Patient leaflet - Vectra Felis
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Vectra Felis 423 mg/42.3 mg spot-on solution for cats
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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
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Vectra Felis 423 mg/42.3 mg spot-on solution for cats dinotefuran/pyriproxyfen
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each 0.9 ml spot-on applicator delivers: 423 mg dinotefuran and 42.3 mg pyriproxyfen. Colourless to pale yellow spot-on solution.
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4. INDICATION(S)
This veterinary medicine kills fleas (Ctenocephalides felis ) on infested cats and prevents further infestations for one month. It also prevents the multiplication of fleas, by inhibiting immature flea emergence in the cat’s environment, for 3 months.
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5. CONTRAINDICATIONS
Do not use in cats or kittens weighing less than 0.6 kg.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
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6. ADVERSE REACTIONS
Slight scales, transient erythema and alopecia can be observed in rare cases, which usually disappear spontaneously without treatment.
Transient neurological signs such as muscle tremors or lethargy may occur very rarely and in particular after application site licking.
Transient cosmetic effects such as wet hair and a white dry residue may occur at the application site very rarely and may persist up to 7 days; however, these effects are usually not noticeable after 48 hours. These changes do not affect the safety or the efficacy of the veterinary medicinal product. Other application site disorders such as erythema, pruritus, lesions and inflammation may occur very rarely.
Hyperactivity and tachypnoea may occur very rarely.
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)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– 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.
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7. TARGET SPECIES
Cats.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Method and route of administration:
Spot-on use.
Care should be taken to apply the veterinary medicine only onto intact (undamaged) cat's skin.
Dosage:
Use one spot-on applicator for one administration on one cat only.
The use in cats younger than 7 weeks or weighing less than 0.6 kg is not recommended.
(The minimum recommended dose is 42.3 mg dinotefuran/kg bodyweight and 4.23 mg pyriproxyfen/kg bodyweight. The treatment dose range is 42.3 to 705 mg dinotefuran/kg bodyweight and 4.23 to 70.5 mg pyriproxyfen/kg bodyweight for cats which weigh between 0.6 kg and 10 kg).
Treatment schedule:
Following a single administration, the veterinary medicinal product will prevent flea infestation for one month and further flea multiplication by inhibiting flea emergence in the environment of the cat for 3 months. The need to re-treat cats which are likely to be re-infested, and the time interval between such treatments, should be based on an assessment by a veterinarian.
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ADVICE ON CORRECT 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 cat should be standing or in a comfortable position for easy application. At the base of cat’s head, part the hair until the skin is visible. Apply the veterinary medicinal product slowly with the tip of the applicator on the skin. Avoid superficial application to the cat’s hair.
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10. WITHDRAWAL PERIOD(S)
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
This veterinary medicinal product 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.
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12. SPECIAL WARNING(S)
Special warnings for each target species:
All cats within the household should be treated. Dogs in the household should only be treated with a veterinary medicinal product authorised for use in that species.
Fleas can infest the cat’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.
The impact of shampooing on the efficacy of the veterinary medicinal product has not been evaluated. In case of suspicion of dermatitis (itch and skin irritation), seek for veterinary advice.
Special precautions for use in animals:
For external use only.
Apply only to the skin surface. Do not administer orally or via any other route.
The safety of this veterinary medicine has not been established in cats younger than 7 weeks of age or weighing less than 0.6 kg (see section “Contraindications”).
After accidental ingestion of the product, transient reactions such as salivation, abnormal faeces and emesis may occur, however these should resolve without treatment within 4 hours.
Care should be taken to apply the dose to an area where the animal cannot lick it off (as described in section „Advice on correct administration“), and to ensure that animals do not groom each other immediately following treatment.
Care should be taken to ensure that the contents of the spot-on applicator, or the applied dose, do not come into contact with the eyes of the cat to be treated and/or any other animals.
No studies have been performed in sick or convalescent cats, therefore use in these cats should be based on the benefit-risk assessment of a veterinarian.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
People with known hypersensitivity to dinotefuran, pyriproxyfen or dimethyl sulfoxide should avoid contact with this veterinary medicinal product.
The 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, eyes or mouth.
- 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 rinsed with water immediately, with the eyelids open, and for a sufficient length of time.
- Treated animals must not be handled for at least eight hours after application of the product. It is therefore recommended to treat the animal in the evening.
- Treated animals should not be allowed to sleep with their owners, especially children, on the day of treatment.
- Used applicators should be disposed of immediately and not left within the sight or reach of children.
If skin or if eye irritation persists, or in case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in adult female cats. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Laboratory studies with the active substances, dinotefuran or pyriproxyfen, in rats and rabbits have not produced any evidence of birth defects or other harmful effects in the developing embryo or foetus (teratogenic, foetotoxic) or harmful effects for the mother (maternotoxic effects).
In rats, dinotefuran has been shown to cross the blood-milk barrier and is excreted in the milk.
Interaction with other medicinal products and other forms of interaction:
None known.
Overdose (symptoms, emergency procedures, antidotes):
No important adverse reactions were observed in healthy kittens aged 7 weeks or more, topically treated 7 times at 2 week intervals and with up to 4 times the highest recommended dose except transient oedema or dry skin at the application site.
Incompatibilities:
None known.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Vectra Felis should not enter water courses as this may be dangerous for fish and other aquatic organisms. Do not contaminate ponds, waterways or ditches with the veterinary medicinal product or with used containers.
Medicines should not be disposed of via wastewater or household waste.
Unused product or waste material derived from the product should be disposed of following local regulation. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED