Product Description

Tylan G50 Premix is indicated for the prevention, control, and treatment of specific bacterial infections in pigs. The presence of disease in the group or flock must be established before the product is used. Use 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 considered for first-line treatment where susceptibility testing suggests the likely efficacy of this approach. Official, national and regional antimicrobial policies must be taken into account.

For Pigs:

Prevention and control of enzootic pneumonia

Treatment and control of Lawsonia intracellularis, the organism associated with Porcine Intestinal Adenomatosis (Ileitis) and Porcine Haemorrhagic Enteropathy (PHE)

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

Which Animals Can Use Tylan G50 Premix?

Tylan G50 Premix is licensed for use in pigs only. It must not be used in cases of hypersensitivity to tylosin or any of the excipients (soybean mill run, Isopar M). It is formulated exclusively for incorporation into pig feeds — it must not be used in feed for other animal species. Always use only under the direction of your vet.

Available Strengths & Sizes

Not all pack sizes may be marketed. Shelf life as packaged for sale: 2 years. Shelf life after incorporation into meal or pelleted feed: 3 months. Store in a dry place; storage temperature depends on pack type (see Storage & Handling below).

Directions for Use

Tylan G50 Premix is a prescription medication and must be used exactly as directed by your veterinary surgeon. For incorporation into dry feed at the registered mill only. The product must not be administered directly to animals. The medicated feed must be the only ration available to pigs for the entire treatment period.

Preparation: To ensure thorough dispersion, the premix must first be mixed with a small quantity of feed ingredients (20–50 kg of a suitable feed component) before incorporation into the bulk of the feed to be prepared.

Incorporation rate: Both indications are typically achieved by adding the premix at the rate of 2 kg per tonne of finished feed, giving 100 g of tylosin base per tonne.

Dosage: 3–6 mg tylosin activity per kg bodyweight per day (corresponding to 82.5–110 mg of veterinary medicinal product per kg bodyweight per day at the 2 kg/tonne incorporation rate).

Dose adjustment: 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 may need to be adjusted accordingly.

Mixing restriction: A manufacturer who is approved to incorporate veterinary medicinal products or premixtures directly at any concentration must be responsible for mixing when the incorporation rate is less than 2 kg per tonne of final feed. Incorporation at rates below 2 kg per tonne of final feed is restricted to approved manufacturers only.

Contraindications

Source: SPC Section 4.3

Do not use in cases of hypersensitivity to tylosin or to any of the excipients (soybean mill run, Isopar M)

Storage & Handling

Store in a dry place in the original sack. Storage temperature depends on pack type:

2-layer multiwalled sack: Do not store above 25°C

3-layer multiwalled sack: Do not store above 30°C

Shelf life in finished medicated feed: 3 months. Do not dispose of via wastewater; dispose of unused product and waste materials in accordance with local requirements. Keep out of the sight and reach of children.

Withdrawal period:

Pigs — Meat and offal: Zero days

Important Warnings

Source: SPC Sections 4.4, 4.5, 4.7 & 4.8

Disease must be confirmed before use: The presence of disease in the group must be established before the product is used; it must not be used in the absence of confirmed disease

First-line antibiotic choice: An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be considered for first-line treatment where susceptibility testing indicates the likely efficacy of this approach; Tylan G50 should be reserved for cases where first-line alternatives are not expected to be effective, or where susceptibility testing supports its use

Antimicrobial stewardship: Use should be based on identification and susceptibility testing of the target pathogen(s); where this is not possible, therapy should be based on farm-level or local/regional epidemiological data; official, national and regional antimicrobial policies must be followed

For pig feeds only: This product is licensed for incorporation into pig feeds only; it must not be used in feed intended for any other species

Feed mixing: To ensure thorough dispersion, the premix must first be mixed with a small quantity of feed ingredients before incorporation into the final mix; inadequate mixing may result in under-dosing in some animals and inadvertent overdosing in others

Approved manufacturer requirement: Where the incorporation rate is less than 2 kg per tonne of final feed, mixing must be carried out by a manufacturer approved to incorporate veterinary medicinal products at that concentration; this is a legal requirement

Medicated feed as sole ration: The medicated feed must be fed as the only ration for the full 21-day treatment period

Sick animals: The intake of medicated feed depends on the clinical condition of the animals; pigs with severely reduced appetite may not ingest sufficient medicated feed and may require alternative treatment approaches

Drug interactions: None known

Adverse reactions: None known in pigs

Pregnancy, lactation and lay: No adverse effects to tylosin have been seen in fertility, multi-generation, or teratology studies

Human safety — Macrolide hypersensitivity: Tylosin may induce irritation; macrolides including tylosin may cause hypersensitivity (allergy) following injection, inhalation, ingestion, or contact with skin or eyes; hypersensitivity to tylosin may lead to cross-reactions to other macrolides and vice versa; allergic reactions may occasionally be serious and therefore direct contact must be avoided; do not handle this product if you are allergic to any ingredient (including soybean products)

Human safety — Serious allergic reactions: Symptoms such as swelling of the face, lips, or eyes, or difficulty in breathing are serious and require urgent medical attention; if symptoms such as skin rash develop following exposure, seek medical advice and show the package leaflet or the label to the physician

Human safety — PPE required: To avoid exposure during preparation of the medicated feed, wear overalls, safety glasses, and impervious gloves, and wear either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator conforming to EN140 with a filter conforming to EN143

Human safety — Skin and eye contact: 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

Wash hands after use

Disposal: Do not dispose of via wastewater; dispose of unused product and waste materials in accordance with local requirements

POM-V Prescription Notice

This product is a Prescription Only Medicine — Veterinary (POM-V). It may only be supplied by a veterinary surgeon or, when prescribed by a veterinary surgeon, by a pharmacist or SQP. A valid veterinary prescription is required before this product can be dispensed.

MA Number: Vm 52127/5086