recently treated dog, this veterinary medicine can cause serious adverse reactions. Do not use in cases of hypersensitivity to the active ingredients or any excipients.

ADVERSE REACTIONS: Rarely reported are erythema, itching, or other transient signs of discomfort at the application site, which usually disappear without any treatment within 24 hours after administration. Rare cases have reported behavioral disorders such as hyperactivity, vocalization, or anxiety, systemic signs like lethargy or anorexia, and neurological signs such as muscle tremors. Very rarely, signs of ataxia like unsteady movements have been reported. Gastrointestinal symptoms (stomach or intestine) such as vomiting or diarrhea have been very rarely reported. Very rarely, transient cosmetic effects (oily appearance, ruffled coat, or accumulations) at the application site, but these effects are usually no longer visible after 48 hours.

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

- very common (more than 1 in 10 treated animals shows 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 in 10,000 treated animals, including isolated reports)

If side effects occur, including those not already mentioned in this leaflet or if the medicine appears not to have worked, please inform your veterinarian.

SPECIES OF USE:

Dogs.

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

APPLICATION: Be careful to apply the veterinary medicine only on intact skin (not damaged).

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

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

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 along a continuous line from the base of the tail down the center of the back to the shoulder blades, as shown in the figure, pressing the applicator until it is empty.

Treatment scheme: Following a single application, the veterinary medicine will prevent infestation for one month. The treatment can be repeated once a month
if recommended by the veterinarian.

SPECIAL STORAGE PRECAUTIONS: Keep out of reach and sight of children. This veterinary medicine does not require any special storage conditions. Do not use this veterinary medicine after the expiry date shown on the box and on the spot-on applicator after “EXP/Expiry”. The expiry date refers to the last day of the month.

SPECIAL WARNINGS: Special warnings for each target species: All dogs in the household should be treated. Household cats should only be treated with a veterinarian-approved medicine for that species. Fleas can infest the basket, bed, and typical resting areas of the dog, such as carpets, sofas, and armchairs. In case of severe flea infestation and at the beginning of control measures, these areas should be treated with an appropriate insecticide and then regularly vacuumed. Do not use on cats. If this veterinary medicine is accidentally ingested, it can induce 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 coming into contact with this veterinary medicine accidentally, keep cats away from treated dogs until the application site is dry. It is important to ensure that cats do not rub on the application site of a treated dog. In case of such exposure, seek immediate veterinary advice.

Precautions for use in animals: Only for external use. The safety of this veterinary medicine has not been established in dogs under 7 weeks of age or weighing less than 1.5 kg. Care should be taken to avoid contact between this veterinary medicine and the dog's eyes. In case of contact with the eyes, rinse immediately with water. Complete attack of a single tick after treatment cannot be excluded. For this reason, the transmission of infectious diseases cannot be completely ruled out if conditions are favorable. The veterinary medicine remains effective when treated animals are immersed in water (e.g., swimming, bathing). Repeated immersion in water weekly for a month starting 48 hours after treatment, as well as shampooing 2 weeks after treatment, do not affect the effectiveness of this veterinary medicine. However, the duration of efficacy may be reduced with frequent shampooing or baths within 48 hours after treatment. Dogs treated should not enter bodies of water within 48 hours after treatment to avoid adverse reactions to aquatic organisms. See also the paragraph “Special precautions for disposal of unused product or waste.”

Precautions for persons administering the veterinary medicine: Do not eat, drink, or smoke when handling the veterinary medicine. Wash hands thoroughly and immediately after use. This veterinary medicine can cause eye and skin irritation. Avoid contact with skin. In case of accidental spill on the skin, wash immediately with soap and water. If the veterinary medicine accidentally contacts the eyes, rinse thoroughly with water. If eye or skin irritation persists, or if the veterinary medicine is accidentally ingested, seek immediate medical advice showing this leaflet or label. Persons with known hypersensitivity to any component should avoid contact with the veterinary medicine. Children should not touch treated dogs for at least four hours after administration. It is recommended to treat dogs in the evening or before taking them for a walk. On the day of treatment, prevent treated dogs from sleeping with owners, especially children. Used applicators should be disposed of immediately and kept out of sight and reach of children. Wait until the application site dries before allowing treated dogs to come into contact with fabrics or objects.

Pregnancy and lactation: The safety of the veterinary medicine in pregnant or lactating bitches has not been established. Use in pregnant and lactating bitches or in dogs intended for breeding should be based on the veterinarian’s risk-benefit assessment. Laboratory studies with each of the components (dinotefuran, pyriproxyfen, and permethrin) in rats and rabbits have shown no evidence of toxic effects on pregnant or lactating animals, or effects on the embryo or fetus. It has been shown that dinotefuran crosses the blood-milk barrier in lactating animals. N-methylpyrrolidone, an excipient of the veterinary medicine, has shown to cause fetal malformations resulting in birth defects in laboratory animals.

Incompatibility: Unknown.

Overdose (symptoms, emergency procedures, antidotes): Except for local redness of the skin and changes in the appearance of the coat at the application site, adverse reactions have not been observed in healthy 7-week-old puppies treated topically 7 times at 2-week intervals and up to 5 times the maximum recommended dose. In case of accidental ingestion at the maximum recommended dose, vomiting, salivation, and diarrhea may occur but should resolve without treatment.