Vectra 3D 3Pip 3.6Ml Dogs 10-25Kg Blue

Vectra 3d Dog 10-25 Kg Blue 3 Pipettes

Holder of the marketing authorization and responsible manufacturer for the release of 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 / pyriproxyfen / permethrin

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

This veterinary medicine is a light 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 the multiplication of fleas for two months after application by inhibiting the hatching of eggs (ovicidal activity) and inhibiting the transformation of immature fleas into adult fleas. The veterinary medicine can be used as part of a treatment strategy for flea allergic dermatitis (FAD), an inflammation of the skin.

Ticks: This veterinary medicine kills and has repellent action against ticks (Rhipicephalus sanguineus and Ixodes ricinus are controlled for one month; Dermacentor reticulatus for 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. It is recommended to use a special device for removing ticks.

Sandflies, mosquitoes, and flies: This veterinary medicine has 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 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 medicine may cause serious harmful reactions. Do not use in case of hypersensitivity to the active ingredients or any of the excipients.

ADVERSE REACTIONS: Erythema, itching, or other transient signs of discomfort at the application site have been rarely reported, usually disappearing without any treatment and within 24 hours after administration of the veterinary medicine. Rarely reported behavioral disorders include hyperactivity, vocalizations, or anxiety, systemic signs such as lethargy or anorexia, and neurological signs such as muscle tremors. Very rare ataxia signs, such as unstable movements, have also been reported. Very rare gastrointestinal symptoms (stomach or intestine), such as vomiting or diarrhea, have been reported. Very rare transient aesthetic effects (greasy appearance, matted fur, and accumulations) at the application site have also been reported; however, 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 exhibit adverse reactions)
- common (more than 1 but less than 10 animals out of 100 treated)
- uncommon (more than 1 but less than 10 animals out of 1,000 treated)
- rare (more than 1 but less than 10 animals out of 1,000 treated)
- very rare (less than 1 animal out of 10,000 treated, including isolated reports)

If side effects occur, even those not already mentioned in this package leaflet, or if the medicine is thought not to have 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 paragraph “Special warnings”). 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 format of the spot-on applicator to use based on the dog's weight:

APPLICATION: Be careful to apply the veterinary medicine only to 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 skin along the dog's back, starting from the shoulders between the shoulder blades, with a number of applications
and sequence as shown in the figures below and 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 fur at the base of the tail and begin applying the product
directly to the skin in a continuous line from the base of the tail along the middle of the back to the shoulders, as shown in the figure, pressing the applicator until it is empty.

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

SPECIAL STORAGE PRECAUTIONS: Keep out of sight and reach of children. This veterinary medicine does not require any special storage conditions. Do not use this veterinary medicine after the expiry date stated 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 must be treated. Household cats should be treated only with a veterinary medicine authorized for use in that species. Fleas may infest the dog's basket, bed, and usual resting areas such as carpets and sofas and armchairs. In case of a heavy flea infestation
and 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 medicine is accidentally ingested, it may induce seizures in cats that can be fatal. In case of accidental exposure, wash the cat with shampoo or soap, and seek immediate advice from a veterinary doctor. To prevent cats from accidentally coming into contact with this veterinary medicine, 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 medicine. In case of such exposure, seek immediate advice from a veterinary doctor.

Special precautions for use in animals: For external use only. The safety of this veterinary medicine has not been tested in dogs less than 7 weeks old 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. The attack of a single tick after treatment cannot be excluded. For this reason, the transmission of infectious diseases cannot be completely excluded if conditions are favorable. The veterinary medicine remains effective when treated animals are immersed in water (e.g. when swimming or bathing). Repeated immersion in water weekly for one month, starting 48 hours after treatment, as well as shampooing 2 weeks after treatment has no effect on the effectiveness of this veterinary medicine. However, the duration of effectiveness may be reduced in the case of frequent shampooing or bathing within 48 hours after treatment. Treated dogs should not be allowed to enter watercourses for 48 hours after treatment to avoid adverse reactions to aquatic organisms. See also the paragraph “Particular precautions to be taken for the disposal of unused product or any waste.”

Precautions that must be taken by the person administering the veterinary medicine to the animals: Do not eat, drink, or smoke when handling the veterinary medicine. Wash hands thoroughly and immediately after use. This veterinary medicine 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 medicine accidentally comes into contact with the eyes, they must be thoroughly rinsed with water. If irritation to the eyes or skin persists, or if the veterinary medicine is accidentally ingested, seek immediate medical attention, showing the package leaflet or label. People with known hypersensitivity to any of the components should avoid contact with the veterinary medicine. Children should not touch treated dogs for at least four hours after administration of the veterinary medicine. 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 be allowed to sleep with their owners, especially if children are present. Used applicators should 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 medicine in female dogs has not been established during pregnancy and lactation. The use of the veterinary medicine in pregnant and lactating dogs or in dogs intended for breeding should be based on the evaluation of the risk-benefit ratio by the responsible veterinarian. Laboratory studies, with each of the components (dinotefuran, pyriproxyfen, and permethrin) in rats and rabbits have provided no 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 medicine, has been shown to cause fetal malformations leading to birth defects in laboratory animals.

Incompatibility: Not known.

Overdose (symptoms, emergency procedures, antidotes): Except for local reddening of the skin and changes in the appearance of the coat where the veterinary medicine was applied, no adverse reactions were observed in healthy puppies 7 weeks old, 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, but these should resolve without treatment.