Presentation
A sterile aqueous solution containing Oxytetracycline Dihydrate equivalent to 200 mg/ml Oxytetracycline base. 
Sodium Formaldehyde Sulphoxylate Dihydrate USNF 4 mg/ml as an antimicrobial preservative.

Uses

Engemycin LA is specifically formulated to provide a prolonged action resulting in sustained antibacterial activity.   Blood levels persist for at least 4 days.   After administration by the intramuscular route maximum blood levels are achieved after 4 to 8 hours making Engemycin LA suitable for the treatment of acute infections.   Oxytetracycline has been shown to be effective in vitro against the following bacterial species.

Bordetella bronchiseptica, Actinomyces pyogenes, Erysipelothrix rhusiopathiae, Escherichia Coli, Haemophilus somnus, Pasteurella haemolytica, Pasteurella multocida, Salmonella dublin, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus faecalis, Streptococcus pyogenes and Streptococcus uberis.

Engemycin LA is indicated for use in cattle, sheep and pigs in the treatment of:

Atrophic rhinitis  caused by Bordetella bronchiseptica, Pasteurella haemolytica  and Pasteurella multocida.

Navel/joint ill caused by Actinomyces pyogenes, Escherichia Coli  and Staphylococcus aureus.

Mastitis caused byActinomyces pyogenes, Escherichia Coli, Staphylococcus aureus, Streptococcus agalactiae, or Streptococcus uberis.

Metritis caused by E.coli  or Streptococcus pyogenes.

Pasteurellosis and infections of the respiratory tract caused byPasteurella haemolytica and Pasteurella multocida.

Septicaemia caused by Salmonella dublin and Streptococcus pyogenes.

Erysipelas caused by Erysipelothrix rhusiopathiae.

Engemycin LA can also be used in the control of enzootic abortion in sheep.

Dosage and administration

The recommended dosage rate is 20 mg/kg bodyweight (1 ml per 10 kg bodyweight) by deep intramuscular injection. This product is recommended for a single administration only.

Maximum recommended dose at any one site:

Cattle                            20    ml

Pigs                               10    ml

Sheep                            5     ml

Piglets   1 day                0.2   ml

7 days               0.3   ml  

14 days             0.4   ml

21 days             0.5   ml

over 21 days       1    ml/ 10 kg

An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important for small doses.

Contra-indications, warnings, etc.  

1. Engemycin LA is not recommended for use in horses, cats and dogs.
2. Not for use in animals suffering from renal or hepatic damage.
3. The use of tetracyclines during the period of tooth and bone development, including late pregnancy, may lead to tooth discolouration.
4. If concurrent treatment is administered use a separate injection site.
5. Although Engemycin LA is well tolerated, occasionally a slight reaction of a transient nature has been observed.  

Operator warnings:

Wash hands after use.   In case of contact with eyes or skin, wash immediately with water as irritation may occur.

Withdrawal periods:

Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken from cows   after 10 days from the last treatment and milk from ewes may be taken after 7 days from last treatment.

Animals must not be slaughtered for human consumption during treatment. 

Cattle may be slaughtered for human consumption only after 31 days from the last treatment.

Pigs may be slaughtered for human consumption only after 18 days from the last treatment.

Sheep may be slaughtered for human consumption only after 9 days from the last treatment.

FOR ANIMAL TREATMENT ONLY. KEEP OUT OF REACH AND SIGHT OF CHILDREN. 

Pharmaceutical precautions

Do not store above 25^oC. Protect from light.   Do not dilute Engemycin LA.

Following withdrawal of the first dose use the product within 28 days. 

When the product 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.)  Irrespective of this date, discard the product if any apparent growth or discolouration occurs.

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

Package quantities

Multidose vials of 100 ml.

Further information 

If stored as directed Engemycin LA can be expected to retain its potency for 2 years from the manufacturing date. When the vial has been broached and the contents exposed to air, the solution may darken but the potency will be unchanged.

Marketing Authorisation number

Vm 01708/4338

Marketing Authorisation holder

Intervet UK Ltd.                

Walton

Milton Keynes
Buckinghamshire MK7 7AJ

Distributed in Northern Ireland by:

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

DUBLIN 24

Date of text   preparation:

October 2006