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Date: Saturday, May 18, 2024 23:00

Description: Huvepharma
Release 4.67
Apravet 100g/kg Medicated Feed Premix for Pigs
 
Species: Pigs
Therapeutic indication: Medicinal feed additives: Antimicrobials and antimicrobials combination
Active ingredient: Apramycin Sulfate
Product:Apravet 100g/kg Medicated Feed Premix for Pigs
Product index: Apravet 100g/kg Medicated Feed Premix for Pigs
Pig - meat: 1 day
Incorporating:
Qualitative and quantitative composition
Each kg contains:
Apramycin sulfate 100 g, equivalent to apramycin 100,000,000 IU
Pharmaceutical form
Premix for medicated feeding stuff. Light brown granules.
Clinical particulars
Target species
Pigs
Indications for use
Treatment and metaphylaxis of bacterial enteritis caused by micro-organisms susceptible to apramycin such as Escherichia coli.
Contra-indications
Do not use in the cases of hypersensitivity to apramycin or any of the excipients.
Do not use in animals suffering from kidney disorders.
Do not use in cats.
Special warnings for each target species
The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of feed animals should be treated parenterally.
The use of the product should be combined with good management practices e.g. good hygiene, proper ventilation, no overstocking.
Special precautions for use
Special precautions for use in animals
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.
Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Use of the veterinary medicinal product deviating from the instructions given in the Summary of Product Characteristics may increase the prevalence of bacteria resistant to the apramycin and may decrease the effectiveness of treatment with aminoglycosides due to the potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to apramycin should administer the product with care.
During preparation and administration of the medicated feeding stuff, skin, eye and oral contact with the product, as well as inhalation of dust, should be avoided. Wear a protective suit, gloves and an appropriate dust mask (either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator conforming to European Standard EN140 with a filter to EN 143) when mixing and handling the product. Wash any contaminated skin. Wash hands carefully with soap and water after handling of the product. In the event of accidental ingestion, seek medical assistance immediately and show the package label.
Adverse Reactions
None known.
Use during pregnancy, lactation or lay
Laboratory studies have not produced evidence of teratogenic, foetotoxic or maternotoxic effects.
The use is not recommended in pregnant or lactating sows.
Interactions
In certain conditions with a high degree of humidity there might be an apparent interaction with lectins. Aminoglycosides may have a negative influence on the kidney function. The administration of these agents to animals suffering from renal impairment or in combination with agents that also affect renal function may therefore present a risk of intoxication.
Do not administer with other aminoglycosides due to their nephrotoxic potential. Aminoglycosides may cause neuromuscular blockade. It is therefore recommended to take such an effect into account when anaesthetising treated animals.
Amounts to be administered and administration route
The dosage is 4000-8000 IU/kg of bodyweight per day (equivalent to 4-8 g of the product per 100kg of body weight per day).
Administer as the sole feeding stuff for at least 21 days.
It is recommended to mix the required quantity of the product with a small amount of feed (20 – 50 kg) before mixing it in the total volume.
The consumption of the medicated feed may depend of the clinical condition of the animals. In order to guarantee a correct dosing, the concentration of the product in the feed should be adjusted accordingly.
To adjust dosing properly following calculation can be used:
....g product/kg b.w./day x average b.w. of pigs (kg)
Average daily intake of feed (kg/animal)
= ...g of the product/kg of feed
Medicated feed may be pelleted using a pre-conditioning step for 5 minutes at a temperature not exceeding 85°C.
Overdose
A single 100 fold overdosing in 5 pigs did not result in any mortality.
A 25 to 50 fold overdosing for 28 days, did not provoke any toxic effect.
Withdrawal periods
Meat and offal: 1 day
Pharmacological particulars
Pharmacotherapeutic group: intestinal antiinfectives, antibiotics.
ATCvet code: QA07AA92
Pharmacodynamic properties
As an aminoglycoside antibiotic apramycin binds to the 30S ribosomal subunit and interferes with the protein synthesis. Through mechanisms not yet completely elucidated, it acts on the cell wall and is bactericidal. The overall spectrum includes many aerobic or facultative anaerobic Gram-negative bacteria, including Enterobacteriaceae. It has no activity against anaerobic bacteria or under anaerobic conditions.
Susceptibility of the E. coli strains from pigs to apramycin can vary geographically and over time.
The most important mechanism of resistance against apramycin is the production of modifying enzymes that are usually encoded by resistance genes derived from plasmids. Depending on their spectrum, these enzymes may cause cross-resistance between aminoglycosides. Resistance may also be caused by a change of the ribosomal attachment sites, or the conveying system allowing the penetration of the cell.
Until harmonised international interpretative criteria relevant for susceptibility testing are available for apramycin, nationally approved and validated methods should be followed.
Resistance mechanisms: Different aminoglycoside 3-N acetyltransferase enzymes (AAC-3) have been related with resistance to apramycin. These enzymes confer different cross-resistance against other aminoglycosides. Apramycin resistance can be influenced by co-selection (resistance to apramycin has been described to be located in the same mobile genetic element that other resistant determinants in Enterobacteriaceae) and cross resistance (e. g. with gentamicin).
Resistance developed by chromosomal resistance is minimal for most of the aminoglycosides.
Pharmacokinetic properties
The oral administration of apramycin is intended for antimicrobial activity within the gut; apramycin is poorly absorbed, but absorption may be increased in young animals and in animals with disrupted intestinal barrier.
Apramycin is excreted in its active form via the kidney.
Pharmaceutical particulars
Excipients
Starch, pregelatinised
Wheat meal
Major incompatibilities
In absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary products.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening the immediate packaging: 6 months
Shelf life after incorporation into meal feed: 3 months
Shelf life after incorporation into pelleted feed: 1 month
Special precautions for storage
Veterinary medicinal product as packaged for sale: Do not store above 25°C. Store in the original package. Protect from moisture.
Veterinary medicinal product after first opening of the immediate packaging: Do not store above 25°C.
Medicated feed (mashed and pelleted): Do not store above 25°C.
Immediate packaging
Polyethylene-lined multiple-layer paper bags of 1 kg, 5 kg and 20 kg.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium
Marketing Authorisation Number
Vm 30282/4019
Significant changes
Date of the first authorisation or date of renewal
14th August 2013
Date of revision of the text
July 2018
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Apravet 100g/kg Medicated Feed Premix for Pigs
GTIN:20 kg bags 5414916910202
GTIN description:5kg bags 5414916910561
GTIN:1kg bag 5414916910158