SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Engemycin Spray, 25mg/mL, cutaneous spray, suspension for cattle, sheep and pigs

ES: TENICOL, 25 mg/ml, suspensión para pulverización cutánea para bovino, ovino y porcino

FR: Engémycine S, 3.84% w/w, cutaneous spray, suspension for cattle, sheep and pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each mL contains

Active substance:

Oxytetracycline hydrochloride 25.00 mg

(equivalent to oxytetracycline 23.15 mg

Excipients:

Patent blue V (E131) 1.25 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Cutaneous spray, suspension

Green to green-blue suspension

4. CLINICAL PARTICULARS

4.1 Target species

Cattle, sheep and pigs

4.2 Indications for use, specifying the target species

For the treatmentof the followinginfections caused by, or associated with, organisms sensitive to oxytetracycline in cattle, sheep and pigs:

• Treatment of foot infections caused in particular by: Dichelobacter nodosus, Fusobacterium necrophorum and other Fusobacterium spp., and Bacteroides spp.

• Supporting treatment of superficial wound infections following surgery or physical injuries, e.g., tail biting in pigs, scratches and abrasions.

4.3 Contraindications

Do not use for treatment of teats in order to prevent the product from getting into milk.

Do not use in animals in cases of hypersensitivity to oxytetracycline or to any of

the excipients.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

i) Special precautions for use in animals

The animals should be treated in a well ventilated area.

Do not spray in or near the eyes.

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

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

Because of the risk of sensitisation and contact dermatitis, the user should avoid skin contact. Wear appropriate impermeable gloves whilst handling the product.

Because of risk of eye irritation, contact with the eyes should be avoided.

Protect the eyes and face.

Do not spray on a naked flame or any incandescent material.

Do not pierce or burn the container, even after use.

Avoid inhaling vapours.

Apply the product in the open air or in a well ventilated area.

Wash hands after use.

Do not eat or smoke whilst administering the product.

In case of accidental ingestion or in case of contact with eyes, seek medical advice immediately and show the label to the physician.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

For topical use only.

Shake well before use. The spray container is suitable to be used in upright and inverted positions. Before application properly clean the surface to be treated, spray the product for 1-2 seconds, at a distance of 15-20 cm, until the area has a homogeneous colour. Repeat the treatment every 12 hours for 1 to 3 days, depending on the healing process.

To achieve the best results in case of pedal lesions the following instructions are recommended:

• fully clean the foot area, completely removing foreign material, exudates and necrotic tissue

• keep the animal on dry ground for 12 hours after each application.

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

None known.

4.11 Withdrawal period(s)

Cattle, sheep:

Meat and offal: Zero days

Milk: Zero hours

Pigs:

Meat and offal: Zero days

Stained part of the pig skin must be removed prior to the rest of the animal being used for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: antibiotics for topical use, tetracyclines

ATCvet code: QD06AA03

5.1 Pharmacodynamic properties

Oxytetracycline is produced by fermentation of Streptomyces rimosus.

It possesses broad spectrum antimicrobial activity against a wide range of Gram +ve and Gram -ve bacteria including target pathogens Dichelobacter nodosus, Fusobacterium necrophorumand other Fusobacteriumspp., and Bacteroidesspp.,.

Oxytetracycline is bacteriostatic and acts by inhibiting protein synthesis within the cell.

When administered topically, oxytetracycline absorption is negligible and the drug comes into direct contact with bacteria on the skin and in superficial lesions on external body surfaces. The marker dye indicates the extent of the treated area.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Patent Blue V (E131)

Polysorbate 80

Isopropyl alcohol

Mixture of hydrocarbons on butane basis (n-butane. isobutane, propane), with denaturant

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

6.4. Special precautions for storage

Pressurised container: protect from sunlight and do not expose to temperatures exceeding 50°C.Keep away from sources of ignition - No smoking.

6.5 Nature and composition of immediate packaging

Pressurised lacquered aluminium spray container containing in each 200 ml pack 5 g oxytetracycline hydrochloride and a blue colourant. The spraying valve consists of lacquered tinplate and different plastic materials and enables the container to be operated in upright and inverted positions.

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

8. MARKETING AUTHORISATION NUMBER

Vm 01708/4545

9. DATE OF FIRST AUTHORISATION

13 October 2009

10 DATE OF REVISION OF THE TEXT

September 2014

Approved: 25/09/2014