Company name: MSD Animal Health

Address: Walton Manor

Walton

Milton Keynes

MK7 7AJ

Telephone: 01908 685685 (Customer Support Centre)

Fax: 01908 685555

Email: vet-support.uk@merck.com

Website: www.msd-animal-health.co.uk

Presentation

A sterile aqueous solution containing Oxytetracycline Dihydrate equivalent to 200 mg/ml Oxytetracycline base.

Sodium Formaldehyde Sulphoxylate 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 shown to be effective in vitro against the following bacterial species.

Bordetella bronchiseptica, Actinomyces pyogenes, Erysipelothrix rhusiopathiae, Escherichia coli, Haemophilus somnus, Mannheimia 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 B. bronchiseptica, M. haemolytica and P. multocida.

Navel/joint ill caused by A. pyogenes, E. coli and S. aureus.

Mastitis caused by A. pyogenes, E. coli, S. aureus, S. agalactiae, or S. uberis.

Metritis caused by E. coli or S. pyogenes.

Pasteurellosis and infections of the respiratory tract caused by M. haemolytica and P. multocida.

Septicaemia caused by S. dublin and S. pyogenes.

Erysipelas caused by E. 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	1.0 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, dogs and cats.

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 warning

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 240 hours (10 days) from the last treatment and milk from ewes may be taken after 168 hours (7 days) from the 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°C. Protect from light. Do not dilute Engemycin LA.

Following withdrawal of the first dose use the product within 28 days. Keep container in outer carton.

When the vial is broached and the contents exposed to air the solution may darken but the potency will be unchanged.

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.)

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging 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 manufacture date. When the vial has been broached and the contents exposed to air, the solution may darken but the potency will be unchanged.