Extract from the measure # 194 of March 27, 2015: Pesticide Spray 0.25 g/100 g veterinary medicinal product for dogs 250 ml aluminium Cylinder-A.I.C. # 103,099,026 Number variation V/2015/27458/144/365 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, convalescent or debilitated.
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.
Does not apply to animals with lesions.
Do not apply to puppies under 3 months of age.
Do not use in cases of known hypersensitivity to propoxur or any of the excipients.
Do not apply in animals intended for human consumption.
In point 4.5 special precautions for use precautions for use in animals changes the following sentence: "avoid spraying the product on the face, nose and eyes" special precautions to be taken by the person administering the veterinary medicinal product to animals "will change as follows:" do not Pierce or burn, even after use. Do not spray on a naked flame or any incandescent material. Do not use in presence of open flames, embers or other sources of ignition and do not light fires before the restaurant was well ventilated. Use only in well ventilated areas. Ventilate the room thoroughly before using it again. Do not exceed the quantities indicated in order to prevent accumulation of flammable gases in the air. Avoid inhaling the product. Do not spray into the wind. Do not drink, eat or smoke while operating 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. After treatment remove wet clothing, wash thoroughly with SOAP and water your hands, exposed skin and face. While applying to avoid exposure to other individuals. People with known hypersensitivity to the active substance propoxur or any of the excipients should avoid contact with the product. The product must not be used by pregnant women, especially in the third quarter. Prevent children from coming into contact with treated animals until they are wet. Keep out of reach of children. In case of accidental ingestion, seek medical attention immediately. For animal treatment only. This product contains a carbamate. If symptoms of toxicity please seek medical attention ".
4.6 adverse reactions (frequency and seriousness) Allergic reactions may occur In susceptible people. 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 section 4.10.
4.7 use during pregnancy, lactation or lay Information of 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. Because the spray is only for short term use, the risk is considered to be even shorter.
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 and diarrhea, may occur in people or animals as a result of multiple overdose or ingestion. In these cases, seek medical advice immediately and show the label.
Antidote: atropine sulfate 6.4. Special precautions for storage, the following sentence is added: "keep away from food and feed".
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.