Vectra 3D 3Pip 4.7Ml Dogs 25-40Kg Violet

Vectra 3d Dog 25-40 Kg Violet 3 Pipette

Holder of the marketing authorization and manufacturer responsible for batch release:

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

Vectra® 3D spot-on solution for dogs 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 / pyriproxifen / permethrin

Each ml contains 54 mg of dinotefuran, 4.84 mg of pyriproxifen, 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 on 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 preventing immature fleas from developing 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 repels ticks (Rhipicephalus sanguineus and Ixodes ricinus are controlled for one month; Dermacentor reticulatus for up to three weeks). If ticks are present at the time of application, they may not all be killed within the first 48 hours but can die within a week. To remove ticks, it is recommended to use a dedicated tick removal device.

Sandflies, mosquitoes, and flies: This veterinary medicinal product 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 post-application.

CONTRAINDICATIONS: Do not use on cats (see “Special warnings”). Due to their unique physiology and inability to metabolize permethrin (one of the active ingredients of this veterinary medicinal product), it must not be used on cats. If applied to a cat or ingested by a cat actively rubbing against a recently treated dog, this veterinary medicinal product can cause serious adverse reactions. Do not use if hypersensitive to the active ingredients or any excipients.

ADVERSE REACTIONS: Erythema, itching, or other transient signs of discomfort at the application site, which usually resolve without treatment within 24 hours. Rarely, behavioral disturbances such as hyperactivity, vocalizations, or anxiety have been reported, as well as systemic signs like lethargy or anorexia, and neurological signs like muscle tremors. Very rare signs of ataxia (unsteady movements) have been observed. Gastrointestinal symptoms (stomach or intestines) such as vomiting or diarrhea have been very rarely reported. Rarely, transient cosmetic effects (oily appearance, coat frizz, and deposits) at the application site have been noted, but these effects are usually no longer visible after 48 hours.

The frequency of adverse reactions is classified as follows:

- Very common (more than 1 in 10 treated animals experience adverse reactions)
- Common (more than 1 but less than 10 animals in 100)
- Uncommon (more than 1 but less than 10 animals in 1,000)
- Rare (more than 1 but less than 10 animals in 1,000)
- Very rare (less than 1 animal in 10,000, including isolated reports)

If side effects occur, even those not listed in this leaflet, or if the medicine does not seem to work, please inform your veterinarian.

TARGET SPECIES:

Dogs.

DOSAGE: Spot-on. Your veterinarian will determine the correct spot-on applicator for your dog (see also the “Special warnings” section). The recommended minimum dose is 6.4 mg dinotefuran/kg body weight, 0.6 mg pyriproxifen/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: Make sure to apply the veterinary medicinal product only on intact (healthy) skin.

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

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

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

Treatment schedule: After a single application, the veterinary medicinal product 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 medicinal product does not require any particular storage conditions. Do not use after the expiry date indicated on the box and on the spot-on applicator after “EXP/Expiry.” The expiry date is the last day of the month.

SPECIAL WARNINGS: Special warnings for each target species: All dogs in the household must be treated. Cats must be treated only with a veterinary medicine authorized for use in that species. Fleas can infest the basket, bed, and usual resting areas of the dog, such as carpets and sofas and armchairs. In case of a heavy flea infestation and at the start of control measures, these areas should be treated with an appropriate insecticide and then cleaned regularly with a vacuum cleaner. Do not use on cats. If this veterinary medicinal product 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 accidental 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 treated dog. In such cases, seek immediate advice from a veterinarian.

Precautions for use in animals: For external use only. The safety of this veterinary medicinal product 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 medicinal product and the dog’s eyes. In case of contact with eyes, rinse immediately with water. Single tick bites after treatment cannot be entirely ruled out. For this reason, the transmission of infectious diseases cannot be completely excluded if conditions are favorable. The veterinary medicinal product remains effective when treated animals are immersed in water (e.g., swimming, bathing). Repeated immersion in water weekly for a month and starting 48 hours after treatment, as well as shampooing 2 weeks after treatment, do not affect the efficacy of this veterinary medicinal product. However, the duration of effectiveness may be reduced with frequent shampoos or baths within 48 hours post-treatment. Dogs treated should not enter water courses for 48 hours after treatment to avoid adverse reactions in aquatic organisms. See also the “Precautions for disposal of unused or waste product” section.

Precautions for the person administering the veterinary medicinal product: Do not eat, drink, or smoke while handling the veterinary medicinal product. Wash hands thoroughly and immediately after use. This veterinary medicinal product causes eye and skin irritation. Avoid contact with skin. In case of accidental spillage on the skin, wash immediately with soap and water. If the veterinary medicinal product comes into contact with the eyes, rinse thoroughly with water. If eye or skin irritation persists, or if the veterinary medicinal product is accidentally ingested, seek immediate medical advice and show the package leaflet or label. Persons with known hypersensitivity to any of the components should avoid contact with the veterinary medicinal product. Children must not touch treated dogs for at least four hours after administration. Therefore, it is advisable to treat dogs in the evening or before taking them for a walk. On the day of treatment, treated dogs should not sleep with owners, especially if children are present. Used applicators should be disposed of immediately and should not be left where children can access them. Wait until the application site is 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 in pregnant or lactating bitches, or in dogs intended for breeding, should be based on a risk-benefit assessment by the responsible veterinarian. Laboratory studies with each of the components (dinotefuran, pyriproxifen, and permethrin) in rats and rabbits have shown no evidence of toxic effects on pregnant or lactating animals or on embryonic or fetal development. It has been demonstrated that dinotefuran crosses the blood-milk barrier in lactating animals. N-methylpyrrolidone, an excipient in the veterinary medicinal product, has been shown to cause fetal malformations resulting in birth defects in laboratory animals.

Incompatibility: Not known.

Overdose (symptoms, emergency procedures, antidotes): Apart from localized skin redness and changes in the appearance of the coat at the application site, no adverse reactions have 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.