PACKAGE LEAFLET:

Aivlosin 42.5 mg/g premix for medicated feeding stuff for pigs

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

   
   

   Marketing authorisation holder:

   
   

   ECO Animal Health Europe Limited 6th Floor, South Bank House Barrow Street

   Dublin 4 D04 TR29 IRELAND

   
   

   Manufacturer responsible for batch release:

   
   

   Acme Drugs s.r.l.

   Via Portella della Ginestra 9/a 42025 CAVRIAGO (RE) ITALY

   
   

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

   
   

   Aivlosin 42.5 mg/g premix for medicated feeding stuff for pigs Tylvalosin (as tylvalosin tartrate)

   
   

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

   
   

   Active substance:

   Tylvalosin (as tylvalosin tartrate) 42.5 mg/g. A beige granular powder.

   Carrier:

   Hydrated magnesium silicate, wheat flour.

   
   

4. INDICATIONS

   
   

   • Treatment and metaphylaxis of swine enzootic pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae. At the recommended dose, lung lesions and weight loss are reduced but infection with Mycoplasma hyopneumoniae is not eliminated.

   • Treatment of porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis in herds where there is a diagnosis based on clinical history, post-mortem findings and clinical pathology results.

     Treatment and metaphylaxis of swine dysentery in herds, caused by Brachyspira hyodysenteriae,

     where the disease has been diagnosed.

     
     

5. CONTRAINDICATIONS

   
   

   None.

6. ADVERSE REACTIONS

   
   

   None known.

   If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

   
   

7. TARGET SPECIES

   
   

   Pigs.

   
   

8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

   
   

   In-feed use.

   For incorporation into dry feed only.

   
   

   For treatment and metaphylaxis of swine enzootic pneumonia:

   The dose is 2.125 mg tylvalosin per kg bodyweight per day in-feed for 7 consecutive days. Secondary infection by organisms such as Pasteurella multocida and Actinobacillus pleuropneumoniae may complicate enzootic pneumonia and require specific medication.

   
   

   For treatment of porcine proliferative enteropathy (ileitis):

   The dose is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.

   
   

   For treatment and metaphylaxis of swine dysentery:

   The dose is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.

   
   

   Indication	Dose of active ingredient	Duration of treatment	In feed inclusion rate
   Treatment and metaphylaxis of swine enzootic pneumonia	2.125 mg/kg bodyweight/day	7 days	1 kg/tonne*
   Treatment of PPE (ileitis)	4.25 mg/kg bodyweight/day	10 days	2 kg/tonne*
   Treatment and metaphylaxis of swine dysentery	4.25 mg/kg bodyweight/day	10 days	2 kg/tonne*

   * Important: these inclusion rates assume a pig eats the equivalent of 5% bodyweight per day.

   
   

   In older pigs, or in pigs with reduced appetite, or on restricted feed intake, inclusion levels may need to be increased to achieve target dose. Where feed intake is reduced, use the following formula:

   
   

   Kg premix/tonne feed = Dose rate (mg/kg bodyweight) x bodyweight (kg)

   Daily feed intake (kg) x Premix strength (mg/g)

   
   

   Acute cases and severely diseased pigs with reduced food and water intake should be treated with a suitable injectable product.

   In addition to medical treatment, good management and hygiene practices should be established on the farm in order to reduce the risk of infection and to control the build-up of resistance.

   The medicated feed should be fed as the sole ration.

9. ADVICE ON CORRECT ADMINISTRATION

   
   

   Mixing instructions

   
   

   A horizontal ribbon mixer should be used to incorporate the veterinary medicinal product into feeding stuff. It is recommended that Aivlosin is first mixed with 10 kg of the feeding stuff, followed by the rest of the feeding stuff and mixed well. Medicated feed may then be pelleted. Pelleting conditions involve a single pre-conditioning step with steam for 5 minutes and pelleting at not more than 70 °C under normal conditions.

   
   

10. WITHDRAWAL PERIOD(S)

    
    

    Meat and offal: 2 days.

    
    

11. SPECIAL STORAGE PRECAUTIONS

    
    

    Keep out of the sight and reach of children. Store below 30 °C.

    Keep the container tightly closed. Store in the original container.

    
    

    Shelf life after first opening the immediate packaging: use immediately. Opened bags should not be stored.

    Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.

    
    

    Shelf life after incorporation into feed: meal and pellets: 1 month.

    
    

12. SPECIAL WARNINGS

    
    

    Special warnings for each target species:

    
    

    Acute cases and severely diseased pigs with reduced food or water intake should be treated with a suitable injectable product.

    
    

    Generally, strains of B. hyodysenteriae have higher minimal inhibitory concentration (MIC) values in cases of resistance against other macrolides, such as tylosin. The clinical relevance of this reduced susceptibility is not fully explored. Cross-resistance between tylvalosin and other macrolides cannot be excluded.

    
    

    Special precautions for use in animals:

    
    

    Good management and hygiene practices should be followed 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 premix, 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.

    
    

    Pregnancy and lactation:

    
    

    The safety of Aivlosin during pregnancy and lactation has not been established in pigs. Use only in accordance with benefit-risk assessment by the responsible veterinarian. Laboratory studies in animals have not produced any evidence of a teratogenic effect. Maternal toxicity in rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity.

    
    

    Overdose (symptoms, emergency procedures, antidotes):

    
    

    No signs of intolerance have been observed in growing pigs at up to 10 times the recommended dose. Major incompatibilities:

    In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

    
    

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

    
    

    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

    
    

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

    
    

    ).

    
    

15. OTHER INFORMATION

Available in pack sizes containing 5 kg or 20 kg of product.

Not all pack sizes may be marketed. Consideration should be given to official guidance on the incorporation of medicated premixes in final feed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

PACKAGE LEAFLET:

Aivlosin 625 mg/g granules for use in drinking water for pigs

(attached as concertina label directly to the immediate package or as a back label for the 400 g sachet for one language)

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

   
   

   Marketing authorisation holder:

   
   

   ECO Animal Health Europe Limited 6th Floor, South Bank House Barrow Street

   Dublin 4 D04 TR29 IRELAND

   
   

   Manufacturer responsible for batch release:

   
   

   Acme Drugs s.r.l.

   Via Portella della Ginestra 9/a 42025 CAVRIAGO (RE) ITALY

   
   

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

   
   

   Aivlosin 625 mg/g granules for use in drinking water for pigs Tylvalosin (as tylvalosin tartrate)

   
   

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT

   
   

   Active substance:

   Tylvalosin (as tylvalosin tartrate) 625 mg/g.

   
   

   White granules.

   
   

4. INDICATION(S)

   
   

   Treatment and metaphylaxis of porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis.

   
   

   Treatment and metaphylaxis of swine enzootic pneumonia caused by susceptible strains of

   Mycoplasma hyopneumoniae.

   
   

   The presence of the disease in the group must be established before metaphylaxis.

   
   

5. CONTRAINDICATIONS

   
   

   None.

6. ADVERSE REACTIONS

   
   

   None known.

   
   

   If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

   
   

7. TARGET SPECIES

   
   

   Pigs.

   
   

8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

   
   

   For use in drinking water.

   
   

   To ensure a correct dosage, bodyweight should be determined as accurately as possible. Water consumption should be monitored, and the concentration of the product adjusted if needed to avoid underdosing.

   
   

   The product should be added to a volume of water that the pigs will consume in one day. No other source of drinking water should be available during treatment.

   
   

   Porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis

   
   

   The dose is 5 mg tylvalosin per kg bodyweight per day in drinking water for 5 consecutive days.

   
   

   Calculate the total amount of product required with the formula:

   Total weight of product in grams = total bodyweight of the heaviest pig to be treated in kg x number of pigs x 5 / 625.

   
   

   Select the correct number and size of sachets according to the amount of product required.

   
   

   The 40 g sachet is sufficient to treat a total of 5,000 kg of pigs (e.g. 250 pigs with the heaviest pig weighing 20 kg) for one day.

   
   

   The 160 g sachet is sufficient to treat a total of 20,000 kg of pigs (e.g. 400 pigs with the heaviest pig weighing 50 kg) for one day.

   
   

   The 400 g sachet is sufficient to treat a total of 50,000 kg of pigs (e.g. 1000 pigs with the heaviest pig weighing 50 kg) for one day.

   
   

   Swine enzootic pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae

   
   

   The dose is 10 mg tylvalosin per kg bodyweight per day in drinking water for 5 consecutive days. Calculate the total amount of product required with the following formula:

   Total weight of product in grams = total bodyweight of the heaviest pig to be treated in kg x number of pigs to be treated x 10 / 625.

   
   

   Select the correct number of sachets according to the amount of product required.

   
   

   The 40 g sachet is sufficient to treat a total of 2,500 kg of pigs (e.g. 125 pigs with the heaviest pig weighing 20 kg) for one day.

   The 160 g sachet is sufficient to treat a total of 10,000 kg of pigs (e.g. 200 pigs with the heaviest pig weighing 50 kg) for one day.

   
   

   The 400 g sachet is sufficient to treat a total of 25,000 kg of pigs (e.g. 500 pigs with the heaviest pig weighing 50 kg) for one day.

   
   

9. ADVICE ON CORRECT ADMINISTRATION

   
   

   In order to achieve a correct dose, accurate and properly calibrated equipment should be used for weighing out the required amount of product.

   
   

   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 of product per 1,500 ml, 160 g of product per 6,000 ml or 400g of product per 15,000 ml water and it is necessary to mix the solution for 10 minutes. After this time, any remaining cloudiness will not affect the efficacy of the veterinary medicinal 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.

   
   

   After end of the medication period, the water supply system should be cleaned appropriately to avoid intake of subtherapeutic amounts of the active substance.

   
   

   As an adjunct to medication, good management and hygiene practices should be introduced in order to reduce the risk of infection and to control the build-up of resistance.

   
   

10. WITHDRAWAL PERIOD(S)

    
    

    Meat and offal: 2 days.

    
    

11. SPECIAL STORAGE PRECAUTIONS

    
    

    Keep out of the sight and reach of children. 40 g sachet: do not store above 25 ºC.

    160 g sachet: do not store above 25 ºC. 400 g sachet: do not store above 25 °C.

    
    

    Shelf life after opening the immediate packaging: 5 weeks.

    Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.

    
    

    Shelf life of the medicated drinking water: 24 hours.

12. SPECIAL WARNINGS

    
    

    Special warnings for each target species:

    
    

    In severely diseased pigs, if water intake is reduced, pigs should be treated with a suitable injectable veterinary medicinal product prescribed by a veterinarian.

    At the recommended dose, lung lesions and clinical signs are reduced but infection with Mycoplasma hyopneumoniae is not eliminated.

    
    

    Special precautions for use in animals:

    
    

    Official, national and regional antimicrobial policies should be taken into account when the product is used.

    
    

    Good management and hygiene practices should be followed 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.

    
    

    An antibacterial with a lower risk of antimicrobial resistance selection, if available for the same indication, should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.

    
    

    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.

    
    

    Pregnancy and lactation:

    
    

    The safety of the veterinary medicinal product has not been established during pregnancy and lactation in pigs. Use only in accordance with benefit-risk assessment by the responsible veterinarian.

    
    

    Laboratory studies in animals have not produced any evidence of a teratogenic effect. Maternal toxicity in rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity.

    
    

    Overdose (symptoms, emergency procedures, antidotes):

    
    

    No signs of intolerance have been observed in pigs at up to 100 mg tylvalosin per kg bodyweight per day for 5 days.

    Major incompatibilities:

    
    

    In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

    
    

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

    
    

    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

    
    

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

    
    

    ).

    
    

15. OTHER INFORMATION

Available in sachets containing 40 g, 160 g or 400 g of granules. Not all pack sizes may be marketed. For any information about this veterinary medicinal product, please contact the local representative of

the marketing authorisation holder.

PACKAGE LEAFLET:

Aivlosin 625 mg/g granules for use in drinking water for pheasants

(attached as concertina label directly to the immediate package or as a back label for the 400 g sachet for one language)

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

   
   

   Marketing authorisation holder:

   
   

   ECO Animal Health Europe Limited 6th Floor, South Bank House Barrow Street

   Dublin 4 D04 TR29 IRELAND

   
   

   Manufacturer responsible for batch release:

   
   

   Acme Drugs s.r.l.

   Via Portella della Ginestra 9/a 42025 CAVRIAGO (RE) ITALY

   
   

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

   
   

   Aivlosin 625 mg/g granules for use in drinking water for pheasants Tylvalosin (as tylvalosin tartrate)

   
   

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT

   
   

   Active substance:

   Tylvalosin (as tylvalosin tartrate) 625 mg/g.

   
   

   White granules.

   
   

4. INDICATION(S)

   
   

   Treatment of respiratory disease associated with Mycoplasma gallisepticum in pheasants.

   
   

5. CONTRAINDICATIONS

   
   

   None.

   
   

6. ADVERSE REACTIONS

   
   

   None known.

   
   

   If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

   
   

   Pheasants.

   
   

8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

   
   

   For use in drinking water.

   The dose is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days. Determine the combined bodyweight (in kg) of all the birds to be treated. For example, one sachet of

   40 g is sufficient to treat a total of 1,000 birds with an average bodyweight of 1 kg; one sachet of 400 g is sufficient to treat a total of 10,000 birds with an average bodyweight of 1kg.

   
   

   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 veterinary medicinal product should be added to a volume of water that the birds will consume in one day. No other source of drinking water should be available during the medication period.

   
   

9. ADVICE ON CORRECT ADMINISTRATION

   
   

   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 veterinary medicinal 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 of product per 1,500 ml of water and it is necessary to mix the solution for 10 minutes. After this time, any remaining cloudiness will not affect efficacy of the veterinary medicinal 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. WITHDRAWAL PERIOD(S)

    
    

    Meat and offal: 2 days.

    Do not release pheasants for at least two days after the end of medication.

    
    

    Not for use in birds producing or intended to produce eggs for human consumption. Do not use within 14 days of the start of the laying period.

11. SPECIAL STORAGE PRECAUTIONS

    
    

    Keep out of the sight and reach of children. 40 g sachet: do not store above 25 °C.

    400 g sachet: do not store above 25 °C.

    Shelf life after opening the immediate packaging: 5 weeks.

    Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.

    
    

    Shelf life of the medicated drinking water: 24 hours.

    
    

12. SPECIAL WARNINGS

    
    

    Special warning for each target species:

    
    

    Treat as soon as possible after clinical signs suggestive of mycoplasmosis are observed. Treat all the birds in the affected flock.

    
    

    Special precautions for use in animals:

    
    

    Good management and hygiene practices should be introduced in order to reduce the risk of re- infection.

    
    

    Use of the product should be based 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 the target bacteria.

    
    

    Use of the 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.

    
    

    Lay:

    
    

    Use only in accordance with benefit-risk assessment by the responsible veterinarian. Overdose (symptoms, emergency procedures, antidotes):

    No signs of intolerance have been observed in poultry species at up to 150 mg tylvalosin per kg bodyweight per day for 5 days.

    Major incompatibilities:

    
    

    In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

    
    

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

    
    

    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

    
    

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

    
    

    ).

    
    

15. OTHER INFORMATION

Available in sachets containing 40 g or 400 g of product. Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

PACKAGE LEAFLET:

Aivlosin 42.5 mg/g oral powder for pigs

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

   
   

   Marketing authorisation holder:

   
   

   ECO Animal Health Europe Limited 6th Floor, South Bank House Barrow Street

   Dublin 4 D04 TR29 IRELAND

   
   

   Manufacturer responsible for batch release:

   
   

   Acme Drugs s.r.l.

   Via Portella della Ginestra 9/a 42025 CAVRIAGO (RE) ITALY

   
   

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

   
   

   Aivlosin 42.5 mg/g oral powder for pigs Tylvalosin (as tylvalosin tartrate)

   
   

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

   
   

   Active substance:

   Tylvalosin 42.5 mg/g.

   (as tylvalosin tartrate)

   
   

   A beige granular powder

   
   

4. INDICATION(S)

   
   

   • Treatment and metaphylaxis of swine enzootic pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae. At the recommended dose, lung lesions and weight loss are reduced but infection with Mycoplasma hyopneumoniae is not eliminated.

   • Treatment of porcine proliferative enteropathy caused by Lawsonia intracellularis.

   • Treatment and metaphylaxis of swine dysentery in herds, where the disease has been diagnosed.

   
   

5. CONTRAINDICATIONS

   
   

   None.

6. ADVERSE REACTIONS

   
   

   None known.

   
   

   If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

   
   

7. TARGET SPECIES

   
   

   Pigs.

   
   

8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

   
   

   For oral use.

   
   

   The oral powder is for use in individual pigs on farms where only a small number of pigs are to receive the treatment. Larger groups should be treated with medicated feeding stuff containing the premix.

   
   

   For treatment and metaphylaxis of swine enzootic pneumonia

   The dose is 2.125 mg tylvalosin per kg bodyweight per day in-feed for 7 consecutive days. Secondary infection by organisms such as Pasteurella multocida and Actinobacillus pleuropneumoniae may complicate enzootic pneumonia and require specific medication.

   
   

   For treatment of porcine proliferative enteropathy (ileitis)

   The dose is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.

   
   

   For treatment and metaphylaxis of swine dysentery

   The dose is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.

   
   

9. ADVICE ON CORRECT ADMINISTRATION

   
   

   This is achieved by thoroughly mixing Aivlosin into approximately 200–500 g of feed and then thoroughly mixing this pre-mixture into the remainder of the daily ration.

   
   

   Scoops of 2 sizes are provided for measuring the correct amount of Aivlosin for mixing with the daily ration, according to the schedule below. The feed containing the oral powder should be provided as the sole ration for the periods recommended above.

   
   

   The pig to be treated should be weighed and the amount of feed that the pig is likely to consume should be estimated, based on a daily feed intake equivalent to 5% of bodyweight. Consideration must be given to pigs whose daily feed intake is reduced or restricted. The correct quantity of Aivlosin

   42.5 mg/g oral powder should then be added to the estimated quantity of daily ration for each pig, in a bucket or similar receptacle, and thoroughly mixed.

   
   

   The veterinary medicinal product should only be added to dry non-pelleted feed.

   
   

   Swine enzootic pneumonia 2.125 mg/kg bodyweight
   Bodyweight range (kg)	Scoop size	Number of scoops
   7.5–12	1 ml	1
   13–25	1 ml	2
   26–38	1 ml	3
   39–67	5 ml	1
   68–134	5 ml	2
   135–200	5 ml	3
   201–268	5 ml	4

   
   

   PPE (ileitis) and swine dysentery

   4.25 mg/kg bodyweight

   Bodyweight range (kg)	Scoop size	Number of scoops
   7.5–12	1 ml	2
   13–19	1 ml	3
   20–33	5 ml	1
   34–67	5 ml	2
   68–100	5 ml	3
   101–134	5 ml	4
   135–200	5 ml	6
   201–268	5 ml	8

   NB: A level scoop of the product should be measured.

   
   

   Acute cases and severely diseased pigs with reduced food or water intake should be treated with a suitable injectable veterinary medicinal product.

   
   

   In addition to medical treatment, good management and hygiene practices should be established on the farm in order to reduce the risk of infection and to control the potential development of resistance.

   
   

10. WITHDRAWAL PERIOD(S)

    
    

    Meat and offal: 2 days.

    
    

11. SPECIAL STORAGE PRECAUTIONS

    
    

    Keep out of the sight and reach of children. Store below 30 °C.

    Keep the container tightly closed. Store in the original container.

    Shelf life after opening the immediate packaging: 4 weeks.

    Do not use this veterinary medicinal product after the expiry date stated on the label after “EXP”. Feed to which the oral powder has been added should be replaced if not consumed within 24 hours.

    
    

12. SPECIAL WARNINGS

    
    

    Special warnings for each target species:

    
    

    Acute cases and severely diseased pigs with reduced food or water intake should be treated with a suitable injectable product.

    
    

    Generally, strains of B. hyodysenteriae have higher minimal inhibitory concentration (MIC) values in cases of resistance against other macrolides, such as tylosin. The clinical relevance of this reduced susceptibility is not fully explored.

    
    

    Cross-resistance between tylvalosin and other macrolides cannot be excluded.

    Special precautions for use in animals:

    
    

    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.

    Good management and hygiene practices should be followed to reduce the risk of re-infection. 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 oral powder, 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.

    
    

    Pregnancy and lactation:

    
    

    The safety of Aivlosin during pregnancy and lactation has not been established in pigs. Use only in accordance with benefit-risk assessment by the responsible veterinarian. Laboratory studies in animals have not produced any evidence of a teratogenic effect. Maternal toxicity in rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity.

    
    

    Overdose (symptoms, emergency procedures, antidotes):

    
    

    No signs of intolerance have been observed in growing pigs at up to 10 times the recommended dose. Major incompatibilities:

    In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

    
    

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

    
    

    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

    
    

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

    
    

    ).

15. OTHER INFORMATION

Available in a sachet containing 500 g of product.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

PACKAGE LEAFLET:

Aivlosin 625 mg/g granules for use in drinking water for chickens and turkeys

(attached as concertina label directly to the immediate package or as a back label for the 400 g sachet for one language)

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

   
   

   Marketing authorisation holder:

   
   

   ECO Animal Health Europe Limited 6th Floor, South Bank House Barrow Street

   Dublin 4 D04 TR29 IRELAND

   
   

   Manufacturer responsible for batch release:

   
   

   Acme Drugs s.r.l.

   Via Portella della Ginestra 9/a 42025 CAVRIAGO (RE) ITALY

   
   

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

   
   

   Aivlosin 625 mg/g granules for use in drinking water for chickens and turkeys Tylvalosin (as tylvalosin tartrate)

   
   

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT

   
   

   Active substance:

   Tylvalosin as tartrate 625 mg/g.

   
   

   White granules.

   
   

4. INDICATION(S)

   
   

   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.

   
   

   Turkeys

   Treatment of respiratory disease associated with tylvalosin sensitive strains of Ornithobacterium rhinotracheale in turkeys.

5. CONTRAINDICATIONS

   
   

   None.

   
   

6. ADVERSE REACTIONS

   
   

   None known.

   
   

   If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

   
   

7. TARGET SPECIES

   
   

   Chickens and turkeys

   
   

8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

   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 for 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 tylvalosin-sensitive strains of 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 for 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.

   
   

9. ADVICE ON CORRECT ADMINISTRATION

   
   

   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 water and it is necessary to mix the solution for 10 minutes. After this time, any remaining cloudiness will not affect the efficacy of the veterinary medicinal 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. WITHDRAWAL PERIOD(S)

    
    

    Meat and offal: 2 days. Eggs (chicken): zero days.

    
    

    Turkeys: Not for use in birds producing or intended to produce eggs for human consumption. Do not use within 21 days of the start of the laying period.

    
    

11. SPECIAL STORAGE PRECAUTIONS

    Keep out of the sight and reach of children. 40 g sachet: do not store above 25 ºC.

    400 g sachet: do not store above 25 ºC.

    Shelf life after opening the immediate packaging: 5 weeks.

    
    

    Do not use this veterinary medicinal product after the expiry date, which is stated on the label as “EXP”.

    
    

    Shelf life of the medicated drinking water: 24 hours.

12. SPECIAL WARNINGS

    
    

    Special precautions for use in animals:

    
    

    Good management and hygiene practices should be introduced in order to reduce the risk of re- infection.

    
    

    Special warnings for each target species

    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.

    
    

    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 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.

    
    

    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 the product 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.

    
    

    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.

    
    

    Use during 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 and breeding birds producing eggs for hatching broiler stock or replacement layers.

    
    

    Overdose (symptoms, emergency procedures, antidotes):

    
    

    No signs of intolerance have been observed in poultry species at up to 150 mg tylvalosin per kg bodyweight per day for 5 days.

    
    

    No adverse effects on egg production, egg fertility, hatchability and chick viability were observed in broiler breeder stock administered 75 mg tylvalosin per kg bodyweight per day for 28 consecutive days.

    
    

    Major incompatibilities:

    
    

    In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

    
    

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

    
    

    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

    
    

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

    
    

    <date>

    
    

    ).

    
    

15. OTHER INFORMATION

Aivlosin 625 mg/g granules for use in drinking water for chickens and turkeys is available in sachets containing 40 g or 400 g. Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien

Vaccifar BVBA

Sint Damiaanstraat 18 B-2160 Wommelgem BELGIUM

Tel : +32 3 355 29 50

Email : info@vaccifar.com

Luxembourg/Luxemburg

Vaccifar BVBA

Sint Damiaanstraat 18 B-2160 Wommelgem BELGIUM

Tel : +32 3 355 29 50

Email : info@vaccifar.com