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Zero Day egg withdrawal - European Approval

Aivlosin® Water Soluble Granules, the mycoplasma treatment from ECO Animal Health, has been granted a zero day egg withdrawal period by the European Medicines Agency (EMA).

It is now approved for the treatment and metaphylaxis of respiratory infections caused by Mycoplasma gallisepticum in chickens; the presence of the disease in the flock should be established before metaphylactic treatment. It has a withdrawal period of two days for meat and offal, and zero days for chicken eggs.

Aivlosin® Water Soluble Granules - SPC information

  1. NAME OF THE VETERINARY MEDICINAL PRODUCT Aivlosin 625 mg/g granules for use in drinking water for chickens and turkeys
  2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Tylvalosin (as tylvalosin tartrate) 625 mg/g. For the full list of excipients, see section 6.1.
  3. PHARMACEUTICAL FORM Granules for use in drinking water. White granules.
  4. CLINICAL PARTICULARS
    1. Target species Chickens and turkeys.
    2. Indications for use, specifying the target species Chickens Treatment and metaphylaxis of respiratory infections caused by Mycoplasma gallisepticum in chickens. The presence of the disease in the flock should be established before metaphylactic treatment. As an aid in reducing the development of clinical signs and mortality from respiratory disease in flocks, where infection in ovum with Mycoplasma gallisepticum is likely because the disease is known to exist in the parent generation. The strategy should include efforts to eliminate the infection from the parent generation. Turkeys Treatment of respiratory disease associated with tylvalosin sensitive strains of Ornithobacterium rhinotracheale in turkeys.
    3. Contraindications None.
    4. Special warnings for each target species In field studies investigating the effect of treatment and metaphylaxis on mycoplasmosis, all birds (approximately 3 weeks old) received the product when clinical signs were evident in 2 - 5% of the flock. At 14 days after initiation of treatment, 16.7 - 25.0% morbidity and 0.3 - 3.9% mortality were observed in the treated group in comparison to 50.0 - 53.3% morbidity and 0.3 - 4.5% mortality in an untreated group. In further field studies, chicks from parent stock with evidence of Mycoplasma gallisepticum infection were administered Aivlosin for the first three days of life followed by a second course at 16 - 19 days of age (a period of management stress). By 34 days after the initiation of treatment, 17.5 - 20.0% morbidity and 1.5 - 2.3% mortality were observed in the treated groups in comparison to 50.0 - 53.3% morbidity and 2.5 - 4.8% mortality in the untreated groups.
    5. Special precautions for use Special precautions for use in animals Good management and hygiene practices should be introduced to reduce the risk of re-infection. It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of target bacteria. Use of the veterinary medicinal product deviating from the instructions may increase the risk of development and selection of resistant bacteria and decrease the effectiveness of treatment with other macrolides due to the potential for cross-resistance. Special precautions to be taken by the person administering the veterinary medicinal product to animals Tylvalosin has been shown to cause hypersensitivity (allergic) reactions in laboratory animals; therefore, people with known hypersensitivity to tylvalosin should avoid contact with this product. When mixing the veterinary medicinal product and handling the medicated water, direct contact, with eyes, skin and mucous membranes should be avoided. Personal protective equipment consisting of impervious gloves and a half-mask respirator conforming to European Standard EN 149 or a non- disposable respirator conforming to European Standard EN 140, with a filter conforming to European Standard EN 143 should be worn when mixing the product. Wash contaminated skin. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
    6. Adverse reactions (frequency and seriousness) None known.
    7. Use during pregnancy, lactation or lay The safety of the veterinary medicinal product has not been established during lay in turkeys. The product can be used in chickens laying eggs for human consumption as it has been shown to have no adverse effects on egg formation or the laying process at the recommended treatment dose. As the effect of the product on egg fertility, hatchability and chick viability has not been investigated, use in breeding birds producing eggs for broiler stock or as replacement layers is not recommended.
    8. Interaction with other medicinal products and other forms of interaction None known.
    9. Amounts to be administered and administration route For use in drinking water. Chickens For treatment of respiratory disease associated with Mycoplasma gallisepticum: The dose is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days. When used as an aid in reducing the development of clinical signs and mortality (where infection in ovum with Mycoplasma gallisepticum is likely): The dose is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days at 1 day old. This is followed by a second treatment with 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days at the period of risk, i.e. at times of management stress such as administration of vaccines (typically when birds are 2-3 weeks old). Determine the combined bodyweight (in kg) of all the chickens to be treated. Select the correct number of sachets according to the amount of product required. One sachet of 40 g is sufficient to treat a total of 1,000 kg of chickens (e.g. 20,000 birds with an average bodyweight of 50 g). One sachet of 400 g is sufficient to treat a total of 10,000 kg of chickens (e.g. 20,000 birds with an average bodyweight of 500 g). In order to achieve a correct dose, the preparation of a concentrated (stock) solution might be required (e.g. to treat a total of 500 kg total bird weight, only 50% of the prepared stock solution prepared from the 40 g sachet should be used). The product should be added to a volume of water that the chickens will consume in one day. No other source of drinking water should be available during the medication period. Turkeys For treatment of respiratory disease associated with Ornithobacterium rhinotracheale: The dose is 25 mg tylvalosin per kg bodyweight per day in drinking water for 5 consecutive days. Determine the combined bodyweight (in kg) of all the turkeys to be treated. Select the correct number of sachets according to the amount of product required. One sachet of 40 g is sufficient to treat a total of 1,000 kg of turkeys (e.g. 10,000 birds with an average bodyweight of 100 g). One sachet of 400 g is sufficient to treat a total of 10,000 kg of turkeys (e.g. 10,000 birds with an average bodyweight of 1 kg). In order to achieve a correct dose, the preparation of a concentrated (stock) solution might be required (e.g. to treat a total of 500 kg total bird weight, only 50% of the prepared stock solution prepared from the 40 g sachet should be used). The product should be added to a volume of water that the turkeys will consume in one day. No other source of drinking water should be available during the medication period. Mixing instructions: The veterinary medicinal product may be mixed directly into the drinking water system or first mixed as a stock solution into a smaller amount of water, which is then added into the drinking water system. When mixing the product directly into the drinking water system, the contents of the sachet should be sprinkled onto the surface of the water and mixed thoroughly until a clear solution is produced (usually within 3 minutes). When preparing a stock solution the maximum concentration should be 40 g per 1,500 ml or 400 g of product per 15 litres and it is necessary to mix the solution for 10 minutes. After this time, any remaining cloudiness will not affect efficacy of the product. Only a sufficient amount of medicated drinking water should be prepared to cover the daily requirements. Medicated drinking water should be replaced every 24 hours.
    10. Overdose (symptoms, emergency procedures, antidotes), if necessary No signs of intolerance have been observed in poultry species at up to 150 mg tylvalosin per kg bodyweight per day for 5 days.The effects of overdose on egg formation and the egg laying process have not been established in chickens.
    11. Withdrawal period(s) Meat and offal: 2 days. Eggs (chicken): zero days. Not authorised for use in turkeys producing eggs for human consumption. Turkeys: do not use within 21 days of the onset of lay.
  5. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: antibacterials for systemic use, macrolides. ATCvet code: QJ01FA92.
    1. Pharmacodynamic properties Tylvalosin is a macrolide antibiotic. Macrolides are metabolites or derivatives of metabolites of soil organisms obtained by fermentation. They interfere with protein synthesis by reversibly binding to the 50S ribosome subunit. They are generally considered bacteriostatic. Tylvalosin has activity against pathogenic organisms isolated from a range of animal species-mainly Gram-positive organisms and mycoplasma but also some Gram-negative organisms. Macrolides (including tylvalosin) have been shown to have effects on the innate immune system, which may augment the direct effects of the antibiotic on the pathogen and aid the clinical situation. Chickens Tylvalosin has activity against the following mycoplasma species found in chickens: Mycoplasma gallisepticum. The minimal inhibitory concentration (MIC) of tylvalosin for M. gallisepticum ranges from 0.007 to 0.25 μg/ml. Turkeys Tylvalosin has activity against Ornithobacterium rhinotracheale, a Gram-negative organism found in turkeys and chickens. The MIC of tylvalosin for Ornithobacterium rhinotracheale ranges from 0.016 to 32 μg/ml. Efficacy of tylvalosin against O. rhinotracheale in turkeys was demonstrated in a challenge model using co-infection with avian metapneumovirus and a single strain of O. rhinotracheale under strictly controlled conditions. These studies demonstrated a modest but statistically significant reduction in the incidence of lower respiratory lesions (lung and air sac) and clinical signs in turkeys treated with tylvalosin compared with negative controls. Efficacy studies under field conditions have not been conducted. Bacteria can develop resistance to antimicrobial substances. There are multiple mechanisms responsible for resistance development to macrolide compounds. Cross-resistance within the macrolide group of antibiotics cannot be excluded. Reduced susceptibility for tylvalosin was generally noted in tylosin resistant strains.
    2. Pharmacokinetic particulars Tylvalosin tartrate is rapidly absorbed after oral administration of the veterinary medicinal product. Tylvalosin is widely distributed in tissues with the highest concentrations found in the respiratory tissues, bile, intestinal mucosa, spleen, kidney and liver. Tylvalosin has been shown to concentrate in phagocytic cells and gut epithelial cells. Concentrations (up to 12 times) were achieved in the cells (intracellular), compared to the extracellular concentration. In vivo studies have shown tylvalosin to be present in higher concentrations in the mucous lining of the respiratory and gut tissues compared to the plasma. The major metabolite of tylvalosin is 3-acetyltylosin (3-AT), which is also microbiologically active. The terminal half-lives for the elimination of tylvalosin and its active metabolite 3-AT range from 1 to 1.45 hours in the chicken. Six hours after treatment, the concentration of tylvalosin in the gastrointestinal tract mucosa has a mean concentration of 133 ng/g and in the gastrointestinal contents of 1,040 ng/g. The active metabolite 3-AT has a mean concentration of 57.9 ng/g and 441 ng/g, respectively.
  6. PHARMACEUTICAL PARTICULARS
    1. List of excipients Lactose monohydrate
    2. Incompatibilities In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
    3. Shelf life Shelf life of the veterinary medicinal product as packaged for sale: 40 g sachet - 3 years. 400 g sachet - 2 years. Shelf life after first opening of the immediate packaging: Use immediately. Opened sachets should not be stored. Shelf life of the medicated drinking water: 24 hours.
    4. Special precautions for storage 40 g sachet: do not store above 30 °C. 400 g sachet: do not store above 25 °C.
    5. Nature and composition of immediate packaging Aluminium foil laminated sachet containing 40 g or 400 g. Not all pack sizes may be marketed.
    6. Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
  7. MARKETING AUTHORISATION HOLDER ECO Animal Health Limited
    78 Coombe Road
    New Malden
    Surrey
    KT3 4QS
    UNITED KINGDOM
  8. MARKETING AUTHORISATION NUMBERS Chickens EU/2/04/044/007 - 40 g EU/2/04/044/008 - 400 g Turkeys EU/2/04/044/015 - 40 g EU/2/04/044/016 - 400 g
  9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 September 2004. Date of last renewal: 9 September 2014.
  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).
  11. PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
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