Vectra 3D 3Pip 8Ml Dogs >40Kg Red

Vectra 3d Dog +40 Kg Red 3 Pipettes

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

Ceva Santé Animale, 10 av. de La Ballastière, 33500 Libourne, France. Each spot-on dispenser 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 / piriproxifen / permethrin

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

This veterinary medicinal product is a bright 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 product also prevents flea multiplication for two months after application by inhibiting egg hatch (ovicidal activity) and preventing immature flea development 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 a month; Dermacentor reticulatus for 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.

Sand flies, mosquitoes, and flies: This veterinary medicinal product has a repellent activity (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 medication must 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 can cause severe 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 of administration. Rarely, behavioral disorders such as hyperactivity, vocalizations, or anxiety, systemic signs like lethargy or anorexia, and neurological signs such as muscle tremors have been reported. Very rarely, signs of ataxia like unstable movements have been reported. Very rarely, gastrointestinal symptoms (stomach or intestine) like vomiting or diarrhea. Very rarely, transient cosmetic effects (oily appearance, matted fur, and accumulations) at the application site have been reported, 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 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 side effects occur, even those not already mentioned in this package leaflet, or if the medicine appears not 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 minimum recommended dose is 6.4 mg dinotefuran/kg body weight, 0.6 mg piriproxifen/kg body weight, and 46.6 mg permethrin/kg body weight, equivalent to 0.12 ml of the veterinary medicinal product per kg body weight. The following table shows the format of the spot-on applicator to be used based on the dog’s weight:

APPLICATION: Be careful to apply the veterinary medicinal product 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 medicinal product on 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 start applying the product
directly on the skin along a continuous line from the base of the tail along the midline of the back to the shoulder blades, 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 special storage conditions. Do not use this veterinary medicinal product after the expiration date indicated on the box and on the spot-on applicator after “EXP/Expire”. The expiration date refers to the last day of the month.

SPECIAL WARNINGS: Specific warnings for each target species: 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 bedding, sleeping areas, and usual resting places of the dog such as carpets, sofas, and armchairs. In case of heavy flea infestation and 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, it can cause seizures in cats which 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 contact accidentally 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 treated with this veterinary medicinal product. In such cases, seek immediate advice from a veterinarian.

Special 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. Attention should be paid to avoid contact between this veterinary medicinal product and the eyes of the dog. In case of eye contact, rinse immediately with water. A single tick attack after treatment cannot be excluded. Therefore, the transmission of infectious diseases cannot be fully 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, starting 48 hours after treatment, as well as shampooing 2 weeks after treatment, does not affect the efficacy of this veterinary medicinal product. However, the duration of efficacy may be reduced by frequent shampoos or baths within 48 hours after treatment. Dogs treated should not enter bodies of water for 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 medicinal product: Do not eat, drink, or smoke when 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. If it accidentally comes into contact with the skin, wash immediately with soap and water. If the veterinary medicinal product accidentally contacts the eyes, rinse thoroughly with water. If eye or skin irritation persists, or if the veterinary medicinal product is swallowed accidentally, seek immediate medical advice and show this leaflet or label. People with known hypersensitivity to any component should avoid contact with the veterinary medicinal product. Children should not handle 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, do not allow treated dogs to sleep 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 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 pregnant bitches has not been established. The use in pregnant or lactating dogs or those intended for breeding should be based on the risk-benefit assessment by the veterinarian. Laboratory studies with each of the components (dinotefuran, piriproxifen, 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. N-methylpyrrolidone, an excipient of this veterinary medicinal product, has shown to cause fetal malformations resulting in birth defects in laboratory animals.

Incompatibility: Not known.

Overdose (symptoms, emergency procedures, antidotes): Apart from local skin reddening 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 two-week intervals 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.