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Date: Sunday, April 21, 2024 12:14

Release 21.617
Aivlosin 42.5 mg/g Premix for Medicated Feeding Stuff for Pigs
 
Species: Pigs
Therapeutic indication: Medicinal feed additives: Antimicrobials and antimicrobials combination
Active ingredient: Tylvalosin Tartrate
Product:Aivlosin 42.5 mg/g Premix for Medicated Feeding Stuff for Pigs
Product index: Aivlosin 42.5 mg/g Premix for Medicated Feeding Stuff for Pigs
Pig - meat: and offal: 2 days
Incorporating:
Presentation
Aivlosin® 42.5 mg/g Premix for medicated feeding stuff 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 (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, caused by Brachyspira hyodysenteriae in herds where the disease has been diagnosed.
Dosage and 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 substance
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:
Dose rate (mg/kg bodyweight) x bodyweight (kg)
kg premix/tonne feed =
______________________________________
Daily feed intake (kg) x Premix strength (mg/g)
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.
A horizontal ribbon mixer should be used to incorporate the product into the feeding stuff. It is recommended that Aivlosin is first mixed into 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.
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 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.
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 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 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.
Major incompatibilities
In the absence of compatibility studies, this veterinary medical 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 medicinal product as packaged for sale: 3 years.
Shelf life after first opening of the immediate packaging: 4 weeks.
Shelf-life after incorporation into feed: 1 month in meal or pellets.
Legal category
Legal category: POM-V
Packaging quantities
2 kg, 5 kg or 20 kg.
Not all pack sizes may be marketed.
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 13277/5000
UK (NI): EU/2/04/044/001 - 20 kg
UK (NI): EU/2/04/044/002 - 5 kg
Significant changes
GTIN
GTIN description:Aivlosin 42.5 mg/g Premix for Medicated Feeding Stuff for Pigs: 5 kg
GTIN:5060162990989
GTIN description:Aivlosin 42.5 mg/g Premix for Medicated Feeding Stuff for Pigs: 20 kg
GTIN:5060162990965