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.

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.

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 horses intended for human consumption.

Not for use in sheep producing milk for human consumption.

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.

Legal category

POM-V

Package quantities 
Glass bottles or polyethylene terephthalate (PET) bottles containing 100 ml.

Further information 

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

Marketing Authorisation holder

Intervet International B.V., Boxmeer, Holland

Represented by:

IntervetUK Ltd.                

Walton

Milton Keynes

Buckinghamshire MK7 7AJ

Distributed in Northern Ireland by:

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin24 

Date of preparation:

August 2006