excitatory impulses kills the insect. Insects do not have to ingest dinotefuran, it kills by contact. Dinotefuran has a low affinity for mammalian acetylcholine receptor sites. Fleas are killed by dinotefuran within 2 hours after treatment or infestation.

Pyriproxyfen is a photostable insect growth regulator (IGR). It acts through contact, by mimicking the juvenile hormone which regulates the moulting of insects from one life stage to the next. Pyriproxyfen stops the flea life cycle by both inducing premature oviposition and also suppressing yolk deposition in flea eggs, leading to the production of infertile eggs. Pyriproxyfen also blocks the development of juvenile stages (larvae and early (pharate) pupae) into adult emergence. This prevents infestation within the environment of the treated animal.

5.2    Pharmacokinetic particulars

Following topical application, the two actives rapidly distribute over the body surface of the animal within the first day and were still measurable in different zones of the hair coat one month after treatment.

Dinotefuran and pyriproxyfen are partially absorbed by the cat skin (30% and 12% respectively), but this systemic absorption is not relevant for the clinical efficacy of the product.
 
In laboratory species, after intra-peritoneal administration, dinotefuran is rapidly eliminated as the unchanged parent molecule mainly via the urine. After oral administration, pyriproxyfen is rapidly metabolized, principally by hydroxylation, and eliminated mainly in the faeces, and to a lesser extent in the urine.

Environmental properties

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.


6.    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Dimethyl sulfoxide

6.2    Major incompatibilities

None known.

6.3    Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first opening the immediate packaging: use immediately.

6.4    Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5    Nature and composition of immediate packaging

Spot-on applicator made of a multilayered complex of aluminium and polyethylene (PE) with a head made of HDPE, top-sealed with a liner complex (aluminium/polyester/sealable PE layer).

Pack sizes:
Cardboard box of 1, 3, 4, 6, 12 or 24 spot-on applicator(s). Not all pack sizes may be marketed.
6.6    Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

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.
 
7.    MARKETING AUTHORISATION HOLDER

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


8.    MARKETING AUTHORISATION NUMBER(S)

EU/2/14/165/001–004 EU/2/14/165/006–007


9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 06/06/2014 Date of last renewal: 08/02/2019


10.    DATE OF REVISION OF THE TEXT


Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).


PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.