Tylan G50 Premix for Medicated Feedingstuff

Composition

Active substance:

50 g per kg Tylosin activity (as tylosin phosphate)

For a full list of excipients, see section 6.1.

6.1 List of excipients

Soybean mill run

Isopar M

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Pharmaceutical form

Premix for medicated feedingstuff.

Light tan coloured, free flowing granular material.

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Pharmacological properties

Pharmacotherapeutic group: Macrolides

ATCvet code: QJ01FA90

5.1 Pharmacodynamic properties

Tylosin is a macrolide antibiotic produced by a strain of Streptomyces fradiae. It exerts its antimicrobial effect by inhibiting protein synthesis of susceptible micro-organisms.

The tylosin spectrum of activity includes Gram-positive bacteria, some Gram-negative strains such as Pasteurella and Mycoplasma spp. at concentrations of 16µg/ml or less.

5.2 Pharmacokinetic particulars

Absorption: Tylosin reaches maximal blood levels between 1 and 3 hours after an oral dose. Minimal or no blood levels remain 24 hours after an oral dose.

Distribution: After oral doses were given to pigs, tylosin was found in all tissues, between 30 minutes and two hours after administration, except for the brain and spinal cord.

Biotransformation and Elimination: It has been shown that most of the material which is excreted is to be found in the faeces and consists of tylosin (factor A), relomycin (factor D) and dihydrodesmycosin.

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Target species

Pigs.

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Indications

For the prevention and control of enzootic pneumonia.

For the treatment and control of Lawsonia intracellularis, the organism associated with Porcine Intestinal Adenomatosis (Ileitis) and Porcine Haemorrhagic Enteropathy.

The presence of the disease in the group or flock must be established before the product is used.

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Dosage

For incorporation into dry feed at the registered mill.

A manufacturer who is approved to incorporate directly at any concentration, veterinary medicinal products or premixtures containing such products must be responsible for mixing when incorporation is less than 2kg per tonne for final feed.

For oral administration.

Prevention and control of enzootic pneumonia:

3-6 mg tylosin activity/kg bodyweight, which may normally be achieved by adding the product at the rate of 2 kg per tonne, giving 100 g tylosin base per tonne. Feed as the only ration for 21 days.

Treatment and control of Lawsonia intracellularis:

3-6 mg tylosin activity/kg bodyweight, which may normally be achieved by adding the product at the rate of 2 kg per tonne, giving 100 g tylosin base per tonne. Feed as the only ration for 21 days.

The required levels of tylosin are obtained by mixing the appropriate quantity of premix with 20-50 kg of a suitable feed component, prior to incorporation into the bulk of the feed to be prepared.

The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of the veterinary medicinal product has to be adjusted accordingly.

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Contraindications

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

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Adverse reactions

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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Use of the product should be in accordance with official, national and regional antimicrobial policies.

Special precautions for use in animals

For use in pig feeds only.

To ensure thorough dispersion of the product it should first be mixed with a small quantity of feed ingredients before incorporation into the final mix.

Use of the product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.

An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.

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

Tylosin may induce irritation. Macrolides, such as tylosin, may also cause hypersensitivity (allergy) following injection, inhalation, ingestion or contact with skin or eye. Hypersensitivity to tylosin may lead to cross reactions to other macrolides and vice versa. Allergic reactions to these substances may occasionally be serious and therefore direct contact should be avoided.

To avoid exposure during preparation of the medicated feed, wear overalls, safety glasses, impervious gloves and wear either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 with a filter to EN143. Wash hands after use.

In the event of accidental skin contact, wash thoroughly with soap and water. In case of accidental eye contact, flush the eyes with plenty of clean, running water.

Do not handle the product if you are allergic to ingredients in the product.

If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the package leaflet or the label to the physician. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.

Special precautions for the protection of the environment

Not applicable.

Other precautions

Not applicable.

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Use during pregnancy, lactation or lay

Fertility:

No adverse effects to tylosin have been seen in fertility, multi-generation or teratology studies.

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Interactions

None known.

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Overdose

Produced no adverse effects when fed to pigs at 600 ppm in the feed (six times the recommended maximum level) for 28 days.

The LD 50 for both the rat and the mouse is >6200 mg tylosin activity/kg.

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Special warnings

None.

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Withdrawal period

Meat and offal: Zero days.

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Incompatibilities

None known.

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Immediate packaging

2 kg multiwalled sack comprising two layers (outer: bleached kraft paper and inner: low density polyethylene) stitched with tape and jute/cord filler.

2 kg multiwalled sack comprising three layers (outer: bleached kraft paper, mid: kraft paper and inner: kraft paper, low density polythene, aluminium foil, low density polyethylene), with heat sealed closure.

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Storage

Bag i) (2 layered multi-walled sack) Do not store above 25°C. Store in a dry place.

Bag ii) (3 layered multi-walled sack) Do not store above 30°C. Store in a dry place.

In the finished feed the product will remain stable for three months.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after incorporation into meal or pelleted feed: 3 months.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

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

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Additional information

Vm 52127/5086

9 DATE OF FIRST AUTHORISATION

22 October 1998

10 DATE OF REVISION OF THE TEXT

April 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

Elanco GmbH

Heinz-Lohmann Strasse 4

D-27472 Cuxhaven

Groden

Germany

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