Vectra 3D - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

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

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Ceva Santé Animale, 10, av. de La Ballastière, 33500 Libourne, Fran­ce

Manufacturer responsible for batch release:

Ceva Santé Animale, 10, av. de La Ballastière, 33500 Libourne, Fran­ce

AB7 SANTE, Chemin des Monges, 31450 Deyme, France

NAME OF THE VETERINARY MEDICINAL PRODUCT

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 / pyriproxyfen / permethrin

3. STATEMENT OF THE ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS

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

Each spot-on applicator delivers:

Weight of dog (kg)	Colour of applicator cap	Volume (ml)	Dinotefuran (mg)	Pyriproxyfen (mg)	Permethrin (mg)
for dogs 1.5- 4 kg	Yellow	0.8	44	3.9	317
for dogs > 4- 10 kg	Teal	1.6	87	7.7	635
for dogs > 10- 25 kg	Blue	3.6	196	17.4	1,429
for dogs > 25- 40 kg	Purple	4.7	256	22.7	1,865
for dogs > 40 kg	Red	8.0	436	38.7	3,175

The veterinary medicine is a pale-yellow spot-on solution, packaged in single dose spot-on applicators.

Fleas:

This veterinary medicine kills fleas on infested animals and prevents further infestations for one month. It is effective against the following fleas found on dogs (Ctenocephalides canis and

Ctenocephalides felis ). This veterinary medicine also prevents the multiplication of fleas for two months after use by inhibiting flea egg hatching (ovicidal activity) and by inhibiting the transformation of immature fleas into adult fleas.

Ticks:

This veterinary medicine kills and repels ticks (Rhipicephalus sanguineus and Ixodes ricinus ticks are controlled for one month; Dermacentor reticulatus ticks are controlled for up to three weeks).

If ticks are present when this veterinary medicine is applied, the ticks may not all be killed within the first 48 hours after use, but they may be killed within a week. To remove ticks, it is recommended to use an appropriate tick removal device.

Sand flies, mosquitoes and stable flies:

The veterinary medicine repels (prevents biting) flying insects such as sand flies (Phlebotomus perniciosus ), mosquitoes (Culex pipiens, Aedes aegypti) and stable flies (Stomoxys calcitrans ) for one month after use. It also kills mosquitoes (Aedes aegypti ) and stable flies for one month after use.

• 5. CONTRAINDI­CATIONS

Do not use on cats (see ‘Special warnings’). Due to their unique physiology and inability to metabolise permethrin (one of the active substances in this veterinary medicine), this veterinary medicine must not be used on cats. If applied to a cat, or ingested by a cat that actively grooms a recently treated dog, this veterinary medicine may have serious harmful effects.

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

• 6. ADVERSE REACTIONS

Skin redness, itching or other signs of discomfort at the application site have been reported rarely. These signs may be mild and transient. If signs persist or worsen, veterinary advice should be sought. Behavioural disorders such as hyperactivity, vocalisation or anxiety, systemic signs such as lethargy or anorexia, and neurological signs such as muscle tremor have been reported in rare cases. Signs of ataxia such as unsteady movement have been reported in very rare cases.

Gastrointestinal (stomach or gut) adverse reactions, such as vomiting or diarrhoea, have also been reported very rarely.

Transient cosmetic effects (wet appearance, spiking of hair coat and deposits) at the application site have been reported very rarely, however these effects are usually not noticeable after 48 hours.

In addition, isolated reports on convulsions have been received.

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

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Dogs.

• 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Spot-on use. 1 applicator per dog.

Care should be taken to apply the veterinary medicine only onto intact (undamaged) dog's skin.

Dosage:

Determine the correct size of spot-on applicator needed for your dog (the use in dogs younger than 7 weeks or weighing less than 1.5 kg is not recommended, see also section “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 body weight.

The following table shows the size of spot-on applicator to be used according to the weight of the dog:

Weight of dog (kg)	Colour of applicator cap	Volume (ml)	Applicator to be used
for dogs 1.5–4 kg	Yellow	0.8	1 applicator of	Vectra 3D for dogs 1.5–4 kg
for dogs > 4–10 kg	Teal	1.6		Vectra 3D for dogs > 4–10 kg
for dogs >10–25 kg	Blue	3.6		Vectra 3D for dogs > 10–25 kg
for dogs > 25–40 kg	Purple	4.7		Vectra 3D for dogs > 25–40 kg
for dogs > 40 kg	Red	8.0		Vectra 3D for dogs > 40 kg

ADVICE ON CORRECT ADMINISTRATION

Administration:

How to apply:

Remove the spot-on applicator from the pack.

Step 1: Hold the applicator upright, placing fingers below the larger disk as shown.

Step 2: With the other hand, press downwards on the smaller disk until the 2 disks meet evenly. This will pierce the seal.

Step 3: The dog should be standing or in a comfortable position for easy application. Part the hair until the skin is visible. Apply the veterinary medicine (as directed in step 4 below) slowly with the tip of the applicator on the skin.

Step 4

Use according to 4a or 4b recommendation: 4a recommendation: Gently squeeze the applicator and apply the veterinary medicine to the skin along the dog's back, beginning between the shoulder blades, in the number of spots and order shown in the diagrams below and squeezing until the applicator is empty. Avoid superficial application to the dog’s hair. The number of application spots will depend on the body weight of the dog.

Dogs from 1.5 to 4 kg body weight 1 yellow pipette per dog

Dogs over 4 kg and up to 10 kg body weight 1 teal pipette per dog to be split in 2 spots

Dogs over 10 kg and up to 40 kg body weight

1 blue or purple pipette per dog to be split in 3 spots

Dogs over 40 kg body weight

1 red pipette per dog to be split in 4 spots

4b recommendation: Regardless of the dog’s body weight, using the applicator tip, part the hair at the base of the tail and begin applying the veterinary medicine directly onto the skin in a continuous line from the base of the tail along the centre of the back all the way up to the shoulder blades, as shown in the diagram, squeezing the applicator until it is empty.

Treatment schedule:

Following a single administration, the veterinary medicine will prevent infestation for one month. The treatment can be repeated once a month.

• 10. WITHDRAWAL PERIOD(S)

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicine does not require any special storage conditions.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and spot-on applicator after “EXP”. The expiry date refers to the last day of that month.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

All dogs within the household should be treated. Cats in the household should only be treated with a veterinary medicinal product authorised for use in cats.

Fleas can infest the dog’s basket, bedding and regular resting areas such as carpets and soft furnishings. In case of massive flea infestation and at the beginning of the control measures, these areas should be treated with a suitable insecticide and then vacuumed regularly.

In case of suspicion of dermatitis (itch and skin irritation), seek for veterinary advice.

Do not use on cats. If the veterinary medicine is accidentally swallowed it can cause convulsions in cats that could be fatal. In case of accidental exposure, wash the cat with shampoo or soap, and seek veterinary advice immediately. To prevent cats from being accidentally exposed to the veterinary medicine, keep cats away from treated dogs until the application site is dry. It is important to ensure that cats do not groom the site of application on a dog which has been treated with this veterinary medicine. In case of exposure of this type seek veterinary advice immediately.

Special precautions for use in animals:

For external use only.

The safety of this veterinary medicine has not been established in dogs younger than 7 weeks or weighing less than 1.5 kg.

Care should be taken to avoid contact between the veterinary medicine and the eyes of the dog. If in eyes, immediately flush with water.

The attachment of a single tick after treatment cannot be excluded. For this reason the transmission of infectious diseases cannot be completely excluded if conditions are favourable.

The veterinary medicine remains effective when treated animals are immersed in water (e.g. swimming, bathing). Water immersion repeated weekly for one month and starting 48 hours after treatment, as well as shampooing 2 weeks after treatment do not affect the efficacy of this veterinary medicine. However, in case of frequent shampooing, or bathing within 48 hours after treatment, the duration of activity may be reduced.

Treated dogs should not be allowed to enter surface water for 48 hours after treatment to avoid adverse effects on aquatic organisms. See also section „Special precautions for the disposal of unused product or waste materials“.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Do not eat, drink or smoke while handling the veterinary medicine.

People with known hypersensitivity to any of the ingredients should avoid contact with the veterinary medicinal product.

Because the excipient N-methylpyrrolidone has shown evidence of foetal malformations in rabbits and rats in laboratory studies, pregnant women and women suspected of being pregnant should not administer the product and should avoid direct contact with the application site until the application site is no longer noticeable.

This veterinary medicinal product is irritating to the eyes and skin.

To avoid adverse reactions:

• Wash hands thoroughly and immediately after use.
• Avoid contact with the skin.
• In case of accidental spillage onto skin, wash off immediately with soap and water.
• If the veterinary medicinal product accidentally gets into the eyes, they should be thoroughly flushed with water.
• Children must not handle treated dogs for at least four hours after administration of the veterinary medicinal product. It is therefore recommended to treat dogs in the evening, or before taking them for a walk.
• On the day of treatment, treated dogs should not be permitted to sleep with their owners, especially children.
• Used applicators should be disposed of immediately and not left within the sight or reach of children.

If skin or eye irritation persists, or if the veterinary medicine is accidentally swallowed, seek medical advice immediately and show the package leaflet or the label to the physician.

Wait for the application site to dry before allowing the treated dog to come in contact with fabrics or furnishings.

Pregnancy and lactation:

The safety of this veterinary medicine in bitches has not been established during pregnancy and lactation. The use of the veterinary medicine in pregnant and lactating bitches or in dogs intended for breeding should be based on a benefit-risk assessment by the responsible veterinarian.

Studies with each active ingredient (dinotefuran, permethrin or pyriproxyfen) in rats and rabbits have not produced any evidence of toxicity on pregnant or lactating animals.

Dinotefuran has been shown to pass into the milk of lactating animals.

N-methylpyrrolidone, an excipient in the veterinary medicine, has been shown to cause foetal malformations leading to birth defects in laboratory animals.

Incompatibili­ties:

None known.

Overdose (symptoms, emergency procedures, antidotes):

Apart from local skin redness and cosmetic hair coat changes where the veterinary medicine was applied, no adverse reactions were observed in healthy puppies aged 7 weeks, given the veterinary medicine on the skin 7 times at 2-week intervals and with up to 5 times the highest recommended dose.

After accidental swallowing of the highest recommended dose, vomiting, salivation and diarrhoea may occur, however these should disappear without treatment.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

This veterinary medicine should not enter water courses as it is dangerous for fish and other aquatic organisms. Do not contaminate ponds, waterways or ditches with the veterinary medicine or with used containers.

Unused product or waste material derived from the product should be disposed of following local regulation. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.

• 15. OTHER INFORMATION