Engemycin 10% DD 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 5mg per ml.
Uses
The treatment of infections caused by organisms 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., 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
DD = dual dosage. Engemycin 10% DD 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 in large animals, subcutaneous or intramuscular injection in small animals.
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, dogs or cats.
|
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 Dog Cat | 500 100 500 100 150 25 50 25 10 5 | 5 10 3 8 5 8 8 8 10 10 | 25 10 15 8 7.5 2 4 2 1 0.5 | Not recommended Not recommended 10 20 10 20 20 20 Not recommended Not recommended | 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: 20 ml for cattle, 10 ml for sheep and pigs.
Repeat doses should be administered at different sites, and the sites massaged well after injection.
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.
Photodermatitis may occur after treatment if exposure to intense sunlight occurs.
Not for intravenous administration in dogs or cats.
It is not recommended to administer bacteriostatic and bactericidal antimicrobials concurrently.
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 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. Keep container in outer carton.
Dilution with calcium salts is not recommended as this may lead to precipitation of crystals.
When the container is broached for the first time, calculate the discard date and write this in the space provided on the label. (A statement of the in-use shelf life of the product is given on the packaging insert, from which the discard date may be calculated.)
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
This product 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.
Exercise caution in animals with renal or hepatic impairment.
Marketing Authorisation number
Vm 06376/4007
