MAXUS
SUMMARY OF PRODUCT CHARACTERISTICS
Name of the veterinary medicinal product
Maxus G100 vet.
Composition
1kg of the product contains as active substance:
Avilamycin - 100g
Excipients: mineral oil and rice hulls
Pharmaceutical form
Granulated powder for peroral administration.
Pharmacological characteristics
ATC vet. code: QJ01 – antibacterial veterinary product for systemic use.
Avilamycin – oligosaccharide antibiotic. It exerts its antimicrobial effect by inhibiting protein synthesis of susceptible organisms. The spectrum of activity is primarily against Gram-positive bacteria (e.g. Clostridium perfringens, Streptococcus spp., Staphylococcus spp.) Avilamycin does not transfer cross-resistance to other micro-organisms.
Avilamycin is poorly absorbed when administered orally and the main indication of the drug is in infections of the intestinal tract.
Absorption rate in plasma is so low that it cannot be measured and a half-life cannot be calculated. Main route of excretion is via feaces.
Avilamycin and its metabolites, present in chicken manure, rapidly dissipate from soil and water (hydrolysis) and do not present a hazard to the environment.
Clinical Particulars
Target species
Broiler and replacement chickens
Indications for use specifying the target species
For the treatment of bacterial enteritis in chickens and replacements caused by microorganisms susceptible to avilamycin.
Contra-indications
No known contraindications for the use of avilamycin.
Undesirable effects (frequency and seriousness)
No undesirable effects have been reported in broiler chickens fed avilamycin at 3000 ppm for a period of 62 days.
Special precautions for use
The safety of avilamycin has not been evaluated in breeding poultry.
Use during pregnancy and lactation
Laboratory studies in mice, rats or rabbits have not produced any evidence of a teratogenic, phito-toxic or reproductive-toxic effect.
Interaction with other medicinal products and other forms of interaction
None observed.
Posology and method of administration for animals at different age
Peroral administration via feed at the dose of 10 g avilamycin per 1 ton of feed during first 2 weeks of life, dose for the treatment against necrotic enteritis is - 20 g avilamycin per 1 ton of feed (or 200 g of the product per 1 ton of feed) during 7 days.
Overdose (symptoms, emergency procedures, antidotes)
The prolonged administration of avilamycin at levels of up to 300 times the maximum proposed use level for chickens did not result in adverse clinical or toxicological effects.
Special warnings
Simultaneous use of the product with ksilazin and other drugs that that act as central nervous system depressants, (barbiturates, drugs, anesthetics, phenothiazines) may intensify the CNS depression.
Withdrawal period(s)
Withdrawal days: 0
Special precautions to be taken by the person administering the medicinal product to animals
When working with the drug you need to follow the general rules of personal hygiene and safety which are required when handling with veterinary drugs.
Pharmaceutical Particulars
Major incompatibilities
None observed
Shelf-life
2 years
Special precautions for storage
Store in dark, dry place at 15° to 25°C
Nature and contents of container
25 kg multiwall paper bags with an inner facing polyethylene coated middle ply.
6.5 Special precautions for the disposal of unused medicinal product or waste materials
Any unused product or waste material or expired product should be disposed of in accordance with national requirements.
Name or corporate name and address or registered place of business of the marketing authorization holder
Eli Lilly Regional Operations GmbH
(Elanco Animal Health)
Kölblgasse 8-10
A - 1030 Vienna
Austria
Tel. 43 711 78 316
Fax. 43 711 78 441
Name and address of manufacturer
Eli Lilly do Brasil Ltda; Divisao Elanco Saude Animal
Av. Morumbi, 8264 Sao Paulo – SP Brasil
Tel. 55 11 5532 6911