Aivlosin 625 mg/g Granules for Use in Drinking Water for Chickens and Turkeys

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 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%
50.0‒53.3% morbidity and 2.5‒4.8% mortality in the untreated groups.
The strategy for Mycoplasma gallisepticum infection should include efforts to
eliminate the pathogen from the parent generation.
Infection with Mycoplasma gallisepticum is reduced but not eliminated at the
recommended dose.
Medication should only be used for short-term amelioration of clinical signs in
breeder flocks whilst awaiting confirmation of diagnosis of Mycoplasma
gallisepticum infection.
4.5 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 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
nondisposable respirator conforming to European Standard EN 140 with a filter

Issued: December 2024
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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.
Special precautions for the protection of the environment:
Not applicable.
Other precautions:
Not applicable.
4.6 Adverse reactions (frequency and seriousness)
Chicken and turkeys.
None known.
Reporting adverse events is important. It allows continuous safety monitoring of
a veterinary medicinal product. Reports should be sent, preferably via a
veterinarian, to either the marketing authorisation holder or its local
representative or the national competent authority via the national reporting
system. See also section 16 of the package leaflet for contact details.
4.7 Use during pregnancy, lactation or lay
The product can be used in chickens laying eggs for human consumption and
breeding birds producing eggs for hatching broiler stock or replacement layers.
The safety of the veterinary medicinal product has not been established during
lay in turkeys.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amount(s) to be administered and administration route
For use in drinking water.
Chickens
For treatment of respiratory disease associated with
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

Issued: December 2024
AN: 02144/2023
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 chicken (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 chicken (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 chicken 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
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.

Issued: December 2024
AN: 02144/2023
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 water 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.
4.10 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.
4.11 Withdrawal period(s)
Meat and offal: 2 days.
Eggs (chicken): zero days.
Turkeys: Not for use in birds producing eggs for human consumption. Do not
use within 21 days of the start of the laying period.
5.