Download ERYTHROCIN Proportioner - Veterinary Medicines Directorate

Summary of Product Characteristics
1.
Name of Veterinary Medicinal Product
Erythrocin Proportioner.
2.
Composition
g/100 g
Active ingredient:
Erythromycin phosphate
29.641
Other ingredients:
Amaranth
0.025
Benzethonium chloride (antimicrobial preservative) 12.860
3.
Pharmaceutical Form
A soluble, fine, off-white powder for dissolution in water and subsequent oral
administration.
4.
Pharmacological Properties
Erythromycin is a macrolide antibiotic with a bacteriostatic action against a
wide range of bacteria, although it also has a bactericidal action against certain
pathogenic organisms. It is highly active against gram-positive bacteria and at
low concentrations it inhibits many other types of micro-organisms. In
addition to the gram-positive bacteria, most strains of Neisseria and
Haemophilus are sensitive as are some strains of Bordetella, Brucella,
Pasteurella, Listeria, Actinomyces, Mycoplasma, Rickettsia, certain large
viruses and Treponema pallidum.
Erythromycin exerts its effect only against multiplying bacteria. It inhibits
protein synthesis by binding to 50 S ribosomal subunits of sensitive microorganisms. Certain resistant micro-organisms with mutational changes in
components of this subunit of the ribosome fail to bind the drug.
Erythromycin is absorbed rapidly when administered orally and diffusion
occurs into most tissues and fluids. Elimination of erythromycin occurs
primarily through hepatic metabolism and the remainder is excreted in active
form in the urine and bile.
5.
Clinical Particulars
5.0
Target species:
Broilers up to 6 days of age.
Birds intended as replacement layers up to 6 days of age.
Broiler-Breeders of any age.
5.1
Indications for use:
For the treatment of Chronic Respiratory Disease caused by
Mycoplasma infection.
5.2
Contra-indications:
None.
5.3
Undesirable effects:
None reported.
5.4
Special precautions for use:
The water system to which the product is added must be in good
working order and the header tanks and troughs must be free of dust,
algae or other particulate matter.
Due to a lack of information on the fate and effects of erythromycin in
the environment veterinary surgeons prescribing this product under the
cascade should satisfy themselves that there will be no adverse impact
on the environment.
5.5
Use during pregnancy and lactation:
Not applicable.
5.6
Interaction with other medicaments and other forms of interaction:
None reported.
5.7
Posology and method of administration:
For oral administration via the drinking water.
1 sachet (78 g powder) per 90 litres (20 gallons) of drinking
water (approximately 25.5 mg/Kg bodyweight per day).
To prepare the solution, slowly add the contents of one sachet
to 1.1 litres (2 pints) of clean water, stirring continuously until
completely dissolved. Set medicator to deliver 13 ml per litre
(2 fluid ounces per gallon). Medicate the drinking water
continuously for 1-5 days, depending on response.
5.8
Overdose:
No information available.
5.9
Special warnings for each target species:
None.
5.10
Withdrawal periods:
Chickens:
Eggs:
5.11
3 days.
6 days.
Special precautions to be taken by the person administering the product
to animals:
Do not eat, drink or smoke whilst preparing the formulation or while
animals are being treated.
In case of contact with the eyes, rinse immediately with clean water
and seek medical advice if irritation persists.
6.
Pharmaceutical Particulars
6.1
Incompatibilities:
None reported.
6.2
Shelf life:
5 years.
Any medicated drinking water which is not consumed within 24 hours
should be discarded.
6.3
Special precautions for storage:
Do not store above 25°C. Store in a dry place.
6.4
Nature and contents of container:
Thermofusing unit with 4 layers:
aluminium, polyethylene.
white kraft, polyethylene,
Contents = 78.0 g.
6.5
Name and address of holder of the authorisation:
CEVA Animal Health Limited
90, The Broadway,
Chesham,
Bucks,
HP5 1EG.
6.6
Special precautions for the disposal of unused product or waste
materials, if any.
Any unused product or waste material should be disposed of in
accordance with national requirements.
7.
Final information
Current Marketing Authorisation No:
Date of approval:
Date Renewal Issued:
Date this SPC modified:
15052/4001.
30th May 1996.
14th May 2002
26th November 2007