Engemycin 10% Farm Pack Solution for Injection Data Sheet
Presentation
A clear, yellow aqueous solution for injection containing 100 mg per ml of oxytetracycline (as the hydrochloride). Antioxidant sodium formaldehyde sulphoxylate.
Uses
The treatment of infections caused by organisms sensitive to oxytetracycline in horses, cattle, sheep, and pigs.
In vitro, oxytetracycline is active against a range of both Gram-positive and Gram-negative micro organisms including: Streptococcus spp., Staphylococcus spp., Listeria monocytogenes, Mannheimia haemolytica, Haemophilus parahaemolyticus and Bordetella bronchiseptica, and against Chlamydophila abortus (formerly Chlamydia psittaci), the causative organism of enzootic abortion in sheep.
Dosage and administration
Engemycin 10% Farm Pack can be administered at either a low dose rate for a 24 hour duration of activity or at a high dose rate for prolonged duration of activity.
24 hour dosage regime
The recommended dosage rate is 3-10 mg/kg bodyweight (depending on age and species - see table) by intramuscular or intravenous injection. The treatment may be repeated at 24 hour intervals up to 4 times (5 treatments in all).
Intravenous injections must be given slowly over a period of at least one minute.
Prolonged action dosage regime
10 or 20 mg/kg bodyweight depending on age and species (see table) by intramuscular injection only, repeated once after 48-60 hours if required. This dosage regime is not advised for use in horses.
|
Animal | Weight Kg | 24 hour dosage | Prolonged action dosage | |
Dose mg/kg | Volume ml | Dose mg/kg | Volume ml | |
Horse Foal Cow Calf Sow/boar Pig Sheep Lamb | 500 100 500 100 150 25 50 25 | 5 10 3 8 5 8 8 8 | 25 10 15 8 7.5 2 4 2 | Not recommended Not recommended 10 20 10 20 20 20 | 50 20 15 5 10 5 | |
Prophylactic treatment of enzootic abortion in sheep
20 mg/kg administered about day 95-100 of gestation. A further treatment may be given 2-3 weeks later.
Before administration, clean the area of the injection site and swab with spirit.
Maximum recommended dose at any one site: Cattle 20 ml , sheep and pigs 10 ml.
Repeat doses should be administered at different sites, and the sites massaged well after injection.
Contra-indications, warnings, etc.
1. Do not administer to horses during concomitant therapy with corticosteroids.
2. A transient swelling may be observed following intramuscular administration in horses.
3. The use of tetracyclines during the period of tooth and bone development, including late pregnancy, may lead to discolouration.
Operator warnings
Take care to avoid accidental injection.
In case of contact with eyes or skin, wash immediately with plenty of water as irritation may occur.
Wash hands after use.
Withdrawal periods
Animals must not be slaughtered for human consumption during treatment. Animals may be slaughtered for human consumption after the number of days stated below. Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken from cows after the number of days stated below.
24 hour dose
Cattle milk | 6 days |
Cattle meat | 35 days |
Sheep | 14 days |
Pigs | 14 days |
Prolonged action dose
Cattle milk | 6 days |
Cattle meat | 21 days |
Sheep | 14 days |
Pigs | 10 days |
Not for use in sheep producing milk for human consumption.
Not for use in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.
For animal treatment only. Keep out of reach and sight 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. Keep container in outer carton.
Legal category
POM-V
Package quantities
Polyethylene terephthalate (PET) bottles containing 250 ml.
Further information
Engemycin 10% Farm Pack 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 01708/4374