Review Of The Marketing Authorisation For Veterinary Antiparasitic Product Kiltix Collar ' Percani '.

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso veterinario «Kiltix» collare antiparassitario percani.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-18&atto.codiceRedazionale=15A03581&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved measure # 195 of March 27, 2015 veterinary antiparasitic for dogs small size KILTIX Collar 38 cm (12.5 g)-medium size Collar # 103,064,010 A.I.C. 53 cm (30.2 g)-large format # 103,064,022 A.I.C. Collar 70 cm (45 g)-A.I.C. # 103,064,034 Number variation V/2015/27456/144/378 type II variation Proprietor: BAYER S.p.A. with registered office and tax domicile in Milano-Viale Certosa , 130-tax code # 05849130157.
You authorize, for the given medicinal product in question, the changes as described below.
The effect of this change in the summary of product characteristics, and its points of printed leaflets must be modified as follows: 4.3 contraindications do not use on sick or debilitated dogs.
Does not apply to animals with lesions.
Do not use in animals with mechanical obstruction of the digestive and urinary tracts, bronchial asthma or other pulmonary or cardiovascular conditions as carbamates can trigger the contraction of smooth muscles. Do not apply to puppies under 3 months of age.
People with known hypersensitivity to the active substance propoxur or flumethrin or any of the excipients should avoid contact with the veterinary medicinal product.
Do not apply in animals intended for human consumption.
In point 4.5 special precautions for use-special precautions to be taken by the person administering the veterinary medicinal product to animals "will change as below:" Wash hands thoroughly with SOAP and water after he handled the product.
Avoid contact with skin and eyes.
People with known hypersensitivity to the active substance propoxur or flumethrin or any of the excipients should avoid contact with the veterinary medicinal product.
Keep out of reach of children. Prevent children from coming into contact with animals wearing the collar. Don't play with the collar, especially children. Do not suck or chew the collar, especially children. Keep tightly closed packaging until ready to use.
This product is highly toxic to aquatic organisms, birds and bees. Prevent dogs wearing the collar to swim in streams containing aquatic organisms.
This product may cause long-term adverse effects in the aquatic environment.
Do not contaminate rivers, reservoirs, streams, dams and other water sources with the unused product.
Do not drink, eat or smoke while handling the product.
Prevent contamination of food, drink and containers with the product to contain them.
This product contains a carbamate. If symptoms of toxicity please seek medical attention. For animal treatment only ". 4.6 adverse reactions (frequency and seriousness) behavioral Signs such as shaking or lethargy can be observed very rarely.
In very rare cases, application site reactions may occur as itching, rash, lesions and hair loss.
In very rare cases, after applying the collar some dogs can have mild itching or redness of the skin.
Very rarely, after oral exposure to product may manifest symptoms such as vomiting, diarrhea or salivation. Do not use in cases of known hypersensitivity reactions to the active substance or to any of the excipients. See also section 4.10 4.7 use during pregnancy, lactation or lay the information from clinical studies, although limited, conclude that there is no risk due to treatment with the product for pregnant and lactating animals or even for their pups.
See also section 4.3-4.9 Contraindications dosage and route of administration, the following sentence is added: "make sure there are no typos plastic connectors inside the collar. Adjust the collar loosely around the cat's neck (as a guide, it must be possible to insert 2 fingers between the collar and the cat's neck). Slide the excess collar through the loop and trim any excess of over 2 cm. " 4.10 overdose (symptoms, emergency procedures, antidotes), if necessary, the following sentence is added: "carbamate poisoning Symptoms as pupillary constriction, salivation, vomiting or diarrhea may occur especially when the collar is chewed or swallowed. If you notice any signs of carbamate poisoning treatment consists of symptomatic and supportive measures from the intravenous administration of atropine. " 6.6 special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products do not reuse container.
Destroy or dispose of empty container in accordance with local regulations. Dispose of any unused product or waste safely empty container in accordance with local regulations.
This product is highly toxic to aquatic organisms, birds and bees. Prevent dogs recently treated animals swim in streams with aquatic organisms.
This product may cause long-term adverse effects in the aquatic environment.
Do not contaminate rivers, reservoirs, streams, dams and other water sources with the unused product.
The adaptation of printed boxes already on the market must be made within 180 days.
This abstract will be published in the official journal of the Italian Republic, and its decision will be notified to the undertaking in question.