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Date: Thursday, May 30, 2024 8:57

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.51
Apralan G200 Premix for medicated feeding stuff
 
Species: Pigs
Therapeutic indication: Medicinal feed additives: Antimicrobials and antimicrobials combination, Pharmaceuticals: Antimicrobials: Oral preparations: Others
Active ingredient: Apramycin Sulfate
Product:Apralan G200 Premix for medicated feeding stuff
Product index: Apralan G200 Premix for medicated feeding stuff
Pig - meat: 14 Days
Incorporating:
Qualitative and quantitative composition
Active substance:
Apramycin (as apramycin sulphate) 200g apramycin per kg
For a full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Premix for medicated feeding stuff.
Light tan granular free flowing premix
Clinical particulars
Target species
Apralan G200 Premix is indicated for use in young pigs.
Indications for use, specifying the target species
For the treatment and control of bacterial enteritis in young pigs caused by Escherichia coli and other apramycin sensitive organisms.
In vitro, the following organisms were susceptible to apramycin at concentrations of 16 µg/ml or less:
i) Gram-positive bacteria
Staphylococcus aureus.
ii) Gram-negative bacteria
Bordetella bronchiseptica
Escherichia coli
Campylobacter spp
Klebsiella spp
Salmonella spp
Proteus spp
Pseudomonas aeruginosa
Shigella sonnei
iii) Mycoplasma
Mycoplasma hyopneumoniae
Contraindications
Do not use in cases of known hypersensitivity to apramycin.
Do not use in cats.
Special warnings for each target species
None.
Special precautions for use
i. Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken into account when the product is used.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid inhaling the powder while preparing the medicated feed.
Avoid contact with skin and eyes. In the event of skin contact, wash thoroughly with soap and water.
In the event of accidental eye contact, wash the affected eye with fresh running water and seek medical attention if irritation persists. Wash hands after use.
Adverse reactions (frequency and seriousness)
None known.
Use during pregnancy, lactation or lay
Apralan G200 Premix is not intended for use in pregnant or lactating animals. However, laboratory studies in the rat and rabbit have not produced any evidence of a teratogenic effect.
Interaction with other medicinal products and other forms of interaction
None observed.
Amounts to be administered and administration route
For oral administration.
The dose is 4-8 mg kg bodyweight. To achieve this, thoroughly mix 0.5 kg of Apralan G200 Premix in one tonne of finished feed to provide 100 ppm apramycin activity. It is recommended to first thoroughly mix 1 part of product to 20 parts of feed (e.g. 0.5 kg of Apralan G200 Premix to 10 kg feed) before incorporation into the finished feed. The product can be incorporated into pelleted feed preconditioned with steam for up to 15 minutes at a temperature of not greater than 75°C.
The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of Apralan G200 has to be adjusted accordingly.
Feed as the only ration for a maximum of 28 days or as directed by the veterinary surgeon.
For incorporation into dry feed at the registered mill.
A manufacturer who is approved to incorporate directly at any concentration, veterinary medicinal products or premixtures containing such products must be responsible for mixing when incorporation is less than 2kg per tonne for final feed.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Groups of five male and five female four-week old pigs received apramycin ad libitum in the feed at up to 550 ppm for 28 days. No reactions were detected.
Withdrawal period(s)
Meat: 14 days
Pharmacological particulars
Pharmacotherapeutic group: Antibacterials for systemic use, Aminoglycoside antibacterials, Other amnioglycosides
ATCvet code: QJ01GB90
Pharmacodynamic properties
Apramycin is a broad-spectrum aminocyclitol antibiotic produced by a strain of Streptomyces tenebrarius. Apramycin is bactericidal at minimum inhibitory concentrations.
Apramycin is effective against both Gram-negative and Gram-positive bacteria and some strains of mycoplasma at concentrations of 16 µg/ml or less. It is effective against most field strains of Escherichia coli and salmonellae.
Pharmacokinetic particulars
The oral administration of apramycin is intended for antimicrobial activity within the gut; apramycin is poorly absorbed, particularly in older animals:
Absorption: Pigs. Nine mg of apramycin/kg bodyweight administered orally is well absorbed in 2-day old pigs, slightly absorbed in 4-week old pigs and not absorbed in 8-week old pigs. Calves: Serum levels peak at approximately 6 hours with a value of 2.4 µl/ml following oral administration of 40 mg apramycin/kg bodyweight. Duration of serum activity is between 24 and 36 hours.
Distribution, Biotransformation and Excretion: Pigs. Very little metabolism of apramycin takes place in the animal. Dosing 10 kg pigs with 14C apramycin resulted in approximately 83% being recovered from the faeces, and 4% from the urine, as 14C apramycin.
Pharmaceutical particulars
List of excipients
Pregelatinized starch
Solvent extracted soybean feed special
Incompatibilities
None known.
Shelf life
The shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after incorporation into meal or pelleted feed: 3 months.
Special precautions for storage
Bags i) and iii) Do not store above 25°C. Store in a dry place.
Bag ii) Store in a dry place.
Nature and composition of immediate packaging
Apralan G200 is presented in 5 and 25 kg packs in either of:
i) polythene lined multiwalled paper bags
ii) flexible laminate bag with aluminium foil layer
iii) polypropylene tote bags
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national requirements
Marketing Authorisation Holder (if different from distributor)
N/A
Marketing Authorisation Number
Vm 00879/4167
Significant changes
Date of the first authorisation or date of renewal
6 April 1998
Date of revision of the text
March 2010
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:Apralan G200 Premix for medicated feeding stuff
GTIN:05014602853112