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Date: Sunday, April 21, 2024 11:26

Release 18.539
Aivlosin 42.5 mg/g Oral Powder for Pigs
 
Species: Pigs
Therapeutic indication: Medicinal feed additives: Antimicrobials and antimicrobials combination
Active ingredient: Tylvalosin Tartrate
Product:Aivlosin 42.5 mg/g Oral Powder for Pigs
Product index: Aivlosin 42.5 mg/g Oral Powder for Pigs
Pig - meat: and Offal: 2 days
Incorporating:
Presentation
Aivlosin® 42.5 mg/g Oral Powder for Pigs is a beige granular powder containing 42.5 mg/g tylvalosin (as tylvalosin tartrate).
Uses
Treatment and metaphylaxis of Swine Enzootic Pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae in pigs. 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 in herds where there is a diagnosis based on clinical history, post-mortem findings and clinical pathology results.
Treatment and metaphylaxis of Swine Dysentery, caused by Brachyspira hyodysenteriae in herds where the disease has been diagnosed.
Dosage and administration
For in-feed use.
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 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.
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 should 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
NB: A level scoop of the product should be measured.
PPE (ileitis) and Swine Dysentery - 4.25 mg/kg bodyweight
Bodyweight range (kg)
Scoop size
Number of scoops
7.5 - 12
1ml
2
13 - 19
1ml
3
20 - 33
5ml
1
34 - 67
5ml
2
68 - 100
5ml
3
101 - 134
5ml
4
135 - 200
5ml
6
201 - 268
5ml
8
NB: A level scoop of the product should be measured.
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 potential build up of resistance.
Overdose
No signs of intolerance have been observed in growing pigs at up to 10 times the recommended dose.
Contra-indications, warnings, etc
Withdrawal Period
Meat and Offal: 2 days
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. 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.
Special warnings for each target species
Acute cases and severely diseased pigs with reduced food and water intake should be treated with a suitable injectable veterinary medicinal 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 in the SPC 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 medical 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.
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Pharmaceutical precautions
Store below 30°C.
Keep the container tightly closed.
Store in the original container.
Shelf life of the veterinary product as packaged for sale: 3 years.
Shelf life after first opening of the immediate packaging: 4 weeks.
Feed to which the oral powder has been added should be replaced if not consumed within 24 hours.
Legal category
Legal category: POM-V
Packaging quantities
500 g.
Scoops of 1 ml and 5 ml are attached.
Further information
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
UK(GB): Vm 13277/5001
UK(NI): EU/2/04/044/013
Significant changes
GTIN
GTIN description:Aivlosin 42.5 mg/g Oral Powder for Pigs
GTIN:5060162990972