Review Product Marketing Authorisation For Veterinary Antiparasitic Shampoo Dog «0.11 G/100 Ml. "

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso veterinario «Shampoo antiparassitario 0.11 g/100ml per cani».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-27&atto.codiceRedazionale=15A02971&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Extract from the decision # 197 of March 27, 2015:0.11 g/100 ml SHAMPOO veterinary ANTIPARASITIC for dogs, 250 ml-Bottle packaging: angular A.I.C. oval Bottle 250 ml # 103097061-# 103097059 100 ml-tube A.I.C. A.I.C. # 103097010.
Number variation V/2015/27457/144/364 type II variation Proprietor: BAYER S.p.A. with registered office and tax domicile in Milano-Viale Certosa, 130-VAT # 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 convalescent animals.
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.
Does not apply to animals with lesions.
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 follows:" use a pair of protective gloves for the application of the product.
Avoid contact with eyes, skin, and clothing.
In case of accidental spill on skin, wash with SOAP and water; in case of accidental spill in your eyes flush with water.
Do not ingest the product.
After treatment remove wet clothing, wash thoroughly with SOAP and water your hands, exposed skin and face.
Accidentally contaminated clothing must be removed immediately.
Do not drink, eat or smoke while operating the product.
People with known hypersensitivity to the active substance propoxur or any of the excipients should avoid contact with the product.
For animal treatment only.
This product contains a carbamate. If symptoms of toxicity please seek medical attention.
The product must not be used by pregnant women, especially in the third quarter.
Keep out of reach of children so that children come in contact with treated animals until they are wet.
In the container do not store water, food or products for human or animal consumption. "
4.6 adverse reactions (frequency and seriousness) after accidental ingestion of the product may manifest symptoms such as vomiting, diarrhea and salivation. In very rare cases, skin reactions may occur after use of the product, such as erythema or itch.
See also section 4.10 4.7 use during pregnancy, lactation or lay Information from clinical trials with the collar containing propoxur, although limited, conclude that there is no risk due to treatment with the product for pregnant and lactating animals or even for their pups. Since the shampoo is washed off immediately, the risk is considered to be even shorter.
4.9 recommended dosage and route of Administration Is adding the phrase: "the product immediately kills fleas present but does not have a long-lasting effect."
4.10 overdose (symptoms, emergency procedures, antidotes) tests on dogs and cats did not show signs of intolerance when applied at twice the normal dose. However, carbamates poisoning symptoms, such as an increase in salivation, miosis, vomiting or diarrhea, can occur in people or animals as a result of multiple overdose or ingestion. In these cases, consult a veterinarian.
Antidote: atropine sulfate.
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 the empty container according to local requirements.
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.
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