Company
Engemycin 5% Solution for Injection Data Sheet
Presentation
An injectable clear, yellow aqueous solution containing 50 mg per ml of oxytetracycline (as the hydrochloride). Antioxidant sodium formaldehyde sulphoxylate.
Uses
The treatment of infections caused by bacteria sensitive to oxytetracycline in horses, cattle, sheep, pigs, dogs and cats.
In vitro, oxytetracycline is active against a range of both Gram-positive and Gram-negative micro-organisms including Streptococcus spp., Staphylococcus spp, L. monocytogenes, P. haemolytica, H. parahaemolyticus and B. bronchiseptica.
Dosage and administration
Large animals 3 - 10 mg oxytetracycline per kg bodyweight (depending on age and species - see table) by intramuscular or intravenous injections. Small animals 10 mg oxytetracycline per kg bodyweight by subcutaneous or intramuscular injection.
Animal | Dose Rate(mg/kg) | Weight (kg) | Dose Volume (ml) |
Horse | 5 | 500 | 50 |
Foal | 10 | 100 | 20 |
Cow | 3 | 500 | 30 |
Calf | 8 | 100 | 16 |
Sow/boar | 5 | 150 | 15 |
Pig | 8 | 25 | 4 |
Sheep | 8 | 50 | 8 |
Lamb | 8 | 25 | 4 |
Dog | 10 | 10 | 2 |
Cat | 10 | 5 | 1 |
Maximum recommended dose at any one site 20 ml. Clean the area of the injection site and swab with spirit. The treatment may be repeated at 24 hour intervals up to 4 times (5 treatments in all). Repeat doses should be administered at different sites and the sites massaged well after injection. Intravenous injections must be given slowly over a period of at least one minute.
Contra-indications, warnings, etc.
- Do not administer to horses during concomitant therapy with corticosteroids.
- A transient swelling may be observed following intramuscular administration in horses and subcutaneous administration in dogs.
- The use of tetracyclines during the period of tooth and bone development, including late pregnancy, may lead to discolouration.
Operator warnings:
Care should be taken to avoid self-injection.
Wash hands after use.
Withdrawal periods:
Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken only from cows only after 6 days from the last treatment.
Animals must not be slaughtered for human consumption during treatment.
Cattle may be slaughtered for human consumption only after 35 days from the last treatment.
Sheep and pigs may be slaughtered for human consumption only after 14 days from the last treatment.
Not to be used in sheep producing milk for human consumption.
Not to be used in horses intended for human consumption.
For animal treatment only. Keep out of reach of children.
Pharmaceutical precautions
Do not store above 25°C. Protect from light. Do not freeze.
Following withdrawal of the first dose use the product within 28 days. Dilution with calcium salts is not recommended as this may lead to precipitation of crystals.
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
Legal category
POM-V
Package quantities
Glass bottles or polyethylene terephthalate (PET) bottles containing 100 ml.
Further information
Engemycin 5% has been specifically formulated to reduce pain on injection without the need for addition of a local anaesthetic.
As with other tetracyclines, caution should be exercised in treating horses under stress.
Marketing Authorisation number
Vm 06376/4006
Marketing Authorisation holder
Intervet International B.V., Boxmeer,Holland
Represented by:
IntervetUK Ltd.
Walton
Milton Keynes
Buckinghamshire MK7 7AJ
Date of preparation
April 2005
Distributed in Northern Ireland by:
Intervet Ireland Ltd.
Cookstown
Tallaght
Dublin24