Engemycin Spray, 25 mg/ml, Cutaneous Spray, Suspension for Cattle, Sheep and Pigs

Composition

Each ml contains:

Active substances:

23.15 mg oxytetracycline equivalent to 25.00 mg Oxytetracycline hydrochloride

Excipients:

Patent blue V (E131) 1.25 mg

For the full list of excipients, see section 6.1.

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

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Pharmaceutical form

Green to green-blue suspension

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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 positive and Gram negative bacteria including target pathogens Dichelobacter nodosus, Fusobacterium necrophorum and other Fusobacterium spp., and Bacteroides spp., Oxytetracycline is bacteriostatic and acts by inhibiting protein synthesis within the cell.

5.2 Pharmacokinetic particulars

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.

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Target species

Cattle, sheep and pigs.

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Indications

For the treatment of the following infections 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.

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Dosage

For cutaneous use.

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 veterinary medicinal 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.

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Contraindications

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

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Cattle, sheep and pigs

None known.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

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 veterinary medicinal 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 take 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 veterinary medicinal 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 veterinary medicinal product in the open air or in a well ventilated area.

Wash hands after use.

Do not eat or smoke whilst administering the veterinary medicinal product. In case of accidental ingestion or in case of contact with eyes, seek medical advice immediately and show the package leaflet or the label to the physician.

Special precautions for the protection of the environment:

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

Can be used during pregnancy and lactation.

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Interactions

None known.

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Overdose

None known.

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Special warnings

None.

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Withdrawal period

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.

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Incompatibilities

None known.

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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.

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Storage

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

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Shelf life

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

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Disposal of unused product

Medicines should not be disposed of via wastewater.

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

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Additional information

Vm 06376/5019

9 DATE OF FIRST AUTHORISATION

13 October 2009

10 DATE OF REVISION OF THE TEXT

January 2025

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ or ‘PID’ on www.gov.uk.

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Registration holder

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Netherlands

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