TYLOPLUS 20%

200 mg/g, oral powder for pigs and chickens (broilers)

Indications

For the treatment and metaphylaxis of respiratory disease in chicken flocks, associated with Mycoplasma gallisepticum and M. synoviae.

For the treatment and metaphylaxis of respiratory disease in pig herds, associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.

COMPOSITION

Active substance:

Tilmicosin phosphate 200 mg/g

Excipients:

Dextrose monohydrate 800 mg/g

CONTRAINDICATIONS

Do not allow horses and other equines access to drinking water containing tilmicosin.

Do not use in case of hypersensitivity to tilmicosin or to any of the excipients.

ADVERSE REACTIONS

None known.

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Pigs: 8-20 mg active substance/kg body weight/day, equivalent to 40-100 mg Tyloplus 20% /kg body weight /day, for 7 to10 days.

WEIGHT CATEGORY	10-20 kg	21-40 kg	41-60 kg	61-80 kg	81-100 kg	Sows and gilts before mating
Daily Water Requirement	1-2 L	2-4 L	4-5 L	5-6 L	6-7 L	7-8 L
Tyloplus 20% (g /1000 L water)	1000 g	1000 g	1100 g	1300 g	1400 g	1700 g

Chickens (broilers): 10-25 mg active substance/kg body weight/day, equivalent to 50-125 mg Tyloplus 20% /kg body weight /day, for 3-5 days.

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CATEGORY	Broiler 0 – 14 days	Broiler 15 - 28 days	Broiler 29 - 35 days
Tyloplus 20% (g /1000 L water)	300 g	600 g	750 g

The product will be administered orally in drinking water or in the liquid feed.

To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing/overdosing.

ADVICE ON CORRECT ADMINISTRATION

The treatment consists of oral administration of Tyloplus 20%, to individual or to the groups in drinking water, in different doses depending on the species, age, body weight, clinical condition and health. It will not be administered for more than 21 days.

WITHDRAWAL PERIODS

Meat and offal:

Pigs: 12 days.

Chickens (broilers): 14 days.

Not authorised for use in birds producing eggs for human consumption.

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children. Do not store above 25°C. Store in the original package. Do not refrigerate or freeze. Store in a dry place.

Protect from direct sunlight. Do not use this veterinary medicinal product after the expiry date which is stated on the label.

SHELF-LIFE

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

Shelf life after first opening the immediate packaging: 28 days.

Shelf life after reconstitution into drinking water: 24 hours.

SPECIAL WARNINGS

Special precautions for use in animals

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

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to tilmicosin and may decrease the efficacy of the treatment with antimicrobials from the macrolide group due to cross-resistance.

Ingestion of the medicated water may be decreased depending on the clinical condition of the animal. In case of insufficient ingestion of the medicated water, the treatment schedule will be reviewed. Medicated water must be renewed every 24 hours.

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

Tilmicosin may induce irritation following inhalation or eye contact. Appropriate protective measures must be taken during administration.

To avoid exposure during the administration of the product wear protective glasses and mask. In case of accidental eye contact, rinse the eyes thoroughly with clean running water immediately.Do not eat, drink or smoke when handling this product.

In case of accidental ingestion seek medical advice and show the package leaflet to the physician

Use during pregnancy, lactation or lay

Do not use in birds producing eggs for human consumption.

Do not use pregnant or lactating animals.

Interaction with other medicinal products and other forms of interaction

None known.

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

No symptoms were reported in case of overdose.

Major incompatibilities

Do not mix in food containing bentonite. Bentonite may affect the effectiveness of tilmicosin.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.

PRESENTATION/PACKAGE

Laminated foil PET/low density polyethylene bags of 50 g, 100 g, 1 kg and 5 kg.