1 NAME OFthe VETERINARY MEDICINAL PRODUCT FOLLOWED BY THE STRENGTH AND THE PHARMACEUTICAL FORM

Engemycin LA 200 mg/ml, solution for injection

2 NAME AND PROPORTION OF EACH ACTIVE SUBSTANCE, AND OF ANY EXCIPIENT, IF KNOWLEDGE OF THE EXCIPIENT IS NEEDED FOR SAFETY REASONS

Active substance per ml:

Oxytetracycline 200 mg

as oxytetracycline dihydrate

Antioxidant preservatives per ml:

Sodium Formaldehyde Sulphoxylate 4 mg/ml (0.4% w/v)

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Clear amber solution for injection

4 CLINICAL PARTICULARS

4.1 Target species

Cattle, sheep and pigs

4.2 Indications for use, specifying the target species

Treatment of:

Atrophic rhinitiscaused by Bordetella bronchiseptica, Mannheimia haemolytica and Pasteurella multocida.

Navel/joint illcaused by Actinomyces pyogenes, Escherichia Coli andStaphylococcus aureus.

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

Metritiscaused by E.colior Streptococcus pyogenes.

Pasteurellosis and infections of the respiratory tractcaused byMannheimia haemolytica and Pasteurella multocida.

Septicaemiacaused by Salmonella dublin and Streptococcus pyogenes.

Erysipelascaused byErysipelothrix rhusiopathiae.

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

4.3 Contra-indications

The product is not recommended for use in horses, cats and dogs.

Not for use in animals suffering from renal or hepatic damage.

4.4 Special warning for each target species

None

4.5 Special precautions for use

(i) Special precautions for use in animals

None

(ii) Special precautions to be taken by the person administering the medicinal product to the animals

Wash hands after use.

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

4.6 Adverse reactions (frequency and seriousness)

Although the product is well tolerated, occasionally a slight reaction of a transient nature has been observed.

4.7 Use during pregnancy, lactation or lay

The use of tetracyclines during the period of tooth and bone development, including late pregnancy, may lead to tooth discolouration.

4.8 Interaction with other medicinal products and other forms of interaction

None known

4.9 Amounts to be administered and administration route

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.

If concurrent treatment is administered use a separate injection site.

Do not dilute the product.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No specific treatment or antidote recommended.

4.11 Withdrawal periods for the various foodstuffs, including those for which the withdrawal period is zero

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.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Oxytetracycline belongs to the tetracycline class of antibiotics. It has a broad spectrum of activity and is active against a large number of Gram-positive and Gram-negative organisms including: Bordetella bronchiseptica, Actinomyces pyogenes, Erysipelothrix rhusiopathiae, Escherichia Coli, Haemophilus somnus, Mannheimia haemolytica, Pasteurella multocida, Salmonella dublin, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus faecalis, Streptococcus pyogenes andStreptococcus uberis.

The product is specifically formulated to provide a prolonged action resulting in sustained antibacterial activity. Blood levels persist for at least 4 days after administration by intramuscular route. Maximum blood levels are achieved between 4 and 8 hours making the product suitable for the treatment of acute infections.

ATC Vet Code: QJ01AA06

5.2 Pharmacokinetic particulars

Blood levels persist for at least 4 days after administration by the intramuscular route. Maximum blood levels are achieved between 4 and 8 hours following intramuscular administration.

6 PHARMACEUTICAL PARTICULARS

Magnesium Oxide Light

Dimethylacetamide

Sodium Formaldehyde Sulphoxylate

Disodium edetate

Water for Injection

6.2 Major incompatibilities

None known

6.3 Shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time

Shelf life: 2 years

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

6.4 Special precautions for storage

Do not store above 25^oC. Protect from light. When the vial has been broached and the contents exposed to air the solution may darken but the potency will be unchanged. Discard unused material.

6.5 Nature and composition of immediate packaging

Amber glass Type I or II (Ph Eur) vial with bromo butyl bung with aluminium overseal.

Multi-dose vials of 100 ml.

6.6 Special precautions for disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

Any unused product, or waste material should be disposed of in accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER

Intervet UK Ltd.

Walton

Milton Keynes, Bucks., MK7 7AJ

8. MARKETING AUTHORISATION Number

Vm 01708/4338

9. Date of first AUTHORISation or date of renewal of the authorisation

20 February 2006

10. Date of Revision of text

August 2006

11. Any other information required by the Secretary of State