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

Vectra 3d Dog 10-25 Kg Blue 3 Pipette

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 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 the development of immature fleas into adults. The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD), a skin inflammation.

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, 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 dedicated tick removal device.

This veterinary medicinal product has a repellent effect (prevents bites) against flying insects such as sand flies (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 medicinal product), this medicinal product should not be used on cats. If applied on a cat, or ingested by a cat that has actively rubbed against a recently treated dog, this veterinary medicinal product can cause serious harmful reactions. Do not use in cases of hypersensitivity to the active ingredients or any excipients.

ADVERSE REACTIONS: Rarely, erythema, itching or other transient signs of discomfort at the application site have been reported, usually resolving without treatment within 24 hours after administration. Rare cases of behavioral disorders such as hyperactivity, vocalization or anxiety, systemic signs like lethargy or anorexia, and neurological signs like muscle tremors have been reported. Very rarely, signs of ataxia such as unsteady movements. Also, gastrointestinal symptoms (stomach or intestine) such as vomiting or diarrhea have been very rarely reported. Transient cosmetic effects (oily appearance, unkempt hair and accumulations) at the application site have also been very rarely 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 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 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 to have not worked, inform the veterinarian immediately.

INTENDED SPECIES:

Dogs.

DOSAGE: Spot-on. Your veterinarian will determine the correct spot-on applicator for your dog (see also the “Special warnings” section). The minimum recommended 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 spot-on applicator format to be used based on the dog's weight:

APPLICATION: Be careful to apply the veterinary medicinal product only on intact (healthy) skin.

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

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 a number of applications
and sequence as illustrated in the figures below, pressing until the applicator is empty. Avoid superficial application to the fur of the dog. The number of applications will depend on the dog's weight.

Recommendation 4b: Regardless of the dog's weight, using the rounded tip 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 along 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.

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

SPECIAL WARNINGS: Special warnings for each species of destination: All dogs in the household must be treated. Household cats should only be treated with a veterinary medicinal product authorized for use in that species. Fleas can infest baskets, bedding, and usual resting areas of the dog such as rugs, sofas, and armchairs. In case of heavy flea infestation and at the start of control measures, these areas should be treated with an appropriate insecticide and then regularly vacuumed. Do not use on cats. If this veterinary medicinal product is accidentally ingested by a cat, it can induce seizures that may 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 their contact points on the application site of a treated dog. In case of such exposure, 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 less than 7 weeks old or weighing less than 1.5 kg. Care should be taken to avoid contact of this veterinary medicinal product with the dog’s eyes. In case of eye contact, rinse immediately with water. It cannot be completely excluded that a single tick may attach after treatment. Therefore, the transmission of infectious diseases cannot be completely ruled out 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 post-treatment, do not affect the efficacy of this veterinary medicinal product. However, the duration of efficacy may be reduced with frequent shampoos or baths within 48 hours after treatment. Treated dogs should not be allowed to enter bodies of water for 48 hours after treatment to avoid adverse reactions in aquatic organisms. See also the section “Special precautions for disposal of unused product or waste.”

Precautions for 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 eye and skin irritation. Avoid contact with the 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 accidentally, rinse thoroughly with water. If eye or skin irritation persists, or if the veterinary medicinal product is accidentally ingested, consult a doctor immediately and show him the leaflet or label. Persons with known hypersensitivity to one of the components should avoid contact with the veterinary medicinal product. 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, treated dogs should not sleep with their owners, especially children. Used applicators should be disposed of immediately and kept out of 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 pregnant and lactating bitches has not been established. Use in pregnant and lactating bitches or dogs intended for reproduction should be based on the veterinarian’s risk-benefit assessment. 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 the embryo or fetus. It has been shown that dinotefuran crosses the blood-milk barrier in lactating animals. The excipient N-methylpyrrolidone 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 skin redness and changes in coat appearance where the veterinary medicinal product was applied, 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.